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[Federal Register Volume 80, Number 244 (Monday, December 21, 2015)]
[Rules and Regulations]
[Pages 79267-79273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31655]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0397; FRL-9937-18]

Pendimethalin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
pendimethalin in or on multiple commodities which are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested the tolerances associated with pesticide petition 
number (PP) 4E8282, and BASF requested the tolerances associated with 
(PP) 4F8261, under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 21, 2015. Objections and 
requests for hearings must be received on or before February 19, 2016, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2014-0397, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: 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 
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-2014-0397 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 
February 19, 2016. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified

[[Page 79268]]

by docket ID number EPA-HQ-OPP-2014-0397, 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 December 17, 2014 (79 FR 75107) (FRL-
9918-90), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP) 
4E8282 by Interregional Research Project Number 4 (IR-4), 500 College 
Road East, Princeton, NJ 08540. The petition requested that 40 CFR 
180.361 be amended by establishing 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 caneberry subgroup 13-07A at 
0.10 parts per million (ppm) and bushberry subgroup 13-07B at 0.10 ppm, 
and amending the existing crop group tolerance for nut, tree, group 14 
to nut, tree, group 14-12. That document referenced a summary of the 
petition prepared on behalf of IR-4 by BASF, the registrant, which is 
available in the docket EPA-HQ-OPP-2014-0397 at http://www.regulations.gov.
    In the Federal Register of August 26, 2015 (80 FR 51759) (FRL-9931-
74), 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) 
4F8261 by BASF Corp., 26 Davis Drive, Research Triangle Park, NC 27709. 
The petition requested that 40 CFR 180.361 be amended by establishing 
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 
milk at 0.04 parts per million (ppm); cattle, fat at 0.30 ppm; cattle, 
liver at 1.5 ppm; cattle, meat at 0.1 ppm; cattle, meat byproducts, 
except liver at 3.0 ppm; goat, fat at 0.30 ppm; goat, liver at 1.5 ppm; 
goat, meat at 0.10 ppm; goat, meat byproducts, except liver at 3.0 ppm; 
horse, fat at 0.30 ppm; horse, liver at 1.5 ppm; horse, meat at 0.10 
ppm; horse, meat byproducts, except liver at 3.0 ppm; sheep, fat at 
0.30 ppm; sheep, liver at 1.5 ppm; sheep, meat at 0.10 ppm; and sheep, 
meat byproducts, except liver at 3.0 ppm. This petition additionally 
requested that 40 CFR 180.361 be amended by revising the existing 
tolerance in or on grass forage, fodder, and hay crop group 17, forage 
at 1,000 ppm and grass forage, fodder, and hay crop group 17, hay at 
2,000 ppm. That document referenced a summary of the petition prepared 
on behalf of IR-4 by BASF, the registrant, which is available in the 
docket EPA-HQ-OPP-2014-0397 at http://www.regulations.gov.
    Two comments were received on these notices of filing. EPA's 
response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
revised the petitioned-for tolerance in or on cattle, meat byproduct, 
meat byproduct except liver, and liver; goat, meat byproduct, meat 
byproduct except liver, and liver; horse, meat byproduct, meat 
byproduct except liver, and liver; and sheep, meat byproduct, meat 
byproduct except liver, and liver. The Agency has determined that the 
tolerance expression for the ruminant commodities is different than 
that for plant commodities. Additionally, the EPA is removing existing 
tolerances for Juneberry; nut, tree, group 14; and pistachio since they 
are superseded by this action. The reason for these changes are 
explained 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 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, 
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.
    The points of departure (PODs) used for the chronic and short-term 
risk assessments were based on co-critical studies of a 92-day thyroid 
function study in rats, a 56-day thyroid study in rats, and a 14-day 
intra thyroid metabolism study in rats. An uncertainty factor (UF) of 
30X (3X for interspecies extrapolation and 10X for intraspecies 
variation) is applied for the chronic and short-term risk assessments. 
The interspecies UF which used to account for animal to human 
differences in toxicokinetics and toxicodynamics

[[Page 79269]]

was reduced to 3X due to several important quantitative dynamic 
differences between rats and humans with respect to thyroid function. A 
UF of 100X (10X for interspecies extrapolation and 10X for intraspecies 
variation) was used in the acute risk assessment because the POD was 
based on an acute neurotoxicity study, not a thyroid study.
    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 can be found at http://www.regulations.gov in document, ``Pendimethalin--Human Health Risk 
Assessment to Support the Proposed New Uses on the Caneberry Subgroup 
13-07A, and the Bushberry Subgroup 13-07B, Amended Use on Grasses and 
Establishment of Tolerances for Pendimethalin in/on Grass Forage, 
Fodder, and Hay (Crop Group 17) with New Ruminant Tolerances; Crop 
Group Conversion for Tree Nut Crop Group 14.'' in pages 14-20 in docket 
ID number EPA-HQ-OPP-2014-0397.

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 discussed in the final rule published in the 
Federal Register of August 29, 2012 (77 FR 52240) (FRL-9360-5).

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 percent crop 
treated (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 
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

[[Page 79270]]

(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:
    [cir] Gardening: Adults (dermal) and children 6 or 
golfing because of the conservative assumptions and inputs within each 
estimated exposure scenario. The Agency believes that combining 
exposures resulting from handler and post-application activities 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 Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There 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 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 1 to 2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic

[[Page 79271]]

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 to 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: 
residuemethods@epa.gov.

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.

C. Response to Comments

    Two comments were received to the Notices of Filing for PP 4E8282 
and PP 4F8261. One commenter stated: ``Pesticide/Herbicide contents 
must be made available to the public due to allergies. Labeling foods 
that have been exposed to Pesticides/Herbicides protects the public 
from potentially ingesting a known allergen. This safe practice allows 
health care professionals to determine the cause of a life threatening 
severe reaction to avoid these products in the future. I am a nurse 
hence my concern.'' The second commenter stated that no residue should 
be allowed for pendimethalin and that they do not support manufacture 
or use of this product. The Agency understands the commenters' concerns 
and recognizes that some individuals believe that pesticides should be 
banned on agricultural crops. However, the existing legal framework 
provided by Section 408 of the Federal Food, Drug and Cosmetic Act 
(FFDCA) states that tolerances may be set when persons seeking such 
tolerances or exemptions have demonstrated that the pesticide meets the 
safety standard imposed by that statute. These comments appear to be 
directed at the underlying statute and not EPA's implementation of it; 
the citizens have made no contention that EPA has acted in violation of 
the statutory framework. EPA has found that there is a reasonable 
certainty of no harm to humans after considering the toxicological 
studies and the exposure levels of humans to pendimethalin.

D. Revisions to Petitioned-for Tolerances

    Based on review of the data supporting the petitions, EPA has 
revised the petitioned-for tolerance in or on ``meat byproduct'' (at 
3.0 ppm) based on anticipated residues in kidney which contained the 
highest residue amongst all ruminant tissues and will therefore cover 
anticipated residues in liver and fat. BASF, proposed setting a 
tolerance on ``meat byproduct except liver'', also at 3.0 ppm based on 
anticipated residues in kidney with a separate lower tolerance on liver 
at 1.5 ppm. However, the anticipated residues in liver versus kidney, 
on which the tolerance for meat byproduct is based on, are not 
significantly different given the limited number of data for those 
tissues and that both are greater than LOQ and within 1 ppm of each 
other. Therefore, a single tolerance on ``meat byproduct'' without a 
separate tolerance on liver is adequate.
    Additionally, the current tolerance expression for pendimethalin 
for plant commodities includes the combined residues of pendimethalin 
and its 3,5-dinitrobenzyl alcohol metabolite (CL 202,347). EPA has 
determined, based on the review of the ruminant feeding study, that the 
residues of concern for setting tolerances and assessing risks in 
ruminants is the parent compound, pendimethalin, and its metabolite, 1-
(1-ethylpropyl)-5, 6-dimethyl-7-nitro-1H-benzimidazole (also known as 
metabolite 6).
    Finally, the Agency is removing Juneberry at 0.1 ppm as it is 
superseded by fruit, bushberry, subgroup 13-07B; as well as nut, tree, 
group 14 and pistachio at 0.1 ppm to account for an updated crop group 
conversion.

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

[[Page 79272]]

stoichiometric equivalent of pendimethalin, in or on bushberry subgroup 
13-07B at 0.10 ppm; caneberry subgroup 13-07A at 0.10 ppm; grass 
forage, fodder, and hay crop group 17, forage at 1,000 ppm; grass 
forage, fodder, and hay crop group 17, hay at 2,000 ppm; and nut, tree 
group 14-12 at 0.1 ppm. Tolerances are established for livestock 
commodities is by measuring only the sum of pendimethalin, [N-(1-
ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its metabolite, 
1-[(1-ethylpropyl)-5,6-dimethyl-7-nitro-1H-benzimidazole (metabolite 
6), calculated as the stoichiometric equivalent of pendimethalin in or 
on cattle, fat at 0.30 ppm; cattle, meat at 0.10 ppm; cattle, meat 
byproduct 3.0 ppm; goat, fat at 0.30 ppm; goat, meat at 0.10 ppm; goat, 
meat byproduct at 3.0 ppm; horse, fat at 0.30 ppm; horse, meat at 0.10 
ppm; horse, byproduct at 3.0 ppm; milk at 0.04 ppm; sheep, fat at 0.30 
ppm; sheep, meat at 0.10 ppm; and sheep, meat byproduct at 3.0 ppm. 
Additionally, the existing tolerances for Juneberry; nut, tree, group 
14; and pistachio are removed.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency 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: December 7, 2015.
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. Redesignate paragraph (a) as (a)(1).
0
b. In the newly redesignated paragraph (a)(1):
0
i. Remove the entries in the table for ``Grass forage, fodder, and hay 
crop group 17, straw''; ``Juneberry''; ``Nut, tree group 14''; and 
``Pistachio''.
0
ii. Revise the entries in the table for ``Grass, forage, fodder, and 
hay crop group 17, forage'' and ``Grass, forage, fodder, and hay crop 
group 17, hay''.
0
iii. Add alphabetically the entries ``Bushberry subgroup 13-07B'' and 
``Caneberry subgroup 13-07A'' to the table.
0
c. Add paragraph (a)(2).
    The additions and revisions read as follows:

Sec.  180.361  Pendimethalin; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
 
                                * * * * *
Bushberry subgroup 13-07B.....................................      0.10
Caneberry subgroup 13-07A.....................................      0.10
 
                                * * * * *
Grass, forage, fodder, and hay crop group 17, forage..........     1,000
Grass, forage, fodder, and hay crop group 17, hay.............     2,000
 
                                * * * * *
Nut, tree, group 14-12........................................      0.10
 
                                * * * * *
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the herbicide 
pendimethalin, including its metabolites and degradates, in or on 
commodities listed in the following table. Compliance with the 
tolerance levels is to be determined by measuring only the sum of 
pendimethalin (N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine)) 
and its metabolite, 1-(1-ethylpropyl)-5, 6-dimethyl-7-nitro-1H-
benzimidazole (metabolite 6), calculated as the stoichiometric 
equivalent of pendimethalin, in or on the commodity.

------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
Cattle, fat...................................................      0.30
Cattle, meat..................................................      0.10
Cattle, meat byproduct........................................       3.0
Goats, fat....................................................      0.30

[[Page 79273]]

 
Goats, meat...................................................      0.10
Goats, meat byproduct.........................................       3.0
Horse, fat....................................................      0.30
Horse, meat...................................................      0.10
Horse, byproduct..............................................       3.0
Milk..........................................................      0.04
Sheep, fat....................................................      0.30
Sheep, meat...................................................      0.10
Sheep, meat byproduct.........................................       3.0
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-31655 Filed 12-18-15; 8:45 am]
BILLING CODE 6560-50-P
```