[Federal Register Volume 63, Number 57 (Wednesday, March 25, 1998)]
[Rules and Regulations]
[Pages 14360-14363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7492]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300632; FRL-5779-3]
RIN 2070-AB78
Titanium Dioxide; Exemption from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of titanium dioxide when used as an inert
ingredient (UV protectant) in microencapsulated formulations of lambda-
cyhalothrin. Zeneca AgProducts requested this tolerance exemption under
the Federal Food, Drug and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (Pub. L. 104-170).
DATES: This regulation is effective March 25, 1998. Objections and
requests for hearings must be received by EPA on or before April 24,
1998.
[[Page 14361]]
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300632], must 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 identified by the docket
control number, [OPP-300632], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 119, CM 1B2,
1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected]. 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 5.1/6.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300632]. 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.
FOR FURTHER INFORMATION CONTACT: By mail: Indira Gairola, Registration
Division (7505W), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location, telephone number, and e-mail address: 4th Floor, Crystal
Station 1B1, 2800 Crystal Drive,, Arlington, VA, 22202, (703)-308-8371,
e-mail: [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of June 20, 1997 (62
FR 33641) (FRL-5723-7), EPA issued a notice pursuant to section 408 of
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e)
announcing the filing of a pesticide petition (PP 6E4675) for a
tolerance exemption by Zeneca Ag. Products, 1800 Concord Pike, P.O Box
15458, Wilmington, DE 19850-5458. This notice included a summary of the
petition prepared by Zeneca Ag. Products, the petitioner. There were no
comments received in response to the notice of filing.
The petition requested that 40 CFR 180.1001 (d) be amended by
establishing an exemption from the requirement of a tolerance for
residues of the inert ingredient titanium dioxide, when used as an
inert ingredient (UV protectant) in microencapsulated formulations of
lambda-cyhalothrin applied to growing crops.
I. Risk Assessment and Statutory Findings
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
II. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action, EPA has sufficient data to assess the hazards of titanium
dioxide and to make a determination on aggregate exposure, consistent
with section 408(b)(2), an exemption from the requirement of a
tolerance for residues of titanium dioxide when used as an inert
ingredient (UV protectant) in microencapsulated formulations of lambda-
cyhalothrin. EPA's assessment of the dietary exposures and risks
associated with establishing the tolerance follows.
A. Toxicological Profile
Titanium is the eighth most abundant element in the earth's crust
and consequently spontaneously enters the food chain to some degree.
Titanium dioxide (TiO2) is a major constituent of a number of minerals,
including rutile, which consists of 95% titanium dioxide. The most
commercially important of the titanium compounds, titanium dioxide
annual worldwide production is estimated to be appoximately two million
metric tons. Titanium dioxide is an opaque powder that is approved for
use as a colorant in food (21 CFR 73.575), in drugs (21 CFR 73.1575),
and in cosmetics (21 CFR 73.2575; 21 CFR 73.3126). It has an extensive
range of industrial uses (e.g., paint, paper, and plastics). Titanium
dioxide is currently exempt from the requirement for a tolerance when
used as a colorant in pesticide formulations (40 CFR 180.1001(d)).
A National Cancer Institute bioassay concluded that titanium
dioxide did not affect mortality, and was not carcinogenic at dose
levels of 25,000 or 50,000 ppm in rats or mice.
The World Health Organization Committee on Food Coloring Materials
has determined that no ADI need be set for the use of titanium dioxide
based on the range of acute, subacute and chronic toxicity assays, all
showing low mammalian toxicity, including a two year chronic feeding
study in mice which was negative for carcinogenicity. Indeed, titanium
dioxide is frequently used as a negative control material in in vivo
chronic dust exposure studies and in in vivo assessments of fibrogenic
potential of dusts.
B. Exposures and Risks
Titanium dioxide is currently approved for use in a significant
number of pharmaceutical, cosmetic, industrial and food products.
Therefore, the potential for aggregate exposure from dietary and non-
dietary routes does exist for titanium dioxide. While it is difficult
to develop a precise estimate of total human exposure to titanium
dioxide, its low toxicity at relatively high doses indicate that
current exposures are likely to be significantly below levels that may
result in adverse health effects. Titanium dioxide is approved for use
in food generally up to
[[Page 14362]]
1% of the final weight of the food (10,000 ppm). Even the most extreme
assumptions regarding its presence in foods following use as an inert
ingredient in lambda-cyhalothrin formulations would not result in a
measurable increase in potential dietary intake of titanium dioxide.
All registered lambda-cyhalothrin products to which titanium
dioxide is added as an inert ingredient are commercial agricultural
products not registered for residential use. The potential for non-
occupational exposures by the general population above current
background levels resulting from the many non-pesticidal uses of
titanium dioxide is unlikely.
Section 408(c)(2)(B) requires that, when considering whether to
establish, modify, or revoke an exemption from the requirement of a
tolerance, the Agency consider ``available information'' concerning the
cumulative effects of a particular pesticide chemical's residues and
``other substances that have a common mechanism of toxicity.'' The
Agency believes that ``available information'' in this context might
include not only toxicity, chemistry, and exposure data, but also
scientific policies and methodologies for understanding common
mechanisms of toxicity and conducting cumulative risk assessments. For
most pesticide chemicals, although the Agency has some information in
its files that may turn out to be helpful in eventually determining
whether a pesticide shares a common mechanism of toxicity with any
other substances, EPA does not at this time have the methodologies to
resolve the complex scientific issues concerning common mechanism of
toxicity in a meaningful way. EPA has begun a pilot process to study
this issue further through the examination of particular classes of
pesticides. The Agency hopes that the results of this pilot process
will increase the Agency's scientific understanding of this question
such that EPA will be able to develop and apply scientific principles
for better determining which chemicals have a common mechanism of
toxicity and evaluating the cumulative effects of such chemicals. The
Agency anticipates, however, that even as its understanding of the
science of common mechanisms increases, decisions on specific classes
of chemicals will be heavily dependent on chemical specific data, much
of which may not be presently available.
Although at present the Agency does not know how to apply the
information in its files concerning common mechanism issues to most
risk assessments, there are pesticides as to which the common mechanism
issues can be resolved. These pesticides include pesticides that are
toxicologically dissimilar to existing chemical substances (in which
case the Agency can conclude that it is unlikely that a pesticide
shares a common mechanism of activity with other substances) and
pesticides that produce a common toxic metabolite (in which case common
mechanism of activity will be assumed).
EPA does not have, at this time, available data to determine
whether titanium dioxide has a common mechanism of toxicity with other
substances or how to include this pesticide chemical in a cumulative
risk assessment. Unlike other pesticide chemicals for which EPA has
followed a cumulative risk approach based on a common mechanism of
toxicity, titanium dioxide does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that titanium dioxide
has a common mechanism of toxicity with other substances.
C. Aggregate Risks and Determination of Safety for U.S. Population,
Infants and Children
Based on its low toxicity, there is reasonable certainty that no
harm will result from aggregate exposure to the U.S. population,
including infants and children, to residues of titanium dioxide. This
includes all anticipated dietary exposures and all other exposures for
which there is reliable information. The Agency has arrived at this
conclusion because of the inconsequential increases in dietary exposure
resulting from its application to growing crops as an inert ingredient
in formulations of lambda-cyhalothrin.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects in calculating a dose level that to account for pre-
and post-natal toxicity and the completeness of the database unless EPA
determines that a different margin of safety will be safe for infants
and children. Margins of safety are incorporated into EPA risk
assessments either directly through the use of margin of exposure
analysis or through using uncertainty (safety) in calculating a dose
level that poses no appreciable risk to humans.
Due to low toxicity of titanium dioxide, EPA has not used a safety
factor analysis in assessing the risk of this compound. For the same
reason, application of the additional safety factor for infants and
children would not be appropriate.
III. Other Considerations
A. Analytical Enforcement Methodology
The Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation; therefore, the Agency has
concluded that an analytical method is not required for enforcement
purposes for titanium dioxide.
B. International Residue Limits
No Codex maximum residue levels have been established for titanium
dioxide.
IV. Conclusion
Therefore, an exemption from the requirement of a tolerance is
established for residues of titanium dioxide when used as an inert
ingredient (UV protectant) in microencapsulated formulations of lambda-
cyhalothrin at no more than 3% by weight of the formulation.
V. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by May 26, 1998, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed 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 issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if
[[Page 14363]]
the Administrator determines that the material submitted shows the
following: There is 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 in the manner
sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). 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.
VI. Public Docket
EPA has established a record for this rulemaking under docket
control number [OPP-300632] (including any comments and data submitted
electronically). 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 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall 1B2, 1921 Jefferson Davis Hwy., Arlington, VA.
Electronic comments may be sent directly to EPA at:
[email protected].
Electronic comments 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 copies of 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 comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
This final rule establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. 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). 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) (Pub. L. 104-4). Nor does it require any
prior consultation as specified by Executive Order 12875, entitled
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28,
1993), or special considerations as required by Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In addition, since these tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerance exemption 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.
Nevertheless, the Agency has previously assessed whether establishing
tolerances, exemptions from tolerances, raising tolerance levels or
expanding exemptions might adversely impact small entities and
concluded, as a generic matter, that there is no adverse economic
impact. The factual basis for the Agency's generic certification for
tolerance actions published on May 4, 1981 (46 FR 24950) and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
VIII. Submission to Congress and the Comptroller General
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 rule in the Federal Register. This 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: March 12, 1998.
James Jones,
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. 346a and 371.
2. Section 180.1195 is added to read as follows:
Sec. 180.1195 Titanium dioxide; exemption from the requirement of a
tolerance.
Titanium dioxide is exempted from the requirement of a tolerance
for residues in or on growing crops, when used as an inert ingredient
(UV protectant) in microencapsulated formulations of the insecticide
lambda-cyhalothrin at no more than 3.0% by weight of the formulation.
[FR Doc. 98-7492 Filed 3-24-98; 8:45 am]
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