Rimsulfuron; Pesticide Tolerance, 41909-41913 [E7-14543]
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Authority: 42 U.S.C. 7401 et seq.
PART 81—[AMENDED]
4. In § 81.339, the table entitled
‘‘Pennsylvania—Ozone (8-Hour
Standard)’’ is amended by revising the
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3. The authority citation for Part 81
continues to read as follows:
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entry for ‘‘Altoona, PA: Blair County’’ to
read as follows:
§ 81.339
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Pennsylvania.
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PENNSYLVANIA—OZONE (8-HOUR STANDARD)
Designationa
Category/Classification
Designated area
Date1
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Altoona, PA: Blair County ............................
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Attainment.
08/01/07
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Date1
Type
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a Includes
1 This
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Indian County located in each county or area, except otherwise noted.
date is June 15, 2004, unless otherwise noted.
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[FR Doc. E7–14560 Filed 7–31–07; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0209; FRL–8139–1]
Rimsulfuron; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: This regulation establishes a
tolerance for residues of rimsulfuron in
or on almond, hulls; fruit, citrus group
10; fruit, pome, group 11; fruit, stone,
group 12; grape; nut, tree, group 14; and
pistachio. E.I. duPont de Nemours and
Company, Inc. requested this tolerance
under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996
(FQPA).
DATES: This regulation is effective
August 1, 2007. Objections and requests
for hearings must be received on or
before October 1, 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–2006–0209. 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
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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:
Vickie Walters, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5704; e-mail
address:walters.vickie@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.
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• 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
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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–2006–0209 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 1, 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–2006–0209, 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 Building), 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 July 14,
2006 (71 FR 40100) (FRL–8058–5), 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 5F7019) by E.I.
duPont de Nemours and Company,
Laurel Run Plaza, P.O. Box 80038,
Wilmington, DE 19880–0038. The
petition requested that 40 CFR 180.478
be amended by establishing a tolerance
for residues of the herbicide
rimsulfuron, N-((4,6dimethoxypyrimidin-2yl)aminocarbonyl)-3-(ethylsulfonyl)-2pyridinesulfonamide, in or on almond
hulls, citrus/pome/stone fruit crop
group, grapes, pistachios and tree nut
crop group at 0.01 parts per million
(ppm). That notice included a summary
of the petition prepared by E.I. duPont
de Nemours and Company, Inc, the
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registrant. There were no comments
received in response to the notice of
filing.
Based upon review of the data
supporting the petition, EPA has
determined that the data support a
tolerance of 0.09 ppm for almond, hulls.
Based on Agency procedures
concerning commodity names, the
Agency is correcting the terminology for
pending commodities and crop groups
to read almond, hulls; fruit, citrus,
group 10; fruit, pome, group 11; fruit,
stone, group 12; grape; nut, tree, group
14, and pistachio.
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 rimsulfuron on almond, hulls at 0.09
ppm; fruit, citrus, group 10 at 0.01 ppm;
fruit, pome, group 11 at 0.01 ppm; fruit,
stone, group 12 at 0.01 ppm; grape at
0.01 ppm; nut, tree, group 14 at 0.01
ppm; and pistachio at 0.01 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
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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 rimsulfuron as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at https://
www.regulations.gov. The referenced
document is entitled Rimsulfuron:
Human Health Risk Assessment for
Proposed Uses on Almonds, Citrus
Fruits, Grapes, Pistachio, Pome Fruit,
Stone Fruit, and Tree Nuts and is
available in the docket established by
this action, which is described under
ADDRESSES, and is identified as EPA–
HQ–OPP–2006–0209–0002.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the toxicological level of concern
(LOC) is derived from the highest dose
at which no adverse effects are observed
(the NOAEL) in the toxicology study
identified as appropriate for use in risk
assessment. However, if a NOAEL
cannot be determined, the lowest dose
at which adverse effects of concern are
identified (the LOAEL) is sometimes
used for risk assessment. Uncertainty/
safety factors (UF) are used in
conjunction with the LOC to take into
account uncertainties inherent in the
extrapolation from laboratory animal
data to humans and in the variations in
sensitivity among members of the
human population as well as other
unknowns. Safety is assessed for acute
and chronic risks by comparing
aggregate exposure to the pesticide to
the acute population adjusted dose
(aPAD) and chronic population adjusted
dose (cPAD). The aPAD and cPAD are
calculated by dividing the LOC by all
applicable uncertainty/safety factors.
Short-, intermediate- and long-term
risks are evaluated by comparing
aggregate exposure to the LOC to ensure
that the margin of exposure (MOE)
called for by the product of all
applicable uncertainty/safety factors is
not exceeded.
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk and
estimates risk in terms of the probability
of occurrence of additional adverse
cases. Generally, cancer risks are
considered non-threshold. For more
information on the general principles,
EPA uses in risk characterization and a
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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 rimsulfuron used for
human risk assessment can be found at
www.regulations.gov in document
Rimsulfuron, Human Health Risk
Assessment for Proposed Uses on
Almonds, Citrus Fruits, Grapes,
Pistachio, Pome Fruit, Stone Fruit, and
Tree Nuts at page 21 in Document 0002
in Docket ID EPA–HQ–OPP–2006–0209.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to rimsulfuron, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing rimsulfuron tolerances in 40
CFR 180.478. EPA assessed dietary
exposures from rimsulfuron 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 rimsulfuron; therefore, a quantitative
acute dietary exposure assessment is
unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure
assessment, EPA used the food
consumption data from the USDA 1994–
1996 and 1998 Nationwide Continuing
Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food,
EPA assumed all foods for which there
are tolerances were treated and contain
tolerance-level residues. Anticipated
residues or estimates of percent crop
treated (PCT) were not used.
iii. Cancer. Rimsulfuron is classified
as a ‘‘not likely to be carcinogenic to
humans’’ based on acceptable chronic/
carcinogenic studies in rats and mice.
Therefore, a cancer exposure assessment
was not performed.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring data to complete a
comprehensive dietary exposure
analysis and risk assessment for
rimsulfuron 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
rimsulfuron. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
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can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the First Index Reservoir
Screening Tool (FIRST) and Screening
Concentrations in Groundwater (SCIGROW) models, the estimated drinking
water concentrations (EDWCs) of
rimsulfuron for acute exposures are
estimated to be 5.596 parts per billion
(ppb) for surface water and 0.016 ppb
for ground water. The EDWCs for
chronic exposures are estimated to be
0.120 ppb for surface water and 0.016
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 0.120 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).
Rimsulfuron 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 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
rimsulfuron and any other substances
and rimsulfuron 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 rimsulfruon 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
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and postnatal toxicity and the
completeness of the data base on
toxicity and exposure unless EPA
determines based on reliable data that a
different margin of safety will be safe for
infants and children. This additional
margin of safety is commonly referred to
as the FQPA safety factor. In applying
this provision, EPA either retains the
default value of 10X when reliable data
do not support the choice of a different
factor, or, if reliable data are available,
EPA uses a different additional FQPA
safety factor value based on the use of
traditional uncertainty/safety factors
and/or special FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity.
In the prenatal developmental toxicity
study in rats, no developmental toxicity
was seen at the highest dose tested. In
the prenatal developmental toxicity
study in rabbits, and in the 2–generation
reproduction study in rats,
developmental/offspring toxicity were
seen in the presence of maternal/
systemic toxicity. Consequently, there is
no evidence (quantitative or qualitative)
of increased susceptibility following
prenatal and postnatal exposures.
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
rimsulfuron is complete.
ii. There is no indication that
rimsulfuron is a neurotoxic chemical
and there is no need for a
developmental neurotoxicity study or
additional uncertainty factors to account
for neurotoxicity.
iii. There is no evidence that
rimsulfuron results in increased
susceptibility in in utero rats or rabbits
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 exposure assessments
were performed based on 100% CT and
tolerance-level residues. Conservative
ground water and surface water
modeling estimates were used. These
assessments will not underestimate the
exposure and risks posed by
rimsulfuron.
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 uncertainty/safety factors.
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For linear cancer risks, EPA calculates
the probability of additional cancer
cases given aggregate exposure. Short-,
intermediate- and long-term risks are
evaluated by comparing aggregate
exposure to the LOC to ensure that the
MOE called for by the product of all
applicable uncertainty/safety factors is
not exceeded.
1. Acute risk. The existing data
showed no indication that rimsulfuron
could cause adverse effects in the U.S.
population or any population subgroups
based on a single dose. Therefore, there
is not a concern for acute dietary
exposure to the general population or
any population subgroup.
2. Chronic risk. Using the exposure
assumptions described in Unit III.C.ii.
for chronic exposure, EPA has
concluded that exposure to rimsulfuron
from food and water will utilize <1% of
the cPAD for the U.S. population, and
for each of the population subgroups
including the most highly exposed
population subgroup (children 1-2 years
old). There are no residential uses for
rimsulfuron that result in chronic
residential exposure to rimsulfuron.
Based on the use pattern, chronic
residential exposure to residues of
rimsulfuron is not expected.
3. Short-term risk. Short-term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Rimsulfuron 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).
Rimsulfuron 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 level of concern.
5. Aggregate cancer risk for U.S.
population. Rimsulfuron is classified as
a ‘‘not likely human carcinogen.’’
Therefore, EPA does not expect that
rimsulfuron will 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 rimsulfuron
residues.
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IV. Other Considerations
A. Analytical Enforcement Methodology
Currently, a high pressure liquid
chromatography method exists for
enforcement of tolerances for residues of
rimsulfuron in or on corn, potato, and
tomato commodities. Two LC/MS/MS
methods have been proposed for
enforcement of tolerances on pending
crops and crop grouping. Because the
extraction procedures do not differ
significantly from the extraction
procedures of the existing enforcement
method, Agency method validation will
not be required.
Adequate enforcement methodology
(high pressure liquid chromatography
MS/MS detection) 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
There are no Codex, Canadian, or
Mexican MRLs established for residues
of rimsulfuron in or on almond, hull;
citrus fruit; pome fruit; stone fruit; tree
nuts; grape; or pistachio.
V. Conclusion
Therefore, the tolerance is established
for residues of rimsulfuron, N-((4,6dimethoxypyrimidin-2yl)aminocarbonyl)-3-(ethylsulfonyl)-2pyridinesulfonamide in or on almond,
hulls at 0.09 ppm; fruit, citrus, group 10
at 0.01 ppm; fruit, pome, group 11 at
0.01 ppm; fruit, stone, group 12 at 0.01
ppm; grape at 0.01 ppm; nut, tree, group
14 at 0.01 ppm; and pistachio at 0.01
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
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information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply
to this rule. In addition, This rule does
not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act of 1995 (UMRA)
(Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
E:\FR\FM\01AUR1.SGM
01AUR1
Federal Register / Vol. 72, No. 147 / Wednesday, August 1, 2007 / Rules and Regulations
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 16, 2007.
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.
Section 180.478 is amended by
alphabetically adding the following
commodities to the table in paragraph
(a) to read as follows:
I
§ 180.478 Rimsulfuron; tolerances for
residues.
(a) * * *
Parts per
million
Commodity
Almond, hulls ............................
*
*
*
*
Fruit, citrus, group 10 ...............
Fruit, pome, group 11 ...............
Fruit, stone, group 12 ...............
Grape ........................................
Nut, tree, group 14 ...................
Pistachio ...................................
*
*
*
*
*
*
*
*
0.09
*
0.01
0.01
0.01
0.01
0.01
0.01
*
*
[FR Doc. E7–14543 Filed 7–31–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2004–0154; FRL–8139–5]
Bromoxynil, Diclofop-methyl, Dicofol,
Diquat, Etridiazole, et al.; Tolerance
Actions
Environmental Protection
Agency (EPA).
ACTION: Final rule.
sroberts on PROD1PC70 with RULES
AGENCY:
SUMMARY: EPA is revoking certain
tolerances for the herbicides
bromoxynil, diclofop-methyl, and
paraquat; the fungicide etridiazole
(terrazole); the miticides dicofol and
VerDate Aug<31>2005
15:44 Jul 31, 2007
Jkt 211001
propargite; and the plant growth
regulator and herbicide diquat. Also,
EPA is removing duplicate tolerances
for the herbicides bromoxynil, paraquat,
and picloram; the fumigant phosphine;
the miticide dicofol; and the
insecticides fenbutatin-oxide and
hydramethylnon. In addition, EPA is
modifying certain tolerances for the
insecticide hydramethylnon; the
herbicides bromoxynil, paraquat, and
triclopyr; the fungicides etridiazole,
folpet, and triphenyltin hydroxide
(TPTH); the miticides dicofol and
propargite; and the plant growth
regulator and herbicide diquat.
Moreover, EPA is establishing new
tolerances for the herbicides
bromoxynil, paraquat, and picloram; the
fungicides etridiazole, folpet, and
TPTH; the miticides dicofol and
propargite; the insecticide fenbutatinoxide; and the plant growth regulator
and herbicide diquat. The regulatory
actions in this document are follow-up
to the Agency’s reregistration program
under the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA), and reassessment program
under the Federal Food, Drug, and
Cosmetic Act (FFDCA) section 408(q).
DATES: This regulation is effective
October 30, 2007. Objections and
requests for hearings must be received
on or before October 1, 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–2004–0154. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
web site to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
index, some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400,
One Potomac Yard (South Building),
PO 00000
Frm 00029
Fmt 4700
Sfmt 4700
41913
2777 S. Crystal Drive, Arlington, VA.
The Docket Facility is open from 8:30
a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT:
Joseph Nevola, Special Review and
Reregistration Division (7508P), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001;
telephone number: (703) 308-8037; email address: nevola.joseph@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS 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 provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at 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 40 CFR part 180
through the Government Printing
E:\FR\FM\01AUR1.SGM
01AUR1
Agencies
[Federal Register Volume 72, Number 147 (Wednesday, August 1, 2007)]
[Rules and Regulations]
[Pages 41909-41913]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-14543]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0209; FRL-8139-1]
Rimsulfuron; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
rimsulfuron in or on almond, hulls; fruit, citrus group 10; fruit,
pome, group 11; fruit, stone, group 12; grape; nut, tree, group 14; and
pistachio. E.I. duPont de Nemours and Company, Inc. requested this
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective August 1, 2007. Objections and
requests for hearings must be received on or before October 1, 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-2006-0209. To access the
electronic docket, go to https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at https://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Vickie Walters, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5704; e-mail address:walters.vickie@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
[[Page 41910]]
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-2006-0209 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 1, 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-2006-0209, 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
Building), 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 July 14, 2006 (71 FR 40100) (FRL-8058-
5), 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
5F7019) by E.I. duPont de Nemours and Company, Laurel Run Plaza, P.O.
Box 80038, Wilmington, DE 19880-0038. The petition requested that 40
CFR 180.478 be amended by establishing a tolerance for residues of the
herbicide rimsulfuron, N-((4,6-dimethoxypyrimidin-2-yl)aminocarbonyl)-
3-(ethylsulfonyl)-2-pyridinesulfonamide, in or on almond hulls, citrus/
pome/stone fruit crop group, grapes, pistachios and tree nut crop group
at 0.01 parts per million (ppm). That notice included a summary of the
petition prepared by E.I. duPont de Nemours and Company, Inc, the
registrant. There were no comments received in response to the notice
of filing.
Based upon review of the data supporting the petition, EPA has
determined that the data support a tolerance of 0.09 ppm for almond,
hulls.
Based on Agency procedures concerning commodity names, the Agency
is correcting the terminology for pending commodities and crop groups
to read almond, hulls; fruit, citrus, group 10; fruit, pome, group 11;
fruit, stone, group 12; grape; nut, tree, group 14, and pistachio.
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 rimsulfuron on almond, hulls at 0.09 ppm; fruit,
citrus, group 10 at 0.01 ppm; fruit, pome, group 11 at 0.01 ppm; fruit,
stone, group 12 at 0.01 ppm; grape at 0.01 ppm; nut, tree, group 14 at
0.01 ppm; and pistachio at 0.01 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 rimsulfuron as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at https://
www.regulations.gov. The referenced document is entitled Rimsulfuron:
Human Health Risk Assessment for Proposed Uses on Almonds, Citrus
Fruits, Grapes, Pistachio, Pome Fruit, Stone Fruit, and Tree Nuts and
is available in the docket established by this action, which is
described under ADDRESSES, and is identified as EPA-HQ-OPP-2006-0209-
0002.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UF) are
used in conjunction with the LOC to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (aPAD) and chronic population adjusted dose
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all
applicable uncertainty/safety factors. Short-, intermediate- and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the margin of exposure (MOE) called for by the product of
all applicable uncertainty/safety factors is not exceeded.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles, EPA uses in risk
characterization and a
[[Page 41911]]
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 rimsulfuron used for
human risk assessment can be found at www.regulations.gov in document
Rimsulfuron, Human Health Risk Assessment for Proposed Uses on Almonds,
Citrus Fruits, Grapes, Pistachio, Pome Fruit, Stone Fruit, and Tree
Nuts at page 21 in Document 0002 in Docket ID EPA-HQ-OPP-2006-0209.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to rimsulfuron, EPA considered exposure under the petitioned-
for tolerances as well as all existing rimsulfuron tolerances in 40 CFR
180.478. EPA assessed dietary exposures from rimsulfuron 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 rimsulfuron; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food, EPA assumed all foods for which
there are tolerances were treated and contain tolerance-level residues.
Anticipated residues or estimates of percent crop treated (PCT) were
not used.
iii. Cancer. Rimsulfuron is classified as a ``not likely to be
carcinogenic to humans'' based on acceptable chronic/carcinogenic
studies in rats and mice. Therefore, a cancer exposure assessment was
not performed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for rimsulfuron 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
rimsulfuron. 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 First Index Reservoir Screening Tool (FIRST) and
Screening Concentrations in Groundwater (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of rimsulfuron for
acute exposures are estimated to be 5.596 parts per billion (ppb) for
surface water and 0.016 ppb for ground water. The EDWCs for chronic
exposures are estimated to be 0.120 ppb for surface water and 0.016 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 0.120 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).
Rimsulfuron 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 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 rimsulfuron and any other
substances and rimsulfuron 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 rimsulfruon has a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's website at https://www.epa.gov/pesticides/
cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (10X) tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA safety factor. In applying
this provision, EPA either retains the default value of 10X when
reliable data do not support the choice of a different factor, or, if
reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional uncertainty/safety
factors and/or special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. In the prenatal
developmental toxicity study in rats, no developmental toxicity was
seen at the highest dose tested. In the prenatal developmental toxicity
study in rabbits, and in the 2-generation reproduction study in rats,
developmental/offspring toxicity were seen in the presence of maternal/
systemic toxicity. Consequently, there is no evidence (quantitative or
qualitative) of increased susceptibility following prenatal and
postnatal exposures.
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 rimsulfuron is complete.
ii. There is no indication that rimsulfuron is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional uncertainty factors to account for neurotoxicity.
iii. There is no evidence that rimsulfuron results in increased
susceptibility in in utero rats or rabbits 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 exposure assessments were performed based
on 100% CT and tolerance-level residues. Conservative ground water and
surface water modeling estimates were used. These assessments will not
underestimate the exposure and risks posed by rimsulfuron.
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 uncertainty/
safety factors.
[[Page 41912]]
For linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-, intermediate- and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the MOE called for by the product of all applicable
uncertainty/safety factors is not exceeded.
1. Acute risk. The existing data showed no indication that
rimsulfuron could cause adverse effects in the U.S. population or any
population subgroups based on a single dose. Therefore, there is not a
concern for acute dietary exposure to the general population or any
population subgroup.
2. Chronic risk. Using the exposure assumptions described in Unit
III.C.ii. for chronic exposure, EPA has concluded that exposure to
rimsulfuron from food and water will utilize <1% of the cPAD for the
U.S. population, and for each of the population subgroups including the
most highly exposed population subgroup (children 1-2 years old). There
are no residential uses for rimsulfuron that result in chronic
residential exposure to rimsulfuron. Based on the use pattern, chronic
residential exposure to residues of rimsulfuron is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Rimsulfuron 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).
Rimsulfuron 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
level of concern.
5. Aggregate cancer risk for U.S. population. Rimsulfuron is
classified as a ``not likely human carcinogen.'' Therefore, EPA does
not expect that rimsulfuron will 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 rimsulfuron residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Currently, a high pressure liquid chromatography method exists for
enforcement of tolerances for residues of rimsulfuron in or on corn,
potato, and tomato commodities. Two LC/MS/MS methods have been proposed
for enforcement of tolerances on pending crops and crop grouping.
Because the extraction procedures do not differ significantly from the
extraction procedures of the existing enforcement method, Agency method
validation will not be required.
Adequate enforcement methodology (high pressure liquid
chromatography MS/MS detection) 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
There are no Codex, Canadian, or Mexican MRLs established for
residues of rimsulfuron in or on almond, hull; citrus fruit; pome
fruit; stone fruit; tree nuts; grape; or pistachio.
V. Conclusion
Therefore, the tolerance is established for residues of
rimsulfuron, N-((4,6-dimethoxypyrimidin-2-yl)aminocarbonyl)-3-
(ethylsulfonyl)-2-pyridinesulfonamide in or on almond, hulls at 0.09
ppm; fruit, citrus, group 10 at 0.01 ppm; fruit, pome, group 11 at 0.01
ppm; fruit, stone, group 12 at 0.01 ppm; grape at 0.01 ppm; nut, tree,
group 14 at 0.01 ppm; and pistachio at 0.01 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 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
[[Page 41913]]
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 16, 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
Section 180.478 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:
Sec. 180.478 Rimsulfuron; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond, hulls.............................................. 0.09
* * * * *
Fruit, citrus, group 10.................................... 0.01
Fruit, pome, group 11...................................... 0.01
Fruit, stone, group 12..................................... 0.01
Grape...................................................... 0.01
Nut, tree, group 14........................................ 0.01
Pistachio.................................................. 0.01
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E7-14543 Filed 7-31-07; 8:45 am]
BILLING CODE 6560-50-S