[Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
[Proposed Rules]
[Pages 27132-27142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12784]
[[Page 27131]]
_______________________________________________________________________
Part VI
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 180
Plant-Pesticides, Supplemental Notice; Proposed Rule
Plant-Pesticides; Nucleic Acids; Proposed Rule
Plant-Pesticides; Viral Coat Proteins; Proposed Rule
Federal Register / Vol. 62, No. 95 / Friday, May 16, 1997 / Proposed
Rules
[[Page 27132]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300368A; FRL-5717-2]
RIN 2070-AC02
Plant-Pesticides; Supplemental Notice of Proposed Rulemaking
AGENCY: Environmental Protection Agency (EPA).
ACTION: Supplemental notice of proposed rulemaking.
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SUMMARY: This document announces the availability of information for
additional public comment regarding a proposed exemption from the
requirement of a tolerance under the Federal Food, Drug, and Cosmetic
Act (FFDCA) for pesticidal substances that are a component of certain
plant-pesticides, i.e., those plant-pesticides that are derived from
closely related plants. Comments on this document may also affect EPA's
final determination on a proposed exemption under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) for this same
category of plant-pesticides. In 1994, EPA proposed to exempt from the
requirement of a tolerance the pesticidal substance portion of plant-
pesticides moved between closely related plants because a tolerance
would not be necessary to protect the public health. Since publication
of the proposal, Congress enacted the Food Quality Protection Act
(FQPA) which amended FFDCA and FIFRA. EPA is issuing this document
today to provide the public with an opportunity to comment on EPA's
analysis of how certain FQPA amendments to FFDCA and FIFRA apply to the
proposed exemption from the requirement of a tolerance for pesticidal
substances moved between closely related plants. EPA believes that it
considered most of the substantive issues associated with the FQPA
amendments when it issued the proposals in 1994. EPA is thus, in this
document, specifically seeking comment only on its evaluation of the
requirements imposed by FQPA that the Agency did not address in the
proposals.
DATES: Comments, identified by the docket control number ``OPP-
300368A,'' must be received on or before June 16, 1997.
ADDRESSES: By mail, submit written comments to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person deliver comments to:
Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Comments and data may also be submitted electronically by following
the instructions under Unit IV.D. of this document. No Confidential
Business Information (CBI) should be submitted through e-mail.
FOR FURTHER INFORMATION CONTACT: By mail: Elizabeth Milewski, Office of
Science, Coordination and Policy, Office of Prevention, Pesticides and
Toxic Substances (7101), Environmental Protection Agency, 401 M St.,
SW., Washington, DC 20460, Telephone: (202) 260-6900, e-mail address:
milewski.elizabeth@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
EPA issued in the November 23, 1994 Federal Register a package of
five separate Federal Register proposals (59 FR 60496, 60519, 60535,
60542 and 60545) (FRL-4755-2, FRL-4755-3, FRL-4758-8, FRL-4755-5, and
FRL-4755-4) which together described EPA's approach to substances
produced in plants that enable the plants to resist pests or disease.
EPA's package of proposals indicated that these substances are
pesticides under section 2 of FIFRA (7 U.S.C. 136(u)) if they are
``intended for preventing, destroying, repelling, or mitigating any
pest'' or if they are ``. . . intended for use as a plant regulator,
defoliant, or desiccant'' regardless of whether the pesticidal
capabilities evolved in the plants or were introduced by breeding or
through the techniques of modern biotechnology. These substances, and
the genetic material necessary to produce them, were designated
``plant-pesticides'' by EPA in the November 23, 1994 Federal Register
notices. The proposals defined a ``plant-pesticide'' as ``a pesticidal
substance that is produced in a living plant and the genetic material
necessary for the production of the pesticidal substance where the
pesticidal substance is intended for use in the living plant'' (59 FR
at 60534).
One of the five documents (59 FR 60535) proposed to exempt the
pesticidal substance portion of plant-pesticides moved between closely
related plants from the FFDCA (21 U.S.C. 346a) requirement of a
tolerance based upon an evaluation of the potential for new dietary
exposures to the substances when they are produced in plants, or in
plant parts, used as food or feed. EPA proposed in the same Federal
Register (59 FR at 60537) to define closely related plants as plants
that are sexually compatible. In the proposal, sexually compatible,
when referring to plants, means capable of forming a viable zygote
through the fusion of two gametes, including the use of bridging
crosses and/or wide crosses. EPA stated in the proposed exemption that
a tolerance is not necessary to protect the public health for these
pesticidal substances because no new dietary exposures are likely to
occur for pesticidal substances moved between sexually compatible
plants. For pesticidal substances in this category, many years of
experience of human use suggest that under normal dietary conditions
these pesticidal substances present negligible risk. Specifically, EPA
proposed that ``residues of pesticidal substances produced in living
plants as plant-pesticides are exempt from the requirement of a
tolerance if the genetic material that encodes for a pesticidal
substance or leads to the production of a pesticidal substance is
derived from plants that are sexually compatible with the recipient
plant and has never been derived from a source that is not sexually
compatible with the recipient plant'' (59 FR at 60542).
This supplemental notice addresses the pesticidal substance portion
of plant-pesticides produced in food plants. A companion supplemental
notice issued elsewhere in today's Federal Register addresses the
proposed exemption for the nucleic acid component of plant-pesticides
with regard to the FQPA amendments to FFDCA.
Because FQPA modified FIFRA (7 U.S.C. 136 et seq.) by incorporating
the FFDCA safety standard into the FIFRA test for determining whether a
pesticide poses an unreasonable adverse effect, comments on these
supplemental notices may also affect EPA's final determination on the
proposed exemption (59 FR 60519) under FIFRA for plant-pesticides that
are derived from plants sexually compatible with the recipient plant.
EPA is issuing this supplemental notice, as well as the companion
supplemental notice on nucleic acids to ensure that the public has had
adequate opportunity to comment on certain new considerations raised by
the FQPA amendments to FFDCA as these considerations relate to the
proposed exemption from tolerance for residues of pesticidal substances
derived from sexually compatible plants. In evaluating a pesticide
chemical residue for exemption from FFDCA tolerance requirements, EPA
must now explicitly address certain factors, and make a determination
that there is a reasonable certainty that aggregate exposure to the
[[Page 27133]]
residue will cause no harm to the public. The factors to be considered
are iterated in Unit II. of this supplemental notice. EPA's evaluation
of these factors relative to the proposed exemption (59 FR 60535) is
contained in Unit IV. of this supplemental notice. Consistent with
FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific
data and other relevant information in support of this action. In
today's supplemental notice, EPA requests comment only on the new
conclusions identified in Unit V.C. of this supplemental notice.
In light of FQPA, EPA is engaged in a process, including
consultation with registrants, states, and other interested
stakeholders, to make decisions on the new policies and procedures that
will be appropriate as a result of enactment of FQPA. In establishing
this exemption from the requirement of a tolerance for pesticidal
substances derived from sexually compatible plants, EPA does not intend
to set precedents for the application of section 408 and the new safety
standard to other tolerances and exemptions. This exemption from the
requirement of a tolerance will not restrict EPA's options with regard
to general procedures and policies for implementation of the amended
FFDCA section 408.
II. Statutory Authority
Under FFDCA, EPA regulates pesticide chemical residues by
establishing tolerances limiting the amounts of residues that may be
present in food, or by establishing exemptions from the requirement of
a tolerance for such residues. Pesticide chemical residues subject to
regulation under FFDCA are defined by reference to the definition of
pesticide under FIFRA. FFDCA section 201(q)(1) defines a ``pesticide
chemical residue'' to mean the residue in or on food of a pesticide
chemical or other added substance resulting primarily from the
metabolism or degradation of a pesticide chemical (21 U.S.C.
321(q)(2)). A ``pesticide chemical'' means ``any substance that is a
pesticide within the meaning of the Federal Insecticide, Fungicide, and
Rodenticide Act, including all active and inert ingredients of such
pesticide'' (21 U.S.C. 321(q)(1)).
FIFRA authorizes EPA to regulate the sale and distribution of
pesticides in the United States and to exempt a pesticide from the
requirements of FIFRA if it is not of a character requiring regulation
(7 U.S.C. 136a(a) and 136w(b)). FIFRA section 2(u) defines
``pesticide'' as: (1) ``any substance or mixture of substances intended
for preventing, destroying, repelling, or mitigating any pest, (2) any
substance or mixture of substances intended for use as a plant
regulator, defoliant, or desiccant, and (3) any nitrogen stabilizer''
(7 U.S.C. 136(u)).
FQPA amends both FFDCA and FIFRA. FQPA, which took effect on August
3, 1996, among other things, amends FIFRA such that a registration
cannot be issued for a pesticide to be used on or in food unless the
residue of the pesticide in food qualifies for a tolerance or exemption
from the requirement for a tolerance. FQPA modified FIFRA section 2(bb)
by incorporating the FFDCA section 408 safety standard into the test
for determining whether a pesticide poses an unreasonable adverse
effect (7 U.S.C. 136(bb)). FIFRA section 2(bb) defines the term
``unreasonable adverse effects on the environment'' to mean (1) any
unreasonable risk to man or the environment, taking into account the
economic, social, and environmental costs and benefits of the use of
any pesticide, or (2) a human dietary risk from residues that result
from a use of a pesticide in or on any food inconsistent with the
standard under section 408 of the FFDCA. Thus, a pesticide used in or
on food that does not meet the FFDCA section 408 safety standard also
would pose an unreasonable adverse effect under FIFRA and would not
qualify for an exemption from the requirements of FIFRA under FIFRA
section 25(b)(2).
FQPA amends FFDCA section 408(c)(2)(A)(i) to allow EPA to establish
an exemption from the requirement of a tolerance for a ``pesticide
chemical residue'' only if EPA determines that the exemption is
``safe'' (21 U.S.C. 346a(c)(2)(A)(i)). Section 408(c)(2)(A)(ii) defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information'' (21 U.S.C. 346a(c)(2)(A)(ii)).
This includes exposure through drinking water, but does not include
occupational exposure. In establishing an exemption from the
requirement of a tolerance, FFDCA section 408(c), like the statute
prior to FQPA, does not require EPA to consider benefits that might be
associated with use of the pesticide chemical.
FFDCA section 408 requires EPA to give special consideration to
exposure of infants and children to the pesticide chemical residue in
establishing an exemption and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue'' (21 U.S.C.
346a(b)(2)(C)(ii)(I)) and (c)(2)(B). Section 408(b)(2)(D) specifies
other, general factors EPA is to consider in establishing an exemption.
Section 408(c)(3)(B) prohibits an exemption unless there is either a
practical method for detecting and measuring levels of pesticide
chemical residue in or on food or there is no need for such a method
(21 U.S.C. 346a(c)(3)(B)).
Specifically, EPA must consider the following in deciding whether
to grant an exemption:
1. The validity, completeness, and reliability of the available
data from studies of the pesticide chemical and pesticide chemical
residue.
2. Nature of any toxic effect shown to be caused by the pesticide
chemical or residues in studies.
3. Available information concerning the relationship of the results
of such studies to human risk.
4. Available information concerning the dietary consumption
patterns of consumers (and major identifiable subgroups of consumers).
5. Available information concerning the cumulative effects of such
residues and other substances that have a common mechanism of toxicity.
6. Available information concerning the aggregate exposure levels
of consumers to the pesticide chemical residue and to other related
substances, including dietary exposure and non-occupational exposures.
7. Available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers.
8. Such information as the Administrator may require on whether the
pesticide chemical may have an effect in humans that is similar to an
effect produced by a naturally-occurring estrogen or other endocrine
effects.
9. Safety factors which in the opinion of experts qualified by
scientific training and experience to evaluate the safety of food
additives are generally recognized as appropriate for the use of animal
experimentation data (21 U.S.C. 346a(b)(2)(D).
Additionally, with respect to exposure of infants and children,
consistent with section 408(b)(2)(C), EPA must assess the risk of the
pesticide based on available information concerning:
1. Consumption patterns that are likely to result in
disproportionately high consumption of food with pesticide residues.
2. Special susceptibility of infants and children to such residues.
3. Cumulative effects of residues with other substances that have a
common
[[Page 27134]]
mechanism of toxicity (21 U.S.C. 346a(b)(2)(C) and (c)(2)(B)).
III. Summary of Proposed Regulations
This supplemental notice affects three of the proposals that
appeared in the November 23, 1994 Federal Register: (1) A proposal
under FFDCA to exempt from the requirement of a tolerance, residues of
the pesticidal substance portion of any plant-pesticide that is derived
from a plant that is sexually compatible with the recipient plant (59
FR 60535); (2) a companion proposal (59 FR 60542) under FFDCA to exempt
``residues of nucleic acids produced in living plants as part of a
plant-pesticide''; and (3) a proposal (59 FR 60519) under FIFRA to
exempt from most of the requirements of FIFRA, plant-pesticides derived
from a plant that is sexually compatible with the recipient plant.
In the November 23, 1994 Federal Register, the Agency proposed to
exempt from the FFDCA requirement of a tolerance (59 FR 60535) and most
requirements of FIFRA (59 FR 60519) pesticidal substances moved between
plants that are closely related. EPA discussed two options for
describing plants that are closely related: (1) Plants that are
sexually compatible, or (2) plants that are within the same taxonomic
genus or are sexually compatible. Sexual compatibility would include
use of techniques such as wide and bridging crosses. EPA's preferred
approach for describing closely related plants was the option based on
sexual compatibility alone. Thus, EPA proposed that plant-pesticides
derived from plants that are sexually compatible would be exempt from
most FIFRA requirements, and residues of pesticidal substances that are
derived from sexually compatible plants would be exempted from the
FFDCA requirement of a tolerance.
The rationale underlying the proposed exemptions is that plants in
a sexually compatible population are likely to have the same
information encoded in their genetic material and to share traits in
common. Groups of plants having a common pool of genetic material have
resulted from the processes of evolution. Generations of directed
breeding to produce improved crops for cultivation have tended to
increase the relatedness of agricultural crop plants and reduce the
variability in the common pools of genetic information of crop plants.
Because sexually compatible plants share a common pool of genetic
material, movement of genetic material encoding pesticidal substances
between plants in a sexually compatible population is unlikely to
result in novel environmental or dietary exposures. If a crop plant
normally produces a pesticidal substance, humans consuming the crop,
and organisms coming into contact with the plant, have been exposed to
that substance in the past, perhaps over long periods of time. No new
exposures are likely to occur. Because of the high degree of
relatedness among plants comprising sexually compatible populations,
the potential for new human exposures, either dietary or environmental,
is low for pesticidal substances in sexually compatible plants or plant
parts used as food or feed. Under the exemptions for plant-pesticides
derived from sexually compatible plants, EPA exempts from the FFDCA
requirement of a tolerance those plant-pesticides that are normally a
component of (not new to) the recipient plant. EPA believes that crops
grown for food in the U.S. today would qualify for this exemption (59
FR at 60535 and 60542) based on the standard of relatedness as
described by sexual compatibility.
The proposed exemption from the requirement of a tolerance (59 FR
60535) was examined within the context of the food supply and dietary
consumption. Many substances having pesticidal activity occur naturally
at low concentrations in the edible parts of plants and have long been
accepted as part of the human diet. Extensive use and experience show
the safety of foods containing these substances. Although very large
numbers of plant varieties are used and large numbers of varieties are
introduced into agricultural use each year, there are only a few
examples of plant varieties causing food safety concerns.
Based on these considerations, and as required by the FFDCA prior
to enactment of the FQPA, EPA concluded that plant-pesticides found in
the current food supply would present no hazard under potential use
conditions and, hence, a tolerance would not be necessary to protect
the public health.
EPA's alternative option for describing relatedness in plants (59
FR at 60537) used both sexual compatibility and taxonomy (genus). Under
this alternative option, if a plant-pesticide was derived from a plant
classified in the same genus as the recipient plant or if the donor
plant was sexually compatible with the recipient plant, that plant-
pesticide would be exempt. The assumption underlying this alternative
option was that the taxonomic grouping of genus correlated to a
relatively high degree of relatedness. This option was not EPA's
preferred approach, because even though plants grouped within a genus
may be fairly closely related, certain species within a genus may never
have contributed traits to plants currently found in the food supply
and thus no known dietary exposure exists for traits from such plants.
Therefore, EPA preferred the option based on sexual compatibility alone
which EPA believes best describes plant-pesticides found in the food
supply.
In the 1994 Federal Register (59 FR 60535), EPA also proposed to
exempt from the requirement of a tolerance a second category of
pesticidal substances. This second category consists of pesticidal
substances that are derived from food plants that are not closely
related to the recipient plant but which would not result in
significantly different dietary exposures when produced in the
recipient plant. This second category will not be addressed in this
supplemental notice but will be addressed in a separate Federal
Register in the future.
IV. Risk Assessment and Safety Determinations
A. Risk Assessment in the 1994 Proposal
This section reviews the analysis that EPA used to support its 1994
proposal (59 FR 60535) to exempt pesticidal substances derived from
sexually compatible plants from the requirement of a food tolerance
under the FFDCA. EPA also relied upon the analysis in the 1994 FFDCA
proposal to evaluate human dietary risks in support of its proposal (59
FR 60519) to exempt plant-pesticides from sexually compatible plants
from most FIFRA requirements. Non-dietary human risks from exposure to
such pesticidal substances were examined under the analysis for the
proposed FIFRA exemption and are discussed in this supplemental notice
only as they pertain to the dietary risks.
When EPA proposed in 1994 to exempt residues of pesticidal
substances that are derived from sexually compatible plants from the
requirement of a tolerance (59 FR 60535), it concluded that a food
tolerance for such substances would not be necessary to protect the
public health because such substances presented no significant hazards
under potential use conditions. EPA based this conclusion upon its
analysis of potential dietary exposure, hazard and risk from
consumption of plants that contain these substances. EPA recognized and
relied on the long history of human experience with growing and
consuming plants for food and with the procedures of plant breeding.
Plant breeding combines the scientific knowledge of experimental
laboratory disciplines such as plant
[[Page 27135]]
physiology, plant genetics, and phytopathology into a practical field
science that develops new plant cultivars for use in agriculture. EPA
has used these bases of knowledge and experience in its estimation of
exposures and hazards of the residues of pesticidal substances
addressed by this supplemental notice as well as for the 1994 proposal.
EPA concluded in the 1994 proposal (59 FR 60535) that the vast
majority of plant varieties developed by plant breeders using traits
from sexually compatible plants produce foods that are safe for human
consumption. This conclusion is based on the experience of consuming
crops resulting from scientific breeding as well as the historical
consumption of crops since the prehistorical origins of agriculture.
These foods undoubtedly contain(ed) pesticidal substances (and the
genetic material necessary to produce them) and share a history of safe
consumption. In addition, appropriate processing procedures are widely
known and are routinely used by consumers in preparation of food from
such sources, including those foods which require specific processing/
preparation steps to avoid dietary problems.
In the 1994 proposal, EPA stated that many substances having
pesticidal activity occur naturally at low concentrations in the edible
parts of plants and have long been accepted as part of the human diet.
Extensive use and experience show the safety of foods containing these
substances. For many foods, the naturally-occurring toxicants they may
contain, some of which might be pesticidal in function, are known.
Also, the established practices that plant breeders employ in selecting
and developing new plant varieties, such as chemical analyses, taste-
testing, and visual analyses, have historically proven to be reliable
for ensuring food safety. That there are few documented cases of new
plant cultivars causing food safety problems despite the large numbers
of new varieties introduced into commerce each year, is a reflection of
the effectiveness of this process (59 FR at 60538).
Plant varieties for the food market have been developed by breeders
seeking better products, higher yields, and other desirable crop
characteristics. In this process, it has been common agricultural
practice to move traits among sexually compatible food plant varieties
as well as to introduce traits from sexually compatible wild relatives
into plant varieties that are used as food plants. This type of
breeding process has been used on most sexually compatible crop plants,
and tended to increase the extent of relatedness among plant varieties
in agricultural crops. The 1994 proposal is based on experience with
the exposure of human populations to crops developed through the
breeding process, i.e., crops developed through 50 to 100 years of
scientific breeding among sexually compatible plant populations using
Mendelian genetics. The sexually compatible, wild relatives of
cultivated plants that are used in this process do not themselves
necessarily have any history of human consumption but have safely
contributed traits through sexual recombination to cultivars on the
market. For example, wild species of tomatoes have been used, in plant
breeding, as a source of increased resistance to economically important
diseases in tomato (Ref. 1). Sexually compatible crop varieties of the
same plant species are also crossed with each other to achieve better
pest resistance in their progeny. Food plant varieties developed in
this way have been introduced, cultivated, and consumed by humans for
many years with very few observed adverse affects (59 FR at 60538).
If a food plant or its close relative normally produces a
pesticidal substance, humans have likely been exposed to that substance
in the past. Experience with both growing agricultural plants and
consuming food from plants which undoubtedly contain pesticidal
substances demonstrates the safety of the current food supply,
including substances in the food supply that may be plant-pesticides.
The Agency believes this experience combined with the knowledge of
plant genetics, plant physiology, phytopathology and plant breeding are
the appropriate considerations in evaluating the potential risks of
residues of the pesticidal substances proposed for the tolerance
exemption (59 FR 60535).
The residues of the pesticidal substances that are the subject of
the proposed exemption have evolved in populations of sexually
compatible plants. They are part of the metabolic cycles of these
plants. They are thus subject to the processes of degradation and decay
that all organic matter undergoes. They are not likely to persist in
the environment nor bioaccumulate in the tissues of living organisms.
Because they do not persist, the potential for new exposures to the
residues to occur, beyond direct physical exposures to the plant, would
be limited. As noted in the proposal (59 FR at 60516), plant-pesticides
present negligible exposure of the pesticidal substances to humans
outside the dietary route because the substances are in the plant
tissue and thus are found either within the plant or in close proximity
to the plant. In contrast, applied synthetic chemicals have much
greater potential for new dietary exposures. Prior to the use of
synthetic pesticides, there may be very little scientific experience
with the new pesticidal substance or even a complete lack of known
dietary exposure to the pesticidal substance.
EPA evaluated the potential risks of a pesticidal substance derived
from a closely-related plant relative based upon the unique
characteristics of plant-pesticides. In evaluating the pesticidal
substance component of plant-pesticides, EPA took into account
available knowledge from a number of scientific disciplines.
Experimental data in the area of plant genetics provided an estimate of
the exchange, between plants, of genetic material that is necessary for
the production of the pesticidal substances. EPA also considered
information from the field of plant physiology regarding plant
metabolism, the production of substances that may have pesticidal
effects, and conditions that may limit the production of such
substances. This information provided a basis for EPA's estimation of
the physiological limitations to production of substances that may have
a pesticidal effect. The Agency also used experimental data derived
from the science of phytopathology to characterize the disease and pest
resistant mechanisms known to occur in plants. All of these bases of
knowledge and experience were integral to EPA's assessment of exposures
and hazards associated with pesticidal substances.
EPA considered whether there are variations in the levels of
pesticidal substances that are the subject of the proposed exemption
(59 FR 60535) within and between plant varieties, and thus variation in
exposure that might affect the Agency's determination that pesticidal
substances that are the subject of the proposed exemption present
negligible risk. The amount of pesticidal substance produced by plants
normally varies among members of a closely related population (even
within a single variety), because of the effects of conditions such as
genetic constitution and environment (e.g., weather) on trait
expression. This variation in turn leads to differences in the levels
and types of exposure to the pesticidal substance. Since such variation
is a natural phenomenon common to all plants, humans have been and are
always exposed to varying levels of the pesticidal substances that are
the subject
[[Page 27136]]
of this exemption when they consume food from plants.
EPA also considered the constraints upon the extent to which any
substance can be increased in highly managed food crop plants without
unwanted effects on other, desirable characteristics of the plant such
as yield or palatability. In general, breeders balance a number of
characteristics (e.g., yield, palatability, uniformity of seed drop) in
developing marketable plant varieties. Plants have, as do all
organisms, only a limited capacity to express a particular trait
without an unacceptable drain on energy reserves. Greatly increased
levels of a pesticidal substance would, in general, only be
accomplished at the expense of expressing other agriculturally
desirable traits (e.g., yield). EPA does not believe that levels of
pesticidal substances that are the subject of the proposed exemption
(59 FR 60535) will be increased to a point that will result in an
adverse dietary effect. EPA has extensively evaluated whether
quantitative changes in levels of the pesticidal substances that are
the subject of the proposed exemption would warrant regulation by the
setting of a food tolerance. EPA has determined that changes in the
levels of these pesticidal substances present a reasonable certainty of
causing no harm because the highest levels likely to be attained in
plants are not likely to result in overall significantly different
dietary exposures. EPA does not anticipate that attempts to increase
the levels of these pesticidal substances would lead to a significantly
different spectrum of exposure than that with which there is
substantial experience.
The evaluation of potential dietary risk associated with the
pesticidal substances that are the subject of the proposed exemption
(59 FR 60535) were considered within the context of the food supply and
dietary consumption patterns. The residues of pesticidal substances
that are the subject of the proposed exemption are components of a
human diet. In developing the proposal, the Agency considered that the
diet includes all of the food items that are customarily eaten by human
populations or subpopulations. The consumption of food plants is part
of a balanced and varied diet. Individuals recognize and are familiar
with the plant crop derived food they consume and, based on prior
experience with food, individuals avoid potential exposures to foods
containing substances they know, either through personal experience or
through acquired knowledge, cause them problems. Since the proposed
exemption will not affect the current pattern of exposure to the
pesticidal substances that are the subject of the proposed exemption,
the current method whereby sensitive individuals recognize and avoid
foods known to cause them problems will not be altered. As noted in the
proposal (59 FR at 60505), ``consumer experience with the handling and
preparation of food from these plants contributes to the safety of food
from these plants.
The approach used by EPA to evaluate the dietary risk posed by the
pesticidal substance component of plant-pesticides derived from
sexually compatible plants (59 FR 60535) differs somewhat from the
approach the Agency uses for other pesticides. For more traditional
pesticides, EPA's risk evaluation relies on, for the most part, data
generated by testing in laboratories using representative, single
species animal model systems to estimate risk end-points such as
toxicity and carcinogenicity. Conclusions from data generated from
these single species testing systems are then extrapolated to
conclusions concerning hazards to humans, including conclusions on
dietary hazards presented by chemical pesticide residues in crops and
domestic animals used as food sources for humans. Mathematical models,
as well as experimental data, on pesticide residues, provide
information on exposure. Exposure and hazard considerations are
combined to quantify the potential risk associated with a traditional
pesticide. Safety factors are often used in the risk assessment as an
added measure of caution when toxicity data from surrogate animal
testing are used to estimate human toxicity. Such safety factors are
not necessary in risk assessment when data on human effects is directly
available, as is the case for the proposed exemption from the
requirement of a tolerance for residues of pesticidal substances
derived from sexually compatible plants.
The approach to assessing risk described in the preceding paragraph
is appropriate for analyzing risks posed by pesticide residues from
pesticides such as chemical pesticides, pesticides extracted from
plants, and some types of non-exempt plant-pesticides. For example,
some chemicals used as pesticides may have no history of safe dietary
consumption because they were created by humans and are synthetic.
Single species animal testing may provide the only data on the effect
of these pesticides on living organisms. Chemical pesticides that do
not occur in nature, but are a product of human intervention, may not
necessarily be subject to the processes by which biotic substances are
degraded or cycled in nature. Thus, they may persist in the environment
for long periods of time and may bioaccumulate in the tissues of living
organisms.
The risk assessment methodology appropriate for such chemicals is
not appropriate for the pesticidal substances that evolved in the plant
and are the subject of the proposed exemption (59 FR 60535). Plant-
pesticides derived from sexually compatible plants differ from more
traditional pesticides in a number of ways. As noted in the proposal
(59 FR at 60511), the major characteristic of plant-pesticides that is
different from traditional pesticides is that the plant itself produces
the pesticidal substance rather than the pesticide being applied to the
plant. Thus, the exposure pattern may be very different for plant-
pesticides than for traditional pesticides both because of how the
pesticide is produced and the biology of plants. . . . the potential
for causing adverse health effects may be more circumscribed than for
traditional pesticides because, in many cases, the only significant
route of human exposure may be oral.'' Several conditions limit the
potential for exposure to plant-pesticides as compared to traditional
pesticides. These include that: (1) Exposure with plant-pesticides
would be primarily through one route (dietary), (2) production of the
pesticidal substance is limited by the plant's physiological
constraints, (3) plant-pesticides derived from sexually compatible
plants are integral parts of a plant's metabolism and thus are
compatible with the biological processes of other organisms. Because of
their biotic nature, the pesticidal substances that are the subject of
the proposed exemption do not persist in the environment nor do they
bioaccumulate in the tissues of living organisms. Thus, the number of
routes of exposure that must be considered in performing a risk
assessment are reduced since the primary route of exposure to plant-
pesticides will be ingestion of plant tissues that contain the
pesticidal substances that are the subject of the proposed exemption.
When EPA proposed to exempt residues of pesticidal substances
derived from sexually compatible plants from the requirement of a
tolerance (59 FR 60535), it considered health risks to the general
population, which included infants and children. Children and infants,
like adults, have been consuming food containing the pesticidal
substances that are the subject of the proposed exemption. There is no
evidence such pesticidal substances, as a component of food, present a
different level of dietary risk for infants and children than they
would for the adult
[[Page 27137]]
population. EPA's risk assessment in the proposed exemption included
subgroups as part of the general population, (i.e., infants and
children and the effects of culture on diet), and allowed for
consumption pattern differences of such subgroups. For infants and
children and other subgroups, EPA relied on the human experience base
that it describes in summary form in this supplemental notice. On the
basis of its analysis, EPA determined that a tolerance would not be
necessary to protect the health of infants and children because
pesticidal substances derived from sexually compatible plants would not
pose significant new dietary exposures and experience indicates that
plant-pesticides that are the subject of the exemption present no
hazard under the use conditions.
B. Risk Assessment in Light of Amendment to FFDCA
After EPA issued its proposed exemption from the requirement of a
tolerance for plant-pesticides derived from sexually compatible plants
(59 FR 60535), Congress enacted FQPA and amended certain FFDCA
provisions governing pesticide chemical residues and FIFRA provisions
governing pesticides (See Unit II. of this supplemental notice).
Congress revised the specific wording of the section 408 standard for
exemptions and provided more specific guidance regarding some of the
factors that EPA should consider in establishing such exemptions (see
Unit II. of this supplemental notice). When EPA proposed the exemption
for residues of pesticidal substances derived from sexually compatible
plants (59 FR 60535), it considered most of the safety factors spelled
out in FQPA even though the Agency may not have explicitly discussed
all those factors using the terminology specified in the FQPA
amendments. This supplemental notice describes how the Agency took
account of most of the FQPA factors in issuing its 1994 proposal to
exempt pesticidal substances derived from sexually compatible plants
and indicates which factors were considered in that proposal. The
information the Agency relied on in considering these factors is part
of the public record which was available to the public when EPA issued
the proposed exemption from the requirement of a food tolerance. The
supplemental notice also identifies the factors that were not
considered in the proposal. Because FQPA amended FIFRA by incorporating
the section 408 safety standard, commenters should be aware that
comments on this supplemental notice may also affect EPA's final
determination on the proposed exemption (59 FR 60519) under FIFRA for
plant-pesticides that are derived from plants sexually compatible with
the recipient plant.
1. Validity, completeness, and reliability of available data. EPA
considered in 1994 the validity, completeness, and reliability of the
available data with regard to pesticidal substances derived from
sexually compatible plants in the proposals (59 FR 60519 and 60535) and
has summarized the evaluation in Unit IV.A. of this supplemental
notice.
2. Nature of toxic effect. EPA in 1994 considered the nature of the
toxic effects caused by pesticidal substances derived from sexually
compatible plants in the proposals (59 FR 60519 and 60535) and has
summarized its evaluation in Unit IV.A. of this supplemental notice.
3. Relationship of studies to humans. EPA in 1994 considered the
available information concerning the relationship to humans of toxic
effects of pesticidal substances that are the subject of the proposed
exemption when it issued the proposals (59 FR 60519 and 60535) and has
summarized that evaluation in Unit IV.A. of this supplemental notice.
EPA based its evaluation on the history of human consumption of food
derived from crop plants, and from products such as meat and milk from
animals that consume forage and other crops (e.g., corn and other
grains) that contain residues of pesticidal substances that are the
subject of the proposed exemption (59 FR 60535). Because knowledge of
human consumption of food derived from sexually compatible plants was
available and adequately addressed the issues of hazard and exposure,
the Agency did not use, for the proposed exemption (59 FR 60535), data
generated in the laboratory through animal testing.
4. Dietary consumption patterns. EPA considered in the 1994
proposal (59 FR 60535) the available information on the varying dietary
consumption patterns of major identifiable consumer subgroups as it
pertains to pesticidal substances derived from sexually compatible
plants. The Agency's evaluation is summarized in Unit IV.A. of this
supplemental notice.
5. Available information concerning cumulative effects of the
pesticide chemical residue and other substances that have a common
mechanism of toxicity. In the 1994 proposal (59 FR 60535), EPA examined
available information on the cumulative effect of pesticidal substances
derived from sexually compatible plants as well as other substances
present in food that may have a common mechanism of toxicity with such
pesticidal substances. EPA summarizes this information and its analysis
in Unit IV.A. of this supplemental notice.
With regard to the pesticidal substance itself, the proposal notes
(59 FR at 60505) that this exemption ``is based upon the premise that
new dietary exposures would not likely arise for plant-pesticides
produced in food plants if the genetic material leading to the
production of the plant-pesticide is derived from sexually compatible
plants.'' Thus, the proposal would exempt residues of pesticidal
substances that are normally components of (not new to) food from
plants in sexually compatible populations. As discussed in Unit IV.A.
of this supplemental notice, differences in the levels of pesticidal
substances present may occur between plants in a sexually compatible
population. EPA determined in the proposals that changes in the levels
of these pesticidal substances are not likely to result in overall
significantly different dietary exposures. As noted in the proposal (59
FR at 60538) ``[e]xtensive use and experience show the safety of foods
containing these substances.'' If, however, information becomes
available that indicates this finding is no longer consistent with the
FFDCA exemption standard for a pesticidal substance in this category,
EPA will consider the validity of the new information and act to amend
this tolerance exemption as necessary to protect the public health. In
the 1994 proposal (59 FR at 60535), EPA is proposing a requirement that
any person who sells or distributes plant-pesticides that have been
exempted must report to EPA any information that comes into their
possession regarding unreasonable adverse effects of an exempted plant-
pesticide on human health or the environment.
With regard to substances in food that may share a common mechanism
of toxicity with the residues of the pesticidal substances that are the
subject of the proposed exemption (59 FR 65035), EPA considered the
effects of these substances when it addressed the safety of food. Food
from plants has thousands of constituents. Thus, EPA cannot rule out
the possibility that the foods humans consume would also contain
substances that have a common mechanism of action with the pesticidal
substances that are the subject of the proposed exemption. However,
because sexually compatible plants share a common pool of genetic
material, any substances that may share a common mechanism of toxicity
with the pesticidal substances that are the subject
[[Page 27138]]
of the proposed exemption (59 FR 60535) are normally components of (not
new to) food from plants in sexually compatible populations. As
discussed in the 1994 preamble and supporting record for the proposal,
food from plants in sexually compatible populations have historically
been safely consumed by humans either directly, or indirectly in
products such as meat and milk that are derived from animals that
consume forage and other crops (e.g., corn and other grains). The
history of safe consumption indicates that any cumulative effects
between substances in food that may have a common mechanism of toxicity
with the pesticidal substances that are the subject of the proposed
exemption present a very low probability of human risk. The analysis
made in the preceding paragraph concerning potential increases in
levels of pesticidal substances apply equally to constituents of food
that may have a common mechanism of action with the pesticidal
substances that are the subject of this exemption (59 FR 60535).
Variation in the levels of these substances are not likely to result in
overall significantly different dietary exposures. As noted in the
proposal (59 FR at 60538) ``plant varieties that meet the sexually
compatible standard produce food that is safe for human consumption
and/or appropriate processing procedures are widely known and routinely
used by consumers in preparation of food from such sources.'' However,
should EPA in the future identify substances with a common mechanism of
toxicity with the plant-pesticides that are the subject of the proposed
exemption, both FIFRA and FFDCA give the Agency adequate authority to
take appropriate action to address any risks to humans health.
EPA is not aware of any other substances outside of the food supply
that may have a common mechanism of toxicity with the residues of the
pesticidal substances that are the subject of the proposed exemption
(59 FR 60535), although it cannot rule out the possibility. Should EPA
in the future identify substances with a common mechanism of toxicity
other than those found in the parts of plants used as food, both FIFRA
and FFDCA give the Agency adequate authority to take appropriate action
to address any risks to humans health.
Because EPA already considered the safety of food containing
residues of pesticidal substances derived from sexually compatible
plants and other constituents of food that may share a common mechanism
of toxicity with those residues when it issued the proposal (FR 60535),
it is not requesting additional comment on that topic. Comments are
requested only on the new issue of whether there are any substances
outside of the food supply that have a common mechanism of toxicity
with the residues of the pesticidal substances that are the subject of
the proposed exemption, and the effects of any such substances on human
health.
6. Aggregate exposures of consumers including non-occupational
exposures. EPA considered the available information on the aggregate
exposure level of consumers to pesticidal substances in the plant-
pesticides to be exempt in the 1994 FFDCA and FIFRA proposals (59 FR
60519 and 60535). This included a consideration of exposures from
dietary sources (59 FR 60535) as well as from other non-occupational
sources (59 FR 60519). As indicated in EPA's policy statement, ``plant-
pesticides are likely to present a limited exposure of the pesticidal
substance to humans. In most cases, the predominant, if not the only,
exposure route will be dietary. Significant respiratory and dermal
exposures will be unlikely'' (59 FR at 60513). As explained in the
FFDCA and FIFRA proposals and the EPA's policy statement (59 FR 60494)
and associated dockets, plant-pesticides present negligible exposure of
pesticidal substances to humans outside of the dietary route because
the substances are in the plant tissue and thus are found either within
the plant or in close proximity to the plant. EPA considered dietary
exposure to the pesticidal substances in the proposed FFDCA exemption
(59 FR 60535) and summarized its evaluation in Unit IV.A. of this
supplemental notice.
Despite EPA's belief that, because of the nature of plant-
pesticides, there is little likelihood of exposure other than through
the dietary route, EPA in this supplemental notice sets forth in
greater detail its considerations concerning other exposure routes.
With regard to the dermal route of exposure, the pesticidal substances
that are the subject of the proposed exemption (59 FR 60535) may in
some cases be present in sap or other exudates from the plant or the
food and thus may present some limited opportunity for dermal exposure
to persons coming physically into contact with the plant or raw
agricultural food from the plant. Individuals preparing meals are those
most likely to experience dermal contact with the substances on a non-
occupational basis. However, on a per person basis, the potential
amounts involved in these exposures are negligible in comparison to
potential exposure through the dietary route. Moreover, substances that
occur naturally in food, including the pesticidal substances that are
the subject of the proposed exemption, are unlikely to cross the
barrier provided by the skin and thus the responses seen on rare
occasions to substances in food are most likely to be localized skin
irritations. Whether these irritations are caused by the pesticidal
substance component of plant-pesticides is unknown but given the
thousands of constituents of any food of plant origin, the probability
that substances other than the plant-pesticides are the irritants is
very high. Because substances present in food are unlikely to pass
through the skin, dermal exposures are not additive to dietary
exposures.
With regard to exposure through inhalation, the pesticidal
substances may in some cases be present in pollen and some individuals
(those near enough to farms, nurseries or other plant-growing areas to
be exposed to wind-blown pollen) may be exposed, through inhalation, to
the pollen. On a per person basis, the potential amounts of pollen
involved in these exposures are negligible in comparison to potential
exposure through the dietary route. Moreover, it is unlikely that
exposure to the pollen is equivalent to exposure to the pesticidal
substance. The pesticidal substance will not in every case be present
in the pollen. When it is present in pollen, the pesticidal substance
will be integrated into the tissue of the pollen grain. EPA cannot rule
out the possibility that in some cases, the pesticidal substance or
some piece of the pesticidal substance might be bound to the surface of
the pollen grain (as opposed to the more likely circumstance of the
substance being within the pollen grain). If the substance is bound to
the surface of the pollen, lung or respiratory tract tissue in humans
might be exposed to the pesticidal substance. Substances that occur
naturally in pollen, including the pesticidal substances that are the
subject of the proposed exemption, are unlikely to cross the barrier
provided by the mucous membrane of the respiratory tract and thus are
not additive to dietary exposure.
EPA also evaluated potential non-occupational exposures in drinking
water. As noted in the preceding paragraphs, the substances in plants
or parts of plants, including the pesticidal substances that are the
subject of the proposed exemption (59 FR 60535), are produced inside
the plant itself. The pesticidal substances are integrated into and an
integral part of the living tissue of the plant. When the plant dies or
a part is removed from the plant,
[[Page 27139]]
microorganisms colonizing the tissue immediately begin to digest it,
using the components of the tissue (including any pesticidal substances
in the tissue) as building blocks for making their own tissues or for
fueling their own metabolisms. The pesticidal substances that EPA
proposed to exempt are subject to the same processes of degradation and
decay that all organic matter undergoes. This turnover of biochemical
materials in nature through a process of degradation occurs fairly
rapidly. Therefore, these pesticidal substances do not persist in the
environment or bioaccumulate. There is no indication that naturally
occurring plant biochemical compounds, including the pesticidal
substances that are the subject of the proposed exemption, are
resistant to this degradation. Because of the fairly rapid turnover of
these substances, even if they reach surface waters (through pollen
dispersal or parts of the plants (leaves, fruits etc.) falling into
bodies of water), they are unlikely to present anything other than a
negligible exposure in drinking water drawn from surface water sources.
Should they resist degradation long enough to enter groundwater, they
are unlikely to present anything other than a negligible exposure in
drinking water drawn from groundwater. Therefore, although a potential
for non-dietary exposure (i.e., non-food oral, dermal and inhalation)
in non-occupational settings may exist, EPA expects such exposure to be
negligible.
With regard to exposure to ``other related substances,'' EPA is not
aware of any other substances that may be related, via a common
mechanism of toxicity, to the pesticidal substances that are the
subject of the proposed exemption (59 FR 60535), other than related
substances that are present in parts of plants used as food. Thousands
of substances are present in the edible parts of plants. These may
include substances related, via a common mechanism of toxicity, to the
pesticidal substances that are the subject of the proposed exemption.
These related substances have long been accepted as part of the human
diet. Extensive use and experience show the safety of foods containing
these substances. It also shows the safety of these substances consumed
in aggregate through the dietary route with the pesticidal substances
that are the subject of the proposed exemption. With regard to non-
occupational exposure through routes other than dietary exposure, no
evidence, in the many years of human experience with the growing and
consumption of food from plants that may contain substances that may be
related via a common mechanism of toxicity to the pesticidal substances
that are the subject of the proposed exemption, indicates that adverse
effects due to aggregate exposure through the dietary, non-food oral,
dermal and inhalation routes occurs.
Should EPA in the future identify substances related via a common
mechanism of toxicity to the pesticidal substances that are the subject
of the proposed exemption, FIFRA and the FFDCA provide the Agency
adequate authority to take appropriate action to address any risks
associated with those related substances. Substances that are isolated
from the plant's tissues, concentrated and then applied topically as
pesticides to the plant or to food would not be covered by the proposed
exemption (59 FR 60535), but would be subject to the tolerance
requirements of FFDCA.
Because the Agency already considered exposure to the pesticidal
substances that are the subject of the proposed exemption (59 FR 60535)
and to substances related via a common mechanism of toxicity to these
pesticidal substances in food when it issued the proposal, it is not
requesting additional comment on this topic. Comments are requested
only on the issue of whether there are additional substances outside
that food supply that are related, via a common mechanism of toxicity,
to residues of the pesticidal substances that are the subject of the
proposed exemption and the effects of exposure to any such substances
on human health.
7. Sensitivities of subgroups. In 1994, EPA considered available
information on the sensitivities of subgroups as it pertains to the
pesticidal substances derived from sexually compatible plants in the
proposal (59 FR 60535) and has summarized the evaluation in Unit IV.A.
of this supplemental notice.
8. Naturally occurring estrogen or other endocrine effects. FFDCA
now directs EPA, in establishing an exemption from the requirement of a
tolerance, to consider ``such information as the Administrator may
require on whether the pesticide chemical may have an effect in humans
that is similar to an effect of a naturally occurring estrogen or other
endocrine effect'' (21 U.S.C. 346(a)(q)). Congress allowed EPA 2 years
to establish a screening program to determine whether certain pesticide
chemicals may have estrogenic effects and an additional year to
implement the program (21 U.S.C. 408(p)). As part of the screening and
implementation process, EPA is determining what information might be
required and how it will address estrogenic effects from pesticide
residues in general.
While there is some information on estrogenic effects from exposure
to certain pesticides, the data are limited. It is known that certain
food plants contain estrogen mimics, termed phytoestrogens. Such
phytoestrogens are currently being consumed by humans in food derived
from plants. EPA cannot rule out the possibility that such
phytoestrogens could be used as plant-pesticides. Potential exposure of
humans via consumption of plant tissue to phytoestrogens exerting
estrogenic effects and used as plant-pesticides may need to be
considered when the issue of endocrine disruptors is examined by EPA.
If dietary exposure to phytoestrogens (that are also plant-pesticides)
is discovered to be a significant factor, the Agency will re-examine
this proposed exemption from the requirement of a tolerance (59 FR
60535) in light of that information.
9. Safety factors. In the 1994 proposal, EPA did not rely on the
available animal data in reaching its determination that a tolerance is
not necessary to protect the public from pesticidal substances derived
from sexually compatible plants (59 FR 60535). As discussed in Unit
IV.A. of this supplemental notice, EPA relied on the long history of
safe human consumption of the pesticidal substances that are the
subject of the proposed exemption in food from sexually compatible
plant populations and in food derived from animals that consume forage
and other crops (e.g., corn and other grains). EPA continues to believe
that long-term evidence of human consumption, not animal
experimentation data, is the appropriate information base for the
proposed exemption (59 FR 60535). Because EPA did not rely on animal
experimentation data, the Agency did not consider which safety factors
would be appropriate to use in assessing risk to humans based on data
generated through experiments on animals.
10. Infants and children.--a. Dietary consumption patterns. In the
1994 proposal (59 FR 60535), EPA considered available information on
the dietary consumption pattern of infants and children as pertains to
the pesticidal substances derived from sexually compatible plants and
has summarized the evaluation in Unit IV.A. of this supplemental
notice. The range of foods consumed by infants and children is in
general more limited than the range of foods consumed by adults. Most
newborns rely on milk products for nutrition, although some infants are
fed soy based products. Infants begin as early as 4-months of age to
consume
[[Page 27140]]
specific types of solid foods containing residues of pesticidal
substances that are the subject of the proposed exemption. Subsequent
to 4 months of age, apart from processing to facilitate swallowing, the
diets of infants are based on foods consumed by the general adult
population albeit in different proportions. As infants and children
mature, more and more of the foods normally consumed by adults become
part of their diets and the relative proportions of the different types
of food consumed changes to more closely resemble an adult diet.
b. Special susceptibility. In the 1994 proposal (59 FR 60535), EPA
considered available information on the potential for susceptibility of
infants and children, including pre- and post-natal toxicity, as these
factors pertain to the pesticidal substances derived from sexually
compatible plants and has summarized the evaluation in Unit IV.A. of
this supplemental notice.
c. Cumulative effects of residues with other substances with a
common mechanism of toxicity. In the 1994 proposal (59 FR 60535), EPA
examined the available information on the cumulative effect of residues
of pesticidal substances derived from sexually compatible plants as
well as other substances in food that may have a common mechanism of
toxicity. The Agency's consideration in the proposal of the effects of
the residues of pesticidal substances that are the subject of the
proposed exemption (59 FR 60535) for the general population also
included consideration of effects for infants and children. See Unit
IV.B.5. of this supplemental notice for a discussion of cumulative
effects of the pesticide chemical residues and other substances that
have a common mechanism of toxicity.
Because EPA already considered the safety of food containing
residues of pesticidal substances derived from sexually compatible
plants and other constituents of food when it issued the proposal (FR
60535), the Agency is not requesting additional comment on that topic.
Comments are requested only on the new issue of whether there are any
substances outside of the food supply with a common mechanism of
toxicity to the residues of the pesticidal substances that are the
subject of the proposed exemption and the effects of any such
substances on infants and children.
d. Margin of safety. In determining whether the residues of the
pesticidal substances that are the subject of the proposed exemption
(59 FR 60535) are safe, FFDCA section 408(b)(2)(C) directs EPA to apply
a tenfold margin of safety for the residues and other sources of
exposure to infants and children to account for potential pre- and
post-natal toxicity and completeness of data on threshold effects with
respect to exposure and toxicity to infants and children, unless a
different margin will be safe. In proposing the exemption, EPA based
its assessment of exposure and toxicity upon reliable information (Ref.
1) including the long history of safe human consumption of food
containing residues of the pesticidal substances that are the subject
of the proposed exemption and other substances in food that may have a
common mechanism of toxicity, and the unique nature of plant-
pesticides. EPA did not rely on animal data. EPA relied on observations
concerning whole food consumption by humans and did not rely on single
entity testing, wherein substances are isolated from a plant source,
and fed to animals at high concentrations (Ref. 1). EPA relied on the
vast experiential base of actual food consumption patterns rather than
limited testing situations. EPA thus, did not utilize animal or other
studies that would yield data that could be subjected to an additional
margin of safety. (See Units IV.A. and IV.B.3. of this supplemental
notice). As a result, the FQPA amendments to FFDCA do not affect EPA's
analysis.
C. Safety Determinations in Light of FFDCA Amendment
Based on the information discussed in the 1994 proposals (59 FR
60496 through 60547), the discussion in Unit IV.A. and the analysis in
Unit IV.B. of this supplemental notice, EPA concludes that there is a
reasonable certainty that no harm will result to the U.S. population in
general, and U.S. infants and children, from aggregate exposure to
residues of pesticidal substances derived from sexually compatible
plants, including all anticipated dietary exposures and all other
exposures for which there is reliable information. Under the proposed
exemption from the requirement for a tolerance (59 FR 60535), EPA would
exempt residues of pesticidal substances that are normally components
of (not new to) food from plants in sexually compatible populations.
Extensive use and experience show the safety of foods containing these
substances. No evidence, in the many years of human experience with the
growing and consumption of food from plants containing the pesticidal
substances that are the subject of the proposed exemption (59 FR
60535), indicates that adverse effects due to aggregate exposure
through the dietary, non-food oral, dermal and inhalation routes occur.
The conclusion that residues of pesticidal substances derived from
sexually compatible plants should be exempt from tolerance requirements
under the FFDCA section 408 safety standard also lends support to EPA's
proposed FIFRA exemption (59 FR 60519) for plant-pesticides derived
from sexually compatible plants with respect to human dietary risks. In
the FIFRA proposal, EPA utilized two criteria to determine whether
plant-pesticides should be exempt: (1) Whether they posed a low
probability of risk, and (2) whether they caused unreasonable adverse
effects on the environment. Based upon the determination that residues
of pesticidal substances subject to the proposed exemption (59 FR
60535) and the nucleic acid component of plant-pesticides (59 FR 60542)
meet the FFDCA section 408 safety test, EPA concludes plant-pesticides
derived from sexually compatible plants would pose only a low
probability of human dietary risk and also would not pose an
unreasonable adverse effect with respect to such risks.
D. Other Considerations
When the Agency proposed to establish an exemption from the
requirement of a tolerance for residues of pesticidal substances
derived from sexually compatible plants (59 FR 60535), EPA did not
propose any numerical limitation on the amount of pesticidal substance
that could be present in food containing these residues. EPA consulted
in 1994 with the Department of Health and Human Services (DHHS) in
developing the proposed exemption (59 FR 60535) and this supplemental
notice and will consult with the Secretary of HHS prior to issuing the
final rule. Because the 1994 proposal was for the exemption from the
requirement of a tolerance, the Agency has concluded that an analytical
method for detecting and measuring the levels of the residues of the
subject pesticidal substances in or on food is not required.
V. Comments
A. Confidential Business Information
Information submitted as comments concerning this supplemental
notice may be claimed confidential by marking any part or all of that
information as ``Confidential Business Information'' (CBI). CBI should
not be submitted through e-mail. Information marked as CBI will not be
disclosed except in accordance with procedures set forth in
[[Page 27141]]
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.
B. 30-Day Comment Period
EPA is allowing a 30-day comment period because it has determined
that such a period will provide the public with an adequate opportunity
to respond to the additional issues raised in this supplemental notice.
FFDCA and FIFRA do not specify a comment period for this type of
notice. EPA has decided that a 30-day comment period is reasonable
because this supplemental notice raises very few new issues that were
not already available for public comment. As discussed in Unit IV. of
this supplemental notice, EPA effectively considered most of the
factors required by the FQPA amendments of FFDCA and FIFRA relevant to
the proposed exemptions when it issued the proposed package of notices
describing EPA's approach in 1994 (59 FR 60496, 60519, 60535, 60542 and
60545). At that time, the public had an opportunity to review both the
Agency's rationale for the proposals and the underlying support
documents during a 90-day public comment period. Only a limited number
of new issues have been raised by the FQPA amendments to FFDCA and
FIFRA and the Agency continues to rely upon the information already in
the docket for the 1994 proposals and thus 30 days should provide
adequate time for public comment. In addition, EPA believes that it is
in the interest of the public to publish the final exemption from the
requirement of a tolerance in a timely manner.
C. Request for Comments
Interested persons are invited to submit written comments on the
new issues raised in this supplemental notice specifically on:
(1) Whether there are substances, outside of the food supply,
sharing a common mechanism of toxicity with pesticidal substances that
are derived from sexually compatible plants. Commenters are asked to
submit information on the cumulative effects of such substances and the
pesticidal substances that are the subject of the proposed exemption
(59 FR 60535).
(2) Whether there are substances, outside of the food supply,
related via a common mechanism of toxicity to pesticidal substances
that are derived from sexually compatible plants, to which humans might
be exposed through non-occupational routes of exposure. Commenters are
asked to describe routes through which such exposure might occur,
including exposure to major identifiable subgroups of human populations
(e.g., infants and children). If such routes are identified, commenters
are requested to provide information on the nature and levels of the
expected exposure.
Entities may also offer comments on issues V.C.1. and V.C.2. above
as they apply to Option 2 as described in the November 23, 1994 Federal
Register (59 FR at 60537) ``Plant-pesticides derived from plants within
the same genus or from sexually compatible plants'' under the revised
FFDCA section 408 safety standard. The Agency will not consider
comments that address issues or information already presented for
public comment in the proposed rule issued in the November 23, 1994,
Federal Register.
Commenters who possess information on substances occurring in food
that may have estrogenic effects and may be used as plant-pesticides
are requested to send such information to EPA.
In this supplemental notice, EPA describes in greater detail the
rationale supporting the statement made in the 1994 Federal Register
(59 FR at 60513) that ``plant-pesticides are likely to present a
limited exposure of pesticidal substances to humans. In most cases, the
predominant, if not the only route of exposure will be dietary.
Significant respiratory and dermal exposures will be unlikely.'' No
comments were received on this statement during the official comment
period. Commenters may comment on this more detailed rationale.
In this supplemental notice, EPA also describes in greater detail
how the rationale presented in the 1994 Federal Register (59 FR at
60538) concerning the safety for human consumption of food from plants
that meet the sexually compatible standard applies to infants and
children. No comments were received on this statement during the
official comment period. Commenters may comment on this more detailed
rationale specifically addressing infants and children as part of the
larger human population.
VI. Public Docket
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket control
number ``OPP-300368A'' (including comments and data submitted
electronically as described below). 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 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The official rulemaking record is located at the address in
``ADDRESSES'' at the beginning of this document.
Electronic comments can be sent directly to EPA at:
opp-docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comment and data
will also be accepted on disks in Wordperfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket control number ``OPP-300368A.'' Electronic
comments on this supplemental notice may be filed online at many
Federal Depository Libraries.
VII. References
(1) International Food Biotechnology Council, 1990. Biotechnologies
and food; Assuring the safety of foods produced by genetic
modification. In: Regulatory Toxicology and Pharmacology. Vol 12.
Academic Press, New York.
VIII. Regulatory Assessment Requirements
This supplemental notice merely seeks additional comments on the
proposed rules with regard to the potential impact that the new
statutory amendments imposed by the August 3, 1996 Food Quality
Protection Act (FQPA) might have on the provisions as proposed. As
such, this notice does not contain any new proposed requirements that
would require additional consideration by the Office of Management and
Budget (OMB) under Executive Order 12866, entitled Regulatory Planning
and Review (58 FR 51735, October 4, 1993) or the Paperwork Reduction
Act (PRA), 44 U.S.C. 3501 et seq. It does not require any other action
under Executive Order 12875, entitled Enhancing the Intergovernmental
Partnership (58 FR 58093, October 28, 1993), Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.). The
Agency's activities related to these regulatory assessment requirements
are discussed in the proposed rules.
EPA did not consider Title II of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Pub. L. 104-4) at the proposal stage because the
proposed rules were
[[Page 27142]]
issued prior to its enactment. Although this supplemental notice is not
subject to UMRA because it neither proposes or finalizes any regulatory
requirements, the applicability of the UMRA requirements will be
addressed in the final rules.
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: May 7, 1997.
Lynn R. Goldman
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 97-12784 Filed 5-15-97; 8:45 am]
BILLING CODE 6560-50-F
