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TSCA Section 21 Petition; Response to Citizen's Petition

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Information about this document as published in the Federal Register.

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Environmental Protection Agency (EPA).




On April 21, 2006, the Sierra Club petitioned EPA under section 21 of the Toxic Substances Control Act (TSCA) to take four actions under TSCA to mitigate risks from lead in toy jewelry. The petitioner requested that EPA: (1) Require TSCA section 8(d) health and safety data reporting; (2) submit a report to the Consumer Product Safety Commission (CPSC) under TSCA section 9; (3) issue a significant new use rule pursuant to TSCA section 5(a); and (4) issue quality control orders under TSCA section 6(b). Of the actions requested by the petitioner, TSCA section 21 applies only to the requests for actions under TSCA sections 6(b) and 8(d). For the reasons set forth in this notice, EPA has denied the petition to initiate rulemaking under these two sections.

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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) 554-1404; e-mail address: TSCA-Hotline&

For technical information contact: Doreen Cantor, 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) 566-0486; e-mail address:

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I. General Information

A. Does this Action Apply to Me

You may potentially be affected by this action if you manufacture, import, or distribute in commerce toy jewelry containing lead, or if you manufacture, import, process, or distribute in commerce lead. Potentially affected entities may include, but are not limited to:

  • (NAICS code 339914) Costume jewelry and novelty manufacturing
  • (NAICS code 339932) Game, toy, and children's vehicle manufacturing

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding some of the 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 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 a docket for this action under docket identification number EPA-HQ-OPPT-2006-0397. The docket is available for public viewing at the EPA Docket Center, Rm. B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The EPA Docket Center Public Reading Room telephone number is (202) 566-1744, and the telephone number for the OPPT Docket 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​fedrgstr/​.

Publicly available docket materials are available electronically at or in hard copy at the OPPT 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 April 21, 2006, the Sierra Club petitioned EPA to take four actions intended to reduce risks from toy jewelry containing lead. The Sierra Club defines toy jewelry as any item that serves a decorative but no or minimal functional purpose that is valued at less than $20 per item. The requested actions are:

  • Require TSCA section 8(d) health and safety data reporting for lead and lead salts.
  • Submit a TSCA section 9 report to CPSC regarding lead and lead salts.
  • Issue a TSCA section 5(a) significant new use rule regarding lead and lead salts in toy jewelry.
  • Issue TSCA section 6(b) quality control orders regarding production of toy jewelry.

The petition also requested certain actions by CPSC.

Again, of the actions requested by the petitioner, TSCA section 21 applies only to actions under TSCA sections 6(b) and 8(d), and these requests are addressed in this notice.

III. Disposition of Petition

EPA does not believe that the actions requested by the petitioner under TSCA sections 6(b) and 8(d) would be helpful in addressing the problem presented by lead in toy jewelry, at this time. These two requests are therefore denied. The other two requests, for actions under TSCA sections 5(a) and 9, are not petitionable under TSCA section 21. Section 21 enumerates specific sections and subsections of TSCA under which any person may petition the Administrator to initiate a proceeding for the issuance, amendment, or repeal of a rule or an order. Sections 5(a) and 9 are not included.

A. Request to Issue Section 6(b) Quality Control Order Regarding Production of Toy Jewelry

EPA does not believe that section 6(b) is an appropriate tool to address the risks associated with lead in toy jewelry at this time. The use of section 6(b) would be most beneficial when the Agency can identify a small number of companies who, by their unique actions, are causing unreasonable risks to be present. In the case at hand, EPA believes that this approach may be inadequate and inefficient. Information Start Printed Page 42641contained in several of the public comments suggests that there may be numerous instances where toy jewelry containing lead is still available in the marketplace. EPA is working in coordination with CPSC to understand the scope of the problem. A holistic and proactive approach may be more effective and less resource intensive than the case-by-case approach provided for under section 6(b).

Where the Administrator has a reasonable basis to conclude that a particular manufacturer or processor is manufacturing or processing a chemical substance or mixture in a manner which unintentionally causes the chemical substance or mixture to present an unreasonable risk, TSCA section 6(b)(1) allows the Administrator to require the manufacturer or processor to provide information regarding the relevant quality control procedures followed in the manufacturing or processing. If the Administrator then determines such procedures are inadequate, TSCA section 6(b)(2) allows the Administrator to require the manufacturer or processor to revise its procedures. EPA notes that only orders under section 6(b)(2) are subject to TSCA section 21. The request contained in this petition is for orders to remedy quality control procedures where necessary (section 6(b)(2)). However, EPA is not in a position to issue such orders at this time because it has not issued any section 6(b)(1) orders that could provide the basis for section 6(b)(2) orders.

The request that EPA identify and issue section 6(b) orders to all manufacturers and processors producing toy jewelry with greater than 0.06% lead is therefore denied. However, EPA is not foreclosing the possibility of issuing section 6(b) orders in the future should it conclude that section 6(b) is an appropriate tool to address risks presented by particular manufacturers or processors.

B. Request to Require TSCA Section 8(d) Health and Safety Data Reporting for Lead and Lead Salts

TSCA section 8(d) authorizes the Agency to promulgate rules requiring that manufacturers, processors, and distributors of chemical substances or mixtures submit lists and copies of such health and safety studies to the Administrator. While this could allow the Agency to require the submission of health and safety studies on lead and lead salts, the Agency does not believe that a section 8(d) rule would provide useful information, at this time.

Extensive and detailed information on the toxicity of lead is already widely available. The Agency is already in possession of voluminous information on the health hazards of lead, and has undertaken numerous rulemakings and other actions based on this information. Along with the rest of the federal government and many other bodies, the Agency has concluded that lead can cause multiple adverse health effects, and has set a goal to eliminate lead poisoning as a major health concern in children by 2010. While the Agency is always open to the receipt of additional information on the health and safety of various substances, it believes that the health effects of lead are already well-known and accepted. Over the course of EPA's many rulemaking and policy development efforts to address lead risks to children, including numerous notice and comment proceedings, public meetings, and other fora for exchange of information, EPA believes that it has assessed the most critical existing lead health and safety studies that EPA and/or CPSC would find most valuable for regulatory purposes.

While it is possible some new information could be obtained from a section 8(d) rule, EPA does not consider it likely that it would gain significant new information through a section 8(d) rule requiring the types of studies identified by the petitioner. In addition, it is not clear that EPA has authority to obtain under section 8(d) all of the information identified by the petitioner (e.g., information on marketing and patterns of use).

For the reasons described above, EPA does not believe, at this time, that the requested section 8(d) rule would be helpful in assessing the risks to children from lead in toy jewelry and is, thus, denying this request. However, EPA is continuing to work with CPSC, and would consider doing a targeted section 8(d) rule should EPA conclude in the future that it has a need for specific information that could likely be obtained through this mechanism.

IV. Related Issues

After receiving this petition, EPA published a notice in the Federal Register soliciting comments and further information on the issues associated with lead in toy jewelry (71 FR 30921, May 31, 2006) (FRL-8069-3). EPA has carefully assessed this information, along with the information provided in the petition, and will continue to evaluate this information and conduct additional analyses to better understand the scope and severity of this issue.

Despite EPA's reservations about the specific approaches requested in this petition, the Agency is concerned about the continuing use of lead in toy jewelry and is working with CPSC to develop the most effective means to address this issue. The two Agencies have met four times since receiving this petition and have established an interagency group to identify the most effective steps to move forward. In the short-term, EPA will work with CPSC to examine approaches to outreach to retailers.

V. Comments Received

EPA received 10 comments in response to the Federal Register notice published May 31, 2006 (71 FR 30921), announcing EPA's receipt of this TSCA section 21 petition.

Five comments were received from state and municipal governmental agencies (Chicago, Minnesota, Minneapolis/Hennepin County, New York State, and Illinois), all of which strongly supported the petition. Several of these comments included survey data and anecdotal information showing that toy jewelry containing lead is available and causes moderate to severe health effects. These comments stressed the need for Federal action to eliminate lead from toy jewelry. Several comments also stressed that Federal action is needed to eliminate lead from other consumer and children's products as well.

Four comments were received from other sources (a private citizen, the Regulated Community Compliance Project of Boston University, the Coastal Health District, and Kids in Danger) which were also supportive of the petition, describing health risks to children from lead in toy jewelry. These comments did not include additional data, except that one (from Kids In Danger) included its 2004 report “Playing With Poison: Lead Poisoning Hazards of Children's Products, 1990-2004”). These comments also urged federal action to eliminate lead in toy jewelry and in other products.

One trade association (the Association of Battery Recyclers (ABR)) submitted comments. This commenter opposed the petition for the TSCA section 8(d) request, on the bases that the petitioner had not identified benefits to be derived from the use of section 8(d), had not demonstrated why EPA action is needed given CPSC programs, and was overly broad. The comment also opposed the TSCA section 9 request on the basis of being overly broad. This commenter had no comment on the requests for action under TSCA sections 5(a) and 6(b).

EPA has considered these comments in responding to the petition.

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Dated: July 20, 2006.

James B. Gilliford

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

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[FR Doc. E6-12044 Filed 7-26-06; 8:45 am]