[Federal Register Volume 71, Number 187 (Wednesday, September 27, 2006)]
[Rules and Regulations]
[Pages 56369-56374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-8254]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0645; FRL-8092-6]


Pendimethalin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine, and its metabolite 4-[(1-ethylpropyl)amino]-2-
methyl-3,5-dinitrobenyzl alcohol in or on alfalfa, forage; alfalfa, 
hay; alfalfa, seed; apple, wet pomace; fruit, pome, group 11; fruit, 
stone, group 12; juneberry; leek; onion, green; onion, welsh; 
pomegranate; shallot; strawberry; vegetable, fruiting, group 8; wheat, 
grain; wheat, forage; wheat, hay; and wheat, straw. BASF Corporation 
and Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective September 27, 2006. Objections and 
requests for hearings must be received on or before November 27, 2006 
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:  EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0645. All documents in the 
docket are listed in the index for the docket. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Jim Tompkins, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305 5697; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.

[[Page 56370]]

     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. 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-2006-0645 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be mailed or delivered to the Hearing Clerk on or 
before November 27, 2006.
    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 that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0645 by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of June 14, 2006 (71 FR 34341-34342) (FRL-
8072-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions PP 
0E6175 (vegetable, fruiting, group 8), PP 2E6450 (fruit, pome, group 
11; apple, wet pomace; and juneberry), PP 2E6464 (fruit, stone, group 
12), PP 2E6449 (pomegranates), by Interregional Research Project Number 
4 (IR-4), 681 U.S. Highway 1 South, New Brunswick, NJ 08902-
390.
    In the Federal Register of June 14, 2006 (71 FR 34344-34345) (FRL-
8072-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions PP 
5E6927 (onion, green; onion, welsh; leek; and shallot), PP 5E6928 
(strawberry), by Interregional Research Project Number 4 (IR-4), 681 
U.S. Highway 1 South, New Brunswick, NJ 08902-390.
    In the Federal Register of August 18, 2006 (71 FR 47810-47811 (FRL-
8084-71), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 
21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions PP 
4F6870 (wheat, grain; wheat, forage; wheat, hay; and wheat, straw), and 
PP 5F6961 (alfalfa, forage; alfalfa, hay; and alfalfa, seed) by BASF 
Corporation Agricultural Products, P.O. Box 13528, Research Triangle 
Park, NC 27709-3528.
    These petitions requested that 40 CFR 180.361 be amended by 
establishing a tolerance for combined 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-dinitrobenyzl 
alcohol in or on vegetables, fruiting, group 8 at 0.10 ppm (PP 0E6175), 
fruit, pome, group 11 at 0.10 ppm; apple, wet pomace at 0.20 ppm; and 
juneberry at 0.10 ppm (PP 2E6450), fruit, stone, group 12 at 0.10 ppm 
(PP 2E6464), pomergranate at 0.10 ppm (PP 2E6449), onion, green at 0.20 
ppm; onion, welsh at 0.20 ppm, leek at 0.20 ppm; and shallot at 0.2 ppm 
(PP 5E6927), strawberry at 0.10 ppm (PP 5E6928), wheat, grain at 0.10 
ppm; wheat, forge at 3.0 ppm; wheat, hay at 0.60 ppm; and wheat, straw 
at 0.30 ppm; (PP 4F6870), alfalfa, forage at 3.0 ppm; alfalfa, hay at 
4.0 ppm; and alfalfa, seed at 0.10 ppm (PP 5F6961). These notices 
included a summary of the petition prepared by IR-4 and BASF 
Corporation, the registrant. One comment was received in response to 
the notices of filing. EPA's response to this comment is discussed in 
Unit IV.C.
    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....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the

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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, consistent with section 
408(b)(2) of FFDCA, for a tolerance for combined residues of 
pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine, 
and its metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenyzl 
alcohol in or on vegetables, fruiting, group 8 at 0.10 ppm; fruit, 
pome, group 11 at 0.10 ppm; apple, wet pomace at 0.20 ppm; juneberry at 
0.10 ppm; fruit, stone, group 12 at 0.10 ppm; pomergranate at 0.10 ppm; 
onion, green at 0.20 ppm; onion, welsh at 0.20 ppm; leek at 0.20 ppm, 
shallot at 0.2 ppm; strawberry at 0.10 ppm; wheat, grain at 0.10 ppm; 
wheat, forge at 3.0 ppm; wheat, hay at 0.60 ppm, wheat, straw at 0.30 
ppm; alfalfa, forage at 3.0 ppm; alfalfa, hay at 4.0 ppm; and alfalfa, 
seed at 0.10 ppm. EPA's assessment of exposures and risks associated 
with establishing the tolerance 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. Specific information on the studies received and the nature 
of the toxic 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/fdmspublic/component/main, see Docket OPP-2005-
0056-0002.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(the NOAEL) from the toxicology study identified as appropriate for use 
in risk assessment is used to estimate the toxicological level of 
concern (LOC). However, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) is sometimes used for risk 
assessment if no NOAEL was achieved in the toxicology study selected. 
An uncertainty factor (UF) is applied to reflect uncertainties inherent 
in the extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for pendimethalin used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of April 12, 2006, 70 FR 18628-18635 
(FRL-7770-4)

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.361) for the combined residues of 
pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine, 
and its metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenyzl 
alcohol, in or on a variety of raw agricultural commodities. Risk 
assessments were conducted by EPA to assess 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 one-day or single exposure. No such effects were 
identified in the toxicological studies for pendimethalin; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII), and accumulated exposure to the chemical for each commodity. 
Tolerance-level residues were assumed for all food commodities with 
current and proposed pendimethalin tolerances, and it was assumed that 
all of the crops included in the analysis were treated (i.e., 100% crop 
treated). These assumptions result in highly conservative estimates of 
dietary exposure and risk.
    iii. Cancer. Pendimethalin is classified ``Group C,'' possible 
human carcinogen, chemical based on a statistically significant 
increased trend and pair-wise comparison between the high dose group 
and controls for thyroid follicular cell adenomas in male and female 
rats. The Agency used a non-linear approach (i.e., reference dose (RfD) 
approach) since mode of action studies are available that 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.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for pendimethalin in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
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 environmental concentrations (EECs) of 
pendimethalin for acute exposures are estimated to be 39 parts per 
billion (ppb) for surface water and 0.024 ppb for ground water. The 
EECs for chronic exposures are estimated to be 4.8 ppb for surface 
water and 0.024 ppb for ground water. Modeled estimates of drinking 
water concentrations were directly entered into the dietary exposure 
model (DEEM-FCID\TM\, Version 2.03). An acute dietary risk assessment 
for the peak water concentration value was not done because no such 
effects were identified in the toxicological studies for pendimethalin. 
For chronic dietary risk assessment, an estimated drinking water 
concentration (EDWC) of 0.039 ppm, the 1 in 10 year annual peak 
concentration in surface water as calculated by PRZM-EXAMS modeling, 
resulting from a single application of pendimethalin to apples at a 
rate of 4.0 lb of active ingredient/acre, was entered into DEEM.
    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

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flea and tick control on pets). Pendimethalin is currently registered 
for use on the following residential non-dietary sites: Landscapes, 
grounds plantings, ornamental crops, turf grass, and lawns. The risk 
assessment for residential non-dietary sites is discussed in Unit 
III.C.3. of the final rule published in the Federal Register of April 
12, 2006, FR Page 18628-18635 (FRL-7770-4)
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to pendimethalin and 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 not assumed that pendimethalin has 
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 the policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold 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 data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
margin of exposure (MOE) analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. In applying this provision, EPA either retains the default 
value of 10X when reliable data do not support the choice of a 
different factor, or, if reliable data are available, EPA uses a 
different additional safety factor value based on the use of 
traditional uncertainty factors and/or special FQPA safety factors, as 
appropriate.
    2. Prenatal and postnatal sensitivity. The data base for 
pendimethalin does not indicate a potential for increased toxicological 
sensitivity from either prenatal or postnatal exposures. No 
developmental toxicity was observed in either the rat or rabbit 
developmental toxicity studies, nor was there evidence in the two-
generation reproduction study of developmental or reproductive toxicity 
at dose levels below those in which parental toxicity was observed. 
There was no neurotoxicity observed in the submitted toxicity studies. 
Therefore, a developmental neurotoxicity (DNT) study is not required.
    Available data show the thyroid is a target organ for 
pendimethalin. The endpoints and doses selected for risk assessment 
were based on the most sensitive effect, thyroid toxicity, which was 
well-characterized in both chronic and subchronic toxicity studies on 
the basis of clear NOAELs and LOAELs. In addition, the exposure data 
used to evaluate risks for the general U.S. population and infants and 
children are conservative, and therefore the calculated risks are 
considered to be protective.
    3. Conclusion. There was no evidence of qualitative or quantitative 
susceptibility in the submitted data. Additionally, exposure estimates 
are based on very conservative data and assumptions that will overstate 
exposure to pendimethalin. There is, however, a concern that 
perturbation of thyroid homeostatis may lead to hypothyroidism, and 
possibly result in adverse effects on the developing nervous system. 
Since thyroid toxicity parameters were not measured in the 
developmental toxicity studies, the Agency has requested a 
developmental thyroid assay be conducted to evaluate the impact of 
pendimethalin on thyroid hormones, structure, and/or thyroid hormone 
homeostasis during development. The Agency has retained the additional 
10X FQPA safety factor in the form of a database uncertainty factor 
(UFDB) for the lack of the study, to be applied in 
determining pendimethalin risks.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. No toxic effects attributed to a single dose were 
identified for pendimethalin. Therefore an acute risk is not 
anticipated for this chemical.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
pendimethalin from food and drinking water will utilize 11% of the 
chronic population adjusted dose (cPAD) for the U.S. population, 19% of 
the cPAD for infants, and 26% of the cPAD for Children 1 to 2 years of 
age. Based on the use pattern, chronic residential exposure to residues 
of pendimethalin is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Pendimethalin is currently registered for use that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for pendimethalin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, drinking water and 
residential exposures aggregated result in aggregate MOEs of 580 for 
adult males, 520 for females 13 years or older, and 310 for children 1 
to 2 years old. These aggregate MOEs do not exceed the Agency's level 
of concern (MOE 300) for aggregate exposure to food, drinking water and 
residential uses. See 71 FR 18628-18630, April 12, 2006.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Based on the 
currently registered and requested uses, there are no scenarios that 
are likely to result in intermediate-term exposure (30 to 180 days, 
continuously). Therefore an intermediate-term risk is not anticipated 
for pendimethalin.
    5. Aggregate cancer risk for U.S. population. The Agency determined 
that the 0.10 mg/kg/day RfD for chronic risks, is protective of both 
the chronic, non-carcinogenic effects as well as the carcinogenic 
effect seen in the rat. Accordingly, based on the risk estimates for 
chronic risk above, EPA concludes that aggregate chronic exposure to 
pendimethalin is not expected to pose a cancer risk of concern.
    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, and to infants and children from aggregate 
exposure to pendimethalin and its metabolite residues.

[[Page 56373]]

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate methods are available for data collection and tolerance 
enforcement for existing and proposed uses of pendimethalin. Methods I 
through IV in PAM Vol. II are gas chromatography/electron capture (GC/
ECD) methods. Methods used for data collection are essentially the same 
as the PAM Vol. II methods, and have been adequately validated.
    The FDA PESTDATA database (PAM Volume I, Appendix I) indicates that 
pendimethalin is completely recovered (>80%) by Multiresidue Methods 
Section 302 (Luke method; Protocol D) and 303 (Mills, Onley, Gaither 
method; Protocol E, nonfatty), and partially recovered (50-80%) by 
Multiresidue Method Section 304 (Mills fatty food method; Protocol E, 
fatty). 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; e-mail address: 
[email protected].

B. International Residue Limits

    There are no established or proposed Codex maximum residue limits 
(MRLs) for pendimethalin residues. Therefore, there are no questions of 
compatibility with respect to Codex MRLs and U.S. tolerances.

C. Response to Comments

    One comment was received in response to the notices of filing for 
this action. The comment contained no scientific data or other 
substantive evidence to rebut the Agency's conclusion that there is a 
reasonable certaintythat no harm will result from aggregate exposure to 
pendimethalin from the establishment of these tolerances.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine, 
and its metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenyzl 
alcohol in or on alfalfa, forage at 3.0 ppm; alfalfa, hay at 4.0 ppm; 
and alfalfa, seed at 0.10 ppm; fruit, pome, group 11 at 0.10 ppm; 
apple, wet pomace at 0.20 ppm and juneberry at 0.10 ppm; fruit, stone, 
group 12 at 0.10 ppm; pomergranate at 0.10 ppm; onion, green at 0.20 
ppm; onion, welsh at 0.20 ppm; leek at 0.20 ppm; and shallot at 0.2 
ppm; strawberry at 0.10 ppm; wheat, grain at 0.10 ppm; wheat, forge at 
3.0 ppm; wheat, hay at 0.60 ppm; wheat, straw at 0.30 ppm; and 
vegetables, fruiting, group 8 at 0.10 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to petitions 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 rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). 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., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). 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), or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA, 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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. 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 this final rule in the Federal Register. This final

[[Page 56374]]

rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects 40 CFR Part 180

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

    Dated: September 19, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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 adding entries to the table in 
paragraph (a) to read as follows:


Sec.  180.361   Pendimethalin, Tolerances for Residues.

    (a) * * *

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Alfalfa, Forage...........................   3.0
Alfalfa, Hay..............................  4.0
Alfalfa, Seed.............................  0.10
Apple, wet pomace.........................  0.20
                                * * * * *
Fruit, pome, group 11.....................  0.10
Fruit, stone, group 12....................  0.10
                                * * * * *
Juneberry.................................  0.10
Leek......................................  0.20
                                * * * * *
Onion, green..............................  0.20
Onion, welsh..............................  0.20
                                * * * * *
Pomegranate...............................  0.10
                                * * * * *
Shallot...................................  0.2
                                * * * * *
Strawberry................................  0.10
                                * * * * *
Vegetable, fruiting, group 8..............  0.10
Wheat, grain..............................  0.10
Wheat, forage.............................  3.0
Wheat, hay................................  0.60
Wheat, straw..............................  0.30
------------------------------------------------------------------------

[FR Doc. 06-8254 Filed 9-26-06; 8:45 am]
BILLING CODE 6560-50-S