[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)]
[Rules and Regulations]
[Pages 6975-6981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03277]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0247; FRL-9973-03]


Pendimethalin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the tolerances for residues of 
pendimethalin in or on alfalfa, forage and alfalfa, hay. BASF 
Corporation requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 16, 2018. Objections and 
requests for hearings must be received on or before April 17, 2018, and 
must be filed in accordance with the instructions provided in 40 CFR 
part

[[Page 6976]]

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-2014-0247, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Director, 
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 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-2014-0247 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 
April 17, 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-2014-0247, 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 August 1, 2014 (79 FR 44729) (FRL-9911-
67), 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 
4F8245) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 
27709. The petition requested that 40 CFR 180.361 be amended by 
increasing the tolerances for residues of the herbicide pendimethalin, 
[N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its 
metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl 
alcohol, in or on alfalfa, forage to 80 parts per million (ppm) and 
alfalfa, hay to 150 ppm. That document referenced a summary of the 
petition prepared by BASF Corporation, the registrant, which is 
available in the docket EPA-HQ-OPP-2014-0397 at http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

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 pendimethalin including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with pendimethalin 
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 target organ for pendimethalin is the thyroid. Thyroid toxicity 
in chronic and subchronic rat and mouse studies was manifested as 
alterations in thyroid hormones (decreased total T4 and T3,

[[Page 6977]]

increased percent of free T4 and T3), increased thyroid weight, and 
microscopic thyroid lesions (including increased thyroid follicular 
cell height, follicular cell hyperplasia, as well as follicular cell 
adenomas). Due to these effects, the Agency required that a 
developmental thyroid assay be conducted to evaluate the impact of 
pendimethalin on thyroid hormones, structure, and/or thyroid hormone 
homeostasis during development. A developmental thyroid study was 
submitted and demonstrated that there is no potential thyroid toxicity 
following pre- and/or post-natal exposure to pendimethalin.
    There is no evidence that pendimethalin is a developmental, 
reproductive, neurotoxic, or immunotoxic chemical. There is no evidence 
of increased qualitative or quantitative susceptibility in the young. 
EPA classified pendimethalin as a ``Group C'', possible human 
carcinogen based on a statistically significant increased trend and 
pair-wise comparison between the high-dose group and controls for 
thyroid follicular cell adenomas in male and female rats. A non-
quantitative approach (i.e., non-linear, reference dose (RfD) approach) 
was used to assess cancer risk since mode-of-action studies are 
available to demonstrate that the thyroid tumors are due to a thyroid-
pituitary imbalance, and also since pendimethalin was shown to be non-
mutagenic in mammalian somatic cells and germ cells.
    Specific information on the studies received and the nature of the 
adverse effects caused by pendimethalin 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 December 21, 2015 (80 FR 79267) 
(FRL-9937-18).

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

 Table 1--Summary of Toxicological Doses and Endpoints for Pendimethalin 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  NOAEL = 100 mg/kg/    Acute RfD = 1 mg/kg/ Acute neurotoxicity study.
 including infants and children).   day.                  day.                LOAEL = 300 mg/kg/day based on
                                   UFA = 10x...........  aPAD = 1 mg/kg/day.   reduced motor activity for males
                                   UFH = 10x...........                        and females on Day 0.
                                   FQPA SF = 1x........
Chronic dietary (All populations)  NOAEL= 10 mg/kg/day.  Chronic RfD = 0.3    92-Day thyroid function study in
                                   UFA = 3x............   mg/kg/day.           rats; 56-day thyroid study in
                                   UFH = 10x...........  cPAD = 0.3 mg/kg/     rats; 14-day intra thyroid
                                   FQPA SF = 1x........   day.                 metabolism study in rats.
                                                                              LOAEL = 31 mg/kg/day based on
                                                                               hormonal and histopathological
                                                                               changes in the thyroid.
Incidental oral short-term (1 to   NOAEL= 10 mg/kg/day.  LOC for MOE = 30...  92-Day thyroid function study in
 30 days).                         UFA = 3x............                        rats; 56-day thyroid study in
                                   UFH = 10x...........                        rats; 14-day intra thyroid
                                   FQPA SF = 1x........                        metabolism study in rats.
                                                                              LOAEL = 31 mg/kg/day based on
                                                                               hormonal and histopathological
                                                                               changes in the thyroid.
Dermal short-term (1 to 30 days).  Dermal (or oral)      LOC for MOE = 30...  92-Day thyroid function study in
                                    study NOAEL = 10 mg/                       rats; 56-day thyroid study in
                                    kg/day (dermal                             rats; 14-day intra thyroid
                                    absorption rate =                          metabolism study in rats.
                                    3%.                                       LOAEL = 31 mg/kg/day based on
                                   UFA = 3x............                        hormonal and histopathological
                                   UFH = 10x...........                        changes in the thyroid.
                                   FQPA SF = 1x........
Dermal intermediate-term (1 to 6   Dermal (or oral)      LOC for MOE = 30...  92-Day thyroid function study in
 months).                           study NOAEL = 10 mg/                       rats; 56-day thyroid study in
                                    kg/day (dermal                             rats; 14-day intra thyroid
                                    absorption rate =                          metabolism study in rats.
                                    3%.                                       LOAEL = 31 mg/kg/day based on
                                   UFA = 3x............                        hormonal and histopathological
                                   UFH = 10x...........                        changes in the thyroid.
                                   FQPA SF = 1x........

[[Page 6978]]

 
Inhalation short-term (1 to 30     Inhalation (or oral)  LOC for MOE = 30...  92-Day thyroid function study in
 days).                             study NOAEL= 10 mg/                        rats; 56-day thyroid study in
                                    kg/day (inhalation                         rats; 14-day intra thyroid
                                    absorption rate =                          metabolism study in rats.
                                    100%).                                    LOAEL = 31 mg/kg/day based on
                                   UFA = 3x............                        hormonal and histopathological
                                   UFH = 10x...........                        changes in the thyroid.
                                   FQPA SF = 1x........
Inhalation (1 to 6 months).......  Inhalation (or oral)  LOC for MOE = 30...  92-Day thyroid function study in
                                    study NOAEL= 10 mg/                        rats; 56-day thyroid study in
                                    kg/day (inhalation                         rats; 14-day intra thyroid
                                    absorption rate =                          metabolism study in rats.
                                    100%).                                    LOAEL = 31 mg/kg/day based on
                                   UFA = 3x............                        hormonal and histopathological
                                   UFH = 10x...........                        changes in the thyroid.
                                   FQPA SF = 1x........
Cancer (Oral, dermal, inhalation)  Group C, possible
                                    human carcinogen
                                    based on a
                                    statistically
                                    significant
                                    increased trend and
                                    pair-wise
                                    comparison between
                                    the high dose group
                                    and controls for
                                    thyroid follicular
                                    cell adenomas in
                                    male and female
                                    rats. The chronic
                                    RfD will be
                                    protective of
                                    cancer effects.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOC = level of concern. mg/kg/day = milligram/kilogram/day.
  MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. LOAEL = lowest observed adverse effect
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term
  risk assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to pendimethalin, EPA considered exposure under the 
petitioned-for tolerances as well as all existing pendimethalin 
tolerances in 40 CFR 180.361. EPA assessed dietary exposures from 
pendimethalin 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 pendimethalin. In estimating acute 
dietary exposure, EPA Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This 
software uses 2003-2008 food consumption data from the U.S. Department 
of Agriculture's (USDA's) National Health and Nutrition Examination 
Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in 
food, EPA used tolerance-level residues, and 100 percent crop treated 
(PCT) for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM-FCID, Version 3.16 software with 2003-2008 
food consumption data from the USDA's NHANES/WWEIA. As to residue 
levels in food, EPA used tolerance-level residues, and 100 PCT for all 
commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that a nonlinear RfD approach is appropriate for assessing 
cancer risk to pendimethalin. 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 pendimethalin. Tolerance-level residues and 100 
PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. In drinking water, the 
residue of concern is pendimethalin, parent only. The Agency used 
screening-level water exposure models in the dietary exposure analysis 
and risk assessment for pendimethalin in drinking water. These 
simulation models take into account data on the physical, chemical, and 
fate/transport characteristics of pendimethalin. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model Ground Water (PRZM GW) and

[[Page 6979]]

Surface Water Concentration Calculator (SWCC) models, the estimated 
drinking water concentrations (EDWCs) of pendimethalin for acute 
exposures are estimated to be 96.4 parts per billion (ppb) for surface 
water and 4.38 x 10\-9\ ppb for ground water. For chronic exposures for 
non-cancer assessments, they are estimated to be 9.73 ppb for surface 
water.
    For acute dietary risk assessment, the water concentration value of 
96.4 ppb was used to assess the contribution to drinking water. For 
chronic dietary risk assessment, the water concentration of value 9.73 
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).
    Pendimethalin is currently registered for the following uses that 
could result in residential exposures: Turf, home gardens, and 
ornamentals. EPA assessed residential exposure using the following 
assumptions:
     For handlers, it is assumed that residential use will 
result in short-term (1 to 30 days) duration dermal and inhalation 
exposures.
     Residential post-application exposure is also assumed to 
be short-term (1-30 days) in duration, resulting from the following 
exposure scenarios:
     Gardening: Adults (dermal) and children 6 < 11 years old 
(dermal);
     Physical activities on turf: Adults (dermal) and children 
1-2 years old (dermal and incidental oral);
     Mowing turf: Adults (dermal) and children 11 < 16 years 
old (dermal); and
     Exposure to golf courses during golfing: Adults (dermal), 
children 11 < 16 years old (dermal), and children 6 < 11 years old 
(dermal).
    EPA did not combine exposure resulting from adult handler and post-
application exposure resulting from treated gardens, lawns, and/or 
golfing because the conservative assumptions and inputs within each 
estimated exposure scenario would result in an overestimate of adult 
exposure. EPA selected the most conservative adult residential scenario 
(adult dermal post-application exposure from gardening) as the 
contributing source of residential exposure to be combined with the 
dietary exposure for the aggregate assessment. The children's oral 
exposure is based on post-application hand-to-mouth exposures. To 
include exposure from object-to-mouth and soil ingestion in addition to 
hand-to-mouth would overestimate the potential for oral exposure. 
However, there is the potential for co-occurrence of dermal and oral 
exposure, since the toxicological effects from the dermal and oral 
routes of exposure are the same. As a result, the children's aggregate 
assessment combines post-application dermal and oral exposure along 
with dietary exposure from food and water. 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 pendimethalin to share a common mechanism of 
toxicity with any other substances, and pendimethalin does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
pendimethalin 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 was no indication of 
pre- and/or post-natal qualitative or quantitative increased 
susceptibility in the developmental studies in rats and rabbits or the 
2-generation reproduction studies in rats. A developmental thyroid 
toxicity study demonstrated that there is no potential thyroid toxicity 
following pre- and/or post-natal exposure to pendimethalin.
    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 pendimethalin is complete. Although a 
subchronic inhalation study was not available in the database, EPA 
determined that one is not needed at this time based on a weight-of-
evidence analysis, considering the following: (1) All relevant hazard 
and exposure information, which indicates its low acute inhalation 
toxicity; (2) its physical/chemical properties, which indicate its low 
volatility; and (3) the use of an oral POD that results in a 
residential inhalation margin of exposure (MOE) more than 10X the level 
of concern (in the case of pendimethalin MOE = 30 based on thyroid 
POD).
    ii. There is no indication that pendimethalin 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 pendimethalin 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. In addition, a developmental thyroid toxicity study demonstrated 
that there is no potential thyroid toxicity following pre- and/or post-
natal exposure to pendimethalin.
    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 pendimethalin 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 
pendimethalin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are

[[Page 6980]]

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 pendimethalin will occupy 2% 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 
pendimethalin from food and water will utilize 2.4% of the cPAD for 
children one to two years old the population group receiving the 
greatest exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
pendimethalin 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).
    Pendimethalin is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to pendimethalin.
    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 130 for adults 
and 92 for children 1-2 years old, the two population subgroups 
receiving the greatest combined dietary and non-dietary exposure. 
Because EPA's level of concern for pendimethalin is a MOE of 30 or 
below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    An intermediate-term adverse effect was identified; however, 
pendimethalin is not registered for any use patterns that would result 
in intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
pendimethalin.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.A., EPA has determined that an RfD approach based on the chronic 
point of departure is appropriate for evaluating cancer risk. As there 
are not chronic aggregate risks of concern, there are no cancer 
aggregate risk concerns.
    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 pendimethalin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, gas chromatography with electron 
capture detection (GC/ECD), 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.
    There are currently no established Codex MRLs for the residues of 
pendimethalin on alfalfa hay, although Codex has established an MRL for 
residues of pendimethalin in alfalfa fodder (which is equivalent to the 
US commodity of alfalfa forage) at 4 ppm. Harmonization is not possible 
because use of the Codex MRL would result in residues of pendimethalin 
exceeding tolerances in the U.S. as a result of use in accordance with 
the approved label.

V. Conclusion

    Therefore, tolerances are established for plant residues by 
measuring only the sum of pendimethalin, [N-(1-ethylpropyl)-3,4-
dimethyl-2,6-dinitrobenzenamine], and its metabolite, 4-[(1-
ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol calculated as the 
stoichiometric equivalent of pendimethalin, in or on alfalfa, forage at 
80 ppm and alfalfa, hay at 150 ppm. In addition, the Agency is revising 
the tolerance expression for paragraph (a)(1) to clarify that the 
residues of the parent compound are to be summed with the residues of 
the metabolite in order to determine compliance with the tolerance. 
This revision does not substantively change the existing language; the 
current language already requires measurement of both residues. The 
insertion of the words ``the sum'' just provides a small clarification 
for measuring residues to determine compliance with the tolerance.

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); Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997); or 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

[[Page 6981]]

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 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: January 30, 2018.
Daniel J. Rosenblatt,
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.  180.361:
0
a. Revise the introductory text of paragraph (a)(1).
0
b. Revise the entries for ``Alfalfa, forage''; and ``Alfalfa, hay'' in 
the table in paragraph (a)(1).
    The revisions read as follows:


Sec.  180.361  Pendimethalin; tolerances for residues.

    (a)(1) General. Tolerances are established for residues of the 
herbicide pendimethalin, including its metabolites and degradates, in 
or on the commodities. Compliance with the tolerance levels specified 
in the following table below is to be determined by measuring only the 
sum of pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine] and its metabolite, 4-[(1-ethylpropyl)amino]-2-
methyl-3,5-dinitrobenzyl alcohol, calculated as the stoichiometric 
equivalent of pendimethalin, in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage............................................           80
Alfalfa, hay...............................................          150
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-03277 Filed 2-15-18; 8:45 am]
BILLING CODE 6560-50-P