Document ID: EPA-HQ-OPP-2013-0768-0005
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Pendimethalin
Posted Date: 2015-02-11T05:00Z

[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Rules and Regulations]
[Pages 7541-7547]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02705]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0768; FRL-9921-89]

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. In addition, this regulation removes 
existing tolerances on fruit, citrus, group 10; fruit, pome, group 11; 
fruit, stone, group 12; garlic; leek; onion, bulb; onion, green; onion, 
welsh; shallot; strawberry; sunflower seed; and vegetable, fruiting, 
group 8, which are superseded by this action. Interregional Research 
Project Number 4 (IR-4) requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 11, 2015. Objections and 
requests for hearings must be received on or before April 13, 2015, 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-2013-0768, 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

[[Page 7542]]

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-2013-0768 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
April 13, 2015. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2013-0768, 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 Friday, February 21, 2014 (79 FR 9870) 
(FRL-9904-98), 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 3E8212) by IR-4, IR-4 Project Headquarters, 500 College 
Road East, Suite 201 W, 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, calculated as the stoichiometric 
equivalent of pendimethalin, in or on berry, low growing subgroup 13-
07G at 0.1 parts per million (ppm); fruit, citrus, group 10-10 at 0.1 
ppm; fruit, pome, group 11-10 at 0.1 ppm; fruit, stone, group 12-12 at 
0.1 ppm; hops, dried cones at 0.1 ppm; onion, bulb subgroup 3-07A at 
0.1 ppm; onion, green subgroup 3-07B at 0.2 ppm; sunflower, subgroup 
20B at 0.1 ppm; and vegetable, fruiting, group 8-10 at 0.1 ppm. That 
document referenced a summary of the petition prepared by BASF 
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for pendimethalin including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with pendimethalin 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity database 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 toxicity by the oral, dermal, or 
inhalation route of exposure. It is not an eye or skin irritant, and is 
not a skin sensitizer. The target organ 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 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. Due to several important quantitative dynamic 
differences between rats and humans with respect to thyroid function, 
the interspecies uncertainty factor (UF), which used to account for 
animal to human differences in toxicokinetics and toxicodynamics, was 
reduced to 3X for

[[Page 7543]]

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. Although a subchronic 
inhalation study was not available in the database, EPA determined that 
one is not needed at this time based on the following:
    1. All relevant hazard and exposure information, including its low 
acute inhalation toxicity.
    2. Its physical/chemical properties, including its low volatility.
    3. The use of an oral POD that results in occupational and 
residential inhalation margin of exposure (MOE) (in the case of 
pendimethalin MOE = 30 based on thyroid POD).
    There is no evidence that pendimethalin is a developmental, 
reproductive, neurotoxic, or immunotoxic chemical. There is no evidence 
of increased qualitative or quantitative susceptibility in the young. 
EPA classified pendimethalin as a ``Group C'', possible human 
carcinogen based on a statistically significant increased trend and 
pair-wise comparison between the high-dose group and controls for 
thyroid follicular cell adenomas in male and female rats. A non-
quantitative approach (i.e., non-linear, reference dose (RfD) approach) 
was used to assess cancer risk since mode-of-action studies are 
available to demonstrate that the thyroid tumors are due to a thyroid-
pituitary imbalance, and also since pendimethalin was shown to be non-
mutagenic in mammalian somatic cells and germ cells.
    Specific information on the studies received and the nature of the 
adverse effects caused by pendimethalin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule 
published in the Federal Register of August 29, 2012 (77 FR 52240) 
(FRL-9360-5) and in ``Pendimethalin: Human Health Risk Assessment to 
Support New Use on Hops and Crop Subgroup Conversions/Expansions for 
Low Growing Berry Subgroup 13-07G, Onion, Bulb Subgroup 3-07A, Onion, 
Green Subgroup 3-07B, and Sunflower Subgroup 20B; Crop Group Expansions 
for Citrus Fruit, Group 10, Pome Fruit, Group 11, Stone Fruit, Group 
12, and Fruiting Vegetable, Group 8,'' in docket ID number EPA-HQ-OPP-
2013-0768.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological 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 the NOAEL and the LOAEL are identified. 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 RfD--and a safe 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 discussed in the final rule published in the 
Federal Register on Wednesday, August 29, 2012 (77 FR 52240) (FRL-9360-
5) establishing tolerances for residues of pendimethalin and its 
metabolite in or on various commodities.

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 conducting the 
acute dietary exposure assessment for pendimethalin, EPA used the 
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). The deterministic acute analysis is based 
on tolerance-level residues; 100 percent crop treated (PCT) assumptions 
for all of the pendimethalin use commodities in this assessment and 
DEEMTM default processing factors or empirical processing 
factors where available.
    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. The deterministic 
unrefined chronic analysis is based on tolerance-level residues; 100 
PCT assumptions for all of the pendimethalin use commodities in this 
assessment and DEEMTM default processing factors or 
empirical processing factors where available.
    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 PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
pendimethalin. Tolerance-level residues, default processing factors 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--New York grape scenario) and Screening 
Concentration in Ground Water (SCI-GROW) models the estimated drinking 
water concentrations (EDWCs) of pendimethalin for acute exposures are 
estimated to be 77.7 parts per billion (ppb) for surface water and 
0.036 ppb for ground water; and for chronic exposures are estimated to 
be 6.0 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 77.7 ppb was used to 
assess the contribution to

[[Page 7544]]

drinking water. For chronic dietary risk assessment, the water 
concentration of value 6.0 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 most residential use will 
result in short-term (1 to 30 days) duration dermal and inhalation 
exposures. Residential handlers are assumed to be adults wearing short-
sleeved shirts, short pants, shoes and socks during application of 
pendimethalin.
    Residential post-application exposure is also assumed to be short-
term (1-30 days) in duration, resulting from the following exposure 
scenarios: Gardening: Adults (dermal) and children 6<11 years old 
(dermal); physical activities on turf: Adults (dermal) and children 1-2 
years old (dermal and incidental oral); mowing turf: Adults (dermal) 
and children 11<16 years old (dermal); and exposure to golf courses 
during golfing: Adults (dermal), children 11<16 years old (dermal), and 
children 6<11 years old (dermal).
    EPA did not combine exposure resulting from adult handler and post-
application exposure resulting from treated gardens, lawns, and/or 
golfing because 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://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    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 Federal 
Quality Protection Act Safety Factor (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. 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 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, tolerance-level residues and default processing factors. 
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 population adjusted dose (aPAD) and chronic population adjusted 
dose (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 1.7% of the aPAD for all infants less than 
1 year old, the population group receiving the greatest exposure. 
Aggregate acute risk is by definition considered to include

[[Page 7545]]

exposure to food and drinking water only.
    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 1.7% 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 (dermal and 
inhalation) 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 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 
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. Therefore, an intermediate-term 
aggregate assessment is not required.
    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 analytical methodologies are available to 
enforce the proposed tolerances. BASF Method D1005 is adequate to 
enforce the proposed tolerance for hops. Additionally, the FDA PESTDATA 
database pesticide analytical manual (PAM Volume II, Appendix I) lists 
four gas chromatograph with electron capture detection (GC/ECD) methods 
for the determination of pendimethalin residues of concern in plant 
commodities. These GC/ECD methods are suitable to enforce the 
tolerances associated with the crop conversions.
    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.

V. Conclusion

    Therefore, tolerances are established for residues of the herbicide 
pendimethalin in or on berry, low growing subgroup 13-07G at 0.1 ppm; 
fruit, citrus, group 10-10 at 0.1 ppm; fruit, pome, group 11-10 at 0.1 
ppm; fruit, stone, group 12-12 at 0.1 ppm; hops, dried cones at 0.1 
ppm; onion, bulb subgroup 3-07A at 0.1 ppm; onion, green subgroup 3-07B 
at 0.2 ppm; sunflower, subgroup 20B at 0.1 ppm; and vegetable, 
fruiting, group 8-10 at 0.1 ppm. Compliance with these tolerances will 
be determined by measuring only pendamethalin [N-(1- ethylpropyl)-3,4-
dimethyl-2,6- dinitrobenzenamine], and its metabolite, 4-[(1-
ethylpropyl)amino]-2-methyl-3,5- dinitrobenzyl alcohol, calculated as 
the stoichiometric equivalent of pendimethalin. In addition, this 
regulation removes existing tolerances under 40 CFR 180.361 on 
pendimethalin in or on fruit, citrus, group 10 at 0.1 ppm; fruit, pome, 
group 11 at 0.1 ppm; fruit, stone, group 12 at 0.1 ppm; garlic at 0.1 
ppm; leek at 0.20 ppm; onion, bulb at 0.1 ppm; onion, green at 0.20 
ppm; onion, welsh at 0.20 ppm; shallot at 0.20 ppm; strawberry at 0.10 
ppm; sunflower seed at 0.10 ppm; and vegetable, fruiting, group 8 at 
0.10 ppm, as they are superseded by this action.

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

[[Page 7546]]

proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: January 30, 2015.
Susan Lewis,
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. Remove the entries for ``fruit, citrus, group 10 at 0.1 ppm; fruit, 
pome, group 11 at 0.1 ppm; fruit, stone, group 12 at 0.1 ppm; garlic at 
0.1 ppm; leek at 0.20 ppm; onion, bulb at 0.1 ppm; onion, green at 0.20 
ppm; onion, welsh at 0.20 ppm; shallot at 0.20 ppm; strawberry at 0.10 
ppm; sunflower seed at 0.10 ppm; and vegetable, fruiting, group 8 at 
0.10 ppm,'' from the table in paragraph (a).
0
b. Add alphabetically the commodities to the table in paragraph (a).
    The additions read as follows:

Sec.  180.361  Pendimethalin; tolerance for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                              * * * * * * *
Berry, low growing subgroup 13-07G......................             0.1
 
                              * * * * * * *
Fruit, citrus, group 10-10..............................             0.1
Fruit, pome, group 11-10................................             0.1
 
                              * * * * * * *
Fruit, stone, group 12-12...............................             0.1
 
                              * * * * * * *
Hop, dried cones........................................             0.1
 
                              * * * * * * *
Onion, bulb subgroup 3-07A..............................             0.1
Onion, green subgroup 3-07B.............................             0.2
 
                              * * * * * * *
Sunflower subgroup 20B..................................             0.1
 
                              * * * * * * *
Vegetable, fruiting, group 8-10.........................             0.1
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 2015-02705 Filed 2-10-15; 8:45 am]
BILLING CODE 6560-50-P