[Federal Register: June 21, 2001 (Volume 66, Number 120)]
[Rules and Regulations]
[Page 33195-33198]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jn01-13]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301136; FRL-6785-6]
RIN 2070-AB78
L-Glutamic Acid and Gamma Aminobutyric Acid; Exemptions from the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes exemptions from the requirement
of
a tolerance for residues of L-glutamic acid and gamma aminobutyric
acid
on all food commodities when applied/used in accordance with good
agricultural practices. Emerald BioAgriculture Corporation submitted
two petitions to EPA under the Federal Food, Drug, and Cosmetic Act,
as
amended by the Food Quality Protection Act of 1996, requesting
exemptions from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of L-glutamic acid and gamma aminobutyric acid.
DATES: This regulation is effective June 21, 2001. Objections and
requests for hearings, identified by docket control number OPP-301136,
must be received by EPA on or before August 20, 2001.
ADDRESSES: Written objections and hearing requests may be submitted
by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301136 in
the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Carol E. Frazer, c/o Product
Manager (PM) 90, Biopesticides and Pollution Prevention Division
(7511C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number:
(703) 308-8810; and e-mail address: frazer.carol@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an
agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories
NAICS codes potentially
affected entities
------------------------------------------------------------------------
Industry
111
Crop production
112
Animal production
311
Food manufacturing
32532
Pesticide manufacturing
------------------------------------------------------------------------
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 the table could also
be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you
have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies
of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up
the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml_00/Title_40/40cfr180._00.html, a beta site currently
under development.
2. In person. The Agency has established an official
record for
this action under docket control number OPP-301136. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available
for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of December 6, 2000 (65 FR
76241) (FRL-
6748-9), EPA issued a notice pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), as amended
by
the Food Quality Protection Act (FQPA) (Public Law 104-170) announcing
the filing of two pesticide tolerance petitions by Emerald
BioAgriculture Corporation, 3125 Sovereign Drive, Suite B, Lansing,
MI
48911-4240. This notice included a summary of the petitions prepared
by
the petitioner Emerald BioAgriculture Corporation. There were no
comments
[[Page 33196]]
received in response to the notice of filing.
The petition requested that 40 CFR 180.1187 and
180.1188 be amended
by establishing exemptions from the requirement of a tolerance for
residues of L-glutamic acid and gamma aminobutyric acid.
III. Risk Assessment
New section 408(c)(2)(A)(i) of the FFDCA allows EPA
to establish an
exemption from the requirement for a tolerance (the legal limit for
a
pesticide chemical residue in or on a food) only if EPA determines
that
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) defines ``safe''
to
mean that ``there is a reasonable certainty that no harm will result
from aggregate exposure to the pesticide chemical residue, including
all anticipated dietary exposures and all other exposures for which
there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) requires EPA to give
special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''Additionally, section 408(b)(2)(D) requires that the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA performs a number of analyses to determine the
risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur
as
a result of pesticide use in residential settings.
IV. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA
has reviewed the
available scientific data and other relevant information in support
of
this action and considered its validity, completeness, and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
Supporting data for these sections were submitted
with Pesticide
Petitions PP 7F4842 and 7F4843 (65 FR 76241).
V. Aggregate Exposures
In examining aggregate exposure, FFDCA section 408
directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).
A. Dietary Exposure
1. Food. No differences in exposure are expected
when compared to
those described in PPs 7F4842 and 7F4843.
2. Drinking water exposure. No differences in exposure
are expected
when compared to those described in PPs 7F4842 and 7F4843.
B. Other Non-Occupational Exposure
No differences in exposure are expected when compared
to those
described in PPs 7F4842 and 7F4843.
VI. Cumulative Effects
No differences in exposure are expected when compared
to those
described in PPs 7F4842 and 7F4843.
VII. Determination of Safety for U.S. Population, Infants and
Children
1. U.S. population. Based on its abundance in nature
and long
history of use by humans without deleterious effects, there is
reasonable certainty that no harm will result from aggregate exposure
to the U.S. population, including infants and children, to residues
of
L-glutamic and gamma aminobutyric acids. This includes all dietary
exposure and all other exposures for which there is reliable
information. This is a reasonable conclusion because the preponderance
of data from open literature supporting the safe use of L-glutamic
acid
in foods, that GABA does not cross the blood-brain barrier, both
chemicals are consumed daily by the human population from naturally
occurring sources, and the supporting acute toxicity data on AuxiGro
and inconsequential exposure resulting from its application to crops.
2. Infants and children. No differences in exposure
are expected
compared to those in PPs 7F4842 and 7F4843.
VIII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by
the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests
for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made
to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new 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(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing
on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301136 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before August
20, 2001.
1. Filing the request. Your objection must specify
the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(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).
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.
Mail your written request to: Office of the Hearing
Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from
8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection
or request a
hearing, you
[[Page 33197]]
must also pay the fee prescribed by 40 CFR 180.33(i) or request a
waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the
fee
to: EPA Headquarters Accounting Operations Branch, Office of Pesticide
Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the
fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when
in the
judgement of the Administrator such a waiver or refund is equitable
and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance
objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing
an objection or
hearing request with the Hearing Clerk as described in Unit IX.A.,
you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket number OPP-301136, to: Public Information
and Records Integrity Branch, Information Resources and Services
Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid 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 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit
an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
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 issues(s) in the manner sought
by the requestor would be adequate to justify the action requested
(40
CFR 178.32).
IX. Regulatory Assessment Requirements
This final rule establishes an exemption from the
tolerance
requirement under FFDCA section 408(d) in response to a petition
submitted to the Agency. 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) (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 tolerances and
exemptions that are established on the basis of a petition under FFDCA
section 408(d), such as the exemption in this final rule, do not
require the issuance of a proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
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 final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this 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 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 rule.
X. 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 this final
[[Page 33198]]
rule in the Federal Register. This final 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: May 31, 2001.
Kathleen Knox,
Acting Director, Biopesticides and Pollution Prevention Division,
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. 321(q), 346(a) and 371.
2. Sections 180.1187 and 180.1188 are revised to
read as follows:
Sec. 180.1187 L-glutamic acid; exemption from the requirement
of a
tolerance.
L-glutamic acid is exempt from the requirement of
a tolerance on
all food commodities when used in accordance with good agricultural
practices.
Sec. 180.1188 Gamma aminobutyric acid; exemption from the requirement
of a tolerance.
Gamma aminobutyric acid is exempt from the requirement
of a
tolerance on all food commodities when used in accordance with good
agricultural practices.
[FR Doc. 01-15615 Filed 6-20-01; 8:45 am]
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