[Federal Register Volume 59, Number 143 (Wednesday, July 27, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17912]
[[Page Unknown]]
[Federal Register: July 27, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4E4310/P585; FRL-4898-5]
RIN 2070-AC18
Watermelon Mosaic Virus-2 Coat Protein, Zucchini Yellow Mosaic
Virus Coat Protein and the Genetic Material Necessary for Production of
These Proteins in Transgenic Squash Plants; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes establishing an exemption from the
requirement for a tolerance under the Federal Food, Drug, and Cosmetic
Act for residues of the plant-pesticides watermelon mosaic virus-2
(WMV2) coat protein and zucchini yellow mosaic virus (ZYMV) coat
protein, as expressed in Asgrow line ZW20 of Cucurbita pepo L. and the
genetic material necessary for the production of these proteins. This
exemption was requested by Asgrow Seed Co.
DATES: Written comments, identified by the document control number [PP
4E4310/P585], must be received on or before August 26, 1994.
ADDRESSES: By mail, submit written comments 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 comments to: Rm. 1128, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA 22202.
Information submitted as a comment concerning this document 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 comment 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. All
written comments will be available for public inspection in Rm. 1128 at
the Virginia address given above, from 8 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Steve Robbins, Product
Manager (PM) 21, Registration Division (7505C), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 227, CM #2, 1921 Jefferson Davis
Hwy., Arlington, VA 22202, (703)-305-6900.
SUPPLEMENTARY INFORMATION: EPA received from Asgrow Seed Co., Kalamzoo,
MI 49004, pesticide petition (PP) 4E4310 on December 6, 1993, proposing
to amend 40 CFR part 180 by establishing a regulation pursuant to the
Federal Food, Drug and Cosmetic Act, 21 U.S.C. 346a, to exempt from the
requirement of a tolerance, the residues of the plant-pesticides
watermelon mosaic virus-2 coat protein and zucchini yellow mosaic virus
coat protein as expressed in Asgrow line ZW20 of Cucurbita pepo L., and
subsequent generations obtained through normal sexual reproduction. An
amendment to this petition was received on April 4, 1994, which changed
the proposed exemption by including the genetic material necessary for
the production of these proteins.
The squash plants identified as Asgrow line ZW20 have been
genetically modified to produce the coat proteins of two viruses which
commonly infect squash plants (watermelon mosaic virus-2 and zucchini
yellow mosaic virus). Production of specific viral coat proteins by the
plant will protect it from infection by those viruses. Viral coat
proteins, along with the genetic material (nucleic acids) necessary to
produce them in the plant, are designated as plant pesticides by EPA.
The data submitted in the petition and all other relevant material
have been evaluated. The data considered in support of the exemption
from the requirement of a tolerance include the following: Sequences of
the engineered WMV2 and ZYMV coat protein coding regions and their
resulting coat proteins, Southern blots to show absence of NPT2 gene
and non-T-DNA sequences in ZW 20 squash, levels of WMV2 and ZYMV coat
protein deduced from amino acid sequence, and levels of viral coat
proteins in fruit collected from local markets.
The Agency agrees with the petitioner's contention that components
of plant pathogenic viruses, as represented by the protein coats of
zucchini yellow mosaic virus and watermelon mosaic virus-2, present no
health concerns when expressed in edible portions of the plant. The
data include evidence to support the lack of any NPT2 marker gene in
the ZW20 plants. Therefore, the only transgene expressed is the viral
coat protein. The submitted data include results of tests to determine
the levels of the proteins in market-ready fruit from line ZW20 and
related this information to the normal levels of these viruses in
cucurbit fruits pruchased at local markets. These data demonstrated
that, overall, the levels of viral coat proteins in locally grown
cucurbit plants were higher than those expressed in the transgenic
squash.
The exemption from the requirement of a tolerance for specific
viral coat proteins WMV2 and ZYMV is based on the following: (1) Virus-
infected plants have always been a part of the human and domestic
animal food supply since most crops are frequently infected with plant
viruses, and food from these crops has been and is being consumed
without observed adverse human health effects; (2) plant viruses have
never been shown to be infectious to humans or mammals. Plant viruses
are not able to replicate in mammals or other vertebrates. Thus, there
is no possibility of human infection. In addition, only the portion of
the viral genome coding for the whole coat protein or a subcomponent of
the coat protein will be expressed in the ZW20 plants. This portion by
itself is incapable of forming infectious particles. Since whole intact
plant viruses are not known to cause deleterious human health effects,
it is reasonable to assume that a subunit of these viruses likewise
will not cause adverse human health effects.
Asgrow Seed Co. amended its petition to include the genetic
material necessary for the production of the proteins because EPA
considers such genetic material to be part of the plant-pesticide
product. It is the genetic material that is introduced into the plant
with the intent that it will ultimately result in a pesticidal effect
(i.e., the plant will produce the viral coat protein). Moreover, the
pesticidal proteins could not be produced without the genetic material
being present in the plant. The exemption from a tolerance for the
genetic material which codes for the production of the viral coat
proteins 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 on animals and humans.
None of these constituents of nucleic acids are know to be acute
toxicants by themselves but, like proteins and other normal
constituents of 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 balanced diet. Nucleic acids will not occur at
these high amounts in ZW20 plants. Thus, EPA does not believe there is
any potential for adverse health effects related to the consumption of
the ZW20 plants.
The data and information submitted with this petition are
acceptable and are adequate to show that there are no forseeable human
or domestic health hazards likely to arise from the consumption of
fruit from the Asgrow line ZW20 of Cucurbita pepo L.
Acceptable daily intake (ADI) and maximum permissible intake (MPI)
considerations are not relevant to this petition because the data
submitted demonstrate that these plant pesticides are not toxic to
humans. No enforcement actions are expected based upon the level of
residues of viral coat proteins and the genetic material necessary for
their production. Therefore, the requirement for an analytical method
for enforcement purposes is not applicable to this exemption request.
This will be the first exemption from the requirement of a tolerance
for this plant pesticide.
The plant pesticides in the Asgrow squash line ZW20 are considered
useful for the purpose for which the exemption from the requirement of
a tolerance is sought. Based on the information considered, the Agency
concludes that establishment of the exemption will protect the public
health. Therefore, the regulation is proposed as set forth below.
Interested persons are invited to submit written comments on the
proposed rule. Comments must bear a notation indicating the document
control number, [PP 4E4310/P585]. All written comments filed in
response to this petition will be available in the Public Response and
Program Resources Branch at the address given above from 8 a.m. to 4
p.m., Monday through Friday, except legal holidays.
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 an economic impact on a substantial number of small
entities. A certification statement to this effect was published in the
Federal Register of May 4, 1981 (46 FR 24950).
Interested persons are invited to submit written comments on the
proposed rule. Comments must bear a notation indicating the document
control number [PP 4E4310/P585]. All written comments filed in response
to this petition will be available in the Public Response and Program
Resources Branch at the address given above from 8 a.m. to 4 p.m.,
Monday through Friday, except legal holidays.
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 an economic impact on a substantial number of small
entities. A certification statement to this effect was published in the
Federal Register of May 4, 1981 (46 FR 24950).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Food additives, Pesticides and pests,
Processed foods, Reporting and recordkeeping requirements.
Dated: July 11, 1994.
Lois Rossi,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be 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. 180.1132, to read as follows:
Sec. 180.1132 Watermelon mosaic virus-2 coat protein, zucchini yellow
mosaic virus coat protein and the genetic material necessary for the
production of these proteins; exemption from the requirement of a
tolerance.
The plant-pesticides watermelon mosaic virus-2 coat protein and
zucchini yellow mosaic virus coat protein as expressed in Asgrow line
ZW20 of Cucurbita pepo L. and the genetic material (nucleic acids)
necessary for the production of these proteins are exempted from the
requirement of a tolerance in this transgenic plant and in subsequent
generations of Asgrow line ZW20 of cucurbita pepo L. obtained through
normal sexual reproduction.
[FR Doc. 94-17912 Filed 7-26-94; 8:45 am]
BILLING CODE 6560-50-F
