[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]
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