Daily Rules, Proposed Rules, and Notices of the Federal Government
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
To address these questions, in the
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
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.
This final rule is issued under the authority of FIFRA sections 3, 5, 10, 12, and 25 (7 U.S.C. 136
To access the OSCPP test guidelines referenced in this final rule electronically, please go to
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.
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.
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).
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
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).
Pursuant to RFA section 605(b) (5 U.S.C. 601
This action only clarifies existing regulatory text to allow EPA and stakeholders a clearer understanding of
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.
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.
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.
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.
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.
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).
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).
Pursuant to CRA (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
7 U.S.C. 136-136y; 21 U.S.C. 346a.
(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.
The amendments read as follows:
(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).
The amendments read as follows:
(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).