[Federal Register: August 25, 2004 (Volume 69, Number 164)]
[Notices]
[Page 52262-52264]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au04-71]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0205; FRL-7367-3]
Pesticides; Implementation of Globally Harmonized System; Notice
of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability.
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SUMMARY: EPA is issuing for comment a White Paper entitled, The
Globally Harmonized System of Classification and Labelling of
Chemicals: Implementation Planning Issues for the Office of Pesticide
Programs. This document describes the background and context of the
international Globally Harmonized System (GHS) for chemical hazard
classification and labeling. Further, the document describes EPA's
proposed approach to implementing this system for pesticide products
that are registered under the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA). The Agency is also making available a side-by-
side comparison document summarizing current hazard classification and
labeling policies and the corresponding elements of the GHS.
When implemented, the GHS will increase international consistency
in hazard classification and labeling for pesticide and other chemical
products. EPA believes that such consistency will promote greater
clarity and understanding of the hazards of pesticide products, thereby
reducing potential hazardous exposures and adverse effects from use,
without reducing benefits to users or imposing burdens on the pesticide
industry.
DATES: Comments, identified by docket identification (ID) number OPP-
2004-0205, must be received on or before October 25, 2004.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Mary Frances Lowe, Field and External
Affairs Division (7506C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-5689; fax number: (703) 308-1850; e-
mail address: lowe.maryfrances@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general, and may be of
particular interest to those persons who register pesticide products in
the United States. Regulated categories and entities may include, but
are not limited to:
Pesticide producers (NAICS 32532)
Producers of antimicrobial pesticides (NAICS 32561)
Producers of antifoulant pesticides (NAICS 32551)
Producers of wood preservatives (NAICS 32519)
This listing 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 unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket ID number OPP-2004-0205. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket
is the collection of materials that is available for public viewing at
the Public Information and Records Integrity
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Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 South Bell St.,
Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The docket telephone
number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket ID number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B.1. EPA intends to work
towards providing electronic access to all of the publicly available
docket materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and to Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/
, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2004-0205. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID Number OPP-2004-0205. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2004-0205.
3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1801 South Bell St., Arlington, VA, Attention: Docket ID
Number OPP-2004-0205. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be
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disclosed except in accordance with procedures set forth in 40 CFR part
2.
In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.
II. Background
A. The Globally Harmonized System of Classification and Labelling of
Chemicals (GHS)
The GHS is a major international activity mandated by the 1992 UN
Conference on Environment and Development and endorsed by the 2002
World Summit on Sustainable Development (WSSD) and the
Intergovernmental Forum on Chemical Safety (IFCS). The United States
and other countries and stakeholders worked for over a decade to
develop the GHS, which is designed to provide a common approach to
defining and classifying hazards and communicating hazard information
on labels and safety data sheets. The anticipated benefits of
harmonization include, for example:
Enhanced protection of human health and the environment:
GHS will help promote greater consistency in the classification and
hazard labeling of all chemicals, thereby enhancing safer handling and
use of chemicals in transport, in the workplace, and in consumer use
settings.
Sound management of chemicals worldwide: GHS will provide
a harmonized basis for the first step in sound management of chemicals,
identifying/classifying hazards and communicating them.
Trade facilitation: GHS will reduce costly and time-
consuming activities needed to comply with multiple international
classification and labeling systems, promoting more consistency in
regulation, and reducing non-tariff barriers to trade.
The GHS was formally adopted by the United Nations Economic and
Social Council (UN ECOSOC) in July 2003. For a fuller discussion of the
history and organization of the GHS negotiations, see the Federal
Register of April 3, 1997 (62 FR 15951).
B. Hazard Criteria and Labeling Under FIFRA
Pesticide products are regulated in the United States under FIFRA.
Under FIFRA, each product intended to be distributed or sold
domestically, including imported products, must be registered with EPA.
To register a product, EPA reviews data and information concerning the
pesticide to determine whether it meets the standard of FIFRA section
3(c)(5), including that the product will not cause ``unreasonable
adverse effects'' on man or the environment. As part of its evaluation,
EPA reviews and approves the label of each product.
EPA regulations on pesticide labeling, located in 40 CFR part 156,
prescribe a number of elements that will be affected by the GHS when
adopted. EPA requires pesticide labeling to bear, among other things:
1. Identifying information, such as a product name, registrant name
and address, and EPA registration number. These identification elements
are currently consistent with the GHS, and would not be affected in
adopting the GHS. EPA also strongly encourages, but does not require, a
telephone contact number on pesticide labels to assist persons who seek
additional information. GHS specifies that a telephone number should be
included on the label as part of supplier identifier information.
2. An ingredients statement that identifies each pesticide active
ingredient and its percentage, as well as the percentage (but not the
identity) of inert ingredients in the product. The GHS encourages the
identification of all ingredients that contribute to the hazard of the
product, but permits national policies concerning disclosure of CBI to
take precedence.
3. Appropriate hazard and precautionary statements in the areas of
physical hazard, acute toxicity hazards, and certain toxicity
statements pertaining to ecological hazards. EPA currently classifies
each pesticide product for acute toxicity (oral, dermal, and
inhalation) and for skin and eye corrosion/irritation using a four-
category scheme that is set out in its regulations. EPA also requires
classification and labeling for skin sensitization, flammability, and
certain environmental hazards. Once a product has been assigned to a
hazard category, EPA prescribes appropriate label hazard statements in
its registration decisions.
The GHS will change the hazard classification criteria, (for
example, by using a five-category scheme for acute oral, dermal, and
inhalation toxicity), and, based upon the new classifications, sets out
standardized hazard statements, signal words, and pictograms by hazard
class and category.
4. Use directions, that, if followed, will be adequate to protect
against unreasonable adverse effects. The GHS does not address use
directions, and EPA would anticipate no changes in current practice.
To adopt the GHS for U. S. pesticide products, EPA must revise its
labeling regulations to make them consistent with the GHS hazard
criteria and hazard statements. In addition, EPA must devise and
implement a process for revising and reviewing the labeling of all
currently registered pesticide products that are affected by the GHS.
Moreover, EPA will be evaluating its other pesticide regulations that
depend on a toxicity categorization scheme to determine whether changes
are necessary.
III. Documents Made Available
The White Paper that EPA is making available describes the
development of the GHS internationally, the background and context of
pesticide regulation in the United States, the changes that adoption of
the GHS would require, and the Agency's initial thinking on how it will
implement the GHS.
To assist commenters in understanding the revisions that will be
proposed, EPA is also making available a document entitled Chemical
Hazard Classification and Labeling: Comparison of OPP Requirements and
the GHS. This document generally compares the specific elements of U.S.
pesticide hazard criteria and labeling as currently required with the
corresponding GHS elements. The document includes a series of tables
providing a side-by-side comparison of the two systems.
List of Subjects
Environmental protection, labeling, occupational safety and health,
pesticides and pests, reporting and recordkeeping requirements.
Dated: August 12, 2004.
Susan B. Hazen,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
[FR Doc. 04-19233 Filed 8-24-04; 8:45 am]
BILLING CODE 6560-50-S