Pesticides; Microbial Pesticide Definitions and Applicability; Clarification and Availability of Test Guideline, 52610-52614 [2012-21430]

Download as PDF 52610 Federal Register / Vol. 77, No. 169 / Thursday, August 30, 2012 / Rules and Regulations (703) 305–5884; email address: kyprianou.rose@epa.gov. ENVIRONMENTAL PROTECTION AGENCY SUPPLEMENTARY INFORMATION: 40 CFR Part 158 I. Does this action apply to me? [EPA–HQ–OPP–2010–0670; FRL–9338–9] RIN 2070–AJ80 Pesticides; Microbial Pesticide Definitions and Applicability; Clarification and Availability of Test Guideline Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This final rule clarifies the distinction between ‘‘isolates’’ and ‘‘strains,’’ and clarifies the requirements applicable to new isolates, which are considered to be new active ingredients under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Additional revisions to regulatory text include several minor corrections to words and references. Finally, EPA is announcing the availability of a final microbial pesticide test guideline that further explains the existing data requirement to deposit a sample in a nationally recognized culture collection. Collectively, the final rule clarifications and revisions, as well as the final microbial pesticide test guideline, are expected to enhance the ability of industry to efficiently manage its microbial pesticide registration submissions. SUMMARY: This final rule is effective October 29, 2012. ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2010–0670, is available either electronically through https://www.regulations.gov or in hard copy at the OPP Docket in the Environmental Protection Agency Docket Center (EPA/DC), located in EPA West, Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460–0001. 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, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Rose Kyprianou, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 305–5354; fax number: erowe on DSK2VPTVN1PROD with DATES: VerDate Mar<15>2010 16:29 Aug 29, 2012 Jkt 226001 You may be potentially affected by this action if you are a producer or registrant of a microbial pesticide product. This action also may affect any person or company who might petition EPA for a tolerance or an exemption from the requirement of a tolerance for residues of a microbial pesticide, holds a pesticide registration with an existing tolerance or tolerance exemption for a microbial pesticide, or is interested in obtaining or retaining a tolerance or tolerance exemption in the absence of a registration (i.e., a tolerance or tolerance exemption for an imported microbial pesticide). The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. Potentially affected entities may include, but are not limited to: • Pesticide and Other Agricultural Chemical Manufacturing (NAICS code 325320), e.g., pesticide manufacturers or formulators of pesticide products, importers, or any person or company who seeks to register a pesticide or to obtain a tolerance or tolerance exemption for a pesticide. • Crop Production (NAICS code 111). • Animal Production (NAICS code 112). • Food Manufacturing and Processing (NAICS code 311). 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. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. II. Background In the Federal Register of October 26, 2007 (72 FR 60988) (FRL–8109–8), a final rule, entitled ‘‘Pesticides; Data Requirements for Biochemical and Microbial Pesticides,’’ revised the data requirements for biochemical and microbial pesticides—regulations that had originally been promulgated in and had remained largely unchanged since 1984. In doing so, EPA established a distinct subpart for microbial pesticides (i.e., 40 CFR part 158, subpart V) that provided a definition for these particular pesticides and clearly identified the data required to support PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 their registration. Since 2007, however, EPA has consistently encountered questions from industry stakeholders on certain portions of 40 CFR part 158, subpart V, particularly with regard to the language set forth in 40 CFR 158.2100(c)(2). To address these questions, in the Federal Register of April 15, 2011 (76 FR 21294) (FRL–8857–7), EPA proposed specific revisions to the regulatory text in 40 CFR 158.2100(c)(2) for purposes of enhanced clarity. In addition, EPA also recognized that an existing data requirement under 40 CFR 158.2120(c) and 40 CFR 158.2171(c), deposition of a sample in a nationally recognized culture collection, did not have an accompanying test guideline and that there were several minor errors in the regulatory text of 40 CFR part 158, subpart V. Therefore, with the proposed rule, EPA also made available for public comment a draft test guideline, entitled ‘‘Deposition of a Sample in a Nationally Recognized Culture Collection’’ and identified as OCSPP Test Guideline 885.1250, addressing the deposition of a sample in a nationally recognized culture collection data requirement, and proposed to make other minor corrections to the regulations. The public comment period for the proposed rule closed on July 14, 2011, and EPA received no comments on the proposed rule or the draft test guideline. III. Final Changes A. What action is EPA taking? EPA is finalizing most of the changes and corrections proposed. Although no comments were received, EPA has revised a few of the originally proposed changes and corrections to further clarify the regulatory text being modified. These changes are not substantive in nature. The specific changes being promulgated with this action and the anticipated benefits of such changes are described in this final rule and the rationale supporting the revisions can be found in the proposed rule (see Unit IV. of the April 15, 2011 proposed rule). Specifically, EPA is making several changes and corrections to the Microbial Pesticides data requirements (40 CFR part 158, subpart V). First, EPA is revising 40 CFR 158.2100(c)(2) to reduce confusion over the distinction between ‘‘isolates’’ and ‘‘strains’’ and exactly how EPA views both of these terms. To this end, EPA substitutes ‘‘active ingredient’’ for ‘‘strain.’’ The E:\FR\FM\30AUR1.SGM 30AUR1 erowe on DSK2VPTVN1PROD with Federal Register / Vol. 77, No. 169 / Thursday, August 30, 2012 / Rules and Regulations clarification to 40 CFR 158.2100(c)(2) also includes a requirement for the use of a unique identifier, as part of the microbial pesticide active ingredient taxonomic name, to allow for improved identification of company-specific registered isolates. The clarification also mentions the possibility for data citation, in lieu of data generation, should sufficient similarity be established between isolates. Moreover, after further consideration, EPA has decided against including the proposed explanatory text (i.e., ‘‘Because of the potential for variation in microorganisms’’) at the beginning of the first sentence in 40 CFR 158.2100(c)(2). This phrase is not necessary or appropriate as regulatory text because it does not add anything to the regulatory provision. Second, in conjunction with the changes detailed for 40 CFR 158.2100(c)(2), EPA is announcing the availability of a final microbial pesticide test guideline under Series 885, entitled ‘‘Deposition of a Sample in a Nationally Recognized Culture Collection’’ and identified as OCSPP Test Guideline 885.1250. This OCSPP test guideline is intended to explain the existing data requirement to deposit a sample in a nationally recognized culture collection found in the tables in 40 CFR 158.2120(c) and 40 CFR 158.2171(c). Additionally, to clarify this microbial deposition data requirement, EPA is adding a test note to 40 CFR 158.2120(d) and 40 CFR 158.2171(d), emphasizing the need for the continuing maintenance of a culture deposit to ensure that it remains available for the duration of an associated registration or experimental use permit in case EPA requests a sample. This requirement already applies to all isolates; thus, the reference to ‘‘new isolates’’ in the proposed rulemaking was an oversight and is just ‘‘isolates’’ in this final rule. Finally, to correct several minor errors, EPA is replacing ‘‘part’’ with ‘‘subpart’’ in 40 CFR 158.2100(c)(1) and removing references to a non-existing paragraph (e) that appears in 40 CFR 158.2120 and 40 CFR 158.2171. The improved clarity and transparency resulting from the insertion of this information in 40 CFR part 158, subpart V, are expected to enhance the ability of industry to efficiently manage its microbial pesticide registration submissions. Applicants may save time and money from an improved understanding of the standards and interpretations of the definitions for the data that are needed. Having all required studies and information available to EPA at the time of application may also reduce potential VerDate Mar<15>2010 14:47 Aug 29, 2012 Jkt 226001 delays in the registration process, thereby enabling registration of microbial pesticides sooner and allowing microbial pesticide products to enter the market sooner. B. What is EPA’s authority for taking this action? This final rule is issued under the authority of FIFRA sections 3, 5, 10, 12, and 25 (7 U.S.C. 136 et seq.), and section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a). C. Electronic Access to the OCSPP Test Guidelines To access the OSCPP test guidelines referenced in this final rule electronically, please go to https:// www.epa.gov/ocspp and select ‘‘Test Methods and Guidelines.’’ You may also access the test guidelines in https:// www.regulations.gov grouped by Series under Docket ID numbers: EPA–HQ– OPPT–2009–0150 through EPA–HQ– OPPT–2009–0159 and EPA–HQ–OPPT– 2009–0576. IV. FIFRA Review Requirements Pursuant to FIFRA sections 25(a) and (d), EPA has submitted a draft of this final rule to the Committee on Agriculture in the House of Representatives; the Committee on Agriculture, Nutrition, and Forestry in the United States Senate; the United States Department of Agriculture (USDA); and the FIFRA Scientific Advisory Panel (SAP). FIFRA SAP and USDA waived review of this final rule. V. Statutory and Executive Order Reviews This action only clarifies existing regulatory text to allow EPA and stakeholders a clearer understanding of 40 CFR part 158, subpart V. It does not otherwise impose any other requirements, involve any significant policy or legal issues, or increase existing costs. As such, EPA is not required to make special considerations or evaluations under the following statutory and Executive Order review requirements. A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review This is not a ‘‘significant regulatory action’’ under Executive Order 12866 (58 FR 51735, October 4, 1993) and was therefore not reviewed by the Office of Management and Budget (OMB) under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 52611 B. Paperwork Reduction Act (PRA) This action does not impose or change any information collection burden that requires additional review by OMB under the provisions of PRA (44 U.S.C. 3501 et seq.). Burden is defined at 5 CFR 1320.3(b). An agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA’s regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument, or form, if applicable. The revisions in this final rule involve existing information collection activities that are already approved by OMB under PRA. Specifically, the submission of data to EPA in order to establish a tolerance or an exemption from the requirement of a tolerance are currently approved under OMB Control No. 2070– 0024 (EPA ICR No. 0597); the activities associated with the application for a new or amended registration of a pesticide are currently approved under OMB Control No. 2070–0060 (EPA ICR No. 0277); the activities associated with the application for an experimental use permit are currently approved under OMB Control No. 2070–0040 (EPA ICR No. 0276); and the activities associated with the generation of data for regulatory review programs are currently approved under OMB Control No. 2070–0174 (EPA ICR No. 2288). C. Regulatory Flexibility Act (RFA) Pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), EPA hereby certifies that this final rule does not have a significant adverse economic impact on a substantial number of small entities. Under RFA, small entities include small businesses, small organizations, and small governmental jurisdictions. In making this determination, the impact of concern is any significant adverse economic impact on small entities because the primary purpose of regulatory flexibility analysis is to identify and address regulatory alternatives ‘‘which minimize any significant economic impact of the rule on small entities.’’ 5 U.S.C. 603 and 604. Thus, an agency may certify under RFA when the rule relieves regulatory burden, or otherwise has no expected economic impact on small entities subject to the rule. This action only clarifies existing regulatory text to allow EPA and stakeholders a clearer understanding of E:\FR\FM\30AUR1.SGM 30AUR1 52612 Federal Register / Vol. 77, No. 169 / Thursday, August 30, 2012 / Rules and Regulations 40 CFR part 158, subpart V. It does not otherwise amend or impose any other requirements. As such, this final rule will not have any adverse economic impact on any entities, large or small. D. Unfunded Mandates Reform Act (UMRA) State, local, and Tribal governments are rarely pesticide applicants or registrants, so this final rule is not expected to affect these governments and is not expected to adversely affect the private sector. Accordingly, pursuant to Title II of UMRA (2 U.S.C. 1531–1538), EPA has determined that this action is not subject to the requirements in UMRA sections 202 and 205 because it does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and Tribal governments, in the aggregate, or for the private sector in any 1 year. In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in UMRA sections 203 and 204. E. Executive Order 13132: Federalism This action will not have federalism implications because it is not expected to 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 (64 FR 43255, August 10, 1999). Thus, Executive Order 13132 does not apply to this action. erowe on DSK2VPTVN1PROD with F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments EPA is not aware of any Tribal governments that are pesticide registrants. This action will not, therefore, have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes, will not significantly or uniquely affect the communities of Indian Tribal governments, and does not involve or impose any requirements that affect Indian Tribes, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). Accordingly, the requirements of Executive Order 13175 do not apply to this action. G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety VerDate Mar<15>2010 14:47 Aug 29, 2012 Jkt 226001 risks, such that the analysis required under section 5–501 of the Executive Order has the potential to influence the regulation. This action is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks, nor is it an ‘‘economically significant regulatory action’’ as defined by Executive Order 12866. Dated: August 24, 2012. James Jones, Acting Assistant Administrator, Office of Chemical Safety and Pollution Prevention. H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use Authority: 7 U.S.C. 136–136y; 21 U.S.C. 346a. This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866, nor will it affect energy supply, distribution, or use. I. National Technology Transfer and Advancement Act (NTTAA) This action does not involve technical standards that would require the consideration of voluntary consensus standards pursuant to NTTAA section 12(d) (15 U.S.C. 272 note). J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations This action does not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. Therefore, this action does not involve special consideration of environmental justice-related issues as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). VI. Congressional Review Act (CRA) Pursuant to CRA (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 158 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 Therefore, 40 CFR chapter I is amended as follows: PART 158—[AMENDED] 1. The authority citation for part 158 continues to read as follows: ■ 2. In § 158.2100, revise paragraphs (c)(1) and (2) to read as follows: ■ § 158.2100 Microbial pesticides definition and applicability. * * * * * (c) * * * (1) This subpart applies to microbial pesticides as specified in paragraphs (c)(2), (c)(3), and (c)(4) of this section. (2) Each new isolate of a microbial pesticide is a new active ingredient and must be registered independently of any similarly designated and already registered microbial pesticide active ingredient. Each new isolate for which registration is sought must have a unique identifier following the taxonomic name of the microorganism, and the registration application must be supported by data required in this subpart. This does not preclude the possibility of using data from another isolate, provided sufficient similarity is established, to support registration. * * * * * ■ 3. In § 158.2120: ■ a. Revise paragraphs (a), (b), and (c). ■ b. Redesignate in paragraph (d), test notes 1 through 4 as test notes 2 through 5 and add new test note 1. The amendments read as follows: § 158.2120 Microbial pesticides product analysis data requirements table. (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the product analysis data requirements and the substance to be tested for a particular microbial pesticide. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are identified in paragraph (d) of this section. (b) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above. (c) Table. The table in this paragraph shows the data requirements for microbial pesticides product analysis. E:\FR\FM\30AUR1.SGM 30AUR1 Federal Register / Vol. 77, No. 169 / Thursday, August 30, 2012 / Rules and Regulations 52613 The test notes are shown in paragraph (d) of this section. TABLE—MICROBIAL PESTICIDES PRODUCT ANALYSIS DATA REQUIREMENTS Test guideline No. Test substance All use patterns MP EP Test notes R R R MP .................................. TGAI and MP ................. TGAI ............................... EP .................................. TGAI and EP ................. TGAI ............................... ............ ............ 1 R TGAI and MP ................. TGAI and EP ................. ............ TGAI and EP ................. EP .................................. 2 ............ TGAI TGAI TGAI TGAI ............................... ............................... ............................... ............................... ............ ............ ............ ............ TGAI and EP ................. EP .................................. EP .................................. TGAI ............................... EP .................................. TGAI ............................... ............ 3 4 ............ 5 ............ Data requirement Product Chemistry and Composition 885.1100 ...... 885.1200 ...... 885.1250 ...... 885.1300 ...... Product identity ...................................................... Manufacturing process ........................................... Deposition of a sample in a nationally recognized culture collection. Discussion of formation of unintentional ingredients. Analysis and Certified Limits 885.1400 ...... 885.1500 ...... Analysis of samples ............................................... Certification of limits ............................................... R R TGAI and MP ................. MP .................................. Physical and Chemical Characteristics 830.6302 830.6303 830.6304 830.6313 ...... ...... ...... ...... 830.6317 830.6319 830.6320 830.7000 830.7100 830.7300 ...... ...... ...... ...... ...... ...... Color ....................................................................... Physical state ......................................................... Odor ....................................................................... Stability to normal and elevated temperatures, metals, and metal ions. Storage stability ...................................................... Miscibility ................................................................ Corrosion characteristics ........................................ pH ........................................................................... Viscosity ................................................................. Density/relative density/bulk density (specific gravity). (d) * * * 1. Required for each isolate of a microbial pesticide. Isolates must be deposited with an agreement to ensure that the sample will be maintained and will not be discarded for the duration of the associated registration(s). * * * * * ■ 4. In § 158.2171: ■ a. Revise paragraphs (a), (b), and (c). ■ b. Redesignate in paragraph (d), test notes 3 through 6 as test notes 4 through 7 and add new test note 3. The amendments read as follows: R R R R TGAI TGAI TGAI TGAI ............................... ............................... ............................... ............................... R R R R R R TGAI and MP ................. MP .................................. MP .................................. TGAI ............................... MP .................................. TGAI ............................... § 158.2171 Experimental use permit microbial pesticides product analysis data requirements table. (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the product analysis data requirements and the substance to be tested for a particular microbial pesticide. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are identified in paragraph (d) of this section. (b) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above. (c) Table. The table in this paragraph shows the data requirements for experimental use permit microbial pesticides product analysis. The test notes are shown in paragraph (d) of this section. TABLE—EUP MICROBIAL PESTICIDES PRODUCT ANALYSIS DATA REQUIREMENTS Test guideline No. Test substance All use patterns MP EP Test notes R R R MP .................................. TGAI and MP ................. TGAI ............................... EP .................................. TGAI and EP ................. TGAI ............................... ............ 1, 2 3 R TGAI and MP ................. TGAI and EP ................. 2 TGAI and EP ................. EP .................................. 2, 4 ............ Data requirement Product Chemistry and Composition 885.1100 ...... 885.1200 ...... 885.1250 ...... erowe on DSK2VPTVN1PROD with 885.1300 ...... Product identity ...................................................... Manufacturing process ........................................... Deposition of a sample in a nationally recognized culture collection. Discussion of formation of unintentional ingredients. Analysis and Certified Limits 885.1400 ...... 885.1500 ...... VerDate Mar<15>2010 Analysis of samples ............................................... Certification of limits ............................................... 14:47 Aug 29, 2012 Jkt 226001 PO 00000 Frm 00027 R R Fmt 4700 TGAI and MP ................. MP .................................. Sfmt 4700 E:\FR\FM\30AUR1.SGM 30AUR1 52614 Federal Register / Vol. 77, No. 169 / Thursday, August 30, 2012 / Rules and Regulations TABLE—EUP MICROBIAL PESTICIDES PRODUCT ANALYSIS DATA REQUIREMENTS—Continued Test guideline No. Test substance All use patterns Data requirement MP EP Test notes Physical and Chemical Characteristics 830.6302 830.6303 830.6304 830.6313 ...... ...... ...... ...... 830.6317 830.6319 830.6320 830.7000 830.7100 830.7300 Color ....................................................................... Physical state ......................................................... Odor ....................................................................... Stability to normal and elevated temperatures, metals, and metal ions. Storage stability ...................................................... Miscibility ................................................................ Corrosion characteristics ........................................ pH ........................................................................... Viscosity ................................................................. Density/relative density/bulk density (specific gravity). ...... ...... ...... ...... ...... ...... (d) * * * 3. Required for each isolate of a microbial pesticide. Isolates must be deposited with an agreement to ensure that the sample will be maintained and will not be discarded for the duration of the associated experimental use permit(s). * * * * * [FR Doc. 2012–21430 Filed 8–29–12; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Part 152 [CMS–9995–IFC2] RIN 0938–AQ70 Pre-Existing Condition Insurance Plan Program Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). ACTION: Amendment to interim final rule with request for comments. AGENCY: This document contains an amendment regarding program eligibility to the interim final regulation implementing the Pre-Existing Condition Plan program under provisions of the Patient Protection and Affordable Care Act. In light of a new process recently announced by the Department of Homeland Security, eligibility for the program is being amended so that the program does not inadvertently expand the scope of that process. DATES: Effective date. These interim final regulations are effective on August 30, 2012. Comment date. Comments are due on or before October 29, 2012. erowe on DSK2VPTVN1PROD with SUMMARY: VerDate Mar<15>2010 14:47 Aug 29, 2012 Jkt 226001 R R R R TGAI TGAI TGAI TGAI ............................... ............................... ............................... ............................... R R R R R R TGAI and MP ................. MP .................................. MP .................................. TGAI ............................... MP .................................. TGAI ............................... Applicability date. This amendment to the interim final regulation generally applies to individuals on August 30, 2012. ADDRESSES: Written comments may be submitted to any of the addresses specified below. Please do not submit duplicates. All comments will be made available to the public. Warning: Do not include any personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publicly disclosed. All comments are posted on the Internet exactly as received, and can be retrieved by most Internet search engines. No deletions, modifications, or redactions will be made to the comments received, as they are public records. Comments may be submitted anonymously. In commenting, please refer to file code CMS–9995–IFC2. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation to https://www.regulations.gov. Follow the ‘‘Submit a comment’’ instructions. 2. By regular mail. You may mail written comments to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–9995–IFC2, P.O. Box 8016, Baltimore, MD 21244–8016. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 TGAI TGAI TGAI TGAI ............................... ............................... ............................... ............................... ............ ............ ............ ............ TGAI and EP ................. EP .................................. EP .................................. TGAI ............................... EP .................................. TGAI ............................... ............ 5 6 ............ 7 ............ Services, Attention: CMS–9995–IFC2, Mail Stop C4–26–05, 7500 Security Boulevard, Baltimore, MD 21244–1850. Please allow sufficient time for mailed comments to be received before the close of the comment period. 4. By hand or courier. Alternatively, you may deliver (by hand or courier) your written comments only to the following addresses prior to the close of the comment period: a. For delivery in Washington, DC— Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445–G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201. (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) b. For delivery in Baltimore, MD— Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244–1850. If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786–4492 in advance to schedule your arrival with one of our staff members. Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web E:\FR\FM\30AUR1.SGM 30AUR1

Agencies

ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 77, Number 169 (Thursday, August 30, 2012)]
[Rules and Regulations]
[Pages 52610-52614]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-21430]

[[Page 52610]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 158

[EPA-HQ-OPP-2010-0670; FRL-9338-9]
RIN 2070-AJ80

Pesticides; Microbial Pesticide Definitions and Applicability;
Clarification and Availability of Test Guideline

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This final rule clarifies the distinction between ``isolates''
and ``strains,'' and clarifies the requirements applicable to new
isolates, which are considered to be new active ingredients under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Additional
revisions to regulatory text include several minor corrections to words
and references. Finally, EPA is announcing the availability of a final
microbial pesticide test guideline that further explains the existing
data requirement to deposit a sample in a nationally recognized culture
collection. Collectively, the final rule clarifications and revisions,
as well as the final microbial pesticide test guideline, are expected
to enhance the ability of industry to efficiently manage its microbial
pesticide registration submissions.

DATES: This final rule is effective October 29, 2012.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2010-0670, is available either
electronically through https://www.regulations.gov or in hard copy at
the OPP Docket in the Environmental Protection Agency Docket Center
(EPA/DC), located in EPA West, Rm. 3334, 1301 Constitution Ave. NW.,
Washington, DC 20460-0001. 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, and the
telephone number for the OPP Docket is (703) 305-5805. Please review
the visitor instructions and additional information about the docket
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Rose Kyprianou, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 305-5354; fax number: (703) 305-5884;
email address: kyprianou.rose@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

You may be potentially affected by this action if you are a
producer or registrant of a microbial pesticide product. This action
also may affect any person or company who might petition EPA for a
tolerance or an exemption from the requirement of a tolerance for
residues of a microbial pesticide, holds a pesticide registration with
an existing tolerance or tolerance exemption for a microbial pesticide,
or is interested in obtaining or retaining a tolerance or tolerance
exemption in the absence of a registration (i.e., a tolerance or
tolerance exemption for an imported microbial pesticide). The North
American Industrial Classification System (NAICS) codes have been
provided to assist you and others in determining whether this action
might apply to certain entities. Potentially affected entities may
include, but are not limited to:
Pesticide and Other Agricultural Chemical Manufacturing
(NAICS code 325320), e.g., pesticide manufacturers or formulators of
pesticide products, importers, or any person or company who seeks to
register a pesticide or to obtain a tolerance or tolerance exemption
for a pesticide.
Crop Production (NAICS code 111).
Animal Production (NAICS code 112).
Food Manufacturing and Processing (NAICS code 311).
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. If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.

II. Background

In the Federal Register of October 26, 2007 (72 FR 60988) (FRL-
8109-8), a final rule, entitled ``Pesticides; Data Requirements for
Biochemical and Microbial Pesticides,'' revised the data requirements
for biochemical and microbial pesticides--regulations that had
originally been promulgated in and had remained largely unchanged since
1984. In doing so, EPA established a distinct subpart for microbial
pesticides (i.e., 40 CFR part 158, subpart V) that provided a
definition for these particular pesticides and clearly identified the
data required to support their registration. Since 2007, however, EPA
has consistently encountered questions from industry stakeholders on
certain portions of 40 CFR part 158, subpart V, particularly with
regard to the language set forth in 40 CFR 158.2100(c)(2).
To address these questions, in the Federal Register of April 15,
2011 (76 FR 21294) (FRL-8857-7), EPA proposed specific revisions to the
regulatory text in 40 CFR 158.2100(c)(2) for purposes of enhanced
clarity. In addition, EPA also recognized that an existing data
requirement under 40 CFR 158.2120(c) and 40 CFR 158.2171(c), deposition
of a sample in a nationally recognized culture collection, did not have
an accompanying test guideline and that there were several minor errors
in the regulatory text of 40 CFR part 158, subpart V. Therefore, with
the proposed rule, EPA also made available for public comment a draft
test guideline, entitled ``Deposition of a Sample in a Nationally
Recognized Culture Collection'' and identified as OCSPP Test Guideline
885.1250, addressing the deposition of a sample in a nationally
recognized culture collection data requirement, and proposed to make
other minor corrections to the regulations. The public comment period
for the proposed rule closed on July 14, 2011, and EPA received no
comments on the proposed rule or the draft test guideline.

III. Final Changes

A. What action is EPA taking?

EPA is finalizing most of the changes and corrections proposed.
Although no comments were received, EPA has revised a few of the
originally proposed changes and corrections to further clarify the
regulatory text being modified. These changes are not substantive in
nature. The specific changes being promulgated with this action and the
anticipated benefits of such changes are described in this final rule
and the rationale supporting the revisions can be found in the proposed
rule (see Unit IV. of the April 15, 2011 proposed rule).
Specifically, EPA is making several changes and corrections to the
Microbial Pesticides data requirements (40 CFR part 158, subpart V).
First, EPA is revising 40 CFR 158.2100(c)(2) to reduce confusion over
the distinction between ``isolates'' and ``strains'' and exactly how
EPA views both of these terms. To this end, EPA substitutes ``active
ingredient'' for ``strain.'' The

[[Page 52611]]

clarification to 40 CFR 158.2100(c)(2) also includes a requirement for
the use of a unique identifier, as part of the microbial pesticide
active ingredient taxonomic name, to allow for improved identification
of company-specific registered isolates. The clarification also
mentions the possibility for data citation, in lieu of data generation,
should sufficient similarity be established between isolates. Moreover,
after further consideration, EPA has decided against including the
proposed explanatory text (i.e., ``Because of the potential for
variation in microorganisms'') at the beginning of the first sentence
in 40 CFR 158.2100(c)(2). This phrase is not necessary or appropriate
as regulatory text because it does not add anything to the regulatory
provision.
Second, in conjunction with the changes detailed for 40 CFR
158.2100(c)(2), EPA is announcing the availability of a final microbial
pesticide test guideline under Series 885, entitled ``Deposition of a
Sample in a Nationally Recognized Culture Collection'' and identified
as OCSPP Test Guideline 885.1250. This OCSPP test guideline is intended
to explain the existing data requirement to deposit a sample in a
nationally recognized culture collection found in the tables in 40 CFR
158.2120(c) and 40 CFR 158.2171(c). Additionally, to clarify this
microbial deposition data requirement, EPA is adding a test note to 40
CFR 158.2120(d) and 40 CFR 158.2171(d), emphasizing the need for the
continuing maintenance of a culture deposit to ensure that it remains
available for the duration of an associated registration or
experimental use permit in case EPA requests a sample. This requirement
already applies to all isolates; thus, the reference to ``new
isolates'' in the proposed rulemaking was an oversight and is just
``isolates'' in this final rule.
Finally, to correct several minor errors, EPA is replacing ``part''
with ``subpart'' in 40 CFR 158.2100(c)(1) and removing references to a
non-existing paragraph (e) that appears in 40 CFR 158.2120 and 40 CFR
158.2171.
The improved clarity and transparency resulting from the insertion
of this information in 40 CFR part 158, subpart V, are expected to
enhance the ability of industry to efficiently manage its microbial
pesticide registration submissions. Applicants may save time and money
from an improved understanding of the standards and interpretations of
the definitions for the data that are needed. Having all required
studies and information available to EPA at the time of application may
also reduce potential delays in the registration process, thereby
enabling registration of microbial pesticides sooner and allowing
microbial pesticide products to enter the market sooner.

B. What is EPA's authority for taking this action?

This final rule is issued under the authority of FIFRA sections 3,
5, 10, 12, and 25 (7 U.S.C. 136 et seq.), and section 408 of the
Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a).

C. Electronic Access to the OCSPP Test Guidelines

To access the OSCPP test guidelines referenced in this final rule
electronically, please go to https://www.epa.gov/ocspp and select ``Test
Methods and Guidelines.'' You may also access the test guidelines in
https://www.regulations.gov grouped by Series under Docket ID numbers:
EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159 and EPA-HQ-OPPT-
2009-0576.

IV. FIFRA Review Requirements

Pursuant to FIFRA sections 25(a) and (d), EPA has submitted a draft
of this final rule to the Committee on Agriculture in the House of
Representatives; the Committee on Agriculture, Nutrition, and Forestry
in the United States Senate; the United States Department of
Agriculture (USDA); and the FIFRA Scientific Advisory Panel (SAP).
FIFRA SAP and USDA waived review of this final rule.

V. Statutory and Executive Order Reviews

This action only clarifies existing regulatory text to allow EPA
and stakeholders a clearer understanding of 40 CFR part 158, subpart V.
It does not otherwise impose any other requirements, involve any
significant policy or legal issues, or increase existing costs. As
such, EPA is not required to make special considerations or evaluations
under the following statutory and Executive Order review requirements.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

This is not a ``significant regulatory action'' under Executive
Order 12866 (58 FR 51735, October 4, 1993) and was therefore not
reviewed by the Office of Management and Budget (OMB) under Executive
Orders 12866 and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

This action does not impose or change any information collection
burden that requires additional review by OMB under the provisions of
PRA (44 U.S.C. 3501 et seq.). Burden is defined at 5 CFR 1320.3(b). An
agency may not conduct or sponsor, and a person is not required to
respond to a collection of information that requires OMB approval under
PRA, unless it has been approved by OMB and displays a currently valid
OMB control number. The OMB control numbers for EPA's regulations in
title 40 of the CFR, after appearing in the Federal Register, are
listed in 40 CFR part 9, and included on the related collection
instrument, or form, if applicable.
The revisions in this final rule involve existing information
collection activities that are already approved by OMB under PRA.
Specifically, the submission of data to EPA in order to establish a
tolerance or an exemption from the requirement of a tolerance are
currently approved under OMB Control No. 2070-0024 (EPA ICR No. 0597);
the activities associated with the application for a new or amended
registration of a pesticide are currently approved under OMB Control
No. 2070-0060 (EPA ICR No. 0277); the activities associated with the
application for an experimental use permit are currently approved under
OMB Control No. 2070-0040 (EPA ICR No. 0276); and the activities
associated with the generation of data for regulatory review programs
are currently approved under OMB Control No. 2070-0174 (EPA ICR No.
2288).

C. Regulatory Flexibility Act (RFA)

Pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), EPA hereby
certifies that this final rule does not have a significant adverse
economic impact on a substantial number of small entities. Under RFA,
small entities include small businesses, small organizations, and small
governmental jurisdictions. In making this determination, the impact of
concern is any significant adverse economic impact on small entities
because the primary purpose of regulatory flexibility analysis is to
identify and address regulatory alternatives ``which minimize any
significant economic impact of the rule on small entities.'' 5 U.S.C.
603 and 604. Thus, an agency may certify under RFA when the rule
relieves regulatory burden, or otherwise has no expected economic
impact on small entities subject to the rule.
This action only clarifies existing regulatory text to allow EPA
and stakeholders a clearer understanding of

[[Page 52612]]

40 CFR part 158, subpart V. It does not otherwise amend or impose any
other requirements. As such, this final rule will not have any adverse
economic impact on any entities, large or small.

D. Unfunded Mandates Reform Act (UMRA)

State, local, and Tribal governments are rarely pesticide
applicants or registrants, so this final rule is not expected to affect
these governments and is not expected to adversely affect the private
sector. Accordingly, pursuant to Title II of UMRA (2 U.S.C. 1531-1538),
EPA has determined that this action is not subject to the requirements
in UMRA sections 202 and 205 because it does not contain a Federal
mandate that may result in expenditures of $100 million or more for
State, local, and Tribal governments, in the aggregate, or for the
private sector in any 1 year. In addition, this action does not
significantly or uniquely affect small governments or impose a
significant intergovernmental mandate, as described in UMRA sections
203 and 204.

E. Executive Order 13132: Federalism

This action will not have federalism implications because it is not
expected to 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 (64 FR 43255, August
10, 1999). Thus, Executive Order 13132 does not apply to this action.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

EPA is not aware of any Tribal governments that are pesticide
registrants. This action will not, therefore, have Tribal implications
because it is not expected to have substantial direct effects on Indian
Tribes, will not significantly or uniquely affect the communities of
Indian Tribal governments, and does not involve or impose any
requirements that affect Indian Tribes, as specified in Executive Order
13175 (65 FR 67249, November 9, 2000). Accordingly, the requirements of
Executive Order 13175 do not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
action is not subject to Executive Order 13045 because it does not
establish an environmental standard intended to mitigate health or
safety risks, nor is it an ``economically significant regulatory
action'' as defined by Executive Order 12866.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001) because it is not a significant regulatory action under
Executive Order 12866, nor will it affect energy supply, distribution,
or use.

I. National Technology Transfer and Advancement Act (NTTAA)

This action does not involve technical standards that would require
the consideration of voluntary consensus standards pursuant to NTTAA
section 12(d) (15 U.S.C. 272 note).

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

This action does not have disproportionately high and adverse human
health or environmental effects on minority or low-income populations
because it does not affect the level of protection provided to human
health or the environment. Therefore, this action does not involve
special consideration of environmental justice-related issues as
specified in Executive Order 12898 (59 FR 7629, February 16, 1994).

VI. Congressional Review Act (CRA)

Pursuant to CRA (5 U.S.C. 801 et seq.), EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of the rule in the Federal Register.
This action is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 158

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: August 24, 2012.
James Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.

Therefore, 40 CFR chapter I is amended as follows:

PART 158--[AMENDED]

0
1. The authority citation for part 158 continues to read as follows:

Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a.

0
2. In Sec. 158.2100, revise paragraphs (c)(1) and (2) to read as
follows:

Sec. 158.2100 Microbial pesticides definition and applicability.

* * * * *
(c) * * *
(1) This subpart applies to microbial pesticides as specified in
paragraphs (c)(2), (c)(3), and (c)(4) of this section.
(2) Each new isolate of a microbial pesticide is a new active
ingredient and must be registered independently of any similarly
designated and already registered microbial pesticide active
ingredient. Each new isolate for which registration is sought must have
a unique identifier following the taxonomic name of the microorganism,
and the registration application must be supported by data required in
this subpart. This does not preclude the possibility of using data from
another isolate, provided sufficient similarity is established, to
support registration.
* * * * *

0
3. In Sec. 158.2120:
0
a. Revise paragraphs (a), (b), and (c).
0
b. Redesignate in paragraph (d), test notes 1 through 4 as test notes 2
through 5 and add new test note 1.
The amendments read as follows:

Sec. 158.2120 Microbial pesticides product analysis data requirements
table.

(a) General. Sections 158.100 through 158.130 describe how to use
this table to determine the product analysis data requirements and the
substance to be tested for a particular microbial pesticide. Notes that
apply to an individual test and include specific conditions,
qualifications, or exceptions to the designated test are identified in
paragraph (d) of this section.
(b) Key. R = Required; CR = Conditionally required; NR = Not
required; MP = Manufacturing-use product; EP = End-use product; TEP =
Typical end-use product; TGAI = Technical grade of the active
ingredient; All = All of the above.
(c) Table. The table in this paragraph shows the data requirements
for microbial pesticides product analysis.

[[Page 52613]]

The test notes are shown in paragraph (d) of this section.

Table--Microbial Pesticides Product Analysis Data Requirements
----------------------------------------------------------------------------------------------------------------
Test substance
Test guideline No. Data requirement All use ---------------------------------------- Test
patterns MP EP notes
----------------------------------------------------------------------------------------------------------------
Product Chemistry and Composition
----------------------------------------------------------------------------------------------------------------
885.1100............ Product identity....... R MP................ EP................ .......
885.1200............ Manufacturing process.. R TGAI and MP....... TGAI and EP....... .......
885.1250............ Deposition of a sample R TGAI.............. TGAI.............. 1
in a nationally
recognized culture
collection.
885.1300............ Discussion of formation R TGAI and MP....... TGAI and EP....... .......
of unintentional
ingredients.
----------------------------------------------------------------------------------------------------------------
Analysis and Certified Limits
----------------------------------------------------------------------------------------------------------------
885.1400............ Analysis of samples.... R TGAI and MP....... TGAI and EP....... 2
885.1500............ Certification of limits R MP................ EP................ .......
----------------------------------------------------------------------------------------------------------------
Physical and Chemical Characteristics
----------------------------------------------------------------------------------------------------------------
830.6302............ Color.................. R TGAI.............. TGAI.............. .......
830.6303............ Physical state......... R TGAI.............. TGAI.............. .......
830.6304............ Odor................... R TGAI.............. TGAI.............. .......
830.6313............ Stability to normal and R TGAI.............. TGAI.............. .......
elevated temperatures,
metals, and metal ions.
830.6317............ Storage stability...... R TGAI and MP....... TGAI and EP....... .......
830.6319............ Miscibility............ R MP................ EP................ 3
830.6320............ Corrosion R MP................ EP................ 4
characteristics.
830.7000............ pH..................... R TGAI.............. TGAI.............. .......
830.7100............ Viscosity.............. R MP................ EP................ 5
830.7300............ Density/relative R TGAI.............. TGAI.............. .......
density/bulk density
(specific gravity).
----------------------------------------------------------------------------------------------------------------

(d) * * *
1. Required for each isolate of a microbial pesticide. Isolates
must be deposited with an agreement to ensure that the sample will be
maintained and will not be discarded for the duration of the associated
registration(s).
* * * * *

0
4. In Sec. 158.2171:
0
a. Revise paragraphs (a), (b), and (c).
0
b. Redesignate in paragraph (d), test notes 3 through 6 as test notes 4
through 7 and add new test note 3.
The amendments read as follows:

Sec. 158.2171 Experimental use permit microbial pesticides product
analysis data requirements table.

Table--EUP Microbial Pesticides Product Analysis Data Requirements
----------------------------------------------------------------------------------------------------------------
Test substance
Test guideline No. Data requirement All use patterns ---------------------------------------- Test
MP EP notes
----------------------------------------------------------------------------------------------------------------
Product Chemistry and Composition
----------------------------------------------------------------------------------------------------------------
885.1100............ Product identity....... R MP................ EP................ .......
885.1200............ Manufacturing process.. R TGAI and MP....... TGAI and EP....... 1, 2
885.1250............ Deposition of a sample R TGAI.............. TGAI.............. 3
in a nationally
recognized culture
collection.
885.1300............ Discussion of formation R TGAI and MP....... TGAI and EP....... 2
of unintentional
ingredients.
----------------------------------------------------------------------------------------------------------------
Analysis and Certified Limits
----------------------------------------------------------------------------------------------------------------
885.1400............ Analysis of samples.... R TGAI and MP....... TGAI and EP....... 2, 4
885.1500............ Certification of limits R MP................ EP................ .......
----------------------------------------------------------------------------------------------------------------

[[Page 52614]]

Physical and Chemical Characteristics
----------------------------------------------------------------------------------------------------------------
830.6302............ Color.................. R TGAI.............. TGAI.............. .......
830.6303............ Physical state......... R TGAI.............. TGAI.............. .......
830.6304............ Odor................... R TGAI.............. TGAI.............. .......
830.6313............ Stability to normal and R TGAI.............. TGAI.............. .......
elevated temperatures,
metals, and metal ions.
830.6317............ Storage stability...... R TGAI and MP....... TGAI and EP....... .......
830.6319............ Miscibility............ R MP................ EP................ 5
830.6320............ Corrosion R MP................ EP................ 6
characteristics.
830.7000............ pH..................... R TGAI.............. TGAI.............. .......
830.7100............ Viscosity.............. R MP................ EP................ 7
830.7300............ Density/relative R TGAI.............. TGAI.............. .......
density/bulk density
(specific gravity).
----------------------------------------------------------------------------------------------------------------

(d) * * *
3. Required for each isolate of a microbial pesticide. Isolates
must be deposited with an agreement to ensure that the sample will be
maintained and will not be discarded for the duration of the associated
experimental use permit(s).
* * * * *
[FR Doc. 2012-21430 Filed 8-29-12; 8:45 am]
BILLING CODE 6560-50-P

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