[Federal Register Volume 88, Number 161 (Tuesday, August 22, 2023)]
[Proposed Rules]
[Pages 57026-57029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18050]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2023-0409; FRL-11232-01-OCSPP]
RIN 2070-ZA16


Phenol; Revoking Exemption From the Requirement of a Pesticide 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to revoke the tolerance exemption for 
residues of the antimicrobial pesticide ingredient phenol when used as 
an inert ingredient (solvent/cosolvent) in pesticide formulations 
applied to growing crops. This rulemaking is proposed on the Agency's 
own initiative under the Federal Food, Drug, and Cosmetic Act (FFDCA) 
to implement a tolerance action the Agency determined was appropriate 
during the registration review conducted under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) for phenol. EPA is proposing to 
revoke this tolerance exemption because it corresponds to a use no 
longer current or registered under FIFRA in the United States.

DATES: Comments must be received on or before October 23, 2023.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2023-0409, is available at 
https://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 and the OPP Docket is (202) 566-1744. Please review the 
visitor instructions and additional information about the docket 
available at https://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: 
202-566-0736; email address: [email protected].

SUPPLEMENTARY INFORMATION:

[[Page 57027]]

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or 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.
     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 Office of the Federal Register's e-CFR site at 
https://www.ecfr.gov/current/title-40.

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 number EPA-HQ-OPP-2023-0409, 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 
October 23, 2023. 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 number EPA-HQ-OPP-2023-0409, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background

A. What action is the Agency taking?

    EPA is proposing to revoke the tolerance exemption in 40 CFR 
180.920 for residues of the antimicrobial pesticide ingredient phenol 
when used as an inert ingredient (solvent/cosolvent) in pesticide 
formulations applied to growing crops, because this tolerance exemption 
corresponds to a use no longer current or registered under FIFRA in the 
United States.

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

    EPA is proposing this action pursuant to its authority under 
section 408 of the FFDCA, 21 U.S.C. 346a. The Agency previously 
determined this action was appropriate during the registration review 
of phenol conducted under FIFRA, 7 U.S.C. 136 et seq.
    Under FIFRA section 3(g), 7 U.S.C. 136a(g), EPA is required to 
periodically review all registered pesticides and determine if those 
pesticides continue to meet the standard for registration under FIFRA. 
See also 40 CFR 155.40(a). As part of registration review, EPA 
evaluates whether existing tolerances are safe, whether any changes to 
existing tolerances are necessary or appropriate, and whether any new 
tolerances are necessary. 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. 346a, authorizes the establishment, modification, and revocation 
of tolerances or exemptions from the requirement of a tolerance for 
residues of pesticide chemicals in or on raw agricultural commodities 
and processed foods. Residues of pesticides in or on food that are not 
covered by a tolerance or exemption are deemed unsafe, 21 U.S.C. 
346a(a)(1). Any food containing unsafe residues is considered 
adulterated and may not be distributed in interstate commerce, 21 
U.S.C. 331(a), 342(a)(2)(B). For a food-use pesticide to be sold and 
distributed, the pesticide must not only have appropriate tolerances 
under the FFDCA but also must be registered under FIFRA, 7 U.S.C. 136 
et seq. Moreover, residues of food-use pesticides not registered in the 
United States must also be covered by a tolerance or exemption in order 
for commodities treated with those pesticides to be imported into the 
United States.
    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement of a tolerance only if EPA determines 
that the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of the 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) of the FFDCA 
requires EPA, when making a safety determination concerning an 
exemption, to take into account, among other relevant considerations, 
the considerations listed in section 408(b)(2)(C) and (D). Section 
408(b)(2)(C) requires EPA to give special consideration to exposure of 
infants and children to the pesticide chemical residue 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. . . .'' Section 408(b)(2)(D) identifies various factors, 
including available information on aggregate and cumulative exposure, 
for EPA's consideration in making a safety determination.
    Section 408(e) of the FFDCA, 21 U.S.C. 346a(e), authorizes EPA to 
initiate a rulemaking to establish, modify, or revoke tolerances or 
exemptions from the requirement of a tolerance on its own initiative. 
Prior to issuing the final regulation, section 408(e)(2) requires EPA 
to issue a notice of proposed rulemaking for a 60-day public comment 
period, unless the

[[Page 57028]]

Administrator for good cause finds that it would be in the public 
interest to have a shorter period and states the reasons in the 
rulemaking.
    Consistent with its obligations under FIFRA section 3(g) and FFDCA 
section 408, EPA has reviewed the available scientific data and other 
relevant information and determined it is appropriate to take the 
action being proposed in this rulemaking.

C. When does this action become effective?

    EPA is proposing that this action become effective six months after 
the date of publication of the final rule in the Federal Register. EPA 
is proposing this effective date for this action to allow a reasonable 
interval for producers in exporting members of the World Trade 
Organization's (WTO's) Sanitary and Phytosanitary (SPS) Measures 
Agreement to adapt to the requirements of the final rule.
    Any commodities treated with phenol in the channels of trade 
following the tolerance exemption revocation shall be subject to FFDCA 
section 408(l)(5), 21 U.S.C. 346a(l)(5). Under this section, any 
residues of this pesticide in or on such food shall not render the food 
adulterated so long as it is shown to the satisfaction of the Food and 
Drug Administration that the residue is present as the result of an 
application or use of the pesticide at a time and in a manner that was 
lawful under FIFRA and the residue does not exceed the level that was 
authorized at the time of the application or use to be present on the 
food under a tolerance or exemption, unless EPA determines that 
consumption of legally treated food during the period of its likely 
availability in commerce will pose unreasonable dietary risk. Evidence 
to show that food was lawfully treated may include records that verify 
the dates when the pesticide was applied to such food.

III. Proposed Rule

    EPA is proposing to revoke the tolerance exemption in 40 CFR 
180.920 for residues of phenol when used as an inert ingredient 
(solvent/cosolvent) in pesticide formulations applied to growing crops. 
In the August 2020 Phenol and Salt Interim Registration Review Decision 
(available at https://www.regulations.gov in docket ID number EPA-HQ-
OPP-2012-0810), EPA determined that there are no current registrations 
for pesticide products containing phenol as an inert ingredient 
(solvent/cosolvent) for use on growing crops, and therefore the 
tolerance exemption for phenol under 40 CFR 180.920 is not necessary 
and should be revoked. Moreover, there have been no registrations for 
use associated with this tolerance exemption for many years. The Agency 
therefore believes that existing stocks of pesticide products 
containing phenol for the use associated with this tolerance exemption 
have been exhausted and that treated commodities have cleared the 
channels of trade.

IV. Conclusion

    Therefore, EPA is proposing to revoke the exemption from the 
requirement of a tolerance for residues of phenol when used as an inert 
ingredient (solvent/cosolvent) in pesticide products used on growing 
crops.

V. Statutory and Executive Order Reviews

    In this proposed rule, EPA is proposing to revoke a specific 
tolerance exemption under its authority in FFDCA section 408(e). The 
Office of Management and Budget (OMB) has exempted this type of action 
(e.g., tolerance exemption revocation for which extraordinary 
circumstances do not exist) 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). 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 revocations of tolerances 
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 was published in the Federal Register of December 17, 
1997 (62 FR 66020) (FRL-5753-1) and was provided to the Chief Counsel 
for Advocacy of the Small Business Administration. Taking into account 
this analysis, and available information concerning the pesticide named 
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. In a memorandum dated May 25, 
2001, EPA determined that eight conditions must all be satisfied in 
order for an import tolerance or tolerance exemption revocation to 
adversely affect a significant number of small entity importers, and 
that there is a negligible joint probability of all eight conditions 
holding simultaneously with respect to any particular revocation. (This 
Agency document titled ``RFA/SBREFA Certification for Import Tolerance 
Revocation'' is available in the docket of this proposed rule.) 
Furthermore, for the pesticide 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 ``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

[[Page 57029]]

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: August 14, 2023.
Edward Messina,
Director, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR chapter I be amended 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.


Sec.  180.920  [Amended]

0
2. In Sec.  180.920, amend table 1 by removing the inert ingredient 
``Phenol''.

[FR Doc. 2023-18050 Filed 8-21-23; 8:45 am]
BILLING CODE 6560-50-P