Fed. Reg. Notices — Final rule

BILLING CODE 4810-02-P DEPARTMENT OF THE TREASURY Fiscal Service 31 CFR Part 356 [Docket No. BPD GSRS 06-02] Sale and Issue of Marketable Book-Entry Treasury Bills, Notes, and Bonds—Customer Confirmation Reporting Requirement Threshold Amount AGENCY: Bureau of the Public Debt, Fiscal Service, Treasury. ACTION: Final rule. SUMMARY: The Department of the Treasury (“Treasury,” “We,” or “Us”) is issuing in final form an amendment to 31 CFR part 356 (Uniform Offering Circular for the Sale and Issue of Marketable Book-Entry Treasury Bills, Notes, and Bonds) that raises the customer confirmation reporting requirement threshold amount from $500 million to $750 million.

Beginning on December 31, 2006, any customer awarded a par amount of $750 million or more in a Treasury marketable securities auction must send us a confirmation of its awarded bid(s) by 10 a.m. on the day following the auction. This final rule also clarifies that customer confirmations may now be sent by e-mail as well as by fax or hand delivery. DATES: *Effective Date:* January 1, 2007. ADDRESSES: You may download this final rule from the Bureau of the Public Debt's Web site at *http://www.treasurydirect.gov* or from the Electronic Code of Federal Regulations (e-CFR) Web site at *http://www.gpoaccess.gov/ecfr.* It is also available for public inspection and copying at the Treasury Department Library, Room 1428, Main Treasury Building, 1500 Pennsylvania Avenue, NW., Washington, DC 20220.

To visit the library, call

(202)622-0990 for an appointment. FOR FURTHER INFORMATION CONTACT: Lori Santamorena (Executive Director) or Chuck Andreatta (Associate Director), Bureau of the Public Debt, Government Securities Regulations Staff,

(202)504-3632 or e-mail us at *govsecreg@bpd.treas.gov.* SUPPLEMENTARY INFORMATION: The Uniform Offering Circular (UOC), in conjunction with the announcement for each auction, provides the terms and conditions for the sale and issuance in an auction to the public of marketable Treasury bills, notes and bonds. 1 Since 1992 Treasury has required customers 2 awarded a par amount of $500 million or more in a Treasury marketable securities auction to provide a written confirmation of their awarded bids, including the name of the submitter that submitted the bids on their behalf. 3 The confirmation must also include a statement with certain information related to the customer's net long position. 4 The confirmation must be sent no later than 10 a.m. on the day following the auction. According to the UOC, the confirmation must be in writing and signed by the customer or by an authorized representative. 5 In addition, since November 2005, we have permitted customers to e-mail us their confirmations. 1 The Uniform Offering Circular was published as a final rule on January 5, 1993 (58 FR 412). The circular, as amended, is codified at 31 CFR part 356. A final rule converting the UOC to plain language and making certain other minor changes was published in the **Federal Register** on July 28, 2004 (69 FR 45202). 2 “Customer” is defined in the UOC as a bidder that directs a depository institution or dealer to submit or forward a bid for a specific amount of securities in a specific auction on the bidder's behalf. See § 356.2. 3 Department of the Treasury, Securities and Exchange Commission and Board of Governors of the Federal Reserve System Joint Report on the Government Securities Market, pp. 7-8. (January 1992). See also § 356.24(d). 4 See § 356.24(d)(2). 5 If an authorized representative signs the confirmation, it must include the capacity in which the representative is acting. The customer confirmation requirement helps prevent large, false (unauthorized) customer bids from being awarded securities in an auction. On May 3, 2006, Treasury announced that it was contemplating changes to the customer confirmation requirement and cited the fact that the reporting threshold has never been changed despite changes in average auction sizes and transaction volumes. 6 On August 2, 2006, Treasury announced that, beginning on December 31, 2006, the customer confirmation reporting requirement threshold amount will be raised from $500 million or more to $750 million or more. 7 We are raising the threshold amount to reduce the regulatory burden on customers complying with this requirement, since auction offering amounts, on average, are substantially higher than they were when the requirement was first implemented. 6 See Quarterly Refunding Statement by Emil W. Henry, Jr., Assistant Secretary for Financial Institutions (May 2006). 7 See Quarterly Refunding Statement by Emil W. Henry, Jr., Assistant Secretary for Financial Institutions (August 2006). We are also adding e-mail into the UOC as an acceptable method for customers to send confirmations. This addition supports our goal of allowing securities auction transactions to be conducted with us electronically whenever possible. We are not making any changes to the requirement that a submitter or intermediary submitting bids for a customer notify the customer of the confirmation requirement if its auction awards are equal to or greater than the threshold. Also, no change is being made to the information that is required on the confirmation and the deadline for us to receive it. This final rule will be effective for all marketable Treasury securities auctions occurring after December 31, 2006. Procedural Requirements This final rule is not a significant regulatory action for purposes of Executive Order 12866. The notice and public procedures requirements of the Administrative Procedure Act do not apply, under 5 U.S.C. 553(a)(2). Since a notice of proposed rulemaking is not required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ) do not apply. The Office of Management and Budget previously approved the collections of information in this final amendment in accordance with the Paperwork Reduction Act under control number 1535-0112. We are not making substantive changes to these requirements that would impose additional burdens on auction bidders. List of Subjects in 31 CFR Part 356 Bonds, Federal Reserve System, Government securities, Securities. For the reasons stated in the preamble, 31 CFR part 356 is amended as follows: PART 356—SALE AND ISSUE OF MARKETABLE BOOK-ENTRY TREASURY BILLS, NOTES, AND BONDS (DEPARTMENT OF THE TREASURY CIRCULAR, PUBLIC DEBT SERIES NO. 1-93) 1. The authority citation for part 356 continues to read as follows: Authority: 5 U.S.C. 301; 31 U.S.C. 3102 *et seq.* ; 12 U.S.C. 391. 2. Revise § 356.24

(d)to read as follows: § 356.24 Will I be notified directly of my awards and, if I am submitting bids for others, do I have to provide confirmations?

(d)*Customer confirmation.* Any customer awarded a par amount of $750 million or more in an auction must send us a confirmation in written form or via e-mail containing the information in paragraphs (d)(1) and

(2)of this section. The confirmation must be sent no later than 10 a.m. on the day following the auction. If sent in written form, the confirmation must be signed by the customer or authorized representative. Confirmations sent by e-mail must be sent by the customer or authorized representative. Confirmations signed or sent by an authorized representative must include the capacity in which the representative is acting. A submitter or intermediary submitting or forwarding bids for a customer must notify the customer of this reporting requirement if we award the customer $750 million or more as a result of those bids. The information the customer must provide is:

(1)A confirmation of the awarded bid(s), including the name of the submitter that submitted the bid(s) on the customer's behalf, and

(2)A statement indicating whether the customer had a reportable net long position as defined in § 356.13. If a position had to be reported, the statement must provide the amount of the position and the name of the submitter that the customer requested to report the position. Dated: December 12, 2006. Donald V. Hammond, Fiscal Assistant Secretary. [FR Doc. E6-21668 Filed 12-19-06; 8:45 am] BILLING CODE 4810-39-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [CGD 07-05-156] RIN 1625-AA08 Special Local Regulation; Annual Gasparilla Marine Parade, Hillsborough Bay, Tampa, FL AGENCY: Coast Guard, DHS. ACTION: Final rule. SUMMARY: The Coast Guard is amending the permanent special local regulation for the Annual Gasparilla Marine Parade, Hillsborough Bay, and Tampa Bay, FL. This rule will change the date of the event from the first weekend in February to the last weekend in January. Additionally, this regulation will create a parade staging area and a 50 foot safety zone around officially entered parade boats during the parade. This action is necessary because the date on which the parade is held annually has changed. Restricting access to the parade staging area box is necessary to ensure the official parade boats are properly lined up to begin the parade. A 50 foot safety zone around officially entered parade boats is necessary to ensure the safety of the parade participants due to safety concerns caused by an increasing number of spectator vessels that gather to watch the parade. DATES: This rule is effective January 19, 2007. ADDRESSES: Comments and material received from the public, as well as documents indicated in this preamble as being available in the docket, are part of [CGD 07-05-156] and are available for inspection or copying at Coast Guard Sector St. Petersburg, Prevention Department, 155 Columbia Dr. Tampa, Florida 33606-3598 between 7:30 a.m. and 3:30 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: LT Ronaydee Marquez at Coast Guard Sector St. Petersburg

(813)228-2191, Ext. 8307. SUPPLEMENTARY INFORMATION: Regulatory Information On July 7, 2006 we published a notice of proposed rulemaking

(NPRM)entitled Special Local Regulation; Annual Gasparilla Marine Parade in the **Federal Register** (71 FR 38561). We received no letters commenting on the proposed rule. No public meeting was requested, and none was held. Background and Purpose The Annual Gasparilla Marine Parade is currently held annually on the first Saturday in February and is governed by a permanent regulation published at 33 CFR 100.734. The Annual Gasparilla Marine Parade has been moved permanently to the last Saturday in January. Law enforcement officials have also identified a need for a parade staging area for vessels officially entered in the parade. This area will prohibit vessels not officially entered in the parade from entering the area and allow for the lineup of official boats prior to the start of the parade. Law enforcement personnel also identified a need for a 50 foot safety zone around all official parade boats during the parade due to safety concerns associated with an increased number of spectator vessels that gather to watch this parade. Discussion of Comments and Changes No comments were received for this rule. Discussion of Rule This rule is necessary to accommodate the change in the date of the event, to create a parade staging area, and to create a 50 foot safety area around all official parade boats. This regulation will change the enforcement date from the first Saturday in February to the last Saturday in January. It will also prohibit vessels not officially entered in the parade from entering the parade staging area and prohibit vessels from entering within 50 feet of all officially entered parade boats during the parade without prior permission of Coast Guard Sector St. Petersburg. Regulatory Evaluation This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. The short duration of this regulation would have little, if any economic impact. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will effect the following entities, some of which may be small entities: The Owners or operators of vessels intending to transit or anchor in a portion of Hillsborough Bay and its tributaries north of a line drawn along latitude 27°51′18″ (Coordinates Referenced Datum: NAD 83). The amendments to the current existing regulation will not have a significant economic impact on a substantial number of small entities for the following reasons. This rule will be enforced for only 5.5 hours a year. Before the effective period, we will issue maritime advisories widely available to users of the waterway. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). Collection of Information This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. Civil Justice Reform This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Protection of Children We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children. Indian Tribal Governments This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Energy Effects We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. Technical Standards The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( *e.g.,* specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this rule under Commandant Instruction M16475.lD and Department of Homeland Security Management Directive 5100.1, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969

(NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(h), of the Instruction, from further environmental documentation. As a special local regulation issued in conjunction with a marine parade, this rule satisfies the requirements of paragraph (34)(h). Under figure 2-1, paragraph (34)(h), of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule. List of Subjects in 33 CFR Part 100 Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows: PART 100—MARINE EVENTS & REGATTAS 1. The authority citation for part 100 continues to read as follows: Authority: 33 U.S.C. 1233; Department of Homeland Security Delegation No. 0170.1. 2. Revise § 100.734 to read as follows: § 100.734 Annual Gasparilla Marine Parade; Hillsborough Bay, Tampa, FL.

(a)*Regulated Area* . A regulated area is established consisting of all waters of Hillsborough Bay and its tributaries north of 27°51′18″ north latitude and south of the John F. Kennedy Bridge. The regulated area includes the following in their entirety: Hillsborough Cut “D” Channel, Seddon Channel, and the Hillsborough River south of the John F. Kennedy Bridge. All coordinates referenced use datum: NAD 83.

(b)*Special local regulations.*

(1)Entrance into the regulated area is prohibited to all commercial marine traffic from 9 a.m. to 2:30 p.m. EST on the day of the event.

(2)The regulated area is a “no wake” zone.

(3)All vessels within the regulated area shall stay 50 feet away from and give way to all officially entered vessels in parade formation in the Gasparilla Marine Parade.

(4)When within the marked channels of the parade route, vessels participating in the Gasparilla Marine Parade may not exceed the minimum speed necessary to maintain steerage.

(5)Jet skis and vessels without mechanical propulsion are prohibited from the parade route.

(6)Northbound vessels in excess of 80 feet in length without mooring arrangements made prior to the date of the event are prohibited from entering Seddon Channel unless the vessel is officially entered in the Gasparilla Marine Parade. All northbound vessels in excess of 80 feet without prior mooring arrangements and not officially entered in the Gasparilla Marine Parade must use the alternate route through Sparkman Channel.

(7)Vessels not officially entered in the Gasparilla Marine Parade may not enter the Parade staging area box within the following coordinates: 27°53′53″ N 082°27′47″ W 27°53′22″ N 082°27′10″ W 27°52′36″ N 082°27′55″ W 27°53′02″ N 082°28′31″ W

(c)*Enforcement Period* . This section will be enforced from 9 a.m. until 2:30 p.m. EST, annually on the last Saturday in the month of January. Dated: November 9, 2006. D.W. Kunkel, RADM, U.S. Coast Guard, Commander, Seventh Coast Guard District. [FR Doc. E6-21645 Filed 12-19-06; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF THE INTERIOR National Park Service 36 CFR Part 7 RIN 1024-AD45 Dry Tortugas National Park—Special Regulations AGENCY: National Park Service, Interior. ACTION: Final rule. SUMMARY: This rule will delete obsolete regulations; limit the area, extent and methods of recreational fishing within portions of the park's boundaries; implement a Research Natural Area (RNA); clarify the Superintendent's authority to regulate fishing, boating, and permitted activities; regulate vessel operation, anchoring and human activity; provide enhanced protection for shipwrecks consistent with State and Federal law; and restrict discharges into park waters. Definitions have also been added to clarify terminology. DATES: *Effective Dates:* This rule is effective January 19, 2007. FOR FURTHER INFORMATION CONTACT: Superintendent, Everglades and Dry Tortugas National Parks, 40001 SR 9336, Homestead, FL 33034. E-mail: *ever_superintendent@nps.gov*

(305)242-7710. SUPPLEMENTARY INFORMATION: Background On April 7, 2006, the NPS published in the **Federal Register** proposed special regulations for Dry Tortugas National Park. (71 FR 17785). Previous regulations pertained to Fort Jefferson National Monument. The Monument was established by a presidential proclamation in 1935 for the purpose of preserving the Dry Tortugas group of islands within the original 1845 federal military reservation of islands, keys, and banks. In 1980, Congress legislatively affirmed the Fort Jefferson National Monument. In 1992, Congress enacted Public Law 102-525 (16 U.S.C. 410xx *et seq.* ) abolishing the Fort Jefferson National Monument and establishing Dry Tortugas National Park in its place. Congress established the park “to preserve and protect for the education, inspiration and enjoyment of present and future generations nationally significant natural, historic, scenic, marine, and scientific values in South Florida.” In addition, Congress directed the Secretary of the Interior to manage the park for the following specific purposes, including:

(1)To protect and interpret a pristine subtropical marine ecosystem, including an intact coral reef community.

(2)To protect populations of fish and wildlife, including (but not limited to) loggerhead and green sea turtles, sooty terns, frigate birds, and numerous migratory bird species.

(3)To protect the pristine natural environment of the Dry Tortugas group of islands.

(4)To protect, stabilize, restore and interpret Fort Jefferson, an outstanding example of nineteenth century masonry fortification.

(5)To preserve and protect submerged cultural resources.

(6)In a manner consistent with paragraphs

(1)through

(5)above to provide opportunities for scientific research. (16 U.S.C. 410xx-1(b)). The NPS developed the Final General Management Plan Amendment/Environmental Impact Statement (FGMPA/EIS), approved through a Record of Decision

(ROD)in July 2001, to comply with its statutory mandate to manage and protect Dry Tortugas National Park, and to respond to pressures from increased visitation and over-utilization of park resources. As described in the FGMPA/EIS, there were indications that, despite the park's remote location approximately 70 miles west of Key West, Florida, rapidly increasing visitor use was negatively impacting the resources and values that make Dry Tortugas National Park unique. Visitation to Dry Tortugas National Park increased 400 percent from 1994 through 2000, going from 23,000 to 95,000 annual visitors. The resources and infrastructure at the park could not sustain a growth rate of this magnitude while ensuring protection of park resources consistent with the park's legislative mandate. Scientific studies documented significant declines in the size and abundance of commercially and recreationally important fish species, particularly snapper, grouper, and grunts in Dry Tortugas National Park. These declines threaten the sustainability of reef fish communities both within the park and throughout the Florida Keys. Studies demonstrate that both fish size and abundance in the Tortugas area, including Dry Tortugas National Park, are essential to spawning and recruitment for regional fish stocks and the multi-billion dollar fishing and tourism industry in the Florida Keys. The population of South Florida is projected to increase from its current level of 6.3 million people to more than 12 million by 2050. With continued technological innovations such as global positioning systems and larger, faster vessels, the increase in population and recreational tourism will result in more pressure on the resources in the Tortugas area. In recent years, interest has grown in the commercial sector to provide increased transportation to the park and to conduct additional activities in the park, which would bring many more visitors and greater impacts to park resources. A plan was started in 1998 to address pressures and update the 1983 Fort Jefferson National Monument General Management Plan. At that time, park managers placed a moratorium on the authorization of any new commercial activity in the park until an FGMPA/EIS could be completed and implemented that would adequately protect park resources. The FGMPA/EIS addressed specific issues including:

(1)Protection of near-pristine resources such as coral reefs and sea grasses;

(2)protection of fisheries and submerged cultural resources;

(3)management of commercial services; and

(4)determination of appropriate levels and types of visitor use. After extensive public involvement and collaboration with state and federal agencies, the NPS selected a management alternative that affords a high level of protection to park resources as well as providing for appropriate types and levels of high quality visitor experiences. This will be accomplished by establishing management zones and visitor carrying capacity limits for specific locations in the park, using commercial services to direct and structure visitor use, and instituting a permit system for private as well as commercial boats. A research natural area

(RNA)will encompass a 46 square-mile area protecting a representative range of terrestrial and marine resources that will ensure protection of spawning fish and fish diversity and protect near-pristine habitats and processes to ensure high quality research opportunities. This rule prohibits extractive activities in the RNA, including fishing. A range of recreational and educational opportunities will be available for visitors as long as appropriate resource conditions are maintained. The quality of visitor experiences will be enhanced by maintaining the quality of resources while expanding visitor access throughout the park. Summary of Public and Agency Involvement for the Final General Management Plan Amendment and the Proposed Rule This rule is the culmination of an extensive general management planning process for Dry Tortugas National Park that began in 1998. NPS planning was undertaken concurrently and collaboratively with planning by the National Oceanic and Atmospheric Administration (NOAA), the Florida Fish and Wildlife Conservation Commission (FWC), and the Gulf of Mexico Fisheries Management Council (GMFMC), leading to establishment of the Tortugas Ecological Reserve

(TER)in the Florida Keys National Marine Sanctuary (FKNMS) adjoining the park. To assist in developing alternatives for the TER, NOAA established a 25-member Working Group composed of commercial and recreational fishermen, divers, scientists, non-governmental organizations and other concerned citizens, stakeholder representatives, FKNMS Advisory Council members, and federal and state government representatives charged with resource management authority in the Tortugas area. The Working Group used an “ecosystem approach,” recommending alternatives based on natural resources rather than jurisdictional boundaries. The NPS and FWC participated in the Working Group that gathered ecological and socio-economic information through two public meetings, a site characterization document, and the firsthand experiences of commercial and recreational fishermen and others. To maximize public participation in the park and the sanctuary planning, the NPS and FKNMS held 5 joint scoping meetings in the fall of 1998. To gain additional information, in 1999, the NPS and NOAA asked the National Research Council of the National Academy of Sciences to examine the utility of marine reserves and protected areas for conserving fisheries, habitats, and biological diversity. The Council's report, Marine Protected Areas: Tools for Sustaining Ocean Ecosystems, endorsed the increased use of “no-take” reserves, in concert with conventional management approaches, as a tool for managing ocean resources. In May 1999, the Working Group reached consensus on proposed boundaries for the TER and a proposed no-fishing zone inside Dry Tortugas National Park. All public and agency comments were considered by the NPS and incorporated into the issues and alternatives evaluated in the draft GMPA and EIS. In June 2000, the NPS and FKNMS released their draft management plans for public review and held 6 joint public hearings with the FWC and the GMFMC. Comments on the draft GMPA were overwhelmingly supportive of establishing the RNA. Out of 6,104 comments received, 97% supported the prohibition of extractive activities in this area. All public and agency comments were carefully considered by the NPS and the proposed action was modified in several areas in response to the comments. In January 2001, the Dry Tortugas National Park FGMPA was made available to the public. The NPS received several hundred letters from citizens and organizations reflecting a variety of viewpoints about the FGMPA. The NPS carefully considered all comments including those for and against prohibiting recreational fishing in the proposed RNA. On July 27, 2001, the Secretary of the Interior approved the FGMPA, and the Record of Decision was signed. In announcing approval of the plan, the Secretary stated, “This plan has been developed with broad public outreach and a great deal of participation with the State of Florida, fishing organizations and interest groups. * * * My goal for this plan in the future is that recreational and commercial fishermen will see more and bigger fish, more conch and lobster in Florida Bay and the Straits of Florida, as a result of the critical spawning and marine nurseries we are protecting in the park.” Additional details on public involvement for the FGMPA are included in the ROD which may be viewed or downloaded from the park's Web site at *http://www.nps.gov/drto/parkmgmt/index.htm.* During the preparation of the FGMPA, the State of Florida indicated to the NPS and DOI that it claimed title to submerged lands located within Dry Tortugas National Park. These lands are also claimed by the United States. Rulemaking to implement the FGMPA was delayed pending resolution of this issue. Rather than addressing this issue through potentially protracted litigation, the State and DOI entered into a “Management Agreement for Certain Submerged Lands in Monroe County, Florida, Located within Dry Tortugas National Park” that was approved by the Florida Governor and Cabinet on August 9, 2005 and by the Secretary of the Interior on December 20, 2005. This rule is consistent with the requirements of that agreement which stipulates that the NPS shall submit proposed regulations to the FWC for review and obtain the concurrence of the Board of Trustees of the Internal Improvement Trust Fund of the State of Florida (Governor and Cabinet) regarding that portion of the regulations pertaining to the management of submerged lands within the park. The Governor and Cabinet received comments from a variety of recreational fishing organizations, conservation groups, elected officials, state and federal agencies, and interested parties prior to approving the agreement. The August 9th meeting was publicly noticed and received statewide media coverage. The management agreement may be viewed or downloaded from the park's Web site at *http://www.nps.gov/drto/parkmgmt/index.htm* . A Florida Department of Environmental Protection

(FDEP)statement on the approval of the management agreement is available on its Web site at *http://www.dep.state.fl.us/secretary/news/2005/08/0809_01.htm.* The FWC reviewed the proposed regulations at public meetings in Key Largo, Florida on December 1, 2005 and in Gainesville, Florida on February 2, 2006. The FWC received comments from a variety of recreational fishing organizations, conservation groups, elected officials, State and Federal agencies, and interested parties at these meetings. The FWC approved the proposed regulations at its February 2, 2006 meeting and described the rationale for this action on its Web site at *http://myfwc.com/whatsnew/06/statewide/tortugas.html.* The FWC meetings were announced in advance and received statewide media coverage. On April 5, 2006, the DOI announced publication of the NPS draft special regulations in the **Federal Register** and the initiation of a 60-day public comment period. The press release and the April 7, 2006 **Federal Register** notice invited public comments by mail, e-mail, fax, or in person at a May 17, 2006, public meeting in Key Largo, Florida. On May 11, 2006, the NPS issued a press release seeking comments at the May 17, 2006, meeting. The release was also distributed by electronic mail to more than 500 individuals and organizations on the park's mailing list. Articles announcing the meeting date, location, and how to submit comments were published in the *Miami Herald* and *Florida Keys Keynoter.* Forty-three

(43)people attended the meeting. The NPS received 5,238 responses, including letters, e-mails, and verbal comments during the comment period that closed on June 6, 2006. Ninety-nine percent of the respondents supported NPS implementation of the proposed RNA. The FWC reviewed and approved this final rule, and the NPS obtained the concurrence of the Governor and Cabinet at their November 14, 2006 meeting. This concurrence is for an initial five year period at which time their approval of the rule is again required. The Governor and Cabinet received public comments prior to taking their action. The management agreement also provides that the NPS and the State will work together to implement a research and monitoring program for the park's marine ecosystem, to coordinate this work with similar efforts by the FKNMS, and to provide a status report on the fisheries and activities at least every five years to the Board of Trustees. To further this effort, NPS and the FWC will shortly enter into a joint agreement for cooperative research within the Park and the RNA and to establish measures for evaluating the effectiveness and performance of the RNA. The regulations will be reviewed at least every five years, and as appropriate, revised and reissued based upon the results of the research program and information contained in the status report. Information and data collected regarding the effectiveness and performance of the RNA will also be reviewed and evaluated, and adjustments to the RNA will be undertaken, as appropriate. Any future revisions to these regulations will include opportunities for public review and comment during the rulemaking process. Summary of Comments—Introduction The proposed rule was published for public comment on April 7, 2006, with the comment period lasting until June 6, 2006. The NPS received 5,238 comments regarding the proposed rule, including letters, e-mails, and verbal comments given at a May 17, 2006 public meeting in Key Largo, Florida. Of the total, 63 are original comments and 5175 were form letters supporting implementation of the regulations and the RNA. These comments have been analyzed using a process called “content analysis.” Content analysis is a systematic process of compiling and categorizing public viewpoints and concerns. A goal of the process is to identify all relevant issues, not just those represented by the majority of respondents. The NPS has carefully considered all comments received and in some cases adopted suggestions made. The comments and reasons for accepting or rejecting them are included below. General Overview of Public Comments Research Natural Area

(RNA)• Ninety-nine percent of all commenters supported NPS implementation of a RNA zone. Reasons cited were: —To protect nationally significant corals and benthic habitats —To protect habitats for endangered sea turtles, birds and other species —To replenish depleted fish stocks and protect biological diversity —To achieve park purpose to protect a pristine, intact marine ecosystem —To allow comparative studies in a non-manipulated marine ecosystem —Population pressure and threats to the ecosystem are increasing —The science used in RNA decision making was sound —The RNA will help support fishing/tourism economy of the Florida Keys —Public involvement for the FGMPA and proposed regulations was inclusive, collaborative and adequate • One percent of respondents opposed NPS implementation of the RNA. Reasons cited were: —The science used in RNA decision-making was inadequate —The resources in the Tortugas area (corals and fish stocks) are in good condition —Commercial fishing in the Tortugas area causes far more damage to fish stocks than recreational fishing —Commercial fishing in the Tortugas area should be banned if NPS wants to improve fish stocks —Existing regulations, size and bag limits will adequately protect fish stocks —The RNA will increase fishing pressure on areas remaining open to fishing —The RNA will unnecessarily restrict public access and fishing opportunities in the park —Public involvement for the proposed regulations was inadequate Response to Specific Comments *Comment #1:* The NPS does not have the authority and jurisdiction to issue regulations for Dry Tortugas National Park marine resources because the United States does not have jurisdiction of the submerged lands and waters beyond Duck Key. *NPS Response:* The NPS disagrees. Congress established the present boundary of Dry Tortugas National Park in 1992 (Pub. L. 102-525). The NPS Organic Act (16 U.S.C. 1) authorizes the “NPS to promote and regulate the use of the Federal area know as national parks * * * which purpose is to preserve the scenery and the natural and historic objects and the wildlife therein * * * and to leave unimpaired for the enjoyment of future generations.” Further, 16 U.S.C. 3 authorizes the Secretary of the Interior to make and publish rules and regulations deemed necessary or proper for the use and management of the parks; and 16 U.S.C. 1a-2(h) specifically authorizes the Secretary to promulgate and enforce regulations concerning boating and other activities on or relating to waters within park boundaries. With respect to submerged lands, in August 2005, the U.S. Department of the Interior and the State of Florida entered into a management agreement acknowledging each other's claim to ownership of certain submerged lands within the park. The State and the DOI mutually agreed that the submerged lands will be managed by the NPS consistent with the authorized purpose of the park in the 2001 GMPA. Finally, NPS regulations expressly apply to waters within park boundaries subject to the jurisdiction of the United States without regard to the ownership of submerged lands. *Comment #2:* The NPS should eliminate the rule that states that all fishing gear must be stowed and unavailable when traveling within the RNA zone. This is an impractical rule for most open fishing boats. *NPS Response:* The regulation assures consistency with the immediately adjacent FKNMS Tortugas Ecological Reserve and maintains the integrity of the purpose of the RNA. The NPS agrees that for smaller boats with limited space that the removal of hooks and lures is impractical. The NPS therefore adopts verbatim the FKNMS's definition of “not available for immediate use.” The definition allows for the stowage of unbaited fishing rods in rod holders. *Comment #3:* The science used in the RNA decision-making is inadequate because the methodology, assumptions, and data are flawed and the scientists who did the studies are biased and inexperienced in fishing and fish habits. *NPS Response:* The NPS disagrees with these views. The original scientific studies that support the habitat protection and fisheries management recommendations for the Tortugas region are described in a detailed 1999 report entitled Site Characterization for the Dry Tortugas Region that was jointly commissioned by the NPS and the FKNMS. This report included extensive information on oceanography/water currents, coral reefs/benthic communities, as well as the fisheries essential habitats of the Tortugas region (Schmidt et al. 1999). (An extensive discussion was also included in the NPS 2001 ROD.) The specific studies of Tortugas reef fish communities and their associated benthic habitats were initially compiled in 1999 and 2000 by an inter-disciplinary team of scientists from the National Undersea Research Center (UNC), the University of Miami's Rosenstiel School of Marine and Atmospheric Sciences, the National Marine Fisheries Service (NMFS), and the Florida Wildlife Research Institute (FWRI). This team of Federal, State, and university scientists have extensive experience in marine ecology/oceanography, fisheries management, and coral reef ecosystems based on their work throughout Florida and the Caribbean, and their site-specific studies over the last 2-3 decades in the Florida Keys and Tortugas region. The methodology and results of these scientific studies have been published in numerous scientific journals and have undergone independent scientific peer review. The fish survey methodology (underwater direct visual fish counts) that has been used is designed specifically for assessing coral reef fish stocks (Bohnsack and Bannerot 1986). The Dry Tortugas National Park field sampling plan was devised specifically for the park (Ault et al. 2003). This methodology has undergone extensive design analysis and has been shown to be highly effective and is used around the world. The data analyses and fish stock assessments use standard statistical methods and well-accepted scientific methodologies. All of these methodologies have undergone multiple independent expert scientific reviews through publications in scientific journals. The NPS intends to continue its collaboration with NOAA, FWC, and the other federal and state agencies working in the FKNMS, and to specifically have the Dry Tortugas science program included in the planned independent scientific peer review efforts of the FKNMS Science Program. The lead scientists who designed and conducted the Dry Tortugas National Park coral reef fishery assessment studies are PhD-level senior marine scientists from the University of Miami and the NMFS. They worked with a broad team of scientists from the FWC, the FKNMS, and many other agencies and universities. This team of scientists has many years of experience in coral reef ecology and fishery biology and have worked on fisheries projects throughout the Florida Keys and Tortugas region. The methodology and results have been presented in numerous peer reviewed scientific publications on south Florida coral reef ecology and fishery biology. Most of these scientists also live in the south Florida area and have been engaged in recreational fishing in the Florida Keys for decades. The two lead NPS marine scientists working on the Dry Tortugas National Park science programs also have advanced degrees in marine science and extensive work experience (i.e., M.S. in fishery biology, and PhD in coral reef fish ecology along with 25-30 years experience working in Florida and Caribbean marine ecosystems). *Comment #4:* The science used in RNA decision-making is inadequate because the NPS does not conduct fish counts at Dry Tortugas National Park. *NPS Response:* The NPS does conduct fish counts at Dry Tortugas National Park, using a combination of fishery dependent surveys (angler interviews) and fishery independent surveys (direct visual fish counts). The NPS periodically interviews anglers at the dock on Garden Key, recording catch information (called creel or fishery [angler] dependent surveys). As part of these creel surveys, the NPS asks where anglers caught their fish, the number of people involved, and the duration of their fishing activities. This information allows NPS to estimate the fishing catch per unit effort

(CPUE)for a series of spatially distributed fishing zones across the park. The Dry Tortugas creel survey data collected between 1980-1984 and 2000-2004 were analyzed and compared by Ault et al.

(2006)to determine any trends over time. This analysis found that gray snapper and grunt catch per unit effort

(CPUE)declined between the two periods, suggesting that these species may have experienced long term decline in abundance in the park. The NPS acknowledges that the Dry Tortugas National Park creel survey is not as extensive as that in Everglades National Park because of the logistical problems of collecting such data in the Tortugas region. The NPS is addressing these limitations by designing a more effective Dry Tortugas National Park creel survey and recreational fishing guide reporting system. The NPS also has had extensive park-wide underwater visual direct counts of the important game fish species and other coral reef fishes done regularly since 1999 (including the years 1999, 2000, 2002, 2004, and 2006). This method has been analyzed by marine fisheries experts and was determined to be a more effective method of defining reef fish abundance than a creel survey. The results of these counts and other fish data are used by fisheries managers to calculate indicies to gauge the health of a fishery. One index is a spawning potential ratio

(SPR)for each harvested species. The SPR is a fishery index, developed by NMFS, and is used to estimate the overall reproductive health of fish species and to estimate the impacts of overfishing. A historical study of the SPR of 35 commercially and recreationally important fish species found in the Tortugas region indicates that 13 of 16 grouper species, 7 of 13 snapper species, one wrasse, and 2 of 5 grunt species were found to be below the 30 percent SPR threshold, and are considered overfished by federal standards (Ault et al. 1998). The overall health of the Tortugas fishery as well as the health of its associated coral reefs and other benthic communities formed the primary basis of the scientific recommendation to implement the RNA within Dry Tortugas National Park. *Comment #5:* The Research Natural Area is not needed because resources in the Dry Tortugas area (coral reefs, fisheries) are in good shape. Fish stocks are not overfished. *NPS Response:* The NPS believes that the marine ecological resources (i.e., coral reefs and fisheries) within Dry Tortugas National Park are not “in good shape.” The coral reef fish stocks are well documented and are considered to be overfished based on U.S. Government standards (Ault et al. 2002, Ault et al. 2006). The most recent reef game fish stock assessment, using data collected from the park in 1999-2004, concluded that 17 of 18 grouper and snapper species are overfished, based on their spawning potential ratio (Ault et al. 2006). The park's coral reefs, which are an essential habitat for reef game fish, have similarly experienced substantial declines in the last 30 years. The substantial decline in stony corals, highlighted by the recent listing of the major reef forming Acropora spp. as a threatened species, is one of the most ecologically significant resource stewardship challenges in the park. For example, there were 1180 acres of staghorn coral dominating reefs in the park in 1976 (Davis 1982); however, it is estimated that there are currently, at most, only a few acres of live staghorn thickets left at Dry Tortugas National Park, a greater than 99% loss. The largest acreage of staghorn loss has occurred inside the proposed RNA. The stony coral cover on Bird Key Reef has decreased by over 75% from 1975 to 2005 (W. Jaap, FWC pers. comm.; Beaver et al. 2006). From 1999 to 2004, there was a greater loss in stony coral cover in the Tortugas region than in the rest of the Florida Keys (W. Jaap, FWC pers. comm.). When implemented, the Dry Tortugas RNA will allow NPS to better understand the linkages between recreational fishing and stock depletion, as well as fishery productivity and the coral reef environment. The combination of deep-water habitats in the TER and the shallow water habitats in the RNA should provide for long-term sustainability and productivity of the important game fish species as well as their associated coral reef environments. This was the major justification that the FWC and the Florida Department of Environmental Protection identified when they stated their support for implementing the Dry Tortugas RNA. *Comment #6:* Commercial fishing in the Tortugas area causes far more damage to fish stocks than recreational fishing and should be prohibited around DRTO, if the NPS wants to improve fish stocks. *NPS Response:* Commercial fishing within Dry Tortugas National Park has been prohibited since the original Fort Jefferson National Monument was created in 1935. Since the NPS does not have jurisdiction in the rest of the Tortugas region, this is an issue that NOAA, NMFS, and FWC would need to evaluate. There have been a number of Federal and State actions to limit the impact of commercial fishing in the Tortugas region. In 2001, NOAA prohibited commercial fishing in the TER. However, the TER does not include the important shallow reef habitats critical to many reef game fishes, which would be protected by the proposed RNA. The State of Florida has also outlawed fish traps, and NOAA does not allow fish traps in the Tortugas region. NOAA began a 10-year phase out of fish traps in the Gulf of Mexico in 1997 which will prohibit the use of fish traps throughout the Gulf in 2007. Shrimp trawls are also prohibited in coral reef areas. There are several lines of evidence indicating that recreational fishing does impact fishery stocks in the Tortugas and Florida Keys. A Tortugas coral reef fish stock assessment (Ault et al. 2002) concluded that “The Dry Tortugas National Park fishery for many reef fish stocks is in worse shape than the surrounding broader Tortugas region.” This suggests that recreational fishing is a factor because there has been no commercial fishing in the park since 1935. NMFS has conducted stock assessments for several reef game fishes distinguishing between commercial and recreational effects of landings and bycatch mortality based on landings statistics (SEDAR 2001-2005). These assessments found that for many reef species in the Florida Keys, recreational anglers extract more fish that commercial fishers. Recreational fishing in the park for spiny lobster in the 1960's and early 1970's caused a documented depletion in lobster abundance and a 58% decline in catch rates in the park (Davis 1977, Davis and Dodrill 1980). In response, the NPS closed the park to lobster harvesting in 1974. Finally, the NPS believes that additional protection from increased recreational fishing activities in the Tortugas region is needed because the fishery pressure is expected to greatly increase, because the south Florida population is projected to nearly double by 2050. Studies have shown that the number of registered boat owners in south Florida has grown at a very high rate over the last two decades, while commercial fishing pressures have remained relatively flat during this same period. This again suggests that increased pressure from recreational fishing is a significant factor in the sustainability of the Tortugas fishery. *Comment #7:* Existing regulations and size and bag limits will adequately protect fish stocks. *NPS Response:* Although current recreational fishing regulations are beneficial, they have not been sufficient to sustain this important fishery or to achieve the high standards of ecosystem protection required by the NPS Organic Act and the Dry Tortugas National Park enabling legislation. The well-documented condition of the Tortugas fishery and associated coral reef habitats indicates that additional protective actions are required. No-take marine reserves are commonly implemented for fishery and ecosystem protection and recovery, in addition to ongoing measures including bag limits, size limits, quotas, and gear restrictions. The U.S. Coral Reef Task Force (USCRTF) states that marine reserves are the most powerful tool for conservation of coral reef ecosystems (USCRTF 2002). Similarly, the National Research Council's 2000 review of marine protected areas endorsed the increased use of no-take marine reserves in concert with conventional management approaches (Marine Protected Areas, Tools For Sustaining Ocean Ecosystems. National Academy Press). *Comment #8:* The no-take RNA will increase fishing pressure on areas remaining open to fishing. *NPS Response:* The NPS disagrees with this assumption and believes that the focus should be more on the overall condition of reef game fish stocks and the health of the fishery in areas remaining open to recreational or commercial fishing. A growing number of scientific studies suggest that the ecological effect of implementing no-take marine reserves results in an increase in the abundance and size of target fishery species within areas adjacent to reserves, and thus helps sustain adjacent fisheries, due to a net export of these species from the reserve (also known as “spillover effects”). A 2001 “Scientific Consensus Statement On Marine Reserves And Marine Protected Areas” signed by 161 marine scientists states, “In the few studies that have examined spillover effects, the size and abundance of exploited species increase in areas adjacent to reserves.” (National Center for Ecological Analysis and Synthesis 2001). More recent scientific studies on coral reef fisheries have shown that marine reserves have enhanced adjacent fisheries, including greater fish biomass (i.e., more and/or larger fish), higher catch, increased catch rate, and reduced fishing effort (McClanahan and Mangi 2000, Roberts et al. 2001, Galal et al. 2002, Russ et al. 2003, Russ et al. 2004). DRTO plans to conduct similar scientific studies to assess the spillover effects of the RNA. Even with RNA implementation, the vast majority of the Tortugas area, and 54% of the park will remain open to recreational fishing. *Comment #9:* The RNA will unnecessarily restrict public access and fishing opportunities in the park. *NPS Response:* The NPS disagrees. A variety of recreational and educational opportunities will be available to visitors in the RNA including boating, swimming, snorkeling, scuba diving, wildlife viewing, and scientific research. Fishing will not be allowed in the RNA in order to protect important nursery areas that will help produce greater abundance and diversity of fish. Mooring buoys will be installed to provide private and tour boat access to snorkel and dive sites while protecting corals, shipwrecks, and other sensitive resources from anchor damage. Allowing non-consumptive uses in the RNA, with careful monitoring of impacts of these activities, will provide exceptional resource appreciation and public education benefits. It will also enable the NPS to meet its statutory obligation to “protect and interpret a pristine subtropical marine ecosystem, including an intact coral reef community.” Fifty-four percent of park waters will remain open for recreational fishing including the natural/cultural zone (50 square miles), five of the park's seven islands, and the historic/adaptive use zone surrounding Garden Key and Fort Jefferson (4 square miles). This includes the overnight anchorage and shallows around Garden, Bush, and Long Keys where angling for permit and tarpon is popular. Visitor studies conducted by the NPS in 1995 and 2002 found that while the majority of visitors (78%) did not fish on their visit to the park, it is an important activity for those who do. The areas most heavily fished were a circular area extending 1 mile in radius outwards from Garden Key (64% of all trips) and the southwestern quarter of the park (57%), and these areas will remain open to recreational fishing. Private boaters often fish the anchorage adjacent to Fort Jefferson and the flats surrounding the nearby keys. Fishing from the dock and shoreline of Garden Key is popular with visitors arriving by ferry or seaplane. The areas open for fishing includes 56% of the park's seagrass meadows and 28% of park waters less than 6 feet deep. Significant large areas adjacent to the park also remain open for recreational fishing. They include the southern half of the Tortugas Banks (west of the park), the waters south and east of the park, and the popular king-fishing area northeast of the park. These areas were excluded from the FKNMS TER in order to protect fishing interests in the region. NPS recognizes that some of the private and charter recreational fishing that formerly occurred in the RNA will relocate to other areas within and outside the park. The scientific literature and FKNMS experience with no-take zones strongly suggests that the fishing experience outside the RNA will be enhanced in the future as fish populations increase in size and number as a result of establishing zones dedicated to improving the spawning and juvenile populations. The presence of substantially larger fish should benefit trophy fishing in park waters adjacent to the RNA. These larger fish could also leave the RNA and be caught by recreational or commercial fishermen outside the park. *Comment #10:* Public involvement for the proposed regulations was inadequate. *NPS Response:* Public involvement in the Dry Tortugas National Park GMPA and the proposed regulations has been both extensive and inclusive as described in the background section above. *Comment #11:* To better protect elkhorn coral ( *Acropora palmate* ) and staghorn coral ( *Acropora prolifera* ) patches special protection zones, the NPS should: A: Close the 5 Foot Channel and install closure/marker buoys a sufficient distance inshore (toward the Fort) in 5 Foot Channel and on Long Key-Bird Key forereef near the entrance of 5 Foot Channel. *NPS Response:* NPS agrees, and this closure will be implemented. B: Delineate the zones with marker buoys rather than rely on boaters to determine if they are 100 yards away from the patches. *NPS Response:* NPS agrees, and the zones will be appropriately marked. C: Prohibit aircraft from taxiing, landing, or taking off within the special protection zones. *NPS Response:* NPS agrees. This rule has been revised to read “a landing or takeoff may not be made * * * within five hundred

(500)feet of any closed area.” This includes all special protection zones. D: Include information on threatened status of elkhorn and staghorn corals in the Section by Section analysis paragraph (c). *NPS Response:* NPS agrees and has modified the Section-by-Section Analysis to include this information. *Comment #12:* NPS should prohibit anchoring in rubble bottom anywhere in the park because of potential negative impacts to corals, especially elkhorn and staghorn corals recently listed as threatened species under the Endangered Species Act, and to other ecological resources. Only anchoring in sand bottom should be permitted. Mooring buoys should be installed to facilitate access to coral areas without damage. *NPS Response:* This rule has been revised deleting any reference to anchoring on rubble bottom. More specifically, the definition of the “designated anchorage” has been revised to read: “ *Designated anchorage* means any area of sand within one nautical mile of the Fort Jefferson Harbor Light.” The rule is now consistent with the anchoring provisions applicable in the FKNMS. NPS will make installation of mooring buoys on the Long Key-Bird Key Reef a priority. However, boats will still be able to anchor on sand bottom on the portion of this reef that is in the designated anchorage around Garden Key. NPS will provide educational material to inform boaters of anchoring locations on the reef so as to minimize the ecological effects of anchoring damage and identify reef areas to avoid. NPS will monitor and assess the ecological effects of anchoring on the Long Key-Bird Key Reef and adaptively manage visitor use to minimize ecological impacts. *Comment #13:* The nurse shark mating area between Long Key and the elkhorn coral ( *Acropora palmata* ) patch should be a seasonally closed special protection zone. *NPS Response:* Since this closure is based on a seasonal need that can vary from year-to-year, the NPS will address this closure using authority delegated to the Superintendent by NPS regulations. *Comment #14:* The National Oceanic and Atmospheric Administration noted that the draft regulation and section-by-section discussion regarding discharges into park waters (paragraph (g), while similar to FKNMS regulations at 15 CFR 922.163, are inconsistent with FKNMS regulations for discharges within the Tortugas Ecological Reserve at 15 CFR 922.164(d)(1)(i). NOAA's discharge regulations for the TER only allow for the discharge of cooling water and engine exhaust. As a result, the draft NPS regulations would allow for certain types of discharges in the Research Natural Area zone that are not allowed in the adjacent TER (i.e., fish parts, bilge water, and gray water). *NPS Response:* NPS appreciates the identification of this discrepancy and has revised the rule and section-by-section discussion to make discharge regulations within the Research Natural Area identical to those for the TER. The NPS intends for the RNA regulations to be consistent or “seamless” with FKNMS regulations for the TER as both agencies share identical resource protection goals and wish to maximize public understanding and minimize confusion regarding allowable activities in these zones. Complete citations to publications referenced in the Response to Specific Comments section may be viewed on the park's Web site at: *http://www.nps.gov/drto/parkmgmt/index.htm* . Changes to the Final Rule Based on the preceding comments and responses, the NPS has made four substantive changes to the proposed rule language. 1. The definition of “designated anchorage” (a)(3) was modified by removing the reference to “rubble bottom.” The definition now reads, “any area of sand within one nautical mile of the Fort Jefferson Harbor Light.” 2. The definition of “not available for immediate use” (a)(11) was modified to delete the reference to requiring the removal of hooks and lures from fishing rods. The definition now reads, “ not readily accessible for immediate use, *e.g.* , by being stowed unbaited in a cabin, locker, rod holder, or similar storage area, or being securely covered and lashed to a deck or bulkhead.” 3. (k)(2)(a). The landing and takeoff of aircraft was modified to include all closed areas within the designated landing zone (within a radius of one mile of Garden Key). The proposed regulations restricted aircraft landings and takeoffs to within 500 feet of Bush Key when that island was closed for wildlife nesting. Other sensitive areas within the vicinity have been identified as needing the 500 foot buffer from aircraft landings and takeoffs. These include the staghorn coral ( * Acropora prolifera * ) and elkhorn coral ( *Acropora palmata* ) patches and the nurse shark mating area. The regulation has been modified to read, “Aircraft may be landed on the waters within a radius of one

(1)mile of Garden Key, but a landing or takeoff may not be made within five hundred

(500)feet of any closed area.” 4. Paragraph (g), regulations for discharges into park waters, was modified to prohibit vessel discharges in the Research Natural Area, with the exception of engine cooling water and exhaust. The draft regulation would have allowed for other discharges in the RNA ( *i.e.* , fish parts, bilge water, and gray water) that are inconsistent with the goal of maintaining the highest possible water quality in this zone. The revised regulation will enhance resource protection in the RNA and is consistent with NOAA discharge regulations for the adjacent Tortugas Ecological Reserve. Section-by-Section Analysis

(a)What terms do I need to know? In order to provide clarity and reduce possible confusion, 15 definitions have been included in this paragraph. They include: baitfish, cast net, designated anchorage, dip net, finfish, flat wake, guide fishing, live rock, lobster, marine life, not available for immediate use, ornamental tropical fish, permits, research natural area, and shrimp. Common fish names referred to in the regulations are further clarified by including scientific names.

(b)Are there recreational fishing restrictions that I need to know? Section 2.3(a) of this chapter adopts non-conflicting state fishing laws as part of the general NPS regulations applicable to all units of the National Park System unless regulations for particular park areas specify otherwise. For Dry Tortugas National Park, additional requirements relating to fishing are included to achieve the park's purposes and implement planning decisions. Recreational fishing activities must comply with the state regulations unless those activities are otherwise restricted or prohibited in this section. Any reference to fishing in § 7.27 refers to recreational fishing, which is the taking, attempting to take, or possessing of fish for personal use. This is the same definition used by the State of Florida. All references to commercial fishing have been removed since this activity is already prohibited by 36 CFR 2.3(d)(4). The intent of paragraph (b)(1) allows the Superintendent to impose restrictions or closures to protect fish species within the park. After consulting with and obtaining the concurrence of the FWC, the Superintendent may impose closures and establish conditions or restrictions necessary pertaining to fishing, including but not limited to species of fish that may be taken, seasons and hours during which fishing may take place, methods of taking, and size, bag and possession limits. In emergency situations, after consulting with the FWC, the Superintendent may impose temporary closures and establish conditions or restrictions for up to two thirty-day periods. In emergency situations where consultation in advance is not possible, the Superintendent will consult with the FWC within 24-hours of the initiation of closures or restrictions. This provision of such closures and restrictions is in furtherance of the park's enabling legislation, which identifies protection of fish and wildlife as a purpose of its establishment. The public will receive notice of such closures or restrictions by one or more of the methods listed in § 1.7 of this chapter. Paragraph (b)(2) identifies which fish can be taken and the legal methods for taking these fish. Fishing is limited to fin fish caught by a closely attended hook-and-line, bait fish caught by hook-and-line, cast nets or dip nets, and shrimp caught by dip nets or cast nets. For the last 10 years, these restrictions have been enforced through the Superintendent's Compendium, which serves as a local management guide authorized by 36 CFR 1.5. The previous restriction in 36 CFR 7.27(a)(5)(i), that limits cast nets to 12 feet in diameter, has been deleted. There appears to be no compelling ecological or environmental reason to restrict the size of the cast nets. This change would make the park's regulations consistent with state regulations. Paragraph (b)(3) identifies areas that are closed to fishing, including the RNA. Note, however, that paragraph (b)(3)(i) includes provisions that allow vessels to transit the RNA with legally harvested fish and fishing gear onboard. The provisions of paragraph (b)(3) are consistent with the regulations applicable to the adjacent TER within the FKNMS (15 CFR 922.164; Florida Administrative Code 68B-6.003). The other closed areas are the waters inside the Garden Key moat that surrounds Fort Jefferson and those within the designated swimming and snorkeling area. Fishing in these areas has been found to be incompatible with the identified visitor activities of boating, swimming and snorkeling, and for safety reasons in the helicopter-landing zone. Paragraph (b)(4) identifies specific prohibitions on fishing within the park. This paragraph lists certain fishing practices that differ from those allowed under State of Florida regulations because these practices are incompatible with the goals and management direction of the park. Paragraph (b)(4)(i) provides for complete protection of lobster within the park. All existing regulations found in 36 CFR 7.27(a)(2) related to recreational fishing catch limits for lobster, have been deleted. Prohibiting individuals from being in the water when they have lobster onboard their vessel will further enhance the protection of park resources. This “prima facie” (at first view) evidence of violation is similar to the state of Florida regulations for the Biscayne Bay/Card Sound Spiny Lobster Sanctuary (FAC 68B-11.004), and for John Pennecamp Coral Reef State Park (FAC 68B-24.005). In Dry Tortugas National Park, the harvesting of lobster has been previously prohibited through the use of the Superintendent's authority to regulate public use under 36 CFR 1.5. This prohibition was based on data collected by NPS biologists in a 1975 study, which indicated that legal harvesting was removing almost 90% of the lobster within the park. The Gulf of Mexico Fisheries Management Council concurred with this finding and recommended that the park be established as a sanctuary for lobster to assist in maintaining a population for dispersal to areas outside the park. The proposed regulations in paragraph (b)(4)(ii), concerning possession and use of spearguns and other weapons are similar to regulations for the ecological reserves and sanctuary preservation areas found within the FKNMS (15 CFR 922.164). The State of Florida has similar regulations restricting spearfishing activities found in FS 370.172. This proposed regulation expands on the current regulation, 36 CFR 7.27(a)(7), to include guns, bows and other similarly powered weapons. Paragraph (b)(4)(iii) recognizes that a gaff is a common fishing device used to retrieve legally taken fish from the water, while identifying other prohibited fishing devices. Although all natural resources within a national park area are protected from removal, disturbance, injury, or destruction by the general regulations found at 36 CFR 2.1, the provision at paragraph (b)(4)(iv) clarifies that ornamental tropical fish as well as all other forms of marine life within Dry Tortugas National Park are specifically protected. This additional level of protection will help achieve the congressional direction to protect a pristine subtropical marine ecosystem, including an intact coral reef community. The intent of (b)(4)(v) is to protect coral and other submerged resources from damage or injury by prohibiting the dragging or trawling of nets that are otherwise allowed to be used in the park. Paragraph (b)(4)(vi) prohibits the use of nets, other than dip or cast nets. The State of Florida general recreational fishing regulations allow other nets (bully nets, frame and push nets, beach or haul seines) which are inappropriate and harmful to various submerged resources in the park. Current regulations pertaining to sea turtles and conch found in 36 CFR 7.27(a)(1) and

(3)have been deleted as unnecessary. The State of Florida has prohibited the taking of conch since 1985 and the general NPS regulations already adopt all non-conflicting state laws. Because all sea turtles are currently listed as endangered or threatened species under the Endangered Species Act (16 U.S.C. 1538), it is unnecessary to duplicate prohibitions on their taking in these regulations. Consistent with 36 CFR 5.3, paragraph (b)(4)(vii) requires that all fee-for-service guides (including guides for fishing and diving) obtain a permit or other NPS approved commercial use authorization. This permit system allows the park to better manage the fisheries and other park resources. The Superintendent may limit the number of permitted guides within the park in order to conserve park resources and enhance the visitor experience.

(c)Are there any areas of the park closed to the public? Yes. Paragraph

(c)identifies areas that will be closed to public access. The Long/Bush Keys coral patch has been identified by biologists as “fused” staghorn ( *Acropora prolifera* ), a very rare hybrid of staghorn and elkhorn corals. This coral patch is threatened by a disease that is devastating staghorn and elkhorn coral in Biscayne National Park and the FKNMS. The elkhorn coral ( *Acropora palmata* ) patch also located in this area is the only remaining community of elkhorn coral found in the park. Elkhorn coral assemblages were once very abundant in the park, occupying about 440,000 square meters in 1881. Today this only known remaining elkhorn stand covers only a few hundred square meters. The NMFS has recently designated elkhorn and staghorn coral as “threatened species” under the Endangered Species Act. (May 9, 2006, 71 FR 26852). Hospital and Long Keys have been closed for the last 10 years pursuant to the Superintendent's compendium authority under 36 CFR 1.5. The largest remaining breeding colony of Magnificent Frigate birds in the United States lives on Long Key. The threatened Masked Booby and other sea birds live and breed on Hospital Key. Seasonal closures of Bush Key, East Key and portions of Loggerhead Key for turtle and bird nesting may continue to be designated through the Superintendent's compendium pursuant to 36 CFR 1.5, 1.7.

(d)Is Loggerhead Key open to the public? Loggerhead Key will be open to the public subject to closures in certain areas and restrictions on certain activities. Loggerhead Key is the largest key in the park and contains an operating 150-foot lighthouse and other structures. Most of the island falls within the RNA; however, the center portion, containing the lighthouse and the other structures, falls within a historic preservation/adaptive use zone. Paragraph

(d)is consistent with the FGMPA ROD provision to manage access and recreational activities on Loggerhead Key. To protect the natural and cultural resources of the island, as well as providing appropriate visitor experiences, the Superintendent may impose terms and conditions on activities as necessary. The public will be notified of any such requirements through one or more of the methods listed in § 1.7 of this chapter. Such terms and conditions include, but are not limited to: docking, hiking restrictions, beach and swimming access, and other restrictions or closures necessary to conserve the natural and cultural resources of the island.

(e)Are there restrictions that apply to anchoring a vessel in the park? Paragraph

(e)addresses anchoring locations in general and anchoring prohibitions in the RNA. In the past, boaters have commonly anchored in sea grass beds and rubble bottom, which has resulted in unacceptable impacts to park resources. By restricting anchoring to authorized locations and prohibiting anchoring in all other areas, except in emergencies, degradation to coral reefs and seagrass meadows will be significantly reduced. Paragraph (e)(2) requires vessels to use mooring buoys in the RNA. The RNA requires a higher level of protection for the marine ecosystem; thus the use of anchors in this area is prohibited. Paragraph (e)(3) specifies where vessels can anchor. The “designated anchorage” identified in the existing 36 CFR 7.27(b) is also revised to reflect the GMPA's management zone which calls for limiting anchorage of vessels from sunset to sunrise to the historic preservation/adaptive use zone around Garden Key. This “designated anchorage” is any sand bottom within one nautical mile of the Fort Jefferson Harbor Light. Paragraph (e)(4) imposes restrictions on anchoring by commercial fishing and shrimping vessels consistent with U.S. Coast Guard regulations found in 33 CFR 110.190.

(f)What vessel operations are prohibited? This paragraph addresses several issues of unsafe or otherwise prohibited vessel operations. The Fort Jefferson moat is closed to vessels to preserve and protect the historic scene and prevent damage to the structures. Vessel use in the moat could damage the walls of the fort and the integrity of the moat wall. Because of the large volume of vessel traffic in and around the Garden Key and Bird Key harbors, vessels are required to operate at a flat wake speed to prevent injury and damage resulting from boat wakes.

(g)What are the regulations regarding the discharge of materials in park waters? Paragraph

(g)provides additional protection for water quality within the park by generally prohibiting the discharge or deposit of any material or substance in park waters. The NPS wishes to maintain the highest possible water quality, free of bacterial and chemical contamination, for health and safety reasons as well as to maintain the park's environment. Paragraph (g)(1)(i) prohibits the discharge of any materials or other matter within the Research Natural Area with the only exception being for cooling water or engine exhaust. This regulation is identical to NOAA discharge regulations for the adjacent Tortugas Ecological Reserve at 15 CFR 922.164(d)(1)(i). Paragraph (g)(1)(ii) allows for limited discharges from vessels, (gray water, deck wash water, cooling water, engine exhaust and oil-free bilge water), and some natural substances (fish parts) in park waters outside the Research Natural Area. The NPS recognizes that these discharges would have minimal impact on water quality and are consistent with the recreational fishing and anchoring activities authorized in these zones. These regulations are similar to NOAA discharge regulations for the FKNMS at 15 CFR 922.163. To address future issues regarding the discharge of materials or substances in park waters, paragraph (g)(2) authorizes the Superintendent to impose further restrictions as necessary to protect park resources, visitors, or employees. The public will be notified of any changes through one or more methods listed in § 1.7 of this chapter.

(h)What are the permit requirements in the park? Paragraph

(h)requires that individuals obtain a permit to take part in any recreational activity occurring from a vessel within park boundaries. Permits may be issued in writing or be provided by oral (radio or telephone) authorization. Permitted activities may include snorkeling, diving, wildlife viewing, photography, and the use of mooring buoys. In the RNA, no permits will be issued for anchoring or fishing, both of which are expressly prohibited in this zone. However, a permit is not required for vessels merely transiting the park without stopping to engage in research or recreational activities. All research conducted in the park requires a permit. In the RNA, permits will only be issued for non-manipulative research (i.e., that which does not alter the existing condition).

(i)How are coral and other underwater features protected in the park? The coral formations within the park are internationally recognized as unique and significant. Public Law 102-525 requires protection of the “pristine subtropical marine ecosystems, including an intact coral reef community.” Accordingly, this rule provides new provisions for the protection of corals. Significant damage to coral can be caused by divers or snorkelers handling or standing on coral, especially in areas of heavy use. In this rule, the NPS hopes to better protect the resources by specifically prohibiting these actions, thereby resulting in persons being responsible for any damage that occurs to coral through contact with their body or their equipment, such as fins, SCUBA tanks, gauges, or cameras. Language is also included to prohibit taking or removing corals and live rock. Coral damage caused by vessels is often attributed to carelessness of vessel operators but can be avoided through more careful vessel operation. This rule makes vessel operators responsible for preventing damage to corals by their vessels. These last two provisions are similar to regulations in the adjacent FKNMS (15 CFR 922.163). Paragraph (i)(3) makes vessel operators responsible for any damage to coral, seagrass or any other underwater feature caused by their anchors or anchor parts. This is to prevent damage to fragile resources and assure the highest level of resource protection.

(j)What restrictions do I need to know when on or near shipwrecks found in the park? Paragraph

(j)provides specific protection for wrecked or abandoned craft and their cargo. Dry Tortugas National Park possesses one of the greatest concentrations of historically significant shipwrecks in North America, with some dating back to the 1600's. Within the park boundary, there have been more than 275 documented maritime casualties (shipwrecks, groundings, strandings), and human activity has left a significant historical record. Protection of submerged cultural resources is a park priority, as well as a management purpose identified in Public Law 102-525. Consistent with the park's statutory mandate, this rule will provide specific protection for these cultural resources in addition to protections provided by applicable law.

(k)Can aircraft land in the park? Paragraph

(k)requires the Superintendent to manage aircraft operations by requiring users to obtain a permit to land seaplanes in the park. Seaplanes provide transportation for a significant number of park visitors. The NPS's general regulation at 36 CFR 2.17 authorizes the Superintendent to designate, through a special regulation, operating/landing locations within the park. It also prohibits aircraft from operating under power within 500 feet of swimming beaches, boat docks, or piers unless designated through a special regulation. In order to reach the designated ramp for discharging passengers, seaplanes must taxi within 500 feet of dock areas. This paragraph specifies that a landing or takeoff may not be made within 500 feet of Garden Key or 500 feet of any area designated as closed (e.g., Bush Key when it is closed for wildlife nesting), but taxiing is allowed when seaplane use is permitted. The existing regulations use a 300 yard limit for approaches, landings and takeoffs. The new limit of 500 feet will also bring these regulations in line with the general aircraft regulations provision of 500 feet. Compliance With Other Laws Regulatory Planning and Review (Executive Order 12866) The Office of Management and Budget has determined that this document is a significant rule and has reviewed this rule under Executive Order 12866.

(1)This rule will not have an effect of $100 million or more on the economy. It will not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. The NPS has completed the report ”Cost-Benefit Analysis: Proposed Regulations Implementing the Final General Management Plan Amendment/Environmental Impact Statement for Dry Tortugas National Park.” (August 15, 2005) This document may be viewed on the park's Web site at: *http://www.nps.gov/drto/parkmgmt/index.htm.* This conclusion is based on the fact that the proposed regulations would not impose significant impacts on any business. The regulations are based on the FGMPA/EIS or are restatements, clarifications, and definitions of previously established policies and regulations resulting in no change or effects on the economy.

(2)This rule will not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. Actions taken under this rule will not interfere with other agencies or local government plans, policies, or controls. This rule is an agency specific rule.

(3)This rule will not materially affect budgetary effects of entitlements, grants, user fees, or loan programs or the rights or obligations of their recipients. No grants or other forms of monetary supplements are involved.

(4)OMB has determined that this rule raises novel legal or policy issues and OMB has reviewed the rule under Executive Order 12866. Regulatory Flexibility Act The Department of the Interior certifies that this rulemaking will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). This certification is based on a report entitled “Regulatory Flexibility Threshold Analysis: Proposed Regulations Implementing the Final General Management Plan Amendment/Environmental Impact Statement for Dry Tortugas National Park.” (January 27, 2005). This document may be viewed on the park's Web site at: *http://www.nps.gov/drto/parkmgmt/index.htm.* Small Business Regulatory Enforcement Fairness Act (SBREFA) This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This proposed rule: a. Does not have an annual effect on the economy of $100 million or more. b. Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions. c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. Unfunded Mandates Reform Act This rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule will not have a significant or unique effect on State, local or tribal governments or the private sector. This rule is an agency specific rule and does not impose any other requirements on other agencies, governments, or the private sector. Takings (Executive Order 12630) In accordance with Executive Order 12630, the rule does not have significant takings implications. A taking implication assessment is not required. No taking of personal property will occur as a result of this rule. Federalism (Executive Order 13132) In accordance with Executive Order 13132, the rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. This proposed rule only applies to the use of NPS administered lands and waters. Both the State of Florida and the United States claim title to submerged lands located within the boundaries of the park established by Congress. Rather than addressing this issue through potentially protracted litigation, the State and the Department have entered into the “Management Agreement for Certain Submerged Lands in Monroe County, Florida, Located within Dry Tortugas National Park” approved by the Florida Governor and Cabinet on August 9, 2005 and by the Secretary of the Interior on December 20, 2005. This document may be viewed on the park's Web site at *http://www.nps.gov/drto/parkmgmt/index.htm.* This rule is consistent with the requirements of the management agreement. Once final, the regulations will be reviewed by the NPS at least every five years, and as appropriate, revised, and reissued, based upon the results of the research program conducted pursuant to the management agreement as well as the information contained in the management plan status report prepared by the NPS detailing the status and activities of the implementation of the FGMPA/EIS. Information and data collected regarding the effectiveness and performance of the RNA will also be reviewed and evaluated. Under adaptive management, NPS may consider changes in the RNA, including boundary adjustments and modifications to the protection and conservation management strategies applicable to the RNA. Consistent with the management agreement, the NPS has obtained the concurrence of the Board of Trustees of the Internal Improvement Trust Fund regarding that portion of the regulations pertaining to the management of submerged lands within the park. Further, the NPS will submit for review to the FWC any proposed revisions or amendments thereto. Civil Justice Reform (Executive Order 12988) In accordance with Executive Order 12988, the Office of the Solicitor has determined that this rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order. Paperwork Reduction Act This regulation does not require an information collection from 10 or more parties and a submission under the Paperwork Reduction Act is not required. An OMB Form 83-I is not required. National Environmental Policy Act The Department of the Interior, National Park Service prepared a Final General Management Plan Amendment/Environmental Impact Statement (FGMPA/EIS) for Dry Tortugas National Park, Monroe County, Florida. Five alternatives were evaluated for guiding the management of the park over the next 15 to 20 years. The alternatives incorporate various zoning applications and other management provisions to ensure resource protection and quality visitor experience conditions. The environmental consequences anticipated from implementation of each alternative are addressed in the FGMPA/EIS. Impacts to natural and cultural resources, visitor experience, socioeconomic environment, and park operations/facilities are analyzed. The FGMPA/EIS was prepared in conjunction with planning by the FKNMS, the FWC, and the GMFMC to establish the TER in state and federal waters adjacent to Dry Tortugas National Park. State and Federal approvals for the TER are complete and implementation of the ecological reserve is underway. After careful consideration of legislative mandates, visitation trends, environmental impacts, relevant scientific studies, and comments from the public and agencies, the NPS chose to implement Alternative C as described in the Final GMPA/EIS issued in January 2001 (with some minor clarifications, as listed in Appendix A, Errata). This alternative best accomplishes the legislated purposes of DRTO and the statutory mission of the NPS to provide long-term protection of park resources and values while allowing for visitor use and enjoyment. It also furthers the objectives of Executive Order 13089, Coral Reef Protection. The goal of the selected action is to afford a high level of protection to park resources and provide for appropriate types and levels of high quality visitor experiences. This will be accomplished through management zoning, establishing visitor carrying capacity for specific locations in the park, using commercial services to direct and structure visitor use, and instituting a permit system for private boaters. A wide range of recreational and educational opportunities will be available to visitors provided that appropriate resource conditions are maintained. Visitor experiences will be enhanced due to expanded access throughout the park and higher quality resources to enjoy. Multiple consultations took place with government agencies during the EIS process, including the FKNMS, the FWC, and the GMFMC. The NPS Southeast Regional Director signed the Record of Decision

(ROD)on July 27, 2001. In reaching a decision, NPS carefully considered the comments and concerns expressed by the public throughout the EIS process. The EIS and ROD are available online at: *http://www.nps.gov/drto/parkmgmt/index.htm.* or at Everglades National Park, as indicated above under the heading FOR FURTHER INFORMATION CONTACT . Pursuant to section 7 of the Endangered Species Act, the NPS has consulted with the U.S. Fish and Wildlife Service

(FWS)and the National Marine Fisheries Service

(NMFS)regarding potential effects of the proposed regulations on federally listed species. On December 15, 2005, the FWS determined that the proposed rule would have no effect on the Bald eagle and would not likely adversely affect nesting marine turtles, the American crocodile, West Indian manatee or the Roseate tern. On June 7, 2006, the NMFS issued a Biological Opinion on the proposed rule. NMFS determined that the continuation of hook and line fishing in the park may result in the lethal take of one sea turtle annually. NMFS concluded that this level of take is not likely to jeopardize the continued existence of green, hawksbill, leatherback, or loggerhead sea turtles. The Biological Opinion authorizes lethal take of one sea turtle per year and determined that the following Reasonable and Prudent Measures

(RPM)are necessary and appropriate to minimize impacts of incidental take of sea turtles. 1. NPS must ensure that the Dry Tortugas National Park Sea Turtle Monitoring Program is maintained and capable of both detecting any adverse effects resulting from recreational fishing inside the park and assessing the actual level of incidental take in comparison with the anticipated incidental take documented in this opinion. 2. NPS must implement outreach programs seeking to increase awareness among park anglers and visitors of protected species within the park and ways to reduce encounters with those species. 3. NPS must provide NMFS' Southeast Regional Office of Protected Resources Division (F/SER3) with sufficient information to monitor this Incidental Take Statement. To be exempt from liability for take prohibited by section 9 of the ESA, NPS must comply with the following terms and conditions, which implement the RPMs described above. These terms and conditions are non-discretionary. *To implement RPM No. 1:* 1. NPS must increase its sea turtle stranding surveillance to at least twice weekly. This surveillance should be split equally between shore and in water surveys when feasible. 2. NPS must establish a reporting system that requires anglers or charter boat guides to report interactions between their fishing party and sea turtles. *To implement RPM No. 2:* 3. NPS must develop and implement an outreach program to educate recreational fishers on sea turtle handling protocols, emphasizing release procedures that minimize stress and maximize survival potential. 4. NPS must supply recreational fishers with verbal and/or written information on fishing gear that can reduce sea turtle bycatch ( *i.e.* , circle hooks). *To implement RPM No. 3:* 5. NPS must notify F/SER3 immediately if they believe a sea turtle stranding is related in any way to fishing activities within the park. 6. NPS shall monitor sea turtle strandings to ensure incidental take levels do not exceed the authorized level. If at any time, the take level stated in this opinion is exceeded, NPS must notify F/SER3 immediately. Stranding reports shall be submitted to F/SER3 annually. Submitted reports must include any information on the causes of strandings, with special attention paid to any fishing gear associated with the animal. Government-to-Government Relationship With Tribes In accordance with the President's memorandum of April 29, 1994, “Government to Government Relations with Native American Tribal Governments” (59 FR 22951) and 512 DM 2, we have evaluated potential effects on federally recognized Indian tribes and have determined that there are no potential effects. List of Subjects in 36 CFR Part 7 National parks, Recreation. For reasons stated in the preamble, the National Park Service amends 36 CFR part 7 as follows: PART 7—SPECIAL REGULATIONS, AREAS OF THE NATIONAL PARK SYSTEM 1. The authority for part 7 continues to read as follows: Authority: 16 U.S.C. 1, 3, 9a, 460(q), 462(k); Sec. 7.96 also issued under D.C. Code 8-137

(1981)and D.C. Code 40-721 (1981). 2. Section 7.27 is revised as follows: § 7.27 Dry Tortugas National Park. *(a) What terms do I need to know?* The following definitions apply to this section only:

(1)*Bait fish* means any of the following:

(i)Ballyhoo (family *Exocioetidae* and genus *Hemiramphus* ), other genus may be included in this family;

(ii)Minnow (families *Cyprinodontidae, Peciliidae* , or *Aherinidae* );

(iii)Mojarra (family *Gerreidae* );

(iv)Mullet (family *Mugilidae* );

(v)Pilchard (family *Clupeidae* ); or

(vi)Pinfish (family *Sparidae* , genus *Lagodon* ).

(2)*Cast net* means a type of circular falling net, weighted on its periphery, which is thrown and retrieved by hand, measuring 14 feet or less stretched length (stretched length is defined as the distance from the horn at the center of the net with the net gathered and pulled taut, to the lead line).

(3)*Designated anchorage* means any area of sand within one nautical mile of the Fort Jefferson Harbor Light.

(4)*Dip net* means a hand held device for obtaining bait, the netting of which is fastened in a frame. A dip net may not exceed 3 feet at its widest point.

(5)*Finfish* means a member of subclasses Agnatha, Chondrichthyes, or Osteichthyes.

(6)*Flat wake speed* means the minimum required speed to leave a flat wave disturbance close astern a moving vessel yet maintain steerageway, but in no case in excess of 5 statute miles per hour.

(7)*Guide operations* means the activity of a person, partnership, firm, corporation, or other entity to provide services for hire to visitors of the park. This includes, but is not limited to, fishing, diving, snorkeling, and wildlife viewing.

(8)*Live rock* means any living marine organism or assemblage thereof attached to a hard substrate, including dead coral or rock but not individual mollusk shells.

(9)*Lobster* means any of the following:

(i)Shovelnosed or Spanish Lobster ( *Scyllarides aequinocti* );

(ii)Slipper lobster ( *Parribacus antarcticus* );

(iii)Caribbean spiny lobster ( *Panulirus argus* ); or

(iv)Spotted spiny lobster ( *Panulirus guttatus* ).

(10)*Marine life* means:

(i)Sponges, sea anenomes, corals, jellyfish, sea cucumbers, starfish, sea urchins, octopus, crabs, shrimp, barnacles, worms, conch; and

(ii)Other animals belonging to the Phyla Porifera, Cnidaria, Echinodermata, Mollusca, Bryozoa, Brachiopoda, Arthropoda, Platyhilmenthes, and Annelida.

(11)*Not available for immediate use* means not readily accessible for immediate use ( *e.g.* , by being stowed unbaited in a cabin, locker, rod holder, or similar storage area, or being securely covered and lashed to a deck or bulkhead).

(12)*Ornamental tropical fish* means a brightly colored fish, often used for aquarium purposes and which lives in close relationship to coral communities, belonging to the families Syngathidae, Apogonidae, Pomacentridae, Scaridae, Blennidae, Callionymidae, Gobiidae, Ostraciidae, or Diodontidae.

(13)*Permit* , in the case of 36 CFR part 7.27, means an authorization in writing or orally (e.g., via radio or telephonically).

(14)*Research Natural Area*

(RNA)at Dry Tortugas National Park means the 46-square-statute-mile area in the northwest portion of the park enclosed by connecting with straight lines the adjacent points of 82°51′ W and 24°36′ N, and 82°58′ W and 24°36′ N west to the park boundary, but excluding:

(i)The designated anchorage;

(ii)Garden Key, Bush Key and Long Key; or

(iii)The central portion of Loggerhead key including the lighthouse and associated buildings.

(15)*Shrimp* means a member of the genus *Farfantepenaeus* , Penaeus sp.

(b)Are there recreational fishing restrictions that I need to know?

(1)Yes. After consulting with and obtaining the concurrence of the Florida Fish and Wildlife Conservation Commission, based on management objectives and the park fisheries research, the Superintendent may impose closures and establish conditions or restrictions necessary pertaining to fishing, including, but not limited to, species of fish that may be taken, seasons, and hours during which fishing may take place, methods of taking, and size, bag, and possession limits. The public will be notified of any changes through one or more methods listed in § 1.7 of this chapter. In emergency situations, after consulting with the Florida Fish and Wildlife Conservation Commission, the Superintendent may impose temporary closures and establish conditions or restrictions necessary, but not exceeding 30 days in duration which may be extended for one additional 30 day period, pertaining to fishing, including, but not limited to, species of fish that may be taken, seasons, and hours during which fishing may take place, methods of taking, and size, bag, and possession limits. In emergency situations where consultation in advance is not possible, the Superintendent will consult with the Florida Fish and Wildlife Conservation Commission within 24-hours of the initiation of the temporary closure or restriction.

(2)Only the following may be legally taken from Dry Tortugas National Park:

(i)Fin fish by closely attended hook-and-line;

(ii)Bait fish by closely attended hook and line, dip net, or cast net and limited to 5 gallons per vessel per day; and

(iii)Shrimp may be taken by dip net or cast net.

(3)The following waters and areas are closed to fishing:

(i)The Research Natural Area (RNA): Fish and fishing gear may be possessed aboard a vessel in the RNA, provided such fish can be shown not to have been harvested from within, removed from, or taken within the RNA, as applicable, by being stowed in a cabin, locker, or similar storage area prior to entering and during transit through the RNA, provided further that such vessel is in continuous transit through the RNA. Gear capable of harvesting fish may be aboard a vessel in the RNA, provided such gear is not available for immediate use when entering and during transit through the RNA and no presumption of fishing activity shall be drawn therefrom;

(ii)Garden Key moat;

(iii)Within any swimming and snorkeling areas designated by buoys;

(iv)Within 50 feet of the historic coaling docks;

(v)Helipad areas, including the gasoline refueling dock.

(4)The following are prohibited:

(i)Possessing lobster within the boundaries of the park, unless the individual took the lobster outside park waters and has the proper State/Federal licenses and permits. Vessels with legally taken lobster aboard which was taken outside the park may not have persons overboard in park waters. The presence of lobster aboard a vessel in park waters, while one or more persons from such vessel are overboard, constitutes prima facie evidence that the lobsters were harvested from park waters in violation of this chapter.

(ii)Taking fish by pole spear, Hawaiian sling, rubber powered, pneumatic, or spring loaded gun or similar device known as a speargun, air rifles, bows and arrows, powerheads, or explosive powered guns. Operators of vessels within the park must break down and store all weapons described in this paragraph so that they are not available for immediate use.

(iii)Use of a hand held hook, gig, gaff, or snare, except that a gaff may be used for landing a fish lawfully caught by hook and line when consistent with all requirements in this section, including size and species restrictions.

(iv)Taking, possessing, or touching any ornamental tropical fish or marine life except as expressly provided in this section.

(v)Dragging or trawling a dip net or cast net.

(vi)The use of nets except as provided in paragraphs (b)(3)(ii)and

(iii)of this section.

(vii)Engaging in guide operations (fee for service), including but not limited to fishing and diving, except in accordance with the provisions of:

(A)A permit, contract, or other commercial use authorization; or

(B)Other written agreement with the United States administered under this chapter.

(c)*Are any areas of the park closed to the public?* Yes. The following areas are closed to the public:

(1)The elkhorn ( *Acropora palmata* ) and staghorn ( *Acropora prolifera* ) coral patches adjacent to and including the tidal channel southeast of Long and Bush Keys and extending to 100 yards from the exterior edge of either patch;

(2)Hospital and Long Keys; and

(3)Areas that the Superintendent designates in accordance with § 1.5 and noticed to the public through one or more of the methods listed in § 1.7 of this chapter.

(d)*What restrictions apply on Loggerhead Key?*

(1)The Superintendent will, as necessary to protect park resources, visitors, or employees:

(i)Designate areas on Loggerhead Key open for public use;

(ii)Establish closures or restrictions on and around the waters of Loggerhead Key; and

(iii)Establish conditions for docking, swimming or wading, and hiking.

(2)The Superintendent will notify the public of designations, closures or restrictions through one or more of the methods listed in § 1.7 of this chapter.

(e)*What restrictions apply to anchoring a vessel in the park?*

(1)Anchoring in the Research Natural Area

(RNA)is prohibited.

(2)All vessels in the RNA must use designated mooring buoys.

(3)Anchoring between sunset and sunrise is limited to the designated anchorage area at Garden Key.

(4)Vessels engaged in commercial fishing or shrimping must not anchor in any of the channels, harbors, or lagoons in the vicinity of Garden Key, Bush Key, or the surrounding shoals outside of Bird Key Harbor, except in cases of emergency involving danger to life or property. (Emergencies may include, adverse weather conditions, mechanical failure, medical emergencies, or other public safety situations.)

(f)*What vessel operations are prohibited?* The following vessel operations are prohibited:

(1)Operating a vessel in the Fort Jefferson Moat; and

(2)Operating a vessel above a flat wake speed in the Garden Key and Bird Key Harbor areas.

(g)*What restrictions apply to discharging materials in park waters?*

(1)Discharging or depositing materials or substances of any kind within the boundaries of the park is prohibited, except for the following:

(i)*Research Natural Area:* cooling water or engine exhaust.

(ii)*Park Waters Outside the Research Natural Area:*

(A)Fish, fish parts, chumming materials, or bait used or produced incidental to and while conducting recreational fishing activities in the park;

(B)Water generated by routine vessel operations (e.g., deck wash down and graywater from sinks, consisting of only water and food particles;

(C)Vessel cooling water, engine exhaust, or bilge water not contaminated by oil or other substances.

(2)The Superintendent may impose further restrictions as necessary to protect park resources, visitors, or employees. The Superintendent will notify the public of these requirements through one or more of the methods listed in § 1.7 of this chapter.

(h)*What are the permit requirements in the park?*

(1)A permit, issued by the Superintendent, is required for all non-commercial vessels for which occupants are engaged in recreational activities, including all activities in the RNA. Permitted recreational activities include but are not limited to use of mooring buoys, snorkeling, diving, wildlife viewing, and photography.

(2)A permit, issued by the Superintendent, is required for a person, group, institution, or organization conducting research activities in the park.

(3)Vessels transiting the park without interruption shall not require a permit.

(i)*How are corals and other underwater natural features protected in the park?*

(1)Taking, possessing, removing, damaging, touching, handling, harvesting, disturbing, standing on, or otherwise injuring coral, coral formation, seagrass or other living or dead organisms, including marine invertebrates, live rock, and shells, is prohibited.

(2)Vessel operators are prohibited from allowing their vessel to strike, injure, or damage coral, seagrass, or any other immobile organism attached to the seabed.

(3)Vessel operators are prohibited from allowing an anchor, chain, rope or other mooring device to be cast, dragged, or placed so as to strike, break, abrade, or otherwise cause damage to coral formations, sea grass, or submerged cultural resources.

(j)*What restrictions apply on or near shipwrecks?*

(1)No person may destroy, molest, remove, deface, displace, or tamper with wrecked or abandoned vessels of any type or condition, or any cargo pertaining thereto.

(2)Surveying, inventorying, dismantling, or recovering any wreck or cargo within the boundaries of the park is prohibited unless permitted in writing by the Superintendent.

(k)*How are aircraft operations restricted?*

(1)Landing an aircraft in Dry Tortugas National Park may occur only in accordance with a permit issued by the Superintendent under § 1.6 of this chapter.

(2)When landing is authorized by permit, the following requirements also apply:

(i)Aircraft may be landed on the waters within a radius of 1 mile of Garden Key, but a landing or takeoff may not be made within 500 feet of Garden Key, or within 500 feet of any closed area.

(ii)Operation of aircraft is subject to § 2.17 of this chapter, except that seaplanes may be taxied closer than 500 feet to the Garden Dock while en route to or from the designated ramp, north of the dock.

(iii)Seaplanes may be moored or brought up on land only on the designated beach, north of the Garden Key dock. Dated: October 2, 2006. David M. Verhey, Acting Assistant Secretary for Fish and Wildlife and Parks. [FR Doc. E6-21646 Filed 12-19-06; 8:45 am] BILLING CODE 4312-78-P NATIONAL ARCHIVES AND RECORDS ADMINISTRATION 36 CFR Part 1280 [NARA-06-0005] RIN 3095-AB55 Use of NARA Facilities AGENCY: National Archives and Records Administration (NARA). ACTION: Final rule. SUMMARY: This final rule revises NARA's policy on the inspection of personal property in the possession of a contractor, employee, student intern, visitor, volunteer or other person on NARA properties. Because NARA's current regulations apply specifically only to visitors on NARA property, the final rule clarifies that all persons arriving on, working at, visiting, or departing from NARA property are subject to the inspection of their personal property. The final rule also amends NARA's current regulations to include additional properties under NARA control. This rule will affect members of the public, members of Federal agencies, NARA employees, NARA contract-employees and NARA volunteers. DATES: *Effective Date:* Effective January 19, 2007. FOR FURTHER INFORMATION CONTACT: Jeffrey Landou at 301-837-1899 or fax number 301-837-0293. SUPPLEMENTARY INFORMATION: The proposed rule was published in the September 26, 2006, **Federal Register** (71 FR 56919) for a 60-day comment period. Notification of user groups occurred following publication of the proposed rule. NARA received no comments on the proposed rule and therefore is issuing the final rule with no changes. This final rule is not a significant regulatory action for the purposes of Executive Order 12866 and has not been reviewed by the Office of Management and Budget. As required by the Regulatory Flexibility Act, I certify that this rule will not have a significant impact on a substantial number of small entities because the final rule affects NARA contractors, employees, student interns, visitors, volunteers and other persons on NARA controlled property. This regulation does not have any federalism implications. This rule is not a major rule as defined in 5 U.S.C. Chapter 8, Congressional Review of Agency Rulemaking. List of Subjects in 36 CFR Part 1280 Archives and records. For the reasons set forth in the preamble, NARA amends part 1280 of title 36, Code of Federal Regulations as follows: PART 1280—USE OF NARA FACILITIES 1. The authority citation for part 1280 continues to read as follows: Authority: 44 U.S.C. 2104(a). 2. Revise the heading for part 1280 to read as set forth above: 3. Amend § 1280.2 to add paragraphs (d), (e), and

(f)to read as follows: § 1280.2 What property is under the control of the Archivist of the United States?

(d)*The National Archives Southwest Region.* The National Archives Southeast Region in Morrow, Georgia as specified in 36 CFR 1253.7 (e).

(e)*The Federal Records Centers.* The Federal Records Centers in Ellenwood, Georgia, and Riverside, California, as specified in 36 CFR 1253.6

(d)and (l), respectively.

(f)*Additional Facilities.* As other properties come under the control of the Archivist of the United States, they will be listed in these regulations as soon as practicable. §§ 1280.4, 1280.6 and 1280.8 [Redesignated as §§ 1280.6, 1280.8 and 1280.4] 4. In Subpart A, redesignate §§ 1280.4, 1280.6 and 1280.8 as §§ 1280.6, 1280.8 and 1280.4, respectively. 5. Revise newly designated § 1280.4 to read as follows: § 1280.4 What items are subject to inspection by NARA? NARA may, at its discretion, inspect the personal property in the possession of any NARA contractor, employee, student intern, visitor, volunteer, or other person arriving on, working at, visiting, or departing from NARA property. Dated: December 13, 2006. Allen Weinstein, Archivist of the United States. [FR Doc. E6-21682 Filed 12-19-06; 8:45 am] BILLING CODE 7515-01-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0282; FRL-8105-1] Myclobutanil; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for combined residues of myclobutanil in or on hops, soybean seed, soybean forage, soybean hay, aspirated grain fractions, and soybean refined oil. Interregional Research Project #4 (IR-4) requested the tolerance for hops and Dow AgroSciences requested the tolerances for the soybean commodities under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective December 20, 2006. Objections and requests for hearings must be received on or before February 20, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION) . ADDRESSES: EPA has established a docket for this action under docket identification

(ID)number EPA-HQ-OPP-2006-0282. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)305-6463; e-mail address: *madden.barbara@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0282 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before February 20, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0282, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of April 12, 2006 (71 FR 18740) (FRL-7773-9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 1E6265) by Interregional Research Project No. 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.443 be amended by establishing a tolerance for combined residues of the fungicide myclobutanil, alpha-butyl-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile and its alcohol metabolite (alpha-(3-hydroxybutyl)-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile (free and bound), in or on hop, dried cones at 10 parts per million (ppm). That notice included a summary of the petition prepared by Dow AgroSciences, the registrant. There were no comments received in response to the notice of filing. In the **Federal Register** of August 23, 2006 (71 FR 49448) (FRL-8073-2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5F6997) by Dow AgroSciences, 9330 Zionsville Road, Indianapolis, IN 46268. The petition requested that 40 CFR 180.443 be amended by establishing tolerances for combined residues of the fungicide myclobutanil, alpha-butyl-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile and its alcohol metabolite (alpha-(3-hydroxybutyl)-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile (free and bound), in or on soybean, aspirated grain fractions at 1.1 ppm; soybean, forage at 5.0 ppm; soybean, hay at 13.0 ppm; soybean, hulls at 0.06 ppm; soybean, meal at 0.03 ppm; soybean, oil at 0.1 ppm; and soybean, seed at 0.05 ppm. That notice included a summary of the petition prepared by Dow AgroSciences, the registrant. There were no comments received in response to the notice of filing. Upon completing review of the current myclobutanil database, the Agency concluded that the appropriate tolerance levels for myclobutanil residues in or on pending crops should be established as follows: Hop, dried cones at 10 ppm; soybean, seed at 0.25 ppm; soybean, forage at 3.5 ppm; soybean, hay at 15 ppm; aspirated grain fractions at 35 ppm; and soybean, refined oil at 0.40 ppm. In addition, the proposed tolerances for soybean, hulls and soybean, meal were withdrawn because based on available processing data, tolerances for these commodities are not needed. EPA is also deleting several established tolerances in 40 CFR 180.443(b) that are no longer needed as a result of this action. The tolerance deletions under 40 CFR 180.443(b) are time-limited tolerances established under section 18 emergency exemptions that are superseded by the establishment of general tolerances for myclobutanil and its metabolites under 40 CFR 180.443(a). The revisions to 40 CFR 180.443(b) are as follows: Delete the time-limited tolerance for hop, dried cone at 5.0 ppm. A tolerance for hop, dried cones at 10 ppm is established by this action under 40 CFR 180.443(a). Delete the time-limited tolerance for soybean at 0.05 ppm. A tolerance for soybean, seed at 0.25 ppm is established by this action under 40 CFR 180.443(a). Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for tolerances for combined residues of myclobutanil alpha-butyl-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile and its alcohol metabolite (alpha-(3-hydroxybutyl)-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile (free and bound), in or on hop, dried cones at 10 ppm; soybean, seed at 0.25 ppm; soybean, forage at 3.5 ppm; soybean, hay at 15 ppm; grain, aspirated fractions at 35 ppm; and soybean, refined oil at 0.40 ppm. EPA's assessment of exposures and risks associated with establishing these tolerances follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the toxic effects caused by myclobutanil as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *http://www.epa.gov/fedrgstr/EPA-PEST/2000/May/Day-10/p11571.htm* ( **Federal Register** of May 10, 2000 (65 FR 29963) (FRL-6555-5). B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the LOAEL is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor

(UF)is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at *http://www.epa.gov/pesticides/health/human.htm.* A summary of the toxicological endpoints for myclobutanil used for human risk assessment can be found at *www.regulations.gov* in document 0002 (pages 6 and 7) in docket ID number EPA-HQ-OPP-2006-0282. To locate this information on the *Regulations.gov* website follow these steps: • Select “Advanced Search”, then “Docket Search” • In the “Keyword” field type the chemical name or insert the applicable “Docket ID number.” (example: EPA-HQ-OPP-2005-9999) • Click the “Submit” button. Follow the instructions on the *regulations.gov* web site to view the index for the docket and access available documents. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Tolerances have been established (40 CFR 180.443) for the combined residues of myclobutanil, in or on a variety of raw agricultural commodities. Tolerances have also been established for combined residues of myclobutanil in or on milk, egg, and fat, liver, meat, and meat byproducts of cattle, goat, hog, horse, and sheep as well as fat, meat, and meat byproducts of poultry. Risk assessments were conducted by EPA to assess dietary exposures from myclobutanil in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one-day or single exposure. An acute dietary exposure assessment was performed for females 13-49 years old (no endpoint was identified for the general U.S. population or any other population subgroup). In conducting the acute dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the United States Department of Agriculture

(USDA)1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: Tolerance-level residues and 100 percent crop treated

(PCT)information for all registered and proposed uses. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: A partially refined, chronic dietary exposure assessment was performed for the general U.S. population and various population subgroups using USDA Pesticide Data Program

(PDP)monitoring data for apple juice, bananas (not plantains) and milk and assuming all other commodities covered by registered and proposed tolerances have residues at the appropriate tolerance value. Average PCT information was used for apple (except juice), apricots, asparagus, blackberry, cantaloupe, cherry, cucumber, grape, nectarine, peach, plum, pumpkin, raspberry, squash, strawberry, tomato, and watermelon; 100 PCT was assumed for all other registered and proposed uses. iii. *Cancer* . The Agency has classified myclobutanil as Group E - not likely to be a human carcinogen. Myclobutanil was determined to be not carcinogenic in two acceptable animal studies. Therefore, a cancer dietary exposure assessment was not performed. iv. *Anticipated residue and PCT information* . Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT. The Agency used PCT information as follows: 40% of apples (except juice), 25% of apricots, 5% of asparagus, 15% of blackberry, 10 % of cantaloupe, 35 % of cherry, 1% of cucumber, 25% of grape, 15% of nectarine, 10% of peach, 10% of plum, 15% of pumpkin, 25% of raspberry, 10% of squash, 35% of strawberry, 5% of tomato, and 5% of watermelon. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available federal, state, and private market survey data for that use, averaging by year, averaging across all years, and rounding up to the nearest multiple of five percent except for those situations in which the average PCT is less than one. In those cases <1% is used as the average and <2.5% is used as the maximum. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the single maximum value reported overall from available federal, state, and private market survey data on the existing use, across all years, and rounded up to the nearest multiple of five percent. In most cases, EPA uses available data from USDA/National Agricultural Statistics Service (USDA/NASS), Proprietary Market Surveys, and the National Center for Food and Agriculture Policy (NCFAP) for the most recent six years. The Agency believes that the three conditions listed in Unit III.C.iv. have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which myclobutanil may be applied in a particular area. 3. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for myclobutanil in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of myclobutanil. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm* . Based on the PRZM/EXAMS and SCI-GROW models, the estimated environmental concentrations

(EECs)of myclobutanil for acute exposures are estimated to be 15.3 parts per billion

(ppb)for surface water and 0.35 ppb for ground water. The EECs for chronic exposures are estimated to be 8.5 ppb for surface water and 0.35 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model (DEEM-FCID TM ). The estimates were calculated using the application rate for hops, which has the highest use rate among all existing and proposed uses. For acute dietary risk assessment the 1- in 10-year peak acute of 15.3 ppb was used to assess the contribution to drinking water and for chronic dietary risk assessment the 1- in 10-year estimated annual mean of 8.5 ppb was used to assess the contribution to drinking water. 4. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Myclobutanil is currently registered for use on the following residential non-dietary sites: Turf, ornamentals, and home garden uses on fruit trees, nut trees, berries, mint and vegetables. The risk assessment was conducted using the following residential exposure assumptions: The homeowner use with the greatest potential for exposure is small-scale lawn application. Since myclobutanil is applied at 7- to 14-day intervals, only short-term exposure is expected for the residential handler. Short- and intermediate-term residential post-application exposures are also expected. The current use patterns and labeling indicate that a variety of application equipment could be used by the homeowner to apply myclobutanil to ornamental plants, shrubs, fruit trees, home garden vegetables and lawns. Therefore, the following scenarios were assessed: i. Aerosol Spray Can Application to Ornamentals and Fruit Trees ii. Hose End Sprayer Application to Ornamentals and Fruit Trees iii. Low-pressure

(LP)Handwand Application to Ornamentals iv. LP Handwand Application to Vegetables v. Ready to use

(RTU)Sprayer Application to Vegetables vi. Hose End Sprayer Application to Vegetables vii. Hose End Sprayer - Mix Your Own - Application to Turf viii. Hose End Sprayer - Ready to Use - Application to Turf ix. Belly Grinder Application to Turf x. Broadcast Spreader Application to Turf Unit exposure data were either taken from Pesticide Handler's Exposure Database

(PHED)or from the home garden and turf application studies that were sponsored by the Outdoor Residential Exposure Task Force (ORETF). Home garden post-application exposures can occur when home gardeners perform tasks such as weeding, pruning or hand harvesting following application of myclobutanil. In order to address these risks, the post-application exposure to home gardens and orchard scenarios were assessed based upon the Residential standard operating procedures

(SOP)3.0 for Garden Plants and SOP 4.0 for Trees. Two dislodgeable foliar residue

(DFR)studies on grapes in California were used to assess the home garden exposures. The studies were performed using airblast sprayers while the proposed home garden applications would be made with LP handwand or hose end sprayers. Based upon experience with other fungicides, however, it is anticipated that DFRs resulting from handwand applications would be similar to DFRs from airblast applications. The initial DFR was assumed to be 23% of the application rate. “Pick your own” exposures can occur at commercially operated “pick your own” strawberry farms and orchards where myclobutanil has been applied. To address these risks, post-application exposure for pick your own strawberries and tree fruit were assessed based upon the Residential SOP 15.0 for “pick your own” strawberries. The DFR data that were used for the home gardener post-application risks were also used to assess “pick your own” exposures. The exposure estimates used for pick your own exposures are considered conservative because that scenario is based upon a screening-level transfer coefficient

(TC)and a dermal absorption factor of 50%. The following scenarios were assessed for residential turf post-application exposures and risks: a. Toddlers Playing on Treated Turf b. Adults Performing Yard work on Treated Turf c. Adults Playing Golf on Treated Turf A turf transferable residue

(TTR)study was used to assess the turf exposures. The field portion of this study was in North Carolina and California. The initial TTR for dermal exposures was assumed to be 2.4% of the application rate and was based upon an average of the days after treatment

(DAT)of 0 and DAT of 3 for the California site. The maximum application rate for turf of 0.62-0.68 pounds active ingredient per acre (lb ai/A) was use to assess the turf exposures. Additional information on residential exposure assumptions can be found at *http://www.regulations.gov* (Docket ID number EPA-HQ-OPP-2006-0282-0005, pages 13 through 17). 5. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Myclobutanil is a member of the triazole-containing class of pesticides. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events (EPA, 2002). In conazoles, however, a variable pattern of toxicological responses is found. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's website at *http://www.epa.gov/pesticides/cumulative* . Myclobutanil is a triazole-derived pesticide. This class of compounds can form the common metabolite 1,2,4-triazole and two triazole conjugates (triazole alanine and triazole acetic acid). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, including myclobutanil, U.S. EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, triazole alanine, and triazole acetic acid resulting from the use of all current and pending uses of any triazole-derived fungicide. The risk assessment is a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high end estimates of both dietary and non-dietary exposures). In addition, the Agency retained the additional 10X FQPA safety factor for the protection of infants and children. The assessment includes evaluations of risks for various subgroups, including those comprised of infants and children. The Agency's complete risk assessment is found in the propiconazole reregistration docket at *http://www.regulations.gov* (Docket ID number EPA-HQ-OPP-2005-0497). D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . There is no indication of quantitative or qualitative increased susceptibility in rats or rabbits from *in utero* and/or postnatal exposure to myclobutanil. In the rat developmental toxicity study, maternal toxicity, which included rough hair coat and salivation, alopecia, desquamation and red exudate around mouth occurs at the same dose level as increases in incidences of 14th rudimentary and 7th cervical ribs in the fetuses. The maternal and developmental toxicity NOAELs in the rat developmental toxicity study were 93.8 mg/kg/day. EPA concludes that there is no evidence qualitative susceptibility in rat developmental toxicity study since the fetal variations (14th rudimentary ribs and 7th cervical ribs) are normal occurance control animals that occurred in the presence severe maternal toxicity (red exudate around mouth and salivation). In the rabbit developmental toxicity study there is reduced body weight and body weight gain during the dosing period, clinical signs of toxicity such as bloody urine and bloody urogenital or anal area and a possible increase in abortions (blood and/or aborted material in the cage pan) in the does at the same dose level as developmental toxicity manifested as increased resorptions, decreased litter size and decreased viability index. The maternal and developmental toxicity NOAELs in the rabbit developmental toxicity study were 93.8 mg/kg/day. EPA concludes that there is no evidence qualitative susceptibility in rabbit developmental toxicity study since the fetal effects (resorptions, decreased litter size and viability) occurred in the presence equally severe maternal toxicity (abortions, bloody urine and bloody urogenital or anal area). The maternal NOAEL in the 2-generation reproduction study was 50 ppm (2.5 mg/kg/day) based on hepatocellular hypertrophy and increased in liver weight seen at 200 ppm (10 mg/kg/day; LOAEL). The offspring toxicity NOAEL was 200 ppm (10 mg/kg/day) based on decreased in pup body weight gain during lactation seen at 1,000 ppm (50 mg/kg/day; LOAEL). The reproductive toxicity NOAEL was 200 ppm (10 mg/kg/day) based on increased incidences in the number of still born pups and atrophy of the testes, epididymides and prostate observed at 1,000 ppm (50 mg/kg/day; LOAEL). EPA concludes that there is no evidence on increased susceptibility (qualitative or quantitative) in the 2-generation reproduction study in rats because the offspring and reproductive toxicity were observed at a higher dose than the dose that caused maternal toxicity. 3. *Conclusion* . EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. The decision is base on the following findings: i. There is a complete toxicity data base for myclobutanil. ii. There was no evidence of increased susceptibility in the developmental toxicity studies with rats and rabbits. iii. A developmental neurotoxicity study is not required because neurotoxic compounds of similar structure were not identified and there was no evidence of neurotoxicity in the current toxicity database. iv. The exposure assessments will not underestimate the potential dietary (food and drinking water) and residential (non-occupational) exposures for infants and children from the use of myclobutanil. v. The acute dietary food exposure assessment (females 13-49 years old only) utilizes existing and proposed tolerance level residues and 100 PCT information for all commodities. By using these screening-level assessments, actual exposures/risks will not be underestimated. vi. The chronic dietary food exposure assessment utilizes existing and proposed tolerance level residues; USDA Pesticide Data Program

(PDP)monitoring data for apple juice, bananas (not plantains) and milk; average PCT data for some commodities and 100 PCT information for all other registered and proposed uses. The chronic assessment is somewhat refined and based on reliable data and will not underestimate exposure/risk. vii. The dietary drinking water assessment utilizes water concentration values generated by model and associated modeling parameters, which are designed to provide conservative, health protective, high-end estimates of water concentrations which will not likely be exceeded. viii. The residential handler assessment is based upon the residential SOPs and utilized unit exposure data from the ORETF and the PHED. The residential post-application assessment is based upon chemical-specific turf transferable residue

(TTR)data and DFR data. The chemical-specific study data as well as the surrogate study data used are reliable and also are not expected to underestimate risk to adults as well as to children. In a few cases where chemical-specific data were not available, the SOPs were used alone. The residential SOPs are based upon reasonable “worst-case” assumptions and are not expected to underestimate risk. These assessments of exposure are not likely to underestimate the resulting estimates of risk from exposure to myclobutanil. E. Aggregate Risks and Determination of Safety 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to myclobutanil will occupy 2.4% of the acute Adjusted Population Dose

(aPAD)for females 13 years and older. No endpoint was identified for the general U.S. population or any other population subgroup. Therefore, EPA does not expect the aggregate exposure to exceed 100% of the aPAD. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to myclobutanil from food and water will utilize 10% of the chronic Population Adjusted Dose

(cPAD)for the U.S. population, 17% of the cPAD for all infants less that 1 year old, and 25% of the cPAD for children 1-2 years old, the subpopulation at greatest exposure. There are no residential uses for myclobutanil that result in chronic residential exposure. Therefore, chronic residential exposure to residues of myclobutanil is not expected. EPA does not expect the aggregate exposure to exceed 100% of the cPAD. 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). The short-term aggregate risk assessments estimate risks likely to result from 1-30 days of exposure to myclobutanil residues in food, drinking water, and residential pesticide uses. Myclobutanil is currently registered for uses that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food, water and short-term exposures for myclobutanil. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food, water and residential exposures aggregated result in aggregate margin of exposures

(MOEs)of 180 for the general U.S. population for handler exposures; 300 for the general U.S. population for home gardens post application exposures; 110 for the general U.S. population for “Pick Your Own” fruit tree post application exposures; 130 for the general U.S. population for heavy yard work for turf post application exposures; 1,300 for the general U.S. population for exposures when playing golf and 130 for children 1-2 years old when playing on the lawn post application exposures. These aggregate MOEs do not exceed the Agency's LOC for aggregate exposure to food, water and residential uses. Therefore, EPA does not expect short-term aggregate exposure to exceed the Agency's LOC. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). The intermediate-term aggregate risk assessment estimates risks likely to result from 1 to 6 months exposure to myclobutanil residues in food, drinking water, and residential pesticide scenarios. Myclobutanil is currently registered for uses that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and intermediate-term exposures for myclobutanil. Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that food, water, and residential exposures aggregated result in aggregate MOEs of 300 for the general U.S. population for home garden post application exposures; 110 for the general U.S. population for “Pick Your Own” fruit tree post application exposures; 130 for the general U.S. population for heavy yard work for turf post application exposures; 1,300 for the general U.S. population for exposures when playing golf and 130 for children 1-2 years old when playing on the lawn post application exposures. These aggregate MOEs do not exceed the Agency's LOC for aggregate exposure to food, water, and residential uses. Therefore, EPA does not expect intermediate-term aggregate exposure to exceed the Agency's LOC. 5. *Aggregate cancer risk for U.S. population* . The Agency has classified myclobutanil as Group E - not likely to be a human carcinogen. Myclobutanil was determined to be not carcinogenic in two acceptable animal studies. Myclobutanil is not expected to pose a cancer risk. 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to myclobutanil residues. IV. Other Considerations A. Analytical Enforcement Methodology An adequate enforcement method is available to enforce the proposed tolerances on soybeans and hops. Quantitation is by gas-liquid chromatography

(GLC)using a nitrogen/phosphorus (N/P) detector for myclobutanil and an electron capture detector

(Ni63)for residues measured as the alcohol metabolite. The EPA has conducted a successful method validation of Method 34S-88-10, and the method has been forwarded to the Food and Drug Administration

(FDA)for inclusion in Pesticide Analytical Method Volume II

(PAM)Vol. II. Enforcement methods for the established tolerances on livestock commodities are Methods 34S-88-22, 34S-88-15, 31S-87-02, and 34S-88-21 These methods have been submitted for publication in PAM II. These methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:

(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits There are no current Codex, Canadian or Mexican maximum residue limits

(MRLs)for residues of myclobutanil in/on soybeans. Therefore, harmonization is not an issue. There are no current Canadian or Mexican maximum residue limits

(MRLs)for residues of myclobutanil in/on hops. However, there is a Codex MRL of 2 ppm for the parent compound myclobutanil in/on hops, dry. EPA has concluded the submitted residue chemistry data support a tolerance of 10 ppm for residues of myclobutanil and its alcohol metabolite RH-9090 (free and bound). Therefore, harmonization with the Codex MRL is not possible. V. Conclusion Therefore, tolerances are established for combined residues of myclobutanil alpha-butyl-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile and its alcohol metabolite (alpha-(3-hydroxybutyl)-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile (free and bound), in or on hop, dried cones at 10 ppm; soybean, seed at 0.25 ppm; soybean, forage at 3.5 ppm; soybean, hay at 15 ppm; grain, aspirated fractions at 35 ppm; and soybean, refined oil at 0.40 ppm. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995

(UMRA)(Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: December 8, 2006. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.443 is amended: a. In paragraph (a), in the table, by alphabetically adding commodities to read as set forth below; and b. In paragraph (b), in the table, by removing the commodities “Hop, dried cone” and “Soybean”. § 180.443 Myclobutanil; tolerances for residues.

(a)* * * Commodity Parts per million * * * * * Grain, aspirated fractions 35 * * * * * Hop, dried cones 10 * * * * * Soybean, forage 3.5 Soybean, hay 15 Soybean, refined oil 0.40 Soybean, seed 0.25 [FR Doc. E6-21489 Filed 12-19-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2005-0532; FRL-8104-6] Dimethomorph; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a tolerance for residues of the fungicide, dimethomorph, (E,Z) 4-[3-(4- chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl] morpholine in or on brassica, head and stem, subgroup 5A. The Interregional Research Project No. 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540 requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective December 20, 2006. Objections and requests for hearings must be received on or before February 20, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION) . ADDRESSES: EPA has established a docket for this action under docket identification

(ID)number EPA-HQ-OPP-2005-0532. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)305-7610; e-mail address: *jackson.sidney@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2005-0532 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before February 20, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2005-0532, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of March 10, 2006 (71 FR 12356) (FRL-7761-6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4E6848) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.493 be amended by establishing a tolerance for residues of the fungicide, dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl] morpholine in or on Brassica head and stem (Subgroup 5A) at 2.0 parts per million (ppm). That notice included a summary of the petition prepared by BASF, the registrant. There were no comments received in response to the notice of filing. Supporting documents including the Agency's Human Health Risk Assessment of dimethomorph and other documents are available at *www.regulations.gov* under the index of the docket for this action, docket ID number EPA-HQ-OPP-2005-0537. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of dimethomorph on brassica, head and stem, subgroup 5A food commodities at 2.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the toxic effects caused by dimethomorph as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *www.regulations.gov* under docket ID number EPA-HQ-OPP-2005-0532; entitled, “Amended: Dimethomorph: Human Health Risk Assessment for Proposed Uses on Brassica Stem and Head Subgroup 5A”, dated November 15, 2006. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the LOAEL is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor

(UF)is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at *http://www.epa.gov/pesticides/health/human.htm* . A summary of the toxicological endpoints for dimethomorph used for human risk assessment can be found at *www.regulation.gov* under docket ID number EPA-HQ-OPP-2005-0532, entitled, “Amended: Dimethomorph: Human Health Risk Assessment for Proposed Uses on Brassica Stem and Head Subgroup 5A”, dated November 15, 2006. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Tolerances have been established (40 CFR 180.493) for the residues of dimethomorph, in or on a variety of raw agricultural commodities including: Brassica, leafy greens, subgroup 5B; lettuce, head; lettuce, leaf; potato, wet peel; taro, corm; taro, leaves; vegetable, bulb, group 3; vegetable, cucurbit, group 9; and vegetable, fruiting, group 8. Risk assessments were conducted by EPA to assess dietary exposures from dimethomorph in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for dimethomorph. A quantitative acute dietary exposure and risk assessment was therefore not conducted for dimethomorph. No acute risk is expected from exposure to dimethomorph. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. In conducting a Tier 1 chronic dietary risk assessment, the Agency made the following conservative assumptions: a. All commodities having dimethomorph tolerances contain residues at the level of the tolerance, and b. Treatment of 100% of all registered and proposed crops. iii. *Cancer* . EPA has classified dimethomorph “not likely” to be human carcinogen. Therefore, a quantitative cancer dietary exposure and risk assessment was not performed. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for dimethomorph in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of dimethomorph. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index* . Acute and chronic estimated drinking water concentrations (EDWCs) of dimethomorph in surface water were calculated using Generic Estimated Environmental Concentration (GENEEC) Model. Drinking water residues were then incorporated into the DEEM-FCID( TM ) into the food categories “water, direct, all sources” and “water, indirect, all sources.” Based on the Tier 1 GENEEC and Surface Water and Screening Concentrations in Ground Water (SCI-GROW) models, the EDWCs of dimethomorph for chronic exposures are 28.5 parts per billion

(ppb)for surface water and 0.30 ppb for ground water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Dimethomorph is not registered for use on any sites that would result in residential exposure. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to dimethomorph and any other substances and dimethomorph does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that dimethomorph has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . The toxicology data on dimethomorph provide no indication of enhanced sensitivity of infants and children based on the results from developmental studies conducted with rats and rabbits as well as a 2-generation reproduction study conducted with rats. There were no toxic effects observed in either the rat developmental toxicity or the rat 2-generation reproductive toxicity studies that were lower than doses which produced toxic effects in the parents. No developmental toxicity was demonstrated in the rabbit developmental toxicity study. The developmental and reproductive toxicity data did not indicate increased susceptibility of rats or rabbits to *in utero* and/or postnatal exposure. 3. *Conclusion* . EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: i. The toxicity database for dimethomorph is complete. ii. There is no evidence that dimethomorph results in increased susceptibility in *in utero* rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. iii. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% crop treated

(CT)and tolerance-level residues. Conservative ground water and surface water modeling estimates were used. Residential exposure to dimethomorph is not expected since there are no currently registered residential uses for the pesticide. E. Aggregate Risks and Determination of Safety In examining aggregate risk, the Agency takes into account all available reliable information concerning exposures from pesticide residues in food and other exposures including drinking water and potential residential exposure to pesticides from such uses as lawn care applications (turf), golf course and others. Aggregate risk assessment considerations must also include potential exposures from oral, dermal and inhalation routes. 1. *Acute risk* . No acute dietary toxicity endpoints were identified; no acute risk is expected from exposure to dimethomorph. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to dimethomorph from food + water will utilize 8.6% of the chronic population adjusted dose

(cPAD)for the U.S. population, 7.0% of the cPAD for all infants < 1 year, and 19.9% of the cPAD for children -2 years. There are no residential uses for dimethomorph that result in chronic residential exposure. Risk estimates for all population subgroups are below the Agency's LOC (do not exceed 100% of the cPAD). 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Dimethomorph is not registered for use on any sites that would result in residential exposure. Therefore, a short-tern aggregate risk assessment is not required. The aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's LOC. 4. *Intermediate-term risk* Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Dimethomorph is not registered for use on any sites that would result in residential exposure. Therefore, an intermediate-term risk assessment is not required. The aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's LOC. 5. *Aggregate cancer risk for U.S. population* . Dimethomorph has been classified as a Group E carcinogen showing no evidence of human carcinogenicity. This classification was based upon lack of evidence of carcinogenicity in rat and mice studies. The Agency concludes that the pesticidal uses of dimethomorph are not likely to pose a cancer risk to humans. 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to dimethomorph residues. IV. Other Considerations A. Analytical Enforcement Methodology A reliable method for the determination of dimethomorph residues in brassica, head and stem subgroup 5A exist; this method is the Food and Drug Administration

(FDA)Multi-Residue Method, Protocol D, as published in the Pesticide Analytical Manual I. In addition, the method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:

(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits There are no established or proposed Codex, Canadian or Mexican maximum residue limits or tolerance for dimethomorph in or on brassica, head and stem, subgroup 5A. V. Conclusion Therefore, the tolerance is established for residues of dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl] morpholine in or on brassica, head and stem, subgroup 5A at 2.0 ppm. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq.* , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995

(UMRA)(Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: December 8, 2006. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.493 is amended by alphabetically adding a commodity to the table in paragraph

(a)to read as follows: § 180.493 Dimethomorph; tolerance for residues.

(a)* * * Commodity Parts per million * * * * * Brassica, head and stem, subgroup 5A 2.0 * * * * * [FR Doc. E6-21499 Filed 12-19-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0823; FRL-8100-9] Azoxystrobin; Pesticide Tolerances for Emergency Exemptions AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a time-limited tolerance for combined residues of azoxystrobin and its *Z* isomer, on rice, wild. This action is in response to EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on rice, wild. This regulation establishes a maximum permissible level for combined residues of azoxystrobin in this food commodity. The tolerance expires and is revoked on December 31, 2009. DATES: This regulation is effective December 20, 2006. Objections and requests for hearings must be received on or before February 20, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION . ADDRESSES: EPA has established a docket for this action under docket identification

(ID)number EPA-HQ-OPP-2006-0823. All documents in the docket are listed on the regulations.gov website. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the Office of Pesticide Programs

(OPP)Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Libby Pemberton, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)308-9364; e-mail address: *Sec-18-Mailbox@epa.gov.* SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0823 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before February 20, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0823, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is

(703)305-5805. II. Background and Statutory Findings EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing time-limited tolerances for combined residues of the fungicide, azoxystrobin, methyl ( *E* )-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate and the *Z* isomer of azoxystrobin, methyl ( *Z* )-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate, on rice, wild at 5.0 parts per million (ppm). This tolerance expires and is revoked on December 31, 2009. EPA will publish a document in the **Federal Register** to remove the revoked tolerance from the Code of Federal Regulations (CFR). Section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical combined residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 of the FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party. Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” Section 18 of the FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act of 1996 (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166. III. Emergency Exemption for Azoxystrobin on Rice, Wild and FFDCA Tolerances The Minnesota Department of Agriculture declared a crisis exemption under FIFRA section 18 for the use of azoxystrobin on rice, wild for control of stem rot disease caused by *Nakataea sigmoidea* . Minnesota states that it appears that stem rot is widespread throughout the state and can cause significant damage. As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by combined residues of azoxystrobin and its *Z* isomer on rice, wild. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although this tolerance expires and is revoked on December 31, 2009, under section 408(l)(5) of the FFDCA, combined residues of the pesticide not in excess of the amount specified in the tolerance remaining on rice, wild after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the combined residues do not exceed a level that was authorized by this tolerance at the time of that application. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the combined residues are not safe. Because this tolerance is being approved under emergency conditions, EPA has not made any decisions about whether azoxystrobin meets EPA's registration requirements for use on rice, wild or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this tolerance serves as a basis for registration of azoxystrobin by a State for special local needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for any State other than Minnesota to use this pesticide on this crop under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for azoxystrobin, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT . IV. Aggregate Risk Assessment and Determination of Safety EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide combined residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of azoxystrobin and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for time-limited tolerances for combined residues of azoxystrobin and its *Z* isomer on rice, wild at 5.0 ppm. On August 23, 2006 the Agency published in the **Federal Register** a final rule (71 FR 49358) (FRL-8086-9) establishing tolerances for combined residues of azoxystrobin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2 *H* -1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1 *H* -isoindole-1,3(2 *H* )-dione in or on vegetable, foliage of legume, group 7; vegetable, fruiting, group 8 (except tomato); pea and bean, succulent shelled, subgroup 6B; pea and bean, dried shelled, except soybean, subgroup 6C; citrus, dried pulp; citrus, oil; and fruit, citrus, Group 10. When the Agency conducted the risk assessments in support of those tolerance actions, the Agency also assessed the use of azoxystrobin on wild rice under section 18 of FIFRA. Therefore, establishing the rice, wild tolerance will not change the most recent estimated aggregate risks resulting from use of azoxystrobin, as discussed in the August 23, 2006 **Federal Register** . Refer to the August 23, 2006 **Federal Register** document for a detailed discussion of the aggregate risk assessments and determination of safety. EPA relies upon those risk assessments and the findings made in the **Federal Register** document in support of this action. Based on the risk assessments discussed in the final rule published in the **Federal Register** of August 23, 2006, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to azoxystrobin combined residues. V. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (gas chromatography-nitrogen phosphorus detection) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:

(410)305-2905; e-mail address: * residuemethods@epa.gov* . B. International Residue Limits There are no Codex, Canadian or Mexican maximum residue limits established for azoxystrobin on rice, wild. VI. Conclusion Therefore, tolerances are established for combined residues of azoxystrobin, methyl ( *E* )-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate and the *Z* isomer of azoxystrobin, methyl ( *Z* )-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate, on rice, wild at 5.0 ppm. VII. Statutory and Executive Order Reviews This final rule establishes a time-limited tolerance under section 408 of the FFDCA. The Office of Management and Budget

(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995

(UMRA)(Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 exemption under section 408 of the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq* .) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VIII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: December 6, 2006. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.507 is amended by alphabetically adding the commodity “Rice, wild” to the table in paragraph

(b)to read as follows: § 180.507 Azoxystrobin; tolerances for residues.

(b)* * * Commodity Parts per million Expiration/revocation date * * * * * Rice, wild 5.0 12/31/09 * * * * * [FR Doc. E6-21498 Filed 12-19-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0177; FRL-8105-9] Glyphosate; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of glyphosate in or on sunflower; safflower; noni; pea, dry; and vegetable, legume, group 6 except soybean, and pea, dry. The Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective December 20, 2006. Objections and requests for hearings must be received on or before February 20, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION) . ADDRESSES: EPA has established a docket for this action under docket identification

(ID)number EPA-HQ-OPP-2006-0177. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)308-3194; e-mail address: *brothers.shaja@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at *http://www.epa.gpo/opptsfrs/home/guidelin.htm.* C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0177 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before February 20, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0177, by one of the following methods: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of March 29, 2006 (71 FR 15734) (FRL-7766-9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 4E6878 and 5E6987) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petitions requested that 40 CFR 180.364 be amended by establishing tolerances for residues of the herbicide glyphosate, ( *N* -phosphonomethyl)glycine, in or on sunflower and safflower at 25 parts per million

(ppm)(PP 4E6878); vegetable, legume, group 6, except soybean at 8.0 ppm (5E6987); and mulberry, Indian at 0.2 ppm (5E6987). Following review of the residue chemistry data, EPA determined that the commodities term and tolerance levels should be revised to the following: Sunflower at 85 ppm; safflower at 85 ppm; pea, dry at 8.0 ppm; vegetable, legume, group 6 except soybean and pea, dry at 5.0 ppm; and noni at 0.20 ppm. This notice included a summary of the petitions prepared by Monsanto, the registrant. There were no comments received in response to the notice of filing. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for tolerances for residues of glyphosate on sunflower at 85 ppm; safflower at 85 ppm; noni at 0.20 ppm; pea, dry at 8.0 ppm; and vegetable, legume, group 6 except soybean and pea, dry at 5.0 ppm. EPA's assessment of exposures and risks associated with establishing these tolerances follow. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the toxic effects caused by glyphosate as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *www.regulations.gov* . Docket ID EPA-HQ-OPP-2006-0177, Glyphosate Indian Mulberry and Dry Pea Human Health Risk Assessment, pages 10-11, and Glyphosate Safflower and Sunflower Human Health Risk Assessment, pages 12-14. To locate this information on the *Regulations.gov* website follow these steps: 1. Select “Advanced Search,” then “Docket Search” 2. In the “Keyword” field type the chemical name or insert the applicable “Docket ID number.” (example: EPA-HQ-OPP-2006-0177). 3 Click the “Submit” button. Follow the instructions on the regulations.gov website to view the index for the docket and access available documents. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which the LOAEL is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor

(UF)is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at *http://www.epa.gov/pesticides/health/human.htm* . A summary of the toxicological endpoints for glyphosate used for human risk assessment can be found at *www.regulations.gov,* Docket ID EPA-HQ-OPP-2006-0177, Glyphosate Indian Mulberry and Dry Pea Human Health Risk Assessment, pages 16-17, and Glyphosate Safflower and Sunflower Human Health Risk Assessment, pages 18-19. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Tolerances have been established 40 CFR 180.364 for the residues of glyphosate, in or on a variety of raw agricultural commodities. Additionally tolerances are established for meat, milk, poultry and egg. Risk assessments were conducted by EPA to assess dietary exposures from glyphosate in food as follows: i. *Acute exposure* . No acute effects were identified in the toxicological studies for glyphosate, therefore a quantitative acute dietary exposure assessment is not necessary. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the United States Department of Agriculture

(USDA)1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessment: The Tier 1 chronic dietary analysis for glyphosate is a conservative estimate of dietary exposure that used tolerance level residues and 100% percent crop treated (PCT). iii. *Cancer* . Glyphosate is classified as a not likely human carcinogen, so a cancer dietary exposure analysis is not necessary. 2. *Dietary exposure from drinking water* .The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for glyphosate in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of glyphosate. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/index.htm* . Glyphosate is registered for aquatic use to control weeds in water bodies. Therefore, the Agency estimated the concentration in surface water resulting from direct application to a water body 6 feet deep. This estimate is based on a dilution model that does not take into account degradation in the water body and partitioning into the water column-sediment phases. The estimate considered a single broadcast application at the maximum application rate of 3.75 lb of glyphosate free acid per acre. Based on a maximum total application rate of 3.75 pounds of glyphosate free acid per acre, the estimated concentration for use in the drinking water assessment is 230 g/L parts per billion (ppb). Based on the generic expected environmental concentration (GENEEC) and screening concentration in groundwater (SCI-GROW) models, the estimated environmental concentrations

(EECs)of glyphosate for acute exposures are estimated to be 21 ppb for surface water and 0.0038 ppb for ground water. The EECs for chronic exposures are estimated to be 0.83 ppb for surface water and 0.0038 ppb for ground water, based on glyphosate treatment in crops. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Glyphosate is currently registered for use on broadcast and spot treatments on home lawns and gardens. Glyphosate, isopropylamine salt is registered for broadcast and spot treatments on home lawns and gardens. Glyphosate products for homeowner use are packaged as ready-to-mix formulations and ready-to-use sprayers and are very common in home and garden stores in the U.S. Glyphosate products are also used by lawn care operators for broadcast and spot treatment weed control programs on homeowner lawns. Glyphosate products are also labeled for turf renovation. The risk assessment was conducted using the following residential exposure assumptions: Based on the registered residential use patterns, there is a potential for short-term dermal and inhalation exposures to homeowners who apply products containing glyphosate (residential handlers). Additionally, based on the results of environmental fate studies, there is a potential for short and intermediate-term post-application dermal exposures by adults and toddlers and incidental ingestion exposures by toddlers. However, since short or intermediate-term dermal or inhalation endpoints were not identified, no residential handler or post-application dermal assessment is necessary; only a post-application toddler assessment for incidental ingestion exposures was performed. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to glyphosate and any other substances and glyphosate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that glyphosate has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional UFs and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . Based on the available data, there was no evidence of quantitative or qualitative increased susceptibility following *in utero* glyphosate exposure to rats and rabbits, or following prenatal/postnatal exposure in the 2-generation reproduction study in rats. A developmental neurotoxicity study was not required. 3. *Conclusion* . EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: There is no evidence of quantitative or qualitative increased susceptibility of the young demonstrated in the prenatal developmental studies in rats and rabbits and prenatal/postnatal reproduction study in rats ii. the toxicology data base is complete iii. a developmental neurotoxicity study is not required; and iv. the dietary (food, drinking water, and residential) exposure assessments will not underestimate the potential exposures for infants and children. E. Aggregate Risks and Determination of Safety 1. *Acute risk* . There were no toxic effects attributable to a single dose. An endpoint of concern was not identified to quantitate an acute-dietary risk to the U.S. general population or to the subpopulation females 13-50 years old. Therefore, glyphosate is not expected to pose an acute risk. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to glyphosate from food and water will utilize 2% of the chronic population adjusted dose

(cPAD)for the U.S. population, 7% of the cPAD for all infants < 1 year old, and 5% of the cPAD for children 1-2 years old. Based on the use pattern, chronic residential exposure to residues of glyphosate is not expected. 3. *Short-term and Intermediate-term risk* . Short term and Intermediate term aggregate exposures take into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Glyphosate is currently registered for uses that could result in short and intermediate term residential exposures. Since the incidental oral ingestion exposure estimates for toddlers from residential turf exposures exceeded the incidental oral exposure estimates from post-application swimmer exposures, the Agency conducted this risk assessment using exposure estimates from the worst-case situation. No attempt was made to combine exposures from the swimmer and residential turf scenarios due to the low probability of both occurring concurrently. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 1,400 for children 1-2 years old (the most highly exposed population subgroup), and 4,610 for adults 20-49 years old. 4. *Aggregate cancer risk for U.S. population* . Glyphosate has been classified by the Cancer Peer Review Committee as “a Group E” chemical- negative as a human carcinogen - based on the absence of carcinogenicity in mice and rats. Therefore, a cancer risk assessment was not conducted. 5. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to glyphosate residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methods are available for analysis of residues of glyphosate in or on plant and livestock commodities. These methods include Gas Liquid Chromatography

(GLC)(Method I in Pesticides Analytical Manual II; the limit of detection is 0.05 ppm) and high-performance liquid chromatography

(HPLC)with fluorometric detection. These analytical methods are adequate for residue data collection and enforcement of the proposed tolerances of glyphosate in/on noni and dry peas. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:

(410)305-905; e-mail address: *residuemethods@epa.gov.* B. International Residue Limits The Codex Alimentarius Commission has established several maximum residue limits

(MRLs)for glyphosate residues in various commodities. The Codex and U.S. tolerances are in harmony with respect to MRL/tolerance expression; both regulate the parent glyphosate only. The proposed tolerance of 8.0 ppm in dry peas exceeds the existing Codex MRL of 5.0 ppm. This discrepancy is not expected to result in a trade barrier, however, because the United States accounts for only about 5% of world dry production and is not expected to be a significant exporter of this commodity. There are currently no Codex Maximum Residue Limits for residues of glyphosate on safflower, sunflower, or noni; therefore, there are no international harmonization issues associated with these commodities. V. Conclusion Therefore, the tolerances are established for residues of glyphosate, ( *N* -phosphonomethyl)glycine, in or on sunflower at 85 ppm; safflower at 85 ppm; noni at 0.20 ppm; pea, dry at 8.0 ppm; and vegetable, legume, group 6 except soybean and pea,dry at 5.0 ppm. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq.* , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995

(UMRA)(Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: December 6, 2006. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.364 is amended by alphabetically adding commodities to the table in paragraph

(a)to read as follows: § 180.364 Glyphosate; tolerances for residues.

(a)* * * Commodity Parts per million * * * * * Noni 0.20 * * * * * Pea, dry 8.0 * * * * * Safflower 85 * * * * * Sunflower 85 * * * * * Vegetable, legume, group 6 except soybean and pea,dry 5.0 * * * * *

(b)*Section 18 emergency exemptions* . [Reserved]

(c)*Tolerances with regional registrations* . [Reserved]

(d)*Indirect or inadvertent residues* . [Reserved] [FR Doc. E6-21490 Filed 12-19-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2005-0145; FRL-8107-8] Boscalid; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4′-chloro[1,1′-biphenyl]-2-yl) in or on leafy greens subgroup 4A, except head and leaf lettuce, and leafy petioles subgroup 4B. Interregional Research Project No. 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective December 20, 2006. Objections and requests for hearings must be received on or before February 20, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification

(ID)number EPA-HQ-OPP-2005-0145. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)305-6463; e-mail address: *madden.barbara@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at *http://www.epa.gpo/opptsfrs/home/guidelin.htm* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2005-0145 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before February 20, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2005-0145, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of June 14, 2006 (71 FR 34342-34344) (FRL-8070-8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 3E6791) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.589 be amended by establishing tolerances for residues of the fungicide boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl), in or on the raw agricultural commodities as follows: leafy greens subgroup 4A, expect head and leaf lettuce at 60 parts per million

(ppm)and leaf petioles subgroup 4B at 45 ppm. That notice included a summary of the petition prepared by BASF, the registrant. Comments on the notice of filing were received from one private citizen. EPA's response to these comments is discussed in Unit IV. C. EPA is also deleting several established tolerances in 180.589(a)(1) that are no longer needed as a result of this action. The revisions to 180.589(a)(1) are as follows: 1. Delete celery at 45 ppm, and replaced with leaf petioles, subgroup, 4B, at 45 ppm. 2. Delete spinach at 60 ppm, and replaced with leafy greens, subgroup 4A, except head and leaf lettuce, at 60 ppm. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* and *http://www.epa.gov/fedrgstr/EPA-PEST/2003/July/Day-30/p19357.htm* . III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for tolerances for residues of boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl), in or on the raw agricultural commodities as follows: leafy greens subgroup 4A, expect head and leaf lettuce at 60 ppm and leaf petioles subgroup 4B at 45 ppm. EPA's assessment of exposures and risks associated with establishing these tolerances follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the toxic effects caused by boscalid as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rule published in the **Federal Register** of July 30, 2003 (68 FR 44640) (FRL-7319-6) ( *http://www.epa.gov/fedrgstr/EPA-PEST/2003/July/Day-30/p19357.htm)* . B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor

(UF)is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at *http://www.epa.gov/pesticides/health/human.htm* . A summary of the toxicological endpoints for boscalid used for human risk assessment is discussed in Unit III.B. of the final rule published in the **Federal Register** of July 30, 2003 (68 FR 44640) (FRL-7319-6). C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Tolerances have been established 40 CFR 180.589 (a)(1) for the residues of boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4′-chloro[1,1′-biphenyl]-2-yl) in or on a variety of raw agricultural commodities. Tolerances have been established under 40 CFR 180.589(a)(2) for the combined residues of the fungicide boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4′-chloro[1,1′-biphenyl]-2-yl) and metabolites 2-chloro-N-(4′-chloro-5-hydroxy-biphenyl-2-yl)nicotinamide and glucuronic acid conjugate of 2-chloro-N-(4′-chloro-5-hydroxy-biphenyl-2-yl)nicotinamide in or on egg; milk; and fat, meat and meat byproducts of cattle, goat, hog, horse, poultry, and sheep. Risk assessments were conducted by EPA to assess dietary exposures from boscalid in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one-day or single exposure. No such effects were identified in the toxicological studies for boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl); therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: An unrefined, chronic dietary exposure assessment using tolerance-level residues, default processing factors, and assuming 100% crop treated

(CT)for all registered and proposed commodities was conducted for the general U.S. population and all population subgroups. iii. *Cancer* . A quantitative cancer exposure assessment is not necessary because EPA concluded that boscalid is unlikely to pose a carcinogenic risk to humans. This conclusion was based on the following weight of evidence considerations. First, in male Wistar rats, there was a significant trend (but not pairwise comparison) for the combined thyroid adenomas and carcinomas. This trend was driven by the increase in adenomas. Second, in the female rats, there was only a borderline significant trend for thyroid adenomas (there were no carcinomas). Third, the mouse study was negative as were all of the mutagenic tests. Based on this weak evidence of carcinogenic effects, the Agency concluded that boscalid is not expected to pose a carcinogenic risk. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for boscalid in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of boscalid. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm* . Based on the FIRST and SCI-GROW models, the estimated environmental concentrations

(EECs)of boscalid for acute exposures are estimated to be 87.53 parts per billion

(ppb)for surface water and 0.63 ppb for ground water. The EECs for chronic exposures are estimated to be 25.77 ppb for surface water and 0.63 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model (DEEM-FCID TM , Version 2.03). For chronic dietary risk assessment, the annual average concentration of 25.77 ppb was used to assess the contribution to drinking water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Boscalid is currently registered for use on turf. However, the boscalid registration for turf specifies that this product is intended for golf course use only, and not for use on residential turfgrass or turfgrass being grown for sale or other commercial use such as sod production. Although the registration does not indicate that the product is applied by licensed or commercial applicators, homeowners will not be applying the product to golf courses. Therefore, a risk assessment for residential handler exposure is not required. Boscalid is also registered for use on various fruit crops including U-pick operations. Based on these registrations the EPA determined there are two recreational scenarios associated with boscalid that could lead to non-dietary exposures for adults and children:Adults and youth golfing, and adults and children picking their own fruit. Because U-pick is a one-time event (duration <1 day) and the Agency found that the oral studies indicated there were no endpoints appropriate to quantitate acute risk, the U-pick exposure was not calculated. Therefore, only non-dietary exposure was estimated for the golfing scenario. The risk assessment was conducted using the following residential exposure assumptions: post-application exposures to individuals that occur as a result of being in an environment that has been previously treated with a pesticide. Due to residential application practices and the half-lives observed in the turf transferable residue study, intermediate- and long-term post-application exposures are not expected. Only short-term post application exposures are anticipated for golfers. The scenarios likely to result in dermal short-term exposures are as follows: Adult golfer dermal exposure from contacting treated turf, and adolescent golfer dermal exposure from contacting treated turf. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to boscalid and any other substances and boscalid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that boscalid has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. * In general* . Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure

(MOE)analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . There was no evidence of increased susceptibility in the developmental rat study as no developmental toxicity was seen at the highest dose tested (Limit Dose). There was evidence of qualitative (not quantitative) increased susceptibility in the developmental rabbit study as characterized by an increased incidence of abortions or early delivery at the highest dose tested (1,000 millogram/kilogram/day (mg/kg/day)). It could not be ascertained if the abortions were the result of a treatment-related effect on either the dams, the fetuses or both. There was quantitative evidence of increased susceptibility in the 2-generation reproduction study in rats, where decreases in body weights and body weight gains in male offspring were seen in the F2 generation at a dose that was lower than the dose that induced parental/systemic toxicity. The offspring NOAEL was 10.1/106.8 mg/kg/day in males and females, respectively, and the parental/systemic NOAEL was 101.2/1062.0 mg/kg/day in males and females, respectively. There was quantitative evidence of increased susceptibility in the developmental neurotoxicity study in rats, where decreases in pup body weights (PND 4) and body weight gains (PND 1-4) were seen in the absence of any maternal toxicity. The offspring toxicity NOAEL was 14 mg/kg/day and the maternal NOAEL was 1,442 mg/kg/day. The degree of concern is low for the qualitative evidence of susceptibility seen in the rabbit developmental study as the increased abortions or early delivery was seen only at the Limit Dose and not at the lower levels (i.e. a high-dose effect) and the abortions may have been due to maternal stress. The degree of concern is also low for the quantitative evidence of susceptibility seen in the 2-generation reproduction study in rats because the decreases in body weight and body weight gains were seen primarily in the F2 generation. These may have been due to exposure of the parental animals to high doses (above the Limit Dose). The dose selected for chronic dietary and non-dietary exposure risk assessments would address the concern for the body weight effects. Finally, the degree of concern is low for the quantitative evidence of susceptibility seen in the developmental neurotoxicity study because the decreases in pup body weights seen on postnatal days 1 through 4 (and not at any other time periods) were most likely due to maternal toxicity (the maternal animals were exposed to a very high dose exceeding the limit dose, i.e., 1,442 mg/kg/day); and no treatment-related effects on body weight, body weight gain or any other parameter were noted at postnatal day 21. EPA has concluded that there are no residual uncertainties for pre- and postnatal toxicity as the degree of concern is low for the susceptibility seen in the above studies, and the dose and endpoints selected for the overall risk assessments will address the concerns for the body weight effects seen in the offspring. Although the dose selected for overall risk assessments (21.8 mg/kg/day) is higher than the NOAELs in the 2-generation reproduction study (10.1 mg/kg/day) and the developmental neurotoxicity study (14 mg/kg/day), these differences are considered to be an artifact of the dose selection process in these studies. For example, there is a 10-fold difference between the LOAEL (106.8 mg/kg/day) and the NOAEL (10.1 mg/kg/day) in the two generation reproduction study. A similar pattern was seen with regard to the developmental neurotoxicity study, where there is also a 10-fold difference between the LOAEL (147 mg/kg/day) and the NOAEL (14 mg/kg/day). There is only a 2-3 fold difference between the LOAEL (57 mg/kg/day) and the NOAEL (21.8 mg/kg/day) in the critical study used for risk assessment. Because the gap between the NOAEL and LOAEL in the 2-generation reproduction and developmental neurotoxicity studies was large and the effects at the LOAELs were minimal, the true no-observed-adverse-effect-level was probably considerably higher. Therefore, the selection of the NOAEL of 21.8 mg/kg/day from the 1-year dog study is conservative and appropriate for the overall risk assessments. In addition, the endpoints for risk assessment are based on thyroid effects seen in multiple species (mice, rats and dogs) and after various exposure durations (subchronic and chronic exposures) which were not observed at the LOAELs in either the two-generation reproduction or the developmental neurotoxicity studies. 3. *Conclusion* . EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: The toxicity database for boscalid is complete and for the reasons explained above, there is low concern for pre- and postnatal toxicity. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. Conservative ground and surface water modeling estimates were used. Similarly conservative residential SOPs were used to assess post-application exposure to children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by boscalid. E. Aggregate Risks and Determination of Safety 1. *Acute risk* . As there were no toxic effects attributable to a single dose, an endpoint of concern was not identified to quantitate acute-dietary risk to the general population or to the subpopulation females 13-50 years old. No acute risk is expected from exposure to boscalid. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to boscalid from food and water will utilize 11% of the chronic population adjusted dose

(cPAD)for the U.S. population, 24% of the cPAD for all infants less than 1 year old, and 38% of the cPAD for children 1-2 years old, the most highly exposed population subgroup. There are no residential uses for boscalid that result in chronic residential exposure to boscalid. Therefore, EPA does not expect the aggregate exposure to exceed 100% of the cPAD. 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food, water, and residential exposures aggregated result in an aggregate margin of exposure

(MOE)of 1,400 for the general U.S. population. This MOE is considered to be representative of young golfers as well since young golfers and adults possess similar body surface area to weight ratios and because the dietary exposure for youth (13-19 years old) is less than that of the general U.S. population. Therefore the short-term aggregate risk and exposure is not of concern to the Agency. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because no intermediate term, non-occupational exposures are anticipated from the use of boscalid, boscalid is not expected to pose an intermediate-term risk. 5. *Aggregate cancer risk for U.S. population* . Based on the weight of evidence evaluation described previously herein, EPA concluded that boscalid is not expected to pose a carcinogenic risk to humans. 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to boscalid residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology, method D0008, gas chromatography/mass spectroscopy (GC/MS) for plants and Method DFG S19, gas chromatography/electron-capture detection electron-capture detection (GC/ECD) for animals is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:

(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits There are currently no International or Codex maximum residue levels

(MRLs)for boscalid. C. Response to Comments Several comments were received from a private citizen objecting to IR-4 proposing to increase the use of this pesticide and establishment of tolerances. The Agency has received these same comments from this commenter on numerous previous occasions. Refer to **Federal Register** 70 FR 37686 (June 30, 2005), 70 FR 1354 (January 7, 2005), 69 FR 63096-63098 (October 29, 2004) for the Agency's response to these objections. V. Conclusion Therefore, tolerances are established for residues of boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl), regulated chemical, in or on leafy greens subgroup 4A, except head and leaf lettuce at 60 ppm and leaf petioles subgroup 4B at 45 ppm. IR-4 is requesting the establishment of tolerances for leafy greens subgroup 4A, except head and leaf lettuce, and leaf petioles subgroup 4B. The Agency has approved celery and spinach residue data (previously submitted) and established tolerances for those commodities. These data satisfy the residue data requirements for the requested subgroups, and are accepted as surrogate data for the use of establishing tolerances. Therefore, leafy green subgroup 4A, except head and leaf lettuce, and leafy petioles subgroup 4B will replace the existing tolerances for celery and spinach, respectively. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq.* , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995

(UMRA)(Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: December 8, 2006. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.589 is amended in the table to paragraph (a)(1) by removing the commodities “celery” and “spinach” and by adding alphabetically new commodities to read as follows: § 180.589 Boscalid; tolerances for residues. (a)* * * (1)* * * Commodity Parts per million * * * * * Leafy greens, subgroup 4A, except head and leaf lettuce 60 Leafy petioles, subgroup 4B 45 * * * * * [FR Doc. E6-21491 Filed 12-19-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0655; FRL-8095-4] Metconazole; Pesticide Tolerances for Emergency Exemptions AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes time-limited tolerances for residues of the fungicide metconazole, 5-[(4-chlorophenyl)methyl]-2,2-dimethyl-1-(1 *H* -1,2,4-triazole-1-yl-methyl)cyclopentanol in or on aspirated grain fractions; egg; meat, fat and meat by-products of cattle, goat, hog, horse, poultry and sheep; milk; soybean, hulls; soybean, meal; soybean, refined oil; and soybean, seed. This action is associated with EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on soybeans. This regulation establishes a maximum permissible level for residues of metconazole in these food commodities. These tolerances will expire and be revoked on December 31, 2010. DATES: This regulation is effective December 20, 2006. Objections and requests for hearings must be received on or before February 20, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION . ADDRESSES: EPA has established a docket for this action under docket identification

(ID)number EPA-HQ-OPP-2006-0655. All documents in the docket are listed on the regulations.gov website. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the Office of Pesticide Programs

(OPP)Regulatory Public Docket in Room S-4400, One Potomac Yard (South Bldg.), 2777 South Crystal Dr. Arlington, VA 22202-3553. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Carmen Rodia, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)306-0327; fax:

(703)308-8041; e-mail address: *rodia.carmen@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, as amended by the Food Quality Protection Act of 1996 (FQPA), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0655 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before February 20, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0655, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs (OPP), Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Room S-4400, One Potomac Yard (South Bldg.), 2777 South Crystal Dr., Arlington, VA 22202-3553. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is

(703)305-5805. II. Background and Statutory Findings EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing time-limited tolerances for residues of the fungicide metconazole in or on aspirated grain fractions at 1.00 parts per million (ppm); egg at 0.02 ppm; meat, fat and meat by-products of cattle, goat, hog, horse, poultry and sheep at 0.02 ppm; milk at 0.02 ppm; soybean, hulls at 1.20 ppm; soybean, meal at 0.25 ppm; soybean, refined oil at 1.20 ppm; and soybean, seed at 0.10 ppm. These tolerances will expire and be revoked on December 31, 2010. EPA will publish a document in the **Federal Register** to remove the revoked tolerances from the Code of Federal Regulations (CFR). Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of the section 408 safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” Section 18 of the FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the FQPA. EPA has established regulations governing such emergency exemptions in 40 CFR part 166. III. Emergency Exemption for Metconazole on Soybeans and FFDCA Tolerances Australasian soybean rust

(SBR)is a plant disease caused by two fungal species, *Phakopsora pachyrhizi* and *P. meibomiae* , and is spread primarily by windborne spores that can be transported over long distances. SBR models suggest that most of the soybean acreage in the United States could be compromised by an SBR epidemic. In accordance with the 2002 Agricultural Bioterrorism Protection Act, SBR was identified by the United States Department of Agriculture

(USDA)as a select biological agent with the potential to pose a severe threat to the soybean industry and livestock production, in general. As such, USDA has invested in extensive readiness and outreach activities among soybean producers. The States of Minnesota and South Dakota petitioned EPA to allow under FIFRA section 18 the use of metconazole on soybeans for control of SBR in Minnesota and South Dakota. After having reviewed the submission, EPA concurs that emergency conditions exist for these States. As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of metconazole in or on aspirated grain fractions; egg; meat, fat and meat by-products of cattle, goat, hog, horse, poultry and sheep; milk; soybean, hulls; soybean, meal; soybean, refined oil; and soybean, seed. In doing so, EPA considered the safety standard in section 408(b)(2) of FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in section 408(l)(6) of FFDCA. Although these tolerances will expire and be revoked on December 31, 2010, under section 408(l)(5) of FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on aspirated grain fractions; egg; meat, fat and meat by-products of cattle, goat, hog, horse, poultry and sheep; milk; soybean, hulls; soybean, meal; soybean, refined oil; and soybean, seed after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these tolerances at the time of that application. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Because these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether metconazole meets EPA's registration requirements for use in soybeans or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of metconazole by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for growers in any State other than those in which State lead agencies have obtained an exemption to use this pesticide on this crop under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for metconazole, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT . IV. Aggregate Risk Assessment and Determination of Safety EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of metconazole and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for time-limited tolerances for residues of metconazole in or on aspirated grain fractions at 1.00 ppm; egg at 0.02 ppm; meat, fat and meat by-products of cattle, goat, hog, horse, poultry and sheep at 0.02 ppm; milk at 0.02 ppm; soybean, hulls at 1.20 ppm; soybean, meal at 0.25 ppm; soybean, refined oil at 1.20 ppm; and soybean, seed at 0.10 ppm. EPA's assessment of the dietary exposures and risks associated with establishing these tolerances follows. A. Toxicological Endpoints The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological endpoint. However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor

(UF)is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10x to account for interspecies differences and 10x for intraspecies differences. For dietary risk assessment (other than cancer), the Agency uses the UF to calculate an acute or chronic reference dose (aRfD or cRfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF. For non-dietary risk assessments (other than cancer) the UF is used to determine the level of concern (LOC). For example, when 100 is the appropriate UF (10x to account for interspecies differences and 10x for intraspecies differences), the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure

(MOE)= NOAEL/exposure) is calculated and compared to the LOC. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 - 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for metconazole used for human risk assessment is shown in Table 1 of this unit: **Table 1.—Summary of Toxicological Dose and Endpoints for Metconazole for Use in Human Risk Assessment** Exposure/Scenario Dose Used in Risk Assessment, UF FQPA SF and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary (U.S. general population including infants and children) Not applicable None An endpoint of concern (effect) attributable to a single exposure

(dose)for the U.S. general population was not identified in the oral toxicity studies reviewed. Acute Dietary (Females 13-49 years of age) NOAEL = 12.0 milligram/kilogram/day (mg/kg/day) UF = 100x Acute RfD = 0.12 mg/kg/day FQPA SF = 1x aPAD = acute RfD ÷ FQPA SF = 0.12 mg/kg/day Developmental toxicity—rat; LOAEL = 30.0 mg/kg/day based on increases in skeletal variations. Chronic Dietary (All populations) NOAEL= 4.3 mg/kg/day UF = 100x Chronic RfD = 0.04 mg/kg/day FQPA SF = 1x cPAD = chronic RfD ÷ FQPA SF = 0.04 mg/kg/day Chronic oral toxicity - rat; LOAEL = 13.1 mg/kg/day based on increased liver weights and associated hepatocellular lipid vacuolation and centrilobular hypertrophy observed in males. Similar effects were observed in females at 54 mg/kg/day, plus increased spleen weight. Short-Term Incidental Oral (1 to 30 days) NOAEL = 9.1 mg/kg/day UF = 100x LOC for MOE = 100 28-day oral toxicity - rat; LOAEL = 90.5 mg/kg/day based on decreased body weight gain in males, increased liver and kidney weight and hepatocellular hypertrophy and vacuolation in both sexes. Intermediate-Term Incidental Oral(1 to 6 months) NOAEL = 6.4 mg/kg/day UF =100 x LOC for MOE = 100 90-day oral toxicity—rat; LOAEL = 19.2 mg/kg/day based on hepatic vacuolation in males and increased spleen weight in females. Short-Term Dermal (1 to 30 days) NOAEL = 9.1 mg/kg/day UF = 100x (dermal absorption rate = 5%) LOC for MOE = 100 28-day oral toxicity—rat; LOAEL = 90.5 mg/kg/day based on decreased body weight gain in males, increased liver and kidney weight and hepatocellular hypertrophy and vacuolation in both sexes. Intermediate-Term Dermal(1 to 6 months) NOAEL = 6.4 mg/kg/day UF = 100x (dermal absorption rate = 5%) LOC for MOE = 100 90-day oral toxicity—rat; LOAEL = 19.2 mg/kg/day based on hepatic vacuolation in males and increased spleen weight in females. Long-Term Dermal (>6 months) NOAEL= 4.3 mg/kg/day UF = 100x (dermal absorption rate = 5%) LOC for MOE = 100 Chronic oral toxicity—rat; LOAEL = 13.1 mg/kg/day based on increased liver weights and associated hepatocellular lipid vacuolation and centrilobular hypertrophy observed in males. Similar effects were observed in females at 54 mg/kg/day, plus increased spleen weight. Short-Term Inhalation (1 to 30 days) NOAEL= 9.1 mg/kg/day UF = 100x (inhalation-absorption rate = 100% oral equivalent) LOC for MOE = 100 28-day oral toxicity—rat; LOAEL = 90.5 mg/kg/day based on decreased body weight gain in males, increased liver and kidney weight and hepatocellular hypertrophy and vacuolation in both sexes. Intermediate-Term Inhalation (1 to 6 months) NOAEL= 6.4 mg/kg/day UF = 100x (inhalation-absorption rate = 100% oral equivalent) LOC for MOE = 100 90-day oral toxicity—rat; LOAEL = 19.2 mg/kg/day based on hepatic vacuolation in males and increased spleen weight in females. Long-Term Inhalation (>6 months) NOAEL= 4.3 mg/kg/day UF = 100x (inhalation-absorption rate = 100% oral equivalent) LOC for MOE = 100 Chronic oral toxicity—rat; LOAEL = 13.1 mg/kg/day based on increased liver weights and associated hepatocellular lipid vacuolation and centrilobular hypertrophy observed in males. Similar effects were observed in females at 54 mg/kg/day, plus increased spleen weight. Cancer (oral, dermal, inhalation) Metconazole has been classified as “not likely to be carcinogenic in humans.” As a result, a quantified carcinogenic assessment (Q* approach) is not required for metconazole. B. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Metconazole is not currently registered for any use in the United States. An import tolerance has been established for metconazole on bananas. Risk assessments were conducted by EPA to assess dietary exposures from metconazole in food as follows: i. *Acute exposure* . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. The Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The acute dietary exposure analysis for metconazole was conducted for the proposed food use and drinking water. Except for drinking water, the acute analysis is based on Tier 1 assumptions of the proposed/recommended tolerance-level residues and 100% crop treated (CT). A Tier 2 drinking water assessment for the proposed use in soybeans was performed using the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) model with index reservoir

(IR)scenarios and percent cropped area

(PCA)adjustment factors. Estimated concentrations of metconazole in drinking water (from use in soybeans) were incorporated directly into the acute dietary risk assessment. ii. *Chronic exposure* . In conducting the chronic dietary risk assessment, the DEEM-FCID TM analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide CSFII and accumulated exposure to the chemical for each commodity. The chronic dietary exposure analysis for metconazole was conducted for the proposed food use and drinking water. Except for drinking water, the chronic analysis is based on Tier 1 assumptions of the proposed/recommended tolerance-level residues and 100% CT. A Tier 2 drinking water assessment for the proposed use in soybeans was performed using PRZM/EXAMS model with IR scenarios and PCA adjustment factors. As with the acute analysis, estimated concentrations of metconazole in drinking water (from use in soybeans) were incorporated directly into the chronic dietary risk assessment. As a result, all acute and chronic dietary risk estimates were less than the Agency's LOC for the U.S. general population and all population subgroups (i.e., they are all less than 100% of the aPAD and cPAD). iii. *Cancer* . Metconazole has been classified as “not likely to be carcinogenic in humans” based on convincing evidence that carcinogenic effects are not likely below a defined dose range. As a result, a quantified carcinogenic assessment (Q* approach) is not required for metconazole. 2. *Dietary exposure from drinking water* . The Agency used the PRZM/EXAMS to calculate estimated drinking water concentrations (EDWCs) for the use of metconazole in soybeans, using the IR scenarios and PCA adjustment factors. Thus, the estimated exposure concentrations for water are based on the proposed highest use rate. Ground water concentrations were estimated with the Screening Concentration in Ground Water (SCI-GROW) model. A Tier 2 drinking water assessment was conducted for the proposed use of metconazole in soybeans using the proposed maximum application rate of 0.07 lbs. a.i./acre with 2 applications per year and a 10- to 21-day RTI. The preharvest interval

(PHI)will be 30 days. Based on PRZM/EXAMS, the EDWCs for metconazole in surface water are 1.57 parts per billion

(ppb)and 0.48 ppb for acute and chronic (non-cancer) exposures, respectively. For chronic/cancer assessments, the 30-year annual average from PRZM/EXAMS is 0.34 ppb. The EDWC for both acute and chronic exposures is estimated as 0.04 ppb for ground water using the SCI-GROW model. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Metconazole is not registered for use on any sites that would result in residential exposure. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Metconazole is a member of the triazole-containing class of pesticides. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same sequence of major biochemical events (EPA, 2002). In conazoles, however, a variable pattern of toxicological responses is found. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation). It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's website at *http://www.epa.gov/pesticides/cumulative* . Metconazole is a triazole-derived pesticide. This class of compounds can form the common metabolite 1,2,4-triazole and two triazole conjugates (triazole alanine and triazole acetic acid). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, including metconazole, EPA conducted a human health risk assessment for exposure to 1,2 4-triazole, triazole alanine and triazole acetic acid resulting from the use of all current and pending uses of triazole-derived fungicide. The risk assessment is a highly conservative, screening-level evaluation in terms of hazards associated with the common metabolites (e.g., use of maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high-end estimates of both dietary and non-dietary exposures). In addition, the Agency retained the additional 10x FQPA safety factor for the protection of infants and children. The assessment includes evaluations of risks for various population subgroups, including those comprised of infants and children. The Agency's complete risk assessment is found in the propiconazole reregistration docket at *http://www.regulations.gov* , Docket ID number EPA-HQ-OPP-2005-0497-0013. C. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for pre- and/or post-natal toxicity and the completeness of the database on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. 2. *Developmental toxicity studies* . Developmental studies in rats and rabbits show some evidence of developmental effects (skeletal variations, post-implantation loss, reduction in fetal body weight), but only at dose levels that are maternally toxic. In the developmental toxicity study in rats, skeletal variations (predominantly lumbar ribs) occurred in the presence of maternal toxicity (decreased body weight gains). In the pre-natal developmental toxicity study in rabbits, developmental effects (increased post-implantation loss and reduced fetal body weights) were observed at the same dose that caused maternal toxicity (decreased body weight gains, reduced food consumption and alterations in hematology parameters). In the 2-generation reproduction study in rats with cis metconazole, offspring toxicity (reduced fetal body weights in F 1 and F 2 offspring) were observed only at the highest tested dose which also resulted in evidence of parental toxicity (reduced parental body weight gains and increased ovarian weight). The chemical is non-genotoxic and not likely to be carcinogenic below a defined dose range based on bioassays in the rat and the mouse combined with a lack of *in vitro* or *in vivo* mutagenicity. Metconazole did not demonstrate the potential for neurotoxicity in the four species (mouse, rat, dog and rabbit) tested. NOAELs/LOAELs are well characterized and are used as endpoints for appropriate risk assessments. There are adequate data in the metconazole toxicology database to characterize the potential for pre- and/or post-natal risks to infants and children: a 2-generation reproduction study in rats (cis-only isomer; one with the cis/trans mixture has been completed and will be submitted in the near future); a developmental study in rats; and several developmental studies with rabbits. The effects seen in these studies do not suggest that pups are more susceptible: pup effects were only seen in the presence of maternal toxicity and, in general, were of comparable or less severity to the effects observed in adults. Thus, there are no residual uncertainties for pre- and/or post-natal exposure to metconazole and the Agency has determined that the special FQPA safety factor can be reduced to 1x. 3. *Reproductive toxicity study* . In the submitted 2-generation reproduction study in rats with cis metconazole, offspring toxicity (reduced fetal body weights in F1 and F2 offspring) was observed only at the highest tested dose, which also resulted in evidence of parental toxicity (reduced parental body weight gains and increased ovarian weight). As discussed in Unit IV.C.2., there are no residual uncertainties for pre- and/or post-natal exposure to metconazole. 4. *Pre-natal and post-natal sensitivity* . Please refer to the explanation provided in Unit IV.C.2. for a detailed discussion regarding “pre- and/or post-natal sensitivity.” 5. *Conclusion* . The Agency evaluated the quality of the hazard and exposure database for metconazole to characterize its potential for pre- and/or post-natal risks to infants and children. The effects observed in the developmental and reproductive studies do not suggest that pups are more susceptible; pup effects were only seen in the presence of maternal toxicity and, in general, were of comparable or less severity to the effects observed in adults. Thus, based on the hazard and exposure data, the special FQPA SF is reduced to 1x as there are low concerns and no residual uncertainties with regard to pre- and/or post-natal toxicity. D. Aggregate Risks and Determination of Safety EPA conducted human health risk assessments for acute, chronic and cancer dietary exposures (food + drinking water only) for the proposed use. Because there are no uses of metconazole that are expected to result in residential exposures, this aggregate risk assessment takes into consideration dietary (food + drinking water) exposure only; therefore, the acute and chronic aggregate estimates would be the same as the dietary exposure results. 1. *Acute risk* . Using the exposure assumptions discussed in this unit, the acute dietary exposure from food and water to metconazole will occupy 1% of the aPAD for females 13-49 years old, the population subgroup of concern. Given the proposed use, the Agency has no risk concern for exposure to metconazole through food and/or drinking water. EPA does not expect the aggregate exposure to exceed 100% of the aPAD. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to metconazole from food and water will utilize 2% of the cPAD for the U.S. general population and 5% of the cPAD for children 1-2 years old. There are no residential uses for metconazole that will result in chronic residential exposure to metconazole. Given the proposed use, the Agency has no risk concern for exposure to metconazole through food and/or drinking water. EPA does not expect the aggregate exposure to exceed 100% of the cPAD. 3. *Short- and intermediate-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and drinking water (considered to be a background exposure level). Intermediate-term aggregate exposure takes into account non-dietary, non-occupational exposure plus chronic exposure to food and drinking water (considered to be a background exposure level). Since metconazole is not registered for use on any sites that would result in residential exposure, short- and intermediate-term aggregate risk assessments are not needed. 4. *Aggregate cancer risk for U.S. population* . Metconazole is “not likely to be carcinogenic in humans” based on convincing evidence that carcinogenic effects are not likely below a defined dose range. A non-genotoxic mode of action for mouse liver tumors was established. No quantification is required. 5. *Determination of safety* . Based on all these considerations, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. general population and to infants and children from aggregate exposure to metconazole residues. V. Other Considerations A. Analytical Enforcement Methodology An adequate enforcement methodology (example—gas chromatography) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Road, Ft. Meade, MD 20755-5350; telephone number:

(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits No CODEX, Canadian or Mexican maximum residue limits

(MRLs)or tolerances have been established for metconazole in or on soybeans. Further, no provisional MRL has been established in Japan for imported soybeans. Therefore, international harmonization is not an issue at this time. VI. Conclusion Therefore, time-limited tolerances are established for residues of metconazole in or on aspirated grain fractions at 1.00 ppm; egg at 0.02 ppm; meat, fat and meat by-products of cattle, goat, hog, horse, poultry and sheep at 0.02 ppm; milk at 0.02 ppm; soybean, hulls at 1.20 ppm; soybean, meal at 0.25 ppm; soybean, refined oil at 1.20 ppm; and soybean, seed at 0.10 ppm. VII. Statutory and Executive Order Reviews This final rule establishes a time-limited tolerance under section 408 of FFDCA. The Office of Management and Budget

(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995

(UMRA)(Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 exemption under section 408 of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq* .) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175 requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VIII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: December 5, 2006. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.617 is amended by adding text and table to paragraph

(b)to read as follows: § 180.617 Metconazole; tolerances for residues.

(b)*Section 18 emergency exemptions* . Time-limited tolerances are established for residues of the fungicide metconazole, 5-[(4-chlorophenyl)methyl]-2,2-dimethyl-1-(1 *H* -1,2,4-triazole-1-yl-methyl)cyclopentanol in or on aspirated grain fractions; egg; meat, fat and meat by-products of cattle, goat, hog, horse, poultry and sheep; milk; soybean, hulls; soybean, meal; soybean, refined oil; and soybean, seed in connection with the use of the pesticide under section 18 emergency exemptions granted by EPA. The tolerances will expire and be revoked on the date specified in the following table. Commodity Parts per million Expiration/revocation date Aspirated grain fractions 1.00 12/31/10 Cattle, fat 0.02 12/31/10 Cattle, meat 0.02 12/31/10 Cattle, meat byproducts 0.02 12/31/10 Egg 0.02 12/31/10 Goat, fat 0.02 12/31/10 Goat, meat 0.02 12/31/10 Goat, meat byproducts 0.02 12/31/10 Hog, fat 0.02 12/31/10 Hog, meat 0.02 12/31/10 Hog, meat byproducts 0.02 12/31/10 Horse, fat 0.02 12/31/10 Horse, meat 0.02 12/31/10 Horse, meat byproducts 0.02 12/31/10 Milk 0.02 12/31/10 Poultry, fat 0.02 12/31/10 Poultry, meat 0.02 12/31/10 Poulty, meat byproducts 0.02 12/31/10 Sheep, fat 0.02 12/31/10 Sheep, meat 0.02 12/31/10 Sheep, meat byproducts 0.02 12/31/10 Soybean, hulls 1.20 12/31/10 Soybean, meal 0.25 12/31/10 Soybean, refined oil 1.20 12/31/10 Soybean, seed 0.10 12/31/10 [FR Doc. E6-21493 Filed 12-19-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0942; FRL-8105-4] Extension of Tolerances for Emergency Exemptions (Multiple Chemicals) AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation extends time-limited tolerances for the pesticides listed in this document. These actions are in response to EPA's granting of emergency exemptions under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of these pesticides. Section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA) requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA. DATES: This regulation is effective December 20, 2006. Objections and requests for hearings must be received on or before February 20, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification

(ID)number EPA-HQ-OPP-2006-0942. All documents in the docket are listed on the regulations.gov website. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the Office of Pesticide Programs

(OPP)Regulatory Public Docket, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: See the table in this unit for the name of a specific contact person. The following information applies to all contact persons: Emergency Response Team, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Pesticide/CFR section Contact person Acibenzolar- *S* -methyl, 180.561 Mancozeb, 180.176 Libby Pemberton *pemberton.libby@epa.gov*

(703)308-9364 Bifenthrin, 180.442 Thiophanate-methyl, 180.371 Andrea Conrath *conrath.andrea@epa.gov*

(703)308-9356 Flufenacet, 180.527 Propyzamide, 180.317 Andrew Ertman *ertman.andrew@epa.gov*

(703)308-9367 Zoxamide, 180.567 Stacey Groce *groce.stacey@epa.gov*

(703)305-2505 SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action, if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult one of the persons listed in the table under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, as amended by the Food Quality Protection Act of 1996 (FQPA), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0942 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before February 20, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0942, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is

(703)305-5805. II. Background and Statutory Findings EPA published final rules in the **Federal Register** for each pesticide listed in this document. The initial issuance of these final rules announced that EPA, on its own initiative, under section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170) was establishing time-limited tolerances. EPA established the tolerances because section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances can be established without providing notice or time for public comment. EPA received requests to extend the use of these chemicals for this year's growing season. After having reviewed these submissions, EPA concurs that emergency conditions exist. EPA assessed the potential risks presented by residues for each pesticide. In doing so, EPA considered the safety standard in section 408(b)(2) of FFDCA, and decided that the necessary tolerance under section 408(l)(6) of FFDCA would be consistent with the safety standard and with FIFRA section 18. The data and other relevant material have been evaluated and discussed in the final rule originally published to support these uses. Based on that data and information considered, the Agency reaffirms that extension of these time-limited tolerances will continue to meet the requirements of section 408(l)(6) of FFDCA. Therefore, the time-limited tolerances are extended until the date listed. EPA will publish a document in the **Federal Register** to remove the revoked tolerances from the Code of Federal Regulations (CFR). Although these tolerances will expire and are revoked on the date listed, under section 408(l)(5) of FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on the commodity after that date will not be unlawful, provided the residue is present as a result of an application or use of a pesticide at a time and in a manner that was lawful under FIFRA, the tolerance was in place at the time of the application, and the residue does not exceed the level that was authorized by the tolerance. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Tolerances for the use of the following pesticide chemicals on specific commodities are being extended: 1. *Acibenzolar-S-methyl* . EPA has authorized under FIFRA section 18 the use of acibenzolar- *S* -methyl on onions for control of onion thrips, a vector of iris yellow spot virus in Colorado. This regulation extends time-limited tolerances for residues of acibenzolar- *S* -methyl (benzo(1,2,3)thiadiazole-7-carbothioic acid- *S* -methyl ester) in or on onion, dry bulb and onion, green at 0.05 parts per million

(ppm)for an additional 2½-year period. These tolerances will expire and are revoked on December 31, 2009. Time-limited tolerances were originally published in the **Federal Register** of February 16, 2005 (70 FR 7854) (FRL-7697-8). 2. *Bifenthrin* . EPA has authorized under FIFRA section 18 the use of bifenthrin on orchardgrass for control of the orchardgrass billbug in Oregon. This regulation extends time-limited tolerances for residues of the insecticide bifenthrin in or on orchardgrass, forage and orchardgrass, hay at 0.05 ppm for an additional 2½-year period. These tolerances will expire and are revoked on December 31, 2009. Time-limited tolerances were originally published in the **Federal Register** of July 26, 2002 (67 FR 48790) (FRL-7187-8). 3. *Flufenacet* . EPA has authorized under FIFRA section 18 the use of flufenacet on winter wheat for control of Italian ryegrass in Idaho, Oregon, and Washington. This regulation extends time-limited tolerances for combined residues of the herbicide *N* -(4-fluorophenyl)- *N* -(1-methylethyl)-2-[[-(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide and its metabolites (containing the 4-fluoro- *N* -methylethyl benzenamine) in or on wheat, grain at 1 ppm; wheat, forage at 10 ppm; wheat, hay at 2 ppm; wheat, straw at 0.50 ppm; meat, kidney at 0.50 ppm; fat of cattle, goat, horse, hog, and sheep at 0.05 ppm; and meat byproducts (other than kidney) of cattle, goat, horse, hog, and sheep at 0.10 ppm for an additional 2½-year period. These tolerances will expire and are revoked on December 31, 2009. Time-limited tolerances were originally published in the **Federal Register** of August 6, 1999 (64 FR 42839) (FRL-6091-9). 4. *Mancozeb* . EPA has authorized under FIFRA section 18 the use of mancozeb on ginseng for control of stem and leaf blight in Michigan and Wisconsin. This regulation extends a time-limited tolerance for combined residues of the fungicide mancozeb (calculated as zinc ethylenebisdithiocarbamate and its metabolite, ethylenethiourea (ETU)), in or on ginseng, root at 2.0 ppm for an additional 3-year period. This tolerance will expire and is revoked on December 31, 2009. A time-limited tolerance was originally published in the **Federal Register** of October 9, 1998 (63 FR 54362) (FRL-6029-5). 5. *Propyzamide* . EPA has authorized under FIFRA section 18 the use of propyzamide on cranberries for control of dodder in Massachusetts, New Jersey, and Rhode Island. This regulation extends a time-limited tolerance for combined residues of the herbicide propyzamide and its metabolites (containing the 3,5-dichlorobenzoyl moiety and calculated as 3,5-dichloro- *N* -(1,1-dimethyl-2-propynyl)benzamide) in or on cranberry at 0.05 ppm for an additional 3-year period. This tolerance will expire and is revoked on December 31, 2009. A time-limited tolerance was originally published in the **Federal Register** of September 16, 1998 (63 FR 49479) (FRL-6022-5). 6. *Thiophanate-methyl* . EPA has authorized under FIFRA section 18 the use of thiophanate-methyl on blueberry for control of various fungal diseases in a number of States, including Connecticut, Indiana, Michigan, New Jersey, New York, Ohio, and Pennsylvania. This regulation extends a time-limited tolerance for combined residues of the fungicide thiophanate-methyl and its metabolite, methyl 2-benzimidazoyl carbamate (MBC), in or on blueberry at 1.5 ppm for an additional 2½-year period. This tolerance will expire and is revoked on December 31, 2009. A time-limited tolerance was originally published in the **Federal Register** of September 12, 2002 (67 FR 57748) (FRL-7196-5). 7. *Thiophanate-methyl* . EPA has authorized under FIFRA section 18 the use of thiophanate-methyl on citrus for control of post-bloom fruit drop in Florida and Louisiana. This regulation extends a time-limited tolerance for combined residues of the fungicide thiophanate-methyl and its metabolite, MBC, in or on citrus at 0.5 ppm for an additional 2½-year period. This tolerance will expire and is revoked on December 31, 2009. A time-limited tolerance was originally published in the **Federal Register** of September 12, 2002 (67 FR 57748) (FRL-7196-5). 8. *Zoxamide* . EPA has authorized under FIFRA section 18 the use of zoxamide on ginseng for control of phytophthora blight in Michigan and Wisconsin. This regulation extends a time-limited tolerance for residues of the fungicide zoxamide (3,5-dichloro- *N* -(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide) in or on ginseng at 0.06 ppm for an additional 3-year period. This tolerance will expire and is revoked on December 31, 2009. A time-limited tolerance was originally published in the **Federal Register** of March 31, 2004 (69 FR 16800) (FRL-7349-3). III. Statutory and Executive Order Reviews This final rule establishes time-limited tolerances under section 408 of FFDCA. The Office of Management and Budget

(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866 due to its lack of significance, this final rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995

(UMRA)(Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established under section 408(l)(6) of FFDCA in response to an exemption under FIFRA section 18, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq* .) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132, requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this final rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This final rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this final rule. IV. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this final rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: December 6, 2006. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. § 180.176 [Amended] 2. In § 180.176, in the table to paragraph (b), amend the entry ginseng, root by removing the expiration date “12/31/06” and adding in its place “12/31/09.” § 180.317 [Amended] 3. In § 180.317, in the table to paragraph (b), amend the entry cranberry by removing the expiration date “12/31/06” and adding in its place “12/31/09.” § 180.371 [Amended] 4. In § 180.371, in the table to paragraph (b), amend the entries blueberry and citrus by removing the expiration date “6/30/07” and adding in its place “12/31/09.” § 180.442 [Amended] 5. In § 180.442, in the table to paragraph (b), amend the entries orchardgrass, forage and orchardgrass, hay by removing the expiration date “6/30/07” and adding in its place “12/31/09.” § 180.527 [Amended] 6. In § 180.527, in the table to paragraph (b), amend the entries cattle, fat; cattle, kidney; cattle, meat; cattle, meat byproducts; goat, fat; goat, kidney; goat, meat; goat, meat byproducts; hog, fat; hog, kidney; hog, meat; hog, meat byproducts; horse, fat; horse, kidney; horse, meat; horse, meat byproducts; sheep, fat; sheep, kidney; sheep, meat; sheep, meat byproducts; wheat, forage; wheat, grain; wheat, hay; and wheat, straw by removing the expiration date “6/30/07” and adding in its place “12/31/09.” § 180.561 [Amended] 7. In § 180.561, in the table to paragraph (b), amend the entries onion, dry bulb and onion, green by removing the expiration date “6/30/07” and adding in its place “12/31/09.” § 180.567 [Amended] 8. In § 180.567, in the table to paragraph (b), amend the entry ginseng by removing the expiration date “12/31/06” and adding in its place “12/31/09.” [FR Doc. E6-21506 Filed 12-19-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2005-0536; FRL-8107-7] Fluroxypyr; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for combined residues of fluroxypyr in or on onion, bulb; garlic, bulb; and shallot, bulb. The Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective December 20, 2006. Objections and requests for hearings must be received on or before February 20, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under Docket identification

(ID)number EPA-HQ-OPP-2005-0536. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov.* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 703-308-3194; e-mail address: *brothers.shaja@epa.gov.* SUPPLEMENTARY INFORMATION: I. General Information A. Does This Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of This Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov.* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr.* You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr.* C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify Docket ID number EPA-HQ-OPP-2005-0536 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before February 20, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by Docket ID number EPA-HQ-OPP-2005-0536, by one of the following methods: • Federal eRulemaking Portal: *http://www.regulations.gov.* Follow the on-line instructions for submitting comments. • *Mail:* Office of Pesticide Programs

(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery:* OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of April 21, 2006 (71 FR 20661) (FRL-8065-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 3E6775) by IR-4, 500 College Road East, Suite 201 West, Princeton, NJ 08540. The petition requested that 40 CFR 180.535 be amended by establishing tolerances for combined residues of the herbicide fluroxypyr, 1-methylheptyl ester [1-methylheptyl ((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetate] and its metabolite fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid], in or on garlic and shallot (bulb), and onion (dry bulb) at 0.03 parts per million (ppm). The notice included a summary of the petition prepared by Dow AgroSciences, the registrant. Comments on the notice of filing were received from one private citizen. EPA's response to these comments is discussed in Unit IV.C. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in 4 residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. * * *” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.* III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for tolerances for combined residues of fluroxypyr on onion, bulb; garlic, bulb; and shallot, bulb at 0.03 ppm. EPA's assessment of exposures and risks associated with establishing the tolerances follow. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the toxic effects caused by fluroxypyr as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies can be found at *http://www.regulations.gov.* Docket ID number EPA-HQ-OPP-2005-0536, Fluroxypyr Field Corn Human Health Risk Assessment, pages 12-15. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty, factor

(UF)is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at *http://www.epa.gov/pesticides/health/human.htm.* A summary of the toxicological endpoints for fluroxypyr used for human risk assessment can be found at *www.regulations.gov* . Docket ID number EPA-HQ-OPP-2005-0536, Fluroxypyr Field Corn Human Health Risk Assessment, page 13; and Fluroxypyr Dry Bulb Onion Human Health Risk Assessment, pages 17-18. C. *Exposure Assessment* 1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.535) for the combined residues of fluroxypyr, in or on the following raw agricultural commodities: Barley, corn, grain, oat, sorghum, and wheat. Tolerances are also established for cattle, goat, hog, horse, sheep, and milk. Additionally, time limited tolerances are established in 40 CFR 180.535(b) in or on corn and onion. Risk assessments were conducted by EPA to assess dietary exposures from fluroxypyr in food as follow: i. *Acute exposure.* There were no toxic effects attributable to a single dose. An endpoint of concern was not identified to quantitate an acute-dietary risk to the U.S. general population or to the subpopulation females 13-50 years old. Therefore, an acute aggregate exposure assessment was not performed. ii. *Chronic exposure.* In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII); and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessment: An unrefined, Tier 1 chronic dietary-exposure assessment was conducted for all supported fluroxypyr food uses. In this assessment, tolerance level residues and 100% crop treated

(CT)was assumed for all crops included in the analysis. The assumptions result in highly conservative dietary exposure estimates. iii. *Cancer.* A cancer dietary assessment was not conducted since fluroxypyr has been classified as “not likely” to be carcinogenic. 2. *Dietary exposure from drinking water.* The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for fluroxypyr in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of fluroxypyr. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/index.htm* . Refined (Tier II) surface water concentrations were developed for fluroxypyr with the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) model, using an index reservoir scenario for the aerial application of fluroxypyr on rangeland and permanent grass pastures. The model assumes that fluroxypyr is applied at the maximum label rate (0.5 lb ae/acre). The estimated annual average environmental concentration of fluroxypyr in surface water is 3.3 parts per billion (ppb). For the ground water estimated concentration, the Tier I Screening Concentration in Ground Water (SCI-GROW) model predicts that fluroxypyr will be found at relatively small concentrations when the herbicide is applied at the maximum recommended application rate of 0.5 lbs ae/acre. The estimate is 0.042 ppb (0.042 μg/L). This conservative estimate is a default value generated by the SCI-GROW model. Based on the PRZM/EXAMS and SCI-GROW models, the estimated environmental concentrations

(EECs)of fluroxypyr for surface water are estimated to be 3.3 ppb, and 0.04 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model (DEEM-FCID TM ). For chronic dietary risk assessment, the annual average concentration of 3.3 ppb was used to access the contribution to drinking water. 3. *From non-dietary exposure.* The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Fluroxypyr (Vista TM ) is registered for application to residential turfgrass and recreational sites such as golf courses, parks, and sports fields. The proposed label does not prohibit homeowners from mixing/loading/applying Vista TM . Residential handlers may receive short-term dermal and inhalation exposure to fluroxypyr when mixing, loading and applying the formulations. Adults and children may be exposed to fluroxypyr residues from dermal contact with turf during post-application activities. Toddlers may also receive short and intermediate-term oral exposure from incidental ingestion during post-application activities. In conducting the short and intermediate-term aggregate risk assessments, the Agency made the following conservative assumptions. • Incidental oral and inhalation exposures for the aggregate residential handler scenario included children and adults (U.S. population subgroup). • Incidental oral exposure from treated areas included infants and children (up to age 12) for the aggregate post-application scenario. • Inhalation exposure resulting from residential application included youth (age 13-19 years old), and the adult population subgroups. 4. * Cumulative effects from substances with a common mechanism of toxicity.* Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to fluroxypyr and any other substances and fluroxypyr does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that fluroxypyr has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's Web site at *http://www.epa.gov/pesticides/cumulative.* D. Safety Factor for Infants and Children 1. *In general.* Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity.* There was no evidence (quantitative/qualitative) of increased susceptibility following in utero exposure to the acid and the ester in rats and rabbits, or following prenatal and/or postnatal exposure to the acid form in rats. 3. *Conclusion.* EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: • The toxicity database for fluroxypyr is complete. • There was no evidence of neurotoxicity or neuropathology in the available studies. • There was no evidence (quantitative/qualitative) of increased susceptibility following pre and/or postnatal exposure. • The chronic dietary food exposure assessment utilizes tolerance level residue estimates and assumes 100% CT for all commodities. This assessment is not likely to underestimate exposure/risk. • The dietary drinking water assessment utilizes water concentration values generated by model and associated modeling parameters designed to provide conservative, health protective, high-end estimates of water concentrations which will not likely be exceeded. • The residential exposure assessment was conducted using standard assumptions based on carefully reviewed data. E. Aggregate Risks and Determination of Safety 1. *Acute risk.* There were no toxic effects attributable to a single dose. An endpoint of concern was not identified for any population subgroup. Therefore, fluroxypyr is not expected to pose an acute risk. 2. *Chronic risk.* Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to fluroxypyr from food and water will utilize <1% of the cPAD for the U.S. population, <1% of the cPAD for all infants <1 year old, and 1.4% of the cPAD for children 1-2 years old. Based on the use pattern, chronic residential exposure to residues of fluroxypyr is not expected. 3. *Short and intermediate-term risk.* Short and intermediate-term aggregate exposures are likely to result from exposure to fluroxypyr residues from food, drinking water, and residential pesticide uses. High-end estimates are used for residential exposure, while average values are used for food and drinking water. Short and intermediate-term risk assessments are required for adults (residential handler inhalation exposure scenario), in addition to infants and children (residential post-application oral exposure scenario). Using the exposure assumptions described for non-dietary short and intermediate-term exposures, EPA has concluded that food, water, and residential exposures aggregated result in aggregate MOEs from 4,400 to 54,000 (adults 50+ years old). The MOEs are 8,300 and 4,400 for the U.S. population, and children 1-2 years old (the most highly exposed subgroup), respectively. 4. *Aggregate cancer risk for U.S. population.* Fluroxypyr has been classified as “not likely” to be carcinogenic. Therefore, fluroxypyr is not expected to pose a cancer risk. 5. *Determination of safety.* Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to fluroxypyr residues. IV. Other Considerations A. Analytical Enforcement Methodology The gas chromatography/mass-selective detector (GC/MSD) analytical method used to determine residues of fluroxypyr in both the acid and methylheptyl ester forms is adequate to recover residues of fluroxypyr and fluroxypyr 1-MHE in dry bulb onions. The method converts the methylheptyl ester form of fluroxypyr to the acid and results are reported as the acid equivalent. The lower limit of method validation

(LLMV)for bulb onions was 0.01 ppm. Further, the method is an adaptation of a Dow AgroSciencesmethod GRM 96.02, which has been adequately validated as an enforcement method; therefore the Agency considers the modified method to be adequate to enforce the requested tolerance. Adequate enforcement methodology (GC/MSD) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:

(410)305-2905; e-mail address: *residuemethods@epa.gov.* B. International Residue Limits There are currently no Codex, Canadian, or Mexican maximum residue limits for fluroxypyr or its metabolites in/on dry bulb onions. C. Response to Comments A private citizen of Florham Park, New Jersey submitted public comments on the fluroxypyr notice of filing. The private citizen commented on the cancer finding classification “not likely a carcinogen,” and views the statement deceptive. *EPA's response:* The cancer classification “Not Likely to be Carcinogenic to Humans” comes from EPA's Guidelines for Carcinogen Risk Assessment. These Guidelines recommend this descriptor when the available data are considered robust for deciding that there is no basis for human hazard concern. These Guidelines were developed as part of an Agency-wide guidelines development program by a Technical Panel of the U.S. EPA's Risk Assessment Forum, which was composed of scientists from throughout the Agency. Selected drafts were peer reviewed internally by the U.S. EPA's Science Advisory Board, and by experts from universities, environmental groups, industry and other governmental agencies. The Guidelines were also subjected to several public comment periods. For additional information regarding EPA's Guidelines for Carcinogen Risk and recommended descriptor language please refer to the **Federal Register** of April 7, 2005 (70 FR 17765) (FRL-7896-1) ( *http://www.epa.gov/fedrgstr/EPA-TOX/2005/April/Day-07/t6642.htm]* . The private citizen also commented on profiteers utilizing the Agency to promote poor products to the American citizens. *EPA's response:* This comment is not germane to EPA's statutory basis for acting on fluroxypyr tolerance petition. Thus, a technical response to this comment is not required. The private citizen's comments contained no scientific data or other substantive evidence to rebut the Agency's conclusion that there is a reasonable certainty that no harm will result from aggregate exposure to fluroxypyr from the establishment of these tolerances. V. Conclusion Therefore, the tolerances are established for combined residues of fluroxypyr, 1-methylheptyl ester [1-methylheptyl] ((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetate] and its metabolite fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid], in or on onion, bulb; garlic, bulb; and shallot, bulb at 0.03 ppm. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq.* , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995

(UMRA)(Pub. L. 104-4). Nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Goverument and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping, requirements. Dated: December 12, 2006. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—AMENDED 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.535 is amended by alphabetically adding commodities to the table in paragraph

(a)to read as follows: § 180.535 Fluroxypyr 1-methylheptyl ester; tolerances for residues.

(a)* * * Commodity Parts per million * * * * * Garlic, bulb 0.03 * * * * * Onion, bulb 0.03 Shallot, bulb 0.03 * * * * * [FR Doc. 06-9765 Filed 12-19-06; 8:45 am]

Notices. Final rule