[Federal Register Volume 62, Number 172 (Friday, September 5, 1997)]
[Rules and Regulations]
[Pages 46882-46885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23629]
[[Page 46882]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300546; FRL-5741-3]
RIN 2070-AB78
Glutamic 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 glutamic
acid, when used to enhance the growth, vegetable quality, and yield of
the following crops: broccoli, cabbage, cauliflower, cotton, green
peppers, lettuce, peanuts, potatoes, snap beans, spinach, and tomatoes.
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-300546], 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-300546], 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: opp-docket@epamail.epa.gov. 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-300546]. 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, Crystal Station #1, 2800 Crystal Drive, Arlington,
VA, telephone: (703) 308-8699; e-mail: allen.edward@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: Auxein Corporation, 3125 Sovereign Drive,
Suite B, Lansing, MI 48911 has requested in pesticide petition (PP)
7G4839 the establishment of a temporary exemption from the requirement
of a tolerance for residues of the biochemical glutamic acid. A notice
of filing (FRL-5728-9) was published in the Federal Register (62 FR
36063, July 3, 1997), 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 (EUP) 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 broccoli, cabbage, cauliflower,
cotton, green peppers, lettuce, peanuts, potatoes, snap beans, spinach,
and tomatoes. 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 (lbs) of formulated product/acre(A) per
treatment, not to exceed a maximum of 1.5 lbs/A per growing season. The
proposed EUP program would utilize 462 lbs of active ingredients (231
lbs of gamma aminobutyric acid and 231 lbs of glutamic acid) in 793 lbs
of formulated product. A total of 822 lbs 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
Glutamic acid is an amino acid found in microorganisms, tissues of
animals, all food, and higher plants as free amino acid or bound in
protein. Glutamic acid is a white, practically odorless, free flowing
crystalline powder. It is slightly soluble in water, forming acidic
solutions. The pH of a saturated solution is about 3.22. The specific
gravity for glutamic acid is 1.538 @ 20/4 C and the decomposition point
is 175 deg. C @ 10 millimeters (mm) mercury (Hg).
II. Toxicological Profile
Glutamic acid is highly regulated in man and other organisms, the
mechanisms of which are well understood. Glutamate has been
administered to numerous species in long term dietary studies without
adverse effects. The end-use product containing glutamic acid, AuxiGro
WP, has been evaluated for acute toxicity. Acute oral toxicity in rats
is greater than 5,050 milligram (mg)/kilogram (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 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
glutamic acid's natural occurrence, long history of food
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uses, favorable toxicological profile in chronic toxicology studies,
and inconsequential exposure resulting from label-directed use rates.
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 glutamic is difficult to estimate because of its prevalence in
nature; applications associated with the EUP would be minuscule
compared to levels found in nature. Glutamic acid in the environment is
readily utilized by microorganisms. Furthermore, glutamic acid is
presently consumed by humans in the form of glutamate in relatively
high quantities. The low toxicity, low application rate, and the use
pattern leads the Agency to conclude that residues from use of the
biochemical glutamic acid 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 glutamic acid via lawn care, topical insect repellents,
etc., is not applicable to this EUP.
B. Cumulative Exposure
Glutamic acid is ubiquitous in nature. Incremental exposure
resulting from this EUP program are miniscule when compared to the high
levels of glutamic found naturally occuring in food.
C. Endocrine Disruptors
The Agency has no information to suggest that glutamic acid 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 (yrs) after August
3, 1996, for the Agency to implement a screening program with respect
to endocrine effects.
D. Safety Considerations
Glutamic acid is ubiquitous in nature and is found in
microorganisms, lower- and higher-plant species, fish, birds, insects,
mammals and natural and processed foods. It is the most prevalent amino
acid in plant and animal proteins. Worldwide production of glutamic
acid is over 340,000 tons/yr. Many items in the human daily diet
contain appreciable quantities of free glutamic acid. For example, ripe
tomatoes, mushrooms, peas, corn, potatoes, squash, cheese, eggs,
poultry and meat provide from 20 to 150 mg of glutamic acid per 100
gram (g) serving. Daily consumption for a 70 kg individual of glutamate
has been previously reported to be 10.4 g per day, based on an intake
of 100 g of protein/day.
Glutamic acid is listed as Generally Recognized as Safe (GRAS) for
use as a direct food additive by the Food and Drug Administration (FDA)
and is cleared by the EPA for use as an inert ingredient in certain
pesticide products. Condensed, extracted fermentation glutamic acid is
approved by the FDA for use in animal feed.
Incremental exposure resulting from this EUP is miniscule compared
to levels of glutamic acid consumed from natural and processed food
products. Considering the negligible contributions to the environment
resulting from the application of AuxiGro, the abundance and role of
glutamic acid in foods and in the human body, and the prevalence of
glutamic acid in nature, the Agency concludes that application of
glutamic acid 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 glutamic acid 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 glutamic acid source was the plant or the product
treatment.
F. Codex Maximum Residue Level
There are no CODEX tolerances or international tolerance exemptions
for glutamic acid at this time. Glutamic acid is presently listed as
exempt from tolerances under 40 CFR 180.1001 when used as a plant
nutrient for seed treatment.
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 glutamic acid. 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 glutamic acid 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 glutamic acid, 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 EUP.
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 EUP and
temporary exemption from the requirement of a tolerance. This temporary
exemption from the requirement of a tolerance may be revoked if the EUP
is revoked or if any experience with or scientific data on this
biochemical indicate that the tolerance exemption 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 FFDCA section 408(e) as was provided in the old FFDCA
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
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publication of this document in the Federal Register file written
objections to the regulation and may also request a hearing on those
objections. 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.
IV. Public Record
A record has been established for this rulemaking under the docket
control number [OPP-300546] (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 (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:
opp-docket@epamail.epa.gov.
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 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. 346a and 371.
2. Section 180.1187 is added to subpart D to read as follows:
Sec. 180.1187 Glutamic acid; exemption from the requirement of a
tolerance.
The biochemical glutamic acid 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
[[Page 46885]]
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 EUP is revoked or if any experience with or scientific data
on this pesticide indicate that the tolerance is not safe.
[FR Doc. 97-23629 Filed 9-4-97; 8:45 am]
BILLING CODE 6560-50-P
