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###### Environmental Protection Agency

          - [OPPT-2005-0032; FRL-7730-7]

# AGENCY:

Environmental Protection Agency (EPA).

# ACTION:

Notice.

# SUMMARY:

On May 13, 2005, the Ecology Center of Ann Arbor, Michigan, petitioned EPA under section 21 of the Toxic Substances Control Act (TSCA) to establish regulations prohibiting the manufacture, processing, distribution in commerce, use, and improper disposal of lead wheel balancing weights. For the reasons set forth in this notice, EPA has denied the petition to initiate rulemaking. In this notice, the Agency elaborates the reasons for its denial and the type of information it may need.

# FOR FURTHER INFORMATION CONTACT:

*For general information contact:*                         Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 554-1401; e-mail address:                         *TSCAHotline@epa.gov*.                    

*For technical information contact:*                         Dave Topping, National Program Chemicals Division (7404T), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 566-1974; e-mail address:                        *topping.dave@epa.gov*.                    

# SUPPLEMENTARY INFORMATION:

## I. General Information

### A. Does this Action Apply to Me?

                    You may potentially be affected by this action if you manufacture, import, process, use, distribute, or dispose of lead wheel balancing weights or are an automobile tire retailer. 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 Copies of this Document and Other Related Information?

                    1.                     *Docket*. EPA has established an official public docket for this action under docket identification (ID) number OPPT-2005-0032. 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 EPA Docket Center, Rm. B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8:30 a.m. to                           ( print page 51062)                        4:30 p.m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is (202) 566-1744, and the telephone number for the OPPT Docket, which is located in the EPA Docket Center, is (202) 566-0280.                

                    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, to 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. 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. 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 toward providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.

## 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 TSCA section 4, 6, or 8 or an order under section 5(e) or 6(b)(2). A TSCA section 21 petition must set forth facts that the petitioner believes establish the need for the action requested. EPA is required to grant or deny the petition within 90 days of its filing. 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 the expiration of the 90-day period, if no action is taken, the petitioners may commence a civil action in a U.S. District Court to compel initiation of the requested rulemaking proceeding.                

### B. What Action is Requested Under This TSCA Section 21 Petition?

On May 13, 2005, EPA received a petition under TSCA section 21 from the Ecology Center of Ann Arbor, Michigan. The petition requests that EPA initiate a rulemaking under TSCA section 6(a)(1)(A) to prohibit the manufacture, processing, distribution in commerce, use, and improper disposal of lead wheel balancing weights.

To promulgate a rule under TSCA section 6(a), EPA must find that there is a “reasonable basis to conclude” that activities involving a chemical substance or mixture present or will present “an unreasonable risk of injury to health or the environment.” It is important to note that TSCA section 6 does not require a factual certainty, but only a “reasonable basis to conclude” that a risk is unreasonable. The legislative history of TSCA makes it clear that EPA may take regulatory action to prevent harm even though there are uncertainties as to the threshold levels of risk. Congress recognized that “such action must be based not only on consideration of facts but also on consideration of scientific theories, projections of trends from currently available data, modeling using reasonable assumptions, and extrapolations from limited data.” (H.R. Rep. No. 1341, 94th Cong., 2d Sess. 32 (1976).)

Although TSCA uses unreasonable risk as its basic standard for deciding on appropriate action regarding the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, TSCA does not define the term “unreasonable risk.” Guidance is provided by section 6(c), which requires certain considerations in promulgating a rule under section 6(a). EPA must consider the following: (1) The effects of the chemical on health and the magnitude of human exposure; (2) the effects of the chemical on the environment and the magnitude of environmental exposure; (3) the benefits of the chemical for various uses and the availability of substitutes for such uses; and (4) the reasonably ascertainable economic consequences of the rule, after consideration of the effect on the national economy, small business, technological innovation, the environment, and public health.

Section 6(c) offers no further guidance to decision-makers. In particular, it does not discuss how each of these factors is to be weighed in relationship to each other. However, the House Report on TSCA (H.R. Rep. No. 1341, 94th Cong., 2d Sess. 13-15 (1976)) provides a useful pertinent explanation. The House Report describes the finding of unreasonable risk as involving a balancing of the probability that harm will occur, and the magnitude and severity of that harm, against the adverse effects (social and economic) on society of the proposed Agency action to reduce the harm.

## III. Disposition of Petition

EPA finds that there are insufficient data available for the Agency to initiate a TSCA section 6 rulemaking at this time. EPA has reviewed the supporting information included with the petition, as well as other available information on lead wheel balancing weights. The petition contains very limited, uncertain evidence on the potential environmental releases from lead wheel balancing weights to the air, surface water, ground water, and soil (particularly regarding potential releases in the proximity of roadways and potential releases to particularly sensitive environments or human and ecological populations). Some estimates of potential releases of lead from lead wheel balancing weights to the environment are available within references noted within the petition, or within other sources available in the literature. However, EPA needs additional, verifiable data in order to develop an adequate understanding of the environmental and human exposure associated with releases to the environment from lead wheel balancing weights.

While the hazard of lead and the fate and transport of lead in the environment are well-characterized, without additional information EPA cannot adequately estimate potential exposures and, thus, potential risks. A literature search conducted by the Agency identified little data beyond that cited by the petitioner. In particular, EPA is interested in the following data:
    - The number of sites and number of workers involved in the manufacture, processing, recycling, use, and disposal of lead wheel balancing weights, and any associated exposure of workers to lead.
          ( print page 51063)    
    - Quantities and releases of lead from the point of manufacture of lead wheel weights to the point of deposition on roadways.
    - Whether abrasion of lead wheel balancing weights occurs on the road, and if so, the extent of the abrasion and the mass of lead lost from the abrasion.
    - The contribution of lead from wheel balancing weights to the overall levels of lead near roadways.
    - The quantity of lead from lead wheel balancing weights deposited on roadways that subsequently enters various environmental pathways.
    - The percentage of deposited lead that enters each pathway (to determine which pathways are of concern).
    - The number of salvage yards, automobile shredders, steel mills, and secondary smelting sites and the quantities of lead that are released from recycling and disposal of lead wheel weights.
    - Exposures to hobbyists who melt lead wheel weights to manufacture other items such as fishing sinkers, toy soldiers, and bullets.

While the Agency does not believe information in all of these areas would be necessary, the data currently available are not adequate in any of these areas to support granting the petition or initiating the requested rulemaking; there is insufficient information to adequately estimate potential risks for any one exposure pathway.

In evaluating the petition, the Agency assessed a number of plausible exposure scenarios and associated releases of lead from lead wheel balancing weights in order to identify specific data gaps that should be filled in order to allow a meaningful, realistic assessment of risk. The data gaps are summarized above and the details are presented in the following documents, which are found in the public docket for today's notice:
    -  Preliminary Exposure Assessment Support Document for the TSCA Section 21 Petition on Lead Wheel-Balancing Weights , Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency.                
    -  Occupational Exposures and Environmental Releases of Lead Wheel-Balancing Weights , Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency.                

In addition, the data that are available have significant uncertainties and limitations. The analyses provided by the petitioner in support of statements regarding potential exposure raise several concerns, including: (1) Limitations in scope, both geographically and temporally; (2) potential limitations in the calculated lead wheel balancing weight releases during the weekly surveys that supported these analyses; (3) lack of data on potential routes of exposure from roadways to humans and the environment; and (4) lack of data on lead in soil, dust, and water near the test area to help establish a link between lead wheel balancing weights and measured lead in the environment.

Consequently, the Agency concludes that there are currently not enough data on human or environmental exposures to adequately assess the risks from the manufacturing, processing, distribution in commerce, use, or improper disposal of lead wheel balancing weights, and to initiate a TSCA section 6 rulemaking to prohibit these activities, as requested by the petitioner. In addition, due to the data limitations, the Agency has no basis to determine how significant the contribution of lead to the environment from wheel weights is and whether a rulemaking to address lead wheel weights would be an effective use of Agency resources.

                    However, while EPA cannot at present initiate a rulemaking under TSCA section 6, the Agency is concerned about the potential contribution of lead wheel weights and other products that contain lead to elevated blood lead levels in children. Nationally, the primary source of elevated blood lead levels in children is lead-based paint used before the product was banned in 1978. There are other sources, however, which may contribute to elevated blood lead levels, perhaps significantly. These sources include certain products that contain lead (such as wheel weights), historical contamination of soil, certain foods and folk remedies that contain lead, and releases from stationary sources. (For more information, see                    *http://www.cdc.gov/​nceh/​lead/​faq/​about.htm*.) As part of the Federal Government's effort to meet its goal to eliminate lead poisoning in children by 2010, EPA is working with the Centers for Disease Control and Prevention and other Federal Partners to characterize and address these other sources of lead exposure in children. As part of its focus on children's exposure to lead, EPA is developing an approach to prioritize for further analysis and action the variety of products containing lead, that would be subject to TSCA and/or voluntary initiatives, including lead wheel weights.                

## IV. Comments Received

                    EPA received nine comments in response to the                     ******Federal Register**                     notice published June 21, 2005 (70 FR 35667) (FRL-7720-5), announcing EPA's receipt of this TSCA section 21 petition.                

Three comments were received from members of the public and one from an environmental organization (The Department of the Planet Earth) supporting the petition. These commenters cited the toxicity of lead. None provided any technical data regarding exposure to lead from wheel balancing weights.

Two States (Maine and Minnesota) submitted comments and supported the petition. The State of Maine noted that State water quality data indicate many locations where lead in road and parking lot runoff exceed Ambient Water Quality Standards. This commenter stated that lead is a persistent, bioaccumulative toxic chemical and that a transition to non-lead wheel weights would be a good practical step if less-toxic alternatives are cost effective and available. However, the comment provided no basis for attributing the lead in road and parking lot runoff to wheel weights. The Minnesota Office of Environmental Assistance noted that their State fleet of vehicles had participated in a pilot project to evaluate alternative wheel balancing weights and believes that the lead weights could be replaced with alternatives. They also noted their concern with exposures to people who make products from used lead wheel balancing weights and problems with lead in the waste streams from electric arc furnaces that recycle scrap automobiles.

Three trade associations submitted comments. The Association of Battery Recyclers (ABR) and the Tire Industry Association opposed the petition on the basis that no information is available to demonstrate any exposure to lead from wheel balancing weights. The Steel Manufacturers Association supports the petition, noting that a prohibition would reduce the contamination of scrap metal feedstock with lead, which contributes to the hazardous waste stream from electric arc furnaces that process scrap automobiles. They provided no information on lead exposure from wheel balancing weights.

                    BFS Retail Commercial Operations, LLC, which operates more than 2,200 consumer and commercial vehicle service and tire locations across the United States and Canada, commented that it did not support a ban on lead wheel balancing weights at this time. The commenter opined that there is a lack of substitute materials readily available in the marketplace, a lack of manufacturing capacity for such substitutes, and a lack of consensus in the industry on substitute materials that                           ( print page 51064)                        would be likely to lead to confusion and additional costs in the marketplace. Further, the commenter noted a lack of basic research on the environmental consequences of substitute materials and their effectiveness as a replacement for lead in wheel balancing weights.                

ABR initially requested an extension of the comment period but later timely submitted its comments. EPA has considered these comments in responding to the petition.

# List of Subjects

      - Environmental protection

Dated: August 10, 2005.

Susan B. Hazen,

Acting Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.

[FR Doc. 05-17129 Filed 8-26-05; 8:45 am]

BILLING CODE 6560-50-S