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Cyfluthrin (Miles). June 28, 1995. Food/Feed Additive Regulations. Final Rule. Federal Register.
http://www.epa.gov/docs/fedrgstr/EPA-PEST/1995/June/Day-28/pr-312.html
[Federal Register: June 28, 1995 (Volume 60, Number 124)] [Rules and Regulations] ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 185 and 186
[PP 5H5712/R2140; FRL-4957-1]
RIN 2070-AB78
Cyfluthrin; Food/Feed Additive Regulations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This rule amends a regulation for residues of the synthetic pyrethroid cyfluthrin in food/feed areas of food/feed-handling establishments. Miles Corp., Agricultural Division, petitioned EPA to amend the food/feed additive regulations to allow the use of a dust formulation in crack and crevice treatment. This rule was requested pursuant to the Federal Food, Drug and Cosmetic Act (FFDCA).
EFFECTIVE DATE: This regulation becomes effective June 28, 1995.
ADDRESSES: Written objections and hearing requests, identified by the document
control number, [FAP 5H5712/R2140], may be submitted to: Hearing Clerk (1900),
Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460.
Fees accompanying objections and hearing requests shall be labeled ``Tolerance
Petition Fees'' and forwarded to: EPA Headquarters Accounting Operations Branch,
OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any
objections and hearing requests filed with the Hearing Clerk should be identified
by the document control number and submitted to: Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring copy of objections and hearing requests to: Rm. 1132, CM #2, 1921 Jefferson
Davis Hwy., Arlington, VA 22202.
A copy of objections and hearing requests filed with the Hearing Clerk may also
be submitted electronically by sending electronic mail (e-mail) to: opp-docket@epamail.epa.gov.
Copies of objections and hearing requests must be submitted as an ASCII file
avoiding the use of special characters and any form of encryption. Copies of
objections and hearing requests will also be accepted on disks in WordPerfect
in 5.1 file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number [FAP 5H5712/R2140].
No Confidential Business Information (CBI) should be submitted through e-mail.
Electronic copies of objections and hearing requests on this rule may be filed
online at many Federal Depository Libraries. Additional information on electronic
submissions can be found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: George T. Larocca, Product Manager (PM 13), Registration Division (7505C), Office of Pesticide Programs, [[Page 33361]] Enviromental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm. 204, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305- 6100; e-mail: larocca.george@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a notice in the Federal Register of February 8, 1995 (60 FR 7541), which announced that Miles, Corp., Agricultural Division, had submitted a food/feed additive petition, (FAP) 5H5712, to EPA requesting that the Administrator, pursuant to section 409(e) of the FFDCA (21 U.S.C. 348), amend 40 CFR 185.1250 and 186.1250 by amending the food/feed additive regulation for residues of the synthetic pyrethroid cyfluthrin by adding conditions for use of a dust formulation in crack or crevice treatment in areas of food/feedhandling establishments. The petition was subsequently amended to include spot treatment also.
No new data were submitted in support of this amendment. Food and feed additive
regulations are established under 40 CFR 185.1250(c) and 186.1250(c), respectively,
permitting residues of cyfluthrin at up to 0.05 ppm in food/feed commodities
exposed to the insecticide during treatment of food/feed handling establishments.
Residue data submitted in support of general surface treatment with cyfluthrin
in food/feedhandling establishments under pesticide petition (PP) 6H5515 (51
FR 43663, Dec. 3, 1986) are adequate to demonstrate that residues resulting
from use of a dust formulation will not exceed the established tolerance of
0.05 ppm. The toxicological and metabolism data and analytical methods for enforcement
purposes considered in support of this amended regulation are discussed in detail
in related documents published in the Federal Register of April 12, 1995 (60
FR 18563).
The reference dose (RfD) for cyfluthrin is 0.025 mg/kg bwt/day and is based
on the no-observeable-effect level (NOEL) of 2.5 mg/kg/day in the 2-year rat
feeding study. An uncertainty factor (UF) of 100 was used to calculate the RfD.
The Theoretical Maximum Residue Contribution (TMRC) from established tolerances
utilizes 1112f the RfD for the U.S. population and 3212f the RfD for nonnursing
infants less than 1-year old, the subgroup with the highest estimated exposure
to cyfluthrin residues. The use of a dust formulation in food/feed handling
establishments does not contribute any more to the dietary exposure for the
general population or nonnursing infants than general surface treatment.
There are currently no actions pending against the continued registration of
this chemical.
Based on the information and data considered, the Agency has determined that
the amending of 40 CFR 185.1250 and 186.1250 will be safe. Therefore, the regulation
is amended as set forth below. Any person adversely affected by this regulation
may, within 30 days after publication of this document in the Federal Register,
file written objections and/or request a hearing with the Hearing Clerk, at
the address given above (40 CFR 178.20). A copy of the objections and/ or hearing
requests filed with the Hearing Clerk should be submitted to the OPP docket
for this rulemaking. The objections submitted must specify the provisions of
the regulation deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40 CFR
180.33(i). If a hearing is requested, the objections must include a statement
of the factual issue(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). 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 issue(s) in the manner sought by the
requestor would be adequate to justify the action requested (40 CFR 178.32).
A record has been established for this rulemaking under docket number [FAP 5H5712/R2140]
(including any objections and hearing requests submitted electronically as described
below). A public version of this record, including printed, paper versions of
electronic comments, which does not include any information claimed as CBI,
is available for inspection from 8 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division (7506C), Office
of Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA.
Written objections and hearing requests, identified by the document control
number [FAP 5H5712/R2140], may be submitted to the Hearing Clerk (1900), Environmental
Protection Agency, Rm. 3708, 401 M St., SW., Washington, DC 20460.
A copy of electronic objections and hearing requests filed with the Hearing
Clerk can be sent directly to EPA at: opp-Docket@epamail.epa.gov
A copy of electronic objections and hearing requests filed with the Hearing
Clerk must be submitted as an ASCII file avoiding the use of special characters
and any form of encryption. The official record for this rulemaking, as well
as the public version, as described above will be kept in paper form. Accordingly,
EPA will transfer any objections and hearing requests received electronically
into printed, paper form as they are received and will place the paper copies
in the official rulemaking record which will also include all objections and
hearing requests submitted directly in writing. The official rulemaking record
is the paper record maintained at the address in ``ADDRESSES'' at the beginning
of this document. Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the
Agency must determine whether the regulatory action is ``significant'' and therefore
subject to review by the Office of Management and Budget (OMB) and the requirements
of the Executive Order. Under section 3(f), the order defines a ``significant
regulatory action'' as an action that is likely to result in a rule (1) having
an annual effect on the economy of $100 million or more, or adversely and materially
affecting a sector of the economy, productivity, competition, jobs, the environment,
public health or safety, or State, local, or tribal governments or communities
(also referred to as ``economically significant''); (2) creating serious inconsistency
or otherwise interfering with an action taken or planned by another agency;
(3) materially altering the budgetary impacts of entitlement, grants, user fees,
or loan programs or the rights and obligations of recipients thereof; or (4)
raising novel legal or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in this Executive Order.
Pursuant to the terms of the Executive Order, EPA has determined that this rule
is not ``significant'' and is therefore not subject to OMB review.
Pursuant to the requirements of the Regulatory Flexibility Act (Pub. L. 96-354,
94 Stat. 1164, 5 U.S.C. 601-612), the Administrator has determined that regulations
establishing new tolerances or raising tolerance levels or establishing exemptions
from tolerance [[Page 33362]] requirements do not have a significant economic
impact on a substantial number of small entities. A certification statement
to this effect was published in the Federal Register of May 4, 1981 (46 FR 24950).
List of Subjects in 40 CFR Parts 185 and 186
Environmental protection, Administrative practice and procedure, Agricultural commodities, Food additives, Feed additives, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: June 14, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, chapter I of title 40 of the Code of Federal Regulations is amended as follows:
PART 185--[AMENDED]
b. In Sec. 185.1250, paragraph (c)(2) is revised to read as follows:
Sec. 185.1250 Cyfluthrin.
2. In part 186:
a. The authority citation for part 186 continues to read as follows:
Authority: 21 U.S.C. 348.
b. In Sec. 186.1250, paragraph (c)(2) is revised to read as follows:
Sec. 186.1250 Cyfluthrin.