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cyfluthrin (Baythroid) Food/Feed Additive Regulations 6/95

[Federal Register: June 28, 1995 (Volume 60, Number 124)]
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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.
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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, 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/feed-
handling 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/feed-
handling 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 11% of the RfD for the U.S. 
population and 32% of 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 
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]

    1. In part 185:
    a. The authority citation for part 185 continues to read as 
follows:

    Authority: 21 U.S.C. 346a and 348.

    b. In Sec. 185.1250, paragraph (c)(2) is revised to read as 
follows:


Sec. 185.1250   Cyfluthrin.

* * * * *
    (c) *  *  *  
    (2) Crack and crevice or spot treatments shall be limited to a 
maximum of 0.1 percent of the active ingredient by weight, applied with 
a low-pressure system with a pinpoint or variable-pattern nozzle. Dust 
formulation shall be limited to a maximum of 0.1 percent of the active 
ingredient by weight, applied using a hand duster, power duster, or 
other equipment capable of applying dust insecticide directly into 
voids and cracks and crevices. Dust applications should be made in a 
manner to avoid deposits on exposed surfaces or introducing the 
material into the air. Cover exposed food or remove food from premises. 
Do not apply directly to food. Reapplications may be made at 10-day 
intervals.
* * * * *

PART 186--[AMENDED]

    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.

* * * * *
    (c) *  *  *  
    (2) Crack and crevice or spot treatments shall be limited to a 
maximum of 0.1 percent of the active ingredient by weight, applied with 
a low-pressure system with a pinpoint or variable-pattern nozzle. Dust 
formulation shall be limited to a maximum of 0.1 percent of the active 
ingredient by weight, applied using a hand duster, power duster, or 
other equipment capable of applying dust insecticide directly into 
voids and cracks and crevices. Dust applications should be made in a 
manner to avoid deposits on exposed surfaces or introducing the 
material into the air. Cover exposed feed or remove feed from premises. 
Do not apply directly to feed. Reapplications may be made at 10-day 
intervals.
* * * * *