[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: opp-docket@epamail.epa.gov. 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: reilly.sheryl@epamail.epa.gov.
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:
opp-docket@epamail.epa.gov
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
