Document ID: EPA-HQ-OPP-2014-0153-0015
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Pyriofenone
Posted Date: 2017-04-18T04:00Z

[Federal Register Volume 82, Number 73 (Tuesday, April 18, 2017)]
[Rules and Regulations]
[Pages 18235-18240]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07818]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0153; FRL-9953-96]

Pyriofenone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
pyriofenone in or on the caneberry subgroup (crop subgroup 13-07A), the 
bushberry subgroup (crop subgroup 13-07B), the small fruit vine 
climbing subgroup (crop subgroup 13-07D), the low growing berry 
subgroup except cranberry (crop subgroup 13-07G) and cucurbit 
vegetables (crop group 9). ISK Biosciences Corporation requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 18, 2017. Objections and 
requests for hearings must be received on or before June 19, 2017, and 
must be filed in

[[Page 18236]]

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-2014-0153, 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: RDFRNotices@epa.gov.

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 
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-2014-0153 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 
June 19, 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-2014-0153, 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 May 23, 2014 (79 FR 29729) (FRL-9910-
29), 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 
3F8227) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A 
Concord, OH 44077. The petition requested that 40 CFR part 180 be 
amended by proposing tolerances for residues of the fungicide, 
pyriofenone, in or on, the caneberry subgroup (crop subgroup 13-07A) at 
0.90 ppm, the bushberry subgroup (crop subgroup 13-07B) at 1.5 ppm, the 
small fruit vine climbing subgroup (crop subgroup 13-07D) at 1.5 ppm, 
the low growing berry subgroup except cranberry (crop subgroup 13-07G) 
at 0.50 ppm, and cucurbit vegetables (crop group 9) at 0.30 ppm. That 
document referenced a summary of the petition prepared by ISK 
Biosciences Corporation, the registrant, which is available in the 
docket, http://www.regulations.gov. Comments were received on the 
notice of filing. EPA's response to these comments is discussed 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 pyriofenone including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with pyriofenone 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 liver (dog, rat, and mouse), kidney (rat and mouse), and 
cecum (rat) were the primary organs affected by pyriofenone in toxicity

[[Page 18237]]

studies. Symptoms of liver toxicity observed in the studies were 
increased weight, dark color, histological abnormalities (liver pigment 
deposition, microgranuloma, fatty change, necrosis, and focal hepatic 
congestion), and increases in hepatic enzymes (alkaline phosphatase, 
[gamma]-glutamyltranferase, and triglycerides) in serum. Indications of 
kidney toxicity resulting from pyriofenone exposure included increased 
weight, coarse surface, histological abnormalities (chronic 
nephropathy, cortical tubular basophilia, cortical scaring, and 
cortical cysts), increases in ketones in urine, and perigenital 
staining. Effects of pyriofenone exposure on the cecum included 
increased weight; and enlargement, distension, and inflammation. Tests 
were not conducted to determine toxicity through the inhalation route 
of exposure, because these data were waived. There is no evidence of 
dermal toxicity at the limit dose.
    Exposure to pyriofenone did not result in any developmental effects 
at the limit dose in rats, but abortions were noted in rabbits at 300 
mg/kg/day. The rabbit abortions were associated with decreased maternal 
body weight gain and food consumption. There were no effects on 
reproduction observed at the highest dose tested (334 mg/kg/day), and 
no quantitative or qualitative sensitivity was noted in offspring. 
There was no evidence of genotoxicity nor an increase in the incidence 
of tumors. Based on the results of the immunotoxicity study and other 
studies in the toxicity database, there was no evidence that 
pyriofenone directly targets the immune system.
    Specific information on the studies received and the nature of the 
adverse effects caused by pyriofenone 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 documents ``Pyriofenone. Human Health Risk 
Assessment for the Section 3 Registration on: Cucurbit Vegetable (crop 
group 9) and berry and small fruit, crop group 13-07 (except large 
shrub/tree berry subgroup 13-07C)'' and ``Pyriofenone. Revision to 
Human Health Risk Assessment for the Section 3 Registration on: 
Cucurbit Vegetable (Crop Group 9) and Berry and Small Fruit, Crop Group 
13-07, (Except Large Shrub/Tree Berry Subgroup 13-07C)'' in docket ID 
number EPA-HQ-OPP-2014-0153.

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 pyriofenone used for human risk assessment is shown in 
Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Pyriofenone for Use in Human Health Risk Assessment
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                                     Point of departure and
         Exposure/scenario             uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
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Acute dietary (All populations)....  An endpoint of concern attributable to a single dose was not identified. An
                                      acute RfD was not established.
                                    ----------------------------------------------------------------------------
Chronic dietary (All populations)..  NOAEL = 9.1 mg/kg/day   Chronic RfD =           Carcinogenicity in rat.
                                     UFA = 10x.............  cPAD = 0.091 mg/kg/day  LOAEL = 150 mg/kg/day based
                                     UFH = 10x.............                           on chronic nephropathy in
                                     FQPA SF = 1x..........                           females.
Incidental oral short-term (1 to 30  NOAEL = 61 mg/kg/day    LOC for MOE = 100.....  Subchronic oral toxicity in
 days).                              UFA = 10x.............                           rat.
                                     UFH = 10x.............                          LOAEL = 150 mg/kg/day based
                                     FQPA SF = 1x..........                           on increased cecum weight
                                                                                      in males.
                                    ----------------------------------------------------------------------------
Dermal Short-and Intermediate-Term   No quantitative dermal assessment needed. No dermal toxicity at limit dose.
 (1-30 days; 1-6 months).             No increased quantitative or qualitative susceptibility noted in fetus or
                                      offspring. Developmental effect (abortions) in rats at 100 mg/kg/day. DAF
                                      = 6%. Adjusted value exceeds limit dose. No neurotoxicity observed in ACN
                                      and SCN at the limit dose.
                                    ----------------------------------------------------------------------------
Inhalation short-term and            NOAEL = 61 mg/kg/day    LOC for MOE = 100.....  Subchronic oral toxicity in
 intermediate-term (1 to 30 days; 1-  (inhalation                                     rat.
 6 months).                           absorption rate =                              LOAEL = 150 mg/kg//day
                                      100%)                                           based on increased cecum
                                     UFA = 10x.............                           weight in males.
                                     UFH = 10x.............
                                     FQPA SF = 1x..........
                                    ----------------------------------------------------------------------------

[[Page 18238]]

 
Cancer (Oral, dermal, inhalation)..  Not likely to be carcinogenic to humans.
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ACN = Acute Neurotoxicity Battery. DAF = Dermal Absorption Factor. 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. SCN = Subchronic Neurotoxicity Battery. 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 pyriofenone, EPA considered exposure under the petitioned-
for tolerances as well as all existing pyriofenone tolerances in 40 CFR 
180.660. EPA assessed dietary exposures from pyriofenone 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 pyriofenone; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA assumed pyriofenone residues are present in all 
commodities at tolerance levels and that 100% of primary crops are 
treated. All populations were evaluated for chronic dietary exposure 
and risk from food and drinking water. No risks of concern were 
identified in the chronic dietary exposure analysis.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that pyriofenone 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. 
Tolerance level residues and 100% crop treated were assumed for all 
food commodities for pyriofenone.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for pyriofenone in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of pyriofenone. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Tier 1 Cranberry Model for surface water and Pesticide 
Root Zone Model Ground Water (PRZM GW) for ground water, the estimated 
drinking water concentrations (EDWCs) of pyriofenone for acute 
exposures are estimated to be 20.9 parts per billion (ppb) for surface 
water and 4.3 ppb for ground water. The chronic exposures for non-
cancer assessments are estimated to be 2.7 ppb for surface water and 
3.9 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. Because no acute dietary 
endpoint was identified, no acute dietary assessment was conducted. For 
the chronic dietary risk assessment, the water concentration of value 
3.9 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). Pyriofenone is not 
registered for any specific use patterns that would result in 
residential exposure. Therefore a residential exposure assessment is 
not required.
    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 pyriofenone to share a common mechanism of 
toxicity with any other substances, and pyriofenone does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
pyriofenone 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://www.epa.gov/pesticides/cumulative.

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 FQPA Safety 
Factor (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. Exposure to pyriofenone did 
not result in any developmental effects at the limit dose in rats, but 
abortions were noted in rabbits at 300 mg/kg/day. EPA is regulating 
pyriofenone at doses that are protective of this effect. The abortions 
were associated with decreased maternal body weight gain and food 
consumption. There were no reproductive effects observed in rats at the 
highest tested dose (334 mg/kg/day), nor was any quantitative or 
qualitative sensitivity noted in offspring.
    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 pyriofenone is complete.
    ii. There is no indication that pyriofenone is a neurotoxic 
chemical, and there is no need for a developmental neurotoxicity study 
or

[[Page 18239]]

additional UFs to account for neurotoxicity.
    iii. There is no evidence that pyriofenone 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% crop treated and tolerance-level residues. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to pyriofenone in drinking water. 
These assessments will not underestimate the exposure and risks posed 
by pyriofenone.

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, 
pyriofenone 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 
pyriofenone from food and water will utilize 7.2% of the cPAD for 
children 1 to 2 years old the population group receiving the greatest 
exposure. There are no residential uses for pyriofenone; therefore, the 
chronic aggregate risk is limited to the chronic dietary risk and is 
not of concern
    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). There are no 
residential uses for pyriofenone; therefore, short-term aggregate risks 
are addressed by the chronic aggregate risk estimates and 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). There are no residential uses for pyriofenone; therefore, 
intermediate-term aggregate risks are addressed by the chronic 
aggregate risk estimates and are not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, pyriofenone 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 pyriofenone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The petitioner submitted a liquid chromatography method with tandem 
mass-spectrometry detection (LC-MS/MS) analytical method, ISK Method 
0341/074208, for analysis of residues of pyriofenone in/on plant 
commodities. This method was independently validated to a limit of 
quantitation of 0.01 ppm in grapes, wheat grain, and wheat straw. To 
support the new registration actions for pyriofenone, a radiovalidation 
study was submitted to determine the extraction efficiency of the 
pyriofenone enforcement method. Radiovalidation testing of Analytical 
Method ISK 0341/074208 demonstrated an extraction efficiency of 
approximately 50-60% for pyriofenone residues present in plant samples 
aged 5\1/2\ years.
    Adequate enforcement methodology (liquid chromatography method with 
tandem mass spectrometric detection (LC-MS/MS)) is available to enforce 
the tolerance expression.

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 MRLs for pyriofenone.

C. Response to Comments

    One comment was received from a private citizen objecting to 
establishment of tolerances. The commenter feels that establishment of 
these tolerances would add to the pesticide body load that is already 
carried by the human population. In addition, the commenter also 
indicates that the pesticide body load will increase the exposure to 
carcinogens and increase the prevalence of cancer.
    Agency response: The Agency understands the commenter's concerns 
and recognizes that some individuals believe that pesticides should be 
banned completely. However, under the existing legal framework provided 
by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) EPA 
is authorized to establish pesticide tolerances or exemptions where 
persons seeking such tolerances or exemptions have demonstrated that 
the pesticide meets the safety standard imposed by that statute.
    When new or amended tolerances are requested for the presence of 
the residues of a pesticide and its toxicologically significant 
metabolite(s) in food or feed, the Agency, as is required by Section 
408 of the Federal Food, Drug and Cosmetic Act (FFDCA), estimates the 
risk of the potential exposure to these residues by performing an 
aggregate risk assessment. Such a risk assessment integrates the 
individual assessments that are conducted for food, drinking water, and 
residential exposures, and also assesses cancer risk. Additionally, the 
Agency, as is further required by Section 408 of the FFDCA, considers 
available information concerning what are termed the cumulative 
toxicological effects of the residues of that pesticide and of other 
substances having a common mechanism of toxicity with it. For 
pyriofenone, the Agency has concluded after this assessment that the 
pesticide is not carcinogenic, and that there is a reasonable certainty 
that no harm will result from exposure to residues of this pesticide.

V. Conclusion

    Therefore, tolerances are established for residues of pyriofenone, 
in or on, the

[[Page 18240]]

caneberry subgroup (crop subgroup 13-07A) at 0.90 ppm, the bushberry 
subgroup (crop subgroup 13-07B) at 1.5 ppm, the small fruit vine 
climbing subgroup (crop subgroup 13-07D) at 1.5 ppm, the low growing 
berry subgroup except cranberry (crop subgroup 13-07G) at 0.50 ppm, and 
cucurbit vegetables (crop group 9) at 0.30 ppm. Also, the Agency is 
removing two individual tolerances from the table at 40 CFR 180.660(a) 
that were not identified in the petition to eliminate redundancies upon 
the establishment of the recommended crop group and subgroup 
tolerances: grape at 0.3 ppm, grape, raisin at 0.5 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 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: February 20, 2017.
Richard P. Keigwin, Jr.,
Acting Director, Office of Pesticide Program.

    Therefore, 40 CFR part 180 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.  180.660, revise the table in paragraph (a) to read as 
follows:

Sec.  180.660   Pyriofenone; tolerance for residues.

    (a) * * *

 
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Berry, low growing, subgroup 13-07G (except cranberry).....         0.50
Bushberry subgroup 13-07B..................................         1.5
Caneberry subgroup 13-07A..................................         0.90
Fruit, small vine climbing subgroup 13-07D.................         1.5
Vegetables, cucurbit, crop group 9.........................         0.30
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-07818 Filed 4-17-17; 8:45 am]
 BILLING CODE 6560-50-P