Pendimethalin; Pesticide Tolerance, 27456-27460 [E7-9428]
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Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Rules and Regulations
[(methylamino)carbonyl]phenyl]-1-(3chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide) in or on the following raw
agricultural commodities:
Commodity
Expiration/revocation
date
Parts per million
Apple
0.25
05/01/2010
Apple, wet pomace
0.60
05/01/2010
7.0
05/01/2010
0.10
05/01/2010
Lettuce, head
4.0
05/01/2010
Lettuce, leaf
8.0
05/01/2010
Pear
0.30
05/01/2010
Pepper
0.50
05/01/2010
Spinach
13.0
05/01/2010
Squash
0.40
05/01/2010
Tomato
0.30
05/01/2010
Watermelon
0.20
05/01/2010
Celery
Cucumber
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. E7–9206 Filed 5–15–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0995; FRL–8120–2]
Pendimethalin; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: This regulation establishes a
tolerance for combined residues of
pendimethalin and its metabolite, 4-[(1ethylpropyl)amino]-2-methyl-3,5dinitrobenzyl alcohol in or on beans;
beans, forage; beans, hay; and peas
(except field peas) to replace the current
tolerances for bean, lima, seed; bean,
lima, succulent; bean, forage; bean, hay;
and pea, succulent. BASF Corporation
requested this tolerance under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective May
16, 2007. Objections and requests for
hearings must be received on or before
July 16, 2007, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
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Unit I.C. of the SUPPLEMENTARY
INFORMATION).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0995. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
web site to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. 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
https://www.regulations.gov,or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400,
One Potomac Yard (South Bldg.), 2777
S. Crystal Dr., 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:
Philip V. Errico, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
ADDRESSES:
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Pennsylvania Ave., NW., Washington,
DC 20460-0001; telephone number:
(703) 305–6663; e-mail address:
errico.philip@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 those engaged in the
following activities:
• Crop production (NAICS code 111),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 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 to provide 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
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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.
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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 https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s pilot
e-CFR site athttps://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of the FFDCA,
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–2006–0995 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
as required by 40 CFR part 178 on or
before July 16, 2007.
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 this copy,
identified by docket ID number EPA–
HQ–OPP–2006–0995, by one of the
following methods:
• Federal eRulemaking Portal: https://
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 Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket’s
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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. Petition for Tolerance
In the Federal Register of January 24,
2007 (72 FR 3130) (FRL–8109–7), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 6F7149) by BASF
Corporation, 26 Davis Drive, P.O. Box
13528, Research Triangle Park, NC
27709–3528. The petition 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-2,6dinitrobenzenamine] and its metabolite,
4-[(1-ethylpropyl)amino]-2-methyl-3,5dinitrobenzyl alcohol, in or on beans;
beans, forage; beans, hay; and peas
(except field peas) each at 0.1 parts per
million (ppm). That notice referenced a
summary of the petition prepared by
BASF Corporation, the registrant, which
is available to the public in the docket,
https://www.regulations.gov. There were
no comments received in response to
the notice of filing.
These proposed tolerances seek to
correct an inadvertent error made by
EPA in 2001 when EPA amended the
pendimethalin beans and peas
tolerances following completion of the
pendimethalin reregistration eligibility
determination under the Federal
Insecticide, Fungicide, and Rodenticide
Act, 7 U.S.C. 136 et seq., and FFDCA
tolerance reassessment. (66 FR 63192,
December 5, 2001). In an attempt to
clarify the coverage of the then existing
beans and peas tolerances, EPA
mistakenly narrowed the scope of the
existing tolerances. This action reestablishes the beans and peas
tolerances with the same coverage that
pre-dated the 2001 amendments and
using the terms originally recommended
by the tolerance reassessment decision.
Specifically, the proposed amendments
to the pendimethalin tolerance would
replace the current tolerances for bean,
lima, seed; bean, lima, succulent; bean,
forage; bean, hay; with tolerances for
beans; beans, forage; beans, hay and the
current tolerance for pea, succulent with
a tolerance for peas (except field peas).
The terms beans and peas are defined
under 40 CFR 180.1(g) to encompass
bean and pea commodities not covered
by the current tolerances.
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III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of the 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 the 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 the 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. . . .’’ These
provisions were added to the FFDCA by
the Food Quality Protection Act (FQPA)
of 1996.
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
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
the petitioned-for tolerance for
combined residues of pendimethalin
and its metabolite on beans; beans,
forage; beans, hay; and peas (except
field peas) each at 0.1 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 adverse effects caused
by pendimethalin as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at https://
www.regulations.gov. The referenced
document is available in the docket
established by this action, which is
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described under ADDRESSES, and is
identified as EPA–HQ–OPP–2006–0995
in that docket.
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B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the toxicological level of concern
(LOC) is derived from the highest dose
at which no adverse effects are observed
(the NOAEL) in the toxicology study
identified as appropriate for use in risk
assessment. However, if a NOAEL
cannot be determined, the lowest dose
at which adverse effects of concern are
identified (the LOAEL) is sometimes
used for risk assessment. Uncertainty/
safety factors (UF) are used in
conjunction with the LOC to take into
account 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. Safety is assessed for acute
and chronic risks by comparing
aggregate exposure to the pesticide to
the acute population adjusted dose
(aPAD) and chronic population adjusted
dose (cPAD). The aPAD and cPAD are
calculated by dividing the LOC by all
applicable uncertainty/safety factors.
Short-, intermediate, and long-term risks
are evaluated by comparing aggregate
exposure to the LOC to ensure that the
margin of exposure (MOE) called for by
the product of all applicable
uncertainty/safety factors is not
exceeded.
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk and
estimates risk in terms of the probability
of occurrence of additional adverse
cases. Generally, cancer risks are
considered non-threshold. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
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
(71 FR 18628) (FRL–7770–4).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to pendimethalin, EPA
considered exposure under the petition
for tolerances as well as all existing
pendimethalin tolerances in (40 CFR
180.361). EPA assessed dietary
exposures from pendimethalin in food
as follows:
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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.
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 food consumption data
from the USDA 1994–1996 and 1998
Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII). As to
residue levels in food, EPA assumed all
foods for which there are tolerances
were treated and contain tolerance-level
residues.
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 nonquantitative approach (i.e., non-linear,
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. The chronic risk
assessment is considered to be
protective of any cancer effects;
therefore, a separate quantitative cancer
aggregate risk assessment is not
required.
iv. Anticipated residue and percent
crop treated (PCT) information.
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).
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring 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 environmental fate characteristics of
pendimethalin. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found athttps://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone
Model/Exposure Analysis Modeling
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System (PRZM/EXAMS) and Screening
Concentrations in Groundwater (SCIGROW) models, the estimated
environmental concentrations (EECs) of
pendimethalin for peak 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. For
chronic dietary risk assessment, the
water concentration of value 39 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 nonoccupational, 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 residential non-dietary
sites: Landscape, grounds plantings,
ornamental crops, turf grass, and lawns.
EPA assessed residential exposure using
the following assumptions: Exposures
are short-term in duration, and consist
of dermal (for adults and children), and
oral (hand-to-mouth, object-to-mouth,
and soil ingestion, for children only).
The Agency combines risk values
resulting from separate exposure
scenarios when it is likely they can
occur simultaneously, based on the usepattern and the behavior associated with
the exposed population. The LOC for
oral, dermal and inhalation exposure is
an MOE of less than 300. The residential
exposure estimate for adults, consisting
of dermal exposure only, results in a
total MOE of 740, and is therefore not
of concern. The residential exposure for
children results in a total MOE (dermal
+ oral) of 410 at an application rate of
2 lb ai/acre, and an MOE of 400 for an
application rate of 3 lb ai/acre.
Residential aggregate exposure is not of
concern.
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
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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 EPA’s website at https://
www.epa.gov/pesticides/cumulative.
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D. Safety Factor for Infants and
Children
1. In general. Section 408 of FFDCA
provides that EPA shall apply an
additional (10X) 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. This additional
margin of safety is commonly referred to
as the FQPA safety factor. 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 FQPA
safety factor value based on the use of
traditional uncertainty/safety factors
and/or special FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity.
The database for pendimethalin does
not indicate a potential for increased
toxicological sensitivity from either
prenatal or postnatal exposures.
3. Conclusion. In September 2006 we
said the following: 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 homeostasis 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
(UF[DB]) for the lack of the study, to be
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applied in determining pendimethalin
risks.
E. Aggregate Risks and Determination of
Safety
Safety is assessed for acute and
chronic risks by comparing aggregate
exposure to the pesticide to the acute
population adjusted dose (aPAD) and
chronic population adjusted dose
(cPAD). The aPAD and cPAD are
calculated by dividing the LOC by all
applicable uncertainty/safety factors.
For linear cancer risks, EPA calculates
the probability of additional cancer
cases given aggregate exposure. Short-,
intermediate, and long-term risks are
evaluated by comparing aggregate
exposure to the LOC to ensure that the
margin of exposure (MOE) called for by
the product of all applicable
uncertainty/safety factors is not
exceeded.
1. Acute risk. No toxic effects
attributable to a single dose were
identified for pendimethalin. Therefore,
an acute risk assessment is not
warranted 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 water will utilize 26% of the
cPAD for the population group children
1-2. Based 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, water, and residential exposures
aggregated result in aggregate MOEs of
580 for adult males, 520 for adult
females, 310 for children for an
application rate of 2 lbs ai/acre to
residential turf, and 300 for children for
an application rate of 3 lbs ai/acre to
residential turf.
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 currently
requested uses, there are no scenarios
that are likely to result in intermediateterm exposure (30 to 180 days,
continuous. Therefore, an intermediate-
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27459
term risk assessment was not
conducted.
5. Aggregate cancer risk for U.S.
population. The Agency classifies
pendimethalin as a ‘‘Group C’’ (possible
human) cancinogen based on thyroid
follicular cell adenomas in rats. A nonquantitative approach, non-linear RfD
approach is used to assess the cancer
risk using a chronic assessment, which
is considerated protective of any cancer
effects: Because exposure to
pendimethalin does not exceed the
chronic RfD, pendimethalin is not
expected to pose a cancer risk.
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
Enforcement analytical methods using
gas chromatography and an electron
capture detector are available in the
Pesticide Analytical Manual, Volume II.
B. International Residue Limits
There are no established or proposed
Codex Maximum Residue Levles (MRLs)
for pendimethalin residues. Therefore,
there are no questions of compatibility
with respect to Codex MRLs and U.S.
tolerances.
C. Response to Comments
There were no responses to the Notice
of Filing for the requested tolerance in
beans and peas.
V. Conclusion
Therefore, the tolerance is established
for combined residues of pendimethalin
[N-(1-ethylpropyl)-3,4-dimethyl-2,6dinitrobenzenamine] and its metabolite,
4-[(1-ethylpropyl)amino]-2-methyl-3,5dinitrobenzyl alcohol, in or on beans;
beans, forage; beans, hay; and peas
(except field peas) all at 0.1 ppm each.
VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA 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 rule has
been exempted from review under
Executive Order 12866, this rule is not
subject to Executive Order 13211,
Actions Concerning Regulations That
Significantly Affect Energy Supply,
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Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under 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.
This final rule directly regulates
growers, food processors, food handlers
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. 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 6, 2000) do not apply
to this rule. In addition, This rule does
not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act of 1995 (UMRA)
(Public Law 104–4).
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).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
VerDate Aug<31>2005
18:04 May 15, 2007
Jkt 211001
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 rule 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: May 8, 2007.
Donald R. Stubbs,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.361 is amended by
revising the tolerances for ‘‘Bean, lima,
seed’’; ‘‘Bean, lima, succulent’’; ‘‘Bean,
forage’’; ‘‘Bean, hay’’; and ‘‘Pea,
succulent‘‘, which will be revoked due
to an administrative error, with the
entries to the table in paragraph (a) to
read as follows:
I
§ 180.361 Pendimethalin; tolerances for
residues.
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0160; FRL–8130–6]
Aspergillus flavus NRRL 21882 on
Corn; Temporary Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes a
temporary exemption from the
requirement of a tolerance for residues
of the Aspergillus flavus NRRL 21882 on
corn when applied aerially once per
season at the first sign of corn tasseling
to reduce aflatoxin-producing
Aspergillus flavus. Acta Group, 1203
Nineteenth St., NW., Suite 300,
Washington, DC 20036–2401 on behalf
of Circle One Global, Inc. One Arthur St.
P.O. Box 28, Shellman, GA 39886–0028
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA),
requesting the temporary tolerance
exemption. This regulation eliminates
the need to establish a maximum
permissible level for residues of
Aspergillus flavus NRRL 21882. The
temporary tolerance exemption expires
on May 2, 2009.
DATES: This regulation is effective May
16, 2007. Objections and requests for
hearings must be received on or before
June 15, 2007, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
Commodity
Parts per million
OPP–2007–0160. To access the
electronic docket, go to https://
*
*
*
*
*
Beans ..............................
0.10 www.regulations.gov, select ‘‘Advanced
Beans, forage .................
0.10 Search,’’ then ‘‘Docket Search.’’ Insert
Beans, hay ......................
0.10 the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
*
*
*
*
*
Peas (except field peas)
0.10 the instructions on the regulations.gov
web site to view the docket index or
*
*
*
*
*
access available documents. All
documents in the docket are listed in
*
*
*
*
*
the docket index available in
[FR Doc. E7–9428 Filed 5–15–07; 8:45 am]
regulations.gov. Although listed in the
BILLING CODE 6560–50–S
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.
ADDRESSES:
(a) * * *
PO 00000
Frm 00054
Fmt 4700
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E:\FR\FM\16MYR1.SGM
16MYR1
Agencies
[Federal Register Volume 72, Number 94 (Wednesday, May 16, 2007)]
[Rules and Regulations]
[Pages 27456-27460]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9428]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0995; FRL-8120-2]
Pendimethalin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for combined residues
of pendimethalin and its metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-
3,5-dinitrobenzyl alcohol in or on beans; beans, forage; beans, hay;
and peas (except field peas) to replace the current tolerances for
bean, lima, seed; bean, lima, succulent; bean, forage; bean, hay; and
pea, succulent. BASF Corporation requested this tolerance under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 16, 2007. Objections and
requests for hearings must be received on or before July 16, 2007, 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-2006-0995. To access the
electronic docket, go to https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. 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 https://www.regulations.gov,or, if
only available in hard copy, at the OPP Regulatory Public Docket in Rm.
S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 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: Philip V. Errico, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6663; e-mail address:
errico.philip@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 those
engaged in the following activities:
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 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 to
provide 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
[[Page 27457]]
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 https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site athttps://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, 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-2006-0995 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 as required by 40 CFR part 178 on or
before July 16, 2007.
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 this copy, identified by docket ID number
EPA-HQ-OPP-2006-0995, by one of the following methods:
Federal eRulemaking Portal: https://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
Bldg.), 2777 S. Crystal Dr., 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. Petition for Tolerance
In the Federal Register of January 24, 2007 (72 FR 3130) (FRL-8109-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6F7149) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research
Triangle Park, NC 27709-3528. The petition 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-dinitrobenzyl alcohol, in or on beans; beans, forage; beans,
hay; and peas (except field peas) each at 0.1 parts per million (ppm).
That notice referenced a summary of the petition prepared by BASF
Corporation, the registrant, which is available to the public in the
docket, https://www.regulations.gov. There were no comments received in
response to the notice of filing.
These proposed tolerances seek to correct an inadvertent error made
by EPA in 2001 when EPA amended the pendimethalin beans and peas
tolerances following completion of the pendimethalin reregistration
eligibility determination under the Federal Insecticide, Fungicide, and
Rodenticide Act, 7 U.S.C. 136 et seq., and FFDCA tolerance
reassessment. (66 FR 63192, December 5, 2001). In an attempt to clarify
the coverage of the then existing beans and peas tolerances, EPA
mistakenly narrowed the scope of the existing tolerances. This action
re-establishes the beans and peas tolerances with the same coverage
that pre-dated the 2001 amendments and using the terms originally
recommended by the tolerance reassessment decision. Specifically, the
proposed amendments to the pendimethalin tolerance would replace the
current tolerances for bean, lima, seed; bean, lima, succulent; bean,
forage; bean, hay; with tolerances for beans; beans, forage; beans, hay
and the current tolerance for pea, succulent with a tolerance for peas
(except field peas). The terms beans and peas are defined under 40 CFR
180.1(g) to encompass bean and pea commodities not covered by the
current tolerances.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of the 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 the 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 the 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. . .
.'' These provisions were added to the FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in 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 the petitioned-for tolerance
for combined residues of pendimethalin and its metabolite on beans;
beans, forage; beans, hay; and peas (except field peas) each at 0.1
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 adverse effects caused by pendimethalin as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at https://
www.regulations.gov. The referenced document is available in the docket
established by this action, which is
[[Page 27458]]
described under ADDRESSES, and is identified as EPA-HQ-OPP-2006-0995 in
that docket.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UF) are
used in conjunction with the LOC to take into account 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. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (aPAD) and chronic population adjusted dose
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all
applicable uncertainty/safety factors. Short-, intermediate, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the margin of exposure (MOE) called for by the product of
all applicable uncertainty/safety factors is not exceeded.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see https://
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 (71 FR 18628) (FRL-
7770-4).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pendimethalin, EPA considered exposure under the petition
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.
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 food consumption data from the USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food, EPA assumed all foods for which
there are tolerances were treated and contain tolerance-level residues.
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-quantitative approach (i.e., non-linear,
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. The chronic risk assessment is
considered to be protective of any cancer effects; therefore, a
separate quantitative cancer aggregate risk assessment is not required.
iv. Anticipated residue and percent crop treated (PCT) information.
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).
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring 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 environmental
fate characteristics of pendimethalin. Further information regarding
EPA drinking water models used in pesticide exposure assessment can be
found athttps://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentrations in Groundwater (SCI-
GROW) models, the estimated environmental concentrations (EECs) of
pendimethalin for peak 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. For chronic dietary risk
assessment, the water concentration of value 39 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 residential
non-dietary sites: Landscape, grounds plantings, ornamental crops, turf
grass, and lawns. EPA assessed residential exposure using the following
assumptions: Exposures are short-term in duration, and consist of
dermal (for adults and children), and oral (hand-to-mouth, object-to-
mouth, and soil ingestion, for children only). The Agency combines risk
values resulting from separate exposure scenarios when it is likely
they can occur simultaneously, based on the use-pattern and the
behavior associated with the exposed population. The LOC for oral,
dermal and inhalation exposure is an MOE of less than 300. The
residential exposure estimate for adults, consisting of dermal exposure
only, results in a total MOE of 740, and is therefore not of concern.
The residential exposure for children results in a total MOE (dermal +
oral) of 410 at an application rate of 2 lb ai/acre, and an MOE of 400
for an application rate of 3 lb ai/acre. Residential aggregate exposure
is not of concern.
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
[[Page 27459]]
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 EPA's website at https://
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 (10X) 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. This additional margin of
safety is commonly referred to as the FQPA safety factor. 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 FQPA
safety factor value based on the use of traditional uncertainty/safety
factors and/or special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. The database for
pendimethalin does not indicate a potential for increased toxicological
sensitivity from either prenatal or postnatal exposures.
3. Conclusion. In September 2006 we said the following: 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 homeostasis 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 (UF[DB]) for the lack of the study, to
be applied in determining pendimethalin risks.
E. Aggregate Risks and Determination of Safety
Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the acute population adjusted
dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and
cPAD are calculated by dividing the LOC by all applicable uncertainty/
safety factors. For linear cancer risks, EPA calculates the probability
of additional cancer cases given aggregate exposure. Short-,
intermediate, and long-term risks are evaluated by comparing aggregate
exposure to the LOC to ensure that the margin of exposure (MOE) called
for by the product of all applicable uncertainty/safety factors is not
exceeded.
1. Acute risk. No toxic effects attributable to a single dose were
identified for pendimethalin. Therefore, an acute risk assessment is
not warranted 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 water will utilize 26% of the cPAD for the
population group children 1-2. Based 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, water, and residential
exposures aggregated result in aggregate MOEs of 580 for adult males,
520 for adult females, 310 for children for an application rate of 2
lbs ai/acre to residential turf, and 300 for children for an
application rate of 3 lbs ai/acre to residential turf.
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
currently requested uses, there are no scenarios that are likely to
result in intermediate-term exposure (30 to 180 days, continuous.
Therefore, an intermediate-term risk assessment was not conducted.
5. Aggregate cancer risk for U.S. population. The Agency classifies
pendimethalin as a ``Group C'' (possible human) cancinogen based on
thyroid follicular cell adenomas in rats. A non-quantitative approach,
non-linear RfD approach is used to assess the cancer risk using a
chronic assessment, which is considerated protective of any cancer
effects: Because exposure to pendimethalin does not exceed the chronic
RfD, pendimethalin is not expected to pose a cancer risk.
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
Enforcement analytical methods using gas chromatography and an
electron capture detector are available in the Pesticide Analytical
Manual, Volume II.
B. International Residue Limits
There are no established or proposed Codex Maximum Residue Levles
(MRLs) for pendimethalin residues. Therefore, there are no questions of
compatibility with respect to Codex MRLs and U.S. tolerances.
C. Response to Comments
There were no responses to the Notice of Filing for the requested
tolerance in beans and peas.
V. Conclusion
Therefore, the tolerance is 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-dinitrobenzyl
alcohol, in or on beans; beans, forage; beans, hay; and peas (except
field peas) all at 0.1 ppm each.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA 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 rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply,
[[Page 27460]]
Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order
13045, entitled Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it
require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under 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.
This final rule directly regulates growers, food processors, food
handlers and food retailers, not States or tribes, nor does this action
alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of section
408(n)(4) of FFDCA. 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 6,
2000) do not apply to this rule. In addition, This rule does not impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4).
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).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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 rule 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: May 8, 2007.
Donald R. Stubbs,
Acting 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 revising the tolerances for ``Bean,
lima, seed''; ``Bean, lima, succulent''; ``Bean, forage''; ``Bean,
hay''; and ``Pea, succulent``, which will be revoked due to an
administrative error, with the entries to the table in paragraph (a) to
read as follows:
Sec. 180.361 Pendimethalin; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Beans................................................ 0.10
Beans, forage........................................ 0.10
Beans, hay........................................... 0.10
* * * * *
Peas (except field peas)............................. 0.10
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E7-9428 Filed 5-15-07; 8:45 am]
BILLING CODE 6560-50-S