[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

[[Page 9428]]

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