FLUORIDE ACTION NETWORK PESTICIDE PROJECT
Return to FAN's Pesticide Homepage
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Cyfluthrin. July 29, 1996. Suggested as an alternative for the pesticide Acephate for cockroach control in food handling establishments. EPA determined that Acephate induces cancer under the Delaney Clause. Federal Register.
Note from FAN:
References to cyfluthrin and trifluralin are in this Notice.
http://www.epa.gov/docs/fedrgstr/EPA-PEST/1996/July/Day-29/pr-817DIR/pr-817.txt.html
Federal Register: July 29, 1996 (Volume 61, Number 146)] [Rules and Regulations][[Page 39527]]
Part IV
Environmental Protection Agency
40 CFR Parts 180 and 185
Revocation of Pesticide Food Additive Regulations; Final Rule
[[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
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
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.
CFRPesticide Citation Commodity Basis for Revocation
Imazalil................................. 185.3650 Citrus oil Not neededIprodione................................ 185.3750 Dried Ginseng Violates Delaney
Iprodione................................ Do. Raisins Violates DelaneyTriadimefon.............................. 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:
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:
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 PercentageDiversion from grapes intended Percentage of of Raisin for: grapes diverted Production
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 readyto -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 highdose 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:
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