[Federal Register Volume 81, Number 196 (Tuesday, October 11, 2016)]
[Rules and Regulations]
[Pages 70038-70043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24492]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0285; FRL-9945-37]


Mandestrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of S-2200 
(here after referred to within this document as mandestrobin) in or on 
multiple commodities which are identified and discussed later in this 
document. Valent U.S.A., Corporation requested these tolerances under 
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 11, 2016. Objections and 
requests for hearings must be received on or before December 12, 2016, 
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-2014-0285, 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; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather

[[Page 70039]]

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 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2014-0285 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
December 12, 2016. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2014-0285, 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 Tolerances

    In the Federal Register of December 17, 2014 (79 FR 75107) (FRL-
9918-90), 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 
3F8224) by Valent U.S.A., Corporation,1600 Riviera Ave., Suite 200, 
Walnut Creek, California, 94596. The petition requested that 40 CFR 180 
be amended by establishing tolerances for residues of the fungicide 
mandestrobin, (2-[(2,5-dimethylphenoxy)methyl]-[alpha]-methoxy-N-
methyl-benzeneacetamide), in or on small fruit vine climbing except 
fuzzy kiwifruit crop subgroup 13-07F, fruit at 5 parts per million 
(ppm), juice at 7 ppm, and dried fruit at 10 ppm; low growing berry 
subgroup 13-07G, fruit at 3 ppm; and rapeseed crop subgroup 20A, seed 
at 0.6 ppm. That document referenced a summary of the petition prepared 
by Valent U.S.A. Corporation, the registrant, which is available to the 
public 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 lowered 
the requested tolerance levels for grape, raisin. Tolerances for juice 
and dried fruit are not required. At this time, EPA is not granting a 
tolerance for rapeseed crop group 20A. The reason for these changes is 
explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for mandestrobin including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with mandestrobin as 
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 main target organs for mandestrobin toxicity in all mammalian 
species tested are the liver and gall bladder with effects ranging from 
hepatocyte hypertrophy and increased liver weight (usually considered 
not adverse in the absence of corroborative hepatic enzyme changes or 
histopathology) to centrilobular degeneration, hepatocyte and bile duct 
pigmentation, periductular inflammation and gall stones. Dogs were more 
sensitive to the adverse liver effects than rats; mice showed only non-
adverse liver effects.
    Thyroid effects were observed in rats (increased weight, follicular 
cell hypertrophy, decreased serum hormone levels) at higher doses than 
early signs of liver effects suggesting that effects in the thyroid may 
be secondary to liver effects.
    Gonadal effects were observed at higher doses than the liver 
effects, and were more evident in dogs (immature prostate and/or 
testes, low sperm count, immature ovaries, decrease uterus weight) but 
equivocal and/or not adverse in rats. Gonadal effects did not affect 
the reproductive capacity of rats.
    No developmental effects were observed in rats or rabbits, and no 
adverse reproductive, immunotoxic, or neurotoxic effects were observed 
in any of the studies. No adverse effects were

[[Page 70040]]

seen in a route-specific dermal toxicity study. Mutagenicity studies 
were negative. There is no evidence of carcinogenicity because there 
was no increase in tumor incidence in rat and mouse long-term studies. 
The Agency classified mandestrobin as ``not likely to be a human 
carcinogen''.
    Specific information on the studies received and the nature of the 
toxic effects caused by mandestrobin 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: Mandestrobin. Human Health Risk Assessment for 
Proposed Foliar Uses on Small Fruit Vine Climbing (Except Fuzzy 
Kiwifruit) (Subgroup 13-07F), Low Growing Berry (Subgroup 13-07G) 
(Except Cranberry), Turf, and Seed Treatment Uses on Corn (Field, Pop, 
Sweet), Sorghum Grain (Milo), and Legume Vegetables (Crop Group 6C) 
(Except Cowpea and Field Pea) at page 18 in docket ID number EPA-HQ-
OPP-2014-0285.

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 mandestrobin used for 
human risk assessment is shown in Table 1.

 Table 1--Summary of Toxicological Doses and Endpoints for Mandestrobin for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population     No toxicity was observed that could be attributed to a single exposure.
 including infants and children).
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 92 mg/kg/day  Chronic RfD = 0.92   Chronic Toxicity--Dog LOAEL = 181
                                                          mg/kg/day.           mg/kg/day based on incidence of
                                                         cPAD = 0.92 mg/kg/    liver centrilobular degeneration,
                                                          day.                 hepatocytehypertrophy, hepatocyte
                                                                               pigment, and elevated serum ALP
                                                                               and ALT.
Incidental Oral Short-Term (1-30   UFA = 10x...........  LOC for MOE <100...  Additional supportive study:
 days) and Intermediate-Term (1-6                                              Subchronic Toxicity--Dog NOAEL =
 months).                                                                      91 mg/kg/day
                                                                              LOAEL = 268 mg/kg/day based on
                                                                               incidence of liver centrilobular
                                                                               degeneration in both sexes and
                                                                               elevated serum ALP in females.
Inhalation Short-Term (1-30 days)  UFH = 10x...........
 and Intermediate-Term (1-6        FQPA SF = 1x........
 months).
----------------------------------------------------------------------------------------------------------------
Dermal Short-Term (1-30 days) and  No hazard was identified for dermal exposure; therefore a quantitative dermal
 Intermediate-Term (1-6 months),                              assessment is not needed.
 all populations.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)                          Not likely a human carcinogen.
----------------------------------------------------------------------------------------------------------------
NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose
  (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. ALP =
  alkaline phosphatase. ALT = alanine aminotransferase.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to mandestrobin, EPA considered exposure from the petitioned-
for tolerances only as there are no existing mandestrobin tolerances. 
EPA assessed dietary exposures from mandestrobin 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 mandestrobin; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the 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). As to residue levels in 
food, EPA assumed tolerance-level residues, 100 percent crops treated 
(PCT), and default processing factors for all proposed commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that mandestrobin does not

[[Page 70041]]

pose a cancer risk to humans. Therefore, a dietary exposure assessment 
for the purpose of assessing cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
mandestrobin. Tolerance-level residues and 100 PCT were assumed for all 
food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for mandestrobin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of mandestrobin. 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 First Index Reservoir Screening Tool (FIRST) and 
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated 
drinking water concentrations (EDWCs) of mandestrobin for chronic 
exposures for non-cancer assessments are estimated to be 38 parts per 
billion (ppb) for surface water and 3.9 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 38 ppb was used to assess 
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Mandestrobin is 
currently proposed for use on turf at golf courses, sod farms, 
recreational/athletic fields, and residential/commercial lawns. EPA 
assessed residential exposure using the following scenarios. For 
residential handlers, the worst-case scenario was determined to be 
short-term inhalation exposures to adults from mixing, loading, and 
applying mandestrobin to turf. For post-application exposures, the 
worst-case scenario was determined to be short-term post-application 
incidental oral exposure to children from hand-to-mouth activities on 
turf. 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 mandestrobin to share a common mechanism of 
toxicity with any other substances, and mandestrobin does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
mandestrobin 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 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 
sensitivity/susceptibility in the offspring following mandestrobin 
exposure, including developmental toxicity studies in rats and rabbits, 
and a 2-generation reproductive study in rats. Although pup weights 
were decreased in the rat reproductive study, this change was observed 
at the same dose as maternal liver effects, which included periportal/
bile duct pigment, periductular inflammatory cell infiltration, and 
bile duct proliferation.
    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 the mandestrobin tolerances being 
established is complete.
    ii. There is no indication that mandestrobin 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 mandestrobin 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 mandestrobin 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 
mandestrobin.

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, 
mandestrobin 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 
mandestrobin from food and water will utilize 2.6% 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

[[Page 70042]]

residues of mandestrobin 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). Mandestrobin 
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 mandestrobin.
    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 19,000 for adults 
and 2,900 for children 1-2 years old. Because EPA's level of concern 
for mandestrobin 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). Since the short-and intermediate-term PODs are the same and 
short-term exposure estimates are greater than their intermediate-term 
counterparts, the short-term aggregate risk assessment is protective of 
the intermediate-term aggregate exposure. Therefore a separate 
intermediate-term aggregate assessment is not necessary.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, mandestrobin 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 mandestrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (RM-48C-2A, which uses high 
performance liquid chromatography with tandem mass spectrometry (HPLC/
MS-MS)) is available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for mandestrobin.

C. Revisions to Petitioned-for Tolerances

    Based on an analysis of residue levels from crop field trials, EPA 
is establishing a tolerance for grape, raisin at 7 ppm, rather than the 
requested level of 10 ppm. The highest average field trial (HAFT) for 
grape and the processing factor for raisins supports a 7 ppm tolerance.
    The petitioner requested tolerances for juice and dried fruit 
covered under crop subgroup 13-07F, small fruit. The available 
processing data for grape, the representative commodity for subgroup 
13-07F, indicates that residues in juice will be covered by the 
tolerance being established for subgroup 13-07F. At this time, the 
Agency is not aware of any dried commodities derived from crops in 
subgroup 13-07F other than raisin, for which the Agency is establishing 
a separate tolerance, as indicated in the paragraph above.
    After the petitioner submitted its petition for tolerances on 
subgroup 13-07G, it withdrew its request to include cranberry; 
therefore, the Agency is only establishing tolerances for subgroup 13-
07G, except cranberry.
    At this time, EPA is not establishing a tolerance for rapeseed 
subgroup 20A. The full three year freezer storage stability data (OPPTS 
guideline number 860.1380) for crop field trial data are needed to 
support tolerances. These data are required since samples from crop 
field trials are often stored for a number of years prior to analysis. 
Therefore, it is a requirement to ensure that the residues that are 
found multiple years later are actually representative of the residues 
that would be found on the day of harvest. This ensures that the Agency 
has set a tolerance high enough to cover residues expected in/on the 
commodity of interest. Accordingly, EPA has not made a determination 
with regard to this petitioned-for tolerance at this time.

V. Conclusion

    Therefore, tolerances are established for residues of mandestrobin, 
2-[(2,5-dimethylphenoxy)methyl]-[alpha]-methoxy-N-
methylbenzeneacetamide, in or on berry, low growing, subgroup 13-07G, 
except cranberry at 3.0 ppm; fruit, small vine climbing, except fuzzy 
kiwifruit, subgroup 13-07F at 5.0 ppm; grape, raisin at 7.0 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 tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency

[[Page 70043]]

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

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: September 30, 2016.
Jack E. 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.  180.690 to subpart C to read as follows:


Sec.  180.690  Mandestrobin; tolerances for residues.

    (a) General. Tolerances are established for residues of 
mandestrobin, 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 mandestrobin, 2-
[(2,5-dimethylphenoxy)methyl]-[alpha]-methoxy-N-methylbenzeneacetamide.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Berry, low growing, subgroup 13-07G, except cranberry......          3.0
Fruit, small vine climbing, except fuzzy kiwifruit,                  5.0
 subgroup 13-07F...........................................
Grape, raisin..............................................          7.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent tolerances. [Reserved]

[FR Doc. 2016-24492 Filed 10-7-16; 8:45 am]
BILLING CODE 6560-50-P