[Federal Register Volume 85, Number 187 (Friday, September 25, 2020)]
[Rules and Regulations]
[Pages 60363-60365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19762]



40 CFR Part 180

[EPA-HQ-OPP-2019-0388; FRL-10013-77]

Saflufenacil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
saflufenacil in or on the caneberry subgroup 13-07A, fig, chia seed and 
chia straw. Interregional Research Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 

DATES: This regulation is effective September 25, 2020. Objections and 
requests for hearings must be received on or before November 24, 2020, 
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-2019-0388, is available at http://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 concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and 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, 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].


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 Government 
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2019-0388 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 
November 24, 2020. 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-2019-0388, 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 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 
     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.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 2, 2019 (84 FR 37818) (FRL-9996-
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 
9E8763) by IR-4, IR-4 Project Headquarters, Rutgers, The

[[Page 60364]]

State University of New Jersey, 500 College Road East, Suite 201 W, 
Princeton, NJ 08540. The petition requested the establishment of 
tolerances in 40 CFR 180.613(a) for residues of the herbicide 
saflufenacil, including its metabolites and degradates, in or on the 
following raw agricultural commodities: Caneberry subgroup 13-07A at 
0.03 parts per million (ppm), Chia, seed at 1 ppm, Chia, straw at 15 
ppm, Fig at 0.03 ppm, and Fig, dried at 0.05 ppm. That document 
referenced a summary of the petition prepared by BASF, the registrant, 
which is available in the docket, http://www.regulations.gov. No 
comments were received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA is 
establishing tolerances that vary from what was requested. The reasons 
for these changes are explained 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 saflufenacil including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with saflufenacil follows.
    On November 25, 2015, EPA published in the Federal Register a final 
rule establishing tolerances for residues of saflufenacil in or on 
pomegranate based on the Agency's conclusion that aggregate exposure to 
saflufenacil is safe for the general population, including infants and 
children. See (80 FR 73663) (FRL-9936-71). EPA is incorporating the 
following portions of that document by reference here, as they have not 
changed in the Agency's current assessment of saflufenacil tolerances: 
The toxicological profile and points of departure, the conclusions 
about cumulative risk, and the Agency's determination regarding the 
children's safety factor. EPA's dietary (food and drinking water) 
exposure assessments have been updated to include the additional 
exposure from the new uses of saflufenacil on the caneberry subgroup, 
fig, and chia.
    The assessment used the same assumptions concerning percent crop 
treated and tolerance-level residues and the same estimated drinking 
water concentrations as the November 25, 2015 final rule.
    Acute dietary risks are below the Agency's level of concern of 100% 
of the acute population adjusted dose (aPAD): They are less than 1% of 
the aPAD for all infants less than 1 year old, the population subgroup 
with the highest exposure estimate. Chronic dietary risks are below the 
Agency's level of concern of 100% of the chronic population adjusted 
dose (cPAD): They are 20% of the cPAD for all infants less than 1 year 
old, the population subgroup with the highest exposure estimate. There 
is no short- or intermediate-term exposure expected since there are no 
residential uses. Therefore, the acute and chronic aggregate risks 
consist only of the dietary risks from food and water and, as stated 
above, are below the Agency's level of concern.
    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 saflufenacil residues. More detailed information 
about the Agency's analysis can be found at http://www.regulations.gov 
in the document titled ``Saflufenacil. Human Health Risk Assessment in 
Support of Tolerances for Residues in/on Pomegranate'' dated November 
5, 2015 in docket ID EPA-HQ-OPP-2014-0640 and the document titled 
``Saflufenacil. Human Health Draft Risk Assessment for a Petition to 
Establish Tolerances for Residues in/on Caneberry Subgroup 13-07A, Fig, 
and Chia'' dated August 7, 2020 in docket ID number EPA-HQ-OPP-2019-

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass 
spectroscopy/mass spectroscopy (LC/MS/MS) Method D0603/02 is available 
to enforce the tolerance expression. The method may be requested from: 
Chief, Analytical Chemistry Branch, Environmental Science Center, 701 
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; 
email address: [email protected].

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. No Codex MRLs have been 
established for saflufenacil on fig, chia and caneberry.

C. Revisions to Petitioned-For Tolerances

    The tolerance levels being established by EPA for the caneberry 
subgroup 13-07A and fig differ from those proposed by the petitioner 
due to differences in calculating the combined limits of quantitation 
(LOQs) for residues of saflufenacil and its metabolites. The combined 
LOQs of 0.035 ppm were rounded to 0.04 ppm by EPA versus 0.03 ppm by 
the petitioner. For chia, EPA is translating from the currently 
established tolerances for residues on wheat commodities rather than 
barley commodities, resulting in tolerance levels of 0.6 ppm for Chia, 
seed and 6 ppm for Chia, straw. Quantifiable residues were found in 
dried figs; however, when residues are adjusted for the degree of 
exaggeration, the residue value is below the recommended fresh fig 
tolerance level (0.04 ppm). A separate tolerance for residues on dried 
fig is therefore not required.

[[Page 60365]]

V. Conclusion

    Therefore, tolerances are established for residues of saflufenacil 
in or on the caneberry subgroup 13-07A at 0.04 ppm; chia, seed at 0.6 
ppm; chia, straw at 6 ppm; and fig at 0.04 ppm.

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 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), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). 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 tolerances and 
modifications 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: August 25, 2020.
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:


1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

2. In Sec.  180.649 amend paragraph (a)(1) by designating the table and 
adding, alphabetical order, in newly designated Table 1 to paragraph 
(a)(1) the entries ``Caneberry subgroup 13-07A''; ``Chia, seed''; 
``Chia, straw''; and ``Fig'' to read as follows:

Sec.  180.649  Saflufenacil; tolerances for residues.

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

                       Table 1 to Paragraph (a)(1)
                                                             Parts per
                        Commodity                             million
                              * * * * * * *
Caneberry subgroup 13-07A...............................            0.04
Chia, seed..............................................             0.6
Chia, straw.............................................               6
                              * * * * * * *
Fig.....................................................            0.04
                              * * * * * * *

* * * * *
[FR Doc. 2020-19762 Filed 9-24-20; 8:45 am]