[Federal Register Volume 85, Number 213 (Tuesday, November 3, 2020)]
[Rules and Regulations]
[Pages 69512-69514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23199]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0218 and EPA-HQ-OPP-2013-0219; FRL-10015-39]
RIN 2070-ZA16


Dipropylene Glycol and Triethylene Glycol; Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is exempting 
residues of the antimicrobial pesticide ingredients dipropylene glycol 
and triethylene glycol from the requirement of a tolerance when used on 
or applied to food-contact surfaces in public eating places, dairy-
processing equipment, and food-processing equipment and utensils. The 
Agency is finalizing this rule on its own initiative under the Federal 
Food, Drug, and Cosmetic Act (FFDCA) to address residues identified as 
part of the Agency's registration review program under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA).

DATES: This regulation is effective November 3, 2020. Objections and 
requests for hearings must be received on or before January 4, 2021 and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The dockets for this action, identified by docket 
identification (ID) numbers EPA-HQ-OPP-2013-0219 and EPA-HQ-OPP-2013-
0218, are available at http://www.regulations.gov or at the Office of 
Pesticide Programs Regulatory Public Docket (OPP Docket) in the 
Environmental Protection Agency 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.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Anita Pease, Antimicrobials Division 
(7510P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: ADFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are a 
pesticide manufacturer. 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:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.

[[Page 69513]]

     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID numbers EPA-HQ-OPP-2013-0218 and EPA-HQ-OPP-2013-0219 in the 
subject line on the first page of your submission. All objections and 
requests for a hearing must be in writing and must be received by the 
Hearing Clerk on or before January 4, 2021. Addresses for mail and hand 
delivery of objections and hearing requests are provided in 40 CFR 
178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID numbers EPA-HQ-OPP-2013-0218 and EPA-
HQ-OPP-2013-0219, 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 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.

II. Summary of Proposed Rule-For Exemption

    In the Federal Register of May 22, 2020 (85 FR 31130) (FRL-10008-
87), EPA proposed to exempt residues of the antimicrobial pesticide 
ingredients dipropylene glycol and triethylene glycol from the 
requirement of a tolerance when used on or applied to food-contact 
surfaces in public eating places, dairy-processing equipment, and food-
processing equipment and utensils. These exemptions were proposed on 
the Agency's own initiative under section 408(e) of the FFDCA. 21 
U.S.C. 346a(e). No comments were submitted on the Agency's proposal. 
Therefore, the Agency is finalizing the exemption from the requirement 
of a tolerance for residues of the antimicrobial pesticide ingredients 
dipropylene glycol and triethylene glycol when used on or applied to 
food-contact surfaces in public eating places, dairy-processing 
equipment, and food-processing equipment and utensils as proposed.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings but does not include 
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
FFDCA section 408(b)(2)(C), which requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue . . 
. .''
    Consistent with FFDCA section 408(c)(2)(A) and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for dipropylene glycol and 
triethylene glycol including exposure resulting from the exemption 
established by this action. EPA's assessment of exposures and risks 
associated with dipropylene glycol and triethylene glycol are discussed 
in the preamble to the proposed rule.
    Based on the toxicological and exposure data discussed in the 
proposal and the supporting registration review documents, EPA 
concludes that the exemption from the requirement of a tolerance for 
residues of dipropylene glycol and triethylene glycol when used in 
antimicrobial formulations applied to food-contact surfaces in public 
eating places, dairy-processing equipment, and food-processing 
equipment and utensils will be safe. EPA has determined that there is a 
reasonable certainty that no harm will result to the general 
population, or to infants and children, from aggregate exposure to 
dipropylene glycol and triethylene glycol residues.

IV. Analytical Enforcement Methodology

    An analytical method for residue is not needed. Due to the lack of 
risk, EPA is establishing exemptions without limits for dipropylene 
glycol and triethylene glycol; therefore, measuring residues of 
dipropylene glycol and triethylene glycol is not necessary.

V. Conclusion

    Therefore, EPA is establishing in 40 CFR 180.940(a) exemptions from 
the requirement of a tolerance for residues of dipropylene glycol and 
triethylene glycol when used in antimicrobial formulations applied to 
food-contact surfaces in public eating places, dairy-processing 
equipment, and food-processing equipment and utensils.

VI. Statutory and Executive Order Reviews

    This action establishes exemptions from the requirement of a 
tolerance under FFDCA section 408(e). The Office of Management and 
Budget (OMB) has exempted these types of actions from review under 
Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 
FR 51735, October 4, 1993). Because this action has been exempted from 
review under Executive Order 12866, this action is not subject to 
Executive Order 13211, entitled

[[Page 69514]]

``Actions Concerning Regulations That Significantly Affect Energy 
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive 
Order 13045, entitled ``Protection of Children from Environmental 
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), nor is 
it considered a regulatory action under Executive Order 13771, entitled 
``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339, 
February 3, 2017). This action does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special 
considerations under Executive Order 12898, entitled ``Federal Actions 
to Address Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), the Agency previously assessed whether establishment of 
exemptions from the requirement of a tolerance might significantly 
impact a substantial number of small entities and concluded that, as a 
general matter, these actions do not impose a significant economic 
impact on a substantial number of small entities. This analysis for 
tolerance establishments and modifications was published in the Federal 
Register of May 4, 1981 (46 FR 24950) and was provided to the Chief 
Counsel for Advocacy of the Small Business Administration. Taking into 
account this analysis, and available information concerning the 
pesticides listed in this rule, the Agency hereby certifies that this 
proposed rule will not have a significant negative economic impact on a 
substantial number of small entities. Furthermore, for the pesticides 
named in this rule, the Agency knows of no extraordinary circumstances 
that exist as to the present rule that would change EPA's previous 
analysis. No comments were submitted concerning EPA's similar 
determination in the proposed rule.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

Edward Messina,
Acting Director, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, the EPA amends 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.940 amend paragraph (a) by adding to the table, in 
alphabetical order, the entries of ``Dipropylene glycol'' and 
``Triethylene glycol'' to read as follows:


Sec.  180.940  Tolerance exemptions for active and inert ingredients 
for use in antimicrobial formulations (Food-contact surface sanitizing 
solutions).

* * * * *
    (a) * * *

                            Table 180.940(a)
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       Pesticide chemical          CAS Reg. No.           Limits
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                              * * * * * * *
Dipropylene glycol..............      25265-71-8  None.
 
                              * * * * * * *
Triethylene glycol..............        112-27-6  None.
 
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[FR Doc. 2020-23199 Filed 11-2-20; 8:45 am]
BILLING CODE 6560-50-P


