Submitted to EPA Docket January 18, 2009
Re: EPA–HQ–OPPT–2008–0785
Inventory Reset Program
I do not support the “resetting” of the TSCA Inventory. EPA seriously underestimates the costs of such a radical departure from the new chemicals review program that has worked well over the last 30 years. Requiring submission (or worse, resubmission) of premanufacture notification for chemicals appropriately listed on the TSCA Inventory is an extraordinary addition of burden and confusion in commercial chemicals commerce. Insofar as EPA feels it is necessary to prepare a list of active chemicals, it can do so using the chemicals reported under the Inventory Update Rule. If classes of chemicals now exempt from IUR reporting are deemed of potential concern, then further amendment via rulemaking of the IUR may be appropriate. Regardless, EPA must make a determination that the benefits of such a “reset” outweigh the costs.
EPA’s claim that it needs to reset the Inventory to support ChAMP is disingenuous. The ability to better support risk assessment prioritization was the purported purpose for amending the IUR to collect use information for 2005.[1] EPA now has such data on some 7000 chemicals. That this data is inadequate comes as no surprise due to the confusing set of use categories and instructions under the last IURA, but there is quite a distance between submitting the amended IUR Form and a PMN form as would be required under the “reset” delisting process and the legal jeopardy to companies who have complied under the existing new chemicals program.
EPA routinely underestimates the reporting burden to companies by only looking at the number of companies who wind up reporting to EPA and the number of submissions they actually do. By far, the higher burden is to companies who determine and then appropriately document that they do not have to report most if not all of their potentially affected activities to EPA. In the case of the “voluntary” Reset, this burden will fall on companies EPA seldom deals with – processors. Processors will need to make sure that their current and historical product portfolios are still covered by a smaller Reset Inventory as an involuntary business and legal necessity.
I furthermore strongly recommend that OPPT consult those who were involved in the development and compliance with the original Inventory. The current system has proven to be quite robust and is the basis for world wide TSCA compliance programs. EPA should not be casual or hasty about making such a drastic change. There is no way this could be a “clean” process. Some of the most egregious potential impacts are discussed below.
What costs will resetting the Inventory create for companies?
1. Manufacturers will need to go back through [proposed 3] years of commercial production data to collate all the unique CAS numbers and names that they made. Those companies that relied on a simple checklist that indicated Inventory listing was verified would have to reevaluate historical reactions and resulting composition for commercial intent, regardless of quantity made. This effort will involve chemical and regulatory expert staff.
2. Importers will need to go through [3] years of import records and get their suppliers to identify intentional components rather than the ability to rely on certification that “all components are listed on the TSCA Inventory.” (Currently done for larger volume chemicals only for IUR years.)
3. TSCA chemical processing companies will need to identify the raw materials in every product in its portfolio for the last several years. They would then need to match raw materials to the Reset TSCA Inventory and figure out strategies for any delisted chemicals. At a minimum, processors will need good records to show their inventories came from pre-reset production.
Transaction costs will be incurred by thousands of processors and vendors who will be inundated with requests by and communications with their customers scrambling to verify TSCA Reset Inventory listing. EPA does not appreciate that simply identifying and finding contacts for current and past vendors is a major challenge for processors as mergers/acquisitions, bankruptcies and product name changes are rampant in the chemical industry. Additional issues will arise around:
- confidentiality – as with the original inventory, processors will be stymied by vendors who do not wish to release composition information.
- commercial intent - product experts within the processor company and with vendors will need to identify only intentional components that would be eligible for reporting (MSDS do not differentiate).
- “orphan” chemicals – who will report these and how fast can processors find replacement vendors if necessary?
- article manufacturers – will need to be queried and should query their suppliers. However, this is a class of companies who haven’t paid a lot of attention to TSCA and with whom OPPT has little experience. The burden will be on processors and distributors to explain what this new TSCA Reset Inventory means.
- “intend to” - finding new vendors for chemicals intended to be purchased in the near term, but for which the vendor does not report for the reset Inventory for whatever reason dealt with under the option mentioned by EPA seems impossible to validate and enforce.
There will be a need to do extensive re-education for company personnel up and down the supply chain on what the Reset TSCA Inventory means for new and old commercial chemicals.
Once the Inventory is “reset,” the following costs will occur:
1. New chemical development will be further inhibited and options that use to be available will face a high hurdle if the intimated increase in PMN testing comes to pass.
2. MSDS will need to be reissued to clarify TSCA Inventory status by all manufacturers, processors and distributors. This could well be in the millions of documents worldwide.
3. Continuous training and communication efforts will be needed for company personnel, suppliers and customers to explain the impact of the Reset TSCA Inventory.
4. Compliance systems and data bases will need to be revised and updated, along with the associated training for users. Such changes are costly and disruptive.
5. There will be an increase in the number of chemicals subject to PMN review. The number of PMNs actually submitted will depend on how many chemicals are delisted and how difficult and costly PMNs will become in the future. Incredibly, EPA seems to be proposing that PMN chemicals for which an NOC was submitted but has not been made within a stated period (3 years) would have to be resubmitted. This should not be an automatic default made without consideration as to the previous review or the proposed volume and use of the “new” chemical. At worst, a defined SNUR – with emphasis on the “significance” of the new use could be issued for such temporarily unmanufactured chemicals.
6. Abrupt business stoppage and potential fines for unwittingly continuing to make or use delisted chemicals.
The benefits of such a tremendous effort are few:
1. EPA will be less embarrassed by not being confronted by the claim that there are “89,000 untested commercial chemicals” as appears in every environmentalist tirade against TSCA. However, the same thing could be accomplished by creating a list of “active” chemicals based on NOCs and IUR reports, however.
2. If a formerly “new” chemical was reviewed many years ago under the PMN program before the “chemicals of concern” process was as developed, EPA could now do a more thorough review with a resubmitted PMN. There is no way to tell how many of such re-do PMNs will occur. Of course, if the chemical was commercialized with an NOC, EPA knows about it and could include it in risk assessment, including reporting and testing rules. For chemicals of concern data has been generated and risk has been reviewed. This program has been very successful and impacted the development of new chemicals for which EPA has not been adequately recognized. (They could form the basis for 5(b)(4) listing, but the consequences need to be carefully considered. At a minimum, such chemical categories should be exempt from 12(b) notification.)
3. EPA will finally make the [Reset] TSCA Inventory freely available on line like other countries do. This should be done regardless of a reset!
Authority
EPA makes some extraordinary claims about legislative authority in proposing a Reset Inventory. Again, one has to wonder if it is because memories are fading on the original Inventory effort.
TSCA 8(a): The Administrator may by rule require
manufacturers and processors to maintain records and submit
reports….
TSCA 8(b): The Administrator shall compile, keep current,
and publish a list of each chemical substance which is
manufactured or processed in the United States….
Section 8(b) is directed at the Administrator and does not in and of itself authorize reporting by businesses. The mechanism for reporting is a TSCA 8(a) rulemaking.
By opening companies to the legal jeopardy of having to file PMNs on “new” chemicals defined as not showing on the Reset Inventory, EPA would require companies to report “activity” – whether or not EPA calls this a “voluntary” effort. Such reporting would have to be under TSCA 8(a) – complete with the appropriate conditions to minimize unnecessary burden for small companies and providing for public comment on costs and benefits. As described above there is significant (if not “major”) costs to a wide range of companies associated with evaluating chemicals for a Reset Inventory. There is no way this is not rulemaking and subject to the Administrative Procedures Act.
The alternative of using SNURs for inactive chemicals is likewise a very heavy-handed approach unless EPA were to carefully limit the SNU to chemical categories and exposures of concern.
The unintended consequences of triggering 12(b) export notifications should also be carefully weighed in any system EPA devises. The Agency has erroneously treated section 12(b) as not allowing for reasonable exemptions. Certainly the waste of time for companies, the Agency and embassies is not warranted for mere resumption of production of small volume, single batch, site limited, low exposure, etc. chemical that have no potential to present significant risks.
Categories
EPA has been very successful in using categories of chemicals in PMN review of new chemicals (“chemicals of concern”) and Structure Activity Relationships. EPA should better publicize the success of this program. Industry should also explain how the categories of concern have significantly directed the research and development of new chemicals.
However, EPA has been disinclined to leverage its authority under section 26(c)(1) to better prioritize information collection and review of chemicals.
If an “Active” or “Reset” Inventory goes forward, low risk categories should be expanded as considered to be automatically included on the list as are naturally occurring substances, such as:
Polymers of monomers listed on the Inventory
Small volume chemicals previously reported under the IUR or PMN regulations (small defined as less than 25,000 lbs)
Salts of listed chemicals
Other chemicals and categories (e.g., vegetable oils)
If EPA now determines that some of the previously IUR exempt categories need to be reported under the IUR, then justify why and get reports under 8(a).
EPA should carefully note that section 26(c )(2)(A) states:
(A) The term "category of chemical substances" means …except that such term does not mean a group of chemical substances which are grouped together solely on the basis of their being new chemical substances.
It would appear that by resetting the Inventory and requiring SNUNs solely because the chemical is now “new” would be prohibited.
Conclusion
Resetting the TSCA Inventory could well entail costs worthy of a “major” rulemaking. EPA has offered no substantive arguments that such costs are warranted.
EPA is continuously denigrated for failing to review the thousands of chemicals in commerce when this is simply not true. EPA has a wealth of information on categories of chemicals and has identified priority candidates for action. Furthermore, chemical manufacturers has shown cooperation in providing information in voluntary programs (HPV, VCCEP). EPA has a well-honed process for reviewing new chemicals and is now working through all the data from these voluntary programs.
What the Agency has done poorly is to issue regulations to reduce risk on categories of concern. I believe the root cause for this failure is that EPA tries too hard to eliminate all risks. Critics are seldom satisfied with anything less than a ban. Instead, the agency should look at the variety of exposure-reducing measures it has available under sections 5 and 6 to restrict high exposure uses and/or require (e.g., through labeling) the appropriate risk management procedures. I believe such limited restrictions would generate much more cooperation and fewer challenges to rulemaking from businesses.
A Reset Inventory would be yet another example of EPA going to extremes that go far beyond what is necessary.
I recommend that EPA work with chemical manufacturers to develop an “active” list of chemicals made in significant quantities and/or likely to present exposures of concern without discarding the current Inventory/PMN program.
I would be happy to further discuss these comments with you.
Sincerely,
Georjean L. Adams, President
EHS Strategies, Inc.
779 Bielenberg Dr Ste 107
St. Paul, MN 55125
651-204-3371
[1] EPA is amending the IUR for three primary reasons: (1) To tailor the chemical substance reporting requirements to more closely match the Agency’s information needs; (2) to obtain new and updated information relating to potential exposures to a subset of chemical substances listed on the TSCA Inventory; and (3) to improve the utility of the information reported. These amendments will enhance the information collected through the IUR, improve the scope of chemicals covered by the rule, and improve CBI claims, thereby accomplishing these three goals. Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 page 852