[Federal Register Volume 82, Number 229 (Thursday, November 30, 2017)]
[Rules and Regulations]
[Pages 56739-56744]
[FR Doc No: 2017-25829]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0295; FRL-9967-73]

Nitrapyrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
nitrapyrin in or on almond hulls and the tree nut group 14-12. Dow
AgroSciences requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 30, 2017. Objections and
requests for hearings must be received on or before January 29, 2018,
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-2016-0295, 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through 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-2016-0295 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
January 29, 2018. 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-2016-0295, 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 July 20, 2016 (81 FR 47150) (FRL-9948-
45), 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
6F8470) by Dow AgroSciences, 9330 Zionsville Road, Indianapolis, IN
46268. The petition requested that 40 CFR 180.350 be amended by
establishing tolerances for residues of the herbicide, nitrapyrin [2-
chloro-6-(trichloromethyl) pyridine] and its metabolite, 6-
chloropicolinic acid (6-CPA), in or on nut, tree group 14-12 at 0.02
parts per million (ppm) and almond, hulls at 0.07 ppm. That document
referenced a summary of the petition prepared by Dow AgroSciences, the
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA has
modified the level at which the tolerance is being established for
almond hulls. The reason for this change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for nitrapyrin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with nitrapyrin follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    The liver is the major target organ of nitrapyrin in both
subchronic and chronic studies via the oral route; no toxicity was seen
in the subchronic dermal study. Effects in the oral studies were
generally consistent among the species tested (rat, mouse, rabbit, and
dog), progressed with time, and typically included increased liver
weights, enlarged livers, and/or hepatocellular hypertrophy. Only
increased liver weights in the absence of other toxic effects in the
liver were noted in the rabbit; however, by study design no other liver
parameters were measured. Although some of the observed liver effects
(i.e., increased liver weights and hypertrophy) suggest an adaptive
response, pronounced decreases in body weight were evident in mice at
higher doses and clear signs of hepatotoxicity (i.e., marked changes in
clinical chemistry, indicative of liver toxicity and histopathology,
leading to malignant tumor formation in mice) are seen only after
prolonged exposure. In the chronic dog study, liver toxicity was
indicated by marked changes in clinical chemistry parameters (alkaline
phosphatase and cholesterol), increased liver weight, and hypertrophy.
In rats, increased liver weights were also associated with clinical
chemistry changes and histopathology (vacuolation consistent with fatty
changes). By contrast to the other species, liver toxicity in mice
progressed from liver weight alterations (associated with
histopathological findings of hypertrophy, mitotic figures and
necrosis) to significantly increased liver adenomas and non-
significantly increased liver carcinomas at >=250 mg/kg/day.
    Kidney effects (increased kidney weights accompanied by
intratubular mineralization and multifocal necrosis of the intratubular
epithelium) were observed in male rats only, in both the two generation
reproduction study and the chronic toxicity study. These kidney effects
are indicative of [alpha]-2u-globulin accumulation with eventual
progression to renal tumors. This finding of [alpha]-2u-globulin was
confirmed by immunoperoxidase stain in the rat chronic study. The
response, which only occurs in male rats, is not relevant to humans.
    Nitrapyrin did not show qualitative or quantitative susceptibility
in the rabbit or rat developmental studies. In the developmental
toxicity in the rabbit, an increased incidence of crooked hyoid bones
was seen at the highest dose tested (HDT). This effect is considered to
be treatment-related but not adverse because it does not affect the
health of the animal. In the rat developmental study, delayed
ossification and decreased fetal body weight occurred at the same dose
as maternal toxicity (reduced body weight/weight gain and reduced food
consumption) and are not considered more severe than the maternal
effects. Toxic effects in the two generation reproduction study
occurred at the same dose in both parental animals and the offspring
and included increased liver weights (parental M and F; both
generations), enlarged livers in F2 pups (M and F), and hepatic
vacuolation consistent with fatty changes in parental and offspring
animals (both sexes and both generations).
    In the acute neurotoxicity study, following a single oral dose of
400 mg/kg nitrapyrin, male and female rats showed slight tremors;
females also showed gait incoordination, palpebral closure, and
perineal fecal staining accompanied by decreased total motor activity
([ap]40% M & F) and an effect on distribution of motor activity (i.e.,
characterized as a more rapid decline activity than control in both
sexes) on Day 1 only. In the subchronic neurotoxicity study, increased
landing foot splay in males and females, and increased motor activity
in females (equivocal in males) were observed at the same Lowest
Observed Adverse Effect Level (LOAEL) (120 mg/kg/day) as systemic
effects (increased liver weights, pale livers and increased liver size)
in rats. However, there was no evidence of gross pathology or
neuropathology in these studies or in any other study throughout the
database.

    There is also no evidence of immunotoxicity or mutagenicity.
    The available data on carcinogenicity of nitrapyrin includes
reports of multiple tumor types that were reported (renal tumors in
male rats, stomach, epididymis, or Harderian gland neoplasms in either
male or female mice). Following five peer review meetings to evaluate
the carcinogenic potential of nitrapyrin as a nitrification inhibitor,
EPA concluded that the reported tumors were either not treatment-
related or not relevant for the human risk assessment, with the
exception of the mouse liver tumors. At that time, the Agency
classified nitrapyrin as ``suggestive evidence of carcinogenic
potential''. Following this classification, mode of action (MOA)
studies were submitted that suggest that nitrapyrin is a mitogen that
induces the male mouse liver tumors through activation of the
constitutive androstane receptor (CAR), a nuclear receptor. Since the
MOA data were not considered complete (no MOA data on female mice), a
final decision on the MOA has not been made. The weight of evidence
remains as suggestive of carcinogenicity for the following reasons:
    1. Liver tumors were not seen in the 2-year carcinogenicity study
in rats.
    2. The response is driven by benign adenomas.
    3. Mutagenicity was ruled out as a MOA.
    4. There are adequate data supporting the MOA of mitogenesis
through activation CAR nuclear receptors in male mice.
    Based on the available information and the fact that the chronic
reference dose (0.03 mg/kg/day) is approximately 4000X lower than the
dose at which tumors are seen in the female mouse, the Agency concludes
that quantification of cancer risk using a non-linear Reference Dose
(RfD) approach will be protective of all chronic toxicity.
    Specific information on the studies received and the nature of the
adverse effects caused by nitrapyrin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Nitrapyrin. Human Health
Risk Assessment for Registration Review and New Use on Tree Nuts (Crop
Group 14-12)'' in docket ID number EPA-HQ-OPP-2016-0295.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for nitrapyrin used for
human risk assessment is shown in Table 1 of this unit.

                              Table 1--Summary of Toxicological Doses and Endpoints
                             for Nitrapyrin 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 (General population  NOAEL = 16 mg/kg/day  Acute RfD = 0.16 mg/ Acute neurotoxicity rat study.
 including infants and children).  UFA = 10x...........   kg/day.             LOAEL = 80 mg/kg, based on
                                   UFH = 10x...........  aPAD = 0.16 mg/kg/    decreased total motor activity on
                                   FQPA SF = 1x........   day.                 Day 1 in females.
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Chronic dietary (All populations)  NOAEL = 3 mg/kg/day.  Chronic RfD = 0.03   1-year chronic dog study.
                                   UFA = 10x...........   mg/kg/day.          LOAEL = 15 mg/kg/day, based on
                                   UFH = 10x...........  cPAD = 0.03 mg/kg/    increased absolute and relative
                                   FQPA SF = 1x........   day.                 liver weights, increased clinical
                                                                               chemistry (alkaline phosphatase &
                                                                               cholesterol) and liver
                                                                               hypertrophy in both sexes.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)        Nitrapyrin is classified as ``suggestive evidence of carcinogenic
                                        potential''. EPA has determined that using the chronic RfD to assess
                                       carcinogenic potential will be protective of any potential cancer risk.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to nitrapyrin, EPA considered exposure under the petitioned-
for tolerances as well as all existing nitrapyrin tolerances in 40 CFR
180.350. EPA assessed dietary exposures from nitrapyrin in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for nitrapyrin. In estimating acute
dietary

exposure, EPA used food consumption information from the United States
Department of Agriculture (USDA) 2003-2008 National Health and
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).
As to residue levels in food, EPA assumed tolerance-level residues and
100 percent crop treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance-level
residues and 100 PCT.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that quantification of cancer risk using a non-linear
Reference Dose (RfD) approach adequately accounts for all chronic
toxicity, including carcinogenicity that could result from exposure to
nitrapyrin.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
nitrapyrin. Tolerance-level residues and 100 PCT were assumed for all
food commodities.
    2. Dietary exposure from drinking water. The Agency used water
exposure models in the dietary exposure analysis and risk assessment
for nitrapyrin in drinking water. These simulation models take into
account data on the physical, chemical, and fate/transport
characteristics of nitrapyrin. 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 Tier II pesticide water calculator (PWC), the
estimated drinking water concentrations (EDWCs) of nitrapyrin residues
of concern for acute exposures are estimated to be 51 parts per billion
(ppb) for surface water and 76 ppb for ground water, and for chronic
exposures are estimated to be 15 ppb for surface water and 67 ppb for
ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 76 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 67 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). Nitrapyrin is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found nitrapyrin to share a common mechanism of
toxicity with any other substances, and nitrapyrin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
nitrapyrin 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. Neither quantitative nor
qualitative susceptibility was seen in either the rabbit or rat
developmental studies or in the two generation reproduction study. In
the developmental toxicity in the rabbit, an increased incidence of
crooked hyoid bones was seen at the highest dose tested (HDT). This
effect is considered to be treatment-related but not adverse. In the
rat developmental study, delayed ossification and decreased fetal body
weight occurred at the same dose as maternal toxicity. Toxic effects in
the two generation reproduction study also occurred at the same dose in
both parental animals and the offspring and included increased liver
weights (parental M and F; both generations), enlarged livers in F2
pups (M and F), and hepatic vacuolation consistent with fatty changes
in parental and offspring animals (both sexes and both generations).
Similarly, gross pathological or neuropathological findings in the
neurotoxicity studies were negative.
    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. This decision is based on the following
findings:
    i. The toxicity database for nitrapyrin is complete.
    ii. In an acute neurotoxicity study, nitrapyrin induced tremors and
other functional observation battery effects, (i.e., slight gait
incoordination, palpebral closure and perineal fecal staining) at the
high dose (400 mg/kg) only. Decreased motor activity was seen in both
sexes at 400 mg/kg and in females at 80 mg/kg. In contrast, increased
motor activity was observed in the subchronic neurotoxicity study in
female rats but only at high doses (>=500 mg/kg/day). Because (1) there
are clear NOAELs/LOAELs in the available studies for these effects and
the selected endpoints are protective of the observed effects; (2)
there is no corroborating gross pathological or neuropathological
findings; and (3) there was no evidence of neurotoxicity in other
studies in the database, the Agency's concern for potential
neurotoxicity is low. Accordingly, and due to the lack of concerns for
increased susceptibility in infants and children, there is no need to
require a developmental neurotoxicity to further assess the potential
for neurotoxicity in infants and children.
    iii. There is no evidence that nitrapyrin 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. Effects on the offspring were not adverse or occurred only at
the same parental dose.
    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 to
assess exposure to nitrapyrin in drinking water. The EPA believes that
these assessments will not underestimate the exposure and risks posed
by nitrapyrin.

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, drinking
water, and residential exposure to the appropriate PODs to ensure that
an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to nitrapyrin will utilize 8.5% of the aPAD for all infants less than
1-year-old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
nitrapyrin from food and drinking water will utilize 15% of the cPAD
for children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for nitrapyrin.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). However, nitrapyrin is
not registered for, or proposed for, any residential uses. Therefore,
because there is no short- or intermediate-term residential exposure
and chronic dietary exposure has already been assessed under the
appropriately protective cPAD, no further assessment of short-or
intermediate-term risk is necessary for nitrapyrin.
    4. Aggregate cancer risk for U.S. population. Based on the
discussion in Unit III.A., EPA considers the chronic aggregate risk
assessment to be protective of any aggregate cancer risk. As there is
no chronic risk of concern, EPA does not expect any cancer risk to the
U.S. population from aggregate exposure to nitrapyrin.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to nitrapyrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Seven analytical methods are available in Volume II of the
Pesticide Analytical Manual (PAM II--Pesticide Reg. Sec. 180.350) for
tolerance enforcement for nitrapyrin and/or for metabolite 6-CPA.

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 nitrapyrin.

C. Revisions to Petitioned-For Tolerances

    The tolerance being established for almond hulls is different than
that proposed by the registrant. This difference is due to EPA using
the Organization for Economic Cooperation and Development (OECD)
Maximum Residue Limits (MRL) calculation procedures to determine
appropriate tolerance levels. The results from the spreadsheet
calculator supports a tolerance of 0.06 ppm for almond hulls, rather
than 0.07 ppm as proposed.
    Also, EPA has revised the tolerance expression to clarify (1) that
as provided in FFDCA section 408(a)(3), the tolerance covers
metabolites and degradates of nitrapyrin not specifically mentioned;
and (2) that compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of nitrapyrin,
including its metabolites and degradates, in or on almond, hulls at
0.06 ppm and the nut, tree, group 14-12 at 0.02 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: October 27, 2017.
Daniel Kenny,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.350, paragraph (a):
0
a. Revise the introductory text.
0
b. Add alphabetically entries to the table for ``Almond, hulls''; and
``Nut, tree, group 14-12''.
    The revision and additions read as follows:

Sec.  180.350  Nitrapyrin; tolerances for residues.

    (a) General. Tolerances are established for residues of the
insecticide nitrapyrin, including its metabolites and degradates, in or
on the commodities below. Compliance with the tolerance levels
specified below is to be determined by measuring only the sum of
nitrapyrin (2-chloro-6-(trichloromethyl) pyridine) and its 6-CPA (6-
chloropicolinic acid) metabolite, calculated as the stoichiometric
equivalent of nitrapyrin, in or on the commodity:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        0.06

                                * * * * *
Nut, tree, group 14-12......................................        0.02

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-25829 Filed 11-29-17; 8:45 am]
BILLING CODE 6560-50-P