Thifensulfuron Methyl; Pesticide Tolerance, 13179-13184 [E7-4762]
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does not have any ‘‘tribal implications’’
as described in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
Executive order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
X. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of this final
rule in the Federal Register. This final
rule is not a ‘‘major rule’’ as defined by
5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
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Therefore, 40 CFR chapter I is
amended as follows:
I
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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 180.1150 is revised to read
as follows:
I
§ 180.1150 6-Benzyladenine; exemption
from the requirement of a tolerance.
The biochemical plant regulator 6benzyladenine (6–BA) is exempt from
the requirement of a tolerance in or on
apple and pear when applied at a rate
of ≤182 grams of active ingredient per
acre per season, and in or on pistachio
when applied at a rate of ≤60 grams of
active ingredient per acre per season.
[FR Doc. 07–1386 Filed 3–20–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0208; FRL–8117–1]
Thifensulfuron Methyl; Pesticide
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of thifensulfuron
methyl in or on rice, grain; rice, straw;
sorghum, grain, forage; sorghum, grain,
grain; and sorghum, grain, stover. E. I.
DuPont de Nemours and Company
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective
March 21, 2007. Objections and requests
for hearings must be received on or
before May 21, 2007, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0208. 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
ADDRESSES:
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: February 25, 2007.
Janet L. Andersen,
Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
PART 180—[AMENDED]
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13179
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:
• 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
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the person listed under FOR FURTHER
INFORMATION CONTACT.
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B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s pilot e-CFR site at https://
www.gpoaccess.gov/ecfr. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines at https://www.epa.gpo/
opptsfrs/home/guidelin.htm.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of the FFDCA, as
amended by the FQPA, any person may
file an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2006–0208 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before May 21, 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 your
copies, identified by docket ID number
EPA–HQ–OPP–2006–0208, by one of
the following methods:
• Federal eRulemaking Porta: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S.
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Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket telephone number is (703) 305–
5805.
II. Background and Statutory Findings
In the Federal Register of July 14,
2006 (71 FR 40103) (FRL–8058–8), 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 4F6889) by E.I.
Dupont de Nemours and Company, Inc.,
Laurel Run Plaza, P. O. Box 80038,
Wilmington, DE 19880–0038. The
petition requested that 40 CFR
180.439(a) be amended by establishing
tolerances for residues of the herbicide
thifensulfuron methyl, (methyl-3-[[[[(4methoxy-6-methyl-1,3,5,-triazin-2yl)amino]carbonyl]amino]sulfonyl]-2thiophenecarboxylate, in or on grain
sorghum (forage, grain, stover) and rice
(grain and straw) at 0.05 parts per
million (ppm). That notice referenced a
summary of the petition prepared by E.I.
DuPont de Nemours and Company, Inc,
the registrant, that has been included in
the public docket. A comment was
received in response to the notice of
filing from B. Sachau, 15 Elm Street,
Florham Park, NJ 07932. The comment
and EPA’s response is discussed in Unit
IV.C.4.
During the course of the review the
Agency decided to update the
commodity listings to agree with current
terminology. The commodities are listed
as rice, grain; rice, straw; sorghum,
grain, forage; sorghum, grain, grain; and
sorghum, grain, stover.
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
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aggregate exposure to the pesticide
chemical residue....’’
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. For
further discussion of the regulatory
requirements of section 408 of the
FFDCA and a complete description of
the risk assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and
Determination of Safety
Consistent with section 408(b)(2)(D)
of FFDCA, EPA has reviewed the
available scientific data and other
relevant information in support of this
action. EPA has sufficient data to assess
the hazards of and to make a
determination on aggregate exposure,
consistent with section 408(b)(2) of
FFDCA, for tolerances for residues of
thifensulfuron methyl, (methyl-3-[[[[(4methoxy-6-methyl-1,3,5,-triazin-2yl)amino]carbonyl]amino]sulfonyl]-2thiophenecarboxylate, on rice, grain at
0.05 part per million (ppm); rice, straw
at 0.05 ppm; sorghum, grain, forage at
0.05 ppm; sorghum, grain, grain at 0.05
ppm and sorghum, grain, stover at 0.05
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. Specific
information on the studies received and
the nature of the toxic effects caused by
thifensulfuron methyl as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found in Unit III.A. of the final
rule published in the Federal Register
of September 17, 2004 (69 FR
55975)(FRL–7679–).
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the dose at which no adverse
effects are observed (the NOAEL) from
the toxicology study identified as
appropriate for use in risk assessment is
used to estimate the toxicological level
of concern (LOC). However, the lowest
dose at which adverse effects of concern
are identified (the LOAEL) is sometimes
used for risk assessment if no NOAEL
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was achieved in the toxicology study
selected. An uncertainty factor (UF) is
applied to reflect uncertainties inherent
in the extrapolation from laboratory
animal data to humans and in the
variations in sensitivity among members
of the human population as well as
other unknowns.
The linear default risk methodology
(Q*) is the primary method currently
used by the Agency to quantify nonthreshold hazards such as cancer. The
Q* approach assumes that any amount
of exposure will lead to some degree of
cancer risk, estimates risk in terms of
the probability of occurrence of
additional cancer cases. More
13181
information can be found on the general
principles EPA uses in risk
characterization at https://www.epa.gov/
pesticides/health/human.htm.
A summary of the toxicological
endpoints for thifensulfuron
miethylused for human risk assessment
is shown in Table 1 of this unit:
TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR THIFENSULFURON METHYL FOR USE IN HUMAN RISK
ASSESSMENT
Dose Used in Risk Assessment, Interspecies and
Intraspecies and any Traditional UF
Special FQPA SF and
Level of Concern for Risk
Assessment
Acute dietary (Females 13–50
years of age)
NOAEL = 159 milligrams/kilograms/day (mg/kg/day).
UF = 100 ...............................
Acute RfD = 1.59 mg/kg/day
Special FQPA SF = 1x ......
acute Population adjusted
dose (aPAD) = acute
Referenced dose (RfD).
Special FQPA SF = 1.59
mg/kg/day.
Developmental oral toxicity study in rats.
LOAEL = 725 mg/kg/day based on decreased
mean body weight and increased incidence
of small renal papillae
Chronic dietary (All populations)
NOAEL = 7 mg/kg/day ..........
UF = 100 Chronic RfD = 0.07
mg/kg/day.
Special FQPA SF = 1x
chronic Population adjusted dose (cPAD) =
chronic RfD.
Special FQPA SF = 0.07
mg/kg/day.
90 Day Oral Toxicity in Rat
LOAEL = 177 mg/kg/day based on decreased
body weight and body weight gain in both
males and females, and increased spleen
weights in males
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Exposure/Scenario
1. Dietary exposure from food and
feed uses. Tolerances have been
established (40 CFR 180.439) for the
residues of thifensulfuron methyl, in or
on a variety of raw agricultural
commodities. No tolerances for meat,
milk, poultry and egg are established.
Risk assessments were conducted by
EPA to assess dietary exposures from
thifensulfuron methyl 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.
The acute dietary analysis was
performed for the population subgroup
Females 13–49 only. This subgroup is
the only one for which an acute dietary
endpoint was identified. In conducting
the acute dietary exposure assessment
EPA used the Dietary Exposure
Evaluation Model software with the
Food Commodity Intakes Database
(DEEM-FCIDTM), which incorporates
food consumption data as reported by
respondents in the USDA 1994–1996
and 1998 Nationwide Continuing
Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to
the chemical for each commodity. The
following assumptions were made for
the acute exposure assessments:
Tolerance level residues and 100% crop
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treated (PCT). No empirical processing
factors were used. A DEEM (Version
7.81) default processing factor was used
for corn syrup. Anticipated residues or
estimates of PCT were not used.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the DEEM-FCIDTM, which
incorporates food consumption data as
reported by respondents in the USDA
1994–1996 and 1998 Nationwide CSFII,
and accumulated exposure to the
chemical for each commodity. The
following assumptions were made for
the chronic exposure assessments:
Tolerance level residues and 100 PCT.
No empirical processing factors were
used. A DEEM (Version 7.81) default
processing factor was used for corn
syrup. Anticipated residues or estimates
of PCT were not used.
iii. Cancer. Thifensulfuron methyl is
classified as ‘‘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 exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for
thifensulfuron methyl in drinking water.
Because the Agency does not have
comprehensive monitoring data,
drinking water concentration estimates
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Study and Toxicological Effects
are made by reliance on simulation or
modeling taking into account data on
the physical characteristics of
thifensulfuron methyl. Further
information regarding EPA drinking
water models used in pesticide
exposure assessment can be found at
https://www.epa.gov/oppefed/models/
water/index.htm.
Based on the FQPA Index Reservior
Screening Tool (FIRST) and Screening
concentration in ground water (SCIGROW) models, the estimated drinking
water concentrations (EDWCs) of
thifensulfuron methyl for acute
exposures are estimated to be 3.9 parts
per billion (ppb) for surface water and
0.27 ppb for ground water. The EDWCs
for chronic exposures are estimated to
be 1.5 ppb for surface water and 0.27
ppb for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model (DEEMFCID). For the acute dietary risk
assessment the annual average
concentration in surface water of 3.9
ppb was used. For the chronic dietary
risk assessment the annual average
concentration in surface water of 1.5
ppb was used.
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,
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indoor pest control, termiticides, and
flea and tick control on pets).
Thifensulfuron methyl 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
thifensulfuron methyl and any other
substances and thifensulfuron methyl
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 thifensulfuron methyl has
a common mechanism of toxicity with
other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see the policy statements
released by EPA’s Office of Pesticide
Programs concerning common
mechanism determinations and
procedures for cumulating effects from
substances found to have a common
mechanism on EPA’s website at 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 tenfold margin of safety for
infants and children in the case of
threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the data base on
toxicity and exposure unless EPA
determines based on reliable data that a
different margin of safety will be safe for
infants and children. Margins of safety
are incorporated into EPA risk
assessments either directly through use
of a MOE analysis or through using
uncertainty (safety) factors in
calculating a dose level that poses no
appreciable risk to humans. In applying
this provision, EPA either retains the
default value of 10X when reliable data
do not support the choice of a different
factor, or, if reliable data are available,
EPA uses a different additional safety
factor value based on the use of
traditional uncertainty factors and/or
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special FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity.
There is no evidence in the
developmental study in rabbits and two
generation reproduction study in rats of
increased quantitative or qualitative
susceptibility of the offspring after in
utero or post-natal exposure to
thifensulfuron methyl. The acceptable
developmental toxicity in rats revealed
increased quantitative susceptibility of
the fetus after in utero exposure.
Nonetheless there are no residual
uncertainties for pre and post natal
toxicity because the fetal toxicity seen
in the developmental rat study has been
well-characterized and the NOAEL
relied upon to calculate the chronic RfD
is more than an order of magnitude
lower than the NOAEL from the
developmental rat study.
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
thifensulfuron methyl is complete.
Although the impact of thifensulfuron
methyl on the nervous system has not
been specifically evaluated in
neurotoxicity studies, available
toxicology studies in four species (rat,
mouse, dog, and rabbit) do not indicate
a neurotoxic mode of action for this
chemical and there are no concerns
from potential developmental
neurotoxicity. Therefore, a
developmental neurotoxicity is not
required for thifensulfuron methyl.
ii. As discussed in above Unit III.D.2.,
there are no concerns or residual
uncertainties for pre and/post natal
toxicity.
iii. There are no residual uncertainties
identified in the exposure databases.
The dietary food assessments were
performed based on 100 PCT and
tolerance level residues. Conservative
ground water and surface water
modeling estimates were used in the
risk assessments. These assessments
will not underestimate the exposure and
risks posed by thifensulfuron methyl.
E. Aggregate Risks and Determination of
Safety
1. Acute risk. The acute aggregate risk
assessment is provided for females 13–
50 years old only. The existing data
showed no indication that
thifensulfuron methyl could cause
adverse effects in the general population
based upon a single dose. Thus there is
no concern for acute dietary exposure to
the general population. Using the
exposure assumptions discussed in Unit
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III.C. for acute exposure, the acute
dietary exposure from food and water to
thifensulfuron methyl will occupy
0.03% of the aPAD at the 95%
percentile of exposure for females 13
years and older. EPA does not expect
the aggregate exposure to exceed 100%
of the aPAD,
2. Chronic risk. Using the exposure
assumptions described in Unit III.C. for
chronic exposure, EPA has concluded
that exposure to thifensulfuron methyl
from food and water will utilize <1 %
of the cPAD for the U.S. population,
<1% of the cPAD for all infants less than
1 year old, and <1% of the cPAD for
children 3-5 years old. There are no
residential uses for thifensulfuron
methyl that result in chronic residential
exposure to thifensulfuron methyl. EPA
does not expect the aggregate exposure
to exceed 100% of the cPAD.
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).
Thifensulfuron methyl 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.
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).
Thifensulfuron methyl 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.
5. Aggregate cancer risk for U.S.
population. Thifensulfuron methyl is
classified ‘‘as not likely to be a human
carcinogen.’’ Therefore, EPA does not
expect thifensulfuron methyl 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 and to infants and children
from aggregate exposure to
thifensulfuron methyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(including high performance liquid
chromatography (HPLC) with photoconductivity detection and liquid
chromatography with detection via
electrospray mass spectroscopy) are
available to enforce the tolerance
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expression. These methods 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.
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B. International Residue Limits
There are no established or proposed
Codex Maximum Residue Levels (MRLs)
for residues of thifensulfuron methyl.
Canadian and Mexican MRLs have been
established for residues of
thifensulfuron methyl for several crops.
However no MRLs have been
established for sorghum, grain, forage;
sorghum, grain, grain; sorghum, grain,
stover; rice, grain; or rice, straw.
C. Response to Comments
A comment for thifensulfuron methyl
was received from Ms. B. Sachau, 15
Elm Street, Florham Park, NJ 07932. Ms.
Sachau stated that any residue of this
product in food was dangerous and
questioned the availability of testing for
this chemical in combination with
thousands of other chemicals used in
America today.
EPA generally does not require
companies to conduct studies to
evaluate the potential for synergistic
effects from exposure to combinations of
chemical exposure. Such testing rarely
shows any kind of interaction
(synergistic or antagonistic), and there
are a nearly infinite number of possible
combinations, making the cost of
indiscriminate testing prohibitively
high.
Because synergism does not occur
often, the scientific community believes
that exposure to multiple chemicals is
best assessed by looking at the effects
caused by each chemical individually.
The only exception to that is when
people are exposed to multiple
chemicals that share a common
mechanism of toxicity. Then the effects
of exposure to multiple chemicals are
expected to be additive, adjusted for the
relative toxicity of different chemicals.
This is done through Agency
cumulative risk assessments which are
discussed in Unit III.C.4. of this
document. Ms. Sachau did not submit
any scientific evidence that supported a
revision of Agency conclusions.
Based on the Agency risk assessments
discussed in Unit III.E. of this document
the Agency has concluded that there is
a reasonable certainty that no harm will
result to the general population and to
infants and children from aggregate
exposure to thifensulfuron residues. Ms.
Sachau did not submit any scientific
evidence that supported a revision of
Agency conclusions.
VerDate Aug<31>2005
15:10 Mar 20, 2007
Jkt 211001
V. Conclusion
Therefore, the tolerances are
established for residues of
thifensulfuron methyl, (methyl-3-[[[[(4methoxy-6-methyl-1,3,5,-triazin-2yl)amino]carbonyl]amino]sulfonyl]-2thiophenecarboxylate,on rice, grain at
0.05 part per million (ppm); rice, straw
at 0.05 ppm; sorghum, grain, forage at
0.05 ppm; sorghum, grain, grain at 0.05
ppm and sorghum, grain, stover at 0.05
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 due to its lack of
significance, this rule is not subject to
Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any
enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104–4). Nor does it require any
special considerations under Executive
Order 12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994); or OMB review or any Agency
action under Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are
established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the
Agency has determined that this action
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Fmt 4700
Sfmt 4700
13183
will not have a substantial direct effect
on States, on the relationship between
the national government and the States,
or on the distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism(64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this rule
does not have any ‘‘tribal implications’’
as described in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
Executive order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
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13184
Federal Register / Vol. 72, No. 54 / Wednesday, March 21, 2007 / Rules and Regulations
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of this final
rule in the Federal Register. This final
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: March 5, 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.
2. Section 180.439 is amended by
alphabetically adding commodities to
the table in paragraph (a) to read as
follows:
I
§ 180.439 Thifensulfuron methyl;
Tolerances for residues.
(a) * * *
Commodity
Parts per million
*
*
*
Rice, grain ......................
Rice, straw ......................
Sorghum, grain, forage. ..
Sorghum, grain, grain .....
Sorghum, grain, stover ...
*
*
*
*
*
*
*
*
*
0.05
0.05
0.05
0.05
0.05
*
*
*
[FR Doc. E7–4762 Filed 3–20–07; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF THE INTERIOR
Office of the Secretary
43 CFR Part 10
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RIN 1024–AC84
Native American Graves Protection
and Repatriation Act Regulations—
Future Applicability
Department of the Interior.
Final rule.
AGENCY:
ACTION:
VerDate Aug<31>2005
15:10 Mar 20, 2007
Jkt 211001
SUMMARY: This final rule relates to one
section of the regulations implementing
the Native American Graves Protection
and Repatriation Act of 1990 (‘‘the
Act’’). This section outlines procedures
for the future applicability of the Act to
museums and Federal agencies.
DATES: Effective Date: This rule is
effective April 20, 2007.
ADDRESSES: Mail inquires to Dr. Sherry
Hutt, Manager, National NAGPRA
Program, National Park Service, 1849 C
Street, NW. (2253), Washington, DC
20240–0001. Telephone: (202) 354–
1479. Fax: (202) 371–5197.
FOR FURTHER INFORMATION CONTACT: Jerry
Case, Regulations Program Manager,
National Park Service, 1849 C Street,
NW., Room 7241, Washington, DC
20240. Phone: (202) 208–4206. E-mail:
jerry_case@nps.gov.
SUPPLEMENTARY INFORMATION:
Background
On November 16, 1990, the Native
American Graves Protection and
Repatriation Act (25 U.S.C. 3001 et seq.)
was signed into law. The Act addresses
the rights of lineal descendants, Indian
tribes, and Native Hawaiian
organizations to certain Native
American human remains, funerary
objects, sacred objects, and objects of
cultural patrimony with which they are
affiliated. Section 13 of the Act requires
the Secretary of the Interior to
promulgate regulations to carry out
provisions of the Act.
Final regulations implementing the
Act were published in the Federal
Register on December 4, 1995, (60 FR
62138), and codified as 43 CFR part 10.
Five sections were reserved in the final
regulations with the intention that they
would be published in the future. One
of the five reserved sections, designated
§ 10.13, was set aside to clarify the
applicability of the Act to museums and
Federal agencies following the statutory
deadlines for completion of summaries
and inventories.
The Act requires museums and
Federal agencies, as defined by the Act,
to provide summaries of their
collections to any Indian tribe or Native
Hawaiian organization that is, or is
likely to be, culturally affiliated with the
collection by November 16, 1993. The
Act also requires museums and Federal
agencies to prepare, in consultation
with culturally affiliated Indian tribes
and Native Hawaiian organizations,
inventories of human remains and
associated funerary objects by
November 16, 1995. The Act also
requires museums and Federal agencies
to submit notices for publication in the
Federal Register prior to repatriation.
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Fmt 4700
Sfmt 4700
Four types of situations are
anticipated where a museum or Federal
agency may fall under the jurisdiction of
the Act after the statutory deadlines: (1)
The museum or Federal agency receives
new collections; (2) a previously
unrecognized Indian group is
recognized as an Indian tribe; (3) an
institution in possession or control of
Native American human remains,
funerary objects, sacred objects, or
objects of cultural patrimony receives
Federal funds for the first time; and (4)
the museum or Federal agency revises a
decision previously published in the
Federal Register. In each case, this final
rule establishes deadlines for the
required summaries, inventories, or
notices.
This final rule provides museums and
Federal agencies with a uniform set of
procedures to ensure that lineal
descendants, Indian tribes, and Native
Hawaiian organizations know of the
existence and location of cultural items
with which they are affiliated and
which they may be able to repatriate.
These procedures facilitate the existing
repatriation provisions of the Act, and
are essential to the continued
effectiveness of the Act.
Preparation of the Rulemaking
The proposed rule to clarify future
applicability of the Act was published
in the Federal Register on October 20,
2004 (69 FR 61613). Public comment
was invited for a 90-day period, ending
on January 18, 2005. The proposed rule
was also posted on the National
NAGPRA Program Web site. The Native
American Graves Protection and
Repatriation Review Committee
commented on the proposed rule at its
November 2, 2004 teleconference. In
addition, ten written comments were
received during the comment period,
representing three museums; three
national scientific or museum
organizations; two Federal agencies; one
national Native American organization;
and one non-Federally recognized
Native American group. Comments
addressed all sections of the proposed
rule. All comments were fully
considered when revising the proposed
rule as a final rulemaking.
Changes in Response to Public
Comment
Subsection 10.13(a)
This subsection outlines the purpose
of the proposed rule to clarify the
applicability of the Act to museums and
Federal agencies after expiration of the
statutory deadlines for completion of
summaries and inventories.
E:\FR\FM\21MRR1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 54 (Wednesday, March 21, 2007)]
[Rules and Regulations]
[Pages 13179-13184]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-4762]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0208; FRL-8117-1]
Thifensulfuron Methyl; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
thifensulfuron methyl in or on rice, grain; rice, straw; sorghum,
grain, forage; sorghum, grain, grain; and sorghum, grain, stover. E. I.
DuPont de Nemours and Company requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective March 21, 2007. Objections and
requests for hearings must be received on or before May 21, 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-2006-0208. 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: 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:
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
[[Page 13180]]
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 Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Guidelines
referenced in this document, go directly to the guidelines at https://
www.epa.gpo/opptsfrs/home/guidelin.htm.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0208 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before May 21, 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 your copies, identified by docket ID
number EPA-HQ-OPP-2006-0208, by one of the following methods:
Federal eRulemaking Porta: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of July 14, 2006 (71 FR 40103) (FRL-8058-
8), 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
4F6889) by E.I. Dupont de Nemours and Company, Inc., Laurel Run Plaza,
P. O. Box 80038, Wilmington, DE 19880-0038. The petition requested that
40 CFR 180.439(a) be amended by establishing tolerances for residues of
the herbicide thifensulfuron methyl, (methyl-3-[[[[(4-methoxy-6-methyl-
1,3,5,-triazin-2-yl)amino]carbonyl]amino]sulfonyl]-2-
thiophenecarboxylate, in or on grain sorghum (forage, grain, stover)
and rice (grain and straw) at 0.05 parts per million (ppm). That notice
referenced a summary of the petition prepared by E.I. DuPont de Nemours
and Company, Inc, the registrant, that has been included in the public
docket. A comment was received in response to the notice of filing from
B. Sachau, 15 Elm Street, Florham Park, NJ 07932. The comment and EPA's
response is discussed in Unit IV.C.4.
During the course of the review the Agency decided to update the
commodity listings to agree with current terminology. The commodities
are listed as rice, grain; rice, straw; sorghum, grain, forage;
sorghum, grain, grain; and sorghum, grain, stover.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see https://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for tolerances for residues of thifensulfuron
methyl, (methyl-3-[[[[(4-methoxy-6-methyl-1,3,5,-triazin-2-
yl)amino]carbonyl]amino]sulfonyl]-2-thiophenecarboxylate, on rice,
grain at 0.05 part per million (ppm); rice, straw at 0.05 ppm; sorghum,
grain, forage at 0.05 ppm; sorghum, grain, grain at 0.05 ppm and
sorghum, grain, stover at 0.05 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. Specific information on the studies received and the nature
of the toxic effects caused by thifensulfuron methyl as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found in Unit
III.A. of the final rule published in the Federal Register of September
17, 2004 (69 FR 55975)(FRL-7679-).
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL
[[Page 13181]]
was achieved in the toxicology study selected. An uncertainty factor
(UF) is applied to reflect uncertainties inherent in the extrapolation
from laboratory animal data to humans and in the variations in
sensitivity among members of the human population as well as other
unknowns.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at https://www.epa.gov/pesticides/health/human.htm.
A summary of the toxicological endpoints for thifensulfuron
miethylused for human risk assessment is shown in Table 1 of this unit:
Table 1.--Summary of Toxicological Dose and Endpoints for Thifensulfuron methyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment, Special FQPA SF and
Exposure/Scenario Interspecies and Level of Concern for Study and Toxicological
Intraspecies and any Risk Assessment Effects
Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50 years of NOAEL = 159 milligrams/ Special FQPA SF = 1x... Developmental oral
age) kilograms/day (mg/kg/ acute Population toxicity study in
day). adjusted dose (aPAD) = rats.
UF = 100............... acute Referenced dose LOAEL = 725 mg/kg/day
Acute RfD = 1.59 mg/kg/ (RfD). based on decreased
day. Special FQPA SF = 1.59 mean body weight and
mg/kg/day. increased incidence of
small renal papillae
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL = 7 mg/kg/day.... Special FQPA SF = 1x 90 Day Oral Toxicity in
UF = 100 Chronic RfD = chronic Population Rat
0.07 mg/kg/day. adjusted dose (cPAD) = LOAEL = 177 mg/kg/day
chronic RfD. based on decreased
Special FQPA SF = 0.07 body weight and body
mg/kg/day. weight gain in both
males and females, and
increased spleen
weights in males
----------------------------------------------------------------------------------------------------------------
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.439) for the residues of thifensulfuron methyl,
in or on a variety of raw agricultural commodities. No tolerances for
meat, milk, poultry and egg are established. Risk assessments were
conducted by EPA to assess dietary exposures from thifensulfuron methyl
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.
The acute dietary analysis was performed for the population
subgroup Females 13-49 only. This subgroup is the only one for which an
acute dietary endpoint was identified. In conducting the acute dietary
exposure assessment EPA used the Dietary Exposure Evaluation Model
software with the Food Commodity Intakes Database (DEEM-FCID\TM\),
which incorporates food consumption data as reported by respondents in
the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII), and accumulated exposure to the chemical
for each commodity. The following assumptions were made for the acute
exposure assessments: Tolerance level residues and 100% crop treated
(PCT). No empirical processing factors were used. A DEEM (Version 7.81)
default processing factor was used for corn syrup. Anticipated residues
or estimates of PCT were not used.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEM-FCID\TM\, which incorporates food
consumption data as reported by respondents in the USDA 1994-1996 and
1998 Nationwide CSFII, and accumulated exposure to the chemical for
each commodity. The following assumptions were made for the chronic
exposure assessments: Tolerance level residues and 100 PCT. No
empirical processing factors were used. A DEEM (Version 7.81) default
processing factor was used for corn syrup. Anticipated residues or
estimates of PCT were not used.
iii. Cancer. Thifensulfuron methyl is classified as ``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 exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for thifensulfuron methyl in
drinking water. Because the Agency does not have comprehensive
monitoring data, drinking water concentration estimates are made by
reliance on simulation or modeling taking into account data on the
physical characteristics of thifensulfuron methyl. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at https://www.epa.gov/oppefed/models/water/
index.htm.
Based on the FQPA Index Reservior Screening Tool (FIRST) and
Screening concentration in ground water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of thifensulfuron
methyl for acute exposures are estimated to be 3.9 parts per billion
(ppb) for surface water and 0.27 ppb for ground water. The EDWCs for
chronic exposures are estimated to be 1.5 ppb for surface water and
0.27 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model (DEEM-FCID). For the acute
dietary risk assessment the annual average concentration in surface
water of 3.9 ppb was used. For the chronic dietary risk assessment the
annual average concentration in surface water of 1.5 ppb was used.
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,
[[Page 13182]]
indoor pest control, termiticides, and flea and tick control on pets).
Thifensulfuron methyl 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 thifensulfuron methyl and
any other substances and thifensulfuron methyl 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
thifensulfuron methyl has a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at 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 tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There is no evidence in the
developmental study in rabbits and two generation reproduction study in
rats of increased quantitative or qualitative susceptibility of the
offspring after in utero or post-natal exposure to thifensulfuron
methyl. The acceptable developmental toxicity in rats revealed
increased quantitative susceptibility of the fetus after in utero
exposure. Nonetheless there are no residual uncertainties for pre and
post natal toxicity because the fetal toxicity seen in the
developmental rat study has been well-characterized and the NOAEL
relied upon to calculate the chronic RfD is more than an order of
magnitude lower than the NOAEL from the developmental rat study.
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 thifensulfuron methyl is complete.
Although the impact of thifensulfuron methyl on the nervous system has
not been specifically evaluated in neurotoxicity studies, available
toxicology studies in four species (rat, mouse, dog, and rabbit) do not
indicate a neurotoxic mode of action for this chemical and there are no
concerns from potential developmental neurotoxicity. Therefore, a
developmental neurotoxicity is not required for thifensulfuron methyl.
ii. As discussed in above Unit III.D.2., there are no concerns or
residual uncertainties for pre and/post natal toxicity.
iii. There are no residual uncertainties identified in the exposure
databases. The dietary food assessments were performed based on 100 PCT
and tolerance level residues. Conservative ground water and surface
water modeling estimates were used in the risk assessments. These
assessments will not underestimate the exposure and risks posed by
thifensulfuron methyl.
E. Aggregate Risks and Determination of Safety
1. Acute risk. The acute aggregate risk assessment is provided for
females 13-50 years old only. The existing data showed no indication
that thifensulfuron methyl could cause adverse effects in the general
population based upon a single dose. Thus there is no concern for acute
dietary exposure to the general population. Using the exposure
assumptions discussed in Unit III.C. for acute exposure, the acute
dietary exposure from food and water to thifensulfuron methyl will
occupy 0.03% of the aPAD at the 95% percentile of exposure for females
13 years and older. EPA does not expect the aggregate exposure to
exceed 100% of the aPAD,
2. Chronic risk. Using the exposure assumptions described in Unit
III.C. for chronic exposure, EPA has concluded that exposure to
thifensulfuron methyl from food and water will utilize <1 % of the cPAD
for the U.S. population, <1% of the cPAD for all infants less than 1
year old, and <1% of the cPAD for children 3-5 years old. There are no
residential uses for thifensulfuron methyl that result in chronic
residential exposure to thifensulfuron methyl. EPA does not expect the
aggregate exposure to exceed 100% of the cPAD.
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).
Thifensulfuron methyl 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.
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).
Thifensulfuron methyl 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.
5. Aggregate cancer risk for U.S. population. Thifensulfuron methyl
is classified ``as not likely to be a human carcinogen.'' Therefore,
EPA does not expect thifensulfuron methyl 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 and to infants and children from aggregate
exposure to thifensulfuron methyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (including high performance liquid
chromatography (HPLC) with photo-conductivity detection and liquid
chromatography with detection via electrospray mass spectroscopy) are
available to enforce the tolerance
[[Page 13183]]
expression. These methods may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no established or proposed Codex Maximum Residue Levels
(MRLs) for residues of thifensulfuron methyl. Canadian and Mexican MRLs
have been established for residues of thifensulfuron methyl for several
crops. However no MRLs have been established for sorghum, grain,
forage; sorghum, grain, grain; sorghum, grain, stover; rice, grain; or
rice, straw.
C. Response to Comments
A comment for thifensulfuron methyl was received from Ms. B.
Sachau, 15 Elm Street, Florham Park, NJ 07932. Ms. Sachau stated that
any residue of this product in food was dangerous and questioned the
availability of testing for this chemical in combination with thousands
of other chemicals used in America today.
EPA generally does not require companies to conduct studies to
evaluate the potential for synergistic effects from exposure to
combinations of chemical exposure. Such testing rarely shows any kind
of interaction (synergistic or antagonistic), and there are a nearly
infinite number of possible combinations, making the cost of
indiscriminate testing prohibitively high.
Because synergism does not occur often, the scientific community
believes that exposure to multiple chemicals is best assessed by
looking at the effects caused by each chemical individually. The only
exception to that is when people are exposed to multiple chemicals that
share a common mechanism of toxicity. Then the effects of exposure to
multiple chemicals are expected to be additive, adjusted for the
relative toxicity of different chemicals. This is done through Agency
cumulative risk assessments which are discussed in Unit III.C.4. of
this document. Ms. Sachau did not submit any scientific evidence that
supported a revision of Agency conclusions.
Based on the Agency risk assessments discussed in Unit III.E. of
this document the Agency has concluded that there is a reasonable
certainty that no harm will result to the general population and to
infants and children from aggregate exposure to thifensulfuron
residues. Ms. Sachau did not submit any scientific evidence that
supported a revision of Agency conclusions.
V. Conclusion
Therefore, the tolerances are established for residues of
thifensulfuron methyl, (methyl-3-[[[[(4-methoxy-6-methyl-1,3,5,-
triazin-2-yl)amino]carbonyl]amino]sulfonyl]-2-thiophenecarboxylate,on
rice, grain at 0.05 part per million (ppm); rice, straw at 0.05 ppm;
sorghum, grain, forage at 0.05 ppm; sorghum, grain, grain at 0.05 ppm
and sorghum, grain, stover at 0.05 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 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of FFDCA. For these same reasons, the
Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the
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agency promulgating the rule must submit a rule report, which includes
a copy of the rule, to each House of the Congress and to the
Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final 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: March 5, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.439 is amended by alphabetically adding commodities to
the table in paragraph (a) to read as follows:
Sec. 180.439 Thifensulfuron methyl; Tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Rice, grain......................................... 0.05
Rice, straw......................................... 0.05
Sorghum, grain, forage............................... 0.05
Sorghum, grain, grain................................ 0.05
Sorghum, grain, stover............................... 0.05
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E7-4762 Filed 3-20-07; 8:45 am]
BILLING CODE 6560-50-S
