2378 Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Notices

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–300409; FRL–4991–9]

The Pesticide Coordination Policy;

Response to Petitions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Response to Petition.

SUMMARY: This notice completes EPA’s

response to a petition filed by the

National Food Processors Association

and others in 1992 and additionally

responds to a second petition filed by

the same parties in 1995. The 1992

petition sought the repeal or revision of

several EPA policies and interpretations

related to how EPA coordinates actions

under its various statutory authorities

over pesticide residues in food. EPA has

decided not to alter significantly its

general policy of taking all applicable

legal authorities into account in ruling

on a pesticide use. The 1995 petition

urged EPA to rapidly complete its

response to the 1992 petition. By

publishing this notice EPA has met that

request.

FOR FURTHER INFORMATION CONTACT: By

mail: Jean Frane, Policy and Special

Projects Staff (7501C), Environmental

Protection Agency, 401 M St. SW.,

Washington, DC 20460. Office location,

telephone number, and e-mail address:

Rm. 1113I, Crystal Mall #2, 1921

Jefferson Davis Highway, Arlington, VA,

703-305-5944, e-mail:

frane.jean@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

I. Introduction

In Les v. Reilly, 968 F.2d 985 (9th Cir.

1992), cert. denied, 113 S.Ct. 1361

(1993), the Ninth Circuit U.S. Court of

Appeals held that the Delaney anticancer clause in the food additives

provision of the Federal Food, Drug, and

Cosmetic Act (FFDCA) was not subject

to an exception for pesticide uses which

pose a de minimis cancer risk. Prior to

the decision becoming final, in

September 1992, food processors and

growers filed a petition with EPA

challenging a number of policies and

interpretations relating to how EPA

implements its authority under the

FFDCA. The petition proposes policies

and interpretations that would reduce

the impact of the Les decision. EPA

issued a partial response to the petition

on June 14, 1995 (60 FR 31300) (June

1995 NFPA Response), and this notice

completes EPA’s response. Following

the June 1995 NFPA Response, the same

food processors and growers filed a

second petition urging a prompt

response to the entirety of its 1992

petition and raising various other issues.

This second petition is addressed in this

document as well.

II. Background

A. Statutory Background

Pesticide residues in human and

animal food in the United States are

regulated under provisions of the

FFDCA and the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA). The interplay between sections

402, 408 and 409 of the FFDCA and, to

a more limited extent, between the

FFDCA and FIFRA, have created a

complex and sometimes contradictory

statutory framework underlying residue

regulation in food.

Before a pesticide may be sold or

distributed, it must be registered under

FIFRA. 7 U.S.C. 136 et seq. To qualify

for registration, a pesticide must, among

other things, perform its intended

function without causing ‘‘unreasonable

adverse effects on the environment.’’ 7

U.S.C. 136a(c)(5). The term

‘‘unreasonable adverse affects on the

environment’’ is defined as ‘‘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.’’ 7 U.S.C. 136(bb).

The FFDCA, 21 U.S.C. 301 et. seq.,

authorizes the establishment by

regulation of maximum permissible

levels of pesticides in foods. Such

regulations are commonly referred to as

‘‘tolerances.’’ Without such a tolerance

or an exemption from the requirement

of a tolerance, a food containing a

pesticide residue is ‘‘adulterated’’ under

section 402 of the FFDCA and may not

be legally moved in interstate

commerce. 21 U.S.C. 331, 342.

Monitoring and enforcement of

pesticide tolerances are carried out by

the U.S. Food and Drug Administration

(FDA) and the U.S. Department of

Agriculture (USDA).

The FFDCA has separate provisions

for tolerances for pesticide residues on

raw agricultural commodities (RACs)

and for residues on processed food. For

pesticide residues in or on RACs, EPA

establishes tolerances, or exemptions

from tolerances when appropriate,

under section 408. 21 U.S.C. 346a. EPA

regulates pesticide residues in

processed foods under section 409

which pertains to ‘‘food additives.’’ 21

U.S.C. 348. Maximum residue

regulations established under section

409 are commonly referred to as food

additive tolerances or food additive

regulations (FARs). Section 409 FARs

are needed, however, only for certain

pesticide residues in processed food.

Under section 402(a)(2) of the FFDCA,

a pesticide residue in processed food

generally will not render the food

adulterated if the residue results from

application of the pesticide to a RAC

and the residue in the processed food

when ‘‘ready to eat’’ is below the RAC

tolerance set under section 408. This

exemption in section 402(a)(2) is

commonly referred to as the ‘‘flowthrough’’ provision because it allows the

section 408 raw food tolerance to flow

through to the processed food form.

Thus, a section 409 FAR is only

necessary to prevent foods from being

deemed adulterated when the

concentration of the pesticide residue in

a processed food when ‘‘ready to eat’’ is

greater than the tolerance prescribed for

the RAC, or if the processed food itself

is treated or comes in contact with a

pesticide.

To establish a tolerance regulation

under section 408, EPA must find that

the regulation would ‘‘protect the public

health.’’ 21 U.S.C. 346a(b). In reaching

this determination, EPA is directed to

consider, among other things, the

‘‘necessity for the production of an

adequate, wholesome, and economical

food supply.’’ Id. Prior to establishing a

food additive tolerance under section

409, EPA must determine that the

‘‘proposed use of the food additive

[pesticide], under the conditions of use

to be specified in the regulation, will be

safe.’’ 21 U.S.C. 348(c)(3). Section 409

specifically addresses the safety of

carcinogenic substances in the so-called

Delaney clause which provides that ‘‘no

additive shall be deemed safe if it has

been found to induce cancer when

ingested by man or animal or if it is

found, after tests which are appropriate

for the evaluation of the safety of food

additives, to induce cancer in man or

animal. . . .’’ Id. Although EPA has

interpreted the general standard under

section 408 to require a balancing of

risks and benefits, where a pesticide

which is an animal or human

carcinogen is involved, the section 409

Delaney clause, in contrast to section

408 and FIFRA, explicitly bars such

balancing no matter how infinitesimal

the potential human cancer risk. Les v.

Reilly, 968 F.2d at 989.

B. Coordination of the Statutory

Provisions Governing Pesticides

EPA regulations in 40 CFR 152.112(g)

specify that FIFRA registrations for

food-use pesticides will not be approved

until all necessary tolerances and food

additive tolerances have been obtained.

As a policy matter, EPA has taken a

similar approach to FFDCA sections 408

and 409, not granting section 408
Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Notices 2379

tolerances until needed section 409

FARs have been granted.

EPA describes this linkage of its

statutory authorities as its coordination

policy. Basically, EPA’s coordination

policy is an expression of EPA’s intent

to take into account all of the applicable

provisions governing pesticides in

taking action under any one of the three.

EPA’s view has been that it should not

be approving pesticide uses under one

of the three provisions if an approval

needed under one of the other

provisions cannot be obtained.

Inextricably related to the

coordination policy is EPA’s

concentration policy. The concentration

policy establishes the criteria as to when

approval is needed for food-use

pesticides under FFDCA section 409,

and hence the Delaney clause. Prior to

the June 1995 NFPA Response, EPA

used a ‘‘concentration in fact’’ standard

as the test of whether a use needs a

section 409 FAR. The concentration in

fact standard was met and a FAR

deemed necessary if a processing study

shows that the level of pesticide residue

in the processed food exceeds the level

of residue in the precursor raw

agricultural commodity. In its June 1995

NFPA Response, EPA modified its

concentration policy by recognizing

that: (1) Data and information other than

processing studies are relevant to the

question of whether a section 409 FAR

is needed to prevent the adulteration of

processed food, and (2) the ready-to-eat

criterion in the flow-through proviso

had to be considered in making

determinations as to the need for section

409 FARs.

III. The NFPA Petitions

On September 11, 1992, the National

Food Processors Association (NFPA),

the United Fresh Fruit and Vegetable

Association, the Florida Fruit and

Vegetable Association, the Northwest

Horticultural Council and the Western

Growers Association filed a petition

with EPA challenging the policies

followed by EPA in linking its

regulatory activities under the various

pesticide provisions of FIFRA and

FFDCA. (Petition to the Environmental

Protection Agency Office of Pesticide

Programs Concerning EPA’s Pesticide

Concentration Policy (1992))

(hereinafter cited as ‘‘NFPA petition’’).

The NFPA petition explicitly attacks

what it calls EPA’s ‘‘concentration

policy.’’ In actuality, the petition is a

challenge to two interrelated policies

described by EPA as its coordination

and concentration policies. With respect

to the coordination policy, the NFPA

petition argues that the coordination

policy is both unlawful and

unnecessary. The petition requests that

the EPA coordination policy be repealed

so that section 408 tolerances can

remain in effect (or can be established)

for pesticide uses even when, under the

Les decision, the associated section 409

FARs have to be revoked (or cannot be

established).

EPA sought public comment on the

petition (58 FR 7470; February 5, 1993).

Extensive public comment was received

and significant comments are discussed

in this notice. Following the June 1995

NFPA Response, the main issue in the

NFPA petition that remains to be

addressed is the coordination policy.

On July 10, 1995, NFPA filed a second

petition (NFPA Petition II). This petition

sought a quick decision on the

coordination policy and raised two

additional issues. First, the petition

reiterated arguments made by NFPA in

comments filed on its original petition

that pesticide residues in processed

food exceeding the applicable section

408 tolerance fall under section 406 of

the FFDCA and not section 409. Second,

NFPA asked that EPA rapidly

implement the revised policies in the

June 1995 NFPA Response and

contended that the FFDCA barred EPA

from revoking any FARs on Delaney

clause grounds prior to reexamining the

need for the FARs under the revised

concentration policy.

IV. Summary of EPA Response to NFPA

Petition

Unit V. of this document sets forth

EPA’s response to the NFPA petition

regarding EPA’s coordination policy.

EPA has decided to retain its

coordination policy largely intact. EPA

believes that it has a fundamental

responsibility to avoid inconsistent

action under its statutory authorities

and that this responsibility is best met

by its coordination policy. Legally-used

pesticides should not result in illegal

food. However, EPA is willing to

consider an exception to a coordination

approach to avert severe economic

disruption if other steps are feasible to

prevent adulterated processed food from

entering commerce. EPA rejects NFPA’s

argument that any needed tolerances for

pesticide residues in processed food

should be set under section 406 rather

than section 409.

By publishing this notice, EPA has

met the central request of NFPA Petition

II—that EPA make a decision regarding

the coordination policy. This notice also

responds to the other issues in that

petition. As noted above, EPA rejects

the contention that pesticide residues in

processed food should be regulated

under section 406. Additionally, in Unit

VI. of this document EPA explains that

as a policy matter it intends to examine

whether, for tolerances for which a

proposed revocation on Delaney clause

grounds is pending, revocation on the

basis of its revised concentration policy

is appropriate. However, EPA also

makes clear that it disagrees with

NFPA’s suggestion that such a course is

required by the statute.

V. Coordination of Authorities under

FIFRA and FFDCA

A. Coordination Policy

EPA’s coordination policy represents

EPA’s attempt to apply its various

statutory mandates on pesticides in a

consistent fashion. It is based on the

rationale that actions approved under

one statute or one provision of one

statute should not lead to illegal

consequences under another provision.

Simply put, if farmers use a pesticide

lawfully on their crops, the food made

from those crops should not be rendered

illegal because of the presence of

pesticide residues. The coordination

policy predates the existence of EPA

and can be traced back at least to 1963

when Congress recognized that USDA

and FDA coordinated their actions

under FIFRA and FFDCA, respectively.

S. Rep. No. 573, 88th Cong., 1st Sess. 2-

3, 9-10 (1963). In fact, the drafters of

section 408 actually suggested that

government action on pesticides under

FIFRA and FFDCA should be

coordinated. S. Rep. 1635, 83rd Cong.,

2d Sess. 3 (1954). Congress, however,

has never codified this policy except to

the limited extent it has required that

tolerances be in place before states may

grant special local need registrations

under FIFRA. 7 U.S.C. 136v(c)(3).

EPA has continued the FDA and

USDA practice of coordinating its action

under FIFRA and the FFDCA. By

regulation, EPA has made it a

requirement of FIFRA registration that

all ‘‘needed’’ tolerances under sections

408 and 409 be in place. 40 CFR

152.112(g); see 40 CFR 162.7(d)(3)(v)

(1976) (the predecessor to the current

regulation). Although not included in

any regulation, EPA has generally

followed a policy of not granting a

section 408 tolerance if a section 409

FAR is needed but has not been or

cannot be approved. 53 FR 41104, 41108

(October 19, 1988). EPA believes a

necessary corollary to this policy and

regulation is that if a needed tolerance

is revoked, all corresponding tolerances

and the registration should be removed

as well.

The original NFPA petition, as well as

many of the comments on the petition,

blurs the distinction between the

existence of the coordination policy and
2380 Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Notices

the criteria EPA follows in determining

when a food additive tolerance is

‘‘needed.’’ The criteria for when a food

additive regulation is needed are what

EPA describes as its concentration

policy. In the June 1995 NFPA

Response, EPA has addressed the

concerns expressed regarding its

concentration policy.

The main criticism of the

coordination policy by the NFPA

petition is that through this policy EPA

has ‘‘imported’’ the Delaney clause into

section 408 and FIFRA. EPA, the

petition asserts, has illegally ignored the

risk/benefit standard in FIFRA as well

as section 408’s requirement that EPA

set tolerances so as to ‘‘protect the

public health’’ taking into consideration

the ‘‘necessity for the production of an

adequate, wholesome, and economical

food supply.’’ However, NFPA did

acknowledge that ‘‘[u]nder some

circumstances revocation of a 409 FAR

may appropriately prompt

reexamination of the basis for the

counterpart section 408 tolerance, in

order to determine whether the raw

product tolerance remains consistent

with the statutory criteria prescribed in

section 408.’’ (Comments of the NFPA at

9 n.4)(emphasis in original).

A second legal objection to the

coordination policy raised by the NFPA

petition is that choosing a coordination

policy approach over a policy approach

which focuses on enforcement ‘‘stands

the flow-through provision on its head.’’

(NFPA Petition at 35). According to

NFPA, ‘‘[t]he EPA policy prohibits any

use of a pesticide on a crop if the

Delaney clause precludes issuance of a

section 409 food additive regulation for

the pesticide in the processed food,

regardless of whether processors can in

fact satisfy the conditions of the

proviso.’’ Id. at 36 (emphasis in

original). Finally, the NFPA petition

argues that the coordination policy is

inconsistent with FDA’s

contemporaneous interpretation of the

statute.

Taking a different view, the Natural

Resources Defense Council (NRDC), in

comments on the NFPA petition,

contends that the FFDCA mandates that

EPA follow a coordination policy.

Noting that section 408 requires

consideration of the ‘‘necessity for a

wholesome food supply’’ and ‘‘other

ways in which the consumer may be

affected by the same pesticide

chemical,’’ NRDC argues that for a

pesticide which concentrates above the

section 408 level, these requirements

bar establishment of a tolerance.

(Comments of NRDC at 11-12). NRDC

states that a use of a pesticide which

produces adulterated processed food

does not contribute to a ‘‘wholesome’’

food supply and that EPA is required to

consider that the pesticide produces

adulterated food by the ‘‘other ways in

which the consumer may be affected’’

clause.

1. The proper relationship of the

Delaney clause to FIFRA and FFDCA

section 408. EPA agrees with NFPA that

the Delaney clause is not a legal

standard directly governing section 408

tolerances or FIFRA registrations. See

Environmental Defense Fund v. HEW,

428 F.2d 1083, 1091 (D.C. Cir. 1970).

Nonetheless, EPA believes that in some

circumstances the Delaney clause affects

decisionmaking under FIFRA and

FFDCA section 408. EPA has an

obligation to attempt to construe its

statutory authorities governing the same

matters as harmoniously as possible.

EPA has construed FIFRA and FFDCA

sections 408 and 409 to be overlapping

in some respects, and EPA believes it is

appropriate, where an overlap is

identified, to give some weight to all

aspects of the statute, including the

Delaney clause.

There is an overlap between FIFRA

and FFDCA sections 408 and 409 where

approval of a pesticide use on raw food

under FIFRA or FFDCA section 408 can

lead to residues in processed food

which exceed the section 408 tolerance.

This overlap occurs because EPA takes

into account the exposure which results

from pesticide residue carryover to

processed food from application to the

raw food in considering registrations

under FIFRA and section 408 tolerances

for food-use pesticides. Thus, the

computer model EPA uses for dietary

risk assessment takes into account

potential residues in all forms of foods,

not just the actual raw crop to which the

pesticide is applied. EPA believes

considering pesticide exposure from all

food to be an essential part of its basic

statutory responsibility under FIFRA

and section 408 to evaluate the risk

posed by the specific pesticide use in

question. Given the broad statutory

standards in FIFRA (‘‘unreasonable

risk’’) and FFDCA section 408 (‘‘protect

the public health’’), it would be difficult

to describe consideration of all possible

residues as not in accordance with law

or arbitrary or capricious.

Having identified an overlap, the

question remains as to how the various

provisions are to be construed

harmoniously. EPA believes this is best

accomplished by treating the Delaney

clause as indicating that Congress had a

heightened concern for carcinogenic

pesticide residues in processed food

where those residues exceed the section

408 tolerance. Thus, EPA, in making the

risk/benefit balancing determination

called for under FIFRA and section 408

for a carcinogenic pesticide, takes into

account the likelihood that residues of

the pesticide will exceed the section 408

tolerance in processed food and the

added weight such overtolerance

residues are due in light of the Delaney

clause.

Additionally, in evaluating the

benefits provided by use of a pesticide

in the FIFRA and section 408 risk/

benefit decision, EPA must consider the

extent to which use of a pesticide could

result in adulterated food. Adulterated

food resulting from use of a pesticide

would decrease any benefits the

pesticide provided to society. Thus, the

Delaney clause’s effect of denying a FAR

for carcinogenic pesticides affects

benefits determinations as well as risk

evaluations under FIFRA and section

408.

Thus, EPA’s coordination policy does

not depend on writing the Delaney

clause into FIFRA and FFDCA section

408 but is based on interpretation of the

legal standards of FIFRA and section

408 and a consideration of the full range

of residues that may result from use of

a pesticide consistent with approval

under FIFRA and section 408.

Under EPA’s formulation of how the

Delaney clause is appropriately

considered in FIFRA and section 408

actions, there still remains a degree of

agency flexibility. In situations at the

extremes, either where there is evidence

showing that residues in processed food

would always exceed the section 408

tolerance or that such overtolerance

residues would never occur, EPA will

have little or no discretion. For

example, where the possibility of

residues exceeding the section 408

tolerance depends upon misuse of the

pesticide (and such misuse would

generally not be expected), EPA believes

its authority to revoke the section 408

tolerance associated with such a use and

cancel its FIFRA registration would be

limited. The opposite of course is true

as well: if data show that processed food

will always contain residues at levels

greater than the section 408 tolerance

level and that the raw crop is commonly

processed, EPA would have little

discretion over whether to establish or

continue the FIFRA use and FFDCA

section 408 tolerance. In circumstances

between these two extremes EPA has

more flexibility. For example, where

legal use patterns and normal

circumstances suggest a possibility of

overtolerance residues in more than a

trivial amount of processed food but the

probability of overtolerance residues is

low, EPA has two options.

One option, advocated by NFPA,

would be not to establish a food
Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Notices 2381

additive regulation, but leave the

section 408 tolerance in place and rely

on enforcement actions under the

statutory scheme as laid out in the flowthrough provision to police the food

supply. The second option would be to

follow a coordination policy such as

EPA’s present one which would call for

a revocation of the section 408 tolerance

and cancellation of the FIFRA

registration. Selecting between the two

requires balancing of a number of

factors including resource constraints,

public health considerations, industry

concerns regarding both flexibility and

certainty, agency credibility, effects on

the price and availability of food for

consumers, and impacts upon

agriculture. NRDC’s legal arguments do

not convince EPA that there is no room

for policy judgment in this area. NRDC’s

arguments appear to rely on the premise

that all processed food produced from a

particular crop would have pesticide

residues in excess of the section 408

tolerance.

EPA believes that several policy

factors weigh in favor of its coordination

policy. First, FDA has limited resources

for policing the food supply. The

difference in resource requirements

between charging FDA with finding

adulterated food already in the food

distribution system and requiring EPA

to make a pre-marketing judgment are

enormous. A pre-marketing judgment

can be made on a discrete data set but

after-the-fact policing of the food supply

involves sampling of food throughout

the country. The NFPA in instituting its

Protective Screen Program against

illegal residues has recognized the

limitations of relying on after-the-fact

monitoring. The NFPA’s Protective

Screen Program states that:

It is important to recognize that monitoring

or testing programs cannot serve as the sole

or even primary assurance that finished food

products will be free from illegal pesticide

residues. The emphasis must be on

preventing the occurrence of contamination

rather than reliance on its detection afterthe-fact. (NFPA Petition, App. B at 6).

Second, if EPA places primary

emphasis on an after-the-fact monitoring

scheme and thus FDA increasingly must

seize adulterated food, the public may

become unduly alarmed and as a

consequence avoid foods which are

critical to a healthy, well-balanced diet.

Third, NFPA has not adequately

explained how an after-the-fact

monitoring scheme could be enforced

other than through a massive expansion

of FDA’s sampling program. In fact, the

NFPA itself acknowledges that it relies

on EPA’s coordination policy (legal use

should result in legal food) as its

guiding premise in preventing

adulteration of food. The NFPA

Protective Screen Program provides:

The premise of the NFPA Protective Screen

Program is that if a pesticide is used legally

to produce a raw agricultural commodity,

then the resulting residue on the pesticide in

the food will be legal. Thus, the emphasis of

the program is on the prevention of illegal

pesticide uses and residues, as opposed to

detection after the fact. (NFPA Petition, App.

B at 1).

Finally, EPA must take into account,

as noted in comments by NRDC, that the

history of the FFDCA indicates a

congressional preference in favor of premarket clearance of potentially

deleterious substances rather than a

dependance on after-the-fact seizure of

adulterated food. See Ewig Bros., 502

F.2d at 720-21.

It is more difficult to weigh the risk

considerations relative to removing

specific pesticide uses from the market

under the coordination policy.

Independent of statutory constraints,

EPA’s judgment is that many uses that

would have to be revoked under the

coordination policy pose insignificant

risks. If the risks from these uses were

significant, EPA would likely be taking

action under FIFRA or FFDCA section

408. On the other hand, EPA cannot

ignore that such uses result in levels of

residues in processed food that Congress

has concluded, through passage of the

Delaney clause, should not be allowed.

EPA has also considered the potential

impacts on agriculture that could occur

from the loss of pesticide uses that a

coordination approach might cause. The

Economic Impact Analysis prepared by

EPA shows that, if the concentration

and coordination policies were left

intact, there could be substantial

impacts upon agriculture. The changes

EPA has made in its concentration and

ready-to-eat policies in the June 1995

NFPA response are expected to greatly

diminish the number of section 409

tolerances required and thus the number

of uses affected. In applying those

policies to a proposed revocation of

animal feed tolerances published in the

Federal Register of September 21, 1995

(60 FR 49142), EPA concludes that

almost half of the 36 FARs that were

potentially inconsistent with the

Delaney clause can be revoked as

unnecessary under EPA’s revised

concentration policy. Moreover, if

individual uses are affected, EPA

believes that the impacts on consumers

and agriculture will be minimal. As a

general matter, therefore, EPA

concludes that the various policy factors

weigh strongly in favor of following a

coordination policy.

EPA would emphasize that its choice

of a coordination approach is a policy

judgment and although, as a general

matter, EPA intends to adhere to this

approach, EPA cannot rule out the

possibility that in a given situation the

balance of factors supporting a

coordination policy may shift away

from a pre-market clearance procedure

and toward the more costly and

inefficient process of after-the-fact

enforcement. For example, application

of the coordination policy may result in

the cancellation of a use or group of

uses that is so central to the production

of a certain crop that the revocation of

that use or uses would severely disrupt

domestic production of that commodity

with attendant consequences to the

price and availability of food to the

consumer. In these circumstances, EPA

believes it may be appropriate to allow

an exception to the coordination policy.

EPA believes, however, that the

potential for excepting a pesticide use

from the coordination policy is slight.

EPA would only do so where a clear

showing of severe economic disruption

was made and that economic disruption

outweighs EPA concerns regarding an

after-the-fact monitoring scheme both

generally and as to the specific

commodity involved. One critical factor

here may be the ability of growers and

processors to provide information

demonstrating how an after-the-fact

monitoring program could feasibly be

implemented.

2. Alleged inconsistency with the

flow-through provision. A second legal

objection to the coordination policy

raised by the NFPA petition is that

choosing a coordination policy

approach over one which focuses on

enforcement ‘‘stands the flow-through

provision on its head.’’ (NFPA Petition

at 35). According to NFPA, ‘‘[t]he EPA

policy prohibits any use of a pesticide

on a crop if the Delaney clause

precludes issuance of a section 409 FAR

for the pesticide in the processed food,

regardless of whether processors can in

fact satisfy the conditions of the

proviso.’’ Id. at 36 (emphasis in

original).

When presented in this manner,

NFPA’s claim is overstated. The

coordination policy is based on the

rationale that data show that processing

of legally-treated crops under good

manufacturing practices may produce

adulterated food. If the NFPA is

concerned that EPA has failed to

consider whether food processors can

reduce residues in processed food below

the section 408 tolerance, this is not a

quarrel with the coordination policy so

much as with the EPA criteria as to

when a section 409 FAR is needed. EPA

believes the adjustments to its

concentration policy in the June 1995
2382 Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Notices

NFPA Response respond to NFPA’s

concerns on this issue.

Ultimately, however, there remains

the basic disagreement between EPA

and the views presented by NFPA in its

petition. EPA believes that it has an

important role to play at the pre-market

stage of pesticide regulation to ensure

that legally-treated crops produce legal

food. NFPA argues that pre-market

regulation by EPA is unnecessary—

growers and processors are capable of

insuring that residues in processed food

do not exceed the section 408 tolerance.

NFPA, however, presents no scheme for

enforcing such a system. In fact, as

noted above, NFPA itself has admitted

that generally an enforcement scheme

premised solely on after-the-fact

monitoring cannot work.

3. Contemporaneous interpretation. A

third legal objection to the coordination

policy raised by NFPA is that it departs

from FDA’s interpretation of the

relationship of sections 408 and 409

issued contemporaneously with the

passage of section 409. NFPA claims

that FDA in initially implementing

section 409 did not follow a policy of

requiring that a section 409 FAR for a

pesticide be established where there

was a possibility that residues of the

pesticide in processed food could

exceed the RAC tolerance. NFPA cites

no explicit statement of FDA policy to

support this claim; instead, NFPA relies

solely on inferences drawn from an FDA

regulation and FDA’s purported failure

to require food additive regulations in

situations where a coordination policy

allegedly would have dictated they be

established.

The FDA regulation cited by NFPA

contains an explanation of the flowthrough provision. NFPA places

particular emphasis on the following

example included in the regulation:

If fruit bearing a residue of 7 parts per

million of DDT, permitted on the raw

agricultural commodity is dried and a

residue in excess of 7 parts per million of

DDT results on the dried fruit, the

dehydrated fruit is adulterated unless the

higher tolerance for DDT is authorized by the

regulations in this part. 21 CFR 170.19

(originally adopted 24 FR 2434, March 29,

1959).

According to NFPA, this rather

straightforward explication of the flowthrough provision proves FDA did not

require food additive regulations where

concentration in the processed food was

a possibility because, if it had, the

situation described in the regulation

(processed food having residues above

the RAC tolerance and no section 409

FAR in place) could never occur. If the

situation could never occur, NFPA’s

logic runs, FDA would not have used it

as an example in its regulations.

EPA, however, does not believe the

FDA example is inconsistent with a

coordination policy approach. FDA’s

regulation is designed to explain the

operation of the flow-through provision.

It is difficult to see how FDA could

adequately explain that provision

without using an example similar to the

one chosen. Moreover, a mere

explanation of how statutory language

operates to render certain food

adulterated does not preclude the

existence of a policy designed to

prevent such adulteration from

occurring. The example remains

relevant even if a coordination policy is

in place. EPA’s coordination policy does

not guarantee that residues in processed

food will never exceed the section 408

tolerance. Rather, EPA attempts to

identify at the pre-marketing stage,

pesticide uses which may result in

residues in processed food greater than

the section 408 tolerance. In actual

practice, EPA’s premarketing judgment

may be incorrect and overtolerance

residues may occur in processed food.

FDA’s dried fruit example is consistent

with its responsibility to identify the

consequences of residues over the

section 408 tolerance in processed food

despite whatever policies FDA followed

to avoid that situation in the first place.

NFPA’s reliance on the nonexistence

of certain food additive regulations for

various registered pesticide uses is an

equally weak basis for NFPA’s claim

that FDA’s contemporaneous

construction rejected a coordination

approach to sections 408 and 409. NFPA

claims FDA could not have followed a

coordination policy because FDA issued

numerous RAC tolerances on foods

without establishing food additive

regulations despite the fact that these

foods (e.g., tomatoes) have processed

forms (e.g., tomato paste) in which

residues possibly could concentrate.

However, NFPA fails to mention that

FDA was setting section 409 FARs for

some processed foods as early as 1960

out of concern over concentrating

residues. See 25 FR 2076 (March 11,

1960); 25 FR 10570 (November 4, 1960);

27 FR 3694 (April 16, 1963). This is

consistent with EPA’s current practice

of requiring section 409 FARs only

where data on a specific pesticide use

show that residues concentrate when a

RAC is processed and thus there may be

residues over the section 408 tolerance

in the processed food. EPA has not, for

example, set section 409 FARs on

tomato paste for every pesticide that is

registered on tomatoes. Accordingly, the

fact that FDA did not set food additive

regulations on every processed food in

which residues could possibly

concentrate indicates little.

4. Segregation of crops. One other

significant issue raised in comments on

the NFPA petition relating to EPA’s

coordination policy was the argument

that a coordination policy was not

justified because farmers could

segregate crops between the fresh and

processed markets. EPA believes that

this argument is a valid criticism of the

coordination policy only if it could be

shown that segregation is generally

possible across the entire agriculture

industry. If not, claims that a specific

crop can be segregated relate solely to

the wisdom of applying the

coordination policy in a particular

instance rather than to the rationale for

the underlying coordination policy. EPA

believes that whether segregation can

occur for a specific crop is an issue best

examined on a case-by-case basis.

EPA believes that the comments it

received in response to the NFPA

petition demonstrate that segregation of

crops for fresh markets is not generally

possible. Those commenters most

aggressively asserting that segregation

was possible did not represent

agricultural interests but chemical

companies. Even among chemical

companies, such as the National

Agricultural Chemicals Association,

however, there was recognition that

market separation was not always a

possibility. Comments from growers, for

the most part, support EPA’s own

experience that in many instances

farmers do not and cannot know in

which market a crop will eventually be

sold. Although some growers

representing certain crops in specific

regions of the country claim in their

comments that market segregation is

possible in their unique circumstances,

comments from other growers

emphasize that a decision about

marketing is a product of factors beyond

their control. Comments to this effect

were received from the North Carolina

Farm Bureau, the California Tree and

Grape Association, Sun-Diamond Co.,

and an apple processor. Several

commenters, while noting the general

difficulty of market segregation and thus

their general approval of the

coordination policy, suggested that EPA

should grant exceptions to the policy

where the circumstances show

segregation possible (State of California,

Virginia Agriculture Department,

Florida Agriculture Department, Farmer

Cooperative).

As noted in the June 1995 NFPA

Response, EPA will consider whether

crops can be segregated between the

fresh and processed market on a case-
Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Notices 2383

by-case basis in deciding whether a

section 409 FAR is needed.

B. Regulation of Pesticides Under

Section 406

In comments that NFPA provided in

response to the notice published by

EPA, NFPA retreated in its challenge to

the coordination policy. Instead of

arguing that coordination by the Agency

of its various statutory authorities was

illegal, NFPA asserts that EPA’s real

error had been in construing section 409

to cover pesticides in processed food.

Pesticides in processed foods should be

regulated under FFDCA section 406,

NFPA argues, and it raises no objection

to EPA requiring section 406 tolerances

‘‘if there is a substantial likelihood that

an appreciable quantity of concentrated

processed food when ready to eat will

contain residues significantly in excess

of the raw product tolerance.’’

(Comments of NFPA at 32).

Response to this comment first

requires an explanation of section 406

in the FFDCA. Section 406 was enacted

in 1938 and was the original provision

in the FFDCA granting FDA tolerancesetting authority for pesticide residues

in food. It provides that FDA may set

tolerances for ‘‘poisonous or deleterious

substances added to food’’ where such

substances are required in the

production of food. 21 U.S.C. 346.

Section 406 was rendered obsolete for

pesticides in raw agricultural

commodities by the passage of section

408 in 1954. Congress in passing section

408, however, noted, in legislative

history, that pesticides in processed

foods were still to be governed under

section 406. With the passage of the

section 409 food additives provision in

1958, FDA, and, in turn, EPA, discerned

a change in congressional intent and

began to regulate pesticides in

processed food under section 409. The

principal basis for that interpretation

was the fact that the flow-through

provision of section 402, added in

connection with section 409, exempted

pesticide residues in processed food

that were below the appropriate RAC

tolerance from section 409. FDA and

EPA reasoned that Congress would not

have exempted such pesticide residues

from section 409 unless they would

have fallen within that provision in the

absence of the exemption provided by

section 402. That interpretation has

been upheld. United States v. Ewig Bros.

Co., Inc., 502 F.2d 715, 722 (7th Cir.

1974).

NFPA challenges that interpretation

relying on two statutory bases. First,

NFPA points to the definition of ‘‘food

additive’’ which specifically exempts

from the coverage of that term (1) ‘‘a

pesticide chemical in or on any raw

agricultural commodity;’’ and (2)

pesticide chemicals . . . used in the

production, storage, transportation of

raw agricultural commodities.’’ NFPA

argues that if these two exclusions are

not to be construed as redundant, the

latter must extend to pesticides in foods

other than RACs — i.e. pesticides in

processed foods. Second, NFPA notes

that the flow-through provision is

drafted so as to exclude pesticide

residues in processed foods below the

RAC tolerance not only from section 409

but from section 406 as well. Thus,

NFPA argues, the flow-through

provision, rather than providing a clear

signal that pesticides in processed foods

are food additives, is ambiguous on this

question.

The Ninth Circuit in Les v. Reilly

wrote that ‘‘the statute unambiguously

provides that pesticides which

concentrate in processed food are to be

treated as food additives . . . .’’ Les v.

Reilly, 968 F.2d at 989. Similarly, the

Seventh Circuit in United States v. Ewig

Bros. Co., Inc. 502 F.2d at 723, decision

found it ‘‘clear’’ that section 409

governed pesticide residues in

processed food. Even EPA, in arguing in

its Order adopting a de minimis

exception that there was considerable

confusion in Congress in 1958 regarding

whether section 409 would apply to

pesticides, noted that there is support

for the interpretation that pesticides in

processed foods are ‘‘food additives.’’

(February 25, 1991; 56 FR 7763) It must

be noted, however, that neither the

Ninth nor Seventh Circuits addressed

the exclusion in the food additive

definition for pesticides ‘‘used’’ in the

production of RACs or the references in

the flow-through provision to both

sections 406 and 409. Nonetheless, at

best, NFPA’s argument demonstrates no

more than a possible ambiguity as to

whether Congress intended pesticides in

processed foods to be regulated under

section 406 or 409. See 57 FR 20841

(May 12, 1992) discussing ambiguity in

the statute.

In circumstances where the ambiguity

of the statute allows for more than one

reasonable interpretation, the agency

charged with the administration of the

statute is entitled to considerable

deference on its policy judgment as to

which interpretation best furthers the

goals of the statute. Chevron v. NRDC,

467 U.S. 837, 842-843 (1984). FDA’s

judgment when section 409 was

enacted, as well as both FDA’s and

EPA’s operating premise for the last 37

years, has been that regulating

pesticides in processed food is best

accomplished under section 409.

Adopting NFPA’s section 406

approach would certainly be a step

backward in the evolution of the FFDCA

as an effective regulatory statute.

Section 406 was Congress’ first effort in

conferring tolerance-setting authority. It

had several weaknesses, one of which

was that for covered substances such as

pesticides, where FDA had not set a

tolerance, FDA could only successfully

remove a food containing pesticide

residues from commerce by proving

before a jury as a matter of fact that the

food was injurious to health. This

scheme was abandoned in sections 408

and 409 which make food containing a

pesticide or food additive adulterated as

a matter of law if there is no tolerance

established for the pesticide or food

additive. As the Seventh Circuit

recognized, if EPA were to return

pesticides in processed foods to the

jurisdiction of section 406, it ‘‘would

result in the anomaly that a chemical

such as DDT [for which there are no

tolerances] would adulterate all raw

fish, but adulteration of processed fish

would be determined on an uncertain

case-by-case basis.’’ Ewig Bros., 502 F.2d

at 722.

Certainly, the different standards in

sections 408 and 409 have made the

statutory scheme difficult to administer,

and the Delaney clause has the potential

of removing some beneficial pesticide

uses from the market even though these

uses appear to pose negligible human

cancer risks. By this policy statement,

the June 1995 NFPA Response, and

related actions, however, EPA will have

clarified to a large extent how it will

administer and coordinate action

between sections 408 and 409, which

should ease the administration of the

provisions. Further, the potentially

disruptive effect of the Delaney clause

on agriculture is uncertain. Thus, even

if NFPA is correct that Congress

expressed no clear intent on what

provision should govern pesticide

residues in processed food and therefore

EPA may regulate residues in processed

food under either section 406 or 409,

EPA declines to change from its current

practice of regulating such residues

under section 409 for the reasons stated

above.

VI. The Relationship of Decisions

Regarding the Need for Section 409

FARs and Delaney Clause

Determinations

The NFPA Petition II requests that

EPA implement its new concentration

policy as soon as possible by initiating

revocation proceedings for all section

409 FARs now deemed unnecessary.

The petition asserts that such revocation

proceedings are likely to be less
2384 Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Notices

resource intensive than revocations

based on the Delaney clause. Further,

the petition claims that EPA is barred by

the FFDCA from revoking a FAR under

the Delaney clause or any other safetyrelated grounds prior to reevaluating

under its revised concentration policy

whether the FAR is necessary.

As a policy matter, EPA generally

agrees that it makes sense to revoke

FARs, where appropriate, as

unnecessary rather than to litigate the

difficult science questions involved in

an induce cancer finding. For that

reason, EPA has consistently revoked

FARs that otherwise were barred by the

Delaney clause on lack of need grounds

where it was clear that such grounds

supported revocation. (See mancozeb on

raisins, June 30, 1994; 59 FR 33694, and

trifluralin on mint, July 28, 1995; 60 FR

38781.) However, EPA strongly

disagrees with NFPA’s suggestion that

the statute has established a hierarchy of

grounds for the revocation of FARs that

subordinates the public health concerns

embodied in the safety standard in

section 409 to a determination of

whether residues above the section 408

tolerance are expected. After reviewing

the legal arguments put forward by

NFPA, EPA concludes they are without

basis.

NFPA’s argument is as follows:

As a matter of law, EPA is precluded from

applying the Delaney clause to pesticides

that come within the provisions of the flowthrough proviso in section 402(a)(2). That

proviso flatly prohibits EPA from

determining that an agricultural pesticide in

a processed food is ‘‘unsafe,’’

notwithstanding the provisions of section

409, if the residue has been removed to the

extent possible in good manufacturing

practice and the concentration of the residue

in the processed food when ready to eat is

not greater than the raw commodity

tolerance. Yet, if EPA were to revoke a

section 409 tolerance because the pesticide is

found to induce cancer within the meaning

of the Delaney clause, the statutory basis of

that action would necessarily be that the

pesticide is ‘‘unsafe’’ under the terms of

section 409 and section 402(a)(2)(C). NFPA

Petition II at 3 (footnote omitted).

EPA agrees with NFPA that EPA

cannot declare a pesticide residue that

complies with the flow-through

provision ‘‘unsafe’’ as that term is used

in section 402(a)(2)(C). However, EPA

disagrees that revoking a section 409

FAR on safety grounds could have the

effect of rendering residues in

compliance with the flow-through

provision ‘‘unsafe’’ under section

402(a)(2)(C). Revocation of a FAR for

whatever reason can only affect residues

in food exceeding the section 408

tolerance. Residues in processed food

below the section 408 tolerance are, by

order of the flow-through provision, not

‘‘unsafe’’ within the meaning of section

409. EPA’s conclusion, in revoking a

FAR, that residues exceeding the section

408 tolerance do not meet the safety

standard in section 409(c) is not meant

to, and, for that matter, cannot change

the operation of the flow-through

provision as to residues below the

section 408 tolerance.

NFPA’s argument is based on two

fundamental misreadings of the statute.

First, NFPA apparently misunderstands

the relationship between section 409

FARs and section 402(a)(2)(C) including

the flow-through provision. NFPA

appears to believe that revocation of a

section 409 FAR somehow affects

residues governed by the flow-through

provision. Second, NFPA wrongly treats

as comparable the ‘‘unsafe’’

determination under section

402(a)(2)(C) and the safety finding

required in section 409(c) regarding the

establishment or revocation of FARs. A

correct reading of the statute on either

of these two points shows the flaw in

NFPA’s argument. Below, EPA has set

out in detail an explanation of the

proper interpretation of the

interrelationship between section 402

and section 409.

FARs for food additives, including

pesticide residues in processed food, are

established under section 409. Section

402(a)(2)(C) makes these FARs

enforceable by defining the

circumstances under which a food

containing a food additive is

adulterated.

The key to the operation of sections

402(a)(2)(C) and 409 is the statutory

phrase ‘‘unsafe within the meaning of

section 409.’’ Section 402(a)(2)(C)

declares that a food containing a food

additive is adulterated if the food

additive is ‘‘unsafe within the meaning

of section 409.’’ Subsection (a) of

section 409 reciprocates this

crossreference from section 402(a)(2)(C)

by stating:

[a] food additive shall . . . be deemed to

be unsafe for the purposes of the application

of clause (2)(C) of section 402(a), unless . .

. there is in effect, and it and its use or

intended use are in conformity with, a

regulation issued under this section . . . . 21

U.S.C. 348(a).

Thus, section 409(a) defines ‘‘unsafe

within the meaning of section 409’’ by

means of a mechanical per se rule — a

food additive is ‘‘unsafe’’ and renders

food adulterated unless the additive is

in compliance with a FAR and, where

no FAR exists, a food additive is

necessarily unsafe. The preeminence of

a FAR in adjudicating whether a food

additive is ‘‘unsafe’’ under section

402(a)(2)(C) is confirmed by the closing

sentence of section 409(a) which forbids

enforcement action against a food

additive under a substantive safety

standard (‘‘injurious to health’’) if a FAR

has been established.

Unlike the adulteration determination

under section 402(a)(2)(C), the process

for establishing, modifying, and

revoking FARs does involve substantive

safety determinations. Subsection (c) of

section 409 states FARs shall not be

promulgated unless ‘‘use of the food

additive, under the conditions of use to

be specified in the regulation, will be

safe . . . .’’ Subsection (c) then lists

numerous factors to be considered in

making this substantive safety

determination. 21 U.S.C. 348(c)(5).

The final wrinkle in the section 402/

409 scheme is the flow-through

provision in section 402(a)(2)(C). The

flow-through provision places an

important limitation on the application

of the per se ‘‘unsafe’’ rule of section

409(a) in situations where no FAR has

been established for a pesticide residue

in a processed food. The flow-through

provision specifies that pesticide

residues in processed foods are not

deemed unsafe within the meaning of

section 409 where, among other things,

such residues are in conformity with the

section 408 tolerance established for the

precursor raw agricultural commodity.

Thus, section 402(a)(2)(C) creates, in

essence, two regulatory zones for any

particular pesticide in food. The first

zone covers the range of residues from

zero up to the section 408 tolerance. The

second zone applies to all levels of

residue exceeding the section 408

tolerance. In the first zone, pesticide

residues are statutorily removed from

section 409(a)’s per se ‘‘unsafe’’ rule. In

the second zone, residues are per se

‘‘unsafe’’ and render food adulterated as

a matter of law (i.e. no particularized

safety finding required) unless EPA has

established a FAR finding such level of

residues to be substantively ‘‘safe’’

under section 409(c). Such FARS

permitting residues in zone two apply,

in effect, only to residues in zone two

because if a FAR is revoked, residues in

zone one would once again enjoy the

protection of the flow-through

provision.

Thus, it is clear that the revocation of

a FAR under the section 409(c) safety

standard only affects residues in

processed food above the section 408

tolerance (zone two residues) and not

residues within the flow-through

provision (zone one residues). This is

true even where residues of a pesticide

in processed food do not exceed the

section 408 tolerance. Whether or not

residues in fact exceed the section 408

tolerance, the presence of a section 409
Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Notices 2385

FAR legalizes such residues and

revocation of the FAR can do nothing

more than remove the allowance for

such overtolerance residues. NFPA has

offered no explanation for how the

factual circumstances surrounding the

residue levels of a certain pesticide

could serve to rewrite the statutory

provisions governing the legal effect of

the revocation of a FAR.

Further, it is also clear that the safety

finding under section 409(c) is entirely

distinct from the ‘‘unsafe’’

determination under section

402(a)(2)(C). Section 409(c) involves a

substantive safety evaluation, section

402(a)(2)(C) is a mechanical test for

adulteration which involves nothing

more than evaluating compliance with a

FAR. Although a lack of safety finding

under section 409(c) has an effect on

how the mechanical ‘‘unsafe’’ test under

section 402(a)(2)(C) will operate as to

residues in zone two (once a FAR is

revoked residues in zone two become

‘‘unsafe’’ as a matter of law), such a

finding would have absolutely no legal

effect on residues in zone one. Thus,

NFPA is wrong to treat the lack of safety

finding under section 409(c) as

equivalent to a section 402(a)(2)(C)

‘‘unsafe’’ determination.

Unwittingly, NFPA’s attempt to blur

the distinction between the

determinations in the FAR-setting

process and the FAR enforcement

process threatens to undermine

Congress’ carefully constructed scheme

for the regulation of food additives and

several other substances (pesticides in

raw foods, new animal drugs, and color

additives) which are regulated under the

FFDCA under an identical scheme. As

it now stands, section 402(a)(2) imposes

a straightforward test: a pesticide, food

additive, new animal drug, or color

additive renders a food adulterated

unless the present of the substance is

consistent with a tolerance or use

regulation promulgated under the

applicable section of the FFDCA. If,

however, the ‘‘unsafe’’ determination

under section 402(a)(2)(C) has a

substantive safety component, as

advocated by NFPA, FFDCA tolerance

or use regulations potentially lose their

status as the ultimate arbiter over

whether a food is adulterated. The

consequence would be that proof that a

food containing pesticide residues not

in compliance with a FAR would not

necessarily suffice to justify seizure of

the food by FDA; nor would a showing

that residues of a pesticide in food are

within the FAR necessarily protect the

food from a finding of adulteration. This

lack of clarity concerning the legality of

the residues of pesticides, food

additives, new animal drugs, and color

additives serves neither the public nor

the regulated community. For this

reason alone, NFPA’s argument would

have to be rejected.

In sum, NFPA’s argument that EPA is

legally barred from revoking a FAR on

safety grounds prior to revisiting the

need for the FAR has no basis in the

statute. The premise of NFPA’s

argument — that the revocation of a

FAR on safety grounds somehow

automatically overrides the flowthrough provision — is conceptually

flawed. EPA has never claimed that its

administrative determinations under

section 409(c) disable the statutory

command in the flow-through provision

and NFPA has supplied no reasonable

argument as to why such EPA

determinations should have such effect.

If a section 409 FAR is revoked on safety

grounds, EPA will have to evaluate

whether the corresponding section 408

tolerance, and the protection it provides

to certain residues in processed food,

should remain in place. However, the

determination on the section 408

tolerance, as explained in Unit V. of this

document, will turn on the safety

standard in section 408 and not

automatically follow from any safety

finding under section 409(c).

VII. Potential Impacts on Agriculture

Related to EPA’s Coordination and

Concentration Policies

In connection with its response to the

NFPA petition, EPA conducted an

Economic Impact Assessment as to

potential impacts on agricultural

producers as a result of continuation of

EPA’s existing policies without change.

The assessment concluded that the total

economic impact on affected producers

could be as high as $500 million. The

assessment concluded that some

potentially significant impacts could

occur on a small number of crops, but

only three crops are estimated to incur

impacts greater than 5 percent of their

annual 1989-91 U.S. production value

(pineapple 29%, sugarcane 13%, and

grapes 5.1%). Absolute projected

impacts were highest for sugarcane,

grapes, potatoes, rice, and apples, which

together comprised about 70 percent of

total impacts projected.

For various reasons, however, the

assessment presents a worst-case

scenario and actual impacts are

expected to be far less. The assessment

did not take into account the changes in

EPA’s coordination and concentration

policies adopted in this document and

the June 1995 NFPA Response; rather, it

assumed that all pesticide uses

identified as potentially affected by the

Delaney clause and EPA’s coordination

policy would be cancelled. As the

recent proposed revocation of animal

feed regulations (September 15, 1995; 60

FR 49142) illustrates, these revised

policies have already reduced the

number of uses potentially affected. Nor

did the assessment consider other

factors expected to mitigate impacts: (1)

Only currently registered alternatives

were assumed to be available for

substitution, whereas FIFRA sec. 18

exemptions and section 24(c)

registrations for alternative pesticides

could avert significant impacts; (2) any

cancellations of uses are likely to be

phased in over several years rather than

immediately and simultaneously.

Until new policy definitions and

parameters are fully implemented, the

extent of impact mitigation due to

recent policy modifications cannot be

predicted but the decrease in potential

impacts is expected to be significant.

EPA will update its Economic Impact

Analysis when it evaluates remaining

uses potentially affected by the Delaney

clause.

VIII. Regulatory Assessment

Requirements

Under Executive Order 12866 (58 FR

51735, October 4, 1993), it has been

determined that this policy statement is

a ‘‘significant regulatory action’’ because

this action may raise novel policy issues

arising out of legal mandates. As such,

this action was submitted to the Office

of Management and Budget for review

and any comments or changes have

been documented in the public record.

This action reaffirms existing policy and

has no direct adverse impacts on any

entity, including small entities. I

therefore certify that this policy

statement does not require a separate

Impact Analysis under the Regulatory

Flexibility Act.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Feed

additives, Food additives, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: January 19, 1996.

Lynn R. Goldman,

Assistant Administrator for Prevention,

Pesticides and Toxic Substances.

[FR Doc. 96–1212 Filed 1–22–96; 3:59 pm]

BILLING CODE 6560–50–F