Pyroxsulam; Pesticide Tolerances, 10398-10402 [E8-3490]
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Federal Register / Vol. 73, No. 39 / Wednesday, February 27, 2008 / Rules and Regulations
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: February 6, 2008.
Lois Rossi,
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 180.1277 is added to
subpart D to read as follows:
I
§ 180.1277 Dibasic esters; exemption from
the requirement of a tolerance.
Dibasic esters (CAS Reg. No. 95481–
62–2) is exempted from the requirement
of a tolerance for residues when used as
an inert ingredient (solvent and/or antifreeze) at 10% W/W or less in
microencapsulated pesticide
formulations with the active ingredient
cyfluthrin.
[FR Doc. E8–3492 Filed 2–26–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
I. General Information
EPA–HQ–OPP–2006–0785; FRL–8349–9]
Pyroxsulam; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of pyroxsulam in
or on wheat, forage; wheat, grain; wheat,
hay and wheat, straw. Dow
AgroSciences LLC requested this
tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective
February 27, 2008. Objections and
requests for hearings must be received
on or before April 28, 2008, 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–2006–0785. To access the
electronic docket, go to https://
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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
website 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
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT: Erik
Kraft, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9358; e-mail address:
Kraft.Erik@epa.gov.
SUPPLEMENTARY 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
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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 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–2006–0785 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 April 28, 2008.
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–2006–0785, 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.
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• 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.
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II. Petition for Tolerance
In the Federal Register of September
29, 2006 (71 FR 57507) (FRL–8094–1),
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 6F7101) by Dow
AgroSciences LLC, 9330 Zionsville
Road, Indianapolis, IN 46268–1054. The
petition requested that 40 CFR part 180
be amended by establishing tolerances
for residues of the herbicide
pyroxsulam, N-(5,7dimethoxy[1,2,4]triazolo[1,5a]pyrimidin-2-yl)-2-methoxy-4(trifluoromethyl)-3pyridinesulfonamide, in or on wheat,
forage at 0.04 parts per million (ppm);
wheat, grain at 0.01 ppm; wheat, hay at
0.01 ppm; and wheat, straw at 0.01
ppm. That notice referenced a summary
of the petition prepared by Dow
AgroSciences LLC, the registrant, which
is available to the public in the docket,
https://www.regulations.gov. Comments
were received on the notice of filing.
EPA’s response to these comments is
discussed in Unit IV.C.
Based upon review of the field
residue data supporting the petition,
EPA has modified the tolerance levels
for wheat, forage from 0.04 to 0.06 ppm
and for wheat, straw from 0.01 ppm to
0.03 ppm.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
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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 FFDCA by the Food
Quality Protection Act (FQPA) of 1996.
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for the petitioned-for
tolerances for residues of pyroxsulam on
wheat, forage at 0.06 ppm; wheat, grain
at 0.01 ppm; wheat, hay at 0.01 ppm
and wheat, straw at 0.03 ppm. EPA’s
assessment of exposures and risks
associated with establishing the
tolerances 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.
Pyroxsulam has low or minimal acute
toxicity via the oral (Acute Toxicity
Category III), dermal and inhalation
(Acute Toxicity Category IV) routes of
exposure. It is non-irritating to the eyes
and skin. It is a dermal sensitizer.
Little toxicity was observed in the
repeat-dose toxicology studies via the
oral and dermal routes of exposure. No
treatment-related adverse effects were
observed in the subchronic studies
(mice, rats, or dogs). There was evidence
of increased serum cholesterol levels in
the subchronic exposures, but in light of
a 28–day satellite recovery group in the
subchronic rat study, where the
cholesterol levels returned to normal
after cessation of treatment, these effects
were considered to be adaptive and nonadverse. Increased liver weights were
observed in several of the subchronic
and chronic studies; however, in the
absence of corroborating changes in
histopathology, the increased liver
weights were not considered adverse.
No adverse effects were observed in the
chronic dog study or chronic/
carcinogenicity study in rats. In the
carcinogenicity study in mice, the
lowest-observed-adverse-effect-level
(LOAEL) was 1,000 milligrams/
kilogram/day (mg/kg/day), based on
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increased liver weights with
corroborating evidence of increased
incidence of clear cell foci of alteration
in hepatocytes in males. The noobserved-adverse-effect-level (NOAEL)
was 100 mg/kg/day.
There was no evidence of maternal or
offspring toxicity in the developmental
or 2–generation reproduction studies in
rats up to 1,000 mg/kg/day. Considered
in conjunction with the range-finding
study, the developmental study in
rabbits showed no signs of maternal or
offspring toxicity up to 600 mg/kg/day.
None of these studies showed signs of
increased quantitative or qualitative
susceptibility. Pyroxsulam is not
mutagenic; it is classified as ‘‘not likely
to be carcinogenic to humans.’’
Specific information on the studies
received and the nature of the adverse
effects caused by pyroxsulam as well as
the NOAEL and the 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
described under ADDRESSES, and is
identified as ‘‘Pyroxsulam Human
Health Risk Assessment for Proposed
Uses on Wheat.’’ PC Code: 108702,
Petition No: 6F7101, DP Barcode:
D335496 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 (UFs) 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 UFs. 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 UFs 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 pyroxsulam used for
human risk assessment can be found at
https://www.regulations.gov in document
‘‘Pyroxsulam Human Health Risk
Assessment for Proposed Uses on
Wheat.’’ PC Code: 108702, Petition No:
6F7101, DP Barcode: D335496 at page
23 in docket ID number EPA–HQ–OPP–
2006–0785.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to pyroxsulam, EPA
considered exposure under the
petitioned-for tolerances. EPA assessed
dietary exposures from pyroxsulam 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 pyroxsulam;
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 United States Department of
Agriculture (USDA) 1994–1996, and
1998; Nationwide Continuing Surveys
of Food Intakes 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. Pyroxsulam was negative
for carcinogenicity in feeding studies in
rats and mice and was classified as ‘‘not
likely to be a human carcinogen.’’
Therefore, a quantitative exposure
assessment to evaluate cancer risk is
unnecessary.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring data to complete a
comprehensive dietary exposure
analysis and risk assessment for
pyroxsulam in drinking water. Because
the Agency does not have
comprehensive monitoring data,
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drinking water concentration estimates
are made by reliance on simulation or
modeling taking into account data on
the environmental fate characteristics of
pyroxsulam. 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 Pesticide Root Zone
Model /Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening
Concentration in Ground Water (SCIGROW) models, the estimated
environmental concentrations (EECs) of
pyroxsulam for chronic exposures are
estimated to be 0.102 parts per billion
(ppb) for surface water and 0.465 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 0.465 ppb
was used to assess the contribution of
the estimated drinking water
concentration to the dietary risk
assessment.
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).
Pyroxsulam 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.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
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
pyroxsulam and any other substances
and pyroxsulam 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 pyroxsulam 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 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 UFs and/or special FQPA
safety factors, as appropriate.
2. Prenatal and postnatal sensitivity.
There is no evidence of quantitative
and/or qualitative susceptibility and
there are no residual uncertainties with
regard to prenatal toxicity following in
utero exposure to rats or rabbits.
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
pyroxsulam is complete.
ii. There is no indication that
pyroxsulam is a neurotoxic chemical
and there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity.
iii. There is no evidence that
pyroxsulam results in increased
susceptibility to rats or rabbits in utero
in the prenatal developmental studies or
in young rats in the 2-generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary (food and drinking water)
exposure assessment will not
underestimate the potential exposure for
infants, children, and/or women of
childbearing age. There is no potential
for residential exposure.
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. The aPAD and cPAD are
calculated by dividing the LOC by all
applicable UFs. For linear cancer risks,
EPA calculates the probability of
additional cancer cases given aggregate
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exposure. Short-term, intermediateterm, 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 UFs is
not exceeded.
1. Acute risk. There were no effects
observed in oral toxicity studies
including developmental toxicity
studies in rats and rabbits that could be
attributable to a single dose (exposure).
Therefore, pyroxsulam is not expected
to pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to pyroxsulam from food
and water will utilize <1 % of the cPAD
for all population groups. There are no
residential uses for pyroxsulam that
result in chronic residential exposure to
pyroxsulam.
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).
Pyroxsulam 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.
Intermediate-term aggregate exposure
takes into account residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level).
Pyroxsulam 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 does not exceed
the Agency’s LOC for any population
subgroup.
5. Aggregate cancer risk for U.S.
population. Pyroxsulam is classified as
‘‘not likely to be carcinogenic in
humans’’ based on the results of a
carcinogenicity study in mice and the
combined chronic toxicity and
carcinogenicity study in the rat.
Therefore, pyroxsulam is not expected
to pose a cancer risk to humans.
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 pyroxsulam
residues.
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IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(liquid chromatography with positiveion electrospray ionization (ESI) tandem
mass spectrometry (LC/MS/MS) is
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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
No Codex, Canadian, or Mexican
maximum residue limits (MRLs) have
been established for pyroxsulam.
However, tolerances for pyroxsulam on
wheat are pending in Canada and
Australia. These Canadian and
Australian tolerances are not expected
to result in any harmonization issues.
C. Response to Comments
Public comments were received from
B. Sachau who objected to the proposed
tolerances because of the amounts of
pesticides already consumed and
carried by the American population.
She further indicated that testing
conducted on animals have absolutely
no validity and are cruel to the test
animals. B. Sachau’s comments
contained no scientific data or evidence
to rebut the Agency’s conclusion that
there is a reasonable certainty that no
harm will result from aggregate
exposure to pyroxsulam, including all
anticipated dietary exposures and all
other exposures for which there is
reliable information. EPA has responded
to B. Sachau’s generalized comments on
numerous previous occasions. 70 FR
1349, 1354 (January 7, 2005); 69 FR
63083, 63096 (October 29, 2004).
V. Conclusion
Therefore, tolerances are established
for residues of pyroxsulam, N-(5,7dimethoxy[1,2,4]triazolo[1,5a]pyrimidin-2-yl)-2-methoxy-4(trifluoromethyl)-3pyridinesulfonamide, in or on wheat,
forage at 0.06 ppm; wheat, grain at 0.01
ppm; wheat, hay at 0.01 ppm and
wheat, straw at 0.03 ppm.
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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10401
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
E:\FR\FM\27FER1.SGM
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10402
Federal Register / Vol. 73, No. 39 / Wednesday, February 27, 2008 / Rules and Regulations
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: February 10, 2008.
Debra Edwards,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. E8–3490 Filed 2–26–08; 8:45 am]
BILLING CODE 6560–50–S
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 73
[DA 08–304; MB Docket No. 07–221; RM–
11402]
Radio Broadcasting Service;
Susanville, CA
Federal Communications
Commission.
ACTION: Final rule.
AGENCY:
SUMMARY: The Audio Division grants a
petition for rule making filed by Hilltop
Church (‘‘Petitioner’’) to substitute
I 1. The authority citation for part 180
Channel 264A for vacant Channel 262A
continues to read as follows:
at Susanville, California. Petitioner
Authority: 21 U.S.C. 321(q), 346a and 371.
proposed the foregoing channel
substitution to accommodate its
I 2. Section 180.638 is added to read as
construction permit application to
follows:
modify the allotment of Station KHGQ
§ 180.638 Pyroxsulam; tolerances for
(FM) (‘‘KHGQ’’) from Channel 265A to
residues.
its original Channel 262A allotment at
(a) General. Tolerances are
Quincy, California. Channel 264A can
established for residues of the herbicide be allotted at Susanville, in compliance
pyroxsulam, N-(5,7with the Commission’s technical
dimethoxy[1,2,4]triazolo[1,5engineering requirements, at
a]pyrimidin-2-yl)-2-methoxy-4coordinates of 40–24–59 North Latitude
(trifluoromethyl)-3-pyridinesulfonamide and 120–39–07 West Longitude.
in or on the raw agricultural
DATES: Effective March 24, 2008.
commodities:
ADDRESSES: Secretary, Federal
Communications Commission, 445
Commodity
Parts per million
Twelfth Street, SW., Washington, DC
Wheat, forage .................
0.06 20554.
Wheat, grain ...................
0.01
FOR FURTHER INFORMATION CONTACT: R.
Wheat, hay .....................
0.01
Wheat, straw ...................
0.03 Barthen Gorman, Media Bureau, (202)
418–2187.
ebenthall on PRODPC61 with RULES
PART 180—[AMENDED]
VerDate Aug<31>2005
14:57 Feb 26, 2008
Jkt 214001
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
This is a
synopsis of the Commission’s Report
and Order, MB Docket No. 07–221,
adopted February 6, 2008, and released
February 8, 2008. The full text of this
Commission decision is available for
inspection and copying during regular
business hours at the FCC’s Reference
Information Center, Portals II, 445
Twelfth Street, SW., Room CY–A257,
Washington, DC 20554. The complete
text of this decision may also be
purchased from the Commission’s
duplicating contractor, Best Copy and
Printing, Inc., 445 12th Street, SW.,
Room CY–B402, Washington, DC 20554,
telephone 1–800–378–3160 or https://
www.BCPIWEB.com. The Commission
will send a copy of this Report and
Order in a report to be sent to Congress
and the Government Accountability
Office pursuant to the Congressional
Review Act, see 5 U.S.C. 801(a)(1)(A).
SUPPLEMENTARY INFORMATION:
List of Subjects in 47 CFR Part 73
Radio, Radio broadcasting.
As stated in the preamble, the Federal
Communications Commission amends
47 CFR part 73 as follows:
I
PART 73—RADIO BROADCAST
SERVICES
1. The authority citation for part 73
continues to read as follows:
I
Authority: 47 U.S.C. 154, 303, 334, 336.
§ 73.202
[Amended]
2. Section 73.202(b), the Table of FM
Allotments under California, is
amended by removing Channel 262A
and by adding Channel 264A at
Susanville.
I
Federal Communications Commission.
John A. Karousos,
Assistant Chief, Audio Division, Media
Bureau.
[FR Doc. E8–3704 Filed 2–26–08; 8:45 am]
BILLING CODE 6712–01–P
E:\FR\FM\27FER1.SGM
27FER1
Agencies
[Federal Register Volume 73, Number 39 (Wednesday, February 27, 2008)]
[Rules and Regulations]
[Pages 10398-10402]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-3490]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
EPA-HQ-OPP-2006-0785; FRL-8349-9]
Pyroxsulam; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
pyroxsulam in or on wheat, forage; wheat, grain; wheat, hay and wheat,
straw. Dow AgroSciences LLC requested this tolerance under the Federal
Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective February 27, 2008. Objections and
requests for hearings must be received on or before April 28, 2008, 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-2006-0785. 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 website 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 Facility
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Erik Kraft, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9358; e-mail address: Kraft.Erik@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 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-2006-0785 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 April 28, 2008.
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-2006-0785, 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.
[[Page 10399]]
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 September 29, 2006 (71 FR 57507) (FRL-
8094-1), 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
6F7101) by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN
46268-1054. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the herbicide pyroxsulam, N-
(5,7-dimethoxy[1,2,4]triazolo[1,5-a]pyrimidin-2-yl)-2-methoxy-4-
(trifluoromethyl)-3-pyridinesulfonamide, in or on wheat, forage at 0.04
parts per million (ppm); wheat, grain at 0.01 ppm; wheat, hay at 0.01
ppm; and wheat, straw at 0.01 ppm. That notice referenced a summary of
the petition prepared by Dow AgroSciences LLC, the registrant, which is
available to the public in the docket, https://www.regulations.gov.
Comments were received on the notice of filing. EPA's response to these
comments is discussed in Unit IV.C.
Based upon review of the field residue data supporting the
petition, EPA has modified the tolerance levels for wheat, forage from
0.04 to 0.06 ppm and for wheat, straw from 0.01 ppm to 0.03 ppm.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....'' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for the petitioned-for tolerances
for residues of pyroxsulam on wheat, forage at 0.06 ppm; wheat, grain
at 0.01 ppm; wheat, hay at 0.01 ppm and wheat, straw at 0.03 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerances 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.
Pyroxsulam has low or minimal acute toxicity via the oral (Acute
Toxicity Category III), dermal and inhalation (Acute Toxicity Category
IV) routes of exposure. It is non-irritating to the eyes and skin. It
is a dermal sensitizer.
Little toxicity was observed in the repeat-dose toxicology studies
via the oral and dermal routes of exposure. No treatment-related
adverse effects were observed in the subchronic studies (mice, rats, or
dogs). There was evidence of increased serum cholesterol levels in the
subchronic exposures, but in light of a 28-day satellite recovery group
in the subchronic rat study, where the cholesterol levels returned to
normal after cessation of treatment, these effects were considered to
be adaptive and non-adverse. Increased liver weights were observed in
several of the subchronic and chronic studies; however, in the absence
of corroborating changes in histopathology, the increased liver weights
were not considered adverse. No adverse effects were observed in the
chronic dog study or chronic/carcinogenicity study in rats. In the
carcinogenicity study in mice, the lowest-observed-adverse-effect-level
(LOAEL) was 1,000 milligrams/kilogram/day (mg/kg/day), based on
increased liver weights with corroborating evidence of increased
incidence of clear cell foci of alteration in hepatocytes in males. The
no-observed-adverse-effect-level (NOAEL) was 100 mg/kg/day.
There was no evidence of maternal or offspring toxicity in the
developmental or 2-generation reproduction studies in rats up to 1,000
mg/kg/day. Considered in conjunction with the range-finding study, the
developmental study in rabbits showed no signs of maternal or offspring
toxicity up to 600 mg/kg/day. None of these studies showed signs of
increased quantitative or qualitative susceptibility. Pyroxsulam is not
mutagenic; it is classified as ``not likely to be carcinogenic to
humans.''
Specific information on the studies received and the nature of the
adverse effects caused by pyroxsulam as well as the NOAEL and the 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 described under ADDRESSES, and is identified as
``Pyroxsulam Human Health Risk Assessment for Proposed Uses on Wheat.''
PC Code: 108702, Petition No: 6F7101, DP Barcode: D335496 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 (UFs)
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 UFs. 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
UFs is not exceeded.
[[Page 10400]]
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 pyroxsulam used for
human risk assessment can be found at https://www.regulations.gov in
document ``Pyroxsulam Human Health Risk Assessment for Proposed Uses on
Wheat.'' PC Code: 108702, Petition No: 6F7101, DP Barcode: D335496 at
page 23 in docket ID number EPA-HQ-OPP-2006-0785.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pyroxsulam, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from pyroxsulam 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
pyroxsulam; 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 United States
Department of Agriculture (USDA) 1994-1996, and 1998; Nationwide
Continuing Surveys of Food Intakes 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. Pyroxsulam was negative for carcinogenicity in feeding
studies in rats and mice and was classified as ``not likely to be a
human carcinogen.'' Therefore, a quantitative exposure assessment to
evaluate cancer risk is unnecessary.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for pyroxsulam 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
pyroxsulam. 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 Pesticide Root Zone Model /Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated environmental concentrations (EECs) of
pyroxsulam for chronic exposures are estimated to be 0.102 parts per
billion (ppb) for surface water and 0.465 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 0.465 ppb was used to
assess the contribution of the estimated drinking water concentration
to the dietary risk assessment.
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).
Pyroxsulam 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. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
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 pyroxsulam and any other
substances and pyroxsulam 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 pyroxsulam 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 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 UFs and/or special
FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There is no evidence of
quantitative and/or qualitative susceptibility and there are no
residual uncertainties with regard to prenatal toxicity following in
utero exposure to rats or rabbits.
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 pyroxsulam is complete.
ii. There is no indication that pyroxsulam is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
iii. There is no evidence that pyroxsulam results in increased
susceptibility to rats or rabbits in utero in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary (food and drinking water) exposure assessment
will not underestimate the potential exposure for infants, children,
and/or women of childbearing age. There is no potential for residential
exposure.
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. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate
[[Page 10401]]
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 UFs is not exceeded.
1. Acute risk. There were no effects observed in oral toxicity
studies including developmental toxicity studies in rats and rabbits
that could be attributable to a single dose (exposure). Therefore,
pyroxsulam is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
pyroxsulam from food and water will utilize <1 % of the cPAD for all
population groups. There are no residential uses for pyroxsulam that
result in chronic residential exposure to pyroxsulam.
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).
Pyroxsulam 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. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Pyroxsulam 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 does not exceed the Agency's LOC
for any population subgroup.
5. Aggregate cancer risk for U.S. population. Pyroxsulam is
classified as ``not likely to be carcinogenic in humans'' based on the
results of a carcinogenicity study in mice and the combined chronic
toxicity and carcinogenicity study in the rat. Therefore, pyroxsulam is
not expected to pose a cancer risk to humans.
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 pyroxsulam residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatography with
positive-ion electrospray ionization (ESI) tandem mass spectrometry
(LC/MS/MS) 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
No Codex, Canadian, or Mexican maximum residue limits (MRLs) have
been established for pyroxsulam. However, tolerances for pyroxsulam on
wheat are pending in Canada and Australia. These Canadian and
Australian tolerances are not expected to result in any harmonization
issues.
C. Response to Comments
Public comments were received from B. Sachau who objected to the
proposed tolerances because of the amounts of pesticides already
consumed and carried by the American population. She further indicated
that testing conducted on animals have absolutely no validity and are
cruel to the test animals. B. Sachau's comments contained no scientific
data or evidence to rebut the Agency's conclusion that there is a
reasonable certainty that no harm will result from aggregate exposure
to pyroxsulam, including all anticipated dietary exposures and all
other exposures for which there is reliable information. EPA has
responded to B. Sachau's generalized comments on numerous previous
occasions. 70 FR 1349, 1354 (January 7, 2005); 69 FR 63083, 63096
(October 29, 2004).
V. Conclusion
Therefore, tolerances are established for residues of pyroxsulam,
N-(5,7-dimethoxy[1,2,4]triazolo[1,5-a]pyrimidin-2-yl)-2-methoxy-4-
(trifluoromethyl)-3-pyridinesulfonamide, in or on wheat, forage at 0.06
ppm; wheat, grain at 0.01 ppm; wheat, hay at 0.01 ppm and wheat, straw
at 0.03 ppm.
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, 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
[[Page 10402]]
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: February 10, 2008.
Debra Edwards,
Director, 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 180.638 is added to read as follows:
Sec. 180.638 Pyroxsulam; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide pyroxsulam, N-(5,7-dimethoxy[1,2,4]triazolo[1,5-a]pyrimidin-
2-yl)-2-methoxy-4-(trifluoromethyl)-3-pyridinesulfonamide in or on the
raw agricultural commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Wheat, forage........................................ 0.06
Wheat, grain......................................... 0.01
Wheat, hay........................................... 0.01
Wheat, straw......................................... 0.03
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E8-3490 Filed 2-26-08; 8:45 am]
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