[Federal Register Volume 84, Number 166 (Tuesday, August 27, 2019)]
[Rules and Regulations]
[Pages 44708-44712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18382]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0095; FRL-9996-85]


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 multiple commodities which are identified and 
discussed later in this document. Interregional Research Project No. 4 
(IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective August 27, 2019. Objections and 
requests for hearings must be received on or before October 28, 2019, 
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-2018-0095, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Publishing 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-2018-0095 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 
October 28, 2019. 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-2018-0095, 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 24, 2018 (83 FR 34968) (FRL-9980-
31), 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 
7E8645) by Interregional Research Project No. 4 (IR-4), Rutgers, The 
State University of New Jersey, 500 College Road East, Suite 201W, 
Princeton, NJ 08540. The petition requested that 40 CFR 180.350 be 
amended by establishing tolerances for residues of the nitrification 
inhibitor nitrapyrin (2-chloro-6-(trichloromethyl) pyridine) and its 
metabolite, 6-chloropicolinic acid (6-CPA), calculated as the 
stoichiometric equivalent of nitrapyrin, in or on citrus, dried pulp at 
0.094 parts per million (ppm); citrus, oil at 0.37 ppm; fruit, citrus, 
group 10-10 at 0.03 ppm; leaf petiole vegetable subgroup 22B at 0.4 
ppm; Vegetable, brassica, head and stem, group 5-16 at 0.07 ppm; 
vegetable, bulb, group 3-07 at 0.3 ppm; and vegetable, leafy, group 4-
16 at 0.3 ppm. That document referenced a summary of the petition 
prepared by Dow AgroSciences LLC, 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 is 
establishing tolerances that vary from what the petitioner requested, 
as authorized under FFDCA section 408(d)(4)(A)(i). EPA's explanation 
for those variations is contained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the

[[Page 44709]]

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 their 
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.
    In oral studies, the liver is the target organ for nitrapyrin, and 
liver effects are evident in all species tested. Clear signs of 
hepatotoxicity (i.e., marked changes in clinical chemistry in dogs, 
indicative of liver toxicity and histopathology in rats and mice, 
leading to malignant tumor formation in mice) are seen after repeated 
exposure. Nitrapyrin does not show qualitative or quantitative 
susceptibility in the rat or rabbit developmental studies or in the 2-
generation reproduction study. The observed adverse effects (e.g., 
delayed ossification and decreased fetal body weight in the 
developmental rat study and liver effects in pups in the rat 
reproduction study) occurred at the same doses as maternal toxicity. 
There is low concern for the altered motor activity seen after acute or 
subchronic exposure because: Clear no-observed adverse effect levels 
(NOAELs) and lowest-observed adverse effect levels (LOAELs) have been 
established; no corroborating gross pathological or neuropathological 
effects were found in any other study in the database; and the selected 
endpoints are protective of the observed effects.
    Nitrapyrin is not mutagenic or immunotoxic, and no effects were 
observed in the subchronic dermal toxicity study in rabbits up to the 
limit dose. Nitrapyrin is classified as having ``suggestive'' evidence 
of carcinogenicity, based on liver adenomas and carcinomas in mice. 
This classification is supported by the following factors: (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 mode of action; and (4) There are adequate data supporting the 
MOA of mitogenesis through activation CAR nuclear receptors in male 
mice but not in female mice. In addition, 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. Therefore, 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.
    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 are discussed in the final rule 
published in the Federal Register of November 30, 2017 (82 FR 56739) 
(FRL-9967-73).

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 discussed in Unit III.B of the final rule 
published in the Federal Register of November 30, 2017 (82 FR 56739) 
(FRL-9967-73).

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 cited in Unit III.A., EPA has 
concluded that quantification of cancer risk using a nonlinear RfD 
approach adequately accounts for all chronic toxicity, including 
carcinogenicity that could result from exposure to nitrapyrin. Cancer 
risk was assessed using the same exposure estimates as discussed in 
Unit III.C.1.ii., Chronic exposure.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for nitrapyrin. Tolerance level residues and/or 100 
PCT were assumed for all food commodities.

[[Page 44710]]

    2. Dietary exposure from drinking water. The Agency used screening 
level 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), which 
incorporates the Pesticide Root Zone Model Ground Water (PRZM GW), 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 for non-cancer assessments 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 website 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 are adequate pre- and/
or post-natal toxicity studies that do not show quantitative 
susceptibility in 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. This effect is considered to be treatment-related 
but not adverse. In the rat developmental study, developmental toxicity 
(delayed ossification and decreased fetal body weight) occurred at the 
same dose as maternal toxicity (reduced body weight/weight gain and 
reduced food consumption). Toxic effects in the 2-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. That decision is based on the following 
findings:
    i. The toxicity database for nitrapyrin is complete.
    ii. An acceptable acute neurotoxicity study and an acceptable 
subchronic neurotoxicity study are available for nitrapyrin. Acutely, 
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). However, concern is low since: (1) There are clear 
NOAELs/LOAELs; (2) there are no corroborating gross pathological or 
neuropathological findings; (3) there was no evidence of neurotoxicity 
in other studies in the database; and (4) the selected endpoints are 
protective of the observed effects.
    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 either not treatment-related 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 used 
to assess exposure to nitrapyrin in drinking water. 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, 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 occupy 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

[[Page 44711]]

food and water will utilize 17% of the cPAD for children 1 to 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-term or 
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 short-term risk), no 
further assessment of short- or intermediate-term risk is necessary, 
and EPA relies on the chronic dietary risk assessment for evaluating 
short- and intermediate-term risk 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

    Adequate enforcement methodology (gas chromatograph/electron 
capture detector) is available to enforce the tolerance expression. 
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 a MRL for nitrapyrin.

C. Revisions to Petitioned-For Tolerances

    EPA is establishing tolerances for residues of nitrapyrin at 
different levels than requested in the petition for most commodities. 
For fruit, citrus, group 10-10, dried pulp and fruit, citrus, group 10-
10, oil, EPA established the tolerances based on the processing study 
and highest average field trial residue for the raw agricultural 
commodity lemon. This leads to higher tolerances (0.5 ppm for fruit, 
citrus, group 10-10, dried pulp and 2 ppm for fruit, citrus, group 10-
10, oil) than those proposed by petitioner (0.094 ppm and 0.37 ppm, 
respectively). EPA also corrected the commodity names for these 
commodities.
    Based on the residue chemistry data and the Organization for 
Economic Co-Operation and Development (OECD) tolerance-calculation 
procedure, EPA is establishing different tolerances for fruit, citrus, 
group 10-10; leaf petiole vegetable subgroup 22B; vegetable, Brassica, 
head and stem, group 5-16; and vegetable, leafy, group 4-16, because 
the tolerance values proposed by the petitioner do not include the 
combined residues of nitrapyrin and its metabolite 6-CPA.
    In addition, EPA is revising the tolerance expression in Sec.  
180.350(a) to correctly identify nitrapyrin as a nitrification 
inhibitor rather than the current identification as an insecticide. The 
rest of the tolerance expression remains the same. The revised 
tolerance expression is:
    (a) General. Tolerances are established for residues of the 
nitrification inhibitor nitrapyrin, 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 the sum of nitrapyrin (2-chloro-6-(trichloromethyl) 
pyridine) and its 6-CPA metabolite (6-chloro-picolinic acid), 
calculated as the stoichiometric equivalent of nitrapyrin, in or on the 
commodity.

V. Conclusion

    Therefore, tolerances are established for residues of nitrapyrin, 
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 fruit, citrus, 
group 10-10 at 0.06 ppm; fruit, citrus, group 10-10, dried pulp at 0.5 
ppm; fruit, citrus, group 10-10, oil at 2 ppm; leaf petiole vegetable 
subgroup 22B at 0.5 ppm; vegetable, Brassica, head and stem, group 5-16 
at 0.1 ppm; vegetable, bulb, group 3-07 at 0.3 ppm; and vegetable, 
leafy, group 4-16 at 0.4 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), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). 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

[[Page 44712]]

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: August 8, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. In Sec.  180.350, paragraph (a):
0
a. Revise the introductory text.
0
b. Add alphabetically the entries for ``Fruit, citrus, group 10-10''; 
``Fruit, citrus, group 10-10, dried pulp''; ``Fruit, citrus, group 10-
10, oil''; ``Leaf petiole vegetable subgroup 22B''; ``Vegetable, 
Brassica, head and stem, group 5-16''; ``Vegetable, bulb, group 3-07''; 
and ``Vegetable, leafy, group 4-16'' to the table.
    The revision and additions read as follows:


Sec.  180.350  Nitrapyrin; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
nitrification inhibitor nitrapyrin, 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 the sum of nitrapyrin (2-chloro-6-(trichloromethyl) 
pyridine) and its 6-CPA metabolite (6-chloro-picolinic acid), 
calculated as the stoichiometric equivalent of nitrapyrin, in or on the 
commodity:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Fruit, citrus, group 10-10..................................        0.06
Fruit, citrus, group 10-10, dried pulp......................         0.5
Fruit, citrus, group 10-10, oil.............................           2
Leaf petiole vegetable subgroup 22B.........................         0.5
 
                                * * * * *
Vegetable, Brassica, head and stem, group 5-16..............         0.1
Vegetable, bulb, group 3-07.................................         0.3
Vegetable, leafy, group 4-16................................         0.4
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-18382 Filed 8-26-19; 8:45 am]
 BILLING CODE 6560-50-P


