Bacillus thuringiensis Cry1A.105 Protein; Time Limited Exemption From the Requirement of a Tolerance; Correction, 39540-39543 [E9-18860]

Download as PDF 39540 Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Rules and Regulations on procedures and requirements for a Commission determination or exclusion (74 FR 10475 (March 11, 2009)). E. Effective Date The CPSIA requires the Commission to promulgate a rule providing guidance on inaccessible component parts by August 14, 2009. Although interpretative rules do not require a particular effective date under the Administrative Procedure Act, 5 U.S.C. 553(d)(2), the Commission recognizes the need for providing the guidance expeditiously. Accordingly, the interpretative rule will take effect on August 14, 2009. List of Subjects in 16 CFR Part 1500 Consumer protection, Hazardous materials, Hazardous substances, Imports, Infants and children, Labeling, Law enforcement, and Toys. F. Conclusion For the reasons stated above, the Commission amends 16 CFR chapter II as follows: ■ PART 1500—HAZARDOUS SUBSTANCES AND ARTICLES: ADMINISTRATION AND ENFORCEMENT REGULATIONS 1. The authority citation for part 1500 continues to read as follows: ■ Authority: 15 U.S.C. 1261–1278, 122 Stat. 3016. 2. Add a new § 1500.87 to read as follows: ■ pwalker on DSK8KYBLC1PROD with RULES § 1500.87 Children’s products containing lead: inaccessible component parts. (a) The Consumer Product Safety Improvement Act (CPSIA) provides for specific lead limits in children’s products. Section 101(a) of the CPSIA provides that by February 10, 2009, products designed or intended primarily for children 12 and younger may not contain more than 600 ppm of lead. After August 14, 2009, products designed or intended primarily for children 12 and younger cannot contain more than 300 ppm of lead. On August 14, 2011, the limit may be further reduced to 100 ppm after three years, unless the Commission determines that it is not technologically feasible to have this lower limit. (b) Section 101 (b)(2) of the CPSIA provides that the lead limits do not apply to component parts of a product that are not accessible to a child. This section specifies that a component part is not accessible if it is not physically exposed by reason of a sealed covering or casing and does not become physically exposed through reasonably VerDate Nov<24>2008 15:59 Aug 06, 2009 Jkt 217001 foreseeable use and abuse of the product including swallowing, mouthing, breaking, or other children’s activities, and the aging of the product, as determined by the Commission. Paint, coatings, or electroplating may not be considered to be a barrier that would render lead in the substrate to be inaccessible to a child. (c) Section 101(b)(2)(B) of the CPSIA directs the Commission to promulgate by August 14, 2009, this interpretative rule to provide guidance with respect to what product components or classes of components will be considered to be inaccessible. (d) The accessibility probes specified for sharp points or edges under the Commissions’ regulations at 16 CFR 1500.48–1500.49 will be used to assess the accessibility of lead-component parts of a children’s product. A leadcontaining component part would be considered accessible if it can be contacted by any portion of the specified segment of the accessibility probe. A lead-containing component part would be considered inaccessible if it cannot be contacted by any portion of the specified segment of the accessibility probe. (e) For products intended for children that are 18 months of age or less, the use and abuse tests set forth under the Commission’s regulations at 16 CFR 1500.50 and 16 CFR 1500.51 (excluding the bite test of § 1500.51(c)), will be used to evaluate accessibility of leadcontaining component parts of a children’s product as a result of normal and reasonably foreseeable use and abuse of the product. (f) For products intended for children that are over 18 months but not over 36 months of age, the use and abuse tests set forth under the Commission’s regulations at 16 CFR 1500.50 and 16 CFR 1500.52 (excluding the bite test of § 1500.52(c)), will be used to evaluate accessibility of lead-containing component parts of a children’s product as a result of normal and reasonably foreseeable use and abuse of the product. (g) For products intended for children that are over 36 months but not over 96 months of age, the use and abuse tests set forth under the Commission’s regulations at 16 CFR 1500.50 and 16 CFR 1500.53 (excluding the bite test of § 1500.53(c)), will be used to evaluate accessibility of lead-containing component parts of a children’s product as a result of normal and reasonably foreseeable use and abuse of the product. (h) For products intended for children over 96 months through 12 years of age, the use and abuse tests set forth under PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 the Commission’s regulations at 16 CFR 1500.50 and 16 CFR 1500.53 (excluding the bite test of § 1500.53(c)) intended for children aged 37–96 months will be used to evaluate accessibility of leadcontaining component parts of a children’s product as a result of normal and reasonably foreseeable use and abuse of the product. (i) A children’s product that is or contains a lead-containing part which is enclosed, encased, or covered by fabric and passes the appropriate use and abuse tests on such covers, is inaccessible to a child unless the product or part of the product in one dimension is smaller than 5 centimeters. (j) The intentional disassembly or destruction of products by children older than age 8 years by means or knowledge not generally available to younger children, including use of tools, will not be considered in evaluating products for accessibility of leadcontaining components. Dated: July 31, 2009. Todd A. Stevenson, Secretary, Consumer Product Safety Commission. [FR Doc. E9–18852 Filed 8–6–09; 8:45 am] BILLING CODE 6335–01–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 174 [EPA–HQ–OPP–2009–0101; FRL–8428–7] Bacillus thuringiensis Cry1A.105 Protein; Time Limited Exemption From the Requirement of a Tolerance; Correction AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule, correction. SUMMARY: On May 20, 2009 EPA published a Final Rule that established an 18–month, time-limited exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Cry1A.105 protein in or on the food and feed commodities cotton seed, cotton seed oil, cotton seed meal, cotton hay, cotton hulls, cotton forage and cotton gin byproducts when used as a plantincorporated protectant. Subsequent to the publication of the May 20, 2009 Final Rule, the Agency identified an error in the Analytical Methods section of that Rule’s preamble. Through this action, EPA is republishing the tolerance exemption with a new effective date and opportunity to request a hearing, and a corrected Analytical Methods section. The conditions of the E:\FR\FM\07AUR1.SGM 07AUR1 Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Rules and Regulations time-limited tolerance exemption as established on May 20, 2009 are unchanged: the time-limited tolerance exemption expires and is revoked on November 22, 2010. DATES: This regulation is effective August 7, 2009. Objections and requests for hearings must be received on or before October 6, 2009 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). 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. EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2009–0101. All documents in the docket are listed in the docket index available at https://www.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 https://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305– 5805. FOR FURTHER INFORMATION CONTACT: Denise Greenway, Biopesticides and Pollution Prevention Division (7511P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: 703–308–8263; e-mail address: greenway.denise@epa.gov. B. How Can I Access Electronic Copies of this Document? In addition to accessing electronically available documents at https:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at https://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of 40 CFR part 174 through the Government Printing Office’s e-CFR site at https:// www.gpoaccess.gov/ecfr. ADDRESSES: SUPPLEMENTARY INFORMATION: I. General Information pwalker on DSK8KYBLC1PROD with RULES A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS 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 VerDate Nov<24>2008 15:59 Aug 06, 2009 Jkt 217001 C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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–2009–0101 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 October 6, 2009. 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–2009–0101, by one of the following methods. • Federal eRulemaking Portal: https:// 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 PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 39541 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 Facility’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 March 4, 2009 (74 FR 9395) (FRL–8403–5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 9F7521) by Monsanto Company, 800 North Lindbergh Blvd., St. Louis, MO 63167. The petition requested that 40 CFR part 174 be amended by establishing a timelimited exemption from the requirement of a tolerance for residues of the plantincorporated protectant Bacillus thuringiensis Cry1A.105 protein, in or on the food and feed commodities cotton seed, cotton seed oil, cotton seed meal, cotton hay, cotton hulls, cotton forage and cotton gin byproducts. This notice included a summary of the petition prepared by the petitioner Monsanto Company. This petition was submitted to deal with a small amount — less than an acre — of an unauthorized, genetically-engineered cotton variety containing an unregistered plant-incorporated protectant – the Cry1A.105 protein — that was inadvertently harvested along with 54 acres of a commerciallyavailable, genetically-engineered cotton variety. (https://www.epa.gov/pesticides/ biopesticides/pips/ btcotton_statement.html). In response to EPA’s notice announcing the filing of pesticide petition 9F7521, one comment was received and was addressed in the May 20, 2009, Final Rule, in which EPA presented its rationale for establishing an 18–month time-limited exemption from the requirement of a tolerance. Subsequent to the publication of the May 20, 2009 regulation, the Agency identified an error in the Analytical Methods section of the Rule’s preamble (Unit VII.B.). Specifically, the text in the Analytical Methods section of the preamble to the May 20, 2009 Final Rule erroneously stated that the Polymerase Chain Reaction (PCR) method analyzed for Bacillus thuringiensis Cry1A.105 protein. In fact, the PCR method analyzes for Bacillus thuringiensis E:\FR\FM\07AUR1.SGM 07AUR1 39542 Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Rules and Regulations pwalker on DSK8KYBLC1PROD with RULES Cry1A.105 DNA. This action corrects that error. This action also establishes a new effective date and opportunity to request a hearing. The conditions of the time-limited tolerance exemption as established on May 20, 2009 are unchanged: it still expires and is revoked on November 22, 2010. See Section VII.B., below, for the subject correction to the Analytical Methods section. 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. variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. For a more extensive discussion, see the Final Rule of May 20, 2009 (74 FR 23635, FRL–8417–3). 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 IX. Statutory and Executive Order Reviews VerDate Nov<24>2008 15:59 Aug 06, 2009 Jkt 217001 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). A. Dietary Exposure Food. See the Final Rule of May 20, 2009 (74 FR 23635, FRL–8417–3). B. Other Non-Occupational Exposure Dermal and inhalation exposure. See the Final Rule of May 20, 2009 (74 FR 23635), (FRL–8417–3). V. Cumulative Effects See the Final Rule of May 20, 2009 (74 FR 23635), (FRL–8417–3). VI. Determination of Safety for U.S. Population, Infants and Children See the Final Rule of May 20, 2009 (74 FR 23635), (FRL–8417–3). VII. Other Considerations A. Endocrine Disruptors See the Final Rule of May 20, 2009 (74 FR 23635), (FRL–8417–3). B. Analytical Method A Polymerase Chain Reaction (PCR) method for the detection and (in the context of a tolerance exemption) measurement of the Bacillus thuringiensis Cry1A.105 DNA in cotton has been submitted (MRID 477497–01). C. Codex Maximum Residue Level See the Final Rule of May 20, 2009 (74 FR 23635, FRL–8417–3). VIII. Conclusions See the Final Rule of May 20, 2009 (74 FR 23635, FRL–8417–3). This final rule establishes an 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, PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the 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. 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 9, 2000) do not apply to this final rule. In addition, this final 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 E:\FR\FM\07AUR1.SGM 07AUR1 Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Rules and Regulations (NTTAA), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). X. 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, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: July 27, 2009. W. Michael McDavit, Acting Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: ■ PART 174—[AMENDED] 1. The authority citation for part 174 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 174.502 is revised to read as follows: ■ pwalker on DSK8KYBLC1PROD with RULES § 174.502 Bacillus thuringiensis Cry1A.105 protein; exemption from the requirement of a tolerance. (a) Residues of Bacillus thuringiensis Cry1A.105 protein in or on the food and feed commodities of corn; corn, field, flour; corn, field, forage; corn, field, grain; corn, field, grits; corn, field, meal; corn, field, refined oil; corn, field, stover; corn, sweet, forage; corn, sweet, kernel plus cob with husk removed; corn, sweet, stover; and corn, pop, grain and corn, pop, stover are exempt from the requirement of a tolerance when the Bacillus thuringiensis Cry1A.105 protein is used as a plant-incorporated protectant in these food and feed corn commodities. (b) A time-limited exemption from the requirement of a tolerance is established for residues of Bacillus thuringiensis Cry1A.105 protein in or on the food and feed commodities of cotton; cotton, forage; cotton, gin byproducts; cotton, hay; cotton, hulls; cotton, meal; cotton, VerDate Nov<24>2008 15:59 Aug 06, 2009 Jkt 217001 refined oil; and cotton, undelinted seed when the Bacillus thuringiensis Cry1A.105 protein is used as a plantincorporated protectant in these food and feed cotton commodities. The exemption from the requirement of a tolerance expires and is revoked on November 22, 2010. [FR Doc. E9–18860 Filed 8–6–09; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2009–0601; FRL–8431–8] Inert Ingredients; Extension of Effective Date of Revocation of Certain Tolerance Exemptions with Insufficient Data for Reassessment AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: This document moves the effective date of the revocation of six inert ingredient tolerance exemptions with insufficient data for reassessment as set forth in the Federal Register on August 4, 2008 (73 FR 45312). DATES: In the final rule published August 9, 2006 (71 FR 45415), and delayed on August 4, 2008 (73 FR 45312): 1. The effective date is delayed from August 9, 2009, to October 9, 2009, for the following amendments to § 180.910: 2.m., n., and cc. 2. The effective date is delayed from August 9, 2009, to October 9, 2009, for the following amendments to § 180.930: 4.t., u., and v. Objections and requests for hearings must be received on or before October 6, 2009, 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–2009–0601. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at https://www.regulations.gov, or, if only available in hard copy, at the OPP PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 39543 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: Kerry Leifer, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–8811; e-mail address: leifer.kerry@epa.gov. SUPPLEMENTARY INFORMATION: I. 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. II. Background and Statutory Findings A. Background In a final rule published in the Federal Register on August 9, 2006 (71 FR 45415) (FRL–8084–1), EPA revoked inert ingredient tolerance exemptions because insufficient data were available to the Agency to make the safety determination required by Federal Food, Drug, and Comestic Act (FFDCA) section 408(c)(2). In reassessing the safety of the tolerance exemptions, EPA considered the validity, completeness, and reliability of the data that are available to the Agency [FFDCA section 408 (b)(2)(D)] and the available information concerning the special susceptibility of infants and children (including developmental effects from in utero exposure) [FFDCA section 408 E:\FR\FM\07AUR1.SGM 07AUR1

Agencies

[Federal Register Volume 74, Number 151 (Friday, August 7, 2009)]
[Rules and Regulations]
[Pages 39540-39543]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18860]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2009-0101; FRL-8428-7]


Bacillus thuringiensis Cry1A.105 Protein; Time Limited Exemption 
From the Requirement of a Tolerance; Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule, correction.

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SUMMARY: On May 20, 2009 EPA published a Final Rule that established an 
18-month, time-limited exemption from the requirement of a tolerance 
for residues of the Bacillus thuringiensis Cry1A.105 protein in or on 
the food and feed commodities cotton seed, cotton seed oil, cotton seed 
meal, cotton hay, cotton hulls, cotton forage and cotton gin byproducts 
when used as a plant-incorporated protectant. Subsequent to the 
publication of the May 20, 2009 Final Rule, the Agency identified an 
error in the Analytical Methods section of that Rule's preamble. 
Through this action, EPA is republishing the tolerance exemption with a 
new effective date and opportunity to request a hearing, and a 
corrected Analytical Methods section. The conditions of the

[[Page 39541]]

time-limited tolerance exemption as established on May 20, 2009 are 
unchanged: the time-limited tolerance exemption expires and is revoked 
on November 22, 2010.

DATES: This regulation is effective August 7, 2009. Objections and 
requests for hearings must be received on or before October 6, 2009 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-2009-0101. All documents in the 
docket are listed in the docket index available at https://www.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 https://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Denise Greenway, Biopesticides and 
Pollution Prevention Division (7511P), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: 703-308-8263; e-mail address: greenway.denise@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 electronically available documents at 
https://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at https://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of 40 CFR part 174 through the 
Government Printing Office's e-CFR site at https://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2009-0101 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 October 6, 2009.
    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-2009-0101, by one of the following methods.
     Federal eRulemaking Portal: https://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 Facility'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 March 4, 2009 (74 FR 9395) (FRL-8403-5), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 
9F7521) by Monsanto Company, 800 North Lindbergh Blvd., St. Louis, MO 
63167. The petition requested that 40 CFR part 174 be amended by 
establishing a time-limited exemption from the requirement of a 
tolerance for residues of the plant-incorporated protectant Bacillus 
thuringiensis Cry1A.105 protein, in or on the food and feed commodities 
cotton seed, cotton seed oil, cotton seed meal, cotton hay, cotton 
hulls, cotton forage and cotton gin byproducts. This notice included a 
summary of the petition prepared by the petitioner Monsanto Company. 
This petition was submitted to deal with a small amount -- less than an 
acre -- of an unauthorized, genetically-engineered cotton variety 
containing an unregistered plant-incorporated protectant - the 
Cry1A.105 protein -- that was inadvertently harvested along with 54 
acres of a commercially-available, genetically-engineered cotton 
variety. (https://www.epa.gov/pesticides/biopesticides/pips/btcotton_statement.html). In response to EPA's notice announcing the filing of 
pesticide petition 9F7521, one comment was received and was addressed 
in the May 20, 2009, Final Rule, in which EPA presented its rationale 
for establishing an 18-month time-limited exemption from the 
requirement of a tolerance.
    Subsequent to the publication of the May 20, 2009 regulation, the 
Agency identified an error in the Analytical Methods section of the 
Rule's preamble (Unit VII.B.). Specifically, the text in the Analytical 
Methods section of the preamble to the May 20, 2009 Final Rule 
erroneously stated that the Polymerase Chain Reaction (PCR) method 
analyzed for Bacillus thuringiensis Cry1A.105 protein. In fact, the PCR 
method analyzes for Bacillus thuringiensis

[[Page 39542]]

Cry1A.105 DNA. This action corrects that error. This action also 
establishes a new effective date and opportunity to request a hearing. 
The conditions of the time-limited tolerance exemption as established 
on May 20, 2009 are unchanged: it still expires and is revoked on 
November 22, 2010. See Section VII.B., below, for the subject 
correction to the Analytical Methods section.
    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 identifiable subgroups of consumers, including 
infants and children.
    For a more extensive discussion, see the Final Rule of May 20, 2009 
(74 FR 23635, FRL-8417-3).

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).

A. Dietary Exposure

      Food. See the Final Rule of May 20, 2009 (74 FR 23635, FRL-8417-
3).

 B. Other Non-Occupational Exposure

     Dermal and inhalation exposure. See the Final Rule of May 20, 2009 
(74 FR 23635), (FRL-8417-3).

V. Cumulative Effects

    See the Final Rule of May 20, 2009 (74 FR 23635), (FRL-8417-3).

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

    See the Final Rule of May 20, 2009 (74 FR 23635), (FRL-8417-3).

VII. Other Considerations

A. Endocrine Disruptors

    See the Final Rule of May 20, 2009 (74 FR 23635), (FRL-8417-3).

B. Analytical Method

    A Polymerase Chain Reaction (PCR) method for the detection and (in 
the context of a tolerance exemption) measurement of the Bacillus 
thuringiensis Cry1A.105 DNA in cotton has been submitted (MRID 477497-
01).

C. Codex Maximum Residue Level

    See the Final Rule of May 20, 2009 (74 FR 23635, FRL-8417-3).

VIII. Conclusions

    See the Final Rule of May 20, 2009 (74 FR 23635, FRL-8417-3).

 IX. Statutory and Executive Order Reviews

    This final rule establishes an 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 final rule has been exempted from review under 
Executive Order 12866, this final rule is not subject to Executive 
Order 13211, entitled Actions Concerning Regulations That Significantly 
Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) 
or Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997). This final rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq., nor does it require any special considerations 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the 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.
    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 9, 2000) do not apply to this final rule. In addition, 
this final 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

[[Page 39543]]

(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

X. 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, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: July 27, 2009.
W. Michael McDavit,
Acting 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: 21 U.S.C. 321(q), 346a and 371.


0
2. Section 174.502 is revised to read as follows:


Sec.  174.502  Bacillus thuringiensis Cry1A.105 protein; exemption from 
the requirement of a tolerance.

    (a) Residues of Bacillus thuringiensis Cry1A.105 protein in or on 
the food and feed commodities of corn; corn, field, flour; corn, field, 
forage; corn, field, grain; corn, field, grits; corn, field, meal; 
corn, field, refined oil; corn, field, stover; corn, sweet, forage; 
corn, sweet, kernel plus cob with husk removed; corn, sweet, stover; 
and corn, pop, grain and corn, pop, stover are exempt from the 
requirement of a tolerance when the Bacillus thuringiensis Cry1A.105 
protein is used as a plant-incorporated protectant in these food and 
feed corn commodities.
    (b) A time-limited exemption from the requirement of a tolerance is 
established for residues of Bacillus thuringiensis Cry1A.105 protein in 
or on the food and feed commodities of cotton; cotton, forage; cotton, 
gin byproducts; cotton, hay; cotton, hulls; cotton, meal; cotton, 
refined oil; and cotton, undelinted seed when the Bacillus 
thuringiensis Cry1A.105 protein is used as a plant-incorporated 
protectant in these food and feed cotton commodities. The exemption 
from the requirement of a tolerance expires and is revoked on November 
22, 2010.
[FR Doc. E9-18860 Filed 8-6-09; 8:45 am]
BILLING CODE 6560-50-S
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