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OPP ID: [OPP-2005-0092; FRL-7709-3]
SUBJECT CATEGORY: Propiconazole; Re-Establishment of Tolerance for Emergency Exemption
DOCUMENT SUMMARY: This regulation re-establishes a time-limited tolerance for combined residues of the fungicide propiconazole and its metabolites in or on blueberry at 1.0 parts per million (ppm) for an additional 21/2 year period. This tolerance will expire and is revoked on December 31, 2007. 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 blueberries. Section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA) requires EPA to establish a timelimited 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 FIFRA section 18.
SUMMARY: Propiconazole,
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:
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 and Other Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), 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 ECFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. II. Background and Statutory Findings
EPA issued a final rule, published in the Federal Register of
January 20, 1999 (64 FR 2995) (FRL60498), which announced that on its
own initiative under section 408 of the FFDCA, 21 U.S.C. 346a, as
amended by the FQPA (Public Law 104170), it established a timelimited
tolerance for the combined residues of propiconazole and its
metabolites in or on blueberry at 1.0 ppm, with an expiration date of
December 31, 1999. This timelimited tolerance was subsequently
extended via a Federal Register notice published on March 28, 2002 (67
FR 14866) (FRL68283), which had the effect of extending the time
limited tolerance for blueberry until December 31, 2003. EPA
established the tolerance because section 408(l)(6) of the FFDCA
requires EPA to establish a timelimited 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 FIFRA section 18. Such
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tolerances can be established without providing notice or period for public comment.
EPA received a request to extend the use of propiconazole on blueberry for this year's growing season due to the continued problems with controlling mummy berry disease (Monilinia vaciniicorymbosi) in wild blueberries in Maine, since the cancellation of the fungicide historically used to control this disease. After having reviewed the submission, EPA concurs that emergency conditions exist. EPA has authorized under FIFRA section 18 the use of propiconazole on blueberry for control of mummy berry disease in Maine.
EPA assessed the potential risks presented by residues of propiconazole in or on blueberry. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and decided that the necessary tolerance under section 408(l)(6) of the FFDCA 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 January 20, 1999 (64 FR 2995) (FRL60498), as well as the final rule published in the Federal Register of August 4, 2004 (69 FR 47005) (FRL73521). Based on that data and information considered, the Agency reaffirms that re establishing the timelimited tolerance will continue to meet the requirements of section 408(l)(6) of the FFDCA. Therefore, the time limited tolerance is reestablished for an additional 21/2 year period.
Although the prior blueberry tolerance has expired and was revoked by operation of law on December 31, 2003, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on blueberry after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA and the application occurred prior to the revocation of the tolerance.
In 2002, the Natural Resource Defense Council and various other parties filed objections with EPA to the timelimited tolerance for propiconazole on blueberries as well as to dozens of other tolerances for 14 pesticides. The objections to the expired blueberry tolerance are now moot. EPA will be issuing a denial of the objections to the propiconazole blueberry tolerance on those grounds in a few weeks in conjunction with its resolution of the objections as to the tolerances for the pesticides not previously addressed. Prior to issuing this tolerance for propiconazole on blueberries, EPA reviewed the substance of the objections as to the prior propiconazole blueberry tolerance and the arguments made therein do not convince EPA that there are safety concerns as to the reestablished blueberry tolerance. A full explanation of EPA's analysis of the objections to the propiconazole blueberry tolerance will be included as part of the document responding to the remaining objections.
This action reestablishes a timelimited tolerance for the combined residues of the fungicide propiconazole and its metabolite determined as 2,4dichlorobenzoic acid and expressed as the parent compound in or on blueberry. This tolerance will expire and is revoked on December 31, 2007. This action is in response to EPA's granting of an emergency exemption under Section 18 authorizing use of the pesticide on blueberries. Although this blueberry tolerance will expire and is revoked by operation of law on December 31, 2007, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on blueberry after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA and the application occurred prior to the revocation of the tolerance. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.
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 OPP20050092 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 20, 2005.
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 (1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204600001. You may also deliver your request to the Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., Washington, DC 20005. 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 (202) 5646255.
2. 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 ADDRESSES. Mail your
copies, identified by docket ID number OPP20050092, 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 ADDRESSES. You may also send an electronic copy of your request via e
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mail to: oppdocket@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.
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 issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).
This final rule establishes a timelimited tolerance under section 408 of the FFDCA. 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 1044). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and LowIncome 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 104113, 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 section 408 of the FFDCA, such as the tolerance 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 (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.
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: April 8, 2005.
Lois Rossi,
Director, Registration 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.
Sec. 180.434 [Amended]
2. In Sec. 180.434, amend the item for ``blueberry'' in the table in
paragraph (b) by revising the date ``12/31/2003'' to read ``12/31/ 2007.''
[FR Doc. 057736 Filed 41905; 8:45 am]
BILLING CODE 656050S
FOR FURTHER INFORMATION CONTACT Andrea Conrath, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204600001; telephone number: (703) 3089356; email address: conrath.andrea@epa.gov.
14 CFR Part 39 40 CFR Part 52 14 CFR Part 71 33 CFR Part 165 50 CFR Part 679 26 CFR Part 1 40 CFR Part 180 47 CFR Part 73 50 CFR Part 17 33 CFR Part 117 44 CFR Part 67 50 CFR Part 648 14 CFR Part 97 33 CFR Part 100 40 CFR Part 63 50 CFR Part 622 26 CFR Part 301 39 CFR Part 111 40 CFR Part 300 50 CFR Part 660 44 CFR Part 65 40 CFR Parts 52 and 81 40 CFR Part 271 47 CFR Part 64 50 CFR Part 665 47 CFR Part 76 50 CFR Part 229 14 CFR Part 23 14 CFR Part 25 21 CFR Part 522