[Federal Register Volume 62, Number 172 (Friday, September 5, 1997)]
[Rules and Regulations]
[Pages 46885-46888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23628]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300547; FRL-5741-4]
RIN 2070-AB78
Gamma Aminobutyric Acid; Pesticide Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes a temporary exemption from the
requirement of a tolerance for residues of the biochemical gamma
aminobutyric acid when used to increase yields of the following crops:
snap beans, peanuts, cotton, potatoes, tomatoes, lettuce, green
peppers, spinach, broccoli, cauliflower, and cabbage.
DATES: This regulation is effective September 5, 1997. Objections and
requests for hearings must be received by EPA on or before November 4,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300547], 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-300547], must also be submitted to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7506C), 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. 1132, 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 file format or ASCII file format. All copies
of electronic objections and hearing requests must be identified by the
docket number [OPP-300547]. 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: Edward Allen, Regulatory
Action Leader, Biopesticides and Pollution Prevention Division (7501W),
Office of Pesticide Programs, Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460, Office location, telephone number, and
e-mail: 5th floor CS 1, 2800 Crystal Drive, Arlington, VA, telephone:
(703) 308-8699; e-mail: [email protected].
SUPPLEMENTARY INFORMATION: Auxein Corporation, 3125 Sovereign Drive,
Suite B, Lansing, MI 48911 has requested in pesticide petition # 7G4838
the establishment of a temporary exemption from the requirement of a
tolerance for residues of the biochemical gamma aminobutyric acid
(GABA). A notice of filing was published in the Federal Register on
July 3, 1997 (62 FR 36063)(FRL-5728-9), and the notice announced that
the comment period would end on August 4, 1997; no comments were
received. This temporary exemption from the requirement of a tolerance
will permit the marketing of the above food commodities when treated in
accordance with the provisions of experimental use permit 70810-EUP-1,
which is being issued under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), as amended (Pub. L. 95-396, 92 Stat. 819; 7
U.S.C. 136). The data submitted in the petition and all other relevant
material have been evaluated. Following is a summary of EPA's findings
regarding this petition as required by section 408(d) of the Federal
Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as recently
amended by the Food Quality Protection Act (FQPA), Pub. L. 104-170.
I. Summary
A. Proposed Use Practices
The experimental program will be conducted in the states of
Alabama, Arizona, California, Florida, Georgia, Idaho, Maine, Michigan,
Minnesota, Mississippi, North Carolina, North Dakota, New Jersey, Ohio,
Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Washington, and
Wisconsin. Crops to be treated are snap beans, peanuts, cotton,
potatoes, tomatoes, lettuce, green peppers, spinach, broccoli,
cauliflower, and cabbage. Depending on the crop, application is made at
first bloom, first bud or at the 5-6 leaf stage. Subsequent
applications, for a maximum of three applications, are at 1- to 3-week
intervals. The rate range is 0.125-0.75 pounds of formulated product/
acre per treatment not to exceed a maximum of 1.5 lbs/A per growing
season. The proposed EUP program would utilize 462 pounds of active
ingredients (231 pounds of gamma aminobutyric acid and 231 pounds of
glutamic acid) in 793 pounds of formulated product. A total of 822
pounds of formulated product will be shipped. A maximum of 790 acres
will be treated under this EUP. The experimental program is intended
for evaluation of plant growth, yield and vegetable quality.
B. Product Identity/Chemistry
GABA is a non-protein amino acid that is ubiquitous in nature. It
has been found in microorganisms, lower and higher plants, fish, birds,
insects, and mammals. GABA is a white, crystalline powder with a pH of
6.5 to 7.5. It is freely soluble in water, but insoluble or poorly
soluble in other solvents. The melting point for GABA is 202 deg. C on
rapid heating.
II. Toxicological Profile
GABA is a ubiquitous non-protein amino acid present in all living
things. It is an inhibitory neurotransmitter in many brain regions and
central nervous systems of mammals. Due to GABA's role in the nervous
system, it has been administered to humans with the aim of improving
central GABA-mediated transmission and to control Huntington's disease,
Parkinson's disease, schizophrenia and other seizure states. AuxiGro,
the end-use formula containing 29.2% GABA, has been studied for acute
toxicity. Acute oral toxicity of AuxiGro in rats is greater than 5,050
mg/kg (Toxicity Category IV). Acute dermal toxicity in rabbits is
greater than 5,050 mg/kg (Toxicity Category IV). In an eye irritation
study, all signs of irritation cleared within 24
[[Page 46886]]
hours (washed eyes) following administration of AuxiGro (Toxicity
Category IV); in unwashed eyes, irritation cleared in 5/6 rabbits
within 24 hours. Irritation cleared within 48 hours in the remaining
rabbit. A rabbit dermal irritation study with AuxiGro resulted in
limited signs of irritation that cleared within 24 hours (Toxicity
Category IV). There was no indication of dermal sensitization in a
guinea pig dermal sensitization study.
Waivers were requested for genotoxicity, reproductive and
developmental toxicity, subchronic toxicity, chronic toxicity, and
acute toxicity to nontarget species. Waivers were accepted based on
GABA's natural occurrence, use as a pharmaceutical agent, favorable
toxicological profile in chronic toxicology studies, and
inconsequential exposure resulting from label-directed uses.
A. Aggregate Exposure
In examining aggregate exposure, FQPA directs EPA to consider
available information concerning exposures from the pesticide residue
in food and all other non-occupational exposures. The primary non-food
sources of exposure the Agency considers include drinking water or
groundwater, and exposure through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses).
1. Dietary exposure. Dietary exposure due to topical applications
of GABA is difficult to estimate because of its prevalence in nature;
applications associated with the EUP would be comparable to levels
found in nature. GABA in the environment is readily utilized by
microorganisms. The low toxicity, low application rate, and the use
pattern leads the Agency to conclude that residues from use of GABA
will not pose a dietary risk of concern under reasonable foreseeable
circumstances. Therefore, EPA concludes that there is a reasonable
certainty of no harm from aggregate exposure under this temporary
exemption.
2. Non-dietary, non-occupational exposure. Increased non-dietary
exposure to GABA via lawn care, topical insect repellents, etc., is not
applicable to this EUP.
B. Cumulative Exposure
GABA is ubiquitous in nature. Incremental exposure resulting from
this EUP program are miniscule when compared to the levels found
naturally-occuring in food.
C. Endocrine Disruptors
The Agency has no information to suggest that GABA will adversely
affect the immune or endocrine systems. The Agency is not requiring
information on the endocrine effects of this biochemical pesticide at
this time; Congress has allowed 3 years after August 3, 1996, for the
Agency to implement a screening program with respect to endocrine
effects.
D. Safety Considerations
GABA is naturally-occurring in food and is a pharmaceutical agent.
Incremental exposure to GABA resulting from this EUP is miniscule.
Considering the negligible contributions to the environment resulting
from the application of AuxiGro, the abundance and role of GABA in
foods and in the human body, and its prevalence in nature, the Agency
concludes that application of GABA to the aforementioned vegetable
crops does not pose a dietary risk.
E. Analytical Method
An analytical method using High Performance Liquid Chromatography
(HPLC) for determining the GABA content in AuxiGro, the end-use
product, is available; however, because this amino acid is found
naturally in plants, the Agency has determined that residue analysis
would not yield meaningful results, i.e., the analysis would not
discern whether the source of GABA was the plant or the product
treatment.
F. Codex Maximum Residue Level
There are no CODEX tolerances or international tolerance exemptions
for GABA at this time.
G. Conclusion
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 GABA. This includes all
anticipated dietary exposures and all other exposures for which there
is reliable information. The Agency has arrived at this conclusion
because, as discussed above, exposure to GABA resulting from the EUP
label-directed use is inconsequential, and it is consumed daily by the
human population from both naturally-occurring sources and from
processed foods. As a result, EPA establishes a temporary exemption
from the requirement of a tolerance pursuant to FFDCA section 408(j)(3)
for GABA, on the condition that it be used in accordance with the
experimental use permit 70810-EUP-1, with the following provisions:
The total amount of the active ingredients to be used must not
exceed the quantity authorized by the experimental use permits.
Auxein Corporation must immediately notify the EPA of any findings
from the experimental use that have a bearing on safety. The company
must also keep records of product, distribution, and performance and on
request make the records available to any authorized officer or
employee of the EPA or the Food and Drug Administration (FDA).
This temporary exemption from the requirement of a tolerance
expires and is revoked August 27, 1998. Residues remaining in or on the
raw agricultural commodity after this expiration date will not be
considered actionable if the biochemical is legally applied during the
term of, and in accordance with, the provisions of the experimental use
permit and temporary exemption from the requirement of a tolerance.
This temporary exemption from the requirement of a tolerance may be
revoked if the experimental use permit is revoked or if any experience
with or scientific data on this biochemical indicate that the tolerance
exempton is not safe.
III. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance exemption regulation issued by
EPA under new section 408(e) as was provided in the old section 408.
However, the period for filing objections is 60 days, rather than 30
days. EPA currently has procedural regulations which govern the
submission of objections and hearing requests. These regulations will
require some modification to reflect the new law. However, until those
modifications can be made, EPA will continue to use those procedural
regulations with appropriate adjustments to reflect the new law.
Any person adversely affected by this regulation may within 60 days
after publication of this document in the Federal Register file written
objections to the regulation and may also request a hearing on those
objecitons. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given under ``ADDRESSES'' at the
beginning of this rule (40 CFR 178.20). A copy of the objections and/or
hearing requests filed with the Hearing Clerk should be submitted to
the OPP Docket for this rulemaking. The objections submitted must
specify the
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provisions of the regulation deemed objectionable and the grounds for
the objections (40 CFR 178.25). Each objection must be accompanied by
the fee prescribed by 40 CFR 180.33(i). If a hearing is requested, the
objections must include a statement of the factual issue(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27). A
request for a hearing will be granted if the Administrator determines
that the material submitted shows the following: There is genuine and
substantial issue of fact; there is reasonable possibility that
available evidence identified by the requestor would, if established,
resolve one or more of such issues in favor of the requestor, taking
into account uncontested claims or facts to the contrary; and
resolution of the factual issue(s) in the manner sought by the
requestor would be adequate to justify the action requested (40 CFR
178.32). Information submitted in connection with an objection or
hearing request may be claimed confidential by marking any part or all
of that information as ``Confidential Business Information'' (CBI).
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2. A copy of the information that
does not contain CBI must be submitted for inclusion in the public
record. Information not marked confidential may be disclosed publicly
by EPA without prior notice.
IV. Public Record
A record has been established for this rulemaking under the docket
control number [OPP-300547] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 1132 of Public Information and Records
Integrity Branch, Information Resources and Services Division (7506C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments can be sent directly to EPA at:
[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 above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
address in ``ADDRESSES'' at the beginning of this rule.
V. Regulatory Assessment Requirements
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) (Pub. L. 104-4). Nor does it require any
prior consultation as specified by Executive Order 12875, entitled
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28,
1993), or special considerations as required by Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In addition, 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. Nevertheless, 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.
VI. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the General Accounting Office prior to publication of this rule in
today's Federal Register. This 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: August 27, 1997.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 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 180.1188 is added to subpart D to read as follows:
Sec. 180.1188 Gamma aminobutyric acid; exemption from the requirement
of a tolerance.
The biochemical gamma aminobutyric acid (GABA) is temporarily
exempted from the requirement of a tolerance for residues when used on
crops including: snap beans, peanuts, cotton, potatoes, tomatoes,
lettuce, green peppers, spinach, broccoli, cauliflower, and cabbage to
enhance crop yields. This temporary exemption from the requirement of a
tolerance will permit the marketing of the food commodities in this
paragraph when treated in accordance with the provisions of
experimental use permit 70810-EUP-1, which is being issued under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended
(7 U.S.C. 136). This temporary exemption from the requirement of a
tolerance expires and is revoked August 27, 1998. This temporary
exemption from the requirement of a tolerance may be revoked at any
time if the experimental use permit is revoked or if any experience
with or scientific data on
[[Page 46888]]
this pesticide indicate that the tolerance is not safe.
[FR Doc. 97-23628 Filed 9-4-97; 8:45 am]
BILLING CODE 6560-50-F