Bacillus Thuringiensis Vip3Aa19 Protein in Cotton; Extension of a Temporary Exemption From the Requirement of a Tolerance, 68744-68748 [E7-23660]

Download as PDF 68744 Federal Register / Vol. 72, No. 234 / Thursday, December 6, 2007 / Rules and Regulations (12) Selecting plants that tolerate air pollution agents and toxic soil chemicals; (13) Selecting plants that mitigate odor, PM–10, and PM–2.5; (14) Testing plants for biofuels and other energy-related activities; and (15) Evaluating plants and techniques to combat invasive plant species and for reestablishment of desirable species after eradication. rmajette on PROD1PC64 with RULES § 613.3 NRCS responsibilities in plant materials. NRCS operates or enters into agreements with State universities or other State organizations to operate plant materials centers. Also, NRCS cooperates, both formally and informally, with other Federal, State, county, and nonprofit agencies or organizations on the selection of plants and evaluation of plant technology to increase the capabilities of plant materials centers. NRCS employs specialists for testing and selecting plant materials for conservation uses and the development of plant materials technology. NRCS responsibilities are to: (a) Identify the resource conservation needs and cultural management methods for environmental protection and enhancement. (b) Assemble and comparatively evaluate plant materials at plant materials centers and on sites where soil, climate, or other conditions differ significantly from those at the centers. (c) Make comparative field plantings for final testing of promising plants and techniques in cooperation with conservation districts and other interested cooperators. (d) Release cooperatively improved conservation plants and maintain the breeder or foundation stocks in ways appropriate for particular State and plant species by working with experiment stations, crop improvement associations, and other State and Federal agencies. (e) Produce limited amounts of foundation or foundation-quality seed and plants available by grant to or by exchange with conservation districts, experiment stations, other Federal and State research agencies, and State seed certifying organizations that will use the material to establish seed fields, seed orchards, or plantings for vegetative increase. (f) Encourage and assist conservation districts, commercial seed producers, and commercial and State nurseries to produce needed plant materials for conservation uses. (g) Encourage the use of improved plant materials and plant materials VerDate Aug<31>2005 15:21 Dec 05, 2007 Jkt 214001 technology in resource conservation and environmental improvement programs. ENVIRONMENTAL PROTECTION AGENCY § 613.4 Special production of plant materials. 40 CFR Part 174 NRCS can produce plant materials in the quantity required to do a specific conservation job if this production will serve the public welfare and only if the plant materials are not available commercially. This function will be performed only until the plant materials are available commercially. Specific production of plant materials by NRCS requires the approval of the Chief. § 613.5 Plant materials centers. (a) The National Plant Materials Center. The National Plant Materials Center at Beltsville, Maryland focuses on national initiatives and provides coordination for plant materials work across all 50 States. In addition, the center provides plants and plant technology to address resource concerns in the mid-Atlantic region. (b) Other Plant Materials Centers. There are 26 other plant materials centers; each serves several major land resource areas. Twenty-four of these centers are operated by NRCS and two by cooperating agencies as follows: (1) Operated by NRCS: Tucson, Arizona; Booneville, Arkansas; Lockeford, California; Brooksville, Florida; Americus, Georgia; Molokai, Hawaii; Aberdeen, Idaho; Manhattan, Kansas; Golden Meadows, Louisiana; East Lansing, Michigan; Coffeeville, Mississippi; Elsberry, Missouri; Bridger, Montana; Fallon, Nevada; Cape May Courthouse, New Jersey; Los Lunas, New Mexico; Big Flats, New York; Bismarck, North Dakota; Corvallis, Oregon; Kingsville, Texas; Knox City, Texas; Nacogdoches, Texas; Pullman, Washington; and Alderson, West Virginia. (2) Operated by cooperating agencies with financial and technical assistance from NRCS: Meeker, Colorado—White River and Douglas Creek Soil Conservation Districts with partial funding from NRCS. (3) Operated by cooperating agencies with technical assistance from NRCS: Palmer, Alaska—State of Alaska, Department of Natural Resources. Signed in Washington, DC, on November 20, 2007. Arlen L. Lancaster, Chief. [FR Doc. E7–23525 Filed 12–5–07; 8:45 am] BILLING CODE 3410–16–P PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 [EPA–HQ–OPP–2007–0575; FRL–8340–4] Bacillus Thuringiensis Vip3Aa19 Protein in Cotton; Extension of a Temporary Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation extends the temporary exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Vip3Aa19 protein in cotton when applied or used as a plant-incorporated protectant (PIP). Syngenta Seeds, Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting the temporary tolerance exemption be extended. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus thuringiensis Vip3Aa19 protein in cotton when applied or used as a PIP on cotton. The temporary tolerance exemption expires on May 1, 2009. DATES: This regulation is effective December 6, 2007. Objections and requests for hearings must be received on or before February 4, 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–2007–0575. 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 E:\FR\FM\06DER1.SGM 06DER1 Federal Register / Vol. 72, No. 234 / Thursday, December 6, 2007 / Rules and Regulations 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: Alan Reynolds, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 605–0515; e-mail address: reynolds.alan@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. rmajette on PROD1PC64 with RULES B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http:// www.regulations.gov, you may access this ‘‘Federal Register’’ document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of 40 CFR part 174 through the Government Printing Office’s pilot e-CFR site at http:// www.gpoaccess.gov/ecfr. VerDate Aug<31>2005 15:21 Dec 05, 2007 Jkt 214001 68745 II. Background and Statutory Findings exemption from the requirement of a tolerance for residues of Bacillus thuringiensis Vip3Aa19 insect control protein (vector pCOT1) when applied or used as a PIP on cotton expires on May 1, 2009. This notice included a summary of the petition prepared by the petitioner, Syngenta Seeds, Inc. There were no comments received in response to the notice of filing. Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is ‘‘safe.’’ Section 408(c)(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. Pursuant to section 408(c)(2)(B) of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA, which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....’’ Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency consider ‘‘available information concerning the cumulative effects of a particular pesticide’s residues’’ and ‘‘other substances that have a common mechanism of toxicity.’’ EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. In the Federal Register of August 8, 2007 (72 FR 44521) (FRL–8139–7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 7F7216) by Syngenta Seeds, Inc., 3054 Cornwallis Rd., P.O. Box 12257, Research Triangle Park, NC 27709. The petition requested that 40 CFR 174.501 be amended such that the temporary III. Toxicological Profile Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, as amended by FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2007–0575 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before February 4, 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 your copies, identified by docket ID number EPA–HQ–OPP–2007–0575, 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. PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 E:\FR\FM\06DER1.SGM 06DER1 rmajette on PROD1PC64 with RULES 68746 Federal Register / Vol. 72, No. 234 / Thursday, December 6, 2007 / Rules and Regulations identifiable subgroups of consumers, including infants and children. Data have been submitted demonstrating a lack of mammalian toxicity at high levels of exposure to the pure (microbially expressed) Vip3Aa19 protein. These data demonstrate the safety of Vip3Aa19 at levels well above maximum possible exposure levels that are reasonably anticipated in the crops. This is similar to the Agency position regarding toxicity and the requirement of residue data for the microbial Bacillus thuringiensis products from which this PIP was derived (See 40 CFR 158.740(b)(2)(i)). For microbial products, the need for Tier II and III toxicity testing and residue data to verify the observed effects and clarify the source of these effects is triggered only by significant acute effects in studies such as the mouse oral toxicity study. In previously submitted Vip3A studies and applications, the designation VIP3A or Vip3A was used to describe the Vip PIP protein and/or test material. In the final rule, it is necessary to distinguish the various Vip3A designations based on the Crickmore Bacillus thuringiensis Vip3A nomenclature (see http:// www.lifesci.sussex.ac.uk/Home/ Neil_Crickmore/Bt). The original Vip3A toxin as expressed in COT102 is now known as Vip3Aa19 toxin according to the Crickmore nomenclature designation. A temporary exemption from the requirement of tolerance already has been established for the Bacillus thuringiensis Vip3Aa19 protein in cotton (See the Federal Register issue of July 25, 2007 (72 FR 40752) (FRL– 8134–3); 40 CFR 174.501 that expires May 1, 2008. An acute oral toxicity study was submitted for the Vip3Aa19 protein. Male and female mice (16 of each) were dosed with 3,675 milligrams/kilograms bodyweight (mg/kg bwt) of Vip3Aa19 protein. All mice survived the study, gained weight, had no test materialrelated clinical signs, and had no test material-related findings at necropsy. This acute oral toxicity data supports the prediction that the Vip3Aa19 protein would be non-toxic to humans. When proteins are toxic, they are known to act via acute mechanisms and at very low dose levels (Sjoblad, Roy D., et al. 1992). Therefore, since no effects were shown to be caused by the PIP, even at relatively high-dose levels, the Vip3Aa19 protein is not considered toxic. Amino acid sequence comparisons showed no similarity between the Vip3Aa19 protein and known toxic proteins available in public protein data bases. According to the VerDate Aug<31>2005 15:21 Dec 05, 2007 Jkt 214001 Codex Alimintarius Commission (Codex) guidelines, the assessment of potential toxicity also includes stability to heat (Joint Food and Agriculture Organization of the United Nations/ World Health Organization (FAO/WHO) Food Standard Programme, Codex Alimentarius Commission, 20031). A heat lability study demonstrated that Vip3Aa19 is inactivated against fall armyworm when heated to 55 °C for 30 minutes. Since Vip3Aa19 is a protein, allergenic sensitivities were considered. Currently, no definitive tests exist for determining the allergenic potential of novel proteins. Therefore, EPA uses a weight-of-the-evidence approach where the following factors are considered: source of the trait; amino acid sequence similarity with known allergens; prevalence in food; and biochemical properties of the protein, including in vitro digestibility in simulated gastric fluid (SGF), and glycosylation. This approach was described by the Codex guidelines for the conduct of food safety assessment of food derived from recombinant-DNA plants including the assessment of possible allergenicity in 2003 (Joint FAO/WHO Food Standard Programme, Codex Alimentarius Commission, 20031). Data have been submitted that demonstrate that the Vip3A from recombinant maize (LPPACHA–0199) and E. coli (VIP3A–0100) proteins are rapidly degraded by gastric fluid in vitro. (VIP3A–0100 refers to a microbially expressed Vip3A that has been shown to be the equivalent of the plant-expressed Vip3A protein.) In a solution of SGF (containing pepsin) and either 80 microLiters (µL) of LPPACHA– 0199 or 320 µL of VIP3A–0100 test protein, both were shown to be susceptible to pepsin degradation. These data support the conclusion that Vip3A proteins expressed in transgenic plants will be readily digested as a conventional dietary protein under typical mammalian gastric conditions. Further data demonstrate that Vip3Aa19 is not glycoslylated and a comparison of amino acid sequences of known allergens uncovered no evidence of any homology with Vip3Aa19, even at the level of eight contiguous amino acid residues. These data demonstrated that mean Vip3Aa19 concentration in cotton seed ranged from (circa). 2.51 to 3.23 1 Alinorm 03/34: Joint FAO/WHO Food Standard Programme, Codex Alimentarius Commission, Twenty-Fifth Session, Rome, Italy 30 June–5 July, 2003. Appendix III, Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants and Appendix IV, Annex on the assessment of possible allergenicity. Rome, Codex Alimentarius Commission, 2003, p.p 47–60. PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 micrograms (µg) Vip3A/g dry weight. Vip3Aa19 was not detected in cotton fiber or nectar. Analysis of the refined oil and de-fatted meal by EnzymeLinked Immunosorbent Assay (ELISA) detected Vip3Aa19 protein in COT102 meal, but not in oil. Therefore, based on the data provided for the specific Vip3Aa19 protein, one can conclude that the Vip3Aa19 protein is present in low levels in cotton seed and not detected in cotton fiber. Therefore, the potential for the Vip3Aa19 protein to be a food allergen is minimal. As noted in Unit III., toxic proteins typically act as acute toxins with low dose levels. Therefore, since no effects were shown to be caused by this PIP, even at relatively high-dose levels, the Vip3Aa19 protein is not considered toxic. IV. Aggregate Exposures In examining aggregate exposure, section 408 of FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other nonoccupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). The Agency has considered available information on the aggregate exposure levels of consumers (and major identifiable subgroups of consumers) to the pesticide chemical residue and to other related substances. These considerations include dietary exposure under the tolerance exemption and all other tolerances or exemptions in effect for the PIP chemical residue, and exposure from non-occupational sources. Exposure via the skin or inhalation is not likely since the PIP is contained within plant cells, which essentially eliminates these exposure routes or reduces these exposure routes to negligible. The amino acid homology assessment revealed no similarities to known aeroallergens, indicating that Vip3A has a low potential to be an inhalation allergen. It has been demonstrated that there is no evidence of occupationally related respiratory symptoms, based on a health survey on migrant workers after exposure to Bacillus thuringiensis pesticides (Berstein et al. 1999), which provides further evidence of the negligible respiratory risks of Bacillus thuringiensis PIPs. Exposure via residential or lawn use to infants and children is also not expected because the use sites for the Vip3Aa19 protein are all agricultural for control of insects. Oral exposure, at very low levels may E:\FR\FM\06DER1.SGM 06DER1 Federal Register / Vol. 72, No. 234 / Thursday, December 6, 2007 / Rules and Regulations occur from ingestion of processed corn products and, theoretically, drinking water. However, oral toxicity testing done at a dose in excess of 3 grams/kilogram (gm/kg) showed no adverse effects. Furthermore, the expected dietary exposure from cotton is several orders of magnitude lower than the amounts of Vip3Aa19 protein shown to have no toxicity. Therefore, even if negligible aggregate exposure should occur, the Agency concludes that such exposure would present no harm due to the lack of mammalian toxicity and the rapid digestibility demonstrated for the Vip3Aa19 proteins. V. Cumulative Effects Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered available information on the cumulative effects of such residues and other substances that have a common mechanism of toxicity. These considerations include the cumulative effects on infants and children of such residues and other substances with a common mechanism of toxicity. Because there is no indication of mammalian toxicity, the Agency concludes that there are no cumulative effects arising from Vip3Aa19 protein residues in cotton. VI. Determination of Safety for U.S. Population, Infants and Children rmajette on PROD1PC64 with RULES A. Toxicity and Allergenicity Conclusions The data submitted and cited regarding potential health effects for the Vip3Aa19 protein include the characterization of the expressed Vip3Aa19 protein in cotton, as well as the acute oral toxicity, heat stability, and in vitro digestibility of the proteins. The results of these studies were determined applicable to evaluate human risk, and the validity, completeness, and reliability of the available data from the studies were considered. Adequate information was submitted to show that the Vip3A protein test material derived from microbial cultures (designated VIP3A–0100) was biochemically and functionally similar to the Vip3Aa19 protein expressed in cotton. Microbially produced protein was chosen in order to obtain sufficient material for testing. The acute oral toxicity data submitted supports the prediction that the Vip3Aa19 protein would be non-toxic to humans. As mentioned in Unit III., when proteins are toxic, they are known to act via acute mechanisms and at very low-dose levels (Sjoblad, Roy D., et al. VerDate Aug<31>2005 15:21 Dec 05, 2007 Jkt 214001 1992). Since no effects were shown to be caused by Vip3Aa19 protein, even at relatively high dose levels (3,675 mg Vip3Aa19/kg bwt), the Vip3Aa19 protein is not considered toxic. This is similar to the Agency position regarding toxicity and the requirement of residue data for the microbial Bacillus thuringiensis products from which this PIP was derived. (See 40 CFR 158.740(b)(2)(i)). Moreover, Vip3Aa19 showed no sequence similarity to any known toxin. Protein residue chemistry data for Vip3Aa19 were not required for a human health effects assessment of the subject PIP ingredients because of the lack of mammalian toxicity. Expression data demonstrated that mean Vip3Aa19 concentrations in cotton seed ranged from approximately 2.51 to 3.23 µg Vip3Aa19/g dry weight. Vip3Aa19 was not detected in cotton fiber or nectar. Analysis of the refined oil and de-fatted meal by ELISA detected Vip3Aa19 protein in COT102 meal, but not in oil. Therefore, Vip3Aa19 is present in low levels in cotton seed and not detectable in cotton fiber. Since Vip3Aa19 is a protein, its potential allergenicity is also considered as part of the toxicity assessment. Information considered as part of the allergenicity assessment included data demonstrating that the Vip3Aa19 protein came from a Bacillus thuringiensis which is not a known allergenic source, showed no sequence similarity to known allergens, was readily degraded by pepsin, and was not glycosylated when expressed in the plant. Therefore, there is a reasonable certainty that the Vip3Aa19 protein will not be an allergen. Neither available information concerning the dietary consumption patterns of consumers (and major identifiable subgroups of consumers including infants and children), nor safety factors that are generally recognized as appropriate for the use of animal experimentation data were evaluated. The lack of mammalian toxicity at high levels of exposure to the Vip3Aa19 protein, as well as the minimal potential to be a food allergen, demonstrate the safety of Vip3Aa19 at levels well above possible maximum exposure levels anticipated in the crop. The genetic material necessary for the production of the PIP active ingredients are the nucleic acids Deoxyribonucleic acid, Ribonucleic acid (DNA, RNA) which comprise genetic material encoding these proteins and their regulatory regions. The genetic material DNA, RNA necessary for the production of Vip3Aa19 protein already are exempted from the requirement of a PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 68747 tolerance under a blanket exemption for all nucleic acids (40 CFR 174.507). B. Infants and Children Risk Conclusions Section 408(b)(2)(C) of FFDCA provides that EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) also provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base, unless EPA determines that a different margin of safety will be safe for infants and children. In this instance, based on all the available information, the Agency concludes that there is a finding of no toxicity for the Vip3Aa19 protein and the genetic material necessary for its production in cotton. Because there are no threshold effects of concern, the Agency has determined that the additional tenfold margin of safety is not necessary to protect infants and children. Further, the provisions of consumption patterns, special susceptibility, and cumulative effects do not apply. C. Overall Safety Conclusion There is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of the Vip3Aa19 protein and the genetic material necessary for its production in cotton, when it is applied or used in accordance with good agricultural practices. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion because, as previously discussed, no toxicity to mammals has been observed, nor has there been any indication of allergenicity potential for this PIP. VII. Other Considerations A. Endocrine Disruptors The pesticidal active ingredient is a protein, derived from sources that are not known to exert an influence on the endocrine system. Therefore, the Agency is not requiring information on the endocrine effects of the PIP at this time. E:\FR\FM\06DER1.SGM 06DER1 68748 Federal Register / Vol. 72, No. 234 / Thursday, December 6, 2007 / Rules and Regulations B. Analytical Method(s) A method for extraction and ELISA analysis of the Vip3Aa19 protein in cotton has been submitted and is under review by the Agency. For the temporary tolerance exemption, the ELISA method described with the expression data is sufficient. C. Codex Maximum Residue Level No Codex maximum residue levels exist for the PIP Bacillus thuringiensis Vip3Aa19 protein and the genetic material necessary for its production in cotton. rmajette on PROD1PC64 with RULES VIII. Statutory and Executive Order Reviews This final rule extends the temporary exemption from the requirement of 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 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, VerDate Aug<31>2005 15:21 Dec 05, 2007 Jkt 214001 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). IX. 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). § 174.501 Bacillus thuringiensis Vip3Aa19 protein in cotton; temporary exemption from the requirement of a tolerance. Residues of Bacillus thuringiensis Vip3Aa19 protein in cotton are temporarily exempt from the requirement of a tolerance when used as a plant-incorporated protectant in the food and feed commodities of cotton; vegetative-insecticidal protein in cotton, undelinted seed, cotton, oil, cotton meal, cotton hay, cotton hulls, cotton forage, and cotton, gin byproducts. This temporary exemption from the requirement of tolerance will permit the use of the food commodities in this section when treated in accordance with the provisions of the experimental use permit 67979–EUP–7, which is being extended in accordance with the provisions of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136). This temporary exemption from the requirement of a tolerance expires and is revoked May 1, 2009; however, if the experimental use permit is revoked, or if any experience with or scientific data on this pesticide indicate that the temporary tolerance exemption is not safe, this temporary exemption from the requirement of a tolerance may be revoked at any time. [FR Doc. E7–23660 Filed 12–5–07; 8:45 am] BILLING CODE 6560–50–S DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 64 [Docket No. FEMA–8003] List of Subjects in 40 CFR Part 174 Suspension of Community Eligibility Environmental protection, Administrative practice and procedure, Pesticides and pests, Reporting and recordkeeping requirements. AGENCY: Dated: November 27, 2007. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: I PART 174—[AMENDED] 1. The authority citation for part 174 continues to read as follows: I Authority: 7 U.S.C. 136–136y; 21 U.S.C. 346a and 371. 2. Section 174.501 is revised to read as follows: I PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 Federal Emergency Management Agency, DHS. ACTION: Final rule. SUMMARY: This rule identifies communities, where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP), that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by E:\FR\FM\06DER1.SGM 06DER1

Agencies

[Federal Register Volume 72, Number 234 (Thursday, December 6, 2007)]
[Rules and Regulations]
[Pages 68744-68748]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23660]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2007-0575; FRL-8340-4]


Bacillus Thuringiensis Vip3Aa19 Protein in Cotton; Extension of a 
Temporary Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation extends the temporary exemption from the 
requirement of a tolerance for residues of the Bacillus thuringiensis 
Vip3Aa19 protein in cotton when applied or used as a plant-incorporated 
protectant (PIP). Syngenta Seeds, Inc., submitted a petition to EPA 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by 
the Food Quality Protection Act of 1996 (FQPA), requesting the 
temporary tolerance exemption be extended. This regulation eliminates 
the need to establish a maximum permissible level for residues of 
Bacillus thuringiensis Vip3Aa19 protein in cotton when applied or used 
as a PIP on cotton. The temporary tolerance exemption expires on May 1, 
2009.

DATES: This regulation is effective December 6, 2007. Objections and 
requests for hearings must be received on or before February 4, 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-2007-0575. 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

[[Page 68745]]

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: Alan Reynolds, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 605-0515; e-mail 
address: reynolds.alan@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://
www.regulations.gov, you may access this ``Federal Register'' document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 174 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, as amended by FQPA, any person may 
file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2007-0575 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk on or before February 4, 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 your copies, identified by docket ID 
number EPA-HQ-OPP-2007-0575, 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. Background and Statutory Findings

    In the Federal Register of August 8, 2007 (72 FR 44521) (FRL-8139-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 7F7216) by Syngenta Seeds, Inc., 3054 Cornwallis Rd., P.O. 
Box 12257, Research Triangle Park, NC 27709. The petition requested 
that 40 CFR 174.501 be amended such that the temporary exemption from 
the requirement of a tolerance for residues of Bacillus thuringiensis 
Vip3Aa19 insect control protein (vector pCOT1) when applied or used as 
a PIP on cotton expires on May 1, 2009. This notice included a summary 
of the petition prepared by the petitioner, Syngenta Seeds, Inc. There 
were no comments received in response to the notice of filing.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(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. Pursuant to section 408(c)(2)(B) of FFDCA, in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C) of FFDCA, which require EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....'' Additionally, section 408(b)(2)(D) of FFDCA requires that 
the Agency consider ``available information concerning the cumulative 
effects of a particular pesticide's residues'' and ``other substances 
that have a common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major

[[Page 68746]]

identifiable subgroups of consumers, including infants and children.
    Data have been submitted demonstrating a lack of mammalian toxicity 
at high levels of exposure to the pure (microbially expressed) Vip3Aa19 
protein. These data demonstrate the safety of Vip3Aa19 at levels well 
above maximum possible exposure levels that are reasonably anticipated 
in the crops. This is similar to the Agency position regarding toxicity 
and the requirement of residue data for the microbial Bacillus 
thuringiensis products from which this PIP was derived (See 40 CFR 
158.740(b)(2)(i)). For microbial products, the need for Tier II and III 
toxicity testing and residue data to verify the observed effects and 
clarify the source of these effects is triggered only by significant 
acute effects in studies such as the mouse oral toxicity study.
    In previously submitted Vip3A studies and applications, the 
designation VIP3A or Vip3A was used to describe the Vip PIP protein 
and/or test material. In the final rule, it is necessary to distinguish 
the various Vip3A designations based on the Crickmore Bacillus 
thuringiensis Vip3A nomenclature (see http://www.lifesci.sussex.ac.uk/
Home/Neil_Crickmore/Bt). The original Vip3A toxin as expressed in 
COT102 is now known as Vip3Aa19 toxin according to the Crickmore 
nomenclature designation. A temporary exemption from the requirement of 
tolerance already has been established for the Bacillus thuringiensis 
Vip3Aa19 protein in cotton (See the Federal Register issue of July 25, 
2007 (72 FR 40752) (FRL-8134-3); 40 CFR 174.501 that expires May 1, 
2008.
    An acute oral toxicity study was submitted for the Vip3Aa19 
protein. Male and female mice (16 of each) were dosed with 3,675 
milligrams/kilograms bodyweight (mg/kg bwt) of Vip3Aa19 protein. All 
mice survived the study, gained weight, had no test material-related 
clinical signs, and had no test material-related findings at necropsy. 
This acute oral toxicity data supports the prediction that the Vip3Aa19 
protein would be non-toxic to humans.
    When proteins are toxic, they are known to act via acute mechanisms 
and at very low dose levels (Sjoblad, Roy D., et al. 1992). Therefore, 
since no effects were shown to be caused by the PIP, even at relatively 
high-dose levels, the Vip3Aa19 protein is not considered toxic. Amino 
acid sequence comparisons showed no similarity between the Vip3Aa19 
protein and known toxic proteins available in public protein data 
bases. According to the Codex Alimintarius Commission (Codex) 
guidelines, the assessment of potential toxicity also includes 
stability to heat (Joint Food and Agriculture Organization of the 
United Nations/World Health Organization (FAO/WHO) Food Standard 
Programme, Codex Alimentarius Commission, 2003\1\). A heat lability 
study demonstrated that Vip3Aa19 is inactivated against fall armyworm 
when heated to 55 [deg]C for 30 minutes.
---------------------------------------------------------------------------

    \1\ Alinorm 03/34: Joint FAO/WHO Food Standard Programme, Codex 
Alimentarius Commission, Twenty-Fifth Session, Rome, Italy 30 June-5 
July, 2003. Appendix III, Guideline for the conduct of food safety 
assessment of foods derived from recombinant-DNA plants and Appendix 
IV, Annex on the assessment of possible allergenicity. Rome, Codex 
Alimentarius Commission, 2003, p.p 47-60.
---------------------------------------------------------------------------

    Since Vip3Aa19 is a protein, allergenic sensitivities were 
considered. Currently, no definitive tests exist for determining the 
allergenic potential of novel proteins. Therefore, EPA uses a weight-
of-the-evidence approach where the following factors are considered: 
source of the trait; amino acid sequence similarity with known 
allergens; prevalence in food; and biochemical properties of the 
protein, including in vitro digestibility in simulated gastric fluid 
(SGF), and glycosylation. This approach was described by the Codex 
guidelines for the conduct of food safety assessment of food derived 
from recombinant-DNA plants including the assessment of possible 
allergenicity in 2003 (Joint FAO/WHO Food Standard Programme, Codex 
Alimentarius Commission, 2003\1\).
    Data have been submitted that demonstrate that the Vip3A from 
recombinant maize (LPPACHA-0199) and E. coli (VIP3A-0100) proteins are 
rapidly degraded by gastric fluid in vitro. (VIP3A-0100 refers to a 
microbially expressed Vip3A that has been shown to be the equivalent of 
the plant-expressed Vip3A protein.) In a solution of SGF (containing 
pepsin) and either 80 microLiters ([micro]L) of LPPACHA-0199 or 320 
[micro]L of VIP3A-0100 test protein, both were shown to be susceptible 
to pepsin degradation. These data support the conclusion that Vip3A 
proteins expressed in transgenic plants will be readily digested as a 
conventional dietary protein under typical mammalian gastric 
conditions. Further data demonstrate that Vip3Aa19 is not glycoslylated 
and a comparison of amino acid sequences of known allergens uncovered 
no evidence of any homology with Vip3Aa19, even at the level of eight 
contiguous amino acid residues. These data demonstrated that mean 
Vip3Aa19 concentration in cotton seed ranged from (circa). 2.51 to 3.23 
micrograms ([micro]g) Vip3A/g dry weight. Vip3Aa19 was not detected in 
cotton fiber or nectar. Analysis of the refined oil and de-fatted meal 
by Enzyme-Linked Immunosorbent Assay (ELISA) detected Vip3Aa19 protein 
in COT102 meal, but not in oil. Therefore, based on the data provided 
for the specific Vip3Aa19 protein, one can conclude that the Vip3Aa19 
protein is present in low levels in cotton seed and not detected in 
cotton fiber.
    Therefore, the potential for the Vip3Aa19 protein to be a food 
allergen is minimal. As noted in Unit III., toxic proteins typically 
act as acute toxins with low dose levels. Therefore, since no effects 
were shown to be caused by this PIP, even at relatively high-dose 
levels, the Vip3Aa19 protein is not considered toxic.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA 
to consider available information concerning exposures from the 
pesticide residue in food and all other non-occupational exposures, 
including drinking water from ground water or surface water and 
exposure through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses).
    The Agency has considered available information on the aggregate 
exposure levels of consumers (and major identifiable subgroups of 
consumers) to the pesticide chemical residue and to other related 
substances. These considerations include dietary exposure under the 
tolerance exemption and all other tolerances or exemptions in effect 
for the PIP chemical residue, and exposure from non-occupational 
sources. Exposure via the skin or inhalation is not likely since the 
PIP is contained within plant cells, which essentially eliminates these 
exposure routes or reduces these exposure routes to negligible. The 
amino acid homology assessment revealed no similarities to known 
aeroallergens, indicating that Vip3A has a low potential to be an 
inhalation allergen. It has been demonstrated that there is no evidence 
of occupationally related respiratory symptoms, based on a health 
survey on migrant workers after exposure to Bacillus thuringiensis 
pesticides (Berstein et al. 1999), which provides further evidence of 
the negligible respiratory risks of Bacillus thuringiensis PIPs. 
Exposure via residential or lawn use to infants and children is also 
not expected because the use sites for the Vip3Aa19 protein are all 
agricultural for control of insects. Oral exposure, at very low levels 
may

[[Page 68747]]

occur from ingestion of processed corn products and, theoretically, 
drinking water.
    However, oral toxicity testing done at a dose in excess of 3 grams/
kilogram (gm/kg) showed no adverse effects. Furthermore, the expected 
dietary exposure from cotton is several orders of magnitude lower than 
the amounts of Vip3Aa19 protein shown to have no toxicity. Therefore, 
even if negligible aggregate exposure should occur, the Agency 
concludes that such exposure would present no harm due to the lack of 
mammalian toxicity and the rapid digestibility demonstrated for the 
Vip3Aa19 proteins.

V. Cumulative Effects

    Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered 
available information on the cumulative effects of such residues and 
other substances that have a common mechanism of toxicity. These 
considerations include the cumulative effects on infants and children 
of such residues and other substances with a common mechanism of 
toxicity. Because there is no indication of mammalian toxicity, the 
Agency concludes that there are no cumulative effects arising from 
Vip3Aa19 protein residues in cotton.

VI. Determination of Safety for U.S. Population, Infants and Children

A. Toxicity and Allergenicity Conclusions

    The data submitted and cited regarding potential health effects for 
the Vip3Aa19 protein include the characterization of the expressed 
Vip3Aa19 protein in cotton, as well as the acute oral toxicity, heat 
stability, and in vitro digestibility of the proteins. The results of 
these studies were determined applicable to evaluate human risk, and 
the validity, completeness, and reliability of the available data from 
the studies were considered.
    Adequate information was submitted to show that the Vip3A protein 
test material derived from microbial cultures (designated VIP3A-0100) 
was biochemically and functionally similar to the Vip3Aa19 protein 
expressed in cotton. Microbially produced protein was chosen in order 
to obtain sufficient material for testing.
    The acute oral toxicity data submitted supports the prediction that 
the Vip3Aa19 protein would be non-toxic to humans. As mentioned in Unit 
III., when proteins are toxic, they are known to act via acute 
mechanisms and at very low-dose levels (Sjoblad, Roy D., et al. 1992). 
Since no effects were shown to be caused by Vip3Aa19 protein, even at 
relatively high dose levels (3,675 mg Vip3Aa19/kg bwt), the Vip3Aa19 
protein is not considered toxic. This is similar to the Agency position 
regarding toxicity and the requirement of residue data for the 
microbial Bacillus thuringiensis products from which this PIP was 
derived. (See 40 CFR 158.740(b)(2)(i)). Moreover, Vip3Aa19 showed no 
sequence similarity to any known toxin.
    Protein residue chemistry data for Vip3Aa19 were not required for a 
human health effects assessment of the subject PIP ingredients because 
of the lack of mammalian toxicity. Expression data demonstrated that 
mean Vip3Aa19 concentrations in cotton seed ranged from approximately 
2.51 to 3.23 [micro]g Vip3Aa19/g dry weight. Vip3Aa19 was not detected 
in cotton fiber or nectar. Analysis of the refined oil and de-fatted 
meal by ELISA detected Vip3Aa19 protein in COT102 meal, but not in oil. 
Therefore, Vip3Aa19 is present in low levels in cotton seed and not 
detectable in cotton fiber.
    Since Vip3Aa19 is a protein, its potential allergenicity is also 
considered as part of the toxicity assessment. Information considered 
as part of the allergenicity assessment included data demonstrating 
that the Vip3Aa19 protein came from a Bacillus thuringiensis which is 
not a known allergenic source, showed no sequence similarity to known 
allergens, was readily degraded by pepsin, and was not glycosylated 
when expressed in the plant. Therefore, there is a reasonable certainty 
that the Vip3Aa19 protein will not be an allergen.
    Neither available information concerning the dietary consumption 
patterns of consumers (and major identifiable subgroups of consumers 
including infants and children), nor safety factors that are generally 
recognized as appropriate for the use of animal experimentation data 
were evaluated. The lack of mammalian toxicity at high levels of 
exposure to the Vip3Aa19 protein, as well as the minimal potential to 
be a food allergen, demonstrate the safety of Vip3Aa19 at levels well 
above possible maximum exposure levels anticipated in the crop.
    The genetic material necessary for the production of the PIP active 
ingredients are the nucleic acids Deoxyribonucleic acid, Ribonucleic 
acid (DNA, RNA) which comprise genetic material encoding these proteins 
and their regulatory regions. The genetic material DNA, RNA necessary 
for the production of Vip3Aa19 protein already are exempted from the 
requirement of a tolerance under a blanket exemption for all nucleic 
acids (40 CFR 174.507).

B. Infants and Children Risk Conclusions

    Section 408(b)(2)(C) of FFDCA provides that EPA shall assess the 
available information about consumption patterns among infants and 
children, special susceptibility of infants and children to pesticide 
chemical residues, and the cumulative effects on infants and children 
of the residues and other substances with a common mechanism of 
toxicity.
    In addition, FFDCA section 408(b)(2)(C) also provides that EPA 
shall apply an additional tenfold margin of safety for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the data base, unless EPA 
determines that a different margin of safety will be safe for infants 
and children.
    In this instance, based on all the available information, the 
Agency concludes that there is a finding of no toxicity for the 
Vip3Aa19 protein and the genetic material necessary for its production 
in cotton. Because there are no threshold effects of concern, the 
Agency has determined that the additional tenfold margin of safety is 
not necessary to protect infants and children. Further, the provisions 
of consumption patterns, special susceptibility, and cumulative effects 
do not apply.

C. Overall Safety Conclusion

    There is a reasonable certainty that no harm will result to the 
U.S. population, including infants and children, from aggregate 
exposure to residues of the Vip3Aa19 protein and the genetic material 
necessary for its production in cotton, when it is applied or used in 
accordance with good agricultural practices. This includes all 
anticipated dietary exposures and all other exposures for which there 
is reliable information. The Agency has arrived at this conclusion 
because, as previously discussed, no toxicity to mammals has been 
observed, nor has there been any indication of allergenicity potential 
for this PIP.

VII. Other Considerations

A. Endocrine Disruptors

    The pesticidal active ingredient is a protein, derived from sources 
that are not known to exert an influence on the endocrine system. 
Therefore, the Agency is not requiring information on the endocrine 
effects of the PIP at this time.

[[Page 68748]]

B. Analytical Method(s)

    A method for extraction and ELISA analysis of the Vip3Aa19 protein 
in cotton has been submitted and is under review by the Agency. For the 
temporary tolerance exemption, the ELISA method described with the 
expression data is sufficient.

C. Codex Maximum Residue Level

    No Codex maximum residue levels exist for the PIP Bacillus 
thuringiensis Vip3Aa19 protein and the genetic material necessary for 
its production in cotton.

VIII. Statutory and Executive Order Reviews

    This final rule extends the temporary exemption from the 
requirement of 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 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).

IX. 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 174

     Environmental protection, Administrative practice and procedure, 
Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: November 27, 2007.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

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

PART 174--[AMENDED]

0
1. The authority citation for part 174 continues to read as follows:

    Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a and 371.

0
2. Section 174.501 is revised to read as follows:


Sec.  174.501  Bacillus thuringiensis Vip3Aa19 protein in cotton; 
temporary exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Vip3Aa19 protein in cotton are 
temporarily exempt from the requirement of a tolerance when used as a 
plant-incorporated protectant in the food and feed commodities of 
cotton; vegetative-insecticidal protein in cotton, undelinted seed, 
cotton, oil, cotton meal, cotton hay, cotton hulls, cotton forage, and 
cotton, gin byproducts. This temporary exemption from the requirement 
of tolerance will permit the use of the food commodities in this 
section when treated in accordance with the provisions of the 
experimental use permit 67979-EUP-7, which is being extended in 
accordance with the provisions of the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136). This temporary 
exemption from the requirement of a tolerance expires and is revoked 
May 1, 2009; however, if the experimental use permit is revoked, or if 
any experience with or scientific data on this pesticide indicate that 
the temporary tolerance exemption is not safe, this temporary exemption 
from the requirement of a tolerance may be revoked at any time.
[FR Doc. E7-23660 Filed 12-5-07; 8:45 am]
BILLING CODE 6560-50-S