[Federal Register Volume 84, Number 192 (Thursday, October 3, 2019)]
[Rules and Regulations]
[Pages 52771-52774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20874]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0243; FRL-10000-23]


Furilazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
furilazole in or on sweet corn commodities. The Monsanto Company 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA) requesting these tolerances.

DATES: This regulation is effective October 3, 2019. Objections and 
requests for hearings must be received on or before December 2, 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-2018-0243, 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 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).
     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-2018-0243 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
December 2, 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-2018-0243, 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 October 18, 2018 (83 FR 52787) (FRL-
9984-21), 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 
IN-11139) by Monsanto, 1300 I Street NW, Washington, DC 20005. The 
petition requested that 40 CFR part 180 be amended by establishing 
tolerances for residues of furilazole when used as an inert ingredient 
(safener) in pesticide formulations applied to corn, sweet, forage at 
0.01 parts per million (ppm); corn, sweet, kernel plus cob with husks 
removed at 0.01 ppm; and corn, sweet, stover at 0.01 ppm. That document 
referenced a summary of the petition prepared by Monsanto, the 
registrant, which is available in the docket, http://www.regulations.gov.

[[Page 52772]]

    Based upon review of the data supporting the petition, EPA is 
establishing the tolerances as requested.

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 furilazole including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with furilazole follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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. The toxicological profile of furilazole is discussed in the 
final tolerance rule found in the Federal Register of October 10, 2007 
(72 FR 57489) (FRL-8145-2). Specific information on the studies 
received and the nature of the adverse effects caused by furilazole as 
well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies are 
discussed in the final rule published in Unit III.A. of that Federal 
Register document and in the supporting documents for that rule. In 
addition, due to the similarities between that rule and this, EPA is 
incorporating the findings concerning the children's safety factor and 
cumulative exposure into this rule because they also apply to this 
rulemaking. The summary of toxicological endpoints the Agency used to 
assess risk are discussed in the final tolerance rule found in the 
Federal Register of April 3, 2002 (67 FR 15727) (FRL-6828-4).

B. Exposure Assessment

    1. Dietary exposure (food and drinking water). In evaluating 
dietary exposure to furilazole, EPA considered exposure under the 
proposed exemption from the requirement of a tolerance as well as the 
already established tolerances for furilazole.
    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 
the general population for furilazole; therefore, a quantitative acute 
dietary exposure assessment for the general population is unnecessary.
    However, such effects were identified for furilazole for females 13 
to 50 years old. In estimating acute dietary exposure, EPA used 2003-
2008 food consumption information from the U.S. Department of 
Agriculture's National Health and Nutrition Examination Survey, What We 
Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA 
conducted an unrefined acute dietary exposure and risk assessment 
assuming 100 percent crop treated (PCT), default processing factors, 
and tolerance-level residues for all food commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used 2003-2008 food consumption data from the USDA's 
NHANES/WWEIA. As to residue levels in food, EPA conducted an unrefined 
chronic dietary exposure and risk assessment assuming 100 PCT, default 
processing factors (when available), and tolerance level residues for 
all food commodities.
    iii. Cancer. As indicated in the 2002 Federal Register document, 
EPA has concluded that furilazole should be classified as a possible 
human carcinogen and a linear approach has been used the quantify 
cancer risk since no mode of action data are available. The aggregate 
cancer risk assessment for adults takes into account exposure estimates 
from dietary consumption of furilazole from food and drinking water 
sources. Dietary exposure assessments were quantified using the same 
estimates as discussed in Unit III.B.1.ii, Chronic Exposure.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for furilazole in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of furilazole. 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.
    The estimated drinking water concentrations (EDWCs) of furilazole 
for acute exposures are estimated to be 1.2 parts per billion (ppb) for 
surface water and 0.02 ppb for ground water; for chronic exposures for 
non-cancer assessments are estimated to be 0.8 ppb for surface water 
and 0.02 ppb for ground water; and for chronic exposures for cancer 
assessments are estimated to be 0.22 ppb for surface water and 0.02 ppb 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, a water concentration value of 1.2 ppb was used to assess 
the contribution to drinking water, for the chronic dietary risk 
assessment, the water concentration value of 0.8 ppb was used to assess 
the contribution to drinking water. For the cancer dietary risk 
assessment, the water concentration value of 0.22 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., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables). There 
are no residential uses of furilazole; therefore, a residential 
exposure assessment was not conducted.
    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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach

[[Page 52773]]

based on a common mechanism of toxicity, EPA has not made a common 
mechanism of toxicity finding as to furilazole and any other 
substances; furilazole does not appear to produce any other toxic 
metabolite produced by other substances. For the purposes of this 
action, therefore, EPA has not assumed that furilazole has a common 
mechanism of toxicity with other substances.

C. 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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to furilazole will be less than 1% for females 13 to 49 years old, the 
only population group of concern.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
furilazole from food and water will utilize 13.3% of the cPAD for non-
nursing infants, the population group receiving the greatest exposure. 
There are no expected residential uses and therefore chronic 
residential exposure to residues of furilazole 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). Because there 
are no proposed or registered residential uses of furilazole a short-
term assessment was not performed. The chronic risk assessment is 
protective for any short-term exposures from food and drinking water.
    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). Because there are no proposed or registered residential uses of 
furilazole an intermediate-term assessment was not performed. The 
chronic risk assessment is protective for any intermediate-term 
exposures from food and drinking water. Furilazole is not currently 
registered for uses that could result in intermediate-term residential 
exposure, and the Agency has determined that intermediate-term 
aggregate exposure assessment is not necessary.
    5. Aggregate cancer risk for U.S. population. A cancer aggregate 
assessment was conducted for furilazole since it is classified as a 
``Group C, Possible Human Carcinogen'' with a Q\1\* of 0.0274 (mg/kg/
day)-1 based upon hepatocellular ademonas and carcinomas in 
rats and mice, branchioalveolar adenomas and carcinomas in female mice, 
testicular interstitial cell interstitial cell tumors in male rats, and 
stomach tumors in female mice. The cancer risk estimate for adults is 
1.1 x 10-6.
    EPA generally considers cancer risks (expressed as the probability 
of an increased cancer case) in the range of 1 in 1 million (or 1 x 
10-6) or less to be negligible. The precision which can be 
assumed for cancer risk estimates is best described by rounding to the 
nearest integral order of magnitude on the logarithmic scale; for 
example, risks falling between 3 x 10-7 and 3 x 
10-6 are expressed as risks in the range of 10-6. 
Considering the precision with which cancer hazard can be estimated, 
the conservativeness of low-dose linear extrapolation, and the rounding 
procedure described above, cancer risk should generally not be assumed 
to exceed the benchmark level of concern of the range of 
10-6 until the calculated risk exceeds approximately 3 x 
10-6. This is particularly the case where some conservatism 
is maintained in the exposure assessment. EPA has concluded the cancer 
risk for all existing furilazole uses and the uses associated with the 
tolerances established in this action fall within the range of 1 x 
10-6 and are thus negligible.
    EPA has concluded that using the nonlinear approach based on the 
chronic RfD will be protective of potential carcinogenicity.
    Because the chronic risk is below the Agency's level of concern, 
EPA concludes there is no aggregate cancer risk from exposure to 
furilazole.
    6. Determination of safety. Taking into consideration all available 
information on furilazole, EPA has determined that there is a 
reasonable certainty that no harm to any population subgroup will 
result from aggregate exposure to furilazole.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (capillary gas chromotography 
using electron capture detection) is available to enforce the tolerance 
exemption 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. The Codex has not 
established any MRLs for furilazole.

C. Response to Comments

    Three comments were submitted to the docket for this action. One 
dealt with ``relaxing'' current EPA standards; another argued that 
inert ingredients should be regulated through tolerances. A third 
comment took issue with data submitted about the toxicity of 
``Florazole'' (which EPA assumes is a typographical error and is meant 
to apply to furilazole).
    This action establishes tolerances for an inert ingredient used as 
a safener in pesticide products; it is not relaxing EPA standards or 
ignoring the potential adverse effects of inert ingredients. Inert 
ingredients are evaluated under the same safety standard as active 
ingredients under the FFDCA. Under the existing legal framework 
provided by FFDCA section 408, EPA is authorized to establish pesticide 
chemical tolerances or exemptions where persons seeking such tolerances 
or exemptions have demonstrated that the pesticide chemical meets the 
safety standard imposed by the statute. EPA has evaluated the potential 
adverse

[[Page 52774]]

effects from exposure to this pesticide chemical, taking into 
consideration data on the potential for developmental toxicity and 
carcinogenicity. No new toxicity data were submitted in connection with 
the present petition. After evaluating the available data and other 
information, EPA has determined that the tolerances for this chemical 
are safe. The commenters have provided no other information for the 
Agency to consider in making its safety determination.

V. Conclusion

    Based on available data, the Agency concludes that tolerances for 
residues of furilazole as discussed in this document are safe. 
Accordingly, the Agency is establishing tolerances for residues of 
furilazole in or on corn, sweet, forage; corn, sweet, kernel plus cob 
with husks removed; and corn, sweet, stover at 0.01 ppm. In addition, 
EPA is revising the tolerance expression to clarify that (1) as 
provided in FFDCA section 408(a)(3), the tolerance covers metabolites 
and degradates of furilazole not specifically mentioned and (2) 
compliance with the specified tolerance levels is to be determined by 
measuring only the specific compounds mentioned in the tolerance 
expression. EPA has determined that it is reasonable to make this 
change final without prior proposal and opportunity for comment, 
because public comment is not necessary, in that the change has no 
substantive effect on the tolerance, but rather is merely intended to 
clarify the existing tolerance expression.

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 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: September 17, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
    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.  180.471(a):
0
 a. Revise the introductory text; and
0
 b. Add alphabetically the entries ``Corn, sweet, forage''; ``Corn, 
sweet, kernel plus cob with husks removed''; and ``Corn, sweet, 
stover'' to the table.
    The revision and additions read as follows:


Sec.  180.471  Furilazole; tolerances for residues.

    (a) General. Tolerances are established for residues of furilazole, 
including its metabolites and degradates, when used as an inert 
ingredient (safener) in pesticide formulations applied to the following 
raw agricultural commodities. Compliance with the tolerance levels 
specified in the table in this paragraph (a) is to be determined by 
measuring only furilazole, 3-dichloroacetyl-5-(2-furanyl)-2, 2-
dimethyloxazolidine (CAS Reg. No. 121776-33-8) in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Corn, sweet, forage.........................................        0.01
Corn, sweet, kernel plus cob with husks removed.............        0.01
Corn, sweet, stover.........................................        0.01
 
                                * * * * *
------------------------------------------------------------------------

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[FR Doc. 2019-20874 Filed 10-2-19; 8:45 am]
BILLING CODE 6560-50-P