01-22284. TSCA Section 21 Petition; Notice of Receipt

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces receipt of a petition submitted by the Cystic Fibrosis Foundation under section 21 of the Toxic Substances Control Act (TSCA), and requests comments on the petition. The Foundation has petitioned EPA to initiate a rulemaking proceeding under section 6(a)(1)(A) of TSCA to prohibit the manufacture, processing, distribution in commerce, use, and improper disposal of Burkholderia cepacia complex (Bcc), a group of naturally occurring microorganisms. The Petitioner believes that this action is necessary to “address the significant threat that these microorganisms pose to individuals with cystic fibrosis and other diseases that compromise the immune system.” Under section 21 of TSCA, the Agency must respond to the petition by October 30, 2001. The Agency does not plan at this time to schedule a public hearing for this petition. However, if it is determined that a hearing is needed, the Agency will hold a public hearing in the future.

DATES:

Comments, identified by docket control number OPPTS-211046, should be received on or before September 19, 2001. The Agency will accept comments received after that date, but cannot guarantee that they will be considered prior to preparing its response to the petition.

ADDRESSES:

Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS-211046 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

For general information contact: Barbara Cunningham, Acting Director, Environmental Assistance Division, Office of Pollution Prevention and Toxics (7401), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; e-mail address: [e-mail].

For technical information contact: James Alwood, Chemical Control Division, (7405), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public in general. This action may, however, be of interest to manufacturers (including importers), processors, and users of products that contain living microorganisms subject to jurisdiction under TSCA, especially if that entity knows that its products contain or may contain Bcc. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this Document or Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/​. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr/​.

2. In person. The Agency has established an official record for this action under docket control number OPPTS-211046. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, isavailable for inspection in the TSCA Nonconfidential Information Center, North East Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Center is [phone].

C. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS-211046 in the subject line on the first page of your response.

1. By mail. Submit your comments to: Document Control Office (7407), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier. Deliver your comments to: OPPT Document Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 401 M St., SW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is [phone].

3. Electronically. You may submit your comments electronically by e-mail to: [e-mail], or mail your computer disk to the address identified above. Do not submit any information electronically that you consider to be CBI. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on standard disks in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPPTS-211046. Electronic comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI Information That I Want To Submit to the Agency?

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part 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. 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 version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

We invite you to provide your views on the actions sought by the petitioner, the facts, technical information, supporting rationale which the petitioner believes establishes the need for the requested action, the potential impacts of the requested action (including possible unintended consequences), and any data or information that you would like the Agency to consider during the development of its response to the petition. You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Offer alternative ways to improve the notice.

7. Make sure to submit your comments by the deadline in this notice.

8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. Background

A. What is a TSCA section 21 petition?

Section 21 of TSCA allows citizens to petition EPA to initiate a proceeding for the issuance, amendment, or repeal of a rule under sections 4, 5(a)(2), 6, or an order under section 5(e) or 6(b)(2) of TSCA. A TSCA section 21 petition must set forth facts which the petitioner believes establish the need for the action requested. EPA is required to grant or deny the petition within 90 days of its receipt. If EPA grants the petition, the Agency must promptly commence an appropriate proceeding. If EPA denies the petition, the Agency must publish its reasons for the denial in the Federal Register. Within 60 days of denial or no action, petitioners may commence a civil action in a U.S. district court to compel initiation of the requested rulemaking. When reviewing a petition for a new rule, as in this case, the court must provide an opportunity for de novo review of the petition. After hearing the evidence, the court can order EPA to initiate the requested action.

B. What Action is the Agency Taking/Announcing?

This notice announces receipt by EPA on August 2, 2001, of a petition submitted by the Cystic Fibrosis Foundation under section 21 of TSCA, and requests comments on the petition. The Foundation has petitioned EPA to initiate rulemaking proceeding under section 6(a)(1)(A) of TSCA to prohibit the manufacture, processing, distribution in commerce, use, and improper disposal of Bcc. Under section 21 of TSCA, the Agency must respond to the petition by October 30, 2001.

The petitioner's request for a prohibition under section 6(a)(1)(A) of TSCA is based on their assertion that Bcc consists of a number of naturally occurring microorganisms which are subject to regulation under TSCA as chemical substances and exposure to Bcc resulting from its use in a “wide variety of commercial activities” poses a deadly risk to cystic fibrosis patients and individuals with certain other diseases that compromise the immune system. These commercial uses are asserted to include “products and services that involve drain cleaning, bioremediation, biomonitoring of hazardous wastes, biomass conversion, production of specialty chemicals, oil recovery, wastewater treatment, bio-mining, and desulfurization of oil and coal.” The petitioner's request for action under section 6(a)(1)(A) of TSCA is based on several points including assertions that Bcc is not necessary for such applications, that the manufacturing, and use of Bcc poses an unreasonable risk to cystic fibrosis patients, and, despite limitations and uncertainties in the understanding of the extent to which Bcc is used in various products, that the “only regulatory action that will adequately reduce the risk presented by Bcc is a flat prohibition against manufacturing and use.” EPA has commenced a review of this petition. Comments on the petition may be submitted by any of the methods identified in Unit I.

List of Subjects

• Environmental protection

Dated: August 27, 2001.

William H. Sanders III,

Director, Office of Pollution Prevention and Toxics.