[Federal Register Volume 59, Number 225 (Wednesday, November 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28824]
[[Page Unknown]]
[Federal Register: November 23, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300367; FRL-4755-4]
RIN 2070-AC02
Plant-Pesticides; Proposed Exemption From the Requirement of a
Tolerance Under the Federal Food, Drug, and Cosmetic Act for Viral Coat
Proteins Produced in Plants
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes an exemption from the requirement of a
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA) for
residues of coat proteins from plant viruses when these coat proteins
are produced as plant-pesticides in plants or plant parts used as raw
agricultural commodities. Viral coat proteins are a specific class of
pesticidal substances that can be produced in plants. These pesticidal
substances, along with the genetic material necessary to produce them
are designated ``plant-pesticides'' by EPA. EPA's proposal for
exempting coat proteins from plant viruses from the requirement of a
tolerance is based on virus-infected plants having always been part of
the human and domestic animal food supply without detectable adverse
health effects. Thus, EPA believes that a tolerance for viral coat
proteins produced in plants is not necessary to protect the public
health.
DATES: Comments identified by the docket control number [OPP-300367]
must be received on or before January 23, 1995.
ADDRESSESS: Submit written comments by mail to : Program Resources
Section, Public Response and Program Resources Branch, Field Operations
Division (7506C), Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person, bring comments to Rm. 1132, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
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. 1132 at
the Virginia address given above from 8 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: Bernice Slutsky, Science and Policy
Staff, Office of Prevention, Pesticides and Toxic Substances (7101),
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460,
Telephone number (202) 260-6900.
SUPPLEMENTARY INFORMATION:
I. Introduction and Purpose of Proposed Regulation
Substances that are produced in plants to enable the plants to
resist pests or disease are pesticides under section 2 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) (i.e., if they are
. . .``intended for preventing, destroying, repelling, or mitigating
any pest'') regardless of whether the pesticidal capabilities evolved
in the plants or were introduced by breeding or through the techniques
of modern biotechnology. These substances, along with the genetic
material necessary to produce the substances, are designated by the
Agency as ``plant-pesticides.'' Under this proposal a plant-pesticide
would be defined as ``a pesticidal substance that is produced in a
living plant and the genetic material necessary for the production of
the substance, where the substance is intended for use in the living
plant.'' Viral coat proteins produced in plants for viral coat protein
mediated viral resistance are considered plant-pesticides because of
their intended role in plant resistance to viral infection.
EPA is proposing to exempt from the requirement of a tolerance coat
proteins from plant viruses when these are produced in plants for the
purpose of protecting plants against viral disease. Because of the
characteristics of viral coat proteins, the Agency does not believe
that a tolerance for these pesticidal substances is necessary to
protect the public health.
This proposed rule is one of several proposed exemptions from the
requirement of a tolerance for plant-pesticides published in today's
issue of the Federal Register. The other proposed exemptions under
FFDCA are: (1) A proposed exemption from the requirement of a tolerance
for nucleic acids in plants (``Plant-pesticides; Proposed Exemption
from the Requirement of a Tolerance Under the Federal Food, Drug, and
Cosmetic Act for Nucleic Acids Produced in Plants,'' and (2) a proposed
exemption from the requirement of a tolerance for plant-pesticides that
will not result in significantly different dietary exposures (``Plant-
pesticides; Proposed Exemption from the Requirement of a Tolerance
Under the Federal Food, Drug, and Cosmetic Act.''
II. Statutory Authority
This exemption from the requirement of a tolerance is being
proposed under the authority of section 408 of the Federal Food, Drug,
and Cosmetic Act (FFDCA) (21 U.S.C. 321 et seq.). The reorganization
plan of 1970 reallocated the authority under FFDCA to regulate
pesticide residues in foods and animal feeds to EPA. Under FFDCA
section 408, pesticide chemicals added to a raw agricultural commodity,
that are not ``generally recognized as safe'' (GRAS), are deemed to be
unsafe unless a tolerance, or an exemption from the requirement of a
tolerance, for such pesticide residues is established and the pesticide
residue is within the tolerance limits. Section 408 of the FFDCA
applies to all ``pesticide chemicals'' which are defined in section
201(q) of the FFDCA as:
any substance which, alone, in chemical combination or in
formulation with one or more other substance, is ``a pesticide''
within the meaning of [FIFRA] ... and which is used in the
production, storage, or transportation of raw agricultural
commodities.
Under FFDCA section 408(c) EPA can exempt, by regulation, any
pesticidal chemical from the necessity of a tolerance when such
tolerance is not necessary to protect the public health. The result of
such an exemption is also to authorize residues of the pesticide
chemical in any processed foods made from the raw agricultural
commodity that contain the residue as a result of the pesticide on the
raw agricultural commodity.
III. Scientific Rationale
A. Summary
Coat proteins are those substances that viruses produce to
encapsulate and protect their genetic material. When the genetic
material encoding for the coat protein is introduced into a plant's
genome, the plant is able to resist infections by the virus donating
the genetic material for the coat protein (as well as strains closely
related to the donor virus). This resistance is termed viral coat
protein mediated resistance or vcp-mediated resistance.
EPA's rationale for finding that a tolerance for viral coat
proteins in foods is not necessary to protect the public health rests
on the points discussed in this preamble. These points are: (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 have been and are being consumed
without detectable 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, limiting the
possibility of human infection. In addition, this exemption applies
only to the portion of the viral genome coding for the whole coat
protein or a sub-component of the coat protein which will be expressed
in the plant during viral coat protein mediated resistance. 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.
B. Presence in Food Supply and Inability to Replicate in Vertebrates
Entire infectious particles of the plant pathogenic virus,
including the coat protein component, have been and are being consumed
by humans with no observed adverse effects. Virus-infected food plants
have always been a part of the human and domestic animal food supply
(Refs. 1, 6, and 7). At the beginning of this century virtually every
commercial cultivar of potatoes grown in the United States and Europe
was infected with either one or some complex of potato viruses (Ref.
1).
All plants have viruses that can infect them. While some viruses
may be limited to certain tissues (e.g., the vascular system) or organs
(e.g., roots), most plant viruses are found throughout the various
organs and tissues of plants. Viruses, including the coat protein
component, are found in the fruit, leaves, and stems of most plants.
The long history of inadvertent mammalian consumption of the entire
plant virus particle in foods with no observed ill effects presents a
strong argument to support the human and domestic animal safety of the
entire virus in foods.
Concentrations of the virus particles in infected plants vary
widely according to the host plant, length of infection, and the
reproductive life cycle of the virus itself. Current crop varieties
bred for virus resistance are usually tolerant to virus infection
rather than actually being resistant or immune to infection, i.e., they
do not express gross disease symptoms even though these resistant
varieties can contain concentrations of virus similar to susceptible
varieties (Ref. 5). The levels of virus in virus-infected plants can be
as high as 0.1 to 0.3 mg/gm tissue as seen with Tobacco Mosaic Virus
(Ref. 5). The total amount of virus particles, including the coat
protein component, in naturally infected plants can often be several
orders of magnitude higher than the concentration expected for viral
coat proteins expressed as plant-pesticides. Plants modified to be
virus resistant through viral coat protein mediated resistance
generally express coat proteins from plant viruses at concentrations
two to three orders of magnitude lower than plants naturally infected
by viruses (Ref. 6). Thus, consumers could be exposed to less coat
protein through plants expressing coat proteins than through virus-
infected crops. However, the average amount of coat protein a consumer
might ingest in food from a virus susceptible crop could, in some
instances, be less than the average amount present in food from plants
protected from virus infection through the production of viral coat
proteins since food from the virus susceptible crop might be derived
from both virus-free and virus-infected plants. In general, though, EPA
anticipates that the amounts of viral coat protein consumed in the diet
due to the production of viral coat proteins in vcp-mediated resistance
will be similar to the amounts of viral coat proteins currently
consumed.
Plant pathogenic viruses have never been shown capable of infecting
or replicating in vertebrates (Refs. 2, 3, 4, and 5). Intact,
infectious, whole plant viruses, therefore, are not infectious to
humans. Given that the complete virus is not infectious to vertebrates,
it is reasonable to assume that a noninfectious subcomponent of the
virus would not be hazardous to humans or animals. Purified
preparations of plant viruses have routinely been handled by
researchers without specialized protection of workers (researchers)
against infection. These purified plant virus preparations are also
frequently injected into laboratory animals for the production of
specific antibodies without any adverse effects to the animals. No
specific toxicological testing of purified plant virus preparations has
been reported in the literature.
IV. External Review
In developing its regulatory approach for plant-pesticides, EPA
requested the advice of a Subpanel of the FIFRA Scientific Advisory
Panel (SAP). On December 18, 1992, the SAP Subpanel was convened to
review a draft policy statement for plant-pesticides and respond to a
series of scientific questions posed by the Agency.
One question that the Agency asked the SAP Subpanel was whether
coat proteins from plant viruses might present a dietary risk. In
answer to the question the Subpanel stated that ``[s]ince viruses are
ubiquitous in the agricultural environment at levels higher than will
be present in transgenic plants, and there has been a long history of
`contamination' of the food supply by virus coat protein, there is [a]
scientific rationale for exempting transgenic plants expressing virus
coat protein from the requirement of a tolerance.'' EPA agrees with
this position and is proposing an exemption from the requirement of a
tolerance for coat proteins from plant viruses when produced in plants.
Based on the information presented in this document, EPA finds that
a tolerance for viral coat proteins produced in plants is not necessary
to protect the public health. Thus, it is proposed that an exemption
from the requirement of a tolerance be established by amending 40 CFR
part 180 as set forth in the regulatory text of this document.
V. Rulemaking Record and Procedure
Any person who has registered or submitted an application for
registration of a pesticide, under FIFRA as amended, which contains any
of the ingredients listed herein, may request within 30 days after
publication of this proposed rule in the Federal Register that this
rulemaking proposal be referred to an Advisory Committee in accordance
with section 408(e) of the FFDCA.
EPA has established a record for this rulemaking. Interested
persons are invited to submit written comments on the proposed
regulation. Comments must bear a notation indicating the document
control number, (OPP-300367). All written comments filed in response to
this proposal and the rest of the rulemaking record 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.
VI. Regulatory Requirements
The Office of Management and Budget has exempted this proposed rule
from the requirement of review pursuant to 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 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). This proposed
rule is not subject to the Paperwork Reduction Act because it does not
contain any collection of information.
VII. References
(1) Beemster, A.B.R. and J.A. de Bokx. 1987. Survey of Properties
and Symptoms of Potato Viruses, pp. 84-93 In: Viruses of Potatoes and
Seed Potato Production; J.A. de Bokx and J.P.H. vanderWant. PuDOC,
Wageningen, The Netherlands.
(2) Brun, G. 1991. ``Rhabdoviridae''. Chap. 17, pp. 443-460; In:
Atlas of Invertebrate Viruses eds. J.R. Adams and J.R. Bonami. CRC
Press, Boca Raton, FL.
(3) EPA Issue Paper. Issues associated with the regulation of viral
coat proteins under FIFRA and FFDCA.
(4) Gibbs, A. and B. Harrison. 1976. Plant Virology: The
Principles, Chap. 1. J. Wiley Sons, New York.
(5) Matthews, R.E.F. 1981. Plant Virology. Chaps. 12, 16, and 19.
Second edition, Academic Press, New York.
(6) Palukaitis, P. 1991. Virus-mediated genetic transfer in plants.
In: Risk Assessment in Genetic Engineering. Edited by M.A. Levin and
H.S. Strauss. McGraw-Hill, Inc., New York. pp. 140-161.
(7) Provvidenti, R., R.W. Robinson, and H.M. Munger. 1984.
Occurance of Zucchini Yellow Mosaic Virus in Curcubits from
Connecticut, New York, Florida and California, Plant Disease 68:443-
446.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Plants, Plant-
pesticides, Reporting and recordkeeping requirements.
Dated: November 15, 1994.
Carol M. Browner,
Administrator.
Therefore, it is proposed that 40 CFR part 180 be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 would continue to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. By adding Sec. 180.1136 to read as follows:
Sec. 180.1136 Viral coat proteins used as plant-pesticides; exemption
from the requirement of a tolerance.
(a) Residues of coat proteins from plant viruses, or segments of
the coat proteins, produced in living plants as plant-pesticides are
exempt from the requirement of a tolerance.
(b) For the purpose of this section, the following definitions
apply:
Genetic material necessary for the production means:
(1) Genetic material that encodes for a pesticidal substance or
leads to the production of a pesticidal substance.
(2) Regulatory regions.
It does not include noncoding, nonexpressed nucleotide sequences.
Living plant means a plant that is alive, including periods of
dormancy, and all viable plant parts/organs involved in the plant's
life cycle.
Noncoding, nonexpressed nucleotide sequences means the nucleotide
sequences are not transcribed and are not involved in gene expression.
Examples of noncoding, nonexpressed nucleotide sequences include
linkers, adapters, homopolymers, and sequences of restriction enzyme
recognition sites.
Plant-pesticide means a pesticidal substance that is produced in a
living plant and the genetic material necessary for the production of
the substance, where the substance is intended for use in the living
plant.
Regulatory region means genetic material that controls the
expression of the genetic material that encodes for a pesticidal
substance or leads to the production of a pesticidal substance.
Examples of regulatory regions include promoters, enhancers, and
terminators.
[FR Doc. 94-28824 Filed 11-22-94; 8:45 am]
BILLING CODE 6560-50-F