Pesticides; Implementation of Globally Harmonized System; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of availability.

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 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 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