[Federal Register Volume 63, Number 196 (Friday, October 9, 1998)]
[Rules and Regulations]
[Pages 54360-54362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27270]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300741; FRL-6037-1]
RIN 2070-AB78


Cyromazine; Extension of Tolerance for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule extends a time-limited tolerance for residues of the 
insecticide cyromazine and its metabolites in or on the meat, fat, and 
meat byproducts of turkeys at 0.05 part per million (ppm) for an 
additional 18-month period, to April 1, 2000. This action is in 
response to EPA's granting of an emergency exemption under section 18 
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing 
use of the pesticide on turkeys. Section 408(l)(6) of the Federal Food, 
Drug, and Cosmetic Act (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 section 18 
of FIFRA.

DATES: This regulation becomes effective October 9, 1998. Objections 
and requests for hearings must be received by EPA, on or before 
December 8, 1998.
ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300741], 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-300741], 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]. Follow the instructions in 
Unit II. of this preamble. No Confidential Business Information (CBI) 
should be submitted through e-mail.

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. 272, Crystal Mall 
#2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-308-9367; e-
mail: [email protected].

SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the 
Federal Register of October 22, 1997 (54784-54790) (FRL-5748-9), which 
announced that on its own initiative under section 408(e) of the FFDCA, 
21 U.S.C. 346a(e) and (l)(6), it established a time-limited tolerance 
for the residues of cyromazine and its metabolites in or on the meat, 
fat, and meat byproducts of turkeys at 0.05 ppm, with an expiration 
date of October 1, 1998. 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 section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment.
    EPA received a request to extend the use of cyromazine on turkeys 
this year to control flies. The applicant states that the flies are 
thought to carry spiking mortality, an acute form of Poult Enteritis 
Mortality Syndrome (PEMS). PEMS generally occurs during the summer 
months and strikes young birds between 2 to 6 weeks of age. The onset 
of the active infection is rapid. Birds become infectious within 24 to 
36 hours. Birds stop eating and drinking, and develop diarrhea, losing 
up to 40% of their body weight in about 4 days. Mortality of more than 
20% within a week's time is typical. Total mortality of 50% is not 
uncommon.
     Research into the cause of PEMS has been ongoing since 1991. 
Isolation of the primary agent has eluded researchers. Evidence 
suggests that house fly (Musca domestica) can transmit the PEMS disease 
agent(s). Turkey corona virus and reovirus have been isolated from 
house flies (adults and larvae, and also fly feces) collected from what 
was characterized as a PEMS flock in 1996. Researchers also found that 
feeding house flies to turkeys reproduced the disease. This is the 
strongest piece of evidence that house flies may play a role in the 
transmission of PEMS to turkeys.
     Alternative products available for use on house flies in poultry 
houses, such as tetrachlorvinphos, dichlorvos, and dimethoate, are 
applied as larvicides to the manure accumulated beneath cages or 
slatted floors. These products were developed for use under caged 
layers or in chicken houses with slatted floors; however, market 
turkeys are grown in open-floor environments, and the birds cannot be 
easily moved from areas needing treatment. One problem with this type 
of treatment of turkey houses is that rates for larvicidal use of these 
chemicals are generally the highest rates permitted by the label, 
creating a concern for the exposed birds. A second problem with these 
alternatives is that the residual control is 10 to 14 days at best, 
thus requiring at least two treatments over the course of a brooder 
house flock cycle. Additionally, it may not be possible to penetrate 
the breeding substrate with a low pressure sprayer as recommended, due 
to compaction of the litter. Finally, these alternatives are labeled as 
adulticides, leaving a question of possible resistance development by 
house flies to these chemicals.
    The disease situation has been in existence for approximately 5 
years, however early losses in South Carolina were minimal. Over the 
last 2 to 3 years, the situation has worsened to a critical point. The 
applicant asserts that should losses continue, the stability of the 
turkey industry in South Carolina will be severely compromised and may

[[Page 54361]]

never recover. After having reviewed the submission, EPA concurs that 
emergency conditions exist for this state. EPA has authorized under 
FIFRA section 18 the use of cyromazine on turkeys for control of flies.
    EPA assessed the potential risks presented by residues of 
cyromazine in or on turkeys. 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 rule of October 
22, 1997 (54784-54790) (FRL-5748-9). Based on that 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 tolerance is extended for an additional 18-
month period. Although this tolerance will expire and is revoked on 
October 1, 1998, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on turkeys 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 December 8, 1998, 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 above (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). 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

    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer any copies of objections and hearing requests 
received electronically into printed, paper form as they are received 
and will place the paper copies in the official rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
Virginia address in ``ADDRESSES'' at the beginning of this document.
    Electronic comments may be sent directly to EPA at:
    [email protected].


    Electronic objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption. Objections and hearing requests will also be accepted on 
disks in WordPerfect 5.1/6.1 or ASCII file format. All copies of 
objections and hearing requests in electronic form must be identified 
by the docket control number [OPP- 300741]. No CBI should be submitted 
through e-mail. Electronic copies of objections and hearing requests on 
this rule may be filed online at many Federal Depository Libraries.

III. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule extends a time-limited tolerance that was 
previously established by EPA under FFDCA section 408 (l)(6). 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). In addition, 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) (Pub. L. 104-4). Nor does it require any prior consultation as 
specified by Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28,1993), or 
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).
    Since this extension of an existing time-limited tolerance does 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 has 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.

[[Page 54362]]

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 to 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 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 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: October 1, 1998.

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. 346a and 371.

Sec. 180.414   [AMENDED]

    2. In Sec. 180.414, by amending paragraph (b) by changing the date 
``10/1/98'' to read ``4/1/00.''

[FR Doc. 98-27270 Filed 10-8-98; 8:45 am]
BILLING CODE 6560-50-F