titanium dioxide Tolerance Exemption 6/93
Titanium Dioxide; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes an exemption from the requirement
of a tolerance for residues of titanium dioxide (CAS Reg. No.
13463-67-7) when used as an inert ingredient (colorant on seed)
in pesticide formulations applied to seeds for planting. This
regulation was requested by Becker-Underwood, Inc. The proposed
rule for this exemption also included a proposal for an exemption
for 2-[methyl- [(perfluoroalkyl)- sulfonyl]- amino]alkyl (C2-
C8) acrylate-alkyl (C2-C8) methacrylates-N-methylolacrylamide
copolymer when used as an inert ingredient (water repellant
agent) in pesticide formulations applied to animals. A comment
was received in response to this proposal that questioned the
risks to human health and the environment for this polymer,
and the comment and proposal will be addressed in a separate
Federal Register document.
EFFECTIVE DATE: This regulation becomes effective on June 30,
1993.
ADDRESSES: Written objections, identified by the document control
number, [OPP-300279A], may be submitted to: Hearing Clerk (A-
110), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460.
FOR FURTHER INFORMATION CONTACT: By mail: 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: 6th Floor, North
Tower, 2800 Crystal Drive, Arlington, VA 22202, (703)-308-8354.
SUPPLEMENTARY INFORMATION: In the Federal Register of March
10, 1993 (58 FR 13239), EPA issued a proposed rule giving notice
that SmithKline Beecham Animal Health, 1600 Paoli Pike, P.O.
Box 2650, West Chester, PA 19380-6014, had submitted pesticide
petition 2E4147 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(e) by establishing
an exemption from the requirement of a tolerance for residues
of 2-[methyl- [(perfluoroalkyl)- sulfonyl]- amino]alkyl (C2-
C8) acrylate-alkyl (C2-C8) methacrylates-N-methylolacrylamide
copolymer when used as an inert ingredient (water repellant
agent) in pesticide formulations applied to animals.
Also in the Federal Register of March 10, 1993 (58 FR 13239),
EPA issued a proposed rule giving notice that Becker-Underwood,
Inc., 801 Dayton Ave., Ames, IA 50010, had submitted pesticide
petition (PP) 2E4128 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(d)
to expand an existing exemption from the requirement of a tolerance
for residues of titanium dioxide (CAS Reg. No. 13463-67-7) when
used as an inert ingredient (pigment/coloring agent in plastic
bags used to wrap growing bananas (preharvest) to include the
additional use as a colorant on seeds for planting.
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.
As part of the EPA policy statement on inert ingredients
published in the Federal Register of April 22, 1987 (52 FR 13305),
the Agency established data requirements which will be used
to evaluate the risks posed by the presence of an inert ingredient
in a pesticide formulation. Exemptions from some or all of the
requirements may be granted if it can be determined that the
inert ingredient will present minimal or no risk.
One comment was received in response to the proposed rule
concerning 2-[methyl- [(perfluoroalkyl)- sulfonyl]- amino]alkyl
(C2-C8) acrylate-alkyl (C2-C8) methacrylates-N-methylolacrylamide
copolymer. The comment questioned the risks to human health
and the environment for this polymer based on its characteristics.
The comment indicated that Patent Number 4921696 includes some
structures related to the subject copolymer, which exemplify
why one should not generalize that substances with molecular
weights greater than 1,000 are normally not absorbed through
the intact gastrointestinal (GI) tract. EPA acknowledges that
to protect the public health the comment necessitates further
evaluation of the safety of 2-[methyl- [(perfluoroalkyl)- sulfonyl]-
amino]alkyl (C2-C8) acrylate-alkyl (C2-C8) methacrylates-N-methylolacrylamide
copolymer. EPA's findings in regard to the aforementioned comment
will be discussed in a separate Federal Register document.
However, no comments or requests for referral to an advisory
committee were received in response to the proposed rule for
titanium oxide. The data submitted in the petition and other
relevant material have been evaluated and discussed in the proposed
rule. Based on the data and information considered, the EPA
concludes that the tolerance exemption for titanium dioxide
will protect the public health. Therefore, the tolerance exemption
for residues of titanium dioxide is established 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 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 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).
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 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 Part 180
Administrative practice and procedure, Agricultural commodities,
Pesticides and pests, Reporting and recordkeeping requirements.
Dated: June 18, 1993.
Douglas D. Campt,
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. In . 180.1001, paragraph (d) table is amended by revising
the entry for titanium dioxide, to read as follows:
. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(d) * * *
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Inert ingredients Limits Uses
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* * * * * *
Titanium dioxide (CAS Reg. No. 13463- ....................... Pigment/coloring agent in plastic bags
67-7). used to wrap growing bananas
(preharvest), colorant on seeds for
planting.
* * * * * *
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* * * * *
[FR Doc. 93-15420 Filed 6-29-93; 8:45 am]
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in nature and may no longer be applicable.
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