[Federal Register Volume 62, Number 78 (Wednesday, April 23, 1997)]
[Rules and Regulations]
[Pages 19683-19685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10536]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300477; FRL-5712-8]

RIN 2070-AB78


Kaolin; Pesticide Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule establishes a temporary exemption from the 
requirement of a tolerance for residues of the insecticide Kaolin, when 
used on crops (apples, apricots, bananas, beans, cane berries, citrus 
fruits, corn, cotton, cranberries, cucurbits, grapes, melons, nuts, 
ornamentals, peaches, peanuts, pears, peppers, plums, potatoes, seed 
crops, small grains, soybeans, strawberries, sugar beets, and tomatoes) 
to control certain insect, fungus, and bacterial damage to plants.
DATES: This regulation is effective April 23, 1997 and expires December 
31, 1999. Submit written objections and hearing requests on or before 
June 23, 1997
ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [OPP-300477; PP-7G4793], may be submitted to: 
Hearing Clerk (1900), Environmental Protection Agency, Room 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 should be identified by the document control number and 
submitted to: Public Response and Program Resources Branch, Field 
Operations Division (7506C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
In person, bring a copy of the objections and hearing requests to: 
Crystal Mall #2, Room 1132, 1921 Jefferson Davis Highway, Arlington, 
VA. 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 of encryption. 
Copies of objections and hearing requests will also be accepted on 
disks in WordPerfect in 5.1 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-300477; PP-7G4793]. 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. 
Additional information on electronic submissions can be found in Unit 
IV. of this document.

FOR FURTHER INFORMATION CONTACT: By mail: Sheryl K. Reilly, Regulatory 
Action Leader, Biopesticides and Pollution Prevention Division (7501W), 
Office of Pesticide Programs, Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460, Office location, telephone number, and 
e-mail: Room CS15-W29, 2800 Jefferson Davis Highway, Arlington, VA, 
703-308-8265), e-mail: [email protected].
SUPPLEMENTARY INFORMATION: Engelhard Corporation, Research Center, 101 
Wood Avenue, Iselin, NJ 08830-0770 has requested in pesticide petition 
PP- 7G4793 the establishment of an exemption from the requirement of a 
tolerance for residues of the insecticide Kaolin. A notice of filing 
(FRL-5585-4) was published in the Federal Register (62 FR 6524, 
February 12, 1997), and the notice announced that the comment period 
would end on March 12, 1997; no comments were received. This temporary 
exemption from the requirement of a tolerance will permit the marketing 
of the above food commodities when treated in accordance with the 
provisions of experimental use permit 70060-EUP-1, which is being 
issued under the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA), as amended (Pub. L. 95-396, 92 Stat. 819; 7 U.S.C. 136). The 
data submitted in the petition and all other relevant material have 
been evaluated. Following is a summary of EPA's findings regarding this 
petition as required by section 408(d) of the Federal Food, Drug and 
Cosmetice Act (FFDCA), 21 U.S.C. 346a, as recently amended by the Food 
Quality Protection Act (FQPA), Pub. L. 104-170.

I. Summary

A. Proposed Use Practices

    The experimental program will be conducted in the states of 
Alabama, Arizona, California, Delaware, Florida, Idaho, Indiana, 
Georgia, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, 
Missouri, New Jersey, New York, North Dakota, Ohio, Oklahoma, Oregon, 
Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, 
and West Virginia. Crops to be treated are apples, apricots, bananas, 
beans, cane berries, citrus fruits, corn, cotton, cranberries, 
cucurbits, grapes, melons, nuts, ornamentals, peaches, peanuts, pears, 
peppers, plums, potatoes, seed crops, small grains, soybean, 
strawberries, sugar beets, and tomatoes. Treatment is made shortly 
after leaf or plant emergence and applied at 7 to 10-day intervals to 
crops. Treatment will not be applied within 10 days of harvest. Dosage 
rates are 10 to 100 lbs of the formulated kaolin per acre and are 
applied with standard commercial spray equipment. The first year target 
pests are aphids, apple scab, codling moth, fireblight, leaf hoppers, 
and pear psylla. The second year target pests are aphid complex, apple 
scab, armyworm, bacteria spot, bollworms, citrus canker, citrus rust, 
codling moth, Colorado potato beetle, cotton flea hopper, European and 
spotted red mite, fabrea leaf spot, early and late blight, fireblight, 
flyspeck, Japanese beetle, leaf hopper complex, leaf rollers, mealybug, 
mildews, phylloxera, pear psylla, pear rust mites, Pierce's Disease, 
rots, scales, tarnish plant bug, thrips, wheat stem-saw fly, and 
whitefly.

B. Product Identity/Chemistry

    Kaolin is a white, nonporous, nonswelling, natural aluminosilicate 
mineral with the chemical formula of 
A14Si4O10(OH)8. Kaolin is 
one of the most highly divided and highly refined naturally occurring 
minerals. Median particle size of commercial products vary between 0.1-
10 microns. Kaolin is chemically inert. Its hydrophilic surface allows 
kaolin to be easily dispersed in water at neutral pH values of 6-8. 
Common physical properties of kaolin are: platy shape; high brightness 
(80-95); specific gravity 2.58-2.63; refractive index 1.56-1.62; and 
Mohs hardness 2-3.

C. Toxicological Profile

    Waivers were requested for acute toxicity, genotoxicity, 
reproductive and developmental toxicity, subchronic toxicity, and 
chronic toxicity. The waivers were accepted based on its long history 
of use by humans without any indication of deleterious effects, and on 
the following: Kaolin is used as an indirect food additive for paper/
paper board in wet and fatty food contact, paper/paper board 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;

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Kaolin is used in health products and toiletries, in toothpaste and in 
antiperspirants; Kaolin can be used directly in foods as an anti-caking 
agent (up to 2.5%).

D. Aggregate Exposure

    In examining aggregate exposure, FQPA directs EPA to consider 
available information concerning exposures from the pesticide residue 
in food and all other non-occupational exposures. The primary non-food 
sources of exposure the Agency considers include drinking water or 
groundwater, and exposure through pesticide use in gardens, lawns, or 
buildings (residential and other indoor uses).
    1. Dietary exposure. Dietary exposure of kaolin via food or water 
is difficult to estimate due to the use of kaolin in thousands of 
products and its ubiquitous presence in nature. Kaolin has no known 
mammalian toxicity. The low toxicity, low application rate, and the use 
patterns leads the Agency to conclude that residues from use of the 
biochemical pesticide kaolin will not pose a dietary risk of concern 
under reasonably foreseeable circumstances. Therefore, EPA concludes 
that there is a reasonable certainty of no harm from aggregate exposure 
under this temporary exemption.
    2. Non-dietary, non-occupational exposure. Increased non-dietary 
exposure of kaolin via lawn care or ornamental use will be minimal. 
Kaolin is already widely used in the cosmetic, pharmacological, and 
other products listed above. 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.

E. Cumulative Exposure

    Kaolin has no mode of toxicity and is used in thousands of products 
used by humans. Cumulative exposure would be difficult to calculate due 
to its ubiquitous nature in the environment. Because of its low 
toxicity, low rate of application, and its use patterns, the Agency 
believes that there is no reason to expect any cumulative effects from 
kaolin.

F. Endocrine Disruptors

    The Agency has no information to suggest that kaolin will have an 
effect on the immune and endocrine systems. The Agency is not requiring 
information on the endocrine effects of this biochemical pesticide at 
this time; Congress has allowed 3 years after August 3, 1996, for the 
Agency to implement a screening program with respect to endocrine 
effects.

G. Safety

    For the U.S. population, including infants and children, kaolin has 
no known adverse effects. FFDCA section 408 provides that EPA shall 
apply an additional tenfold margin of exposure (safety) for infants and 
children in the case of threshold effects to account for pre- and post-
natal toxicity and the completeness of the database, unless EPA 
determines that a different margin of exposure (safety) will be safe 
for infants and children. Margins of exposure (safety) are often 
referred to as uncertainty (safety) factors. In this instance, the 
Agency believes there is reliable data to support the conclusion that 
kaolin is not toxic to mammals, including infants and children, and 
thus there are no threshold effects. As a result, the provision 
requiring an additional margin of exposure (safety) do not apply, and 
under reasonable, foreseeable circumstances, kaolin does not pose a 
dietary risk.

H. Analytical Method

    The Agency proposes to establish a temporary 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 kaolin residues.

I. Codex Maximum Residue Level

    There are no CODEX tolerances nor international tolerance 
exemptions for Kaolin at this time. Kaolin is listed as exempt from 
tolerance ``when used in accordance with good agricultural practice as 
an inert (or occasionally active) ingredient in pesticide formulations 
applied to growing crops or to food commodities after harvest.'' 40 CFR 
180.1001 (subpart D).

II. Conclusion

    Based on its long history of use by humans without any indication 
of deleterious effects, there is reasonable certainty that no harm will 
result from aggregate exposure to the United States population, 
including infants and children, to residues of kaolin. This includes 
all anticipated dietary exposures and all other exposures for which 
there is reliable information. The Agency has arrived at this 
conclusion because, as discussed above, no toxicity to mammals has been 
observed for kaolin. As a result, EPA establishes a temporary exemption 
from the requirement of a tolerance pursuant to FFDCA section 408(j)(3) 
for kaolin, on the condition that Kaolin be used in accordance with the 
experimental use permit 70060-EUP-1, with the following provisions:
    The total amount of the active ingredients to be used must not 
exceed the quantity authorized by the experimental use permits.
    Engelhard Corporation must immediately notify the EPA of any 
findings from the experimental use that have a bearing on safety. The 
company must also keep records of production, distribution, and 
performance and on request make the records available to any authorized 
officer or employee of the EPA or the Food and Drug Administration 
(FDA).
    This temporary exemption from the requirement of a tolerance 
expires and is revoked December 31, 1999. Residues remaining in or on 
the raw agricultural commodity after this expiration date will not be 
considered actionable if the pesticides are legally applied during the 
term of, and in accordance with, the provisions of the experimental use 
permit and temporary exemption from the requirement of a tolerance. 
This temporary exemption from the requirement of a tolerance may be 
revoked if the experimental use permit is revoked or if any experience 
with or scientific data on this pesticide indicate that the tolerance 
is not safe.

III. Objections and Hearing Requests

    The new FFDAC section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance exemption regulation issued by 
EPA under new section 408(e) as was provided in the old section 408. 
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 adversely affected by this regulation may on or before 
June 23, 1997 file written objections to the 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 under 
ADDRESSES at the beginning of this rule (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

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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 genuine and substantial issue of fact; there is 
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 ``Confidential Business 
Information'' (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.

IV. Public Record

    A record has been established for this rulemaking under the docket 
control number [OPP-300477; PP-7G4793] (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 1132 of the Public Response and 
Program Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 
1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments can 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 rule.

V. Regulatory Assessment Requirements

    The Office of Management and Budget has exempted this notice from 
the requirement of section 3 of Executive Order 12866. This action does 
not impose any enforceable duty or contain any ``unfunded mandates'' as 
described in Title II of the Unfunded Mandates Reform Act of 1995 (Pub. 
L. 104-4), or require prior consultation as specified by Executive 
Order 12875 (58 FR 58093, October 28, 1993), entitled Enhancing the 
Intergovernmental Partnership, or special consideration as required by 
Executive Order 12898 (59 FR 7629, February 16, 1994).
    Because tolerances established on the basis of a petition under 
section 408(d) of FFDCA do not require issuance of a proposed rule, the 
regulatory flexibility analysis requirements of the Regulatory 
Flexibility Act (RFA), 5 U.S.C. 604(a), do not apply. Prior to the 
recent amendment of the FFDCA, EPA had treated such rulemakings as 
subject to the RFA; however, the amendments to the FFDCA clarify that 
no proposal is required for such rulemakings and hence that the RFA is 
inapplicable. Nonetheless, the Agency has previously assessed whether 
establishing tolerances or exemptions from tolerance, raising tolerance 
levels, or expanding exemptions adversely impact small entities and 
concluded, as a generic matter, that there is no adverse impact. (46 FR 
24950) (May 4, 1981).
    Under 5 U.S.C. 801(a)(1)(A), EPA submitted 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 General 
Accounting Office prior to publication in today's Federal Register. 
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(a).

List of Subjects in 40 CFR Part 180

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

    Dated: April 15, 1997.

    Daniel M. Barolo,

Director, Office of Pesticide Programs.

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 added to subpart D to read as follows:


Sec. 180.1180  Kaolin; exemption from the requirement of a tolerance.

    (a) General. The biochemical pesticide kaolin is temporarily 
exempted from the requirement of a tolerance for residues of the 
insecticide Kaolin, when used on crops (apples, apricots, bananas, 
beans, cane berries, citrus fruits, corn, cotton, cranberries, 
cucurbits, grapes, melons, nuts, ornamentals, peaches, peanuts, pears, 
peppers, plums, potatoes, seed crops, small grains, soybeans, 
strawberries, sugar beets, and tomatoes) to control certain insect, 
fungus, and bacterial damage to plants. This temporary exemption from 
the requirement of a tolerance will permit the marketing of the food 
commodities in this paragraph when treated in accordance with the 
provisions of experimental use permit 70060-EUP-1, which is being 
issued under the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA), as amended (7 U.S.C. 136). This temporary exemption from the 
requirement of a tolerance expires and is revoked December 31, 1999. 
This temporary exemption from the requirement of a tolerance may be 
revoked at any time if the experimental use permit is revoked or if any 
experience with or scientific data on this pesticide indicate that the 
tolerance is not safe.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-10536 Filed 4-22-97; 8:45 am]
BILLING CODE 6560-50-F