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glutamic acid Pesticide Tolerance Exemption 12/97


[Federal Register: January 7, 1998 (Volume 63, Number 4)]
[Rules and Regulations]               
[Page 679-682]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ja98-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300598; FRL-5764-4]
RIN 2070-AB78

 
Glutamic 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 glutamic acid 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-300598], may 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 should be identified by the 
document control number and submitted to: Public Information and 
Records Integrity Branch, Information Resources and Services (7506C), 
Office of Pesticide Programs, Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460. In person, bring copy of objections and 
hearing requests to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., 
Arlington, VA 22202.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect in 5.1/
6.1 file format or ASCII file format. All copies of objections and 
hearing requests in electronic form must be identified by the docket 
control number [OPP-300598]. No Confidential Business Information (CBI) 
should be submitted through e-mail. Electronic copies of 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: allen.edward@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: Auxein Corporation, P.O. Box 27519, 3125 
Sovereign Drive, Suite B, Lansing, MI 48911 had requested in pesticide 
petition 7F4842, the establishment of an exemption from the requirement 
of a tolerance for residues of the biochemical glutamic acid. A notice 
of filing (PF-772) was published in the Federal Register of October 29, 
1997 (62 FR 56268, 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

    Glutamic acid will be incorporated into the end-use product, 
AuxiGro WP Plant Growth Enhancer as an active ingredient. AuxiGro 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 glutamic acid applied at the maximum use rate.

B. Product Identity/Chemistry

    Glutamic acid is an amino acid found in microorganisms, tissues of 
animal, 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 degrees C @ 10 millimeters (mm) mercury (Hg).

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 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.

[[Page 680]]

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.
    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 milligrams per kilogram 
(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). 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.
    Humans have the capacity to rapidly metabolize ingested glutamate 
(the expected exposure route) to keep plasma glutamate levels constant: 
no adverse effects on neurological or hepatic function were observed in 
humans administered levels up to 137 g daily for 14-41 days, which is 
much higher than the rate applied to plants. The blood brain barrier 
further protects the brain from large infusions of glutamate. Likewise, 
the placental barrier protects the developing fetus against up to 
twentyfold increases in maternal glutamate levels.
    Waivers have been requested for acute toxicity, genotoxicity, 
reproductive and developmental toxicity, subchronic toxicity, chronic 
toxicity, and acute toxicity to nontarget species based on glutamic 
acid's ubiquity in nature, long history of food uses, favorable 
toxicological profile in chronic toxicology studies, and 
inconsequential exposure resulting from label-directed use rates.
    Waivers were also requested for acute avian oral toxicity, 
nontarget plants, avian dietary, and nontarget insects. 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. 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 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 grams of protein/day. Regarding the sodium salt of glutamic acid, 
monosodium glutamate (MSG), The Joint Expert Committee on Food 
Additives of the United Nations (JEFCA) has assigned an Acceptable 
Daily Intake of ``not specified'' (no numerical limitation), meaning 
that MSG can be used safely according to food manufacturing practices 
in food by people of all ages.
    Dietary exposure due to topical applications of glutamic acid is 
difficult to estimate because of the amino acid's prevalence in nature. 
However, a comparison of naturally-occurring levels of glutamic acid to 
topically applied levels shows that the applied level is a small 
fraction of that found naturally. Naturally-occurring levels of 
glutamic acid in corn and tomatoes are estimated to be 143 lb/acre and 
195 lb/acre, respectively. Applied levels of glutamic acid resulting 
from the application of AuxiGro at maximum use levels (1.5 lb/acre) is 
0.4 lb/acre, several orders of magnitude lower than naturally-occurring 
levels.
    Considering the low dose of AuxiGro required to achieve the desired 
effect, the levels of glutamic acid found naturally in the diet from 
animal and vegetable proteins and the quantity consumed from processed 
foods, it can be concluded that incremental dietary exposure to 
glutamic acid resulting from AuxiGro applications is negligible.
    2.  Non-dietary, non-occupational exposure. AuxiGro is proposed for 
professional use on turf and ornamentals. Exposure from turfgrass 
applications is expected to be minimal because golfers will be 
protected by shoes and socks. Further, based on the limited frequency 
of use on turfgrass, this non-food use is not likely to result in 
potential chronic exposure and thus should not be factored into a 
chronic exposure assessment. 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

    Glutamic acid 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 
glutamic acid and other substances.

VI. 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 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 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, the toxicity of glutamic acid 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)

[[Page 681]]

factors. In this instance, the Agency believes there is reliable data 
to support the conclusion that glutamic acid 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.
    Glutamic acid is classified 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.

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 glutamic acid.

IX. Codex Maximum Residue Level

    There are no CODEX tolerances or international tolerance exemptions 
for glutamic acid 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 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 of the preponderance of data from the open literature 
supporting the safe use of glutamate in foods, the supporting acute 
toxicity data on AuxiGro, and inconsequential resulting from its 
application to crops. As a result, EPA establishes an exemption from 
the requirement of a tolerance pursuant to FFDCA section 408(c) for 
glutamic acid.

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 
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.

XII. Public Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
control number [OPP-300598] (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:
    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 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

[[Page 682]]

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), EPA 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 in today's Federal Register. 
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(a).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides 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 180.1187 is revised to read as follows:


Sec. 180.1187   Glutamic acid; exemption from the requirement of a 
tolerance.

    Glutamic acid is exempt from the requirement of a tolerance on all 
raw agricultural commodities when used as a plant growth enhancer in 
accordance with good agricultural practices.

[FR Doc. 98-359 Filed 1-6-98; 8:45 am]
BILLING CODE 6560-50-F