Dimethenamid; Pesticide Tolerance, 44384-44388 [E7-15112]
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Federal Register / Vol. 72, No. 152 / Wednesday, August 8, 2007 / Rules and Regulations
Indian tribes, or on the distribution of
power and responsibilities between the
Federal Government and Indian tribes,
as specified by Executive Order 13175
(65 FR 67249, November 9, 2000), nor
will it 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 governments, as specified by
Executive Order 13132 (64 FR 43255,
August 10, 1999). This rule also is not
subject to Executive Order 13045 (62 FR
19885, April 23, 1997), because it is not
economically significant.
This technical correction action does
not involve technical standards; thus
the requirements of section 12(d) of the
National Technology Transfer and
Advancement Act of 1995 (15 U.S.C.
272 note) do not apply. The rule also
does not involve special consideration
of environmental justice related issues
as required by Executive Order 12898
(59 FR 7629, February 16, 1994). In
issuing this rule, EPA has taken the
necessary steps to eliminate drafting
errors and ambiguity, minimize
potential litigation, and provide a clear
legal standard for affected conduct, as
required by section 3 of Executive Order
12988 (61 FR 4729, February 7, 1996).
EPA has complied with Executive Order
12630 (53 FR 8859, March 15, 1998) by
examining the takings implications of
the rule in accordance with the
‘‘Attorney General’s Supplemental
Guidelines for the Evaluation of Risk
and Avoidance of Unanticipated
Takings’’ issued under the executive
order. This rule does not impose an
information collection burden under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
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. Section 808 allows
the issuing agency to make a rule
effective sooner than otherwise
provided by the CRA if the agency
makes a good cause finding that notice
and public procedure is impracticable,
unnecessary or contrary to the public
interest. This determination must be
supported by a brief statement. 5 U.S.C.
808(2). As stated previously, EPA had
made such a good cause finding,
including the reasons therefore, and
established an effective date of August
8, 2007. EPA will submit a report
containing this rule and other required
information to the U.S. Senate, the U.S.
House of Representatives, and the
Comptroller General of the United
States prior to publication of the rule in
the Federal Register. This correction to
40 CFR part 81 for Indiana is not a
‘‘major rule’’ as defined by 5 U.S.C.
804(2).
Dated: July 26, 2007.
Walter W. Kovalick Jr.,
Acting Regional Administrator, Region 5.
Part 81, chapter I, title 40 of the Code
of Federal Regulations is amended as
follows:
I
PART 81—[AMENDED]
1. The authority citation for part 81
continues to read as follows:
I
Authority: 42 U.S.C. 7401 et seq.
2. Section 81.315 is amended by
revising the entries for LaPorte County,
Indiana: LaPorte County in the table
entitled ‘‘Indiana-Ozone (8–Hour
Standard)’’ to read as follows:
I
§ 81.315
*
*
Indiana.
*
*
*
INDIANA—OZONE (8-HOUR STANDARD)
Designation a
Classification
Designated area
Date 1
*
*
LaPorte CO., IN:
LaPorte County ..........................................
*
*
*
Date 1
Type
*
7/19/07
*
Type
*
*
*
*
*
*
Attainment.
*
a Includes
1 This
Indian Country located in each county or area, except as otherwise specified.
date is June 15, 2004, unless otherwise noted.
4) requested this tolerance under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
[FR Doc. E7–15246 Filed 8–7–07; 8:45 am]
BILLING CODE 6560–50–P
This regulation is effective
August 8, 2007. Objections and requests
for hearings must be received on or
before October 9, 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).
DATES:
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0165; FRL–8138–2]
Dimethenamid; Pesticide Tolerance
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SUMMARY: This regulation establishes a
tolerance for residues of dimethenamid
in or on grasses grown for seed.
Interregional Research Project No. 4 (IR-
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EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0165. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
ADDRESSES:
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
PO 00000
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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–
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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
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT: Jim
Tompkins, Registration Division, Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (703) 305–
5639; e-mail address:
Tompkins.jim@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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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
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
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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 at https://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–2006–0165 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 October 9, 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–2006–0165, 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 Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Register of March 22,
2006 (71 FR 14521) (FRL–7766–7), EPA
issued a notice pursuant to section
408(d)(3) of the FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 0F6138) by
Interregional Research Project No. 4 (IR4), Technology Center of New Jersey,
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44385
Rutgers, the State of New Jersey, 681
U.S. Highway #1 South, North
Brunswick, NJ 08902–3390. The petition
requested that 40 CFR 180.464 be
amended by establishing a tolerance for
residues of the herbicide dimethenamid
in or on grass, forage at 0.05 parts per
million (ppm); grass, hay at 0.30 ppm;
grass, straw at 0.01 ppm; and grass, seed
screenings at 0.01 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. Based on review of the
residue data, the EPA determined that
the tolerance for dimethenamid in or on
grass, forage at should be established at
0.15 ppm instead of 0.05 ppm requested
by the registrant, and the tolerance for
grass, hay should be established at 2.5
ppm instead of 0.30 ppm as requested
by the registrant.
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 residues
of dimethenamid in or on grass, forage
at 0.15 parts per million (ppm); grass,
hay at 2.5 ppm; grass, straw at 0.01
ppm; and grass, seed screenings at 0.01
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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 dimethenamid as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found in the document
‘‘Dimethenamid-P Human Health Risk
Assessment for Proposed Use on Grasses
Grown for Seed, PC Codes: 120051 and
129051, Petition No: 0F6138, DP Num:
337887’’. The document is available at
https://www.regulations.gov. in the
docket established by this action, which
is described under ADDRESSES, and is
identified as EPA–HQ–OPP–2006–0165
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-term, intermediate-term,
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.
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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 dimethenamid used for
human risk assessment can be found at
www.regulations.gov in document
‘‘Dimethenamid-P Human Health Risk
Assessment for Proposed Use on Grasses
Grown for Seed, PC Codes: 120051 and
129051, Petition No: 0F6138, DP Num:
337887’’ on page 16 in Docket ID EPA–
HQ–OPP–2006–0165.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to dimethenamid, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing dimethenamid tolerances in (40
CFR 180.464). EPA assessed dietary
exposures from (R,S)-2-chloro-N-[(1methyl-2-methoxy) ethyl]-N-(2,4dimethylthien-3-yl)-acetamide 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. In estimating acute dietary
exposure, EPA used food consumption
information from the United States
Department of Agriculture (USDA)
1994–1996 and 1998 Nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels
in food, EPA assumed all foods for
which there are tolerances were treated
and contain tolerance-level residues.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 1994–1996 and 1998
Nationwide 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. Dimethenamid was
classified as Group C - possible human
carcinogen based on benign liver tumors
(males) in rats. EPA determined that the
chronic Reference dose (cRfD) would be
protective of any cancer risk posed by
dimethenamid because the cRfD of 0.05
milligrams/kilogram/day (mg/kg/day)
used for risk assessment is based on
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non-cancer precursor effects in the liver.
In making this determination, EPA also
took into account that the tumor
incidences were only slightly above
historical control levels, only showed
statistical significance as increased
trends and not by pairwise between
control and treated animals, only
evidenced a statistically significant
trend when benign and malignant
tumors were combined, and were only
seen in one species. Therefore, the cRfD
is considered protective of both noncancer and cancer effects.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring data to complete a
comprehensive dietary exposure
analysis and risk assessment for
dimethenamid 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
dimethenamid. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the EPA’s Pesticide Root
Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS) and
Screening Concentration in Ground
Water (SCI-GROW) models, the
estimated drinking water concentrations
(EDWCs) of dimethenamid for acute
exposures are estimated to be 9.0 parts
per billion (ppb) for surface water and
0.34 ppb for ground water. The EDWCs
for chronic exposures are estimated to
be 3.8 ppb for surface water and 0.34
ppb for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. The
EDWCs for use sites (other than grasses
grown for seed) with the highest values
were used. For acute dietary risk
assessment, the water concentration
value of 66.7 ppb was used to access the
contribution to drinking water. For
chronic dietary risk assessment, the
water concentration of value 20.2 ppb
was used to access 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).
Dimethenamid is not registered for
use on any sites that would result in
residential exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
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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
dimethenamid and any other substances
and dimethenamid 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 dimethenamid 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 the
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 database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA 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.
There is no concern for increased
qualitative and/or quantitative
susceptibility following pre-and postnatal exposure to the (RS) or (S)
dimethenamid technical products in
rats and rabbits. In the developmental
toxicity study in rats there was an
increased incidence of postimplantation loss and minor skeletal
variations. In the developmental toxicity
study in rabbits, late resorptions and
minor skeletal variations were observed
at the highest dose tested. In the rabbit,
the developmental effects occurred at
the same dose as maternal toxicity;
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whereas in the rat, the developmental
effects occurred at much higher doses
than in the dams. The reproduction
study showed decreases in body weight
in both pups and parental animals at the
same dose levels.
3. Conclusion. EPA has determined
that reliable data show that it would be
safe for infants and children to reduce
the FQPA safety factor to 1X. That
decision is based on the following
findings:
i. The toxicity database for
dimethenamid is complete.
ii. The toxicity data showed no
increase in qualitative and/or
quantitative susceptibility in fetuses and
pups with in utero and pre- and postnatal exposure.
iii. There is no evidence that
dimethenamid is a neurotoxic chemical
and there is no need for a
developmental neurotoxicity study or
additional uncertainty factors to account
for neurotoxicity.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessment
utilizes proposed tolerance level
residues and 100% crop treated
information for all commodities, which
results in very high-end estimates of
dietary exposure. The dietary drinking
water assessment utilizes values
generated by model and associated
modeling parameters which are
designed to provide health protective,
high-end estimates of water
concentrations.
E. Aggregate Risks and Determination of
Safety
Safety is assessed for acute and
chronic risks by comparing aggregate
exposure to the pesticide to the aPAD
and cPAD. For linear cancer risks, EPA
calculates the probability of additional
cancer cases given aggregate exposure.
Short-term, intermediate-term, and longterm risks are evaluated by comparing
aggregate exposure to the LOC to ensure
that the MOE called for by the product
of all applicable uncertainty/safety
factors is not exceeded.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
dimethenamid will occupy <1% of the
aPAD for the population group (women
ages 13–49) receiving the greatest
exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to dimethenamid from
food and water will utilize 3% of the
cPAD for the population group (all
infants (<1 year)) receiving the greatest
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exposure. There are no residential uses
for dimethenamid that result in chronic
residential exposure to dimethenamid.
3. Short-term risk. Dimethenamid is
not registered for use on any sites that
would result in residential exposure.
Therefore, the aggregate risk is the sum
of the risk from food and water.
4. Intermediate-term risk.
Dimethenamid is not registered for use
on any sites that would result in
residential exposure. Therefore, the
aggregate risk is the sum of the risk from
food and water, which do not exceed
the Agency’s LOC.
5. Aggregate cancer risk for U.S.
population. The cRfD of 0.05 mg/kg/day
used for risk assessment is based on
non-cancer precursor effects. Therefore,
the cRfD is considered protective of
both non-cancer and cancer effects.
Consequently, a separate aggregate
cancer risk assessment was not
conducted.
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
dimethenamid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(gas chromatography with a nitrogen
phosphorus detector (GC/NPD) method
(AM-0884-0193-1) is available to enforce
the tolerance expression. The method
may be requested from: Chief,
Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905; email address: residuemethods@epa.gov.
B. International Residue Limits
An International Residue Limit (IRL)
Status Sheet is appended to the
Dimethenamid-P Human Health Risk
Assessment located in the docket for
this notice. Codex has established
maximum residue limits (MRLs),
expressed in terms of dimethenamid-P
and its enantiomer, for various crop
commodities but not for grass
commodities. Canada and Mexico have
also established MRLs for
dimethenamid-P and its enantiomer in/
on various crop commodities but not for
grass, hay; grass, forage; grass, straw; or
grass, seed screenings.
V. Conclusion
Therefore, the tolerance is established
for residues of dimethenamid, in or on
grass, forage at 0.15 ppm; grass, hay at
2.5 ppm; grass, straw at 0.01 ppm; and
grass, seed screenings at 0.01 ppm.
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Federal Register / Vol. 72, No. 152 / Wednesday, August 8, 2007 / Rules and Regulations
ebenthall on PRODPC61 with RULES
VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of the 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,
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 the
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
VerDate Aug<31>2005
15:29 Aug 07, 2007
Jkt 211001
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.
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0075; FRL–8141–3]
Fenazaquin, 4-tert-butylphenethyl
Quinazolin-4-yl Ether; Pesticide Import
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
import tolerances for residues of
fenazaquin, 4-tert-butylphenethyl
quinazolin-4-yl ether, in or on apple at
0.2 parts per million (ppm); in or on
pear at 0.2 ppm; in or on citrus fruit
group 10, except grapefruit, at 0.5 ppm;
and in or on citrus oil at 10 ppm. Gowan
Company requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective
August 8, 2007. Objections and requests
for hearings must be received on or
before October 9, 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–
Dated: July 23, 2007.
OPP–2006–0075. To access the
Lois Rossi,
electronic docket, go to https://
Director, Registration Division, Office of
www.regulations.gov, select ‘‘Advanced
Pesticide Programs.
Search,’’ then ‘‘Docket Search.’’ Insert
I Therefore, 40 CFR chapter I is
the docket ID number where indicated
amended as follows:
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
PART 180—[AMENDED]
web site to view the docket index or
access available documents. All
I 1. The authority citation for part 180
documents in the docket are listed in
continues to read as follows:
the docket index available in
Authority: 21 U.S.C. 321(q), 346a and 371.
regulations.gov. Although listed in the
I 2. Section 180.464 is amended by
index, some information is not publicly
alphabetically adding the following
available, e.g., Confidential Business
commodities to the table in paragraph
Information (CBI) or other information
(a) to read as follows:
whose disclosure is restricted by statute.
Certain other material, such as
§ 180.464 Dimethenamid; tolerances for
copyrighted material, is not placed on
residues.
the Internet and will be publicly
(a) * * *
available only in hard copy form.
Publicly available docket materials are
Commodity
Parts per million
available in the electronic docket at
https://www.regulations.gov,or, if only
*
*
*
*
*
Grass, forage ..................
0.15 available in hard copy, at the OPP
Grass, hay ......................
2.5 Regulatory Public Docket in Rm. S–
Grass, seed screenings ..
0.01 4400, One Potomac Yard (South Bldg.),
Grass, straw ...................
0.01 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
[FR Doc. E7–15112 Filed 8–7–07; 8:45 am]
Facility telephone number is (703) 305–
BILLING CODE 6560–50–S
5805.
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
ADDRESSES:
E:\FR\FM\08AUR1.SGM
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Agencies
[Federal Register Volume 72, Number 152 (Wednesday, August 8, 2007)]
[Rules and Regulations]
[Pages 44384-44388]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15112]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0165; FRL-8138-2]
Dimethenamid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
dimethenamid in or on grasses grown for seed. Interregional Research
Project No. 4 (IR-4) requested this tolerance under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective August 8, 2007. Objections and
requests for hearings must be received on or before October 9, 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-2006-0165. 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-
[[Page 44385]]
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 Facility telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Jim Tompkins, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-5639; 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 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 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 at https://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-2006-0165 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 October 9, 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-2006-0165, 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 Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of March 22, 2006 (71 FR 14521) (FRL-7766-
7), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0F6138) by Interregional Research Project No. 4 (IR-4), Technology
Center of New Jersey, Rutgers, the State of New Jersey, 681 U.S.
Highway 1 South, North Brunswick, NJ 08902-3390. The petition
requested that 40 CFR 180.464 be amended by establishing a tolerance
for residues of the herbicide dimethenamid in or on grass, forage at
0.05 parts per million (ppm); grass, hay at 0.30 ppm; grass, straw at
0.01 ppm; and grass, seed screenings at 0.01 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. Based on review of the residue data, the EPA
determined that the tolerance for dimethenamid in or on grass, forage
at should be established at 0.15 ppm instead of 0.05 ppm requested by
the registrant, and the tolerance for grass, hay should be established
at 2.5 ppm instead of 0.30 ppm as requested by the registrant.
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 residues of dimethenamid in or on grass, forage at 0.15 parts per
million (ppm); grass, hay at 2.5 ppm; grass, straw at 0.01 ppm; and
grass, seed screenings at 0.01
[[Page 44386]]
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 dimethenamid 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 in the
document ``Dimethenamid-P Human Health Risk Assessment for Proposed Use
on Grasses Grown for Seed, PC Codes: 120051 and 129051, Petition No:
0F6138, DP Num: 337887''. The document is available at https://
www.regulations.gov. in the docket established by this action, which is
described under ADDRESSES, and is identified as EPA-HQ-OPP-2006-0165 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-term, intermediate-
term, 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 dimethenamid used for
human risk assessment can be found at www.regulations.gov in document
``Dimethenamid-P Human Health Risk Assessment for Proposed Use on
Grasses Grown for Seed, PC Codes: 120051 and 129051, Petition No:
0F6138, DP Num: 337887'' on page 16 in Docket ID EPA-HQ-OPP-2006-0165.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to dimethenamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing dimethenamid tolerances in (40
CFR 180.464). EPA assessed dietary exposures from (R,S)-2-chloro-N-[(1-
methyl-2-methoxy) ethyl]-N-(2,4-dimethylthien-3-yl)-acetamide 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. In estimating acute dietary
exposure, EPA used food consumption information from the United States
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA assumed all foods for which there are tolerances
were treated and contain tolerance-level residues.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Nationwide 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. Dimethenamid was classified as Group C - possible
human carcinogen based on benign liver tumors (males) in rats. EPA
determined that the chronic Reference dose (cRfD) would be protective
of any cancer risk posed by dimethenamid because the cRfD of 0.05
milligrams/kilogram/day (mg/kg/day) used for risk assessment is based
on non-cancer precursor effects in the liver. In making this
determination, EPA also took into account that the tumor incidences
were only slightly above historical control levels, only showed
statistical significance as increased trends and not by pairwise
between control and treated animals, only evidenced a statistically
significant trend when benign and malignant tumors were combined, and
were only seen in one species. Therefore, the cRfD is considered
protective of both non-cancer and cancer effects.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for dimethenamid 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 dimethenamid. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the EPA's Pesticide Root Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS) and Screening Concentration in Ground
Water (SCI-GROW) models, the estimated drinking water concentrations
(EDWCs) of dimethenamid for acute exposures are estimated to be 9.0
parts per billion (ppb) for surface water and 0.34 ppb for ground
water. The EDWCs for chronic exposures are estimated to be 3.8 ppb for
surface water and 0.34 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. The EDWCs for use sites (other
than grasses grown for seed) with the highest values were used. For
acute dietary risk assessment, the water concentration value of 66.7
ppb was used to access the contribution to drinking water. For chronic
dietary risk assessment, the water concentration of value 20.2 ppb was
used to access 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).
Dimethenamid is not registered for use on any sites that would
result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity.
[[Page 44387]]
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 dimethenamid and any other
substances and dimethenamid 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 dimethenamid 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 the 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 database on toxicity and
exposure unless EPA determines based on reliable data that a different
margin of safety will be safe for infants and children. This additional
margin of safety is commonly referred to as the FQPA 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. There is no concern for
increased qualitative and/or quantitative susceptibility following pre-
and post-natal exposure to the (RS) or (S) dimethenamid technical
products in rats and rabbits. In the developmental toxicity study in
rats there was an increased incidence of post-implantation loss and
minor skeletal variations. In the developmental toxicity study in
rabbits, late resorptions and minor skeletal variations were observed
at the highest dose tested. In the rabbit, the developmental effects
occurred at the same dose as maternal toxicity; whereas in the rat, the
developmental effects occurred at much higher doses than in the dams.
The reproduction study showed decreases in body weight in both pups and
parental animals at the same dose levels.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
i. The toxicity database for dimethenamid is complete.
ii. The toxicity data showed no increase in qualitative and/or
quantitative susceptibility in fetuses and pups with in utero and pre-
and post-natal exposure.
iii. There is no evidence that dimethenamid is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional uncertainty factors to account for neurotoxicity.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessment utilizes proposed
tolerance level residues and 100% crop treated information for all
commodities, which results in very high-end estimates of dietary
exposure. The dietary drinking water assessment utilizes values
generated by model and associated modeling parameters which are
designed to provide health protective, high-end estimates of water
concentrations.
E. Aggregate Risks and Determination of Safety
Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. For linear
cancer risks, EPA calculates the probability of additional cancer cases
given aggregate exposure. Short-term, intermediate-term, and long-term
risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the MOE called for by the product of all applicable
uncertainty/safety factors is not exceeded.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to dimethenamid will occupy <1% of the aPAD for the population group
(women ages 13-49) receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
dimethenamid from food and water will utilize 3% of the cPAD for the
population group (all infants (<1 year)) receiving the greatest
exposure. There are no residential uses for dimethenamid that result in
chronic residential exposure to dimethenamid.
3. Short-term risk. Dimethenamid is not registered for use on any
sites that would result in residential exposure. Therefore, the
aggregate risk is the sum of the risk from food and water.
4. Intermediate-term risk. Dimethenamid is not registered for use
on any sites that would result in residential exposure. Therefore, the
aggregate risk is the sum of the risk from food and water, which do not
exceed the Agency's LOC.
5. Aggregate cancer risk for U.S. population. The cRfD of 0.05 mg/
kg/day used for risk assessment is based on non-cancer precursor
effects. Therefore, the cRfD is considered protective of both non-
cancer and cancer effects. Consequently, a separate aggregate cancer
risk assessment was not conducted.
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 dimethenamid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography with a
nitrogen phosphorus detector (GC/NPD) method (AM-0884-0193-1) is
available to enforce the tolerance expression. 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
An International Residue Limit (IRL) Status Sheet is appended to
the Dimethenamid-P Human Health Risk Assessment located in the docket
for this notice. Codex has established maximum residue limits (MRLs),
expressed in terms of dimethenamid-P and its enantiomer, for various
crop commodities but not for grass commodities. Canada and Mexico have
also established MRLs for dimethenamid-P and its enantiomer in/on
various crop commodities but not for grass, hay; grass, forage; grass,
straw; or grass, seed screenings.
V. Conclusion
Therefore, the tolerance is established for residues of
dimethenamid, in or on grass, forage at 0.15 ppm; grass, hay at 2.5
ppm; grass, straw at 0.01 ppm; and grass, seed screenings at 0.01 ppm.
[[Page 44388]]
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of the
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, 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 the 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: July 23, 2007.
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 180.464 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:
Sec. 180.464 Dimethenamid; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Grass, forage........................................ 0.15
Grass, hay........................................... 2.5
Grass, seed screenings............................... 0.01
Grass, straw......................................... 0.01
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E7-15112 Filed 8-7-07; 8:45 am]
BILLING CODE 6560-50-S