[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]]
_______________________________________________________________________
Part IX
Environmental Protection Agency
_______________________________________________________________________
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: opp-docket@epamail.epa.gov. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. 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: nazmi.niloufar@epamail.epa.gov.
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-Docket@epamail.epa.gov
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
