Document ID: EPA-HQ-OPP-2006-0208-0004
Agency: epa
Document Type: Rule
Title: Thifensulfuron Methyl; Pesticide Tolerance
Posted Date: 2007-03-21T04:00Z

[Federal Register: March 21, 2007 (Volume 72, Number 54)]
[Rules and Regulations]               
[Page 13179-13184]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21mr07-6]                         

-----------------------------------------------------------------------

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 http://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 http://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 http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://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 http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines 

referenced in this document, go directly to the guidelines at http://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: http://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 http://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 http://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 http://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 http://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

[[Page 13184]]

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