[Federal Register Volume 59, Number 187 (Wednesday, September 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-23762]
[Federal Register: September 28, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300362; FRL-4912-5]
RIN 2070-AB78
Neomycin Phosphotransferase II; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA)
ACTION: Final rule.
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SUMMARY: This document establishes an exemption from the requirement of
a tolerance for residues of neomycin phosphotransferase II (NPTII) and
the genetic material necessary for its production when used as a plant
pesticide inert ingredient. Monsanto Co. petitioned EPA for this
exemption.
EFFECTIVE DATE: This regulation becomes effective September 28, 1994.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [OPP-300362], 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 to: EPA Headquarters Accounting
Operations Branch, OPP (tolerance fees), P.O. Box 36027M, Pittsburgh,
PA 15251.
FOR FURTHER INFORMATION CONTACT: By mail: Phillip O. Hutton, Product
Manager (PM 18), Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC. Office location and telephone number: Rm. 213, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-7690.
SUPPLEMENTARY INFORMATION: In the Federal Register of December 8, 1993
(58 FR 64582, 64583), EPA issued notices which announced that Monsanto
Co., 700 Chesterfield Parkway North, St. Louis, MO 63193, had submitted
a pesticide petition (PP 3F4273) to EPA proposing to amend 40 CFR part
180 to establish an exemption from the requirement of a tolerance for
neomycin phosphotransferase II (NPTII), and the genetic material
necessary to produce NPTII when produced in plants as a plant pesticide
inert ingredient. The Agency did not receive any comments on the
notices. Selectable markers such as NPTII are considered inert
ingredients by the Agency when they are introduced into a plant in
order to ensure or confirm the presence of a plant pesticide. The
genetic material necessary to produce NPTII (the NPTII gene) is also
considered part of the inert ingredient; therefore, the NPTII gene is
also addressed in this final rule.
Neomycin phosphotransferase II (NPTII) is uniquely different from
other types of inert ingredients because it is a selectable marker used
to identify plant cells early in the product development that had been
successfully transformed to express the active ingredient.
The data submitted in the petition and other relevant material have
been evaluated and deemed sufficient to support the tolerance. The
rationale for this decision is described below.
Assessment of Data
The Agency has evaluated the toxicology data, information on
product identity, equivalence of microbially and plant produced NPTII,
and other information provided by the petitioner. The information
showed that the plant and microbially produced protein are similar with
respect to the protein characteristics of amino acid sequence, enzyme
activity, electrophoretic mobility, lack of glycosylation, and specific
antibody recognition. These findings justified the use of microbial
protein in the toxicity studies. The registrant provided the following
studies: Acute Oral Toxicity of NPTII in Mice and an In Vitro Digestion
of the NPTII Protein. A single oral exposure dose of 5 g/kg NPTII
protein produced no adverse effects in mice. The In Vitro Digestion
study showed that the protein was rapidly degraded in simulated gastric
or intestinal digestive fluids to fragments that were no longer
recognized by specific antibodies to NPTII. These results suggest the
NPTII protein will not survive passage through the gastrointestinal
tract. Therefore, the Agency concluded that the information provided
was sufficient to assess the acute toxicity of NPTII when used as a
marker gene in transgenic plants expressing plant pesticides and to
justify an exemption from the requirement for a food tolerance for
residues of the inert. The Agency recognizes that alternative
information could be used to indicate the lack of mammalian toxicity
and to justify a tolerance exemption.
Since no toxicity was indicated, residue chemistry data were not
required. Residue data are necessary only if the submitted toxicity
studies indicate that additional toxicology data were needed. These
additional data were not needed. Therefore, no residue data are
required in order to grant an exemption from the requirement of a
tolerance for the plant pesticide inert ingredient neomycin
phosphotransferase II when used as a plant pesticide inert ingredient,
as expressed in plant cells.
The exemption from a tolerance for the genetic material which
encodes for production of NPTII is based on the fact that the nucleic
acids which form the genetic material are found in all foods and have
not, by themselves, been associated with toxic or pathogenic effects in
animals and humans. None of the constituents of nucleic acids are known
to be acute toxicants by themselves but, like proteins and other normal
constituents in food, may cause indirect, adverse metabolic effects if
consumed exclusively at high doses over a long period of time in the
absence of a normal diet. The NPTII gene will not occur at these high
amounts in plants. Thus, EPA does not believe there is a potential for
adverse health effects related to the consumption of plants containing
the NPTII gene.
Acceptable daily intake (ADI) and maximum permissible intake (MPI)
considerations are not relevant to this petition because the data/
information submitted demonstrate that this plant-pesticide inert
ingredient (NPTII) and the NPTII gene are not toxic to mammalian
species. No enforcement actions are expected based upon the level of
residue for NPTII and the genetic material necessary for its
production. Therefore, the requirement for an analytical method for
enforcement purposes is not applicable to this exemption.
Based on the above information and review of its use, EPA has found
that when used in accordance with good agricultural practice, this
ingredient is useful for the purpose for which the tolerance exemption
is sought. Based on the information considered, EPA concludes that a
tolerance is not necessary to protect the public health. Therefore, the
exemption from the requirement of a 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 and/or a request for a hearing with the Hearing
Clerk, at the address given above (40 CFR 178.20). A copy of the
objections and 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 each such issue, 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 a genuine and
substantial issue of fact; there is a 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).
The Office of Management and Budget has exempted this rule from the
requirements of section 2 of Executive Order 12866.
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 effect on a substantial number of
small entities. A certification statement to this effect was published
in the Federal Register of May 4, 1981 (49 FR 24950).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 19, 1994.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR part 180 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. In subpart D, by adding new Sec. 180.1134, to read as follows:
Sec. 180.1134 Neomycin phosphotransferase II and genetic material
necessary for its production; exemption from the requirement of a
tolerance.
The neomycin phosphotransferase II (NPTII) and the genetic material
necessary for the production of this protein are exempted from the
requirement of a tolerance in or on all raw agricultural commodities
when used as a plant-pesticide inert ingredient.
[FR Doc. 94-23762 Filed 9-27-94; 8:45 am]
BILLING CODE 6560-50-F
