Glyphosate; Pesticide Tolerance, 76180-76185 [E6-21490]

Download as PDF 76180 Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Rules and Regulations rwilkins on PROD1PC63 with RULES VI. Conclusion Therefore, tolerances are established for combined residues of azoxystrobin, methyl (E)-2-(2-(6-(2cyanophenoxy)pyrimidin-4yloxy)phenyl)-3-methoxyacrylate and the Z isomer of azoxystrobin, methyl (Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin4-yloxy)phenyl)-3-methoxyacrylate, on rice, wild at 5.0 ppm. VII. Statutory and Executive Order Reviews This final rule establishes a timelimited tolerance under section 408 of the FFDCA. 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 FIFRA section 18 exemption under section 408 of the 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 VerDate Aug<31>2005 17:07 Dec 19, 2006 Jkt 211001 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 the 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. VIII. 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 PO 00000 Frm 00070 Fmt 4700 Sfmt 4700 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: December 6, 2006. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: I PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: I Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.507 is amended by alphabetically adding the commodity ‘‘Rice, wild’’ to the table in paragraph (b) to read as follows: I § 180.507 Azoxystrobin; tolerances for residues. * * (b) * * * * * * Parts per million Commodity * * Rice, wild .......... * * * * * * * 5.0 * * Expiration/ revocation date * 12/31/09 * * * [FR Doc. E6–21498 Filed 12–19–06; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2006–0177; FRL–8105–9] Glyphosate; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes tolerances for residues of glyphosate in or on sunflower; safflower; noni; pea, dry; and vegetable, legume, group 6 except soybean, and pea, dry. The E:\FR\FM\20DER1.SGM 20DER1 Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Rules and Regulations Interregional Research Project Number 4 (IR–4) 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 December 20, 2006. Objections and requests for hearings must be received on or before February 20, 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–2006–0177. 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: Shaja R. Brothers, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–3194; e-mail address: brothers.shaja@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information rwilkins on PROD1PC63 with RULES 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 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. VerDate Aug<31>2005 17:07 Dec 19, 2006 Jkt 211001 • Pesticide manufacturing (NAICS 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–2006–0177 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 February 20, 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 PO 00000 Frm 00071 Fmt 4700 Sfmt 4700 76181 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–2006–0177, 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 March 29, 2006 (71 FR 15734) (FRL–7766–9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 4E6878 and 5E6987) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petitions requested that 40 CFR 180.364 be amended by establishing tolerances for residues of the herbicide glyphosate, (N-phosphonomethyl)glycine, in or on sunflower and safflower at 25 parts per million (ppm) (PP 4E6878); vegetable, legume, group 6, except soybean at 8.0 ppm (5E6987); and mulberry, Indian at 0.2 ppm (5E6987). Following review of the residue chemistry data, EPA determined that the commodities term and tolerance levels should be revised to the following: Sunflower at 85 ppm; safflower at 85 ppm; pea, dry at 8.0 ppm; vegetable, legume, group 6 except soybean and pea, dry at 5.0 ppm; and noni at 0.20 ppm. This notice included a summary of the petitions prepared by Monsanto, the registrant. There were no comments received in response to the notice of filing. 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 E:\FR\FM\20DER1.SGM 20DER1 76182 Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Rules and Regulations 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 glyphosate on sunflower at 85 ppm; safflower at 85 ppm; noni at 0.20 ppm; pea, dry at 8.0 ppm; and vegetable, legume, group 6 except soybean and pea, dry at 5.0 ppm. EPA’s assessment of exposures and risks associated with establishing these tolerances follow. rwilkins on PROD1PC63 with RULES 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 glyphosate as well as the no–observed– adverse–effect–level (NOAEL) and the lowest–observed–adverse–effect–level (LOAEL) from the toxicity studies can be found at www.regulations.gov. Docket ID EPA–HQ–OPP–2006–0177, Glyphosate Indian Mulberry and Dry Pea Human Health Risk Assessment, pages 10–11, and Glyphosate Safflower and Sunflower Human Health Risk Assessment, pages 12–14. VerDate Aug<31>2005 17:07 Dec 19, 2006 Jkt 211001 To locate this information on the Regulations.gov website follow these steps: 1. Select ‘‘Advanced Search,’’ then ‘‘Docket Search’’ 2. In the ‘‘Keyword’’ field type the chemical name or insert the applicable ‘‘Docket ID number.’’ (example: EPA– HQ–OPP–2006–0177). 3 Click the ‘‘Submit’’ button. Follow the instructions on the regulations.gov website to view the index for the docket and access available documents. 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 lowest dose at which the LOAEL 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 nonthreshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More 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 glyphosate used for human risk assessment can be found at www.regulations.gov, Docket ID EPA– HQ–OPP–2006–0177, Glyphosate Indian Mulberry and Dry Pea Human Health Risk Assessment, pages 16–17, and Glyphosate Safflower and Sunflower Human Health Risk Assessment, pages 18–19. C. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have been established 40 CFR 180.364 for the residues of glyphosate, in or on a variety of raw agricultural commodities. Additionally tolerances are established for meat, milk, poultry and egg. Risk assessments were conducted by EPA to assess dietary exposures from glyphosate in food as follows: PO 00000 Frm 00072 Fmt 4700 Sfmt 4700 i. Acute exposure. No acute effects were identified in the toxicological studies for glyphosate, therefore a quantitative acute dietary exposure assessment is not necessary. 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-FCIDTM), which incorporates food consumption data as reported by respondents in the United States Department of Agriculture (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 chronic exposure assessment: The Tier 1 chronic dietary analysis for glyphosate is a conservative estimate of dietary exposure that used tolerance level residues and 100% percent crop treated (PCT). iii. Cancer. Glyphosate is classified as a not likely human carcinogen, so a cancer dietary exposure analysis is not necessary. 2. Dietary exposure from drinking water.The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for glyphosate 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 glyphosate. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/ oppefed1/models/index.htm. Glyphosate is registered for aquatic use to control weeds in water bodies. Therefore, the Agency estimated the concentration in surface water resulting from direct application to a water body 6 feet deep. This estimate is based on a dilution model that does not take into account degradation in the water body and partitioning into the water columnsediment phases. The estimate considered a single broadcast application at the maximum application rate of 3.75 lb of glyphosate free acid per acre. Based on a maximum total application rate of 3.75 pounds of glyphosate free acid per acre, the estimated concentration for use in the drinking water assessment is 230 g/L parts per billion (ppb). Based on the generic expected environmental concentration (GENEEC) and screening concentration in groundwater (SCI-GROW) models, the E:\FR\FM\20DER1.SGM 20DER1 rwilkins on PROD1PC63 with RULES Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Rules and Regulations estimated environmental concentrations (EECs) of glyphosate for acute exposures are estimated to be 21 ppb for surface water and 0.0038 ppb for ground water. The EECs for chronic exposures are estimated to be 0.83 ppb for surface water and 0.0038 ppb for ground water, based on glyphosate treatment in crops. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Glyphosate is currently registered for use on broadcast and spot treatments on home lawns and gardens. Glyphosate, isopropylamine salt is registered for broadcast and spot treatments on home lawns and gardens. Glyphosate products for homeowner use are packaged as ready-to-mix formulations and ready-touse sprayers and are very common in home and garden stores in the U.S. Glyphosate products are also used by lawn care operators for broadcast and spot treatment weed control programs on homeowner lawns. Glyphosate products are also labeled for turf renovation. The risk assessment was conducted using the following residential exposure assumptions: Based on the registered residential use patterns, there is a potential for short-term dermal and inhalation exposures to homeowners who apply products containing glyphosate (residential handlers). Additionally, based on the results of environmental fate studies, there is a potential for short and intermediateterm post-application dermal exposures by adults and toddlers and incidental ingestion exposures by toddlers. However, since short or intermediateterm dermal or inhalation endpoints were not identified, no residential handler or post-application dermal assessment is necessary; only a postapplication toddler assessment for incidental ingestion exposures was performed. 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 VerDate Aug<31>2005 17:07 Dec 19, 2006 Jkt 211001 glyphosate and any other substances and glyphosate 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 glyphosate 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 UFs and/or special FQPA safety factors, as appropriate. 2. Prenatal and postnatal sensitivity. Based on the available data, there was no evidence of quantitative or qualitative increased susceptibility following in utero glyphosate exposure to rats and rabbits, or following prenatal/postnatal exposure in the 2generation reproduction study in rats. A developmental neurotoxicity study was not required. 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: There is no evidence of quantitative or qualitative increased susceptibility of the young demonstrated in the prenatal developmental studies in rats and rabbits and prenatal/postnatal PO 00000 Frm 00073 Fmt 4700 Sfmt 4700 76183 reproduction study in rats ii. the toxicology data base is complete iii. a developmental neurotoxicity study is not required; and iv. the dietary (food, drinking water, and residential) exposure assessments will not underestimate the potential exposures for infants and children. E. Aggregate Risks and Determination of Safety 1. Acute risk. There were no toxic effects attributable to a single dose. An endpoint of concern was not identified to quantitate an acute-dietary risk to the U.S. general population or to the subpopulation females 13-50 years old. Therefore, glyphosate is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to glyphosate from food and water will utilize 2% of the chronic population adjusted dose (cPAD) for the U.S. population, 7% of the cPAD for all infants <1 year old, and 5% of the cPAD for children 1-2 years old. Based on the use pattern, chronic residential exposure to residues of glyphosate is not expected. 3. Short-term and Intermediate-term risk. Short term and Intermediate term aggregate exposures take into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Glyphosate is currently registered for uses that could result in short and intermediate term residential exposures. Since the incidental oral ingestion exposure estimates for toddlers from residential turf exposures exceeded the incidental oral exposure estimates from post-application swimmer exposures, the Agency conducted this risk assessment using exposure estimates from the worst-case situation. No attempt was made to combine exposures from the swimmer and residential turf scenarios due to the low probability of both occurring concurrently. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 1,400 for children 1-2 years old (the most highly exposed population subgroup), and 4,610 for adults 20-49 years old. 4. Aggregate cancer risk for U.S. population. Glyphosate has been classified by the Cancer Peer Review Committee as ‘‘a Group E’’ chemicalnegative as a human carcinogen - based on the absence of carcinogenicity in mice and rats. Therefore, a cancer risk assessment was not conducted. E:\FR\FM\20DER1.SGM 20DER1 76184 Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Rules and Regulations 5. 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 glyphosate residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methods are available for analysis of residues of glyphosate in or on plant and livestock commodities. These methods include Gas Liquid Chromatography (GLC) (Method I in Pesticides Analytical Manual II; the limit of detection is 0.05 ppm) and high-performance liquid chromatography (HPLC) with fluorometric detection. These analytical methods are adequate for residue data collection and enforcement of the proposed tolerances of glyphosate in/on noni and dry peas. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–905; e-mail address: residuemethods@epa.gov. B. International Residue Limits The Codex Alimentarius Commission has established several maximum residue limits (MRLs) for glyphosate residues in various commodities. The Codex and U.S. tolerances are in harmony with respect to MRL/tolerance expression; both regulate the parent glyphosate only. The proposed tolerance of 8.0 ppm in dry peas exceeds the existing Codex MRL of 5.0 ppm. This discrepancy is not expected to result in a trade barrier, however, because the United States accounts for only about 5% of world dry production and is not expected to be a significant exporter of this commodity. There are currently no Codex Maximum Residue Limits for residues of glyphosate on safflower, sunflower, or noni; therefore, there are no international harmonization issues associated with these commodities. rwilkins on PROD1PC63 with RULES V. Conclusion Therefore, the tolerances are established for residues of glyphosate, (N-phosphonomethyl)glycine, in or on sunflower at 85 ppm; safflower at 85 ppm; noni at 0.20 ppm; pea, dry at 8.0 ppm; and vegetable, legume, group 6 except soybean and pea,dry at 5.0 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 VerDate Aug<31>2005 17:07 Dec 19, 2006 Jkt 211001 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 PO 00000 Frm 00074 Fmt 4700 Sfmt 4700 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 E:\FR\FM\20DER1.SGM 20DER1 Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Rules and Regulations greens subgroup 4A, except head and leaf lettuce, and leafy petioles subgroup 4B. Interregional Research Project No. 4 Dated: December 6, 2006. (IR-4) requested these tolerances under Donald R. Stubbs, the Federal Food, Drug, and Cosmetic Acting Director, Registration Division, Office Act (FFDCA), as amended by the Food of Pesticide Programs. Quality Protection Act of 1996 (FQPA). I Therefore, 40 CFR chapter I is DATES: This regulation is effective amended as follows: December 20, 2006. Objections and requests for hearings must be received PART 180—[AMENDED] on or before February 20, 2007, and must be filed in accordance with the I 1. The authority citation for part 180 instructions provided in 40 CFR part continues to read as follows: 178 (see also Unit I.C. of the Authority: 21 U.S.C. 321(q), 346a and 371. SUPPLEMENTARY INFORMATION). I 2. Section 180.364 is amended by ADDRESSES: EPA has established a alphabetically adding commodities to docket for this action under docket the table in paragraph (a) to read as identification (ID) number EPA–HQ– follows: OPP–2005–0145. All documents in the § 180.364 Glyphosate; tolerances for docket are listed in the index for the residues. docket. Although listed in the index, (a) * * * some information is not publicly available, e.g., Confidential Business Commodity Parts per million Information (CBI) or other information whose disclosure is restricted by statute. * * * * * Certain other material, such as Noni ................................ 0.20 copyrighted material, is not placed on the Internet and will be publicly * * * * * available only in hard copy form. Pea, dry .......................... 8.0 Publicly available docket materials are * * * * * available in the electronic docket at http://www.regulations.gov, or, if only Safflower ......................... 85 available in hard copy, at the OPP * * * * * Regulatory Public Docket in Rm. S-4400, Sunflower ........................ 85 One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. * * * * * The Docket Facility is open from 8:30 Vegetable, legume, a.m. to 4 p.m., Monday through Friday, group 6 except soyexcluding legal holidays. The Docket bean and pea,dry ........ 5.0 telephone number is (703) 305-5805. * * * * * FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division (b) Section 18 emergency exemptions. (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 [Reserved] Pennsylvania Ave., NW., Washington, (c) Tolerances with regional DC 20460–0001; telephone number: registrations. [Reserved] (703) 305–6463; e-mail address: (d) Indirect or inadvertent residues. madden.barbara@epa.gov. [Reserved] and pests, Reporting and recordkeeping requirements. [FR Doc. E6–21490 Filed 12–19–06; 8:45 am] SUPPLEMENTARY INFORMATION: BILLING CODE 6560–50–S I. General Information A. Does this Action Apply to Me? ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2005–0145; FRL–8107–8] Boscalid; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. rwilkins on PROD1PC63 with RULES AGENCY: SUMMARY: This regulation establishes tolerances for residues of boscalid, 3pyridinecarboxamide, 2-chloro-N-(4′chloro[1,1′-biphenyl]-2-yl) in or on leafy VerDate Aug<31>2005 17:07 Dec 19, 2006 Jkt 211001 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 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; PO 00000 Frm 00075 Fmt 4700 Sfmt 4700 76185 greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 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–2005–0145 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 February 20, 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 E:\FR\FM\20DER1.SGM 20DER1

Agencies

[Federal Register Volume 71, Number 244 (Wednesday, December 20, 2006)]
[Rules and Regulations]
[Pages 76180-76185]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21490]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0177; FRL-8105-9]


Glyphosate; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
glyphosate in or on sunflower; safflower; noni; pea, dry; and 
vegetable, legume, group 6 except soybean, and pea, dry. The

[[Page 76181]]

Interregional Research Project Number 4 (IR-4) 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 December 20, 2006. Objections and 
requests for hearings must be received on or before February 20, 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-2006-0177. 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: Shaja R. Brothers, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address: 
brothers.shaja@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 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 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-2006-0177 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 February 20, 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-2006-0177, 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 March 29, 2006 (71 FR 15734) (FRL-7766-
9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
4E6878 and 5E6987) by IR-4, 500 College Road East, Suite 201 W, 
Princeton, NJ 08540. The petitions requested that 40 CFR 180.364 be 
amended by establishing tolerances for residues of the herbicide 
glyphosate, (N-phosphonomethyl)glycine, in or on sunflower and 
safflower at 25 parts per million (ppm) (PP 4E6878); vegetable, legume, 
group 6, except soybean at 8.0 ppm (5E6987); and mulberry, Indian at 
0.2 ppm (5E6987). Following review of the residue chemistry data, EPA 
determined that the commodities term and tolerance levels should be 
revised to the following: Sunflower at 85 ppm; safflower at 85 ppm; 
pea, dry at 8.0 ppm; vegetable, legume, group 6 except soybean and pea, 
dry at 5.0 ppm; and noni at 0.20 ppm. This notice included a summary of 
the petitions prepared by Monsanto, the registrant. There were no 
comments received in response to the notice of filing.
    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

[[Page 76182]]

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 glyphosate on 
sunflower at 85 ppm; safflower at 85 ppm; noni at 0.20 ppm; pea, dry at 
8.0 ppm; and vegetable, legume, group 6 except soybean and pea, dry at 
5.0 ppm. EPA's assessment of exposures and risks associated with 
establishing these tolerances follow.

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 glyphosate as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at 
www.regulations.gov. Docket ID EPA-HQ-OPP-2006-0177, Glyphosate Indian 
Mulberry and Dry Pea Human Health Risk Assessment, pages 10-11, and 
Glyphosate Safflower and Sunflower Human Health Risk Assessment, pages 
12-14.
    To locate this information on the Regulations.gov website follow 
these steps:
     1. Select ``Advanced Search,'' then ``Docket Search''
    2. In the ``Keyword'' field type the chemical name or insert the 
applicable ``Docket ID number.'' (example: EPA-HQ-OPP-2006-0177).
    3 Click the ``Submit'' button.
    Follow the instructions on the regulations.gov website to view the 
index for the docket and access available documents.

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 lowest 
dose at which the LOAEL 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, 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 glyphosate used for 
human risk assessment can be found at www.regulations.gov, Docket ID 
EPA-HQ-OPP-2006-0177, Glyphosate Indian Mulberry and Dry Pea Human 
Health Risk Assessment, pages 16-17, and Glyphosate Safflower and 
Sunflower Human Health Risk Assessment, pages 18-19.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established 40 CFR 180.364 for the residues of glyphosate, in or on a 
variety of raw agricultural commodities. Additionally tolerances are 
established for meat, milk, poultry and egg. Risk assessments were 
conducted by EPA to assess dietary exposures from glyphosate in food as 
follows:
    i. Acute exposure. No acute effects were identified in the 
toxicological studies for glyphosate, therefore a quantitative acute 
dietary exposure assessment is not necessary.
    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 United States 
Department of Agriculture (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 chronic exposure assessment: The Tier 1 
chronic dietary analysis for glyphosate is a conservative estimate of 
dietary exposure that used tolerance level residues and 100% percent 
crop treated (PCT).
    iii. Cancer. Glyphosate is classified as a not likely human 
carcinogen, so a cancer dietary exposure analysis is not necessary.
    2. Dietary exposure from drinking water.The Agency lacks sufficient 
monitoring exposure data to complete a comprehensive dietary exposure 
analysis and risk assessment for glyphosate 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 glyphosate. 
Further information regarding EPA drinking water models used in 
pesticide exposure assessment can be found at http://www.epa.gov/
oppefed1/models/index.htm.
    Glyphosate is registered for aquatic use to control weeds in water 
bodies. Therefore, the Agency estimated the concentration in surface 
water resulting from direct application to a water body 6 feet deep. 
This estimate is based on a dilution model that does not take into 
account degradation in the water body and partitioning into the water 
column-sediment phases. The estimate considered a single broadcast 
application at the maximum application rate of 3.75 lb of glyphosate 
free acid per acre. Based on a maximum total application rate of 3.75 
pounds of glyphosate free acid per acre, the estimated concentration 
for use in the drinking water assessment is 230 g/L parts per billion 
(ppb).
    Based on the generic expected environmental concentration (GENEEC) 
and screening concentration in groundwater (SCI-GROW) models, the

[[Page 76183]]

estimated environmental concentrations (EECs) of glyphosate for acute 
exposures are estimated to be 21 ppb for surface water and 0.0038 ppb 
for ground water. The EECs for chronic exposures are estimated to be 
0.83 ppb for surface water and 0.0038 ppb for ground water, based on 
glyphosate treatment in crops.
    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).
    Glyphosate is currently registered for use on broadcast and spot 
treatments on home lawns and gardens. Glyphosate, isopropylamine salt 
is registered for broadcast and spot treatments on home lawns and 
gardens. Glyphosate products for homeowner use are packaged as ready-
to-mix formulations and ready-to-use sprayers and are very common in 
home and garden stores in the U.S. Glyphosate products are also used by 
lawn care operators for broadcast and spot treatment weed control 
programs on homeowner lawns. Glyphosate products are also labeled for 
turf renovation.
    The risk assessment was conducted using the following residential 
exposure assumptions: Based on the registered residential use patterns, 
there is a potential for short-term dermal and inhalation exposures to 
homeowners who apply products containing glyphosate (residential 
handlers). Additionally, based on the results of environmental fate 
studies, there is a potential for short and intermediate-term post-
application dermal exposures by adults and toddlers and incidental 
ingestion exposures by toddlers. However, since short or intermediate-
term dermal or inhalation endpoints were not identified, no residential 
handler or post-application dermal assessment is necessary; only a 
post-application toddler assessment for incidental ingestion exposures 
was performed.
    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 glyphosate and any other 
substances and glyphosate 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 glyphosate 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 UFs and/or special FQPA 
safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. Based on the available data, 
there was no evidence of quantitative or qualitative increased 
susceptibility following in utero glyphosate exposure to rats and 
rabbits, or following prenatal/postnatal exposure in the 2-generation 
reproduction study in rats. A developmental neurotoxicity study was not 
required.
    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:
     There is no evidence of quantitative or qualitative increased 
susceptibility of the young demonstrated in the prenatal developmental 
studies in rats and rabbits and prenatal/postnatal reproduction study 
in rats ii. the toxicology data base is complete iii. a developmental 
neurotoxicity study is not required; and iv. the dietary (food, 
drinking water, and residential) exposure assessments will not 
underestimate the potential exposures for infants and children.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. There were no toxic effects attributable to a single 
dose. An endpoint of concern was not identified to quantitate an acute-
dietary risk to the U.S. general population or to the subpopulation 
females 13-50 years old. Therefore, glyphosate is not expected to pose 
an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
glyphosate from food and water will utilize 2% of the chronic 
population adjusted dose (cPAD) for the U.S. population, 7% of the cPAD 
for all infants <1 year old, and 5% of the cPAD for children 1-2 years 
old. Based on the use pattern, chronic residential exposure to residues 
of glyphosate is not expected.
    3. Short-term and Intermediate-term risk. Short term and 
Intermediate term aggregate exposures take into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level). Glyphosate is currently registered for uses 
that could result in short and intermediate term residential exposures. 
Since the incidental oral ingestion exposure estimates for toddlers 
from residential turf exposures exceeded the incidental oral exposure 
estimates from post-application swimmer exposures, the Agency conducted 
this risk assessment using exposure estimates from the worst-case 
situation. No attempt was made to combine exposures from the swimmer 
and residential turf scenarios due to the low probability of both 
occurring concurrently.
     Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 1,400 for children 1-2 years old 
(the most highly exposed population subgroup), and 4,610 for adults 20-
49 years old.
    4. Aggregate cancer risk for U.S. population. Glyphosate has been 
classified by the Cancer Peer Review Committee as ``a Group E'' 
chemical- negative as a human carcinogen - based on the absence of 
carcinogenicity in mice and rats. Therefore, a cancer risk assessment 
was not conducted.

[[Page 76184]]

    5. 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 glyphosate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available for analysis of residues 
of glyphosate in or on plant and livestock commodities. These methods 
include Gas Liquid Chromatography (GLC) (Method I in Pesticides 
Analytical Manual II; the limit of detection is 0.05 ppm) and high-
performance liquid chromatography (HPLC) with fluorometric detection. 
These analytical methods are adequate for residue data collection and 
enforcement of the proposed tolerances of glyphosate in/on noni and dry 
peas. The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-905; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    The Codex Alimentarius Commission has established several maximum 
residue limits (MRLs) for glyphosate residues in various commodities. 
The Codex and U.S. tolerances are in harmony with respect to MRL/
tolerance expression; both regulate the parent glyphosate only. The 
proposed tolerance of 8.0 ppm in dry peas exceeds the existing Codex 
MRL of 5.0 ppm. This discrepancy is not expected to result in a trade 
barrier, however, because the United States accounts for only about 5% 
of world dry production and is not expected to be a significant 
exporter of this commodity. There are currently no Codex Maximum 
Residue Limits for residues of glyphosate on safflower, sunflower, or 
noni; therefore, there are no international harmonization issues 
associated with these commodities.

V. Conclusion

    Therefore, the tolerances are established for residues of 
glyphosate, (N-phosphonomethyl)glycine, in or on sunflower at 85 ppm; 
safflower at 85 ppm; noni at 0.20 ppm; pea, dry at 8.0 ppm; and 
vegetable, legume, group 6 except soybean and pea,dry at 5.0 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

[[Page 76185]]

and pests, Reporting and recordkeeping requirements.

    Dated: December 6, 2006.
Donald R. Stubbs,
Acting 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 180.364 is amended by alphabetically adding commodities to 
the table in paragraph (a) to read as follows:


Sec.  180.364  Glyphosate; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Noni.................................................               0.20
                                * * * * *
Pea, dry.............................................                8.0
                                * * * * *
Safflower............................................                 85
                                * * * * *
Sunflower............................................                 85
                                * * * * *
Vegetable, legume, group 6 except soybean and pea,dry                5.0
                                * * * * *
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E6-21490 Filed 12-19-06; 8:45 am]
BILLING CODE 6560-50-S