84 FR 18993 - Pesticides; Technical Amendment to Data Requirements for Antimicrobial Pesticides

EPA is finalizing 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 was incorrectly implied by the previous 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. This action does not otherwise establish any new data requirements or any other revisions (substantive or otherwise) to existing requirements.

[Federal Register Volume 84, Number 86 (Friday, May 3, 2019)]
[Rules and Regulations]
[Pages 18993-18996]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2019-09115]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 158

[EPA-HQ-OPP-2018-0668; FRL-9984-52]
RIN 2070-AK41


Pesticides; Technical Amendment to Data Requirements for 
Antimicrobial Pesticides

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is finalizing 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 was incorrectly 
implied by the previous 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. This action 
does not otherwise establish any new data requirements or any other 
revisions (substantive or otherwise) to existing requirements.

DATES: This final rule is effective July 2, 2019.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2018-0668 is available online at 
http://www.regulations.gov or in person at the Office of Pesticide 
Programs Regulatory Public Docket (OPP Docket) in the EPA Docket Center 
(EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 
Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading 
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, 
excluding legal holidays. The telephone number for the Public Reading 
Room is (202) 566-1744, and the telephone number for the OPP Docket is 
(703) 305-5805. Please review the visitor instructions and additional 
information about the docket available at 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: [email protected].

SUPPLEMENTARY INFORMATION: 

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

[[Page 18994]]

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:
     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 action is the Agency taking?

    EPA is finalizing a single correction to the data requirements for 
antimicrobial pesticide products that are codified in 40 CFR part 158, 
subpart W. EPA is not making any other changes (substantive or 
otherwise) or establishing any new data requirements. The correction to 
the ``200 ppb level'' that is 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.
    This change will also harmonize the EPA standard with the U.S. Food 
and Drug Administration levels established for indirect food use 
biocides set forth in ``Guidance for Industry: Preparation of Food 
Contact Notifications for Food Contact Substances: Toxicology 
Recommendations,'' Revised April 2002. For reference, a copy of the FDA 
guidance has been placed in the docket for this action.

C. 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).

D. Why is the Agency taking this action?

    EPA has determined that the correction to the ``200 ppb level'' 
that is described in 40 CFR 158.2230(d) is necessary 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.

E. What are the incremental costs and benefits of this action?

    This correction does not result in any new burden or costs being 
imposed. This change represents a technical correction. No new studies 
are being requested, registrants will not submit more studies than they 
are currently submitting in their application packages, and there is no 
increase in the frequency at which existing data are required. 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) 
in which 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.

II. Summary of the Proposed Rule

    On August 18, 2017 (82 FR 39399) (FRL-9965-54), EPA published and 
requested public comment on a proposal to correct the language at 40 
CFR 158.2230(d) in a proposed rule entitled ``Pesticides: Technical 
Amendment to Data Requirements for Antimicrobial Pesticides.'' As 
described in more detail in the proposed rule, the correction is in 
response to a petition filed by the American Chemistry Council (ACC) in 
the United States Court of Appeals for the District of Columbia Circuit 
on July 3, 2013 (American Chemistry Council, Inc. v. Environmental 
Protection Agency, No.13-1207 (D.C. Cir.)). That petition sought 
judicial review of the 2013 final rule, entitled ``Data Requirements 
for Antimicrobial Pesticides'' (78 FR 26936, May 8, 2013) (FRL-8886-5). 
EPA and ACC subsequently entered into a settlement agreement that 
addressed the ACC petition. The settlement agreement, which became 
effective on March 2, 2015, is available at http://www.regulations.gov 
(Document ID No. EPA-HQ-OPP-2008-0110-0139). Under the settlement 
agreement with ACC, EPA agreed to propose a correction to the 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 the FDA document entitled 
``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 rulemaking.
    In the 2017 proposed rule, EPA proposed to clarify that the 200 ppb 
level established in the 2013 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 issued interim guidance on April 30, 2015, which is 
available on EPA's website at https://www.epa.gov/pesticide-registration/epa-data-requirements-registration-antimicrobial-pesticides-part-158w.

III. Comments and Responses

    The Agency appreciates the comments provided by the public, and the 
Agency's detailed response to the comments received is provided in a 
document that is posted in the docket for this action. EPA received two 
public comments. One commenter was supportive of the adoption of the 
technical correction without requesting any revisions to the text. The 
other commenter submitted an inquiry as to why 200 ppb instead of 100 
ppb was the limit for concentrations of biocides on food.
    The 200 ppb level was previously established by FDA for indirect 
food use biocides (see Guidance for Industry: Preparation of Food 
Contact Notifications for Food Contact Substances: Toxicology 
Recommendations, Revised April 2002). The 200 ppb level is derived by 
dividing FDA's cumulative exposure upper limit of 1,000 ppb level by 5 
to be conservative and to account for the fact that antimicrobial 
pesticides (e.g., biocides) are a class of pesticide that are generally 
toxic by design. It is important to note that EPA is not using this 200 
ppb value as a risk level. It is used in this situation to determine if 
additional toxicity data are required. No substantive changes were 
suggested and EPA is finalizing the correction as proposed.

[[Page 18995]]

IV. FIFRA Review Requirements

    In accordance with FIFRA sections 21 and 25(a), EPA submitted a 
draft of this final rule to the Secretary of the Department of Health 
and Human Services (HHS), and the Secretary of the U.S. Department of 
Agriculture (USDA). Under FIFRA section 25(d), EPA submitted a draft of 
this final rule to the FIFRA Scientific Advisory Panel (SAP). The SAP 
waived its review of the final rule on November 14, 2018, because the 
final rule does not contain scientific issues that warrant review by 
the Panel. A copy of FIFRA SAP response is available in the docket.
    As required by FIFRA section 25(a)(3), copies of the draft final 
rule were also provided 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).

V. 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; and Executive 
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action 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).

B. Executive Order 13771: Reducing Regulation and Controlling 
Regulatory Costs

    The burden reduction and controlling provisions in Executive Order 
13771 (82 FR 9339, February 3, 2017), do not apply to this action 
because this action is not a significant regulatory action as defined 
by Executive Order 12866.

C. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection 
requirements that 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 is 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 
approved under OMB Control No. 2070-0060 (EPA ICR No. 0277).
     The information collection activities associated with the 
generation of data for registration review is 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 approved under OMB 
Control No. 2070-0040 (EPA ICR No. 0276).
    This final 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 final 
rule.

D. 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 final 
rule are registrants and manufacturers of antimicrobial pesticide 
products that qualify as a small business as defined by the Small 
Business Administration. Small nonprofit organizations and small 
government jurisdictions as defined by the RFA are not expected to 
become a registrant or manufacturer of an antimicrobial pesticide 
product and are not therefore expected to be impacted by this rule.
    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 the small entities subject to the rule.
    There will not be significant adverse economic impacts on a 
substantial number of small entities by this simple correction. On the 
contrary, all registrants and manufacturers of antimicrobial pesticide 
products, regardless of size, will benefit equally from the correction 
related by likely reduction in the number of requests for further 
clarification of this data requirement, and may also enjoy a more 
streamlined registration process.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded federal mandate 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.

F. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in 
Executive Order 13132 (64 FR 43255, August 4, 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.

G. 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.

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

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) 
as applying only to those regulatory actions that concern 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.

I. 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

[[Page 18996]]

regulatory action under Executive Order 12866, nor does it affect 
energy supply, distribution or use.

J. 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.

K. 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.

L. Congressional Review Act (CRA)

    This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA 
will submit a rule report to the U.S. Senate, and the U.S. House of 
Representatives, and the Comptroller General of the United States. This 
action is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 158

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

    Dated: April 25, 2019.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.

    Therefore, 40 CFR part 158 is amended as follows:

PART 158--[AMENDED]

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

     Authority: 7 U.S.C. 136-136y; 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  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. 2019-09115 Filed 5-2-19; 8:45 am]
 BILLING CODE 6560-50-P