FLUORIDE ACTION NETWORK PESTICIDE PROJECT
Return to FAN's Pesticide Homepage
Return to Oxyfluorfen Index Page
Oxyfluorfen. March 1, 1996. Proposed Retention of Pesticide Tolerances. Federal Register.
Note from FAN:
The following fluorinated pesticides are cited in this Notice; proposal is to retain the pesticide tolerances for:Diflubenzuron, Norflurazon, Oxyfluorfen
http://www.epa.gov/docs/fedrgstr/EPA-PEST/1996/March/Day-01/pr-572.txt.html
[Federal Register: March 1, 1996 (Volume 61, Number 42)] [Proposed Rules]
[Page 8173-8183]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[[Page 8173]]
Part V
Environmental Protection Agency
40 CFR Part 180
Pesticide Tolerances, Proposed Revocations; Proposed Rule
[[Page 8174]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300415; FRL-5351-6]
RIN 2070-AB18
Pesticide Tolerances; Proposed Revocations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: EPA announces its decision on whether to propose revocation of 41 section 408 tolerances for 22 pesticides. Under EPA's policy concerning the coordination of its authorities under sections 408 and 409 of the Federal Food, Drug and Cosmetic Act (FFDCA), EPA proposes to revoke the following nine section 408 tolerances: dicofol on apples, grapes, and plums; mancozeb on oats and wheat; propargite on apples and figs; simazine on sugarcane; and triadimefon on wheat. These proposed revocations are one of a series of actions being taken in response to a decision of the Ninth Circuit Court of Appeals regarding the Delaney clause in section 409 of the Federal Food, Drug and Cosmetic Act (FFDCA). EPA proposes to leave the remaining tolerances in place. DATES: Written comments, identified by the docket number [OPP-300415], must be received on or before May 30, 1996.
ADDRESSES: By mail, submit comments to: Public Response Section, Field Operations
Division (7506C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, bring comments to: OPP Docket,
Public Information Branch, Field Operations Division, Rm. 1132, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA. The telephone number for the OPP
docket is (703) 305-5805. Information submitted as a comment concerning this
document may be claimed confidential by marking any part or all of that information
as ``Confidential Business Information'' (CBI). Information so marked will not
be disclosed except in accordance with procedures set forth in 40 CFR part 2
and in section 10 of the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA). For questions related to disclosure of materials, contact the OPP Docket
at the telephone number given above. A copy of the comment that does not contain
CBI must be submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice. All written
comments will be available for public inspection in the OPP Docket, Rm. 1132
at the Virginia address given above, from 8 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays.
Comments and data may also be submitted electronically by sending electronic
mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic comments must be submitted
as an ASCII file avoiding the use of special characters and any form of encryption.
Comments and data will also be accepted on disks in WordPerfect 5.1 file format
or ASCII file format. All comments and data in electronic form must be identified
by the docket number [OPP-300415]. No CBI should be submitted through e-mail.
Electronic comments on this proposed rule may be filed online at many Federal
Depository Libraries. Additional information on electronic submissions can be
found in [OPP-300415]. of this document.
FOR FURTHER INFORMATION CONTACT: By mail: Niloufar Nazmi, Special Review and Reregistration Division (7508W), Environmental Protection Agency, 401 M St. SW., Washington, DC, 20460. Office location and telephone number: Crystal Station #1, 2800 Crystal Drive, Arlington, VA. Telephone 703-308-8028, nazmi@niloufar@epamail.epa.gov. SUPPLEMENTARY INFORMATION:
Table of Contents:
I. Introduction
II. Background
A. Statutory Background
B. EPA's Policy Concerning Coordination of Its Authorities Under Sections 408
and 409 of the FFDCA C. Regulatory Background
III. Today's Action
IV. Determination of the Need for a Section 409 FAR A. Pesticide Uses that Do
Not Need a Section 409 FAR B. Pesticide Uses Previously Found Not to Need Any
Section 409 FARs
C. Additional Pesticide Uses Found Not to Need Any Section 409 FARs
D. Pesticide Uses that Need a Section 409 FAR V. Delaney Clause Determinations
for Needed Section 409 FARs VI. Proposed Revocations
VII. Consideration of Comments
VIII. Public Docket
IX. Regulatory Requirements
I. Introduction
In this notice, EPA announces its decision whether 41 section 408 tolerances for 22 pesticides should be revoked under EPA's policy concerning the coordination of its authorities under sections 408 and 409 of FFDCA. For those tolerances that EPA has determined should be revoked, EPA is in this notice proposing revocation.
II. Background
A. Statutory Background
The Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 301 et seq.) authorizes
the establishment of maximum permissible levels of pesticides in foods, which
are referred to as ``tolerances'' (21 U.S.C. 346a, 348). Without such a tolerance
or an exemption from a tolerance, a food containing a pesticide residue is ``adulterated''
under section 402 of the FFDCA and may not be legally moved in interstate commerce
(21 U.S.C. 342). Monitoring and enforcement of pesticide residues are carried
out by the U.S. Food and Drug Administration (FDA) and the U.S. Department of
Agriculture (USDA).
The FFDCA governs tolerances for raw agricultural commodities (RACs) and processed
foods separately. For pesticide residues in or on RACs, EPA establishes tolerances,
or exemptions from tolerances when appropriate, under section 408. For processed
foods, food additive regulations (FARs) setting maximum permissible levels of
pesticide residues are established under section 409. Section 409 FARs are needed,
however, only for certain pesticide residues in processed food. Under section
402(a)(2) of the FFDCA, no section 409 FAR is required for pesticide residues
carrying from raw to processed food if the residue in the processed food, when
ready to eat, is equal to or below the section 408 tolerance for that pesticide
in or on the RAC from which it was derived, and all other conditions of section
402(a)(2) are met. This exemption in section 402(a)(2) is commonly referred
to as the ``flow-through'' provision because it allows the section 408 raw food
tolerance to flow through to the processed food form. Thus, a section 409 FAR
is necessary to prevent foods from being deemed adulterated when the concentration
of the pesticide residue in a processed food carrying over from the RAC is greater
than the tolerance prescribed for the RAC, or if the processed food itself is
treated or comes in contact with a pesticide.
To establish a tolerance regulation under section 408, EPA must find that the
regulation would ``protect the public health.'' 21 U.S.C. 346a(b). In reaching
this determination, EPA is directed to consider, among other things, the ``necessity
for the production of an adequate, wholesome, and economical food supply.''
Id. If a food additive regulation must be established, section 409 of the FFDCA
requires that the use of the pesticide will be ``safe'' (21 U.S.C. 348(c)(3)).
Section 409 also contains the
[[Page 8175]]
Delaney clause, which specifically provides that, with little exception, ``no
additive shall be deemed safe if it has been found to induce cancer when ingested
by man or animal'' (21 U.S.C. 348(c)(3)).
B. EPA's Policy Concerning Coordination Of Its Authorities Under Sections 408 and 409 of the FFDCA
EPA traditionally has followed a policy of coordinating its authorities under section 408 and section 409 of the FFDCA. Thus, if use of a pesticide would result in residues in a RAC needing a section 408 tolerance and residues in a processed food needing a section 409 FAR, EPA would not approve either the section 408 tolerance or the section 409 FAR if EPA could not approve both. Similarly, EPA would not approve a FIFRA registration for a use of a pesticide if all needed tolerances and FARs connected with that use could not be approved. In September 1992, the National Food Processors' Association (NFPA) and other food-related organizations filed a petition with EPA challenging the legality of EPA's coordination policy. In a policy statement issued on January 25, 1996, (61 FR 2378) EPA for the most part rejected the NFPA's arguments concerning the coordination policy. EPA will continue to coordinate its actions under sections 408 and 409. Where a pesticide needs a section 409 FAR but such FAR cannot be granted because of the Delaney clause, EPA generally will not grant, or allow to continue, the associated section 408 tolerance. The critical issue in the application of the coordination policy is whether there is a likelihood of residues exceeding the section 408 tolerance in ready-to-eat (RTE) processed food. If there is such a likelihood of over-tolerance residues, EPA believes it is a reasonable interpretation of section 408 to conclude that the section 408 tolerance does not meet the statutory standard under section 408 (``protect the public health'') and thus must be revoked. The criteria EPA follows in determining the likelihood that residues in processed food will exceed the section 408 tolerance are called the concentration policy. Until recently, EPA's concentration policy had focused almost entirely on the results of food processing studies and concentration factors derived from those studies. Concentration factors measure the ratio between residue levels in the processed food and the precursor raw crop (e.g., a concentration factor of 2 indicates that residues in the processed food are twice the level of residues in the raw crop). However, in responding to the NFPA petition on June 14, 1995 (60 FR 31300), EPA announced it would consider a far greater range of information in making the determination concerning the likelihood of residues in processed food exceeding the section 408 tolerance.
C. Regulatory Background
In the California v. Browner settlement, EPA agreed to make decisions by April, 1997 concerning whether 81 section 408 tolerances violated EPA policies regarding the coordination of its authority under sections 408 and 409. The settlement recognized that these policies might be modified by EPA's response to the NFPA petition. Today's notice announces EPA's decisions regarding 41
[[Page 8176]]
of those tolerances (See Table 1 of this document.) EPA has treated the
California v. Browner consent decree as the equivalent of a petition under
section 408(e) requesting the reexamination of the legality, under the coordination
policy, of the tolerances listed in the appendices to the decree. This notice,
in effect, acts on the petition by proposing revocation of those tolerances
that EPA has determined do not meet the statutory standard under section
408 and by proposing not to initiate a revocation proceeding against those
tolerances to which EPA has found the coordination policy is inapplicable.
EPA is seeking comment on both the proposed revocations and its proposed
decisions not to revoke and will issue a final order following the receipt
and review of such comments.
Table 1.--Section 408 Raw Food Tolerances in this Notice.
ProposedPesticide Crop CFR Cite Decisions
Acephate.................... Cottonseed..... 180.108 Retain
Alachlor.................... Sunflower seed. 180.249 Previously
revokedBenomyl..................... Citrus......... 180.294 Retain
.......................... Rice........... 180.294 Retain
Captan...................... Grapes......... 180.103 Retain
.......................... Tomatoes....... 180.103 Retain
Carbaryl.................... Pineapples..... 180.169 Retain
Dicofol..................... Apples......... 180.163 Revoke
.......................... Grapes......... 180.163 Revoke
.......................... Plums.......... 180.163 Revoke
.......................... Tomatoes....... 180.163 Retain
Diflubenzuron............... Soybeans....... 180.377 Retain
Dimethipin.................. Cottonseed..... 180.406 Retain
Ethylene Oxide.............. Whole spices 180.151 Retain
(direct treatment).Iprodione................... Peanuts........ 180.399 Retain
.......................... Rice........... 180.399 Retain
Lindane..................... Tomatoes....... 180.133 Retain
Mancozeb.................... Barley......... 180.176 Retain
.......................... Grapes......... 180.176 Retain
.......................... Oats........... 180.176 Revoke
.......................... Rye............ 180.176 Retain
.......................... Wheat.......... 180.176 Revoke
Maneb....................... Grapes......... 180.110 Retain
Methomyl.................... Wheat.......... 180.253 Retain
Norflurazon................. Grapes......... 180.356 Retain
Oxyfluorfen................. Cottonseed..... 180.381 Retain
.......................... Peppermint..... 180.381 Retain
.......................... Spearmint...... 180.381 Retain
.......................... Soybeans....... 180.381 Retain
PCNB........................ Tomatoes....... 180.319 Retain
Permethrin.................. Tomatoes....... 180.378 Retain
Propargite.................. Apples......... 180.259 Revoke
.......................... Figs........... 180.259 Revoke
.......................... Grapes......... 180.259 Retain
.......................... Plums.......... 180.259 Retain
Simazine.................... Sugarcane...... 180.213 Revoke
Thiodicarb.................. Cottonseed..... 180.407 Retain
.......................... Soybeans....... 180.307 Retain
Triadimefon................. Grapes......... 180.410 Retain
.......................... Wheat.......... 180.410 Revoke
.......................... Pineapple...... 180.410 Retain
In reviewing these 41 section 408 tolerances under its coordination policy, EPA's first step was to determine whether the section 409 FARs for such tolerances were needed. If a section 409 FAR is not needed in connection with a section 408 tolerance, the coordination policy would not be triggered because it only addresses the appropriate action to be taken where approvals are needed under both sections 408 and 409. If EPA determined that a section 409 FAR is needed, EPA then determined whether a section 409 FAR for the pesticide in question would comply with the Delaney clause. If a needed section 409 FAR would violate the Delaney clause, EPA applied its coordination policy and has, where appropriate, proposed in this notice the revocation of each section 408 tolerance for which the Delaney clause bars the establishment or maintenance of a section 409 FAR.
IV. Determination of the Need For a Section 409 FAR
Because the coordination policy has no application to section 408 tolerances that do not need section 409 FARs, EPA has first examined whether each of the 41 section 408 tolerances need FARs under current Agency policies. The determination whether a section 409 FAR is needed to prevent a food from being considered adulterated primarily involves application of EPA's concentration policy. EPA applies the concentration policy to examine the likelihood that use of a pesticide on a raw agricultural commodity will result in residues in a processed food exceeding the section 408 tolerance.
A. Pesticide Uses that Do Not Need a Section 409 FAR
EPA has determined that its coordination policy does not warrant revoking 31 of the 41 section 408 tolerances because no section 409 FAR is needed for these tolerances. EPA has concluded that section 409 FARs are not needed principally for one of three reasons. First, for several pesticide/processed food combinations, EPA has received new processing studies indicating that residues in processed food are not likely to exceed the section 408 tolerance. Second, application of EPA's new concentration policy has shown that, for several of the pesticide uses, residues in processed food are not likely to exceed the section 408 tolerance. Third, several processing byproducts have been dropped from EPA's list of significant animal feed items and therefore FARs are no longer needed for these processed commodities. See 60 FR 49144. In a proposed revocation published September 21, 1995 (60 FR 49142), EPA explained which of these factors applied to several of the section 409 FARs associated with section 408 tolerances addressed in this notice. Those FARs are listed in this unit with a cross-reference to the earlier notice. EPA has also evaluated additional pesticide uses having section 408 tolerances to determine where section 409 FARs would be needed. This notice includes explanations of EPA's conclusions regarding whether section 409 FARs are, or are not needed. A fuller explanation as to each pesticide use is included in the public docket.
B. Pesticide Uses Previously Found Not to Need Any Section 409 FARs
On September 21, 1995, EPA proposed to revoke the following FARs on the ground that no section 409 FAR was needed to prevent processed food from being considered adulterated: (1) Acephate on cottonseed hulls and cottonseed meal; (2) benomyl on dried citrus pulp and rice hulls; (3) carbaryl on pineapple bran; (4) diflubenzuron on soybean hulls and soybean soapstock; (5) dimethipin on cottonseed hulls; (6) iprodione on peanut soapstock, rice bran and rice hulls; (7) mancozeb on milled fractions of barley, oats, rye and wheat; (8) propargite on dried apple pomace and dried grape pomace; (9) thiodicarb on cottonseed hulls and
[[Page 8177]]
soybean hulls; and (10) triadimefon on wet and dry grape pomace and raisin
waste. 60 FR 49142, September 21, 1995). Based on these determinations,
EPA concludes that the following 10 section 408 tolerances have or need
no other section 409 FARs and thus there is no reason under the coordination
policy to revoke these tolerances: (1) Acephate on cottonseed; (2) benomyl
on citrus; (3) carbaryl on pineapple; (4) diflubenzuron
on soybeans; (5) dimethipin on cottonseed, (6) iprodione on peanuts and
rice; (7) thiodicarb on cottonseed and soybeans; and (8) triadimefon on
grapes. It should be noted that unless all needed section 409 FARs can be
approved, EPA will apply the coordination policy to revoke the underlying
section 408 tolerance for the RAC. This means that even if EPA can determine
that one section 409 FAR is not needed by application of the factors noted
above, but other section 409 FARs continue to be needed, the coordination
policy applies. For example, in the list above, propargite no longer requires
a FAR on dried apple pomace because it is not a significant animal feed,
but does require a FAR on wet apple pomace. Since the FAR on wet apple pomace
is needed and violates the Delaney clause (see Unit IV.D. of this document),
EPA is proposing to revoke the section 408 tolerance for propargite on apples.
C. Additional Pesticide Uses Found Not to Need Any Section 409 FARs
Table 2.--Section 408 Raw Food Tolerances Being Proposed for Retention
Raw commodityPesticide ----------------------------------
Crop CFR cite
Acephate............................. Cottonseed............. 180.108
Benomyl.............................. Citrus................. 180.294
................................... Rice................... 180.294
Captan............................... Grapes................. 180.103
................................... Tomatoes............... 180.103
Carbaryl............................. Pineapples............. 180.169
Dicofol.............................. Tomatoes............... 180.163
Diflubenzuron........................ Soybeans............... 180.377
Dimethipin........................... Cottonseed............. 180.406
Ethylene Oxide....................... Whole spices (direct 180.151
treatment).Iprodione............................ Peanuts................ 180.399
................................... Rice................... 180.399
Lindane.............................. Tomatoes............... 180.133
Mancozeb............................. Barley................. 180.176
................................... Grapes................. 180.176
................................... Rye.................... 180.176
Maneb................................ Grapes................. 180.110
Methomyl............................. Wheat.................. 180.253
Norflurazon.......................... Grapes................. 180.356
Oxyfluorfen.......................... Cottonseed............. 180.381
................................... Peppermint............. 180.381
................................... Spearmint.............. 180.381
................................... Soybeans............... 180.381
PCNB................................. Tomatoes............... 180.319
Permethrin........................... Tomatoes............... 180.378
Propargite........................... Grapes................. 180.259
................................... Plums.................. 180.259Thiodicarb........................... Cottonseed............. 180.407
................................... Soybeans............... 180.407
Triadimefon.......................... Grapes................. 180.410
................................... Pineapple.............. 180.410
D. Pesticide Uses that Need a Section 409 FAR
EPA has determined that under its revised concentration policy the
pesticide uses listed in this unit need section 409 FARs to prevent
the adulteration of processed food.
In analyzing the need for section 409 FARs, EPA has taken into account
not only existing section 408 tolerances but also available residue
data bearing on whether the current section 408 tolerance should be
revised under existing tolerance-setting policies. EPA has received
large amounts of residue data as part of the reregistration program.
Review of these data shows that, in several instances, the existing
section 408 tolerance is set either too high or too low. Tolerance adjustments
would normally be accomplished through the reregistration program.
EPA, however, sees no reason to wait until these tolerances are formally
revised to determine whether the pesticide concentrates for the purpose
of applying the coordination policy. EPA has decided that it should
base its concentration decision upon the most recent data on residues
in raw crops. If
[[Page 8179]]
those data indicate that section 408 tolerances should be adjusted,
EPA has used the adjusted section 408 tolerance level as the basis for
its determination of whether a section 409 FAR is needed. The basis
for EPA's determination that the tolerance should be adjusted is in
the docket.
In two cases (dicofol/plums and mancozeb/oats), the level of residues
in the processed food is between the current section 408 tolerance and
an adjusted lower 408 tolerance. If EPA were to make its determination
of the need for a section 409 FAR based on the current higher tolerance,
EPA might in this notice decide that revocation was not warranted only
to have to revise that determination in the near future once the overall
tolerance reassessment for the pesticide is complete. Once the overall
tolerance reassessment for the pesticide is complete, EPA would take
the identical action proposed here: EPA would explain why the tolerance
needed to be lowered but then propose to revoke the existing tolerance
because amending the existing tolerance would not be consistent with
the coordination policy. In two other cases (dicofol/apples and propargite/apples),
the level of residues in the processed food is higher than both the
current and adjusted section 408 tolerances. In this case, adjusting
the tolerance is irrelevant to the need for a section 409 FAR. Nonetheless,
in all situations where a tolerance needs to be adjusted (whether raised
or lowered), EPA believes the focus of the coordination policy analysis
should be the tolerance value that would be set taking into account
the most current data.
V. Delaney Clause Determinations For Needed Section 409 FARs
A. Induce cancer
For each of the pesticides listed in Unit IV.D., section 409 FARs
are either established or needed. In a number of published proposed
revocations, EPA has previously determined that the five pesticides
``induce cancer'' within the meaning of the Delaney clause (59 FR
10993; 59 FR 33941; 60 FR 3607). Full copies of each of these reviews
and other references in this document are available in the OPP Docket,
the location of which is given under `ADDRESSES'' above. Information
on dicofol is contained in OPP Docket OPP-300238, on mancozeb, propargite
and simazine in OPP Docket OPP-300335, and on triadimefon in OPP
Docket OPP-300360.
EPA is currently considering comments on the proposed revocations
of section 409 FARs for propargite, mancozeb, simazine and triadimefon.
B. DES Proviso
EPA may establish or maintain a section 409 FAR for a pesticide
that induces cancer if the DES proviso excepts the FAR from the
Delaney clause. Thus, when a pesticide needing a FAR is found to
induce cancer, EPA must determine if the FAR is nonetheless excepted
from the Delaney clause prohibition by the DES proviso.
The DES proviso applies to a FAR when no detectable residues are
expected in the animal commodities (meat, milk, poultry, eggs) as
a result of animal consumption of feeds containing residues permitted
by the FAR (60 FR 49142, September 21, 1995). If no detectable residues
of the chemical can be found in the animal commodities, the FAR
can be maintained or established.
The nine pesticide uses listed in Unit IV. D of this document have
or need section 409 FARs that are or would be inconsistent with
the Delaney clause. However, only three of these FARs are for animal
feed items and thus have been further analyzed to determine whether
they are allowed under the DES proviso.
VI. Proposed Revocations
A. Section 408 Tolerances
EPA proposes that the nine section 408 tolerances listed in
Table 3 of this unit be revoked. EPA no longer believes that
these tolerances meet the statutory standard under section 408
(``protect the public health'') because use of a pesticide under
these tolerances is likely to result in residues in processed
food exceeding such tolerance. Such residues will render the
processed food adulterated under the FFDCA unless there is a
section 409 FAR. Some of the nine section 408 tolerances have
existing section 409 FARs that are inconsistent with the Delaney
clause and they will be or have been revoked. The others need
FARs but such FARs have not been, and under the Delaney clause
cannot be, established.
As EPA explained in its recent statement on the coordination
policy, (January 25, 1996, 61 FR 2378) it believes that, if
the use of a pesticide under a section 408 tolerance is likely
to result in residues in a processed food which Congress has,
in the clearest terms, deemed unacceptable, Congress' heightened
concern regarding such residues in processed food must be taken
into account in determining whether the section 408 tolerance
complies with the statutory standard for establishing or maintaining
tolerances under section 408. Moreover, EPA believes that where
evaluation of available data indicate that residues in processed
food can exceed the section 408 tolerance, Congress' heightened
concern about such residues is determinative of the finding
under the section 408 standard, absent some extraordinary impact
upon the food supply. EPA believes that its revised concentration
policy (60 FR 31300, June 14, 1995) involves a reasonable approach
to determining the likelihood of residues in processed food
exceeding the associated section 408 tolerance. EPA expressly
noted its willingness to use all relevant and appropriate data
in examining this question. For example, EPA stated it would,
where appropriate, consider some type of average residue value,
average concentration values, and dilution factors for not RTE
food.
Because EPA has concluded that the application of its concentration
policy to each of the nine section 408 tolerances in the following
Table 3 has shown that residues in processed food can exceed
the section 408 tolerance and because removal of these uses
is unlikely to have a significant, much less extraordinary,
impact on the food supply, EPA is proposing to revoke these
section 408 tolerances because they fail to meet the section
408 standard for establishing or maintaining tolerances.
Table 3.--Section 408 Tolerances Proposed for Revocation
Pesticide Raw Crop CFR Cite
Dicofol.............................. Apples................. 180.163
Grapes................. 180.163 Plums.................. 180.163Mancozeb............................. Oats................... 180.176
Wheat.................. 180.176Propargite........................... Apples................. 180.259
Figs................... 180.259Simazine............................. Sugarcane.............. 180.213
B. Impacts
As noted in Unit IV.D. of this document, evaluation of the nine pesticide uses listed in Table 3 of this document, under EPA's concentration policy yields the conclusion that, in all likelihood, residues in processed food can exceed the associated section 408 tolerance. For these pesticide uses, EPA also examined what the impact on the food supply would be if these uses were disallowed. EPA has concluded that removal of the uses would have little or no impact on the price or availability of food to the consumer. In fact, removal of most of these uses is not expected to have much effect on growers. For four of the uses no impact is expected. For the other five, the impact will be minor. Some individual apple, fig, and wheat growers may incur significant impacts. See Unit IX. A. below for details.
VII. Consideration of Comments
Any interested person may submit comments on the proposed revocations of tolerance or EPA's decisions not to revoke certain tolerances on or before May 30, 1996 at the address given under the``ADDRESSES'' section above. Before issuing final orders, EPA will consider all relevant comments. After consideration of comments, EPA will issue a final order. Such order will be subject to objections pursuant to section 409(f) (21 U.S.C. 348(f)). Failure to file an objection within the appointed period will constitute waiver of the right to raise issues resolved in the order in future proceedings.
VIII. Public Docket
A record has been established for this rulemaking under docket number [OPP-300415] (including comments and data submitted electronically as described below). A public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as CBI, is available for inspection from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The public record is located in Room 1132 of the Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. Electronic comments can be sent directly to EPA at: opp-Docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. The official record for this rulemaking, as well as the public version, as described above will be kept in paper form. Accordingly, EPA will transfer all comments received electronically into printed, paper form as they are received and will place the paper copies in the official rulemaking record which will also include all comments submitted directly in writing. The official rulemaking record is the paper record maintained at the address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
A. Executive Order 12866
EPA submitted this action to the Office of Management and
Budget (OMB) for review under Executive Order 12866 (58 FR 51735,
October 4, 1993). Any comments or changes made during that review
have been documented in the public record.
EPA has evaluated the economic impacts of this particular action
for the nine proposed revocations. Below is a summary of the
results of the economic analysis by crop.
Apples. The most significant economic impacts of the 408 tolerances
currently proposed for revocation are expected on apples from
the loss of propargite and dicofol. Eight states produce more
than 7012f the apples grown in the United States; regionally,
these include the Northwest (CA, OR and WA), Michigan in the
Midwest, and the New York/ Pennsylvania and North/South Carolina
areas of the East.
[[Page 8182]]
In these areas, losses will be more acute for propargite which
is used on 2912f the overall acreage, but up to 50267f the acreage
in New York and Michigan. Dicofol, on the other hand, averages
use on only 5 of the overall acreage, with a range of 3% in
the major producing states.
The most likely chemical alternatives are projected to be fenbutatin-oxide,
formetanate hydrochloride, and oxythioquinox. These alternatives
are more toxic than propargite and dicofol to some beneficial
insects in some states, but would likely be used as replacements
in most cases. There are mixed results on efficacy of the alternatives
compared to propargite and dicofol for controlling mite pests
from field trials. Many trials suggest the alternatives have
equal or superior efficacy, while some others suggest that propargite
and dicofol are superior. The Agency assumed a three percent
yield loss due to substitution of the alternatives, resulting
in a projected loss of nearly $16 million annually to current
users of propargite and dicofol. This may overstate potential
yield loss because the data on the relative efficacy of these
pesticides are mixed. This figure does not include losses from
higher toxicity of alternatives to beneficial insects, or increased
development of resistance to the remaining alternatives. Alternatives
are approximately the same or lower cost than propargite and
dicofol, so that there would be little increased cost for alternatives.
Figs. Since there are no miticide alternatives to propargite,
annual loss to growers could be up to $100,000 in those years
when mite pressures are high.
Wheat. Triadimefon use on wheat is insignificant. Mancozeb is
used on less than 512f the wheat acres, and numerous alternatives,
some of which may be more efficacious than mancozeb, are available.
Grapes. Impacts will be limited to the loss of dicofol, which
is expected to cause only marginal impacts. Dicofol was not
used in California in 1994, and is not recommended by grape
specialists because its non-selective mode of action kills beneficial
insects. The preferred alternative (propargite) offers superior
mite control while not harming beneficial insects.
The Delaney clause prohibits establishing or maintaining section
409 FARs for any pesticide meeting the ``induces cancer'' standard,
without regard to economic impacts. However, this proposed action
to revoke section 408 tolerances is due to the combined effect
of the Delaney clause and EPA's coordination policy. EPA believes
that the impacts due to these proposed revocations (and ultimately
the cancellation of the registered uses) are less burdensome
than the alternative of maintaining these tolerances and registrations.
If the uses and 408 tolerances remain in effect without needed
409 FARs (prohibited by the Delaney clause), lawfully treated
foods could potentially be adulterated, and subject to seizure,
and the need for costly Federal monitoring and enforcement would
increase. The possibility of adulterated foods could create
uncertainty among pesticide users and food processors and erode
consumer confidence in the food supply.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act of 1980 (Pub. L. 96-354; 94
Stat. 1164, 5 U.S.C. 601 et seq.) requires EPA to analyze regulatory
options to assess the economic impact on small businesses, small
governments, and small organizations.
Regulating pesticide residues in food is, by its nature, indiscriminate
with respect to the size of the business or farm that was the
source of the food. The existence or absence of a tolerance,
and the levels at which they are set must logically apply to
all food available to U.S. consumers. It is also not feasible
to segregate and track food from different farm sizes, once
it is in channels of trade. Therefore, there is no potential
regulatory option that would treat small farms differently from
large farms with respect to pesticide tolerances.
The Delaney clause leaves no option to retain the applicable
section 409 FARs. The section 408 tolerances could either be
revoked, as called for by the coordination policy, or maintained
in the absence of the needed 409 FARs. It is not feasible to
quantify the economic impacts of retaining the 408 tolerances,
for the reasons discussed above, and therefore a comparison
of the impacts of these two options cannot be made. The Agency's
choice to revoke the 408 tolerances will not disproportionately
affect small farms over large farms, since the loss of a pesticide
is generally proportional to the crop acreage.
C. 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. The costs associated with this action are described in Unit IX. A of this notice. 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.
D. Paperwork Reduction Act
This order does not contain any information collection requirements and therefore is not subject to the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: February 26, 1996.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic Substances.
Therefore, it is proposed that 40 CFR, chapter I, part 180 be amended as follows:
PART 180--[AMENDED]
2. In Sec. 180.163, in the paragraph beginning with ``5 parts per million...,'' remove the entries ``apples,'' ``grapes,'' and ``plums (fresh prunes),''.
Sec. 180.176 [Amended]
3. In Sec. 180.176 by revising the paragraphs beginning with ``25 parts per million...'' and ``5 parts per million...'' to read respectively as follows:
Sec. 180.176 Coordination product of zinc ion and maneb; tolerances for residues.
4. By removing from the table in Sec. 180.213 the entry for ``sugarcane''.
[[Page 8183]]
Sec. 180.259 [Amended]
5. By removing from the table in Sec. 180.259 the entries for ``apples'' and ``figs''.
Sec. 180.410 [Amended]
6. By removing from the table in Sec. 180.410 the entries for ``Wheat, grain'', and ``Wheat, straw''.
[FR Doc. 96-4836 Filed 2-29-96; 8:45 am] BILLING CODE 6560-50-F