Source: https://www.federalregister.gov/documents/2002/08/21/02-20990/imidacloprid-re-establishment-of-tolerance-for-emergency-exemptions
Timestamp: 2017-08-17 14:13:34
Document Index: 385834205

Matched Legal Cases: ['§\u2009180', '§\u2009180', '§\u2009180', '§\u2009180', '§\u2009180', 'art 178', '§\u2009180']

Federal Register :: Imidacloprid; Re-Establishment of Tolerance for Emergency Exemptions
Imidacloprid; Re-Establishment of Tolerance for Emergency Exemptions
This regulation is effective August 21, 2002. Objections and requests for hearings, identified by docket ID number OPP-2002-0150, must be received on or before October 21, 2002.
54108-54111 (4 pages)
OPP-2002-0150
FRL-7188-4
SUPPLEMENTARY INFORMATION:Start Printed Page 54109
IV. Regulatory Assessment Requirements -
https://www.federalregister.gov/d/02-20990 https://www.federalregister.gov/d/02-20990
This regulation re-establishes time-limited tolerances for combined residues of the insecticide imidacloprid (1-[6-chloro-3-pyridinyl) methyl]-N-nitro-2-imidazolidinimine) and its metabolites containing the 6-chloropyridinyl moiety, all expressed as 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine, in or on turnip, roots at 0.3 parts per million (ppm); turnip, tops at 3.5 ppm; beet, garden, roots at 0.3 ppm; and beet, garden, tops for an additional 2-year period. These tolerances will expire and are revoked on June 30, 2004. This action is in response to EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on turnips and garden beets. Section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA.
Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit III. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket ID number OPP-2002-0150 in the subject line on the first page of your response.
By mail: Andrew Ertman, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-9367; e-mail address: ertman.andrew@epa.gov.
2. In person. The Agency has established an official record for this action under docket ID number OPP-2002-0150. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
EPA issued a final rule, published in the Federal Register of November 29, 1996 (FRL-5575-1), which announced that on its own initiative under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170), it established time-limited tolerances for the combined residues of the insecticide imidacloprid (1-[6-chloro-3-pyridinyl) methyl]-N-nitro-2-imidazolidinimine) and its metabolites containing the 6-chloropyridinyl moiety, all expressed as 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine, in or on turnip roots at 0.3 ppm; turnip tops at 3.5 ppm; beet roots at 0.3 ppm; and beet tops at 3.5 ppm with an expiration date of November 29, 1997.
These tolerances were subsequently extended on in Federal Register documents published on December 12, 1997 (extended to Novemer 29, 1998), October 7, 1998 (extended to June 30, 2000), and August 9, 2000 (extended to June 30, 2002). The extension that was published on August 9, 2000 amended § 180.472(b) by extending the expirations dates of turnip roots; turnip tops; beet roots; and beet tops. However; these changes have never been reflected in the tolerance table in § 180.472(b) because the time-limited tolerances for these commodities were originally listed in the tolerance table for § 180.472(a). This document will re-establish the tolerances using the correct commodity terms from the Food and Feed Commodity Vocabulary database, correctly place them in the table to § 180.472(b), and remove the commodities turnip roots, turnip tops, beet roots and beet tops from the table in § 180.472(a).
Recently, EPA has received an objection to a tolerance it established for imidacloprid on a different food commodity. The objection was filed by the Natural Resources Defense Council (NRDC) and raised several issues regarding aggregate exposure estimates and the additional safety factor for the protection of infants and children. Although this objection concerns separate rulemaking proceedings under the FFDCA, EPA has considered whether it is appropriate to re-establish the emergency exemption tolerances for imidacloprid while the objection is still pending.
Factors taken into account by EPA included how close the Agency is to concluding the proceedings on the objection, the nature of the current action, whether NRDC's objection raised frivolous issues, and the extent to which the issues raised by NRDC had already been considered by EPA. Although NRDC's objection is not frivolous, the other factors all support extending these tolerances at this time. First, the objections proceeding is not near to conclusion. NRDC's objections raise complex legal, scientific, policy, and factual matters and EPA has just initiated a 60 day public comment period on them. (See 67 FR 41628, June 19, 2002, FRL-7167-7) Second, the nature of the current actions are extremely time-sensitive as they address emergency situations. Third, the issues raised by NRDC are not new matters but questions that have been the subject of considerable study by EPA and comment by stakeholders. Accordingly, EPA is proceeding with re-establishing the tolerances for imidacloprid.
EPA established the tolerances because section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment.
EPA received a request to extend the use of imidacloprid on turnips and garden beets for this year's growing season due to a continuation of the emergencies in California and Arizona. After having reviewed the submission, EPA concurs that emergency conditions exist. EPA has authorized under FIFRA section 18 the use of imidacloprid on turnips and garden beets for control of aphids in Arizona and California, respectively.
EPA assessed the potential risks presented by residues of imidacloprid in or on turnip roots, turnip tops, garden beet roots, and garden beet tops. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and decided that the necessary tolerances under FFDCA section Start Printed Page 54110408(l)(6) would be consistent with the safety standard and with FIFRA section 18. The data and other relevant material have been evaluated and discussed in the final rule published in the Federal Register of November 29, 1996 (FRL-5575-1). Based on that data and information considered, the Agency reaffirms that re-establishment of the time-limited tolerances will continue to meet the requirements of section 408(l)(6). Therefore, the time-limited tolerances are re-established for an additional 2-year period. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations (CFR). Although these tolerances will expire and are revoked on June 30, 2004, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on turnip, roots; turnip, tops; beet, garden, roots; and beet, garden, tops after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA and the application occurred prior to the revocation of the tolerances. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.
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-2002-0150 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 21, 2002.
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. ---
3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit III.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.2. Mail your copies, identified by docket ID number OPP-2002-0150, 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. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. 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.
This final rule re-establishes time-limited tolerances under FFDCA section 408. 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 Start Printed Page 54111Executive 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 FIFRA section 18 petition under FFDCA section 408, such as the tolerances 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 FFDCA section 408(n)(4). 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 (65 FR 67249, 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.
2. In § 180.472, amend the table in paragraph (a) by removing the entries for the commodities turnip tops; turnip roots; beet tops; and beet roots and amend the table in paragraph (b) by adding alphabetically the following entries:
Beet, garden, roots;- 0.3 06/30/04
Beet, garden, tops;- 3.5 06/30/04
Turnip, roots;- 0.3 06/30/04
Turnip, tops;- 3.5 06/30/04
[FR Doc. 02-20990 Filed 8-20-02; 8:45 am]