[Federal Register Volume 69, Number 164 (Wednesday, August 25, 2004)]
[Notices]
[Pages 52262-52264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19233]


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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: [email protected].

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

[[Page 52263]]

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 [email protected], 
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

[[Page 52264]]

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