Back again to dive into the next section of the new legislation that is currently in committee, which will significantly amend TSCA if it passes (in a form relatively close to the original). I've written about CSIA here, here and here.
Section 5 of CSIA is not quite as radical a change to TSCA as Section 4 is, but there are some significant new changes. But first, the things that stay pretty much the same:
Premanufacture Notices (PMN)
The Premanufacture Notice requirements will stay the same except for conforming requirements to the new systems that the EPA will be developing. The EPA requires PMNs on new chemical substances so that the hazards associated with those substances can be evaluated before it is mass produced.
Significant New Use Rules (SNUR)
These rules give the EPA the authority to evaluate existing chemical substances that will be re-purposed. The way that the EPA determines whether a new chemical use can be considered "significantly new" is by reviewing the following information:
- The projected volume of manufacturing and processing
- The extent to which a use changes the type or form of exposure to the public or the environment
- The extent to which a use increases the magnitude and duration of exposure to the the public or the environment
- The reasonably anticipated manner and methods of manufacturing, processing, distribution and disposal
Now for the changes.
Section 5 imposes a 90-day time period in which to conduct a review upon receipt of a PMN. This may be extended an additional 90 days if that's what it takes to put together a profile of the chemical substance referenced in the notice, as well as understand the potential for exposure to the public or the environment, and make the necessary determinations. The EPA is also required to determine (in reference to SNUR) whether or not the chemical substance is likely to meet the safety standards under the conditions of new use, or if more information is necessary to make a determination.
The EPA can by consent agreement or order stop the manufacturing, processing or use of a chemical substance if more information is necessary to make a determination, and will allow the submitter an opportunity to gather and provide said information.
Section 5 also formalizes the process of submitting a Notice of Commencement after manufacturing and processing has begun on a new chemical substance or an existing chemical substance intended for a significant new use. The EPA can also now review chemicals for which PMNs were submitted before CSIA if they receive "significant new information" regarding the chemical substance. The new transparency of CSIA requires the EPA to make available all information, data, rules, notices and orders.
The last part of Section 5 addresses possible exemptions, which is largely the same as TSCA but with conforming changes required for the new standard. However, under TSCA the language of determination of a chemical is "will not present an unreasonable risk." Under CSIA, the language is stronger: "is expected to meet the safety standard under the intended conditions of use." This has implications for exemptions that have already been carved out for chemical substances that have a variety of uses. It may even imply that a high-priority chemical substance may be evaluated multiple times for multiple uses. Anticipate a lot of litigation if this passes in its current form.