[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