[Federal Register Volume 62, Number 136 (Wednesday, July 16, 1997)]
[Notices]
[Pages 38082-38084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18404]


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

ENVIRONMENTAL PROTECTION AGENCY

[OPP-64035; FRL 5730-5]


Notice of Receipt of Requests for Amendments to Revise Ethylene 
Oxide Labels

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA is issuing a notice of receipt of requests for amendment 
to terminate uses by registrants of products containing the active 
ingredient ethylene oxide under section 6(f)(1) of the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. The 
requests seek amendment of affected ethylene oxide (EtO) registration 
and product labels to terminate the uses covered by the term ``other 
inanimate objects'' on product labels. The registrants' submissions 
also request extension of worker protection requirements to all 
workplaces where EtO is used and improvement of precautionary 
statements to assure accuracy and consistency. These label 
modifications relate to resolution of the special review of EtO.

DATES: Public comment on this notice, in order to be considered, must 
be received by August 15, 1997. Unless EPA publishes a notice in the 
Federal Register modifying this notice, EPA will approve these use 
terminations and make them effective on July 31, 1997. The other label 
modifications have been accepted and will be implemented by July 31, 
1997.

ADDRESSES: By mail, submit comments to the Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7506C), Office of Pesticide Programs, 401 M St., SW., Washington, DC 
20460. In person, deliver comments to Rm. 1132, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically by following 
the instructions under Unit IV of this document. No Confidential 
Business Information (CBI) should be submitted through e-mail.

FOR FURTHER INFORMATION CONTACT: By mail: Lisa Nisenson, Special Review 
Branch, Special Review and Reregistration Division (7508W), 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location, telephone number and e-mail: Special Review Branch, 
3rd floor, 2800 Crystal Drive, Arlington, VA, (703) 308-8031; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Introduction

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide 
product may at any time request that any of its pesticide registrations 
be cancelled or amended to terminate one or more uses. The Act further 
provides that, before acting on the request, EPA must publish

[[Page 38083]]

a notice of receipt of any such request in the Federal Register and 
provide for a 30-day public comment period. Thereafter, the 
Administrator of EPA may approve such a request, unless the 
Administrator determines, in the case of a pesticide that is registered 
for a minor agricultural use, that the cancellation or termination of 
uses would adversely affect the availability of the pesticide for use. 
If such a determination is made, unless certain exceptions apply, the 
Administrator may not approve or reject a request until 180 days have 
passed from the date of publication in the Federal Register of the 
notice of receipt. The Administrator may waive the 180-day period upon 
request of the registrant.

II. Background

    EtO was registered under the Federal Insecticide, Fungicide and 
Rodenticide Act (FIFRA) in 1957 as a sterilizing gas for medical, 
surgical and dental supplies and equipment. EPA initiated a Special 
Review of EtO in 1978 based on worker risk from the reproductive 
toxicity and mutagenic effects of EtO. The carcinogenic effects of EtO 
became known in the early 1980's. Since initiation of the Special 
Review, product labels have been revised on several occasions in order 
to reduce worker exposures to EtO. The most important changes came in 
eliminating the uses that posed the greatest exposure, such as the 
fumigation of railcars or the disinfection of warehouses. In addition, 
labels were amended to specify that EtO could be used only in non-
portable gas-tight chambers designed for use with EtO, and to add 
hazard warnings and other precautionary labeling consistent with signs 
and other warnings that OSHA required in the workplace.
    On March 26, 1996, the two main registrants of EtO, AlliedSignal 
Inc. and ARC Chemical Division (hereafter referred to as ARC), agreed 
to amend their labels to restrict further the types of items that can 
be treated with EtO by revising the directions for use on non-medical 
items to delete the general term ``other inanimate objects'' and to 
specify instead that EtO may be used on irreplaceable materials such as 
library items. The March, 1996 label amendment agreement also 
standardizes the hazard warnings that appear on EtO product labels and 
ensure that all EtO product labels specify that EtO is to be used only 
in non-portable gas-tight chambers designed for use with EtO. In 
addition, EPA required labels to extend the OSHA occupational standard 
for EtO to all workplaces which use EtO. EPA has worked with the 
pesticide lead agencies to develop a compliance monitoring plan to 
assure that the risk mitigation measures are in place. On December 23, 
1996, EPA sent a letter to formulators who use AlliedSignal and ARC's 
products informing them of the required label changes. These 
formulators have submitted draft labels for review. All EtO labels are 
scheduled to bear the revised labeling by July 31, 1997. As part of the 
March 26, 1996 meeting, EPA specified these label modifications work 
towards resolving the EtO Special Review.
    EPA is aware of several letters commenting on the elimination of 
the use of EtO to fumigate beehives to control American foulbrood 
disease. Only 2 states have FIFRA 24(c) registrations which 
specifically allow fumigation of beehives. Other states were fumigating 
beekeeping equipment under the ``other inanimate objects'' provision on 
EtO labels. EPA intends to examine the information concerning the use 
of EtO to control American foulbrood disease, including the information 
submitted in the recent letters, as well as the effect of these 
requests by the registrants to delete uses in determining what further 
steps may be warranted in the EtO Special Review. EPA's position is 
that any use of EtO to fumigation beehives should be under a label 
specifically allowing such use, and not under ``other inanimate 
objects.''

III. Intent to Modify Labels and Terminate Use(s)

    This notice announces receipt of the EtO registrants' requests to 
terminate EtO uses and provides notice of EPA's intent to accept those 
requests. The registrations for which the registrants have requested 
use terminations are listed in the following table. Note that 
registrants have requested, and EPA has accepted, that the 180-day 
comment period be waived. The other label modifications have been 
accepted and will be implemented by July 31, 1997.


 Table 1.--Ethylene Oxide Registrations with Requests for Amendments to 
                             Terminate Uses                             
------------------------------------------------------------------------
     Company Number            Company Name          Products Affected  
------------------------------------------------------------------------
036736.................  ARC Chemical             36736-1, 36736-2,     
                          Corporation              36736-3, 36736-4,    
                                                   36736-5, 36736-6,    
                                                   36736-7              
                                                                        
067470.................  AlliedSignal Inc.        67470-1, 67470-2,     
                                                   67470-3, 67470-4,    
                                                   67470-5, 67470-6,    
                                                   67470-7, 67470-8,    
                                                   67470-9              
                                                                        
10330..................  Praxair Inc.             10330-16, 10330-21    
                                                   10330-17, 10330-18,  
                                                   10330-22, 10330-19   
------------------------------------------------------------------------
Note: Steris Corp., 3M, Pennsylvania Engineering Co., and Andersen      
  Sterilizers Inc. also have EtO registered products, however, their    
  labels do not provide for use on ``other inanimate objects.''         


IV. Public Comment Procedures

    EPA invites interested persons to submit written comments in 
response to this notice of receipt of requests to terminate use(s). 
Comments, to be considered, must be received by August 15, 1997. 
Comments must bear a notation indicating the document control number. 
Three copies of the comments should be submitted to either location 
listed under ``ADDRESSES'' at the beginning of this notice.
    Information submitted as a comment concerning this notice may be 
claimed confidential by marking any 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 comment that does 
not contain CBI must be provided by the submitter for inclusion in the 
public record. Information not marked confidential may be disclosed 
publicly by EPA without prior notice. All written comments will be 
available for public inspection in Rm. 1132, at the address given 
above, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 
holidays.

V. Public Record

    The official record for this notice, as well as the public version, 
has been established for this notice under docket number [64035] 
(including comments and data submitted electronically as described 
below). A public version of this record, including printed, paper 
versions of electronic comments, which does not include any information 
claimed as CBI, is available for inspection from 8:30 a.m. to 4:30 
p.m., Monday through Friday, excluding legal holidays. The official 
notice record is the paper record maintained at the

[[Page 38084]]

address in ``ADDRESSES'' at the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    opp-D[email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comment and data 
will also be accepted on disks in Wordperfect 5.1 file format or ASCII 
format. All comments and data in electronic form must be identified by 
the docket number [OPP-64035]. Electronic comments on this notice may 
be filed online at many Federal Depository Libraries.

VI. Existing Stocks

    For the purposes of this notice, existing stocks will be defined as 
those stocks of EtO products which do not bear the revised labeling 
(i.e. those stocks bearing the term ``other inanimate objects'') that 
were packaged, labeled, and/or released for shipment prior to July 31, 
1997. After July, 31, 1997, EtO registrants may not sell or distribute 
existing stocks of EtO products which bear the terminated uses. Dealers 
and distributors may sell quantities of EtO products bearing the 
terminated use(s) to end users until such stocks are exhausted. End 
users may use existing stocks until such stocks are exhausted.

VII. Proposed Use Termination Order

    The registrants' request for use termination will be accepted and 
will take effect on July 31, 1997 subject to the above-noted existing 
stocks provision, unless EPA publishes a notice in the Federal Register 
modifying this proposed order.

List of Subjects

    Environmental protection, Agricultural commodities, Pesticides and 
pests.

    Dated: July 3, 1997.

Lois A. Rossi,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.

[FR Doc. 97-18404 Filed 7-15-97; 8:45 am]
BILLING CODE 6560-50-F