Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides; Notification to the Secretary of Agriculture, 62738-62739 [2010-25787]

Download as PDF 62738 Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Proposed Rules the information to determine whether it continues to warrant classification pursuant to an Executive Order. * * * * * * * * 3. Section 1.36 is amended by revising paragraphs (e) and (f) to read as follows: ENVIRONMENTAL PROTECTION AGENCY § 1.36 Systems exempt in whole or in part from provisions of 5 U.S.C. 522a and this part. Revisions to EPA’s Rule on Protections for Subjects in Human Research Involving Pesticides; Notification to the Secretary of Agriculture * * * * * (e) Specific exemptions under 5 U.S.C. 552a(k)(1). (1) Under 5 U.S.C. 552a(k)(1), the head of any agency may promulgate rules to exempt any system of records within the agency from certain provisions of the Privacy Act to the extent that the system contains information subject to the provisions of 5 U.S.C. 552(b)(1). This paragraph applies to the following systems of records maintained by the Department of the Treasury: (i) Departmental Offices: Number System name DO .120 ....... Records Related to Office of Foreign Assets Control Economic Sanctions. (ii) Financial Crimes Enforcement Network: Number FinCEN .001 System name FinCEN Database. jlentini on DSKJ8SOYB1PROD with PROPOSALS (2) The Department of the Treasury hereby exempts the systems of records listed in paragraph (e)(1) of this section from the following provisions of 5 U.S.C. 552a, pursuant to 5 U.S.C. 552a(k)(1): 5 U.S.C. 552a(c)(3), 5 U.S.C. 552a(d)(1), (2), (3), and (4), 5 U.S.C. 552a(e)(1), 5 U.S.C. 552a(e)(4)(G), (H), and (I), and 5 U.S.C. 552a(f). (f) Reasons for exemptions under 5 U.S.C. 552a(k)(1). The reason for invoking the exemption is to protect material authorized to be kept secret in the interest of national defense or foreign policy pursuant to Executive Orders 12958, 13526, or successor or prior Executive Orders. * * * * * Dated: July 16, 2010. Melissa Hartman, Acting Deputy Assistant Secretary for Privacy, Transparency, and Records. [FR Doc. 2010–25756 Filed 10–12–10; 8:45 am] BILLING CODE 4810–25–P VerDate Mar<15>2010 19:22 Oct 12, 2010 Jkt 223001 40 CFR Part 26 [EPA–HQ–OPP–2010–0785; FRL–8850–2] RIN 2070–AJ76 Environmental Protection Agency (EPA). ACTION: Notification to the Secretary of Agriculture. AGENCY: This document notifies the public that the Administrator of EPA has forwarded to the Secretary of Agriculture a draft proposed rule as required by section 25(a) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). As described in the Agency’s semi-annual Regulatory Agenda, the draft proposed rule would amend the portions of EPA’s rules for the protection of human subjects of research that apply to third parties who conduct or support research for pesticides involving intentional exposure of human subjects, and to persons who submit the results of human research for pesticides to EPA. EPA agreed to propose these amendments as a result of a settlement agreement resolving a judicial challenge to the promulgation of these rules in 2006, and is now seeking comments on these draft proposed amendments from the Secretary of Agriculture. The draft proposed amendments would clarify the applicability of the rules to human testing for pesticides submitted to EPA under any statute, would disallow consent by a legally authorized representative of participants in pesticide studies who cannot consent for themselves, and would identify specific considerations to be addressed in EPA science and ethics reviews of proposed and completed human research for pesticides, based on the recommendations of the National Academy of Sciences and on the Nuremberg Code. ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2010–0785. All documents in the docket are listed in the docket index available in https://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. SUMMARY: PO 00000 Frm 00047 Fmt 4702 Sfmt 4702 Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at https://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305– 5805. FOR FURTHER INFORMATION CONTACT: Kelly Sherman, Immediate Office of the Director (7501P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–8401; fax number: (703) 308–4776; e-mail address: sherman.kelly@epa.gov. SUPPLEMENTARY INFORMATION: I. Does this action apply to me? This action is directed to the public in general. It simply announces the submission of a draft proposed rule to the U.S. Department of Agriculture (USDA) and does not otherwise affect any specific entities. This action may, however, be of particular interest to pesticide registrants (NAICS code 325320) who sponsor or conduct human research for pesticides, and to other entities that sponsor or conduct human research for pesticides (NAICS code 541710). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be interested in this action. If you have any questions regarding this action, consult the person listed under FOR FURTHER INFORMATION CONTACT. II. What action is EPA taking? Section 25(a)(2) of FIFRA requires the Administrator to provide the Secretary of Agriculture with a copy of any proposed regulation at least 60 days before signing it for publication in the Federal Register. The draft proposed rule is not available to the public until after it has been signed by EPA. If the Secretary comments in writing regarding the draft proposed rule within 30-days after receiving it, the Administrator shall include the comments of the Secretary and the Administrator’s response to those comments in the proposed rule when it is published in the Federal Register. If the Secretary does not comment in writing within 30 days after receiving E:\FR\FM\13OCP1.SGM 13OCP1 Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Proposed Rules the draft proposed rule, the Administrator may sign the proposed regulation for publication in the Federal Register anytime after the 30-day period. III. Do any statutory and executive order reviews apply to this notification? No. This document is not a proposed rule; it is merely a notification of submission to the Secretary of Agriculture. As such, none of the regulatory assessment requirements apply to this document. List of Subjects in 40 CFR Part 26 Environmental protection, Human research, Pesticides. Dated: October 4, 2010. Steven Bradbury, Director, Office of Pesticide Programs. [FR Doc. 2010–25787 Filed 10–12–10; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 85, 86, and 600 DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Parts 531 and 533 [FRL–9212–4] RIN 2127–AK79 2017 and Later Model Year Light Duty Vehicle GHG Emissions and CAFE Standards; Notice of Intent Environmental Protection Agency (EPA) and the National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT). ACTION: Notice of intent to conduct a joint rulemaking. AGENCIES: On May 21, 2010, President Obama issued a Presidential Memorandum requesting that the Environmental Protection Agency (EPA) and the National Highway Traffic Safety Administration (NHTSA), on behalf of the Department of Transportation develop, through notice and comment rulemaking, a coordinated National Program under the Clean Air Act (CAA) and the Energy Policy and Conservation Act (EPCA), as amended by the Energy Independence and Security Act (EISA) to improve fuel efficiency and to reduce greenhouse gas emissions of light-duty vehicles for model years 2017–2025. President Obama requested that the jlentini on DSKJ8SOYB1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 19:22 Oct 12, 2010 Jkt 223001 agencies issue a Notice of Intent to issue a proposed rule that announces plans for setting stringent fuel economy and greenhouse gas emissions standards for light-duty vehicles of model year 2017 and beyond. This joint Notice describes the agencies’ initial assessment of potential levels of stringency for a National Program for model years 2017– 2025, and describes additional work that the agencies will undertake over the next two months to refine this assessment further. This Notice fulfills that request and discusses the agencies’ plans to issue a Supplemental Notice of Intent by November 30, 2010 that will describe plans for the National Program, including an updated analysis of potential GHG and fuel economy standards for model years 2017–2025. This joint Notice also announces the plans by the two agencies to propose such a coordinated National Program by the fall of 2011. DATES: Comments: In order for comments to be most helpful to this ongoing process of ultimately developing a proposed rulemaking, the agencies encourage parties wishing to comment on this Notice to submit their comments by October 31, 2010. See the SUPPLEMENTARY INFORMATION, Section I (Introduction), for more information about the rulemaking process. ADDRESSES: Submit your comments, identified by Docket ID No. EPA–HQ– OAR–0799 and/or NHTSA–2010–0131, by one of the following methods: • https://www.regulations.gov: Follow the on-line instructions for submitting comments. • E-mail: a-and-r-Docket@epa.gov. • Fax: EPA: (202) 566–1741; NHTSA: (202) 493–2251. • Mail: Æ EPA: Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, Attention: Docket ID No. EPA–HQ–OAR–2010–0799. Æ NHTSA: Docket Management Facility, M–30, U.S. Department of Transportation, West Building, Ground Floor, Rm. W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • Hand Delivery: Æ EPA: EPA Docket Center, EPA/ DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC 20004, Attention: Docket ID No. EPA–HQ–OAR–0799. Such deliveries are only accepted during the Docket’s normal hours of operation, and special arrangements should be made for deliveries of boxed information. Æ NHTSA: West Building, Ground Floor, Rm. W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590, PO 00000 Frm 00048 Fmt 4702 Sfmt 4702 62739 between 9 a.m. and 4 p.m. Eastern Time, Monday through Friday, except Federal Holidays. Instructions: Direct your comments to Docket ID No. EPA–HQ–OAR–0799 and/or Docket ID No. NHTSA–2010– 0131. NHTSA and EPA request comment on all aspects of this joint Notice. See the SUPPLEMENTARY INFORMATION section on ‘‘Public Participation’’ for more information about submitting written comments. Docket: All documents listed in the dockets are listed in the https:// www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., confidential business information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically at https:// www.regulations.gov or in hard copy at the following locations: EPA: EPA Docket Center, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744. NHTSA: Docket Management Facility, M–30, U.S. Department of Transportation, West Building, Ground Floor, Rm. W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590. The Docket Management Facility is open between 9 a.m. and 5 p.m. Eastern Time, Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: EPA: Tad Wysor, Office of Transportation and Air Quality, Assessment and Standards Division, Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number: (734) 214– 4332; fax number: (734) 214–4816; email address: wysor.tad@epa.gov or Assessment and Standards Division Hotline, telephone number (734) 214– 4636; e-mail address asdinfo@epa.gov. DOT/NHTSA: Rebecca Yoon, Office of Chief Counsel, National Highway Traffic Safety Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590. Telephone: (202) 366–2992. SUPPLEMENTARY INFORMATION: Public Participation NHTSA and EPA request comment on all aspects of this Notice and the accompanying Interim Joint Technical Assessment Report discussed below. E:\FR\FM\13OCP1.SGM 13OCP1

Agencies

[Federal Register Volume 75, Number 197 (Wednesday, October 13, 2010)]
[Proposed Rules]
[Pages 62738-62739]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-25787]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 26

[EPA-HQ-OPP-2010-0785; FRL-8850-2]
RIN 2070-AJ76


Revisions to EPA's Rule on Protections for Subjects in Human 
Research Involving Pesticides; Notification to the Secretary of 
Agriculture

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification to the Secretary of Agriculture.

-----------------------------------------------------------------------

SUMMARY: This document notifies the public that the Administrator of 
EPA has forwarded to the Secretary of Agriculture a draft proposed rule 
as required by section 25(a) of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA). As described in the Agency's semi-annual 
Regulatory Agenda, the draft proposed rule would amend the portions of 
EPA's rules for the protection of human subjects of research that apply 
to third parties who conduct or support research for pesticides 
involving intentional exposure of human subjects, and to persons who 
submit the results of human research for pesticides to EPA. EPA agreed 
to propose these amendments as a result of a settlement agreement 
resolving a judicial challenge to the promulgation of these rules in 
2006, and is now seeking comments on these draft proposed amendments 
from the Secretary of Agriculture. The draft proposed amendments would 
clarify the applicability of the rules to human testing for pesticides 
submitted to EPA under any statute, would disallow consent by a legally 
authorized representative of participants in pesticide studies who 
cannot consent for themselves, and would identify specific 
considerations to be addressed in EPA science and ethics reviews of 
proposed and completed human research for pesticides, based on the 
recommendations of the National Academy of Sciences and on the 
Nuremberg Code.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2010-0785. All documents in the 
docket are listed in the docket index available in https://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at https://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Kelly Sherman, Immediate Office of the 
Director (7501P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-8401; fax number: (703) 308-4776; e-
mail address: sherman.kelly@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    This action is directed to the public in general. It simply 
announces the submission of a draft proposed rule to the U.S. 
Department of Agriculture (USDA) and does not otherwise affect any 
specific entities. This action may, however, be of particular interest 
to pesticide registrants (NAICS code 325320) who sponsor or conduct 
human research for pesticides, and to other entities that sponsor or 
conduct human research for pesticides (NAICS code 541710). Since other 
entities may also be interested, the Agency has not attempted to 
describe all the specific entities that may be interested in this 
action. If you have any questions regarding this action, consult the 
person listed under FOR FURTHER INFORMATION CONTACT.

II. What action is EPA taking?

    Section 25(a)(2) of FIFRA requires the Administrator to provide the 
Secretary of Agriculture with a copy of any proposed regulation at 
least 60 days before signing it for publication in the Federal 
Register. The draft proposed rule is not available to the public until 
after it has been signed by EPA. If the Secretary comments in writing 
regarding the draft proposed rule within 30-days after receiving it, 
the Administrator shall include the comments of the Secretary and the 
Administrator's response to those comments in the proposed rule when it 
is published in the Federal Register. If the Secretary does not comment 
in writing within 30 days after receiving

[[Page 62739]]

the draft proposed rule, the Administrator may sign the proposed 
regulation for publication in the Federal Register anytime after the 
30-day period.

III. Do any statutory and executive order reviews apply to this 
notification?

    No. This document is not a proposed rule; it is merely a 
notification of submission to the Secretary of Agriculture. As such, 
none of the regulatory assessment requirements apply to this document.

List of Subjects in 40 CFR Part 26

    Environmental protection, Human research, Pesticides.

    Dated: October 4, 2010.
Steven Bradbury,
Director, Office of Pesticide Programs.
[FR Doc. 2010-25787 Filed 10-12-10; 8:45 am]
BILLING CODE 6560-50-P
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