[Federal Register Volume 64, Number 76 (Wednesday, April 21, 1999)]
[Rules and Regulations]
[Pages 19489-19493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10006]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 180 and 185

[OPP-300836; FRL-6074-4]
RIN 2070-AB78


Dimethyl phosphate of 3-hydroxy-N-methyl-cis-crotonamide 
(monocrotophos) Final rule; Tolerance Revocations

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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

SUMMARY: This final rule announces the revocation of tolerances for 
Dimethyl phosphate of 3-hydroxy-N-methyl-cis-crotonamide 
(monocrotophos) for residues of sugarcane, potatoes, cotton seed, 
peanuts, peanut hulls, and tomatoes. The regulatory actions 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 33% of the tolerances in 
existence on August 2, 1996, by August 1999, or about 3,200 tolerances. 
The regulatory actions indicated in this document pertain to the final 
revocation of tolerances and/or exemptions, which count toward the 
August, 1999, review deadline of FFDCA section 408(q), as amended by 
the Food Quality Protection Act (FQPA) of 1996.
DATES: This regulation becomes effective April 21, 1999. Objections and 
requests for hearings must be received on or before July 20, 1999.
ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit IV of the SUPPLEMENTARY INFORMATION section of this 
notice. Be sure to identify the appropriate docket number [OPP-300836], 
which is an addendum to a previous docket.
FOR FURTHER INFORMATION CONTACT:  For technical information contact: 
Jamil Mixon, Reregistration Branch I, mail code (7508C), Special Review 
and Reregistration Division, Office of Pesticide Programs, U.S. 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location: Reregistration Branch I, CM #2, 6th floor, 1921 
Jefferson Davis Hwy., Arlington, VA. Telephone: (703) 308-8032; e-mail: 
mixon.jamil @epa.gov.
SUPPLEMENTARY INFORMATION:

 I. Does this Notice Apply to Me?

    You may be affected by this notice if you sell, distribute, 
manufacture, or use pesticides for agricultural applications, process 
food, distribute or sell food, or implement governmental pesticide 
regulations. Pesticide reregistration and other actions [see FIFRA 
section 4(g)(2)] include tolerance and exemption reassessment under 
FFDCA section 408. In this notice, the tolerance actions are proposed 
in coordination with the cancellation of associated registrations. 
Potentially affected categories and entities may include, but are not 
limited to:

------------------------------------------------------------------------
                                               Examples of Potentially
                 Category                         Affected Entities
------------------------------------------------------------------------
 Agricultural Stakeholders................  Growers/Agricultural Workers
                                              Contractors [Certified/
                                             Commercial Applicators,
                                             Handlers, Advisors, etc.]
                                              Commercial Processors
                                              Pesticide Manufacturers
                                              User Groups
                                              Food Consumers
 
Food Distributors.........................  Wholesale Contractors
                                              Retail Vendors
                                              Commercial Traders/
                                             Importers
 
Intergovernmental Stakeholders............  State, Local, and/or Tribal
                                             Government Agencies
Foreign Entities..........................  Governments, Growers, Trade
                                             Groups
------------------------------------------------------------------------

 This table 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 this table could also be 
affected. If you have any questions regarding the applicability of this 
action to a particular entity, you can consult with the technical 
person listed in the ``FOR FURTHER INFORMATION CONTACT'' section.

[[Page 19490]]

II. How Can I Get Additional Information or Copies of this or Other 
Support Documents?

A. Electronically

    You may obtain electronic copies of this document and various 
support documents from the EPA Internet Home Page at http://
www.epa.gov/. On the Home Page select ``Laws and Regulations'' 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/homepage/fedrgstr/.

 B. In Person or by Phone

    If you have any questions or need additional information about this 
action, please contact the technical person identified in the ``FOR 
FURTHER INFORMATION CONTACT'' section. In addition, the official record 
for this notice, including the public version, has been established 
under docket control number [OPP-300836], (including comments and data 
submitted electronically as described below). A public version of this 
record, including printed, paper versions of any electronic comments, 
which does not include any information claimed as Confidential Business 
Information (CBI), is available for inspection in Room 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 Public 
Information and Records Integrity Branch telephone number is 703-305-
5805.

III. Can I Challenge the Agency's Final Decision Presented in this 
Document?

    Yes. You can file a written objection or request a hearing by June 
21, 1999 in the following manner:

 A. By Paper

    Written objections and hearing requests, identified by the document 
control number [OPP-300836], may be submitted to: Hearing Clerk (1900), 
Environmental Protection Agency, room M3708, 401 M St., SW., 
Washington, DC 20460. Fees accompanying objections and hearing requests 
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA 
Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. 
Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing 
requests filed with the Hearing Clerk should be identified by the 
document control number and submitted to the Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticide Programs, 401 M St., SW., Washington, DC 
20460. In person, bring a copy of objections and hearing requests to 
room 119, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.

B. Electronically

    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending e-mail to opp-
[email protected], per the instructions given in ``By Paper'' 
above. Electronic copies of objections and hearing requests must be 
submitted as an ASCII file avoiding the use of special characters and 
any form of encryption. Copies of objections and hearing requests will 
also be accepted on disks in WordPerfect 5.1 or 6.1 file format or 
ASCII file format. All copies of objections and hearing requests in 
electronic form must be identified by the docket number [OPP-300836]. 
Do not submit CBI through e-mail. Electronic copies of objections and 
hearing requests on this rule may be filed online at many Federal 
Depository libraries.

IV. Why Is EPA Revoking the Tolerances Discussed below?

    On June 13, 1988, the producer of monocrotophos requested voluntary 
cancellation of all registrations with a recall of all products in the 
channels of trade that would not be used by September 30, 1989. The 
last registered uses for monocrotophos were cancelled on January 22, 
1991, for nonpayment of the March 1, 1990, maintenance fees. On June 9, 
1993, the Agency's proposed revocation of tolerances for monocrotophos 
was published in the Federal Register (FRL-4183-6). Comments were 
received from Ciba-Geigy Corporation, now Novartis Crop Protection, 
Inc. and Biologic Research & Development Inc., a U.S. regulatory 
consultant for the Shell International Chemical Company, expressing 
strong interest in maintaining tolerance on commodities imported into 
the United States. As a result, the Agency allowed tolerances to remain 
on peanut hulls, cottonseed, potatoes, sugarcane, and tomatoes.
    On January 22, 1999, Novartis Crop Protection Inc. the sole 
producer of monocrotophos, informed EPA that it no longer intended to 
support monocrotophos tolerances for import purposes. Novartis 
indicates that sale of monocrotophos will end in 1999, and has 
requested that tolerances for import purposes be retained until 
December 31, 2000, in order to fully utilize their existing stock. As 
Novartis is the sole producer of monocrotophos, EPA believes that there 
is no one else who will support tolerances for monocrotophos for import 
commodities. Therefore, EPA is revoking these tolerances for 
monocrotophos in or on peanuts, peanut hulls, tomatoes, cottonseed, 
potatoes and sugarcane (Sec. 180.296) and in concentrated tomato 
products (Sec. 185.2250).

V. What Action Is Being Taken?

    This final rule revokes the FFDCA tolerances for residues of 
certain specified pesticides in or on certain specified commodities. 
EPA is revoking these tolerances because they are not necessary to 
cover residues of the relevant pesticides in or on domestically treated 
commodities or commodities treated outside but imported into the United 
States. These pesticides are no longer used on commodities within the 
United States and no person has provided comment identifying a need for 
EPA to retain the tolerances to cover residues in or on imported foods. 
EPA has historically expressed a concern that retention of tolerances 
that are not necessary to cover residues in or on legally treated foods 
has the potential to encourage misuse of pesticides within the United 
States. Thus it is EPA's policy to issue a final rule revoking those 
tolerances for residues of pesticide chemicals for which there are no 
active registrations under FIFRA, unless any person in comments on the 
proposal demonstrates a need for the tolerance to cover residues in or 
on imported commodities or domestic commodities legally treated.
    EPA is not issuing today a final rule to revoke those tolerances 
for which EPA received comments demonstrating a need for the tolerance 
to be retained. Generally, EPA will proceed with the revocation of 
these tolerances on the grounds discussed above only if, prior to EPA's 
issuance of a section 408(f) order requesting additional data or 
issuance of a section 408(d) or (e) order revoking the tolerances on 
other grounds, commenters retract the comment identifying a need for 
the tolerance to be retained or EPA independently verifies that the 
tolerance is no longer needed.
    In the Federal Register of June 9, 1993, (OPP-300836) (FRL 4183-6), 
EPA issued a proposed rule for specific pesticides announcing the 
proposed revocation of tolerances for canceled food uses and inviting 
public comment for consideration and for support of tolerance retention 
under FFDCA standards. The following comments were received by the 
agency in response

[[Page 19491]]

to the document published in the Federal Register:
     1. Comments from a letter received from Ciba-Geigy Corporation 
July 27, 1993, stated that, `` Monocrotophos is used extensively in 
many countries around the world. The major uses in these countries are 
on crops such as sugarcane, potatoes and cottonseed.'' In addition 
Ciba-Geigy requested that, ``the Agency withhold preceding to revoke 
residue tolerances for monocrotophos on cottonseed, potatoes and 
sugarcane at this time. Revoking these tolerances could create a non 
tariff trade barrier and should therefore be avoided to the extent 
possible. Ciba's proposal is to convert these domestic tolerances `` to 
import tolerances which will help facilitate free trade.''
    Agency Response. The Agency allowed tolerances to remain on peanut 
hulls, tomatoes, cottonseed, potatoes and sugarcane (Sec. 180.296) and 
in concentrated tomato products (Sec. 185.2250).
    2. Comments from correspondence received August 4, 1993, from 
Biologic Research & Development Inc., than a U.S. regulatory consultant 
for the Shell International Chemical Company, requested that EPA 
reconsider its proposal to revoke the existing U.S. tolerances for 
monocrotophos, but rather allow for a review of those tolerances in 
recognition of on going international uses of this compound and those 
residues likely to occur in commodities imported into the U.S.
    Agency Response. The Agency allowed tolerances to remain on 
peanuts, peanut hulls, tomatoes, cottonseed, potatoes and sugarcane 
(Sec. 180.296) and in concentrated tomato products (Sec. 185.2250).

VI. When do These Actions become Effective?

    Tolerance revocation for monocrotophos becomes effective December 
31, 2000, per the manufacturer's request to fully utilize its remaining 
existing stock. If you have comments regarding existing stocks, please 
submit comments as described in Unit IV of the SUPPLEMENTARY 
INFORMATION section of this notice.

----------------------------------------------------------------------------------------------------------------
                                                                                   Parts per      Expiration/
                    Section                                 Commodity               million     Revocation Date
----------------------------------------------------------------------------------------------------------------
180.296.......................................  Peanuts hulls                             0.5         12/31/2000
  ............................................  Tomatoes                                  0.5         12/31/2000
  ............................................  Cottonseed                                0.1         12/31/2000
  ............................................  Potatoes                                  0.1         12/31/2000
  ............................................  Sugarcane                                 0.1         12/31/2000
  ............................................  Peanuts                                  0.05         12/31/2000
185.2250......................................  Tomato concentrated products              2.0         12/31/2000
----------------------------------------------------------------------------------------------------------------

    Any commodities listed in the regulatory text of this document that 
are treated with the pesticides subject to this notice, and that are in 
the channels of trade following the tolerance revocations, shall be 
subject to FFDCA section 408(1)(5), as established by the Food Quality 
Protection Act (FQPA). Under this section, any residue 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, (1) 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 (2) 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.

VII. How do the regulatory assessment requirements apply to this 
action?

A. Is this a ``Significant Regulatory Action''?

    No. Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), this action is not a 
``significant regulatory action.'' The Office of Management and Budget 
(OMB) has determined that tolerance actions, in general, are not 
``significant'' unless the action involves the revocation of a 
tolerance that may result in a substantial adverse and material affect 
on the economy. In addition, this action is not subject to Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997), because this 
action is not an economically significant regulatory action as defined 
by Executive Order 12866. Nonetheless, environmental health and safety 
risks to children are considered by the Agency when determining 
appropriate tolerances. Under FQPA, EPA is required to apply an 
additional 10-fold safety factor to risk assessments in order to ensure 
the protection of infants and children unless reliable data supports a 
different safety factor.

B. Does this Action Contain Any Reporting or Recordkeeping 
Requirements?

    No. This action does not impose any information collection 
requirements subject to OMB review or approval pursuant to the 
Paperwork Reduction Act (44 U.S.C. 3501 et seq.).

C. Does this Action Involve Any ``Unfunded Mandates''? 

    No. This action does not impose any enforceable duty, or contain 
any ``unfunded mandates'' as described in Title II of the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4).

D. Do Executive Orders 12875 and 13084 Require EPA to Consult with 
States and Indian Tribal Governments Prior to Taking the Action in this 
Document? 

    No. Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local or tribal government, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments. If the mandate is unfunded, EPA 
must provide to the Office of Management and Budget (OMB) a description 
of the extent of EPA's prior consultation with representatives of 
affected State, local and tribal governments, the nature of their 
concerns, copies of any written communications from the governments, 
and a statement supporting the need to issue the regulation. In 
addition, Executive Order 12875 requires EPA to develop an effective 
process permitting elected officials and other representatives of 
State, local and tribal governments ``to provide meaningful and timely 
input in the development of

[[Page 19492]]

regulatory proposals containing significant unfunded mandates.''
    Today's rule does not create an unfunded Federal mandate on State, 
local or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of Executive Order 12875 do not apply to this rule.
    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide OMB, in a separately identified 
section of the preamble to the rule, a description of the extent of 
EPA's prior consultation with representatives of affected tribal 
governments, a summary of the nature of their concerns, and a statement 
supporting the need to issue the regulation. In addition, Executive 
Order 13084 requires EPA to develop an effective process permitting 
elected and other representatives of Indian tribal governments ``to 
provide meaningful and timely input in the development of regulatory 
policies on matters that significantly or uniquely affect their 
communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian Tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this rule.

 E. Does Executive Order 12898 Apply to this Action? 

    No. This final rule does not involve special considerations of 
environmental-justice related issues pursuant to Executive Order 12898, 
entitled ``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations'' (59 FR 7629, February 16, 
1994).

F. Does this Action Have a Potentially Significant Impact on a 
Substantial Number of Small Entities? 

    No. The Agency has certified that tolerance actions, including the 
tolerance actions in this document, are not likely to result in a 
significant adverse economic impact on a substantial number of small 
entities. The factual basis for the Agency's determination, along with 
its generic certification under section 605(b) of the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), appears at 63 FR 55565, 
October 16, 1998 (FRL-6035-7). This generic certification has been 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration.

G. Does this Action Involve Technical Standards? 

    No. This tolerance 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), Pub. L. 104-113, section 12(d) (15 
U.S.C. 272 note). Section 12(d) directs EPA to use voluntary consensus 
standards in its regulatory activities unless to do so would be 
inconsistent with applicable law or otherwise impractical. Voluntary 
consensus standards are technical standards (e.g., materials 
specifications, test methods, sampling procedures, business practices, 
etc.) that are developed or adopted by voluntary consensus standards 
bodies. The NTTAA requires EPA to provide Congress, through OMB, 
explanations when the Agency decides not to use available and 
applicable voluntary consensus standards.

 H. Are There Any International Trade Issues Raised by this Action? 

    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. When possible, EPA seeks 
to harmonize U.S. tolerances with Codex MRLs. EPA may establish a 
tolerance that is different from a Codex MRL; however, FFDCA section 
408(b)(4) requires that EPA explain in a Federal Register document the 
reasons for departing from the Codex level. EPA's effort to harmonize 
with Codex MRLs is summarized in the tolerance reassessment section of 
individual REDs. The U.S. EPA is developing a guidance concerning 
submissions for import tolerance support. This guidance will be made 
available to interested stakeholders.

 I. Is this Action Subject to Review under the Congressional Review 
Act?

    Yes. The Congressional Review Act, 5 U.S.C. Sec. 801 et seq., as 
amended by the Small Business Regulatory Enforcement Fairness Act of 
1996, generally provides that before a rule may take effect, the agency 
promulgating the rule must submit a rule report, which includes a copy 
of the rule, to each House of the Congress and to the Comptroller 
General of the United States. EPA will submit a report containing this 
rule and other required information to the U.S. Senate, the U.S. House 
of Representatives, and the Comptroller General of the United States 
prior to publication of the rule in the Federal Register. This action 
is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 180

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

 40 CFR Part 185

    Environmental protection, Food additive, Pesticides and pest.

    Dated: April 12, 1999.
Lois Rossi,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
    Therefore, 40 CFR parts 180 and 185 are amended as follows:

PART 180--[AMENDED]

    1. In part 180:
    a. The authority citation for part 180 is amended to read as 
follows:
    Authority: 21 U.S.C. 321(q), 346(a) and 374.

    b. By revising Sec. 180.296 to read as follows:


Sec. 180.296  Dimethyl phosphate of 3-hydroxy-N-methyl-cis-crotonamide; 
tolerance for residues.

    (a) General. Tolerances are established for residues of the 
insecticide Dimethyl phosphate of 3-hydroxy-N-methyl-cis-crotonamide in 
or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       date
------------------------------------------------------------------------
Cottonseed......................................        0.1     12/31/00
Peanuts.........................................       0.05     12/31/00

[[Page 19493]]

 
Potatoes........................................        0.1     12/31/00
Sugarcane.......................................        0.1     12/31/00
Tomato..........................................        0.5     12/31/00
Tomato, concentrated products...................        2.0     12/31/00
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
     2. In part 185:

PART 185-- [AMENDED]

    a. The authority citation for part 185 is revised to read as 
follows:
     Authority: 21 U.S.C. 346(a) and 348.

Sec.  185.2250 [Removed]

    b. By removing Sec. 185.2250 Dimethyl phosphate of 3-hydroxy-N-
methyl-cis-crotonamide; tolerance for residues.

[FR Doc. 99-10006 Filed 4-20-99; 8:45 am]
BILLING CODE 6560-50-F