'Innocent' Report Shows Variation in Regulations
Column
By Lynn L. Bergeson   
Tuesday, 01 May 2007
In April, Environmental Defense (ED) released Not That Innocent: A Comparative Analysis of Canadian, European Union and United States Policies on Industrial Chemicals, a report that compares how chemicals are managed under the U.S. Toxic Substances Control Act (TSCA), the Canadian Environmental Protection Act (CEPA), and the European Union (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program. The report offers useful information on these chemical-control programs, and is a must-read for entities that have global chemical business interests. The report is available at www.environmentaldefense.org.

Chemical policies in the United States, Canada and the EU include common elements related to the core functions they are intended to serve. These are: identifying and prioritizing chemicals of concern; identifying and tracking chemicals and their production and use; facilitating or requiring the generation and submission of risk-relevant information; assessing information to determine hazard/exposure/risk; imposing controls to mitigate risk; and sharing and disclosing information and protecting confidential business information (CBI). Within each of the six functional elements, the report summarizes best practices in relation to the features of each of the three chemical policies, as compared and contrasted below.

Identifying and prioritizing chemicals of concern – Canada makes greater use of hazard and exposure criteria, especially in the Domestic Substances List (DSL) categorization process. Canada uses specific production quantity and release criteria in determining information requirements for new chemicals. REACH, the new EU chemical management program that became effective in June 2007, is expected to make extensive use of hazard criteria for the purpose of identifying and managing chemicals of concern.

Identifying and tracking chemicals and their production and use – For new chemicals approved for manufacture upon notification of a company’s compliance with specified conditions, any other company seeking to produce or import the same chemical should be required to go through a full notification and review process. In the United States, except in cases where the U.S. Environmental Protection Agency (EPA) has issued a significant new use rule to accompany its decision concerning a premanufacture notification (PMN), any subsequent company may produce or import a chemical without EPA’s approval. Canada has this requirement, also. Under REACH, each producer or importer of a chemical is required to register it with other producers or individually.

Facilitating or requiring the generation and submission of risk-relevant information – In the United States, notification is the submission of a PMN. The majority of notifications are not accompanied by risk data, and EPA works with PMN submitters on a case-by-case basis to provide information as needed. EPA has authority to reassess a chemical after it has entered commerce, but certain legal findings must be made unless EPA has imposed a requirement on the producer or importer of a specific chemical to generate and submit additional information at some point after manufacture has commenced.

A tiered notification or registration approach is employed in Canada and will be used in the EU under REACH, with specific data requirements delineated at each tier, but applied only after manufacture has begun. In the United States and Canada, the government must have evidence of potential risk or toxicity of, or extensive potential exposure to, a chemical to require the industry to generate new risk information. Also, such risk or exposure findings are not necessary for the government to require submission of already existing information. In the United States, imposition of any information generation or submission requirements typically must be done through notice-and-comment rulemaking. In Canada, this can be done through publication of a notice by the government. In all three jurisdictions, producers and users of a chemical are obligated to report immediately new information that indicates significant potential risk.

At the time of chemical registration, REACH will require all manufacturers to submit available information, and to generate (or propose to generate) and submit new information specified under applicable requirements. To require a registrant to generate information beyond that specified under the applicable registration requirements, however, a procedure must be followed that includes approval by the member states of the European Commission and provides the registrant with the right to comment on and appeal the decision.

Assessing information to determine hazard/exposure/risk – In the United States and Canada, government review is required for all new chemicals unless an exemption applies. In the United States, the premanufacture timing of new chemical review provides an opportunity for early identification of potential concerns. EPA often asks the PMN submitter to suspend the statutory 90-day review period if EPA needs more time to review a new chemical.

In Canada and under REACH, the first review comes after manufacture has commenced, but is informed by a required minimum data set. Under REACH, new chemical assessments will be conducted by industry, not the government.

Imposing controls to mitigate risk – In the United States and Canada, risk criteria have been developed, but risk management actions on new chemicals are made principally on a case-by-case basis. REACH, however, will establish risk criteria. Because TSCA is a risk-benefit statute, socio-economic factors play a role in the findings EPA must make to regulate an existing chemical. In Canada, the whether vs. how decisions are more separate, and potential risk is included in the definition of “CEPA-toxic” used to trigger risk management actions.

Sharing/disclosing information and protecting CBI – In the United States, disclosure of CBI is generally prohibited except where entities asserting such claims are unable to support them. Health and safety data cannot be claimed to be confidential. EPA is not required to review and either accept or deny CBI requests, and upfront justifications are not routinely required. Although it has developed criteria for what are legitimate CBI claims, it must challenge them on a case-by-case basis.

In Canada, CBI may only be disclosed where it is in the public interest and that interest is found clearly to outweigh any private loss. CEPA calls for CBI claims to be supported by information prescribed by implementing agencies, which has been done in the guidelines for the notification of new substances. For requests to consider chemical identity as CBI, the guidelines require relatively extensive information to be provided, which the government is able to use to decide whether to grant such requests. CBI claims do not expire or require reassertion. CEPA provides broad authority for the sharing of CBI with other governments, domestic and foreign. CEPA does not generally mandate or encourage public disclosure of information not deemed confidential.

A Robust Debate
The foregoing reveals significant differences among the chemical regulatory programs in effect in the United States, Canada and the EU. It is because of these differences that chemical management policy in the United States is expected to heat up over the next few years. Business interests will need to monitor the situation carefully and participate in the debate, which is expected to be robust.

Lynn L. Bergeson is managing director of Bergeson & Campbell P.C., a Washington, D.C., law firm focusing on conventional and engineered nanoscale chemical, pesticide and specialty chemical product approval and regulation, environmental health and safety law, chemical product litigation and associated business issues. She is president of The Acta Group LLC and The Acta Group EU Ltd. with offices in Washington, D.C., and Manchester, U.K. She can be reached at 202-557-3800.
 
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