Glufosinate-ammonium; Pesticide Tolerance, 72622-72626 [E7-24841]

Download as PDF 72622 Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Rules and Regulations The provisions of § 52.21 except paragraph (a)(1) are hereby incorporated and made a part of the South Dakota State implementation plan and are applicable to proposed major stationary sources or major modifications to be located on Indian reservations. * * * * * [FR Doc. E7–24717 Filed 12–20–07; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2007–0029; FRL–8342–3] I. General Information Glufosinate-ammonium; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. sroberts on PROD1PC70 with RULES AGENCY: SUMMARY: This regulation modifies the tolerances for the combined residues of glufosinate-ammonium and its metabolites expressed as butanoic acid in or on raw agricultural commodities. Bayer CropScience LLC requested this revision under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective December 21, 2007. Objections and requests for hearings must be received on or before February 19, 2008 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–2007–0029. To access the electronic docket, go to http:// www.regulations.gov, select ‘‘Advanced Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated and select the ‘‘Submit’’ button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP VerDate Aug<31>2005 18:20 Dec 20, 2007 Jkt 214001 Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305– 5805. FOR FURTHER INFORMATION CONTACT: Kathryn V. Montague, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–1243; e-mail address: montague.kathryn@epa.gov. SUPPLEMENTARY 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 those engaged in the following activities: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather to provide 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 PO 00000 Frm 00060 Fmt 4700 Sfmt 4700 http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s pilot e-CFR site at http://www.gpoaccess.gov/ ecfr. C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. 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–2007–0029 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 as required by 40 CFR part 178 on or before February 19, 2008. 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 this copy, identified by docket ID number EPA– HQ–OPP–2007–0029, 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 Bldg.), 2777 S. Crystal Dr., 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 Facility telephone number is (703) 305–5805. II. Petition for Tolerance In the Federal Register of February 28, 2007 (72 FR 9000) (FRL–8115–5), 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 6F7161) by Bayer CropScience LLC, 2 T.W. Alexander Dr., E:\FR\FM\21DER1.SGM 21DER1 sroberts on PROD1PC70 with RULES Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Rules and Regulations Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.473 be amended by establishing a tolerance for combined residues of the herbicide, glufosinate-ammonium and its metabolites expressed as butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-, monoammonium salt, 2-acetamido-4methylphosphinico-butanoic acid and 3-methylphosphinico-propionic acid (expressed as glufosinate free acid equivalents), in or on raw agricultural commodities grain aspirated fractions at 25.0 parts per million (ppm); nontransgenic canola, meal at 1.1 ppm; nontransgenic canola, seed at 0.4 ppm; nontransgenic field corn, forage at 4.0 ppm; non- transgenic field corn, grain at 0.2 ppm; non- transgenic field corn, stover at 6.0 ppm; non- transgenic soybean, at 2.0 ppm; non-transgenic soybean, hulls at 5.0 ppm. That notice referenced a summary of the petition prepared by Bayer CropScience LLC, the registrant, which is available to the public in the docket, http://www.regulations.gov. In the Federal Register of June 27, 2007 (72 FR 35237) (FRL–8133–4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the amendment to existing tolerances by filing of a pesticide petition (PP 6F7161) by Bayer CropScience LLC, 2 T.W. Alexander Dr., Research Triangle Park, NC 27709. The petition proposes to amend the tolerances in 40 CFR 180.473(a) to eliminate the reference to transgenic crops tolerant to glufosinate ammonium in §180.473(a)(2) such that the crop tolerances listed under §180.473 (a) General, support uses in all of the crops listed to include both conventional and transgenic crops and to delete §180.473 (a)(1) and (a)(2). This notice clarifies the initial notice of filing published in the Federal Register of February 28, 2007 (72 FR 9000) (FRL–8115–5). The tolerances for glufosinate-ammonium and its metabolites listed for the commodities under both paragraphs (a)(1) and paragraph (a)(2) are proposed to be placed in §180.473 (a) General to read as follows: Tolerances are established for residues of glufosinateammonium (butanoic acid, 2-amino-4(hydroxymethylphosphinyl)monoammonium salt) and its metabolites expressed as butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-, monoammonium salt, 2-acetamido-4methylphosphinico-butanoic acid and 3-methylphosphinico-propionic acid expressed as glufosinate free acid equivalents in or on the raw agricultural commodities: Almond, hulls at 0.50 ppm; apple at 0.05 ppm; grain aspirated fractions at 25.0 ppm; banana at 0.30 VerDate Aug<31>2005 18:20 Dec 20, 2007 Jkt 214001 ppm; banana, pulp at 0.20 ppm; beet, sugar, molasses at 5.0 ppm; beet, sugar, roots at 0.9 ppm; beet, sugar, tops at 1.5 ppm; bushberry subgroup 13B at 0.15 ppm; canola, meal at 1.1 ppm; canola, seed at 0.4 at ppm; cattle, fat at 0.40 ppm; cattle, meat at 0.15 ppm; cattle, meat byproducts at 6.0 ppm; corn, field forage at 4.0 ppm; corn, field, grain at 0.2 ppm; corn, field, stover at 6.0 ppm; cotton, gin byproducts at 15 ppm; cotton, undelinted seed at 4.0 ppm; egg at 0.15 ppm; goat, fat at 0.40 ppm; goat, meat at 0.15 ppm; goat, meat byproducts at 6.0 ppm; grape at 0.05 ppm; hog, fat at 0.40 ppm; hog, meat at 0 .15; hog, meat byproducts at 6.0 ppm; horse, fat at 0.40 ppm; horse, meat at 0.15 ppm; horse, meat byproducts at 6.0 ppm; Juneberry 0.10 ppm; lingonberry at 0.10 ppm; milk at 0.15 ppm; nut, tree, group 14 at 0.10 ppm; potato at 0.80 ppm; potato, chips at 1.60 ppm; potato granules/flakes 2.00 ppm; poultry, fat 0.15 ppm; poultry, meat at 0.15 ppm; poultry, meat byproducts 0.60 ppm; rice, grain at 1.0 ppm; rice, hull at 2.0 ppm; rice, straw at 2.0 ppm; salal at 0.10 ppm; sheep, fat at 0.40 ppm; sheep, meat at 0.15 ppm; sheep, meat byproducts at 6.0 ppm; soybean at 2.0 ppm and soybean, hulls at 5.0 ppm. Comments were received on the notices of filing. EPA’s response to these comments is discussed in Unit IV.C. Bayer’s petition asks EPA to consolidate subsections (a)(1) and (a)(2) of 40 CFR 180.473 which contains tolerances for glufosinate on various non-transgenic crops and transgenic crops, respectively, and remove the restriction as to transgenic crops. In part this petition is related to Bayer’s application to EPA to amend its glufosinate registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to allow preplant burn down application to both transgenic and non-transgenic field corn, canola, and soybean. Glufosinate is currently registered foliar uses on the transgenic forms of these crops. The proposed registration amendment would not alter existing seasonal application amount limitations. There are currently no FFDCA tolerances for glufosinate on non-transgenic field corn, canola, and soybean but FFDCA tolerances are in place for the foliar use on the transgenic form of these crops. Consolidating subsections (a)(1) and (a)(2) and removing the transgenic restriction would address the lack of tolerances for non-transgenic field corn, canola, and soybean. EPA initially concluded that two tolerance expressions were appropriate for plants: non-transgenic (40 CFR 180.473 (a)(1)) with glufosinate PO 00000 Frm 00061 Fmt 4700 Sfmt 4700 72623 ammonium and 3-methylphosphinicopropionic acid and transgenic crops (40 CFR 180.473 (a)(2)) with glufosinate ammonium, N-acetyl-glufosinate, and 3methylphosphinico-propionic acid. Subsequent to this decision, based upon a petition from Bayer, EPA modified the tolerance expressions in subsections (a)(1) and (a)(2) so that they are identical for transgenic and non-transgenic crops. 68 FR 55833 (September 29, 2003). This modification was done because EPA concluded that a single tolerance expression for both transgenic crops and non-transgenic crops (i.e. glufosinate ammonium, N-acetyl-glufosinate, and 3methylphosphinico-propionic acid) was appropriate for the following reasons: 1) Enforcement laboratories do not know if a sample is derived from transgenic or non-transgenic crop and 2) the enforcement method quantifies glufosinate ammonium and N-acetylglufosinate together (both are devitalized to the same compound). As a result of the decision, the tolerance expression for 40 CFR 180.473 (a)(1) was altered to include N-acetylglufosinate; however, the tolerances in 40 CFR 180.473 (a)(2) remains. EPA has determined that consolidating the existing glufosinate tolerances in subsections (a)(1) and (a)(2) and removing the transgenic crop restriction, where applicable, is safe and is appropriate. Tolerance levels will not need to be increased with the addition of a pre-plant burn down use because the same seasonal amount limitations are being retained. Given that foliar applications would result in higher residue levels than pre-plant burn down, allocation of a portion of the permitted application to the pre-plant burn down use will not increase the residue level that could be present. III. Aggregate Risk Assessment and Determination of Safty 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 E:\FR\FM\21DER1.SGM 21DER1 72624 Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Rules and Regulations 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. . . .’’ These provisions were added to FFDCA by the Food Quality Protection Act (FQPA) of 1996. Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), 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 for the petitioned-for proposal to place all the commodities listed in 180.473 (a)(1) and 180.473 (a)(2) together in paragraph 180.473(a) based on the rationale for having a single tolerance expression is appropriate. Tolerance levels for combined residues of glufosinateammonium are unchanged. EPA’s assessment of exposures and risks associated with establishing the tolerance follows. sroberts on PROD1PC70 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 adverse effects caused by glufosinate-ammonium as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies. Specific information on the studies received and the nature of the toxic effects caused by glufosinate ammonium as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rule published in the Federal Register of September 29, 2003 (68 FR 55833) (FRL–7327–9). B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern (LOC) is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes VerDate Aug<31>2005 18:20 Dec 20, 2007 Jkt 214001 used for risk assessment. Uncertainty/ safety factors (UFs) are used in conjunction with the LOC to take into account 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. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http:// www.epa.gov/fedrgstr/EPA-PEST/1997/ November/Day-26/p30948.htm. A summary of the toxicological endpoints for glufosinate ammonium used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of September 29, 2003 (68 FR 55833) (FRL–7327–9). C. Exposure Assessment EPA concludes that the tolerance levels for combined residues of Glufosinate-ammonium are unchanged. The exposure assumptions discussed in the final rule published in the Federal Register of September 29, 2003 (68 FR 55833) (FRL–7327–9) remain the same. D. Safety Factor for Infants and Children A summary of the safety factor for infants and children for glufosinate ammonium is discussed in Unit III.D. of the final rule published in the Federal Register of September 29, 2003 (68 FR 55833) (FRL–7327–9) E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. For linear cancer risks, PO 00000 Frm 00062 Fmt 4700 Sfmt 4700 EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediateterm, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable UFs is not exceeded. Consistent with FFDCA section 408(b)(2)(D), and the factors specified in section 408(b)(2)(D), 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 for the petitioned-for revision in the tolerance expressions for combined residues of glufosinate-ammonium and its metabolites. EPA’s assessment of exposures and risks associated with establishing the tolerance are discussed in the Federal Register of September 29, 2003 (68 FR 55833) (FRL–7327–9). Accordingly 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 glufosinate-ammonium residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology gas chromatography is 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; email address: residuemethods@epa.gov. B. International Residue Limits Since tolerances levels remain the same and since there are no new tolerances established, harmonization with CODEX, Canada or Mexico’s MRLs is impacted. C. Response to Comments Public comments were received from B. Sachau who objected to the proposed tolerances because of the amounts of pesticides already consumed and carried by the American population. She further indicated that testing conducted on animals have absolutely no validity and are cruel to the test animals. B. Sachau’s comments contained no scientific data or evidence to rebut the Agency’s conclusion that there is a reasonable certainty that no harm will result from aggregate exposure to glufosinate ammonium, including all anticipated dietary exposures and all other exposures for which there is reliable information. EPA E:\FR\FM\21DER1.SGM 21DER1 Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Rules and Regulations has responded to B. Sachau’s generalized comments on numerous previous occasions. (January 7, 2005, 70 FR 1349) (October 29, 2004, 69 FR 63083). V. Conclusion Therefore, the tolerance regulation for the combined residues of glufosinateammonium and its metabolites expressed as butanoic acid, 2-amino-4(hydroxymethylphosphinyl)-, monoammonium salt, 2-acetamido-4methylphosphinico-butanoic acid and 3-methylphosphinico-propionic acid (expressed as glufosinate free acid equivalents), are revised by placing all the commodities listed §180.473 (a)(1) and (a)(2) together in §180.473 (a). 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, 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) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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., 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). 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. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not 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). 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). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report 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 14, 2007. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: I PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: I Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.473 is amended by revising paragraph (a) to read as follows. I 180.473 Glufosinate-ammonium; tolerances for residues. (a) General. Tolerances are established for residues of the herbicide glufosinate-ammonium (butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)monoammonium salt) and its metabolites, 2-acetamido-4methylphosphinico-butanoic acid and 3-methylphosphinico-propionic acid, expressed as 2-amino-4(hydroxymethylphosphinyl)butanoic acid equivalents, in or on the following food commodities: sroberts on PROD1PC70 with RULES Commodity Parts per million Almond, hulls ................................................................................................................................................... Apple ................................................................................................................................................................ Banana ............................................................................................................................................................. Banana, pulp .................................................................................................................................................... Beet, sugar, molasses ..................................................................................................................................... Beet, sugar, roots ............................................................................................................................................ Beet, sugar, tops (leaves) ............................................................................................................................... Bushberry subgroup 13B ................................................................................................................................. Canola, meal .................................................................................................................................................... Canola, seed .................................................................................................................................................... Cattle, fat ......................................................................................................................................................... Cattle, meat ..................................................................................................................................................... Cattle, meat byproducts ................................................................................................................................... Corn, field forage ............................................................................................................................................. Corn, field, grain .............................................................................................................................................. Corn, field, stover ............................................................................................................................................ VerDate Aug<31>2005 18:20 Dec 20, 2007 Jkt 214001 PO 00000 Frm 00063 72625 Fmt 4700 Sfmt 4700 E:\FR\FM\21DER1.SGM 0.50 0.05 0.30 0.20 5.0 0.9 1.5 0.15 1.1 0.40 0.40 0.15 6.0 4.0 0.20 6.0 21DER1 72626 Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Rules and Regulations Commodity Parts per million Cotton, gin byproducts ..................................................................................................................................... Cotton, undelinted seed ................................................................................................................................... Egg ................................................................................................................................................................... Goat, fat ........................................................................................................................................................... Goat, meat ....................................................................................................................................................... Goat, meat byproducts .................................................................................................................................... Grain aspirated fractions ................................................................................................................................. Grape ............................................................................................................................................................... Hog, fat ............................................................................................................................................................ Hog, meat ........................................................................................................................................................ Hog, meat byproducts ..................................................................................................................................... Horse, fat ......................................................................................................................................................... Horse, meat ..................................................................................................................................................... Horse, meat byproducts .................................................................................................................................. Juneberry ......................................................................................................................................................... Lingonberry ...................................................................................................................................................... Milk ................................................................................................................................................................... Nut, tree, group 14 .......................................................................................................................................... Pistachio .......................................................................................................................................................... Potato ............................................................................................................................................................... Potato, chips .................................................................................................................................................... Potato granules/flakes ..................................................................................................................................... Poultry, fat ........................................................................................................................................................ Poultry, meat .................................................................................................................................................... Poultry, meat byproducts ................................................................................................................................. Rice, grain ........................................................................................................................................................ Rice, hull .......................................................................................................................................................... Rice, straw ....................................................................................................................................................... Salal ................................................................................................................................................................. Sheep, fat ........................................................................................................................................................ Sheep, meat .................................................................................................................................................... Sheep, meat byproducts .................................................................................................................................. Soybean ........................................................................................................................................................... Soybean, hulls * * * * * FOR FURTHER INFORMATION CONTACT: [FR Doc. E7–24841 Filed 12–20–07; 8:45 am] BILLING CODE 6560–50–S Robert Hayne, Media Bureau (202) 418– 2177. This is a synopsis of the letter from Peter H. Doyle, Chief, Audio Division, Media Bureau to Liberty Productions, a Limited Partnership, et al., released December 11, 2007, (DA 07–4945). The full text of this letter is available for inspection and copying during normal business hours in the FCC Reference Information Center at Portals l1, CY– A257, 445 12th Street, SW., Washington, DC 20554. The complete text of this decision may also be purchased from the Commission’s copy contractor, Best Copying and Printing, Inc., 445 12th Street, SW., Room CY– B402, Washington, DC 20554, telephone 1–800–378–3160 or http:// www.BCPIWEB.com. The Commission, is, therefore, not required to submit a copy of this Letter pursuant to the Government Accountability Office, pursuant to the Congressional Review Act, see 5 U.S.C. 801 (a)(1)(A), because the Petition for Reconsideration was dismissed. SUPPLEMENTARY INFORMATION: FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [DA 07–4945; MB Docket No. 02–352; RM– 10602, RM–10776, RM–10777] Radio Broadcasting Services; Clyde and Glenville, NC, Tazewell, Tennessee and Weaverville, NC Federal Communications Commission. ACTION: Final rule; dismissal. sroberts on PROD1PC70 with RULES AGENCY: SUMMARY: This document approves a Joint Request for Approval of Settlement Agreement filed by Liberty Productions, a Limited Partnership, Saga Communications of North Carolina, LLC, Ashville Radio Partners, LLC, and Willsyr Communications, Limited Partnership, requesting withdrawal of a Petition for Reconsideration and all pleadings filed in connection MB Docket No. 02–352. With this action, the proceeding is terminated. VerDate Aug<31>2005 18:20 Dec 20, 2007 Jkt 214001 PO 00000 Frm 00064 Fmt 4700 Sfmt 4700 15 4.0 0.15 0.40 0.15 6.0 25 0.05 0.40 0.15 6.0 0.40 0.15 6.0 0.10 0.10 0.15 0.10 0.10 0.80 1.6 2.0 0.15 0.15 0.60 1.0 2.0 2.0 0.10 0.40 0.15 6.0 2.0 5.0 Federal Communications Commission. John A. Karousos, Assistant Chief, Audio Division, Media Bureau. [FR Doc. E7–24623 Filed 12–20–07; 8:45 am] BILLING CODE 6712–01–P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 070817468–7715–02] RIN 0648–AV91 Fisheries of the Northeastern United States; Atlantic Sea Scallop Fishery; Framework Adjustment 20 National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Final Rule. AGENCY: SUMMARY: NMFS issues this final rule to approve and implement measures contained in Framework Adjustment 20 (Framework 20) to the Atlantic Sea Scallop Fishery Management Plan (FMP). This action maintains the trip E:\FR\FM\21DER1.SGM 21DER1

Agencies

[Federal Register Volume 72, Number 245 (Friday, December 21, 2007)]
[Rules and Regulations]
[Pages 72622-72626]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24841]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0029; FRL-8342-3]


Glufosinate-ammonium; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation modifies the tolerances for the combined 
residues of glufosinate-ammonium and its metabolites expressed as 
butanoic acid in or on raw agricultural commodities. Bayer CropScience 
LLC requested this revision under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective December 21, 2007. Objections and 
requests for hearings must be received on or before February 19, 2008 
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-2007-0029. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Kathryn V. Montague, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-1243; e-mail address: 
montague.kathryn@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 those 
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to 
provide 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 EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to 
any aspect of this regulation and may also request a hearing on those 
objections. 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-2007-0029 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 as required by 40 CFR part 178 on or 
before February 19, 2008.
    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 this copy, identified by docket ID number 
EPA-HQ-OPP-2007-0029, 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 
Bldg.), 2777 S. Crystal Dr., 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 Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of February 28, 2007 (72 FR 9000) (FRL-
8115-5), 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 
6F7161) by Bayer CropScience LLC, 2 T.W. Alexander Dr.,

[[Page 72623]]

Research Triangle Park, NC 27709. The petition requested that 40 CFR 
180.473 be amended by establishing a tolerance for combined residues of 
the herbicide, glufosinate-ammonium and its metabolites expressed as 
butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-, monoammonium salt, 
2-acetamido-4-methylphosphinico-butanoic acid and 3-methylphosphinico-
propionic acid (expressed as glufosinate free acid equivalents), in or 
on raw agricultural commodities grain aspirated fractions at 25.0 parts 
per million (ppm); non- transgenic canola, meal at 1.1 ppm; non-
transgenic canola, seed at 0.4 ppm; non- transgenic field corn, forage 
at 4.0 ppm; non- transgenic field corn, grain at 0.2 ppm; non- 
transgenic field corn, stover at 6.0 ppm; non- transgenic soybean, at 
2.0 ppm; non-transgenic soybean, hulls at 5.0 ppm. That notice 
referenced a summary of the petition prepared by Bayer CropScience LLC, 
the registrant, which is available to the public in the docket, http://
www.regulations.gov.
     In the Federal Register of June 27, 2007 (72 FR 35237) (FRL-8133-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the amendment to existing tolerances by 
filing of a pesticide petition (PP 6F7161) by Bayer CropScience LLC, 2 
T.W. Alexander Dr., Research Triangle Park, NC 27709. The petition 
proposes to amend the tolerances in 40 CFR 180.473(a) to eliminate the 
reference to transgenic crops tolerant to glufosinate ammonium in 
Sec. 180.473(a)(2) such that the crop tolerances listed under 
Sec. 180.473 (a) General, support uses in all of the crops listed to 
include both conventional and transgenic crops and to delete 
Sec. 180.473 (a)(1) and (a)(2). This notice clarifies the initial 
notice of filing published in the Federal Register of February 28, 2007 
(72 FR 9000) (FRL-8115-5). The tolerances for glufosinate-ammonium and 
its metabolites listed for the commodities under both paragraphs (a)(1) 
and paragraph (a)(2) are proposed to be placed in Sec. 180.473 (a) 
General to read as follows: Tolerances are established for residues of 
glufosinate-ammonium (butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl)-monoammonium salt) and its metabolites 
expressed as butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-, 
monoammonium salt, 2-acetamido-4-methylphosphinico-butanoic acid and 3-
methylphosphinico-propionic acid expressed as glufosinate free acid 
equivalents in or on the raw agricultural commodities: Almond, hulls at 
0.50 ppm; apple at 0.05 ppm; grain aspirated fractions at 25.0 ppm; 
banana at 0.30 ppm; banana, pulp at 0.20 ppm; beet, sugar, molasses at 
5.0 ppm; beet, sugar, roots at 0.9 ppm; beet, sugar, tops at 1.5 ppm; 
bushberry subgroup 13B at 0.15 ppm; canola, meal at 1.1 ppm; canola, 
seed at 0.4 at ppm; cattle, fat at 0.40 ppm; cattle, meat at 0.15 ppm; 
cattle, meat byproducts at 6.0 ppm; corn, field forage at 4.0 ppm; 
corn, field, grain at 0.2 ppm; corn, field, stover at 6.0 ppm; cotton, 
gin byproducts at 15 ppm; cotton, undelinted seed at 4.0 ppm; egg at 
0.15 ppm; goat, fat at 0.40 ppm; goat, meat at 0.15 ppm; goat, meat 
byproducts at 6.0 ppm; grape at 0.05 ppm; hog, fat at 0.40 ppm; hog, 
meat at 0 .15; hog, meat byproducts at 6.0 ppm; horse, fat at 0.40 ppm; 
horse, meat at 0.15 ppm; horse, meat byproducts at 6.0 ppm; Juneberry 
0.10 ppm; lingonberry at 0.10 ppm; milk at 0.15 ppm; nut, tree, group 
14 at 0.10 ppm; potato at 0.80 ppm; potato, chips at 1.60 ppm; potato 
granules/flakes 2.00 ppm; poultry, fat 0.15 ppm; poultry, meat at 0.15 
ppm; poultry, meat byproducts 0.60 ppm; rice, grain at 1.0 ppm; rice, 
hull at 2.0 ppm; rice, straw at 2.0 ppm; salal at 0.10 ppm; sheep, fat 
at 0.40 ppm; sheep, meat at 0.15 ppm; sheep, meat byproducts at 6.0 
ppm; soybean at 2.0 ppm and soybean, hulls at 5.0 ppm.
    Comments were received on the notices of filing. EPA's response to 
these comments is discussed in Unit IV.C.
    Bayer's petition asks EPA to consolidate subsections (a)(1) and 
(a)(2) of 40 CFR 180.473 which contains tolerances for glufosinate on 
various non-transgenic crops and transgenic crops, respectively, and 
remove the restriction as to transgenic crops. In part this petition is 
related to Bayer's application to EPA to amend its glufosinate 
registration under the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) to allow pre-plant burn down application to both transgenic 
and non-transgenic field corn, canola, and soybean. Glufosinate is 
currently registered foliar uses on the transgenic forms of these 
crops. The proposed registration amendment would not alter existing 
seasonal application amount limitations. There are currently no FFDCA 
tolerances for glufosinate on non-transgenic field corn, canola, and 
soybean but FFDCA tolerances are in place for the foliar use on the 
transgenic form of these crops. Consolidating subsections (a)(1) and 
(a)(2) and removing the transgenic restriction would address the lack 
of tolerances for non-transgenic field corn, canola, and soybean.
    EPA initially concluded that two tolerance expressions were 
appropriate for plants: non-transgenic (40 CFR 180.473 (a)(1)) with 
glufosinate ammonium and 3-methylphosphinico-propionic acid and 
transgenic crops (40 CFR 180.473 (a)(2)) with glufosinate ammonium, N-
acetyl-glufosinate, and 3-methylphosphinico-propionic acid. Subsequent 
to this decision, based upon a petition from Bayer, EPA modified the 
tolerance expressions in subsections (a)(1) and (a)(2) so that they are 
identical for transgenic and non-transgenic crops. 68 FR 55833 
(September 29, 2003). This modification was done because EPA concluded 
that a single tolerance expression for both transgenic crops and non-
transgenic crops (i.e. glufosinate ammonium, N-acetyl-glufosinate, and 
3-methylphosphinico-propionic acid) was appropriate for the following 
reasons: 1) Enforcement laboratories do not know if a sample is derived 
from transgenic or non-transgenic crop and 2) the enforcement method 
quantifies glufosinate ammonium and N-acetyl-glufosinate together (both 
are devitalized to the same compound). As a result of the decision, the 
tolerance expression for 40 CFR 180.473 (a)(1) was altered to include 
N-acetyl-glufosinate; however, the tolerances in 40 CFR 180.473 (a)(2) 
remains. EPA has determined that consolidating the existing glufosinate 
tolerances in subsections (a)(1) and (a)(2) and removing the transgenic 
crop restriction, where applicable, is safe and is appropriate. 
Tolerance levels will not need to be increased with the addition of a 
pre-plant burn down use because the same seasonal amount limitations 
are being retained. Given that foliar applications would result in 
higher residue levels than pre-plant burn down, allocation of a portion 
of the permitted application to the pre-plant burn down use will not 
increase the residue level that could be present.

III. Aggregate Risk Assessment and Determination of Safty

    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

[[Page 72624]]

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. . . .'' These provisions were added to 
FFDCA by the Food Quality Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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 for the petitioned-for proposal to 
place all the commodities listed in 180.473 (a)(1) and 180.473 (a)(2) 
together in paragraph 180.473(a) based on the rationale for having a 
single tolerance expression is appropriate. Tolerance levels for 
combined residues of glufosinate-ammonium are unchanged. EPA's 
assessment of exposures and risks associated with establishing the 
tolerance 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 adverse effects caused by glufosinate-ammonium as well as the 
no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies.
    Specific information on the studies received and the nature of the 
toxic effects caused by glufosinate ammonium as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in the 
final rule published in the Federal Register of September 29, 2003 (68 
FR 55833) (FRL-7327-9).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which no adverse effects are observed (the 
NOAEL) in the toxicology study identified as appropriate for use in 
risk assessment. However, if a NOAEL cannot be determined, the lowest 
dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the LOC to take into account 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. Safety is assessed for acute and chronic 
risks by comparing aggregate exposure to the pesticide to the acute 
population adjusted dose (aPAD) and chronic population adjusted dose 
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all 
applicable UFs. Short-term, intermediate-term, and long-term risks are 
evaluated by comparing aggregate exposure to the LOC to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://
www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for glufosinate ammonium 
used for human risk assessment is discussed in Unit III.B. of the final 
rule published in the Federal Register of September 29, 2003 (68 FR 
55833) (FRL-7327-9).

C. Exposure Assessment

    EPA concludes that the tolerance levels for combined residues of 
Glufosinate-ammonium are unchanged. The exposure assumptions discussed 
in the final rule published in the Federal Register of September 29, 
2003 (68 FR 55833) (FRL-7327-9) remain the same.

D. Safety Factor for Infants and Children

    A summary of the safety factor for infants and children for 
glufosinate ammonium is discussed in Unit III.D. of the final rule 
published in the Federal Register of September 29, 2003 (68 FR 55833) 
(FRL-7327-9)

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-term, intermediate-term, 
and long-term risks are evaluated by comparing aggregate exposure to 
the LOC to ensure that the MOE called for by the product of all 
applicable UFs is not exceeded.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in section 408(b)(2)(D), 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 for the petitioned-for revision in 
the tolerance expressions for combined residues of glufosinate-ammonium 
and its metabolites. EPA's assessment of exposures and risks associated 
with establishing the tolerance are discussed in the Federal Register 
of September 29, 2003 (68 FR 55833) (FRL-7327-9).
     Accordingly 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 glufosinate-ammonium residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology gas chromatography is 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

    Since tolerances levels remain the same and since there are no new 
tolerances established, harmonization with CODEX, Canada or Mexico's 
MRLs is impacted.

C. Response to Comments

    Public comments were received from B. Sachau who objected to the 
proposed tolerances because of the amounts of pesticides already 
consumed and carried by the American population. She further indicated 
that testing conducted on animals have absolutely no validity and are 
cruel to the test animals. B. Sachau's comments contained no scientific 
data or evidence to rebut the Agency's conclusion that there is a 
reasonable certainty that no harm will result from aggregate exposure 
to glufosinate ammonium, including all anticipated dietary exposures 
and all other exposures for which there is reliable information. EPA

[[Page 72625]]

has responded to B. Sachau's generalized comments on numerous previous 
occasions. (January 7, 2005, 70 FR 1349) (October 29, 2004, 69 FR 
63083).

V. Conclusion

    Therefore, the tolerance regulation for the combined residues of 
glufosinate-ammonium and its metabolites expressed as butanoic acid, 2-
amino-4-(hydroxymethylphosphinyl)-, monoammonium salt, 2-acetamido-4-
methylphosphinico-butanoic acid and 3-methylphosphinico-propionic acid 
(expressed as glufosinate free acid equivalents), are revised by 
placing all the commodities listed Sec. 180.473 (a)(1) and (a)(2) 
together in Sec. 180.473 (a).

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, 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) or Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). 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., 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).
    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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000) do not apply to this rule. In addition, This 
rule does not 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).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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 14, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.473 is amended by revising paragraph (a) to read as 
follows.


180.473  Glufosinate-ammonium; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide glufosinate-ammonium (butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl)-monoammonium salt) and its metabolites, 2-
acetamido-4-methylphosphinico-butanoic acid and 3-methylphosphinico-
propionic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents, in or on the 
following food commodities:

------------------------------------------------------------------------
              Commodity                        Parts per million
------------------------------------------------------------------------
Almond, hulls.......................                                0.50
Apple...............................                                0.05
Banana..............................                                0.30
Banana, pulp........................                                0.20
Beet, sugar, molasses...............                                 5.0
Beet, sugar, roots..................                                 0.9
Beet, sugar, tops (leaves)..........                                 1.5
Bushberry subgroup 13B..............                                0.15
Canola, meal........................                                 1.1
Canola, seed........................                                0.40
Cattle, fat.........................                                0.40
Cattle, meat........................                                0.15
Cattle, meat byproducts.............                                 6.0
Corn, field forage..................                                 4.0
Corn, field, grain..................                                0.20
Corn, field, stover.................                                 6.0

[[Page 72626]]

 
Cotton, gin byproducts..............                                  15
Cotton, undelinted seed.............                                 4.0
Egg.................................                                0.15
Goat, fat...........................                                0.40
Goat, meat..........................                                0.15
Goat, meat byproducts...............                                 6.0
Grain aspirated fractions...........                                  25
Grape...............................                                0.05
Hog, fat............................                                0.40
Hog, meat...........................                                0.15
Hog, meat byproducts................                                 6.0
Horse, fat..........................                                0.40
Horse, meat.........................                                0.15
Horse, meat byproducts..............                                 6.0
Juneberry...........................                                0.10
Lingonberry.........................                                0.10
Milk................................                                0.15
Nut, tree, group 14.................                                0.10
Pistachio...........................                                0.10
Potato..............................                                0.80
Potato, chips.......................                                 1.6
Potato granules/flakes..............                                 2.0
Poultry, fat........................                                0.15
Poultry, meat.......................                                0.15
Poultry, meat byproducts............                                0.60
Rice, grain.........................                                 1.0
Rice, hull..........................                                 2.0
Rice, straw.........................                                 2.0
Salal...............................                                0.10
Sheep, fat..........................                                0.40
Sheep, meat.........................                                0.15
Sheep, meat byproducts..............                                 6.0
Soybean.............................                                 2.0
Soybean, hulls                                                       5.0
------------------------------------------------------------------------

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[FR Doc. E7-24841 Filed 12-20-07; 8:45 am]
BILLING CODE 6560-50-S