Environmental Protection Agency (EPA).
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).
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 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.Start Further Info
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: email@example.com.End Further Info End Preamble Start Supplemental 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 Start Printed Page 13180the 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 Start Printed Page 13181was 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:
|Exposure/Scenario||Dose Used in Risk Assessment, Interspecies and Intraspecies and any Traditional UF||Special FQPA SF and Level of Concern for Risk Assessment||Study and Toxicological Effects|
|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|
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 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 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, Start Printed Page 13182indoor 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 Start Printed Page 13183expression. 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: firstname.lastname@example.org.
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.
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 Start Printed Page 13184agency 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).Start List of Subjects
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.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:End Amendment Part Start Part
PART 180—[AMENDED]End Part Start Amendment Part
1. The authority citation for part 180 continues to read as follows:End Amendment Part Start Amendment Part
2. Section 180.439 is amended by alphabetically adding commodities to the table in paragraph (a) to read as follows:End Amendment Part
(a) * * *
|Commodity||Parts per million|
|* * * * *|
|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