[Federal Register Volume 63, Number 37 (Wednesday, February 25, 1998)]
[Rules and Regulations]
[Pages 9427-9430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4652]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300614; FRL-5769-9]
RIN 2070-AB78
Kaolin; Exemption from the Requirement of a Tolerance
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 anhydrous kaolin when used in or on food
commodities to aid in the control of insects, fungi, and bacteria
(food/feed use). This regulation was requested by Engelhard
Corporation.
DATES: This regulation becomes effective February 25, 1998. Objections
and requests for hearings must be received by EPA on or before April
27, 1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300614], 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, Pittsburg, PA 15251. A copy of any objections and hearing
requests filed with the Hearing Clerk should be identified by the
docket control number and submitted to: Public Information and Records
Intregrity 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 #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 to the OPP 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
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of encryption. Copies of objections and hearing requests will also be
accepted on disks in WordPerfect in 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 number [OPP-300614]. 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: Driss Benmhend, c/o Product
Manager (PM) 90, Biopesticides and Pollution Prevention Division
(7511W), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. Office location and telephone
number: Rm. 5-W61, CS #1, 2800 Crystal Drive, Arlington, VA 22202,
(703) 308-9525; e-mail: [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of November 26, 1997
(62 FR 63168)(FRL-5753-3), EPA issued a notice pursuant to section
408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C.
346a(d), announcing the filing of a pesticide tolerance petition for
the new active ingredient kaolin (PP 7E4908) by Engelhard Corporation,
Research Center, 101 Wood Avenue, Iselin, NJ 08830. The notice included
a summary of the petition prepared by the petitioner. The summary
contained conclusions and arguments to support its conclusion that the
petition complied with the Food Quality Protection Act (FQPA) of 1996.
The petition requested the establishment of a permanent tolerance
exemption for kaolin for all food commodities. Kaolin is a naturally
occurring aluminosilicate, used as an indirect food additive for
paperboard food contact, adhesives, cellophane, etc. It is also used in
pharmaceuticals (tablet diluents poultices), and in toiletries
(toothpaste, etc.). Prior to the current petition request, EPA
authorized the issuance of an experimental use permit (EUP) to the
registrant for the end-use product, M-96-018 Kaolin (70060-EUP-R),
containing 98.8% active ingredient. In conjunction with the EUP, EPA
approved a petition for a temporary tolerance exemption (PP 7G4793) for
the active ingredient when applied to all food commodities. The
exemption from a temporary tolerance for kaolin on all food commodities
was granted for purposes of the EUP (April 23, 1997, 62 FR 19683) (FRL-
5712-8).
There were no comments or requests for referral to an advisory
committee, received in response to the notice of filing. The data
submitted in the petition and other relevant material have been
evaluated and were considered in support of this tolerance.
I. Toxicological Profile
The submitted toxicology studies are acceptable for these new
registrations. No additional toxicology data are required. The data
reported in the acute oral toxicity studies demonstrated that the acute
oral LD50 for kaolin in rats is >5,000 mg/kg of body weight.
No toxicity or clinical abnormalities were observed throughout the
study period; Toxicity Category IV. The data reported in the acute
dermal toxicity study demonstrated that the acute dermal
LD50 for kaolin in rats is >5,000 mg/kg of body weight. No
toxicity or clinical abnormalities were observed throughout the study
period; Toxicity Category IV. The data reported in the primary eye
irritation study demonstrate that the test substance was minimally
irritating. Kaolin was not corrosive and all eye irritation effects
cleared within 72 hours postdosing; Toxicity Category III. The data
reported in the primary-skin irritation study demonstrated that the
test substance caused no dermal irritation in rabbits treated with 0.5
g kaolin for 4 hours. No toxicity or clinical abnormalities were
observed throughout the study period; Toxicity Category IV.
Kaolin is used as an indirect food additive for paper/paperboard
dry food contact, adhesives, polymeric coatings, rubber articles, and
cellophane. Kaolin is used in pharmaceuticals, tablet diluents,
poultices, and surgical dusting powders. Kaolin is used as a cosmetic
in face powders, face masks, and face packs. Kaolin is used in health
products and toiletries, toothpaste, and antiperspirants. Kaolin can be
used directly in foods as an anti-caking agent (up to 2.5%). Kaolin has
GRAS (Generally Recognized as Safe) status under 21 CFR 186.1256 and is
generally recognized as safe ``as an indirect human food ingredient
with no limitation other than current good manufacturing practice.''
II. Aggregate Exposure
1. Dietary exposure and risk characterization. Dietary exposure of
kaolin via food or water is difficult to estimate due to the use of
kaolin in thousands of products. Kaolin is an inert mineral and has no
known toxicological effects
2. Non-dietary exposure, non-occupational exposure. The amount of
kaolin currently used in the U.S. pesticide industry as an inert is
between 2 million lbs. and 10 million lbs. per year.
3. Aggregate exposure from multiple routes including dermal and
inhalation. Risks associated with dermal and inhalation aggregate
exposure are measured via the acute toxicity studies submitted to
support registration. Because the inhalation toxicity studies for
kaolin showed no toxicity (Toxicity Category IV), the risks anticipated
for this route of exposure are considered minimal. Results of the acute
dermal study indicated low toxicity (Toxicity Category IV), and no
significant dermal irritation (Toxicity Category IV). Based on these
results, the anticipated risks from dermal exposure are also considered
minimal. Therefore, the risks from aggregate exposure via dermal and
inhalation exposure are a compilation of two low risk exposure
scenarios and are considered negligible.
III. Safety Considerations
The lack of toxicity of kaolin is demonstrated by the above
summary. Based on this information, the aggregate exposure to kaolin
over a lifetime should not pose appreciable risks to human health.
There is a reasonable certainty that no harm will result from aggregate
exposure to kaolin residues. Exempting kaolin from the requirement of a
tolerance is safe.
Consistent with section 408(b)(2)(c) of the FFDCA, EPA has assessed
the available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues and the cumulative effects on infants and children of
the residues and other substances with the common mechanism of
toxicity. Based on the available information, the Agency concludes that
kaolin is ubiquitous in all foods including those consumed by infants
and children. Furthermore, kaolin is used as an additive in several
food and non food products. Like adults, infants and children are also
exposed to kaolin in these products, and there is no evidence that
suggests that such exposure may lead to any harm.
IV. Cumulative Effects
Kaolin has no mode of toxicity and therefore no common mechanism of
toxicity with other substances.
V. International Tolerances
No international tolerance exemptions are known to exist.
VI. Summary of Findings
Kaolin is considered as GRAS by FDA under 21 CFR 186.1256. EPA has
not
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identified any toxicity or clinical abnormalities. Moreover, the
ecological effects studies demonstrated that there were no adverse
effects. As a result, the Agency concludes that the exemption from the
requirement of a tolerance is safe. Therefore, the tolerance exemption
is established as set forth below.
VII. 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 (1)(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 April 27, 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 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). 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.
VIII. Public Docket
EPA has established a record for this rulemaking under docket
number [OPP-300614] (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 Rm. 119 of the Public Information and Records
Intregrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA 22202.
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 address in ``ADDRESSES'' at the
beginning of this document.
IX. Regulatory Assessment Requirements
This final rule establishes an exemption from the tolerance
requirement 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 tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(d), such as the
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 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.
X. 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 the 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.
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Dated: February 6, 1998.
Marcia E. Mulkey,
Director, 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 180.1180 is amended by removing the paragraph heading
for paragraph (a), revising paragraph (b), and removing paragraphs (c)
and (d) to read as follows:
Sec. 180.1180 Kaolin; exemption from the requirement of a tolerance.
* * * * *
(b) Kaolin is exempted from the requirement of a tolerance for
residues when used on or in food commodities to aid in the control of
insects, fungi, and bacteria (food/feed use).
[FR Doc. 98-4652 Filed 2-24-98; 8:45 am]
BILLING CODE 6560-50-F