[Federal Register Volume 63, Number 4 (Wednesday, January 7, 1998)]
[Rules and Regulations]
[Pages 679-682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-359]
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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
