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Code · REGISTER · 2007-06-06 · Food and Drug Administration, HHS · Rules and Regulations

Rules and Regulations. Final rule

15,329 words·~70 min read·/register/2007/06/06/07-2684

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 9111-14-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Spectinomycin Sulfate AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending the animal drug regulations to reflect approval of a supplemental new animal drug application
(NADA)filed by Pharmacia & Upjohn Co., a Div. of Pfizer, Inc. The supplemental NADA provides for revising nomenclature for two bovine respiratory pathogens on labeling for spectinomycin sulfate injectable solution. DATES: This rule is effective June 6, 2007. FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: *joan.gotthardt@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., a Div. of Pfizer, Inc., 235 E. 42d St., New York, NY 10017, filed a supplement to NADA 141-077 for ADSPEC (spectinomycin sulfate) Sterile Solution used for the treatment of bovine respiratory disease associated with several bacterial pathogens. The supplemental NADA provides for revising nomenclature for two bacterial pathogens on product labeling. The supplemental NADA is approved as of May 10, 2007, and the regulations in 21 CFR 522.2121 are amended to reflect the approval and a current format. Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required. The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 522 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is amended as follows: PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: Authority: 21 U.S.C. 360b. 2. Revise § 522.2121 to read as follows: § 522.2121 Spectinomycin sulfate.
(a)*Specifications* . Each milliliter of solution contains spectinomycin sulfate tetrahydrate equivalent to 100 milligrams
(mg)spectinomycin.
(b)*Sponsor* . See No. 000009 in § 510.600(c) of this chapter.
(c)*Related tolerances* . See § 556.600 of this chapter.
(d)*Conditions of use in cattle* —(1) *Amount* . 10 to 15 mg per kilogram of body weight at 24-hour intervals for 3 to 5 consecutive days.
(2)*Indications for use* . For the treatment of bovine respiratory disease (pneumonia) associated with *Mannheimia haemolytica, Pasteurella multocida* , and *Histophilus somni* .
(3)*Limitations* . Do not slaughter within 11 days of last treatment. Do not use in female dairy cattle 20 months of age or older. Use in this class of cattle may cause residues in milk. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dated: May 24, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7-10801 Filed 6-5-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF JUSTICE Bureau of Prisons 28 CFR Part 511 [BOP-1128] RIN 1120-AB28 Searching and Detaining or Arresting Non-Inmates AGENCY: Bureau of Prisons, Justice. ACTION: Final rule. SUMMARY: In this document, the Bureau of Prisons (Bureau) finalizes regulations on searching and detaining or arresting non-inmates. This revision reorganizes current regulations and makes changes that subject non-inmates to pat searches, either as random searches or based upon reasonable suspicion, as a condition of entry to a Bureau facility. DATES: This rule is effective July 6, 2007. FOR FURTHER INFORMATION CONTACT: Sarah Qureshi, Office of General Counsel, Bureau of Prisons, phone
(202)307-2105. SUPPLEMENTARY INFORMATION: In this document, the Bureau finalizes regulations on searching and detaining or arresting non-inmates. A proposed rule on this subject was published in the **Federal Register** on January 31, 2006 (71 FR 5026). We received four comments during the comment period. One was supportive of the rule. We respond to issues raised by the other three commenters below. *Comment: Bureau staff should receive equivalent testing/scanning as the regulation requires for visitors.* Two commenters expressed the opinion that Bureau staff should be subject to the same potential searches required for others seeking to enter Bureau facilities. In fact, Bureau employees are subject to search using the same search devices, methods, and technology employed to search other non-inmates seeking to enter Bureau facilities. Current Bureau policy regarding searching non-inmates states that, in accord with Bureau standards of employee conduct, the Bureau retains the right to conduct searches of employees when such a search is believed necessary to ensure institution security and good order. Also, at the beginning of their employment, every Bureau employee receives, and signs for, a copy of the Bureau's Program Statement on Standards of Employee Conduct and Responsibility. This policy, along with signs posted at the entrances to each Bureau facility, notifies employees that they may be subject to any of the types of searches described above. Further, policy states that an employee's refusal to undergo a search (including test) procedure is a basis for disciplinary action, including removal. The range of disciplinary actions that might be taken against an employee determined to be using illegal drugs, or introducing drugs or other forms of contraband, includes dismissal and criminal prosecution. *Comment: There are problems with the Bureau's use of ion spectrometers to perform searches.* Two commenters raised issues surrounding the Bureau's use of ion spectrometers. Essentially, both commenters raised issues regarding the accuracy of such devices with regard to detecting illegal substances. *Bureau's response:* At the outset, we note that the use of an ion spectrometry device is not the sole method of searching non-inmates, and may not be applied to search all non-inmates entering Bureau facilities. As the regulation explains, many types of searches may be conducted, including electronic searches, visual searches, pat searches, and urine surveillance testing, all with the primary goal of ensuring the safety, security and good order of Bureau facilities by reducing the introduction of contraband. Ion spectrometry technology is designed to detect the presence of microscopic traces of illegal drugs on non-inmates and their clothing and belongings. Beginning in 1997, the Bureau conducted extensive testing of ion spectrometry technology to scan non-inmates for drugs as they enter Bureau facilities. Based on the results of this program, the Bureau concluded that using ion spectrometry devices contributed to reducing the amount of contraband on Bureau grounds. Ion spectrometry technology is grounded in the well-established scientific principles of mass spectrometry and gas chromatography. Ion spectrometry devices are a minimally invasive method for screening people, packages, and cargo for traces of illegal substances. Although capable of identifying trace illegal substances within approximately the 1-5 nanogram range (one nanogram equals one billionth of a gram), the Bureau's machines are calibrated to register positive readings only at levels greater than those which may be casually encountered, for example by handling contaminated currency, using a public telephone, or shaking hands. The manufacturer of the Bureau's ion spectrometry devices claims a less than 1% rate of false positive results. We have found that delivery of illicit substances while visiting is a common method for such substances to be introduced into institutions. Such methods include non-inmates swallowing small balloons full of illicit substances before entering the facility, then excreting and delivering the contents once inside. When done by this method, the ion spectrometry device may indicate handling of the illicit substance, while a further visual search of the individual would fail to disclose its presence. Even if not directly transferred to the inmate while visiting, illicit substances can be secreted within the institution for later retrieval by inmates or others. With regard to non-inmates who test positive for the presence of illegal substances and are denied admission into a Bureau facility, under current policy on the ion spectrometry testing program, staff are required to give the non-inmate a written notice describing the reasons for denial of admission and the appeal process. All non-inmates may appeal denial of admission using the process set forth in the notice. *Comment: Searches/random searches are intrusive and unfair.* Two commenters expressed similar sentiments regarding the general concept of searching non-inmates wishing to enter Bureau facilities. One commenter stated that searches were unfair, and therefore discriminatory against non-inmates. The other commenter indicated that random searches were intrusive for non-inmates, and expressed particular concern regarding children. *Bureau's response:* First, we note that both commenters referred to random searches, and not searches based upon reasonable suspicion. Section 511.15(a)(1) requires that random searches be impartial and not discriminate among non-inmates on the basis of age, race, religion, national origin, or sex. Further, Bureau staff are held to the highest standards of professionalism and discretion when conducting searches. With regard to the commenter's concern regarding children, staff would exercise caution and compassion if it becomes necessary to search a child, to ensure that none of the child's rights are violated. However, instituting procedures requiring searches of non-inmates seeking to enter Bureau facilities is a necessity, originating from the need to prevent the introduction of contraband. The possibility of being searched (and the obvious notices so stating) acts as a minimally invasive deterrent to non-inmates seeking to introduce contraband, without unnecessarily or extremely burdening staff resources. Non-inmates are a significant source of contraband introduction into Bureau facilities. 18 U.S.C. 1791 prohibits providing an inmate a prohibited object in violation of a statute or rule issued under statute. Although other search methods, such as visual searches and electronic detection devices, enable us to search non-inmates before they enter Bureau facilities, a 2003 report by the Office of Inspector General found that non-inmates often found unique ways of introducing contraband that may have easily been detected or prevented by random pat searches of non-inmates entering Bureau facilities. We therefore must tighten security measures by instituting a system of random pat searches of non-inmates entering Bureau facilities. This will serve the dual purpose of preventing the introduction of contraband by its detection, and deterring non-inmates who may attempt to introduce contraband. The Bureau's overriding need to prevent introduction of contraband and/or confiscate contraband necessitates searches. In particular, random searches, (without reasonable suspicion) are permissible, especially if the non-inmate is given prior notice of the search, which therefore lowers the non-inmate's reasonable expectation of privacy when seeking entry to the prison facility, and consents to the search. *See Spear* v. *Sowders,* 71 F.3d 626 (6th Cir. 1995); *U.S.* v. *Johnson,* 27 F.3d 564 (unpublished) (4th Cir. 1994); *El* v. *Williams,* 1990 WL 65717 (unpublished) (E.D.Pa. 1990). In addition, we note that the more detailed searches, such as visual searches of the person, would only be performed based on the Warden's reasonable suspicion, as noted in § 511.16(c)(1)(B). Random visual searches of the person are prohibited. *Comment: It is not always possible to provide same-sex pat searches or visual searches, as indicated in the proposed rule.* One commenter was concerned that “although common law enforcement practice is to provide for same sex searches, in some cases this is not possible * * * [Requiring same sex searches] places the public at risk and undermines the professionalism of the Bureau of Prisons.” The commenter also expressed concern regarding situations where a staff member of the same sex cannot be located quickly enough to do a pat search or visual search, or when exigent circumstances necessitate searches by staff who are not the same sex as the non-inmate. *Bureau's response:* We agree with the commenter, and therefore clarify that pat searches, visual searches, and urine surveillance testing will be conducted by staff members of the same sex as the non-inmate being searched whenever possible. This concept is carried forth from the previous rule, § 511.12(f), which states that “[a] pat search, visual search, or urine surveillance test is to be conducted by a person of the same sex as the visitor.” We further strengthen this provision by also requiring that pat searches, visual searches, and urine surveillance testing will only be conducted by staff members of the opposite sex in emergency situations with the Warden's authorization. Executive Order 12866 This rule falls within a category of actions that the Office of Management and Budget
(OMB)has determined to constitute “significant regulatory actions” under section 3(f) of Executive Order 12866 and, accordingly, it was reviewed by OMB. Executive Order 13132 This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or on distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this regulation does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. Regulatory Flexibility Act The Director of the Bureau of Prisons, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and by approving it certifies that this regulation will not have a significant economic impact upon a substantial number of small entities for the following reasons: This regulation pertains to the correctional management of offenders committed to the custody of the Attorney General or the Director of the Bureau of Prisons, and its economic impact is limited to the Bureau's appropriated funds. Unfunded Mandates Reform Act of 1995 This regulation will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995. Small Business Regulatory Enforcement Fairness Act of 1996 This regulation is not a major rule as defined by § 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This regulation will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets. List of Subjects in 28 CFR Part 511 Prisoners. Harley G. Lappin, Director, Bureau of Prisons. Under rulemaking authority vested in the Attorney General in 5 U.S.C. 301; 28 U.S.C. 509, 510 and delegated to the Director, Bureau of Prisons in 28 CFR 0.96, we amend 28 CFR part 511 as follows. Subchapter A—General Management and Administration PART 511—GENERAL MANAGEMENT POLICY 1. Revise the authority citation for 28 CFR part 511 to read as follows: Authority: 5 U.S.C. 301; 18 U.S.C. 751, 752, 1791, 1792, 1793, 3050, 3621, 3622, 3624, 4001, 4012, 4042, 4081, 4082 (Repealed as to offenses committed on or after November 1, 1987), 5006-5024 (Repealed October 12, 1984 as to offenses committed after that date), 5039; 28 U.S.C. 509, 510. 2. Subpart B is revised as follows: Subpart B—Searching and Detaining or Arresting Non-Inmates Sec. 511.10 Purpose and scope. 511.11 Prohibited activities. 511.12 Prohibited objects. 511.13 Searches before entering, or while inside, a Bureau facility or Bureau grounds. 511.14 Notification of possible search. 511.15 When searches will be conducted. 511.16 How searches will be conducted. 511.17 When a non-inmate will be denied entry to or required to leave a Bureau facility or Bureau grounds. 511.18 When Bureau staff can arrest and detain a non-inmate. § 511.10 Purpose and scope.
(a)This subpart facilitates our legal obligations to ensure the safety, security, and orderly operation of Bureau of Prisons (Bureau) facilities, and protect the public. These goals are furthered by carefully managing non-inmates, the objects they bring, and their activities, while inside a Bureau facility or upon the grounds of any Bureau facility (Bureau grounds).
(b)*Purpose.* This subpart covers:
(1)Searching non-inmates and their belongings (for example, bags, boxes, vehicles, containers in vehicles, jackets or coats, etc.) to prevent prohibited objects from entering a Bureau facility or Bureau grounds;
(2)Authorizing, denying, and/or terminating a non-inmate's presence inside a Bureau facility or upon Bureau grounds; and
(3)Authorizing Bureau staff to remove from inside a Bureau facility or upon Bureau grounds, and possibly arrest and detain, non-inmates suspected of engaging in prohibited activity.
(c)*Scope/Application.* This subpart applies to all persons who wish to enter, or are present inside a Bureau facility or upon Bureau grounds, other than inmates in Bureau custody. This subpart applies at all Bureau facilities and Bureau grounds, including administrative offices. § 511.11 Prohibited activities.
(a)“Prohibited activities” include any activities that could jeopardize the Bureau's ability to ensure the safety, security, and orderly operation of Bureau facilities, and protect the public, whether or not such activities are criminal in nature.
(b)Examples of “prohibited activities” include, but are not limited to: Introducing, or attempting to introduce, prohibited objects into a Bureau facility or upon Bureau grounds; assisting an escape; and any other conduct that violates criminal laws or is prohibited by federal regulations or Bureau policies. § 511.12 Prohibited objects.
(a)“Prohibited objects,” as defined in 18 U.S.C. 1791(d)(1), include any objects that could jeopardize the Bureau's ability to ensure the safety, security, and orderly operation of Bureau facilities, and protect the public.
(b)Examples of “prohibited objects” include, but are not limited to, the following items and their related paraphernalia: Weapons; explosives; drugs; intoxicants; currency; cameras of any type; recording equipment; telephones; radios; pagers; electronic devices; and any other objects that violate criminal laws or are prohibited by Federal regulations or Bureau policies. § 511.13 Searches before entering, or while inside, a Bureau facility or Bureau grounds. Bureau staff may search you and your belongings (for example, bags, boxes, vehicles, containers in vehicles, jackets or coats, etc.) before entering, or while inside, any Bureau facilities or Bureau grounds, to keep out prohibited objects. § 511.14 Notification of possible search. We display conspicuous notices at the entrance to all Bureau facilities, informing all non-inmates that they, and their belongings, are subject to search before entering, or while inside, Bureau facilities or grounds. Furthermore, these regulations and Bureau national and local policies provide additional notice that you and your belongings may be searched before entering, or while inside, Bureau facilities or grounds. By entering or attempting to enter a Bureau facility or Bureau grounds, non-inmates consent to being searched in accordance with these regulations and Bureau policy. § 511.15 When searches will be conducted. You and your belongings may be searched, either randomly or based on reasonable suspicion, before entering, or while inside, a Bureau facility or Bureau grounds, as follows:
(a)*Random Searches.* This type of search may occur at any time, and is not based on any particular suspicion that a non-inmate is attempting to bring a prohibited object into a Bureau facility or Bureau grounds.
(1)Random searches must be impartial and not discriminate among non-inmates on the basis of age, race, religion, national origin, or sex.
(2)Non-inmates will be given the option of either consenting to random searches as a condition of entry, or refusing such searches and leaving Bureau grounds. However, if a non-inmate refuses to submit to a random search and expresses an intent to leave Bureau grounds, he or she may still be required to be searched if “reasonable suspicion” exists as described in paragraph
(b)of this section.
(b)*Reasonable Suspicion Searches.* Notwithstanding staff authority to conduct random searches, staff may also conduct *reasonable suspicion* searches to ensure the safety, security, and orderly operation of Bureau facilities, and protect the public. “Reasonable suspicion” exists if a staff member knows of facts and circumstances that warrant rational inferences by a person with correctional experience that a non-inmate may be engaged in, attempting, or about to engage in, criminal or other prohibited activity. § 511.16 How searches will be conducted. You may be searched by any of the following methods before entering, or while inside, a Bureau facility or Bureau grounds:
(a)*Electronically.*
(1)You and your belongings may be electronically searched for the presence of contraband, either randomly or upon reasonable suspicion.
(2)Examples of electronic searches include, but are not limited to, metal detectors and ion spectrometry devices.
(b)*Pat Search.*
(1)You and your belongings may be pat searched either randomly or upon reasonable suspicion.
(2)A pat search of your person or belongings involves a staff member pressing his/her hands on your outer clothing, or the outer surface of your belongings, to determine whether prohibited objects are present.
(3)Whenever possible, pat searches of your person will be performed by staff members of the same sex. Pat searches may be conducted by staff members of the opposite sex only in emergency situations with the Warden's authorization.
(c)*Visual Search.* You and your belongings may be visually searched as follows:
(1)*Person.*
(i)A visual search of your person involves removing all articles of clothing, including religious headwear, to allow a visual (non-tactile) inspection of your body surfaces and cavities.
(ii)Visual searches of your person must always be authorized by the Warden or his/her designee and based on reasonable suspicion; random visual searches are prohibited.
(iii)When authorized, visual searches will be performed discreetly, in a private area away from others, and by staff members of the same sex as the non-inmate being searched. Visual searches may be conducted by staff members of the opposite sex in emergency situations with the Warden's authorization.
(iv)Body cavity (tactile) searches of non-inmates are prohibited.
(2)*Belongings.* A visual search of your belongings involves opening and exposing all contents for visual and manual inspection, and may be done either as part of a random search or with reasonable suspicion.
(d)*Drug Testing.*
(1)You may be tested for use of intoxicating substances by any currently reliable testing method, including, but not limited to, breathalyzers and urinalysis.
(2)Drug testing must always be authorized by the Warden or his/her designee and must be based on reasonable suspicion that you are under the influence of an intoxicating substance upon entering, or while inside, a Bureau facility or Bureau grounds.
(3)Searches of this type will always be performed discreetly, in a private area away from others, and by staff members adequately trained to perform the test. Whenever possible, urinalysis tests will be conducted by staff members of the same sex as the non-inmate being tested. Urinalysis tests may be conducted by staff members of the opposite sex only in emergency situations with the Warden's authorization. § 511.17 When a non-inmate will be denied entry to or required to leave a Bureau facility or Bureau grounds. At the Warden's, or his/her designee's, discretion, and based on this subpart, you may be denied entry to, or required to leave, a Bureau facility or Bureau grounds if:
(a)You refuse to be searched under this subpart; or
(b)There is reasonable suspicion that you may be engaged in, attempting, or about to engage in, prohibited activity that jeopardizes the Bureau's ability to ensure the safety, security, and orderly operation of its facilities, or protect the public. “Reasonable suspicion,” for this purpose, may be based on the results of a search conducted under this subpart, or any other reliable information. § 511.18 When Bureau staff can arrest and detain a non-inmate.
(a)You may be arrested and detained by Bureau staff anytime there is probable cause indicating that you have violated or attempted to violate applicable criminal laws while at a Bureau facility, as authorized by 18 U.S.C. 3050.
(b)“Probable cause” exists when specific facts and circumstances lead a reasonably cautious person (not necessarily a law enforcement officer) to believe a violation of criminal law has occurred, and warrants consideration for prosecution.
(c)Non-inmates arrested by Bureau staff under this regulation will be physically secured, using minimally necessary force and restraints, in a private area of the facility away from others. Appropriate law enforcement will be immediately summoned to investigate the incident, secure evidence, and commence criminal prosecution. [FR Doc. E7-10925 Filed 6-5-07; 8:45 am] BILLING CODE 4410-05-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [CGD09-07-013] RIN 1625-AA00 Safety Zone, Kenosha Harbor, Kenosha, WI AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone near Kenosha Harbor, Kenosha, Wisconsin. This zone is intended to control the movement of vessels on portions of Lake Michigan and Great Lakes Naval Training Center Harbor during the Spill of National Significance
(SONS)exercise on June 19 and 20, 2007. This zone is necessary to protect the public from the hazards associated with ships and boats deploying oil containment equipment. DATES: This rule is effective from June 19, 2007 through June 20, 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 docket [CGD09-07-013] and are available for inspection or copying at Coast Guard Sector Lake Michigan (spw), 2420 South Lincoln Memorial Drive, Milwaukee, WI 53207, between 8 a.m. and 3 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: CWO Brad Hinken, Prevention Department, Coast Guard Sector Lake Michigan, Milwaukee, WI at
(414)747-7154. SUPPLEMENTARY INFORMATION: Regulatory Information On April 23, 2007 we published a notice of proposed rulemaking
(NPRM)entitled Safety Zone, Kenosha Harbor, Kenosha, WI in the **Federal Register** (72 FR 20089). We received no letters commenting on the proposed rule. No public meeting was requested and none was held. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the **Federal Register** . Delaying this rule's effective date would be contrary to public interest. This rule is necessary in order to prevent traffic from transiting the waters during the SONS exercise and provide for the safety of life and property on navigable waters. Background and Purpose This temporary safety zone is necessary to ensure the safety of vessels and people from hazards associated with numerous vessels deploying oil containment boom and conducting diving operations. Based on the experiences in other Captain of the Port zones, the Captain of the Port Lake Michigan has determined numerous vessels engaged in the deployment of oil containment boom in close proximity to watercraft pose significant risk to public safety and property. The likely combination of large numbers of recreation vessels and congested waterways could result in serious injuries or fatalities. Establishing a safety zone to control vessel movement around the location of the SONS exercise will help ensure the safety of persons and property at these events and help minimize the associated risks. Discussion of Comments The Coast Guard did not receive comments in response to the Notice of proposed rulemaking
(NPRM)published in the **Federal Register** . Discussion of Rule A temporary safety zone is necessary to ensure the safety of vessels during the deployment and recovery of oil containment boom in conjunction with the SONS exercise. The safety zone will be enforced between 8 a.m. and 6 p.m. on June 19 and 20, 2007. The safety zone for the SONS exercise will encompass all waters of Lake Michigan 2,300 yards north of Kenosha Breakwater Light (Lightlist number 20430) and from the shoreline to 1,500 yards east Kenosha Breakwater Light (Lightlist number 20430) and bounded by a line with of point origin at 42°36′29″ N, 087°47′17″ W; then west to 42°36′29″ N, 087°49′07″ W; then south along the shoreline to 42°35′19″ N, 087°48′41″ W; then east, northeast to 42°35′24″ N, 087°47′17″ W; then north to the point of origin (NAD 83). All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port or the designated on-scene representative. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Lake Michigan or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16. 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. We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation is unnecessary. The Coast Guard will only enforce this safety zone for 10 hours a day on the two days specified. This safety zone has been designed to allow vessels to transit unrestricted to portions of the harbor not affected by the zone. The Captain of the Port will allow vessels to enter and depart Great Lakes Naval Training Center Harbor. The Coast Guard expects insignificant adverse impact to mariners from the activation of this zone. 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 would not have a significant economic impact on a substantial number of small entities. This rule would affect the following entities, some of which might be small entities: The owners of vessels intending to transit or anchor in a portion of Lake Michigan between 8 a.m. and 6 p.m. (local) on June 19, 2007 and June 20, 2007. The safety zone would not have a significant economic impact on a substantial number of small entities for the following reasons. This rule would be in effect for only 20 hours. Vessel traffic can safely pass around the safety zone and enter and depart Kenosha Harbor. 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 this rule so that they can better evaluate its effects on them and participate in the rulemaking. 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, call1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. 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 the 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 might disproportionately affect children. Indian Tribal Governments The Coast Guard recognizes the treaty rights of Native American Tribes. Moreover, the Coast Guard is committed to working with Tribal Governments to implement local policies and to mitigate tribal concerns. We have determined that this safety zone and fishing rights protection need not be incompatible. We have also determined that 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. Nevertheless, Indian Tribes that have questions concerning the provisions of this Proposed Rule or options for compliance are encourage to contact the point of contact listed under FOR FURTHER INFORMATION CONTACT . 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)(g) of the Instruction, from further environmental documentation. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES . List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways. For the reasons discussed in the preamble, the Coast Guard has amended 33 CFR part 165 as follows: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. Add § 165.T09-013 to read as follows: § 165.T09-013 Safety Zone, Kenosha Harbor, Kenosha, WI.
(a)*Location.* The following area is a temporary safety zone: All waters of Lake Michigan 2,300 yards north of Kenosha Breakwater Light (Lightlist number 20430) and from the shoreline to 1,500 yards east Kenosha Breakwater Light (Lightlist number 20430) and bounded by a line with of point origin at 42°36′29″ N, 087°47′17″ W; then west to 42°36′29″ N, 087°49′07″ W; then south along the shoreline to 42°35′19″ N, 087°48′41″ W; then east, northeast to 42°35′24″ N, 087°47′17″ W; then north to the point of origin (NAD 83).
(b)*Effective period.* This regulation is effective from 8 a.m. (local) on June 19, 2007 to 6 p.m. (local) on June 20, 2007.
(c)*Enforcement Period.* This regulation will be enforced from 8 a.m. (local) to 6 p.m. (local) on June 19, 2007 and from 8 a.m. (local) to 6 p.m. (local) on June 20, 2007.
(d)*Regulations.*
(1)In accordance with the general regulations in section 165.23 of this part, entry into, transiting, or anchoring within this safety zone is prohibited unless authorized by the Captain of the Port Lake Michigan, or his designated on-scene representative.
(2)This safety zone is closed to all vessel traffic, except as may be permitted by the Captain of the Port Lake Michigan or his designated on-scene representative.
(3)The “on-scene representative” of the Captain of the Port is any Coast Guard commissioned, warrant or petty officer who has been designated by the Captain of the Port to act on his behalf. The on-scene representative of the Captain of the Port will be aboard either a Coast Guard or Coast Guard Auxiliary vessel. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.
(4)Vessel operators desiring to enter or operate within the safety zone shall contact the Captain of the Port Lake Michigan or his on-scene representative to obtain permission to do so. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the Captain of the Port Lake Michigan or his on-scene representative. Dated: May 16, 2007. Bruce C. Jones, Captain, U.S. Coast Guard, Captain of the Port Lake Michigan. [FR Doc. E7-10906 Filed 6-5-07; 8:45 am] BILLING CODE 4910-15-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2007-0091, FRL-8322-5] Findings of Failure To Attain; State of Arizona, Phoenix Nonattainment Area; State of California, Owens Valley Nonattainment Area; Particulate Matter of 10 Microns or Less AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: EPA is finalizing its findings that the Phoenix Planning Area (Phoenix nonattainment area) and the Owens Valley Planning Area (Owens Valley nonattainment area) did not attain the 24-hour National Ambient Air Quality Standard (NAAQS) for particulate matter of 10 microns or less (PM-10) by the deadline mandated in the Clean Air Act (CAA or the Act), December 31, 2006. These findings are based on monitored air quality data for the PM-10 NAAQS from 2004 through September 2006. Several Indian tribes have reservations located within the boundaries of the Phoenix and Owens Valley nonattainment areas. EPA implements CAA provisions for determining whether such areas have attained the NAAQS by the applicable attainment deadline. After affording the affected tribal leaders the opportunity to consult with EPA on its proposed actions, the Agency is also finding that the tribal areas have failed to attain the 24-hour PM-10 NAAQS. As a result of these failures to attain findings, Arizona and California must submit by December 31, 2007, plan provisions that provide for attainment of the 24-hour PM-10 NAAQS and that achieve 5 percent annual reductions in PM-10 or PM-10 precursor emissions as required by CAA section 189(d). DATES: *Effective Date:* This rule is effective on July 6, 2007. ADDRESSES: EPA has established docket number EPA-R09-OAR-2007-0091 for this action. The index to the docket is available electronically at *http://www.regulations.gov* and in hard copy at EPA Region 9, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available in either location (e.g., CBI). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed in the FOR FURTHER INFORMATION CONTACT section. FOR FURTHER INFORMATION CONTACT: For Phoenix issues contact Doris Lo, EPA Region IX,
(415)972-3959, *lo.doris@epa.gov* ; for Owens Valley issues contact Larry Biland, EPA Region IX,
(415)947-4132, *biland.larry@epa.gov.* SUPPLEMENTARY INFORMATION: Throughout this document, wherever “we,” “us,” or “our” are used, we mean EPA. I. Proposed Action and Subsequent Air Quality Data On March 23, 2007, EPA proposed to find that the Phoenix and Owens Valley nonattainment areas failed to attain the 24-hour PM-10 NAAQS by the CAA deadline, December 31, 2006. For details on the background and air quality data supporting these proposed findings, please see the proposed rule. 72 FR 13725. In our proposed rule we noted that the data on which we based our proposed findings of failure to attain were collected from January 2004 through September 2006. EPA normally uses three complete calendar years of data to determine an area's attainment status. However, when less data are sufficient to unambiguously establish nonattainment, 40 CFR part 50, appendix K, section 2.3(c) allows EPA to determine that a monitor is in violation of the PM-10 NAAQS. In the case of the Phoenix and Owens Valley nonattainment areas, two years and nine months of data were available at the time of the proposed rule and clearly indicated that the areas were in violation of the 24-hour PM-10 NAAQS. Thereafter Arizona and California have submitted data for October through December 2006 to EPA's Air Quality System
(AQS)database. These data indicate that there have been no additional exceedances of the PM-10 standard in the Phoenix and Owens Valley areas. 1 Therefore, the inclusion of these data does not affect EPA's proposed nonattainment findings for these areas. 1 Table 1 in the proposed rule (“Phoenix Nonattainment Area PM-10 Data Summary 2004-2006 Sites in Violation of the 24-hour PM-10 NAAQS”) provides details on the number of observed and estimated exceedances recorded at five monitoring sites in the Phoenix nonattainment area from January 2004 through September 2006. 72 FR at 13725. While the attainment status of the monitors did not change based on the inclusion of data from October through December 2006, we no longer consider one of the sites listed in Table 1, Higley (AQS# 04-013-4006), to be in violation of the NAAQS. As indicated in footnote 2 of the proposed rule, EPA has concurred with several of Arizona's requests to exclude certain exceedances of the 24-hour PM-10 NAAQS from consideration in our nonattainment finding because these exceedances were due to exceptional or natural events. *Id.* Since we prepared the proposed rule, EPA has also concurred with Arizona's request to exclude two exceedance days at the Higley monitor (April 14 and 15, 2006) as being due to natural events. (March 14, 2007 letter to Nancy C. Wrona, Arizona Department of Environmental Quality from Sean Hogan, EPA). When these exceedances are excluded, the average annual estimated number of exceedances at Higley drops from 1.2 per year to 1.0 per year. The standard is attained when the estimated number of exceedances is less than or equal to one per year. See 40 CFR 50.6(a). However, even with the exclusion of the Higley data, the Phoenix nonattainment area is still in violation of the 24-hour PM-10 NAAQS based on the exceedances listed in Table 1 for the other four sites. II. Public Comments and EPA Responses By letters dated March 15, 2007, EPA invited the Indian tribes located within the boundaries of the Phoenix and Owens Valley nonattainment areas to consult with us on the proposed findings. We received no response from the tribes. Moreover, EPA did not receive any adverse comments regarding the findings of failure to attain. Below is a summary of the comments we received and our responses. *Comments regarding Phoenix:* In general, commenters agreed with EPA's proposed nonattainment finding for the Phoenix nonattainment area. Two commenters wanted EPA to impose sanctions because the area has received attainment date extensions and has still failed to achieve the attainment deadline. *Response:* The consequence of the Phoenix nonattainment area's failure to attain the 24-hour PM-10 standard by December 31, 2006 is a finding of failure to attain that results in new PM-10 planning requirements and deadlines. See CAA sections 179(c) and 189(d). Under the CAA, failure to meet attainment deadlines does not result in the imposition of sanctions. However, under CAA section 179(a) and (b), if EPA determines that Arizona fails to submit a new plan by December 31, 2007, or determines that such a plan is incomplete, or if EPA disapproves such a plan in whole or in part, the Agency must impose offset or highway sanctions unless the deficiency has been corrected within 18 months. *Comment regarding Owens Valley:* EPA received comments on the history of the Owens Valley nonattainment area's PM-10 nonattainment problem and the controls undertaken and committed to by the City of Los Angeles. *Response:* EPA appreciates the information. The Great Basin Unified Air Pollution Control District and the City of Los Angeles will need to continue to work together to attain the PM-10 standard in the Owens Valley nonattainment area. III. EPA Action EPA is finding that the Phoenix and Owens Valley nonattainment areas did not attain the 24-hour PM-10 NAAQS by the December 31, 2006 attainment deadline. Under section 189(d) of the Act, serious PM-10 nonattainment areas that fail to attain are required to submit within 12 months of the applicable attainment date, “plan revisions which provide for attainment of the PM-10 air quality standard and, from the date of such submission until attainment, for an annual reduction in PM-10 or PM-10 precursor emissions within the area of not less than 5 percent of the amount of such emissions as reported in the most recent inventory prepared for such area.” In accordance with CAA section 179(d)(3), the attainment deadline applicable to an area that misses the serious area attainment date is as soon as practicable, but no later than 5 years from the publication date of the nonattainment finding notice. EPA may, however, extend the attainment deadline to the extent it deems appropriate for a period no greater than 10 years from the publication date, “considering the severity of nonattainment and the availability and feasibility of pollution control measures.” In addition to the attainment demonstration and 5 percent requirements, the plans under section 189(d) for the Phoenix and Owens Valley nonattainment areas must address all applicable requirements of the CAA, including sections 110(a), 172(c), 176(c) and 189(c)(1). Because the applicable attainment date for both nonattainment areas was December 31, 2006, under section 189(d), the submittal deadline for the plans will be December 31, 2007. IV. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action in and of itself establishes no new requirements, it merely notes that the air quality in the Phoenix nonattainment area and the Owens Valley nonattainment area did not meet the federal health standard for PM-10 by the CAA deadline. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). Because this rule does not in and of itself establish new requirements, EPA believes that it is questionable whether a requirement to submit a SIP revision constitutes a federal mandate. The obligation for a State to revise its SIP arises out of sections 110(a), 179(d), and 189(d) of the CAA and is not legally enforceable by a court of law, and at most is a condition for continued receipt of highway funds. Therefore, it is possible to view an action requiring such a submittal as not creating any enforceable duty within the meaning of section 421(5)(9a)(I) of the Unfunded Mandates Reform Act
(UMRA)(2 U.S.C. 658(a)(I)). Even if it did, the duty could be viewed as falling within the exception for the condition of Federal assistance under section 421(5)(a)(i)(I) of UMRA (2 U.S.C. 658(5)(a)(i)(I)). Therefore, today's action does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Several Indian tribes have reservations located within the boundaries of the Phoenix and Owens Valley nonattainment areas. EPA is responsible for the implementation of federal Clean Air Act programs in Indian country, including findings of failure to attain. EPA has notified the affected tribal officials and consulted with all interested tribes, as provided for by Executive Order 13175 (65 FR 67249, November 9, 2000). EPA contacted each tribe and gave them the opportunity to enter into consultation on a government-to-government basis. This action also does not have Federalism implications because it does not 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action does not in and of itself create any new requirements and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant. Because these findings of failure to attain are factual determinations based on air quality considerations, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). 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 the rule in the **Federal Register** . A major rule cannot take effect until 60 days after it is published in the **Federal Register** . This action is not a “major rule” as defined by 5 U.S.C. 804(2). Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 6, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).) List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Carbon monoxide, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Volatile organic compounds. Authority: 42 U.S.C. 7401 *et seq.* Dated: May 24, 2007. Jane Diamond, Acting Regional Administrator, Region IX. [FR Doc. E7-10857 Filed 6-5-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 261 [EPA-R07-RCRA-2006-0923; FRL-8322-6] Hazardous Waste Management System; Identification and Listing of Hazardous Waste; Final Exclusion AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: EPA is granting a petition submitted by the Ford Motor Company Kansas City Assembly Plant
(Ford)to exclude (or delist) a wastewater treatment plant
(WWTP)sludge generated by Ford in Claycomo, Missouri, from the lists of hazardous wastes. This final rule responds to the petition submitted by Ford to delist F019 WWTP sludge generated from the facility's waste water treatment plant. After careful analysis and use of the Delisting Risk Assessment Software (DRAS), EPA has concluded the petitioned waste is not hazardous waste. This exclusion applies to 2,000 cubic yards per year of the F019 WWTP sludge. Accordingly, this final rule excludes the petitioned waste from the requirements of hazardous waste regulations under the Resource Conservation and Recovery Act
(RCRA)when it is disposed in a Subtitle D Landfill. DATES: The final rule is effective on June 6, 2007. ADDRESSES: EPA has established a docket for this action under Docket ID No. EPA-R07-RCRA-2006-0923. All documents in the docket are listed on www.regulations.gov Web site. Although listed in the index, some information is not publicly available, e.g., confidential business information or other information the disclosure of which 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 electronically in www.regulations.gov or by appointment by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section below. Appointments can be made during the hours of 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. A reasonable fee may be charged for copying docket materials. FOR FURTHER INFORMATION CONTACT: For more information on this rulemaking, contact Kenneth Herstowski at
(913)551-7631, or *herstowski.ken@epa.gov* , RCRA Corrective Action and Permits Branch, Air, RCRA and Toxics Division, 901 North 5th Street, Kansas City, Kansas 66101. SUPPLEMENTARY INFORMATION: The information in this section is organized as follows: I. Overview Information A. What action is EPA finalizing? B. Why is EPA approving this action? C. What are the limits of this exclusion? D. How will Ford manage the waste if it is delisted? E. When is the final delisting exclusion effective? F. How does this final rule affect states? II. Background A. What is a delisting petition? B. What regulations allow facilities to delist a waste? C. What information must the generator supply? III. EPA's Evaluation of the Waste Information and Data A. What waste did Ford petition EPA to delist? B. How much waste did Ford propose to delist? C. How did Ford sample and analyze the waste data in this petition? IV. Public Comments Received on the Proposed Exclusion A. Who submitted comments on the proposed rule? B. What were the comments and what are EPA's responses to them? V. Statutory and Executive Order Reviews I. Overview Information A. What action is EPA finalizing? After evaluating the petition, EPA proposed on December 20, 2006, to exclude the waste water treatment plant sludge from the lists of hazardous waste under 40 Code of Federal Regulations
(CFR)261.31 and 261.32 (see 71 FR 76255). EPA is finalizing the decision to grant Ford's delisting petition to have its waste water treatment sludge managed and disposed as non-hazardous waste provided certain verification and monitoring conditions are met. B. Why is EPA approving this action? Ford's petition requests a delisting from the F019 waste listing under 40 CFR 260.20 and 260.22. Ford does not believe that the petitioned waste meets the criteria for which EPA listed it. Ford also believes no additional constituents or factors could cause the waste to be hazardous. EPA's review of this petition included consideration of the original listing criteria and the additional factors required by the Hazardous and Solid Waste Amendments of 1984. See section 3001(f) of RCRA, 42 United States Code (U.S.C.) 6921(f), and 40 CFR 260.22 (d)(1)-(4) (hereinafter all sectional references are to 40 CFR unless otherwise indicated). In making the final delisting determination, EPA evaluated the petitioned waste against the listing criteria and factors cited in § 261.11(a)(2) and (a)(3). Based on this review, EPA agrees with the petitioner that the waste is nonhazardous with respect to the original listing criteria. If EPA had found, based on this review, that the waste remained hazardous based on the factors for which the waste was originally listed, EPA would have proposed to deny the petition. EPA evaluated the waste with respect to other factors or criteria to assess whether there is a reasonable basis to believe that such additional factors could cause the waste to be hazardous. EPA considered whether the waste is acutely toxic, the concentration of the constituents in the waste, their tendency to migrate and to bioaccumulate, their persistence in the environment once released from the waste, plausible and specific types of management of the petitioned waste, the quantities of waste generated, and waste variability. EPA believes that the petitioned waste does not meet the listing criteria and thus should not be a listed waste. EPA's final decision to delist waste from Ford's facility is based on the information submitted in support of this rule, including descriptions of the wastes and analytical data from the Claycomo, Missouri, facility. C. What are the limits of this exclusion? This exclusion applies to the waste described in the petition only if the requirements described in § 261, Appendix IX, Table 1 and the conditions contained herein are satisfied. D. How will Ford manage the waste if it is delisted? The WWTP sludge from Ford will be disposed of in a RCRA Subtitle D landfill. E. When is the final delisting exclusion effective? This rule is effective June 6, 2007. The Hazardous and Solid Waste Amendments of 1984 amended Section 3010 of RCRA, 42 U.S.C. 6930(b)(1), allows rules to become effective less than six months after the rule is published when the regulated community does not need the six-month period to come into compliance. That is the case here because this rule reduces, rather than increases, the existing requirements for persons generating hazardous waste. This reduction in existing requirements also provides a basis for making this rule effective immediately, upon publication, under the Administrative Procedure Act, pursuant to 5 U.S.C. 553(d). F. How does this final rule affect states? Because EPA is issuing this exclusion under the Federal RCRA delisting program, only states subject to Federal RCRA delisting provisions would be affected. This would exclude states which have received authorization from EPA to make their own delisting decisions. EPA allows states to impose their own non-RCRA regulatory requirements that are more stringent than EPA's, under section 3009 of RCRA, 42 U.S.C. 6929. These more stringent requirements may include a provision that prohibits a Federally-issued exclusion from taking effect in the state. If so, Ford must obtain authorization from that state before it can transport or manage the waste as nonhazardous in the state. Because a dual system (that is, both Federal
(RCRA)and State (non-RCRA) programs) may regulate a petitioner's waste, EPA urges petitioners to contact each State regulatory authority to establish the status of their wastes under the State law while it is transported or managed as nonhazardous in the state. EPA has also authorized some states (for example, Georgia, Illinois, Louisiana, Nebraska, and Oklahoma) to administer a RCRA delisting program in place of the Federal program; that is, to make state delisting decisions. Therefore, this exclusion does not apply in authorized states unless that state makes the rule part of its authorized program. If Ford transports the petitioned waste to or manages the waste in any state with delisting authorization, Ford must obtain delisting authorization from that state before it can transport or manage the waste as nonhazardous in the state. II. Background A. What is a delisting petition? A delisting petition is a request from a generator to EPA, or another agency with jurisdiction, to exclude or delist from the RCRA list of hazardous waste, certain wastes the generator believes should not be considered hazardous under RCRA. B. What regulations allow facilities to delist a waste? Under §§ 260.20 and 260.22, facilities may petition EPA to remove their wastes from hazardous waste regulation by excluding them from the lists of hazardous wastes contained in §§ 261.31 and 261.32. Specifically, § 260.20 allows any person to petition the Administrator to modify or revoke any provision of 40 CFR Parts 260 through 265 and 268. Section 260.22 provides generators the opportunity to petition the Administrator to exclude a waste from a particular generating facility from the hazardous waste lists. C. What information must the generator supply? Petitioners must provide sufficient information to EPA to allow EPA to determine that the waste to be excluded does not meet any of the criteria under which the waste was listed as a hazardous waste. In addition, the Administrator must determine, where he/she has a reasonable basis to believe that factors (including additional constituents) other than those for which the waste was listed could cause the waste to be a hazardous waste and that such factors do not warrant retaining the waste as a hazardous waste. III. EPA's Evaluation of the Waste Information and Data A. What waste did Ford petition EPA to delist? On May 31, 2006, Ford petitioned EPA to exclude from the lists of hazardous wastes contained in § 261.31, WWTP sludge
(F019)generated from its facility located in Claycomo, Missouri. The waste falls under the classification of listed waste pursuant to § 261.31. B. How much waste did Ford propose to delist? Specifically, in its petition, Ford requested that EPA grant a standard exclusion for 2,000 cubic yards per year of the WWTP sludge. C. How did Ford sample and analyze the waste data in this petition? To support its petition, Ford submitted:
(1)Historical information on waste generation and management practices;
(2)Analytical results from six samples for total concentrations of constituents of concern; and
(3)Analytical results from six samples for Toxicity Characteristic Leaching Procedure
(TCLP)extract values. IV. Public Comments Received on the Proposed Exclusion A. Who submitted comments on the proposed rule? Comments were submitted by Ford Motor Company requesting clarification of certain testing requirements, the Alliance of Automobile Manufacturers supporting the proposed delisting and the Missouri Department of Natural Resources to correct information in the proposed rule. B. What were the comments and what are EPA's responses to them? 1. Revision of the F019 Listing as it Pertains to Auto Manufacturers *Comment:* The Alliance of Automobile Manufacturers in its comments urged EPA to comprehensively resolve the longstanding issue of the F019 listing as it pertains to auto manufacturers by issuing an interpretive rule, which would exclude for the F019 classification all wastewater treatment sludges from facilities that use zinc phosphate aluminum processes rather than hexavalent chromium and cyanide processes that led to the original listing of F019 sludge. *Response:* EPA has proposed changes to the F019 listing that are responsive to the commenter (see 72 FR 2219, January 18, 2007). Given EPA's proposed rulemaking on this issue, EPA will not provide further response here. 2. Analysis of Excluded Wastes *Comment:* The Alliance of Automobile Manufacturers in its comments requests EPA remove the requirements for analysis of total concentrations of constituents as part of the verification testing of Ford's delisted sludge. The commenter believes that total concentrations of a constituent have no scientific correlation with environmental impacts. *Response:* EPA evaluates the potential environmental impact of plausible mismanagement of the waste in a solid waste landfill. EPA evaluates the potential off-site migration of waste particles and volatile organic compounds via air and surface water pathways as a result of inadequate cover and runoff control. EPA believes that inadequate daily cover and rainwater runoff control are plausible mismanagement scenarios for a solid waste landfill. Furthermore, since the source of this potential off-site migration is newly deposited waste at the surface of the landfill, total concentrations are appropriate inputs for fate and transport modeling. 3. Delisting Levels Toxicity Characteristic Leaching Procedure *Comment:* The Missouri Department of Natural Resources comments that as proposed Ford's sludge could exhibit a characteristic of hazardous waste and still be excluded. Specifically, the commenter points out that Toxicity Characteristic Leaching Procedure
(TCLP)results greater than those which would make a solid waste hazardous under 40 CFR 261.24 are allowed in the proposal. *Response:* EPA reviewed the proposed TCLP delisting levels in Appendix IX to Part 261—Waste Excluded Under §§ 260.20 and 260.22, Table 1.—Wastes Excluded from Non-Specific Sources. The constituents found in 40 CFR 261.24 for which TCLP delisting levels were proposed included: barium—100 mg/l, chromium—5 mg/l, and mercury—0.155 mg/l. All of those levels are at or below the levels at which a solid waste would exhibit a characteristic of hazardous waste and therefore be a hazardous waste. There may be confusion regarding the application of these delisting levels as when the waste meets the exclusion. EPA has clarified in the final language that the TCLP concentrations may not equal or exceed the levels given in the table. The commenter may also be suggesting that the exclusion should include delisting levels for all TCLP parameters. EPA evaluated all the constituents in Ford's waste and developed delisting levels based upon that information. Inclusion of additional TCLP parameters is not justified at this time. Ford must notify EPA of any significant changes in the manufacturing process, the chemicals used, the treatment process or the chemicals used in the treatment process. If any of those changes occur, Ford must manage the sludge as a hazardous waste until it can be demonstrated that it still meets the delisting levels in the exclusion, that no new hazardous constituents listed in Appendix VIII of 40 CFR part 261 have been introduced and has received approval from EPA for the changes. Land Disposal Restrictions and Delisting Levels *Comment:* The Missouri Department of Natural Resources comments that the delisting levels proposed do not correspond to the Land Disposal Restriction treatment standards found in 40 CFR part 268. *Response:* Ford is requesting delisting of its F019 waste at the point of its generation. EPA's proposed exclusion was also at the point of generation. Since the waste will be excluded at the point of its generation (subject to periodic verification testing), the land disposal restrictions will not apply. This is in contrast to a hypothetical case where a hazardous waste is treated subsequent to its generation and the residuals from the treatment of the hazardous waste would be subject to the land disposal restrictions. If a person were to seek delisting of the residuals in the aforementioned hypothetical case, the land disposal restriction treatment standards for which the original waste were subject to would continue to apply and would be considered in determining the appropriate delisting levels. 4. Verification Sample Analysis *Comment:* Ford requests clarification if the TCLP cyanides parameter listed in the proposed exclusion for quarterly verification sampling is a total cyanide test on the TCLP leachate. The possible options would be amenable or available cyanide. Response: EPA affirmed the distinction between free cyanide and complex metal cyanides in its 1992 final rule, Drinking Water; National Primary Drinking Water Regulations—Synthetic Organic Chemicals and Inorganic Chemicals (57 FR 31776, July 17, 1992). EPA specifically stated that the maximum contaminant level goal
(MCLG)of 0.2 mg/L cyanide applies to free cyanides, not complex metal cyanides. EPA further stated that a total cyanide analytical technique is allowed to screen samples. If the total cyanide results are greater than the MCL, then the analysis for free cyanide would be required to determine whether there is an exceedance of the MCL. EPA specifies the use of the cyanide amenable to chlorination test for determining free cyanide. Therefore, the cyanide amenable to chlorination test is the appropriate test for verification sampling and analysis to demonstrate continued compliance with the exclusion. Ford may use a total cyanide test for the TCLP leachate as a screening test. However, if the results of a total cyanide test on the TCLP leachate exceed the delisting levels and the cyanide amenable to chlorination test is not conducted, then EPA will rely on the total cyanide test results to determine Ford's compliance with the exclusion. V. Statutory and Executive Order Reviews Under Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993) this rule is not of general applicability and therefore is not a regulatory action subject to review by the Office of Management and Budget (OMB). This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ) because it applies to a particular facility only. Because this rule is of particular applicability relating to a particular facility, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ), or to sections 202, 204, and 205 of the Unfunded Mandates Reform Act of 1995
(UMRA)(Pub. L. 104-4). Because this rule will affect only a particular facility, it will not significantly or uniquely affect small governments, as specified in section 203 of UMRA. Because this rule will affect only a particular facility, this final rule does not have federalism implications. It will not 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, as specified in Executive Order 13132, “Federalism” (64 FR 43255, August 10, 1999). Thus, Executive Order 13132 does not apply to this rule. Similarly, because this rule will affect only a particular facility, this final rule does not have tribal implications, as specified in Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000). Thus, Executive Order 13175 does not apply to this rule. This rule also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. The basis for this belief is that the Agency used the DRAS program, which considers health and safety risks to infants and children, to calculate the maximum allowable concentrations for this rule. 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) because it is not a significant regulatory action under Executive Order 12866. This rule does not involve technical standards; thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988, “Civil Justice Reform”, (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. 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. Section 804 exempts from section 801 the following types of rules:
(1)Rules of particular applicability;
(2)rules relating to agency management or personnel; and
(3)rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties 5 U.S.C. 804(3). EPA is not required to submit a rule report regarding today's action under section 801 because this is a rule of particular applicability. List of Subjects in 40 CFR Part 261 Environmental protection, Hazardous waste, Recycling, Waste treatment and disposal. Authority: Section 3001(f) RCRA, 42 U.S.C. 6921(f). Authority for this action has been delegated to the Regional Administrator (61 FR 32798, June 25, 1996). Dated: May 29, 2007. John B. Askew, Regional Administrator, Region 7. For the reasons set out in the preamble, 40 CFR part 261 is amended as follows: PART 261—IDENTIFICATION AND LISTING OF HAZARDOUS WASTE 1. The authority citation for part 261 continues to read as follows: Authority: 42 U.S.C. 6905, 6912(a), 6921, 6922, and 6938. 2. In Table 1 of Appendix IX of part 261 the following wastestream is added in alphabetical order by facility to read as follows: Appendix IX to Part 261—Wastes Excluded Under §§ 260.20 and 260.22 Table 1.—Wastes Excluded From Non-Specific Sources Facility Address Waste description * * * * * * * Ford Motor Company, Kansas City Assembly Plant Claycomo, Missouri Wastewater treatment sludge, F019, that is generated at the Ford Motor Company
(Ford)Kansas City Assembly Plant
(KCAP)at a maximum annual rate of 2,000 cubic yards per year. The sludge must be disposed of in a lined landfill with leachate collection, which is licensed, permitted, or otherwise authorized to accept the delisted wastewater treatment sludge in accordance with 40 CFR part 258. The exclusion becomes effective as of June 6, 2007. 1. Delisting Levels:
(a)The concentrations in a TCLP extract of the waste measured in any sample may not equal or exceed the following levels (mg/L): barium—100; chromium—5; mercury—0.155; nickel—90; thallium—0.282; zinc—898; cyanides—11.5; ethyl benzene—42.6; toluene—60.8; total xylenes—18.9; bis(2-ethylhexyl) phthalate—0.365; p-cresol—11.4; 2,4-dinitrotoluene—0.13; formaldehyde—343; and napthalene—.728;
(b)The total concentrations measured in any sample may not exceed the following levels (mg/kg): chromium 760000; mercury—10.4; thallium—116000; 2,4-dinitrotoluene—100000; and formaldehyde—6880. 2. Quarterly Verification Testing: To verify that the waste does not exceed the specified delisting levels, Ford must collect and analyze one representative sample of KCAP's sludge on a quarterly basis. 3. Changes in Operating Conditions: Ford must notify the EPA in writing if the manufacturing process, the chemicals used in the manufacturing process, the treatment process, or the chemicals used in the treatment process at KCAP significantly change. Ford must handle wastes generated at KCAP after the process change as hazardous until it has demonstrated that the waste continues to meet the delisting levels and that no new hazardous constituents listed in appendix VIII of part 261 have been introduced and Ford has received written approval from EPA for the changes. 4. Data Submittals: Ford must submit the data obtained through verification testing at KCAP or as required by other conditions of this rule to EPA Region 7, Air, RCRA and Toxics Division, 901 N. 5th, Kansas City, Kansas 66101. The quarterly verification data and certification of proper disposal must be submitted annually upon the anniversary of the effective date of this exclusion. Ford must compile, summarize, and maintain at KCAP records of operating conditions and analytical data for a minimum of five years. Ford must make these records available for inspection. All data must be accompanied by a signed copy of the certification statement in 40 CFR 260.22(i)(12). 5. Reopener Language—(a) If, anytime after disposal of the delisted waste, Ford possesses or is otherwise made aware of any data (including but not limited to leachate data or groundwater monitoring data) relevant to the delisted waste at KCAP indicating that any constituent is at a level in the leachate higher than the specified delisting level, or is in the groundwater at a concentration higher than the maximum allowable groundwater concentration in paragraph (e), then Ford must report such data in writing to the Regional Administrator within 10 days of first possessing or being made aware of that data.
(b)Based on the information described in paragraph
(a)and any other information received from any source, the Regional Administrator will make a preliminary determination as to whether the reported information requires Agency action to protect human health or the environment. Further action may include suspending, or revoking the exclusion, or other appropriate response necessary to protect human health and the environment.
(c)If the Regional Administrator determines that the reported information does require Agency action, the Regional Administrator will notify Ford in writing of the actions the Regional Administrator believes are necessary to protect human health and the environment. The notice shall include a statement of the proposed action and a statement providing Ford with an opportunity to present information as to why the proposed Agency action is not necessary or to suggest an alternative action. Ford shall have 30 days from the date of the Regional Administrator's notice to present the information.
(d)If after 30 days Ford presents no further information, the Regional Administrator will issue a final written determination describing the Agency actions that are necessary to protect human health or the environment. Any required action described in the Regional Administrator's determination shall become effective immediately, unless the Regional Administrator provides otherwise. * * * * * * * [FR Doc. E7-10854 Filed 6-5-07; 8:45 am] BILLING CODE 6560-50-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 2 [ET Docket No. 03-108; FCC 07-66] Cognitive Radio Technologies and Software Defined Radios AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: This document responds to two petitions concerning the rules adopted in the *Report and Order* in this proceeding (“Cognitive Radio Report and Order”). The Commission granted a petition for clarification filed by Cisco Systems, Inc. (“Cisco”) requesting that the Commission clarify the requirement to approve certain devices as software defined radios, and its policy on the confidentiality of software that controls security measures in software defined radios. The Commission also granted in part and denied in part a petition for reconsideration filed by Marcus Spectrum Solutions (“MSS”) requesting that the Commission clarify the rules concerning the submission of radio software source code, clarify the rules concerning the certification of software defined amateur radio equipment, and initiate a further proceeding to adopt regulatory requirements for high-power, high-speed digital-to-analog (D/A) converters. DATES: Effective July 6, 2007. FOR FURTHER INFORMATION CONTACT: Hugh Van Tuyl, Policy and Rules Division, Office of Engineering and Technology,
(202)418-7506, e-mail: *Hugh.VanTuyl@fcc.gov.* SUPPLEMENTARY INFORMATION: This is a summary of the Commission's *Memorandum Opinion and Order,* ET Docket No. 03-108, FCC 07-66, adopted April 20, 2007 and released April 25, 2007. The full text of this document is available on the Commission's Internet site at *http://www.fcc.gov.* It is also available for inspection and copying during regular business hours in the FCC Reference Center (Room CY-A257), 445 12th Street, SW., Washington, DC 20554. The full text of this document also may be purchased from the Commission's duplication contractor, Best Copy and Printing Inc., Portals II, 445 12th St., SW., Room CY-B402, Washington, DC 20554; telephone
(202)488-5300; fax
(202)488-5563; e-mail *FCC@BCPIWEB.COM.* Summary of the Memorandum Opinion and Order 1. On March 17, 2005, the Commission adopted the *Cognitive Radio Report and Order* 70 FR 23032, May 4, 2005, in which it modified the rules to reflect ongoing technical developments in cognitive and software defined radio technologies. In response to the *Cognitive Radio Report and Order,* Cisco and MSS each filed a petition seeking reconsideration or clarification of various aspects of the Commission's decisions in the *Cognitive Radio Report and Order.* The Information Industry Technology Council (“ITI”) filed comments in opposition of MSS' petition. No comments were filed in response to Cisco's petition. In response to the two petitions concerning the rules adopted in the *Cognitive Radio Report and Order* in this proceeding, the Commission granted the petition for clarification filed by Cisco Systems, Inc. (“Cisco”) requesting that the Commission clarify:
(1)The requirement to approve certain devices as software defined radios, and
(2)its policy on the confidentiality of software that controls security measures in software defined radios. The Commission also granted in part and denied in part a petition for reconsideration filed by Marcus Spectrum Solutions (“MSS”) requesting that the Commission
(1)Clarify the rules concerning the submission of radio software source code,
(2)clarify the rules concerning the certification of software defined amateur radio equipment, and
(3)initiate a further proceeding to adopt regulatory requirements for high-power, high-speed digital-to-analog (D/A) converters. 2. In the *Cognitive Radio Report and Order,* the Commission modified the rules to require that radios in which the software is designed or expected to be modified by a party other than the manufacturer be certified as software defined radios. To minimize the filing burden on manufacturers, this requirement was narrowly tailored to affect only those radios where the software can be modified by a party other than the manufacturer because such radios pose a higher risk of interference to authorized radio services. The definition of software defined radio
(SDR)is intentionally broad, while the category of equipment that is required to be certified as SDRs is intentionally narrow. The Commission agrees with Cisco that a reading of the definition of SDR in the rules by itself may give the incorrect impression that more devices must be certified as SDRs than the rules intended to require. The Commission finds that the appropriate solution to Cisco's concern is to add an additional sentence following the definition of SDR to indicate the class of radios that must be certified as SDRs. It therefore clarifies the rules by adding the following statement to the definition of SDR: “In accordance with § 2.944 of this part, only radios in which the software is designed or expected to be modified by a party other than the manufacturer and would affect the listed operating parameters or circumstances under which the radio transmits must be certified as software defined radios.” This action clarifies the intent of the rules adopted in the *Cognitive Radio Report and Order.* 3. With regard to Cisco's second request, the Commission recognizes that some manufacturers may wish to use open source software ( *e.g.* , GNU/Linux) in developing SDRs. The use of such software may have advantages for manufacturers such as lower cost and decreased product development time. However, as Cisco notes, open source software may be subject to licensing agreements that require the party modifying the code to make the source code publicly available. The Commission did not address the possibility of manufacturers using open source software to implement security measures. However, it recognizes that hardware and software security measures that interact with the open source software need not be subject to an open source agreement. The Commission hereby states that it is its policy, consistent with the intent of *Cognitive Radio Report and Order* and Cisco's request, that manufacturers should not intentionally make the distinctive elements that implement that manufacturer's particular security measures in a software defined radio public, if doing so would increase the risk that these security measures could be defeated or otherwise circumvented to allow operation of the radio in a manner that violates the Commission's rules. A system that is wholly dependent on open source elements will have a high burden to demonstrate that it is sufficiently secure to warrant authorization as a software defined radio. 4. In response to the MSS petition for reconsideration, the Commission clarifies that in the event that questions arise about the compliance of a particular device, its staff has the authority to request and examine any component, whether software or hardware, of a radio system when needed for certification under Commission rules. The manufacturer could request that the Commission hold the information confidential, and the Commission would generally grant such a request absent a compelling reason otherwise. The Commission expects that requests for software source code would be extremely rare. It would not be burdensome for a manufacturer to request confidentiality for software source code, and the Commission finds there is no need to modify the confidentiality rules to address a specific class of information that would be requested only infrequently. 5. The Commission declines to take any actions with respect to regulating the marketing of certain types of D/A converters. MSS does not demonstrate any current need for regulation of D/A converters. It admits that the types of D/A converters that it is concerned about are not presently on the market, and that it is not aware of any discussions about the possible marketing of these types of D/A converters. The Commission therefore finds that MSS’ concerns about possible misuse of equipment not available now or in the foreseeable future are premature, speculative, and not a basis for initiating a further rule making proceeding at this time. 6. In regard to MSS’ request for clarification about the regulatory treatment of amateur radio equipment, the Commission did not intend to impose any new certification requirements for amateur radio equipment in the *Cognitive Report and Order.* External RF amplifiers that operate below 144 MHz that are marketed for use with amateur stations will continue to require certification before they can be marketed. Other amateur radio equipment, including equipment that meets the definition of a software defined radio and that has software that is designed or expected to be modified by a party other than the manufacturer, will continue to be exempt from a certification requirement. However, as the Commission noted in the *Cognitive Report and Order,* certain unauthorized modifications of amateur transmitters are unlawful. It may revisit the issue of the certification of amateur equipment with software modifiable features as identified above in the future if misuse of such devices results in significant interference to authorized spectrum users. Procedural Matters 7. *Final Regulatory Flexibility Certification.* The Regulatory Flexibility Act of 1980, as amended (RFA), 1 requires that a regulatory flexibility analysis be prepared for rulemaking proceedings, unless the agency certifies that “the rule will not have a significant economic impact on a substantial number of small entities.” 2 The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” 3 In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. 4 A small business concern is one which:
(1)Is independently owned and operated;
(2)is not dominant in its field of operation; and
(3)satisfies any additional criteria established by the Small Business Administration. 1 The RFA, *see* 5 U.S.C. 601-612, has been amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), Public Law 104-121, Title II, 110 Stat. 857 (1996). 2 5 U.S.C. 605(b). 3 5 U.S.C. 601(6). 4 5 U.S.C. 601(3) (incorporating by reference the definition of “small business concern” in the Small Business Act, 15 U.S.C. 632). Pursuant to 5 U.S.C. 601(3), the statutory definition of a small business applies “unless an agency, after consultation with the Office of Advocacy of the Small Business Administration and after opportunity for public comment, establishes one or more definitions of such term which are appropriate to the activities of the agency and publishes such definition(s) in the **Federal Register** .” 8. In the *Cognitive Radio Report and Order,* the Commission expanded the definition of software defined radio
(SDR)to include radios in which software can control the circumstances under which the radio operates in accordance with the Commission's rules. This broad definition covers both radios that have software embedded on chips or implemented in other ways so that the software cannot be readily changed by the user, as well as radios that are designed so the software can be easily changed after manufacture. In the *Cognitive Radio Report and Order,* the Commission also modified the rules to require that a radio be approved as an SDR if the software that controls the operating parameters or the circumstances under which it transmits is designed or expected to be modified by a party other than the manufacturer. This requirement applies to only a narrow subset of radios that meet the definition of SDR. A Final Regulatory Flexibility Analysis was incorporated in the *Cognitive Radio Report and Order.* Following publication of the *Cognitive Radio Report and Order,* Cisco filed its petition seeking clarification of which radios require certification as SDRs. In the *Memorandum Opinion and Order* , the Commission amended the definition of SDR to reference the requirements concerning which radios must be certified as SDRs. This change clarifies the rules adopted in the *Cognitive Radio Report and Order* and does not modify any compliance requirements. For this reason, this change will not result in a “significant economic burden” on manufacturers. Therefore, we certify that the amendments included in the *Memorandum Opinion and Order* will not have a significant economic impact on a substantial number of small entities. 9. The Commission will send a copy of the *Memorandum Opinion and Order,* including a copy of this final certification, in a report to Congress pursuant to the Congressional Review Act. 5 In addition, the *Memorandum Opinion and Order* and this certification will be sent to the Chief Counsel for Advocacy of the Small Business Administration, and will be published in the **Federal Register** . 6 5 *See* 5 U.S.C. 801(a)(1)(A). 6 *See* 5 U.S.C. 605(b). 10. This document does not contain any information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. Ordering Clauses 11. Pursuant to the Section 1, 4, 301, 302(a), and 303, of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154, 301, 302(a), and 303, the *Memorandum Opinion and Order* *is adopted,* and part 2 of the Commission's Rules is amended as specified in the attached appendix, and will become effective 30 days after publication in the **Federal Register** . 12. The petition for clarification filed by Cisco Systems, Inc. is hereby granted. This action is taken pursuant to the authority contained in Sections 4(i), 301, 302, 303(e), 303(f), and 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. Sections 154(i), 301, 302, 303(e), 303(f), and 303(r). 13. The petition for reconsideration filed by Marcus Spectrum Solutions is hereby granted in part and denied in part. This action is taken pursuant to the authority contained in Sections 4(i), 301, 302, 303(e), 303(f), and 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. Sections 154(i), 301, 302, 303(e), 303(f), and 303(r). 14. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of the *Memorandum Opinion and Order* , including the Final Regulatory Flexibility Certification, to the Chief Counsel for Advocacy of the Small Business Administration. List of Subjects in 47 CFR Part 2 Communications equipment, Radio, Reporting, and recordkeeping requirements. Federal Communications Commission. William F. Caton, Deputy Secretary. Final Rule For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 2 to read as follows: PART 2—FREQUENCY ALLOCATIONS AND RADIO TREATY MATTERS; GENERAL RULES AND REGULATIONS 1. The authority citation for part 2 continues to read as follows: Authority: 47 U.S.C. 154, 302a, 303, and 336, unless otherwise noted. Section 2.1(c) is amended by revising the definition of “software defined radio” to read as follows: § 2.1 Terms and definitions.
(c)* * * *Software defined radio.* A radio that includes a transmitter in which the operating parameters of frequency range, modulation type or maximum output power (either radiated or conducted), or the circumstances under which the transmitter operates in accordance with Commission rules, can be altered by making a change in software without making any changes to hardware components that affect the radio frequency emissions. In accordance with § 2.944 of this part, only radios in which the software is designed or expected to be modified by a party other than the manufacturer and would affect the above-listed operating parameters or circumstances under which the radio transmits must be certified as software defined radios. [FR Doc. 07-2684 Filed 6-5-07; 8:45 am]
Connectionstraces to 35
Traces to 35 documents
U.S. Code
25 references not yet in our index
  • 21 CFR 522
  • 5 USC 801-808
  • 28 CFR 511
  • 71 F.3d 626
  • 27 F.3d 564
  • 33 CFR 165
  • 5 USC 601-612
  • Pub. L. 104-121
  • 44 USC 3501-3520
  • 2 USC 1531-1538
  • 42 USC 4321-4370f
  • Pub. L. 107-295
  • 40 CFR 52
  • 40 CFR 50
  • Pub. L. 104-4
  • 40 CFR 261
  • 40 CFR 260.20
  • 40 CFR 260.22
  • 40 CFR 261.24
  • 40 CFR 268
  • 40 CFR 258
  • 40 CFR 260.22(i)(12)
  • 47 CFR 2
  • 110 Stat. 857
  • Pub. L. 104-13
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C.F.R.§ 522.2121
C.F.R.§ 25.33
U.S.C.§ 804
U.S.C.§ 360b
U.S.C.§ 1791
Fed. Reg.Notices
Fed. Reg.Proposed Rules
U.S.C.§ 605
U.S.C.§ 301
F. App'x71 F.3d 626
F. App'x27 F.3d 564
Cite21 CFR 522
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