Consumer Products Law Blog

Welcome to Dorsey's Consumer Products Law blog. This blog provides visitors with informative, up-to-date and easy-to-understand commentary on consumer products matters. Our purpose is to help manufacturers, importers, warehousers, retailers, e-tailers, consumers, and lenders better understand the legal issues impacting the consumer products industry.

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California Department of Toxic Substances Control Releases Outline of Draft Regulations for Safer Products

June 11, 2010 | Posted by Kristin M Stastny

On April 15, 2010, the California Department of Toxic Substances Control (DTSC) released an Outline of its Draft Regulations for Safer Products. This outline is one step toward the adoption of regulations that are likely to significantly affect manufacturers of consumer products that are sold, manufactured, imported, marketed, or distributed in California. The regulations propose to require manufactures to conduct analyses of products containing specifically identified chemicals and to consider alternatives to using those chemicals. The regulations would also authorize DTSC to implement regulatory responses ranging from requests for information to complete prohibitions on the use of specified chemicals. Because DTSC is still in the early stages of developing regulations, manufacturers now have the opportunity become involved in shaping the regulations in ways that will ensure the regulations are not overly costly or burdensome.

Background

In September 2008, California Governor Arnold Schwarzenegger signed two Green Chemistry framework laws—SB 509 and AB 1879. These laws are designed to reduce hazardous chemicals in consumer products and to stimulate the green design and manufacture of such products.

SB 509 creates an online Toxics Information Clearinghouse—a web-based database, to increase consumer knowledge about the toxicity and hazards of thousands of chemicals used in California. AB 1879 establishes authority for DTSC to develop regulations that create a process for identifying and prioritizing chemicals of concern and to create methods for analyzing alternatives to existing hazardous chemicals. It also allows DTSC to take certain actions based on the alternatives analysis that range from "no action" to "restrictions or bans."

Under the authority of AB 1879, DTSC has released an Outline of its Draft Regulations for Safer Products and is now seeking public comment before initiating its formal rulemaking process.

Proposed Regulatory Framework

The approach proposed by DTSC in its outline would require DTSC to identify “Chemicals Under Consideration,” “Chemicals of Concern,” “Products Under Consideration,” and “Priority Products.” Under DTSC’s outline, these classifications will affect how products are regulated. The list of Chemicals Under Consideration would be developed based on consideration of a number of factors including adverse impacts on the environment, adverse impacts on sensitive subpopulations, physical properties, and anticipated rates of exposure. From that list, DTSC would develop a list of priority Chemicals of Concern. Products under Consideration are products that contain a Chemical of Concern. Priority Products are products from the list of Products under Consideration that are determined to be of highest priority. Products are identified as Products Under Consideration and Priority Products based on consideration of a number of factors identified in the outline. Additionally, any person may petition DTSC to evaluate a chemical or product during the prioritization process to be added as a Priority Product.

The outline proposes the following regulatory framework:

•Certificate of Compliance: Products listed as Priority Products could only be sold with a certificate of compliance stating that the manufacturer is in compliance with, or is exempt from, the regulations.

•Information Submission: The DTSC would have authority to request extensive information from manufacturers including product marketing data and chemical information submitted to the United States Environmental Protection Agency, the Canadian Environmental Protection Agency, or the European Commission under the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulations.

•Alternatives Assessments: Manufacturers of Priority Products would be required to perform an Alternatives Assessment of their product. This process would begin with the preparation of an Alternatives Assessment Work Plan, which would identify the alternatives to be considered and the proposed methodology. DTSC would review the Work Plan for compliance with AB 1879. Once DTSC determined that the Work Plan meets the requirements of AB 1879 and the regulations, the manufacturer would be required to complete an Alternatives Assessment and prepare an Alternatives Assessment Report. Based on this report, DTSC would identify appropriate regulatory responses.

•Regulatory Response: After a manufacturer prepared an Alternatives Assessment Report, DTSC would have authority to determine the most appropriate regulatory response to limit the effect of the Chemical of Concern on public health and the environment. Potential regulatory responses would include: (1) requiring additional information regarding the Chemical of Concern or proposed safer alternative(s); (2) requiring product information disclosure to consumers; (3) placing restrictions on the use of Chemicals of Concern in the consumer product; (4) prohibiting use of Chemical of Concern in the consumer product; (5) imposing safety measures to control access to the Chemical of Concern in the consumer product; (6) requiring end of life management of the product; and (7) requiring research and development with respect to the product. Alternatively, DTSC may determine that no further action is required.

Next Steps

The next step in the regulatory process will be the creation of draft regulations based on the outline already developed by DTSC and any comments received in response to this outline. According to DTSC, the draft regulations will be released in the very near future and will begin a formal rule-making process. Under AB 1879, the regulations must be adopted by January 1, 2011.

Manufacturers who may be impacted by these regulations may want to submit comments to DTSC’s outline, before the formal rulemaking process commences. DTSC is currently accepting feedback on its outline by e-mail at green.chemistry@dtsc.ca.gov. Additionally, interested parties may wish to submit comments during the rulemaking process. To track DTSC’s progress in preparing final regulations, visit DTSC’s Green Chemistry website.

Kristin M Stastny is an Associate in the Regulatory Affairs Department at Dorsey & Whitney, LLP. Please see our web site at www.dorsey.com.

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Canada Introduces Product Safety Legislation

July 16, 2010 | Posted by Valerie Paula

On June 9th, Canada introduced the Canada Consumer Product Safety Act (bill C-36) in the House of Commons. The bill would modernize Canada’s 40 year-old existing consumer product laws and would give the government more oversight and enforcement power.
Canada
Bill C-36 amends the schedule of prohibited products to include Bisphenol A in polycarbonate baby bottles. The new law would also prohibit products deemed to be unsafe, prohibit labels with false or deceptive health and safety claims, and give authority to Health Canada to recall dangerous products. The key provisions proposed include:

• A General Prohibition against the manufacture, importation, advertisement or sale of consumer products that pose an unreasonable danger to human health or safety.

• Orders for Corrective Measures, including Recall. This allows for quicker government response to address an emerging health of safety problem.

• Mandatory Reporting of Incidents. Industry must report when they have knowledge of a serious incident, or death, to provide an early warning to the government.

• Ministerial Orders for Test/Study Results. Manufacturers or importers must provide information on products when so ordered to verify compliance or prevent noncompliance.

• Document Retention by Industry. This facilitates product tracing throughout the supply chain, in particular in situations where a consumer product would need to be recalled.

• Increased Fines and Penalties for Violations.

• Administrative Monetary Penalties. Penalties will be allowed to deal with noncompliance, including criminal prosecutions.

• Scope. The new law expands the scope of consumer product laws to cover the manufacture of consumer products.

• Packaging and Labeling. New prohibitions are placed on packaging, labeling or advertising that is false, misleading or deceptive, as it relates to health or safety.

Bill C-36 contains significant differences from a previous product safety bill (C-6) that was introduced in January 2009. Bill C-6 passed the House of Commons, but died in the Parliament. New changes contained in bill C-36 include, but are not limited to, authorizing the Minister to order product recalls, adding specific time frames for a review officer to complete recall orders, and eliminating an exemption from liability for inspectors entering onto or crossing over private property during an inspection.

As noted above, the new law would require industry to provide information to the Minister of Health. Such reporting will be required for any of the following consumer product safety incidents, including near misses:

• An occurrence that resulted or could reasonably be expected to have resulted in death or serious adverse health effects;

• A defect or characteristic that may reasonably be expected to result in death or serious adverse health effects;

• Inadequate labeling or instructions that could lead to such results; and/or

• A recall order or other corrective measure initiated for human health or safety reasons.

Valerie Paula is an Associate in the Regulatory Affairs Department at Dorsey & Whitney, LLP. Please see our web site at www.dorsey.com.

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