[Federal Register Volume 61, Number 146 (Monday, July 29, 1996)]
[Rules and Regulations]
[Pages 39528-39542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19076]
[[Page 39527]]
_______________________________________________________________________
Part IV
Environmental Protection Agency
_______________________________________________________________________
40 CFR Parts 180 and 185
_______________________________________________________________________
Revocation of Pesticide Food Additive Regulations; Final Rule
Federal Register / Vol. 61, No. 146 / Monday, July 29, 1996 / Rules
and Regulations
[[Page 39528]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 185
[OPP-300360B; FRL-5388-2]
RIN 2070-AB78
Revocation of Pesticide Food Additive Regulations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is revoking six food additive regulations (tolerances) for
four pesticides. EPA is revoking four tolerances because they violate
the Delaney clause of the Federal Food, Drug, and Cosmetic Act, and the
other two tolerances because they are not needed to prevent adulterated
food.
EFFECTIVE DATE: This final rule is effective September 27, 1996.
Written objections, requests for a hearing, and/or requests for stays
identified by the docket number OPP-300360B, must be submitted by
August 28, 1996.
ADDRESSES Written objections and hearing requests, identified by the
docket number, [OPP-300360B], may be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. Fees accompanying objections and hearing requests
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA
Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O.
Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing
requests filed with the Hearing Clerk should be identified by the
docket number and submitted to: Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. In person, bring copy of objections and hearing requests to:
Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect in 5.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number
[OPP-300360B]. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic copies of objections and hearing
requests on this rule may be filed online at many Federal Depository
Libraries. Additional information on electronic submissions can be
found below in this document.
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'' (CBI). Information so marked will
not be disclosed except in accordance with procedures set forth in 40
CFR Part 2. A copy of the comment that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice. All
written comments will be available for public inspection in Rm. 1132 at
the address given above, from 8 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT By mail: Jean M. Frane, Policy and
Special Projects Staff (7501C), Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. Office location and telephone number:
Rm. 1113, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA,
(703) 305-5944. e-mail: frane.jean@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: This document is divided into the following
areas for discussion: Table of Contents
I. Introduction
A. Regulated Entities
B. Terms and Acronyms
C. Statutory Background
D. Regulatory Background
E. EPA Actions Since Proposed Rule
F. Today's Action
II. Relevant Policy Changes Since the Proposal
A. Concentration Policy
B. Ready-to-Eat Definition
C. RAC Interpretation
III. Decision Framework
IV. Is a Processed Food Tolerance Needed?
A. Acephate in Food Handling Establishment
B. Imazalil in Citrus Oil
C. Iprodione on Dried Ginseng
D. Iprodione on Raisins
E. Triadimefon on Milled Fractions of Wheat (Wheat Bran)
F. Triadimefon on Milled Fractions of Barley (Barley Bran)
V. Do Needed Processed Food Tolerances Violate the Delaney
Clause?
VI. Revocations
A. Processed Food Tolerances That are Not Needed
B. Processed Food Tolerances That Violate the Delaney Clause
VII. General Comments Common to All Proposed Revocations.
VIII. Comments Related to Specific Pesticides
A. Acephate
B. Triadimefon
C. Iprodione
IX. Procedural Matters
A. Filing of Objections and Requests for Hearings
B. Effective Date
C. Request for Stays of Effective Date
X. Regulatory Assessment Requirements
A. Executive Order 12866
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
D. Unfunded Mandates Reform Act and Executive Order 12875
E. Review by Congress and the General Accounting Office
I. Introduction
A. Regulated Entities
------------------------------------------------------------------------
Examples of Regulated
Category Entities
------------------------------------------------------------------------
Industry.................................. Users of the pesticides
covered by this notice
........................................ Food processors
------------------------------------------------------------------------
This table is not exhaustive, but is a guide to the entities EPA
believes are regulated by this action.
B. Terms and Acronyms
In today's document, EPA uses a number of terms and acronyms that
may not be familiar to the reader. For the convenience of readers,
principal terms and acronyms used in this document are listed here.
Federal Food, Drug, and Cosmetic Act - FFDCA
Federal Insecticide, Fungicide and Rodenticide Act - FIFRA
408 tolerance - a raw food tolerance established under section 408
of the FFDCA.
409 tolerance - a processed food tolerance established under
section 409 of the FFDCA.
CF - concentration factor
DF - dilution factor
HAFT - highest average field trial
RAC - raw agricultural commodity
RTE - ready to eat
C. Statutory Background
The Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et
seq., authorizes the establishment by regulation of maximum permissible
levels of pesticides in foods. Such regulations are commonly referred
to as ``tolerances.'' Without such a tolerance or an exemption from the
requirement of a tolerance, a food containing a pesticide residue is
``adulterated'' under section 402 of the FFDCA and may not be legally
moved in interstate
[[Page 39529]]
commerce. 21 U.S.C. 331, 342. Monitoring and enforcement of pesticide
tolerances are carried out by the U.S. Food and Drug Administration
(FDA) and the U.S. Department of Agriculture. EPA can establish a
tolerance in response to a petition or on its own initiative.
The FFDCA has separate provisions for tolerances for pesticide
residues in raw agricultural commodities (RACs) and in processed food.
EPA establishes tolerances, or exemptions from tolerances when
appropriate, for RACs under section 408 (hereafter referred to as ``408
tolerances'' or ``RAC tolerances''). 21 U.S.C. 346a. EPA establishes
food additive regulations for pesticide residues in processed foods
under section 409, which pertains to ``food additives.'' 21 U.S.C. 348.
Food additive regulations under section 409 are referred to hereafter
as ``409 tolerances'' or ``processed food tolerances.''
Section 409 tolerances are needed, however, only for certain
pesticide residues in processed food. Under section 402(a)(2) of the
FFDCA, a pesticide residue in processed food generally will not render
the food adulterated if the residue results from application of the
pesticide to a RAC and the residue in the processed food when ready to
eat is below the RAC tolerance. This exemption in section 402(a)(2) is
commonly referred to as the ``flow-through'' provision because it
allows the RAC tolerance to flow through and apply to the processed
food forms as well. Thus, a 409 tolerance is only necessary to prevent
foods from being deemed adulterated when the level of the pesticide
residue in a processed food when ready to eat is greater than the
tolerance established for the RAC, or if the processed food itself is
treated or comes in contact with a pesticide.
If a 409 tolerance 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)). Relevant factors in this safety determination include (1)
the probable consumption of the pesticide or its metabolites; (2) the
cumulative effect of the pesticide in the diet of man or animals,
taking into account any related substances in the diet; and (3)
appropriate safety factors to relate the animal data to the human risk
evaluation. Section 409 also contains the Delaney clause, which
specifically provides that ``no additive shall be deemed to be safe if
it is found, after tests which are appropriate for the evaluation of
the safety of food additives, to induce cancer in man or animal.''
D. Regulatory Background
1. On January 18, 1995 (60 FR 3602)(FRL-4910-8), EPA published in
the Federal Register a proposal to revoke six 409 tolerances for 4
pesticides. EPA's action was prompted by a decision of the Ninth
Circuit Court of Appeals, which ruled on July 8, 1992, in the case of
Les v. Reilly, 968 F.2d 985 (9th Cir.), cert. denied, 113 S.Ct. 1361
(1993), that the Delaney clause barred the establishment of a 409
tolerance for a pesticide which ``induces cancer,'' no matter how
infinitesimal the risk.
In response to the court's decision in Les v. Reilly, EPA
identified and proposed to revoke all 409 tolerances for pesticides
which it determined ``induce cancer in man or animals.'' EPA decided to
evaluate these pesticides in phases. The initial phase of revocations
included 26 uses of 7 pesticides and was finalized on March 22, 1996
(61 FR 11993)(FRL-5357-7). The second phase of revocations includes 6
uses of 4 pesticides and was proposed on January 18, 1995 (60 FR 3602).
Today's final revocations address those pesticides. A third set of
revocations was proposed on September 21, 1995 (60 FR 49141)(FRL-4977-
3) and will be finalized by March 1997.
E. EPA Actions Since Proposed Rule
1. Settlement of California v. Browner case. 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 a
timetable for making the decisions. Today's revocations comply with the
timeframes in that settlement.
2. Revised tolerance-setting policies. In September 1993 the
National Food Processors' Association (NFPA) filed a petition with the
EPA, challenging a number of policies under which EPA administers its
tolerance-setting program, including the concentration policy, ready-
to-eat policy and coordination policy. Several of these policies are
relevant to today's revocation decisions. In the Federal Register of
June 14, 1995 (60 FR 31300)(FRL-4944-2) and January 25, 1996 (61 FR
2378)(FRL-4991-9), EPA responded to the NFPA petition by modifying or
establishing policies concerning concentration of residues, ready-to-
eat foods, raw agricultural commodities and coordination of its
regulatory authorities. Unit II of this document summarizes the policy
changes that are relevant to today's revocations.
F. Today's Action
EPA is revoking the 409 tolerances for six uses of four pesticides.
Table 1 below summarizes the revocations and their basis. Each of these
is discussed later in this notice.
----------------------------------------------------------------------------------------------------------------
CFR
Pesticide Citation Commodity Basis for Revocation
----------------------------------------------------------------------------------------------------------------
Acephate................................. 185.100 Food handling establishments Violates Delaney
Imazalil................................. 185.3650 Citrus oil Not needed
Iprodione................................ 185.3750 Dried Ginseng Violates Delaney
Iprodione................................ Do. Raisins Violates Delaney
Triadimefon.............................. 185.800 Barley, milled fractions Not needed
(except flour)
Do. Wheat, milled fractions Violates Delaney
(except flour)
----------------------------------------------------------------------------------------------------------------
The 409 tolerance revocations being finalized in this notice were
proposed on January 18, 1995, before EPA had responded to the NFPA
petition and adopted its new policies. In addition, EPA received
petitions from registrants of three pesticides requesting revocation of
four 409 tolerances (imazalil/citrus oil, iprodione/raisins and dried
ginseng, and triadimefon/barley milled fractions) on the basis that
they are not needed. For each petition, EPA published a notice of
availability in the Federal Register requesting comment. Although not
required to do so, where appropriate EPA has based its revocation
decision on the reasons cited by the petitioners rather than the
requirements of the Delaney clause as proposed.
[[Page 39530]]
II. Relevant Policy Changes Since the Proposal
A. Concentration Policy
In its June 1995 notice, EPA announced a new policy on how it would
determine whether a pesticide needs a 409 tolerance. To determine
whether the use of a pesticide on a growing crop needs a 409 tolerance
in addition to a 408 tolerance, EPA evaluates the likelihood that the
residue levels in the processed food when ready to eat will exceed the
408 tolerance level. In the past, EPA focussed almost exclusively on
the results of processing studies using treated crops in making this
determination. EPA now considers a greater range of information in
determining the likelihood that residues in processed food will exceed
the 408 tolerance. For example:
1. Mixing and blending of treated food commodities decreases the
likelihood that residues in processed food will exceed the 408
tolerance. EPA takes potential mixing and blending into account by
using information on the highest average field trial residue (referred
to as the HAFT).
2. If multiple processing studies demonstrate different
concentration factors (CFs), EPA now uses the average CF rather than
the highest CF to determine the expected level of concentration.
3. At the same time, EPA examines 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 a RAC, EPA may decide not to include that study in the
calculation of the average CF. EPA's concentration policy bears on
today's decision on triadimefon/wheat.
B. Ready-to-Eat Definition
In its June 1995 notice, EPA also adopted a definition of ``ready
to eat'' (RTE) as it applies to human food and animal feed. EPA stated
it would interpret the phrase ``RTE food'' as meaning food ready for
consumption ``as is'' without further preparation. If a food is not
RTE, EPA considers 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 408 tolerance. EPA's RTE
definition bears on today's decision on imazalil on citrus oil.
C. RAC Interpretation
On January 25, 1996 (61 FR 2386), EPA published its interpretation
of the term RAC as applied to dried commodities under the FFDCA. EPA
based its interpretation on the purpose of drying, such that
commodities dried for the purpose of creating a new marketable
commodity are treated as processed food, while those dried for storage
or transportation needs are treated as raw foods. EPA's RAC
interpretation bears on today's decision on iprodione on raisins.
III. Decision Framework
In analyzing whether the six 409 tolerances addressed in this
document should be revoked, EPA generally has used the following
decision framework. First, EPA determined whether a 409 tolerance was
necessary to prevent adulteration, applying its RAC, concentration, and
RTE policies. Unit IV.A. of this document discusses EPA's determination
for each chemical. If no 409 tolerance is needed, EPA in most cases has
revoked the 409 tolerance on that ground. If a 409 tolerance is needed,
then EPA has determined whether that 409 tolerance is permitted under
the Delaney clause. Unit IV.B. of this document discusses the Agency's
determinations on ``induce cancer'' for each chemical for which a 409
tolerance is needed. EPA does not believe that this decision hierarchy
is legally required under the FFDCA but has chosen this approach in its
discretion.
Under current policy, a 409 tolerance is needed when EPA determines
that some processed food can contain residues exceeding the section 408
tolerance. This determination is made on a case-by-case basis, taking
into account the sensitivity of the analytical method used to detect
the residues.
Before determining whether a 409 tolerance is needed, however, EPA
also examines whether available residue data indicate that the current
408 tolerance should be revised. EPA has received large amounts of
residue data as part of the pesticide reregistration program of section
4 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Review of these data shows that, in one instance (triadimefon/wheat),
the existing 408 tolerance should be lowered.
EPA has decided that it should base its concentration decision upon
the most recent data on residues in raw crops. If those data indicate
that a 408 tolerance should be adjusted, EPA has used the adjusted 408
tolerance level as the basis for its determination whether a 409
tolerance is needed because the pesticide concentrates. The basis for
EPA's determination that a 408 tolerance should be adjusted is in the
docket.
In examining whether a 409 tolerance is needed, EPA followed a
stepwise process involving a series of questions. In brief, the
questions are:
1. Is there actual concentration of residues during processing? If
processing studies demonstrate that the level of residues in the
processed food is less than or equal to the level of residues in the
precursor crop (i.e., no ``concentration in fact''), residues in the
processed food would not be expected to exceed the 408 tolerance and no
409 tolerance is needed.
2. If there is actual concentration, what is the concentration
factor? If there are multiple processing studies, what is the average
CF? Does the use of an average CF in itself alter EPA's determination
of the likelihood of residues in processed food exceeding the RAC
tolerance?
3. Is the commodity mixed or blended during processing, such that
use of the HAFT value is appropriate?
4. Can the pesticide residue in the processed food exceed the
section 408 tolerance, taking into account the HAFT and CF (or average
CF if appropriate).
5. Is the processed food form a not RTE food? If the processed food
is not RTE, a 409 tolerance is not needed for that food. If residues in
a processed not RTE food can exceed the 408 tolerance, EPA will
establish a maximum residue level under FFDCA section 701.
6. What is the likelihood that residues in RTE food can exceed the
408 tolerance? If the dilution of residues in RTE food preparation is
greater than the concentration of residues in processing (DF > CF), it
is likely that the residues in the RTE food will be less than the 408
tolerance. In this case, no 409 tolerance would be necessary for the
RTE food. If, as is frequently the case, there is more than one RTE
food form, EPA must determine whether residues in the food form having
the highest level of expected residues (the lowest dilution factor) can
exceed the 408 tolerance.
If, after consideration of the above factors, EPA determined that a
409 tolerance is needed, EPA then examines whether the existing 409
tolerance violates the Delaney clause.
IV. Is a Processed Food Tolerance Needed?
EPA has determined that under its revised concentration, RTE, and
RAC policies, three 409 tolerances are not needed to prevent
adulterated food, while three 409 tolerances are needed. This unit
discusses the Agency's findings with respect to each pesticide and use.
[[Page 39531]]
A. Acephate in Food Handling Establishments
The current 409 tolerance for the use of acephate in food handling
establishments is 0.02 ppm. Acephate is directly applied in food
handling establishments and residues in processed food are likely to
result from application. Policies on RAC, concentration, and dilution
in RTE foods are not relevant to processed foods where residues result
from direct application rather than carryover from raw foods.
Therefore, a 409 tolerance is needed to prevent adulterated food.
B. Imazalil in Citrus Oil
The current 408 tolerance for residues of imazalil in citrus is 10
ppm (40 CFR 180.413) and the 409 tolerance is 25 ppm (40 CFR 185.3650).
On December 14, 1995, EPA published notice in the Federal Register (60
FR 64163)(FRL-4986-5) of a petition filed by Janssen Pharmaceutica
which sought to revoke the 409 tolerance because it is not needed.
Janssen maintained that citrus oil is not a RTE food, and submitted
data showing the maximum residue of imazalil in RTE foods to be below
the 408 tolerance.
EPA has reviewed the public comments and reconsidered the available
processing studies in light of its RTE policy. EPA agrees with Janssen
that citrus oil is not consumed ``as is,'' and is therefore not a
processed RTE food. Typically citrus oil is incorporated into food such
as candies as a flavoring agent. The minimum level of dilution of
citrus oil in RTE foods (its use in chewing gum) is 238X, and residues
in the RTE food items are not expected to exceed the 408 tolerance of
10 ppm. Therefore a 409 tolerance is not needed.
C. Iprodione on Dried Ginseng
The current 408 tolerance for ginseng is 2 ppm (40 CFR 180.399) and
the 409 tolerance for iprodione on dried ginseng is 4 ppm (40 CFR
185.3750). On June 5, 1996, EPA published notice in the Federal
Register (61 FR 28578)(FRL-5374-8) of a petition filed by Rhone-Poulenc
which sought to revoke the 409 tolerance because it is not needed.
Rhone-Poulenc claims that dried ginseng is not a RTE commodity, and
once diluted to its RTE form, the residues do not exceed the 408
tolerance. No comments were received on the petition.
EPA has concluded that the petition is moot. In response to
comments received on EPA's proposed revocation, EPA has determined that
dried ginseng meets the criteria for a RAC. Ginseng is dried not to
create a new marketable commodity, but as an essential step in
preventing rotting during storage and transportation. EPA's
determination that ginseng is a RAC means that EPA need not further
evaluate Rhone- Poulenc's petition.
However, EPA has not had time since its reclassification of dried
ginseng to provide notice and comment of the RAC classification as a
possible alternate ground for revocation. EPA is obligated under the
terms of its consent order in the California v. Browner case to issue a
final decision on iprodione on dried ginseng by July 18. The basis for
its original proposal has not changed: the current 409 tolerance for
dried ginseng violates the Delaney clause because iprodione induces
cancer within the meaning of the Delaney clause. EPA does not believe
it should simply announce its RAC determination in this final notice
without providing notice and comment. In its discretion, therefore, EPA
is revoking the current 409 tolerance for iprodione on ginseng on
Delaney grounds as proposed.
D. Iprodione on Raisins
The current 408 tolerance for iprodione on grapes is 60 ppm (40 CFR
180.399) and the 409 tolerance for raisins is 300 ppm (40 CFR
185.3750). In the same petition noted above for iprodione/ginseng,
Rhone-Poulenc sought to have EPA revoke the 409 tolerance for raisins
because it is not needed.
Rhone-Poulenc argues that the likelihood of iprodione residues in
raisins from application to grapes is minimal because iprodione use can
be limited to grapes grown for fresh table use by means of a label
statement (``Grapes treated with [iprodione] must not be used to
produce raisins''). The label statement, Rhone-Poulenc states, will be
enforceable for two reasons: First, because grapes intended for fresh
use versus raisin use have sufficiently different cultural practices
that a label limitation based upon ``market segregation'' is practical,
and second, because Rhone-Poulenc will undertake an educational program
to ensure that grape growers, pesticide applicators, State regulators
and raisin producers will be fully informed of the proposed label
prohibition against use of iprodione on grapes intended for raisins.
Rhone-Poulenc also asserts that current tracking systems for pesticide
use in California would provide adequate oversight over the use of
iprodione on grapes, and that contractual arrangements with raisin
producers also would preclude use on grapes intended for raisins.
With respect to the feasibility and effectiveness of ``market
segregation'' based on cultural practices, Rhone-Poulenc suggested that
differences in trellising systems, in pesticides used (use of the plant
hormone gibberellin for fresh grapes) and in irrigation practices would
ensure market segregation. However, Rhone-Poulenc provided no support
for these assertions, such as substantiating information from the
State, grape growers, or raisin producers.
Based on other information available to EPA, it appears that the
cultural practices cited in the petition do occur. However, based on
that information, EPA has concluded that the level of market
segregation between grapes grown for the fresh/wine/juice market and
grapes grown for the raisin market is insufficient to support a finding
that a 409 tolerance would not be necessary to protect the public
health.
The National Academy of Sciences, in their Report on ``Pesticides
in the Diets of Infants and Children'' (1993), states that children may
be a sensitive subpopulation; children differ significantly from adults
in their body systems and potential physiological and biological
responses to pesticide exposures. Information from the USDA National
Food Consumption Survey (1977-78) indicates that children age 1 to 6
consume more than 4 times the amount of raisins on a body weight basis
than the U.S. population at large. Because of this disproportionate
consumption, and the different sensitivities of children to pesticides
in their diet, EPA, as a policy matter, has concluded that it must have
a high degree of confidence that grapes treated with iprodione will not
be diverted to raisin production. The information currently available
to the Agency suggests that complete market segregation between grape
and raisin production cannot be achieved, and that Rhone-Poulenc's
proposed labeling restrictions and education program will not prevent
iprodione residues on raisins.
The Thompson seedless grape is by far the major grape grown for
both fresh table grapes and for raisin production. In addition, while
varietal wine grapes are not used to make raisins, a small percentage
of Thompson seedless grapes that are grown for the wine/juice market
may be made into raisins. Thus there is a significant potential for
crossover or diversion of grapes intended for fresh or wine/juice use
into raisin processing. While there are no data directly addressing the
amount of crossover between grape markets, information from experts and
extrapolated from the
[[Page 39532]]
California Agricultural Statistics Service (contained in the docket)
indicates that a low but relatively constant amount of grapes grown for
fresh use and wine/juice use are diverted into raisin production. The
following Table 2 sets out potential grape diversion to raisin
production.
Table 2.-- Diversion of Grapes to Raisin Production
------------------------------------------------------------------------
Maximum Percentage
Diversion from grapes intended Percentage of of Raisin
for: grapes diverted Production
------------------------------------------------------------------------
Fresh market use................ 1 to 4 percent 1.8 percent
Wine/juice use.................. 1 to 5 percent 1.9 percent
--------------------===================
Total......................... 3.7 percent
------------------------------------------------------------------------
Thus, market segregation based on the cultural practices cited by
Rhone-Poulenc, while substantial, clearly does not account for or
prevent some diversion of grapes to raisins.
EPA's concern about the lack of complete market segregation is
heightened by the fact that grapes for fresh use are likely to be
treated with iprodione more frequently and later in the growing season
than grapes intended for raisins. If diversion occurs late in the grape
season, residues in raisins produced from diverted fresh market grapes
could be significantly higher than in raisins from grapes grown for
raisin production. In years with heavy early rainfall, when natural
drying is not possible, fresh market grapes may be diverted into golden
raisin production (oven-dried) after iprodione application. The
potentially higher risk posed by raisins diverted from fresh/wine/juice
grape production reinforces EPA's belief that complete market
segregation is essential.
In its policy statement of June 14, 1995 (61 FR 31300), EPA
discussed the possibility that market segregation could be used to
determine that a 409 tolerance would not be needed. EPA said that it
believed that total market segregation would be difficult to achieve.
The information available to EPA on grapes/raisins illustrates this
difficulty. Without a clear demonstration that market segregation can
be achieved and monitored, EPA cannot conclude that a labeling
prohibition premised on market segregation would be an effective means
of ensuring that iprodione treated grapes are not used for raisins.
Rhone-Poulenc contends that contractual arrangements govern the
purchase of grapes for raisins and that limitations on iprodione use on
such grapes can therefore be enforced by raisin processors. Even if
true, and the petition provided no information to support this
assertion, contracts for raisin production would not affect the
production of, or pesticides used on, grapes grown for other uses.
Contracts between raisin processors and growers obligate the grower to
sell his grapes to a particular buyer, but may not necessarily be
brought to bear on a grower of fresh market grapes who sells his crop
to a non-contracted raisin processor.
In its June 1995 policy statement, EPA discussed the possibility
that processing industry practices could be taken into account in
determining the likelihood of residues in processed food. One of the
criteria that EPA would need to consider is whether residue levels in
the raw food (grapes) could be adequately monitored by the processing
industry such that EPA could be assured that there is no reasonable
expectation of residues in raisins. EPA has no information on the
residue monitoring practices of the raisin industry, and therefore
cannot evaluate whether grapes bearing iprodione residues could be
adequately detected.
For the same reasons, Rhone-Poulenc's proposed education/
information and labeling proposals, and existing systems for tracking,
authorizing and reporting pesticide use do not alleviate EPA's
concerns. All of these activities focus on ensuring that iprodione is
not used on grapes initially intended for raisins, but do not address
the possibility that grapes grown for fresh or wine/juice use (which
may also be Thompson seedless variety) may be diverted. By the time a
decision is made to divert grapes into raisin processing, iprodione may
have already been applied several times. Systems for tracking pesticide
use do not prevent a grower from selling grapes unusable for the fresh
market to a raisin processor directly. Other grapes may be sold to an
intermediary, who purchases cull grapes or ``strippings'' and funnels
the grapes into whichever processing stream offers the greatest return
(wine/juice or raisins). In this latter case, the grape grower may not
know the destination of his grapes, and the intermediary may not know
whether iprodione has been applied to the grapes.
In sum, EPA believes that complete market segregation is needed,
and is not persuaded on the basis of the available information that
market segregation of grapes can be achieved. EPA therefore denies the
Rhone-Poulenc petition with respect to raisins. Because raisins are a
processed RTE food under EPA's interpretation, a 409 tolerance is
needed.
E. Triadimefon on Milled Fractions of Wheat (Wheat Bran)
The current 408 tolerance for triadimefon on wheat grain is 1 ppm
(40 CFR 180.410) and the 409 tolerance for milled fractions of wheat,
except flour, is 4.0 ppm (40 CFR 185.800). Evaluation of new residue
data indicates that the 408 tolerance should be reduced to 0.2 ppm.
Based on the HAFT of 0.14 ppm for the wheat grain and an average CF of
3.7 in wheat bran, the expected residue in wheat bran is calculated as
0.52 ppm. (The HAFT multiplied by the CF is 0.14 ppm x 3.7 = 0.52
ppm.) Therefore, EPA believes that it is likely that some wheat bran
will contain residues exceeding an adjusted RAC tolerance at 0.2 ppm.
Milled fraction wheat bran is a processed RTE food and needs a 409
tolerance.
F. Triadimefon on Milled Fractions of Barley (Barley Bran)
The current 408 tolerance for triadimefon on barley grain is 1 ppm
(40 CFR 180.410) and the 409 tolerance for milled fractions of barley
(except flour) is 4.0 ppm (40 CFR 185.800). This use is no longer
registered and the 409 tolerance is no longer needed. On June 19, 1996,
EPA published a notice (61 FR 31081)(FRL-5379-7) proposing to revoke
the 408 tolerance for triadimefon on barley grain, forage and straw and
the 409 tolerance on milled fractions of barley because they are not
needed.
In its notice of June 19, 1996, EPA proposed to make the
triadimefon revocations effective as of May 23, 1997. However, the
registration was cancelled in August 1993, effective November 1993,
with provision for sale and distribution of existing stocks of
triadimefon labeled for use on barley until May 1995. More than a year
has passed since the last product bearing the barley use could be sold
and distributed. EPA now believes that this year is sufficient time for
barley treated with triadimefon to have cleared channels of trade.
Since no comments were received indicating that triadimefon is still
being used on barley, EPA is revoking the various barley tolerances on
the same day as the other revocations in this notice (effective 60 days
after publication in the Federal Register). EPA believes that since the
cancellations were at the request of the registrant in August 1993, it
is unlikely that significant amounts of triadimefon were being used on
barley even then. Therefore, this earlier revocation should not result
in economic impacts from loss of use or adulterated barley.
[[Page 39533]]
V. Do Needed Processed Food Tolerances Violate the Delaney Clause?
EPA has determined that 409 tolerances are needed for acephate/food
handling establishments, iprodione/raisins and triadimefon/wheat bran.
And although EPA has determined that a 409 tolerance is not needed for
iprodione/dried ginseng because dried ginseng is a RAC as explained in
Unit IV.C. of this document, EPA has chosen not to revoke the current
409 tolerance on that ground.
If a 409 tolerance is needed to prevent adulterated food, EPA must
determine whether the tolerance is permitted under the Delaney clause,
i.e., whether the pesticide induces cancer within the meaning of the
Delaney clause. In its January 18 proposal, EPA proposed to determine
that acephate, iprodione, imazalil and triadimefon ``induce cancer''
within the meaning of the Delaney clause. Copies of EPA's reviews of
each chemical and other references in this document are available in
OPP docket 300360.
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.)
EPA has considered the comments submitted on the proposed rule, and
has applied this interpretation to the 3 pesticides that need 409
tolerances.
Based on this analysis, EPA concludes that acephate, iprodione, and
triadimefon induce cancer within the meaning of the Delaney clause.
Because EPA has determined that the 409 tolerance for imazalil in
citrus oil should be revoked on grounds other than the Delaney clause,
the Agency is not issuing a final finding that imazalil induces cancer
within the meaning of the Delaney clause.
VI. Revocations
A. Processed Food Tolerances That Are Not Needed
Imazalil/citrus oil. EPA is revoking the 409 tolerance for imazalil
in citrus oil (40 CFR 185.3650). EPA is revoking this tolerance because
the Agency has determined that it is not needed to prevent adulterated
food. As discussed in Unit IV.B. of this document, EPA is revoking this
409 tolerance because citrus oil is not a processed RTE food, and
residues in RTE foods are not likely to exceed the 408 tolerance for
citrus.
Triadimefon/milled fractions of barley. EPA is revoking the 409
tolerance for triadimefon in or on milled fractions of barley (except
flour) (40 CFR 185.800). As discussed in Unit IV.F. of this document,
EPA is revoking this tolerance because the use is no longer registered.
For the same reason, EPA is revoking the 408 tolerances for triadimefon
on barley grain, straw and green forage.
B. Processed Food Tolerances That Violate the Delaney Clause
Acephate/food handling establishments. EPA is revoking the 409
tolerance for acephate in food-handling establishments (40 CFR
185.100). EPA is revoking this tolerance because the Agency has
determined that acephate induces cancer in animals. Thus, the 409
tolerance violates the Delaney clause.
Iprodione/dried ginseng. EPA is revoking the 409 tolerance for
iprodione in dried ginseng (40 CFR 185.3750). As discussed in Unit IV.C
of this document, although EPA has determined that dried ginseng is a
RAC, EPA has chosen to revoke the 409 tolerance because iprodione
induces cancer in animals. Thus the 409 tolerance violates the Delaney
clause.
Iprodione/raisins. EPA is revoking the 409 tolerance for iprodione
in raisins (40 CFR 185.3750). EPA is revoking this tolerance because
the Agency has determined that iprodione induces cancer in animals.
Thus, the 409 tolerance violates the Delaney clause.
Triadimefon/milled fractions of wheat. EPA is revoking the 409
tolerance for triadimefon in or on milled fractions of wheat (except
flour)(40 CFR 185.800). EPA is revoking this tolerance because the
Agency has determined that triadimefon induces cancer in animals. Thus,
the 409 tolerance violates the Delaney clause.
VII. General Comments Common to All Proposed Revocations
Because EPA's proposed revocation of these 409 tolerances was
published prior to EPA's issuance of its modified tolerance-setting
policies, a number of comments were received urging EPA to reconsider
many of those tolerance setting policies, including the coordination,
concentration, RTE and RAC policies. EPA has now adopted these
policies. EPA presumes that the comments pertaining to the
concentration, RTE, RAC and coordination policies were based on EPA's
previous policies, and not to its revised policies. Because these
comments were all previously raised in response to the petition
submitted by the National Food Processors' Association, EPA believes
that it has adequately addressed the comments in EPA's previous
notices, and so has not addressed them again in this document. Readers
should refer to EPA's policy statements of June 14, 1995 (60 FR 31300)
and January 25, 1996 (61 FR 2378, 2386) for a full discussion of the
issues.
Comment. Bayer, Valent, Rhone-Poulenc, and ACPA raised comments
that had previously been raised in response to EPA's proposed
revocation of 26 section 409 FARs, on the grounds that they violate the
Delaney Clause. (59 FR 33941, July 1, 1994). Many of the comments
suggested that EPA has incorrectly applied the legal standard ``induce
cancer'' because EPA failed to duplicate prior FDA practice. The
commenters contend that EPA's application of the standard was not
sufficiently thorough and that EPA had failed to consider relevant
evidence of biologic and mechanistic data, and the relevance of the
results of animal studies to humans. The commenters also assert that
EPA failed to take account of the fact that an ``induce cancer''
finding is appropriate only where the evidence is ``conclusive'', and
that this high standard cannot be met, by definition, where EPA has
classified a chemical as a Group C carcinogen. A Group C carcinogen is
one for which the evidence of carcinogenicity is based on limited
animal evidence that is normally judged to represent insufficient
evidence to support the determination that a chemical is known to cause
or can reasonably be anticipated to cause cancer in humans.
EPA response. EPA has previously responded at length to the issues
raised by the commenters. Rather than repeat the arguments and EPA's
response
[[Page 39534]]
verbatim, a summary of EPA's response follows. Readers should refer to
EPA's March 22, 1996, Final Revocation of Pesticide Food Additive
Regulations for a complete discussion of the issues. (61 FR 11994, and
12000-12002, March 22, 1996).
EPA believes its application of the ``induce cancer'' standard and
the weight of the evidence approach has sufficiently addressed all
relevant evidence. Where commenters have raised questions concerning
how specific data were considered for specific chemicals, EPA has in
this notice or in the docket responded to those comments.
EPA does not believe that it is required to conclude that the
carcinogenicity found in the animal studies is relevant to humans, in
order to conclude that the Delaney clause applies. Once a finding of
animal carcinogenicity is made the operation of the Delaney clause is
``automatic.'' Public Citizen v. Young, 831 F.2d 1108, 1121 (D.C. Cir.
1987), cert. denied, 485 U.S. 1006 (1988). The D.C. Circuit has
previously concluded that the Delaney clause indicates that ``Congress
did not intend the FDA to be able to take a finding that a substance
causes only trivial risk in humans and work back from that to a finding
that the substance does not 'induce cancer in . . . animals.'' Id.
Similarly, EPA may not work back from a conclusion that the results of
an animal study are irrelevant to humans to a finding that the
substance does not induce cancer in animals. Id.
EPA believes that mechanistic and biologic information may be
relevant to the Delaney clause determination on animal carcinogenicity
to the extent such information bears on the question of whether a
substance induces cancer in the test animal. Some mechanistic and
biologic information may have particular relevance to the issue of
causation. However, having said that, EPA recognizes that proper
evaluation under the Delaney clause of mechanistic and biologic
information poses difficult questions. EPA does not believe that EPA or
FDA has ever squarely decided this legal question in taking final
action on a substance under the Delaney clause. Nor does EPA believe
that question needs to be addressed in this notice. Although secondary
mechanism arguments have been raised as to several of the pesticides at
issue in this notice, as discussed below, EPA has decided either as a
factual matter those arguments are not adequately supported or that
there exists other evidence showing cancer induction independent from
any cancer produced through a secondary mechanism.
EPA also disagrees that section 409 and FDA precedent hold EPA to
an unusually high standard to support a finding that a substance
induces cancer for purposes of the Delaney clause. Neither the statute
nor FDA precedent support using any other than the general
administrative standard of proof which is generally described as a
preponderance of the evidence. The relevant words of the statute bar
the establishment of a regulation for a food additive ``found to induce
cancer when ingested by man or animal . . .'' The plain language of the
statute certainly does not impose some extraordinary level of proof.
Comment. Valent and Bayer argue that ``Congress, the courts and
FDA--the agency that has administered the clause the longest and most
often--have all recognized that the [Delaney] Clause simply does not
apply when the results of animal studies create merely the suggestion
that a substance induces cancer.'' The commenters argue that the
studies upon which EPA relied to make its determination that
triadimefon and acephate induce cancer in animals are so seriously
flawed that they merely ``suggest'' the induction of cancer. The
commenters further argue that the General Food Safety clause in section
409 would instead apply, and cites the legislative history of section
409 and FDA's decision regarding the artificial sweetener cyclamate as
support.
EPA Response. The commenters' argument is premised on the assertion
that the Delaney clause imposes an unusually high burden of proof. As
noted above, EPA disagrees with this assertion.
EPA also disagrees with the commenters' assertion that the studies
on which EPA based on its finding of animal carcinogenicity create
merely the suggestion that triadimefon and acephate induce cancer in
animals. EPA believes that the studies provide positive evidence to
support the finding that the pesticides induce cancer in animals.
However, if the commenters are correct that the data are fatally
flawed, then EPA lacks the data to demonstrate that acephate and
triadimefon are ``safe'' for purposes of either the general safety
clause or the Delaney clause. Since the FFDCA places the burden of
demonstrating the safety of the product on the proponent of the 409
tolerance, the lack of reliable data to support the tolerance would
still result in revocation of the 409 tolerance under either clause.
Comment. Bayer commented that EPA has denied them procedural due
process by proposing to revoke the 409 tolerance without simultaneously
proposing to revoke the corresponding 408 tolerances and to cancel the
corresponding pesticide use under FIFRA sec. 6. Bayer asserts that, as
a result of EPA's coordination policy, revoking a section 409 on
Delaney grounds is tantamount to a de facto revocation of the 408
tolerance and cancellation of the use under FIFRA, and that EPA has
failed to make the requisite findings and to comply with the procedural
requirements necessary to complete such actions.
EPA response. EPA disagrees that revoking a 409 tolerance is
tantamount to a de facto revocation of the underlying 408 tolerance and
to cancellation of the use. The revocation of a 409 tolerance does not,
in itself, affect the status of a 408 tolerance or a pesticide
registration. Nor does the revocation of a 409 tolerance have the
effect of revoking the 408 or cancelling the registration. Revocation
of a pesticide's 409 tolerance does not prevent raw food with residues
of the pesticide from travelling in commerce, nor does it prohibit
farmers from using the pesticide on a particular crop.
Moreover, it is not clear that revocation of a 409 tolerance would
necessarily have an effect on the processed commodity. A 409 tolerance
allows processed ready-to-eat food to travel within commerce when
pesticide residues exceed the levels permitted by a 408 tolerance. If
residues remain within the levels permitted by the 408 tolerance,
processed food may legally continue to travel in commerce under the
flow-through provision of section 402(a)(2), regardless of whether a
409 tolerance exists. Until EPA finally revokes the 408 tolerance or
cancels use on wheat, conceivably no impact may be felt from revocation
of the 409 tolerance.
With regard to triadimefon, it is unclear that revocation of the
409 tolerance would have any impact. Bayer asserted that triadimefon
residues in wheat bran fall within the 408 tolerance, and that no
triadimefon residues were found in routine FDA monitoring the processed
food; if that is accurate, then revocation of the 409 tolerance should
have no effect on the current status of wheat bran.
EPA has complied with all of the procedural requirements of the
FFDCA in revoking the 409 tolerance and in proposing to revoke the 408
tolerance for triadimefon on wheat. See 61 FR 8174 (March 1, 1996)(FRL-
5351-6). Further, EPA has clearly stated its policy on coordination
between FIFRA and the FFDCA (January 25, 1996, 61 FR 2378). Congress
has charged EPA with
[[Page 39535]]
administering two statutes with different procedural schemes. As
discussed in EPA's coordination policy, EPA has taken an approach which
harmonizes the two statutory standards to the extent possible. FIFRA
does not require EPA to take action under FIFRA before acting under the
FFDCA. Nor does EPA believe that the rulemaking procedures in the FFDCA
violate Constitutional due process.
Comment. Bayer also commented that EPA would bear the burden of
proof in any hearing under sections 409 or 408 of the FFDCA or under
section 6 of FIFRA. To support this, the commenter cited Director,
Office of Workers' Compensation Programs, Department of Labor v.
Greenwich Collieries, 114 S Ct 2251 (1994). According to the
commenters:
Section 7(c) of the APA is controlling in food additive
hearings, as the FFDCA is silent with regard to the burden of proof
and other procedural issues, and exemptions to the APA are not
lightly presumed. As such, the holding in Greenwich Collieries
applies with equal force and effect to hearings held by EPA under
section 409(f)(1) of the FFDCA. As the proponent of the revocation
action, the agency bears the burden of persuasion and cannot shift
that burden to Bayer or any other party objecting to the revocation
action. EPA's procedural rule, 40 CFR 179.91, which provides for a
contrary result is implicitly overruled by the holding in Greenwich
Collieries.... Indeed, the holding in Greenwich Collieries, supra,
applies with equal force and effect to hearings held pursuant to
FFDCA section 408 and FIFRA section 6. EPA's procedural rules 40 CFR
164.80 and 179.91, and case law which provide for a contrary result
are implicitly overruled. (Bayer Comments, 46-48)
EPA response. EPA disagrees that section 7(c) of the Administrative
Procedures Act (APA) governs the allocation of the burden of proof in
food additive hearings. EPA believes that both the FFDCA and FIFRA
clearly allocate the burden of persuasion to the proponent of the
registration or the tolerance. Consequently, EPA also disagrees that
the holding in Greenwich Collieries has implicitly shifted the ultimate
burdens of proof and persuasion in a hearing under either the FFDCA or
FIFRA, from the proponents of a tolerance or a registration.
The Supreme Court did not consider the FFDCA, FIFRA, or EPA's
regulations allocating the burden of proof in Greenwich Collieries. The
court only examined the question of whether section 7(c) of the APA, in
providing that the proponent of a rule or order has the burden of
proof, has allocated to the proponent merely the burden of going
forward or whether it has also allocated to the proponent the burden of
persuasion. The court also considered whether section 7(c)'s allocation
of the burden of proof applies to adjudications under the Longshore and
Harbor Workers' Compensation Act (LHWCA) and the Black Lung Benefits
Act (BLBA). The Court held that section 7(c) did allocate both the
burdens of production and persuasion, and that section 7(c)'s
allocation applied to both the LHWCA and the BLBA finding that both
statutes explicitly incorporated section 7(c) of the APA.
Section 7(c) of the APA provides that ``[e]xcept as otherwise
required by statute, the proponent of a rule or order has the burden of
proof.'' As both statutes place the burden squarely on the proponent of
registration and of permitting pesticide residues, of demonstrating
that the pesticide product and its residues meet the statutory
standards, both the FFDCA and FIFRA fall within the exception specified
in section 7(c).
The legislative histories of both statutes clearly demonstrate that
Congress intended to place the burden of demonstrating the safety of
the product on the proponents of a registration or a tolerance. e.g.,
H.R. Rep. No. 1125, 88th Cong., 1st Sess., 2 (1964); H.R. Rep. No.
1385, 83d Cong., 2d Sess., 5 (1954); S. Rep. No. 1635, 83d Cong., 2d
Sess., 4 (1954). Case law also supports EPA's interpretation that
section 7(c) of the APA does not apply to FIFRA or the FFDCA. e.g.,
Environmental Defense Fund v. EPA, 548 F.2d 1012, 1015 (D.C. Cir.
1976)(Supplemental Opinion on Petition for Rehearing)(``We hold that in
light of the legislative history of FIFRA, and the numerous cases
holding that its 1964 amendment was specifically intended to shift the
burden of proof from the Secretary to the registrant, this case is one
where the allocation of the burden of proof is, in the language of the
APA, 'otherwise provided by statute.''); Environmental Defense Fund v.
U.S. Dept. of Health Education and Welfare, 428 F.2d 1083,1087, 1092,
n.27 (``In light of Congress' strong concern about the safety of
pesticide residues and the congressional intent to place the burden of
persuasion on those proposing to permit a residue to remain, the fact
that the present petition seeks revocation of an existing tolerance
does not affect the burden of persuasion established by Congress....
Once new evidence bearing on the safety of pesticide residues has been
adduced or cited sufficient to justify reopening the validity of
existing tolerances, as in the present case, the burden of establishing
the safety of any tolerances remains on those who seek to permit a
residue.'').
Comment. Valent and Bayer assert that EPA has failed to conduct a
weight of the evidence review of their chemicals, but is merely relying
on the classification of acephate and triadimefon as ``C'' carcinogens,
which fails to meet the ``high degree of certainty necessary to
conclude that a chemical induces cancer within the meaning of the
Delaney clause, and is inconsistent with EPA's previous acknowledgment
that a Group C classification doesn't equate to a finding that a
chemical is either an animal carcinogen or induces cancer under the
Delaney clause. To support the statement that EPA's assessment is
inconsistent with previous statements, the commenters cite to EPA's
policy statement, Regulation of Pesticides in Food: Addressing the
Delaney Paradox (53 FR 41104, October 19, 1988) and the final rule
revoking the 409 tolerance for dicofol (59 FR 10994, March 9, 1994).
EPA response. EPA's determination that triadimefon and acephate
induce cancer is based on a weight-of-the-evidence review of all
available studies for triadimefon and acephate, not merely on the fact
that EPA had previously classified the chemicals as Group C
carcinogens. And as noted above, EPA does not agree that the Delaney
clause imposes a burden of certainty on the Agency greater than a
preponderance of evidence.
Moreover, the commenter's use of the two notices to support its
assertion is misleading. As EPA acknowledged in the dicofol revocation
cited by the commenter, EPA believes that the language from the 1988
Delaney policy statement referred to by the commenter has only limited
relevance to current decisions because that notice dealt primarily with
whether certain types of pesticides in Group C would come within a de
minimis exception to the Delaney clause. EPA continues to believe, as
acknowledged in the dicofol revocation notice referred to by the
commenters, that it is necessary to carefully examine pesticides
classified in Group C according to the Cancer Assessment Guidelines to
determine whether they meet the Delaney clause's induce cancer
standard, which is exactly what EPA has done in concluding that
triadimefon and acephate induce cancer.
Comment. Bayer and Valent assert that the proposed classifications
of triadimefon and acephate are inconsistent with previous EPA actions,
and are therefore, legally insupportable. The commenters point to more
recent reviews by EPA of pesticides with ``comparable data'' that have
classified those compounds as Group D
[[Page 39536]]
carcinogens, or that have ``otherwise resolved concerns.''
Specifically, the commenters cite EPA's decisions to establish
tolerances for primisulfuron-methyl (55 FR 21547, May 25, 1990),
hexazinone (55 FR 15104, March 22, 1995)(FRL-4935-1), quizalofop-p
ethyl ester (57 FR 24553, June 10 1992) and bromoxynil (60 FR 16111,
March 29, 1995)(FRL-4944-7).
EPA Response. The focus of both Bayer's and Valent's comments
appears to be that EPA has been inconsistent in how it classifies
pesticides with ``comparable'' data as carcinogens. Bayer suggests that
were triadimefon to be evaluated in the same manner as pesticides with
comparable data, or against current scientific standards, it would be
classified as a Group D (insufficient data to classify) rather than as
a Group C carcinogen. Bayer did not elaborate on what study
observations or Agency determinations for the cited pesticides it
considered ``comparable.'' However, its citations are presumably
intended to bolster its point.
Valent, in similar but more extensive comments, detailed the
Agency's findings on mouse liver tumors observed for quizalofop-ethyl,
primisulfuron-methyl and hexazinone (bromoxynil was not mentioned in
Valent's comment). Valent raised points concerning the type of tumors
(malignant/benign), the dose levels at which tumors were observed (the
MTD was exceeded), the historical incidence of liver tumors in mice,
the statistical significance of the findings (trends versus pairwise
comparisons), and other specific factors that it believes illustrate
EPA's lack of consistency in its cancer classifications.
As a scientific matter, a weight-of-the-evidence approach to
determining the classification of a carcinogen is inherently inexact. A
number of factors must be considered, including all those mentioned by
Valent, and these factors weighed against each other. Thus, even with
apparently comparable data, under a weight-of-the-evidence approach, it
is scientifically valid and even to be expected that EPA should arrive
at different conclusions that lead to different cancer classifications.
EPA's cancer peer review documents explain the relevance of each factor
in EPA's classification decision.
However, the finding that a pesticide ``induces cancer in man or
animals'' within the meaning of the Delaney clause is more
straightforward and less scientifically onerous, since it requires only
a finding of carcinogenicity in animals. Since cancer studies are
conducted using animals, the data can directly demonstrate whether a
pesticide does or does not result in cancer in animals. The cancer
classification system used by EPA since 1986, on the other hand,
focusses on cancer risk to humans. It is entirely possible that EPA
could determine that a pesticide classified as a Group D carcinogen
(insufficient data for humans) meets the ``induce cancer'' standard for
animals. Under the Delaney clause, this is all that is required.
Accordingly, EPA disagrees with comments purporting to find flaws
in EPA's ``induce cancer'' determination based on perceived
inconsistencies in cancer classification for humans or comparability of
cancer profiles within the classification system. Notwithstanding
differences in classification among acephate, triadimefon and other
chemicals apparently similarly situated, a preponderance of the
evidence demonstrates that both triadimefon and acephate induce cancer
in animals.
In the case of triadimefon and acephate, however, EPA classified
those chemicals as C carcinogens based upon stronger evidence of
carcinogenicity than was found with the four pesticides cited by Valent
and Bayer as having comparable cancer profiles but which were
classified only as Group D carcinogens. For both acephate and
triadimefon, liver tumors were observed in a pairwise manner at dosages
that were not determined to be excessive. In the case of acephate, the
tumors were heavily malignant in female mice. In the case of
triadimefon, although only benign adenomas were seen, they were found
in a pairwise comparison in both sexes at doses clearly under the MTD.
In each of the other cases, either the tumors were observed only at
excessive doses (primisulfuron-methyl and quizalofop-ethyl) or showed
only a trend for liver tumors that was not statistically significant
upon pairwise comparison (hexazinone). A trend for expression of tumors
is a less significant finding than a pairwise comparison and would not
in itself normally lead to a positive cancer classification. Although
Bayer claims that EPA had determined that bromoxynil is a Group D
carcinogen, EPA has always classified bromoxynil as a Group C
carcinogen. The FIFRA Scientific Advisory Panel recommended a Group D
classification, which EPA did not adopt.
Comment. Bayer also argued that EPA has applied a ``shifting
definition of what it means to 'induce cancer' for purposes of the
Delaney clause,'' citing the final regulation revoking 409 tolerances
for benomyl, mancozeb, phosmet and trifluralin (58 FR 37863, July 14,
1993), the proposed revocation for several 409 tolerances found to be
inconsistent with the Delaney clause (59 FR 33942, July 1, 1994), and
the proposed revocation for triadimefon (60 FR 3608, January 18, 1995).
EPA response. It is true that the definition of ``induce cancer''
in the first two notices referred to by the commenter do not include,
as cancer, the class in which only benign neoplasms occur. However, EPA
disagrees that this is a substantive change to its interpretation of
``induce cancer.'' EPA's interpretation is supported by the court in
California v. Browner, which agreed that the change was not
substantive. No.Civ. S-89-0752, slip op. at 5 (E.D. Cal. Feb. 1995)
VIII. Comments Related to Specific Pesticides
A. Acephate
Comment. Valent contended that acephate does not induce cancer
because the MTD was exceeded in the mouse study, and that testing at
lower dose levels which showed no evidence of carcinogenicity should be
used. Valent also proposes a secondary mechanism for carcinogenesis of
acephate, based on upon a theory that acephate at high doses alters the
homeostasis of female mice such that they are phenotypically similar to
male mice in their expression of liver tumors.
EPA Response. EPA believes that the high dose used in the study
represents an MTD that was well-tolerated by the test animals.
Moreover, the toxicity seen at the high dose level does not alter the
finding of malignant liver carcinomas at that dose. With respect to the
hypothesis that acephate causes female mice to respond as if they were
male mice, Valent provided little support for this hypothesis.
Moreover, it is uncertain that this hypothesis has been peer reviewed
or found acceptance in the scientific community. In the absence of any
data to support its contentions, EPA believes that the acephate induces
cancer in animals.
Comment. Valent also raised a number of points concerning the
individual mutagenicity studies for acephate, suggesting that they are
flawed by today's scientific standards, and thus do not support an
induce cancer determination.
EPA Response. Although individually, Valent's points may have
merit, the mutagenicity data base is considered in its entirety and
only in a supporting capacity to a determination of carcinogenicity.
That is, while positive evidence of genotoxicity may support a weight
of evidence finding that a pesticide is carcinogenic, the lack
[[Page 39537]]
of a complete mutagenicity data base, or deficiencies or negative
results in individual mutagenicity studies, do not negate positive
cancer findings in other studies. Acephate's mutagenicity studies,
while perhaps less than optimal by today's standards as noted by
Valent, overall showed consistently positive responses in in vitro
studies, and in any case do not negate the clear finding that acephate
induces cancer in animals.
Comment. Valent argued that the 409 tolerance for acephate is not
needed, for several reasons. Valent argues that EPA improperly requires
a 409 tolerance for every use in a food handling establishment without
regard to whether residues actually occur. They further state that use
of acephate does not result in finite residues, that no finite residues
have ever been found, and that EPA's establishment of the 409 tolerance
at the level of quantification implicitly recognizes that no residues
are expected to be present. Finally Valent states that, since the 409
tolerance is not needed, the use of acephate need not be cancelled, and
that it is in the public interest to retain the use.
EPA Response. Contrary to Valent's assertion, EPA does not
``automatically'' require a food additive tolerance for all pesticides
used in food handling establishments. EPA considers the nature of the
pesticide and how it is applied in determining whether residues are
likely to result in food, and therefore that a 409 tolerance is needed.
For example, an insecticidal bait enclosed in a ``bait station'' would
normally not require a 409 tolerance because the use is not likely to
result in residues in food. Bait station uses in which the pesticide is
contained are, however, a far cry from typical food handling
establishment insecticide applications, which are applied in an
relatively uncontained manner through sprays and dusts. While a crack
and crevice treatment (such as that for acephate) may be less likely to
result in residues in food than a broad general treatment, EPA believes
that there is sufficient likelihood that residues may occur from crack
and crevice treatments that the pesticide is a food additive for which
a 409 tolerance will normally be needed.
Valent goes on to assert that ``no detectable residues have ever
been found'' in food, and would not be expected to result from its use
pattern. Valent cited in support of its contention a 1981 study in
which acephate was applied at twice the maximum label rate, and
residues were not found above the limit of detection.
However, in this study, residues were found in some samples at
close to the detection limit. At an application rate of 1 percent
active ingredient, residues were found in lettuce at 0.02 ppm and in
cheese at 0.009 ppm, at or close to the limit of detection of 0.01 ppm.
At 2X rates, quantifiable residues were found in lettuce (0.034 ppm),
meat (0.016 ppm), bread (0.023 ppm) and apple juice (0.011 ppm), all
above the limit of detection. Thus at a 2X rate, finite residues at or
above the level of detection can be expected. Valent's study clearly
demonstrates that quantifiable residues can result in at least some
foods at label rates. It is difficult to argue that these data
demonstrate that residues are not likely to be present.
For several reasons, EPA believes that it needs a demonstration of
no residues using highly exaggerated rates (considerably higher than
2X) to be persuaded that there is no reasonable expectation of residues
in food such that a 409 tolerance is not needed. First, food handling
establishments cover a wide range of operations, from processing
facilities such as bakeries, canneries and dairies, to restaurants and
grocery stores. Thus the circumstances under which food might be
exposed to the pesticide may vary considerably in a manner that is
difficult to capture in a single residue study. Second, EPA requires
residue studies using a representative but relatively limited set of
foods, which is necessary given the number and variety of foods that
may be present in a food handling establishment and the impracticality
of determining residues for all foods individually.
Valent cites its label instructions and admonitions as further
support of their contention that the use pattern would not be expected
to lead to residues in food. Even within the permissible label
instructions, however, the actual application of the pesticide may
vary. Applicators may mix and apply the pesticide differently, using
application equipment and techniques that lend themselves to higher
amounts of actual pesticide deposited. Moreover, the applicator's
ability to physically control the application so as to comply with
label admonitions about food and surface contact may be highly
variable. While label instructions and warnings if followed will
minimize the possibility that the pesticide will contact food or food
surfaces, they still allow considerable judgment and skill on the part
of the applicator. The applicator cannot know the extent to which he
has been successful in his efforts to ``avoid contamination of food''
or to ``use care to avoid depositing the material onto exposed surfaces
or introducing the material into the air.'' EPA cannot rely on the fact
of label instructions as assurance of success in precluding residues in
food, particularly in light of data that demonstrate actual residues in
food from application according to label instructions.
Moveover, the presence of residues from a particular application is
not totally dependent on how well the applicator can comply with label
instructions. Factors unrelated to the application itself, and
therefore unrelated to label instructions, may contribute equally to
residues in food. Environmental factors such as temperature, humidity,
and ventilation, and product characteristics such as volatility cannot
be controlled by the applicator. Therefore, label instructions alone
are not sufficient proof that residues will not result from
application.
EPA categorically rejects Valent's claim that EPA's use of the
level of quantitation as the numerical tolerance level implies that EPA
believes that there is no reasonable expectation of residues from use
of acephate in food handling establishments. EPA has never so stated.
Moreover, the data cited by Valent in its comments indicate that
residues close to the detection limit of the analytical method are
possible under actual use conditions. The Agency believes it is
appropriate in these circumstances to set numerical tolerance limits,
especially considering the potential variability in foods, exposures,
and application that may result in quantifiable residues. Accordingly,
tolerances are established at the limit of quantitation of the
analytical method. This is a logical approach to the regulation of
residues generally in food handling establishments, and cannot be read
as supporting any EPA belief that residues are unlikely to occur.
Finally, since EPA believes that use of acephate requires a 409
tolerance which is not permitted under the Delaney clause, arguments
concerning public health considerations or the benefits of use are not
relevant to EPA's decision to revoke the FAR for acephate. The Delaney
clause does not permit such considerations.
B. Triadimefon
Comment. Bayer comments that a 409 tolerance on milled fractions of
wheat is unnecessary, because milled fractions of wheat are not ready-
to-eat.
EPA response: EPA considers that milled fractions of wheat, or
wheat bran, are ready-to-eat human food, as EPA noted in its notice
proposing to revoke
[[Page 39538]]
the 408 tolerance for wheat (61 FR 8189, March 1, 1996).
Comment. Bayer argues that the residues of triadimefon do not
concentrate above the 408 tolerance, and thus EPA should revoke the 409
tolerance on the grounds that it is unnecessary. Bayer asserts that EPA
based its determination that a 409 tolerance for triadimefon was
necessary on processing studies that do not reflect the current label
of the registered pesticide product, and that EPA has failed to
consider the degree to which triadimefon residues are further diluted
by mixing and blending with untreated wheat, and by further dissipation
of residues during the time the food leaves the processor until it
reaches the supermarket shelf.
To prove that residues in wheat bran do not exceed the 408
tolerance, Bayer relies on ``extensive monitoring data'' conducted by
industry and FDA to support its argument, and points generally to 27
FDA market basket surveys and samples collected under FDA's regulatory
monitoring program. More specifically, Bayer asserts that as part of
its routine monitoring, FDA tested 86 samples of whole grain wheat and
178 various food forms of wheat for levels of triadimefon between the
years of 1985-1992. None of the 264 samples contained residues of
triadimefon above the analytical limit of quantification. Bayer asserts
that these data are ``slanted towards high residue situations'' and
thus are ``worst case surveillance conditions.''
Finally, Bayer argues that EPA is legally required by the language
of the flow-through provision and the statutory definition of a food
additive to determine whether a 409 tolerance is needed based on the
measured residues on the actual commodities and not on theoretical
calculations that do not reflect actual use practices or label
requirements. All of the commenters raised some variant of this
argument in their comments. According to Bayer, the definition of a
food additive requires that the intended use of a substance must
actually result in, or reasonably be expected to result in, directly or
indirectly, the substance becoming a component of food. Based on the
current label for triadimefon and based on the likelihood of additional
dilution and degradation of residues from current processing methods,
Bayer asserts that EPA can have no reasonable expectation that
triadimefon residues will be present in processed foods at levels above
the 408 tolerance.
EPA Response. EPA disagrees with the commenter's assertion that EPA
improperly failed to consider several factors that could result in
significantly diluted residues in wheat bran and that EPA improperly
relied on studies that do not reflect current triadimefon use
practices. EPA based its determination that triadimefon residues in
wheat bran were likely to exceed the 408 tolerance on processing
studies demonstrating that triadimefon residues were present at higher
levels in wheat bran than in wheat.
EPA has considered that triadimefon residues will be diluted by
mixing and blending of treated wheat. In accordance with the policy
discussed in its June 1995 policy statement (60 FR 31305, June 14,
1995), EPA compared the highest average residue values from field
trials times the concentration factor to the 408 tolerance, and
determined that residues in wheat bran would likely exceed the 408
tolerance. As EPA noted above, the average concentration factor in the
processing of milled fractions of wheat is 3.7 and the HAFT for
triadimefon on wheat is 0.14 ppm. Because multiplying the average
concentration factor by the HAFT exceeds the adjusted section 408
tolerance for triadimefon on wheat (0.2 ppm), EPA believes that it is
likely that some milled fractions will contain residues exceeding the
408 tolerance.
It is true that EPA did not consider the extent to which farmers
may be applying triadimefon at lower rates, or the extent to which
wheat bran containing triadimefon residues is mixed with wheat
containing no residues, but for the reasons discussed at 60 FR 31302-
31306, EPA has determined that such considerations would be
inappropriate. It is also true that EPA did not consider further
degradation of residues during the time the food leaves the processor
until the moment it is actually eaten, but it is not apparent how EPA
could take this into account, other than to the extent the effects of
degradation are captured in the processing study. In any event, if
wheat bran at one stage of its production and marketing has residues
that exceed the 408 tolerance, it is no defense to a charge of
adulteration that at some later time in the production and marketing
scheme residues will be below the 408 tolerance. EPA has also
previously discussed the rationale for this decision at length in 60 FR
31305.
Further, EPA does not conduct studies to support the registration
or tolerance for a particular pesticide. FIFRA and the FFDCA clearly
place that responsibility on the manufacturer seeking to register or to
establish a tolerance for a pesticide product. To the extent that EPA
is relying on data that Bayer believes no longer reflects actual
conditions of triadimefon use, it is Bayer's responsibility to submit
new processing studies that accurately reflect whether triadimefon is
likely to concentrate above the 408 tolerance. Under the statutory
scheme, which requires EPA to rely on data conducted by manufacturers
to determine whether a tolerance level is safe, EPA is legally
justified in basing its regulatory decisions on the data presented to
it. Should Bayer submit new processing studies EPA will consider the
data, as appropriate.
As EPA has previously noted at 60 FR 31305-31306, the Agency bases
its concentration determinations primarily on whether processing
studies show that the processing of a commodity results in a level of
residues in the processed food which is greater than the level of
residues in the raw food. However, EPA has acknowledged that it would
consider data from marketplace studies and FDA monitoring, where
circumstances permit. The relevance of marketplace studies, however,
would depend on how the marketplace study was conducted. For example,
the principal reason marketplace studies have been conducted in the
past is to obtain better data concerning actual residue values close to
the point at which food is consumed. Thus, marketplace studies
generally involve sampling commodities in retail grocery stores. A
tolerance for processed food would not only apply to foods in retail
stores, but at all prior points at which the food moved in interstate
commerce. This fact would need to be taken into account in assessing
the relevance of a marketplace study in determining the likelihood of
residues in processed food in excess of the 408 tolerance.
Monitoring data can also be relevant to determining the likelihood
of processed food exceeding the 408 tolerance. However, FDA monitoring
data, especially monitoring data on processed foods, generally have
been limited and thus may not be a reliable predictor of the level of
residues of triadimefon in milled fractions of wheat. The monitoring
referred to by the commenter is not so thorough and reliable that it
would cause EPA to ignore the results of the processing studies.
Comment. Bayer contends that triadimefon does not induce cancer
because the high doses used in both rat and mice studies exceeded the
maximum tolerated dose (MTD), and thus tumors seen at these levels are
not related to administration of triadimefon. Bayer also asserted that
the mid-dose level of these studies did provide an adequate MTD for
purposes of
[[Page 39539]]
evaluating the carcinogenic potential of triadimefon. Therefore Bayer
argues that carcinogenic potential should be evaluated on the basis of
the findings at the mid-dose level rather than the purportedly
excessive high dose level. Bayer also cited the fact that mutagenicity
studies showed that triadimefon is not genotoxic or mutagenic.
EPA Response. EPA disagrees with Bayer that the data from the high
dose were not appropriate to consider in making the ``induce cancer''
determination, and also that the mid-dose was adequate in these
studies. In both the rat and mouse studies, the high dose (1800 ppm) is
considered adequate because there were no signs of excessive toxicity
at that level. Moreover, the mid-dose level in each study (300 ppm) was
not considered adequate as an MTD because the effects seen at that
level were relatively minor increases in liver enzyme levels and liver
weight, as well as slight to moderate liver hypertrophy and cell
changes. EPA does not consider these changes adequate to demonstrate
that an MTD has been achieved. By comparison, at the high dose level
(which still did not show excessive toxic effects), liver effects were
more pronounced, and included (in the rat) increased food consumption,
increased fat in the liver, significant physiological and cellular
changes in liver cells and formation of hyperplastic nodules. Similar
evidence of increased liver damage was seen in the mouse at the high-
dose level.
As stated in EPA's response on acephate, mutagenicity studies are
considered only supporting evidence of carcinogenicity and do not
negate clear evidence of carcinogenicity from other studies.
Comment. Bayer argued that the increase in follicular cell thyroid
adenomas seen in the rat study occurred as a result of a hormonal
effect, an increase in thyroid stimulating hormone, and thus is not
directly caused by the triadimefon.
EPA Response. In its final notice revoking tolerances for mancozeb
on oat bran (March 22, 1996, 61 FR 12003), EPA noted that the legal
relevance of secondary mechanisms claims to the Delaney clause ``induce
cancer'' finding has not been resolved. In that notice EPA also
specifically discussed whether thyroid tumors could be demonstrated to
occur via a secondary mechanism and the scientific information needed
to support such a contention. Bayer has submitted no such information.
EPA reiterates its position on thyroid tumors as stated in that notice.
With respect to triadimefon, EPA has determined that, independent of
any possible secondary mechanism that might be operating for the
thyroid adenomas, the hepatocellular adenomas were related to the
administration of triadimefon, and thus the question of a secondary
mechanism need not be addressed.
C. Iprodione
Comment. Rhone-Poulenc argued that a 409 tolerance for iprodione in
raisins is not required because (1) raisins should be classified as a
RAC; and (2) because, even if not a RAC, iprodione does not concentrate
in raisins above the 408 tolerance for grapes.
EPA Response. As noted in Unit VII, these revocations were proposed
before EPA modified its tolerance policies in June 1995 and January
1996. Comments on the RAC status of dried commodities have been
addressed in the Agency's interpretive policy of January 25, 1996 (61
FR 2386), in which EPA concluded that raisins are a processed food
because they are dried for the purpose of creating a new marketable
commodity, and not incidental to storage or transportation needs of the
raw agricultural commodity grapes.
With respect to the assertion that residues in grapes do not
concentrate in raisins, Rhone-Poulenc cited studies previously
submitted in 1982 and 1983 in which residues in raisins did not exceed
the current 60 ppm tolerance in grapes. Rhone-Poulenc, however, failed
to note in its comments that in 1994, it petitioned EPA to reduce the
tolerances for both grapes (from 60 ppm to 10 ppm) and raisins (from
300 ppm to 50 ppm). In conjunction with the petition and to satisfy
reregistration data requirements, Rhone-Poulenc submitted additional
residue data. These data show that the HAFT for grapes is 4.1 ppm, and
the average CF, based on 8 sets of processing studies, is 3.56. The
simple calculation of likely residues in raisins, therefore (4.1 ppm X
3.56 = 14.6 ppm), shows that residues would exceed the proposed 10 ppm
tolerance in grapes. As noted in Unit III, EPA is using its latest
residue data to inform its decisions on revocation of tolerances under
the Delaney clause.
Comment. Rhone-Poulenc raised secondary mechanism issues associated
with iprodione, namely that Leydig cell tumors seen in male rats are
caused by a ``mechanism operative only at the high test doses'' and the
ovarian tumors observed in female mouse studies are caused by ``a
prolonged and profound perturbation of sex hormone regulation at the
target organ level.'' Moreover, Rhone-Poulenc asserts that the Leydig
cell tumors have no relevance to humans.
EPA Response. In neither case were supporting data submitted to
demonstrate that these speculative mechanisms of action occur. In the
absence of any evidence of the plausibility of the secondary
mechanisms, EPA considers the observed tumors to be evidence that
iprodione induces cancer in animals. EPA cannot judge the argument that
Leydig cell tumors are not relevant to humans, since, from the data
currently available to EPA, no specific mechanism of action of any
hormonal alteration has been clearly characterized for iprodione. In
any event, whether tumors observed in animals are relevant to humans
has no bearing on a determination that iprodione induces cancer in
animals.
Comment. Finally, Rhone-Poulenc also contended that liver tumors in
mice were observed only at dose levels at the MTD.
EPA Response. EPA considers the dose level to be adequate (but not
excessive) in both rat and mouse studies for the purpose of assessing
carcinogenicity.
Commenters on acephate, iprodione and triadimefon all raised the
issue of the MTD, and suggested that tumors observed only at dosage
levels above the MTD should not be considered to support an ``induce
cancer'' finding. Indeed, each suggested that unless tumors result at
levels that do not express ``excessive'' non-cancer toxicity, EPA
should reverse its finding that the pesticide induces cancer.
EPA Response. EPA disagrees in each case with commenters that
dosage levels were excessive, and believes that the tumors are
attributable to the pesticide in question.
IX. Procedural Matters
A. Filing of Objections and Requests for Hearings
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections to the regulation and may also request a hearing on
those objections. Objections and hearing requests must be filed with
the Hearing Clerk, at the address given above (40 CFR 178.20). A copy
of the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
[[Page 39540]]
statement of the factual issue(s) on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the objector (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issue(s) in the manner sought by the requestor would be
adequate to justify the action requested (40 CFR 178.32).
Any person wishing to comment on any objections or requests for a
hearing may submit such comments to the hearing Clerk on or before
September 12, 1996.
B. Effective Date
This final rule is effective September 27, 1996. In addition, if
EPA does not receive objections to this order, this order and the
factual and legal basis for this order, become final and are not
judicially reviewable. See section 409(g)(1), 21 U.S.C. 348(g)(1) and
Nader v. EPA: 859 F.2d 747 (9th Cir. 1988), cert. denied, 490 U.S. 1931
(1989). For example, if an interested person disagrees with a necessary
finding in this order but agrees with the outcome, that person must
file timely objections to that finding in this order; if no objection
to the finding is made, the finding will become final for purposes of
any future proceedings to which that finding is relevant.
C. Request for Stays of Effective Date
A person filing objections to this final rule may submit with the
objections a petition to stay the effective date of this final rule.
Such stay petitions must be submitted to the Hearing Clerk on or before
August 28, 1996. A copy of the stay request filed with the Hearing
Clerk shall be submitted to the Office of Pesticide Programs Docket
Room. A stay may be requested for a specific time period or for an
indefinite time period. The stay petition must include a citation to
this final rule, the length of time for which the stay is requested,
and a full statement of the factual and legal grounds upon which the
petitioner relies for the stay. In determining whether to grant a stay,
EPA will consider the criteria set out in the Food and Drug
Administration's regulations regarding stays of administrative
proceedings at 21 CFR 10.35. Under those rules, a stay will be granted
if it is determined that:
(1) The petitioner will otherwise suffer irreparable injury.
(2) The petitioner's case is not frivolous and is being pursued in
good faith.
(3) The petitioner has demonstrated sound public policy grounds
supporting the stay.
(4) The delay resulting from the stay is not outweighed by public
health or other public interests.
Under FDA's criteria, EPA may also grant a stay if EPA finds such
action is in the public interest and in the interest of justice.
Any person wishing to comment on any stay request may submit such
comments and objections to a stay request to the Hearing Clerk, on or
before September 12, 1996. Any subsequent decisions to stay the effect
of this order, based on a stay request filed, will be published in the
Federal Register, along with EPA's response to comments on the stay
request.
D. Public Docket
A record has been established for this rulemaking under the docket
number [OPP-300360B] (including any comments and data submitted
electronically). 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 22202.
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 any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rule-making record
which will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
X. Regulatory Assessment Requirements
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not ``significant.'' Nevertheless, EPA submitted this action
to the Office of Management and Budget (OMB) for an informal review.
Any changes made during that review have been documented in the public
record.
Three of the 409 tolerances being revoked today because they
violate Delaney (iprodione/raisins and ginseng and triadimefon/wheat)
also have 408 tolerances. If the uses and 408 tolerances remain in
effect without needed 409 tolerances (prohibited by the Delaney
clause), lawfully treated foods could potentially be adulterated, and
subject to seizure. In each case, however, EPA believes that there is
little likelihood of adulterated food.
Raisins. Grapes grown for raisins are generally not extensively
treated for Botrytis rot (the almost exclusive use of iprodione in
California). Grapes intended for fresh market are more likely to be
treated with iprodione because they may be exposed to late-season rain,
or need protection against rotting in post-harvest storage. A grower
whose grape crop is intended for raisins is likely to make that
decision early in the season because of the differing cultural
practices that are employed in fresh market production, and thus will
not typically use significant amounts of iprodione.
Iprodione is used on approximately 9 percent of the total grape
acreage in California. EPA has little information on use of iprodione
segregated by the intended use of grapes, but estimates that iprodione
is used on less than 4 percent of grapes intended for raisins, but up
to 20 percent of grapes for fresh market use.
In 1994, total California grape production was 5.253 million tons
of fresh grapes (California Agricultural Statistics Service, September
1995). Of that total, 36 percent was dried into raisins. If iprodione
were applied equally to all grapes, regardless of ultimate use, a
maximum of 170,200 tons of raisins containing iprodione residues could
be estimated (.09 x .36 x 5.253 million tons). However, as noted,
EPA believes this is a significant overestimate, since in typical years
grapes intended for raisins would seldom be treated with iprodione.
Similarly, in typical years, grapes grown for the fresh market would
not be
[[Page 39541]]
expected to be diverted to the raisin market in large quantities, and
all raisins produced from iprodione-treated grapes would not be
expected to contain residues above the RAC tolerance. Accordingly,
although EPA believes that revocation of the 409 tolerance for
iprodione on raisins would result in some raisins being subject to
seizure, the Agency estimates that the tonnage of raisins subject to
seizure would not be substantial taking into account annual production
figures. However, as noted earlier, evidence shows that some percentage
of the grape crop is diverted to raisin production.
Wheat. Today's action does not affect the current 408 tolerance for
wheat, which will remain in effect. As noted in Unit IV.E, EPA
estimates that residues in wheat bran based on recent residue data can
be expected to be as high as 0.5 ppm. While such residues would exceed
an adjusted 408 tolerance of 0.2 ppm, they are not likely to exceed the
existing 1 ppm tolerance. In any event, as noted in EPA's proposed
revocation of the 408 tolerance for wheat (March 1, 1996, 61 FR 8174),
triadimefon use on wheat is insignificant (generally in the range of 1
percent or less), and thus the potential for seizure of large amounts
of wheat bran is low.
Ginseng. Today's action does not affect the current 408 tolerance
for ginseng of 2 ppm (Sec. 180.399). EPA believes that, at this level,
there may be some adulterated ginseng, but does not have sufficient
information to estimate how much. Residue field trial data from
Wisconsin (which produces 90 percent of ginseng) conducted at the
maximum label rate and minimum pre-harvest interval (PHI) of 36 days
indicate that residues in fresh and dried ginseng were below the 2 ppm
RAC tolerance. Other data from North Carolina indicate that residues in
dried ginseng could be as high as 3.3 ppm, but these data were based on
a shorter PHI than allowed by the label. From this limited field trial
data, EPA cannot determine whether the existing 2 ppm tolerance is
adequate to cover residues in all dried ginseng.
Food handling establishments. For the purposes of this economic
analysis, EPA has assumed that revocation of the 409 tolerance for use
of acephate in food handling establishments results in the elimination
of this use. EPA estimates that discontinuing the use of acephate in
food handling establishments will cause negligible overall economic
impact, since there are numerous cost-effective alternatives for insect
control in food handling establishments.
Target pests in food handling establishments are cockroaches and
stored product pests. Any impacts that would occur would most likely be
where acephate is used for cockroach control, not for stored product
insect control. For cockroach control alternatives include, but are not
limited to, chlorpyrifos, cyfluthrin, boric acid, hydramethylnon,
diazinon, propetamphos, and bendiocarb. Acephate has quick
``knockdown'' capability, and less resistance problems than most quick
knockdown alternatives, but there are sufficient alternatives that EPA
believes economic impacts from the loss of acephate will not be
significant.
Barley. EPA is today revoking both raw food and processed food
tolerances for triadimefon on barley because they are not needed. The
impacts associated with the revocation of the 408 tolerance on barley
are expected to be minimal because the use of triadimefon on barley was
cancelled by the registrant in August 1993. EPA believes that the three
years that have elapsed are sufficient for existing stocks of product
and treated barley to clear channels of trade.
Citrus oil. For this 409 tolerance, the 408 tolerance and
registered use will remain effective, and therefore, no impact is
expected.
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the
Agency must consider whether a regulatory action will have an adverse
economic impact on small entities. Section 605(b) requires the Agency
to either certify that the regulatory action will not have a
significant economic impact on a substantial number of small entities,
or prepare a regulatory flexibility analysis. For the reasons cited in
Unit X.A. of this document, EPA certifies that this regulatory action
does not impose significant adverse economic impacts on a substantial
number of entities, large or small. Therefore, a Regulatory Flexibility
Analysis is not required.
C. Paperwork Reduction Act
This order does not contain any information collection requirements
subject to review by Office of Management and Budget under the
Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq.
D. Unfunded Mandates Reform Act and Executive Order 12875
Under Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4), this action does not result in the expenditure of $100 million
or more by any State, local or tribal governments, or by anyone in the
private sector, and will not result in any ``unfunded mandates'' as
defined by Title II.
Under Executive Order 12875 (58 FR 58093, October 28, 1993), EPA
must consult with representatives of affected State, local, and tribal
governments before promulgating a discretionary regulation containing
an unfunded mandate. This action does not contain any mandates on
States, localities or tribes and is therefore not subject to the
requirements of Executive Order 12875.
E. Review by Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted
a report containing this rule and other required information to the
U.S. Senate, the U.S. House of Representatives and the Comptroller
General of the General Accounting Office prior to publication of the
rule in today's Federal Register. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2) of the APA as amended.
List of Subjects
40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, report and
recordkeeping requirements.
40 CFR Part 185
Food additive, Pesticides and pests.
Dated: July 18, 1996.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Therefore, 40 CFR Chapter I, Subchapter E, is amended as follows:
1. In part 180:
PART 180--[AMENDED]
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
Sec. 180.410 [Amended]
b. By removing from the table in Sec. 180.410 the entries for
``Barley, grain,'' ``barley, green forage,'' and ``barley, straw.''
2. In part 185:
PART 185--[AMENDED]
a. The authority citation for part 185 continues to read as
follows:
Authority: 2l U.S.C. 346a and 348.
[[Page 39542]]
Sec. 185.100 [Removed]
b. By removing Sec. 185.100.
Sec. 185.800 [Removed]
c. By removing Sec. 185.800.
Sec. 185.3650 [Removed]
d. By removing Sec. 185.3650.
Sec. 185.3750 [Removed]
e. By removing Sec. 185.3750.
[FR Doc. 96-19076 Filed 7-26-96; 8:45 am]
BILLING CODE 6560-50-F
