[Federal Register Volume 60, Number 183 (Thursday, September 21, 1995)]
[Proposed Rules]
[Pages 49142-49149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23443]




[[Page 49141]]

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Part IX





Environmental Protection Agency





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40 CFR Part 186



Pesticide Tolerances; Revocation of Certain Feed Additive Regulations; 
Proposed Rule and Notice

  Federal Register / Vol. 60, No. 183 / Thusday, September 21, 1995 / 
Proposed Rules  

[[Page 49142]]


ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 186

[OPP-300397; FRL-4977-3]
RIN 2070-AC18


Pesticides; Feed Additive Regulation Revocations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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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 

[[Page 49143]]
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 

[[Page 49146]]
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