82 FR 39399 - Pesticides; Technical Amendment to Data Requirements for Antimicrobial Pesticides
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 159 (August 18, 2017)
Federal Register Volume 82, Issue 159 (August 18, 2017)
| Page Range | 39399-39402 | |
| FR Document | 2017-17339 |
[Federal Register Volume 82, Number 159 (Friday, August 18, 2017)] [Proposed Rules] [Pages 39399-39402] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-17339] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 158 [EPA-HQ-OPP-2015-0683; FRL-9965-54] RIN 2070-AK41 Pesticides; Technical Amendment to Data Requirements for Antimicrobial Pesticides AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: EPA is proposing a correction pertaining to the ``200 ppb (parts per billion) level'' described in the antimicrobial pesticides data requirements regulation to clarify that the 200 ppb level is based on total estimated daily dietary intake for an individual and not on the amount of residue present on a single food, as is incorrectly implied by the current regulatory text. This change is intended to enhance understanding of the data required to support an antimicrobial pesticide registration and does not alter the burden or costs associated with these previously-promulgated requirements. Through this action, EPA is not proposing any new data requirements or any other revisions (substantive or otherwise) to existing requirements. DATES: Comments must be received on or before October 17, 2017. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2015-0683, by one of the following methods:Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Cameo Smoot, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; (703) 305-5454; email address: smoot.cameo@epa.gov. I. Executive Summary 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 or device. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include, but are not limited to: NAICS code 325320, Pesticide and Other Agricultural Chemical Manufacturing, e.g., pesticide manufacturers or formulators of pesticide products, importers, exporters, or any person or company who seeks to register a pesticide product or to obtain a tolerance for a pesticide product. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. What is the Agency's authority for taking this action? This action is issued under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. and the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d). C. What action is the Agency taking? EPA is proposing a single correction to the data requirements for antimicrobial pesticide products that are codified in 40 CFR part 158, subpart W. EPA is not proposing any other changes (substantive or otherwise) or any new data requirements. The correction to the ``200 ppb level'' described in 40 CFR 158.2230(d) will clarify that the 200 ppb level is based on total estimated daily dietary intake for an individual and not on the amount of residue present on a single food, as is incorrectly implied by the current regulatory text. D. What are the incremental costs and benefits of this action? No new data requirements are proposed and this correction does not result in any new burden or costs being imposed. The proposed change represents a technical correction; therefore, registrants will not submit more studies than they are currently submitting in their application packages. As a result, this change will not cause any increase in the cost to register an antimicrobial pesticide product. EPA believes the correction should provide registrants with more specific information such that it could reduce the number of consultations (emails, phone calls, and meetings) registrants seek to ensure that they are correctly interpreting the regulations before they begin their testing programs. Applicants may save time and money by better understanding when studies are needed and by not submitting unneeded studies. Submission of all required studies at the time of application may reduce potential delays in the registration process, thereby allowing products to enter the market earlier. The clarity derived from having more understandable data requirements may be especially important to small firms and new firms entering the industry who may have less experience with the pesticide registration program than those firms that routinely work with the Agency. Although we believe that the correction reduces uncertainty and will result in a decrease in the number of inquiries registrants may make to EPA seeking clarification on this particular point, EPA did not attempt to determine whether or not, or the extent to which, the correction might result in any cost savings for the registrants or for EPA. Because EPA is not proposing any new data requirements and also made sure not to increase the frequency at which the existing data are required, EPA determined there is no need to perform an economic analysis for this proposed rulemaking. E. What should I consider as I prepare my comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one [[Page 39400]] complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html. II. Background Under FIFRA, every pesticide product must be registered (or specifically exempted from registration under FIFRA section 25(b)) by EPA before the pesticide may be sold or distributed in the United States. To obtain a registration, an applicant or registrant must demonstrate to the Agency's satisfaction that, among other things, the pesticide product, when used in accordance with widespread and commonly recognized practice, will not cause ``unreasonable adverse effects'' to humans or the environment. Under FIFRA, anyone seeking to register a pesticide product is required to provide information to EPA that demonstrates, among other things, that the product can be used without posing unreasonable adverse effects on the environment. The FFDCA section 408 dietary safety factor is incorporated into FIFRA's definition of ``unreasonable adverse effects on the environment.'' Moreover, EPA has authority under FFDCA to establish a tolerance or an exemption from the need for a tolerance for a pesticide chemical residue in or on food, provided there is a reasonable certainty that no harm will result from aggregate exposures to the residues of the pesticide product, including all anticipated dietary exposures and all other exposures for which there is reliable information. EPA's data requirement regulations in 40 CFR part 158 outline the kinds of data and related information typically needed to register a pesticide product. The data requirements are organized by major pesticide type (e.g., conventional, biochemical, microbial, or antimicrobial), scientific discipline (e.g., toxicology or residue chemistry) and major use sites (e.g., outdoor vs. indoor, terrestrial, aquatic, or greenhouse). The data requirements in 40 CFR part 158 were first promulgated in 1984 (49 FR 42856, October 24, 1984), and principally focused on the data needed to register agricultural pesticide chemicals. In the Federal Register of October 26, 2007, EPA promulgated a final rule to revise and update the data requirements for conventional pesticides (72 FR 60934) (FRL-8106-5). Also on October 26, 2007, EPA promulgated a rule to specifically describe the data requirements for biochemical and microbial pesticides (72 FR 60988) (FRL-8109-8). In the Federal Register of May 8, 2013, the data requirements specific to antimicrobial pesticides were promulgated (78 FR 26936) (FRL-8886-5) and became effective on July 8, 2013. III. Legal Challenge to the 2013 Rule, Resulting Settlement Agreement, and This Proposal On July 3, 2013, the American Chemistry Council (ACC) filed a petition for judicial review of the 2013 final rule, entitled ``Data Requirements for Antimicrobial Pesticides'' (78 FR 26936, May 8, 2013), in the United States Court of Appeals for the District of Columbia Circuit. (American Chemistry Council, Inc. v. Environmental Protection Agency, No.13-1207 (D.C. Cir.)). On July 8, 2013, the final rule became effective. EPA and ACC subsequently entered into a settlement agreement that addressed ACC's petition for judicial review of the 40 CFR part 158, subpart W data requirements rule. The settlement agreement, which became effective on March 2, 2015, is available at http://www.regulations.gov using the docket identifier EPA-HQ-OPP-2008-0110- 0139. Under the settlement agreement with ACC, EPA agreed to propose by September 2, 2017, a correction to the current language at 40 CFR 158.2230(d) referring to the 200 ppb level as ``the concentration of the antimicrobial residues in or on the food item'' in order to make the language consistent with the U.S. Food and Drug Administration's (FDA) policy set forth in ``Guidance for Industry, Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations. Final Guidance. April 2002.'' A copy of the FDA guidance has been placed in the docket for this proposed rulemaking. Accordingly, the proposal clarifies that the 200 ppb level established in the rule is based on total estimated daily dietary intake, and not on the amount of residue present on a single food item or commodity. As part of its obligations under the settlement agreement, EPA previously addressed this issue in interim guidance issued on April 30, 2015. This guidance is available on EPA's Web site at https://www.epa.gov/pesticide-registration/epa-data-requirements-registration-antimicrobial-pesticides-part-158w. IV. Request for Comments The Agency invites the public to provide its views and suggestions for the proposed change in this document, and will formally respond to any comments on this proposed change at the time of issuing a final rule. EPA is particularly interested in comments and any suggestions for better characterizing the benefits of burden reduction or savings resulting from this correction. V. FIFRA Review Requirements In accordance with FIFRA sections 21 and 25(a), EPA submitted a draft of this proposed rule to the Secretary of the U.S. Department of Agriculture (USDA), and the Secretary of the Department of Health and Human Services (HHS), with copies to the appropriate Congressional Committees (i.e., the Committee on Agriculture in the U.S. House of Representatives, and the Committee on Agriculture, Nutrition, and Forestry in the United States Senate). On June 1, 2017, USDA completed their review of the draft proposed rule and informed EPA that they did not have any comments. On July 17, 2017, HHS completed their review of the draft proposed rule and provided two comments. First, with regard to the section II. Background summary paragraph about FIFRA and FFDCA authority, HHS submitted suggested text to avoid the suggestion that the FFDCA contains provisions related to the registration of a pesticide product, and also inserted language concerning ``aggregate'' exposures. EPA has addressed the comments submitted by HHS in the proposed rule and has provided additional clarifying language. The proposed rule now states that ``Under FIFRA, anyone seeking to register a pesticide product is required to provide information to EPA that demonstrates, among other things, that the product can be used without posing unreasonable adverse effects on the environment. The FFDCA section 408 dietary safety factor is incorporated into FIFRA's definition of ``unreasonable adverse effects on the environment.'' Moreover, EPA has authority under FFDCA to establish a tolerance or an exemption from the need for a tolerance for a pesticide chemical residue in or on food, provided there is a reasonable certainty that no harm will result from aggregate exposures to the residues of the pesticide product, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' In the second HHS comment, HHS suggested that we specifically identify the FDA policy cited in the draft proposed rule. In [[Page 39401]] response, EPA has specifically identified the FDA policy and placed a copy of the FDA's ``Guidance for Industry, Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations. Final Guidance. April 2002,'' in the docket for this action. Under FIFRA section 25(d), EPA also submitted a draft of this proposed rule to the FIFRA Scientific Advisory Panel (SAP). The SAP waived its review of the proposed rule on June 2, 2017, because the proposed rule does not contain scientific issues that warrant review by the Panel. VI. Statutory and Executive Order Reviews Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders. A. Executive Order 12866: Regulatory Planning and Review; Executive Order 13563: Improving Regulation and Regulatory Review; and Executive Order 13777: Reducing Regulation and Controlling Regulatory Costs This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). In addition, since this action does not contain a new requirement or impose any new burden or costs, the burden reduction and controlling provisions in Executive Order 13771 (82 FR 9339, February 3, 2017), do not apply. Although we believe that the correction reduces uncertainty and will result in a decrease in the number of inquiries registrants may make to EPA seeking clarification on this particular point, EPA did not attempt to determine whether or not, or the extent to which, the correction might result in any cost savings for the registrants or for EPA. B. Paperwork Reduction Act (PRA) This action does not impose any new information collection requirements that would require additional review or approval by OMB under the PRA, 44 U.S.C. 3501 et seq. The information collection requirements associated with the submission of data under 40 CFR part 158 have already been approved by OMB pursuant to the PRA and are covered by the following existing Information Collection Requests (ICRs): The information collection activities associated with the establishment of a tolerance are currently approved under OMB Control No. 2070-0024 (EPA ICR No. 0597). The information collection 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 information collection activities associated with the generation of data for registration review are currently approved under OMB Control No. 2070-0174 (EPA ICR No. 2288). The information collection activities associated with the generation of data for experimental use permits are currently approved under OMB Control No. 2070-0040 (EPA ICR No. 0276). This proposed rule does not involve a change in information collection activities associated with the generation of data for antimicrobial pesticide products or devices. EPA believes no additional burden for data submission would be imposed by the simple correction in this proposed rule. The most that may be needed is for an applicant to become familiar with the change. Although we believe that the correction reduces uncertainty and will result in a decrease in the number of inquiries registrants may make to EPA seeking clarification on this particular point, EPA did not attempt to determine whether or not, or the extent to which, the correction might result in any cost savings for the registrants or for EPA. EPA is seeking comment on this point in particular. C. Regulatory Flexibility Act (RFA) I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601 et seq. The small entities directly regulated by this proposed rule are small manufacturers of antimicrobial pesticide products. After considering the economic impacts of this proposed rule on small entities, EPA certifies that this action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses 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 that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect on all of the small entities subject to the rule. There will not be significant adverse economic impacts on a substantial number of small entities by the simple correction proposed. On the contrary, all registrants of pesticide products, regardless of size, will benefit equally by receiving the clearer editorial and/or technical direction, likely reduce the number of requests for further clarification of data requirements, and likely enjoy a more streamlined registration process. We continue to be interested in the potential impacts of the correction in this proposed rule on small entities and welcome comments on issues related to such impacts. D. Unfunded Mandates Reform Act (UMRA) This action does not contain an unfunded federal mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. Accordingly, this action is not subject to the requirements of UMRA, 2 U.S.C. 1501 et seq. E. Executive Order 13132: Federalism This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). It will not 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. Thus, Executive Order 13132 does not apply to this action. F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). This action will not have any effect on tribal governments, 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. Thus, Executive Order 13175 does not apply to this action. EPA specifically solicits additional comment on this proposed action from tribal officials. 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 [[Page 39402]] actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of ``covered regulatory action'' in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk. 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 does it affect energy supply, distribution or use. I. National Technology Transfer and Advancement Act (NTTAA) This action does not involve any 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 involve special consideration of environmental justice related issues as specified in Executive Order 12898 (59 FR 7629, February 16, 1994), because this action does not address human health or environmental risks or otherwise have any disproportionate high and adverse human health or environmental effects on minority, low-income or indigenous populations. List of Subjects in 40 CFR Part 158 Environmental protection, Administrative practice and procedure, Pesticides and pests, Reporting and recordkeeping requirements. Dated: August 4, 2017. Louise P. Wise, Acting Assistant Administrator, Office of Chemical Safety and Pollution Prevention. Therefore, the EPA proposes to amend 40 CFR part 158 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; subpart U is also issued under 31 U.S.C. 9701. 0 2. In Sec. 158.2230, revise paragraph (d) to read as follows: Sec. 158.2230 Antimicrobial toxicology. * * * * * (d) 200 parts per billion (ppb). The 200 ppb level was originally used by the Food and Drug Administration with respect to the concentration of residues in or on food for tiering of data requirements for indirect food use biocides. The Agency has also adopted this same residue level for determining toxicology data requirements for indirect food uses of antimicrobial pesticides. The 200 ppb level is the concentration of antimicrobial residues in the total estimated daily dietary intake. * * * * * [FR Doc. 2017-17339 Filed 8-17-17; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 82, No. 159 / Friday, August 18, 2017 / Proposed Rules 39399
Dated: July 26, 2017. information about dockets generally, is D. What are the incremental costs and
Debra H. Thomas, available at http://www.epa.gov/ benefits of this action?
Acting Regional Administrator, Region 8. dockets. No new data requirements are
[FR Doc. 2017–17219 Filed 8–17–17; 8:45 am] proposed and this correction does not
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 6560–50–P?≤
Cameo Smoot, Field and External result in any new burden or costs being
imposed. The proposed change
Affairs Division (7506P), Office of
represents a technical correction;
ENVIRONMENTAL PROTECTION Pesticide Programs, Environmental
therefore, registrants will not submit
AGENCY Protection Agency, 1200 Pennsylvania
more studies than they are currently
Ave. NW., Washington, DC 20460; (703) submitting in their application
40 CFR Part 158 305–5454; email address: packages. As a result, this change will
[EPA–HQ–OPP–2015–0683; FRL–9965–54] smoot.cameo@epa.gov. not cause any increase in the cost to
RIN 2070–AK41 I. Executive Summary register an antimicrobial pesticide
product.
A. Does this action apply to me? EPA believes the correction should
Pesticides; Technical Amendment to
Data Requirements for Antimicrobial provide registrants with more specific
You may be potentially affected by
Pesticides information such that it could reduce
this action if you are a producer or the number of consultations (emails,
AGENCY: Environmental Protection registrant of an antimicrobial pesticide phone calls, and meetings) registrants
Agency (EPA). product or device. The following list of seek to ensure that they are correctly
ACTION: Proposed rule. North American Industrial interpreting the regulations before they
Classification System (NAICS) codes is begin their testing programs. Applicants
SUMMARY: EPA is proposing a correction not intended to be exhaustive, but rather may save time and money by better
pertaining to the ‘‘200 ppb (parts per provides a guide to help readers understanding when studies are needed
billion) level’’ described in the determine whether this document and by not submitting unneeded
antimicrobial pesticides data applies to them. Potentially affected studies. Submission of all required
requirements regulation to clarify that entities may include, but are not limited studies at the time of application may
the 200 ppb level is based on total to: reduce potential delays in the
estimated daily dietary intake for an
individual and not on the amount of • NAICS code 325320, Pesticide and registration process, thereby allowing
Other Agricultural Chemical products to enter the market earlier. The
residue present on a single food, as is clarity derived from having more
incorrectly implied by the current Manufacturing, e.g., pesticide
manufacturers or formulators of understandable data requirements may
regulatory text. This change is intended be especially important to small firms
to enhance understanding of the data pesticide products, importers, exporters,
or any person or company who seeks to and new firms entering the industry
required to support an antimicrobial who may have less experience with the
pesticide registration and does not alter register a pesticide product or to obtain
a tolerance for a pesticide product. pesticide registration program than
the burden or costs associated with those firms that routinely work with the
these previously-promulgated If you have any questions regarding Agency.
requirements. Through this action, EPA the applicability of this action to a Although we believe that the
is not proposing any new data particular entity, consult the person correction reduces uncertainty and will
requirements or any other revisions listed under FOR FURTHER INFORMATION result in a decrease in the number of
(substantive or otherwise) to existing CONTACT. inquiries registrants may make to EPA
requirements. seeking clarification on this particular
B. What is the Agency’s authority for
DATES: Comments must be received on point, EPA did not attempt to determine
taking this action?
or before October 17, 2017. whether or not, or the extent to which,
ADDRESSES: Submit your comments, This action is issued under the the correction might result in any cost
identified by docket identification (ID) Federal Insecticide, Fungicide and savings for the registrants or for EPA.
number EPA–HQ–OPP–2015–0683, by Rodenticide Act (FIFRA), 7 U.S.C. 136 Because EPA is not proposing any new
one of the following methods: et seq. and the Federal Food, Drug, and data requirements and also made sure
• Federal eRulemaking Portal: http:// Cosmetic Act (FFDCA), 21 U.S.C. not to increase the frequency at which
www.regulations.gov. Follow the online 346a(d). the existing data are required, EPA
instructions for submitting comments. determined there is no need to perform
Do not submit electronically any C. What action is the Agency taking? an economic analysis for this proposed
information you consider to be rulemaking.
Confidential Business Information (CBI) EPA is proposing a single correction
to the data requirements for E. What should I consider as I prepare
or other information whose disclosure is
antimicrobial pesticide products that are my comments for EPA?
restricted by statute.
• Mail: OPP Docket, Environmental codified in 40 CFR part 158, subpart W. 1. Submitting CBI. Do not submit this
Protection Agency Docket Center (EPA/ EPA is not proposing any other changes information to EPA through
DC), (28221T), 1200 Pennsylvania Ave. (substantive or otherwise) or any new regulations.gov or email. Clearly mark
mstockstill on DSK30JT082PROD with PROPOSALS
NW., Washington, DC 20460–0001. data requirements. The correction to the the part or all of the information that
• Hand Delivery: To make special ‘‘200 ppb level’’ described in 40 CFR you claim to be CBI. For CBI
arrangements for hand delivery or 158.2230(d) will clarify that the 200 ppb information in a disk or CD–ROM that
delivery of boxed information, please level is based on total estimated daily you mail to EPA, mark the outside of the
follow the instructions at http:// dietary intake for an individual and not disk or CD–ROM as CBI and then
www.epa.gov/dockets/contacts.html. on the amount of residue present on a identify electronically within the disk or
Additional instructions on commenting single food, as is incorrectly implied by CD–ROM the specific information that
or visiting the docket, along with more the current regulatory text. is claimed as CBI. In addition to one
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![39402 Federal Register / Vol. 82, No. 159 / Friday, August 18, 2017 / Proposed Rules
actions that concern environmental § 158.2230 Antimicrobial toxicology. on October 25, 2017, from 9 a.m. to 5
health or safety risks that the EPA has * * * * * p.m. and on October 26, 2017, from 9
reason to believe may (d) 200 parts per billion (ppb). The a.m. to 3 p.m.
disproportionately affect children, per 200 ppb level was originally used by the ADDRESSES: The third meeting will take
the definition of ‘‘covered regulatory Food and Drug Administration with place at Ronald Reagan Building and
action’’ in section 2–202 of the respect to the concentration of residues International Trade Center, Oceanic
Executive Order. This action is not in or on food for tiering of data Suite, 1300 Pennsylvania Ave NW.,
subject to Executive Order 13045 requirements for indirect food use Washington, DC 20004, while the fourth
because it does not concern an biocides. The Agency has also adopted meeting will be held at William
environmental health risk or safety risk. this same residue level for determining Jefferson Clinton East Building, Room
H. Executive Order 13211: Actions toxicology data requirements for 1153, 1201 Constitution Avenue NW.,
Concerning Regulations That indirect food uses of antimicrobial Washington, DC 20004.
Significantly Affect Energy Supply, pesticides. The 200 ppb level is the FOR FURTHER INFORMATION CONTACT: Any
Distribution, or Use concentration of antimicrobial residues member of the public wishing to obtain
in the total estimated daily dietary information concerning the public
This action is not subject to Executive intake. meetings may contact Jonah Richmond,
Order 13211 (66 FR 28355, May 22, * * * * * Designated Federal Officer (DFO),
2001), because it is not a significant [FR Doc. 2017–17339 Filed 8–17–17; 8:45 am] Conflict Prevention and Resolution
regulatory action under Executive Order BILLING CODE 6560–50–P Center, Office of General Counsel, 1200
12866, nor does it affect energy supply, Pennsylvania Ave. NW., Washington,
distribution or use. DC 20460–0001; telephone number:
I. National Technology Transfer and ENVIRONMENTAL PROTECTION (202) 564–0210; email address:
Advancement Act (NTTAA) AGENCY Richmond.jonah@epa.gov. General
[EPA–HQ–OPPT–2016–0597; FRL–9965–96] information about the Committee, as
This action does not involve any well as any updates concerning the
technical standards that would require 40 CFR Part 711 meetings announced in this notice, may
the consideration of voluntary be found at https://www.epa.gov/
consensus standards pursuant to RIN 2070–AK31
chemical-data-reporting/negotiated-
NTTAA section 12(d), 15 U.S.C. 272 rulemaking-committee-chemical-data-
Negotiated Rulemaking Committee;
note. reporting-requirements.
Chemical Data Reporting;
J. Executive Order 12898: Federal Requirements for Inorganic Byproduct For information on access or services
Actions To Address Environmental Chemical Substances; Notice of Public for individuals with disabilities, or to
Justice in Minority Populations and Meetings request accommodation for a disability,
Low-Income Populations please contact the DFO, preferably at
AGENCY: Environmental Protection least ten days prior to the meetings to
This action does not involve special Agency (EPA). give EPA as much time as possible to
consideration of environmental justice ACTION: Rulemaking committee meeting. process your request.
related issues as specified in Executive For technical information contact:
Order 12898 (59 FR 7629, February 16, SUMMARY: EPA is giving notice that it is Susan Sharkey, Chemical Control
1994), because this action does not holding two additional meetings of the Division (7405M), Office of Pollution
address human health or environmental Negotiated Rulemaking Committee Prevention and Toxics, Environmental
risks or otherwise have any (Committee) established on June 5, Protection Agency, 1200 Pennsylvania
disproportionate high and adverse 2017. The objective of the Committee is Ave. NW., Washington, DC 20460–0001;
human health or environmental effects to negotiate a proposed rule that would telephone number: (202) 564–8789;
on minority, low-income or indigenous limit chemical data reporting email address: Sharkey.susan@epa.gov.
populations. requirements under the Toxic For general information contact: The
Substances Control Act (TSCA), as TSCA-Hotline, ABVI-Goodwill, 422
List of Subjects in 40 CFR Part 158
amended by the Frank R. Lautenberg South Clinton Ave., Rochester, NY
Environmental protection, Chemical Safety for the 21st Century 14620; telephone number: (202) 554–
Administrative practice and procedure, Act, for manufacturers of any inorganic 1404; email address: TSCA-Hotline@
Pesticides and pests, Reporting and byproduct chemical substances when epa.gov.
recordkeeping requirements. such byproduct chemical substances are
subsequently recycled, reused, or SUPPLEMENTARY INFORMATION:
Dated: August 4, 2017.
reprocessed. The purpose of the I. General Information
Louise P. Wise,
Committee is to conduct discussions in
Acting Assistant Administrator, Office of A. Does this action apply to me?
a good faith attempt to reach consensus
Chemical Safety and Pollution Prevention.
on proposed regulatory language. This You may be potentially affected by
Therefore, the EPA proposes to amend negotiation process is required by the this action if you manufacture
40 CFR part 158 as follows: TSCA. This notice announces the (including manufacture as a byproduct
details of two upcoming meetings of the chemical substance and including
mstockstill on DSK30JT082PROD with PROPOSALS
PART 158—[AMENDED] Committee, which are both open to the import) chemical substances listed on
public, and which serve as the third and the TSCA Inventory. The following list
■ 1. The authority citation for part 158 fourth meetings of the Committee. of North American Industrial
continues to read as follows:
DATES: The third Committee meeting Classification System (NAICS) codes are
Authority: 7 U.S.C. 136–136y; subpart U will be held on September 13, 2017, not intended to be exhaustive, but rather
is also issued under 31 U.S.C. 9701. from 9 a.m. to 5 p.m. and on September provides a guide to help readers
■ 2. In § 158.2230, revise paragraph (d) 14, 2017, from 9 a.m. to 3 p.m. The determine whether this action may
to read as follows: fourth Committee meeting will be held apply to them:
VerDate Sep<11>2014 16:16 Aug 17, 2017 Jkt 241001 PO 00000 Frm 00034 Fmt 4702 Sfmt 4702 E:\FR\FM\18AUP1.SGM 18AUP1](https://thefederalregister.org/doc/82_FR_39558/page/4.svg)
Document Created: 2017-08-18 07:40:55
Document Modified: 2017-08-18 07:40:55
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Proposed rule. | |
| Dates | Comments must be received on or before October 17, 2017. | |
| Contact | Cameo Smoot, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; | |
| FR Citation | 82 FR 39399 | |
| RIN Number | 2070-AK41 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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