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Any Edible Food Commodity Used As A Pesticide; Exemption From the Requirement of a Tolerance
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: December 4, 1998 (Volume 63, Number 233)]
[Rules and Regulations]
[Page 66999-67001]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04de98-13]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-300749; FRL-6039-5]
40 CFR Part 180
RIN 2070-AB78
Any Edible Food Commodity Used As A Pesticide; 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 any edible food commodity (except for
peanuts, tree nuts, milk, soybeans, eggs, fish, crustacea, and wheat)
used as a pesticide, when applied in accordance with good agricultural
practices, in or on all food commodities. Any edible food commodity
used as a pesticide under this exemption must not be ``adulterated
food'' as defined in the Federal Food, Drug, and Cosmetic Act (FFDCA)
section 402 (21 U.S.C. 342). The exemption from the requirement of a
tolerance is being established by the Agency on its own initiative,
under the FFDCA as Amended by Food Quality Protection Act (FQPA) of
1996.
DATES: This regulation becomes effective December 4, 1998. Written
objections and requests for hearings must be received by February 2,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300749], 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-300749], 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 #2, 1921 Jefferson Davis
Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: opp-docket@epamail.epa.gov. Copies of electronic objections
and hearing requests must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Copies of
electronic objections and hearing requests will also be accepted on
disks in WordPerfect 5.1/6.1 or ASCII file format. All copies of
electronic objections and hearing requests must be identified by the
docket control number [OPP-300749]. No Confidential Business
Information (CBI) should be submitted through e-mail. Copies of
electronic objections and hearing requests on this rule may be filed
online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Freshteh Toghrol,
Biopesticides and Pollution Prevention Division (7511C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: 9th Floor, Crystal Mall 2, 1921 Jefferson David Highway,
Arlington, VA; (703) 308-7014, e-mail:
toghrol.freshteh@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 10, 1998 (62
FR 38513) (FRL-6016-1), EPA proposed, pursuant to section 408(e) of the
FFDCA, 21 U.S.C. 346a(d) to amend 40 CFR 180.1164 by establishing an
exemption from the requirement of a tolerance for residues of any
edible food commodities (except for peanuts, tree nuts, milk, soybeans,
eggs, fish, crustacea, and wheat) in or on all food commodities, when
applied in accordance with good agricultural practice. The term edible
food commodity means a food that is widely consumed for its nutrient
properties. The term only applies to food in the form it is sold or
distributed to the public for consumption. This language has been added
to the rule text for the sake of clarity. EPA has excluded peanuts,
tree nuts, milk, soybeans, eggs, fish, crustacea, and wheat from this
exemption because these foods or food groups have been identified as
common allergens. Normally, a person allergic to one of these foods
would be able to avoid the food because the food is recognizable. When
a food is used as a pesticide, however, the presence of its residues on
another food commodity, if that occurred, could not be readily
identified. Therefore, EPA has excluded these common allergens from
this exemption.
There were no comments received (exept for one positive comment
from Nurfam Americas, Inc.) in response to the proposed rule. Nurfam
Americas, Inc. has supported the proposed tolerance exemption for ``its
overall practicality, efficiency and reasonable presumption of safety.
However, the proposed exceptions from the exemption for peanuts, tree
nuts, milk, soybeans, eggs, fish, crustacea and wheat are overly
conservative and call into question several currently exempt
products.'' Nurfam Americas, Inc. has listed several commodities that
are exempted when used as inert ingredients under 40 CFR 180.1001(c),
(d), and (e) and has shown concern that this proposed rule may affect
the exemptions from tolerances already in effect for these inert
ingredients. This rule is for food used as active ingredients only and
will not affect the tolerance exemption for food used as inert
ingredients, which already are established under 40 CFR 180.1001(c),
(d), and (e). The commenter suggested including the excepted foods
based on a restriction that the food was applied prior to crop
emergence or when edible portions of crops are not present. An
exemption for these foods may be appropriate under such restrictions if
it could be shown that no residues would be present. However,
examination of that issue is beyond the scope of the present
rulemaking.
Based on the reasons set forth in the preamble to the proposed
rule, EPA establishes an exemption from tolerance for residues of any
edible food commodities as provided below in 40 CFR 180.1164(d) below.
I. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a regulation for an exemption from the
requirement of a tolerance issued by EPA under new section 408(e) 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 governs 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.
[[Page 67000]]
Any person may, by February 2, 1999, file written objections to any
aspect of this regulation (including the automatic revocation
provision) 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 the ADDRESSES section (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) or a request for a fee waiver. 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.
II. Public Record and Electronic Submissions
EPA has established a record for this rulemaking under docket
control number [OPP-300749] (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 #2, 1921 Jefferson Davis Hwy., Arlington, VA.
Electronic comments may 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 in this unit 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.
III. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes an exemption from the requirement of a
tolerance under FFDCA section 408(e). 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).
In addition, under the Regulatory Flexibility Act (RFA) (5 U.S.C.
601 et seq.), 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.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local, or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide to OMB, in a separately
identified section of the preamble to the rule, a description of the
extent of EPA's prior consultation with representatives of affected
tribal governments, a summary of the nature of their concerns, and a
statement supporting the need to issue the regulation. In addition,
Executive Order 13084 requires EPA to develop an effective process
permitting elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on
[[Page 67001]]
matters that significantly or uniquely affect their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
IV. 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.
Dated: November 2, 1998.
Stephen L. Johnson,
Acting 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 180.1164 is amended by adding a new paragraph (d) to
read as follows:
Sec. 180.1164 Food and food by-products; exemption from the
requirement of a tolerance.
* * * * *
(d) Any edible food commodity (except for peanuts, tree nuts, milk,
soybeans, eggs, fish, crustacea, and wheat) used as a pesticide is
exempted from the requirement of a tolerance when used in accordance
with good agricultural practice in or on all food commodities. This
exemption shall not apply to any edible food commodity that is
adulterated under section 342 of Title 21 of the United States Code.
The term edible food commodity means a food that is widely consumed for
its nutrient properties. The term only applies to food in the form it
is sold or distributed to the public for consumption.
[FR Doc. 98-32073 Filed 12-3-98; 8:45 am]
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