[Federal Register Volume 63, Number 233 (Friday, December 4, 1998)]
[Rules and Regulations]
[Pages 66999-67001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32073]


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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: [email protected]. 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: 
[email protected].
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:
    [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 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]
BILLING CODE 6560-50-F