[Federal Register Volume 61, Number 55 (Wednesday, March 20, 1996)]
[Proposed Rules]
[Pages 11359-11362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6727]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180, 185 and 186
[OPP-300413; FRL-5347-6]
RIN 2070-AB18
Hexakis (2-methyl-2-phenylpropyl)distannoxane; Proposed Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA has completed the reregistration process and issued a
Reregistration Eligibility Decision (RED) for hexakis (2-methyl-2
phenylpropyl)distannoxane, also known as and hereafter referred to in
this document as fenbutatin oxide. In the reregistration process, all
information to support a pesticide's continued registration is reviewed
for adequacy and, when needed, supplemented with new scientific
studies. Based on the RED tolerance assessments for the pesticide
fenbutatin oxide, EPA is proposing to revoke certain individual
tolerances, establish group tolerances, correct some commodity
definitions and divide food crop and animal tolerances into two
separate tables, so that only animal tolerance expressions include both
the parent compound and metabolites. Since the publication of the RED,
the Agency has revised Table II of the Subdivision O, Residue Chemistry
Pesticide Assessment Guidelines for raw agricultural and processed
commodities. Consequently, revocations are proposed for commodities
which are not considered significant food or feed commodities. In
addition, the food additive regulation for citrus oil is being proposed
for revocation, and the establishment of a maximum residue level (MRL)
for citrus oil is proposed.
DATES: Written comments should be submitted to EPA by May 20, 1996.
ADDRESSES: By mail, submit written comments 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 comments to: Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA.
Information submitted and any comment(s) concerning this notice 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(s) 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 to
the submitter. Information on the proposed test and any written
comments will be available for public inspection in 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-300413]. 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 below in this document.
[[Page 11360]]
FOR FURTHER INFORMATION CONTACT: Jude Andreasen, Special Review and
Reregistration Division (7508W), Environmental Protection Agency, 401 M
St., SW, Washington, DC 20460. Telephone number: (703) 308-8016; e-
mail: andreasen.jude@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
I. Legal Authorization
The Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. 301 et
seq.) authorizes the establishment of tolerances (maximum legal residue
levels) and exemptions from the requirement of a tolerance for residues
of pesticide chemicals in or on raw agricultural commodities pursuant
to section 408 [21 U.S.C. 346(a)]. Without such tolerances or
exemptions, a food containing pesticide residues is considered
``adulterated'' under section 402 of the FFDCA, and hence may not
legally be moved in interstate commerce [21 U.S.C. 342]. To establish a
tolerance or an exemption under section 408 of the FFDCA, EPA must make
a finding that the promulgation of the rule would ``protect the public
health'' [21 U.S.C. 346a(b)]. For a pesticide to be sold and
distributed, the pesticide must not only have appropriate tolerances
under the FFDCA, but also must be registered under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA, 7 U.S.C. 136 et
seq.).
In 1988, Congress amended FIFRA and required EPA to review and
reassess the potential hazards arising from currently registered uses
of pesticides registered prior to November 1, 1984. As part of this
process, the Agency must determine whether a pesticide is eligible for
reregistration or whether any subsequent actions are required to fully
attain reregistration status. EPA has chosen to include in the
reregistration process a reassessment of existing tolerances or
exemptions from the need for a tolerance. Through this reassessment
process, based on more recent data, EPA can determine whether a
tolerance must be amended, revoked, or established, or whether an
exemption from the requirement of one or more tolerances must be
amended or is necessary.
The procedure for establishing, amending, or revoking tolerances or
exemptions from the requirement of tolerances is set forth in 40 CFR
parts 177 through 180. The Administrator or EPA, or any person by
petition, may initiate an action proposing to establish, amend, revoke,
or exempt a tolerance for a pesticide registered for food uses. Each
petition or request for a new tolerance, an amendment to an existing
tolerance, or a new exemption from the requirement of a tolerance must
be accompanied by a fee. Current Agency policy on tolerance actions
identified during the reregistration process is to waive the payment of
fees if the tolerance action concerns revision or revocation of an
established tolerance, or if the proposed exemption from the
requirement of a tolerance requires the concurrent revocation of an
approved tolerance. Comments submitted in response to the Agency's
published proposals are reviewed; the Agency then publishes its final
determination regarding the specific tolerance actions.
II. Chemical--Specific Information and Proposed Actions
A. Fenbutatin oxide
1. Regulatory background. Fenbutatin oxide is a miticide/acaricide
first registered under FIFRA in 1974; a Registration Standard was
issued in March, 1987. The Reregistration Eligibility Decision document
(RED) was issued in November 1994. The RED required that all fenbutatin
oxide products be classified as restricted use due to very high
toxicity to aquatic organisms, and imposed other label changes
regarding restricted entry intervals (REI), personal protective
equipment (PPE), toxicity statements, drift reductions and geographical
restrictions. The RED required the following generic data to confirm
EPA's regulatory assessments and conclusions: discussion of formulation
impurities, pH, bioaccumulation in fish, droplet size spectrum, and
drift field evaluation. The RED also required product-specific data
including product chemistry and acute toxicity studies, revised
Confidential Statements of Formula (CSFs) and revised labeling for
reregistration.
2. Current proposal. Tolerances for fenbutatin oxide listed in 40
CFR 180.362(a), (b), (c), 185.3550, and 186.3550. Tolerances listed
under 40 CFR 180.362(a) will be separated into paragraph (a) for food
crop tolerances and paragraph (b) for animal tolerances. Tolerances
with regional registrations, currently listed under 40 CFR 180.362(b)
will be redesignated as 40 CFR 180.362(c). Based on the available
residue data and to better harmonize with CODEX, the Agency has
concluded that the tolerance expression for plants should include the
parent compound only, and for meat, milk, poultry and eggs the
tolerance expression should include fenbutatin oxide and its organotin
metabolites dihydroxybis(2- methyl-2-phenylpropyl)stannane (SD-31723)
and 2-methyl-2- phenylpropylstannoic acid (SD-33608). These changes
will be incorporated into the tables.
Individual tolerances for almonds, pecans, and walnuts will be
deleted and a combined tolerance for residues in or on ``tree nuts
group'' will be established. The available residue data support this
crop group tolerance.
The separate tolerances for cherries, sour and cherries, sweet will
be combined into a single tolerance for residues in or on cherries.
Certain commodity definitions listed in these sections will be
revised to conform to the definitions listed in the Commodity Index
Report dated October 28, 1992.
The RED inadvertently attributed a feed additive tolerance for
``citrus, oil, refined'' under Sec. 186.3550. The correct designation
is under Sec. 185.3550 as a food additive tolerance. In 40 CFR (July 1,
1994 edition), citrus oil is correctly listed as a food additive
tolerance under Sec. 185.3550. However, EPA is proposing to revoke this
food additive regulation because EPA has determined that it is no
longer necessary to prevent the adulteration of food.
In June, 1995, EPA issued a revised policy concerning when section
409 food and feed additive regulations were needed to prevent the
adulteration of foods and animal feeds. (60 FR 31300, June 14, 1995).
Under EPA's revised policy, a section 409 regulation is necessary for
pesticide residues in processed food when it is likely that the level
of some residues of the pesticide will exceed the section 408
regulation level in ``ready to eat'' processed food. Of particular
relevance to the citrus oil food additive regulation, is EPA's decision
to interpret the term ``ready-to-eat'' processed food as food ready for
consumption as is without further preparation. For foods that are found
to be not ``ready-to-eat,'' EPA takes into account the dilution of
residues that occurs in preparing a ``ready-to-eat'' food.
EPA has determined that citrus oil is not a ``ready-to-eat'' food.
EPA has found no evidence that citrus oil is consumed ``as is.''
Rather, citrus oil is used as a flavoring ingredient in other foods. As
such, citrus oil can comprise up to 4,000 ppm (0.4 percent) of human
foods such as chewing gum, which corresponds to a dilution factor of
250. Since the dilution factor in ready-to-eat foods far exceeds the
concentration factor resulting from citrus processing, a food additive
regulation for fenbutatin oxide on citrus oil is not necessary.
Accordingly, EPA is proposing to revoke the fenbutatin oxide food
additive regulation for citrus oil.
[[Page 11361]]
To aid in the efficient enforcement of the Act, EPA is proposing to
establish a maximum residue limit (MRL) for fenbutatin oxide residues
in citrus oil. The MRL will reflect the maximum residue of fenbutatin
oxide in processed food consistent with a legal level of such residues
being present on citrus and the use of good manufacturing practices.
See 60 FR 11302, December 6, 1995, regarding imidacloprid. Processed
foods not in compliance with an applicable MRL will be deemed
adulterated under section 402. Taking into account the degree to which
fenbutatin oxide may concentrate during processing using good
manufacturing processes (6.9 times) and the level of residues expected
in citrus (20 ppm), EPA proposes a MRL of 140 ppm. For purposes of
enforcement of the MRL, the same analytical method used for enforcement
of the section 408 regulations should be used.
Since the RED was published, the Agency has revised Table II of the
Subdivision O, Residue Chemistry Pesticide Assessment Guidelines for
raw agricultural and processed commodities. Consequently, revocations
are proposed for fresh and dried marigolds, as well as for dried grape
pomace and raisin waste, which are not considered significant food or
feed commodities.
III. Public Comment Procedures
EPA invites interested parties to submit written comments,
information, or data in response to this proposed rule. Comments must
be submitted by May 20, 1996. Comments must bear a notation indicating
the docket number. Three copies of the comments should be submitted to
either location listed under ``ADDRESSES.''
Information submitted as a comment concerning this document may be
claimed confidential by marking any or all of that information as
``Confidential Business Information'' (CBI). EPA will not disclose
information so marked, except in accordance with procedures set forth
in 40 CFR part 2. A second copy of such comments, with the CBI deleted,
must also be submitted for inclusion in the public record. EPA may
publically disclose without prior notice information not marked
confidential.
Any person who has registered or submitted an application for
registration of a pesticide, under FIFRA, as amended, that contains any
of the ingredients listed herein, may request within 30 days after
publication of this notice in the Federal Register that this rulemaking
proposal be referred to an Advisory Committee in accordance with
section 408(e) of the FFDCA.
EPA has established a record for this proposed rule under docket
number [OPP-300413] (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, except 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
The official record for this proposed rule, 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 proposed rule record which will also include all comments
submitted directly in writing. The official proposed rule record is the
paper record maintained at the ``ADDRESSES'' listed at the beginning of
this document.
IV. References
1. U.S. Environmental Protection Agency. 60 FR 4912, Reregistration
Eligibility Decision Documents for Hexadecadienol, et al. and Notice to
Remove Benzocaine; Availability for Comment, January 25, 1995.
2. U.S. Environmental Protection Agency. Reregistration Eligibility
Decision: Fenbutatin Oxide, November 1994, EPA Case 0245.
V. Regulatory Assessment Requirements
To satisfy requirements for analysis specified by Executive Order
12866, the Regulatory Flexibility Act, the Paperwork Reduction Act, and
the Unfunded Mandates Reform Act, EPA has considered the impacts of
this proposal.
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in a rule: (1) Having an annual effect on the
economy of $100 million or more, or adversely and materially affecting
a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or state, local, or tribal tribal
governments or communities (also referred to as ``economically
significant''; (2) creating serious inconsistency or otherwise
interfering with an action taken or planned by another agency; (3)
materially altering the budgetary impacts of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) raising novel legal or policy issues arising out of
legal mandates, the President's priorities, or the principles set forth
in this Executive Order. The nature of the revisions as proposed will
not cause significant impacts. For example, combining the individual
tolerances for almonds, pecans and walnuts into a single ``tree nuts
group'' will not affect the use of fenbutatin oxide on these sites. It
simply reclassifies the sites to a crop grouping.
Pursuant to the terms of this Executive Order, EPA has determined
that this rule is not a ``significant regulatory action,'' because it
does not meet any of the regulatory-significance criteria listed above.
B. Regulatory Flexibility Act
EPA has reviewed this proposed rule under the Regulatory
Flexibility Act of 1980 [Pub. L. 96-354; 94 Stat. 1164, 5 U.S.C. 601 et
seq.], and has determined that it will not have a significant economic
impact on any small businesses, governments, or organizations.
Accordingly, I certify that this proposed rule does not require a
separate regulatory flexibility analysis under the Regulatory
Flexibility Act.
C. Paperwork Reduction Act
This proposed regulatory action does not contain any information
collection requirements subject to review by OMB under the Paperwork
Reduction Act of 1980, 44 U.S.C. 3501 et seq. This proposed action is
not expected to have a significant impact on entities of any size.
D. Unfunded Mandates
This proposed rule contains no Federal mandates under Title II of
the Unfunded Mandates Reform Act of 1995, Pub. L. 104-4, for State,
local, or tribal governments or the private sector, because it would
not impose enforceable duties on them.
[[Page 11362]]
List of Subjects in 40 CFR Parts 180, 185, and 186
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Animal feeds, Food additives, Pesticides and
pests, Reporting and Recordkeeping requirements.
Dated: February 28, 1996.
Lois Rossi,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
Therefore, it is proposed that 40 CFR parts 180, 185 and 186 be
amended as follows:
1. In part 180:
PART 180--[AMENDED]
a. The authority citation for part 180 would continue to read as
follows:
Authority: 15 U.S.C. 346a and 371.
b. Section 180.362 is revised to read as follows:
Sec. 180.362 Hexakis (2-methyl-2-phenylpropyl)distannoxane;
tolerances for residues.
(a) Tolerances are established for residues of hexakis (2-methyl-2-
phenylpropyl)distannoxane in or on raw agricultural commodities as
follows:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Almonds, hulls....................................... 80.0
Apples............................................... 15.0
Cherries............................................. 6.0
Citrus fruits group.................................. 20.0
Cucumbers............................................ 4.0
Eggplant............................................. 6.0
Grapes............................................... 5.0
Papayas.............................................. 2.0
Peaches.............................................. 10.0
Pears................................................ 15.0
Plums (fresh prunes)................................. 4.0
Strawberries......................................... 10.0
Tree nuts group...................................... 0.5
------------------------------------------------------------------------
(b) Tolerances are established for the combined residues of hexakis
(2-methyl-2-phenylpropyl)distannoxane and its metabolites
dihydroxybis(2-methyl-2-phenylpropyl)stannane (SD-31723) and 2-methyl-
2-phenylpropylstannoic acid (SD-33608) in or on raw agricultural
commodities as follows:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cattle, fat.......................................... 0.5
Cattle, mbyp......................................... 0.5
Cattle, meat......................................... 0.5
Eggs................................................. 0.1
Goats, fat........................................... 0.5
Goats, mbyp.......................................... 0.5
Goats, meat.......................................... 0.5
Hogs, fat............................................ 0.5
Hogs, mbyp........................................... 0.5
Hogs, meat........................................... 0.5
Horses, fat.......................................... 0.5
Horses, mbyp......................................... 0.5
Horses, meat......................................... 0.5
Milk, fat............................................ 0.1
Poultry, fat......................................... 0.1
Poultry, mbyp........................................ 0.1
Poultry, meat........................................ 0.1
Sheep, fat........................................... 0.5
Sheep, mbyp.......................................... 0.5
Sheep, meat.......................................... 0.5
------------------------------------------------------------------------
(c) Tolerances with regional registrations are established for
residues of hexakis (2-methyl-2-phenyl-propyl) distannoxane in or on
raw agricultural commodities as follows:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Raspberries.......................................... 10.0
------------------------------------------------------------------------
2. In part 185:
a. The authority citation for part 185 would continue to read as
follows:
Authority: 15 U.S.C. 346a and 348.
b. Section 185.3550 is revised to read as follows:
Sec. 185.3550 Hexakis.
(a) A regulation is established permitting residues of hexakis (2-
methyl-2-phenylpropyl) distannoxane in or on the following food items:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Prunes............................................... 20.0
Grapes, raisins...................................... 20.0
------------------------------------------------------------------------
(b) A maximum residue level regulation is established permitting
residues of hexakis (2-methyl-2-phenylpropyl)distannoxane in or on the
following food resulting from application to citrus:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Citrus oil........................................... 140.0
------------------------------------------------------------------------
This regulation reflects the maximum level of residues in citrus oil
consistent with use of hexakis (2-methyl-2- phenylpropyl)distannoxane
on citrus in conformity with 40 CFR 180.362 and with the use of good
manufacturing practices.
3. In part 186
PART 186--[AMENDED]
a. The authority citation for part 186 would continue to read as
follows:
Authority: 15 U.S.C. 348
b. Section 186.3550 is revised to read as follows:
Sec. 186.3550 Hexakis (2-methyl-2-phenylpropyl)distannoxane.
Regulations are established for residues of exakis (2-methyl-2-
phenylpropyl)distannoxane in or on the following processed feeds when
present therein as a result of application to growing crops:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Apples, pomace, wet.................................. 30
Citrus, pulp, dried.................................. 100
------------------------------------------------------------------------
[FR Doc. 96-6727 Filed 3-19-96; 8:45 am]
BILLING CODE 6560-50-F
