Tribenuron Methyl; Pesticide Tolerance

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes tolerances for residues of tribenuron methyl in or on corn, field, forage; corn, field, grain; corn, field, stover; rice, grain; rice, straw; sorghum, forage; sorghum, grain, grain; sorghum, grain, stover; soybean, seed; and sunflower, seed. E.I. DuPont de Nemours and Company, Inc. 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 14, 2007. Objections and requests for hearings must be received on or before May 14, 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-2006-0207. All documents in the docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT:

Vickie Walters, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 703-305-7504; 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 codes 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.
• Animal production (NAICS codes 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS codes 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS codes 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at 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-2006-0207 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 14, 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-2006-0207, by one of the following methods:

• Federal eRulemaking Portal: 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 Building), 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 40102) (FRL-8058-7), 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 4F6890) by E.I. DuPont de Nemours and Company, Laurel Run Plaza, P. O. Box 80038, Wilmington, DE 19880-0038 and Interregional Research Project No. 4 (IR-4), 681 Highway No. 1 South, North Brunswick, NJ 08902. The petition requested that 40 CFR 180. 451 be amended by establishing a tolerance fo residues of the herbicide tribenuron methyl (methyl 2-[[[[(4-methoxy-6-methyl-1, 3, ,5-triazin-2-yl)methylamino]carbonyl]amino]sulfonyl]benzoate, in or on field corn and grain sorghum (forage, grain, and stover) rice (grain and straw); soybean ,seed; and sunflowers at 0.05.parts per million (ppm). The notice referenced a summary of the petition prepared by E.I. DuPont de Nemours and Company, the registrant, that has been placed into the public docket. A comment was received in response to this notice of filing from B. Sachau, 15 Elm Street, Florham Park, NJ 07932. The comment and EPA's response to this comment is discussed in Unit IV C below

During the course of the review the Agency noticed that the name of the regulated chemical is incorrect and that the Petition Number for the sunflowers tolerance was inadvertently left out of the notice. The Agency is correcting these errors at this time. The Agency is also updating the commodity listing to agree with current terminology. Therefore the proposed tolerances are corrected to read: tolerances are established for residues of the herbicide tribenuron methyl, (methyl-2-[[[[N-(4-methoxy-6-methyl-1, 3, 5-triazin -2-yl)methylamino]carbonyl]amino]sulfonyl]benzoate) in or on corn, field, forage at 0.05 ppm; corn, field, grain at 0.05 ppm; corn, field, stover at 0.05 ppm; rice, grain at 0.05 ppm; rice, straw at 0.05 ppm; sorghum, grain, forage at 0.05 ppm; sorghum, grain, grain at 0.05 ppm; sorghum, grain, stover at 0.05 ppm, soybean, seed at 0.05 ppm (4F6890) and sunflower, seed at 0.05 ppm (4E6855).

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 a tolerance for residues of tribenuron methyl, (methyl-2-[[[[N-(4-methoxy-6-methyl-1, 3, 5-triazin -2-yl)methylamino]carbonyl]amino]sulfonyl]benzoate) in or on corn, field, forage at 0.05 ppm; corn, field, grain at 0.05 ppm; corn, field, stover at 0.05 ppm; rice, grain at 0.05 ppm; rice; straw at 0.05 ppm; sorghum, grain, forage at 0.05 ppm; sorghum, grain, grain at 0.05 ppm; sorghum, grain, stover at 0.05 ppm, soybean, seed at 0.05 ppm and sunflower, seed 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 tribenuron 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 22, 2004 (69 FR 56711) (FRL-7679-5).

B. Toxicological Endpoints

For hazards that have a threshold below which there is no appreciable risk, the dose at which 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 LOAEL of concern are identified is sometimes used for risk assessment if no NOAEL 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, and 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 tribenuron methyl used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of September 22, 2004 (69 FR 56711) (FRL-7679-5).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.451) for the residues of tribenuron methyl, in or on a variety of raw agricultural commodities. No tolerances for meat product, eggs, or milk are established. Risk assessments were conducted by EPA to assess dietary exposures from tribenuron 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. No effect attributable to a single dose was observed in any studies in the toxicology database for tribenuron methyl. As a result, no acute dietary endpoint was identified and no acute risk assessment was performed.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake 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 Intakes by Individuals (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% crop treated (CT). No empirical processing factors were used. A DEEM (Version 7.81) default processing factor was used for corn syrup. Anticipated residues or estimates of percent crop treated (PCT) were not used.

iii. Cancer. Tribenuron methyl is classified as a Group C (possible human carcinogen) because of the increased incidence of mammary gland adenocarcinomas in female Sprague-Dawley rats. Tribenuron methyl was not shown to be mutagenic in any tests conducted. EPA considers the chronic risk assessment to be protective of any potential risk of carcinogenicity. Further discussion is found in Unit III.C. of the final rule published in the Federal Register of September 22, 2004, 69 FR 56711 (FRL-7679-5).

2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for tribenuron 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 tribenuron 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 first index reservoir screening tool (FIRST) and screening concentration in ground water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of tribenuron methyl for acute exposures are estimated to be 4.1 parts per billion (ppb) for surface water and 6.8 ppb for ground water. The EDWCs for chronic exposures are estimated to be 2.7 ppb for surface water and 6.8 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model (DEEM-FCID). For the chronic dietary risk assessment the higher ground water value of 6.8 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, indoor pest control, termiticides, and flea and tick control on pets)Tribenuron 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 tribenuron methyl and any other substances and tribenuron 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 tribenuron 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. Developmental and reproductive toxicity studies in rats and rabbits indicated no increased susceptibility (quantitative or qualitative) following in utero or prenatal and/or postnatal exposure to tribenuron methyl.

3. Conclusion. EPA 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 data base for tribenuron methyl is complete. The impact of tribenuron methyl on the nervous system has been specially evaluated in neurotoxicity studies. There was no evidence of neurotoxicity or neuropathology seen in the acute, subchronic, chronic or reproductive studies. Therefore, a developmental neurotoxicity study is required for tribenuron methyl.

ii. The available data from the developmental and reproductive toxicity studies do not indicate a potential susceptibility of infants and children to tribenuron methyl.

iii. There are no residual uncertainties identified in the exposure databases. The dietary food assessments were performed based on 100% CT and tolerance level residues. Conservative ground water estimates were used in the risk assessment. This assessment will not underestimate the exposure and risks posed by tribenuron methyl.

E. Aggregate Risks and Determination of Safety

1. Acute risk. No toxic effect attributable to a single dose was observed in any studies in the toxicology database. As a result, no acute risk is expected.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to tribenuron methyl from food and water will utilize 4.7% of the cPAD for the U.S. population, 9.8% of the cPAD for all infants (<1 year old), and 9.1% of the cPAD for children 3-5 years old. There are no residential uses for tribenuron methyl that result in chronic residential exposure to tribenuron 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).

Tribenuron 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 level of concern.

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).

Tribenuron 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 level of concern.

5. Aggregate cancer risk for U.S. population. The Agency considers the chronic risk assessment, making use of the cPAD, to be protective of any aggregate cancer risk. See Unit III. E.2. Therefore, the aggregate risk is not expected to exceed the Agency's level of concern.

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 tribenuron methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (including high performance liquid chromatography (HPLC) with photo-conductivity and liquid chromatography with detection via electrospray mass spectroscopy (LC/MS)) are available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov.

B. International Residue Limits

No Mexican or Codex Maximum Residue Levels (MRLs) have been established for tribenuron methyl. Canadian MRLs have been established for tribenuron methyl on certain crops; however, no MRLs have been established for corn, field, forage; corn, field, grain; corn, field, stover; rice, grain; rice, straw; sorghum, grain, forage; sorghum, grain, grain; sorghum, grain, stover; soybean, seed; or sunflower, seed, therefore no questions of compatibility exist for these commodities.

C. Response to Comments

A comment was received from Ms. B. Sachau in response to the notice of filing. Ms. Sachau stated that the chemical should not be manufactured or sold. Ms. Sachau based her conclusion on the following: eye irritation potential, effects on the liver and kidney, and its carcinogenic potential. Ms. Sachau also questioned the availability of testing for this chemical in combination with other chemicals in use today.

The effects on the kidney and liver were the basis of the chronic reference dose (cRfD) and cPAD used for the chronic dietary risk assessment. As discussed in Unit III. E.2, EPA does not expect the aggregate exposure to exceed 100% of the cPAD which does not exceed the Agency's level of concern. After review of available data, the Agency considers the chronic risk assessment, making use of the cPAD, to be protective of any aggregate cancer risk. Ms. Sachau did not submit any scientific information to support a revision of Agency conclusions.

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 the effects caused by exposure to 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 the 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 information to support a revision of Agency conclusions.

V. Conclusion

Therefore, the tolerances are established for residues of tribenuron methyl, (methyl-2-[[[[N-(4-methoxy-6-methyl-1, 3, 5-triazin -2-yl)methylamino]carbonyl]amino]sulfonyl]benzoate) in or on corn, field, forage at 0.05 ppm; corn, field, grain at 0.05 ppm; corn, field, stover at 0.05 ppm; rice, grain at 0.05 ppm; rice; straw at 0.05 ppm; sorghum, grain, forage at 0.05 ppm; sorghum, grain, grain at 0.05 ppm; sorghum, grain, stover at 0.05 ppm, soybean, seed at 0.05 ppm and sunflower, seed 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 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

Therefore, 40 CFR chapter I is amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

2. Section 180.451 is amended by alphabetically adding commodities to the table in paragraph (a) to read as follows:

(a) * * *