[Federal Register: September 27, 2006 (Volume 71, Number 187)]
[Rules and Regulations]
[Page 56369-56374]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27se06-12]
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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: tompkins.jim@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.
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
[[Page 56371]]
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
[[Page 56372]]
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:
residuemethods@epa.gov.
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