80 FR 79267 - Pendimethalin; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 244 (December 21, 2015)

Page Range		79267-79273
FR Document		2015-31655

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).

Federal Register, Volume 80 Issue 244 (Monday, December 21, 2015)

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

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 < 11 years old
(dermal);
[cir] Physical activities on turf: Adults (dermal) and children 1-2
years old (dermal and incidental oral);
[cir] Mowing turf: Adults (dermal) and children 11 < 16 years old
(dermal); and
[cir] 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 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

Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Rules and Regulations 79267

November 9, 2000), nor will it impose § 52.1991 Section 110(a)(2) infrastructure DC 20460–0001; main telephone
substantial direct costs on tribal requirements. number: (703) 305–7090; email address:
governments or preempt tribal law. * * * * * RDFRNotices@epa.gov.
The Congressional Review Act, 5 (d) The EPA approves Oregon’s June SUPPLEMENTARY INFORMATION:
U.S.C. 801 et seq., as added by the Small 28, 2010 submittal as meeting the
requirements of CAA section I. General Information
Business Regulatory Enforcement
Fairness Act of 1996, generally provides 110(a)(2)(D)(i)(I) for the 2008 ozone A. Does this action apply to me?
that before a rule may take effect, the NAAQS.
You may be potentially affected by
agency promulgating the rule must [FR Doc. 2015–31915 Filed 12–18–15; 8:45 am]
this action if you are an agricultural
submit a rule report, which includes a BILLING CODE 6560–50–P producer, food manufacturer, or
copy of the rule, to each House of the pesticide manufacturer. The following
Congress and to the Comptroller General list of North American Industrial
of the United States. The EPA will ENVIRONMENTAL PROTECTION Classification System (NAICS) codes is
submit a report containing this action AGENCY not intended to be exhaustive, but rather
and other required information to the provides a guide to help readers
U.S. Senate, the U.S. House of 40 CFR Part 180
determine whether this document
Representatives, and the Comptroller [EPA–HQ–OPP–2014–0397; FRL–9937–18] applies to them. Potentially affected
General of the United States prior to entities may include:
publication of the rule in the Federal Pendimethalin; Pesticide Tolerances • Crop production (NAICS code 111).
Register. A major rule cannot take effect AGENCY: Environmental Protection • Animal production (NAICS code
until 60 days after it is published in the Agency (EPA). 112).
Federal Register. This action is not a
ACTION: Final rule.
• Food manufacturing (NAICS code
‘‘major rule’’ as defined by 5 U.S.C. 311).
804(2). SUMMARY: This regulation establishes • Pesticide manufacturing (NAICS
Under section 307(b)(1) of the CAA, tolerances for residues of pendimethalin code 32532).
petitions for judicial review of this in or on multiple commodities which B. How can I get electronic access to
action must be filed in the United States are identified and discussed later in this other related information?
Court of Appeals for the appropriate document. Interregional Research
circuit by February 19, 2016. Filing a Project Number 4 (IR–4) requested the You may access a frequently updated
petition for reconsideration by the tolerances associated with pesticide electronic version of EPA’s tolerance
Administrator of this final rule does not petition number (PP) 4E8282, and BASF regulations at 40 CFR part 180 through
affect the finality of this action for the requested the tolerances associated with the Government Printing Office’s e-CFR
purposes of judicial review nor does it (PP) 4F8261, under the Federal Food, site at http://www.ecfr.gov/cgi-bin/text-
extend the time within which a petition Drug, and Cosmetic Act (FFDCA). idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
for judicial review may be filed, and 40tab_02.tpl.
DATES: This regulation is effective
shall not postpone the effectiveness of December 21, 2015. Objections and C. How can I file an objection or hearing
such rule or action. This action may not requests for hearings must be received request?
be challenged later in proceedings to on or before February 19, 2016, and
enforce its requirements. See section Under FFDCA section 408(g), 21
must be filed in accordance with the U.S.C. 346a, any person may file an
307(b)(2). instructions provided in 40 CFR part objection to any aspect of this regulation
List of Subjects in 40 CFR Part 52 178 (see also Unit I.C. of the and may also request a hearing on those
SUPPLEMENTARY INFORMATION).
objections. You must file your objection
Environmental protection, Air ADDRESSES: The docket for this action, or request a hearing on this regulation
pollution control, Incorporation by identified by docket identification (ID) in accordance with the instructions
reference, Intergovernmental relations, number EPA–HQ–OPP–2014–0397, is provided in 40 CFR part 178. To ensure
Ozone, Reporting and recordkeeping available at http://www.regulations.gov proper receipt by EPA, you must
requirements. or at the Office of Pesticide Programs identify docket ID number EPA–HQ–
Dated: December 8, 2015. Regulatory Public Docket (OPP Docket) OPP–2014–0397 in the subject line on
Dennis J. McLerran, in the Environmental Protection Agency the first page of your submission. All
Regional Administrator, Region 10. Docket Center (EPA/DC), West William objections and requests for a hearing
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be
For the reasons set forth in the Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or
preamble, 40 CFR part 52 is amended as 20460–0001. The Public Reading Room before February 19, 2016. Addresses for
follows: is open from 8:30 a.m. to 4:30 p.m., mail and hand delivery of objections
Monday through Friday, excluding legal and hearing requests are provided in 40
PART 52—APPROVAL AND holidays. The telephone number for the CFR 178.25(b).
PROMULGATION OF Public Reading Room is (202) 566–1744, In addition to filing an objection or
IMPLEMENTATION PLANS and the telephone number for the OPP hearing request with the Hearing Clerk
Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please
■ 1. The authority citation for part 52 the visitor instructions and additional submit a copy of the filing (excluding
continues to read as follows: information about the docket available any Confidential Business Information
Lhorne on DSK5TPTVN1PROD with RULES

Authority: 42 U.S.C. 7401 et seq. at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket.
FOR FURTHER INFORMATION CONTACT: Information not marked confidential
Subpart MM—Oregon Susan Lewis, Registration Division pursuant to 40 CFR part 2 may be
(7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior
■ 2. Section 52.1991 is amended by Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
adding paragraph (d) to read as follows: Pennsylvania Ave. NW., Washington, objection or hearing request, identified

VerDate Sep<11>2014 15:24 Dec 18, 2015 Jkt 238001 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 E:\FR\FM\21DER1.SGM 21DER1

Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Rules and Regulations 79271

residential exposure to residues of IV. Other Considerations states that tolerances may be set when
pendimethalin is not expected. persons seeking such tolerances or
A. Analytical Enforcement Methodology
3. Short-term risk. Short-term exemptions have demonstrated that the
aggregate exposure takes into account Adequate enforcement methodology, pesticide meets the safety standard
short-term residential exposure plus gas chromatography with electron imposed by that statute. These
chronic exposure to food and water capture detection (GC/ECD), is available comments appear to be directed at the
(considered to be a background to enforce the tolerance expression. underlying statute and not EPA’s
exposure level). The method may be requested from: implementation of it; the citizens have
Pendimethalin is currently registered Chief, Analytical Chemistry Branch, made no contention that EPA has acted
for uses that could result in short-term Environmental Science Center, 701 in violation of the statutory framework.
residential exposure, and the Agency Mapes Rd., Ft. Meade, MD 20755–5350; EPA has found that there is a reasonable
has determined that it is appropriate to telephone number: (410) 305–2905; certainty of no harm to humans after
aggregate chronic exposure through food email address: residuemethods@ considering the toxicological studies
and water with short-term residential epa.gov. and the exposure levels of humans to
exposures to pendimethalin. B. International Residue Limits pendimethalin.
Using the exposure assumptions In making its tolerance decisions, EPA D. Revisions to Petitioned-for
described in this unit for short-term seeks to harmonize U.S. tolerances with Tolerances
exposures, EPA has concluded the international standards whenever Based on review of the data
combined short-term food, water, and possible, consistent with U.S. food supporting the petitions, EPA has
residential exposures result in aggregate safety standards and agricultural revised the petitioned-for tolerance in or
MOEs of 130 for adults and 92 for practices. EPA considers the on ‘‘meat byproduct’’ (at 3.0 ppm) based
children 1 to 2 years old, the two international maximum residue limits on anticipated residues in kidney which
population subgroups receiving the (MRLs) established by the Codex contained the highest residue amongst
greatest combined dietary and non- Alimentarius Commission (Codex), as all ruminant tissues and will therefore
dietary exposure. Because EPA’s level of required by FFDCA section 408(b)(4). cover anticipated residues in liver and
concern for pendimethalin is a MOE of The Codex Alimentarius is a joint fat. BASF, proposed setting a tolerance
30 or below, these MOEs are not of United Nations Food and Agriculture on ‘‘meat byproduct except liver’’, also
concern. Organization/World Health at 3.0 ppm based on anticipated
4. Intermediate-term risk. Organization food standards program, residues in kidney with a separate lower
Intermediate-term aggregate exposure and it is recognized as an international tolerance on liver at 1.5 ppm. However,
takes into account intermediate-term food safety standards-setting the anticipated residues in liver versus
residential exposure plus chronic organization in trade agreements to kidney, on which the tolerance for meat
exposure to food and water (considered which the United States is a party. EPA byproduct is based on, are not
to be a background exposure level). may establish a tolerance that is significantly different given the limited
An intermediate-term adverse effect different from a Codex MRL; however, number of data for those tissues and that
was identified; however, pendimethalin FFDCA section 408(b)(4) requires that both are greater than LOQ and within 1
is not registered for any use patterns EPA explain the reasons for departing ppm of each other. Therefore, a single
that would result in intermediate-term from the Codex level. tolerance on ‘‘meat byproduct’’ without
residential exposure. Intermediate-term There are currently no established a separate tolerance on liver is adequate.
risk is assessed based on intermediate- Codex MRLs for the residues of Additionally, the current tolerance
term residential exposure plus chronic pendimethalin. expression for pendimethalin for plant
dietary exposure. Because there is no commodities includes the combined
intermediate-term residential exposure C. Response to Comments
residues of pendimethalin and its 3,5-
and chronic dietary exposure has Two comments were received to the dinitrobenzyl alcohol metabolite (CL
already been assessed under the Notices of Filing for PP 4E8282 and PP 202,347). EPA has determined, based on
appropriately protective cPAD (which is 4F8261. One commenter stated: the review of the ruminant feeding
at least as protective as the POD used to ‘‘Pesticide/Herbicide contents must be study, that the residues of concern for
assess intermediate-term risk), no made available to the public due to setting tolerances and assessing risks in
further assessment of intermediate-term allergies. Labeling foods that have been ruminants is the parent compound,
risk is necessary, and EPA relies on the exposed to Pesticides/Herbicides pendimethalin, and its metabolite, 1-(1-
chronic dietary risk assessment for protects the public from potentially ethylpropyl)-5, 6-dimethyl-7-nitro-1H-
evaluating intermediate-term risk for ingesting a known allergen. This safe benzimidazole (also known as
pendimethalin. practice allows health care professionals metabolite 6).
5. Aggregate cancer risk for U.S. to determine the cause of a life Finally, the Agency is removing
population. As discussed in Unit III.A., threatening severe reaction to avoid Juneberry at 0.1 ppm as it is superseded
EPA has determined that an RfD these products in the future. I am a by fruit, bushberry, subgroup 13–07B; as
approach based on the chronic point of nurse hence my concern.’’ The second well as nut, tree, group 14 and pistachio
departure is appropriate for evaluating commenter stated that no residue at 0.1 ppm to account for an updated
cancer risk. As there are not chronic should be allowed for pendimethalin crop group conversion.
aggregate risks of concern, there are no and that they do not support
cancer aggregate risk concerns. manufacture or use of this product. The V. Conclusion
6. Determination of safety. Based on Agency understands the commenters’ Therefore, tolerances are established
Lhorne on DSK5TPTVN1PROD with RULES

these risk assessments, EPA concludes concerns and recognizes that some for plant residues by measuring only the
that there is a reasonable certainty that individuals believe that pesticides sum of pendimethalin, [N-(1-
no harm will result to the general should be banned on agricultural crops. ethylpropyl)-3,4-dimethyl-2,6-
population, or to infants and children However, the existing legal framework dinitrobenzenamine], and its metabolite,
from aggregate exposure to provided by Section 408 of the Federal 4-[(1-ethylpropyl)amino]-2-methyl-3,5-
pendimethalin residues. Food, Drug and Cosmetic Act (FFDCA) dinitrobenzyl alcohol calculated as the

VerDate Sep<11>2014 15:24 Dec 18, 2015 Jkt 238001 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 E:\FR\FM\21DER1.SGM 21DER1

79272 Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Rules and Regulations

stoichiometric equivalent of the requirements of the Regulatory PART 180—[AMENDED]
pendimethalin, in or on bushberry Flexibility Act (RFA) (5 U.S.C. 601 et
subgroup 13–07B at 0.10 ppm; seq.), do not apply. ■ 1. The authority citation for part 180
caneberry subgroup 13–07A at 0.10 continues to read as follows:
This action directly regulates growers,
ppm; grass forage, fodder, and hay crop food processors, food handlers, and food Authority: 21 U.S.C. 321(q), 346a and 371.
group 17, forage at 1,000 ppm; grass retailers, not States or tribes, nor does ■ 2. In § 180.361:
forage, fodder, and hay crop group 17, a. Redesignate paragraph (a) as (a)(1).
this action alter the relationships or ■
hay at 2,000 ppm; and nut, tree group ■ b. In the newly redesignated
distribution of power and
14–12 at 0.1 ppm. Tolerances are paragraph (a)(1):
responsibilities established by Congress
established for livestock commodities is ■ i. Remove the entries in the table for
by measuring only the sum of in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency ‘‘Grass forage, fodder, and hay crop
pendimethalin, [N-(1-ethylpropyl)-3,4- group 17, straw’’; ‘‘Juneberry’’; ‘‘Nut,
dimethyl-2,6-dinitrobenzenamine], and has determined that this action will not
have a substantial direct effect on States tree group 14’’; and ‘‘Pistachio’’.
its metabolite, 1-[(1-ethylpropyl)-5,6- ■ ii. Revise the entries in the table for
dimethyl-7-nitro-1H-benzimidazole or tribal governments, on the
‘‘Grass, forage, fodder, and hay crop
(metabolite 6), calculated as the relationship between the national
group 17, forage’’ and ‘‘Grass, forage,
stoichiometric equivalent of government and the States or tribal
fodder, and hay crop group 17, hay’’.
pendimethalin in or on cattle, fat at 0.30 governments, or on the distribution of ■ iii. Add alphabetically the entries
ppm; cattle, meat at 0.10 ppm; cattle, power and responsibilities among the ‘‘Bushberry subgroup 13–07B’’ and
meat byproduct 3.0 ppm; goat, fat at various levels of government or between ‘‘Caneberry subgroup 13–07A’’ to the
0.30 ppm; goat, meat at 0.10 ppm; goat, the Federal Government and Indian table.
meat byproduct at 3.0 ppm; horse, fat at tribes. Thus, the Agency has determined ■ c. Add paragraph (a)(2).
0.30 ppm; horse, meat at 0.10 ppm; that Executive Order 13132, entitled The additions and revisions read as
horse, byproduct at 3.0 ppm; milk at ‘‘Federalism’’ (64 FR 43255, August 10, follows:
0.04 ppm; sheep, fat at 0.30 ppm; sheep, 1999) and Executive Order 13175,
meat at 0.10 ppm; and sheep, meat entitled ‘‘Consultation and Coordination § 180.361 Pendimethalin; tolerances for
byproduct at 3.0 ppm. Additionally, the residues.
with Indian Tribal Governments’’ (65 FR
existing tolerances for Juneberry; nut, 67249, November 9, 2000) do not apply (a) General. (1) * * *
tree, group 14; and pistachio are to this action. In addition, this action
removed. Parts
does not impose any enforceable duty or Commodity per
VI. Statutory and Executive Order contain any unfunded mandate as million
Reviews described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
This action establishes tolerances 1501 et seq.). * * * * *
under FFDCA section 408(d) in Bushberry subgroup 13–07B .......... 0.10
response to a petition submitted to the This action does not involve any Caneberry subgroup 13–07A ......... 0.10
Agency. The Office of Management and technical standards that would require
Budget (OMB) has exempted these types Agency consideration of voluntary * * * * *
of actions from review under Executive consensus standards pursuant to section Grass, forage, fodder, and hay
12(d) of the National Technology crop group 17, forage ................. 1,000
Order 12866, entitled ‘‘Regulatory
Grass, forage, fodder, and hay
Planning and Review’’ (58 FR 51735, Transfer and Advancement Act
crop group 17, hay ...................... 2,000
October 4, 1993). Because this action (NTTAA) (15 U.S.C. 272 note).
has been exempted from review under * * * * *
VII. Congressional Review Act
Executive Order 12866, this action is Nut, tree, group 14–12 ................... 0.10
not subject to Executive Order 13211, Pursuant to the Congressional Review
entitled ‘‘Actions Concerning Act (5 U.S.C. 801 et seq.), EPA will * * * * *
Regulations That Significantly Affect submit a report containing this rule and
Energy Supply, Distribution, or Use’’ (66 (2) Tolerances are established for
other required information to the U.S.
FR 28355, May 22, 2001) or Executive residues of the herbicide pendimethalin,
Senate, the U.S. House of
Order 13045, entitled ‘‘Protection of including its metabolites and
Representatives, and the Comptroller
Children from Environmental Health degradates, in or on commodities listed
General of the United States prior to
Risks and Safety Risks’’ (62 FR 19885, in the following table. Compliance with
publication of the rule in the Federal
April 23, 1997). This action does not the tolerance levels is to be determined
Register. This action is not a ‘‘major by measuring only the sum of
contain any information collections
rule’’ as defined by 5 U.S.C. 804(2). pendimethalin (N-(1-ethylpropyl)-3,4-
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44 List of Subjects in 40 CFR Part 180 dimethyl-2,6-dinitrobenzenamine)) and
U.S.C. 3501 et seq.), nor does it require its metabolite, 1-(1-ethylpropyl)-5, 6-
any special considerations under Environmental protection, dimethyl-7-nitro-1H-benzimidazole
Executive Order 12898, entitled Administrative practice and procedure, (metabolite 6), calculated as the
‘‘Federal Actions to Address Agricultural commodities, Pesticides stoichiometric equivalent of
Environmental Justice in Minority and pests, Reporting and recordkeeping pendimethalin, in or on the commodity.
Populations and Low-Income requirements.
Populations’’ (59 FR 7629, February 16, Parts
Lhorne on DSK5TPTVN1PROD with RULES

Dated: December 7, 2015. Commodity per
1994). Daniel J. Rosenblatt, million
Since tolerances and exemptions that
are established on the basis of a petition Acting Director, Registration Division, Office
of Pesticide Programs. Cattle, fat ........................................ 0.30
under FFDCA section 408(d), such as Cattle, meat .................................... 0.10
the tolerances in this final rule, do not Therefore, 40 CFR chapter I is Cattle, meat byproduct ................... 3.0
require the issuance of a proposed rule, amended as follows: Goats, fat ........................................ 0.30

VerDate Sep<11>2014 15:24 Dec 18, 2015 Jkt 238001 PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 E:\FR\FM\21DER1.SGM 21DER1

Document Created: 2015-12-19 02:57:39
Document Modified: 2015-12-19 02:57:39

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
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).
Contact		Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation		80 FR 79267
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements