[Federal Register Volume 69, Number 159 (Friday, October 8, 2004)]
[Proposed Rules]
[Pages 60320-60328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22584]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9, 23, 163, 177, 178, 179, and 180
[OPP-2003-0176; FRL-7308-2]
Updating Generic Pesticide Chemical Tolerance Regulations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This action proposes to update the generic provisions in 40
CFR parts 9, 23, 163, 177-180 pertaining to pesticide chemical
tolerances and exemptions from the requirement of a tolerance under
section 408 of the Federal Food, Drug, and Cosmetic Act. This update is
necessary due to various changes made in the underlying statute by the
Food Quality Protection Act of 1996. The proposed amendments are
primarily procedural in nature.
DATES: Comments must be received on or before December 7, 2004.
ADDRESSES: Submit your comments, identified by docket ID number OPP-
2003-0176, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov/.
Follow the on-line instructions for submitting comments.
Agency Website: http://www.epa.gov/edocket/. EDOCKET,
EPA's electronic public docket and comment system, is EPA's preferred
method for receiving comments. Follow the on-line instructions for
submitting comments.
E-mail: Comments may be sent by e-mail to [email protected], Attention: Docket ID Number OPP-2003-0176.
Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001, Attention: Docket ID Number OPP-2003-0176.
Hand Delivery: Public Information and Records Integrity
Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental
Protection Agency, Rm. 119, Crystal Mall 2, 1801 S. Bell St.,
Arlington, VA, Attention: Docket ID Number OPP-2003-0176. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
Instructions: Direct your comments to docket ID number OPP-2003-
0176. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
http://www.epa.gov/edocket/, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through EDOCKET,
regulations.gov, or e-mail. The EPA EDOCKET and the regulations.gov
websites are ``anonymous access'' systems, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA
without going through EDOCKET or regulations.gov, your e-mail address
[[Page 60321]]
will be automatically captured and included as part of the comment that
is placed in the public docket and made available on the Internet. If
you submit an electronic comment, EPA recommends that you include your
name and other contact information in the body of your comment and with
any disk or CD ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit EDOCKET on-line or see the Federal Register of May 31,
2002 (67 FR 38102) (FRL-7181-7).
Docket: All documents in the docket are listed in the EDOCKET index
at http://www.epa.gov/edocket/. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in EDOCKET or in hard
copy at the Public Information and Records Integrity Branch (PIRIB),
Rm. 119, Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This
docket facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Jonathan Fleuchaus, Office of General
Counsel, Mail code 2333A, Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (202) 564-5628; fax number: (202) 564-5644; e-mail
address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111)
Animal production (NAICS 112)
Food manufacturer (NAICS 311)
Pesticide manufacturer (NAICS 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR is
available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
C. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
EDOCKET, regulations.gov, or e-mail. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM
as CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the rulemaking by docket ID number and other
identifying information (subject heading, Federal Register date, and
page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree, suggest alternatives, and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What Action is the Agency Taking?
EPA is proposing to amend various sections of 40 CFR parts 9, 23,
163, and 177-180 to make them consistent with the changes to section
408 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a,
contained in the Food Quality Protection Act of 1996 (FQPA).
EPA is proposing to revoke 40 CFR part 163 in its entirety. Part
163 addresses ``certifications of usefulness'' for pesticide chemicals.
In amending section 408, the FQPA dropped all requirements pertaining
to certifications of usefulness. EPA is proposing several general
changes throughout parts 177-180. These changes are:
1. Remove most references to FFDCA section 409. The FQPA
consolidated FFDCA regulation of pesticides, for the most part, under
FFDCA section 408. See 21 U.S.C. 346a(a)(1). Previously, pesticide
residues in processed food were regulated, in part, under FFDCA section
409. Most references in 40 CFR parts 177-180 to section 409 thus have
become obsolete and are proposed to be removed. This includes 40 CFR
part 177 in its entirety because it is devoted to providing procedures
for establishing regulations under section 409.
2. Remove most references to ``food additives.'' Because ``food
additives'' are addressed by section 409 and not section 408, for
similar reasons, most references to ``food additives'' are proposed to
be removed. See 21 U.S.C. 348.
3. Revise statutory cross-references where appropriate. In some
instances, the FQPA moved various provisions in section 408 to
different subsections. For example, the procedures pertaining to filing
objections are now located in section 408(g) not section 408(d) as they
were previously. These cross-references are proposed to be corrected.
4. Remove provisions addressing advisory committees. Previously,
section 408 had a provision permitting affected parties to request the
formation of science advisory panels regarding tolerance actions.
Because this provision was dropped by the FQPA, EPA is proposing to
remove the implementing regulations.
[[Page 60322]]
5. Remove provisions addressing the time requirements for acting on
petitions. Previously, section 408 required action on petitions in
certain timeframes. Because this provision was dropped by the FQPA, EPA
is proposing to remove implementing regulations concerning these
timeframes.
6. Revise changed statutory time periods. In a few instances, the
FQPA revised statutory time periods pertaining to actions concerning
tolerances. For example, the period in which objections to final
tolerance rules can be made was extended from 30 to 60 days. See 21
U.S.C. 346a(g)(2). EPA is proposing to change its regulations to be
consistent with the statute.
7. Remove obsolete references to the ``Registration Division.'' 40
CFR part 180 contains several references to the Registration Division
of the Office of Pesticide Programs. Because tolerance activities are
now divided among several divisions in the Office of Pesticide
Programs, the references to the Registration Division may be confusing,
and EPA is proposing to either replace these references with a
reference to ``the Agency'' or simply delete them, as appropriate.
Although this change is not directly responsive to the FQPA changes,
the potential confusion that might be caused by the obsolete references
was deemed important to correct at this time.
8. Correct Agency addresses. 40 CFR 178.25(a)(5) and 180.33(m)
currently list obsolete addresses for mailings to the Agency. These
addresses are proposed to be corrected.
Other changes involving individual sections include:
1. 40 CFR 178.35. This provision addresses modification or
revocation of a tolerance regulation on the basis of objections filed
with the Agency. EPA is proposing to change the language in this
section to track the language in new section 408(g)(2)(C). See 21
U.S.C. 346a(g)(2).
2. 40 CFR 180.1(f). The FQPA amended the provision addressing the
manner in which pesticide chemical tolerances written for raw
agricultural commodities apply to processed foods manufactured from
those commodities. This provision is commonly referred to as the
``flow-through'' provision because it generally legalizes residues in
processed food that are not higher than the residue levels permitted in
the raw agricultural commodity. See 21 U.S.C. 346a(a)(2). EPA is
proposing to amend 40 CFR 180.1(f) to track the language in new section
408(a)(2).
EPA calls attention to the fact that one of the changes in the
flow-through provision, and thus in the revised 40 CFR 180.1(f), is
that it no longer focuses on whether processed food is ``ready to
eat.'' For many years prior to the passage of the FQPA, EPA determined
the need for processed food tolerances without regard to whether the
processed food was ``ready to eat'' or not, despite statutory language
specifying that the flow-through provision applied to ``ready to eat''
processed food. This led to the establishment of several processed food
tolerances that were unnecessary because the tolerances were
established on not ``ready to eat'' commodities and when these
commodities underwent further processing to reach the ``ready to eat''
stage, residues declined below the raw agricultural commodity
tolerance. Shortly before passage of the FQPA, EPA revoked several
tolerances on not ``ready to eat'' processed foods on the ground they
were not necessary given the existing raw agricultural commodity
tolerance level and the level of residues present in the ``ready to
eat'' processed food. As part of the tolerance reassessment process
required by the FQPA, EPA will determine if such tolerances need to be
reestablished and, if so, take steps to reinstate such tolerances. In
the meantime, because section 408(j)(3) preserves the effectiveness of
raw agricultural commodity tolerances in existence at the time of
passage of the FQPA, EPA believes that the raw agricultural commodity
tolerances corresponding to the revoked not ``ready to eat'' processed
food tolerances should be enforced under the pre-FQPA ``flow-through''
provision thus not subjecting not ``ready to eat'' processed food to a
changed regulatory environment. Otherwise, the effect of these raw
agricultural commodity tolerances will not be maintained as specified
by section 408(j)(3).
3. 40 CFR 180.2. New section 408(k) mandates that pesticide
chemicals regarded by the Administrator as generally recognized as safe
(GRAS) shall be regarded as exempt from the requirement for a
tolerance. This section further directs EPA to indicate, by regulation,
which substances have been converted from GRAS to being covered by a
tolerance exemption. 40 CFR 180.2 now contains a listing of GRAS
substances. Pursuant to section 408(k), EPA is proposing in this action
to create tolerance exemptions in separate sections of 40 CFR part 180
for all but three of these substances (citric acid, fumaric acid, and
sodium chloride). The remainder of 40 CFR 180.2, which contains
procedures for obtaining GRAS status is proposed to be deleted. Citric
acid, fumaric acid, and sodium chloride are the subject of a separate
rulemaking intended to create tolerance exemptions for these substances
in 40 CFR 180.950.
4. 40 CFR 180.7. Three important, specific changes are proposed for
40 CFR 180.7. First, it is proposed that this section be expanded from
addressing tolerances just for raw agricultural commodities to
tolerances for raw agricultural commodities and processed foods. This
is consistent with the changes in the FQPA which expanded section 408
to include pesticide chemical tolerances for processed foods. See 21
U.S.C. 346a(a)(1). Second, EPA is proposing to expand the requirements
pertaining to petition contents consistent with the expanded statutory
language in the FQPA, including the requirement that the petition
contain a summary. See 21 U.S.C. 346a(d)(2).
Third, EPA is specifying that the full text of the petitioner's
summary of its petition will be added to EPA's Electronic Public Docket
(http://www.epa.gov/edocket) and requiring that a specific reference to
the internet address for the summary be included in the Notice of
Filing. To date, EPA has published the full text of the petitioner's
summary in the Federal Register notice announcing the Notice of Filing.
EPA is proposing to include the petitioner's summary in the Notice of
Filing Federal Register notice through a reference and to publish the
summary on its internet website because petition ``summaries'' have
expanded, in many instances, well beyond the concept of a petition
summary and could be better described as the petition itself. Rather
than continue to add these lengthy documents to the Federal Register or
attempt to influence how petitioners prepare such summaries, EPA
believes that publication in the Electronic Public Docket on its
internet website, with a reference to that internet site address in the
Federal Register, conforms to the statute and provides the public with
the greatest amount of information in a manner that is readily
accessible.
Other changes to 40 CFR 180.7 include: (1) Amending paragraph (b)
to be in the form of a list of requirements for a petition rather than
a model letter to the Registration Division; (2) amending paragraph (d)
to drop now meaningless provisions pertaining to the date a petition is
deemed to be filed; and (3) amending paragraph (e) to update the
language regarding publication of a petitioner-provided summary of the
petition.
5. 40 CFR 180.29. Previously, FFDCA section 408 contained different
procedures for pesticide registrants and other parties. 40 CFR 180.29,
in part,
[[Page 60323]]
implemented the procedures for establishing tolerances pertaining to
non-registrants. The new FFDCA section 408(d) requires all parties to
follow the same petition process. See 21 U.S.C. 346a(d). EPA is
proposing to remove the old procedures in 40 CFR 180.29 that have been
dropped from the statute. Similar changes are proposed for 40 CFR
180.32 addressing modification and revocation of tolerances.
6. 40 CFR 180.30. The FQPA expanded and clarified the exclusive
judicial review procedures under section 408. See 21 U.S.C. 346a(h).
EPA is proposing to revise 40 CFR 180.30 to track the statutory changes
regarding this topic.
7. 40 CFR 180.31. The FQPA changed the procedures for establishing
temporary tolerances for experimental use of pesticides under the
Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et
seq. See 21 U.S.C. 346a(r). EPA is proposing to modify 40 CFR 180.31 to
reflect these statutory changes. In brief, the FQPA requires that
temporary tolerances be established under the same procedures
pertaining to all except emergency tolerances.
8. 40 CFR 180.32. The language in 40 CFR 180.32 of the regulations
is proposed to be modified to make it consistent with the FQPA.
Existing 40 CFR 180.32 speaks in terms of ``amendment'' and ``repeal''
of tolerances, whereas the FQPA describes such actions as
``modifications'' and ``revocations.''
9. 40 CFR 23.10. The language in this section is proposed to be
modified to conform the statutory citations to the new subsection in
section 408 governing judicial review and to conform the language
pertaining to reviewable actions to the language of section 408's
revised judicial review provision.
10. 40 CFR 9.1. Now obsolete 40 CFR parts 163 and 177 are proposed
to be removed from the table in 40 CFR part 9.
The Agency is also considering minor adjustments to 40 CFR part 180
to accommodate recent legislation concerning pesticide registration and
tolerance fees. See Pesticide Registration Improvement Act of 2003,
Public Law 108-199 (HR 2673).
B. What is the Agency's Authority for Taking this Action?
These changes are being proposed under EPA's authority in FFDCA
section 408(e)(1)(C) to establish general procedures and requirements
to implement section 408.
III. Regulatory Assessment Requirements
This proposed rule makes several changes in the EPA regulations
governing pesticide tolerances and exemptions from tolerance. The
amendments are procedural in nature and, for the most part, correct the
CFR so that it is consistent with FFDCA section 408, as amended by the
FQPA, and EPA's ongoing implementation of FFDCA. Other than making EPA
regulations more accurate, these amendments are not expected to have
any impact on regulated parties or the public. Accordingly, these
amendments are not subject to review under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993),
as a significant regulatory action. Because this proposed rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this proposed rule is not subject to Executive Order
13211, Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This proposed
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) (Public Law 104-4). Nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or OMB review or any
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note).
Since, as detailed above, these amendments will have no detrimental
impact on regulated parties or the public, EPA certifies under the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) that the
amendments will not have a significant impact on a substantial number
of small entities. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This proposed rule is directed at pesticide manufacturers
and others who seek to establish, modify, or revoke pesticide
tolerances and exemptions, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of the
FFDCA. For these same reasons, the Agency has determined that this
proposed rule does not have any ``tribal implications'' as described in
Executive Order 13175, entitled Consultation and Coordination with
Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive
Order 13175, requires EPA to develop an accountable process to ensure
``meaningful and timely input by tribal officials in the development of
regulatory policies that have tribal implications.'' ``Policies that
have tribal implications`` is defined in the Executive Order to include
regulations that have ``substantial direct effects on one or more
Indian tribes, on the relationship between the Federal Government and
the Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.'' This proposed rule
will not have substantial direct effects on tribal governments, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.
List of Subjects in 40 CFR Parts 9, 163, 177, 178, 179, 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides
[[Page 60324]]
and pests, Reporting and recordkeeping requirements.
Dated: September 20, 2004.
Susan B. Hazen,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
Therefore, 40 CFR chapter I is amended as follows:
PART 9--[AMENDED]
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
Sec. 9.1 [Amended]
2. Section 9.1 is amended by removing the entries and center
headings for parts 163 and 177 in the table.
PART 23--[AMENDED]
3. The authority citation for part 23 continues to read as follows:
Authority: Clean Water Act, 33 U.S.C. 1361(a), 1369(b); Clean
Air Act, 42 U.S.C. 7601(a)(1), 7607(b); Resource, Conservation and
Recovery Act, 42 U.S.C. 6912(a), 6976; Toxic Substances Control Act,
15 U.S.C. 2618; Federal Insecticide, Fungicide, and Rodenticide Act,
7 U.S.C. 136n(b), 136w(a); Safe Drinking Water Act, 42 U.S.C. 300j-
7(a)(2), 300j-9(a); Atomic Energy Act, 42 U.S.C. 2201, 2239; Federal
Food, Drug, and Cosmetic Act, 21 U.S.C. 371(a), 346a, 348; 28 U.S.C.
2112(a), 2343, 2344.
4. Section 23.10 is revised to read as follows:
Sec. 23.10 Timing of Administrator's action under the Federal Food,
Drug, and Cosmetic Act.
Unless the Administrator otherwise explicitly provides in a
particular order, the time and date of the entry of a regulation issued
under section 21 U.S.C. 346a(e)(1)(C), or any order issued under 21
U.S.C. 346a(f)(1)(C) or 21 U.S.C. 346a(g)(2)(C), or any regulation that
is the subject of such an order, shall, for purposes of 21 U.S.C.
346a(h), be at 1 p.m. eastern time (standard or daylight, as
appropriate) on the date that is for a Federal Register document, 2
weeks after the date when the document is published in the Federal
Register, or for any other document, 2 weeks after it is signed.
PART 163--[REMOVED]
5. Part 163 is removed.
PART 177--[REMOVED]
6. Part 177 is removed.
PART 178--[AMENDED]
7. The authority citation for part 178 continues to read as
follows:
Authority: 21 U.S.C. 346a, 348, 371(a); Reorg. Plan No. 3 of
1970.
8. Section 178.20 is amended by revising paragraph (a) to read as
follows:
Sec. 178.20 Right to submit objections and requests for a hearing.
(a) On or before the 60th day after the date of publication in the
Federal Register of an order under part 180 of this chapter
establishing, modifying, or revoking a regulation, or denying all or
any portion of a petition, a person adversely affected by such order or
petition denial may submit, in accordance with Sec. 178.25, one or
more written objections to the order (or to the action that is the
subject of the order).
* * * * *
9. Section 178.25 is amended by revising paragraphs (a)(7) and
(b)(2) to read as follows:
Sec. 178.25 Form and manner of submission of objections.
(a) * * *
(7) Be received by the Hearing Clerk not later than the close of
business of the 60th day following the date of the publication in the
Federal Register of the order to which the objection is taken (or, if
such 60th day is a Saturday, Sunday, or Federal holiday, not later than
the close of business of the next government business day after such
60th day).
* * * * *
(b) * * *
(2) For personal delivery, the Office of the Hearing Clerk is
located at: Room 104, Crystal Mall 2, 1801 S. Bell St.,
Arlington, VA.
10. Section 178.35 is amended as follows:
a. By revising paragraph (a).
b. By revising ``rule'' to read ``order'' in paragraph (b).
c. By revising the section heading.
Sec. 178.35 Modification or revocation of regulation or prior order.
(a) If the Administrator determines upon review of an objection or
request for hearing that the regulation or prior order in question
should be modified or revoked, the Administrator will publish an order
setting forth any revision to the regulation or prior order that the
Administrator has found to be warranted.
* * * * *
11. Section 178.37 is amended by revising the introductory text of
paragraph (a) and paragraph (c) to read as follows:
Sec. 178.37 Order responding to objections on which a hearing was
not requested or was denied.
(a) The Administrator will publish in the Federal Register an order
under FFDCA section 408(g)(2)(B) or section 408(g)(2)(C) setting forth
the Administrator's determination on each denial of a request for a
hearing, and on each objection submitted under Sec. 178.20 on which:
* * * * *
(c) Each order published under paragraph (a) of this section must
state its effective date.
12. Section 178.65 is revised to read as follows:
Sec. 178.65 Judicial review.
An order issued under Sec. 178.37 is final agency action
reviewable in the courts as provided by FFDCA sections 408(h), as of
the date of entry of the order, which shall be determined in accordance
with Sec. Sec. 23.10 and 23.11 of this chapter. The failure to file a
petition for judicial review within the period ending on the 60th day
after the date of the entry of the order constitutes a waiver under
FFDCA section 408(h) of the right to judicial review of the order and
of any regulation promulgated by the order.
Sec. 178.70 [Amended]
13. Section 178.70 is amended by removing paragraphs (a)(2) and
(a)(3) and redesignating existing paragraphs (a)(4) through (a)(8) as
paragraphs (a)(2) through (a)(6), respectively.
PART 179--[AMENDED]
14. The authority citation for part 179 continues to read as
follows:
Authority: 21 U.S.C. 346a, 348, 371(a); Reorg. Plan No. 3 of
1970.
Sec. 179.20 [Amended]
15. Section 179.20(a)(3) is amended by removing the phrase ``Sec.
177.81 or ''.
Sec. 179.24 [Amended]
16. Section 179.24 is amended by removing ``177,'' and removing the
comma after ``1978'' in paragraph (a).
[[Page 60325]]
Sec. 179.83 [Amended]
17. Section 179.83 is amended by revising ``parts 177, or 180'' to
read ``part 180'' in paragraph (a)(1).
18. Section 179.91 is amended by revising paragraph (b) to read as
follows:
Sec. 179.91 Burden of going forward; burden of persuasion.
* * * * *
(b) The party or parties who contend that a regulation satisfies
the criteria of section 408 of the FFDCA has the burden of persuasion
in the hearing on that issue, whether the proceeding concerns the
establishment, modification, or revocation of a tolerance or exemption
from the requirement for a tolerance.
Sec. 179.125 [Amended]
19. Section 179.125 is amended by revising ``408(i) or 409(g)(1)''
wherever it appears to read ``408(h)'' in paragraph (a).
Sec. 179.130 [Amended]
20. Section 179.130 is amended by removing paragraphs (a)(2) and
(a)(3) and redesignating existing paragraphs (a)(4) through (a)(12) as
paragraphs (a)(2) through (a)(10), respectively.
PART 180--[AMENDED]
21. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
22. Section 180.1 is amended by removing paragraph (d),
redesignating existing paragraphs (e) through (p) as paragraphs (d)
through (o), respectively, and revising newly designated paragraph (e)
to read as follows:
Sec. 180.1 Definitions and interpretations.
* * * * *
(e) Where a raw agricultural commodity bearing a pesticide chemical
residue that has been exempted from the requirement of a tolerance, or
which is within a tolerance permitted under section 408, is used in
preparing a processed food, the processed food will not be considered
unsafe within the meaning of sections 402 and 408(a), despite the lack
of a tolerance or exemption for the pesticide chemical residue in the
processed food, if:
(1) The pesticide chemical has been used in or on the raw
agricultural commodity in conformity with a tolerance under this
section;
(2) The pesticide chemical residue has been removed to the extent
possible in good manufacturing practice; and
(3) The concentration of the pesticide chemical residue in the
processed food is not greater than the tolerance prescribed for the
pesticide chemical residue on the raw agricultural commodity.
* * * * *
Sec. 180.2 [Removed]
23. Section 180.2 is removed.
24. The undesignated center heading that precedes Sec. 180.7 and
Sec. 180.7 are revised to read as follows:
Procedure for Filing Petitions Seeking the Establishment,
Modification, or Revocation of Tolerances or Exemptions
Sec. 180.7 Petitions proposing tolerances or exemptions for pesticide
residues in or on raw agricultural commodities or processed foods.
(a) Petitions to be filed with the Agency under the provisions of
section 408(d) shall be submitted in duplicate. If any part of the
material submitted is in a foreign language, it shall be accompanied by
an accurate and complete English translation. The petition shall be
accompanied by an advance deposit for fees described in Sec. 180.33.
The petition shall state the petitioner's mail address to which notice
of objection under section 408(g)(2) may be sent. The petition must be
signed by the petitioner or by his attorney or agent, or (if a
corporation) by an authorized official.
(b) Petitions shall include the following information:
(1) An informative summary of the petition and of the data,
information, and arguments submitted or cited in support of the
petition. Both a paper and electronic copy of the summary should be
submitted. The electronic copy should be formatted according to the
Office of Pesticide Programs' current standard for electronic data
submission as specified at http://www.epa.gov/oppfead1/eds/edsgoals.htm.
(2) A statement that the petitioner agrees that such summary or any
information it contains may be published as a part of the notice of
filing of the petition to be published under section 408(d)(3) and as a
part of a proposed or final regulation issued under section 408.
(3) The name, chemical identity, and composition of the pesticide
chemical residue and of the pesticide chemical that produces the
residue.
(4) Data showing the recommended amount, frequency, method, and
time of application of the pesticide chemical.
(5) Full reports of tests and investigations made with respect to
the safety of the pesticide chemical, including full information as to
the methods and controls used in conducting those tests and
investigations.
(6) Full reports of tests and investigations made with respect to
the nature and amount of the pesticide chemical residue that is likely
to remain in or on the food, including a description of the analytical
methods used. (See Sec. 180.34 for further information about residue
tests.)
(7) Proposed tolerances for the pesticide chemical residue if
tolerances are proposed.
(8) Practicable methods for removing any amount of the residue that
would exceed any proposed tolerance.
(9) A practical method for detecting and measuring the levels of
the pesticide chemical residue in or on the food, or for exemptions, a
statement why such a method is not needed.
(10) If the petition relates to a tolerance for a processed food,
reports of investigations conducted using the processing method(s) used
to produce that food.
(11) Such information as the Administrator may require to make the
determination under section 408(b)(2)(C).
(12) Such information as the Administrator may require on whether
the pesticide chemical may have an effect in humans that is similar to
an effect produced by a naturally occurring estrogen or other endocrine
effects.
(13) Information regarding exposure to the pesticide chemical
residue due to any tolerance or exemption already granted for such
residue.
(14) Information concerning any maximum residue level established
by the Codex Alimentarius Commission for the pesticide chemical residue
addressed in the petition. If a Codex maximum residue level has been
established for the pesticide chemical residue and the petitioner does
not propose that this level be adopted, a statement explaining the
reasons for this departure from the Codex level.
(15) Such other data and information as the Administrator requires
by regulation to support the petition.
(16) Reasonable grounds in support of the petition.
(c) The data specified under paragraphs (b)(1) through (b)(16) of
this section should be on separate sheets or sets of sheets, suitably
identified. If such data have already been submitted with an earlier
application, the present petition may incorporate it by reference to
the earlier one.
(d) Except as noted in paragraph (e) of this section, a petition
shall not be
[[Page 60326]]
accepted for filing if any of the data prescribed by section 408(d) are
lacking or are not set forth so as to be readily understood. The
availability to the public of information provided to, or otherwise
obtained by, the Agency under this part shall be governed by part 2 of
this chapter. The Administrator shall make the full text of the summary
referenced in paragraph (b)(1) of this section available to the public
in the Environmental Protection Agency Electronic Docket at http://www.epa.gov/edocket no later than publication in the Federal Register
of the notice of the petition filing.
(e) The Administrator shall notify the petitioner within 15 days
after its receipt of acceptance or nonacceptance of a petition, and if
not accepted the reasons therefor. If petitioner desires, the
petitioner may supplement a deficient petition after notification as to
deficiencies. If the petitioner does not wish to supplement or explain
the petition and requests in writing that it be filed as submitted, the
petition shall be filed and the petitioner so notified.
(f) A notice of the filing of a petition for a pesticide chemical
residue tolerance that the Administrator determines has met the
requirements of paragraph (b) of this section shall be published in the
Federal Register by the Administrator within 30 days after such
determination. The notice shall state the name of the pesticide
chemical residue and the commodities for which a tolerance is sought
and announce the availability of a description of the analytical
methods available to the Administrator for the detection and
measurement of the pesticide chemical residue with respect to which the
petition is filed or shall set forth the petitioner's statement of why
such a method is not needed. The notice shall explicitly reference the
specific address in the Agency's Electronic Docket (http://www.epa.gov/edocket) where the full text of the summary required in paragraph (b)
of this section and refer interested parties to this document for
further information on the petition. The full text of the summary may
be omitted from the notice.
(g) The Administrator may request a sample of the pesticide
chemical at any time while a petition is under consideration. The
Administrator shall specify in its request for a sample of the
pesticide chemical, a quantity which it deems adequate to permit tests
of analytical methods used to determine residues of the pesticide
chemical and of methods proposed by the petitioner for removing any
residues of the chemical that exceed the tolerance proposed.
(h) The Administrator shall determine, in accordance with the Act,
whether to issue an order that establishes, modifies, or revokes a
tolerance regulation (whether or not in accord with the action proposed
by the petitioner), or whether to publish a proposed tolerance
regulation and request public comment thereon under Sec. 180.29. The
Administrator shall publish in the Federal Register such order or
proposed regulation. After receiving comments on any proposed
regulation, the Administrator may issue an order that establishes,
modifies, or revokes a tolerance regulation. An order published under
this section shall describe briefly how to submit objections and
requests for a hearing under part 178 of this chapter. A regulation
issued under this section shall be effective on the date of publication
in the Federal Register unless otherwise provided in the regulation.
25. Section 180.8 is revised to read as follows:
Sec. 180.8 Withdrawal of petitions without prejudice.
In some cases the Administrator will notify the petitioner that the
petition, while technically complete, is inadequate to justify the
establishment of a tolerance or the tolerance requested by petitioner.
This may be due to the fact that the data are not sufficiently clear or
complete. In such cases, the petitioner may withdraw the petition
pending its clarification or the obtaining of additional data. This
withdrawal may be without prejudice to a future filing. A deposit for
fees as specified in Sec. 180.33 shall accompany the resubmission of
the petition.
26. Section 180.9 is revised to read as follows:
Sec. 180.9 Substantive amendments to petitions.
After a petition has been filed, the petitioner may submit
additional information or data in support thereof, but in such cases
the petition will be given a new filing date.
Sec. Sec. 180.10, 180.11 and 180.12 [Removed]
27. Sections 180.10, 180.11 and 180.12 are removed.
28. The undesignated center heading that precedes Sec. 180.29, and
Sec. 180.29 are revised to read as follows:
Establishment, Modification, and Revocation of Tolerance on
Initiative of Administrator; Judicial Review; Temporary Tolerances;
Modification and Revocation of Tolerances; Fees
Sec. 180.29 Establishment, modification, and revocation of tolerance
on initiative of Administrator.
(a) Upon the Administrator's own initiative, the Administrator may
propose, under section 408(e) of the Federal Food, Drug, and Cosmetic
Act, the issuance of a regulation establishing a tolerance for a
pesticide chemical or exempting it from the necessity of a tolerance,
or a regulation modifying or revoking an existing tolerance or
exemption.
(b) The Administrator shall provide a period of not less than 60
days for persons to comment on the proposed regulation, except that a
shorter period for comment may be provided if the Administrator for
good cause finds that it would be in the public interest to do so and
states the reasons for the finding in the notice of proposed
rulemaking.
(c) After reviewing any timely comments received, the Administrator
may by order establish, modify, or revoke a tolerance regulation, which
order and regulation shall be published in the Federal Register. An
order published under this section shall state that persons may submit
objections and requests for a hearing in the manner described in part
178 of this chapter.
(d) Any final regulation issued under this section shall be
effective on the date of publication in the Federal Register unless
otherwise provided in the regulation.
29. Section 180.30 is revised to read as follows:
Sec. 180.30 Judicial review.
(a) Under section 408(h) of the FFDCA, judicial review is available
in the United States Courts of Appeal as to the following actions:
(1) Regulations establishing general procedures and requirements
under FFDCA section 408(e)(1)(C).
(2) Orders issued under FFDCA section 408(f)(1)(C) requiring the
submission of data.
(3) Orders issued under FFDCA section 408(g)(2)(C) ruling on
objections to establishment, modification, or revocation of a tolerance
or exemption under FFDCA section 408(d)(4), or any regulation that is
the subject of such an order. The underlying action here is Agency
disposition of a petition seeking the establishment, modification, or
revocation of a tolerance or exemption.
(4) Orders issued under FFDCA section 408(g)(2)(C) ruling on
objections
[[Page 60327]]
to the denial of a petition under FFDCA section 408(d)(4).
(5) Orders issued under FFDCA section 408(g)(2)(C) ruling on
objections to the establishment, modification, suspension, or
revocation of a tolerance or exemption under FFDCA section 408(e)(1)(A)
or (e)(1)(B). The underlying action here is the establishment,
modification, suspension, or revocation of a tolerance or exemption
upon the initiative of EPA including EPA actions pursuant to FFDCA
sections 408(b)(2)(B)(v), 408(b)(2)(E)(ii), 408(d)(4)(C)(ii),
408(l)(4), and 408(q)(1).
(6) Orders issued under FFDCA section 408(g)(2)(C) ruling on
objections to the revocation or modification of a tolerance or
exemption under FFDCA section 408(f)(2) for noncompliance with
requirements for the submission of data.
(7) Orders issued under FFDCA section 408(g)(2)(C) ruling on
objections to rules issued under FFDCA sections 408(n)(3) and 408(d) or
(e) regarding determinations pertaining to State authority to establish
regulatory limits on pesticide chemical residues.
(8) Orders issued under FFDCA section 408(g)(2)(C) ruling on
objections to orders issued under FFDCA section 408(n)(5)(C)
authorizing States to establish regulatory limits not identical to
certain tolerances or exemptions.
(b) Any issue as to which review is or was obtainable under
paragraph (a) of this section shall not be the subject of judicial
review under any other provision of law. In part, this means that, for
the Agency actions subject to the objection procedure in FFDCA section
408(g)(2), judicial review is not available unless an adversely
affected party exhausts these objection procedures, and any petition
procedures preliminary thereto.
30. Section 180.31 is revised to read as follows:
Sec. 180.31 Temporary tolerances.
(a) A temporary tolerance (or exemption from a tolerance)
established under the authority of section 408(r) of the Act shall be
deemed to be a tolerance (or exemption from the requirement of a
tolerance) for the purposes of section 408(a)(1) or (a)(2) of the Act
and for the purposes of Sec. 180.30.
(b) A request for a temporary tolerance or a temporary exemption
from a tolerance by a person who has obtained or is seeking an
experimental permit for a pesticide chemical under the Federal
Insecticide, Fungicide, and Rodenticide Act shall be accompanied by
such data as are available on subjects outlined in Sec. 180.7(b) and
an advance deposit to cover fees as provided in Sec. 180.33.
(c) To obtain a temporary tolerance, a requestor must comply with
the petition procedures specified in FFDCA section 408(d) and Sec.
180.7 except as provided in this section.
(d) A temporary tolerance or exemption from a tolerance may be
issued for a period designed to allow the orderly marketing of the raw
agricultural commodities produced while testing a pesticide chemical
under an experimental permit issued under authority of the Federal
Insecticide, Fungicide, and Rodenticide Act if the Administrator
concludes that the safety standard in FFDCA section 408(b)(2) or (c),
as applicable, is met. Subject to the requirements of section 408(e), a
temporary tolerance or exemption from a tolerance may be revoked if the
experimental permit is revoked, or may be revoked at any time if it
develops that the application for a temporary tolerance contains a
misstatement of a material fact or that new scientific data or
experience with the pesticide chemical indicates that it does not meet
the safety standard in FFDCA section 408(b)(2) or (c), as applicable.
(e) Conditions under which a temporary tolerance is established
shall include:
(1) A limitation on the amount of the chemical to be used on the
designated crops permitted under the experimental permit.
(2) A limitation for the use of the chemical on the designated
crops to bona fide experimental use by qualified persons as indicated
in the experimental permit.
(3) A requirement that the person or firm which obtains the
experimental permit for which the temporary tolerance is established
will immediately inform the Environmental Protection Agency of any
reports on findings from the experimental use that have a bearing on
safety.
(4) A requirement that the person or firm which obtained the
experimental permit for which the temporary tolerance is established
will keep records of production, distribution, and performance for a
period of 2 years and, on request, at any reasonable time, make these
records available to any authorized officer or employee of the
Environmental Protection Agency.
31. Section 180.32 is revised to read as follows:
Sec. 180.32 Procedure for modifying and revoking tolerances or
exemptions from tolerances.
(a) The Administrator on his/her own initiative may propose the
issuance of a regulation modifying or revoking a tolerance for a
pesticide chemical residue on raw agricultural commodities or processed
foods or modifying or revoking an exemption from tolerance for such
residue.
(b) Any person may file with the Administrator a petition proposing
the issuance of a regulation modifying or revoking a tolerance or
exemption from a tolerance for a pesticide chemical residue. The
petition shall furnish reasonable grounds for the action sought.
Reasonable grounds shall include an explanation showing wherein the
person has a substantial interest in such tolerance or exemption from
tolerance and an assertion of facts (supported by data if available)
showing that new uses for the pesticide chemical have been developed or
old uses abandoned, that new data are available as to toxicity of the
chemical, or that experience with the application of the tolerance or
exemption from tolerance may justify its modification or revocation.
Evidence that a person has registered or has submitted an application
for the registration of an pesticide under the Federal Insecticide,
Fungicide, and Rodenticide Act will be regarded as evidence that the
person has a substantial interest in a tolerance or exemption from the
requirement of a tolerance for a pesticide chemical that consists in
whole or in part of the pesticide. New data should be furnished in the
form specified in Sec. 180.7(b) for submitting petitions, as
applicable.
(c) The procedures for completing action on an Administrator-
initiated proposal or a petition shall be those specified in Sec. Sec.
180.29 and 180.7, as applicable.
32. Section 180.33 is amended as follows:
a. In paragraphs (a), (b), (c), and (h) remove the phrase ``or
request''.
b. Remove paragraph (j) and redesignate existing paragraphs (k)
through (p) as paragraphs (j) through (o), respectively.
c. In newly designated paragraph (j) revise ``408(d)(5) or (e)'' to
read ``408(h)''.
d. In newly designated paragraph (l) remove the phrase
``Registration Division (7505C),''.
e. In newly designated paragraph (m) remove the phrase
``Registration Division, (7505C),''.
f. Revise paragraph (f) and the third sentence of newly designated
paragraph (l) to read as follows:
Sec. 180.33 Fees.
* * * * *
(f) Each petition for revocation of a tolerance shall be
accompanied by a fee
[[Page 60328]]
of $10,125. Such fee is not required when, in connection with the
change sought under this paragraph, a petition is filed for the
establishment of new tolerances to take the place of those sought to be
revoked and a fee is paid as required by paragraph (a) of this section.
* * * * *
(l) * * * A fee of $2,025 shall accompany every request for a
waiver or refund, as specified in paragraph (m) of this section, except
that the fee under this paragraph shall not be imposed on any person
who has no financial interest in any action requested by such person
under paragraphs (a) through (j) of this section. * * *
* * * * *
33. Section 180.40 is amended by revising the last sentence in
paragraph (f) to read as follows:
Sec. 180.40 Tolerances for crop groups.
* * * * *
(f) * * * Processing data will be required prior to establishment
of a group tolerance, and tolerances will not be granted on a group
basis as to processed foods prepared from crops covered by the group
tolerance.
* * * * *
34. Section 180.1229 is added to subpart D to read as follows:
Sec. 180.1229 Benzaldehyde; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of benzaldehyde when used as a bee repellant in the harvesting
of honey.
35. Section 180.1230 is added to subpart D to read as follows:
Sec. 180.1230 Ferrous sulfate; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of ferrous sulfate.
36. Section 180.1231 is added to subpart D to read as follows:
Sec. 180.1231 Lime; exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of lime.
37. Section 180.1232 is added to subpart D to read as follows:
Sec. 180.1232 Lime-sulfur; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of lime-sulfur.
38. Section 180.1233 is added to subpart D to read as follows:
Sec. 180.1233 Potassium sorbate; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of potassium sorbate.
39. Section 180.1234 is added to subpart D to read as follows:
Sec. 180.1234 Sodium carbonate; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of sodium carbonate.
40. Section 180.1235 is added to subpart D to read as follows:
Sec. 180.1235 Sodium hypochlorite; exemption from the requirement of
a tolerance.
An exemption from the requirement of a tolerance is established for
residues of sodium hypochlorite.
41. Section 180.1236 is added to subpart D to read as follows:
Sec. 180.1236 Sulfur; exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of sulfur.
42. Section 180.1237 is added to subpart D to read as follows:
Sec. 180.1237 Sodium metasilicate; exemption from the requirement of
a tolerance.
An exemption from the requirement of a tolerance is established for
residues of sodium metasilicate when used as plant desiccants, so long
as the metasilicate does not exceed 4% by weight in aqueous solution.
43. Section 180.1238 is added to subpart D to read as follows:
Sec. 180.1238 Oil of lemon; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of oil of lemon when used as a postharvest fungicide.
44. Section 180.1239 is added to subpart D to read as follows:
Sec. 180.1239 Oil of orange; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of oil of orange when used as a postharvest fungicide.
[FR Doc. 04-22584 Filed 10-7-04; 8:45 am]
BILLING CODE 6560-50-S