Pesticides; Feed Additive Regulation Revocations

SUMMARY: EPA has made determinations regarding 36 feed additive

regulations (FARs) for 16 pesticides in animal feeds that were

previously reported as potentially inconsistent with the Delaney clause

in section 409 of the Federal Food, Drug and Cosmetic Act (FFDCA). EPA

is proposing to revoke 34 animal feed FARs because they are not needed

to prevent adulterated food, and two additional animal feed FARs

because they violate the Delaney clause.

DATES: Written comments, identified by the document control number

[OPP-300397], must be received on or before December 19, 1995.

ADDRESSES: By mail, submit comments to: Public Response Section, Field

Operations Division (7506C), Office of Pesticide Programs,

Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.

In person, bring comments to: OPP Docket, Public Information Branch,

Field Operations Division, Rm. 1132, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA. The telephone number for the OPP docket is

(703)-305-5805. Information submitted as a comment concerning this

document may be claimed confidential by marking any part or all of that

information as ``Confidential Business Information'' (or CBI).

Information so marked will not be disclosed except in accordance with

procedures set forth in 40 CFR part 2 and in section 10 of the Federal

Insecticide, Fungicide and Rodenticide Act (FIFRA). For questions

related to disclosure of materials, contact the OPP Docket at the

telephone number given above. A copy of the comment that does not

contain CBI must be submitted for inclusion in the public record.

Information not marked confidential may be disclosed publicly by EPA

without prior notice. All written comments will be available for public

inspection in the OPP Docket, Rm. 1132, at the Virginia address given

above, from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal

holidays.

Comments and data may also be submitted electronically by sending

electronic mail (e-mail) to: [email protected]. Electronic

comments must be submitted as an ASCII file avoiding the use of special

characters and any form of encryption. Comments and data will also be

accepted on disks in WordPerfect in 5.1 file format or ASCII file

format. All comments and data in electronic form must be identified by

the docket number [OPP-300397]. No Confidential Business Information

(CBI) should be submitted through e-mail. Electronic comments on this

proposed rule may be filed online at many Federal Depository Libraries.

Additional information on electronic submissions can be found below in

this document.

FOR FURTHER INFORMATION CONTACT: By mail: Niloufar Nazmi, Special

Review and Reregistration Division (7508W), Environmental Protection

Agency, 401 M St., SW., Washington, DC, 20460. Office location and

telephone number: Crystal Station #1, 2800 Crystal Drive, Arlington,

VA. Telephone: 703-308-8010; e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents:

I. Introduction

II. Background

A. Statutory Background

B. Regulatory Background

III. Revised Agency Policies, Guidelines, and Legal

Interpretations

A. Concentration and ``Ready to Eat'' Policies

B. Guidelines on Significant Animal Feeds

C. DES Proviso

IV. Decision Framework

A. Significant Animal Feed

B. Concentration Policy Including RTE

V. EPA's Decisions

A. Food Additive Regulation is not Needed

B. Food Additive Regulation is Needed

C. Induce Cancer Call for Pesticides that Need 409s

D. DES Proviso

VI. Proposed Rules

A. Proposed Revocations: FAR Is Not Needed

B. Proposed Revocations: Violates Delaney Clause

VII. Consideration of Comments

VIII. Executive Order 12866

IX. Regulatory Flexibility Act

X. Paperwork Reduction Act

I. Introduction

In this document, EPA examines whether 36 FARs for 16 pesticides in

animal feeds should be revoked, either because the FAR is inconsistent

with the Delaney clause in section 409(c)(3) of the FFDCA or because

the FAR is not needed to prevent adulterated feed under current Agency

policies and guidelines. For those FARs which EPA determines should be

revoked, EPA is in this document proposing revocation.

EPA concludes that the Delaney clause affects few of the FARS

involved in this document, primarily because of revised Agency policies

and guidelines governing when FARs are required to prevent adulterated

animal feed. Although a combination of factors are responsible for this

result, perhaps the most significant point is that the FARs in this

document involve animal feeds. For example, almost half of the 36 FARs

were judged unnecessary because EPA concluded that the animal feeds in

question were not a significant portion of the livestock diet.

EPA will in the near future be making decisions concerning the fate

of a number of FARs for processed human foods. EPA proposals are

pending to revoke human food FARs for 11 pesticides covering 32 uses.

The policies announced in the Agency's June 14, 1995 response to the

National Food Processors' Association (NFPA) petition have been

instituted, and EPA has begun to review the effects of those policies

on its earlier proposals. EPA has not completed this analysis and so

its results are uncertain, but the Agency believes that the effects of

its policy changes will not be as dramatic for human, as opposed to

animal, foods. For example, in general EPA has concluded that most

processing byproducts used as animal feeds are not ready to eat;

processed human foods are not as obviously amenable to such a broadly

drawn conclusion. EPA anticipates that case-by-case determinations will

be the rule for human foods.

Finally, EPA notes that the identification of pesticides and uses

that are potentially subject to the Delaney clause is an ongoing

process as EPA receives new cancer and processing studies required as

part of reregistration. When EPA concludes that a processed food or

feed tolerance is necessary under FFDCA section 409 for a pesticide

that induces cancer within the meaning of the Delaney clause, EPA will

take action to revoke or deny that tolerance.

II. Background

A. Statutory Background

The Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 301 et

seq.) authorizes the establishment of maximum permissible levels of

pesticides in foods, which are referred to as ``tolerances'' (21 U.S.C.

346a, 348). Under the FFDCA, a tolerance is required for pesticide

residues in food for consumption by humans or by food animals. Without

such a tolerance or an exemption from a tolerance, a food or

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feed 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. 342). Monitoring and enforcement of pesticide residues are

carried out by the U.S. Food and Drug Administration (FDA) and the U.S.

Department of Agriculture (USDA).

The FFDCA governs tolerances for raw agricultural commodities

(RACs) and processed foods separately. For pesticide residues in or on

RACs, EPA establishes tolerances, or exemptions from tolerances when

appropriate, under section 408. For processed foods, food additive

regulations (FARs) setting maximum permissible levels of pesticide

residues are established under section 409. Section 409 FARs are

needed, however, only for certain pesticide residues in processed food.

Under section 402(a)(2) of the FFDCA, no section 409 FAR is required if

any pesticide residue in a processed food, when ready to eat, is equal

to or below the tolerance for that pesticide in or on the RAC from

which it was derived and all other conditions of section 402(a)(2) are

met. This exemption in section 402(a)(2) is commonly referred to as the

``flow-through'' provision because it allows the section 408 raw food

tolerance to flow through to the processed food form. Thus, a section

409 FAR is necessary to prevent foods from being deemed adulterated

when the concentration of the pesticide residue in a processed food is

greater than the tolerance prescribed for the RAC, or if the processed

food itself is treated or comes in contact with a pesticide.

If a food additive regulation must be established, section 409 of

the FFDCA requires that the use of the pesticide will be ``safe'' (21

U.S.C. 348(c)(3)). Section 409 also contains the Delaney clause, which

specifically provides that, with little exception, ``no additive shall

be deemed safe if it has been found to induce cancer when ingested by

man or animal'' (21 U.S.C. 348(c)(3)).

B. Regulatory Background

1. Les v. Reilly. On May 25, 1989, the State of California, the

Natural Resources Defense Council, Public Citizen, the AFL-CIO, and

several individuals filed a petition requesting that EPA revoke several

food additive regulations. The petitioners argued that these food

additive regulations should be revoked because they violate the Delaney

clause.

EPA responded to the petition by revoking certain food additive

regulations, but retained several others on the grounds that the

Delaney clause provides an exception for pesticide residues posing de

minimis risk. EPA denied the petition for the food additive regulations

determined to fall under this exception. EPA's response was challenged

by the petitioners in the U.S. Court of Appeals, Ninth Circuit. On July

8, 1992, the court ruled in Les v. Reilly, 968 F.2d 985 (9th Cir.),

cert. denied, 113 S.Ct. 1361 (1993), that the Delaney clause of section

409 barred the establishment of a food additive regulation for

pesticides which ``induce cancer,'' even if the risks are considered de

minimis. In response to the court's decision in Les v. Reilly, EPA has

taken steps to identify and revoke all section 409 FARs for pesticides

which ``induce cancer.'' In the Federal Register of March 30, 1994 (59

FR 14980), EPA issued a list of pesticide uses which were likely to be

affected by the court's decision. (Note that for the purpose of this

document, the list has been superseded by Appendices to the court-

approved settlement in California v. Browner, discussed below.)

EPA first revoked certain FARs of six pesticides that were the

subject of the original NRDC petition. (58 FR 37862, 58 FR 59663 and 59

FR 10993). A number of these actions have been challenged in court;

some have been stayed. EPA decided to evaluate the remaining FARs

potentially inconsistent with the Delaney clause in phases. The first

two phases focused on processed human foods. EPA proposed the first set

of revocations, including 26 FARs for seven pesticides, in the Federal

Register of July 1, 1994 (59 FR 33941). A second set of proposed

revocations, including six FARs for four pesticides, was published in

the Federal Register of January 18, 1995 (60 FR 3607). These two

proposed revocations have not yet been finalized. This document, which

focuses on FARs for animal feeds, completes EPA's review of the FARs

earlier identified as potentially inconsistent with the Delaney clause.

2. California v. Browner. In a court-approved settlement, entered

on February 9, 1995, in the case of California v. Browner, EPA agreed

to make decisions regarding pesticides that may be affected by the

Delaney clause. This settlement agreement includes Appendices listing

pesticides and uses upon which EPA must make decisions and a timetable

for making the decisions. The settlement required EPA to rule on the

NFPA petition that challenged a number of policies under which EPA

administers its tolerance-setting program. This document is consistent

with the timeframes in that settlement.

In the Federal Register of June 14, 1995 (60 FR 31300), EPA issued

a partial response to the NFPA petition. In that document, EPA

concluded that some changes were warranted to its policies concerning

application of the Delaney clause. The proposals below in this document

are consistent with these new policies.

III. Revised Agency Policies, Guidelines, and Legal Interpretations

A. Concentration and ``Ready to Eat'' Policies

To determine whether the use of a pesticide on a growing crop needs

a section 409 FAR in addition to a section 408 tolerance, EPA looks at

the likelihood that the residue levels in the processed food will

exceed the section 408 tolerance level. In the past, EPA applied this

policy focusing almost exclusively on the results of processing studies

using treated crops. In response to the NFPA petition, EPA announced

new policies on how it would determine whether a pesticide needs a

section 409 FAR. EPA stated that it would consider a greater range of

information in determining the likelihood of residues in processed food

exceeding the section 408 tolerance. EPA also adopted a definition of

``ready to eat'' (RTE) as it applies to human food and animal feed.

Whether a food is RTE or not is critical to application of the

concentration policy. If a food is not RTE, EPA must consider the

degree of dilution that occurs in producing a RTE food from the not-RTE

food in determining the likelihood that residues in RTE food will

exceed the section 408 tolerance.

Perhaps the most significant new information that EPA stated it

would consider is information bearing on the average residue value from

crop field trials. The data from field residue trials show that it is

possible to obtain significantly different residue values from multiple

field trials. EPA concluded that where a crop is mixed or blended

during processing, it would be appropriate to use an average residue

value rather than the highest field trial sample value in estimating

the potential level of residue in processed food. As EPA noted, EPA

believes that generally the most appropriate average value to use is

the highest average field trial (HAFT) value. Consequently, EPA revised

its procedures and is now using the HAFT as the basis for determining

whether a section 409 FAR is needed.

Another outcome of the new concentration policy is that EPA has

revised its policies for the use of multiple processing studies. EPA

may receive several processing studies for a

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crop, with each showing a different concentration factor. When

different concentration factors result from multiple processing

studies, EPA will now use the average concentration factor to determine

concentration. EPA explained the basis for this change in its response

to comments filed on the NFPA petition. In addition, EPA is examining

processing studies to ensure that they reflect typical commercial

practices. If a study does not include a step (e.g., washing) that is

considered typical practice in processing an RAC, EPA may not include

that study in the calculation of the average concentration factor.

In response to the NFPA petition, EPA stated it would interpret the

phrase RTE food as meaning food ready for consumption ``as is'' without

further preparation. EPA also announced that it will apply a similar

approach to processing byproducts used as animal feeds. With regard to

animal feed, EPA announced that if a feed item is considered

unpalatable when fed ``as is'' or if for nutritional or other reasons

the feed item is generally further processed or mixed, EPA will

consider that feed item not RTE. EPA has applied this new

interpretation on a case-by-case basis in making determinations on

several of the feed items that are the subject of this document.

B. Guidelines on Significant Animal Feeds

EPA requires processing data and sets tolerances and FARs only on

animal feeds that are consumed in significant amounts in the United

States. Table II of the Pesticide Assessment Guidelines, Subdivision O,

Residue Chemistry, provides a listing of all significant food and feed

commodities, both raw and processed, for which residue data are

collected and tolerances or FARs are established. On June 8, 1994, EPA

revised Table II and sought comments on these revisions (59 FR 29603).

In response, EPA received extensive new data and many comments

concerning the amounts of raw agricultural commodities and processing

byproducts that are used as animal feeds. As a result, EPA has updated

Table II and modified its guidelines regarding which raw commodities

and processing byproducts EPA will consider as animal feeds possibly

requiring FARs.

The general cutoff point used by EPA in deciding which feed items

are considered ``significant'' is whether the feed item constitutes

greater than 0.04 percent, by weight, of the total feed available to

livestock in the U.S. However, feed items constituting less than 0.04

percent are also considered significant if:

1. Greater than 10,000 tons are fed annually (ca. 0.0015% of total

feed), and the crop is grown exclusively for use as animal feed (e.g.,

vetch); or

2. The feed is of particular regional concern (e.g., animal feeds

likely to result in residues in regionally produced commodities such as

milk and eggs) or has had historical incidence issues (e.g., pineapple

process residue); or

3. The feed is included in commodities market listings and is thus

traded and likely to be found in interstate commerce. Using these

criteria, approximately 99.8% of feeds available to livestock in the

U.S. are accounted for in the updated Table II.

Although many feed items, including processing byproducts, are no

longer included in Table II as a result of the new information used to

revise the table, these commodities combined represent less than 0.2

percent by weight of total livestock feeds. The percentage represented

by any single feed item is negligible.

Elsewhere in this issue of the Federal Register, EPA is issuing a

Notice of Availability of the revised table.

C. DES Proviso

The Delaney clause in section 409 of the FFDCA contains an

exception for animal feed additives that do not harm the animal and are

not found in the resulting animal food products by an analytical method

approved or prescribed by FDA or EPA as applicable. In full, this

exception reads:

The Delaney clause shall not apply with respect to the use of a

substance as an ingredient of feed for animals which are raised for

food production, if the Secretary finds:

(i) That, under the conditions of use and feeding specified in

proposed labeling and reasonably certain to be followed in practice,

such additive will not adversely affect the animals for which such feed

is intended; and

(ii) That no residue of the additive will be found (by methods of

examination prescribed or approved by the Secretary by regulations, * *

*) in any edible portion of such animal after slaughter or in any food

yielded by or derived from the living animal. 21 U.S.C. 348(c)(3)(A).

This exception historically has been referred to as the ``DES proviso''

because it was enacted, in part, in response to the use of the animal

drug diethylstilbestrol (DES). A similar provision is included in the

Delaney clauses in the color additives and animal drug provisions of

the FFDCA. See 21 U.S.C. 360b(d)(1)(I) and 379e(b)(5)(B).

FDA has a long history of rulemaking on the DES proviso. FDA's

current regulations regarding the DES proviso codify what FDA has

described as a ``sensitivity of method'' (SOM) approach. In brief, the

SOM approach uses quantitative risk assessment to define a level of

residue in the edible animal product which represents no more than a 1-

in-1 million lifetime risk. This residue level is then taken to

represent an insignificant risk level to the public, and FDA designates

that residue level and below as ``no residue'' under the DES proviso

whether or not such residues are detected by the approved method. See

21 CFR 500.84. Additionally, under the SOM approach, FDA requires

sponsors of compounds to develop analytical methods which are at least

sensitive enough to measure residues down to the level of residue

corresponding to an insignificant risk. 21 CFR 500.88.

Although the DES proviso and the SOM approach were not part of the

Les v. Reilly decision, EPA undertook a full review of its policies

related to the Delaney clause including the SOM approach in the wake of

that decision. For that reason, EPA requested comment on the SOM

approach in its notice announcing receipt of the NFPA petition. 58 FR

7474 (February 5, 1993). After reviewing the comment received and after

consulting with FDA and the Department of Justice, EPA has decided

generally to continue to rely on the SOM approach including taking risk

considerations into account in determining whether an analytical method

is sufficiently sensitive to be approved. EPA, however, will not rely

on one aspect of the SOM approach. EPA will not rely upon estimates of

risks posed by residues to designate a ``no residue'' level, at or

below which residues are presumed not to be found. Rather, EPA will

determine whether residues could be found by (1) determining the level

of residue expected in animal products given the conditions of use of

the pesticide and the levels of residue expected in feed, and then (2)

examining whether the approved method could detect such residue levels

in animal products. If the method could detect the residues expected in

animal products (even residues below the risk level determined under

the SOM approach), then these residues would be considered to be

``found'' under the DES proviso, and the DES proviso could not be

invoked as an exception to the Delaney clause.

EPA does not anticipate that this approach to determining whether

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residues are ``found'' will change the substance of EPA's current

practices involving method development and approval. As required by the

DES proviso, however, EPA will formally approve methods by regulation

when the DES proviso is invoked to support a FAR. EPA will not approve

a method, and therefore not exercise the DES proviso, if the method

cannot detect residues that the Agency considers to pose a risk of

concern.

EPA believes that its decision to interpret the DES proviso as

imposing a strict detectability standard is consistent with the plain

language of the statute. The DES proviso requires that ``no residue of

the additive will be found [] by methods of examination prescribed or

approved by the Secretary * * * .'' The use of the term ``found'' and

the express mention of analytical methods support reading the DES

proviso as imposing a detectability test. This conclusion is confirmed

by the legislative history which shows both that Congress understood

that the DES proviso imposed a detectability standard and that Congress

was opposed to the principle that any detected residue of a carcinogen

could be found to be safe.

The prior justification for the taking risk into account in

determining whether residues are ``found'' was that a literal approach

to the term ``no residue'' would render the DES proviso meaningless

because scientists could never conclude that a substance introduced

into an animal left absolutely no molecules of residue in edible animal

products. (52 FR 49572, December 31, 1987). To avoid construing the DES

proviso so as to render it inconsequential, the concept of risk was

introduced as a way of defining ``no residue.'' After further

evaluation, EPA believes that reading the DES proviso as imposing a

detectability standard is both consistent with the statutory language

and avoids making the DES proviso a meaningless provision. EPA's

experience has been that the presence of pesticide residues in animal

feeds often does not lead to detectable residues in edible animal

products. EPA regulations in 40 CFR 180.6 reflect that experience by

explicitly directing that no tolerance for pesticide residues in animal

products is required when appropriate studies show that detectable

residues are not reasonably expected.

IV. Decision Framework

In analyzing whether the 36 FARs addressed in this document should

be revoked, EPA has used the following decision framework. First, EPA

determined whether a section 409 FAR is necessary to prevent

adulteration, given the revisions to the animal feed guidelines, the

concentration policy, or new data which have been submitted. If

application of the revised guidelines and concentration policy shows no

FAR is needed, this document proposes that the FAR be revoked on that

ground. Second, if this analysis showed that a FAR is still needed,

then the FAR's consistency with the Delaney clause was analyzed.

In examining whether a FAR was needed, EPA followed a stepwise

process involving a series of questions. In brief, the questions are:

A. Significant Animal Feed

Is the feed for which the FAR was established a significant animal

feed? EPA has updated its table of significant animal feeds. In the

process, the Agency has identified a number of processed animal feed

items that are not significant according to the criteria in Unit.

III.B. of this preamble. If the animal feed for which the FAR was

established has been dropped from the list of significant animal feeds,

the FAR is not necessary.

B. Concentration Policy Including RTE

1. Using highest average residue value from field trials (HAFT), do

residues in processed food exceed the section 408 tolerance? Use of the

HAFT for feed commodities that are likely to be mixed or blended

decreases the likelihood that residues in processed feed will exceed

the section 408 tolerance. Typically, EPA would determine the HAFT as

part of its review of field residue data for a new tolerance. For the

pesticides that are the subject of this proposed rule, however, EPA did

not determine the HAFT in most cases, because other factors, notably

new processing studies and use of average concentration factors, were

sufficient for EPA to conclude that residues would not exceed the 408

tolerance.

2. Do processing data show that there is concentration of residues

during processing? If processing studies demonstrate that the level of

residues in the processed animal feed is less than the level of

residues in the precursor crop (i.e., no ``concentration in fact''), a

FAR is unnecessary. For some pesticides subject to this proposed rule,

EPA has received new processing studies which change its previous

conclusion that concentration occurs in processing.

3. Does use of the average concentration factor show that there is

concentration of residues during processing? Use of the average

concentration factor from multiple processing studies generally

decreases the likelihood that residues in the processed animal feed

will exceed the section 408 tolerance.

4. Is the dilution that occurs during preparation of RTE animal

feed sufficient to reduce pesticide residues below the section 408

tolerance? If a processed feed item is not fed to animals ``as is,''

EPA must evaluate the expected residue level in RTE animal feed

containing the processed feed item. EPA has determined that many of

processed feed items covered by the FARs addressed in this proposal are

not RTE. Information available to EPA shows that processed feed items

are rarely fed to animals singly or ``as is,'' that they are typically

mixed or blended with other feed items to create a finished RTE feed.

Blending of processed feed items is necessary to make them palatable or

to ensure that the animal receives a nutritionally sufficient diet. For

example, soybean hulls by themselves are neither palatable to animals

nor an adequate nutritional source, and are therefore fed only in a

feed mixture.

To determine the levels of pesticides residues in the RTE animal

feed, EPA obtained information on the amount of dilution that occurs

from mixing and blending feed items into finished feeds (a ``dilution

factor''). Since the amount of dilution in finished animal feeds varies

due to differences in animal dietary needs, EPA used the lowest

dilution factor (the highest level of potential residues in finished

feed) in its determinations. If the dilution of residues resulting from

mixing and blending is greater than the concentration of residues

resulting from processing (the dilution factor is greater than the

concentration factor), it is likely that the residues in the finished

RTE feed will be less than the section 408 tolerance. In this case, no

FAR is necessary for the RTE animal feed.

5. Does a combination of concentration factors show that it is

unlikely that the residues in processed food will exceed the section

408 tolerance? For some pesticides, the factors analyzed individually

might indicate that residues exceed the section 408 tolerance, but when

analyzed in combination they allow EPA to conclude that, in actuality,

residues are not likely to exceed the section 408 tolerance. Therefore,

the final step in this analysis was to look at the above factors in

combination to determine if a FAR is needed.

If, after consideration of the above factors, a FAR is determined

to be necessary, EPA then examined whether

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a FAR for the pesticide chemical is consistent with the Delaney clause.

That examination focused on whether the pesticide induces cancer within

the meaning of the Delaney clause. If EPA concluded that the pesticide

induces cancer, then EPA determined whether the FAR is nonetheless

excepted from the Delaney clause prohibition by the DES proviso.

V. EPA's Decisions

Based on the above analyses, EPA proposes to revoke 34 FARs on the

basis that they are not needed to prevent adulterated food and two FARs

because they violate the Delaney clause.

A. Food Additive Regulation Is Not Needed

1. Not considered significant feed item. As a result of the

updating of the guideline on significant animal feeds, 16 of the 36

FARs are no longer considered necessary. EPA proposes to revoke on this

ground the following FARs: (1) benomyl on dried apple pomace, dried

grape pomace and raisin waste; (2) diflubenzuron on soybean soapstock;

(3) iprodione on dried grape pomace, raisin waste, and peanut

soapstock; (4) mancozeb on milled fractions of barley, oats, and rye;

(5) norflurazon on citrus molasses; (6) propargite on dried apple

pomace and dried grape pomace; (7) thiophanate-methyl on dried apple

pomace; and (8) triadimefon on wet/dry grape pomace and raisin waste.

Documentation explaining EPA's conclusions on what animal feeds are

significant is included in the docket.

After this reassessment, only 20 of the original 36 FARs require

further consideration.

2. Revised concentration policy including RTE--i. Highest average

field trial value. Consideration of HAFT values from crop field trials

did not alone affect whether any FARs were needed. (The HAFT was

considered in combination with other factors in determining that a

tolerance for diflubenzuron on soybean hulls was not necessary.)

ii. New processing study. EPA has received new processing studies

that show that 4 of the remaining FARs are unnecessary because

processing results in no concentration in fact of residues. EPA

proposes to revoke on this ground the following FARs: (1) dimethipin on

cottonseed hulls; (2) norflurazon on dried citrus pulp; (3) propargite

on dried citrus pulp; and (4) thiodicarb on cottonseed hulls.

Documentation on these new processing studies is included in the

docket.

After this reassessment, only 16 of the original 36 FARs require

further consideration.

iii. Average concentration factor shows no concentration in fact.

Calculation of the average concentration factor from more than one

processing study shows that 4 of the remaining FARs are unnecessary

because processing results in no concentration in fact of residues. EPA

proposes to revoke on this ground the following FARs: (1) acephate on

cottonseed meal and soybean meal; (2) carbaryl on pineapple bran; and

(3) dimethoate on dried citrus pulp. Documentation on the calculation

of the average concentration factors is included in the docket.

After this reassessment, only 12 of the original 36 FARs require

further consideration.

iv. Dilution factor is greater than concentration factor during

processing For the remaining FARs, EPA concluded that the following

processed feed items are not RTE: Cottonseed hulls, dried citrus pulp,

rice bran and hulls, milled fractions of wheat, and soybean hulls.

EPA concluded that the following processed feed item is RTE:

Sugarcane molasses.

Evaluation of the degree of dilution involved in the preparation of

RTE animal feeds from not-RTE processed feed items showed that 8 of the

remaining FARs are unnecessary because residues are unlikely to exceed

the section 408 tolerance in the RTE animal feeds. EPA proposes to

revoke on this ground the following FARs: (1) acephate on cottonseed

hulls; (2) benomyl on dried citrus pulp and rice hulls; (3) imazalil on

dried citrus pulp; (4) iprodione on rice bran and rice hulls; (5)

mancozeb on milled fractions of wheat; and (6) thiodicarb on soybean

hulls.

For these pesticide/processed feed item combinations, EPA plans to

use its general rulemaking authority under FFDCA sec. 701, to establish

maximum residue levels. Documentation of EPA's conclusions regarding

concentration factors, RTE status, and dilution factors for these

processed feed items is provided in the docket.

After this reassessment, only 4 of the original 36 FARs require

further consideration.

v. Combination of factors. Analysis of the combined effect of the

use of the above factors for RTE feeds showed that two of the remaining

FARs are unnecessary. EPA is proposing to revoke on this ground the

FARs for diflubenzuron on soybean hulls and triadimefon on wet apple

pomace.

The tolerance for diflubenzuron in soybeans is at the limit of

quantification (LOQ) of the analytical method (0.05 ppm). A single

processing study shows residues of diflubenzuron in soybean hulls

concentrate to eight times the soybean level. Using the HAFT of 0.03

ppm obtained using a more sensitive analytical method, a concentration

factor of 8 and a dilution factor of 4 for soybean hulls, residues in

finished RTE feed are calculated to be 0.06 ppm (0.03 X 8 divided by

4). This is within the limit of analytical variability of the LOQ

tolerance of 0.05 ppm. Documentation on consideration of these factors

for this FAR is provided in the docket.

Several factors were considered in the determination as to whether

the feed additive tolerance for triadimefon on wet apple pomace is

still necessary. (The existing feed additive tolerance covers both wet

and dry apple pomace; however, dry apple pomace is no longer considered

a significant feed item.) All registered uses of triadimefon on apples

have been amended to extend the preharvest interval (PHI) from 0 days

to 45 days. Available residue data reflecting a 45-day PHI support a

tolerance of 0.2 ppm on raw apples. The HAFT from these studies is 0.09

ppm, and a new processing study indicates a concentration factor of

1.6X for residues in wet apple pomace. Residues in wet apple pomace can

thus be calculated as 0.09 ppm X 1.6 = 0.14 ppm, which is below the

0.2-ppm tolerance needed for apples. Therefore, a section 409 tolerance

for wet apple pomace is not required.

After this reassessment, only 2 of the original 36 FARs require

further consideration.

B. Food Additive Regulation is Needed

EPA has determined that one of the remaining FARs is necessary

because the application of the pesticide to the RAC could lead to

residues in RTE processed feed that exceed the applicable section 408

tolerance. This is simazine on sugarcane molasses. Documentation as to

why this FAR is needed under the revised concentration policy is

included in the docket.

The last FAR, tetrachlorvinphos in processed feed items, is needed

because it is a direct additive to processed animal feed. None of the

above factors is relevant to a direct additive to processed animal

feeds.

C. Induce Cancer Call for Pesticides that Need 409s

If a FAR is necessary to prevent adulterated food, as in the case

of the two pesticides named in Unit V.B. above, EPA next determined

whether the pesticide induces cancer within the meaning of the Delaney

clause.

[[Page 49147]]

In construing the ``induce cancer'' standard as to animals, EPA

follows a weight-of-the-evidence approach. In regard to animal

carcinogenicity, EPA, in general, interprets ``induces cancer'' to

mean:

The carcinogenicity of a substance in animals is established when

administration in an adequately designed and conducted study or studies

results in an increase in the incidence of one or more types of

malignant (or, where appropriate, benign or a combination of benign and

malignant) neoplasms in treated animals compared to untreated animals

maintained under identical conditions except for exposure to the test

compound. Determination that the incidence of neoplasms increases as

the result of exposure to the test compound requires a full biological,

pathological, and statistical evaluation. Statistics assist in

evaluating the biological significance of the observed responses, but a

conclusion on carcinogenicity is not determined on the basis of

statistics alone. Under this approach, a substance may be found to

``induce cancer'' in animals despite the fact that increased tumor

incidence occurs only at high doses, or that only benign tumors occur,

and despite negative results in other animal feeding studies. (See 58

FR 37863, July 14, 1993; 53 FR 41108, October 19, 1988; and 52 FR

49577, December 31, 1987).

In a proposed revocation issued in 1994, EPA concluded that

simazine meets this standard. EPA is currently considering comments on

this proposal. EPA believes that tetrachlorvinphos also qualifies as an

animal carcinogen under this test.

Summarized below is the information supporting EPA's determination

that tetrachlorvinphos induces cancer. Full copies of each of these

reviews and other references in this document are available in the OPP

Docket, the location of which is given under ``ADDRESSES'' above.

Information on simazine is contained in OPP Docket OPP-300335.

Tetrachlorvinphos

After a full evaluation of the data and supporting information

regarding animal carcinogenicity, EPA concludes that exposure to

tetrachlorvinphos results in an increased incidence of hepatocellular

carcinomas and combined adenomas/carcinomas (predominantly malignant

carcinomas) in female B6C3Fl mice.

In male mice there are also increases in hepatocellular combined

adenomas/carcinomas and tumors of the kidney (carcinomas, adenomas and

combined adenomas/carcinomas with a large contribution from malignant

carcinoma). In the male Sprague-Dawley rat there are nonsignificant

increases in adrenal benign pheochromocytomas (significant positive

trend) and thyroid C-cell adenomas. These latter two tumor types are

consistent with the same tumor types observed in another earlier study

in Osborne-Mendel rats.

The mutagenicity data for tetrachlorvinphos demonstrate clastogenic

activity, which supports a carcinogenicity concern. Analogs

structurally similar to tetrachlorvinphos (DDVP and phosphamidon) are

also carcinogenic. Tetrachlorvinphos can undergo hydrolysis and then

tautomerize to generate a potentially carcinogenic reactive ketone

intermediate.

Discussions of the various studies on the carcinogenicity of

tetrachlorvinphos can be found in the Peer Review of tetrachlorvinphos

(Dec. 12, 1994) in the docket.

D. DES Proviso

EPA may establish or maintain a section 409 FAR for a pesticide

that induces cancer only if the DES proviso excludes it from the

Delaney clause (see Unit III.C. of this preamble). When a pesticide

needing a FAR is found to induce cancer, the final step in the analysis

is to determine if the FAR is nonetheless excepted from the Delaney

clause prohibition by the DES proviso.

The DES proviso applies when no detectable residues are expected in

the animal commodities (meat, milk, poultry, eggs) as a result of

animal consumption of feeds containing tolerance level residues. If no

detectable residues of the chemical can be found in the animal

commodities, the FAR can be maintained or established.

1. Tetrachlorvinphos. EPA concludes that the DES proviso does not

except the tetrachlorvinphos FAR from the Delaney clause. The

tetrachlorvinphos FAR does not qualify because the existing enforcement

method has not been approved under the DES proviso and EPA does not

believe it would be appropriate to approve that method because it

determines residues of parent only and not several metabolites of

carcinogenic concern. Moreover, EPA has estimated, if a method covering

these metabolites were developed, the method would be expected to be

able to detect residues of tetrachlorvinphos in animal products,

assuming the method is of comparable sensitivity to the existing

method.

2. Simazine. EPA has concluded that the DES proviso does not except

the simazine FAR from the Delaney clause. Using the existing

enforcement method for simazine, EPA has estimated, residues of

simazine will not be found in edible products of animals. However this

enforcement method has not been approved by regulation for use by

applying the DES proviso and EPA does not believe the method is

sufficiently sensitive that it should be approved. As FDA's regulations

concerning the DES proviso make clear, methods used in applying the DES

proviso must be capable of detecting residues at a level representing a

maximum lifetime cancer risk of 1-in-1 million. 21 CFR 500.88(b). The

current enforcement method for simazine detects residues in edible

animal products only down to a level representing a lifetime cancer

risk from simazine in such products of approximately 1 in 100,000.

Because this method is not sufficiently sensitive, EPA is not proposing

it for approval, and therefore EPA cannot conclude that the DES proviso

is available to exempt the simazine FAR from the Delaney clause. If a

method for simazine is available that has greater sensitivity, EPA will

reexamine the question of whether the DES proviso does apply.

VI. Proposed Rules

A. Proposed Revocations: Section 409 FAR Is Not Needed.

EPA is proposing to revoke the following 34 of the original 36 FARs

because the Agency has determined they are not needed:

------------------------------------------------------------------------

Name of pesticide 40 CFR cite Processed feed item

------------------------------------------------------------------------

Acephate.................. 186.100 Cottonseed meal,

cottonseed hulls,

soybean meal

Benomyl................... 186.350 Dried apple pomace, dried

citrus pulp, dried grape

pomace, raisin waste,

rice hulls

Carbaryl.................. 186.550 Pineapple bran (wet and

dry)

Diflubenzuron............. 186.2000 Soybean hulls, soybean

soapstock

Dimethipin................ 186.2050 Cottonseed hulls

[[Page 49148]]

Dimethoate................ 186.2100 Dried citrus pulp

Imazalil.................. 186.3650 Dried citrus pulp

Iprodione................. 186.3750 Dried grape pomace,

raisin waste, peanut

soapstock, rice bran,

rice hulls

Mancozeb.................. 186.6300 Milled barley fractions,

milled oat fractions,

milled rye fractions,

milled wheat fractions

Norflurazon............... 186.4450 Dried citrus pulp, citrus

molasses

Propargite................ 186.5000 Dried apple pomace, dried

citrus pulp, dried grape

pomace

Thiodicarb................ 186.5650 Cottonseed hulls, soybean

hulls

Thiophanate-methyl........ 186.5700 Dried apple pomace

Triadimefon............... 186.800 Grape pomace (wet and

dry), raisin waste,

apple pomace (wet/dry)

------------------------------------------------------------------------

B. Proposed Revocations: Violates Delaney Clause

1. Tetrachlorvinphos. EPA is proposing to revoke the FAR for

tetrachlorvinphos (2-chloro-1-(2,4,5-trichlorophenyl)vinyl dimethyl

phosphate) when used as a direct feed additive. This FAR is codified at

40 CFR 186.950. EPA is proposing to revoke this FAR because EPA has

determined that tetrachlorvinphos induces cancer in animals. Because a

section 409 FAR is required and the DES proviso does not apply, the

regulation violates the Delaney clause in section 409 of the FFDCA.

2. Simazine. EPA is proposing to revoke the FAR for simazine

residues on sugarcane molasses. This FAR is codified at 40 CFR

186.5350. EPA is proposing to revoke this FAR because EPA has

determined that simazine induces cancer in animals. Because a section

409 FAR is required and the DES proviso does not apply, the regulation

violates the Delaney clause in section 409 of the FFDCA.

VII. Consideration of Comments

Any interested person may submit comments on this proposed action

to the address given in the ``ADDRESSES'' section (see above). Before

issuing a final rule based on this proposal, EPA will consider all

relevant comments. EPA also welcomes comment on whether its proposed

revocations issued on July 1, 1994 (59 FR 33941; OPP Docket 300335) and

January 18, 1995 (60 FR 3607; OPP Docket 300360) should be revised

based on the changed policies and guidelines discussed in this proposed

rule. Any comment on these prior proposals should bear their

appropriate OPP docket control numbers. After consideration of

comments, EPA will issue a final order determining whether revocation

of the regulations is appropriate. Such order will be subject to

objections pursuant to section 409(f) (21 U.S.C. 348(f)). Failure to

file an objection within the appointed period will constitute waiver of

the right to raise issues resolved in the order in future proceedings.

A record has been established for this rulemaking under docket

number [OPP-300397] (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 a.m. to 4:30 p.m., Monday through Friday, excluding legal

holidays. The public record is located in Room 1132 of the Public

Response and Program Resources Branch, Field Operations Division

(7506C), Office of Pesticide Programs, Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.

Electronic comments can be sent directly to EPA at:

opp-D[email protected]

Electronic comments must be submitted as an ASCII file avoiding the

use of special characters and any form of encryption.

The official record for this rulemaking, as well as the public

version, as described above will be kept in paper form. Accordingly,

EPA will transfer all comments received electronically into printed,

paper form as they are received and will place the paper copies in the

official rulemaking record which will also include all comments

submitted directly in writing. The official rulemaking record is the

paper record maintained at the address in ``ADDRESSES'' at the

beginning of this document.

VIII. Executive Order 12866

EPA believes that there will be no significant economic impacts

from this action. Revocation of 34 unnecessary tolerances does not

affect the availability of the pesticides for use on the crops

involved. EPA has not completed an evaluation of the economic impacts

of this particular action for the two proposed revocations under the

Delaney clause, since the Delaney clause requires EPA to act without

considering the costs or benefits of the action. Nevertheless, EPA

believes that the revocation of simazine on sugarcane molasses and

tetrachlorvinphos on processed animal feed will have little economic

impact.

Simazine residues on domestically produced molasses are assumed to

be zero since simazine is no longer registered for use on sugarcane

domestically. No impacts are expected to U.S. sugarcane growers from

this proposed revocation. However, there could be short-term impacts to

the domestic market due to decreased supply or increased price for

imported molasses for animal feed. EPA cannot accurately estimate the

amount of molasses from sugarcane that is imported to the U.S. Data on

sugarcane molasses are generally aggregated with other molasses

imports. Moreover, EPA lacks information on pesticide usage from some

countries with significant molasses exportation. However, based on

available information from countries for which EPA has data and

alternative sources of molasses, EPA believes impacts upon domestic

users of molasses will be minor and temporary.

Tetrachlorvinphos is used as a feed-through insecticide for control

of flies on cattle, hogs, and horses. The bulk is used as a cattle

feed-through; little is used for hogs or horses. Both diflubenzuron and

methoprene are registered alternatives for cattle. For hogs and horses,

although there are no feed-through alternatives available, dimethoate,

cyromazine, and dichlorvos are available as nonfeed-through

alternatives, and tetrachlorvinphos remains available for direct

application to animals. Given that the costs of some of the

alternatives are less than tetrachlorvinphos, alternatives exist, and

dermal applications are permitted, EPA believes that there will be no

significant adverse economic effects

[[Page 49149]]

from revocation of the animal feed tolerance for tetrachlorvinphos.

IX. Regulatory Flexibility Act

As explained above, the Agency is compelled to take this action

without regard to the economic impacts, including impacts on small

businesses. Therefore, this rule has not been reviewed under the

provisions of sec. 3(a) of the Regulatory Flexibility Act.

X. Paperwork Reduction Act

There are no information collection requirements in this proposed

order.

List of Subjects in 40 CFR Part 186

Environmental protection, Agricultural commodities, Pesticides and

pests, Feed additives, Reporting and recordkeeping requirements.

Dated: September 15, 1995.

Lynn R. Goldman,

Assistant Administrator for Prevention, Pesticides and Toxic

Substances.

Therefore, it is proposed that 40 CFR part 186 be amended as

follows:

PART 186--[AMENDED]

1. The authority citation for part 186 continues to read as

follows:

Authority: 2l U.S.C. 348.

Sec. 186.100 [Removed]

2. By removing Sec. 186.100 Acephate.

Sec. 186.350 [Removed]

3. By removing Sec. 186.350 Benomyl.

Sec. 186.550 [Removed]

4. By removing Sec. 186.550 Carbaryl.

Sec. 186.800 [Removed]

5. By removing Sec. 186.800 1-(4-chlorophenoxy)-3,3-dimethyl -1-

(1H-1,2,4-triazol-1-yl)-2-butanone.

Sec. 186.950 [Removed]

6. By removing Sec. 186.950 2-Chloro-1-(2,4,5-trichlorophenyl)vinyl

dimethyl phosphate.

Sec. 186.2000 [Removed]

7. By removing Sec. 186.2000 Diflubenzuron.

Sec. 186.2050 [Removed]

8. By removing Sec. 186.2050 Dimethipin.

Sec. 186.2100 [Removed]

9. By removing Sec. 186.2100 Dimethoate including its oxygen

analog.

Sec. 186.3650 [Removed]

10. By removing Sec. 186.3650 Imazalil.

Sec. 186.3750 [Removed]

11. By removing Sec. 186.3750 Iprodione.

Sec. 186.4450 [Removed]

12. By removing Sec. 186.4450 Norflurazon.

Sec. 186.5000 [Removed]

13. By removing Sec. 186.5000 Propargite.

Sec. 186.5350 [Removed]

14. By removing Sec. 186.5350 Simazine.

Sec. 186.5650 [Removed]

15. By removing Sec. 186.5650 Thiodicarb.

Sec. 186.5700 [Removed]

16. By removing Sec. 186.5700 Thiophanate-methyl.

Sec. 186.6300 [Removed]

17. By removing Sec. 186.6300 Zinc ion and maneb coordination

product.

[FR Doc. 95-23443 Filed 9-18-95; 1:26 pm]

BILLING CODE 6560-50-F