A minimum data set: Why, what, how much and when?

Richard Denison, Ph.D., is a Senior Scientist.

As I noted in my last post, EDF and the Safer Chemicals Healthy Families coalition believe TSCA needs to ensure that basic safety data are developed and made available for all chemicals in commerce.  Such information is:

• a core element of the public’s right-to-know;
• embodied in the “no data, no market” concept already in place under the EU’s REACH; and
• most importantly, critical for identifying BOTH:
  •  chemicals of concern we have not yet identified, due to data gaps; and
  • chemicals  presenting little or no concern, which may serve as safer alternatives to chemicals of concern but we need to be able to identify with greater confidence.

The chemical industry’s opposition to comprehensive data requirements is an inherent contradiction:  It is often the first to claim “regrettable substitution” when a chemical is restricted, asking: “How do we know the substitute is any better?”  The answer is we often won’t – UNLESS we take a comprehensive approach to data development

So what types of data, and how much, should comprise a minimum safety data set?  And when should it be submitted?

WHAT types of chemical information are needed

Minimum data sets (MDS) need to contain a number of types of safety-relevant information, which Congress should specify as elements EPA must include in developing the specifics of the MDS:

• Identifying information on the chemical, its name and identifying CAS number, its physical and chemical properties, impurities.
• Manufacturing and processing information on what companies produce, import and make and process the chemical, in which quantities and at which locations.
• Exposure-relevant information including the physical form and concentration of the chemical at sites of manufacture, processing and use, the number of workers potentially exposed,
• Monitoring data that indicate the presence of the chemical in people, other organisms, food, drinking water and environmental media.
• Use information on the function of the chemical, its commercial and consumer uses, its presence in article to which children may be exposed.
• Post-use information on the disposal or other post-use management of the chemical or products containing it, and any by-products of such management.
• Hazard information on the environmental and biological fate and transport of the chemical, acute and chronic health effects and ecotoxicity, potential for synergistic effects in combination with other chemicals.

HOW MUCH chemical information is needed

MDSs need not be one size fits all:

• EPA should have authority to require more information for some types of chemicals than others, based on criteria indicating higher exposure (e.g., use in consumer products, higher production volume) or higher hazard (e.g., evidence indicating likelihood of particular types of toxicity, persistence and/or bioaccumulation potential).
• Our proposal is that EPA be required to consider a broad range of potential impacts in making safety determinations, and to require submission of information sufficient for EPA to determine whether a chemical has these properties of concern.  This is not the same as a long list of endpoints for which testing would always be required.
• We also propose EPA have authority to “tier” testing requirements.  This could be done to reflect the different exposure or hazard potentials described in the first bullet above.  For some chemicals, it could also be used to initially apply screening tests, to be followed by more detailed tests should the screening tests raise red flags.
• We further propose that EPA could develop and tailor MDSs for categories of chemicals that have similar properties, hazards, use profiles or exposure potential.
• Finally, EPA should also have authority to require MDSs for mixtures of chemicals as well as individual chemicals.  In some cases, data on the mixture will be more useful in determining safety than data on the individual components.

WHEN chemical information should be provided

Because chemical information serves so many purposes (as I noted in my earlier post on this topic), its development and submission should be expedited as much as possible.  And because such information changes over time, it needs to be updated with sufficient frequency to ensure users have current and timely information.

Of course, EPA will need some time to develop a rule that specifies the details of MDSs, the methods to be used to develop the data, etc.  And a reasonable period of time then needs to be provided for companies to develop and submit the data.  Finally, chemicals that are prioritized will be subject to safety determinations sooner, so their MDSs will be needed to be developed and submitted sooner than those for other chemicals.

We propose, therefore:

• Companies should be required to submit information they already possess about a chemical’s identity, properties, production, use, hazards and exposure potential within one year of enactment.
• Companies should update such information at a minimum every three years, and immediately whenever significant new information becomes available or significant changes in a chemical’s production or use occur.
• EPA should develop and publish the MDS requirements within one year of enactment.
• MDSs for all new chemicals should be submitted at the time companies submit notices of intent to manufacture them.  (A transition for new chemicals may be needed during the period between enactment of legislation and EPA’s issuance of the details of the MDS).
• MDSs for all existingchemicals should be submitted within either:
  • five years of enactment, or
  • for priority chemicals, 18 months after they are so identified,

whichever comes first.

• If significant time has passed between initial submission of the MDS for a chemical and when it comes up for its safety determination, companies should have an opportunity and mandate to update their MDSs, so that the most current information is available to EPA.