
[Federal Register Volume 82, Number 159 (Friday, August 18, 2017)]
[Proposed Rules]
[Pages 39399-39402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17339]



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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.



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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



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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




