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FD&C RED NO. 40 - Tolerance Exemption 5/93

FD & C Red No. 40; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is establishing an exemption from the requirement
of a tolerance for residues of FD & C Red No. 40 (CAS Reg. No.
25956-17-6) when used as an inert ingredient (dye, coloring
agent) in pesticide formulations applied to growing crops or
to raw agricultural commodities after harvest. This regulation
was requested by the UNOCAL Corp.

EFFECTIVE DATE: This regulation becomes effective on June 9,
1993.

ADDRESSES: Written objections, identified by the document control
number [OPP-300277A], may be submitted to the: Hearing Clerk
(A-110), Environmental Protection Agency, rm. 3708M, 401 M St.,
SW., Washington, DC 20460.

FOR FURTHER INFORMATION CONTACT: Rosalind Gross, Registration
Support Branch, Registration Division (H7505W), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: WS 28, CS .1,
2800 Crystal Drive, North Tower, Arlington, VA 22202, (703)-
308-8354.

SUPPLEMENTARY INFORMATION: In the Federal Register of March
3, 1993 (58 FR 12200), EPA issued a proposed rule announcing
that UNOCAL Corp., 1201 5th St., Los Angeles, CA 09934, had
submitted pesticide petition (PP) 2E04132 to EPA requesting
that the Administrator, pursuant to section 408(e) of the Federal
Food, Drug, and Cosmetic Act, 21 U.S.C. 346a(e), propose to
amend 40 CFR 180.1001(c) by establishing an exemption from the
requirement of a tolerance for residues of FD & C Red No. 40
(CAS Reg. No. 2596-17-6), principally disodium salt of 6-hydroxy-
5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic
acid) when used as an inert ingredient (dye, coloring agent)
not to exceed 0.002 percent by weight in pesticide formulations
applied to growing crops or to raw agricultural commodities
after harvest.
   Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125, and include, but are
not limited to, the following types of ingredients (except when
they have a pesticidal efficacy of their own): Solvents such
as alcohols and hydrocarbons; surfactants such as polyoxyethylene
polymers and fatty acids; carriers such as clay and diatomaceous
earth; thickeners such as carrageenan and modified cellulose;
wetting, spreading, and dispersing agents; propellants in aerosol
dispensers; microencapsulating agents; and emulsifiers. The
term "inert" is not intended to imply nontoxicity; the ingredient
may or may not be chemically active.
   One comment was received in response to the proposed rule.
The comment addressed the use and the amount of dyes in pesticide
formulations used to treat seeds. According to the commenter,
if the FD & C Red No. 40 were to be used in coloration of seed
treated with pesticides, the dye would have to be 2 percent
by weight of the pesticide formulation to distinguish treated
seed from untreated seed. This comment will be addressed in
a separate Federal Register notice.
   The proposed regulation as requested by the UNOCAL Corporation
was for FD & C Red No. 40 to be exempt from the requirement
of a tolerance when used as an inert ingredient (dye, coloring
agent) at a level not to exceed 0.002 percent by weight in the
pesticide formulation. Based on the information cited in the
proposed rule, EPA finds when used in accordance with good agricultural
practice, this ingredient is useful and a tolerance is not necessary
to protect the public health. Therefore, EPA is establishing
the exemption from the requirement of a tolerance as set forth
below.
   Any person adversely affected by this regulation may, within
30 days after the date of publication of this document in the
Federal Register, file written objections and/or a request for
a hearing with the Hearing Clerk at the address given above.
40 CFR 178.20. 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 each such issue, 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.
   The Office of Management and Budget has exempted this rule
from the requirements of section 3 of Executive Order 12291.
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 food additive regulations or raising tolerance levels or
food additive regulations 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 Part 180

   Administrative practice and procedure, Agricultural commodities,
Pesticides and pests, Reporting and recordkeeping requirements.

   Dated: May 27, 1993.

Daniel M. Barolo,

Acting Director, Office of Pesticide Programs.

   Therefore, 40 CFR part 180 is amended as follows:

PART 180-[AMENDED]

   1. The authority citation for part 180 continues to read
as follows:

   Authority: 21 U.S.C. 346a and 371.

   2. Section 180.1001(c) is amended in the table therein by
adding and alphabetically inserting the inert ingredient, to
read as follows:

 180.1001   Exemptions from the requirement of a tolerance.

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   (c) * * *

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           Inert ingredients                     Limits
Uses

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FD & C Red No. 40 (CAS Reg. No. 25956-  Not to exceed 0.002% by  Dye, coloring
agent.

 17-6) conforming to 21 CFR 74.340.      weight of pesticide

                                         formulation

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[FR Doc. 93-13574 Filed 6-8-93; 8:45 am]