[Federal Register Volume 77, Number 168 (Wednesday, August 29, 2012)]
[Rules and Regulations]
[Pages 52240-52246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-21361]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0521; FRL-9360-5]


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 No. 4 
(IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective August 29, 2012. Objections and 
requests for hearings must be received on or before October 29, 2012, 
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-2011-0521, 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), EPA West 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: Andrew Ertman, Registration Division, 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(703) 308-9367; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or

[[Page 52241]]

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://ecfr.gpoaccess.gov/cgi/t/text/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-2011-0521 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
October 29, 2012. 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 CBI) for inclusion in the public docket. 
Information not marked confidential pursuant to 40 CFR part 2 may be 
disclosed publicly by EPA without prior notice. Submit the non-CBI copy 
of your objection or hearing request, identified by docket ID number 
EPA-HQ-OPP-2011-0521, 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 Confidential Business 
Information (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.htm.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 20, 2011 (76 FR 43231) (FRL-8880-
1), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 1E7878) 
by IR-4, 500 College Road East, Suite 201W, 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-2,6dinitrobenzenamine, and its 3, 5-
dinitrobenzyl alcohol metabolite (CL 202347), in or on lettuce, leaf at 
3.0 parts per million (ppm); Brassica, leafy greens, subgroup 5B at 0.2 
ppm; turnip greens at 0.2 ppm; melons subgroup 9A at 0.1 ppm; 
vegetable, soybean, succulent at 0.1 ppm; and small fruit vine climbing 
subgroup 13-07E, except grape at 0.1 ppm. That notice referenced a 
summary of the petition prepared by BASF, the registrant, which is 
available in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified the level for which the tolerance is being established for 
leaf lettuce. The reason for this change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue * * 
*.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for 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.
    Pendimethalin has low acute oral, dermal, and inhalation toxicity, 
and is not a dermal sensitizer. The thyroid is a target organ for 
pendimethalin. Thyroid toxicity in chronic and subchronic rat and mouse 
studies was manifested as alterations in thyroid hormones, increased 
thyroid weight, and microscopic thyroid lesions. 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 available prenatal and postnatal developmental 
toxicity data provided no indication of qualitative or quantitative 
susceptibility to the young. The overall weight of evidence suggests 
that this chemical does not directly target the immune system. There is 
no evidence of neurotoxicity for pendimethalin exposure.
    The points of departure (PODs) used for the chronic and short-term 
risk assessments were based on a 92-day thyroid function study in rats, 
a 56-day thyroid study in rats, and a 14-day intra

[[Page 52242]]

thyroid metabolism study in rats. Due to several important quantitative 
dynamic differences between rats and humans with respect to thyroid 
function, the interspecies uncertainty factor ((UF); used to account 
for animal to human differences in toxicokinetics and toxicodynamics) 
was reduced to 3X for the chronic and short-term risk assessments. A 
10X interspecies UF was used in the acute risk assessment because the 
POD was based on an acute neurotoxicity study, not a thyroid study. The 
use of an oral POD, assuming 100 percent inhalation absorption is 
considered protective for assessing short-term inhalation exposure 
since pendimethalin has a low vapor pressure (1.24 x 10-8 
Millimeter (mm) mercury (Hg) at 20[deg]C) and is not likely to 
volatilize substantially. It also has a relatively low solubility in 
water (0.275 ppm at 25 [deg]C). Further, the EPA has determined a 
subchronic inhalation study is not needed at this time.
    Pendimethalin is considered a possible human carcinogen based on a 
statistically significant increased trend and pair-wise comparison 
between the high dose group and controls for thyroid folliculate cell 
adenomas in male and female rats. A threshold approach is being used to 
evaluate cancer risk because mode of action studies are available 
demonstrating that the thyroid tumors are due to a thyroid-pituitary 
imbalance (a threshold effect), and also because 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, on pp. 51-54 in the document titled ``Revised 
Pendimethalin: Human Health Risk Assessment for Proposed Use on Leaf 
lettuce; Leafy brassica greens; Melons; Edamame; Kiwi and other small 
fruit vines'' in docket ID number EPA-HQ-OPP-2011-0521.

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://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for pendimethalin used for 
human risk assessment is shown in the Table of this unit.

  Table--Summary of Toxicological Doses and Endpoints for Pendimethalin for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  NOAEL = 100 mg/kg/    Acute RfD = 1 mg/kg/ Acute neurotoxicity study
 including infants and children).   day                   day                 LOAEL = 300 mg/kg, based on
                                   UFA = 10X...........  aPAD = 1 mg/kg/day.   reduced motor activity for males
                                   UFH = 10X...........                        and females on Day 0
                                   FQPA SF = 1X........
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 10 mg/kg/day   Chronic RfD = 0.3    92-Day thyroid function study in
                                   UFA = 3X............   mg/kg/day            rats; 56-day thyroid study in
                                   UFH = 10X...........  cPAD = 0.3 mg/kg/     rats; 14-day intra thyroid
                                   FQPA SF = 1X........   day.                 metabolism study in rats
                                                                              LOAEL = 31 mg/kg/day based on
                                                                               hormonal and histopathological
                                                                               changes in the thyroid
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to   NOAEL= 10 mg/kg/day   LOC for MOE = 30     92-Day thyroid function study in
 30 days).                         UFA = 3X............                        rats; 56-day thyroid study in
                                   UFH = 10X...........                        rats; 14-day intra thyroid
                                   FQPA SF = 1X........                        metabolism study in rats
                                                                              LOAEL = 31 mg/kg/day based on
                                                                               hormonal and histopathological
                                                                               changes in the thyroid
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days).  Oral study NOAEL =    LOC for MOE = 30     92-Day thyroid function study in
                                    10 mg/kg/day                               rats; 56-day thyroid study in
                                    (dermal absorption                         rats; 14-day intra thyroid
                                    rate = 3%                                  metabolism study in rats
                                   UFA = 3X............                       LOAEL = 31 mg/kg/day based on
                                   UFH = 10X...........                        hormonal and histopathological
                                   FQPA SF = 1X........                        changes in the thyroid
----------------------------------------------------------------------------------------------------------------

[[Page 52243]]

 
Inhalation short-term (1 to 30     Oral study NOAEL= 10  LOC for MOE = 30     92-Day thyroid function study in
 days).                             mg/kg/day                                  rats; 56-day thyroid study in
                                    (inhalation                                rats; 14-day intra thyroid
                                    absorption rate =                          metabolism study in rats
                                    100%)                                     LOAEL = 31 mg/kg/day based on
                                   UFA = 3X............                        hormonal and histopathological
                                   UFH = 10X...........                        changes in the thyroid
                                   FQPA SF = 1X........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Pendimethalin has been classified as a 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, RfD
                                    approach) was used since mode of action studies are available
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to 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 used food consumption information from the United 
States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, EPA assumed 100 percent crop treated (PCT) and 
tolerance-level residues for all current and proposed crops.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA assumed 100 PCT and 
tolerance-level residues for all current and proposed crops.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or nonlinear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or nonlinear approach is used and a cancer RfD is 
calculated based on an earlier noncancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action data 
determines a mutagenic mode of action, a default linear cancer slope 
factor approach is utilized. 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 PCT information. EPA did not use 
anticipated residue 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. 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://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models the estimated drinking water concentrations (EDWCs) of 
pendimethalin for acute exposures are estimated to be 80.5 parts per 
billion (ppb) for surface water and 0.036 ppb for ground water; and for 
chronic exposures are estimated to be 6.2 ppb for surface water and 
0.036 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 80.5 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 6.2 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 and ornamentals. EPA 
assessed residential exposure using the following assumptions: For 
handlers, it is assumed that most residential use will result in short-
term (1 to 30 days) dermal and inhalation exposures. Residential 
handlers are assumed to be wearing short-sleeved shirts, short pants, 
shoes and socks during application of pendimethalin.
    Residential post-application exposure is assumed to be short-term 
(1-30 days) in duration, resulting from the following: physical 
activities on turf: adults (dermal) and children 1-2 years old (dermal 
and incidental oral); mowing: adults (dermal) and children 11 < 16 
years old (dermal); and golfing: adults (dermal), children 11 < 16 
years

[[Page 52244]]

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 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 (adults 50+ years old; dermal 
post-application exposure) 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 could result in a very 
conservative estimation of exposure, as it would overestimate the 
potential for oral exposure. However, there is potential for co-
occurrence of the dermal and oral exposure based on the use pattern and 
combining them is appropriate because risk estimated from the dermal 
and oral routes of exposure are based on the same toxicological study. 
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://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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://www.epa.gov/pesticides/cumulative.

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 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. In addition, 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.
    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 postapplication 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 
aPAD and 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 2.0% 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 1.6% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
pendimethalin is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Pendimethalin is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to pendimethalin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 125 for adults 
and 93 for children 1-2 years old, the two population subgroups 
receiving the greatest combined dietary and non-dietary exposure. 
Because EPA's level of concern for pendimethalin is a MOE of 30 or 
below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure

[[Page 52245]]

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. Pendimethalin is 
considered a ``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, RfD 
approach) was used 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. The chronic dietary risk 
assessment is considered to be protective of any cancer effects.
    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

    PAM Volume II lists four Gas Chromatography/Electron Capture 
Detector (GC/ECD), methods for the determination of pendimethalin and 
its 3,5-dinitrobenzyl alcohol metabolite in plant commodities. Methods 
I and III determine residues of the parent, whereas Methods II and IV 
determine residues of the 3,5-dinitrobenzyl alcohol metabolite.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established MRLs for pendimethalin on any of 
these new uses.

C. Revisions to Petitioned-For Tolerances

    The proposed tolerance of 3.0 ppm on leaf lettuce is being 
increased to 4.0 ppm. This is because the Agency used the Organization 
of Economic Cooperation and Development (OECD) tolerance calculation 
procedures in determining appropriate tolerance levels, whereas the 
petitioner used the North American Free Trade Agreement (NAFTA) 
tolerance calculation procedures.

V. Conclusion

    Therefore, tolerances are established for residues of 
pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6dinitrobenzenamine, 
and its 3, 5-dinitrobenzyl alcohol metabolite (CL 202347), in or on 
lettuce, leaf at 4.0 ppm; Brassica, leafy greens, subgroup 5B at 0.20 
ppm; turnip greens at 0.20 ppm; melon subgroup 9A at 0.10 ppm; 
vegetable, soybean (edamame) at 0.10 ppm; and fruit, small vine 
climbing subgroup 13-07E, except grape at 0.10 ppm.

VI. Statutory and Executive Order Reviews

    This final rule 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 final rule has 
been exempted from review under Executive Order 12866, this final rule 
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 final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (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

[[Page 52246]]

General of the United States prior to publication of the rule in the 
Federal Register. This action is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: August 17, 2012.
Lois Rossi,
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. Section 180.361 is amended by alphabetically adding the following 
commodities to the table in paragraph (a) to read as follows:


Sec.  180.361  Pendimethalin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Brassica, leafy greens, subgroup 5B.....................            0.20
 
                                * * * * *
Fruit, small vine climbing, except grape, subgroup 13-              0.10
 07E....................................................
 
                                * * * * *
Lettuce, leaf...........................................            4.0
Melon subgroup 9A.......................................            0.10
 
                                * * * * *
Turnip greens...........................................            0.20
 
                                * * * * *
Vegetable, soybean, succulent...........................            0.10
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-21361 Filed 8-28-12; 8:45 am]
BILLING CODE 6560-50-P