Plant-Pesticides; Viral Coat Proteins; Supplemental Notice of Proposed Rulemaking

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300367A; FRL-5716-6]

RIN 2070-AC02

Plant-Pesticides; Viral Coat Proteins; 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 the proposed 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 and used as plant-pesticides in plants or

plant parts used as raw agricultural commodities. 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 viral coat

proteins produced in plants as part of a plant-pesticide 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 viral coat proteins produced in plants as part of a

plant-pesticide. EPA believes that it considered most of the

substantive issues associated with the FQPA amendments when it issued

the proposal 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 that proposal.

DATES: Comments, identified by the docket number ``OPP-300367A,'' must

be received on or before June 16, 1997.

considered most of the

substantive issues associated with the FQPA amendments when it issued

the proposal 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 that proposal.

DATES: Comments, identified by the docket number ``OPP-300367A,'' 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 VI. of this document. No Confidential

Business Information (CBI) should be submitted through e-mail.

FOR FURTHER INFORMATION CONTACT: 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:

[email protected].

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 `` . .

n 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 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 viral coat proteins produced in plants as part of a plant-

pesticide. For pesticidal substances in this category, many years of

human experience with consumption of food containing plant viruses

suggest that these pesticidal substances present negligible risk.

Specifically, EPA proposed that ``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'' (59

FR at 60547).

This supplemental notice addresses the coat protein portion of the

plant-pesticide 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 this supplemental notice may

also affect EPA's final determination on a proposed exemption under

FIFRA (59 FR at 60535) for plant-pesticides that are coat proteins from

plant viruses.

EPA is publishing this supplemental notice 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 a tolerance for

residues of viral coat proteins produced in plants as part of a plant-

pesticide

ant-pesticides that are coat proteins from

plant viruses.

EPA is publishing this supplemental notice 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 a tolerance for

residues of viral coat proteins produced in plants as part of a plant-

pesticide. 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 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 60545) 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 residues of

viral coat proteins produced in plants as part of a plant-pesticide,

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

s produced in plants as part of a plant-pesticide,

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

lation

(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))

so

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

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

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 mechanism of toxicity (21 U.S.C. 346a(b)(2)(C) and (c)(2)(B)).

III. Summary of Proposed Rule

In the November 23, 1994 Federal Register, EPA proposed to exempt

from

the requirement of a tolerance coat proteins from plant viruses, or

segments of such proteins when these proteins, or segments of these

proteins, are produced in plants for the purpose of protecting plants

against viral disease. Coat proteins are those substances that viruses

produce to encapsulate and protect their genetic material. When the

genetic material encoding 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 infections by

virus strains closely related to the donor virus). This resistance is

termed viral coat protein mediated resistance or vcp-mediated

resistance.

IV. Risk Assessment and Safety Determinations

A. Risk Assessment in Proposal

rotein 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 infections by

virus strains closely related to the donor virus). This resistance is

termed viral coat protein mediated resistance or vcp-mediated

resistance.

IV. Risk Assessment and Safety Determinations

A. Risk Assessment in Proposal

EPA's rationale for its 1994 proposal for an exemption from the

requirement of a tolerance for viral coat proteins was based on the

following points: (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, including children and infants, 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 segment of the coat protein which will be expressed in the

plant. The coat protein or a segment of the coat protein 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 when consumed at rates currently

found in the food supply.

In developing its regulatory approach for plant-pesticides, EPA

requested the advice of a subpanel, composed of experts in the relevant

scientific disciplines, 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

food supply.

In developing its regulatory approach for plant-pesticides, EPA

requested the advice of a subpanel, composed of experts in the relevant

scientific disciplines, 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.''

As described in the proposed regulation (59 FR 60545), entire

infectious particles of the plant viruses, 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, 2, 3, and 4). For

example, 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

th 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. In

general, 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. 1, 2, and 5). Intact, infectious,

whole plant viruses, therefore, are not infectious to humans, including

children and infants. Given that the complete virus is not infectious

to vertebrates, it is reasonable to assume that a noninfectious

subcomponent (i.e., a coat protein or a segment of a coat protein) of

the virus would not be hazardous to humans or animals.

B. Risk Assessment in Light of Amendment to FFDCA

, infectious,

whole plant viruses, therefore, are not infectious to humans, including

children and infants. Given that the complete virus is not infectious

to vertebrates, it is reasonable to assume that a noninfectious

subcomponent (i.e., a coat protein or a segment of a coat protein) of

the virus would not be hazardous to humans or animals.

B. Risk Assessment in Light of Amendment to FFDCA

After EPA issued its proposed exemption from the requirement of a

tolerance for viral coat proteins produced in plants as part of a

plant-pesticide (59 FR 60545), 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 viral coat proteins produced in

plants as part of a plant-pesticide, or segments of such proteins, 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 viral coat proteins, or

segments of such proteins, produced in plants as part of a plant-

pesticide 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.

This supplemental notice also identifies the factors that were not

considered in the proposal

as part of a plant-

pesticide 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.

This 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

viral coat proteins produced in plants as plant-pesticides.

1. Available data. EPA considered in 1994, the validity,

completeness and reliability of the available data with regard to coat

proteins from plant viruses in the proposals (59 FR 60519 and 60545)

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 viral coat proteins produced in plants as part

of a plant-pesticide in the proposals (59 FR 60519 and 60545) 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 viral coat proteins produced in plants as part of a plant-

pesticide when it issued the proposals (59 FR 60519 and 60545) 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

d 60545) 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. Because knowledge of human

consumption of food from virus infected crop plants (as well as meat

and milk products derived from animals eating such plants) was

available and adequately addressed the issues of hazard and exposure,

the Agency did not use, for the proposed exemption (59 FR 60545), data

generated in the laboratory through animal testing.

4. Dietary consumption patterns. EPA considered in the 1994

proposal the available information on the varying dietary consumption

patterns of major identifiable consumer subgroups as it pertains to

consumption of food from virus infected 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. EPA has examined the available information on

the cumulative effect of consuming virus infected plants and other

substances in plants that may have a common mechanism of human

toxicity. EPA summarizes this information and its analysis in Unit

IV.A. of this supplemental notice.

Viral coat proteins are nontoxic proteins widespread in food. They

have not been associated with toxic or pathogenic effects to animals or

humans. Because viral coat proteins in foods have no known human

toxicity, no cumulative effects can be identified for viral coat

proteins produced in plants as part of a plant-pesticide

ormation and its analysis in Unit

IV.A. of this supplemental notice.

Viral coat proteins are nontoxic proteins widespread in food. They

have not been associated with toxic or pathogenic effects to animals or

humans. Because viral coat proteins in foods have no known human

toxicity, no cumulative effects can be identified for viral coat

proteins produced in plants as part of a plant-pesticide. FQPA also

directs the Agency to examine whether there are other substances that

have a common mechanism of toxicity with residues of viral coat

proteins produced in plants as part of a plant-pesticide. Based on

available information which indicates that viral coat proteins in food

have no human toxicity, EPA is not aware of any other substances that

might have a common mechanism of human toxicity with residues of viral

coat proteins produced in plants as part of a plant-pesticide.

Experience with residues of viral coat proteins in the current food

supply gives no indication of human or animal toxicity. If information

becomes available that indicates this finding is not appropriate, EPA

will consider the validity of the new information and act to amend this

tolerance exemption as needed.

EPA is not aware of any substances outside of the food supply that

may have a common mechanism of toxicity with residues of viral coat

proteins produced in plants as part of a plant-pesticide since viral

coat proteins are not toxic to humans or animals.

EPA considered the safety of foods containing residues of viral

coat proteins when it issued the proposal and is not requesting

additional comment on that topic. Comments are only requested on EPA's

conclusion that there are no substances outside of the food supply that

may have a cumulative toxic effect with residues of viral coat proteins

produced in plants as part of a plant-pesticide.

6. Aggregate exposures including non-occupational exposures

viral

coat proteins when it issued the proposal and is not requesting

additional comment on that topic. Comments are only requested on EPA's

conclusion that there are no substances outside of the food supply that

may have a cumulative toxic effect with residues of viral coat proteins

produced in plants as part of a plant-pesticide.

6. Aggregate exposures including non-occupational exposures. EPA

has considered the available information on the aggregate exposure

level of consumers to viral coat proteins produced in plants as part of

a plant-pesticide in the 1994 FFDCA and FIFRA proposals (59 FR 60519

and 60545). This included a consideration of exposures from dietary

sources (59 FR 60545) 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 EPA's policy statement (59 FR 60496) 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 residues of viral coat proteins produced in plants as part

of a plant-pesticide in the proposed FFDCA exemption (59 FR 60545) and

summarized its evaluation in Unit IV.A. of this supplemental notice.

Despite EPA's belief that, because of the nature of viral coat

proteins produced in plants as part of a plant-pesticide, 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

FR 60545) and

summarized its evaluation in Unit IV.A. of this supplemental notice.

Despite EPA's belief that, because of the nature of viral coat

proteins produced in plants as part of a plant-pesticide, 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, viral coat proteins produced in plants as

part of a plant-pesticide 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

viral coat proteins produced in plants as part of a plant-pesticide,

are unlikely to cross the barrier provided by the skin.

With regard to exposure through inhalation, viral coat proteins

produced in plants as part of a plant-pesticide 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. It is unlikely that exposure to the pollen is

equivalent to exposure to viral coat proteins produced in plants as

part of a plant-pesticide

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. It is unlikely that exposure to the pollen is

equivalent to exposure to viral coat proteins produced in plants as

part of a plant-pesticide. When present in pollen, the viral coat

proteins produced in plants as part of plant-pesticides will likely be

integrated into the tissue of the pollen grain and not likely to be

bound to the surface of the pollen grain. Pollen grains and the

substances that occur naturally in pollen are unlikely to cross the

barrier provided by the mucous membrane of the respiratory tract and

thus are not additive to dietary exposure. Some viruses are transmitted

by wind-borne vectors, i.e., pollen or fungal spores and individuals

near enough to farms, nurseries or other plant-growing areas to be

exposed to these wind-blown vectors may be exposed, through inhalation,

to the whole virus particle. Since no evidence suggests that exposure

to whole plant viruses borne by wind-blown pollen or fungal spores

results in adverse effects, it is unlikely that exposure to pollen that

may contain viral coat proteins produced in plants as part of a plant-

pesticide would result in adverse effects.

EPA also evaluated potential non-occupational exposures in drinking

water. As noted in the preceding paragraphs, most substances in plants

or parts of plants, including viral coat proteins produced in plants as

part of a plant-pesticide, are found only inside the plant itself.

Viral coat proteins produced in plants as part of a plant-pesticide are

an integral part of the living tissue of the plant

lso evaluated potential non-occupational exposures in drinking

water. As noted in the preceding paragraphs, most substances in plants

or parts of plants, including viral coat proteins produced in plants as

part of a plant-pesticide, are found only inside the plant itself.

Viral coat proteins produced in plants as part of a plant-pesticide are

an integral part of the living tissue of the plant. When the plant dies

or a part is removed from the plant, microorganisms colonizing the

tissue immediately begin to digest it, using the components of the

tissue (including viral coat proteins produced in plants as part of a

plant-pesticide) as building blocks for making their own tissues or for

fueling their own metabolisms. Viral coat proteins, or segments of

these proteins, produced in plants as part of a plant-pesticide 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,

viral coat proteins produced in plants as part of a plant-pesticide do

not persist in the environment or bioaccumulate. There is no indication

that naturally occurring plant biochemical compounds, including viral

coat proteins produced in plants as part of plant-pesticides, are

particularly resistant to this degradation. Because of the rapid

turnover of these substances, even if they reach surface waters, they

are unlikely to present anything other than a very negligible exposure

in drinking water drawn from either surface or ground water sources.

Therefore, the potential for non-dietary exposure (i.e., non-food oral,

dermal and inhalation) in non-occupational settings is limited and EPA

expects such exposure to be negligible

id

turnover of these substances, even if they reach surface waters, they

are unlikely to present anything other than a very negligible exposure

in drinking water drawn from either surface or ground water sources.

Therefore, the potential for non-dietary exposure (i.e., non-food oral,

dermal and inhalation) in non-occupational settings is limited and EPA

expects such exposure to be negligible.

With regard to exposure to ``other related substances,'' EPA is not

aware of any other substances either in food or outside the food supply

that may be related, via a common mechanism of toxicity, to viral coat

proteins produced in plants as part of a plant-pesticide since viral

coat proteins are not toxic to humans or animals. With regard to non-

occupational exposure through routes other than dietary exposure, since

viral coat proteins are not toxic, EPA is not aware of substances

outside the food supply that may be related via a common mechanism of

toxicity to the viral coat proteins produced in plants as part of a

plant-pesticide. No evidence indicates that adverse effects due to

aggregate exposure of viral coat proteins with such substances through

the dietary, non-food oral, dermal and inhalation routes occurs.

EPA considered exposure to residues of viral coat proteins produced

in plants as part of a plant-pesticide when it issued the proposal and

is not requesting additional comment on that topic. Comments are only

requested on EPA's conclusion that there are no substances outside of

the food supply that are related, via a common mechanism of action, to

residues of viral coat proteins produced in plants as part of a plant-

pesticide for which EPA must consider exposure in aggregate with viral

coat proteins.

7. Sensitivities of subgroups. In 1994, EPA considered available

information on the sensitivities of subgroups as it pertains to viral

coat proteins produced in plants as part of a plant-pesticide in the

proposal (59 FR 60545). The Agency's evaluation is summarized in Unit

IV.A

in plants as part of a plant-

pesticide for which EPA must consider exposure in aggregate with viral

coat proteins.

7. Sensitivities of subgroups. In 1994, EPA considered available

information on the sensitivities of subgroups as it pertains to viral

coat proteins produced in plants as part of a plant-pesticide in the

proposal (59 FR 60545). The Agency's evaluation is summarized 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.

There is some information on estrogenic effects by exposure to

pesticides but the data are limited and do not pertain to viral coat

proteins. Based on available information concerning the presence of

viruses in the food supply with no detectable adverse human health

effects, EPA does not expect viral coat proteins expressed in plants as

part of a plant-pesticide to cause estrogen or other endocrine effects.

If EPA becomes aware of a potential for estrogenic or endocrine effect

from exposure to viral coat proteins produced in plants as part of a

plant-pesticide, EPA will reexamine this tolerance exemption in light

of that information.

9. Safety factors

effects, EPA does not expect viral coat proteins expressed in plants as

part of a plant-pesticide to cause estrogen or other endocrine effects.

If EPA becomes aware of a potential for estrogenic or endocrine effect

from exposure to viral coat proteins produced in plants as part of a

plant-pesticide, EPA will reexamine this tolerance exemption 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 viral coat proteins produced

in plants as part of a plant-pesticide (59 FR 60545). As discussed in

Unit IV.A. of this supplemental notice, EPA relied on the long history

of safe human consumption of food containing plant viruses and

consumption of food derived from animals that consume forage and other

crops (e.g., corn and other grains) that are also likely to contain

plant viruses. 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 60545). 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 60545), EPA considered available information on

the dietary consumption pattern of infants and children as it pertains

to viral coat proteins in food 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

etary consumption pattern of infants and children as it pertains

to viral coat proteins in food 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 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. Since plant viruses are ubiquitous in

plant foods, EPA concluded that infants and children are exposed as

part of a normal diet to viral coat proteins. There is no evidence that

such exposure leads to any harm.

b. Special susceptibility. In the 1994 proposal (59 FR 60545), EPA

considered available information on the potential for susceptibility of

infants and children, including pre- and post-natal toxicity, as these

factors pertain to viral coat proteins produced in plants as part of a

plant-pesticide. There is no scientific evidence that viral coat

proteins as a component of food would have a different effect on

children than

the 1994 proposal (59 FR 60545), EPA

considered available information on the potential for susceptibility of

infants and children, including pre- and post-natal toxicity, as these

factors pertain to viral coat proteins produced in plants as part of a

plant-pesticide. There is no scientific evidence that viral coat

proteins as a component of food would have a different effect on

children than

they would on the adult population. EPA summarizes its analysis of the

effect of consumption in food of viral coat proteins on human health 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 60545), EPA

examined the available information on the cumulative effect of residues

of viral coat proteins produced in plants as part of a plant-pesticide

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 viral coat proteins produced in plants as part of a

plant-pesticide on 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 viral

coat proteins and other substances that have a common mechanism of

toxicity.

EPA considered the safety of foods containing residues of viral

coat proteins when it issued the proposal and it is not requesting

additional comment on that topic. Comments are only requested on EPA's

conclusion that there are no substances outside of the food supply that

may have a cumulative toxic effect with residues of viral coat proteins

produced in plants as part of a plant-pesticide.

d. Margin of safety

afety of foods containing residues of viral

coat proteins when it issued the proposal and it is not requesting

additional comment on that topic. Comments are only requested on EPA's

conclusion that there are no substances outside of the food supply that

may have a cumulative toxic effect with residues of viral coat proteins

produced in plants as part of a plant-pesticide.

d. Margin of safety. In determining whether the residues of viral

coat proteins produced in plants as part of a plant-pesticide 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 including the long history of

safe human consumption of food containing residues of viral coat

proteins produced in plants as part of a plant-pesticide and other

substances in food, 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 animals are exposed to high concentrations of substances

isolated from a plant source. EPA relied on the vast base of the human

experience with actual food consumption rather than limited testing

situations involving exposure to high concentrations of viral coat

proteins. 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.

situations involving exposure to high concentrations of viral coat

proteins. 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 viral coat proteins produced in plants as part of a plant-

pesticide, 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 60545), EPA would

exempt residues of viral coat proteins produced in plants as part of a

plant-pesticide. 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 viral coat proteins, indicates that adverse effects due to

aggregate exposure through the dietary, non-food oral, dermal and

inhalation routes occur.

The conclusion that residues of viral coat proteins produced in

plants as part of a plant-pesticide should be exempt from tolerance

requirements under the FFDCA section 408 safety standard also lends

support to one of EPA's proposed FIFRA exemptions (59 FR 60519) with

respect to human dietary risks: plant-pesticides that are coat proteins

from plant viruses (59 FR at 60535)

ion routes occur.

The conclusion that residues of viral coat proteins produced in

plants as part of a plant-pesticide should be exempt from tolerance

requirements under the FFDCA section 408 safety standard also lends

support to one of EPA's proposed FIFRA exemptions (59 FR 60519) with

respect to human dietary risks: plant-pesticides that are coat proteins

from plant viruses (59 FR at 60535). 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 viral coat proteins (59

FR 60545) and the nucleic acid component of a plant-pesticide (59 FR

60542) meet the FFDCA section 408 safety test, EPA concludes viral coat

proteins produced in plants as part of a plant-pesticide 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 viral coat proteins produced in plants

as part of a plant-pesticide (59 FR 60545), EPA did not propose any

numerical limitation on the amount of viral coat proteins 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 and this supplemental notice, and will consult with

the Secretary of HHS prior to issuing the final rule. Because the 1994

proposal was an 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 viral coat proteins in or on

food is not required.

V. Comments

A. Confidential Business Information

nd this supplemental notice, and will consult with

the Secretary of HHS prior to issuing the final rule. Because the 1994

proposal was an 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 viral coat proteins in or on

food is not required.

V. Comments

A. Confidential Business Information

Information submitted as a comment 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 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 raise 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

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) EPA's conclusion that there are no substances outside of the

food supply that may have a cumulative toxic effect with residues of

viral coat proteins produced in plants as part of a plant-pesticide.

(2) EPA's conclusion that there are no substances outside of the

food supply that are related via a common mechanism of toxicity to

residues of viral coat proteins produced in plants as part of a plant-

pesticide to which humans might be exposed through non-occupational

routes of exposure.

Commenters who possess information on viral coat proteins causing

estrogenic effects 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

ogenic effects 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 for

viral coat proteins.

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 containing

viral coat proteins applies to infants and children. No comments were

received on this rationale 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-300367A'' 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:

n 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:

[email protected]

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-300367A.'' Electronic

comments on this supplemental notice may be filed online at many

Federal Depository Libraries.

VII. References

(1) Gibbs, A. and B Harrison. 1976. Plant Virology: The Principles,

Chap. 1. J. Wiley Sons, New York.

(2) Matthews, R.E.F. 1981. Plant Virology. Chaps. 12, 16, and 19.

Second edition, Academic Press, New York.

(3) Provvidenti, R., R.W. Robinson, and H.M. Munger. 1984.

Occurrence of Zucchini Yellow Mosaic Virus in Curcubits from

Connecticutt, New York, Florida and California, Plant Disease 68:443-

446.

(4) 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.

on, and H.M. Munger. 1984.

Occurrence of Zucchini Yellow Mosaic Virus in Curcubits from

Connecticutt, New York, Florida and California, Plant Disease 68:443-

446.

(4) 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.

(5) 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.

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 issued prior to its enactment

ons (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 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. 97-12785 Filed 5-15-97; 8:45 am]

BILLING CODE 6560-50-F