[Federal Register Volume 64, Number 162 (Monday, August 23, 1999)]
[Rules and Regulations]
[Pages 45885-45888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21830]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300907; FRL-6096-3]
RIN 2070-AB78


Buprofezin; Extension of Tolerance for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation extends a time-limited tolerance for residues 
of the insecticide buprofezin and its metabolites in or on tomatoes at 
0.7 part per million (ppm) and tomato paste at 1.0 ppm for an 
additional 2-year period, and citrus fruit at 2.0 ppm; dried citrus 
pulp at 10 ppm; cotton seed at 1.0 ppm; cotton gin byproducts at 20 
ppm; milk at 0.03 ppm; and cattle, sheep, hogs, goats, and horse meat 
and fat at 0.02 ppm; and meat byproducts at 0.5 ppm for an additional 
29-month period. These tolerances will expire and are revoked on 
December 31, 2001. This action is in response to EPA's granting of 
emergency exemptions under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide 
on tomatoes, citrus, and cotton. Section 408(l)(6) of the Federal Food, 
Drug, and Cosmetic Act requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under FIFRA 
section 18.

DATES: This regulation becomes effective August 23, 1999. Objections 
and requests for hearings must be received by EPA, on or before October 
22, 1999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number [OPP-300907], must be submitted to: Hearing Clerk 
(1900), Environmental Protection Agency, Rm. 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 identified by the docket control 
number, [OPP-300907], must also be submitted to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. In person, bring a copy of 
objections and hearing requests to Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. Copies of electronic 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 5.1/6.1 
or ASCII file format. All copies of electronic objections and hearing 
requests must be identified by the docket control number [OPP-300907]. 
No Confidential Business Information (CBI) should be submitted through 
e-mail. Copies of electronic objections and hearing requests on this 
rule may be filed online at many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail address: Rm. 280, Crystal Mall 
#2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-9367, 
[email protected].

SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the 
Federal Register of August 5, 1998 (63 FR 41720)(FRL-6018-5), which 
announced that on its own initiative under section 408(l)(6) of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), as 
amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 
104-170) it established a time-limited tolerance for the residues of 
buprofezin and its metabolites in or on tomatoes at 0.7 ppm and tomato 
paste at 1.0 ppm, with an expiration date of December 31, 1999. EPA 
established the tolerance because section 408(l)(6) of the FFDCA 
requires EPA to establish a time-limited tolerance or exemption from 
the requirement for a tolerance for pesticide chemical residues in food 
that will result from the use of a pesticide under an emergency 
exemption granted by EPA under FIFRA section 18. Such tolerances can be 
established without providing notice or period for public comment.
    EPA issued a final rule, published in the Federal Register of July 
30, 1997 (63 FR 40735)(FRL-5732-1), which announced that on its own 
initiative under section 408(1)(6), as amended by FQPA (Public Law 104-
170) it established time-limited tolerances for the residues of 
buprofezin and its metabolites in or on citrus fruit at 2.0 ppm; dried 
citrus pulp at 10 ppm; cotton seed at 1.0 ppm; cotton gin byproducts at 
20 ppm; milk at 0.03 ppm; and cattle, sheep, hogs, goats, and horse 
meat and fat at 0.02 ppm; and meat byproducts at 0.5 ppm; with an 
expiration date of July 31, 1998. EPA subsequently published a final 
rule in the Federal Register of June 19, 1998 (63 FR 33583) (FRL-5794-
7), extending these tolerances to expire on July 31, 1999. EPA 
established the tolerances because section 408(l)(6) of the FFDCA 
requires EPA to establish a time-limited tolerance or exemption from 
the requirement for a tolerance for pesticide chemical residues in food 
that will result from the use of a pesticide under an emergency 
exemption granted by EPA under FIFRA section 18. Such tolerances can be 
established without providing notice or period for public comment.
    EPA received a request to extend the use of buprofezin on tomatoes 
for this year's growing season due to the continuation of the emergency 
condition with silverleaf whiteflies. Silverleaf whitefly is a key pest 
on tomatoes from the seedling stage through harvest in Florida year-
round in all production regions. High populations feeding on plants 
cause irregular ripening, reducing fruit value. Whiteflies may also 
transmit tomato mottle geminivirus (TMV) and tomato yellow leaf curl 
virus (TYLCV) during feeding. TYLCV was discovered in tomatoes in 
Florida in the summer of 1997 and is, therefore, a new pest-related 
problem. Because whitefly is such a good vector of the virus and the 
virus is so prevalent, only minimal infestations of whitefly are 
required to transmit TYLCV to tomato plants. After having reviewed the 
submission, EPA concurs that emergency conditions

[[Page 45886]]

exist. EPA has authorized under FIFRA section 18 the use of buprofezin 
on tomatoes for control of silverleaf whiteflies in Florida.
    EPA received a request to extend the use of buprofezin on citrus 
for this year's growing season to control red scale, which has 
developed resistance to available controls in some areas of California, 
and has caused significant losses for affected growers; this situation 
remains unchanged from that of last year. EPA also received requests 
from California and Arizona to extend the use of buprofezin on cotton 
for this year's growing season since the situation has remained the 
same as last year; a recently-introduced new strain or species of 
whitefly has caused significant losses to cotton growers and has 
demonstrated resistance to available controls. After having reviewed 
the submission, EPA concurs that emergency conditions exist for these 
states. EPA has authorized under FIFRA section 18 the use of buprofezin 
on citrus for control of red scale and on cotton for control of 
whiteflies.
    EPA assessed the potential risks presented by residues of 
buprofezin in or on tomatoes, citrus and cotton. In doing so, EPA 
considered the safety standard in FFDCA section 408(b)(2), and decided 
that the necessary tolerance under FFDCA section 408(l)(6) would be 
consistent with the safety standard and with FIFRA section 18. The data 
and other relevant material have been evaluated and discussed in the 
final rules of July 30, 1997 (62 FR 40735) and August 5, 1998 (63 FR 
41720). Based on the data and information considered, the Agency 
reaffirms that extension of the time-limited tolerance will continue to 
meet the requirements of section 408(l)(6). Therefore, the time-limited 
tolerances on tomatoes and tomato paste are extended for an additional 
2-year period and the tolerances for citrus fruit, dried citrus pulp, 
cotton seed, cotton gin byproducts, milk, and cattle, sheep, hogs, 
goats, and horse meat, fat, and meat byproducts are extended for an 
additional 29-month period. EPA will publish a document in the Federal 
Register to remove the revoked tolerances from the Code of Federal 
Regulations (CFR). Although these tolerances will expire and are 
revoked on December 31, 2001, under FFDCA section 408(l)(5), residues 
of the pesticide not in excess of the amounts specified in the 
tolerance remaining in or on tomatoes, tomato paste, citrus fruit, 
dried citrus pulp, cotton seed, cotton gin byproducts, milk, and 
cattle, sheep, hogs, goats, and horse meat, fat, and meat byproducts 
after that date will not be unlawful, provided the pesticide is applied 
in a manner that was lawful under FIFRA and the application occurred 
prior to the revocation of the tolerance. EPA will take action to 
revoke this tolerance earlier if any experience with, scientific data 
on, or other relevant information on this pesticide indicate that the 
residues are not safe.

I. Objections and Hearing Requests

     The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) as was provided in the old section 408 
and in section 409. However, the period for filing objections is 60 
days, rather than 30 days. EPA currently has procedural regulations 
which govern the submission of objections and hearing requests. These 
regulations will require some modification to reflect the new law. 
However, until those modifications can be made, EPA will continue to 
use those procedural regulations with appropriate adjustments to 
reflect the new law.
    Any person may, by October 22, 1999, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given under the ``ADDRESSES'' section (40 
CFR 178.20). A copy of the objections and/or hearing requests filed 
with the Hearing Clerk should be submitted to the OPP docket for this 
rulemaking. The objections submitted must specify the provisions of the 
regulation deemed objectionable and the grounds for the objections (40 
CFR 178.25). Each objection must be accompanied by the fee prescribed 
by 40 CFR 180.33(i). EPA is authorized to waive any fee requirement 
``when in the judgement of the Administrator such a waiver or refund is 
equitable and not contrary to the purpose of this subsection.'' For 
additional information regarding tolerance objection fee waivers, 
contact James Tompkins, Registration Division (7505C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, (703) 305-5697, [email protected]. Requests for 
waiver of tolerance objection fees should be sent to James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460.
    If a hearing is requested, the objections must include a statement 
of the factual issues on which a hearing is requested, the requestor's 
contentions on such issues, and a summary of any evidence relied upon 
by the requestor (40 CFR 178.27). A request for a hearing will be 
granted if the Administrator determines that the material submitted 
shows the following: There is genuine and substantial issue of fact; 
there is a reasonable possibility that available evidence identified by 
the requestor would, if established, resolve one or more of such issues 
in favor of the requestor, taking into account uncontested claims or 
facts to the contrary; and resolution of the factual issues in the 
manner sought by the requestor would be adequate to justify the action 
requested (40 CFR 178.32). Information submitted in connection with an 
objection or hearing request may be claimed confidential 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. A copy of the information 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.

II. Public Record and Electronic Submissions

    EPA has established a record for this regulation under docket 
control number [OPP-300907] (including any comments and data submitted 
electronically). 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 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Room 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    Objections and hearing requests may be sent by e-mail directly to 
EPA at:
    [email protected]


    E-mailed objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption.
    The official record for this regulation, as well as the public 
version, as described in this unit will be kept in paper form. 
Accordingly, EPA will transfer any copies of objections and hearing 
requests received electronically

[[Page 45887]]

into printed, paper form as they are received and will place the paper 
copies in the official record which will also include all comments 
submitted directly in writing. The official record is the paper record 
maintained at the Virginia address in ``ADDRESSES'' at the beginning of 
this document.

III. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a tolerance under section 408 of the 
FFDCA. The Office of Management and Budget (OMB) has exempted these 
types of actions from review under Executive Order 12866, entitled 
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This 
final 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 as required by Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994), or require OMB 
review in accordance with Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997).
    In addition, since tolerances and exemptions that are established 
under section 408(l)(6) of FFDCA, such as the tolerance in this final 
rule, do not require the issuance of a proposed rule, the requirements 
of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not 
apply. Nevertheless, the Agency previously assessed whether 
establishing tolerances, exemptions from tolerances, raising tolerance 
levels or expanding exemptions might adversely impact small entities 
and concluded, as a generic matter, that there is no adverse economic 
impact. The factual basis for the Agency's generic certification for 
tolerance actions published on May 4, 1981 (46 FR 24950), and was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration.

B. Executive Order 12875

    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 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 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.

C. Executive Order 13084

    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 officials 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.

IV. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added 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 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 rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

Dated: August 11, 1999.

James Jones,

Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180-[AMENDED]

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

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

    2. In Sec.  180.511, by revising the table in paragraph (b) to read 
as follows:

Sec.  180.511   Buprofezin; tolerances for residues.

    *    *    *    *    *
    (b)   *    *    *

------------------------------------------------------------------------
                                                     Parts   Expiration/
                    Commodity                         per     Revocation
                                                    million      Date
------------------------------------------------------------------------
Cattle, fat......................................   0.02        12/31/01
Cattle, MBYP.....................................   0.5         12/31/01
Cattle, meat.....................................   0.02        12/31/01
Citrus fruit.....................................   2.0         12/31/01
Citrus, pulp, dried..............................  10           12/31/01
Cotton seed......................................   1.0         12/31/01
Cotton, gin byproducts...........................  20           12/31/01
Curcurbits.......................................   0.5         12/31/99
Goats, fat.......................................   0.02        12/31/01
Goats, MBYP......................................   0.5         12/31/01
Goats, meat......................................   0.02        12/31/01
Hogs, fat........................................   0.02        12/31/01
Hogs, MBYP.......................................   0.5         12/31/01

[[Page 45888]]

 
Hogs, meat.......................................   0.02        12/31/01
Horses, fat......................................   0.02        12/31/01
Horses, MBYP.....................................   0.5         12/31/01
Horses, meat.....................................   0.02        12/31/01
Milk.............................................   0.03        12/31/01
Sheep, fat.......................................   0.02        12/31/01
Sheep, MBYP......................................   0.5         12/31/01
Sheep, meat......................................   0.02        12/31/01
Tomatoes.........................................   0.7         12/31/01
Tomato paste.....................................   1.0         12/31/01
------------------------------------------------------------------------

*    *    *    *    *

[FR Doc. 99-21830 Filed 8-20-99; 8:45 am]
BILLING CODE 6560-50-F