Document ID: EPA-HQ-OPP-2020-0347-0006
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Propamocarb
Posted Date: 2021-10-19T04:00Z

[Federal Register Volume 86, Number 199 (Tuesday, October 19, 2021)]
[Rules and Regulations]
[Pages 57753-57757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22707]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0347; FRL-8871-01-OCSPP]

Propamocarb; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
propamocarb in or on Vegetable, Brassica, head and stem, group 5-16. 
The Interregional Project Number 4 (IR-4) requested this tolerance 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 19, 2021. Objections and 
requests for hearings must be received on or before December 20, 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 docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2020-0347, 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 is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805.
    Due to the public health emergency, the EPA Docket Center (EPA/DC) 
and

[[Page 57754]]

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: Marietta Echeverria, Acting Director, 
Registration Division (7505P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; main telephone number: (703) 305-7090; 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 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).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 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-2020-0347 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 
December 20, 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 number EPA-HQ-OPP-2020-0347, 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/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. Summary of Petitioned-For Tolerance

    In the Federal Register of September 10, 2020 (85 FR 55810) (FRL-
10013-78), EPA issued a document pursuant to FFDCA section 408(d)(3), 
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
0E8832) by Interregional Project Number 4 (IR-4), Rutgers, The State 
University of New Jersey, 500 College Road East, Suite 201W, Princeton, 
NJ 08540. The petition requested that 40 CFR 180.499 be amended by 
establishing a tolerance for residues of the fungicide propamocarb, 
(propyl N-[3-(dimethylamino)propyl]carbamate), in or on Vegetable, 
Brassica, head and stem, group 5-16 at 15 parts per million (ppm). That 
document referenced a summary of the petition prepared by IR-4, the 
petitioner, which is available in docket for this action, Docket ID 
EPA-HQ-OPP-2020-0347, at https://www.regulations.gov. Two comments were 
received on the notice of filing. EPA's response to these comments is 
discussed in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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(b)(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(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), and the factors 
specified in 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 for propamocarb including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with propamocarb follows.
    In an effort to streamline its publications in the Federal 
Register, EPA is not reprinting sections of the rule that would repeat 
what has been previously published in tolerance rulemakings for the 
same pesticide chemical. Where scientific information concerning a 
particular pesticide chemical remains unchanged, the content of those 
sections would not vary between tolerance rulemakings and republishing 
the same sections is unnecessary and duplicative. EPA considers 
referral back to those sections as sufficient to provide an explanation 
of the information EPA considered in making its safety determination 
for the new rulemaking.
    EPA has previously published a number of tolerance rulemakings for 
propamocarb, in which EPA concluded, based on the available 
information, that there is a reasonable certainty that no harm would 
result from aggregate exposure to propamocarb and established 
tolerances for residues of that chemical. EPA is incorporating 
previously published sections from

[[Page 57755]]

those rulemakings as described further in this rulemaking, as they 
remain unchanged.

A. Toxicological Profile

    For a summary of the Toxicological Profile of propamocarb, see Unit 
III.A. of the December 5, 2019 rulemaking (84 FR 66616) (FRL-10000-33).

B. Toxicological Points of Departure/Levels of Concern

    For a summary of the Toxicological Points of Departure/Levels of 
Concern used for the risk assessment, see Unit III.B. of the February 
7, 2017 rulemaking (82 FR 9519) (FRL-9957-68).

C. Exposure Assessment

    Much of the exposure assessment remains the same, although the 
dietary exposure and risk assessments for propamocarb were updated. 
These updates are discussed in this section; for a description of the 
rest of EPA's approach to and assumptions for the exposure assessment, 
see Unit III.C. of the December 5, 2019 rulemaking.
    EPA's dietary exposure assessments have been updated to include the 
additional exposures for the new use of propamocarb on the commodities 
in crop group 5-16. The assessment used the same assumptions as the 
December 5, 2019 rule concerning tolerance-level residues, default and 
empirical processing factors and 100% crop treated (PCT) for all 
commodities in both the acute and chronic dietary exposure assessments.
    Drinking water, non-occupational, and cumulative exposures. 
Drinking water and non-occupational exposures are not impacted by the 
new use, and thus have not changed since the last assessment. For a 
summary of the dietary exposures from drinking water, see Unit III.C.2. 
of the December 5, 2019 rulemaking. Propamocarb is registered for use 
on golf course turf resulting in potential residential post-application 
dermal exposure. During Registration Review, a dermal endpoint was not 
selected; therefore, a quantitative residential dermal exposure 
assessment was not necessary and was not conducted. EPA's conclusions 
concerning cumulative risk remain unchanged from Unit III.C.4. of the 
December 5, 2019 rulemaking.
    Safety factor for infants and children. EPA continues to conclude 
that there is reliable data showing that the safety of infants and 
children would be adequately protected if the FQPA SF were reduced from 
10X to 1X for all exposure scenarios. The reasons for that decision are 
articulated in Unit III.D in the December 5, 2019 rulemaking.
    Aggregate risks and Determination of safety. EPA determines whether 
acute and chronic dietary pesticide exposures are safe by comparing 
dietary exposure estimates to the acute population adjusted dose (aPAD) 
and the chronic population adjusted dose (cPAD). Short-, intermediate-, 
and chronic-term risks are evaluated by comparing the estimated 
aggregate food, water, and residential exposure to the appropriate 
points of departure to ensure that an adequate margin of exposure (MOE) 
exists. For linear cancer risks, EPA calculates the lifetime 
probability of acquiring cancer given the estimated aggregate exposure.
    Acute dietary risks are below the Agency's level of concern of 100% 
of the aPAD; they are 42% of the aPAD for all infants, the most highly 
exposed subpopulation. Chronic dietary risks are below the Agency's 
level of concern of 100% of the cPAD; they are 54% of the cPAD for 
females 13 to 49 years old, the most highly exposed subpopulation.
    A short-and intermediate-term oral adverse effect was identified; 
however, propamocarb is not registered for any use patterns that would 
result in either short- or intermediate-term oral residential exposure. 
Short- and intermediate-term risk is assessed based on short- and 
intermediate-term residential exposure plus chronic dietary exposure. 
Because there is no short- or intermediate-term oral residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess short- or intermediate-term risk), no further 
assessment of short- or intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating short- and 
intermediate-term risk for propamocarb. Additionally, based on the lack 
of evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, propamocarb is not expected to pose a cancer risk to humans.
    Therefore, based on the risk assessments and information described 
above, EPA concludes there is a reasonable certainty that no harm will 
result to the general population, or to infants and children, from 
aggregate exposure to propamocarb residues. More detailed information 
about the Agency's analysis can be found at https://www.regulations.gov 
in the document titled ``Propamocarb Hydrochloride (HCl). Human Health 
Risk Assessment for Proposed Uses in/on Vegetable, Brassica, Head and 
Stem, group 5-16'' in docket ID number EPA-HQ-OPP-2020-0347.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the December 5, 2019 rulemaking.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    Codex MRLs for residues of propamocarb in/on cabbage, cauliflower, 
and broccoli are 3 ppm, 2 ppm, and 1 ppm, respectively. As these levels 
are significantly less than the recommended tolerance level of 15 ppm 
for Vegetable, Brassica, head and stem, group 5-16, harmonization is 
not possible because U.S. growers could have violative residues despite 
legal use of propamocarb according to the label.

C. Response to Comments

    Two comments were submitted to the docket in response to the 
September 10, 2020 Notice of Filing. The first commenter stated that 
there need to be regulations for residues of pesticide chemicals in/on 
various commodities but expressed concern about the increasing use of 
pesticides. The commenter urged EPA to fully evaluate the submitted 
data as soon as possible to protect the U.S. public. Another commenter 
expressed concerns regarding producers making products cheaper or using 
pesticides for economic gain without considering human health. The 
commenter stated that the government should have the ability to monitor 
the chemicals put into food.
    The Agency appreciates these comments and believes that the laws 
applicable to pesticide tolerances address these concerns. 
Specifically, the existing legal framework provided by

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section 408 of the FFDCA authorizes EPA to establish tolerances when it 
determines that the tolerance is safe. As explained in this rule and in 
the supporting human health risk assessment in docket ID number EPA-HQ-
OPP-2020-0347, EPA makes this determination based on an analysis of the 
toxicology studies and then conducting detailed exposure and risk 
assessments. The Agency's thorough process considers the validity, 
completeness, and reliability of the available data as well as other 
factors required by the FFDCA. For more information on the general 
principles EPA uses in risk characterization and a complete description 
of the risk assessment process, see https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticide.

V. Conclusion

    Therefore, tolerances are established for residues of propamocarb, 
(propyl N-[3-(dimethylamino)propyl]carbamate), in or on Vegetable, 
Brassica, Head and Stem, Group 5-16 at 15 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in 
response to petitions submitted to the Agency. 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 ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001), or to Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    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.

    Dated: October 8, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
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.  180.499, amend table 1 to paragraph (a) by adding in 
alphabetical order the entry ``Vegetable, Brassica, Head and Stem, 
Group 5-16'' to read as follows:

Sec.  180.499   Propamocarb; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                              * * * * * * *
Vegetable, Brassica, Head and Stem, Group 5-16..............          15
 
                              * * * * * * *
------------------------------------------------------------------------

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[FR Doc. 2021-22707 Filed 10-18-21; 8:45 am]
BILLING CODE 6560-50-P