80 FR 45438 - Isofetamid; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 146 (July 30, 2015)

Page Range		45438-45443
FR Document		2015-18738
This regulation establishes tolerances for residues of isofetamid in or on multiple commodities that are identified and discussed later in this document. ISK Biosciences Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Federal Register, Volume 80 Issue 146 (Thursday, July 30, 2015)
[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Rules and Regulations]
[Pages 45438-45443]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18738]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0138; FRL-9923-86]


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 that are identified and 
discussed later in this document. ISK Biosciences Corporation requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective July 30, 2015. Objections and 
requests for hearings must be received on or before September 28, 2015, 
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-2013-0138, 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: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 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

[[Page 45439]]

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-2013-0138 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 28, 2015. 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-2013-0138, 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 June 5, 2013 (78 FR 33785) (FRL-9386-2), 
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 3F8142) 
by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, 
Ohio 44077. The petition requested that 40 CFR part 180 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 almond at 0.02 parts per million 
(ppm); almond, hulls at 0.2 ppm; lettuce, head at 6.0 ppm; lettuce, 
leaf at 7.0 ppm; low growing berry crop subgroup 13-07G at 4.0 ppm; 
rapeseed, crop subgroup 20A at 0.04 ppm; and small fruit vine climbing 
crop subgroup 13-07F at 3.0 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 
determined that additional tolerances are necessary; revised some of 
the proposed tolerances; and corrected some commodity definitions for 
the tolerances. The reasons for these changes are 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 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 can be found at http://www.regulations.gov in document 
Isofetamid. Aggregate Human Health Risk Assessment for the Proposed New 
Uses of the New Active Fungicide,

[[Page 45440]]

including Agricultural Uses on Almonds, Lettuce, Small Vine Climbing 
Fruits (Crop Subgroup 13-07F), Low Growing Berries (Crop Subgroup 13-
07G), and Rapeseed (Crop Subgroup 20A); and Uses on Turfgrass 
(including Golf Courses, Sod Farms, Seed Farms, Recreational Fields, 
and Commercial/Residential Lawns) at pages 12-18 in docket ID number 
EPA-HQ-OPP-2013-0138.

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

  Table 1--Summary of Toxicological Doses and Endpoints for Isofetamid for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute Dietary (All Populations)    A toxicity endpoint was not identified.
                                   Toxicological effects attributable to a single exposure (dose) were not
                                    observed in oral toxicity studies.
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Chronic dietary (All populations)  NOAEL = 76.6 mg/kg/   Chronic RfD = 0.77   Reproduction and fertility effects
                                    day                   mg/kg/day            (rat)
                                   UFA = 10X...........  cPAD = 0.77 mg/kg/   LOAEL = 679/775 mg/kg/day based on
                                   UFH = 10X...........   day.                 hepatocellular hypertrophy in the
                                   FQPA SF = 1X........                        liver and follicular cell
                                                                               hypertrophy in the thyroid in
                                                                               both sexes and generations,
                                                                               decreased spleen weights and
                                                                               cytoplasmic eosinophilic
                                                                               inclusion bodies in the liver of
                                                                               F1 males, and decreased pup body
                                                                               weight in both sexes and
                                                                               generations.
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Incidental oral short-term (1 to   NOAEL = 76.6 mg/kg/   Residential LOC for  Reproduction and fertility effects
 30 days) and Incidental oral       day                   MOE = 100.           (rat)
 intermediate-term (1 to 6         UFA = 10X...........                       LOAEL = 679/775 mg/kg/day based on
 months)                           UFH = 10X...........                        hepatocellular hypertrophy in the
                                   FQPA SF = 1X........                        liver and follicular cell
                                                                               hypertrophy in the thyroid in
                                                                               both sexes and generations,
                                                                               decreased spleen weights and
                                                                               cytoplasmic eosinophilic
                                                                               inclusion bodies in the liver of
                                                                               F1 males, and decreased pup body
                                                                               weight in both sexes and
                                                                               generations
----------------------------------------------------------------------------------------------------------------
Dermal Short-Term (1-30 days)      A toxicity endpoint was not identified.
                                   Systemic toxicity was not seen in 28-day dermal toxicity in rats up to the
                                    limit dose (1,000 mg/kg/day). There are no concerns for developmental or
                                    reproductive toxicity or neurotoxicity in rat and rabbit studies.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     NOAEL = 76.6 mg/kg/   Residential LOC for  Reproduction and fertility effects
 days)                              day                   MOE = 100            (rat)
                                   UFA = 10X...........                       LOAEL = 679/775 mg/kg/day based on
                                   UFH = 10X...........                        hepatocellular hypertrophy in the
                                   FQPA SF = 1X........                        liver and follicular cell
                                                                               hypertrophy in the thyroid in
                                                                               both sexes and generations,
                                                                               decreased spleen weights and
                                                                               cytoplasmic eosinophilic
                                                                               inclusion bodies in the liver of
                                                                               F1 males, and decreased pup body
                                                                               weight in both sexes and
                                                                               generations.
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Cancer (Oral, dermal, inhalation)  Classification: ``Not likely to be Carcinogenic to Humans'' based on the
                                    absence of significant tumor increases in two adequate rodent
                                    carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
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). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term
  risk assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. 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.

[[Page 45441]]

    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the 2003-2008 food consumption data from the 
USDA's National Health and Nutrition Examination Survey, What We Eat in 
America (NHANES/WWEIA). A partially refined chronic (food and drinking 
water) dietary assessment was conducted assuming mean field trial 
residues of the combined residues of parent and GPTC for all proposed 
crops and 100% CT. Empirical and default processing factors were used 
as available.
    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 PCT information in the dietary assessment for 
isofetamid. Mean field trial residues of the combined residues of 
parent and GPTC were used.
    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://www.epa.gov/oppefed1/models/water/index.htm.
    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 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 under review for registering the following 
uses that could result in residential exposures: Foliar and systemic 
fungicide for control in turfgrass including golf courses, residential 
lawns, and recreational turfgrass. Since there may be residential use 
sites, residential handler exposure and risk estimates were calculated 
for all possible residential exposure scenarios. Including all possible 
residential exposure scenarios provides a conservative and health 
protective assessment for the potential for homeowners to use the 
professionally labeled products on residential use sites. Since there 
is no dermal toxicity endpoint, the residential handler assessment only 
includes the inhalation route of exposure. Residential handler exposure 
is expected to be short-term in duration as a maximum of eight 
applications are allowed per year. Thus, intermediate-term exposures 
are not likely because of the intermittent nature of applications by 
homeowners. Unit exposure values and estimates for area treated or 
amount handled were taken from the Agency's 2012 Residential SOPs \1\ 
(Lawns/Turf). The algorithms used to estimate exposure and dose for 
residential handlers can be found in the 2012 Residential SOPs \2\ 
(Lawns/Turf). Risk estimates of all possible scenarios are not of 
concern. Short-term inhalation MOEs range from 850,000 to 18,000,000. 
Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
---------------------------------------------------------------------------

    \1\ Available: http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
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    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://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. 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 average (mean) field trial 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

[[Page 45442]]

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 <1% 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 aggregate MOEs of 24,000 and 3,900 
for adults and children (1-2 years old) respectively. Because EPA's 
level of concern for isofetamid is a MOE of 100 or below, these MOEs 
are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). 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.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology liquid chromatography with tandem 
mass spectrometry (LC-MS/MS) method (Document Number JSM0119; MRID 
49011967) 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 any MRLs for isofetamid. Canada is 
concurrently establishing tolerances for all of the same commodities 
identified in this document except almond hulls because Canada does not 
set tolerances on livestock feed commodities. Canada's recommended 
tolerance levels for these commodities are the same as the U.S. 
established tolerance levels. The tolerance expression for the U.S. and 
Canada is the same, with isofetamid as the residue of concern for 
primary crops.

C. Revisions to Petitioned-For Tolerances

    The Agency has made revisions to some of the petitioned-for 
tolerance levels based on the following reasons:
    1. Organization for Economic Cooperation and Development (OECD) 
tolerance calculation procedures;
    2. The parent only is the residue of concern for primary crop 
tolerances rather than parent and the metabolite GPTC; and
    3. The concentration of residues in two processed commodities.
    Since all residues of isofetamid (parent) were nondetectable (<0.01 
ppm) in almond nutmeat and hulls, the proposed tolerances of 0.02 ppm 
for almond (nutmeat) and 0.2 ppm for almond hulls will both be reduced 
to 0.01 ppm, the limit of quantitation of the analytical method.
    Based on the OECD tolerance calculation procedures, the proposed 
tolerance for head lettuce of 6.0 ppm will be reduced to 5.0 ppm. Based 
on the OECD tolerance calculation procedures, the proposed tolerance 
for the rapeseed subgroup 20A of 0.04 ppm will be reduced to 0.015 ppm.
    The petitioner did not propose tolerances for the processed 
commodities, canola oil and raisins. Since residues concentrate 
significantly in canola oil and raisins, tolerances will be established 
at 0.03 ppm for canola, refined oil, and 5.0 ppm for grape, raisin. 
These Agency recommendations are based on the highest average field 
trial (HAFT) residues for canola seed and grape and the processing 
factors for canola oil and raisins. The petitioner did not propose 
tolerances for flaxseed oil, mustard seed oil, or sesame oil. However, 
flaxseed, mustard seed, and sesame are members of the rapeseed subgroup 
20A, with canola as the representative crop, and treated commodities 
could be processed to produce sesame oil, mustard seed oil and flaxseed 
oil. Therefore, the Agency is also establishing tolerances for residues 
in flaxseed oil, mustard seed oil, and sesame oil. Tolerances are being 
established at 0.03 ppm, the same level as for refined canola oil.
    Additionally, some of the requested tolerances have been corrected. 
Almond has been revised from 0.02 ppm to 0.01 ppm; almond, hulls from 
0.2 ppm to 0.01 ppm; lettuce, head from 6.0 ppm to 5.0 ppm; and 
rapeseed, subgroup 20A from 0.04 ppm to 0.015 ppm. The Agency is 
setting tolerances on some processed commodities that were not

[[Page 45443]]

proposed by the petitioner including canola, refined oil at 0.03 ppm; 
flax, seed, oil at 0.03 ppm; grape, raisin at 5.0 ppm; mustard, seed, 
oil at 0.03 ppm and sesame, oil at 0.03 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of isofetamid, 
in or on almond at 0.01 ppm; almond, hulls at 0.01 ppm; canola, refined 
oil at 0.03 ppm; flax, seed, oil at 0.03 ppm; grape, raisin at 5.0 ppm; 
lettuce, head at 5.0 ppm; lettuce, leaf at 7.0 ppm; berry, low growing, 
subgroup 13-07G at 4.0 ppm; mustard, seed, oil at 0.03 ppm; rapeseed 
subgroup 20A at 0.015 ppm; sesame, oil at 0.03 ppm; and fruit, small 
vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 3.0 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 and pests, Reporting and 
recordkeeping requirements.

    Dated: July 21, 2015.
Jack Housenger,
Director, 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. Add Sec.  180.681 to subpart C to read as follows:


Sec.  [emsp14]180.681  Isofetamid; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide isofetamid, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only 
isofetamid, N-[1,1-dimethyl-2-[2-methyl-4-(1-methylethoxy)phenyl]-2-
oxoethyl]-3-methyl-2-thiophenecarboxamide, in or on the following 
commodities:

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Almond..................................................            0.01
Almond, hulls...........................................            0.01
Berry, low growing, subgroup 13-07G.....................             4.0
Canola, refined oil.....................................            0.03
Flax, seed, oil.........................................            0.03
Fruit, small vine climbing, except fuzzy kiwifruit,                  3.0
 subgroup 13-07F........................................
Grape, raisin...........................................             5.0
Lettuce, head...........................................             5.0
Lettuce, leaf...........................................             7.0
Mustard, seed, oil......................................            0.03
Rapeseed subgroup 20A...................................           0.015
Sesame, oil.............................................            0.03
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2015-18738 Filed 7-29-15; 8:45 am]
 BILLING CODE 6560-50-P
45438 Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Rules and Regulations

any special considerations under and pests, Reporting and recordkeeping document. ISK Biosciences Corporation
Executive Order 12898, entitled requirements. requested these tolerances under the
‘‘Federal Actions to Address Dated: July 22, 2015. Federal Food, Drug, and Cosmetic Act
Environmental Justice in Minority Susan Lewis, (FFDCA).
Populations and Low-Income DATES: This regulation is effective July
Director, Registration Division, Office of
Populations’’ (59 FR 7629, February 16, Pesticide Programs. 30, 2015. Objections and requests for
1994). hearings must be received on or before
Therefore, 40 CFR chapter I is
Since tolerances and exemptions that
amended as follows: September 28, 2015, and must be filed
are established on the basis of a petition
in accordance with the instructions
under FFDCA section 408(d), such as PART 180—[AMENDED] provided in 40 CFR part 178 (see also
the tolerance in this final rule, do not
Unit I.C. of the SUPPLEMENTARY
require the issuance of a proposed rule, ■ 1. The authority citation for part 180 INFORMATION).
the requirements of the Regulatory continues to read as follows:
Flexibility Act (RFA) (5 U.S.C. 601 et The docket for this action,
ADDRESSES:
Authority: 21 U.S.C. 321(q), 346a and 371.
seq.), do not apply. identified by docket identification (ID)
This action directly regulates growers, ■ 2. In § 180.418, revise the entries for number EPA–HQ–OPP–2013–0138, is
food processors, food handlers, and food ‘‘corn, field, forage,’’ ‘‘corn, field, available at http://www.regulations.gov
retailers, not States or tribes, nor does stover,’’ and ‘‘corn, pop, stover’’ in the or at the Office of Pesticide Programs
this action alter the relationships or table in paragraph (a)(2) to read as Regulatory Public Docket (OPP Docket)
distribution of power and follows: in the Environmental Protection Agency
responsibilities established by Congress Docket Center (EPA/DC), West William
§ 180.418 Cypermethrin and isomers
in the preemption provisions of FFDCA alpha-cypermethrin and zeta-cypermethrin; Jefferson Clinton Bldg., Rm. 3334, 1301
section 408(n)(4). As such, the Agency tolerances for residues. Constitution Ave. NW., Washington, DC
has determined that this action will not (a) * * * 20460–0001. The Public Reading Room
have a substantial direct effect on States (2) * * * is open from 8:30 a.m. to 4:30 p.m.,
or tribal governments, on the Monday through Friday, excluding legal
relationship between the national Parts per holidays. The telephone number for the
Commodity
government and the States or tribal million Public Reading Room is (202) 566–1744,
governments, or on the distribution of and the telephone number for the OPP
power and responsibilities among the Docket is (703) 305–5805. Please review
various levels of government or between * * * * *
the visitor instructions and additional
the Federal Government and Indian Corn, field, forage ................. 9.0 information about the docket available
tribes. Thus, the Agency has determined at http://www.epa.gov/dockets.
that Executive Order 13132, entitled FOR FURTHER INFORMATION CONTACT:
‘‘Federalism’’ (64 FR 43255, August 10, * * * * * Susan Lewis, Registration Division
1999) and Executive Order 13175, (7505P), Office of Pesticide Programs,
entitled ‘‘Consultation and Coordination Corn, field, stover ................. 30 Environmental Protection Agency, 1200
with Indian Tribal Governments’’ (65 FR Pennsylvania Ave. NW., Washington,
67249, November 9, 2000) do not apply DC 20460–0001; telephone number:
* * * * *
to this action. In addition, this action 703–305–7090; email address:
does not impose any enforceable duty or Corn, pop, stover .................. 30 RDFRNotices@epa.gov.
contain any unfunded mandate as SUPPLEMENTARY INFORMATION:
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C. * * * * * I. General Information
1501 et seq.). A. Does this action apply to me?
This action does not involve any
technical standards that would require * * * * * You may be potentially affected by
Agency consideration of voluntary [FR Doc. 2015–18737 Filed 7–29–15; 8:45 am] this action if you are an agricultural
consensus standards pursuant to section BILLING CODE 6560–50–P producer, food manufacturer, or
12(d) of the National Technology pesticide manufacturer. The following
Transfer and Advancement Act list of North American Industrial
(NTTAA) (15 U.S.C. 272 note). ENVIRONMENTAL PROTECTION Classification System (NAICS) codes is
AGENCY not intended to be exhaustive, but rather
VII. Congressional Review Act provides a guide to help readers
Pursuant to the Congressional Review 40 CFR Part 180 determine whether this document
Act (5 U.S.C. 801 et seq.), EPA will [EPA–HQ–OPP–2013–0138; FRL–9923–86] applies to them. Potentially affected
submit a report containing this rule and entities may include:
other required information to the U.S. Isofetamid; Pesticide Tolerances • Crop production (NAICS code 111).
Senate, the U.S. House of • Animal production (NAICS code
AGENCY: Environmental Protection
Representatives, and the Comptroller 112).
Agency (EPA).
General of the United States prior to • Food manufacturing (NAICS code
ACTION: Final rule.
publication of the rule in the Federal 311).
Register. This action is not a ‘‘major • Pesticide manufacturing (NAICS
Lhorne on DSK7TPTVN1PROD with RULES

SUMMARY: This regulation establishes
rule’’ as defined by 5 U.S.C. 804(2). tolerances for residues of isofetamid in code 32532).
List of Subjects in 40 CFR Part 180 or on multiple commodities that are B. How can I get electronic access to
identified and discussed later in this other related information?
Environmental protection,
Administrative practice and procedure, You may access a frequently updated
Agricultural commodities, Pesticides electronic version of EPA’s tolerance

VerDate Sep<11>2014 17:16 Jul 29, 2015 Jkt 235001 PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 E:\FR\FM\30JYR1.SGM 30JYR1
Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Rules and Regulations 45443

proposed by the petitioner including section 408(n)(4). As such, the Agency and degradates, in or on the
canola, refined oil at 0.03 ppm; flax, has determined that this action will not commodities in the table below.
seed, oil at 0.03 ppm; grape, raisin at 5.0 have a substantial direct effect on States Compliance with the tolerance levels
ppm; mustard, seed, oil at 0.03 ppm and or tribal governments, on the specified below is to be determined by
sesame, oil at 0.03 ppm. relationship between the national measuring only isofetamid, N-[1,1-
V. Conclusion government and the States or tribal dimethyl-2-[2-methyl-4-(1-
governments, or on the distribution of methylethoxy)phenyl]-2-oxoethyl]-3-
Therefore, tolerances are established power and responsibilities among the methyl-2-thiophenecarboxamide, in or
for residues of isofetamid, in or on various levels of government or between on the following commodities:
almond at 0.01 ppm; almond, hulls at the Federal Government and Indian
0.01 ppm; canola, refined oil at 0.03 tribes. Thus, the Agency has determined Parts per
Commodity
ppm; flax, seed, oil at 0.03 ppm; grape, that Executive Order 13132, entitled million
raisin at 5.0 ppm; lettuce, head at 5.0 ‘‘Federalism’’ (64 FR 43255, August 10,
ppm; lettuce, leaf at 7.0 ppm; berry, low Almond .................................. 0.01
1999) and Executive Order 13175, Almond, hulls ........................ 0.01
growing, subgroup 13–07G at 4.0 ppm; entitled ‘‘Consultation and Coordination Berry, low growing, subgroup
mustard, seed, oil at 0.03 ppm; rapeseed with Indian Tribal Governments’’ (65 FR 13–07G ............................. 4.0
subgroup 20A at 0.015 ppm; sesame, oil 67249, November 9, 2000) do not apply Canola, refined oil ................ 0.03
at 0.03 ppm; and fruit, small vine to this action. In addition, this action Flax, seed, oil ....................... 0.03
climbing, except fuzzy kiwifruit, does not impose any enforceable duty or Fruit, small vine climbing, ex-
subgroup 13–07F at 3.0 ppm. contain any unfunded mandate as cept fuzzy kiwifruit, sub-
described under Title II of the Unfunded group 13–07F .................... 3.0
VI. Statutory and Executive Order Grape, raisin ......................... 5.0
Reviews Mandates Reform Act (UMRA) (2 U.S.C. Lettuce, head ........................ 5.0
This action establishes tolerances 1501 et seq.). Lettuce, leaf .......................... 7.0
This action does not involve any Mustard, seed, oil ................. 0.03
under FFDCA section 408(d) in
technical standards that would require Rapeseed subgroup 20A ...... 0.015
response to a petition submitted to the
Agency consideration of voluntary Sesame, oil ........................... 0.03
Agency. The Office of Management and
consensus standards pursuant to section
Budget (OMB) has exempted these types
12(d) of the National Technology (b) Section 18 emergency exemptions.
of actions from review under Executive
Transfer and Advancement Act [Reserved]
Order 12866, entitled ‘‘Regulatory
(NTTAA) (15 U.S.C. 272 note). (c) Tolerances with regional
Planning and Review’’ (58 FR 51735,
registrations. [Reserved]
October 4, 1993). Because this action VII. Congressional Review Act (d) Indirect or inadvertent residues.
has been exempted from review under Pursuant to the Congressional Review [Reserved]
Executive Order 12866, this action is Act (5 U.S.C. 801 et seq.), EPA will [FR Doc. 2015–18738 Filed 7–29–15; 8:45 am]
not subject to Executive Order 13211, submit a report containing this rule and BILLING CODE 6560–50–P
entitled ‘‘Actions Concerning other required information to the U.S.
Regulations That Significantly Affect Senate, the U.S. House of
Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller ENVIRONMENTAL PROTECTION
FR 28355, May 22, 2001) or Executive General of the United States prior to AGENCY
Order 13045, entitled ‘‘Protection of publication of the rule in the Federal
Children from Environmental Health Register. This action is not a ‘‘major 40 CFR Part 180
Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2). [EPA–HQ–OPP–2013–0714; FRL–9927–63]
April 23, 1997). This action does not
contain any information collections List of Subjects in 40 CFR Part 180 Benalaxyl-M; Pesticide Tolerances
subject to OMB approval under the Environmental protection,
Paperwork Reduction Act (PRA) (44 Administrative practice and procedure, AGENCY: Environmental Protection
U.S.C. 3501 et seq.), nor does it require Agricultural commodities, Pesticides Agency (EPA).
any special considerations under and pests, Reporting and recordkeeping ACTION: Final rule.
Executive Order 12898, entitled requirements.
‘‘Federal Actions to Address SUMMARY: This regulation establishes
Dated: July 21, 2015. tolerances for residues of benalaxyl-M
Environmental Justice in Minority
Populations and Low-Income Jack Housenger, in or on grape and tomato. Since there
Populations’’ (59 FR 7629, February 16, Director, Office of Pesticide Programs. are currently no U.S. registrations of
1994). Therefore, 40 CFR chapter I is benalaxyl-M for use on grape and
Since tolerances and exemptions that amended as follows: tomato, this tolerance will allow the
are established on the basis of a petition import of grape and tomato containing
under FFDCA section 408(d), such as PART 180—[AMENDED] residues of benalaxyl-M. Technology
the tolerance in this final rule, do not Sciences Group, on behalf of Isagro
require the issuance of a proposed rule, ■ 1. The authority citation for part 180 S.p.A, requested these tolerances under
the requirements of the Regulatory continues to read as follows: the Federal Food, Drug, and Cosmetic
Flexibility Act (RFA) (5 U.S.C. 601 et Authority: 21 U.S.C. 321(q), 346a and 371. Act (FFDCA).
seq.), do not apply. DATES: This regulation is effective July
■ 2. Add § 180.681 to subpart C to read
This action directly regulates growers, 30, 2015. Objections and requests for
Lhorne on DSK7TPTVN1PROD with RULES

as follows:
food processors, food handlers, and food hearings must be received on or before
retailers, not States or tribes, nor does § 180.681 Isofetamid; tolerances for September 28, 2015, and must be filed
this action alter the relationships or residues. in accordance with the instructions
distribution of power and (a) General. Tolerances are provided in 40 CFR part 178 (see also
responsibilities established by Congress established for residues of the fungicide Unit I.C. of the SUPPLEMENTARY
in the preemption provisions of FFDCA isofetamid, including its metabolites INFORMATION).

VerDate Sep<11>2014 13:32 Jul 29, 2015 Jkt 235001 PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 E:\FR\FM\30JYR1.SGM 30JYR1
Document Created: 2018-02-23 09:30:15
Document Modified: 2018-02-23 09:30:15
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 30, 2015. Objections and requests for hearings must be received on or before September 28, 2015, 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		Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
FR Citation		80 FR 45438
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements