[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:
nisenson.lisa@epamail.epa.gov.
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-Docket@epamail.epa.gov
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
