[Federal Register Volume 85, Number 162 (Thursday, August 20, 2020)]
[Rules and Regulations]
[Pages 51354-51357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17155]



40 CFR Part 180

[EPA-HQ-OPP-2019-0659; FRL-10012-03]

Fludioxonil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
fludioxonil in or on Brassica, leafy greens, subgroup 4-16B, except 
watercress, at 15 parts per million (ppm); vegetable, Brassica, head 
and stem, group 5-16 at 2 ppm; kohlrabi at 2 ppm; modifies the current 
watercress tolerance from 7 ppm to 10 ppm; and removes existing 
tolerances for Brassica, head and stem, subgroup 5A and Brassica, leafy 
greens, subgroup 5B. Syngenta Crop Protection, LLC requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 20, 2020. Objections and 
requests for hearings must be received on or before October 19, 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-2019-0659, 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.
    Please note that due to the public health emergency the EPA Docket 
Center (EPA/DC) and Reading Room was closed to public visitors on March 
31, 2020. Our EPA/DC staff will continue to provide customer service 
via email, phone, and webform. For further information on EPA/DC 
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, 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-2019-0659 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 19, 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-2019-0659, 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

[[Page 51355]]

available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of February 10, 2020 (85 FR 7500) (FRL-
10005-02), 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 
9F8754) by Syngenta Crop Protection, LLC, 410 Swing Road, Greensboro, 
NC 27409. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the fungicide fludioxonil, 4-
(2, 2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile, in or 
on Brassica leafy greens subgroup 4-16B at 10.0 parts per million 
(ppm); Vegetable, Head and Stem Brassica, Group 5-16 at 2.0 ppm; and 
Kohlrabi at 2.0 ppm. The petition also requested that the following 
established tolerances be removed: Brassica, leafy greens, subgroup 5B 
at 10.0 ppm and Brassica, head and stem, subgroup 5A at 2.0 ppm. That 
document referenced a summary of the petition prepared by Syngenta Crop 
Protection, LLC, the registrant, which is available in the docket, 
    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, EPA is 
establishing the requested tolerances, with slight modifications for 
consistency with the Organisation for Economic Co-Operation and 
Development (OECD) tolerance-rounding class practice and EPA's 
commodity vocabulary and harmonization with the Codex Alimentarius 
Commission (Codex). In addition, EPA is establishing tolerances for 
watercress and subgroup 4-16B that vary slightly from what the 
petitioner requested. The reasons for these changes are discussed 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 fludioxonil including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with fludioxonil follows.
    In the Federal Register on November 6, 2018 (83 FR 55491) (FRL-
9982-75), EPA published a final rule establishing a tolerance for 
residues of the fungicide fludioxonil in or on beet, sugar, roots. That 
document contains a summary of the toxicological profile and points of 
departure, assumptions for exposure assessment, and the Agency's 
determination concerning the children's safety factor, which have not 
changed. Those discussions are incorporated by reference into this 
document. The Agency conducted a revised risk assessment to incorporate 
exposure to residues of fludioxonil from use on Brassica, leafy greens, 
subgroup 4-16B; Vegetable, Brassica, head and stem, group 5-16; and 
    An acute dietary assessment was not performed because there were no 
adverse effects resulting from a single oral exposure was identified 
and no acute dietary endpoint was selected. Therefore, fludioxonil is 
not expected to pose an acute risk. As to residue levels in food, an 
unrefined chronic dietary exposure and risk assessment was conducted 
assuming 100% percent crop treated (PCT) and tolerance-level residues 
for all food commodities. EPA assessed the exposure in drinking water, 
additional dietary exposure and the overall aggregate exposure.
    Chronic dietary risks are below the Agency's level of concern: 54% 
of the chronic population-adjusted dose (cPAD) for children 1 to 2 
years old, the population group receiving the greatest exposure. 
Moreover, the short-term aggregate risk for the populations with the 
highest total exposure margin of exposure (MOEs) of 15,000 for adults 
and 4,600 for children 1 to 2 years old. Using the exposure assumptions 
described for short-term exposures, EPA has concluded the combined 
short-term food, water, and residential exposures result in aggregate 
MOEs above the level of concern (LOC) of 100 for all scenarios assessed 
and are not of concern.
    Intermediate- and long-term aggregate risk assessments were not 
performed because there are no registered or proposed uses of 
fludioxonil that result in intermediate- or long-term residential 
exposures. The chronic aggregate exposure assessment consists of 
exposure from food and water only.
    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, including infants and children, from 
aggregate exposure to fludioxonil residues. More detailed information 
on the subject action to establish a tolerance in or on Brassica, leafy 
greens, subgroup 4-16B; Vegetable, Brassica, head and stem, group 5-16; 
and Kohlrabi can be found in the document entitled, ``Human Health Risk 
Assessment for Section 3 Registration for Crop Group Conversions/
Expansions for Brassica, Leafy Greens, Subgroup 4-16B Vegetable and 
Brassica, Head and Stem, Group 5-16 and to Establish an Individual 
Tolerance on Kohlrabi'' by going to http://www.regulations.gov. The 
referenced document is available in the docket established by this 
action, which is described under ADDRESSES. Locate and click on the 
hyperlink for docket ID number EPA-HQ-OPP-2019-0659.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology high-performance liquid 
chromatography/ultraviolet (HPLC/UV) methods (Methods AG-597 and AG-
597B) are available for enforcing tolerances for fludioxonil on plant 
commodities. Additionally, fludioxonil is recoverable by the Quick Easy 
Cheap Effective Rugged and Safe (QuEChERS) multiresidue method using 
HPLC with tandem mass spectrometry detection (MS/MS) for analysis. An 
adequate liquid chromatography, tandem MS (LC-MS/MS) method (Analytical 
Method GRM025.03A) is available for enforcing tolerances for residues 
of fludioxonil in or on livestock commodities.
    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].

[[Page 51356]]

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 tolerance expressions are harmonized for the United States, 
Canada, and Codex. Codex has adopted MRLs for many commodities 
contained in subgroup 4-16B: 9 ppm on upland cress; 10 ppm on 
watercress; 15 ppm on arugula; broccoli raab; cabbage, Chinese, 
bokchoy; cabbage, Chinese, Napa; collards; cress, garden; kale; mizuna; 
mustard greens; rape greens; turnip tops; and 20 ppm on radish tops. 
EPA is establishing a tolerance at 15 ppm for subgroup 4-16B and 10 ppm 
on watercress, which harmonizes most of the commodities in the group. 
EPA is not harmonizing the U.S. tolerances for upland cress and radish 
tops with the Codex MRLs because no data are available to EPA for those 
commodities that would indicate a tolerance different than the crop 
group tolerance would be appropriate. Codex has also adopted MRLs for 
broccoli (0.7 ppm) and cabbage (2 ppm) which are both commodities in 
the vegetable, Brassica, head and stem, group 5-16. The group 5-16 
tolerance level of 2 ppm is harmonized with Codex for cabbage, but the 
Codex MRL of 0.7 ppm for broccoli is too low to harmonize. There are no 
Codex MRLs for residues of fludioxonil in or on kohlrabi.

C. Response to Comments

    EPA received two anonymous comments in response to the notice of 
filing for fludioxonil proposed new uses. In summary, one comment 
states that commodities need to be free from pesticides in order for us 
to be safe. The other states that the product should not be sold, that 
it is fluoride on plants, that no one needs to have fluoride ingested 
from eating plants with pesticides, and that accumulation of pesticides 
over many years kills people, and should not be authorized.
    In response to both comments, the Agency recognizes that some 
individuals believe that pesticides should be banned on agricultural 
crops. However, the existing legal framework provided by section 408 of 
the Federal Food, Drug, and Cosmetic Act states that tolerances may be 
set when persons seeking such tolerances or exemptions have 
demonstrated that the pesticide meets the safety standard imposed by 
that statute. In examining whether the pesticide is safe, EPA has 
evaluated hazard and exposure data and conducted dietary, residential, 
and aggregate exposure assessments to estimate the risk to human health 
that will result from all registered and proposed uses of fludioxonil. 
Based on its assessment of the available information, EPA has concluded 
that the tolerances for fludioxonil are safe. The commenter has 
provided no information that would support an Agency determination that 
these tolerances are not safe. Regarding the comment on fluoride: The 
benzodioxole group remains intact during fludioxonil metabolism; i.e., 
all metabolites identified retained both fluorine atoms; therefore, 
there is no exposure--and thus no risk from exposure--to fluoride.

D. Revisions to Petitioned-for Tolerances

    The petitioner requested a conversion of the existing subgroup 
brassica, leafy greens subgroup 5B at 10 ppm to the new subgroup, 
brassica, leafy greens, subgroup 4-16B at 10 ppm. EPA has decided to 
establish this new subgroup tolerance at 15 ppm in order to harmonize 
with a larger number of Codex MRLs for the commodities contained in 
subgroup 4-16B, with the exception of watercress. Watercress is not a 
commodity in subgroup 5B; therefore, EPA had previously established a 
separate tolerance for watercress, which was lower than the subgroup 5B 
tolerance. At the request of the petitioner, EPA is retaining the 
separate tolerance for watercress, rather than simply covering residues 
in or on watercress as part of the subgroup, but is increasing that 
separate tolerance to 10 ppm, which is in line with the petitioner's 
request to establish the subgroup 4-16B tolerance at 10 ppm (since 
watercress is a commodity covered by that subgroup) and harmonized with 
the Codex MRL for watercress.

V. Conclusion

    Therefore, tolerances are established for residues of fludioxonil: 
[4-(2, 2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile], in 
or on brassica, leafy greens, subgroup 4-16B, except watercress at 15 
ppm; vegetable, brassica, head and stem, group 5-16 at 2 ppm; and 
kohlrabi at 2 ppm. In addition, EPA is revising the existing tolerance 
for watercress from 7.0 ppm to 10 ppm and removing existing tolerances 
for brassica leafy greens subgroup 5B at 10.0 ppm and brassica, head 
and stem, subgroup 5A at 2.0 ppm as they are superseded by the new 
tolerances established in this rule.

VI. Statutory and Executive Order Reviews

    This action establishes and modifies 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 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

[[Page 51357]]

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: July 16, 2020.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, for the reasons stated in the preamble, EPA amends 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.  180.516, paragraph (a)(1):
i. Add a heading to the table;
ii. Remove the entries for ``Brassica, head and stem, subgroup 5A'' and 
``Brassica, leafy greens subgroup 5B'';
iii. Add alphabetically the entries ``Brassica, leafy greens, subgroup 
4-16B, except watercress''; ``Kohlrabi'' and ``Vegetable, brassica, 
head and stem, group 5-16''; and
iv. Revise the entry for ``Watercress''.
    The additions and revision read as follows:

Sec.  180.516  Fludioxonil; tolerance for residues.

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

                       Table 1 to Paragraph (a)(1)
                                                               Parts per
                          Commodity                             million
                                * * * * *
Brassica, leafy greens, subgroup 4-16B, except watercress...          15
                                * * * * *
Kohlrabi....................................................           2
                                * * * * *
Vegetable, Brassica, head and stem, group 5-16..............           2
                                * * * * *
Watercress..................................................          10

* * * * *
[FR Doc. 2020-17155 Filed 8-19-20; 8:45 am]