82 FR 34870 - Fenpyroximate; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 143 (July 27, 2017)

Page Range		34870-34875
FR Document		2017-15728
This regulation increases existing tolerances for residues of fenpyroximate in or on dried citrus pulp, citrus oil, and the citrus fruit group 10-10. Nichino America, Inc. requested these tolerance increases under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Federal Register, Volume 82 Issue 143 (Thursday, July 27, 2017)
[Federal Register Volume 82, Number 143 (Thursday, July 27, 2017)]
[Rules and Regulations]
[Pages 34870-34875]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-15728]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0307; FRL-9963-22]


Fenpyroximate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation increases existing tolerances for residues of 
fenpyroximate in or on dried citrus pulp, citrus oil, and the citrus 
fruit group 10-10. Nichino America, Inc. requested these tolerance 
increases under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 27, 2017. Objections and 
requests for hearings must be received on or before September 25, 2017, 
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-2016-0307, 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

[[Page 34871]]

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-2016-0307 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 
September 25, 2017. 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-2016-0307, 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 August 29, 2016 (81 FR 59165) (FRL-9950-
22), 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 
6F8465) by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501, 
Wilmington, DE 19808. The petition requested to increase the tolerances 
in 40 CFR 180.566 for residues of the insecticide fenpyroximate in or 
on fruit, citrus, group 10-10 to 1.0 parts per million (ppm), citrus 
dried pulp to 4.0 ppm, and citrus oil to 14 ppm. That document 
referenced a summary of the petition prepared by Nichino America, Inc., 
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 
modified the level of the citrus oil tolerance from 14 ppm to 15 ppm. 
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 fenpyroximate including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with fenpyroximate 
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.
    The effects following repeated oral exposures to fenpyroximate were 
based on systemic toxicity (no specific target organ/tissue 
identified). The most sensitive species tested was the dog. The effects 
reported in the dog included slight bradycardia, deficits in food 
consumption, body weight, body-weight gain, and an increased incidence 
of emesis and diarrhea. Emaciation and torpor (sluggish inactivity) 
were reported in female dogs at lower dose levels than males. The 
highest dose tested in the dog (50 milligram/kilogram bodyweight/day 
(mg/kg bw/day)) resulted in first- and second-degree heart block, 
increased urea concentration, decreased glucose, and altered plasma 
electrolyte levels among other signs of toxicity. In subchronic and 
chronic studies with rats, the primary effect was decreased body-weight 
gain in both sexes with hematological changes (e.g., higher counts of 
red blood cells) at higher doses.
    In a rat prenatal developmental toxicity study, a dose level that 
marginally affected maternal body weight and food consumption also 
resulted in an increased litter incidence of increased thoracic ribs, 
indicating increased prenatal (qualitative) susceptibility. In the 
rabbits, there were no developmental effects reported at the levels 
tested. In the rat two-generation reproductive toxicity study, maternal 
toxicity (decreased body weight) and offspring toxicity (decreased 
lactational weight gain in both generations) occurred at the same dose.
    There is no evidence that fenpyroximate specifically targets the 
nervous or immune system based on the results of recently submitted 
studies. In the acute neurotoxicity study, neurotoxicity signs such as 
decreases in motor activity occurred in the presence of other effects 
including decreases in body weight and food consumption, and in the 
absence of neuropathology. Similar results were noted in a delayed 
acute neurotoxicity study in the hen where no effects (neurotoxic or 
otherwise) were reported. The results of the rat subchronic 
neurotoxicity study did not indicate any neurotoxicity-specific 
effects; deficits in body weight and food consumption were the main 
effects reported. Similarly, the effects reported in a rat 
immunotoxicity study were limited to decreased body-weight gain.

[[Page 34872]]

    In a 21-day dermal toxicity study in rats, there were clinical 
signs in females consisting of red nose and mouth/nasal discharge, 
decreased body weights, body-weight gains, and food consumption in 
males and females. There were also increased liver weights and 
hepatocellular necrosis reported in females.
    In a 4-week rat inhalation study, treatment-related effects 
included clinical observations (labored breathing and rales), increased 
lung weights, decreases in body-weight gain and food consumption, and 
changes in hematology parameters (increased counts of erythrocytes and 
leukocytes). There were also histopathology findings in the nasal 
passage mucosa consisting of atrophy and squamous metaplasia.
    Fenpyroximate was classified as ``not likely to be carcinogenic to 
humans'' based on the results of rat and mouse carcinogenicity studies. 
Genotoxicity studies including mutagenicity did not demonstrate any 
genotoxic potential associated with fenpyroximate.
    Specific information on the studies received and the nature of the 
adverse effects caused by fenpyroximate 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 the document titled ``Fenpyroximate. Human-
Health Risk Assessment for Proposed Section 3 Uses on Stone Fruits 
(Group 12-12), Tuberous and Corm Vegetables (Subgroup 1C), and Small 
Vine Climbing Fruits Except Kiwifruit (Subgroup 13-07F)'' on page 28 in 
docket ID number EPA-HQ-OPP-2016-0307.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for fenpyroximate used for 
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Fenpyroximate for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50       NOAEL = 5.0 mg/kg/    Acute RfD = 0.05 mg/ Prenatal Developmental Toxicity
 years of age).                     day.                  kg/day.              Study--Rat.
                                   UFA = 10x...........  aPAD = 0.05 mg/kg/   LOAEL = 25 mg/kg/day based on
                                   UFH = 10x...........   day.                 increase in the fetal incidence
                                   FQPA SF = 1x........                        of additional thoracic ribs.
Acute dietary (General population  NOAEL = 37.5 mg/kg/   Acute RfD = 0.375    Acute Neurotoxicity Study--Rat.
 including infants and children).   day.                  mg/kg/day.          LOAEL = 150 mg/kg bw based on
                                   UFA = 10x...........  aPAD = 0.375 mg/kg/   decreased motor activity (total
                                   UFH = 10x...........   day.                 activity counts and total time
                                   FQPA SF = 1x........                        spent in movement) in both sexes,
                                                                               and a reduction in auditory
                                                                               startle response in females at 24
                                                                               hours post dose, and mild
                                                                               dehydration in males.
Chronic dietary (All populations)  NOAEL= 5.0 mg/kg/day  Chronic RfD = 0.05   Chronic toxicity--Dog.
                                   UFA = 10x...........   mg/kg/day.          LOAEL = 15 mg/kg/day based on an
                                   UFH = 10x...........  cPAD = 0.05 mg/kg/    increased incidence of
                                   FQPA SF = 1x........   day.                 bradycardia, diarrhea, and
                                                                               decreases in cholesterol, body-
                                                                               weight gain, and food consumption
                                                                               (M); vomiting, diarrhea, excess
                                                                               salivation and decrease
                                                                               cholesterol in females.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Cancer (Oral, dermal, inhalation)  Classification: ``Not likely to be carcinogen,'' cancer risk assessment is
                                    not required
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fenpyroximate, EPA considered exposure under the 
petitioned-for tolerances as well as all existing fenpyroximate 
tolerances in 40 CFR 180.566. EPA assessed dietary exposures from 
fenpyroximate 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.
    Such effects were identified for fenpyroximate. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) National Health and Nutrition

[[Page 34873]]

Examination Survey, What We Eat in America, (NHANES/WWEIA; 2003-2008). 
As to residue levels in food, EPA assumed 100 percent crop treated 
(PCT) and tolerance level residues for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA (2003-2008). As to residue levels in food, EPA assumed 100 PCT 
and tolerance level residues for all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fenpyroximate does not pose a cancer risk to humans. 
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 or PCT information in the dietary 
assessment for fenpyroximate. Tolerance level residues and 100 PCT 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 fenpyroximate in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fenpyroximate. 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 Food Quality Protection Act (FQPA) Index Reservoir 
Screening Tool (FIRST) and a Provisional Cranberry Model for 
fenpyroximate and its metabolites (M1 and M3) in surface water and with 
Screening Concentration in Ground Water (SCI-GROW) for ground water, 
the estimated drinking water concentrations (EDWCs) of fenpyroximate 
for acute exposures are estimated to be 43 parts per billion (ppb) for 
surface water and 0.27 ppb for ground water, and for chronic exposures 
are estimated to be 8.6 ppb for surface water and 0.27 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 43 ppb was used to assess 
the contribution to drinking water and for the chronic dietary risk 
assessment, the water concentration of value 8.6 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). Fenpyroximate is not 
registered for any specific use patterns that would result in 
residential exposure.
    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 fenpyroximate to share a common mechanism of 
toxicity with any other substances, and fenpyroximate does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
fenpyroximate 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 Web site at http://www2.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 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 
SF when reliable data available to EPA support the choice of a 
different factor.
    2. Prenatal and postnatal sensitivity. There is evidence of 
increased prenatal (qualitative) susceptibility in a rat prenatal 
developmental toxicity study. A dose level that marginally affected 
maternal body weight and food consumption also resulted in an increased 
litter incidence of increased thoracic ribs. However, concern for 
prenatal and postnatal toxicity to fenpyroximate is low because:
    i. There was a clear NOAEL in the rat prenatal developmental 
toxicity study;
    ii. The NOAEL for this developmental study is being used as POD for 
the acute dietary risk assessment for the population of concern-females 
13-49 years old;
    iii. In the rabbit, there were no developmental effects reported at 
the levels tested; and
    iv. In the rat 2-generation reproductive toxicity study, there was 
no indication of increased prenatal or postnatal susceptibility.
    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 fenpyroximate is complete.
    ii. There is no indication that fenpyroximate is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is evidence that fenpyroximate results in increased 
susceptibility in utero rats or rabbits in the prenatal developmental 
studies or in young rats in the two-generation reproduction study. 
Increased (qualitative) prenatal susceptibility was seen following oral 
exposures in the rat developmental toxicity study, but the concern for 
these effects is low, for the reasons noted in Unit III.D.2. Therefore, 
a 10x FQPA SF is not necessary to account for this increased 
susceptibility of infants and children.
    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 fenpyroximate in drinking water. These 
assessments will not underestimate the exposure and risks posed by 
fenpyroximate.

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

[[Page 34874]]

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 fenpyroximate will occupy 14% of the aPAD for females 13-49 years 
old and 6.4% of the aPAD for children 1-2 years old, the population 
groups with the greatest risk estimate.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fenpyroximate from food and water will utilize 16% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for fenpyroximate.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Short- and 
intermediate-term adverse effects were identified; however, 
fenpyroximate is not registered for any use patterns that would result 
in either short- or intermediate-term residential exposure. Short- and 
intermediate-term risk is assessed based on short- and intermediate-
term residential exposure plus chronic dietary exposure. Because there 
is no short- or intermediate-term residential exposure and chronic 
dietary exposure has already been assessed under the appropriately 
protective cPAD (which is at least as protective as the POD used to 
assess short- or intermediate-term risk), no further assessment of 
short- or intermediate-term risk is necessary, and EPA relies on the 
chronic dietary risk assessment for evaluating short- and intermediate-
term risk for fenpyroximate.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, chemical name is not expected to pose a cancer risk to humans.
    5. 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 fenpyroximate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography method with 
nitrogen/phosphorus detection (GC/NPD), Method S19) is available to 
enforce the tolerance expression. Method S19 has passed an Agency 
validation and has a limit of quantitation (LOQ) of 0.05 ppm for the 
combined residues of fenpyroximate and M-1 in snap beans and avocados. 
A data-gathering liquid chromatography/mass spectroscopy/mass 
spectroscopy (LC/MS/MS) method is also available.
    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 established MRLs for fenpyroximate in or on citrus 
fruits at 0.5 ppm. This MRLs is different than the tolerance being 
established for fenpyroximate in the United States, however, 
harmonization with the Codex MRL is not possible because the U.S. 
tolerance expression includes an additional isomer and the U.S. use 
pattern requires a higher numerical value.

C. Revisions to Petitioned-For Tolerances

    Based on the Organization for Economic Co-operation and Development 
(OECD) tolerance-calculation procedure, the Agency is increasing the 
tolerance on citrus oil to 15 ppm rather than 14 ppm as proposed by the 
registrant.

V. Conclusion

    Therefore, existing tolerances for residues of fenpyroximate are 
increased in or on citrus, dried pulp from 2.5 ppm to 4.0 ppm; citrus, 
oil from 10 ppm to 15 ppm; and fruit, citrus, group 10-10 from 0.50 ppm 
to 1.0 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). 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

[[Page 34875]]

tribes. Thus, the Agency has determined that Executive Order 13132, 
entitled ``Federalism'' (64 FR 43255, August 10, 1999) and Executive 
Order 13175, entitled ``Consultation and Coordination with Indian 
Tribal Governments'' (65 FR 67249, November 9, 2000) do not apply to 
this action. In addition, this action does not impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: June 22, 2017.
Michael L. 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.  180.566, revise the entries for ``Citrus, dried pulp'', 
``Citrus, oil'', and ``Fruit, citrus, group 10-10'' in the table in 
paragraph (a)(1) to read as follows:


Sec.  180.566   Fenpyroximate; tolerances for residues.

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

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Citrus, dried pulp..........................................         4.0
Citrus, oil.................................................          15
 
                                * * * * *
Fruit, citrus, group 10-10..................................         1.0
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-15728 Filed 7-26-17; 8:45 am]
BILLING CODE 6560-50-P
34874 Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Rules and Regulations

are evaluated by comparing the IV. Other Considerations 15 ppm rather than 14 ppm as proposed
estimated aggregate food, water, and by the registrant.
A. Analytical Enforcement Methodology
residential exposure to the appropriate V. Conclusion
PODs to ensure that an adequate MOE Adequate enforcement methodology
exists. (gas chromatography method with Therefore, existing tolerances for
nitrogen/phosphorus detection (GC/ residues of fenpyroximate are increased
1. Acute risk. Using the exposure in or on citrus, dried pulp from 2.5 ppm
NPD), Method S19) is available to
assumptions discussed in this unit for to 4.0 ppm; citrus, oil from 10 ppm to
enforce the tolerance expression.
acute exposure, the acute dietary 15 ppm; and fruit, citrus, group 10–10
Method S19 has passed an Agency
exposure from food and water to validation and has a limit of from 0.50 ppm to 1.0 ppm.
fenpyroximate will occupy 14% of the quantitation (LOQ) of 0.05 ppm for the
aPAD for females 13–49 years old and VI. Statutory and Executive Order
combined residues of fenpyroximate Reviews
6.4% of the aPAD for children 1–2 years and M–1 in snap beans and avocados.
old, the population groups with the This action establishes tolerances
A data-gathering liquid
greatest risk estimate. under FFDCA section 408(d) in
chromatography/mass spectroscopy/
response to a petition submitted to the
2. Chronic risk. Using the exposure mass spectroscopy (LC/MS/MS) method
Agency. The Office of Management and
assumptions described in this unit for is also available.
Budget (OMB) has exempted these types
chronic exposure, EPA has concluded The method may be requested from: of actions from review under Executive
that chronic exposure to fenpyroximate Chief, Analytical Chemistry Branch, Order 12866, entitled ‘‘Regulatory
from food and water will utilize 16% of Environmental Science Center, 701 Planning and Review’’ (58 FR 51735,
the cPAD for children 1–2 years old, the Mapes Rd., Ft. Meade, MD 20755–5350; October 4, 1993). Because this action
population group receiving the greatest telephone number: (410) 305–2905; has been exempted from review under
exposure. There are no residential uses email address: residuemethods@ Executive Order 12866, this action is
for fenpyroximate. epa.gov. not subject to Executive Order 13211,
3. Short- and intermediate-term risk. B. International Residue Limits entitled ‘‘Actions Concerning
Short- and intermediate-term aggregate Regulations That Significantly Affect
In making its tolerance decisions, EPA Energy Supply, Distribution, or Use’’ (66
exposure takes into account short- and seeks to harmonize U.S. tolerances with FR 28355, May 22, 2001) or Executive
intermediate-term residential exposure international standards whenever Order 13045, entitled ‘‘Protection of
plus chronic exposure to food and water possible, consistent with U.S. food Children from Environmental Health
(considered to be a background safety standards and agricultural Risks and Safety Risks’’ (62 FR 19885,
exposure level). Short- and practices. EPA considers the April 23, 1997). This action does not
intermediate-term adverse effects were international maximum residue limits contain any information collections
identified; however, fenpyroximate is (MRLs) established by the Codex subject to OMB approval under the
not registered for any use patterns that Alimentarius Commission (Codex), as Paperwork Reduction Act (PRA) (44
would result in either short- or required by FFDCA section 408(b)(4). U.S.C. 3501 et seq.), nor does it require
intermediate-term residential exposure. The Codex Alimentarius is a joint any special considerations under
Short- and intermediate-term risk is United Nations Food and Agriculture Executive Order 12898, entitled
assessed based on short- and Organization/World Health ‘‘Federal Actions to Address
intermediate-term residential exposure Organization food standards program, Environmental Justice in Minority
plus chronic dietary exposure. Because and it is recognized as an international Populations and Low-Income
there is no short- or intermediate-term food safety standards-setting Populations’’ (59 FR 7629, February 16,
residential exposure and chronic dietary organization in trade agreements to 1994).
exposure has already been assessed which the United States is a party. EPA Since tolerances and exemptions that
under the appropriately protective may establish a tolerance that is are established on the basis of a petition
different from a Codex MRL; however, under FFDCA section 408(d), such as
cPAD (which is at least as protective as
FFDCA section 408(b)(4) requires that the tolerance in this final rule, do not
the POD used to assess short- or
EPA explain the reasons for departing require the issuance of a proposed rule,
intermediate-term risk), no further
from the Codex level. the requirements of the Regulatory
assessment of short- or intermediate-
The Codex has established MRLs for Flexibility Act (RFA) (5 U.S.C. 601 et
term risk is necessary, and EPA relies on
fenpyroximate in or on citrus fruits at seq.), do not apply.
the chronic dietary risk assessment for 0.5 ppm. This MRLs is different than the This action directly regulates growers,
evaluating short- and intermediate-term tolerance being established for food processors, food handlers, and food
risk for fenpyroximate. fenpyroximate in the United States, retailers, not States or tribes, nor does
4. Aggregate cancer risk for U.S. however, harmonization with the Codex this action alter the relationships or
population. Based on the lack of MRL is not possible because the U.S. distribution of power and
evidence of carcinogenicity in two tolerance expression includes an responsibilities established by Congress
adequate rodent carcinogenicity studies, additional isomer and the U.S. use in the preemption provisions of FFDCA
chemical name is not expected to pose pattern requires a higher numerical section 408(n)(4). As such, the Agency
a cancer risk to humans. value. has determined that this action will not
have a substantial direct effect on States
5. Determination of safety. Based on C. Revisions to Petitioned-For
mstockstill on DSK30JT082PROD with RULES

or tribal governments, on the
these risk assessments, EPA concludes Tolerances
relationship between the national
that there is a reasonable certainty that Based on the Organization for government and the States or tribal
no harm will result to the general Economic Co-operation and governments, or on the distribution of
population, or to infants and children Development (OECD) tolerance- power and responsibilities among the
from aggregate exposure to calculation procedure, the Agency is various levels of government or between
fenpyroximate residues. increasing the tolerance on citrus oil to the Federal Government and Indian

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tribes. Thus, the Agency has determined Parts per I. General Information
Commodity
that Executive Order 13132, entitled million
A. Does this action apply to me?
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175, * * * * * You may be potentially affected by
entitled ‘‘Consultation and Coordination Fruit, citrus, group 10–10 ........... 1.0 this action if you are an agricultural
with Indian Tribal Governments’’ (65 FR producer, food manufacturer, or
* * * * *
67249, November 9, 2000) do not apply pesticide manufacturer. The following
to this action. In addition, this action list of North American Industrial
* * * * *
does not impose any enforceable duty or [FR Doc. 2017–15728 Filed 7–26–17; 8:45 am]
Classification System (NAICS) codes is
contain any unfunded mandate as not intended to be exhaustive, but rather
BILLING CODE 6560–50–P
described under Title II of the Unfunded provides a guide to help readers
Mandates Reform Act (UMRA) (2 U.S.C. determine whether this document
1501 et seq.). ENVIRONMENTAL PROTECTION applies to them. Potentially affected
This action does not involve any AGENCY entities may include:
technical standards that would require • Crop production (NAICS code 111).
Agency consideration of voluntary 40 CFR Part 180 • Animal production (NAICS code
consensus standards pursuant to section 112).
12(d) of the National Technology [EPA–HQ–OPP–2016–0518; FRL–9963–04] • Food manufacturing (NAICS code
Transfer and Advancement Act 311).
(NTTAA) (15 U.S.C. 272 note).
Ametoctradin; Pesticide Tolerance • Pesticide manufacturing (NAICS
AGENCY: Environmental Protection code 32532).
VII. Congressional Review Act
Agency (EPA). B. How can I get electronic access to
Pursuant to the Congressional Review ACTION: Final rule. other related information?
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and You may access a frequently updated
SUMMARY: This regulation amends a
other required information to the U.S. electronic version of EPA’s tolerance
tolerance for residues of ametoctradin in
Senate, the U.S. House of regulations at 40 CFR part 180 through
or on hops. BASF Corporation requested
Representatives, and the Comptroller the Government Printing Office’s e-CFR
this tolerance amendment under the
General of the United States prior to site at http://www.ecfr.gov/cgi-bin/text-
Federal Food, Drug, and Cosmetic Act
publication of the rule in the Federal idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
(FFDCA).
Register. This action is not a ‘‘major 40tab_02.tpl.
rule’’ as defined by 5 U.S.C. 804(2). DATES: This regulation is effective July
27, 2017. Objections and requests for C. How can I file an objection or hearing
List of Subjects in 40 CFR Part 180 hearings must be received on or before request?
Environmental protection, September 25, 2017, and must be filed Under FFDCA section 408(g), 21
Administrative practice and procedure, in accordance with the instructions U.S.C. 346a, any person may file an
Agricultural commodities, Pesticides provided in 40 CFR part 178 (see also objection to any aspect of this regulation
and pests, Reporting and recordkeeping Unit I.C. of the SUPPLEMENTARY and may also request a hearing on those
requirements. INFORMATION). objections. You must file your objection
or request a hearing on this regulation
Dated: June 22, 2017. ADDRESSES: The docket for this action,
in accordance with the instructions
Michael L. Goodis, identified by docket identification (ID)
provided in 40 CFR part 178. To ensure
Director, Registration Division, Office of number EPA–HQ–OPP–2016–0518, is
proper receipt by EPA, you must
Pesticide Programs. available at http://www.regulations.gov
identify docket ID number EPA–HQ–
or at the Office of Pesticide Programs
Therefore, 40 CFR chapter I is OPP–2016–0518 in the subject line on
Regulatory Public Docket (OPP Docket)
amended as follows: the first page of your submission. All
in the Environmental Protection Agency
objections and requests for a hearing
PART 180—[AMENDED] Docket Center (EPA/DC), West William
must be in writing, and must be
Jefferson Clinton Bldg., Rm. 3334, 1301
received by the Hearing Clerk on or
■ 1. The authority citation for part 180 Constitution Ave. NW., Washington, DC
before September 25, 2017. Addresses
continues to read as follows: 20460–0001. The Public Reading Room
for mail and hand delivery of objections
Authority: 21 U.S.C. 321(q), 346a and 371.
is open from 8:30 a.m. to 4:30 p.m.,
and hearing requests are provided in 40
Monday through Friday, excluding legal
■ 2. In § 180.566, revise the entries for CFR 178.25(b).
holidays. The telephone number for the
‘‘Citrus, dried pulp’’, ‘‘Citrus, oil’’, and In addition to filing an objection or
Public Reading Room is (202) 566–1744,
‘‘Fruit, citrus, group 10–10’’ in the table hearing request with the Hearing Clerk
and the telephone number for the OPP
in paragraph (a)(1) to read as follows: as described in 40 CFR part 178, please
Docket is (703) 305–5805. Please review
submit a copy of the filing (excluding
§ 180.566 Fenpyroximate; tolerances for the visitor instructions and additional
any Confidential Business Information
residues. information about the docket available
(CBI)) for inclusion in the public docket.
(a) * * * at http://www.epa.gov/dockets.
Information not marked confidential
(1) * * * FOR FURTHER INFORMATION CONTACT: pursuant to 40 CFR part 2 may be
Michael Goodis, Registration Division disclosed publicly by EPA without prior
(7505P), Office of Pesticide Programs,
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Parts per notice. Submit the non-CBI copy of your
Commodity million Environmental Protection Agency, 1200 objection or hearing request, identified
Pennsylvania Ave. NW., Washington, by docket ID number EPA–HQ–OPP–
DC 20460–0001; main telephone 2016–0518, by one of the following
* * * * *
Citrus, dried pulp ........................ 4.0
number: (703) 305–7090; email address: methods:
Citrus, oil ..................................... 15 RDFRNotices@epa.gov. • Federal eRulemaking Portal: http://
SUPPLEMENTARY INFORMATION: www.regulations.gov. Follow the online

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Document Created: 2017-07-27 02:07:38
Document Modified: 2017-07-27 02:07:38
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 July 27, 2017. Objections and requests for hearings must be received on or before September 25, 2017, 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 Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation		82 FR 34870