Document ID: EPA-HQ-OPP-2016-0263-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Isofetamid
Posted Date: 2017-06-14T04:00Z

[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)]
[Rules and Regulations]
[Pages 27149-27154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12346]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0263; FRL-9961-80]

Isofetamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
isofetamid in or on multiple commodities which are identified and 
discussed later in this document. ISK Biosciences Corporation requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA). The regulation also removes the existing time-limited 
tolerances for residues on ``bushberry subgroup 13-07B'' and 
``caneberry subgroup 13-07A'' because they are no longer needed as a 
result of this action.

DATES: This regulation is effective June 14, 2017. Objections and 
requests for hearings must be received on or before August 14, 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-2016-0263, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
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-2016-0263 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 
August 14, 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-2016-0263, 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

[[Page 27150]]

dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of February 7, 2017 (82 FR 9555) (FRL-9956-
86), 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 
6F8457) by ISK Biosciences Corporation, 7470 Auburn Rd., Suite A, 
Concord, OH 44077. The petition requested that 40 CFR 180.681 be 
amended by establishing tolerances for residues of the fungicide 
isofetamid, N-[1,1-dimethyl-2-[2-methyl-4-(1-methylethoxy)phenyl]-2-
oxoethyl]-3-methyl-2-thiophenecarboxamide, in or on caneberry subgroup 
13-07A at 3.0 parts per million (ppm); apple, wet pomace, at 2.0 ppm; 
bushberry, subgroup 13-07B at 6.0 ppm; cattle, fat at 0.01 ppm; cattle, 
meat byproducts at 0.01 ppm; cherry subgroup 12-12A at 5.0 ppm; fruit, 
pome, group 11-10 at 0.6 ppm; fruit, small vine climbing, except grape, 
subgroup 13-7E at 9.0 ppm; goat, fat at 0.01 ppm; goat, meat byproducts 
at 0.01 ppm; horse, fat at 0.01 ppm; horse, meat byproducts at 0.01 
ppm; pea and bean, dried shelled, except soybean, subgroup 6C, except 
cowpea and field pea at 0.05 ppm; pea and bean, succulent shelled, 
subgroup 6B, except cowpea at 0.04 ppm; peach subgroup 12-12B at 3.0 
ppm; plum, prune, dried at 3.5 ppm; plum subgroup 12-12C at 0.8 ppm; 
sheep, fat at 0.01 ppm; sheep, meat byproducts at 0.01 ppm; and 
vegetable, legume, edible podded, subgroup 6A at 1.5 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. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised some of the proposed tolerances; determined that tolerances for 
residues in livestock commodities are not required; and corrected some 
of the commodity definitions. The reason for these changes are 
explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue . . 
. .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for isofetamid including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with isofetamid 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 toxicology database is complete for isofetamid. In 
repeated dose studies, the liver was the primary target organ in the 
rat, mouse, and dog, as indicated by increased liver weights, changes 
in the clinical chemistry values, and liver hypertrophy. A second 
target organ was the thyroid in the rat and dog, as indicated by 
changes in thyroid weights and histopathology. Adrenal weight changes 
were observed in the subchronic rat and dog studies. In the rat and 
dog, the dose levels where toxicity was observed were similar or higher 
in the chronic studies compared with the respective subchronic studies, 
showing an absence of progression of liver toxicity with time. There 
was no evidence of carcinogenicity in the rat or mouse cancer studies; 
the mutagenicity battery was negative. There are no genotoxicity, 
neurotoxicity, or immunotoxicity concerns observed in the available 
toxicity studies. Developmental toxicity was not observed in the rat or 
rabbit, and offspring effects such as decreased body weight were seen 
only in the presence of parental toxicity in the multi-generation rat 
study. Isofetamid is classified as ``Not Likely to be Carcinogenic to 
Humans'' based on the absence of increased tumor incidence in 
acceptable/guideline carcinogenicity studies in rats and mice. 
Isofetamid is not acutely toxic; it is classified as Toxicity Category 
III for acute oral and dermal exposure, and Toxicity Category IV for 
inhalation exposure. Furthermore, it is not irritating to the eye or 
skin, and it is not a dermal sensitizer.
    Specific information on the studies received and the nature of the 
adverse effects caused by isofetamid as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are can be found at http://www.regulations.gov in document Isofetamid. Aggregate Human Health Risk 
Assessment for the Proposed New Agricultural Uses on Bushberry, 
Subgroup 13-07B; Caneberry, Subgroup 13-07A; Cherry, Subgroup 12-12A; 
Dried Shelled Pea and Bean, Except Soybean, Subgroup 6C; Edible-Podded 
Legume Vegetables, Subgroup 6A; Peach, Subgroup 12-12B; Plum, Subgroup 
12-12C; Pome Fruit, Group 11-10; Small Vine Climbing Fruit, Except 
Grape, Subgroup 13-07E; Succulent Shelled Pea and Bean, Subgroup 6B; as 
well as Livestock Commodities; in Addition to Uses on Ornamental Plants 
(including Residential Use Sites). pages 12-18 in docket ID number EPA-
HQ-OPP-2016-0263.

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

[[Page 27151]]

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 isofetamid used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of July 30, 2015 (80 FR 45440) (FRL-
9923-86).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to isofetamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing isofetamid tolerances in 40 CFR 
180.681. EPA assessed dietary exposures from isofetamid 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 isofetamid; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. An unrefined chronic (food and drinking 
water) dietary assessment was conducted for all registered and proposed 
food uses of isofetamid using the Dietary Exposure Evaluation Model 
software with the Food Commodity Intake Database (DEEM-FCID) Version 
3.16. This software uses 2003-2008 food consumption data from the U.S. 
Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA). The chronic 
dietary (food and drinking water) exposure assessment for isofetamid 
incorporated existing tolerance-level residues, Agency-recommended 
tolerance-level residues for proposed tolerances, DEEM default 
processing factors, and 100 PCT (percent crop treated). Some tolerance 
levels were adjusted to include residues of the metabolite, GPTC (a 
residue of concern for risk assessment). DEEM default processing 
factors were used for dried apples, apple juice, dried pear, cherry 
juice, dried apricot, dried peach, plum, prune juice, cranberry juice, 
and grape juice. The EDWC of 110 microgram/Liter ([micro]g/L) was 
incorporated directly into the dietary assessment.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that isofetamid 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 and/or PCT information in the 
dietary assessment for isofetamid. Tolerance level residues and/or 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 isofetamid in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of isofetamid. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Flooded Application Model and the Pesticide 
Root Zone Model Ground Water (PRZM GW) the estimated drinking water 
concentrations (EDWCs) of isofetamid for chronic exposures for non-
cancer assessments are estimated to be 110 parts per billion (ppb) for 
surface water and 43 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration value of 110 ppb was used to assess 
the contribution from 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).
    Isofetamid is currently registered for the following uses that 
could result in residential exposures: Turfgrass including golf 
courses, residential lawns, and recreational turfgrass. It is currently 
under review for registering use on ornamental plants. The proposed 
ornamental use is not intended for homeowner use and therefore a 
quantitative residential handler assessment was not conducted. 
Additionally, post-application exposures for adults and children are 
expected to be negligible. However, the existing turf use may result in 
short- and intermediate-term exposures. Residential exposure may occur 
by the dermal and incidental oral routes of exposures following the 
application of isofetamid on residential turf. However, since dermal 
hazard has not been identified for isofetamid, the only exposure 
scenario quantitatively assessed is for post-application incidental 
oral (for children 1 to <2 years old). These exposures have been 
assessed with current policies, which include the Agency's 2012 
Residential Standard Operating Procedures (http://www.epa.gov/pesticides/science/residential-exposure-sop.html) along with policy 
changes for body weight assumptions.
    Even though a previous risk assessment identified residential 
handler risk estimates for use in aggregate assessment, based on 
current policy and that isofetamid products are intended for sale/use 
to/by professional applicators, residential handler exposure 
assessments for turf are no longer applicable to the isofetamid 
aggregate risk assessment. Therefore, the aggregate assessment for this 
action only includes a risk contribution from residential post-
application incidental oral exposure for children 1 to <2 years old.
    There is the potential for post-application exposure for 
individuals as a result of being in an environment that has been 
previously treated with isofetamid such as residential ornamental 
lawns. Since dermal hazard has not been identified for isofetamid, a 
quantitative assessment for dermal exposure is not necessary and the 
only exposure scenarios quantitatively assessed are for children 1 to 
<2 years old who may experience short-term incidental oral exposure to 
isofetamid from treated turf. Intermediate-term incidental oral post-
application exposures are possible (i.e., from soil ingestion due to 
the persistence of isofetamid); however, the short-term incidental oral 
exposures are protective of the possible intermediate-term incidental 
oral exposures because the POD for both durations is the same. Post-
application inhalation exposure is expected to be negligible for the 
proposed residential uses.
    The post-application incidental oral MOE values were calculated 
based on the scenario of liquid application of isofetamid to turf. 
Post-application risk estimates for all incidental oral scenarios are 
not of concern (MOEs range from 5,900 to 4,000,000). The incidental 
oral scenarios (i.e., hand-to-mouth and object-to-mouth) should be 
considered inter-related and it is likely that they occur interspersed 
amongst

[[Page 27152]]

each other across time. However, combining these scenarios would be 
overly-conservative because of the conservative nature of each 
individual assessment. Incidental oral risk estimates are highly 
conservative because the short- and intermediate-term incidental oral 
POD is based on a 90-day exposure duration which represents daily 
exposure for 90 days. Further information regarding EPA standard 
assumptions and generic inputs for residential exposures may be found 
at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found isofetamid to share a common mechanism of 
toxicity with any other substances, and isofetamid does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
isofetamid 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 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
developmental toxicity or reproductive susceptibility, and there are no 
residual uncertainties concerning pre- or post-natal toxicity or 
exposure.
    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 isofetamid is complete.
    ii. There is no indication that isofetamid is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is no evidence that isofetamid results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to isofetamid in drinking water. EPA used similarly 
conservative assumptions to assess post application exposure of 
children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
isofetamid.

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, 
isofetamid 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 
isofetamid from food and water will utilize 4.0% of the cPAD for 
children (1-2 years old), the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
isofetamid 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). Isofetamid is 
currently registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to isofetamid.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in an aggregate MOE of 1,600 for 
children (1-2 years old). Because EPA's level of concern for isofetamid 
is a MOE of 100 or below, this MOE is 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). An intermediate-term adverse effect was identified; however, 
isofetamid is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no 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 intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
isofetamid.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, isofetamid 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 isofetamid residues.

[[Page 27153]]

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology liquid chromatography with tandem 
mass spectrometry (LC-MS/MS) method is available to enforce the 
tolerance expression. Multiresidue methods testing data have been 
submitted for isofetamid and GPTC. The data indicate that multiresidue 
methods are not suitable for analysis of isofetamid and GPTC, so the 
multiresidue methods cannot serve as enforcement methods. The 
multiresidue data have been forwarded to the Food and Drug 
Administration (FDA).

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 isofetamid. There are no 
Canadian, Codex, or Mexican maximum residue limits (MRLs) for 
isofetamid in/on the commodities included in this petition.

C. Revisions to Petitioned-For Tolerances

    All tolerance levels are based upon the Organization for Economic 
Co-operation and Development's (OECD) tolerance calculation procedures. 
Thus, the tolerance levels established in this notice for isofetamid 
in/on bushberry, subgroup 13-07B; cherry, subgroup 12-12A; plum, prune, 
dried; dried shelled pea and bean, except soybean, subgroup 6C; and 
succulent shelled pea and bean, subgroup 6B are lower than those 
requested by the petitioner. The tolerance levels established in this 
notice for caneberry, subgroup 13-07A and fruit, small vine climbing, 
except grape, subgroup 13-07E are higher than those requested by the 
petitioner based on the OECD calculation procedures.
    Additionally, the Agency has determined that tolerances requested 
for residues in livestock commodities are not required. These 
tolerances fall under 40 CFR 180.6(a)(3) regarding secondary residues 
in livestock commodities, i.e., it is not possible to establish with 
certainty whether finite residues will be incurred, but there is no 
reasonable expectation of finite residues.
    The following commodity definitions have been corrected: Bushberry 
subgroup 13-07B; fruit, small vine climbing, except grape, subgroup 13-
07E; pea and bean, dried shelled, except soybean, subgroup 6C; and pea 
and bean, succulent shelled, subgroup 6B.

V. Conclusion

    Therefore, tolerances are established for residues of isofetamid, 
in or on apple, wet pomace, at 2.0 parts per million (ppm); bushberry 
subgroup 13-07B at 5.0 ppm; caneberry subgroup 13-07A at 4.0 ppm; 
cherry subgroup 12-12A at 4.0 ppm; fruit, pome, group 11-10 at 0.60 
ppm; fruit, small vine climbing, except grape, subgroup 13-07E at 10.0 
ppm; pea and bean, dried shelled, except soybean, subgroup 6C, at 0.040 
ppm; pea and bean, succulent shelled, subgroup 6B, at 0.030 ppm; peach 
subgroup 12-12B at 3.0 ppm; plum, prune, dried at 1.50 ppm; plum 
subgroup 12-12C at 0.80 ppm; and vegetable, legume, edible podded, 
subgroup 6A at 1.50 ppm. Additionally, the existing time-limited 
tolerances are being removed for both Caneberry subgroup 13-07A at 4.0 
ppm, and for Bushberry subgroup 13-07B at 5.0 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 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

[[Page 27154]]

and pests, Reporting and recordkeeping requirements.

    Dated: May 4, 2017.
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. Section 180.681 is amended as follows:
0
a. In the table in paragraph (a) alphabetically add the following 
commodities: ``Apple, wet pomace''; ``Bushberry subgroup 13-07B''; 
``Caneberry subgroup 13-07A''; ``Cherry subgroup 12-12A''; ``Fruit, 
pome, group 11-10''; ``Fruit, small vine climbing, except grape, 
subgroup 13-07E''; ``Pea and bean, dried shelled, except soybean, 
subgroup 6C''; ``Pea and bean, succulent shelled, subgroup 6B''; 
``Peach subgroup 12-12B''; ``Plum, Prune, Dried''; ``Plum subgroup 12-
12C''; ``Vegetable, legume, edible podded, subgroup 6A''.
0
b. Paragraph (b) is revised.
    The additions and revision read as follows:

Sec.  180.681   Isofetamid; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Apple, wet pomace..........................................          2.0
Bushberry subgroup 13-07B..................................          5.0
Caneberry subgroup 13-07A..................................          4.0
 
                                * * * * *
Cherry subgroup 12-12A.....................................          4.0
 
                                * * * * *
Fruit, pome, group 11-10...................................         0.60
 
                                * * * * *
Fruit, small vine climbing, except grape, subgroup 13-07E..         10.0
 
                                * * * * *
Pea and bean, dried shelled, except soybean, subgroup 6C...        0.040
Pea and bean, succulent shelled, subgroup 6B...............        0.030
Peach subgroup 12-12B......................................          3.0
Plum, Prune, Dried.........................................         1.50
Plum subgroup 12-12C.......................................         0.80
 
                                * * * * *
Vegetable, legume, edible podded, subgroup 6A..............         1.50
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *

[FR Doc. 2017-12346 Filed 6-13-17; 8:45 am]
 BILLING CODE 6560-50-P