[Federal Register Volume 63, Number 4 (Wednesday, January 7, 1998)]
[Rules and Regulations]
[Pages 676-679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-360]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300599; FRL-5764-5]
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 an exemption from the requirement of a
tolerance for residues of the biochemical gamma aminobutyric acid
(GABA) in or on all food commodities, when applied as a plant growth
and crop yield enhancer in accordance with good agricultural practices.
This exemption was requested by Auxein Corporation.
DATES: This regulation becomes effective February 6, 1998. Objections
and requests for hearings must be received by EPA on or before March 9,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300599], 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-300599], must also be submitted to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, bring a copy of
objections and hearing requests to Rm. 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 5.1/6.1 or ASCII file format. All copies of
electronic objections and hearing requests must be identified by the
docket number [OPP-300599]. 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 (7511W),
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 22202,
Telephone No. (703) 308-8699), e-mail: [email protected].
SUPPLEMENTARY INFORMATION: Auxein Corporation, P.O. Box 27519, 3125
Sovereign Drive, Suite B, Lansing, MI 48911 had requested in pesticide
petition 7F4843, the establishment of an exemption from the requirement
of a tolerance for residues of the biochemical gamma aminobutyric acid
(GABA). A notice of filing (PF-772) was published in the Federal
Register of October 29, 1997 (62 FR 57170; FRL-5751-3), and the notice
announced that the comment period would end on November 28, 1997; no
comments were received. 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.
I. Summary
A. Proposed Use Practices
Gamma aminobutyric acid (GABA) will be incorporated into the end-
use product, AuxiGroTM WP Plant Growth Enhancer as an active
ingredient. AuxiGro WP is proposed for use in a variety of
agricultural, horticultural, and floricultural applications to enhance
plant growth and crop productivity.
Depending on the crop, the first application of AuxiGro is made at
first bloom, first bud, at the 4-6 leaf stage, or at a prescribed
growth stage. A subsequent application, for a maximum of two (2)
applications, may be made 1-3 weeks later. The rate range is 0.10 -
0.75 pounds of formulated product/acre per treatment, not to exceed a
maximum of 1.5 lb/acre per growing season. This equates to 0.4 lb/acre
(0.2 kg) of GABA applied at the maximum use rate.
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 degrees C
on rapid heating.
II. Risk Assessment and Statutory Findings
New section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(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(c)(2)(B) requires EPA to give
special
[[Page 677]]
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...''
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.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
scientific data and other relevant information in support of this
action and considered its validity, completeness, reliability, and
relationship 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.
The open literature reports studies involving prolonged chronic
administration of large doses (up to 1 g/kg/day) of GABA to rats and
dogs. No signs of toxicity or untoward effects were observed in these
studies. According to the literature, similar doses have been
administered repeatedly to unanesthetized dogs without untoward
effects. In clinical studies, daily oral doses of 8 mM/kg (0.8 g/kg)
have been administered to humans for a year or more with no indication
of chronic or cumulative toxicity.
AuxiGro WP, 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 48 hours
following administration of AuxiGro (Toxicity Category III). 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 have been requested for acute toxicity, 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.
They were accepted based on the following rationale: (a) low acute
toxicity in mammalian species, (b) natural occurrence and lack of
persistence in the environment, and (c) natural occurrence in plants
and ability to promote growth of numerous plant species.
IV. 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. GABA is ubiquitous innature. Therefore,
applications of AuxiGro WP would only incrementally add to levels
occurring naturally in the environment. GABA concentrations in plants
have been reported to range from 0.03 to 32.5 uM/g (0.000005 g to
0.0000325 g), fresh weight. It is presumed that the higher levels are
probably due to stress and/or localized high levels within certain
plant tissues. Based on these figures, the naturally-occurring level of
GABA is calculated to be 0.1 kg/acre - 7.15 kg/acre. The high-end
(maximum application rate) estimate of incremental loading of GABA
resulting from application of AuxiGro is 0.2 kg/acre. Thus, applied
GABA is well within the range of that found in nature.
2. Non-dietary, non-occupational exposure. AuxiGro WP is proposed
for use on turf and ornamentals. Exposure from turfgrass applications
are expected to be minimal to non-existent because of the low
application rates. Exposures resulting from application to ornamentals
is also anticipated to be negligible because consumers will not be in
contact with treated plants until after the foliage is dry.
V. Cumulative Effects
GABA has a very low toxicity to humans. Because of its low
toxicity, low rate of application, and use patterns, the Agency
believes that there is no reason to expect any cumulative effects from
GABA and other substances.
VI. 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.
VII. Safety Determination for U.S. Population, Infants and Children
Based on the information discussed above, EPA concludes that 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, the
toxicity of GABA to mammals is very low and under reasonably
foreseeable circumstances it does not pose a risk.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of exposure (safety) for infants and children in the
case of threshold effects to account for pre- and post-natal toxicity
and the completeness of the database, unless EPA determines that a
different margin of exposure (safety) will be safe for infants and
children. Margins of exposure (safety) are often referred to as
uncertainty (safety) factors. In this instance, the Agency believes
there is reliable data to support the conclusion that GABA is
practically non-toxic to mammals, including infants and children, and,
thus, a margin of exposure (safety) approach is not needed to protect
adults or infants and children.
VIII. Analytical Method
The Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation; therefore, the Agency has
concluded that an analytical method is not required for enforcement
purposes for GABA.
IX. Codex Maximum Residue Level
There are no CODEX tolerances or international tolerance exemptions
for GABA at this time.
X. 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
[[Page 678]]
because, as discussed above, exposure to GABA resulting from label-
directed use is inconsequential, does not cross the blood-brain
barrier, and is consumed daily by the human population from naturally-
occurring sources. As a result, EPA establishes an exemption from the
requirement of a tolerance pursuant to FFDCA section 408(c) for GABA,
on the condition that it be used in accordance with use directions
provided on the product label.
XI. 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
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.
XII. Public Record and Electronic Submissions
EPA has established a record for this rulemaking under docket
number [OPP-300599] (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 the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments may be sent directly to EPA at:
[email protected].
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described 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 document.
XIII. 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.
XIV. 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
[[Page 679]]
and pests, Reporting and recordkeeping requirements.
Dated: December 30, 1997.
Janet L. Andersen,
Acting Director, Office of Pesticide Programs.
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 revised to read as follows:
Sec. 180.1188 Gamma aminobutyric acid; exempt from the requirement of
a tolerance.
Gamma aminobutyric acid is exempt from the requirement of a
tolerance on all food commodities when used as a plant growth enhancer
in accordance with good agricultural practices.
[FR Doc. 98-360 Filed 1-6-98; 8:45 am]
BILLING CODE 6560-50-F