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Pesticides: Redesignation of part 158; Technical Amendments
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[Federal Register: October 24, 2007 (Volume 72, Number 205)] [Rules and Regulations] [Page 60251-60255] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr24oc07-13] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 158 and 161 [EPA-HQ-OPP-2004-0387; FRL-8116-2] Pesticides: Redesignation of part 158; Technical Amendments AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: EPA is redesignating certain pesticide data requirements currently located in 40 CFR part 158 into a new part 161. The data requirements being transferred apply to antimicrobial pesticides. EPA is also making conforming changes and cross-reference revisions to the newly redesignated material. The redesignation is intended to preserve regulatory data requirements for antimicrobial pesticides, while preparing for the promulgation of final rules pertaining to data requirements for conventional pesticides, biochemical, and microbial pesticides. DATES: This final rule is effective December 24, 2007. ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2004-0387. To access the electronic docket, go to http://www.regulations.gov, select ``Advanced Search,'' then ``Docket Search.'' Insert the docket ID number where indicated and select the ``Submit'' button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in 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 either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Public Docket, in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305-5805. FOR FURTHER INFORMATION CONTACT: Jean Frane, Field and External Affairs Division 7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington DC 20460-0001; telephone number: (703) 305-5944; e-mail address: frane.jean@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are a producer or registrant of an antimicrobial pesticide product, including wood preservatives and antifouling products. This action may also affect any person or company who might petition the Agency for new tolerances, hold a pesticide registration with existing tolerances, or any person or company who is interested in obtaining or retaining a tolerance in the absence of a registration, that is, an import tolerance. Potentially affected entities may include, but are not limited to: • Producers of cleaning preparations that include an antimicrobial pesticide (NAICS code 3256). • Pesticide manufacturers or formulators of paints or coatings that contain an antimicrobial pesticide (NAICS code 32551). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) code has been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the persons listed under FOR FURTHER INFORMATION CONTACT. [[Page 60252]] B. How Can I Access Electronic Copies of this Document and Other Related Information? In addition to using regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr. II. What Does this Redesignation Do? In the Federal Register of March 11, 2005 (70 FR 12276), EPA issued a proposed rule to revise its pesticide data requirements for conventional pesticides. Those data requirements, currently located in 40 CFR part 158, cover all pesticides. EPA's purpose in developing data requirements devoted to conventional pesticides (and subsequently for biochemical and microbial pesticides) was to tailor data requirements for different types of pesticides to make them more transparent and flexible. As part of that effort, EPA intends in the future to issue a proposed rule updating data requirements for antimicrobial pesticides, including wood preservatives and antifoulants. EPA is shortly issuing final rules for conventional pesticides, biochemical and microbial pesticides. Those rules would supersede current part 158 data requirements in their entirety. Unless EPA acts to preserve the data requirements applicable to antimicrobial pesticides, the promulgation of the final rules would eliminate any regulatory data requirements for antimicrobial pesticides. Accordingly, EPA is issuing a final rule that would preserve the current data requirements for antimicrobial pesticides until such time as a final rule can be promulgated and made effective. To accomplish this, EPA is moving those portions of current part 158 that apply to antimicrobial pesticides into new part 161, and making technical corrections to accommodate the change. Specifically, the following changes are being made: 1. EPA is removing sections of part 158 that relate only to biochemical and microbial pesticides, including Sec. Sec. 158.65, 158.690 and 158.740. These sections had, and would not have, any bearing on antimicrobial data requirements. 2. EPA is also removing Sec. 158.50 pertaining to the formulators' exemption because this material will be consolidated in Sec. 152.85 when final rules for conventional pesticides and biochemical and microbial pesticides are promulgated. 3. EPA is making internal cross-reference changes from ``158'' to ``161'' throughout the redesignated material. 4. In new Sec. 161.108, EPA has updated the Guidelines information to reflect the current order numbers from the National Technical Information Service. III. Why is this Redesignation Issued as a Final Rule? Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), provides that, when an Agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the Agency may issue a final rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making today's rule final without prior proposal and opportunity for comment, because EPA is acting to preserve existing data requirements that would otherwise be removed from the Code of Federal Regulations by promulgation of an impending final rule. Redesignating the material in advance of promulgation will also avoid potential errors in accomplishing a complex transition in the Code of Federal Regulations. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B). IV. Do Any of the Statutory and Executive Order Reviews Apply to this Action? This rule redesignates, makes technical changes and cross-reference corrections in the EPA regulations governing pesticides. The amendments are administrative in nature. Other than making EPA regulations clearer and more transparent, these amendments are not expected to have any impact on regulated parties or the public. Accordingly, these amendments are not subject to review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), as a significant regulatory action. Because the Agency has made a ``good cause''finding that this action is not subject to notice-and-comment requirements under the Administrative Procedure Act or any other statute. this rule has been exempted from review under Executive Order 12866. Moreover, for the same reason, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since, as detailed above, these amendments will have no detrimental impact on regulated parties or the public, EPA certifies under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) that the amendments will not have a significant impact on a substantial number of small entities. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' ``Policies that have federalism implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This rule is directed at pesticide manufacturers and others who seek to register, amend or maintain a registration or to establish, modify, or revoke a pesticide tolerances or exemptions, not States. For these same reasons, the Agency has determined that this rule does not have any ``tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (59 FR 22951, November 6, 2000). Executive [[Page 60253]] Order 13175, requires EPA to develop an accountable process to ensure ``meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' ``Policies that have tribal implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. V. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the Agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects 40 CFR Part 158 Environmental protection, Confidential business information, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements 40 CFR Part 161 Environmental protection, Pesticides and pests, Reporting and recordkeeping requirements Dated: October 11, 2007. James B. Gulliford, Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances. PART 158--[AMENDED] • 1. The authority citation for part 158 continues to read as follows: Authority: 7 U.S.C. 136 - 136y. Sec. Sec. 158.50, 158.65, 158.690 and 158.740 [Removed] • 2. Sections 158.50, 158.65, 158.690, and 158.740 are removed. PART 158--[REDESIGNATED AS PART 161 AND AMENDED] • 3. The remainder of part 158, consisting of subparts A, B, C, and D are redesginated as part 161, subparts A, B, C, and D as shown in the Redesignation table below: ------------------------------------------------------------------------ Old part, subpart or section New part, subpart or section ------------------------------------------------------------------------ Part 158--Data Requirements for Part 161--Data Requirements for Registration Registration of Antimircobial Pesticides ------------------------------------------------------------------------ Subpart A Subpart A ------------------------------------------------------------------------ 158.20 161.20 ------------------------------------------------------------------------ 158.25 161.25 ------------------------------------------------------------------------ 158.30 161.30 ------------------------------------------------------------------------ 158.32 161.32 ------------------------------------------------------------------------ 158.33 161.33 ------------------------------------------------------------------------ 158.34 161.34 ------------------------------------------------------------------------ 158.35 161.35 ------------------------------------------------------------------------ 158.40 161.40 ------------------------------------------------------------------------ 158.45 161.45 ------------------------------------------------------------------------ 158.55 161.55 ------------------------------------------------------------------------ 158.60 161.60 ------------------------------------------------------------------------ 158.70 161.70 ------------------------------------------------------------------------ 158.75 161.75 ------------------------------------------------------------------------ 158.80 161.80 ------------------------------------------------------------------------ 158.85 161.85 ------------------------------------------------------------------------ Subpart B Subpart B ------------------------------------------------------------------------ 158.100 161.100 ------------------------------------------------------------------------ 158.101 161.101 ------------------------------------------------------------------------ [[Page 60254]] 158.102 161.102 ------------------------------------------------------------------------ 158.108 161.108 ------------------------------------------------------------------------ Subpart C Subpart C ------------------------------------------------------------------------ 158.150 161.150 ------------------------------------------------------------------------ 158.153 161.153 ------------------------------------------------------------------------ 158.155 161.155 ------------------------------------------------------------------------ 158.160 161.160 ------------------------------------------------------------------------ 158.162 161.162 ------------------------------------------------------------------------ 158.165 161.165 ------------------------------------------------------------------------ 158.167 161.167 ------------------------------------------------------------------------ 158.170 161.170 ------------------------------------------------------------------------ 158.175 161.175 ------------------------------------------------------------------------ 158.180 161.180 ------------------------------------------------------------------------ 158.190 161.190 ------------------------------------------------------------------------ Subpart D Subpart D ------------------------------------------------------------------------ 158.202 161.202 ------------------------------------------------------------------------ 158.240 161.240 ------------------------------------------------------------------------ 158.290 161.290 ------------------------------------------------------------------------ 158.340 161.340 ------------------------------------------------------------------------ 158.390 161.390 ------------------------------------------------------------------------ 158.440 161.440 ------------------------------------------------------------------------ 158.490 161.490 ------------------------------------------------------------------------ 158.540 161.540 ------------------------------------------------------------------------ 158.590 161.590 ------------------------------------------------------------------------ 158.640 161.640 ------------------------------------------------------------------------ Appendix A To Part 158--Data Appendix A To Part 161--Data Requirements For Registration: Use Requirements For Registration: Use Pattern Index Pattern Index ------------------------------------------------------------------------ Sec. 161.25 [Amended] • 4. In newly redesignated Sec. 161.25, references to ``Sec. 158.35,'' ``Sec. 158.40,'' ``Sec. 158.45,'' ``Sec. 158.60,'' ``Sec. 158.100'' and ``Sec. 158.101'' are revised to read ``Sec. 161.35,'' ``Sec. 161.40,'' ``Sec. 161.45,'' ``Sec. 161.60,'' ``Sec. 161.100,'' and ``Sec. 161.101,'' respectively, wherever they occur. Sec. 161.30 [Amended] • 5. In newly redesignated Sec. 161.30, references to ``part 158,'' ``Sec. 158.75,'' and ``Sec. 158.160'' are revised to read ``part 161,'' ``Sec. 161.75,'' and ``Sec. 161.160,'' respectively, wherever they occur. Sec. 161.32 [Amended] • 6. In newly redesignated Sec. 161.32, references to ``Sec. 158.33,'' and ``Sec. 158.34(b)'' are revised to read ``Sec. 161.33,'' and ``Sec. 161.34(b),'' respectively, wherever they occur. Sec. 161.34 [Amended] • 7. In newly redesignated Sec. 161.34, in paragraph (b), the reference to ``Sec. 158.34(c)'' is revised to read ``paragraph (c) of this section'' and in paragraphs (c)(1) and (c)(2) the reference to ``40 CFR 158.34'' is revised to read to read ``40 CFR 161.34,''. Sec. 161.35 [Amended] • 8. In newly redesignated Sec. 161.35, references to ``Sec. 158.20(b),'' ``Sec. 158.40,'' ``Sec. 158.45,'' ``Sec. 158.60,'' ``Sec. 158.75'' and ``Sec. 158.80'' are revised to read ``Sec. 161.20(b),'' ``Sec. 161.40,'' ``Sec. 161.45,'' ``Sec. 161.60,'' ``Sec. 161.75,'' and ``Sec. 161.80,'' respectively. Sec. 161.70 [Amended] • 9. In newly redesignated Sec. 161.70, reference to ``Sec. 158.20(d)'' is revised to read ``Sec. 161.20(d).'' Sec. 161.75 [Amended] • 10. In newly redesignated Sec. 161.75(a), reference to ``part 158'' is revised to read ``part 161''. [[Page 60255]] Sec. 161.100 [Amended] • 11. In newly redesignated Sec. 161.100, reference to``Sec. Sec. 158.150 through 158.740'', is revised to read ``Sec. Sec. 161.150 through 161.640'' and the reference to ``Sec. 158.108'' is revised to read ``Sec. 161.108''. Sec. 161.101 [Amended] • 12. In newly redesignated Sec. 161.101, reference to ``Sec. 158.45'' is revised to read ``Sec. 161.45,'' wherever it occurs. • 13. Newly redesignated Sec. 161.108 is revised to read as follows: Sec. 161.108 Relationship of Pesticide Assessment Guidelines to data requirements. The Pesticide Assessment Guidelines contain the standards for conducting acceptable tests, guidance on evaluation and reporting of data, definition of terms, further guidance on when data are required, and examples of acceptable protocols. They are available through the National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703-605-6000). The following Subdivisions of the Pesticide Assessment Guidelines, referenced to the appropriate sections of this part, are currently available: ---------------------------------------------------------------------------------------------------------------- Corresponding section(s) Subdivision Title NTIS order no. in this part ---------------------------------------------------------------------------------------------------------------- D Product Chemistry PB83-153890 161.150 - 161.190 ---------------------------------------------------------------------------------------------------------------- E Hazard Evaluation: PB83-153908 161.490 Wildlife and Aquatic Organisms ---------------------------------------------------------------------------------------------------------------- F Hazard Evaluation: PB83-153916 161.340 Humans and Domestic Animals ---------------------------------------------------------------------------------------------------------------- G Product Performance PB83-153924 161.640 ---------------------------------------------------------------------------------------------------------------- I Experimental Use PB83-153932 161.20 - 161.640 Permits ---------------------------------------------------------------------------------------------------------------- J Hazard Evaluation: PB83-153940 161.540 Nontarget Plants ---------------------------------------------------------------------------------------------------------------- K Reentry Protection PB85-120962 161.390 ---------------------------------------------------------------------------------------------------------------- L Hazard Evaulation: PB83-153957 161.590 Nontarget Insect ---------------------------------------------------------------------------------------------------------------- N Environmental Fate PB83-153973 161.290 ---------------------------------------------------------------------------------------------------------------- O Residue Chemistry PB83-153961 161.240 ---------------------------------------------------------------------------------------------------------------- R Spray Drift Evaluation PB84-189216 161.440 ---------------------------------------------------------------------------------------------------------------- Sec. 161.150 [Amended] • 14. In newly redesignated Sec. 161.150, references to ``Sec. Sec. 158.175,'' and ``Sec. 158.155,'' are revised to read ``Sec. 161.175'' and ``Sec. 161.155,'' respectively, wherever they occur. Sec. 161.155 [Amended] • 15. In newly redesignated Sec. 161.155, reference to ``Sec. 158.175'' is revised to read ``Sec. 161.175,'' whereever it occurs. Sec. 161.162 [Amended] • 16. In newly redesignated Sec. 161.162, reference to ``Sec. 158.165'' is revised to read ``Sec. 161.165.'' Sec. 161.165 [Amended] • 17. In newly redesignated Sec. 161.165, reference to ``Sec. 158.162'' is revised to read ``Sec. 161.162'', whereever it occurs. Sec. Sec. 161.190, 161.240, 161.290, 161.340, 161.390, 161.440, 161.490, 161.540, 161.590, and 161.640 [Amended] • 18. In newly redesignated Sec. Sec. 161.190, 161.240, 161.290, 161.340, 161.390, 161.440, 161.490, 161.540, 161.590, and 161.640, reference to the phrase ``Sections 158.50 and 158.100 through 158.102'' is revised to read ``Sections 161.100 through 161.102''. Sec. 161.340 [Amended] • 19. Newly redesignated Sec. 161.340 is further amended in paragraph (b)(22)(i) by revising the reference to ``Sec. 158.202'' to read ``Sec. 161.202.'' Appendix A [Amended] • 20. Appendix A to newly redesignated part 161 is amended under the topic ``How to use this Index,'' in paragraph 4, by revising the phrase ``in Sec. Sec. 158.120 through 153.170'' to read ``in Sec. Sec. 161.155 through 161.640''. [FR Doc. E7-20836 Filed 10-23-07; 8:45 am] BILLING CODE 6560-50-S