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hexakis (Vendex) Proposed Tolerance 2/96

[Federal Register: March 20, 1996 (Volume 61, Number 55)]
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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.

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.
    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.


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-phenyl 
propyl)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
------------------------------------------------------------------------