[Federal Register Volume 61, Number 150 (Friday, August 2, 1996)]
[Rules and Regulations]
[Pages 40338-40340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19813]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 5E4516/R2269; FRL-5391-2]
RIN 2070-AB78
Plant Pesticide Inert Ingredient CP4 Enolpyruvylshikimate-3-D and
the Genetic Material Necessary for Its Production in All Plants
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 plant pesticide inert ingredient CP4
Enolpyruvylshikimate-3-D (CP4 EPSPS) and the genetic material necessary
for its production in all plants. A request for an exemption from the
requirement of a tolerance was submitted by Monsanto Company
(Monsanto). This
[[Page 40339]]
regulation eliminates the need to establish a maximum permissible level
for residues of these plant pesticide inert ingredients in all plants.
EFFECTIVE DATE: Effective on August 2, 1996.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 5E4516/R2269], may be submitted to:
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M
St., SW., Washington, DC 20460. 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 Response and Program
Resources Branch, Field Operations Division (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. Fees accompanying objections shall be labeled ``Tolerance
Petition Fees'' and forwarded: EPA Headquarters Accounting Operations
Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251.
An electronic copy of objections and hearing requests filed with
the Hearing Clerk may be submitted to OPP 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 [PP 5E4516/R2269] . 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. Additional
information on electronic submissions can be found below in this
document.
FOR FURTHER INFORMATION CONTACT: By mail: Michael L. Mendelsohn,
Biopesticides and Pollution Prevention Division (7501W), Office of
Pesticide Programs, U. S. Environmental Protection Agency, 401 M St.,
SW., Washington, DC 20460. Office location and telephone number: 5th
Floor CS, 2800 Crystal Drive, Arlington, VA 22202, Telephone No. 703-
308-8715; e-mail: [email protected].
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of October 25, 1995 (60 FR 54689)(FRL-4984-4), which
announced that Monsanto Company, 700 Chesterfield Parkway North, St.
Louis, MO 63198, had submitted a pesticide petition (PP) 5E4516 to EPA
requesting that the Administrator, pursuant to section 408(d) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d),
establish an exemption from the requirement of a tolerance for the
plant pesticide inert ingredient CP4 EPSPS and the genetic material
necessary for the production of this protein in or on all raw
agricultural commodities when used as a plant pesticide inert
ingredient. EPA has assigned these inert ingredients the name CP4 EPSPS
and the genetic material necessary for its production in plants.
``Genetic material necessary for its production'' means the genetic
material which comprise (1) genetic material encoding the CP4 EPSPS and
(2) its regulatory regions. ``Regulatory regions'' are the genetic
material that control the expression of the genetic material encoding
the CP4 EPSPS, such as promoters, terminators, and enhancers.
There were no adverse comments, or requests for referral to an
advisory committee received in response to the notice of filing of the
pesticide petition 5E4516.
Toxicology Assessment
Product Characterization
CP4 EPSPS protein produced in E. coli gave SDS-PAGE, western blot,
N-terminal amino acid sequence and enzyme activity similar to the
reference standard. The E. coli preparation lacked detectable
glycosylation based on the staining reaction compared to transferritin
and horseradish peroxidase positive controls.
CP4 EPSPS protein as expressed in either E. coli or corn line 523-
06-1 were compared by SDS-PAGE, western blot, N-terminal amino acid
sequence and specific enzyme activity against shikimate-3-phosphate and
shown to have essentially equivalent characteristics save the specific
activity which was lower in the plant preparation. The similarity of
the CP4 EPSPS expressed in corn line 523-06-1 and MON80100 were shown
to yield identical banding patterns indicating similar molecular weight
and immunoreactivity.
Western blot and enzymatic activity assays indicate that CP4 EPSPS
is readily degraded in less than 2 minutes by incubation in simulated
gastric fluid. In simulated intestinal fluid the enzyme activity and
immunoreactivity lasts longer being still detectable at 10 minutes and
undetectable by 270 minutes.
CP4 EPSPS is an enzyme involved in aromatic amino acid synthesis.
CP4 EPSPS is not closely related in amino acid homology to other
described EPSPS enzymes. CP4 EPSPS is no more than 51.1% similar and
26.0% identical to EPSPS in plants and 59.3% similar and 41.1%
identical to EPSPS in other bacteria. The unique character of CP4 EPSPS
is its ability to function in the presence of glyphosate which is a
competitive inhibitor with PEP for the active site of other EPSPS
enzymes.
Toxicology
In an acute oral toxicity test of bacterially-derived CP4 EPSPS
protein, no test substance related deaths occurred at a dose of 572 mg/
kg.
The Agency expects that proteins with no significant amino acid
homology to known mammalian protein toxins and which are readily
inactivated by heat or mild acidic conditions and are readily degraded
in an in vitro digestibility assay would have little likelihood for
displaying oral toxicity.
The data submitted and cited by Monsanto support the prediction
that the CP4 EPSPS protein would be non-toxic to humans. When proteins
are toxic, they are known to act via acute mechanisms and at very low
dose levels [Sjobald, Roy D., et al. ``Toxicological Considerations for
Protein Components of Biological Pesticide Products,'' Regulatory
Toxicology and Pharmacology 15, 3-9 (1992)]. Therefore, since no
significant acute effects were observed, even at relatively high dose
levels, the CP4 EPSPS is not considered acutely or chronically toxic.
Adequate information was submitted to show that the test material
derived from microbial cultures was biochemically similar to the CP4
EPSPS as produced by the plant-pesticide in corn. Production of
microbially produced protein was chosen in order to obtain sufficient
material for testing.
The genetic material necessary for the production of the CP4 EPSPS
are the nucleic acids (DNA) which comprise (1) genetic material
encoding the CP4 EPSPS and (2) its regulatory regions. ``Regulatory
regions'' are the genetic material that control the expression of the
genetic material encoding CP4 EPSPS, such as promoters, terminators,
and enhancers. DNA is common to all forms of plant and animal life and
the Agency knows of no instance where these nucleic acids have been
associated with toxic effects related to their
[[Page 40340]]
consumption. These ubiquitous nucleic acids as they appear in the
subject active ingredient have been adequately characterized by the
applicant. Therefore, no mammalian toxicity is anticipated from dietary
exposure to the genetic material necessary for the production of the
CP4 EPSPS in any plant.
Conclusion
Based on the information considered, the Agency concludes that
establishment of a tolerance is not necessary to protect the public
health. Therefore, the exemption from tolerance is established as set
forth below.
Any person adversely affected by this regulation may, within 30
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 above (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, a summary of any evidence
relied upon by the objector as well as the other materials required by
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).
A record has been established for this rulemaking under the docket
number [PP 5E4516/R2269] (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 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 1132 of the Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2,
1921 Jefferson Davis Highway, Arlington, VA 22202.
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 rule-making 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.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and, since this
action does not impose any information collection requirements as
defined by the Paperwork Reduction Act, 44 U.S.C . 3501 et seq., it is
not subject to review by the Office of Management and Budget. In
addition, this action does not impose any enforceable duty or contain
any unfunded mandate as described in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104-4), or require prior consultation with State
officials as specified by Executive Order 12875 (58 FR 58093, October
28, 1993), or special considerations as required by Executive Order
12898 (59 FR 7629, February 16, 1994).
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator
has determined that regulations establishing new tolerances or raising
tolerance levels or establishing exemptions from tolerance requirements
do not have a significant economic impact on a substantial number of
small entities. A statement contianing the factual basis for this
certification was published in the Federal Register of May 4, 1981 (46
FR 24950).
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), 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 of the
rule in today's Federal Register. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2) of the APA as amended.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 30, 1996.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
PART 180--[AMENDED]
Therefore, 40 CFR Part 180 is amended as follows:
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In subpart D, by adding new Sec. 180.1174, to read as follows:
Sec. 180.1174 CP4 Enolpyruvylshikimate-3-phosphate (CP4 EPSPS) and
the genetic material necessary for its production in all plants.
CP4 Enolpyruvylshikimate-3-phosphate (CP4 EPSPS) and the genetic
material necessary for its production in all plants are exempt from the
requirement of a tolerance when used as plant pesticide inert
ingredients in all raw agricultural commodities. ``Genetic material
necessary for its production'' means the genetic material which
comprise genetic material encoding the CP4 EPSPS and its regulatory
regions. ``Regulatory regions'' are the genetic material that control
the expression of the genetic material encoding the CP4 EPSPS, such as
promoters, terminators, and enhancers.
[FR Doc. 96-19813 Filed 8-1-96; 8:45 am]
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