[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]



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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: [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-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: [email protected].

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:
    [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 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

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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