[Federal Register Volume 85, Number 100 (Friday, May 22, 2020)]
[Proposed Rules]
[Pages 31130-31133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10805]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0219; FRL-10008-87]
RIN 2070-ZA16


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

AGENCY: Environmental Protection Agency (EPA).

[[Page 31131]]


ACTION: Proposed rule.

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SUMMARY: EPA is proposing 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. This rulemaking is proposed on the 
Agency's 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: Comments must be received on or before July 21, 2020.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) numbers EPA-HQ-OPP-2013-0219 and EPA-HQ-OPP-2013-0218 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: Anita Pease, Antimicrobials Division 
(7508P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
703-305-0392; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are 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).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. 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 
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

A. What action is the Agency taking?

    EPA is proposing to establish an exemption from the requirement of 
a tolerance for residues of the antimicrobial pesticides dipropylene 
glycol and triethylene glycol on food-contact surfaces in public eating 
places, dairy-processing equipment, and food-processing equipment and 
utensils. EPA is proposing this exemption to cover residues of 
dipropylene glycol and triethylene glycol that may be found in food as 
a result of the use of these antimicrobials on food-contact surfaces.
    As noted in the December 2017, Propylene Glycol, Dipropylene Glycol 
and Triethylene Glycol Interim Registration Review Decision (``Glycol 
Interim Decision'') (available at http://www.regulations.gov in docket 
ID numbers EPA-HQ-OPP-2013-0219 and EPA-HQ-OPP-2013-0218), dipropylene 
glycol and triethylene glycol are registered for use as disinfectants 
on food-contact surfaces in public eating places, dairy-processing 
equipment, and food-processing equipment and utensils. As a result of 
that use, residues of dipropylene glycol and triethylene glycol may be 
found in food that comes into contact with treated surfaces.
    According to the Agency's 2016 Antimicrobial Use Site Index 
(https://www.epa.gov/pesticide-registration/antimicrobial-pesticide-use-site-index), EPA categorizes that use as an ``indirect food use.'' 
40 CFR 158W requires a tolerance or exemption for direct and indirect 
food uses. Historically, EPA did not require a tolerance or tolerance 
exemption for the registered uses of dipropylene glycol and triethylene 
glycol because the labels required a potable water rinse after 
application. EPA's scientific assumption had been that if an 
antimicrobial pesticide use required a potable water rinse on the 
label, residues of the pesticide would be rinsed away. With no residues 
available to transfer to foods coming into contact with the treated 
food surface, the use was considered nonfood, and no tolerance or 
tolerance exemption was needed. That presumption of no available 
residues for transfer is no longer supportable because available data 
now suggests that a potable water rinse may not be 100% efficient in 
removing residues; therefore, the Agency no longer considers a use to 
be ``nonfood'' just because the label requires a potable water rinse. 
Absent information supporting a conclusion that no residues would be 
available for transfer to food from the use, a tolerance or tolerance 
exemption is required. As of this time, the Agency has not received any 
information supporting a conclusion that residues of dipropylene glycol 
and triethylene glycol would not be available for transfer to food 
after application to food surfaces.

B. What is the Agency's authority for taking this action?

    A ``tolerance'' represents the maximum level for residues of 
pesticide chemicals legally allowed in or on raw agricultural 
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 
346(a), authorizes the establishment of tolerances, exemptions from 
tolerance requirements, modifications in tolerances, and revocation of 
tolerances for residues of pesticide chemicals in or on raw 
agricultural commodities and processed foods. Without a tolerance or 
exemption, food containing pesticide residues are considered unsafe and 
therefore ``adulterated'' under FFDCA section 402(a), 21 U.S.C. 342(a). 
Such food may not be distributed in interstate commerce, 21 U.S.C. 
331(a).
    Section 408(e)(1)(B) of the FFDCA authorizes EPA to issue an 
exemption from the requirement of a tolerance on its own initiative. 21 
U.S.C.

[[Page 31132]]

346a(e)(1)(B). It is under section 408(e) of the FFDCA that EPA is 
proposing to establish the exemption in this rulemaking. The standard 
for establishing an exemption is found in section 408(c)(2)(A) of the 
FFDCA and is discussed below. 21 U.S.C. 346a(c)(2)(A).

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 of a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance 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. Section 408(c)(2)(B) requires EPA to take into 
account, among other things, the considerations set forth in section 
408(b)(2)(C) and (D). Specifically, section 408(b)(2)(C) of FFDCA 
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(b)(2)(D), 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 to support the establishment 
of exemptions from the requirement of a tolerance for residues of 
dipropylene glycol and triethylene glycol.
    As noted in the Glycol Interim Decision, there is no evidence of 
adverse effects for dipropylene and triethylene glycol in the toxicity 
database; therefore, EPA did not identify any toxicological endpoints 
of concern for assessing risk. Although the current uses have the 
potential to result in exposure to residues of dipropylene and 
triethylene glycol in or on food, including uses of these chemicals as 
inert ingredients, the low order of toxicity and low application rates 
from the current uses of these chemicals support a conclusion that 
exemptions from the requirement of a tolerance for these pesticide 
chemicals when used in antimicrobial formulations on food-contact 
surfaces in public eating places, on dairy-processing equipment, and on 
food-processing equipment and utensils would be safe. Based on the low 
order of toxicity and low exposure levels, EPA concludes that there is 
a reasonable certainty that no harm will result to the U.S. population, 
including all subpopulation groups, from aggregate exposure to 
dipropylene glycol or triethylene glycol. For further information, the 
Glycol Interim Decision can be found at https://www.regulations.gov in 
docket identification numbers EPA-HQ-OPP-2013-0218 (propylene and 
dipropylene glycol) and EPA-HQ-OPP-2013-0219 (triethylene glycol).

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 proposing to establish an 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.

IV. Statutory and Executive Order Reviews

    In this document, EPA is proposing to establish 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 proposed rule has 
been exempted from review under Executive Order 12866 due to its lack 
of significance, this proposed rule is not subject to Executive Order 
13211, entitled ``Actions Concerning Regulations That Significantly 
Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 
2001), nor is it subject to Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This proposed rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA) (44 
U.S.C. 3501 et seq.), or 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.). Nor does it require any 
special considerations as required by Executive Order 12898, entitled 
``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations'' (59 FR 7629, February 16, 
1994); or OMB review or any other Agency action under Executive Order 
13045, entitled ``Protection of Children from Environmental Health 
Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This proposed 
rule 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).
    Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), the Agency previously assessed whether establishment of 
tolerances, exemptions from tolerances, raising of tolerance levels, 
expansion of exemptions, or revocations 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. These analyses for tolerance 
establishments and modifications, and for tolerance revocations were 
published in the Federal Register of May 4, 1981 (46 FR 24950) and 
December 17, 1997 (62 FR 66020) (FRL-5753-1), respectively, and were 
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 proposed 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 proposed rule, 
the Agency knows of no extraordinary circumstances that exist as to the 
present proposed rule that would change EPA's previous analysis. Any 
comments about the Agency's determination should be submitted to the 
EPA along with comments on the proposed rule and will be addressed 
prior to issuing a final rule.
    In addition, the Agency has determined that this proposed rule will 
not have a substantial direct effect on 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, 
as specified in Executive Order 13132, entitled

[[Page 31133]]

``Federalism'' (64 FR 43255, August 10, 1999). Executive Order 13132 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by State and local officials in the development of 
regulatory policies that have federalism implications.'' ``Policies 
that have federalism implications'' is defined in the Executive order 
to include regulations that 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.'' This proposed rule directly regulates 
growers, food processors, food handlers, and food retailers, not 
States. This proposed rule does not alter the relationships or 
distribution of power and responsibilities established by Congress in 
the preemption provisions of FFDCA section 408(n)(4). For these same 
reasons, the Agency has determined that this proposed rule does not 
have any ``tribal implications'' as described in Executive Order 13175, 
entitled ``Consultation and Coordination with Indian Tribal 
Governments'' (65 FR 67249, November 9, 2000). Executive Order 13175 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, 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.'' This proposed rule will not 
have substantial direct effects on tribal governments, on the 
relationship between the Federal Government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this proposed rule.

List of Subjects in 40 CFR Part 180

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

    Dated: May 3, 2020.
Richard Keigwin,
Director, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 180--AMENDED

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. Revise Sec.  180.940 to add alphabetically the entries of 
``Dipropylene glycol'' and ``Triethylene glycol'' in the table in 
paragraph (a) 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)
* * * * *

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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. 2020-10805 Filed 5-21-20; 8:45 am]
 BILLING CODE 6560-50-P