83 FR 55491 - Fludioxonil; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 215 (November 6, 2018)

Page Range		55491-55495
FR Document		2018-24265
This regulation establishes revised tolerances for residues of fludioxonil in or on beet, sugar, roots at 4.0 parts per million. Syngenta Crop Protection, LLC requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Federal Register, Volume 83 Issue 215 (Tuesday, November 6, 2018)
[Federal Register Volume 83, Number 215 (Tuesday, November 6, 2018)]
[Rules and Regulations]
[Pages 55491-55495]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-24265]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0538; FRL-9982-75]


Fludioxonil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes revised tolerances for residues of 
fludioxonil in or on beet, sugar, roots at 4.0 parts per million. 
Syngenta Crop Protection, LLC requested this tolerance under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 6, 2018. Objections and 
requests for hearings must be received on or before January 7, 2019, 
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-2017-0538, 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 review the visitor instructions and 
additional information about the docket available at http://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].

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).

[[Page 55492]]

     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 
Printing 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-2017-0538 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 
January 7, 2019. 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-2017-0538, 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 
20460-0001.
     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 December 15, 2017 (82 FR 59604) (FRL-
9970-50), 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 
7F8592) by Syngenta Crop Protection, LLC, 410 Swing Road, Greensboro, 
NC 27409. The petition requested that the existing tolerance in 40 CFR 
180.516 for residues of the fungicide fludioxonil, 4-(2, 2-difluoro-
1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile, in or on beet, sugar, 
roots be amended to 5.0 parts per million (ppm). That document 
referenced a summary of the petition prepared by Syngenta Crop 
Protection, LLC, the registrant, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
determined that the tolerance be set at 4.0 ppm, which is less than the 
tolerance level of 5.0 ppm proposed by the petitioner. The reason for 
this change is 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 fludioxonil including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with fludioxonil follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    In all species tested, the effects in the fludioxonil database are 
indicative of toxicity to the liver, kidney, and hematopoietic system 
(dogs only). There were also decreased body weights and clinical signs 
throughout the database. Fludioxonil was non-toxic through the dermal 
route and there was no evidence of immunotoxicity when tested up to the 
limit dose. Fludioxonil was not mutagenic in the tests for gene 
mutations. There was no quantitative or qualitative evidence of 
increased susceptibility following in utero exposure to rats and 
rabbits or following pre-/postnatal exposure to rats.
    In a rat developmental toxicity study, fludioxonil caused an 
increase in fetal incidence and litter incidence of both dilated renal 
pelvis and ureter at the limit dose (1000 mg/kg/day). These effects are 
known to occur spontaneously in the rat, in addition to being transient 
and reversible, which is consistent with the fludioxonil hazard 
database (not seen in offspring in the two-generation reproductive 
study). Maternal toxicity occurred at the same dose and manifested as 
body-weight decrements. Fludioxonil was not developmentally toxic in 
rabbits. In the two-generation reproduction study, parental and 
offspring effects occurred at the same dose and consisted of decreased 
body weights in parental and offspring animals, as well as increased 
clinical signs in parental animals.
    Fludioxonil was classified as a Group D carcinogen (not 
classifiable as to human carcinogenicity); therefore, there is no need 
for a quantitative cancer risk assessment.
    Specific information on the studies received and the nature of the 
adverse effects caused by fludioxonil as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Fludioxonil. ``Human Health Risk 
Assessment for the Proposed New Post

[[Page 55493]]

Harvest Use on Sugar Beets.'' at pg. 11 in docket ID number EPA-HQ-OPP-
2017-0538.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for fludioxonil used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of April 14, 2015 (80 FR 48743) (FRL-
9931-06).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fludioxonil, EPA considered exposure under the petitioned-
for tolerance as well as all existing fludioxonil tolerances in 40 CFR 
180.516. EPA assessed dietary exposures from fludioxonil in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for 
fludioxonil; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United States 
Department of Agriculture (USDA) 2003-2008 National Health and 
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). 
As to residue levels in food, EPA an unrefined chronic dietary exposure 
and risk assessment was conducted assuming 100% percent crop treated 
(PCT) and tolerance-level residues for all food commodities. The 
Processing Factor Focus (PFFG) default processing factors were used.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
classified fludioxonil as a group D carcinogen, i.e., not classifiable 
as to human carcinogenicity. Therefore, a dietary exposure assessment 
for the purpose of assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
    EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for fludioxonil. Tolerance level residues and/or 
100% CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for fludioxonil in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fludioxonil. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM) and the Variable Volume Water Model (VVWM) along with the 
Pesticide Root Zone Model Ground Water (PRZM GW) were used, the 
estimated drinking water concentrations (EDWCs) of fludioxonil for 
chronic exposures for non-cancer assessments are estimated to be 17.7 
parts per billion (ppb) for surface water and 48.34 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 48.34 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Fludioxonil is currently registered for the following uses that 
could result in residential exposures: Parks, golf courses, athletic 
fields, residential lawns, ornamentals, and greenhouses. EPA assessed 
residential exposure based on the following: The residential exposure 
for use in the adult aggregate assessment reflects inhalation exposures 
from handler exposure to applying paints with airless sprayers. The 
residential exposure for use in the children 1 to <2 years old 
aggregate assessment reflects incidental oral exposures (hand-to-mouth) 
from post-application exposure to outdoor treated turf.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found fludioxonil to share a common mechanism of 
toxicity with any other substances, and fludioxonil does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
fludioxonil does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of

[[Page 55494]]

safety is commonly referred to as the Food Quality Protection Act 
Safety Factor (FQPA SF). In applying this provision, EPA either retains 
the default value of 10X, or uses a different additional safety factor 
when reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There was no quantitative or 
qualitative evidence of increased susceptibility following in utero 
exposure to rats and rabbits or following pre-/postnatal exposure. In a 
rat developmental toxicity study, fludioxonil caused an increase in 
fetal incidence and litter incidence of dilated renal pelvis at the 
limit dose (1,000 mg/kg/day). Maternal toxicity occurred at the same 
dose and manifested as body weight decrements. Fludioxonil was not 
developmentally toxic in rabbits. In the 2-generation reproduction 
study, parental and offspring effects occurred at the same dose and 
consisted of decreased body weights in parental and offspring animals, 
as well as increased clinical signs in parental animals.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for fludioxonil is complete.
    ii. There is low concern that fludioxonil is a neurotoxic chemical. 
The only potential indicator of neurotoxicity for fludioxonil was 
convulsions in mice following handling in the mouse carcinogenicity 
study at the mid- and high-doses. There was no supportive 
neuropathology, the effect was not seen at similar doses in a second 
mouse carcinogenicity study, there were no other signs of potential 
neurotoxicity observed in the database, and selected endpoints are 
protective of the effect seen in mice. Therefore, there is no residual 
uncertainty concerning neurotoxicity and no need to retain the FQPA 10X 
safety factor.
    iii. There is no evidence that fludioxonil results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to fludioxonil in drinking water. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to fludioxonil in drinking water. EPA 
used similarly conservative assumptions to assess postapplication 
exposure of children as well as incidental oral exposure of toddlers. 
These assessments will not underestimate the exposure and risks posed 
by fludioxonil.

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 PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect 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.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fludioxonil from food and water will utilize 51% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
fludioxonil is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Fludioxonil is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to fludioxonil.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 15,000 for adults 
and 4,600 for children 1-2 years old. Because EPA's level of concern 
for fludioxonil is a MOE of 100 or below, these MOEs are not of 
concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    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.
    5. Aggregate cancer risk for U.S. population. Based on the 
discussion contained in Unit III.A., fludioxonil is not expected to 
pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to fludioxonil residues.

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. An adequate liquid chromatography, tandem mass 
spectrometry (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].

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

[[Page 55495]]

different from a Codex MRL; however, FFDCA section 408(b)(4) requires 
that EPA explain the reasons for departing from the Codex level.
    There is no Codex MRL for sugar beet roots for fludioxonil.

C. Revisions to Petitioned-For Tolerances

    All tolerance levels are based upon the Organization for Economic 
Co-operation and Development's (OECD) tolerance calculation procedures. 
Based on the residue chemistry data and the OECD tolerance-calculation 
procedure, the tolerance level established in this notice for 
fludioxonil on beet, sugar, roots is lower (4.0 ppm) than that 
requested by the petitioner (5.0 ppm).

V. Conclusion

    Therefore, the tolerance is amended for residues of fludioxonil: 
[4-(2, 2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile], in 
or on beet, sugar, roots from 0.02 ppm to 4.0 ppm.

VI. Statutory and Executive Order Reviews

    This action amends a tolerance 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 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 16, 2018.
Michael Goodis,
Director, Registration Division, Office of Pesticide Program.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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.  180.516, revise the tolerance for ``Beet, sugar, roots'' in 
the table of paragraph (a)(1), to read as follows:


Sec.  180.516  Fludioxonil; tolerance for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Beet, sugar, roots......................................             4.0
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-24265 Filed 11-5-18; 8:45 am]
 BILLING CODE 6560-50-P
55494 Federal Register / Vol. 83, No. 215 / Tuesday, November 6, 2018 / Rules and Regulations

safety is commonly referred to as the and surface water modeling used to 4. Intermediate-term risk.
Food Quality Protection Act Safety assess exposure to fludioxonil in Intermediate-term aggregate exposure
Factor (FQPA SF). In applying this drinking water. EPA used similarly takes into account intermediate-term
provision, EPA either retains the default conservative assumptions to assess residential exposure plus chronic
value of 10X, or uses a different postapplication exposure of children as exposure to food and water (considered
additional safety factor when reliable well as incidental oral exposure of to be a background exposure level).
data available to EPA support the choice toddlers. These assessments will not Intermediate- and long-term aggregate
of a different factor. underestimate the exposure and risks risk assessments were not performed
2. Prenatal and postnatal sensitivity. posed by fludioxonil. because there are no registered or
There was no quantitative or qualitative proposed uses of fludioxonil that result
evidence of increased susceptibility E. Aggregate Risks and Determination of
Safety in intermediate- or long-term residential
following in utero exposure to rats and exposures.
rabbits or following pre-/postnatal EPA determines whether acute and 5. Aggregate cancer risk for U.S.
exposure. In a rat developmental chronic dietary pesticide exposures are population. Based on the discussion
toxicity study, fludioxonil caused an safe by comparing aggregate exposure contained in Unit III.A., fludioxonil is
increase in fetal incidence and litter estimates to the acute PAD (aPAD) and not expected to pose a cancer risk to
incidence of dilated renal pelvis at the chronic PAD (cPAD). For linear cancer humans.
limit dose (1,000 mg/kg/day). Maternal risks, EPA calculates the lifetime 6. Determination of safety. Based on
toxicity occurred at the same dose and probability of acquiring cancer given the these risk assessments, EPA concludes
manifested as body weight decrements. estimated aggregate exposure. Short-, that there is a reasonable certainty that
Fludioxonil was not developmentally intermediate-, and chronic-term risks no harm will result to the general
toxic in rabbits. In the 2-generation are evaluated by comparing the population, or to infants and children
reproduction study, parental and estimated aggregate food, water, and from aggregate exposure to fludioxonil
offspring effects occurred at the same residential exposure to the appropriate residues.
dose and consisted of decreased body PODs to ensure that an adequate MOE
weights in parental and offspring exists. IV. Other Considerations
animals, as well as increased clinical 1. Acute risk. An acute aggregate risk A. Analytical Enforcement Methodology
signs in parental animals. assessment takes into account acute
3. Conclusion. EPA has determined exposure estimates from dietary Adequate enforcement methodology
that reliable data show the safety of consumption of food and drinking high-performance liquid
infants and children would be water. No adverse effect resulting from chromatography/ultraviolet (HPLC/UV)
adequately protected if the FQPA SF a single oral exposure was identified methods (Methods AG–597 and AG–
were reduced to 1X. That decision is and no acute dietary endpoint was 597B) are available for enforcing
based on the following findings: selected. Therefore, fludioxonil is not tolerances for fludioxonil on plant
i. The toxicity database for fludioxonil expected to pose an acute risk. commodities. An adequate liquid
is complete. 2. Chronic risk. Using the exposure chromatography, tandem mass
ii. There is low concern that assumptions described in this unit for spectrometry (LC–MS/MS) method
fludioxonil is a neurotoxic chemical. chronic exposure, EPA has concluded (Analytical Method GRM025.03A) is
The only potential indicator of that chronic exposure to fludioxonil available for enforcing tolerances for
neurotoxicity for fludioxonil was from food and water will utilize 51% of residues of fludioxonil in or on
convulsions in mice following handling the cPAD for children 1–2 years old, the livestock commodities.
in the mouse carcinogenicity study at population group receiving the greatest The method may be requested from:
the mid- and high-doses. There was no exposure. Based on the explanation in Chief, Analytical Chemistry Branch,
supportive neuropathology, the effect Unit III.C.3., regarding residential use Environmental Science Center, 701
was not seen at similar doses in a patterns, chronic residential exposure to Mapes Rd., Ft. Meade, MD 20755–5350;
second mouse carcinogenicity study, residues of fludioxonil is not expected. telephone number: (410) 305–2905;
there were no other signs of potential 3. Short-term risk. Short-term email address: residuemethods@
neurotoxicity observed in the database, aggregate exposure takes into account epa.gov.
and selected endpoints are protective of short-term residential exposure plus B. International Residue Limits
the effect seen in mice. Therefore, there chronic exposure to food and water
is no residual uncertainty concerning (considered to be a background In making its tolerance decisions, EPA
neurotoxicity and no need to retain the exposure level). seeks to harmonize U.S. tolerances with
FQPA 10X safety factor. Fludioxonil is currently registered for international standards whenever
iii. There is no evidence that uses that could result in short-term possible, consistent with U.S. food
fludioxonil results in increased residential exposure, and the Agency safety standards and agricultural
susceptibility in in utero rats or rabbits has determined that it is appropriate to practices. EPA considers the
in the prenatal developmental studies or aggregate chronic exposure through food international maximum residue limits
in young rats in the 2-generation and water with short-term residential (MRLs) established by the Codex
reproduction study. exposures to fludioxonil. Alimentarius Commission (Codex), as
iv. There are no residual uncertainties Using the exposure assumptions required by FFDCA section 408(b)(4).
identified in the exposure databases. described in this unit for short-term The Codex Alimentarius is a joint
The dietary food exposure assessments exposures, EPA has concluded the United Nations Food and Agriculture
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were performed based on 100 PCT and combined short-term food, water, and Organization/World Health
tolerance-level residues. EPA made residential exposures result in aggregate Organization food standards program,
conservative (protective) assumptions in MOEs of 15,000 for adults and 4,600 for and it is recognized as an international
the ground and surface water modeling children 1–2 years old. Because EPA’s food safety standards-setting
used to assess exposure to fludioxonil in level of concern for fludioxonil is a organization in trade agreements to
drinking water. EPA made conservative MOE of 100 or below, these MOEs are which the United States is a party. EPA
(protective) assumptions in the ground not of concern. may establish a tolerance that is

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Federal Register / Vol. 83, No. 215 / Tuesday, November 6, 2018 / Rules and Regulations 55495

different from a Codex MRL; however, Environmental Justice in Minority Register. This action is not a ‘‘major
FFDCA section 408(b)(4) requires that Populations and Low-Income rule’’ as defined by 5 U.S.C. 804(2).
EPA explain the reasons for departing Populations’’ (59 FR 7629, February 16,
from the Codex level. 1994). List of Subjects in 40 CFR Part 180
There is no Codex MRL for sugar beet Since tolerances and exemptions that Environmental protection,
roots for fludioxonil. are established on the basis of a petition Administrative practice and procedure,
C. Revisions to Petitioned-For under FFDCA section 408(d), such as Agricultural commodities, Pesticides
Tolerances the tolerance in this final rule, do not and pests, Reporting and recordkeeping
require the issuance of a proposed rule, requirements.
All tolerance levels are based upon the requirements of the Regulatory
the Organization for Economic Co- Flexibility Act (RFA) (5 U.S.C. 601 et Dated: October 16, 2018.
operation and Development’s (OECD) seq.), do not apply. Michael Goodis,
tolerance calculation procedures. Based
This action directly regulates growers, Director, Registration Division, Office of
on the residue chemistry data and the
food processors, food handlers, and food Pesticide Program.
OECD tolerance-calculation procedure,
retailers, not States or tribes, nor does
the tolerance level established in this Therefore, 40 CFR chapter I is
this action alter the relationships or
notice for fludioxonil on beet, sugar, amended as follows:
distribution of power and
roots is lower (4.0 ppm) than that
responsibilities established by Congress
requested by the petitioner (5.0 ppm). PART 180—[AMENDED]
in the preemption provisions of FFDCA
V. Conclusion section 408(n)(4). As such, the Agency
has determined that this action will not ■ 1. The authority citation for part 180
Therefore, the tolerance is amended
have a substantial direct effect on States continues to read as follows:
for residues of fludioxonil: [4-(2, 2-
difluoro-1,3-benzodioxol-4-yl)-1H- or tribal governments, on the Authority: 21 U.S.C. 321(q), 346a and 371.
pyrrole-3-carbonitrile], in or on beet, relationship between the national
sugar, roots from 0.02 ppm to 4.0 ppm. government and the States or tribal ■ 2. In § 180.516, revise the tolerance for
governments, or on the distribution of ‘‘Beet, sugar, roots’’ in the table of
VI. Statutory and Executive Order power and responsibilities among the paragraph (a)(1), to read as follows:
Reviews various levels of government or between
§ 180.516 Fludioxonil; tolerance for
This action amends a tolerance under the Federal Government and Indian
residues.
FFDCA section 408(d) in response to a tribes. Thus, the Agency has determined
petition submitted to the Agency. The that Executive Order 13132, entitled (a) General. (1) * * *
Office of Management and Budget ‘‘Federalism’’ (64 FR 43255, August 10,
(OMB) has exempted these types of 1999) and Executive Order 13175, Commodity Parts per
actions from review under Executive entitled ‘‘Consultation and Coordination million
Order 12866, entitled ‘‘Regulatory with Indian Tribal Governments’’ (65 FR
Planning and Review’’ (58 FR 51735, 67249, November 9, 2000) do not apply
to this action. In addition, this action * * * * *
October 4, 1993). Because this action
Beet, sugar, roots ................. 4.0
has been exempted from review under does not impose any enforceable duty or
Executive Order 12866, this action is contain any unfunded mandate as
* * * * *
not subject to Executive Order 13211, described under Title II of the Unfunded
entitled ‘‘Actions Concerning Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.). * * * * *
Regulations That Significantly Affect [FR Doc. 2018–24265 Filed 11–5–18; 8:45 am]
Energy Supply, Distribution, or Use’’ (66 This action does not involve any
BILLING CODE 6560–50–P
FR 28355, May 22, 2001) or Executive technical standards that would require
Order 13045, entitled ‘‘Protection of Agency consideration of voluntary
Children from Environmental Health consensus standards pursuant to section
Risks and Safety Risks’’ (62 FR 19885, 12(d) of the National Technology
April 23, 1997) nor is it considered a Transfer and Advancement Act
regulatory action under Executive Order (NTTAA) (15 U.S.C. 272 note).
13771, entitled ‘‘Reducing Regulations
VII. Congressional Review Act
and Controlling Regulatory Costs’’ (82
FR 9339, February 3, 2017). This action Pursuant to the Congressional Review
does not contain any information Act (5 U.S.C. 801 et seq.), EPA will
collections subject to OMB approval submit a report containing this rule and
under the Paperwork Reduction Act other required information to the U.S.
(PRA) (44 U.S.C. 3501 et seq.), nor does Senate, the U.S. House of
it require any special considerations Representatives, and the Comptroller
under Executive Order 12898, entitled General of the United States prior to
‘‘Federal Actions to Address publication of the rule in the Federal
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Document Created: 2018-11-06 00:18:23
Document Modified: 2018-11-06 00:18:23
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This regulation is effective November 6, 2018. Objections and requests for hearings must be received on or before January 7, 2019, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
Contact		Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
FR Citation		83 FR 55491
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements