[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

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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

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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