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放大字体  缩小字体 发布日期:2018-01-29  来源:美国环境保护署  浏览次数:47
核心提示:美国环境保护署发布一则最终条例,豁免来源于苏云金芽孢杆菌的Cry51Aa2.834_16蛋白在棉花中的限量要求,并在40 CFR 174中增加相应内容。
【发布单位】 美国环境保护署
【发布文号】 83 FR 3601
【发布日期】 2018-01-26
【生效日期】 2018-01-26
【效  力】
【食品伙伴网解读】 美国环境保护署发布一则最终条例,豁免来源于苏云金芽孢杆菌的Cry51Aa2.834_16蛋白在棉花中的限量要求,并在40 CFR 174中增加相应内容。



Environmental Protection Agency (EPA).


Final rule.


This regulation establishes an exemption from the requirement of a tolerance for residues of the Cry51Aa2.834_16 protein derived from Bacillus thuringiensis in or on cotton, when used as a plant-incorporated protectant. Monsanto Company submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting this exemption from the requirement of a tolerance. This regulation eliminates the need under FFDCA to establish a maximum permissible level for such residues.


This regulation is effective January 26, 2018. Objections and requests for hearings must be received on or before March 27, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).


The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0401, is available at or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at​dockets.


Robert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:


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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

· Crop production (NAICS code 111).

· Animal production (NAICS code 112).

· Food manufacturing (NAICS code 311).

· Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

You may access a frequently updated electronic version of 40 CFR part 174 through the Government Printing Office's e-CFR site at​cgi-bin/​text-idx?​&​c=​ecfr&​tpl=​/​ecfrbrowse/​Title40/​40tab_​02.tpl.

C. How can I file an objection or hearing request?

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0401 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before March 27, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

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 (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0401, by one of the following methods:

·  Federal eRulemaking Portal: Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

·  Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

·  Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at​dockets/​contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at​dockets.

II. Background

In the Federal Register of October 23, 2017 (82 FR 49020 (FRL-9967-370)), EPA issued notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 7F8566) by Monsanto Company, 800 North Lindbergh Blvd., St. Louis, MO 63167. The petition requested that 40 CFR part 174 be amended by establishing permanent exemption from the requirement of a tolerance for the plant-pesticide Bacillus thuringiensis Cry51Aa2.834_16 protein in or on cotton. A summary of the petition prepared by the petitioner Monsanto Company, is available in the docket via There were no comments received in response to the notice.

One modification has been made to the original request for a tolerance exemption: EPA changed “plant-pesticide” to “plant-incorporated protectant”, to align with the Agency's vocabulary, which is published in 40 CFR part 174.3.Start Printed Page 3602

III. Final Rule

A. EPA's Safety Determination

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 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 FFDCA 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 FFDCA 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 or tolerance exemption 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, FFDCA section 408(b)(2)(D) requires that EPA consider “available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity.”

EPA evaluated the available toxicity and exposure data on Cry51Aa2.834_16 and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its risk assessment based on that data can be found within the document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Assessment of the Plant-Incorporated Protectant Bacillus thuringiensis Cry51Aa2.834_16.” This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES.

Based upon available data, EPA concludes that the Cry51Aa2.834_16 protein, which is a modified version of the wild-type Cry51Aa2 protein derived from Bacillus thuringiensis, does not show evidence of toxicity. Moreover, the source is not allergenic, nor is there any significant similarity between the Cry51Aa2.834_16 protein and known toxins and allergens. In addition, the Cry51Aa2.834_16 protein readily digests in simulated gastric fluids and therefore cumulative, chronic, and acute effects are unlikely.

Given the lack of toxicity or allergenicity of the Cry51Aa2.834_16 protein, the Agency has not identified any toxicological endpoints for assessing risk. Consequently, the Agency's assessment of exposure is qualitative. In addition, due to the lack of any threshold effects, EPA has determined that the provision to retain a 10X safety factor for the protection of infants and children does not apply. Similarly, the lack of any toxic mode of action or toxic metabolites means that the provision requiring an assessment of cumulative effects does not apply.

Oral exposure to Cry51Aa2.834_16 may occur from ingestion of cotton-derived foods, such as refined, bleached, and deodorized (RBD) cottonseed oil. Based on the lack of adverse effects and the rapid digestibility of the protein, however, the Agency does not anticipate any risk from reasonably foreseeable levels of exposure. Residues in drinking water may theoretically be present because cotton PIP plant stubble may release modified Cry51Aa2.834_16 protein into ground water upon decay. However, the protein would not be expected to survive in the soil due to microbial degradation, adherence to soil components, and removal upon drinking water treatment procedures. In addition, oral toxicity testing showed no adverse effects. Moreover, because the PIP is currently only proposed to be used only in plants grown for commercial use, the Agency does not anticipate residential exposures. In the event that future uses are sold for residential use, the Agency does not expect there to be residential, non-occupational dermal or inhalation exposures, due to containment of the Cry51Aa2.834_16 protein within the plant.

Based on the lack of any evidence of adverse effects in the toxicological database, dietary exposure to the Cry51Aa2.834_16 protein is not anticipated to pose any harm to the U.S. population. EPA concludes that 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 Cry51Aa2.834_16 protein derived from Bacillus thuringiensis. Therefore, an exemption from the requirement of a tolerance is established for residues of the plant-incorporated protectant Bacillus thuringiensis Cry51Aa2.834_16 protein in or on cotton.

B. Analytical Enforcement Methodology

An analytical method is not required because the lack of adverse effects makes enforcement and monitoring of residues unnecessary to ensure food safety.

IV. Statutory and Executive Order Reviews

This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to EPA. 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 action has been exempted from review under Executive Order 12866, this action 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 action 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 FFDCA section 408(d), such as the tolerance exemption in this action, 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 action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA 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, EPA has determined that Executive Order 13132, entitled Start Printed Page 3603“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 action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require EPA's consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

V. Congressional Review Act

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal Register. This action 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: December 28, 2017.

Hayley Hughes,

Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:


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

Authority: 7 U.S.C. 136-136y; 21 U.S.C. 321(q), 346a and 371.

2.Add § 174.539 to subpart W to read as follows:

§ 174.539

Cry51Aa2.834_16 protein; exemption from the requirement of a tolerance.

Residues of the Cry51Aa2.834_16 protein, which is a modified protein derived from the Cry51Aa2 protein of Bacillus thuringiensis, in or on cotton are exempt from the requirement of a tolerance, when the Cry51Aa2.834_16 protein is used as a plant-incorporated protectant.

[FR Doc. 2018-01519 Filed 1-25-18; 8:45 am]





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