[Federal Register Volume 89, Number 123 (Wednesday, June 26, 2024)]
[Rules and Regulations]
[Pages 53356-53359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14001]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2023-0639; FRL-11977-01-OCSPP]


Spiromesifen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
spiromesifen in or on Oranges and Orange, oil. Bayer CropScience, LP 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective June 26, 2024. Objections and 
requests for hearings must be received on or before August 26, 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-2023-0639, 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 OPP Docket is (202) 566-1744. For the latest status 
information on EPA/DC services, docket access, visit https://www.epa.gov/.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration 
Division (7505T), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; 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(g), 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-2023-0639 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 
August 26, 2024. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    EPA's Office of Administrative Law Judges (OALJ), in which the 
Hearing Clerk is housed, urges parties to file and serve documents by 
electronic means only, notwithstanding any other particular 
requirements set forth in other procedural rules governing those 
proceedings. See ``Revised Order Urging Electronic Service and 
Filing'', dated June 22, 2023, which can be found at https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf.
    Although EPA's regulations require submission via U.S. Mail or hand 
delivery, EPA intends to treat submissions filed via electronic means 
as properly filed submissions; therefore, EPA believes the preference 
for submission via electronic means will not be prejudicial. When 
submitting documents to the OALJ electronically, a person should 
utilize the OALJ e-filing system at https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf.
    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

[[Page 53357]]

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-2023-0639, 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. Summary of Petitioned-For Tolerance

    In the Federal Register of February 9, 2024 (89 FR 9103) (FRL-
10579-12-OCSPP), EPA issued a document pursuant to FFDCA section 
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide 
petition (PP 2E9039) by Bayer CropScience, AG, 800 N Lindbergh Blvd., 
St. Louis, MO 63141. The petition requested that 40 CFR 180.607 be 
amended by establishing tolerances for residues of the miticide 
spiromesifen, in or on orange at 0.15 parts per million (ppm); orange, 
oil at 40.0 ppm. That document referenced a summary of the petition 
prepared by Bayer CropScience, the registrant, which is available in 
the docket, 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.
    Based upon review of the data supporting the petition and in 
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA 
is establishing tolerances that vary from what is requested. The reason 
for these changes is explained in Unit IV.D.

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 spiromesifen including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with spiromesifen follows.
    In an effort to streamline its publications in the Federal 
Register, EPA is not reprinting sections that repeat what has been 
previously published for tolerance rulemaking of the same pesticide 
chemical. Where scientific information concerning a particular chemical 
remains unchanged, the content of those sections would not vary between 
tolerance rulemaking, and 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 tolerance rulemaking for 
spiromesifen in which EPA concluded, based on the available 
information, that there is a reasonable certainty that no harm would 
result from aggregate exposure to spiromesifen and established 
tolerances for residues of that chemical. EPA is incorporating 
previously published sections from this rulemaking as described further 
in this rulemaking, as they remain unchanged.

A. Toxicological Profile

    For a discussion of the Toxicological Profile of spiromesifen, see 
Unit III.A. of the spiromesifen tolerance rulemaking published in the 
Federal Register of September 11, 2018 (83 FR 45844) (FRL-9982-21).

B. Toxicological Points of Departure/Levels of Concern

    For a summary of the toxicity endpoint and point of departure 
selections for spiromesifen, please reference Unit III.B. of the 
September 11, 2018, rulemaking.

C. Exposure Assessment Updates

    EPA's exposure assessments have been updated to include the 
additional dietary exposure of spiromesifen on oranges and orange, oil. 
EPA's aggregate exposure assessment incorporated this additional 
dietary exposure, as well as exposure in drinking water and from 
residential sources, although the latter exposures are not impacted by 
the new import tolerance on oranges and thus have not changed since the 
last assessment. The registered residential uses and exposures that are 
incorporated into the aggregate assessment are described in Unit 
III.C.3 of the September 11, 2018, final rule.
    Further information about EPA's risk assessment and determination 
of safety can be found at https://www.regulations.gov in the document 
titled ``Spiromesifen. Section 3 Human Health Risk Assessment for 
Tolerances without U.S. Registration on Oranges from Brazil'' dated 
December 20, 2023, in docket ID EPA-HQ-OPP-2023-0639.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an 
additional tenfold (10X) margin of safety for infants and children to 
account for potential prenatal and postnatal toxicity. In applying this 
provision, EPA either retains the default value of 10X, or uses a 
different safety factor supported by the completeness and reliability 
of the toxicity database and exposure considerations that is considered 
protective of infants and children. For spiromesifen, the risk 
assessment supports the reduction of the Food Quality Protection Act 
(FQPA) Safety Factor (SF) to 1X based on the following: (1) there was 
no evidence of increased susceptibility observed in the developmental 
toxicity studies in rats and rabbits, (2) while there was 
susceptibility observed in the 2-generation reproduction study in rats, 
the current PODs are based on these effects, with clear NOAELs/LOAELs 
established, and are therefore considered protective, (3) while the dog 
appears to be the more sensitive species in regards to thyroid toxicity 
in the spiromesifen database, the current PODs

[[Page 53358]]

based on offspring effects in rats are 2.5X lower than the lowest dose 
where thyroid effects occurred in dogs, (4) label changes have been 
made that result in MOEs at least 10X above the LOC and lower %cPAD 
estimates based on a less refined dietary assessment, which adds an 
additional built in margin of safety. Based on the overall weight of 
evidence, EPA concludes that the current endpoints and PODs, along with 
the additional built in safety margins from the recent label changes, 
result in risk estimates that are protective of any potential thyroid 
effects that may occur at sensitive lifestages in humans, including 
infants and children. For more details about the FQPA Safety Factor and 
the justification for lowering the margin from 10X to 1X, see the 
December 20, 2023, human health risk assessment, in docket ID EPA-HQ-
OPP-2023-0639.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute population-adjusted dose (aPAD) and 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.
    1. Acute risk. No acute dietary endpoint was selected as no 
appropriate toxicological effects attributable to a single dose were 
observed. As a result, spiromesifen is not expected to pose an acute 
risk.
    2. Chronic risk. Chronic dietary risk estimates are below the 
Agency's level of concern of 100% of the cPAD; which were 11% of the 
cPAD for the general U.S. population and 21% of the cPAD for children 1 
to 2 years old, the most highly exposed population subgroup. As no 
long-term residential exposures are expected based on the use pattern 
for spiromesifen, the Agency is confident that the assessment does not 
underestimate risk to the general U.S. population or any population 
subgroup.
    3. Short- and Intermediate-term risk. EPA has concluded the highest 
anticipated short-/intermediate term aggregate risk estimates for 
children and adults did not present risks of concern, with margins of 
exposure of 580 for adults, and 750 for children 6 to 11 years old, 
which are all above the level of concern of 100. Long-term aggregate 
exposure is not anticipated for residential uses. Therefore, chronic 
aggregate risk estimates for spiromesifen include food and drinking 
water only, and are equivalent to the chronic dietary risk estimates, 
which are below the level of concern.
    4. Aggregate cancer risk for U.S. Based on the lack of evidence of 
carcinogenicity in two adequate rodent carcinogenicity studies, 
spiromesifen is not expected to pose a cancer risk to humans.
    5. Determination of safety. 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 
spiromesifen residues. More detailed information on the subject action 
to establish a tolerance on oranges and orange, oil can be found in the 
document entitled, ``Spiromesifen. Human Health Risk Assessment for 
Tolerances without U.S. Registration on Oranges from Brazil'' in docket 
ID EPA-HQ-OPP-2023-0639.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the September 11, 2018, 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.
    The Codex has not established a MRL for spiromesifen on oranges or 
orange, oil.

C. Response to Comments

    The Agency received two comments from anonymous sources, both 
expressing dislike for pesticide tolerances in general, and requesting 
that EPA eliminate all pesticide tolerances. While the Agency 
recognizes that some people do not like pesticides, it nevertheless has 
a statutory obligation to review pesticide applications and determine 
whether use of a pesticide meets the FIFRA and FFDCA/FQPA safety 
standards of causing no unreasonable adverse effects to people or the 
environment, and to ensure a reasonable certainty of no harm from 
potential dietary exposure (including drinking water), respectively. 
Here, the Agency has evaluated the aggregate risk of spiromesifen and 
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 spiromesifen residues. The commentors offered no 
relevant information that would warrant a reconsideration of the 
Agency's determination.

D. Revisions to Petitioned-For Tolerances

    The Agency-recommended tolerance in/on orange is identical to that 
proposed by the petitioner. However, the Agency has determined that the 
proposed tolerance for orange, oil at 40 ppm should instead be set for 
the correct commodity definition, orange subgroup 10-10A, oil and at 10 
ppm. The revised tolerance level addresses an error in the petitioner's 
calculations, as it appears the petitioner calculated a proposed 
tolerance level of 40 ppm for oil using the proposed tolerance level 
for orange of 0.15 ppm, multiplied by the median processing factor. 
However, the Agency uses the average residue for a blended commodity 
multiplied by the median processing factor. Using the OECD Rounding 
Class Practice, the recommended tolerance level for residues in/on 
orange subgroup 10-10A, oil is 10 ppm. For more detailed information on 
this revision see ``Spiromesifen. Human Health Risk Assessment for 
Tolerances without U.S. Registration on Oranges from Brazil'' in docket 
ID EPA-HQ-OPP-2023-0639.

V. Conclusion

    Therefore, tolerances are established for residues of spiromesifen 
on orange at 0.15 parts per million and orange subgroup 10-10A, oil at 
10 parts per million.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and

[[Page 53359]]

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 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).
    Because 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: June 21, 2024.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA amends 40 
CFR chapter 1 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.  180.607, amend the table in paragraph (a)(1) by:
0
a. Adding the table heading ``Table 1 to paragraph (a)(1)''; and
0
b. Adding in alphabetical order the entries ``Orange\2\''; and ``Orange 
subgroup 10-10A, oil\2\''.
    The additions read as follows:


Sec.  180.607  Spiromesifen; tolerances for residues.

    (a) * * *
    (1) * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Orange \2\.................................................         0.15
Orange subgroup 10-10A, oil \2\............................           10
 
                                * * * * *
------------------------------------------------------------------------
\1\ This use has not been registered in the United States as of August
  28, 2018.
\2\ There are no U.S. registrations for these commodities as of June 26,
  2024.

* * * * *
[FR Doc. 2024-14001 Filed 6-25-24; 8:45 am]
BILLING CODE 6560-50-P