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Norflurazon. September 21, 1995. Pesticide Tolerances; Feed Additive Regulations. Proposed Rule. Federal Register.
http://www.epa.gov/docs/fedrgstr/EPA-PEST/1995/September/Day-21/pr-419.txt.html
[Federal Register: September 21, 1995 (Volume 60, Number 183)] [Proposed Rules][[Page 49141]]
Part IX
Environmental Protection Agency
40 CFR Part 186
Pesticide Tolerances; Revocation of Certain Feed Additive Regulations; Proposed Rule and Notice
[[Page 49142]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 186
[OPP-300397; FRL-4977-3]
RIN 2070-AC18
Pesticides; Feed Additive Regulation Revocations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: EPA has made determinations regarding 36 feed additive regulations (FARs) for 16 pesticides in animal feeds that were previously reported as potentially inconsistent with the Delaney clause in section 409 of the Federal Food, Drug and Cosmetic Act (FFDCA). EPA is proposing to revoke 34 animal feed FARs because they are not needed to prevent adulterated food, and two additional animal feed FARs because they violate the Delaney clause.
DATES: Written comments, identified by the document control number [OPP-300397], must be received on or before December 19, 1995.
ADDRESSES: By mail, submit comments to: Public Response Section, Field Operations
Division (7506C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, bring comments to: OPP Docket,
Public Information Branch, Field Operations Division, Rm. 1132, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA. The telephone number for the OPP
docket is (703)-305-5805. Information submitted as a comment concerning this
document may be claimed confidential by marking any part or all of that information
as ``Confidential Business Information'' (or CBI). Information so marked will
not be disclosed except in accordance with procedures set forth in 40 CFR part
2 and in section 10 of the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA). For questions related to disclosure of materials, contact the OPP Docket
at the telephone number given above. A copy of the comment that does not contain
CBI must be submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice. All written
comments will be available for public inspection in the OPP Docket, Rm. 1132,
at the Virginia address given above, from 8 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays.
Comments and data may also be submitted electronically by sending electronic
mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic comments must be submitted
as an ASCII file avoiding the use of special characters and any form of encryption.
Comments and data will also be accepted on disks in WordPerfect in 5.1 file
format or ASCII file format. All comments and data in electronic form must be
identified by the docket number [OPP-300397]. No Confidential Business Information
(CBI) should be submitted through e-mail. Electronic comments on this proposed
rule may be filed online at many Federal Depository Libraries. Additional information
on electronic submissions can be found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: Niloufar Nazmi, Special Review and Reregistration Division (7508W), Environmental Protection Agency, 401 M St., SW., Washington, DC, 20460. Office location and telephone number: Crystal Station #1, 2800 Crystal Drive, Arlington, VA. Telephone: 703-308-8010; e-mail: nazmi.niloufar@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents:
I. Introduction
II. Background
A. Statutory Background
B. Regulatory Background
III. Revised Agency Policies, Guidelines, and Legal Interpretations
A. Concentration and ``Ready to Eat'' Policies B. Guidelines on Significant
Animal Feeds C. DES Proviso
IV. Decision Framework
A. Significant Animal Feed
B. Concentration Policy Including RTE V. EPA's Decisions
A. Food Additive Regulation is not Needed B. Food Additive Regulation is Needed
C. Induce Cancer Call for Pesticides that Need 409s D. DES Proviso
VI. Proposed Rules
A. Proposed Revocations: FAR Is Not Needed B. Proposed Revocations: Violates
Delaney Clause VII. Consideration of Comments
VIII. Executive Order 12866
IX. Regulatory Flexibility Act
X. Paperwork Reduction Act
I. Introduction
In this document, EPA examines whether 36 FARs for 16 pesticides in animal
feeds should be revoked, either because the FAR is inconsistent with the Delaney
clause in section 409(c)(3) of the FFDCA or because the FAR is not needed to
prevent adulterated feed under current Agency policies and guidelines. For those
FARs which EPA determines should be revoked, EPA is in this document proposing
revocation. EPA concludes that the Delaney clause affects few of the FARS involved
in this document, primarily because of revised Agency policies and guidelines
governing when FARs are required to prevent adulterated animal feed. Although
a combination of factors are responsible for this result, perhaps the most significant
point is that the FARs in this document involve animal feeds. For example, almost
half of the 36 FARs were judged unnecessary because EPA concluded that the animal
feeds in question were not a significant portion of the livestock diet. EPA
will in the near future be making decisions concerning the fate of a number
of FARs for processed human foods. EPA proposals are pending to revoke human
food FARs for 11 pesticides covering 32 uses. The policies announced in the
Agency's June 14, 1995 response to the National Food Processors' Association
(NFPA) petition have been instituted, and EPA has begun to review the effects
of those policies on its earlier proposals. EPA has not completed this analysis
and so its results are uncertain, but the Agency believes that the effects of
its policy changes will not be as dramatic for human, as opposed to animal,
foods. For example, in general EPA has concluded that most processing byproducts
used as animal feeds are not ready to eat; processed human foods are not as
obviously amenable to such a broadly drawn conclusion. EPA anticipates that
case-by-case determinations will be the rule for human foods.
Finally, EPA notes that the identification of pesticides and uses that are potentially
subject to the Delaney clause is an ongoing process as EPA receives new cancer
and processing studies required as part of reregistration. When EPA concludes
that a processed food or feed tolerance is necessary under FFDCA section 409
for a pesticide that induces cancer within the meaning of the Delaney clause,
EPA will take action to revoke or deny that tolerance.
II. Background
A. Statutory Background
The Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 301 et seq.) authorizes the establishment of maximum permissible levels of pesticides in foods, which are referred to as ``tolerances'' (21 U.S.C. 346a, 348). Under the FFDCA, a tolerance is required for pesticide residues in food for consumption by humans or by food animals. Without such a tolerance or an exemption from a tolerance, a food or
[[Page 49143]]
feed containing a pesticide residue is ``adulterated'' under section 402 of
the FFDCA and may not be legally moved in interstate commerce (21 U.S.C. 342).
Monitoring and enforcement of pesticide residues are carried out by the U.S.
Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA).
The FFDCA governs tolerances for raw agricultural commodities (RACs) and processed
foods separately. For pesticide residues in or on RACs, EPA establishes tolerances,
or exemptions from tolerances when appropriate, under section 408. For processed
foods, food additive regulations (FARs) setting maximum permissible levels of
pesticide residues are established under section 409. Section 409 FARs are needed,
however, only for certain pesticide residues in processed food. Under section
402(a)(2) of the FFDCA, no section 409 FAR is required if any pesticide residue
in a processed food, when ready to eat, is equal to or below the tolerance for
that pesticide in or on the RAC from which it was derived and all other conditions
of section 402(a)(2) are met. This exemption in section 402(a)(2) is commonly
referred to as the ``flow-through'' provision because it allows the section
408 raw food tolerance to flow through to the processed food form. Thus, a section
409 FAR is necessary to prevent foods from being deemed adulterated when the
concentration of the pesticide residue in a processed food is greater than the
tolerance prescribed for the RAC, or if the processed food itself is treated
or comes in contact with a pesticide. If a food additive regulation must be
established, section 409 of the FFDCA requires that the use of the pesticide
will be ``safe'' (21 U.S.C. 348(c)(3)). Section 409 also contains the Delaney
clause, which specifically provides that, with little exception, ``no additive
shall be deemed safe if it has been found to induce cancer when ingested by
man or animal'' (21 U.S.C. 348(c)(3)).
B. Regulatory Background
A. Concentration and ``Ready to Eat'' Policies
To determine whether the use of a pesticide on a growing crop needs a
section 409 FAR in addition to a section 408 tolerance, EPA looks at the
likelihood that the residue levels in the processed food will exceed the
section 408 tolerance level. In the past, EPA applied this policy focusing
almost exclusively on the results of processing studies using treated crops.
In response to the NFPA petition, EPA announced new policies on how it would
determine whether a pesticide needs a section 409 FAR. EPA stated that it
would consider a greater range of information in determining the likelihood
of residues in processed food exceeding the section 408 tolerance. EPA also
adopted a definition of ``ready to eat'' (RTE) as it applies to human food
and animal feed. Whether a food is RTE or not is critical to application
of the concentration policy. If a food is not RTE, EPA must consider the
degree of dilution that occurs in producing a RTE food from the not-RTE
food in determining the likelihood that residues in RTE food will exceed
the section 408 tolerance.
Perhaps the most significant new information that EPA stated it would consider
is information bearing on the average residue value from crop field trials.
The data from field residue trials show that it is possible to obtain significantly
different residue values from multiple field trials. EPA concluded that
where a crop is mixed or blended during processing, it would be appropriate
to use an average residue value rather than the highest field trial sample
value in estimating the potential level of residue in processed food. As
EPA noted, EPA believes that generally the most appropriate average value
to use is the highest average field trial (HAFT) value. Consequently, EPA
revised its procedures and is now using the HAFT as the basis for determining
whether a section 409 FAR is needed.
Another outcome of the new concentration policy is that EPA has revised
its policies for the use of multiple processing studies. EPA may receive
several processing studies for a
[[Page 49144]]
crop, with each showing a different concentration factor. When different
concentration factors result from multiple processing studies, EPA will
now use the average concentration factor to determine concentration. EPA
explained the basis for this change in its response to comments filed on
the NFPA petition. In addition, EPA is examining processing studies to ensure
that they reflect typical commercial practices. If a study does not include
a step (e.g., washing) that is considered typical practice in processing
an RAC, EPA may not include that study in the calculation of the average
concentration factor. In response to the NFPA petition, EPA stated it would
interpret the phrase RTE food as meaning food ready for consumption ``as
is'' without further preparation. EPA also announced that it will apply
a similar approach to processing byproducts used as animal feeds. With regard
to animal feed, EPA announced that if a feed item is considered unpalatable
when fed ``as is'' or if for nutritional or other reasons the feed item
is generally further processed or mixed, EPA will consider that feed item
not RTE. EPA has applied this new interpretation on a case-by-case basis
in making determinations on several of the feed items that are the subject
of this document.
B. Guidelines on Significant Animal Feeds
EPA requires processing data and sets tolerances and FARs only on animal
feeds that are consumed in significant amounts in the United States. Table
II of the Pesticide Assessment Guidelines, Subdivision O, Residue Chemistry,
provides a listing of all significant food and feed commodities, both raw
and processed, for which residue data are collected and tolerances or FARs
are established. On June 8, 1994, EPA revised Table II and sought comments
on these revisions (59 FR 29603). In response, EPA received extensive new
data and many comments concerning the amounts of raw agricultural commodities
and processing byproducts that are used as animal feeds. As a result, EPA
has updated Table II and modified its guidelines regarding which raw commodities
and processing byproducts EPA will consider as animal feeds possibly requiring
FARs.
The general cutoff point used by EPA in deciding which feed items are considered
``significant'' is whether the feed item constitutes greater than 0.04 percent,
by weight, of the total feed available to livestock in the U.S. However,
feed items constituting less than 0.04 percent are also considered significant
if:
The Delaney clause in section 409 of the FFDCA contains an exception
for animal feed additives that do not harm the animal and are not found
in the resulting animal food products by an analytical method approved
or prescribed by FDA or EPA as applicable. In full, this exception reads:
The Delaney clause shall not apply with respect to the use of a substance
as an ingredient of feed for animals which are raised for food production,
if the Secretary finds: (i) That, under the conditions of use and feeding
specified in proposed labeling and reasonably certain to be followed
in practice, such additive will not adversely affect the animals for
which such feed is intended; and
(ii) That no residue of the additive will be found (by methods of examination
prescribed or approved by the Secretary by regulations, * * *) in any
edible portion of such animal after slaughter or in any food yielded
by or derived from the living animal. 21 U.S.C. 348(c)(3)(A). This exception
historically has been referred to as the ``DES proviso'' because it
was enacted, in part, in response to the use of the animal drug diethylstilbestrol
(DES). A similar provision is included in the Delaney clauses in the
color additives and animal drug provisions of the FFDCA. See 21 U.S.C.
360b(d)(1)(I) and 379e(b)(5)(B). FDA has a long history of rulemaking
on the DES proviso. FDA's current regulations regarding the DES proviso
codify what FDA has described as a ``sensitivity of method'' (SOM) approach.
In brief, the SOM approach uses quantitative risk assessment to define
a level of residue in the edible animal product which represents no
more than a 1- in-1 million lifetime risk. This residue level is then
taken to represent an insignificant risk level to the public, and FDA
designates that residue level and below as ``no residue'' under the
DES proviso whether or not such residues are detected by the approved
method. See 21 CFR 500.84. Additionally, under the SOM approach, FDA
requires sponsors of compounds to develop analytical methods which are
at least sensitive enough to measure residues down to the level of residue
corresponding to an insignificant risk. 21 CFR 500.88. Although the
DES proviso and the SOM approach were not part of the Les v. Reilly
decision, EPA undertook a full review of its policies related to the
Delaney clause including the SOM approach in the wake of that decision.
For that reason, EPA requested comment on the SOM approach in its notice
announcing receipt of the NFPA petition. 58 FR 7474 (February 5, 1993).
After reviewing the comment received and after consulting with FDA and
the Department of Justice, EPA has decided generally to continue to
rely on the SOM approach including taking risk considerations into account
in determining whether an analytical method is sufficiently sensitive
to be approved. EPA, however, will not rely on one aspect of the SOM
approach. EPA will not rely upon estimates of risks posed by residues
to designate a ``no residue'' level, at or below which residues are
presumed not to be found. Rather, EPA will determine whether residues
could be found by (1) determining the level of residue expected in animal
products given the conditions of use of the pesticide and the levels
of residue expected in feed, and then (2) examining whether the approved
method could detect such residue levels in animal products. If the method
could detect the residues expected in animal products (even residues
below the risk level determined under the SOM approach), then these
residues would be considered to be ``found'' under the DES proviso,
and the DES proviso could not be invoked as an exception to the Delaney
clause. EPA does not anticipate that this approach to determining whether
[[Page 49145]]
residues are ``found'' will change the substance of EPA's current practices
involving method development and approval. As required by the DES proviso,
however, EPA will formally approve methods by regulation when the DES
proviso is invoked to support a FAR. EPA will not approve a method,
and therefore not exercise the DES proviso, if the method cannot detect
residues that the Agency considers to pose a risk of concern.
EPA believes that its decision to interpret the DES proviso as imposing
a strict detectability standard is consistent with the plain language
of the statute. The DES proviso requires that ``no residue of the additive
will be found [] by methods of examination prescribed or approved by
the Secretary * * * .'' The use of the term ``found'' and the express
mention of analytical methods support reading the DES proviso as imposing
a detectability test. This conclusion is confirmed by the legislative
history which shows both that Congress understood that the DES proviso
imposed a detectability standard and that Congress was opposed to the
principle that any detected residue of a carcinogen could be found to
be safe.
The prior justification for the taking risk into account in determining
whether residues are ``found'' was that a literal approach to the term
``no residue'' would render the DES proviso meaningless because scientists
could never conclude that a substance introduced into an animal left
absolutely no molecules of residue in edible animal products. (52 FR
49572, December 31, 1987). To avoid construing the DES proviso so as
to render it inconsequential, the concept of risk was introduced as
a way of defining ``no residue.'' After further evaluation, EPA believes
that reading the DES proviso as imposing a detectability standard is
both consistent with the statutory language and avoids making the DES
proviso a meaningless provision. EPA's experience has been that the
presence of pesticide residues in animal feeds often does not lead to
detectable residues in edible animal products. EPA regulations in 40
CFR 180.6 reflect that experience by explicitly directing that no tolerance
for pesticide residues in animal products is required when appropriate
studies show that detectable residues are not reasonably expected.
IV. Decision Framework
In analyzing whether the 36 FARs addressed in this document should be revoked, EPA has used the following decision framework. First, EPA determined whether a section 409 FAR is necessary to prevent adulteration, given the revisions to the animal feed guidelines, the concentration policy, or new data which have been submitted. If application of the revised guidelines and concentration policy shows no FAR is needed, this document proposes that the FAR be revoked on that ground. Second, if this analysis showed that a FAR is still needed, then the FAR's consistency with the Delaney clause was analyzed. In examining whether a FAR was needed, EPA followed a stepwise process involving a series of questions. In brief, the questions are:
A. Significant Animal Feed
Is the feed for which the FAR was established a significant animal feed? EPA has updated its table of significant animal feeds. In the process, the Agency has identified a number of processed animal feed items that are not significant according to the criteria in Unit. III.B. of this preamble. If the animal feed for which the FAR was established has been dropped from the list of significant animal feeds, the FAR is not necessary.
B. Concentration Policy Including RTE
V. EPA's Decisions
Based on the above analyses, EPA proposes to revoke 34 FARs on the basis that they are not needed to prevent adulterated food and two FARs because they violate the Delaney clause.
A. Food Additive Regulation Is Not Needed
EPA has determined that one of the remaining FARs is necessary
because the application of the pesticide to the RAC could lead
to residues in RTE processed feed that exceed the applicable
section 408 tolerance. This is simazine on sugarcane molasses.
Documentation as to why this FAR is needed under the revised
concentration policy is included in the docket.
The last FAR, tetrachlorvinphos in processed feed items, is
needed because it is a direct additive to processed animal feed.
None of the above factors is relevant to a direct additive to
processed animal feeds.
C. Induce Cancer Call for Pesticides that Need 409s
If a FAR is necessary to prevent adulterated food, as in the case of the two pesticides named in Unit V.B. above, EPA next determined whether the pesticide induces cancer within the meaning of the Delaney clause.
[[Page 49147]]
In construing the ``induce cancer'' standard as to animals,
EPA follows a weight-of-the-evidence approach. In regard to
animal carcinogenicity, EPA, in general, interprets ``induces
cancer'' to mean:
The carcinogenicity of a substance in animals is established
when administration in an adequately designed and conducted
study or studies results in an increase in the incidence of
one or more types of malignant (or, where appropriate, benign
or a combination of benign and malignant) neoplasms in treated
animals compared to untreated animals maintained under identical
conditions except for exposure to the test compound. Determination
that the incidence of neoplasms increases as the result of exposure
to the test compound requires a full biological, pathological,
and statistical evaluation. Statistics assist in evaluating
the biological significance of the observed responses, but a
conclusion on carcinogenicity is not determined on the basis
of statistics alone. Under this approach, a substance may be
found to ``induce cancer'' in animals despite the fact that
increased tumor incidence occurs only at high doses, or that
only benign tumors occur, and despite negative results in other
animal feeding studies. (See 58 FR 37863, July 14, 1993; 53
FR 41108, October 19, 1988; and 52 FR 49577, December 31, 1987).
In a proposed revocation issued in 1994, EPA concluded that
simazine meets this standard. EPA is currently considering comments
on this proposal. EPA believes that tetrachlorvinphos also qualifies
as an animal carcinogen under this test.
Summarized below is the information supporting EPA's determination
that tetrachlorvinphos induces cancer. Full copies of each of
these reviews and other references in this document are available
in the OPP Docket, the location of which is given under ``ADDRESSES''
above. Information on simazine is contained in OPP Docket OPP-300335.
Tetrachlorvinphos
After a full evaluation of the data and supporting information
regarding animal carcinogenicity, EPA concludes that exposure
to tetrachlorvinphos results in an increased incidence of hepatocellular
carcinomas and combined adenomas/carcinomas (predominantly malignant
carcinomas) in female B6C3Fl mice.
In male mice there are also increases in hepatocellular combined
adenomas/carcinomas and tumors of the kidney (carcinomas, adenomas
and combined adenomas/carcinomas with a large contribution from
malignant carcinoma). In the male Sprague-Dawley rat there are
nonsignificant increases in adrenal benign pheochromocytomas
(significant positive trend) and thyroid C-cell adenomas. These
latter two tumor types are consistent with the same tumor types
observed in another earlier study in Osborne-Mendel rats.
The mutagenicity data for tetrachlorvinphos demonstrate clastogenic
activity, which supports a carcinogenicity concern. Analogs
structurally similar to tetrachlorvinphos (DDVP and phosphamidon)
are also carcinogenic. Tetrachlorvinphos can undergo hydrolysis
and then tautomerize to generate a potentially carcinogenic
reactive ketone intermediate.
Discussions of the various studies on the carcinogenicity of
tetrachlorvinphos can be found in the Peer Review of tetrachlorvinphos
(Dec. 12, 1994) in the docket.
D. DES Proviso
EPA may establish or maintain a section 409 FAR for a pesticide
that induces cancer only if the DES proviso excludes it from
the Delaney clause (see Unit III.C. of this preamble). When
a pesticide needing a FAR is found to induce cancer, the final
step in the analysis is to determine if the FAR is nonetheless
excepted from the Delaney clause prohibition by the DES proviso.
The DES proviso applies when no detectable residues are expected
in the animal commodities (meat, milk, poultry, eggs) as a result
of animal consumption of feeds containing tolerance level residues.
If no detectable residues of the chemical can be found in the
animal commodities, the FAR can be maintained or established.
A. Proposed Revocations: Section 409 FAR Is Not Needed.
EPA is proposing to revoke the following 34 of the original 36 FARs because the Agency has determined they are not needed:
Acephate.................. 186.100 Cottonseed meal,
cottonseed hulls, soybean mealBenomyl................... 186.350 Dried apple pomace, dried
citrus pulp, dried grape pomace, raisin waste, rice hullsCarbaryl.................. 186.550 Pineapple bran (wet and
dry)Diflubenzuron............. 186.2000 Soybean hulls, soybean
soapstockDimethipin................ 186.2050 Cottonseed hulls
[[Page 49148]]
Dimethoate................ 186.2100 Dried citrus pulp Imazalil.................. 186.3650 Dried citrus pulp Iprodione................. 186.3750 Dried grape pomace,
raisin waste, peanut soapstock, rice bran, rice hullsMancozeb.................. 186.6300 Milled barley fractions,
milled oat fractions, milled rye fractions, milled wheat fractionsNorflurazon............... 186.4450 Dried citrus pulp, citrus
molassesPropargite................ 186.5000 Dried apple pomace, dried
citrus pulp, dried grape pomaceThiodicarb................ 186.5650 Cottonseed hulls, soybean
hullsThiophanate-methyl........ 186.5700 Dried apple pomace Triadimefon............... 186.800 Grape pomace (wet and
dry), raisin waste, apple pomace (wet/dry)
B. Proposed Revocations: Violates Delaney Clause
Any interested person may submit comments on this proposed action to the address given in the ``ADDRESSES'' section (see above). Before issuing a final rule based on this proposal, EPA will consider all relevant comments. EPA also welcomes comment on whether its proposed revocations issued on July 1, 1994 (59 FR 33941; OPP Docket 300335) and January 18, 1995 (60 FR 3607; OPP Docket 300360) should be revised based on the changed policies and guidelines discussed in this proposed rule. Any comment on these prior proposals should bear their appropriate OPP docket control numbers. After consideration of comments, EPA will issue a final order determining whether revocation of the regulations is appropriate. Such order will be subject to objections pursuant to section 409(f) (21 U.S.C. 348(f)). Failure to file an objection within the appointed period will constitute waiver of the right to raise issues resolved in the order in future proceedings. A record has been established for this rulemaking under docket number [OPP-300397] (including comments and data submitted electronically as described below). A public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as CBI, is available for inspection from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The public record is located in Room 1132 of the Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. Electronic comments can be sent directly to EPA at: opp-Docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. The official record for this rulemaking, as well as the public version, as described above will be kept in paper form. Accordingly, EPA will transfer all comments received electronically into printed, paper form as they are received and will place the paper copies in the official rulemaking record which will also include all comments submitted directly in writing. The official rulemaking record is the paper record maintained at the address in ``ADDRESSES'' at the beginning of this document.
VIII. Executive Order 12866
EPA believes that there will be no significant economic
impacts from this action. Revocation of 34 unnecessary
tolerances does not affect the availability of the pesticides
for use on the crops involved. EPA has not completed
an evaluation of the economic impacts of this particular
action for the two proposed revocations under the Delaney
clause, since the Delaney clause requires EPA to act
without considering the costs or benefits of the action.
Nevertheless, EPA believes that the revocation of simazine
on sugarcane molasses and tetrachlorvinphos on processed
animal feed will have little economic impact.
Simazine residues on domestically produced molasses
are assumed to be zero since simazine is no longer registered
for use on sugarcane domestically. No impacts are expected
to U.S. sugarcane growers from this proposed revocation.
However, there could be short-term impacts to the domestic
market due to decreased supply or increased price for
imported molasses for animal feed. EPA cannot accurately
estimate the amount of molasses from sugarcane that
is imported to the U.S. Data on sugarcane molasses are
generally aggregated with other molasses imports. Moreover,
EPA lacks information on pesticide usage from some countries
with significant molasses exportation. However, based
on available information from countries for which EPA
has data and alternative sources of molasses, EPA believes
impacts upon domestic users of molasses will be minor
and temporary. Tetrachlorvinphos is used as a feed-through
insecticide for control of flies on cattle, hogs, and
horses. The bulk is used as a cattle feed-through; little
is used for hogs or horses. Both diflubenzuron
and methoprene are registered alternatives for cattle.
For hogs and horses, although there are no feed-through
alternatives available, dimethoate, cyromazine, and
dichlorvos are available as nonfeed-through alternatives,
and tetrachlorvinphos remains available for direct application
to animals. Given that the costs of some of the alternatives
are less than tetrachlorvinphos, alternatives exist,
and dermal applications are permitted, EPA believes
that there will be no significant adverse economic effects
[[Page 49149]]
from revocation of the animal feed tolerance for tetrachlorvinphos.
IX. Regulatory Flexibility Act
As explained above, the Agency is compelled to take this action without regard to the economic impacts, including impacts on small businesses. Therefore, this rule has not been reviewed under the provisions of sec. 3(a) of the Regulatory Flexibility Act.
X. Paperwork Reduction Act
There are no information collection requirements in this proposed order.
List of Subjects in 40 CFR Part 186
Environmental protection, Agricultural commodities, Pesticides and pests, Feed additives, Reporting and recordkeeping requirements.
Dated: September 15, 1995.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and
Toxic Substances.
Therefore, it is proposed that 40 CFR part 186 be amended as follows:
PART 186--[AMENDED]
2. By removing Sec. 186.100 Acephate.
Sec. 186.350 [Removed]
3. By removing Sec. 186.350 Benomyl.
Sec. 186.550 [Removed]
4. By removing Sec. 186.550 Carbaryl.
Sec. 186.800 [Removed]
5. By removing Sec. 186.800 1-(4-chlorophenoxy)-3,3-dimethyl -1- (1H-1,2,4-triazol-1-yl)-2-butanone.
Sec. 186.950 [Removed]
6. By removing Sec. 186.950 2-Chloro-1-(2,4,5-trichlorophenyl)vinyl dimethyl phosphate.
Sec. 186.2000 [Removed]
7. By removing Sec. 186.2000 Diflubenzuron.
Sec. 186.2050 [Removed]
8. By removing Sec. 186.2050 Dimethipin.
Sec. 186.2100 [Removed]
9. By removing Sec. 186.2100 Dimethoate including its oxygen analog.
Sec. 186.3650 [Removed]
10. By removing Sec. 186.3650 Imazalil.
Sec. 186.3750 [Removed]
11. By removing Sec. 186.3750 Iprodione.
Sec. 186.4450 [Removed]
12. By removing Sec. 186.4450 Norflurazon.
Sec. 186.5000 [Removed]
13. By removing Sec. 186.5000 Propargite.
Sec. 186.5350 [Removed]
14. By removing Sec. 186.5350 Simazine.
Sec. 186.5650 [Removed]
15. By removing Sec. 186.5650 Thiodicarb.
Sec. 186.5700 [Removed]
16. By removing Sec. 186.5700 Thiophanate-methyl.
Sec. 186.6300 [Removed]
17. By removing Sec. 186.6300 Zinc ion and maneb coordination product.
[FR Doc. 95-23443 Filed 9-18-95; 1:26 pm] BILLING CODE 6560-50-F