Sen. Lautenberg’s Safe Chemicals Act (SCA) bill throws out the old TSCA Inventory and starts everything anew. What I think the bill would require is a quasi-“reset” of the TSCA Inventory – with all sorts of additional information well beyond the previous Inventory Update Rule. See the list below. Anyone not filing this report will have to file something like a Significant New Use Notification, complete with a minimum test data set and a declaration that proves the "new" chemical and its use(s) will cause "no harm." I will cover the new chemical/new use declarations in a separate blog.
Within a year of passage of the act, each manufacturer or processor shall submit a "declaration" of current commercial activity to EPA containing the following new §8(a)(2) information:
1. chemical identity - which means any name: trade, common, IUPAC, CAS#, molecular structure, and (as determined by rule) size, shape, reactivity or anything else EPA considers “special substance characteristics” [e.g., nanomaterials and who knows what for polymers. At least this is by rulemaking so there'll be an opportunity to comment.]
2. Facility name and location where the chemical is made, processed or distributed under the control of submitter [proponents want to be able to map the location of all chemicals]
3. List of health and safety studies and copies not previously submitted to EPA [there's no more separate 8(d); appears any study is reportable]
4. Physical, chemical properties
5. Toxicological properties - which under new definition §(26) means
“actual or potential toxicity or other adverse effects…on… biological functions in humans or nonhuman organisms.“ “Adverse effect” means “…affects or alters the performance of an anatomic structure of a vital system of an organism or progeny of an organism…” [not sure what isn’t included]
6. Annual production
7. Known uses
8. exposure and fate of the substance
9. Name and location of all ‘ship to’ facilities [not clear how far down the supply chain one goes]
The bill also expands the definition of "chemical substance" to include chemicals contained in or formed into an article (presumably eliminating the current exemption under 40 CFR 710.4(d)(6) and 720.30(h)(6)). It will be interesting to figure out what all that might cover.
R&D remains exempt as are chemicals used only for FDA, pesticide, etc. - regulated uses, at least for SCA declaration purposes. EPA is to consider all aggregate exposures regardless of TSCA/SCA use in evaluating risk, however.
Updates are required every 3 years.
But a report is due "immediately" when a manufacturer or processor has "significant new information" regarding:
- physical/chemical or toxicological properties,
- use, and/or
- exposure
that demonstrates a new potential toxic effect or corroborates previous information demonstrating or suggesting a toxic effect or effect at a lower dose. new §8(a)(4)(B)
And if you stop making or processing a chemical you reported, you have to notify EPA within 180 days.
While EPA is required to publish a new Inventory list, the driver for a new chemical declaration (SCA-speak for the new PMN) is whether or not the manufacturer or processor has submitted the above information, not whether a chemical appears on the Inventory list.
The purpose of the new inventory list is to identify currently manufactured and processed chemicals and for EPA to categorize them according to known health/environmental effects, exposure or insufficient data. New chemicals declared to EPA will be added to the inventory, but that doesn't change reporting responsibilities.
REPEAT: Each and every manufacturer and PROCESSOR would have to provide the extended information in an inventory "declaration" or stop commercial activity for the chemical. To make or use a chemical for the first time or in any other way than previously reported, a company will have to file a chemical declaration with a minimum data set and anything else EPA says it needs to prove that the chemical's use is safe. Look for my next posts on the new PMN/SNUN -like process in the bill.
This new reporting on commercial activity goes well beyond REACH by including processor reporting (REACH's downstream users) and collecting potentially unlimited toxicological data and customer location information. The definition of "process" hasn't been changed - preparation for distribution in commerce, including as part of an article. That makes for a lot of new companies who've never messed with TSCA Inventory reporting before.
Gone from TSCA §8:
- EPA's requirement to avoid unnecessary or duplicative reporting.
- Any small business exemption.
- Confidentiality for chemical identity, toxicity information or presence in a consumer article that might expose children.
- A requirement that EPA use rulemaking to obtain information. EPA will be able to use orders to get any information it wants to administer the SCA.
The scope of this bill is overwhelming. Legislators need to ask questions about this new "declarations of current manufacture and processing" data collection effort:
- how many companies will be subject to the reporting requirements of this new declaration inventory?
- what are the implications of the expansion of the definition of chemical substance to include internationally exempt chemical reaction products formed as part of an article?
- what will be the economic and legal impact on newly regulated processors and small chemical manufacturers?
- how much of this information is "nice to" have vs how much can be reasonably used by EPA (or anyone else)?
- why are there no requirements that EPA must avoid unnecessary and duplicative reporting?
- can EPA administer and enforce this requirement?
And those are just some of the issues around the revision of the TSCA Inventory. Watch for my next blog on safety declarations for new chemicals and uses.