Rules and Regulations. Notice
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BILLING CODE 6560-50-M ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPPT-2007-1080; FRL-8340-3] RIN [2070-AD61] Endocrine Disruptor Screening Program (EDSP); Draft Policies and Procedures for Initial Screening; Request for Comment AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: This document announces the availability of and solicits public comment on EPA's draft policies and procedures for initial screening under the Agency's Endocrine Disruptor Screening Program (EDSP).
The EDSP is established under section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which requires endocrine screening of all pesticide chemicals and was established in response to growing scientific evidence that humans, domestic animals, and fish and wildlife species have exhibited adverse health consequences from exposure to environmental chemicals that interact with their endocrine systems. This document provides specific details on the policies and the related procedures that EPA is considering adopting for initial screening under the EDSP.
In general, the Agency has tried to develop policies that could be used in subsequent data collection efforts. However, EPA expects that these policies may be modified as a result of the Agency's experience applying them to the first chemicals to undergo testing. This document also discusses the statutory requirements associated with and format of the test orders, as well as EPA's procedures for fair and equitable sharing of test costs and data confidentiality. EPA will also be holding a public meeting to discuss these policies and procedures.
A separate **Federal Register** document announced the details of the public meeting. DATES: Comments must be received on or before February 11, 2008. ADDRESSES: Submit your comments, identified by docket identification
(ID)number EPA-HQ-OPPT-2007-1080, by one of the following methods: • *Federal e-Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Hand Delivery* : OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID number EPA-HQ-OPPT-2007-1080. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is
(202)564-8930. Such deliveries are only accepted during the DCO's normal hours of operation, and special arrangements should be made for deliveries of boxed information. Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2007-1080. EPA's policy is that all comments received will be included in the docket without change and may be made available online at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an ‘‘anonymous access'' system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket, visit the EPA Docket Center homepage at *http://www.epa.gov/epahome/dockets.htm* . Docket: All documents in the docket are listed in the docket index available at *http://www.regulations.gov* . Follow the instructions on the regulations.gov website to view the docket index or access available documents. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at *http://www.regulations.gov* , or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. The telephone number of the EPA/DC Public Reading Room is
(202)566-1744, and the telephone number for the OPPT Docket is
(202)566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure. FOR FURTHER INFORMATION CONTACT: William Wooge, Office of Science Coordination and Policy (OSCP), Mailcode 7201M, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202)564-8476; fax number:
(202)564-8482; e-mail address: *wooge.william@epa.gov.* SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you produce, manufacture, use, or import pesticide/agricultural chemicals and other chemical substances; or if you are or may otherwise be involved in the testing of chemical substances for potential endocrine effects. To determine whether you or your business may have an interest in this notice you should carefully examine section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a(p)). Potentially affected entities and others may use the North American Industrial Classification System (NAICS) codes to assist in determining whether this action might apply an entity. Potentially affected entities may include, but are not limited to: • Chemical manufacturers, importers and processors (NAICS code 325), e.g., persons who manufacture, import or process chemical substances. • Pesticide, fertilizer, and other agricultural chemical manufacturing (NAICS code 3253), e.g., persons who manufacture, import or process pesticide, fertilizer and agricultural chemicals. • Scientific research and development services (NAICS code 5417), e.g., persons who conduct testing of chemical substances for endocrine effects. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in Unit IV.E. of this document, and examine section 408(p) of the FFDCA. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. What Should I Consider as I Prepare My Comments for EPA? 1. *Submitting CBI* . Do not submit CBI to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. *Tips for preparing your comments* . When submitting comments, remember to: a. Identify the document by docket ID number and other identifying information (subject heading, **Federal Register** date and page number). b. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations
(CFR)part or section number. c. Explain why you agree or disagree and suggest alternatives and substitute language for your requested changes. d. Describe any assumptions and provide any technical information and/or data that you used. e. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. f. Provide specific examples to illustrate your concerns and suggest alternatives. g. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. h. Make sure to submit your comments by the comment period deadline identified. C. Where Can I Access Information about the EDSP? In addition to accessing the public docket for this document through *www.regulations.gov* , you can access other information about the EDSP through the Agency's website at *http://www.epa.gov/scipoly/oscpendo/index.htm* . II. Overview A. What Action is the Agency Taking? The Agency is announcing the availability of and seeking public comment on the draft policies and procedures that it is considering to issue test orders pursuant to the authority provided by section 408(p)(5) of FFDCA. This document provides specific details on the requirements associated with section 408(p) of FFDCA, format of FFDCA section 408(p) test orders, and procedures. This document also describes the actions and/or procedures that EPA is considering to: • Minimize duplicative testing (see Unit IV.C.). • Promote fair and equitable sharing of test costs (see Unit IV.C.). • Address issues surrounding data compensation (see Unit IV.C.) and confidentiality (see Unit IV.D.). • Determine to whom orders will be issued (see Unit IV.E.). • Identify how order recipients should respond to FFDCA section 408(p) test orders, including procedures for challenging the orders (see Unit IV.F. and H.). • Ensure compliance with FFDCA section 408(p) test orders (see Unit IV.G.). EPA has also developed a template for the test order and an information collection request
(ICR)to obtain the necessary clearances under the Paperwork Reduction Act (PRA). The templates for the test orders and the draft ICR are available in the docket associated with this **Federal Register** Notice. In addition, through a separate **Federal Register** document, EPA is seeking public comment on the draft ICR and draft templates. In addition, EPA will be holding a public meeting to discuss these draft policies and procedures. In the **Federal Register** of November 23, 2007 (72 FR 65732) (FRL-8341-3), EPA announced the details of the public meeting, which is posted on the EDSP website at *www.epa.gov/scipoly/oscpendo/meetings/mtg_121707.htm* . This document is intended to describe the administrative policies and procedures that EPA is considering adopting as part of the Endocrine Disruptor Screening Program (EDSP). The policies and procedures presented in this document are not intended to be binding on either EPA or any outside parties, and EPA may depart from the policies and procedures presented in this document where circumstances warrant and without prior notice. The policies and procedures presented in this document may eventually be incorporated into an order issued pursuant to section 408(p) of FFDCA. This document only addresses the procedural framework applicable to EPA's implementation of FFDCA section 408(p)(5), and it does not address the tests or assays that are under development for use under the EDSP or the approach for selecting chemicals under the EDSP. In a September 27, 2005, **Federal Register** Notice (70 FR 56449) (FRL-7716-9), the Agency announced the approach that was used to identify chemicals for initial screening under EDSP. The draft list of 73 chemicals to undergo initial screening was published in a June 18, 2007 **Federal Register** Notice (72 FR 33486) (FRL-8129-3). In a separate public process, the Agency is coordinating the scientific validation and peer review of the assays, which includes the development of protocols for the assays. Additional information about all aspects of the EDSP, including current status of these related parallel activities, is available at *http://www.epa.gov/scipoly/oscpendo/pubs/edspoverview/index.htm* . B. What is the Endocrine Disruptor Screening Program (EDSP)? The EDSP was established in 1998 to carry out the mandate in section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA) [21 U.S.C. 346a *et. seq* .], which directed EPA “to develop a screening program . . . to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as the Administrator may designate.” If a substance is found to have an effect, FFDCA section 408(p)(6) directs the Administrator to take action under available statutory authority to ensure protection of public health. That is, the ultimate purpose of the EDSP is to provide information to the Agency that will allow the Agency to evaluate the risks associated with the use of a chemical and take appropriate steps to mitigate any risks (Ref. 1). The necessary information includes identifying any adverse effects that might result from the interaction of a substance with the endocrine system and establishing a dose-response curve (Ref. 1). Section 1457 of the Safe Drinking Water Act
(SDWA)also authorizes EPA to screen substances that may be found in sources of drinking water, and to which a substantial population may be exposed, for endocrine disruption potential. [42 U.S.C. 300j-17]. The Agency first proposed the basic components of the EDSP on August 11, 1998 (63 FR 42852) (FRL-6021-3). After public comments, external consultations and peer review, EPA provided additional details on December 28, 1998 (63 FR 71542) (FRL-6052-9). The design of the EDSP was based on the recommendations of the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), which was chartered under the Federal Advisory Committee Act
(FACA)[5 U.S.C. App.2, 9(c)]. The EDSTAC was comprised of members representing the commercial chemical and pesticides industries, Federal and State agencies, worker protection and labor organizations, environmental and public health groups, and research scientists. EDSTAC recommended that EPA's program address both potential human and ecological effects; examine effects on estrogen, androgen, and thyroid hormone-related processes; and include non-pesticide chemicals, contaminants, and mixtures in addition to pesticides (Ref. 1). Based on these recommendations, EPA developed a two-tiered approach, referred to as the EDSP. The purpose of Tier 1 screening (referred to as “screening”) is to identify substances that have the potential to interact with the estrogen, androgen, or thyroid hormone systems using a battery of assays. The fact that a substance may interact with a hormone system, however, does not mean that when the substance is used, it will cause adverse effects in humans or ecological systems. The purpose of Tier 2 testing (referred to as “testing”), therefore, is to identify and establish a dose-response relationship for any adverse effects that might result from the interactions identified through the Tier 1 assays (Ref. 1). In addition, because of the large number of chemicals that might be included in the program, EDSTAC also recommended that EPA establish a priority-setting approach for choosing chemicals to undergo Tier 1 screening. The Science Advisory Board (SAB)/Scientific Advisory Panel
(SAP)Subcommittee further recommended that initial screening be limited to 50 to 100 chemicals. EPA currently is implementing its EDSP in three major parts that are being developed in parallel, with substantial work on each well underway. This document deals only with the third component of the EDSP (i.e., policies and procedures related to the issuance of orders). The other aspects of the EDSP have been or will be addressed in separate documents published in the **Federal Register** . The three parts are briefly summarized as follows: 1. *Assay validation* . Under FFDCA section 408(p), EPA is required to use “appropriate validated test systems and other scientifically relevant information” to determine whether substances may have estrogenic effects in humans. EPA is validating assays that are candidates for inclusion in the Tier 1 screening battery and Tier 2 tests, and will select the appropriate screening assays for the Tier 1 battery based on the validation data. Validation is defined as the process by which the reliability and relevance of test methods are evaluated for the purpose of supporting a specific use (Ref. 2). The status of each assay can be viewed on the EDSP website in the Assay Status table: *http://www.epa.gov/scipoly/oscpendo/pubs/assayvalidation/status.htm* . In addition, on July 13, 2007, EPA published a **Federal Register** document that outlined the approach EPA intends to take for conducting the peer reviews of the Tier 1 screening assays and Tier 2 testing assays and EPA's approach for conducting the peer review of the Tier 1 battery (72 FR 38577) (FRL-8138-4). EPA also announced the availability of a “list server” (Listserv) that will allow interested parties to sign up to receive e-mail notifications of EDSP peer review updates, including information on the availability of peer review materials to be posted on the EDSP website. 2. *Priority setting* . EPA described its priority setting approach to select pesticide chemicals for initial screening on September 27, 2005 (70 FR 567449), and announced the draft list of initial pesticide active ingredients and pesticide inerts to be considered for screening under FFDCA on June 18, 2007 (72 FR 33486). The Agency expects to publish a final list of chemicals that will be subject to initial screening before EPA begins issuing orders to require testing in 2008. More information on EPA's priority setting approach and the draft list of chemicals is available at *http://www.epa.gov/scipoly/oscpendo/pubs/prioritysetting* . The first group of pesticide chemicals to undergo screening is also referred to as “initial screening” in this document. 3. *Procedures* . The procedures are addressed by this document, which describes EPA's policies relating to: • Procedures that EPA would use to issue orders. • How joint data development, cost sharing, data compensation, and data protection would be addressed. • Procedures that order recipients would use to respond to an order. • Other related procedures or policies. C. What Chemicals May Be Covered by the EDSP? FFDCA section 408(p)(3) specifically requires that EPA “shall provide for the testing of all pesticide chemicals.” Section 201 of FFDCA defines “pesticide chemical” as “any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), including all active and inert ingredients of such pesticide.” [FFDCA section 201(q)(1), 21 U.S.C. 231(q)(1)]. Active ingredients are the substances that suppress, control or kill the target pests. Inert ingredients generally have no direct effect on the target pests although they may have some degree of toxicity. Inert ingredients may simply dilute the active ingredient or they may perform some function such as allowing the product to adhere better to leaves or other surfaces to improve contact with the pests. Inert ingredients also include fragrances, which may mask the smell of residential pesticides, and odorizers, which may act as warning agents. Many of these chemicals, including both active and inert ingredients, also have other, non-pesticidal uses. FFDCA also provides EPA with discretionary authority to “provide for the testing of any other substance that may have an effect that is cumulative to an effect of a pesticide chemical if the Administrator determines that a substantial population may be exposed to such a substance.” [21 U.S.C. 346a(p)(3)]. In addition, EPA may provide for the testing of “any other substance that may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed to such substance.” [SDWA 1457, 42 U.S.C. 300j-17]. Lastly, it is important to clarify that the procedures and policies described in this document do not in any way limit the Agency's use of other authorities or procedures to require testing of chemicals for endocrine disruptor effects. For example, section 4 of the Toxic Substances Control Act
(TSCA)provides EPA with the authority to require testing of TSCA chemical substances, provided that the Agency makes certain risk and/or exposure findings. [15 U.S.C. 2603]. Similarly, section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) grants EPA the authority to require pesticide registrants to submit additional data that EPA determines are necessary to maintain an existing registration. [7 U.S.C. 346a(c)(2)(B)]. As discussed in EPA's priority setting approach for the EDSP (70 FR 56449, September 27, 2005), the Agency is initially focusing its chemical selection on pesticide chemicals, both active ingredients and high production volume chemicals used as an inert ingredient in pesticides. If chemicals identified for future screening and testing under the EDSP are not used in pesticides, the Agency will consider whether the policies and procedures identified in this document and used for pesticide chemicals would be appropriate for other categories of substances. D. How Will EDSP Data be Used? In general, EPA will use data collected under the EDSP, along with other information, to determine if a pesticide chemical, or other substance that may be found in sources of drinking water, may pose a risk to human health or the environment due to disruption of the endocrine system. Under the tiered approach, Tier 1 screening data will be used to identify substances that have the potential to interact with the endocrine system. Chemicals that go through Tier 1 screening and are found to exhibit the potential to interact with the estrogen, androgen, or thyroid hormone systems will proceed to Tier 2 for testing. Tier 2 testing data will identify any adverse endocrine-related effects caused by the substance, and establish a quantitative relationship between the dose and that adverse effect. As the EDSP screening and testing requirements mature into routine evaluations, the Agency intends to utilize the pesticide registration review process as the framework for managing its responsibilities regarding the endocrine screening of pesticides, and intends to eventually incorporate these requirements into the pesticide registration review process. At that point, EPA will regard the endocrine disruptor screening and testing required under FFDCA as part of the risk characterization of the pesticide that is intrinsic to the FIFRA decision. While EPA has discretionary authority to issue, at any time, testing orders requiring manufacturers to conduct Tier 1 assays, the Agency plans to assess the performance of the Tier 1 battery based on the test data received for the initial list of chemicals before beginning to routinely issue orders to test additional chemicals. If EDSP data exist at the time of a pesticide's registration review, the Agency will consider the data when it makes its FIFRA (3)(c)(5) finding under registration review. III. Authority A. What is the Statutory Authority for the Policies Discussed in this Document? FFDCA section 408(p)(1) requires EPA “to develop a screening program, using appropriate validated test systems and other scientifically relevant information to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other effects as [EPA] may designate.” [21 U.S.C. 346a(p)]. FFDCA section 408(p)(3) expressly requires that EPA “shall provide for the testing of all pesticide chemicals.” FFDCA section 201 defines “pesticide chemical” as “any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), including all active and inert ingredients of such pesticide.” [FFDCA section 201(q)(1), 21 U.S.C. 231(q)(1)]. The statute also provides EPA with discretionary authority to “provide for the testing of any other substance that may have an effect that is cumulative to an effect of a pesticide chemical if the Administrator determines that a substantial population may be exposed to such a substance.” [21 U.S.C. 346a(p)(3)]. FFDCA section 408(p)(5)(A) provides that the Administrator “shall issue an order to a registrant of a substance for which testing is required [under FFDCA section 408(p)], or to a person who manufactures or imports a substance for which testing is required [under FFDCA section 408(p)], to conduct testing in accordance with the screening program, and submit information obtained from the testing to the Administrator within a reasonable time period” that the Agency determines is sufficient for the generation of the information. FFDCA section 408(p)(5)(B) requires that, “to the extent practicable, the Administrator shall minimize duplicative testing of the same substance for the same endocrine effect, develop, as appropriate, procedures for fair and equitable sharing of test costs, and develop, as necessary, procedures for handling of confidential business information. . . .” [21 U.S.C. 346a (p)(5)(B)]. If a registrant fails to comply with a FFDCA section 408(p)(5) test order, the Administrator is required to issue “a notice of intent to suspend the sale or distribution of the substance by the registrant. Any suspension proposed under this paragraph shall become final at the end of the 30-day period beginning on the date that the registrant receives the notice of intent to suspend, unless during that period, a person adversely affected by the notice requests a hearing or the Administrator determines that the registrant has complied fully with this paragraph.” [21 U.S.C. 346a (p)(5)(C)]. Any hearing is required to be conducted in accordance with section 554 of the Administrative Procedures Act (APA). [5 U.S.C. 554]. FFDCA section 408(p) explicitly provides that “the only matter for resolution at the hearing shall be whether the registrant has failed to comply with a test order under subparagraph
(A)of this paragraph.” [21 U.S.C. 346a (p)(5)(C)(ii)]. A decision by the Administrator after completion of a hearing is considered to be a final Agency action. [21 U.S.C. 346a (p)(5)(C)(ii)]. The Administrator shall terminate a suspension issued with respect to a registrant if the Administrator determines that the registrant has complied fully with FFDCA section 408(p)(5). [21 U.S.C. 346a (p)(5)(C)(iii)]. FFDCA section 408(p)(5)(D) provides that any person (other than a registrant) who fails to comply with a FFDCA section 408(p)(5) test order shall be liable for the same penalties and sanctions as are provided under section 16 of the Toxic Substances Control Act
(TSCA)[15 U.S.C. 2615] in the case of a violation referred to in that section. [21 U.S.C. 346a (p)(5)(D)]. Such penalties and sanctions shall be assessed and imposed in the same manner as provided in TSCA section 16. Under section 16 of TSCA, civil penalties of up to $25,000 per day may be assessed, after notice and an administrative hearing held on the record in accordance with section 554 of the APA. [15 U.S.C. 2615(a)(1)-(2)(A)]. B. Other Statutory Authorities Relevant to this Notice A number of other statutory provisions are discussed in this document, and consequently, are described below. This document does not affect the existing policies or related procedures that have been established under these other provisions. The following is a brief summary of these other relevant authorities. 1. *FIFRA.* FIFRA section 3(c)(1)(F) provides certain protections for people who submit data to EPA in connection with decisions under EPA's pesticide regulatory program. Specifically, FIFRA section 3(c)(1)(F) confers “exclusive use” or “data compensation” rights on certain persons (“original data submitters”) who submit data (in which they have an ownership interest), in support of an application for registration, reregistration, or experimental use permit, or to maintain an existing registration. Applicants, who cite qualifying data previously submitted to the Agency by the original data submitter, must certify that the submitter has been granted permission to cite data or that an offer of compensation has been made to the original data submitter. In the case of “exclusive use” data, the applicant must obtain the permission of the original data submitter and certify to the Agency that the applicant has obtained written authorization from the original data submitter. (Data are entitled to “exclusive use” for 10 years after the date of the initial registration of a pesticide product containing a new active ingredient.) If data are not subject to exclusive use but are compensable, an applicant may cite the data without the permission of the original data submitter, so long as the applicant offers to pay compensation for the right to rely on the data. (Data are “compensable” for 15 years after the date on which the data were originally submitted.) If an applicant and an original data submitter cannot agree on the appropriate amount of compensation, either may initiate binding arbitration to reach a determination. If an applicant fails to comply with either the statutory requirements or the provisions of a compensation agreement or an arbitration decision, the application or registration is subject to denial or cancellation. [See also 7 U.S.C. 136a (c)(1)(F)(ii)-(iii)]. FIFRA section 3(c)(2)(B) provides that: . . .[i]f the Administrator determines that additional data are required to maintain in effect an existing registration of a pesticide, the Administrator shall notify all existing registrants of the pesticide to which the determination relates and provide a list of such registrants to any interested person.” [7 U.S.C. 136a(c)(2)(B)]. Continued registration of a pesticide requires that its use not result in “unreasonable adverse effects on the environment” (defined as “any unreasonable risk to man or the environment, taking into account the economic, social, and environmental cost and benefits of the use of any pesticide, or a human dietary risk from residues that results from a use of a pesticide in or on any food inconsistent with the standard under section 408 of the [FFDCA]. FIFRA section 3(c)(2)(B) explicitly directs EPA to send notices of data requirements (referred to as “Data Call-In notices” or “DCI notices”) to all registrants affected by the data requirement. It also contains a mechanism by which recipients of DCI notices may jointly develop data and provides that “[a]ny registrant who offers to share in the cost of producing the data shall be entitled to examine and rely upon such data in support of maintenance of such registration.” The section establishes procedures to allow registrants who received DCI notices to use binding arbitration to resolve disputes about each person's fair share of the testing costs. Further, FIFRA section 3(c)(1)(F) makes clear that data submitted under FIFRA section 3(c)(2)(B) are also “compensable” when cited in support of an application for a registration. In other words, a pesticide company that chooses to rely on such data rather than develop its own data must offer compensation to the data generator if the data are relevant to the company's product and the company applies to register its product after the required data have been submitted to EPA. Lastly, the Agency may suspend the registration of a pesticide if the registrant fails to provide data required under a DCI notice in a timely manner. Finally, FIFRA section 3(c)(2)(D) contains a provision, referred to as the “formulator's exemption” that is intended to simplify and promote equity in the implementation of the data compensation program under FIFRA section 3(c)(1)(F). The generic data exemption, in effect, relieves an applicant of the obligation to cite and obtain permission or offer to pay data compensation to cite the results of any study if the study is relevant to the safety assessment of a registered product that the applicant buys from another person and uses to make the applicant's product. Congress' rationale for this exemption is that the seller will recover any data generation costs associated with its product by charging buyers a higher purchase price. Thus, if a pesticide formulator applies to register a product containing an active ingredient that the formulator purchased from the basic manufacturer of the active ingredient, the formulator does not need to submit or cite and offer to pay compensation for any data specifically relevant to the purchased product. The Agency has extended the generic data exemption to data requirements under FIFRA section 3(c)(2)(B). Consequently, if the formulator received a DCI notice requiring data on the active ingredient, the formulator could comply by providing documentation that it bought the active ingredient from another registrant. 2. *SDWA* . SDWA section 1457 provides EPA with discretionary authority to provide for testing, under the FFDCA section 408(p) screening program, “of any other substances that may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed to such substance.” [42 U.S.C. 300j-17]. Because SDWA section 1457 specifically mandates that EPA “may provide for testing. . . in accordance with the provisions of [FFDCA section 408(p)],” EPA may rely on many of the procedures discussed in this document to require testing under SDWA section 1457. 3. *Other sections of FFDCA* . FFDCA section 408(f) establishes procedures that the Agency “shall use” to require data to support the continuation of a tolerance or exemption that is in effect. The provision identifies three options: • Issuance of a notice to the person holding a pesticide registration under FIFRA section 3(c)(2)(B) [FFDCA section 408(f)(1)(A)]. • Issuance of a rule under section 4 of TSCA [FFDCA section 408(f)(1)(B)]. • Publication of a notice in the **Federal Register** requiring submission, by certain dates, of a commitment to generate the data “by one or more interested persons.” [FFDCA section 408(f)(1)(C)]. Before using the third option, however, EPA must demonstrate why the data “could not be obtained” using either of the first two options. FFDCA section 408(f)(1) expressly provides that EPA may use these procedures to “require data or information pertaining to whether the pesticide chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects.” Finally, FFDCA section 408(f)(1)(B) provides that, in the event of failure to comply with a rule under TSCA section 4 or an order under FFDCA section 408(f)(1)(C), EPA may, after notice and opportunity for public comment, modify or revoke any tolerance or exemption to which the data are relevant. In addition, FFDCA section 408(i) provides that “[d]ata that are or have been submitted to the Administrator under this section or FFDCA section 409 in support of a tolerance or an exemption from a tolerance shall be entitled to confidential treatment for reasons of business confidentiality and to exclusive use and data compensation to the same extent provided by section 3 and section 10 of [FIFRA].” IV. Policies and Procedures for the EDSP (Initial Screening) This Unit describes the policies and procedures that EPA is considering to adopt for the initial screening required under the program referred to above in Unit II.B. In general, the Agency has tried to develop policies that could be used in subsequent data collection efforts, including those under SDWA. However, the Agency expects that these policies may be modified as a result of the Agency's experience applying them to the first chemicals to undergo testing. A diagram that graphically presents the overall process is available in the docket. A. Background On December 28, 1998 (63 FR 71542) (Ref. 1), EPA first discussed a number of the more complicated policy issues relating to the implementation of the screening program. These issues included: • Under what authority EPA would require testing. • How EPA would approach issues relating to minimizing duplicative testing; sharing of test costs; and appropriate compensation for the use or reliance on data submitted by a company (i.e., data compensation). • EPA's approach to protecting CBI and trade secrets, and the public release of such information. • Who would be required to conduct testing, including whether exemptions would be available. (Ref. 1). In this document, EPA is describing the policies and procedures that it intends to use for the initial EDSP screening of pesticide chemicals. For some of these issues, EPA now has a preferred policy approach; for other issues, EPA has laid out the various considerations for public comment. EPA is soliciting comment on all of the draft policies announced in this document. Prior to requiring screening and testing under the EDSP, EPA will publish in the **Federal Register** the announcement of the final policies and procedures it will adopt for initial screening. However, EPA anticipates that it may modify the policies and procedures for future EDSP screening efforts based on EPA's experience in applying these policies and procedures during initial screening. B. How Will EPA Require Testing of Pesticide Chemicals Under the EDSP? For the initial screening, EPA intends to issue “test orders” pursuant to section 408(p)(5) of FFDCA. This is consistent with the December 1998 Notice, where EPA indicated that it intended to rely primarily on FFDCA and SDWA to require testing, and would “use other testing authorities under FIFRA and TSCA to require the testing of those chemical substances that the FFDCA and SDWA do not cover.” (Ref. 1). Because EPA is focusing on pesticide chemicals in registered pesticide products for initial screening, there is no need to rely on TSCA or SDWA. However, as discussed in Unit IV.C.-IV.D., in order to address some of the more complex issues surrounding joint data development and the availability of data compensation and data protection, EPA is proposing to issue some orders jointly under the authority of FFDCA section 408(p)(5) and FIFRA section 3(c)(2)(B). The Agency has drafted basic templates that would be used for such test orders. These templates, which reflect EPA's preferred approaches, differ according to whether the recipients are: • Pesticide registrants, or • Manufacturers and importers of inert ingredients. Finally, the test order templates may differ to accommodate differences in the Agency's procedures for data compensation, and for the minimization of duplicative data. Copies of the current draft test order templates are included in the Docket and the Agency welcomes your comments on the structure and clarity of these documents. There are some pesticide active and inert ingredients that are not registered in the U.S. but for which there are tolerances on foods imported from other countries. When these chemicals are to be tested in the future, EPA may rely on FFDCA 408(f)(1) to require “interested persons” to submit data for the EDSP. C. What Can EPA Do To Minimize Duplicative Testing and Promote Cost Sharing and Data Compensation Under EDSP? One of the complex issues discussed in the December 1998 Notice related to joint data development, and how EPA would implement the FFDCA section 408(p)(5)(B) directive that “[t]o the extent practicable, the Administrator shall minimize duplicative testing of the same substance for the same endocrine effect. . . .” As noted in the December 1998 Notice (63 FR 71563), EPA also considered it appropriate to promote cost sharing and data compensation. EPA also originally contemplated that it would adopt new procedures unique to the EDSP. After considering all of the issues, EPA is currently considering adopting an approach that is similar to that announced in the December 1998 Notice, but with some significant distinctions which are discussed in more detail in this section. In summary, EPA's preferred approach to “minimize duplicative testing of the same substance” and to promote the “fair and equitable sharing of test costs” would be as follows: • The companies, who are the basic producers of an active ingredient or inert ingredient at the time EPA issues a data requirements notice (FFDCA section 408(p) test order), would bear the costs of testing and would be informed of all other order recipients. • The recipients of the FFDCA section 408(p) test orders would have strong incentives to work together to develop data jointly and to share test costs. • Subsequent entrants into the marketplace would receive “catch-up” FFDCA section 408(p) test orders making them subject to the same data requirements with the same provisions to comply with the requirement by making an appropriate offer to share the test costs that includes a reasonable process for resolving disputes. • Customers who purchase an inert ingredient from a basic producer (who becomes/is an original data submitter) would not have to participate in joint development of, or offer to pay compensation for the right to rely on, required EDSP data. EPA believes its preferred approach would achieve for inert ingredients essentially the same outcome as the procedures under FIFRA section 3(c)(2)(B) and section 3(c)(1)(F) will produce for active ingredients. In summary, EPA is considering adopting a policy that encourages joint data developers to agree on how to share costs and also encourages companies that enter the marketplace after the data are developed to pay reasonable compensation to the data generators. EPA's policy will resemble the provisions and procedures of FIFRA to the extent allowed by FFDCA. 1. *Minimizing duplicative testing* . As a point of clarification, a substantial amount of overlap exists between the goal of minimizing duplicative testing and the topic discussed in the next section, allowing parties to share the costs of conducting the testing. Consequently, some of the measures discussed in this section that EPA is considering adopting to try to minimize duplicative testing will have certain implications for the decisions pertaining to cost sharing, and vice versa. The Agency recognizes that, if EPA sends test orders under the EDSP screening program to multiple companies that produce the same substance and then each recipient of the test order conducts the required studies, there could be a great deal of duplicative testing. Although not discussed in the 1998 Notice, one way to avoid such duplicative testing is to send the test orders only to a single person who would be responsible for producing the required data. Unlike FIFRA section 3(c)(2)(B), FFDCA section 408(p) does not specifically require that test orders be sent to all registrants of a particular pesticide. But, when there are multiple people that produce the substance to be tested, such an approach could potentially undercut the second goal mentioned in FFDCA section 408(p)(5)(B)—promoting “fair and equitable sharing of test costs.” Each company that manufactures a substance subject to EDSP screening would benefit from the production of the data, and under the most equitable approach, each should potentially pay a fair share of the cost of testing. As a practical matter, however, people would have little or no incentive to contribute to the cost of generating EDSP data unless they each received a test order. Therefore, when there are multiple producers of the substance, EPA believes that EDSP test orders should generally be issued to each producer, and not just to a single producer. The Agency originally anticipated relying on the authority of FFDCA section 408(p) to establish new procedures to promote joint development of data by recipients of FFDCA section 408(p) test orders (63 FR 71563). Now, however, the Agency no longer believes that FFDCA section 408(p)(5) provides the authority to create express requirements for joint data development. In EPA's view, FFDCA section 408(p)(5)(B) merely establishes a qualified direction that the Agency “[t]o the extent practicable . . . minimize duplicative testing . . . .” This, standing alone, does not create new authority to compel companies to use arbitration to resolve disputes arising from an effort to develop data jointly, nor does it even authorize EPA to impose a requirement for joint data development. Rather, EPA believes that this provision directs the Agency to create procedures that operate within the confines of existing statutory authorities. While FFDCA section 408(p) does not allow EPA to impose requirements identical to those authorized by FIFRA section 3 that would minimize duplicative testing, EPA has the authority under FFDCA section 408(p) to develop Agency procedures that achieve many of the same ends. Specifically, the Agency has discretion to determine what actions constitute compliance with a FFDCA section 408(p) test order, and EPA can apply this discretion in a manner that creates strong incentives for companies to voluntarily develop data jointly. While there are good policy reasons not to require the same data from multiple entities, under FFDCA section 408(p), each recipient of a data requirements notice has a separate obligation to provide the required data. EPA thinks that FFDCA section 408(p) confers adequate discretion to consider that a recipient has fulfilled its obligation to provide data when: • The recipient actually submits results from the required studies, or • EPA judges that it would be equitable to allow the recipient to rely on, or cite, results of studies submitted by another person. The Agency believes that it would generally be equitable to allow a recipient of a FFDCA section 408(p) test order to rely on the results of studies submitted by another person where: • The data generator has given permission to the recipient to cite the results, or • Within a reasonable period after receiving the FFDCA section 408(p) test order, the recipient has made an offer to commence negotiations regarding the amount and terms of paying a reasonable share of the cost of testing, and has included an offer to submit to a neutral third party with authority to bind the parties, to resolve any dispute over the recipient's share of the test costs, (e.g., through binding arbitration or through a state or federal court action). The Agency believes this approach to minimizing duplicative testing, which parallels that used under FIFRA section 3(c)(2)(B), would adequately address any disincentives for the recipients of FFDCA section 408(p) test orders to develop data jointly. In the first instance, where the data generator had granted permission for another party to cite its data, the equities are clear, and EPA would have no reason for refusing to allow it. In the second instance, where the data generator received an offer to commence negotiations regarding the amount and terms of compensation and to go to a neutral decisionmaker with authority to bind the parties failing successful negotiations, EPA believes that the company has demonstrated a good faith effort to develop data jointly, and consequently would typically consider that the order recipient had complied with the order. Based on EPA's experience under FIFRA, there should be little or no reason for a data generator to decline such an offer. Moreover, if EPA did not adopt such an approach, the end result would effectively confer the sort of “exclusive use” property rights established under FIFRA section 3(c)(1)(F), on a broad category of data, and EPA does not believe that FFDCA section 408(p)(5) creates such rights, or provides EPA with the authority to create such rights. In addition to the specific procedures discussed in Unit IV.C.1., many of the procedures EPA is considering adopting to address cost sharing and data compensation will effectively function to minimize duplicative testing. Similarly, EPA has taken the directive to minimize duplicative testing to the extent practicable into account in determining who would receive FFDCA section 408(p) test orders. See Units IV.C.2. and IV.D. for further discussion of these topics. In summary, EPA currently intends that it will typically treat a suitably expressed offer to join in the development of a required study as sufficient to comply with a test order under FFDCA section 408(p). 2. *Promoting cost sharing and data compensation* . As noted in Unit IV.C.1., FFDCA section 408(p)(5)(B) directs the Agency to “develop, as appropriate, procedures for fair and equitable sharing of test costs.” Informed by its experience under FIFRA, EPA sees this provision as containing two related directives: • Promotion of the sharing of costs by companies that agree to develop data jointly (“cost sharing”). • Payment of compensation to a data generator by a person whose activity subsequent to the submission of the required data would make such payment equitable (“data compensation”). The first directive relates to sharing the cost of developing data between parties on the market when a test order is issued. The second directive relates to the payment by a person (who was not part of a joint data development agreement) to those that originally generated and submitted data, in exchange for relying on the results of their previously submitted study. These mirror the data generation and data compensation processes that have been followed for years under FIFRA, and the Agency believes those processes are a good starting point for dealing with these issues in the context of 408(p)(5) orders. Consistent with section 408(p)(5)(B), EPA would, “to the extent practicable,” like to “develop procedures for fair and equitable sharing of test costs” not only by persons in business when the initial 408(p) test orders were issued, but also by persons who enter the marketplace after the data are submitted. FFDCA section 408(p)(5)(B) merely establishes a qualified direction that the Agency develop “as appropriate, procedures for fair and equitable sharing of test costs.” This, standing alone, does not create new data compensation rights, nor does it authorize EPA to create such rights. EPA has no inherent authority to create new rights to compensation; such rights are created only by Congress, and must be explicitly created by statute. FFDCA section 408(p)(5)(B) provides none of the indicia that Congress intended to expand the current expectation as to which data are compensable. For example, FFDCA section 408(p)(5)(B) is silent on a reimbursement period, processes and acceptable arbitration organizations, EPA's role in the process, penalties for non-compliance, and exemptions. Not only does EPA believe that FFDCA section 408(p)(5) fails to provide EPA with the authority to establish unique procedures for the EDSP, but EPA believes that this provision does not authorize EPA to modify existing data compensation rights established under FIFRA section 3 or FFDCA section 408(i). By contrast, FIFRA, TSCA, and FFDCA section 408(i) all provide specific directions to the Agency on all of these issues. FIFRA section 3(c)(1)(F) establishes an elaborate set of criteria and procedures governing the rights of data submitters to obtain either “exclusive use” over or data compensation for data they submit to EPA. TSCA section 4 has similarly detailed provisions. [See also 7 U.S.C. 136a (c)(1)(F)(ii)-(iii); 15 U.S.C. 2603(c)(3)-(4)]. Similarly, section 408(i) of FFDCA, which extends FIFRA data compensation rights to data submitted “in support of a tolerance or tolerance exemption,” effectively provides guidance on all of these issues, providing that such data “shall be entitled to. . .exclusive use and data compensation to the same extent provided by [section 3 of FIFRA].” In summary, EPA interprets FFDCA section 408(p)(5)(B)'s direction to require EPA to develop procedures that will promote cost sharing among test order recipients and to provide for compensation for data submitted pursuant to a FFDCA section 408(p) test order, but only to the extent either FIFRA section 3 or FFDCA section 408(i) provide for cost sharing or data compensation. As explained more fully in the remainder of this unit, however, EPA believes that its approach to minimizing duplicative testing will not only promote joint data development, but also encourage cost sharing among all test order recipients. In addition, EPA believes that most EDSP data developed in response to FFDCA section 408(p) test orders will be compensable under FIFRA, or pursuant to FFDCA section 408(i). As discussed in Unit IV.C.1., EPA intends to adopt procedures implementing FFDCA section 408(p) screening that will minimize duplicative testing; these measures will also have the effect of substantially fostering cost sharing among those who receive the initial test order. By using an approach which parallels that used under FIFRA section 3(c)(2)(B), any disincentives for the recipients of FFDCA section 408(p) test orders to develop data jointly would be addressed. EPA's experience with FIFRA section 3(c)(2)(B) indicates that when multiple registrants receive DCI notices to produce the same data on the same active ingredient, they form consortia that work together to develop the required data. If manufacturers and importers receive FFDCA section 408(p) test orders containing the provisions previously discussed, EPA expects that they would behave in the same manner. *a. What data are compensable under the EDSP?* With respect to determining the extent to which compensation for previously submitted studies is warranted, the threshold issue is what EDSP data will be “compensable.” Given EPA's belief that FFDCA section 408(p)(5)(B) does not give EPA the inherent authority to create new rights to compensation, the threshold for what is “compensable” requires consideration of existing statutory authority for compensation. To the extent the data are otherwise covered by any provision of FFDCA or FIFRA that requires a person to offer compensation for the right to cite or rely on data submitted by another person in connection with a pesticide regulatory matter, EPA must continue to enforce those provisions. FFDCA section 408(i) provides that data submitted under FFDCA section 408 “in support of a tolerance or an exemption from a tolerance shall be entitled to . . . exclusive use and data compensation to the same extent provided by section 3 of [FIFRA].” The Agency considers any data generated in response to requirements under FFDCA section 408(p) on a pesticide chemical for which there is an existing tolerance, tolerance exemption, or pending petition to establish a tolerance or an exemption to be data submitted in support of a tolerance or an exemption. In fact, FFDCA section 408(b)(2)(D)(viii) explicitly requires EPA to consider “such information as the Administrator may require on whether the pesticide chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects,” as part of its determination that a substance meets the safety standard. [21 U.S.C. 136a(b)(2)(D)(viii)]. Thus, EDSP data on active and inert ingredients for which there is a tolerance or tolerance exemption will be compensable as outlined under FIFRA section 3(c)(1)(F). Moreover, data establishing whether a pesticide chemical (either active or inert) has the potential to interact with the endocrine system would be relevant to a FIFRA registration decision. Under FIFRA, EPA has a continuing duty to ensure that a pesticide meets the registration standard; EPA must consider all available data relevant to this determination. [See 7 U.S.C. 136a (2)(bb) and 3(c)(5)]. In the terms of FIFRA section 3(c)(1)(F), such data “support or maintain in effect an existing registration.” Thus, data generated in response to a FFDCA section 408(p) test order would be compensable as outlined in FIFRA section 3(c)(1)(F) if the data are submitted by a pesticide registrant. In summary, most EDSP data will be compensable under FIFRA or FFDCA section 408(i). Data for active and inert ingredients that have a tolerance or tolerance exemption or are the subject of a pending petition will be compensable regardless of what companies submit the data. Other active ingredients will also be compensable as long as, in the case of a joint submission, at least one of the submitters is a pesticide registrant or applicant. While much EDSP data will be compensable under FIFRA or FFDCA section 408(i), some EDSP data will be generated by chemical manufacturers and importers of inert ingredients that have neither a tolerance nor tolerance exemption and are not the subject of a pending petition. (EPA refers to these substances as “non-food use inerts.”) Because such EDSP data could not be considered “data submitted in support of a tolerance or exemption,” the data submitted on such substances in response to a FFDCA section 408(p) test order would not be entitled to compensation under FFDCA section 408(i). Moreover, since FIFRA section 3(c)(1)(F) establishes compensation rights only for data submitted by an applicant or a registrant, data submitted to EPA in response to a FFDCA section 408(p) order by a person who is neither a registrant nor an applicant would not become compensable under FIFRA. However, although data on a non-food use inert are not compensable when submitted by a non-registrant pursuant to FFDCA section 408(p), such data would become compensable when submitted jointly by a registrant to support continued registration of a pesticide product. In addition, EPA believes that the internal procedures it intends to adopt would effectively provide manufacturers and importers with the same opportunity for cost sharing/compensation available to all other order recipients. Given EPA's belief that FFDCA section 408(p)(5)(B) does not give EPA the authority to modify FIFRA data compensation rights, the fact that much EDSP data will also potentially be compensable under FIFRA raises questions about the interplay between the two statutes. For example, unlike FIFRA section 3(c)(2)(B), FFDCA section 408(p) does not give EPA the authority to enforce an offer to pay compensation. Thus, unless and until such data are used in support of a pesticide regulatory action under FIFRA, if a recipient of a test order made an offer but then refused to pay compensation or to participate in binding arbitration following the data submitters acceptance of that offer, the data generator's only recourse would be to seek any judicial remedies that may be available. Consequently, rather than leave recipients with any ambiguity, EPA is considering issuing orders to registrants to conduct EDSP testing pursuant to both FIFRA section 3(c)(2)(B) and FFDCA section 408(p). Although EPA believes there are ways to make all EDSP data generated on inert ingredients compensable, EPA must consider what procedures to use to ensure persons who did not share in the cost of testing, but who benefit from the existence of such data, actually pay compensation. Under FIFRA section 3(c)(1)(F), companies that apply for registrations of pesticide products after the data were submitted either would have to offer to pay compensation for the right to cite the data or would have to generate comparable data. Consequently, in the case of active ingredients, everyone who benefits from the existence of EDSP data on an active ingredient either shares the cost of the testing as part of the joint data development under FIFRA section 3(c)(2)(B) or offers to pay compensation to the original data submitter under FIFRA section 3(c)(1)(F). The same is not true for inert ingredients. There is no mechanism under either FIFRA or FFDCA for directly requiring payment of compensation by companies that start to manufacture or import an inert ingredient after an original data submitter has provided EDSP data on the inert ingredient. Such companies are not subject to FIFRA data compensation obligations because they are not registrants or applicants for registration. Nonetheless, EPA believes that, by using its discretion under FFDCA section 408(p) to issue test orders to those manufacturers or importers of a substance for which EDSP data had previously been submitted who subsequently enter the market, EPA can achieve substantially the same ends. FFDCA section 408(p)(5) provides that “[t]he Administrator shall issue an order to “. . .a person who manufactures or imports a substance for which testing is required under this subsection, to conduct testing in accordance with the screening program . . . .” Thus, under FFDCA section 408(p)(5), EPA may issue a test order to a manufacturer or importer who begins to sell an inert ingredient following the submission of required EDSP data on the ingredient by manufacturers or importers who were in the marketplace when the initial test orders were issued. The Agency refers to these as “catch-up” test orders. As with the initial FFDCA section 408(p) test order, recipients could fulfill the testing requirement either by submitting the results of a new study or by citing the data submitted by another person. In furtherance of the goal of “fair and equitable sharing of test costs,” the Agency would accept citation of existing data only if the recipient either had the original data submitter's permission or the recipient had made an appropriate offer to pay compensation to the original data submitter that also determined how disputes would be resolved. Unless new manufacturers or importers requested pesticide registrations, EPA could not readily identify new entrants in the market. EPA would largely rely on the manufacturers and importers who are part of the data submitters' task force to inform the Agency about new entrants to the market, at which time EPA could issue the FFDCA section 408(p) catch-up orders. An issue arising under this approach is whether to send FFDCA section 408(p) test orders to subsequent entrants into the marketplace indefinitely or only to send them for a limited period of time. EPA is proposing to only send “catch-up” FFDCA section 408(p) test orders to subsequent entrants into the marketplace within 15 years—a time frame matching the period of compensability under FIFRA section 3(c)(1)(F). An additional issue that will need to be resolved is whether manufacturers of inert ingredients who do not themselves market the ingredients for use in pesticide products should be required to generate data in response to a 408(p) test order. See Unit IV.F.1. for further discussion of this topic. The Agency invites public comment on these issues. *b. Who will provide compensation?* Although the procedures described should result in having all companies that manufacture or import an inert ingredient share equitably in the cost of generating required EDSP data, FIFRA imposes additional compensation requirements on the customers of such companies who purchase the inert ingredients for use in formulating their registered pesticides. Specifically, FIFRA section 3(c)(1)(F) requires an applicant for a new or amended registration to offer to pay compensation to the original submitter of EDSP data if the applicant's product contains an ingredient (active or inert) for which EDSP data have been submitted. For all pesticide chemical ingredients except non-food use inerts, the Agency interprets the formulator's exemption to be applicable. Under FIFRA section 3(c)(2)(D), an applicant for registration of a product may be excused from submitting or citing data pertaining to registered products that the applicant has purchased from another person. EPA has also taken the position that this principle extends to a FIFRA applicant's purchase of food use inert ingredients, when all applicable inert ingredient data requirements have been satisfied by the inert ingredient manufacturer. The formulator's exemption under FIFRA section 3(c)(2)(D) is not applicable to EDSP data generated on non-food use inerts (unless the data are submitted jointly by a registrant or applicant for registration). However, EPA believes that it can effectively achieve the same ends through the internal procedures it adopts, and through its discretion to selectively issue FFDCA section 408(p) test orders only to importers and manufacturers of such inert ingredients. The policy rationale underlying FIFRA's formulator's exemption is equally applicable in the case of non-food use inerts. Specifically, Congress believed that, so long as the requirements apply equally to manufacturers of a particular ingredient, the price of their product should also reflect any data development costs. Accordingly, requiring compensation of product purchasers would have the effect of requiring purchasers to pay data development costs twice—once as a condition of satisfying a FFDCA section 408(p) test order, and thereafter as part of the price of the inert ingredients they purchase to make their products. [See 49 FR 30892, August 1, 1984]. As a result, EPA is considering adopting the following procedures to determine whether the end-use formulators had met their obligations to submit EDSP screening data. c. *How will EPA determine whether compensation obligations have been met* ? Currently, EPA maintains a list of all data on active ingredients that would support a technical registration along with contact information on the owners of the data. This is the Data Submitters List. Product registrants must identify the chemicals in their product and, in the case of the active ingredient(s), they must identify the source of the ingredient(s). Product registrants typically cite the data submitted on the active ingredients to support a technical registration. The citation is accompanied by either a claim that the registrant is eligible for a formulator's exemption or proof that an offer to pay was made to the owners of the data. FIFRA requires that an applicant/registrant agree to binding arbitration to resolve issues of reasonable compensation. If the applicant or registrant fails to fulfill the agreement, the owner of the data may petition the Agency to cancel the registration. These procedures would also be applicable to EDSP data that are subject to FFDCA section 408(i). As previously noted, compensation for data on inert ingredients has not been an issue to date so implementation of data compensation for EDSP data on inert ingredients would involve new procedures. The approach outlined here is also being considered for administering the formulator's exemption for all food use inert data; EPA intends that the procedures ultimately adopted for the EDSP will be consistent with (if not the same as) those adopted generically for all food use inert data, as there is no reason for creating separate procedures for EDSP inert data and all other food use inert data. First, for each inert ingredient on which EPA receives EDSP data, EPA would identify the data submitter on an “Inerts Suppliers List.” This list would contain the names of every company that had either submitted the required EDSP data or fulfilled its obligation under a FFDCA section 408(p) test order by offering to share the cost of testing with other data developers. Second, EPA would need to require pesticide applicants and registrants to identify the source of every inert ingredient for which there are compensable EDSP data. Then, EPA would consider that the end-use formulator had adequately complied with FFDCA section 408(p)(3)'s requirement to conduct EDSP screening only if the person identified as the source for the inert ingredient appeared on the “Inerts Suppliers List” for that inert ingredient. If the applicant or registrant of the end-use product chose to use a source for the inert ingredient that is not on the “Inerts Suppliers List,” EPA would issue an order to the manufacturer of the inert ingredient, and/or to the applicant or registrant, requiring the manufacturer and/or applicant or registrant to generate the EDSP test data. The Agency could take the following possible approaches for applying these procedures to determine whether the end-use formulators had met their obligations to conduct EDSP screening: i. *Determine compliance in conjunction with applications for new and amended registrations.* EPA could apply these procedures as part of the routine processing of applications for new and amended registrations. Under FIFRA section 3(c)(1)(F), the action of submitting an application would trigger the obligation to identify the source of an inert ingredient for which there were EDSP data. If the source cited by the applicant was not on the “Inerts Suppliers List,” the applicant would have the choice of either offering to pay compensation to a source on the list or of changing sources to a supplier already on the list. Should the applicant choose neither option, EPA would require the applicant to generate EDSP data in order to obtain its registration. ii. *Determine compliance both in conjunction with applications for registration, and during registration review* . In addition to relying on existing procedures under FIFRA section 3(c)(1)(F), EPA could also use the registration review program authorized under FIFRA section 3(g). Under registration review, EPA reexamines all previously registered pesticide products approximately once every 15 years and, as necessary, requires the registrants to take steps necessary to come into compliance with the applicable statutory and regulatory requirements. As part of such updating, EPA could require registrants to comply with FIFRA section 3(c)(1)(F) with respect to the right to cite and rely on EDSP data pertaining to an inert ingredient in their products. Thereafter, the registrants would proceed as under the first option. iii. *Issue test orders to end-use formulators.* This option is similar to the second, except that EPA would issue test orders under either FFDCA section 408(p) or FIFRA section 3(c)(2)(B) to end-use formulators whose products contain a particular inert ingredient, rather than waiting until registration review. Under this approach, EPA would continue to determine compliance in conjunction with applications for registration, and would also issue test orders shortly after submission of the EDSP data for a particular inert ingredient, to all registrants whose products contain a particular inert ingredient. The test orders would require the registrants either to provide the EDSP data, to cite and offer to pay compensation for existing EDSP data, or to demonstrate that the registrant purchased its product from a company on the “Inerts Suppliers List.” Under this approach, EPA would also determine compliance in conjunction with applications for new or amended registrations. Among these three options, EPA prefers the first whereby data compensation would be triggered as registrants sought new or amended registrations. (As long as a registrant did not amend its registration, it would not have to make an offer to pay compensation.) This is because EPA believes that the registration and amended registration processes should effectively capture all new and existing products. EPA recognizes that although each of these procedures would make the registration process more complex and require additional resources from both the regulated community and EPA, the first seems to involve the smallest increase in administrative burden. However, EPA requests comment on the merits of the various approaches. The alternatives differ primarily by how quickly the original data submitters could be assured that pesticide formulators are either offering to pay compensation or are buying only from a supplier on the “Inerts Suppliers List.” Under the third option, this accounting would occur shortly after submission of the EDSP data when all affected registrants would receive test orders shortly after the submission of the EDSP data and orders would require affected registrants to comply within a short time period. The second option would require registrant responses only as EPA reviewed products containing a particular active ingredient. At the end of 15 years, however, all registrants would have been required to comply with FIFRA section 3(c)(1)(F). While these differences may seem significant, the Agency thinks that, in reality, there is little difference between the options. If all manufacturers and importers were parties to the initial submission, and so long as EPA promptly issues “catch up” orders under FFDCA section 408(p) to new manufacturers and importers of the inert ingredient as they enter the marketplace, a product registrant should always discover that its supplier is already on the list. As discussed, the requirements for instituting such procedures could be onerous and would become more onerous over time as more inert ingredients go through the EDSP. Registrants would eventually have to identify the source of all inert ingredients, many of which can pass through multiple packaging, wholesale, and retail steps before being purchased by a formulator. Any time the registrant, or an actor in the supply chain, changed sources, an amendment would be necessary along with a new claim of exemption or offer to pay compensation. This would discourage registrants from changing sources, even between suppliers on the “Inerts Suppliers List,” potentially limiting competition and leading to higher costs for producers and consumers of pesticide products. EPA would have to process all changes, verify that exemptions are valid, and maintain the “Inerts Suppliers List,” as well as distinguish between compensable data and non-compensable data. D. What Procedures Can EPA Apply for Handling CBI? FFDCA section 408(p)(5)(B) also requires that EPA, to the extent practicable, develop, as necessary, procedures for the handling of CBI. Many of the same considerations laid out in Unit III.C. are equally relevant to EPA's implementation of this directive. EPA is therefore adopting a consistent approach with respect to the handling of CBI. As with the directives to develop procedures for sharing test costs and minimizing duplicative testing, EPA also does not believe that FFDCA section 408(p)(5)(B) provides the authority for the Agency to either create new rights or to modify existing rights to confidentiality. Rather, EPA believes that this provision directs the Agency to create procedures that operate within the existing confines of FFDCA section 408(i), FIFRA section 10, the Freedom of Information Act (FOIA), and the Trade Secrets Act. As explained in Unit IV.C., because EPA will consider much of the data submitted in response to FFDCA section 408(p) orders to be submitted in support of a tolerance or tolerance exemption, such data would be entitled to confidential treatment to the same extent as under FIFRA section 10, pursuant to FFDCA section 408(i). In addition, CBI submitted by pesticide registrants in response to a FFDCA section 408(p) test order would be considered as part of the registration process, and would therefore be considered to be data submitted in support of a registration. As such that information would be directly subject to FIFRA section 10. However covered, data subject to FIFRA section 10 would be provided certain protections that go beyond those authorized by FOIA. For example, FIFRA section 10(g) generally prohibits EPA from releasing information submitted by a registrant under FIFRA to a foreign or multinational pesticide producer, and requires the Agency to obtain an affirmation from all persons seeking access to such information that they will not disclose the information to a foreign or multinational producer. FFDCA section 408(i) extends the protection available under FIFRA section 10 for data submitted in support of a tolerance or tolerance exemption. All other CBI submitted in response to a FFDCA section 408(p) test order (i.e., data not in support of a registration or tolerance/tolerance exemption) is only protected by the provisions of the Trade Secrets Act which incorporates the confidentiality standard in FOIA Exemption 4. FOIA requires agencies to make information available to the public upon request, except for information that is “specifically made confidential by other statutes” or data that are “trade secrets and commercial or financial information obtained from a person and is privileged or confidential.” [5 U.S.C. 552(b)(4)]. Note that substantive criteria must be met to claim confidentiality of business information, as specified in 40 CFR 2.208. As with EPA's approach for data compensation, EPA would consider that data submitted jointly with a registrant, or as part of a consortium in which pesticide registrants participate, to be data submitted in support of a tolerance/tolerance exemption or registration, and therefore entitled to protection under FIFRA section 10. However, if a non-registrant chooses not to partner with a registrant, such data would only be subject to the protections available under FOIA and the Trade Secrets Act. E. Who Would Receive FFDCA Section 408(p) Test Orders Under the EDSP and How Will They Be Notified? Under FFDCA section 408(p)(5)(A), EPA “shall issue” EDSP test orders “to a registrant of a substance for which testing is required . . . or to a person who manufactures or imports a substance for which testing is required.” EPA has generally identified the following categories of potential test order recipients: • *Technical registrants (basic manufacturers of pesticide active ingredients)* - Entities who manufacture or import an active ingredient *and* hold an active EPA registration (technical registrants in most cases). Usually a product with technical registration is used in the formulation of other pesticide products. However, EPA also uses this term in this Notice to include registrants who use an integrated system to produce their own active ingredient, as well as those who use an unregistered technical active ingredient. In the interest of simplifying this document, the phrase “technical registrant” will be used to refer to:
(1)Registrants of a technical grade of active ingredient;
(2)registrants whose products are produced using an integrated system, as defined in 40 CFR 158.1539(g); and
(3)registrants who use an unregistered technical active ingredient to manufacture their pesticide product. • *End-use registrants (customers)* - Registrants whose products contain an active ingredient or an inert ingredient. The registrant does not necessarily manufacture or import the active pesticide ingredient or inert. • *Manufacturers/importer* - Entities who manufacture or import an inert ingredient that do not necessarily have to hold an EPA registration for the sale of pesticide products. This would also include those manufacturers of pesticide products that are intended solely for export, so long as another company has a U.S. pesticide registration for the chemical, or an import tolerance exists for that chemical. 1. *Technical registrants and manufacturers/importers vs. all registrants and manufacturers/importers* . Under FFDCA section 408(p)(5)(A), EPA “shall issue” EDSP test orders “to a registrant of a substance for which testing is required . . . or to a person who manufactures or imports a substance for which testing is required.” Registrants are entities that hold a license for the sale of pesticide products. Pesticide products contain multiple substances, including both active and inert ingredients. EPA thinks that this language gives EPA the discretion to send FFDCA section 408(p) test orders to: a. Persons who manufacture or import an active ingredient or inert ingredient. b. Registrants whose products contain an active ingredient or an inert ingredient. c. People in both groups. Thus, the universe of recipients of FFDCA section 408(p) test orders is potentially very large. In most cases, however, the Agency expects that only one or a few companies would actually take the lead in organizing and conducting required EDSP studies. For pesticide active ingredients, the data developers are likely to be the companies that manufacture the substances subject to test orders (or who import the substances from a foreign manufacturer), as opposed to those who purchase the ingredient from a manufacturer or importer and mix it to make a pesticide product. For pesticide active ingredients, EPA believes sending FFDCA section 408(p) test orders both to the technical registrant and to the end-use registrant (their customers) would lead to unnecessary administrative costs for EPA and the regulated industry. Similarly for inert ingredients, EPA believes sending FFDCA section 408(p) test orders to both the manufacturers/importers of the inert ingredient and to the end-use registrants (whose pesticide product contains that inert ingredient and the manufacturer's/importer's customer) would also be unduly burdensome to the Agency and the regulated community. Issuing FFDCA section 408(p) test orders to all registrants of pesticide products containing the chemical would also serve to increase the number of recipients, making the formation of data development groups more challenging administratively. Further, issuing FFDCA section 408(p) test orders to all registrants of pesticide products containing the chemical is unnecessary to promote fair and equitable sharing of test costs. Product registrants, which are often small businesses, would be quite unlikely to directly contribute to the actual conduct of the required testing and may simply reformulate their products in response to an order. Accordingly, EPA is considering an approach that limits the issuance of FFDCA section 408(p) orders only to the technical registrant of an active ingredient and to the manufacturer/importer of the inert ingredients rather than to all registrants whose products contain the ingredient. 2. *Pesticide active ingredients* . The Agency can easily identify the technical registrants of active ingredients. As previously noted, a technical registrant holds a registration for a specific active ingredient that the technical registrant formulates into end-use (or retail) products they produce or that the technical registrant sells to other companies for formulation into end-use products. Typically much of the safety data EPA requires is conducted on the technical grade active ingredient, rather than on the end-use product. [See generally, 40 CFR part 158]. Consequently, the “technical registrants,” who are typically larger companies, have historically been responsible for generating the data to support the end-use registrations. Registrants of end-use products generally rely on the data generated by the technical registrants in accordance with the “formulator's exemption” in FIFRA section 3(c)(2)(D). In addition, there is a subset of registrants that do not purchase a substance for use as an active ingredient, but produce it themselves through an integrated process. These registrants cannot rely on the formulator's exemption to satisfy data requirements, but must generate data themselves or offer to pay for relevant data that were previously generated by another registrant (such as a technical registrant). As noted previously, some active ingredients do not have a separate technical registration because a single company manufactures the chemical and formulates it into pesticide products, but does not sell the chemical separately to other formulators. The data to support a technical registration exist, but are incorporated into the data for the product registrations. Test orders under FFDCA section 408(p) may be sent either to pesticide active ingredient technical registrants, or to both pesticide active ingredient technical registrants and all end-use registrants that utilize that pesticide active ingredient in their registered product. EPA prefers the first approach. The primary disadvantage to issuing orders solely to technical registrants arises in the (unlikely) event that the technical registrant fails to submit the EDSP data. The penalty for failure to comply with a FFDCA section 408(p) test order is suspension of the technical registrant's registration. However, because EPA had not issued a test order to the end-use registrant, EPA would have no basis for suspending the end-use registrant's registration, and the end-use registrant could legally continue to sell its products, even though, just like the technical registrant, it had not submitted EDSP data. Moreover, even if EPA immediately issued a test order to the end-use registrant, the test order could not compel immediate compliance; the registrant would need to be given adequate time to generate the data. Nonetheless, EPA believes that this disadvantage is ultimately unlikely to be significant. First, if the technical registration has been suspended, EPA expects that the end-use formulator would be unlikely to find a source for its active ingredient, and consequently would be unable to produce a product even though it could legally sell one. Second, it has been EPA's experience that the technical registrants rarely, if ever, fail to comply with DCIs, and thus, the issue is unlikely to arise in practice. A second issue is that some active ingredients are “commodity chemicals,” that is, they may be used both in non-pesticidal products, such as drugs or cleaning products, and as active ingredients in pesticide products. When a company produces such a commodity chemical without specifying its future use, FIFRA does not require registration of the chemical until it appears in a product that is intended for a pesticidal purpose. However, FFDCA section 408(p)(5) specifies that EPA is to send test orders to manufacturers and importers of “a substance for which testing is required under this subsection,” and does not limit testing requirements only to manufacturers/importers of a pesticide chemical. Once EPA issues a test order for a pesticide chemical, a person who manufactures that chemical, even if not for use as a pesticide, is clearly manufacturing a substance for which testing is required, and consequently, is subject to EPA's authority under the plain language of FFDCA section 408(p)(5). EPA requests comment on whether or not to send FFDCA section 408(p) test orders to producers of commodity chemicals that do not hold a pesticide registration for a product containing the substance to be tested. 3. *Inert ingredients* . For inert ingredients, test orders under FFDCA section 408(p) may be sent to manufacturers/importers only, or to both manufacturers/importers and one or more pesticide registrants who use the inert ingredient in their pesticide product. For inert ingredients, manufacturers/importers include any company that manufactures or imports the inert chemical regardless of whether they are a registrant and regardless of whether they directly sell the chemical for use as a pesticide inert. For the purposes of discussion, EPA identified two subclasses of inerts: • Food use inerts, i.e., inert ingredients with an existing or pending tolerance or an existing or pending tolerance exemption. • Non-food use inerts. In addition, Unit IV.E.3.c. discusses the special considerations that arise when an inert ingredient is contained within a mixture whose composition is both proprietary and unknown by the registrant who purchases it for use in a registered pesticide product; EPA refers to this as an “inert in a proprietary mixture.” a. *Food-use inerts* . If an inert has an existing or pending tolerance or tolerance exemption, data compensation and data confidentiality protection are available pursuant to FFDCA section 408(i). For this class of inert ingredients, EPA's preferred option is to issue FFDCA section 408(p) test orders only to manufacturers and importers. Limiting the universe of FFDCA section 408(p) test order recipients should reduce the resources needed to issue the test order
(EPA)and to comply with the test order (regulated community) and facilitate joint data submissions and cost sharing. Another approach would be to issue test orders to both manufacturers and importers and to all registrants (both technical and end-use) of products containing the inert(s). While this approach would use the procedures familiar to registrants under FIFRA section 3(c)(2)(B), this advantage does not outweigh the added administrative burdens associated with the process of identifying and notifying all registrants using an inert ingredient in their pesticide formulations, and the requirement for all of these registrants to respond to the FFDCA section 408(p) test orders and DCI notices, without compromising CBI. Moreover, many product registrants may simply reformulate their products in response to such an order, which would require altering their registrations. EPA would like to avoid such disruptions if there are no data to indicate that the current formulation poses any risks. However, as discussed in Unit IV.C., issuing FFDCA section 408(p) test orders to both end-use registrants and manufacturers and importers of food use inerts would have implications for the timing of the accounting with respect to registered end-use pesticide products. In other words, issuing orders would assure that EPA determined shortly after receiving the data that all end-use formulators either purchased their ingredient from a company on the “Inert Suppliers List”; made an offer to pay; or received a test order to generate data. EPA's preferred approach is to address compensation obligations as registrants apply for or amend registrations. Unit IV.C., however, discusses in more detail two other alternatives. b. *Non-food use inerts.* EDSP data submitted on non-food use inerts are not covered by the data compensation and data confidentiality provisions of FFDCA section 408(i) or by FIFRA, unless the data are submitted by a registrant or a consortium that includes at least one registrant. In recognition of this fact, EPA has identified two possible options with regard to who receives the FFDCA section 408(p) test orders and under what legal authority the orders are issued. The options differ in administrative complexity and in the extent to which the resulting data receive protections under FIFRA section 3 and section 10. First, EPA could send the FFDCA section 408(p) test orders only to manufacturers/importers of the substance used as a non-food use inert ingredient. This option has the principal advantage of simplicity (compared to the other options) and it limits the administrative resources required for implementation by both the regulated community and EPA. Under this option, however, data generators may not receive added protections under FIFRA for proprietary information or compensation from applicants and registrants that used the inert ingredient to formulate their pesticide products. Even if FIFRA's compensation provisions would not apply, the procedure whereby companies entering the market after submission of the EDSP data would receive “catch-up” FFDCA section 408(p) test orders would most likely lead to the manufacturers and importers subject to the initial FFDCA section 408(p) test orders receiving offers to share test costs equitably. The second option would involve sending FFDCA section 408(p) test orders to both manufacturers and importers and sending both FFDCA section 408(p) test orders and DCI notices under FIFRA section 3(c)(2)(B) to registrants whose products contain the inert ingredient (end-use registrant). This option has one principal disadvantage over the first option—assuming at least one registrant participated in the data development, this option would basically double the administrative burden to EPA and the regulated community and have the same significant disadvantages as discussed in connection with sending FFDCA section 408(p) test orders to all registrants of products containing a food use inert. (See Unit IV.E.3.a.). After weighing the advantages and disadvantages of these options, EPA believes that the first option represents the best balance. In large measure, this is based on the Agency's judgment that the burden to both the Agency and the recipients associated with issuing test orders to all end-use registrants cannot be justified by the slight advantages offered by issuing orders to end-use registrants. EPA expects that manufacturers generally know who purchases their products, and thus do not need EPA to identify them. Thus, manufacturers who wish to partner with a registrant would still be able to do so, without the need for EPA to also issue a test order to the end-use registrant. c. *Inert ingredients in a proprietary mixture.* The Agency faces unique and particularly complex issues when dealing with a registrant whose pesticide product contains an inert ingredient that is present only because the registrant purchases a “proprietary mixture.” A proprietary mixture is a product that contains one or more inert ingredients and for which the exact composition is not known by the purchaser. EPA requires the manufacturer of proprietary mixtures to identify the ingredients in the product, and EPA considers this information in deciding whether to approve the registration of the product. But because the manufacturer of the proprietary mixture considers its composition a trade secret, EPA is prohibited from disclosing this confidential information to the registrant or others. For example, an end-use pesticide product may contain “Super Surfactant Ultra” as an inert chemical component, but the formulator of the end-use pesticide product does not know the exact contents of “Super Surfactant Ultra.” The Agency would face a difficult (if not impossible) dilemma if EPA determined that it was necessary to obtain EDSP data on one of the ingredients in “Super Surfactant Ultra,” and EPA had chosen a procedure that involved sending FFDCA section 408(p) test orders and/or DCI notices to all registrants whose product contained that ingredient. In such a case, EPA may be prohibited from disclosing information that could divulge the contents or nature of the inert ingredients in “Super Surfactant Ultra” to the pesticide end-use registrant. Since the very issuance of the test order could divulge confidential proprietary information (the fact that “Super Surfactant Ultra” contains a particular inert ingredient) to the recipient (the registrant who purchases “Super Surfactant Ultra” but does not know its composition), EPA may not be able to include the registrants who purchase “Super Surfactant Ultra” among the recipients of the test orders. If EPA does not send test orders to the registrants whose products contain a proprietary mixture from the list of recipients, these registrants would unfairly escape the obligation to respond to the test order. On the other hand, if EPA does send test orders to generate data on a specific inert ingredient to registrants whose products contain a proprietary mixture, EPA would potentially violate the prohibitions against disclosing CBI. If an inert ingredient appears in a pesticide product only as a constituent of a proprietary mixture, there appears to be no practicable way to minimize duplicative testing or to extend data compensation and data confidentiality protections to data submitted for the purposes of the EDSP unless the inert manufacturer is willing to disclose the confidential composition of the mixture to at least one pesticide registrant. EPA believes that a manufacturer might give EPA permission to disclose to a registrant the fact that a proprietary mixture contains a particular inert ingredient in order to ensure that the registrant complied with the data compensation procedures to identify the source of an inert ingredient. As previously discussed, EPA cannot issue test orders or DCI notices to pesticide registrants unless EPA can identify the substance to be tested. Consequently, because of confidentiality issues (among other reasons), EPA's preference would be to issue FFDCA 408(p) test orders involving inert ingredients in confidential mixtures only to manufacturers/importers and to registrants whose production, sale, or use of the inert ingredient can be determined by publicly available information. Another alternative would be to issue test orders to the manufacturer/importer of the confidential mixture, rather than for its individual components. This would not involve any disclosure of CBI, but it could lead to duplicative testing in that an ingredient may already have been tested separately. In addition, this option raises difficult scientific issues involved in testing mixtures. EPA will continue to explore this issue, and would welcome commenters' suggestions. 4. *Summary of who would receive orders under EPA's preferred approaches* . Specifically under EPA's preferred approach, EPA would take the following actions to maximize joint data development, data compensation, data confidentiality protections, and resource efficiency: • Pesticide active ingredients. Test orders issued pursuant to FFDCA section 408(p) and FIFRA section 3(c)(2)(B) would be sent to technical registrants of the pesticide active ingredient. • Inert ingredients. Test orders issued pursuant to FFDCA section 408(p) would be sent to current manufacturers and importers; “catch-up” FFDCA section 408(p) test orders would be sent to manufacturers and importers who subsequently enter the marketplace after the original orders had been issued. 5. *How will EPA identify order recipients* ? For FFDCA section 408(p) test orders involving pesticide active ingredients, the Agency will rely on the Office of Pesticide Programs' (OPP's) Office of Pesticide Programs Information Network (OPPIN). OPPIN is an internal OPP database for query, input and tracking of pesticide products, ingredients, studies, regulatory decisions and other information. The OPPIN system is typically used to produce study bibliographies or lists of registered products. For FFDCA section 408(p) test orders involving inerts, the Agency will use OPPIN (where applicable) and rely on other databases to identify appropriate manufacturers/importers and end-use registrants. These other databases may include publicly available sources like Dun and Bradstreet, online marketing material, etc. The Agency is interested in public comment on the Agency's approach to identify FFDCA section 408(p) test order recipients for inert ingredients. EPA generally plans to make public the list of recipients of FFDCA section 408(p) test orders and DCI notices and to invite comments from the public identifying additional persons who should have received the data requirements notices. Commenters could either identify themselves or another person as additional candidates (with proper substantiation) for receipt of a FFDCA section 408(p) test order. Although not the Agency's preferred approach, if EPA sends test orders to pesticide registrants for EDSP data on inert ingredients, the Agency may not be able to release a complete list of test order recipients that includes the names of all affected registrants because this list could effectively disclose proprietary information about the composition of their formulations. (As discussed in Unit IV.C., EPA would have to give affected registrants the option of identifying an agent to represent them in matters relating to the test order, including being listed on the list of recipients of the test order.) The list of recipients could be published in the **Federal Register** , or posted on the Agency's website. For example, the Agency is considering posting the status of the orders on the website so that both recipients and the public can check on the status of responses to the orders, and the list of recipients could be part of that posting. The Agency seeks comment on the mechanism for making the list of recipients public. 6. *How will order recipients be notified* ? Order recipients would be notified through their direct receipt of a FFDCA section 408(p) test order via registered mail. They would receive an order packet that will contain the instructions, background materials, and forms needed to comply with the order. (See the draft order template in the docket). F. How Should Recipients Respond to a Test Order? The following procedures would be used by recipients who are responding either to an initial FFDCA section 408(p) test order or to a “catch-up” test order issued to a person who began to manufacture or import an inert ingredient after EDSP data on a substance had been submitted to EPA. These options would also be appropriate for responding to test orders issued jointly under the authority of FFDCA section 408(p) and FIFRA section 3(c)(2)(B). 1. *Initial response* . Each recipient would be directed to provide a response to EPA within 90 days of the issuance of the order. This response is intended to allow the recipient to provide EPA with its intended response. To simplify completion of this initial response within the 90 days, EPA has created a simple Order Response Form. EPA intends to include the form in the order packet, pre-populated with the basic information to connect it to the specific order. A copy of the draft form is available in the public docket for your review and EPA encourages your comments and suggestions. The recipients of a test order would have several potential response actions from which they could choose. The 90-day response options include: a. *Recipient indicates that they intend to generate new data.* The recipient would choose this option to indicate that they agree to individually generate new data for each test specified to meet the requirements of the order. In the case of data pertaining to an inert ingredient for which there is no tolerance or exemption, the recipient may negotiate an agreement to have a registrant of a product containing the inert ingredient submit the data so that the data qualify for compensation under FIFRA—the data generator and the registrant could work out among themselves how actual compensation would be apportioned. b. *Recipient indicates that they intend to enter (or offer to enter) into an agreement to form a consortium to generate the data.* The recipient would choose this option to indicate that they are forming a task force or consortium to comply with the test order. Recipients would identify who is part of the consortium, as well as indicate for which tests data will be generated. Alternatively, recipients may provide EPA with documentation that they have made an offer to commence negotiations regarding the amount and terms of paying a reasonable share of the cost of testing, and have included an offer to submit to a neutral third party with authority to bind the parties, to resolve any dispute over the recipient's share of the test costs, (e.g., through binding arbitration or through a state or federal court action). Note: if the required data are not generated by the person(s) to whom the offer is made, all parties, including those that have made offers to pay or otherwise joined the consortium, would be held to have violated the test order. c. *Recipient indicates that they intend to rely on existing data.* The recipient would choose this option to indicate that they intend to submit or cite existing data that satisfies the request in the test order. The recipient's response would include either the data or a reference to the data for each test that are being cited. Data compensation procedures may apply. If the study is not exactly as specified in the protocols attached to the test order, the recipient should provide an explanation as to why the data should be accepted as satisfaction of the test order. The Agency would expect that any such hazard-related data would be scientifically comparable to data that would be generated by the EDSP. For the initial screening, EPA expects that opportunities for order recipients to respond in this manner will be limited. As mandated by the statute, EPA has developed and validated appropriate assays and it is unlikely that other studies would be acceptable under data quality standards. During the validation process, however, a chemical on the initial list might have been a test subject for a study listed in the order. Order recipients may be able to cite these data if protocols, which were modified over the course of validation, are sufficiently similar. EPA intends to provide recipients with information about the availability of validation studies along with the orders. d. *Recipient claims that they are not subject to the test order.* The recipient would choose this option to indicate that they are not subject to the order because:
(i)They are not a pesticide registrant, or
(ii)they do not currently manufacture or import a chemical that anyone uses as a pesticide active or inert ingredient. An explanation of the basis for the claim, along with appropriate information to substantiate that claim, would be required to allow EPA to evaluate the claim. e. *Recipient indicates that they intend to voluntarily cancel or reformulate the product registration or discontinue the manufacture/importation of the chemical.* Registrants may request voluntary cancellation of their product's pesticide registration pursuant to FIFRA section 6(f). Doing so would initiate the existing procedures for a voluntary cancellation. Under those procedures, the registrant may either adopt the standard procedures for sale or use of existing stocks of their pesticide, or may propose an alternative procedure. Alternatively, in the case of an inert ingredient, (if EPA issues orders to end-use registrants) a registrant may submit an application to amend the formulation of its product by removing the ingredient. In the case of manufacturers/importers of both inert ingredients and commodity chemical active ingredients, the recipient would choose this option to indicate that they intend to agree to cease manufacture or importation of the chemical. An additional option that EPA is considering would allow the manufacturer/importer to continue production of the chemical, but would involve their commitment to cease supplying the chemical for use in pesticide products. EPA does not prefer this alternative because of the practical difficulties in enforcing such agreements, given that there may not be a direct link between the manufacturer and the ultimate consumer. For example, if Company A receives the order and commits to sell that product only for non-pesticidal uses, it is unclear how Company A could enforce that agreement on its customers. Thus, Company A may agree not to sell it to Company B for use as a pesticide, but if Company B sells it to Company C for use as a pesticide inert, it is unlikely that EPA would discover it. Moreover, the most that EPA could do in that circumstance would be to send an order to Company B requiring testing. Further, tracking such agreements by reviewing the source of the end-use registrant's inert ingredient would be extremely complicated and burdensome for both the Agency and the end-use registrant. If, as a result of comments or further analysis, EPA determines that orders will be sent to pesticide product registrants (end-use registrants), recipients may have an additional response option of claiming a formulator's exemption as discussed in the next section. *f. Claim a formulator's exemption.* A product registrant who receives an order to test a chemical who purchases the chemical from another recipient who has agreed to generate the data may be eligible for a formulator's exemption. EPA will confirm claims of eligibility. A formulator's exemption would become invalid if the supplier of the chemical were not to submit the data either individually or jointly with other recipients. *g. Request an exemption under FFDCA section 408(p)(4).* EPA recognizes that FFDCA section 408(p)(4) provides that “the Administrator may, by order, exempt from the requirements of this section a biologic substance or other substance if the Administrator determines that the substance is anticipated not to produce any effect in humans similar to an effect produced by a naturally occurring estrogen.” In 1998, the Agency assessed the need to develop a specific list of substances to be exempted from EDSP testing or an exemption process for those substances that might not be anticipated to produce endocrine effects in humans (See section L of the December 1998 notice at 63 FR 71542). In the 1998 FR notice, EPA also provided several examples of substances that might possibly be exempted. As the EDSP has evolved and more endocrine research has been conducted, it has become evident that, at this time, development of criteria to exempt certain substances or to otherwise identify any pre-determined or blanket exemptions from endocrine disruptor testing is premature. For the initial screening, EPA is not aware of sufficient data that would allow the Agency to confidently determine that a chemical meets the statutory standard for an exemption—i.e., that it is not anticipated to interact with the endocrine system. Although a relatively broad range of toxicity data are available for pesticide active ingredients regulated under FIFRA, in most cases EPA has not yet established how the available data might be confidently used to predict the endocrine disruption potentials of these chemicals. This may be due to the non-specific nature of an effect or effects observed, questions related to whether the mode of action in producing a given effect or effects is or are endocrine system-mediated in whole or in part, or the lack of relevant data to make a judgment altogether. However, if an order recipient believes that this showing can be made for its chemical, the Agency will consider requests to issue such an exemption order on a case-by-case or chemical-by-chemical basis in response to individual submissions. In order for the Agency to make the necessary statutory finding to issue the exemption, the request would need to provide any hazard-related information that you believe would allow EPA to determine that your chemical is anticipated to not be an endocrine disruptor, i.e., is not anticipated “to produce any effect in humans similar to an effect produced by a naturally occurring estrogen.” In addition, the Agency does not expect an FFDCA section 408(p) test order recipient to submit a request to bypass Tier 1 screening as part of their response to the test order. As indicated in the September 2005 **Federal Register** notice announcing the Agency's chemical selection approach and again in the June 2007 **Federal Register** notice announcing the availability of the draft list of chemicals for initial screening under the EDSP, any company subject to a testing requirement under Tier 1 may assert during the comment period for the draft list that the chemical is an endocrine disruptor and that the Tier 1 EDSP screening is unnecessary. EPA does not intend to permit chemicals on the draft list to bypass Tier 1 screening and move directly to Tier 2 testing without appropriate data to support such an action. As such, EPA expects that this issue will be addressed in finalizing the list of chemicals for initial screening, which will occur before any FFDCA section 408(p) test orders are issued. 2. *Generate the data specified in the test order* . As indicated in their Initial Response Form, the recipient's next step would be to generate the data specified in the FFDCA section408(p) test order. EPA currently anticipates that the tests would need to be conducted using the test protocols that would be attached to the order as background materials because of the statutory requirement that the test method be validated. If, however, an order recipient believes a deviation from the required protocol is needed, they should first consult the Agency before deviating from the test protocol. All requests should be submitted with a clear rationale to allow the Agency to evaluate the request in a timely manner. All protocol variations would be reviewed by EPA and a response would be sent to the specific order recipient in a timely fashion. In addition, recipients generating data must adhere to the good laboratory practice
(GLP)standards described in 40 CFR part 160 when conducting studies in response to a FFDCA section 408(p) test order. 3. *Submit the data specified in the test order* . The Agency intends to adopt the same submission procedures as those that are currently used for submitting other data in support of a pesticide registration, with only a few modifications. Once the data are generated, the recipient would prepare a submission package for transmittal to EPA. The orders will include requirements on how the data should be formatted. If EPA were issuing orders today, it is likely the Agency would require that the submission be consistent with the following requirements. a. *Format for data submission.* As part of a cooperative NAFTA project, EPA and the Canadian Pest Management Regulatory Agency
(PMRA)developed standard data evaluation formats, or templates. The templates have been in use by these agencies since 2002 for writing their data evaluation records
(DERs)of studies submitted under FIFRA and FFDCA to EPA and the Canadian data codes (DACOs). Although such templates do not currently reflect the assays being considered for the EDSP Tier 1 battery, the Agency intends to review and, as necessary, develop new or revised templates before the deadlines for submission of the data under the EDSP. The DER that the agencies prepare contains a study profile documenting basic study information such as materials, methods, results, applicant's conclusions and the evaluator's conclusions. The templates provide pesticide registrants and the public an opportunity to gain a better understanding of the regulatory science review and decision-making process. The agencies encourage registrants to include study profiles based on these templates in their study documents for all pesticide types. These templates describe the layout and scope of information that should be contained within a study profile and can serve as guides for preparation of study documents. Use of the templates improves the likelihood of a successful submission, since the information necessary for an efficient agency review is outlined. Additional details about these templates are available at: *http://www.epa.gov/pesticides/regulating/studyprofile_templates/* . In addition, Pesticide Registration
(PR)Notice 86-5, entitled *Standard Format for Data Submitted Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Certain Provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA)* , describes the requirements for organizing and formatting submittals of data supporting a pesticide registration ( *http://www.epa.gov/PR_Notices/pr86-5.html* ). The Agency has begun the process of updating the guidance in PR Notice 86-5 to further clarify the data submission process for pesticide related submissions and will provide the public with an opportunity to comment on the proposed revisions to PR 86-5 consistent with the procedures described in PR Notice 2003-3, entitled *Procedural Guidance for EPA's Office of Pesticide Programs Procedures Concerning the Development, Modification, and Implementation of Policy Guidance Documents* ; ( *http://www.epa.gov/PR_Notices/pr2003-3.pdf* ). The Agency also encourages FFDCA section 408(p) test order recipients to submit completed study profiles and supporting data in an electronic format
(PDF)whether submitting one or several studies. For more information, go to the electronic data submissions website at *http://www.epa.gov/oppfead1/eds/edsgoals.htm* . b. *Transmittal document.* In order for EPA to track the compliance of each order recipient, each submission in satisfaction of a FFDCA section 408(p) test order must be accompanied by a transmittal document that includes the following information: • Identity of the submitter. • The date on which the submission package was prepared for transmittal to EPA. • Identification of the FFDCA section 408(p) test order associated with the submission (e.g., the test order number). • A list of the individual documents included in the submission. c. *Individual study or test result documents.* Unless otherwise specified by the Agency, each submission must be in the form of individual documents or studies. EPA does not anticipate requiring the resubmission of previously submitted documents absent a specific Agency request. Instead it would be sufficient for previously submitted documents to be cited with adequate information to identify the previously submitted document. EPA would typically expect each study or document to include the following: i. A title page including the following information: • The title of the study, including identification of the substance(s) tested and the test name or data requirement addressed. • The author(s) of the study. • The date the study was completed. • If the study was performed in a laboratory, the name and address of the laboratory, project numbers or other identifying codes. • If the study is a commentary on or supplement to another previously submitted study, full identification of the other study with which it should be associated in review. • If the study is a reprint of a published document, all relevant facts of publication, such as the journal title, volume, issue, inclusive page numbers, and date of publication. ii. Upon submission to EPA, each document must be accompanied by a signed and dated document containing the appropriate statement(s) regarding any data confidentiality claims as described in the FFDCA section 408(p) test order. iii. A statement of compliance or non-compliance with respect to GLP standards as required by 40 CFR 160.12, if applicable. iv. A complete and accurate English translation must be included for any information that is not in English. 4. *Request an extension* . The FFDCA section 408(p) test order would identify a due date for completing the data specified and submitting it to EPA. If an order recipient would like to request an extension of time to complete the testing, the request should be submitted with a clear rationale for the extension, and any supporting material, in order to allow the Agency to properly and timely assess the request. All such requests would be reviewed by EPA and a response would be sent to the requester in a timely fashion. 5. *Maintaining records* . The FFDCA section 408(p) test order would identify the records that the recipient should maintain. In general, the Agency expects recipients to maintain copies of the data and other information submitted to the Agency. Under FIFRA section 8, all producers of pesticides, devices, or active ingredients used in producing pesticides subject to FIFRA, including pesticides produced pursuant to an experimental use permit and pesticides, devices, and pesticide active ingredients produced for export, are required to maintain certain records. As such, any recipients who are pesticide registrants or otherwise submit their data in support of a pesticide registration would be held to the recordkeeping standards in 40 CFR part 169. Recipients who are not a registrant would also be asked to maintain records related to the generation of the data as specified in the order. Consistent with 40 CFR 169.2(k), this includes all test reports submitted to the Agency in support of a registration or in support of a tolerance petition, *all* underlying raw data, and interpretations and evaluations thereof. These records shall be retained as long as the registration is valid and the producer is in business, and made available to EPA or its agent for inspection. G. What are the Consequences for a Recipient Who Fails to Respond or Comply with the Test Order? For pesticide active ingredients, FFDCA section 408(p)(5)(C)(i) allows EPA to issue to any registrant that fails to comply with a FFDCA section 408(p) test order “a notice of intent to suspend the sale or distribution of the substance by the registrant.” The proposed suspension “shall become final at the end of the 30-day period beginning on the date that the registrant receives the notice of intent to suspend, unless during that period a person adversely affected by the notice requests a hearing or the Administrator determines that the registrant has complied” with the FFDCA section 408(p) test order. As specified by FFDCA section 408(p)(5)(C)(iii), the Administrator shall terminate a suspension if the Administrator determines that the registrant has complied fully. For all inert ingredient manufacturers/importers, FFDCA section 408(p)(5)(D) allows EPA to apply the penalties and sanctions provided under section 16 of TSCA (15 U.S.C. 2615) “to any person (other than a registrant) who fails to comply with an [FFDCA section 408(p)] order.” H. Process for Contesting a Test Order/Pre-enforcement Review FFDCA section 408(p) does not explicitly address the process for challenging a test order (e.g., if the test order recipient disagrees that a particular study is appropriate or valid, or believes the time frame for completing the study is too short). The statute only specifies the rights and procedures available to test order recipients who have failed to comply with a test order. Further, the issue is somewhat complicated by the fact that the statute establishes different procedures for enforcing the test orders against pesticide registrants and against chemical manufacturers or importers. [Compare 21 U.S.C. 136a(p)(3)(C) and (D)]. Nor is this issue resolved by FFDCA section 408's general judicial review provision; that provision is applicably solely to the enumerated actions, which do not include FFDCA section 408(p) test orders. [21 U.S.C. 136a(h)]. Consequently, FFDCA section 408(p) is ambiguous on a number of issues, such as the availability of pre-enforcement review, and the issues that may be raised in an enforcement hearing. EPA has considered two alternative interpretations to resolve this ambiguity. Under one approach, EPA would interpret the statute such that the same procedures are applicable to both registrants and other test order recipients. EPA prefers this approach because it would simplify the process for both EPA and order recipients. The other approach would result in different procedures for pesticide registrants and all other test order recipients based on the disparate requirements established by FFDCA section 408(p)(5)(C) and (D). For pesticide registrants, FFDCA section 408(p)(5)(C) directs EPA to initiate proceedings to suspend the registration when a registrant fails to comply with a test order. [21 U.S.C. 136a(p)(3)(C)(i)]. Prior to the suspension, a registrant may request a hearing, but the statute restricts the issues in the hearing solely to whether the registrant has complied with the test order. [21 U.S.C. 136a(p)(3)(C)(ii)]. The substance of the test order may not be challenged during this hearing. Thus, for example, to challenge whether EPA should have required a particular study, the registrant would need to challenge the test order in the appropriate district court *at the time the order is issued. [See* , e.g., *Atochem v EPA,* 759 F.Supp. 861, 869-872 (D.D.C 1991)]. The basis for the statutory restriction is that the FFDCA section 408(p) test order constitutes final agency action, and as such, is subject to review upon issuance. [ *See, Atochem, supra]* . In addition, as discussed above, EPA currently intends to issue the test orders for testing of active ingredients jointly under FFDCA section 408(p) and FIFRA section 3(c)(2)(B). The procedures discussed above for challenging an FFDCA section 408(p) test order are wholly consistent with the procedures applicable to FIFRA section 3(c)(2)(B), which similarly limits the issues for resolution in any suspension hearing held for failure to comply with the order. [See 7 U.S.C. 136a(c)(2)(B)(iv)]. Accordingly, EPA believes that for pesticide registrants, pre-enforcement review of the test order would be available directly in federal district courts under any approach, and based on the plain meaning of the statute, would be the only means to obtain judicial review of the validity of the test order itself. By contrast, FFDCA section 408(p)(5)(D) provides that non-registrants (manufacturers or importers of inert ingredients) are subject to monetary penalties through an enforcement proceeding, using the process established by TSCA section 16. Under TSCA section 16, civil penalties of up to $25,000 per day may be assessed, after an administrative hearing is held on the record in accordance with section 554 of the Administrative Procedures Act (APA). [15 U.S.C. 2615(a)(1)-(2)(A)]. Before issuing a final penalty order, EPA must provide notice of its intention to assess the penalty, including a draft of the final penalty order, and provide the recipient with the opportunity to request a hearing within 15 days of the date the notice has been received. [15 U.S.C. 2615(a)(2)(A)]. [ *See also* , 40 CFR 22.13-22.14]. TSCA section 16 also specifies that the following issues shall be taken into account in determining the amount of a civil penalty: The nature, circumstances, extent and gravity of the violation(s); the violator's ability to pay; the effect on the violator's ability to continue to do business; any history of prior violations; the degree of culpability; and such other matters as justice may require. [5 U.S.C. 2615(a)(2)(B)]. Although neither FFDCA section 408(p) nor TSCA section 16 expressly imposes the same restriction on the issues that a non-registrant may raise in the penalty hearing, EPA's preferred interpretation of the statutes and existing regulations would be to impose a similar restriction. In large measure this interpretation turns on the fact that, at least for pesticide registrants, FFDCA section 408(p) test orders constitute final agency action, and consequently, would be subject to review in the appropriate district court. Logically, it makes sense to interpret the test order to be final for all parties, as the provisions of FFDCA section 408(p)(5)(A) that describe the test order do not distinguish between registrants and other test order recipients. Moreover, EPA believes that, in general, it would simplify matters to have a single set of procedures for all test order recipients. Accordingly, pre-enforcement judicial review of the test order would be available, and would be the means by which any test order recipient would challenge the validity of the test order. As a consequence of that interpretation, EPA would interpret TSCA section 16 to restrict the issues that may be raised in any enforcement hearing to whether the test order recipient had violated the test order, as well as the appropriate amount of any penalty. This interpretation would be consistent with the issues listed in TSCA section 16(a)(2)(B), which do not expressly relate to the validity of the underlying requirement. Alternatively, EPA could interpret the legal status of the order to differ between registrants and non-registrants, based on the procedural distinctions created by FFDCA section 408(p)(5)(C) and (D). Under this approach, FFDCA section 408(p) test orders would constitute final agency action only for pesticide registrants, and only those test orders would be subject to pre-enforcement review in federal district courts. Accordingly, non-registrants would only be able to challenge the provisions of the order in an enforcement proceeding, and would not be entitled to pre-enforcement review in district court. I. Informal Administrative Review Procedure EPA intends to include a provision in the FFDCA section 408(p) test order that requires the order recipients to raise any questions or challenges concerning the issuance of the test order to the Agency in response to the order. EPA would review the issues presented and provide a written response within a specified time frame. The Agency understands that it would need to respond within sufficient time for the order recipient to either comply with the order or determine whether to pursue its concerns through judicial review. EPA requests comment on whether such a provision would be appropriate, and on the appropriate parameters for such a requirement, including the deadline for order recipients to initially provide their concerns, and the time frame for the Agency's response. J. Adverse Effects Reporting Requirements Under FIFRA section 6(a)(2), pesticide product registrants are required to submit adverse effects information about their products to the EPA. Among other things, the implementing regulations in 40 CFR part 159, subpart D provide registrants with detailed instructions on whether, when, and how to report information in the possession of the registrant or its agents. In addition, under TSCA section 8(c), companies can be required to record, retain and in some cases report “allegations of significant adverse reactions” to any substance/mixture that they produce, import, process, or distribute. EPA's TSCA section 8(c) rule requires producers, importers, and certain processors of chemical substances and mixtures to keep records concerning significant adverse reaction allegations and report those records to EPA upon notice in the **Federal Register** or upon notice by letter. The TSCA section 8(c) rule also provides a mechanism to identify previously unknown chemical hazards in that it may reveal patterns of adverse effects which otherwise may not be otherwise noticed or detected. Further information is available under 40 CFR part 717. Under TSCA section 8(e), U.S. chemical manufacturers, importers, processors and distributors are required to notify EPA within 30 calendar days of new, unpublished information on their chemicals that may lead to a conclusion of substantial risk to human health or to the environment. The term “substantial risk” information refers to that information which offers reasonable support for a conclusion that the subject chemical or mixture poses a substantial risk of injury to health or the environment and need not, and typically does not, establish conclusively that a substantial risk exists. For additional information about TSCA section 8(e), please go to *http://www.epa.gov/oppt/chemtest/pubs/sect8e.htm* . EPA does not require duplicate submission of EDSP results under FIFRA section 6(a)(2) or TSCA section 8(c) or (e). Any information submitted under FIFRA section 6(a)(2) or TSCA section 8(c) or 8(e) procedures does not need to be submitted again to satisfy the FFDCA section 408(p) test order. The test order recipient should instead submit the necessary information to cite to the previously submitted information as described earlier in this document. V. Specific Topics for Commenters While interested person are invited to comment on any issue discussed in this notice, the Agency would find it particularly helpful if interested commenters address the general issues and specific questions, set forth below. If, for example, commenters have ideas on how the Agency could minimize duplicative testing that are not captured in the questions below, the Agency welcomes comments on the general issue itself. A. Minimizing Duplicative Testing 1. If there are multiple entities who manufacture or import a substance for which EDSP data are needed, under what circumstances, if any, should EPA send test orders only to a single entity? 2. When issuing test orders for EDSP data on an active ingredient, should EPA issue the test order under the authority of FFDCA section 408(p), under FIFRA section 3(c)(2)(B), or under both authorities? 3. When issuing test orders for EDSP data on an inert ingredient, should EPA issue the test order under the authority of FFDCA section 408(p), under FIFRA section 3(c)(2)(B), or under both authorities? B. Cost Sharing What evidence of a willingness to share the cost of generating EDSP data should EPA require? C. Data Compensation 1. What evidence of a willingness to pay compensation for previously submitted EDSP data should EPA require? 2. Should EPA issue “catch-up” FFDCA section 408(p) test orders to people who begin to manufacture or import an inert ingredient after required EDSP data have been submitted? 3. If so, at what point (e.g., during registration review) and for how long should EPA issue such “catch-up” test orders? 4. What alternatives should EPA consider for the 15-year period proposed, and why? D. Who Should Receive Test Orders? 1. If EPA relies on FIFRA section 3(c)(2)(B) as an authority to require data for an active ingredient, should EPA send the DCI only to technical registrants or to all registrants whose products contain the active ingredient? 2. Should EPA send FFDCA section 408(p) test orders to producers of commodity chemicals that do not hold a pesticide registration for a product containing the substance to be tested? 3. How should EPA address the issuance of test orders for an inert ingredient that is contained in a “proprietary mixture”? 4. After EPA has received compensable EDSP data on an inert ingredient, which authority should EPA use to ensure that pesticide registrants are buying their inert ingredient only from sources on the “Inert Suppliers List”: FIFRA section 3(c)(1)(F) only, FIFRA section 3(c)(1)(F) and FIFRA section 3(g), or FIFRA section 3(c)(1)(F) and FIFRA section 3(c)(2)(B)? E. How to Identify Potential Recipients of Test Orders 1. Please suggest an efficient approach to identify potential recipients of FFDCA section 408(p) test orders for inert ingredients. Please identify any databases that will provide the best information. 2. Please comment on the preferred mechanism for making the list of recipients of FFDCA section 408(p) test orders public. 3. Please comment on a mechanism to identify entities that should have received a test order, but that were not initially identified. 4. How should EPA evaluate requests for exemptions under FFDCA section 408(p)(4)? F. How to Respond to Test Orders 1. Is 90 days sufficient time for recipients of a test order to respond with their intentions for complying with the order? 2. Should EPA allow a person to “fulfill” the requirements of a test order by promising not to manufacture or import an active ingredient? An inert ingredient? 3. Should EPA allow a person to “fulfill” the requirements of a test order on an inert ingredient by promising not to manufacture or import the inert ingredient for use in a pesticide product? If so, how would EPA enforce such an agreement? G. Procedural Issues 1. When should a recipient of a test order for EDSP data on an inert ingredient be able to judicially challenge the issuance of the order? 2. Should EPA include an optional or mandatory informal administrative review procedure by which a person who wishes to judicially challenge the validity of a test order would raise the objections first with the Agency? 3. Should the 90-day response form be mandatory or optional? 4. Should test protocols be attached to the order and/or posted on a website? 5. Should the Agency establish a website of FFDCA section 408(p) test order recipients to facilitate the formation of consortia? H. Due Process Options EPA requests comment on whether the informal administrative review procedures (as outlined in this document) would be appropriate. Please also comment on the appropriate parameters for such a requirement, including the deadline for order recipients to initially provide their concerns, and the time frame for the Agency's response. I. CBI Provide comments on how best to address CBI concerns associated with notifying HPV inert manufacturers, including the difficulty of informing registrants, without disclosing the identity of the inert. J. Estimated Test Costs and Paperwork Burden 1. Please provide comments on the estimated test costs and burden hours presented in the draft ICR. Explain the basis for your estimates in sufficient detail to allow EPA to reproduce the estimates. 2. Provide comments on the methodology used by EPA to estimate the burden for data generation, which is based on the total estimated test costs. 3. Is it reasonable to continue to assume that as much as 35% of the test costs represents the paperwork burden? VI. Statutory and Executive Order Reviews A. Regulatory Planning and Review Under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993, as amended by Executive Order 13422 on January 18, 2007 (72 FR 2763), this policy statement is considered to be a “significant guidance document” under the terms of the amended Executive Order because this policy might raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. Accordingly, EPA notified the Office of Management and Budget
(OMB)and submitted a draft of this policy to OMB under Executive Order 12866. Any changes made in response to OMB recommendations have been documented in the docket for this action as required by section 6(a)(3)(E) of the Executive Order. B. Paperwork Reduction Act
(PRA)The information collection requirements described in this document have been submitted for review by the OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 *et seq.* Elsewhere in today's **Federal Register** is a separate document that announces the availability of the draft Information Collection Request
(ICR)document that has been prepared by EPA, identified by EPA ICR No. 2249.01). Pursuant to the PRA, the Agency is seeking public review and comment on the ICR before it submits the ICR to OMB for approval under the PRA. The following is a brief summary of the ICR document, which describes the information collection activities and EPA's estimated burden in more detail. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations codified in Chapter 40 of the CFR, after appearing in the preamble of the final rule, are listed in 40 CFR part 9, are displayed either by publication in the **Federal Register** or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers in certain EPA regulations is consolidated in 40 CFR part 9. As a new ICR, the Agency does not yet have an OMB control number for this information collection activity. Once assigned, EPA will announce the OMB control number for this information collection in the **Federal Register** , and will add it to any related collection instruments or forms used. Burden under the PRA means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Under the EDSP, the information collection activities include reviewing the order and related instructions, providing the initial response, participating in a consortia, generating the data, submitting the data, requesting an extension, and maintaining records. As described in more detail in the ICR, the total estimated per chemical/per respondent paperwork burden is 2,649 hours, with an estimated cost of $194,252. The total annualized estimated paperwork burden for this ICR is 93,655 hours, with an estimated total annual cost of $6,887,418. The Agency believes that this is an over estimate because this estimate assumes that the respondent actively participates in all potential activities, including developing a consortia, generating all of the potential data, requesting an extension and submitting the data. The Agency also assumed that all of the potential tests currently scheduled for validation would be used for each chemical. It is highly unlikely that any one respondent would need to participate at this level, or that all of the tests would be performed for each respondent. Direct your comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, to EPA using the public docket that has been established for the ICR (Docket ID No. EPA-HQ-OPPT-2007-1081). The Agency will consider and address comments received on the ICR as it develops the final policy and related final ICR. VII. References 1. EPA. Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) Final Report. August 1998. *http://www.epa.gov/scipoly/oscpendo/pubs/edspoverview/finalrpt.htm.* 2. Organization for Economic Cooperation and Development (OECD). Final Report of the OECD Workshop on Harmonization of Validation and Acceptance Criteria for Alternative Toxicological Test Methods. August 1996. List of Subjects Environmental protection, Chemicals, Endocrine disruptors, Pesticides and pests, Reporting and recordkeeping. Dated: December 7, 2007. James B. Gulliford, Assistant Administrator for Prevention, Pesticides and Toxic Substances. [FR Doc. E7-24166 Filed 12-12 ndash;07; 8:45 am] BILLING CODE 6560-50-S FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 *et seq.* ) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at *www.ffiec.gov/nic/* . Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than January 4, 2008. **A. Federal Reserve Bank of Atlanta** (David Tatum, Vice President) 1000 Peachtree Street, N.E., Atlanta, Georgia 30309: *1. Summerville/Trion Bancshares, Inc.* , Summerville, Georgia; to acquire 100 percent of the voting shares of Dunnellon State Bank, Dunnellon, Florida. **B. Federal Reserve Bank of Dallas** (W. Arthur Tribble, Vice President) 2200 North Pearl Street, Dallas, Texas 75201-2272: * 1. First National Bank Group, Inc.* , Edinburg, Texas; to acquire 9.90 percent of the voting shares of Southside Bancshares, Inc., Tyler, Texas, and thereby indirectly acquire voting shares of Southside Delaware Financial Corporation, Dover, Delaware, and Southside Bank, Tyler, Texas. Board of Governors of the Federal Reserve System, December 6, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E7-23930 Filed 12-12-07; 8:45 am] BILLING CODE 6210-01-S FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 *et seq.* ) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at *www.ffiec.gov/nic/* . Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than January 7, 2008. **A. Federal Reserve Bank of Atlanta** (David Tatum, Vice President) 1000 Peachtree Street, N.E., Atlanta, Georgia 30309: *1. Floridian Financial Group, Inc.* , Daytona Beach, Florida; to acquire 100 percent of the voting shares of Orange Bank of Florida, Orlando, Florida. **B. Federal Reserve Bank of Chicago** (Burl Thornton, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414: *1. Black River BancVenture, Inc.* , Memphis, Tennessee; to become a bank holding company by acquiring 42 percent of the voting shares of Michigan Community Bancorp, Ltd., and thereby indirectly acquire voting shares of Lakeside Community Bank, both of Sterling Heights, Michigan. *2. Black River BancVenture, Inc.* , Memphis, Tennessee; to acquire 15 percent of the voting shares of Community Shores Bank Corp., and thereby indirectly acquire voting shares of Community Shores Bank, both of Muskegon, Michigan. *3. Black River BancVenture, Inc.* , Memphis, Tennessee; to acquire 15 percent of the voting shares of Allegiance Bank of North America, Bala Cynwood, Pennsylvania. *4. Black River BancVenture, Inc.* , Memphis, Tennessee; to acquire 15 percent of the voting shares of Bay Commercial Bank, Walnut Creek, California. *5. Capitol Bancorp LTD, and Capital Development Bancorp Limited VII* , both of Lansing, Michigan; to acquire 51 percent of the voting shares of Pisgah Community Bank, Asheville, North Carolina (in organization). *6. Capitol Bancorp LTD, and Capital Development Bancorp Limited VII* , both of Lansing, Michigan; to acquire 51 percent of the voting shares of Colonia Bank, Phoenix, Arizona (in organization). *7. Capitol Bancorp LTD, and Capital Development Bancorp Limited VII* , both of Lansing, Michigan; to acquire 51 percent of the voting shares of Reidsville Community Bank, Reidsville, North Carolina (in organization). **C. Federal Reserve Bank of Dallas** (W. Arthur Tribble, Vice President) 2200 North Pearl Street, Dallas, Texas 75201-2272: *1. CSB Financial Corporation* ; to become a bank holding company by acquiring 100 percent of the voting shares of Citizens State Bank, both of Miles, Texas. Board of Governors of the Federal Reserve System, December 10, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E7-24141 Filed 12-12-07; 8:45 am] BILLING CODE 6210-01-S FEDERAL RESERVE SYSTEM Notice of Proposals to Engage in Permissible Nonbanking Activities or to Acquire Companies that are Engaged in Permissible Nonbanking Activities The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y (12 CFR Part 225) to engage *de novo* , or to acquire or control voting securities or assets of a company, including the companies listed below, that engages either directly or through a subsidiary or other company, in a nonbanking activity that is listed in § 225.28 of Regulation Y (12 CFR 225.28) or that the Board has determined by Order to be closely related to banking and permissible for bank holding companies. Unless otherwise noted, these activities will be conducted throughout the United States. Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act. Additional information on all bank holding companies may be obtained from the National Information Center website at *www.ffiec.gov/nic/* . Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than January 7, 2008. **A. Federal Reserve Bank of Chicago** (Burl Thornton, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414: *1. Black River BancVenture, Inc.* , Memphis, Tennessee; to acquire 6 percent of the voting shares of SFB Bancorp, Inc., and thereby indirectly acquire voting shares of Security Federal Bank, both of Elizabethton, Tennessee, and thereby engage in operating a savings association, pursuant to section 225.28(b)(4)(ii) of Regulation Y. *2. Black River BancVenture, Inc.* , Memphis, Tennessee; to acquire 9.9 percent of the voting shares of Quaint Oak Bancorp, and thereby indirectly acquire Quaint Oak Savings Bank, both of Southampton, Pennsylvania, and thereby engage in operating a savings association, pursuant to section 225.28(b)(4)(ii) of Regulation Y. Board of Governors of the Federal Reserve System, December 10, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E7-24139 Filed 12-12-07; 8:45 am] BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee AGENCY: National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), HHS. ACTION: Meeting announcement and request for comments. SUMMARY: Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee (TRR Subcommittee). The primary agenda topic is the peer review of the findings and conclusions presented in seven draft NTP Technical Reports of rodent toxicology and carcinogenicity studies in conventional rats and mice, one draft NTP Technical Report on a study in Crl:SKH-1 hairless mice, and one draft NTP Toxicity Report (see Preliminary Agenda below). The TRR Subcommittee meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on any draft report discussed at the meeting (see “Request for Comments” below). The TRR Subcommittee deliberations on the draft reports will be reported to the NTP Board of Scientific Counselors
(BSC)at a future date. DATES: The TRR Subcommittee meeting will be held on February 27-28, 2008. All individuals who plan to attend are encouraged to register online by February 20, 2008, at the NTP Web site ( *http://ntp.niehs.nih.gov/go/15833* ). Written comments on the draft reports should be received by February 13, 2008. Persons needing special assistance, such as sign language interpretation or other reasonable accommodation in order to attend, should contact 919-541-2475 (voice), 919-541-4644 TTY (text telephone), through the Federal TTY Relay System at 800-877-8339, or by e-mail to *niehsoeeo@niehs.nih.gov.* Requests should be made at least 7 days in advance of the event. ADDRESSES: The TRR Subcommittee meeting will be held in the Rodbell Auditorium, Rall Building at the NIEHS, 111 T. W. Alexander Drive, Research Triangle Park, NC 27709. Public comments and any other correspondence should be submitted to Dr. Barbara Shane, Executive Secretary (NTP Office of Liaison, Policy, and Review, NIEHS, P.O. Box 12233, MD A3-01, Research Triangle Park, NC 27709; telephone: 919-541-4253, fax: 919-541-0295; or e-mail: *shane@niehs.nih.gov* ). SUPPLEMENTARY INFORMATION: Background The primary agenda topic is the peer review of the findings and conclusions of eight draft NTP Technical Reports of rodent toxicology and carcinogenicity studies and one draft NTP Toxicity Report (see Preliminary Agenda below). Attendance and Registration The meeting is scheduled for February 27-28, 2008, from 8:30 a.m. to adjournment and is open to the public with attendance limited only by the space available. Individuals who plan to attend are encouraged to register online at the NTP website by February 20, 2008 ( *http://ntp.niehs.nih.gov/go/15833* ) to facilitate access to the NIEHS campus. Please note that a photo ID is required to access the NIEHS campus. The NTP is making plans to videocast the meeting through the Internet at *http://www.niehs.nih.gov/news/video/live. * Availability of Meeting Materials A copy of the preliminary agenda, committee roster, and any additional information, when available, will be posted on the NTP Web site ( *http://ntp.niehs.nih.gov/go/15833* ) or may be requested in hardcopy from the Executive Secretary (see ADDRESSES above). The draft reports will be posted on the NTP website after January 15, 2008. Following the meeting, summary minutes will be prepared and made available on the NTP Web site. Request for Comments Public input at this meeting is invited and time is set aside for the presentation of public comments on any draft report. Each organization is allowed one time slot per agenda topic. At least 7 minutes will be allotted to each speaker, and if time permits, may be extended to 10 minutes at the discretion of the chair. Persons wishing to make an oral presentation are asked to notify Dr. Barbara Shane via online registration at *http://ntp.niehs.nih.gov/go/15833,* phone, or email (see ADDRESSES above) by February 13, 2008, and if possible, to send a copy of the statement or talking points at that time. Written statements can supplement and may expand the oral presentation. Registration for oral comments will also be available on-site, although time allowed for presentation by on-site registrants may be less than that for pre-registered speakers and will be determined by the number of persons who register at the meeting. Written comments on the draft reports in lieu of an oral presentation are also welcome and should also be received by February 13, 2008, to enable review by the TRR Subcommittee and NTP staff prior to the meeting. Written comments received in response to this notice will be posted on the NTP website. Persons submitting written comments should include their name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization (if any) with the document. Background Information on the NTP Board of Scientific Counselors The NTP BSC is a technical advisory body comprised of scientists from the public and private sectors who provide primary scientific oversight to the overall program and its centers. Specifically, the BSC advises the NTP on matters of scientific program content, both present and future, and conducts periodic review of the program for the purposes of determining and advising on the scientific merit of its activities and their overall scientific quality. The TRR Subcommittee is a standing subcommittee of the BSC. BSC members are selected from recognized authorities knowledgeable in fields such as toxicology, pharmacology, pathology, biochemistry, epidemiology, risk assessment, carcinogenesis, mutagenesis, molecular biology, behavioral toxicology and neurotoxicology, immunotoxicology, reproductive toxicology or teratology, and biostatistics. Its members are invited to serve overlapping terms of up to four years. BSC and TRR Subcommittee meetings are held annually or biannually. Dated: December 3, 2007. Samuel H. Wilson, Acting Director, National Institute of Environmental Health Sciences and National Toxicology Program. Preliminary Agenda National Toxicology Program
(NTP)Board of Scientific Counselors Technical Reports Review Subcommittee Meeting February 27-28, 2008, Rodbell Auditorium, Rall Building, National Institute of Environmental Health Sciences, 111 TW Alexander Drive, Research Triangle Park, NC 27709 NTP Technical Reports
(TR)Scheduled for Review—February 27, 2008 TR 544 Dibromoacetonitrile (CAS No. 3252-43-5) ○ Water disinfection by-product formed from the reaction of chlorine oxidizing compounds with nitrogen containing organic compounds in water containing bromine; by-product of ozone disinfection. TR 549 Bromochloroacetic Acid (CAS No. 5589-96-8) ○ Water disinfection by-product. TR 553 Aloe Phototoxicity Studies (Aloe vera gel CAS No. 8001-97-6; Aloe-emodin CAS No. 481-72-1) in Crl:SKH-1 hairless mice ○ Used as a therapeutic dermatologic agent in the treatment of burns and in healthcare and cosmetic products. TR 556 Chromium Picolinate Monohydrate (CAS No. 27882-76-4) ○ Used as a dietary supplement for losing weight. TR 557 β-Myrcene (CAS No. 123-35-3) ○ Intermediate in the manufacture of terpene alcohols that are intermediates in the synthesis of aroma and flavoring chemicals; used as a scent in the manufacture of cosmetics, soaps, and detergents and as a peripheral analgesic; active ingredient in lemon grass tea; identified in numerous plants and in the emissions of plywood veneer dryers. TR 555 1,2-Dibromo-2,4-dicyanobutane (CAS No. 35691-65-7) ○ Used in cosmetics and other household products. February 28, 2008 TOX 82 Estragole (CAS No. 140-67-0) ○ Used in perfumes, as a flavoring agent in foods and liquors, and as an antimicrobial agent against acid-tolerant microorganisms, and to produce anise oil. TR 551 Isoeugenol (CAS No. 97-54-1) ○ Food flavoring agent; found in cloves, bay leaves, cinnamon, and tobacco; used as a fragrance in household and personal hygiene products including perfumes, lotions, soaps, and detergents. TR 554 5-(Hydroxymethyl)-2-furfural (CAS No. 67-47-0) ○ Occurs naturally in honey, apple juice, citrus juices, beer, brandy, milk, and breakfast cereals; used in the synthesis of dialdehydes, glycols, ethers, amino alcohols, acetals, and phenol/furfural novolak-type resins. [FR Doc. E7-24131 Filed 12-12-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY: The Department of Health and Human Services
(HHS)gives notice of a decision to designate a class of employees at the Nuclear Materials and Equipment Corporation (NUMEC) in Apollo, Pennsylvania, as an addition to the Special Exposure Cohort
(SEC)under the Energy Employees Occupational Illness Compensation Program Act of 2000. On November 29, 2007, the Secretary of HHS designated the following class of employees as an addition to the SEC: Atomic Weapons Employer
(AWE)employees who were monitored or should have been monitored for exposure to ionizing radiation while working at the Nuclear Materials and Equipment Corporation (NUMEC) in Apollo, Pennsylvania from January 1, 1957, through December 31, 1983, for a number of workdays aggregating at least 250 workdays or in combination with workdays within the parameters established for one or more other classes of employees in the Special Exposure Cohort. This designation will become effective on December 29, 2007, unless Congress provides otherwise prior to the effective date. After this effective date, HHS will publish a notice in the **Federal Register** reporting the addition of this class to the SEC or the result of any provision by Congress regarding the decision by HHS to add the class to the SEC. FOR FURTHER INFORMATION CONTACT: Larry Elliott, Director, Office of Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS C-46, Cincinnati, OH 45226, Telephone 513-533-6800 (this is not a toll-free number). Information requests can also be submitted by e-mail to *OCAS@CDC.GOV.* Dated: December 3, 2007. John Howard, Director, National Institute for Occupational Safety and Health. [FR Doc. E7-24110 Filed 12-12-07; 8:45 am] BILLING CODE 4160-17-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-08-0020] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention
(CDC)publishes a list of information collection requests under review by the Office of Management and Budget
(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at
(404)639-5960 or send an e-mail to *omb@cdc.gov.* Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to
(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project National Coal Workers' X-ray Surveillance Program (CWXSP)—Reinstatement with change—The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description The CWXSP is a federally mandated program under the Federal Mine Safety and Health Act of 1977, Public Law-95-164. The Act provides the regulatory authority for the administration of the CWXSP, a surveillance program to protect the health and safety of underground coal miners. This Program requires the gathering of demographic and logistical information from coal mine operators, participating miners, participating x-ray facilities, and participating physicians. The Appalachian Laboratory for Occupational Safety and Health (ALOSH), located in Morgantown, WV, is charged with administration of this Program. Over the past two years, participation in the CWXSP has increased, which is reflected in this submission for renewal. Physicians taking the B Reader Examination are asked to complete a registration form. There are approximately 300 physicians each year taking the certification exam. Miners participating in the CWXSP must fill out the Miner Identification Document. Mine operators are required to file a Mine X-ray Plan with NIOSH approximately every 3 years. Approximately 200 mine operators have X-ray plans that are due for renewal each year. An X-ray facility that applies to be a NIOSH-approved facility for providing miners X-rays must complete an approval packet. There are approximately 25 X-ray facilities each year seeking approval into the CWXSP Program. There will be no costs to study participants. The total estimated annualized burden hours are 2330. Estimated Annualized Burden Respondents Number of respondents Number of responses/respondent Average burden/response (in hrs.) Physicians/interpretations 10,000 1 3/60 Physicians/certification 300 1 10/60 Miners 5000 1 20/60 Mine operators 200 1 30/60 X-ray facilities 25 1 30/60 Dated: December 6, 2007. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-24137 Filed 12-12-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-08-05CL] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention
(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov* . Comments are invited on:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Formative Evaluation of Adults' and Children's Views Related to Promotion of Healthy Food Choices—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description In Fiscal Year
(FY)2004, Congress directed the Centers for Disease Control and Prevention
(CDC)to conduct formative research on the attitudes of children and parents regarding nutrition behavior. Specifically, the conferees' FY 04 Appropriation Language instructs CDC to research parents' and children's viewpoints on “the characteristics of effective marketing of foods to children to promote healthy food choices.” Upon completion, a report detailing CDC's findings is to “be submitted to the appropriate Committees of jurisdiction of Congress.” In response, CDC has contracted with the Academy for Educational Development
(AED)to conduct focus groups to identify key audience concepts around food choices, and develop and test concepts and messages aimed at increasing healthy food choices among children. For the research to be useful to Congress and to the nation's public health agenda, a thorough understanding of children at different developmental stages regarding their attitudes toward healthy food choices, and the barriers and motivations for adopting and sustaining these choices is essential. Additionally, a thorough understanding of parents and caregivers who can influence the health behaviors of children is important. A total of 384 children and 336 parents will be organized into 90 focus groups (8 respondents per focus group). The 90 focus groups will be conducted in three phases (36 focus groups in Phase 1, 36 focus groups in Phase 2, and 18 focus groups in Phase 3). The 36 focus groups in Phase 1 will consist of 24 focus groups of “tweens” (children ages 9-12 years) and 12 focus groups of their parents or key caregivers. Current literature and opinion leaders both strongly suggest that tweens greatly influence nutritional decisions made by their parents and younger siblings. Similarly, the 36 focus groups in Phase 2 will consist of 24 focus groups of children (ages 5-8 years) and 12 focus groups of their parents. Although parents and children may be recruited as parent-child dyads, parents will participate in focus groups for parents only, and children will participate in focus groups for children only. Phase 3 will consist of 18 focus groups involving parents or caregivers of children ages 2-4 years; no children in this age group will be recruited. Focus group recruitment will incorporate appropriate representation of diverse ethnic groups, and the groups will be held in several cities to ensure broad geographic representation. Participants will be recruited by focus group facilities utilizing their database to solicit and screen interested parties. Both parents and children will participate in the screening process as well as focus group participation. It is expected that two households will be screened in order to recruit each participating Parent, Child, or Parent-Child dyad. Each focus group will be asked to respond verbally. The moderator will utilize a prepared guide which is designed to specifically ensure that the discussion is limited to 2 hours. The focus group moderator will use one guide for all focus groups involving children, and a similar but distinct guide for all focus groups involving parents or caregivers. The intent of this research is to solicit input and feedback from potential audiences. The information gathered will be used to develop, refine, and modify messages and strategies to increase healthy food choices by children and parents. There is no cost to respondents other than their time to participate in the survey. Estimated Annualized Burden Hours Type of respondents Form name Number of respondents Number of responses per respondent Average burden (in hours) Total burden (in hours) Children Screener D1 for Parent & Child Groups 384 1 3/60 19 Screener D2 for Child Only Groups 384 1 3/60 19 Focus Group Moderator's Guide for Children/Youth 384 1 2 768 Parents Screener D1 for Parent & Child Groups 192 1 7/60 22 Screener D2 for Child Only Groups 192 1 7/60 22 Screener D3 for Parent Only Groups 288 1 7/60 34 Focus Group Moderator's Guide for Parents 336 1 2 672 Total 1,556 Dated: December 6, 2007. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-24138 Filed 12-12-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-08-06AO] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention
(CDC)publishes a list of information collection requests under review by the Office of Management and Budget
(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at
(404)639-5960 or send an e-mail to *omb@cdc.gov* . Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to
(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project Evaluation of an Occupational Safety and Health
(OSH)Program for the Small Business Wood Pallet Industry—New—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Federal Occupational Safety and Health Act of 1970, Section 501, enables CDC/NIOSH to carry out research relevant to the health and safety of workers. The goal of this project is to determine whether receipt of a NIOSH informational manual about occupational safety and health
(OSH)concerns specific to pallet manufacturing and recycling will motivate owners or managers to take actions resulting in a safer workplace. The theoretical basis of the study follows the Transtheoretical Model
(TTM)of Prochaska and DiClemente [1984]. This model states that change is defined by 5 stages:
(1)Pre-contemplation—people are unaware of problems and are not thinking seriously about changing within the next 6 months,
(2)contemplation—the stage where people become aware that a problem exists and intend to take action within the next 6 months,
(3)preparation—investigating options and intending to take action in the next 30 days,
(4)action—people institute environmental changes and change their overt behavior, and
(5)maintenance—people continue the gains obtained during the action stage for longer than 6 months. Small business entrepreneurship is a vital component of the U.S. economy. OSH activities, including research, regulation, enforcement, and intervention historically have not focused on small businesses despite their predominance and relatively large numbers of employees overall. Few small business establishments provide on-site occupational health units, medical screening tests, pre-placement physicals, or employ or use industrial hygiene or safety personnel/consultants. As a consequence, prevention of occupational injury and illness is often difficult in small business establishments because they generally have few safety and health resources, do not hire staff devoted to safety and health activities, and often lack the ability to identify occupational hazards and conduct surveillance. The pallet manufacturing industry has higher injury rates than general industry. The incidence rate for non-fatal injuries in the wood pallet and skid (SIC 2448) manufacturing industry was 226% greater than that for general industry. The type of injuries sustained at wood pallet manufacturers and their rates of increase [2002] compared to general industry included amputations (2220% higher), cuts and punctures (378% higher), fractures (237% higher), bruises (221% higher) sprains and strains (133% higher) and back pain (305% higher). Through this study, NIOSH will evaluate the feasibility and effectiveness of providing carefully constructed OSH information to one segment of small business pallet makers. The informational manual will be divided into eight chapters targeting specific hazards relevant to pallet work and will provide the owners/managers with suggestions for controlling those hazards. Chapters were selected based on prior NIOSH site visits to a sample of pallet makers and in consultation with the National Wood Pallet and Container Association. The chapters include: An introduction to OSH, developing a site-specific safety program, controlling noise, improving ventilation, saw safety, forklift safety, preventing build up of carbon monoxide, and prevention of musculoskeletal injury through ergonomics. This project will utilize two groups—a treatment group and a control group—in a pre-post design. One hundred eighty pallet companies will be randomly selected and assigned to two groups from a list of small pallet businesses in the United States that was provided by a market research firm. Both groups will participate in a baseline survey conducted by telephone. The treatment group will then receive the NIOSH informational manual by mail and the control group will not receive the manual until the conclusion of the study. Five months after the mailing, both groups will participate in a follow-up telephone survey designed to assess whether receipt and use of the material encouraged owners/managers to contemplate, plan, or initiate OSH changes at their facility. The questionnaire will determine whether owners/managers have progressed from baseline along the stage of change continuum because of receipt and use of the NIOSH material, or if some other factor is influencing their safety and health actions. It is possible that improvements in OSH may occur due to other influences and not from the informational manual. For example, it is possible that some event will occur that will make the entire industry more aware of OSH. Use of a similar control group will help in this determination. Data collection will occur within a 12 month period. However, the entire NIOSH study will occur over a two-year period. There will be no cost to respondents except their time to participate in the telephone survey. The total estimated annualized burden hours are 40. Estimated Annualized Burden Table Type of respondents Form name Number of respondents Number of responses per respondent Average burden per response (in hours) Pallet company safety and health managers Initial Questionnaire (screening only) 9 1 3/60 Initial Questionnaire (complete) 48 1 12/60 Treatment Group Follow-up Questionnaire 45 1 15/60 Pallet company safety and health managers Initial Questionnaire (screening only) 9 1 3/60 Initial Questionnaire (complete) 48 1 12/60 Control Group Follow-up Questionnaire* 45 1 9/60 Dated: December 6, 2007. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-24140 Filed 12-12-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Privacy Act of 1974; New System of Records AGENCY: Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC). ACTION: Notice of a New System of Records. SUMMARY: In accordance with the requirements of the Privacy Act, the Centers for Disease Control and Prevention
(CDC)is proposing to establish a new system of records (SOR), 09-20-0171, “Quarantine and Traveler-Related Activities, Including Records for Contact Tracing Investigation and Notification Under 42 CFR Parts 70 and 71, HHS/CDC/CCID.” The purpose of the system is to maintain records on the conduct of activities (e.g., quarantine, isolation) that fulfill HHS's and CDC's statutory authority under sections 311 and 361-368 of the Public Health Service Act: To prevent the introduction, transmission and spread of serious communicable diseases from persons arriving into the United States from foreign countries or engaged in interstate or international movement. Identifiable records are collected when an individual known or suspected to have been exposed to such communicable diseases arrives in the U.S. from a foreign country or travels from one state or possession to another state or possession. These records are used to:
(1)Document reports of illness on airplanes, maritime vessels, and at land-border crossings of persons that may pose a public health risk and who are arriving from foreign countries or traveling between states;
(2)perform contact tracing investigations and notifications of passengers and crew when known or suspected exposures to serious communicable diseases occur on board a conveyance arriving in the United States from a foreign country or while traveling from one state or possession to another;
(3)inform state or local public health authorities so that these authorities may act to protect public health or safety; and
(4)take actions (e.g., quarantine or isolation) as necessary to prevent the introduction, transmission, and spread of serious communicable diseases from persons arriving into the United States from foreign countries or persons engaged in interstate or international movement. Additional background information about the new system is included in the SUPPLEMENTARY INFORMATION section below. DATES: *Effective Date:* CDC filed a new SOR report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security and Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget
(OMB)on December 7, 2007. CDC invites interested parties to submit comments on the proposed routine uses. To ensure that all parties have adequate time in which to comment, the new system will be effective 30 days from the publication of this notice, or 40 days from the date it was submitted to OMB and the Congress, whichever is later, unless CDC receives comments that persuade CDC to defer implementation. ADDRESSES: Address comments to HHS Privacy Act Officer, Room 5416, Mary E. Switzer Building, Department of Health and Human Services, 330 “C” Street, SW., Washington, DC 20201, or via electronic mail to *MAGGIE.BLACKWELL@hhs.gov* . Comments will be available for public viewing in the public reading room located at the same address, or on the HHS Web site at *http://www.hhs.gov* . To review comments in person, please call the Division of Freedom of Information and Privacy at 202-690-7453 for an appointment. FOR FURTHER INFORMATION CONTACT: Maggie Blackwell, HHS Privacy Act Officer, Department of Health and Human Services, Room 5416, Mary E. Switzer Building, 330 “C” Street, SW., Washington, DC 20201,
(202)690-7453. SUPPLEMENTARY INFORMATION: CDC proposes to establish a new system of records: 09-20-0171, “Quarantine and Traveler-Related Activities, Including Records for Contact Tracing Investigation and Notification under 42 CFR Parts 70 and 71, HHS/CDC/CCID.” The CDC Division of Global Migration and Quarantine (DGMQ), the agency component responsible for quarantine- and isolation-related activities, is located within the National Center for Preparedness, Detection and Control of Infectious Diseases, the Coordinating Center for Infectious Diseases (CCID). In addition to the contact tracing investigations and notification of travelers who may have been exposed to a communicable disease, this record system supports the mission of DGMQ in meeting public health, scientific, and regulatory responsibilities. The overall DGMQ mission is to decrease morbidity and mortality from infectious diseases among mobile populations (immigrants, refugees, migrant workers, international travelers, etc.) crossing international borders to come into the United States, and to decrease the risk of importation and spread of infectious diseases via humans, animals, and cargo. This new Privacy Act system of records is focused on decreasing the spread of infectious diseases via humans. These records concern activities (e.g., quarantine, isolation) fulfilling HHS's statutory authority under Sections 311 and 361-368 of the Public Health Service Act to prevent the spread of serious communicable diseases among persons arriving from foreign countries into the United States or engaged in interstate or international movement. A related purpose is to collect individually identified records so that contact tracing investigations and notifications of passengers and crew can be made when known or suspected exposures to serious communicable diseases occur on board a conveyance arriving in the United States from a foreign country or while traveling from one state or possession to another state or possession. I. Description of the Proposed System of Records *Statutory and Regulatory Basis for SOR.* Sections 311 and 361-368 of the Public Health Service Act provides authorities related to preventing the introduction, transmission, and spread of serious communicable diseases from foreign countries into the United States or from one state or possession into another. These sections of the Act delineate the various quarantine- and isolation-related activities that CDC may be required to conduct. Individually identified records must be maintained for CDC to effectively conduct many of its major quarantine- and isolation-related activities, including screening arriving international or interstate travelers for symptoms of illness that may pose a public health risk; informing state or local health authorities so that these authorities may act to protect public health or safety; and other activities required to fulfill CDC's regulatory responsibility in this area. Examples of other CDC quarantine- and isolation-related activities that require the maintenance of individually identified records include, but are not limited to, the following: • Responding to reports of illnesses on airplanes, maritime vessels, and at land-border crossings of persons that may pose a public health risk and who are arriving from foreign countries or traveling between states; • Taking quarantine-related actions (e.g., quarantine, isolation) as necessary to prevent the spread of serious communicable diseases from persons arriving from foreign countries into the United States or engaged in interstate or international movement. *Collection and Maintenance of Data in the System.* CDC will collect only the minimum amount of personal data necessary to achieve the purpose of this system, which is to maintain records on the conduct of quarantine-related activities that fulfill HHS's and CDC's statutory authority under Sections 311 and 361-368 of the Public Health Service Act: To prevent the introduction, transmission and spread of serious communicable diseases from persons who arrive into the United States from foreign countries or are engaged in interstate or international movement. To effectively do contact tracing investigations and notifications of passengers and crew when known or suspected exposures of serious communicable diseases occur on board of conveyance, individually identified data, such as name of traveler, country of residence, address and phone at which they can be contacted, travel documents (e.g., passport), and seat number must be obtained. CDC collects only the minimal amount of information needed to perform contact tracing and other follow-up activities. II. Agency Policies, Procedures, and Restrictions on the Routine Use The Privacy Act permits CDC to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible disclosure of data is known as a “routine use.” The government will only release quarantine- and traveler-related information that can be associated with an individual as provided for under “Section III. Proposed Routine Use Disclosures of Data in the System,” collecting only the minimum personal data necessary to achieve the purpose of this system. CDC has the following policies and procedures concerning disclosures of information that will be maintained in the system. Disclosure of information from the SOR will be approved only to the extent necessary to accomplish the purpose of the disclosure and only after CDC: A. Determines that: 1. The use or disclosure is consistent with the reason that the data are being collected, e.g., to maintain records on the conduct of quarantine- and traveler-related activities that fulfill HHS's and CDC's statutory authority to prevent the introduction, transmission and spread of communicable diseases. 2. The purpose for which the disclosure is to be made can only be accomplished if the record is provided in individually identifiable form; 3. The purpose for which the disclosure is to be made is of sufficient importance to warrant the effect on and/or risk to the privacy of the individual that additional exposure of the record might bring; 4. There is a strong probability that the proposed use of the data would in fact accomplish the stated purpose(s); and 5. The data are valid and reliable. B. Requires the information recipient to: 1. Establish administrative, technical, and physical safeguards to prevent unauthorized use of disclosure of the record; 2. Remove or destroy at the earliest time all identifiable information; and 3. Agree not to use or disclose the information for any purpose other than the stated purpose under which the information was disclosed. III. Proposed Routine Use Disclosures of Data in the System The Privacy Act permits CDC to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected and CDC complies with administrative requirements including publishing a notice in the **Federal Register** and allowing 30 days for public comment regarding any such new “routine use.” The proposed routine uses in this system meet the compatibility requirement of the Privacy Act. CDC is proposing to establish the following routine use disclosures of information maintained in the system: A. Records may be disclosed to contractors who will perform many of the same duties as Full Time Equivalents
(FTEs)within DGMQ in situations where additional staff are required. Contractors are required to maintain Privacy Act safeguards with respect to such records. These functions may include collating, analyzing, aggregating, or otherwise refining records. DGMQ contracts out certain functions when doing so would contribute to efficient and effective operations of the agency. DGMQ must be able to give a contractor the information necessary for the contractor to fulfill their duties. Safeguards are provided in the contract prohibiting the contractor from using or disclosing the information for any purpose other than that described in the Statement of Work and requires the contractor to return or destroy all information at the contract's completion. B. Records may be disclosed to state and local health departments and cooperating public health or medical authorities and their counsel to more effectively deal with outbreaks and conditions of public health significance. CDC works closely with state and local health partners to investigate possible outbreaks or other conditions of public health significance. CDC's ability to share information could prove beneficial to the health department's investigation. C. Personal information from this system may be disclosed as a routine use to appropriate conveyance personnel, Federal agencies, state and local health departments, Department of State and embassy personnel (U.S. and foreign), and health authorities in foreign countries. These agencies and departments (U.S. and foreign) need the information to perform contact tracing investigations and to notify individuals exposed to an ill traveler that they were possibly exposed to a disease or condition of public health significance. This is compatible with the overall purpose of the system—to prevent the spread of communicable diseases. D. Records may be disclosed to the Department of Homeland Security
(DHS)to enable DHS to restrict the travel of persons who pose a public health risk and to aid in its investigations of domestic or international terrorism. This routine use helps prevent the introduction, transmission, and spread of communicable disease, particularly where terrorism is involved. E. Identifiable information may need to be shared with medical personnel to evaluate or care for ill or exposed persons, including travelers, with the ultimate goal of protecting the public's health and safety. F. Records may also be shared with the World Health Organization in accordance with U.S. responsibilities to ensure that CDC is in compliance with its obligations under the International Health Regulations and other international agreements—a use in line with CDC's statutory authority with regard to quarantine- and isolation-related activities. G. Also in line with the overriding purpose of protecting public health and safety by preventing the introduction, transmission, or spread of communicable diseases, personal information may be disclosed to federal, state, and local authorities to enable them to take actions needed to place someone under quarantine or isolation, or to enforce quarantine regulations. This is again in line with CDC's statutory authority to take quarantine and isolation related actions to restrict movement if someone poses a significant health risk to others. H. Identifiable information may be disclosed to cooperating state and local legal departments enforcing concurrent legal authority relevant to quarantine- and isolation-related activities. This is in accord with the federal government's statutory authority to cooperate with and aid state and local authorities in the enforcement of their quarantine and other health regulations. I. Identifiable records may be referred to the appropriate agency, whether federal, foreign, state or local charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing the statute, or rule, regulation or order issued pursuant thereto when records collected within this SOR for quarantine activities indicate a violation or potential violation of law, whether civil, criminal or regulatory in nature, and whether arising by general statute or particular program statute, or by regulation, rule or order issued pursuant thereto. This routine use is compatible in that this disclosure is being done to allow for effective enforcement of quarantine- and isolation-related requirements at various levels of government. J. Disclosure may be made to a congressional office from the record of an individual in response to a verified inquiry from the congressional office made at the written request of that individual. When a constituent requests a congressional office to facilitate obtaining information from this CDC system, it is compatible to provide such information, since this is in line with the overall purpose of the Privacy Act, which is to provide access to the subject individual of the records the government has on him or her. K. In the event of litigation in which the defendant is:
(a)the Department, any component of the Department, or any employee of the Department in his or her official capacity;
(b)the United States, where the Department determines that the claim, if successful, is likely to directly affect the operations of the Department or any of its components; or
(c)any Department employee in his or her individual capacity, when the Justice Department has agreed to represent such employee, disclosure may be made to the Department of Justice to enable that Department to present an effective defense, provided that such disclosure is compatible with the purpose for which the records were collected. Whenever CDC is involved in litigation dealing with quarantine- or isolation-related activities and CDC policies or operations could be affected by the outcome of the litigation, CDC must be able to disclose identifiable information to the Department of Justice so that an effective defense can be presented. IV. Safeguards The CDC/DGMQ has safeguards in place for authorized users and monitors such users to ensure against unauthorized use. Access to quarantine records is restricted to protect the privacy of the individuals involved, and personnel with such access have been trained in Privacy Act and information security requirements. CDC/DGMQ maintains very stringent administrative, procedural and technical safeguards for the entire system of records. Access will be limited to authorized CDC/DGMQ FTEs and contractor staff who have a bona fide need for the identifiable information to perform official job-related duties. DGMQ staff are required to have supervisory approval to access identifiable data and receive ongoing training in how to protect sensitive data. A database security package on computers controls unauthorized access to the systems. Data administrators continually review the database to ensure privacy provisions are in place and only appropriate personnel have access to the data. Attempts by unauthorized individuals are automatically recorded and reviewed regularly. Employees maintaining records are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal and HHS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the E-Government Act of 2002; the Clinger-Cohen Act of 1996, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS and CDC policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications and the HHS Information Systems Program Handbook. V. Effects of the Proposed System of Records on Individual Rights CDC proposes to establish this system in accordance with the principles and requirements of the Privacy Act and will collect, use, and disseminate information only as prescribed therein. Data in this system will be subject to the authorized releases in accordance with the routine uses identified in this system of records. CDC will take precautionary measures to minimize the risks of unauthorized access to the records and the potential harm to individual privacy or other personal or property rights of individuals whose data are maintained in the system. CDC will collect only that information necessary to perform the system's purpose. In addition, CDC will make disclosures from the system only with consent of the subject individual, or his/her legal representative, or in accordance with an applicable exception provision of the Privacy Act. CDC, therefore, does not anticipate an unfavorable effect on individual privacy as a result of information relating to individuals. Dated: December 6, 2007. James D. Seligman, Chief Information Officer, Office of the Director, Centers for Disease Control and Prevention. Privacy Act System of Records Notice; No. 09-20-0171 SYSTEM NAME: Quarantine- and Traveler-Related Activities, Including Records for Contact Tracing Investigation and Notification under 42 CFR Parts 70 and 71, HHS/CDC/CCID. SECURITY CLASSIFICATION: None. SYSTEM LOCATION: Division of Global Migration and Quarantine, National Center for the Preparedness, Detection, and Control of Infectious Disease (NCPDCID), Coordinating Center for Infectious Diseases (CCID), Centers for Disease Control and Prevention, 1600 Clifton Road, NE., Building 16; MS E03, Atlanta, GA 30333. Records may occasionally be stored at Quarantine Stations located at key ports of entry and at contractor sites. CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: Individuals subject to quarantine or isolation orders, ill travelers (i.e., passengers and crew), contacts of ill travelers, and/or individuals exposed or suspected of being exposed to serious communicable diseases. CATEGORIES OF RECORDS IN THE SYSTEM: Passenger and crew manifests from conveyances carrying individuals subject to 42 CFR parts 70 and 71, case reports, illness response forms, medical assessments, medical records (including but not limited to clinical, hospital and laboratory data and data from other relevant tests), name, address, date of birth, and related information and documents collected for the purpose of carrying out agency responsibilities under sections 311 and 361-368 of the Public Health Services Act. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: Sections 311, 361-368 of the Public Health Service Act. PURPOSE(S): This system maintains records on the conduct of activities (e.g., quarantine, isolation) that fulfill HHS's and CDC's statutory authority under sections 311, 361-368 of the Public Health Service Act to prevent the introduction, transmission and spread of communicable diseases. Records are collected when individual known or suspected to have been exposed to serious communicable diseases arrives into the United States from foreign countries or is engaged in interstate or international movement These records are used to
(1)document reports of illness that may pose a public health risk occurring while on board airplanes, maritime vessels, and at land-border crossings of persons arriving from foreign countries or traveling between states;
(2)perform contact tracing investigations and notifications of passengers and crew when known or suspected exposures to serious communicable diseases occur on board a conveyance arriving in the United States from a foreign country or traveling from one state or possession to another;
(3)inform international, federal, state or local public health authorities so that these authorities may act to protect public health or safety; and
(4)take such actions (e.g., quarantine or isolation) as necessary to prevent the introduction, transmission, and spread of serious communicable diseases from persons arriving into the United States from foreign countries or persons engaged in interstate or international movement. ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES:
(1)Records may be disclosed to contractors to handle program work duties, performing many of the same functions as FTEs within DGMQ in situations where additional staff is required. Contractors are required to maintain Privacy Act safeguards with respect to such records.
(2)Records may be disclosed to state and local health departments and other cooperating medical and public health authorities and their counsel to more effectively deal with outbreaks and other significant public health conditions.
(3)Personal information from this system may be disclosed as a routine use to appropriate conveyance personnel, Federal agencies, state and local health departments, Department of State and embassy personnel (U.S. and foreign), and health authorities in foreign countries for contact tracing investigations and notifications of possible exposures to serious communicable diseases in connection with travel.
(4)Records may be disclosed to the Department of Homeland Security to restrict travel of persons who pose a public health risk and in the instance of suspected domestic or international terrorism.
(5)Disclosure may be made to medical personnel providing evaluation and care for ill or exposed persons, including travelers.
(6)Records may be disclosed to the World Health Organization in accordance with U.S. responsibilities as a signatory to the International Health Regulations or other international agreements.
(7)Personal information may be disclosed to federal, state, and local authorities for taking necessary actions to place someone under quarantine or isolation, for enforcement of other quarantine regulations, or to protect the public's health and safety.
(8)Records may be disclosed to cooperating state and local legal departments enforcing concurrent legal authority related to quarantine or isolation activities.
(9)In the event that a system of records maintained by this agency to carry out its functions indicates a violation or potential violation of law, whether civil, criminal or regulatory in nature, and whether arising by general statute or particular program statute, or by regulation, rule or order issued pursuant thereto, the relevant records in the system of records may be referred, as a routine use, to the appropriate agency, whether federal, foreign, state or local, charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing the statute, or rule, regulation or order issued pursuant thereto.
(10)Disclosure may be made to a congressional office from the record of an individual in response to a verified inquiry from the congressional office made at the written request of that individual
(11)In the event of litigation where the defendant is:
(a)The Department, any component of the Department, or any employee of the Department in his or her official capacity;
(b)the United States where the Department determines that the claim, if successful, is likely to directly affect the operations of the Department or any of its components; or
(c)any Department employee in his or her individual capacity where the Justice Department has agreed to represent such employee, disclosure may be made to the Department of Justice to enable that Department to present an effective defense. POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: STORAGE: Electronic media and file folders for hard-copy records. RETRIEVABILITY: By name of individual or other identifying particulars. SAFEGUARDS: 1. *Authorized Users:* A database security package is implemented on CDC's computer systems to control unauthorized access to the system. Attempts to gain access by unauthorized individuals are automatically recorded and reviewed on a regular basis. Access is granted to only a limited number of physicians, scientists, statisticians, and designated support staff of the Centers for Disease Control and Prevention (CDC), or its contractors, as authorized by the system manager to accomplish the stated purposes for which the data in this system have been collected. 2. *Physical Safeguards:* Access to the CDC Clifton Road facility where the mainframe computer is located is controlled by a cardkey system. Access to the computer room is controlled by a cardkey and security code (numeric keypad) system. Access to the data entry area is also controlled by a cardkey system. Guard service in buildings provides personnel screening of visitors. The local fire department is located directly next door to the Clifton Road facility. The computer room is protected by an automatic sprinkler system, numerous automatic sensors (e.g., water, heat, smoke, etc.) are installed, and a proper mix of portable fire extinguishers is located throughout the computer room. Computer files are backed up on a routine basis. Hard-copy records are stored in locked cabinets at CDC headquarters and CDC Quarantine stations which are located in a secure area of the airport. 3. *Procedural Safeguards:* Protection for computerized records, both on the mainframe and the National Center Local Area Network (LAN), includes programmed verification of valid user identification code and password prior to logging on to the system, mandatory password changes, limited log-ins, virus protection, and user rights/file attribute restrictions. Password protection imposes user name and password log-in requirements to prevent unauthorized access. Each user name is assigned limited access rights to files and directories at varying levels to control file sharing. There are routine daily back-up procedures, and secure off-site storage is available. To avoid inadvertent data disclosure, measures are taken to ensure that all data are removed from electronic media containing Privacy Act information. Additional safeguards may be built into the program by the system analyst, as warranted by the sensitivity of the data. CDC and contractor employees who maintain records are instructed to check with the system manager prior to making disclosures of data. When individually identified data are being used in a room, admittance at either CDC or contractor sites is restricted to specifically authorized personnel. Privacy Act provisions are included in contracts, and the CDC Project Director, contract officers and project officers oversee compliance with these requirements. Upon completion of the contract, all data will be either returned to CDC or destroyed, as specified by the contract. *Implementation Guidelines:* The safeguards outlined above are in accordance with the HHS Information Security Program Policy and FIPS Pub 200, “Minimum Security Requirements for Federal Information and Information Systems.” Data maintained on CDC's Mainframe and the National Centers' LANs are in compliance with OMB Circular A-130, Appendix III. Security is provided for information collection, processing, transmission, storage, and dissemination in general support systems and major applications. Retention and disposal: Contact tracing records will be maintained in the agency until the contact investigation is complete or no longer than twelve months, in accordance with proposed retention schedules; remaining quarantine records would be maintained 10 or 20 years, based on the applicable CDC records control schedule. Disposal methods include wiping electronic media and macerating paper materials. System manager(s) and address: Director, NCPDCID, Coordinating Center for Infectious Diseases, Bldg. 1, Rm. 6013, MS C12, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., Atlanta, GA 30333. Notification procedure: An individual may learn if a record exists about himself or herself by contacting the system manager at the address listed above. Requesters in person must provide driver's license or other positive identification. Individuals who do not appear in person must either:
(1)Submit a notarized request to verify their identity; or
(2)certify that they are the individuals they claim to be and that they understand that the knowing and willful request for or acquisition of a record pertaining to an individual under false pretenses is a criminal offense under the Privacy Act subject to a $5,000 fine. An individual who requests notification of or access to medical records shall, at the time the request is made, designate in writing a responsible representative who is willing to review the record and inform the subject individual of its contents at the representative's discretion. A parent or guardian who requests notification of, or access to, a child's medical record shall designate a family physician or other health professional (other than a family member) to whom the record, if any, will be sent. The parent or guardian must verify relationship to the child by means of a birth certificate or court order, as well as verify that he or she is who he or she claims to be. Record access procedures: Same as notification procedures. Requesters should also reasonably specify the record contents being sought. An accounting of disclosures that have been made of the record, if any, may be requested. Contesting record procedures: Contact the official at the address specified under System Manager above, reasonably identify the record and specify the information being contested, the corrective action sought, and the reasons for requesting the correction, along with supporting information to show how the record is inaccurate, incomplete, untimely, or irrelevant. Record source categories: Individuals, private physicians, state and local health departments, other health-care providers, conveyance personnel, cooperating public health agencies, foreign governments including ministries of health, and other federal agencies. Systems exempted from certain provisions of the act: None. [FR Doc. E7-24142 Filed 12-12-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0200] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Health and Diet Survey AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget
(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by January 14, 2008. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to *baguilar@omb.eop.gov* . All comments should be identified with the OMB control number 0910-0545. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,301-827-4659. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Health and Diet Survey—(OMB Control Number 0910-0545)—Extension FDA is seeking extension of OMB approval for the Health and Diet Survey, which is a voluntary consumer survey intended to gauge and track consumer attitudes, awareness, knowledge, and behavior regarding various topics related to health, nutrition, and physical activity. The authority for FDA to collect the information derives from the Commissioner of Food and Drugs' authority provided in section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)). The survey consists of two independent data collection activities. One collection, entitled “Health and Diet Survey—General Topics,” tracks a broad range of consumer attitudes, awareness, knowledge, and self-reported behaviors related to key diet and health issues. The other collection, entitled “Health and Diet Survey— *Dietary Guidelines* Supplement,” will provide FDA with updated information about consumer attitudes, awareness, knowledge, and behavior regarding various elements of nutrition and physical activity based on the key recommendations of the *Dietary Guidelines for Americans* , which are jointly issued by the Department of Health and Human Services and Department of Agriculture every 5 years. The information to be collected with the Health and Diet Survey—General Topics will include:
(1)Awareness of diet-disease relationships;
(2)food and dietary supplement label use;
(3)dietary practices including strategies to lose or maintain weight; and
(4)awareness and knowledge of dietary fats. The information to be collected with the Health and Diet Survey— *Dietary Guidelines* Supplement will include:
(1)Opinions about the nutrition information provided by the government;
(2)awareness and familiarity with government nutrition programs and publications such as the Food Guide Pyramid and the *Dietary Guidelines for Americans* ;
(3)knowledge of the relationships between food choices, exercise habits, weight loss, and health;
(4)choices surrounding exercise, calorie intake, saturated and trans fats, fruits and vegetables, whole grains, dairy, fish, meat, cholesterol, carbohydrates, salt, and sugar. The survey will also ask about use of Federal nutrition information, special diet, weight status, health status, and demographics. FDA and other Federal agencies will use the information from the Health and Diet Survey to evaluate and develop strategies and programs to encourage and help consumers adopt healthy lifestyles. The information will also help FDA and other Federal agencies evaluate and track consumer awareness and behavior as outcome measures of their achievement in improving public health. *Description of Respondents* : The respondents are adults, age 18 and older, drawn from the 50 states and the District of Columbia. Participation will be voluntary. In the **Federal Register** of May 25, 2007 (72 FR 29332), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. **Table 1.—Estimated Annual Reporting Burden** 1 Activity No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours General Topics: Pretest 27 1 27 0.25 6.75 General Topics: Screener 10,000 1 10,000 0.02 200 General Topics: Survey 3,000 1 3,000 0.25 750 *Dietary Guidelines* Supplement: Screener 4,000 1 4,000 0.02 80 *Dietary Guidelines* Supplement: Survey 1,200 1 1,200 0.22 264 Total 1,300.75 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA has based its estimate of the number of respondents and the burden hours per response on its experience with the Health and Diet Survey over the past 3 years. The agency will use a screener to select an eligible adult respondent in each household to participate in the survey. For the Health and Diet Survey—General Topics data collection activity a total of 3,000 adults in the 50 states and the District of Columbia will be interviewed by telephone. We estimate that it will take a respondent 1.2 minutes (0.02 hours) to complete the screening questions and 15 minutes (0.25 hours) to complete the entire survey. Prior to the administration of the survey, the agency plans to conduct a pretest to identify and resolve potential problems. The pretest will be conducted with 27 participants; we estimate that it will take a respondent 15 minutes (0.25 hours) to complete the pretest. For the Health and Diet Survey— *Dietary Guidelines* Supplement data collection activity a total of 1,200 adults in the 50 states and the District of Columbia will be interviewed by telephone. We estimate that it will take a respondent 1.2 minutes (0.02 hours) to complete the screening questions and 13.2 minutes (0.22 hours) to complete the entire survey. Target sample size of the combined data collection is 4,200 respondents who complete the survey. Dated: December 7, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-24123 Filed 12-12-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Quality System Regulation Educational Forum on Design Controls; Public Workshop; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing an amendment to the notice of public workshop entitled “Quality System Regulation Educational Forum on Design Controls.” This workshop was announced in the **Federal Register** of October 11, 2007 (72 FR 57951). The amendment is made to reflect a change in the *Location* portion of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: David Arvelo, Food and Drug Administration, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253-4970, e-mail: *david.arvelo@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: In the **Federal Register** of October 11, 2007 (72 FR 57951), FDA announced that a public workshop entitled “Quality System Regulation Educational Forum on Design Controls” would be held on Friday, April 4, 2008. On page 57951, in the second column, the *Location* portion of the document is amended to read as follows: *Location* : The public workshop will be held at the Adam's Mark Hotel Dallas, 400 North Olive St., Dallas, TX 75201, 214-922-8000. Directions to the facility and additional information are available at the FDA Medical Device Industry Coalition Web site at *http://www.fmdic.org/* . Dated: December 7, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-24144 Filed 12-12-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and/or contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Cancer Institute Special Emphasis Panel, Operations and Technical Support at the NCI-Frederick. *Date:* January 7, 2008. *Time:* 8 a.m. to 4 p.m. *Agenda:* To review and evaluate contract proposals. *Place:* Gaithersburg Hilton, 620 Perry Parkway, Gaithersburg, MD 20877. *Contact Person:* Lalita D. Palekar, PhD. Scientific Review Administrator, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Blvd., Bethesda, MD 20892-7405, 301-496-7575, *palekarl@mail.nih.gov.* *Name of Committee:* National Cancer Institute Initial Review Group, Subcommittee G-Education. *Date:* February 12-13, 2008. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Crowne Plaza Washington Silver Spring, 8777 Georgia Ave., Silver Spring, MD 20910. *Contact Person:* Sonya Roberson, PhD, Scientific Review Administrator, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Blvd., Room 8109, Bethesda, MD 20892, 301-594-1182, *robersos@mail.nih.gov.* *Name of Committee:* National Cancer Institute Special Emphasis Panel, R25(E) Special Emphasis Panel (SEP). *Date:* February 12, 2008. *Time:* 5 p.m. to 6 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Crowne Plaza Washington Silver Spring, 8777 Georgia Ave., Silver Spring, MD 20910. *Contact Person:* Lynn M. Amende, PhD, Scientific Review Administrator, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Boulevard Room 8105 Bethesda, MD 20892-8328, 301-451-4759, *amendel@mail.nih.gov.* (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research, 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: December 4, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07-6034 Filed 12-12-07; 8:45 am]
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U.S. Code
- Tolerances and exemptions for pesticide chemical residues§ 346a
- Estrogenic substances screening program§ 300j–17
- Testing of chemical substances and mixtures§ 2603
- Adjudications§ 554
- Penalties§ 2615
- Registration of pesticides§ 136a
- Collection of fees for inspection services§ 136a
- Public information; agency rules, opinions, orders, records, and proceedings§ 552
- Purposes§ 3501
- Definitions§ 1841
- Acquisition of bank shares or assets§ 1842
- Interests in nonbanking organizations§ 1843
- Public information collection activities; submission to Director; approval and delegation§ 3507
- Food and Drug Administration§ 393
CFR
17 references not yet in our index
- 40 CFR 2
- 21 USC 231(q)(1)
- 7 USC 346a(c)(2)(B)
- 40 CFR 158.1539(g)
- 40 CFR 158
- 40 CFR 160
- 40 CFR 160.12
- 40 CFR 169
- 40 CFR 169.2(k)
- 759 F. Supp. 861
- 40 CFR 22.13-22
- 5 USC 2615(a)(2)(B)
- 40 CFR 159
- 40 CFR 717
- 40 CFR 9
- 12 CFR 225
- Pub. L. 92-463
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Cite21 USC 231(q)(1)
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