[Federal Register Volume 66, Number 148 (Wednesday, August 1, 2001)]
[Proposed Rules]
[Pages 39705-39709]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19166]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301140; FRL-6786-4]
RIN 2070-AB78


Oxadiazon and Tetradifon; Proposed Revocation of Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This document proposes to revoke specific tolerances for 
residues of the herbicide oxadiazon and the insecticide tetradifon. EPA 
expects to determine whether any individuals or groups want to support 
these tolerances. The regulatory actions proposed in this document are 
part of the Agency's reregistration program under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the tolerance 
reassessment requirements of the Federal Food, Drug, and Cosmetic Act 
(FFDCA). By law, EPA is required to reassess 66% of the tolerances in 
existence on August 2, 1996, by August 2002, or about 6,400 tolerances. 
The regulatory actions proposed in this document pertain to the 
proposed revocation of 47 tolerances which would be counted among 
tolerance/exemption reassessments made toward the August 2002 review 
deadline of FFDCA section 408(q), as amended by the Food Quality 
Protection Act (FQPA) of 1996.

DATES: Comments, identified by docket control number OPP-301140, must 
be received on or before October 1, 2001.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper 
receipt by EPA, it is imperative that you identify docket control 
number OPP-301140 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Joseph Nevola, Special Review 
and Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave, NW., 
Washington, DC 20460; telephone number: (703) 308-8037; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
  ..............................  112                 Animal production
                                  311                 Food manufacturing
  ..............................  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development.

[[Page 39706]]

    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301140. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPP-301140 in the subject line on 
the first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB 
telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described in this unit. Do not submit any information electronically 
that you consider to be CBI. Electronic comments must be submitted as 
an ASCII file avoiding use of special characters and any form of 
encryption. Comments and data will also be accepted on standard disks 
in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic 
form must be identified by docket control number OPP-301140. Electronic 
comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI that I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the proposed rule or 
collection activity.
    7. Make sure to submit your comments by the deadline in this 
document.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

F. What Can I do if I Wish the Agency to Maintain a Tolerance that the 
Agency Proposes to Revoke?

    This proposed rule provides a comment period of 60 days for any 
person to state an interest in retaining a tolerance proposed for 
revocation. If EPA receives a comment within the 60-day period to that 
effect, EPA will not proceed to revoke the tolerance immediately. 
However, EPA will take steps to ensure the submission of any needed 
supporting data and will issue an order in the Federal Register under 
FFDCA section 408(f) if needed. The order would specify data needed and 
the time frames for its submission, and would require that within 90 
days some person or persons notify EPA that they will submit the data. 
If the data are not submitted as required in the order, EPA will take 
appropriate action under FFDCA.
     EPA issues a final rule after considering comments that are 
submitted in response to this proposed rule. In addition to submitting 
comments in response to this proposal, you may also submit an objection 
at the time of the final rule. If you fail to file an objection to the 
final rule within the time period specified, you will have waived the 
right to raise any issues resolved in the final rule. After the 
specified time, issues resolved in the final rule cannot be raised 
again in any subsequent proceedings.

II. Background

A. What Action is the Agency Taking?

     EPA is proposing to revoke specific tolerances for residues of 
oxadiazon and tetradifon in or on commodities listed in the regulatory 
text because these pesticides are not registered under FIFRA for uses 
on those commodities or because use of the pesticide is otherwise 
prohibited. The registrations for these pesticide chemicals were 
canceled because the registrant failed to pay the required maintenance 
fee or the registrant requested voluntary cancellation or deletion of 
one or more registered uses of the pesticide. It is EPA's general 
practice to propose revocation of those tolerances for residues of 
pesticide active ingredients on crop uses for which there are no active 
registrations under FIFRA, unless any person in comments on the 
proposal indicates a need for the tolerance to cover residues in or on 
imported commodities or domestic commodities legally treated.
    1. Oxadiazon. There have been no active registrations for oxadiazon 
concerning food uses since 1991. In a confirmatory letter to EPA, dated 
January 24, 2001, the registrant maintained its previous position that 
it will not support the 16 oxadiazon tolerances; although, it is 
supporting the continued (noncrop) use of oxadiazon for turf and 
ornamentals. EPA is

[[Page 39707]]

proposing to revoke all the tolerances in 40 CFR 180.346 for the 
combined residues of the herbicide oxadiazon and its metabolites in or 
on milk; cattle, fat; cattle, meat; cattle, meat byproducts; goats, 
fat; goats, meat; goats, meat byproducts; hogs, fat; hogs, meat; hogs, 
meat byproducts; horses, fat; horses, meat; horses, meat byproducts; 
sheep, fat; sheep, meat; and sheep, meat byproducts. Therefore, EPA is 
proposing to remove 40 CFR 180.346 in its entirety.
    2. Tetradifon. There are no active registrations for tetradifon, 
which was canceled in 1990 due to non-payment of maintenance fees. EPA 
is proposing to revoke all the tolerances in 40 CFR 180.174 for 
residues of the insecticide tetradifon in or on apples; apricots; 
cherries; citrus citron; crabapples; cucumber; figs; figs, dried; 
grapefruit; grapes; hops, dried; hops, fresh; lemons; limes; meat; 
melons; milk; nectarines; oranges; peaches; pears; peppermint; plums 
(fresh prunes); pumpkins; quinces; spearmint; strawberries; tangerines; 
tea, dried; tomatoes; and winter squash. Therefore, EPA is proposing to 
remove 40 CFR 180.174 in its entirety.

B. What is the Agency's Authority for Taking this Action?

    A ``tolerance'' represents the maximum level for residues of 
pesticide chemicals legally allowed in or on raw agricultural 
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 301 et 
seq., as amended by the FQPA of 1996, Public Law 104-170, authorizes 
the establishment of tolerances, exemptions from tolerance 
requirements, modifications in tolerances, and revocation of tolerances 
for residues of pesticide chemicals in or on raw agricultural 
commodities and processed foods 21 U.S.C. 346(a). Without a tolerance 
or exemption, food containing pesticide residues is considered to be 
unsafe and therefore ``adulterated'' under section 402(a) of the FFDCA. 
If food containing pesticide residues is considered to be 
``adulterated,'' you may not distribute the product in interstate 
commerce (21 U.S.C. 331(a) and 342(a). For a food-use pesticide to be 
sold and distributed, the pesticide must not only have appropriate 
tolerances under the FFDCA, but also must be registered under FIFRA (7 
U.S.C. et seq). Food-use pesticides not registered in the United States 
have tolerances for residues of pesticides in or on commodities 
imported into the United States.
    It is EPA's general practice to propose revocation of tolerances 
for residues of pesticide active ingredients on crop uses for which 
FIFRA registrations no longer exist and the pesticide can no longer be 
used. EPA has historically been concerned that retention of tolerances 
that are not necessary to cover residues in or on legally treated foods 
may encourage misuse of pesticides within the United States. 
Nonetheless, EPA will establish and maintain tolerances even when 
corresponding domestic uses are canceled if the tolerances, which EPA 
refers to as ``import tolerances,'' are necessary to allow importation 
into the United States of food containing such pesticide residues. 
However, where there are no imported commodities that require these 
import tolerances, the Agency believes it is appropriate to revoke 
tolerances for unregistered pesticides in order to prevent potential 
misuse.
    Furthermore, as a general matter, the Agency believes that 
retention of import tolerances not needed to cover any imported food 
may result in unnecessary restriction on trade of pesticides and foods. 
Under section 408 of the FFDCA, a tolerance may only be established or 
maintained if EPA determines that the tolerance is safe based on a 
number of factors, including an assessment of the aggregate exposure to 
the pesticide and of the cumulative effects of such pesticide and other 
substances that have a common mechanism of toxicity. In doing so, EPA 
must consider potential contributions to such exposure from all 
tolerances. If the cumulative risk is such that the tolerances in 
aggregate are not safe, then every one of these tolerances is 
potentially vulnerable to revocation. Furthermore, if unneeded 
tolerances are included in the aggregate and cumulative risk 
assessments, the estimated exposure to the pesticide would be inflated. 
Consequently, it may be more difficult for others to obtain needed 
tolerances or to register needed new uses. To avoid these trade-
restricting situations, the Agency is proposing to revoke tolerances 
for residues on crops uses for which FIFRA registrations no longer 
exist, unless someone expresses a need for such tolerances. Through 
this proposed rule, the Agency is inviting individuals who need these 
import tolerances to identify themselves and the tolerances that are 
needed to cover imported commodities.
    Parties interested in retention of the tolerances should be aware 
that additional data may be needed to support retention. These parties 
should be aware that, under FFDCA section 408(f), if the Agency 
determines that additional information is reasonably required to 
support the continuation of a tolerance, EPA may require that parties 
interested in maintaining the tolerances provide the necessary 
information. If the requisite information is not submitted, EPA may 
issue an order revoking the tolerance at issue.

C. When do These Actions Become Effective?

    EPA proposes that these actions become effective 90 days following 
publication of a final rule in the Federal Register. EPA is proposing 
this effective date because EPA believes that by this date all existing 
stocks of pesticide products labeled for the uses associated with the 
tolerances proposed for revocation will have been exhausted, giving 
ample time for any treated fresh produce to clear trade channels. 
Therefore, EPA believes the effective date proposed in this document is 
reasonable. However, if EPA is presented with information that existing 
stocks would still be available for use after the expiration date and 
that information is verified, EPA will consider extending the 
expiration date of the tolerance. If you have comments regarding 
existing stocks and whether the effective date accounts for these 
stocks, please submit comments as described under SUPPLEMENTARY 
INFORMATION.
     Any commodities listed in this proposal treated with the 
pesticides subject to this proposal, and in the channels of trade 
following the tolerance revocations, shall be subject to FFDCA section 
408(1)(5), as established by FQPA. Under this section, any residues of 
these pesticides in or on such food shall not render the food 
adulterated so long as it is shown to the satisfaction of FDA that, the 
residue is present as the result of an application or use of the 
pesticide at a time and in a manner that was lawful under FIFRA, and 
the residue does not exceed the level that was authorized at the time 
of the application or use to be present on the food under a tolerance 
or exemption from tolerance. Evidence to show that food was lawfully 
treated may include records that verify the dates that the pesticide 
was applied to such food.

D. What Is the Contribution to Tolerance Reassessment?

    By law, EPA is required to reassess 66% or about 6,400 of the 
tolerances in existence on August 2, 1996, by August 2002. EPA is also 
required to assess the remaining tolerances by August 2006. As of May 
21, 2001, EPA has reassessed over 3,630 tolerances. This document 
proposes to revoke 47 tolerances and/or exemptions. Therefore, 47 
tolerance reassessments would be counted when the final rule is 
published toward the

[[Page 39708]]

August 2002 review deadline of FFDCA section 408(q), as amended by FQPA 
in 1996.

III. Are The Proposed Actions Consistent with International 
Obligations?

    The tolerance revocations in this proposal are not discriminatory 
and are designed to ensure that both domestically-produced and imported 
foods meet the food safety standards established by the FFDCA. The same 
food safety standards apply to domestically produced and imported 
foods.
     EPA is working to ensure that the U.S. tolerance reassessment 
program under FQPA does not disrupt international trade. EPA considers 
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in 
reassessing them. MRLs are established by the Codex Committee on 
Pesticide Residues, a committee within the Codex Alimentarius 
Commission, an international organization formed to promote the 
coordination of international food standards. It is EPA's policy to 
harmonize U.S. tolerances with Codex MRLs to the extent possible, 
provided that the MRLs achieve the level of protection required under 
FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the 
tolerance reassessment section of individual Reregistration Eligibility 
Decision documents. The U.S. EPA has developed guidance concerning 
submissions for import tolerance support (65 FR 35069, June 1, 2000) 
(FRL-6559-3). This guidance will be made available to interested 
persons. Electronic copies are available on the internet at http://www.epa.gov/. On the Home Page select ``Laws and Regulations,'' then 
select ``Regulations and Proposed Rules'' and then look up the entry 
for this document under ``Federal Register--Environmental Documents.'' 
You can also go directly to the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.

IV. Regulatory Assessment Requirements

    In this proposed rule, EPA is proposing to revoke specific 
tolerances established under FFDCA section 408. The Office of 
Management and Budget (OMB) has exempted this type of action; i.e., a 
tolerance revocation for which extraordinary circumstances do not 
exist, from review under Executive Order 12866, entitled Regulatory 
Planning and Review (58 FR 51735, October 4, 1993). This proposed rule 
does not contain any information collections subject to OMB approval 
under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or 
impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Public Law 104-4). Nor does it require any special 
considerations under Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or OMB review or any other 
Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). This action does not involve any technical standards 
that would require Agency consideration of voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) 
(15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency previously assessed whether 
revocations of tolerances might significantly impact a substantial 
number of small entities and concluded that, as a general matter, these 
actions do not impose a significant economic impact on a substantial 
number of small entities. This analysis was published on December 17, 
1997 (62 FR 66020), and was provided to the Chief Counsel for Advocacy 
of the Small Business Administration. Taking into account this 
analysis, and available information concerning the pesticides listed in 
this rule, I certify that this action will not have a significant 
economic impact on a substantial number of small entities. 
Specifically, as per the 1997 notice, EPA has reviewed its available 
data on imports and foreign pesticide usage and concludes that there is 
a reasonable international supply of food not treated with canceled 
pesticides. Furthermore, for the pesticides named in this proposed 
rule, the Agency knows of no extraordinary circumstances that exist as 
to the present proposed revocations that would change EPA's previous 
analysis. Any comments about the Agency's determination should be 
submitted to EPA along with comments on the proposal, and will be 
addressed prior to issuing a final rule.
     In addition, the Agency has determined that this action will not 
have a substantial direct effect on States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government, as 
specified in Executive Order 13132, entitled Federalism (64 FR 43255, 
August 10, 1999). Executive Order 13132 requires EPA to develop an 
accountable process to ensure ``meaningful and timely input by State 
and local officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This proposed rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.



[[Page 39709]]


    Dated: July 18, 2001.

Marcia E. Mulkey,
Director, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR part 180 be amended as 
follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

Sec. 180.174  [Removed]

    2. Section 180.174 is removed.


Sec. 180.346  [Removed]

    3. Section 180.346 is removed.

[FR Doc. 01-19166 Filed 7-31-01; 8:45 am]
BILLING CODE 6560-50-S