[Federal Register Volume 89, Number 169 (Friday, August 30, 2024)]
[Rules and Regulations]
[Pages 70525-70527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19531]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2023-0409; FRL-12214-01-OCSPP]
RIN 2070-ZA16


Phenol; Revoking Exemption From the Requirement of a Pesticide 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation revokes 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 established 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.

DATES: This regulation is effective February 26, 2025. Objections and 
requests for hearings must be received on or before October 29, 2024, 
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 docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2023-0409, is available at 
https://www.regulations.gov or in person 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. Additional instructions for visiting the docket, along with 
more information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Anita Pease, Antimicrobials Division 
(7510M), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
202-566-0736; email address: [email protected] or 
[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 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 Federal Register Office'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 29, 2024. Notwithstanding the procedural requirements of 40 CFR 
178.25(b), the Office of the Administrative Law Judges has issued an 
order urging parties to file and serve documents with the Tribunal by 
electronic means only. See Revised Order Urging Electronic Filing and 
Service (dated June 22, 2023), https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf.
    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.

[[Page 70526]]

     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/contacts.html.
    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. Proposed Rule

    In the Federal Register of August 22, 2023 (88 FR 57026) (FRL-
11232-01-OSCPP), EPA proposed 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 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. Additionally, the Registration Review Draft Risk Assessment 
for Phenol and Salts indicated aggregate risks of concern are likely to 
result from exposures to phenol pesticide products. Updates have been 
made to phenol pesticide labels to reduce exposures to phenol through 
the dietary pathway by preventing the use of these products on food 
contact surfaces, thereby mitigating the aggregate risks of concern. 
Revoking phenol's inert tolerance exemption will ensure that dietary 
exposures do not result from the inert uses of phenol, further 
mitigating potential exposures that would contribute to aggregate risks 
of concern. 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.

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

    Under section 408(e) of the FFDCA, EPA can establish, modify, or 
revoke an exemption from the requirement of a tolerance for residues of 
a pesticide chemical after publishing a proposed rule and providing 60-
day period for public comment. 21 U.S.C. 346a(e). EPA published the 
proposed rule on August 22, 2023, and provided 60 days for public 
comment (until October 23, 2023).

C. When does this action become effective?

    EPA is establishing this rule with an effective date that is six 
months after the date of publication of the final rule in the Federal 
Register (February 26, 2025). EPA is setting 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. Final Rule

A. Comments

    Three individuals submitted comments that supported the proposed 
rule. Public comments are posted to the docket for this tolerance 
rulemaking action (docket EPA-HQ-OPP-2023-0409 at https://www.regulations.gov). There were no comments requesting retention of 
the phenol tolerance exemption.

B. Final Rule

    As discussed in the proposed rule, EPA is revoking 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. EPA has 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 at this time. Because 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 revoking 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

    Additional information about these statutes and Executive Orders 
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders#influence.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulations and Regulatory Review

    This action is exempt from review by the Office of Management and 
Budget (OMB) under Executive Orders 12866 (58 FR 51735, October 4, 
1993) and 13563 (76 FR 3821, January 21, 2011). OMB has exempted this 
type of action (e.g., tolerance revocation for which extraordinary 
circumstances do not exist) from review. These revocations are not 
expected to present extraordinary circumstances because no 
registrations containing phenol or relying on these tolerances have 
existed for several years. Because this rule has been exempted from 
review under Executive Order 12866, this 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).

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under 
the PRA, 44 U.S.C. 3501 et seq., because it does not contain any 
information collection activities.

[[Page 70527]]

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. Because this use has not been registered in the 
United States for some time, there has been no need for this tolerance 
exemption and thus the revocation will impose no net burden on small 
entities subject to the rule. Furthermore, the Agency did not receive 
any comments on these conclusions as presented in the proposed rule.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in 
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect 
small governments. The action imposes no enforceable duty on any state, 
local or tribal governments or the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in 
Executive Order 13132, August 10, 1999 (64 FR 43255). 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.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications as specified in 
Executive Order 13175, November 9, 2000 (65 FR 67249), because it will 
not have substantial direct effects 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.

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

    Executive Order 13045 (62 FR 19885, April 23, 1997) directs federal 
agencies to include an evaluation of health and safety effects of the 
planned regulation on children in federal health and safety standards 
and explain why the regulation is preferable to potential effective and 
reasonably feasible alternatives. This action is also not subject to 
Executive Order 13045 because it is not a significant regulatory action 
under section 3(f)(1) of Executive Order 12866 (See Unit V.A.). 
However, EPA's Policy on Children's Health applies to this action. 
Since phenol has not been used in any registered pesticides for several 
years, it is unlikely that there has been much, if any, exposure to 
children from pesticide use. The revocation of the tolerance exemption 
also ensures that residues of the pesticide will not be in food.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution or Use

    This action is not a subject to Executive Order 13211 (66 FR 28355, 
May 22, 2001) because it is not a significant regulatory action under 
Executive Order 12866.

I. National Technology Transfer Advancement Act (NTTAA)

    This action does not involve technical standards under NTTAA 
section 12(d), 15 U.S.C. 272.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) directs 
federal agencies, to the greatest extent practicable and permitted by 
law, to make environmental justice part of their mission by identifying 
and addressing, as appropriate, disproportionately high and adverse 
human health or environmental effects of their programs, policies, and 
activities on minority populations (people of color and/or indigenous 
peoples) and low-income populations. As discussed in more detail in the 
pesticide specific risk assessments conducted as part of the 
registration review for phenol, EPA has considered the safety risks for 
phenol. EPA believes that the human health and environmental conditions 
that exist prior to this action do not result in disproportionate and 
adverse effects on people of color, low-income populations, and/or 
indigenous peoples. Furthermore, EPA believes that this action is not 
likely to result in new disproportionate and adverse effects on people 
of color, low-income populations and/or indigenous peoples.

K. 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 each House of the Congress and to 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 180

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

    Dated: August 26, 2024.
Anita Pease,
Director, Antimicrobials Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended to read 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. 2024-19531 Filed 8-29-24; 8:45 am]
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