Environmental Protection Agency (EPA).
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).
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).
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.Start Further Info
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: email@example.com.End Further Info End Preamble Start Supplemental Information
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to 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., Start Printed Page 72623Research 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 §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 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 Start Printed Page 72624tolerance 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: firstname.lastname@example.org.
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 Start Printed Page 72625has responded to B. Sachau's generalized comments on numerous previous occasions. (January 7, 2005, 70 FR 1349) (October 29, 2004, 69 FR 63083).
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 §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).Start List of Subjects
List of Subjects in 40 CFR Part 180
- Environmental protection
- Administrative practice and procedure
- Agricultural commodities
- Pesticides and pests
- Reporting and recordkeeping requirements
Dated: December 14, 2007.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:End Amendment Part Start Part
PART 180—[AMENDED]End Part Start Amendment Part
1. The authority citation for part 180 continues to read as follows:End Amendment Part Start Amendment Part
2. Section 180.473 is amended by revising paragraph (a) to read as follows.End Amendment Part
(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|
|Beet, sugar, molasses||5.0|
|Beet, sugar, roots||0.9|
|Beet, sugar, tops (leaves)||1.5|
|Bushberry subgroup 13B||0.15|
|Cattle, meat byproducts||6.0|
|Corn, field forage||4.0|
|Corn, field, grain||0.20|
|Corn, field, stover||6.0|
|Start Printed Page 72626|
|Cotton, gin byproducts||15|
|Cotton, undelinted seed||4.0|
|Goat, meat byproducts||6.0|
|Grain aspirated fractions||25|
|Hog, meat byproducts||6.0|
|Horse, meat byproducts||6.0|
|Nut, tree, group 14||0.10|
|Poultry, meat byproducts||0.60|
|Sheep, meat byproducts||6.0|
[FR Doc. E7-24841 Filed 12-20-07; 8:45 am]
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