![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}
Bacillus Thuringiensis Cry3Bb1; Exemption from the Requirement of a Tolerance
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: March 31, 2004 (Volume 69, Number 62)] [Rules and Regulations] [Page 16809-16814] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr31mr04-20] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [OPP-2003-0415; FRL-7350-5] Bacillus Thuringiensis Cry3Bb1; Exemption from the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production in corn on field corn, sweet corn, and popcorn when applied/used as a plant- incorporated protectant. Monsanto Company, 800 North Lindberg Blvd., St. Louis, Missouri 63167 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 an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production in corn. DATES: This regulation is effective March 31, 2004. Objections and requests [[Page 16810]] for hearings, identified by docket ID number OPP-2003-0415, must be received on or before June 1, 2004. ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Mike Mendelsohn, Biopesticides and Pollution Prevention Division (7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8715; e-mail address: mendelsohn.mike@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: ? Crop production (NAICS 111) ? Animal production (NAICS 112) ? Food manufacturing (NAICS 311) ? Pesticide manufacturing (NAICS 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 Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0415. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/ A frequently updated electronic version of 40 CFR part 180 is available at http://www.gpoaccess.gov/ecfr/,a beta site currently under development. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.regulations.gov/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select ``search,'' then key in the appropriate docket ID number. II. Background and Statutory Findings In the Federal Register of October 22, 2003 (68 FR 60371) (FRL- 7328-4), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 7F4888) by Monsanto Company, 800 North Lindberg Blvd., St. Louis, Missouri 63167. This notice included a summary of the petition prepared by the petitioner Monsanto. There were two comments received in response to the notice of filing. One comment was from a private citizen who opposed the granting of the tolerance exemption and felt the EPA was not fulfilling its duty of protecting public health and the environment. The second comment was from Valent BioSciences Corporation, a producer of microbial Bacillus thuringiensis pesticide products. Valent maintained that the basis of the safety assessment for the Cry3Bb1 protein is the expression of Cry proteins in Bacillus thuringiensis microbial pesticides that have been safely used for over 40 years. The commenter contends that the strain of B. thuringiensis subspecies kumamotoensis has never been registered as a microbial pesticide and therefore Cry3Bb1 does not deserve to benefit from the implied 40 years of safe use argument. The commenter also states that any new strain of B.thuringiensis, such as B. thuringiensis subspecies kumamotoensis, would be required to demonstrate safety through new data on mammalian toxicology and pathogenicity for non-target organisms. The commenter also raised questions concerning whether the fact that the Cry3Bb1 protein subject to the tolerance determination is a variant of the natural Cry3Bb1 endotoxin that has been engineered specifically to enhance activity against the corn rootworm larvae means that the binding characteristics have been altered. The results of toxicity tests indicate a toxicity category III designation. The commenter is concerned about these toxicity results reflecting negatively on the currently registered microbial Bt use. Finally, the commenter is concerned whether the validated ELISA method for detecting Cry3Bb1 protein would distinguish the variant from the natural toxins. In response to the first commentor, EPA takes seriously its duty to protect human health and the environment. Specifically, under the FFDCA, EPA must make a finding that there is a reasonable certainty of no harm from the granting of the proposed tolerance exemption. EPA is making such a finding and herein sets forth the bases for this finding. Regarding the comments from Valent BioScience, the basis of the Cry3Bb1 tolerance determination is toxicology data that has been generated separately from any registered microbial B. thuringiensis. While EPA acknowledges that it has made reference to the safe use of microbial formulations in both the 2000 reassessment of the B. thuringiensis-based PIPs and several registered PIPs, all of these PIP proteins have had extensive mammalian safety data generated for the expressed protein itself. Therefore, Monsanto's reference in the notice of filing to the safe use of microbial B. thuringiensis, while cogent to the safety assessment as useful generic information on previous exposure to the Cry proteins, is not the basis of the safety finding to support a tolerance exemption. The fact that all three variants of Cry3Bb1 protein [see Unit. III.] have been tested for toxicity and allergenicity indicate that the safety of these three variants at least, is similar for mammalian species. The indication of these test results is that minor modifications due to protein engineering for enhanced target activity does not necessarily alter non-target toxicity for mammalian species. This supposition does not mean that all protein engineering modifications would result in equally benign results for non-target species. No insecticidal [[Page 16811]] activity was seen in specific insect species, including six species of coleopteran and two species of lepidopteran pests with the variant Cry3Bb1 protein suggesting that the host range activity is limited. There are also results from bioassays with two of the variant Cry3Bb1 proteins against two sensitive coleopteran species (Leptinotarsa decemlineata and Diabrotica virgifera) that indicates that there are not significant changes in the activity between the two variants. The category III designation for the results of the acute oral toxicity test using purified Cry3Bb1 toxin do not represent any change from the results that would be seen with microbial preparations. The category classification is due to the limitation of dose volume for the test animal rather than any sign of toxicity in the test or concern for possible exposure. The oral tests were done with purified protein doses that are orders of magnitude higher than would be seen in any microbial B. thuringiensis products. Actual exposure to Cry proteins in PIP products are not expected to represent any hazard of oral toxicity given the results seen in these tests. Regarding the analytical method, there are features of the assay procedures that could lessen the likelihood of recognizing a microbial source of Cry3Bb1 [delta]-endotoxin. The microbial B. thuringiensis products are known to be rapidly weathered away by environmental conditions like rain and UV radiation lessening the possibility of a microbial product being present. In addition, if a positive result was obtained for the presence of Cry3Bb1 protein in an unexpected source, the test could be confirmed by washing the suspect crop then retesting. Any surface contamination by residues from treatment with a B. thuringiensis product would be removed. Any subsequent positive finding should be a true Cry3Bb1 detection since it would represent an internal tissue detection which could be reasonably assumed to result only from plant expression of the Cry3Bb1 gene. The petition requested that 40 CFR part 180 be amended by establishing an temporary exemption from the requirement of a tolerance for residues of Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production in corn. Section 408(c)(2)(A)(i) of the 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 the 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), 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), 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 the 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 the 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 identifiable subgroups of consumers, including infants and children. Data have been submitted demonstrating the lack of mammalian toxicity at high levels of exposure to the pure Cry3Bb1 proteins. These data demonstrate the safety of the products 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 plant-incorporated protectant was derived (See 40 CFR 158.740(b)(2)(i)). For microbial products, further toxicity testing and residue data are triggered by significant acute effects in studies such as the mouse oral toxicity study, to verify the observed effects and clarify the source of these effects (Tiers II and III). Three acute oral studies were submitted for Cry3Bb1 proteins. These studies were done with three variants of the Cry3Bb1 protein engineered with either four or five internal amino acid sequence changes to enhance activity against the corn rootworm. The acute oral toxicity data submitted support the prediction that the Cry3Bb1 protein would be non-toxic to humans. Male and female mice (10 of each) were dosed with 36, 396, or 3,780 milligrams/kilograms bodyweight (mg/kg bwt) of Cry3Bb1 protein for one variant. The mice were dosed with 38.7, 419, or 2,980 mg/kg bwt of Cry3Bb1 protein for the second variant. The mice were dosed with 300, 900, or 2,700 mg/kg bwt of Cry3Bb1 protein for the third variant. In one study, two animals in the high dose group died within a day of dosing. These animals both had signs of trauma probably due to dose administration (i.e., lung perforation or severe discoloration of lung, stomach, brain and small intestine). No clinical signs were observed in the surviving animals and body weight gains were recorded throughout the 14-day study for the remaining animals. Gross necropsies performed at the end of the study indicated no findings of toxicity attributed to exposure to the test substance in any of the three studies. No other mortality or clinical signs attributed to the test substance were noted during either study. When proteins are toxic, they are known to act via acute mechanisms and at very low dose levels (Sjoblad, Roy D., et al. ``Toxicological Considerations for Protein Components of Biological Pesticide Products,'' Regulatory Toxicology and Pharmacology 15, 3-9 (1992)). Therefore, since no effects were shown to be caused by the plant- incorporated protectants, even at relatively high dose levels, the Cry3Bb1 proteins are not considered toxic. Further, amino acid sequence comparisons showed no similarity between Cry3Bb1 proteins to known toxic proteins available in public protein data bases. Since Cry3Bb1 are proteins, allergenic sensitivities were considered. Current scientific knowledge suggests that common food allergens tend to be resistant to degradation by heat, acid, and proteases, may be glycosylated and present at high concentrations in the food. Data have been submitted that demonstrate that the Cry3Bb1 protein is [[Page 16812]] rapidly degraded by gastric fluid in vitro. In a solution of simulated gastric fluid (pH 1.2 - U.S. Pharmacopeia), complete degradation of detectable Cry3Bb1 protein occurred within 30 seconds. Insect bioassay data indicated that the protein loss insecticidal activity within 2 minutes of incubation in SGF. Incubation in simulated intestinal fluid resulted in a 59 kDa protein digestion product. A comparison of amino acid sequences of known allergens uncovered no evidence of any homology with Cry3Bb1, even at the level of 8 contiguous amino acids residues. The potential for the Cry3Bb1 proteins to be food allergens is minimal. Regarding toxicity to the immune system, the acute oral toxicity data submitted support the prediction that the Cry3Bb1 proteins would be non-toxic to humans. As noted above, toxic proteins typically act as acute toxins with low dose levels. Therefore, since no effects were shown to be caused by the plant-incorporated protectants, even at relatively high dose levels, the Cry3Bb1 proteins are not considered toxic. IV. Aggregate Exposures In examining aggregate exposure, section 408 of the 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 plant-incorporated protectant chemical residue, and exposure from non-occupational sources. Exposure via the skin or inhalation is not likely since the plant-incorporated protectant is contained within plant cells, which essentially eliminates these exposure routes or reduces these exposure routes to negligible. Oral exposure, at very low levels, may occur from ingestion of processed corn products and, potentially, drinking water. However a lack of mammalian toxicity and the digestibility of the plant-incorporated protectants have been demonstrated. The use sites for the Cry3Bb1 proteins are all agricultural for control of insects. Therefore, exposure via residential or lawn use to infants and children is not expected. Even if negligible exposure should occur, the Agency concludes that such exposure would present no risk due to the lack of toxicity demonstrated for the Cry3Bb1 proteins. V. Cumulative Effects Pursuant to section 408(b)(2)(D)(v) of FFDCA, EPA has considered available information on the cumulative effects of such residues and other substances that have a common mechanism of toxicity. These considerations included 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 to these plant-incorporated protectants, we conclude that there are no cumulative effects for the Cry3Bb1 proteins. 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 Cry3Bb1 proteins include the characterization of the expressed Cry3Bb1 protein in corn, as well as the acute oral toxicity, 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 Cry3Bb1 test material derived from microbial cultures was biochemically and, functionally similar to the protein produced by the plant-incorporated protectant ingredients in corn. Production of microbially produced protein was chosen in order to obtain sufficient material for testing. The acute oral toxicity data submitted supports the prediction that the Cry3Bb1 proteins 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. ``Toxicological Considerations for Protein Components of Biological Pesticide Products,'' Regulatory Toxicology and Pharmacology 15, 3-9 (1992)). Since no effects were shown to be caused by Cry3Bb1, even at relatively high dose levels (3,780 mg Cry3Bb1/kg bwt), the Cry3Bb1 proteins are 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 plant-incorporated protectant was derived. See 40 CFR 158.740(b)(2)(i). For microbial products, further toxicity testing and residue data are triggered by significant acute effects in studies such as the mouse oral toxicity study to verify the observed effects and clarify the source of these effects (Tiers II and III). Cry3Bb1 residue chemistry data were not required for a human health effects assessment of the subject plant-incorporated protectant ingredients because of the lack of mammalian toxicity. Both available information concerning the dietary consumption patterns of consumers (and major identifiable subgroups of consumers including infants and children); and safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of food additives, are generally recognized as appropriate for the use of animal experimentation data were not evaluated. The lack of mammalian toxicity at high levels of exposure to the Cry3Bb1 proteins demonstrate the safety of the product at levels well above possible maximum exposure levels anticipated in the crop. The genetic material necessary for the production of the plant- incorporated protectant active ingredients are the nucleic acids (DNA, RNA) which comprise genetic material encoding these proteins and their regulatory regions. The genetic material (DNA, RNA) necessary for the production of Cry3Bb1 proteins in corn have been exempted under the blanket exemption for all nucleic acids (40 CFR 174.175). 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, section 408(b)(2)(C) of FFDCA also provides that EPA shall apply an additional ten-fold 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 [[Page 16813]] toxicity for the Cry3Bb1 proteins and the genetic material necessary for their production. Thus, there are no threshold effects of concern and, as a result, the provision requiring an additional margin of safety does not apply. 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 from aggregate exposure to the U.S. population, including infants and children, to the Cry3Bb1 proteins and the genetic material necessary for their production. 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 discussed above, no toxicity to mammals has been observed for the plant- incorporated protectants. VII. Other Considerations A. Endocrine Disruptors The pesticidal active ingredients are proteins, 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 these plant-incorporated protectants at this time. B. Analytical Method(s) Validated methods for extraction and direct ELISA analysis of Cry3Bb1 in corn grain have been submitted and found acceptable by the Agency. C. Codex Maximum Residue Level No Codex maximum residue levels exists for the plant-incorporated protectants Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production in corn. VIII. Objections and Hearing Requests Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA provides essentially the same process for persons to ``object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of the FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days. A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2003-0415 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 June 1, 2004. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it ``Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement ``when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VIII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2003-0415, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries. B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual [[Page 16814]] issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). IX. Statutory and Executive Order Reviews This final rule establishes an exemption from the tolerance requirement under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104 -113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications '' is defined in the Executive order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any ``tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (59 FR 22951, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ``meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' ``Policies that have tribal implications '' is defined in the Executive order to include regulations that have ``substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. X. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: March 18, 2004. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. ? Therefore, 40 CFR chapter I is amended as follows: PART 180--[AMENDED] ? 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. ? 2. Section 180.1214 in subpart D is revised to read as follows: Sec. 180.1214 Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production in corn; exemption from the requirement of a tolerance. Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production in corn are exempt from the requirement of a tolerance when used as plant-incorporated protectants in the food and feed commodities of field corn, sweet corn and popcorn. Genetic material necessary for its production means the genetic material which comprise genetic material encoding the Cry3Bb1 protein and its regulatory regions. Regulatory regions are the genetic material, such as promoters, terminators, and enhancers, that control the expression of the genetic material encoding the Cry3Bb1 protein. [FR Doc. 04-6930 Filed 3-30-04; 8:45 am] BILLING CODE 6560-50-S