Submitted the following comment to EPA EPA-HQ-OPPT-2009-0187-0033 today:
Comment on TSCA Inventory Update Reporting Modifications; Proposed Rule August 13, 2010 EPA-HQ-OPPT-2009-0187
Comments on some of the changes proposed are offered below based on my experience in submitting IURs for large companies since the first IUR.
EPA has proposed numerous amendments to the Inventory Reporting Rule (IUR) for 2011 and provided a very short time frame for comment and response prior to the reporting deadline. Some of the proposals will be manageable and are reasonable and arguably “necessary for the enforcement of” TSCA. Several are overreaching and would not appear to offer adequate benefit for the Agency’s estimate of approximately $90 million cost to industry in 2011. “Nice to know” is not sufficient justification.
1. Technical Contact. The language that currently appears in the proposed rule should be revised as indicated:
711.15(b)(ii) The name of a person who will serve as technical contact for the submitter company, and who will be able to provide answer to questions about the information submitted by the company to EPA, the contact person’s full mailing address, telephone number, and e-mail address.
It is highly unlikely that a site-located individual will have the breadth of information required under the IUR, especially if Part III becomes mandatory for all chemicals. TSCA compliance oversight is typically a headquarters-based process. At best, a site technical contact will have direct access to production (but not import) records and on site worker information – which he has reported up to headquarters for creating the site IUR report. The technical contact should be identified at the discretion of the submitter.
2. Retroactive production reporting for the previous 4 years. EPA cannot reasonably expect that companies can generate such information without extensive effort, especially with regard to imports. Painstaking calculations are necessary to cull through imported mixtures that may contain reportable chemicals. Some companies put in place specific recordkeeping practices only effective for the expected IUR reporting year and have done so for the calendar year 2010. EPA underestimates the extraordinary manual effort that would be needed to collate information for previous years.
In addition, given that state of the economy over the last four years it’s not clear what EPA would learn about “normal” fluctuations in production. One can but hope that things will be stabilizing for the next reporting period.
This reporting change should only be effective for the next IUR reporting cycle.
3. Change the standard for reporting under Part III from “not readily obtainable to “known to or reasonably ascertainable.” According to EPA guidance in the draft instructions:
“Known to or reasonably ascertainable by means all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know. [my highlights]
This is information possessed by employees or other agents of the company reporting under the IUR rule, including persons involved in the research, development, manufacturing, or marketing of a chemical substance. This information includes knowledge gained through discussions, symposia, and technical publications. For purposes of IUR, the known to or reasonably ascertainable by standard applies to all the information required by the rule. Examples of types of information that are considered to be in a person’s possession or control, or that a reasonable person similarly situated might be expected to possess, control, or know are:
• Files maintained by the submitter or employees in the submitter’s company;
• Information contained in standard references, such as MSDSs, that contain use information or concentrations of chemicals in mixtures; and
• Information from the Chemical Abstracts Service (CAS) and from Dun & Bradstreet.”
The plain words of the definition says that “all“ information “known” to a company (and to each of its employees and agents) must inform the reporting. Wouldn’t this include every sales and technical service employee interacting with customers? The above guidance would imply file searches of a large number of employees would be required. While the “known” standard may make sense for the small number of environmental and health experts and files in a company reporting studies under 8(d), 8(e) or PMN rules, it does not make sense for downstream use information. The standard for reporting should remain “not readily obtainable” for Part III as currently stated in 40 CFR 710.43:
Readily obtainable information means information which is known by management and supervisory employees of the submitter company who are responsible for manufacturing, processing, distributing, technical services, and marketing of the reportable chemical substance. Extensive file searches are not required.
My experience is that managers and supervisors did provide what they knew and were confident estimating based on knowledge downstream users as a result of their oversight and planning responsibilities. The issue was a lack of specific knowledge and a reluctance to “guess” on a certified report at the level of detail required by EPA. On the other hand, if EPA is basing it’s assumption that companies know more than they are reporting based on PMN experience, it is mistaken. For a new chemical specifically being developed for a new or existing market that must justify an investment in development, yes, downstream use is critical. For a chemical that has been on the market for some time, those downstream uses, which may extend for several different supply chains may or may not be known.
Alternatives EPA may want to consider:
a. Add the underlined phrase to the last sentence of the definition of readily obtainable information:
….Extensive file searches are not required, however management and supervisory employees should briefly survey appropriate staff for whether relevant and representative information is available within the company.
b. Offer an alternate reporting sections for “best guesses” that allow for open-ended responses, have broader ranges and/or higher level descriptors. While this would present collation challenges, it would provide better information at less cost that could be used by EPA in evaluating individual chemicals.
At a minimum, EPA must clarify that surveys of downstream customers and literature reviews are not required to be conducted solely for the purpose of IUR reporting. If such information has been collected and is the possession of the company prior to the effective date of the rule and is timely and retrievable, it should be consulted.
4. Eliminate the 300,000 lb threshold for Part III for any chemicals >25,000 lbs. While it’s not easy to parse the agency’s economic analysis, it would appear that EPA estimates this requirement will generate additional information on some 8,200 forms covering perhaps 2,000 chemicals for an additional cost of $33 million to industry for 2011.
What is EPA going to do with all this information that makes it “necessary for enforcement of this Act”? Can EPA honestly say that it cannot select enough priority chemicals to more than overwhelm its ability to conduct risk assessment and management without information on all these chemicals?
EPA should be more selective on the categories of chemicals of concern (due to use in children’s products or molecular structure) for which it reasonably anticipates taking next step action. Even then, EPA may want to consider more tailored reporting to get relevant data.
$33 million is not a trivial figure. EPA should have more than “nice to have” as the basis for information collection of this magnitude.
Most definitely EPA should not drop the threshold any further for all chemicals.
5. Totally eliminate the 25,000 lb. threshold for those chemicals that are: (1) the subject of a rule promulgated under section 5(a)(2), 5(b)(4), or 6 of TSCA; (2) the subject of an order issued under section 5(e) or 5(f) of TSCA; (3) the subject of relief that has been granted under a civil action under section 5 or 7 of TSCA, or (4) the subject to an Enforceable Consent Agreement.
In general, manufacturers and importers of chemicals regulated under these provisions of TSCA should have systems in place to identify activity regarding such chemicals. Nevertheless, EPA should set a de minimis level, e.g. 2,200 lbs (1 metric tonne) and < 1% concentration as such small quantities will not significantly affect EPA risk assessments. If EPA has substantial concerns about any quantity of a chemical then it would be more appropriate to use the full course of a separate section 8(a) reporting rule (or even PAIR) or use subpoenas to acquire detailed information beyond what would be collected under the IUR. This should be preceded by an “IUR-EZ” identifying that a company has current activity with a simple check-box that the chemical is <1 metric tonne (with imports containing <1% exempt from reporting).
Of course, the impact of this provision will depend on the scope of regulations issued under these sections of TSCA. At present, the universe of such regulated chemicals is “relatively” small (only ~1,100). But given discussions that EPA may expand the use of SNURs and possibly 5(b)(4) to include large categories of chemicals or ones with particularly high production volumes, identifying a chemical specific cutoff based on % total market may be more useful.
6. Report volume exported. EPA should modify 711.15(b)(3)(iv) to read:
(iv) For the principal reporting year only, the volume used on site and the volume directly exported of each reportable chemical substance domestically manufactured and imported at each site.
This appears to be EPA’s intent from the preamble. As currently read it implies any export reasonably ascertainable to the company would be reportable (see concerns in #3.
7. Identify whether a chemical substance is to be recycled, remanufactured, reprocessed, reused, or reworked instead of being disposed of as a waste or included in a waste stream. Once again EPA appears to stray into the “nice to know” category of information collection. No definitions are offered for this requirement that delves into the processing details at a plant that can vary lot to lot and represents a potential for significant new recordkeeping programs to be established. If EPA wishes to collect information regarding pollution prevention methods employed by companies, I recommend the agency do a focused rule on that subject and not via a casual checkbox. My guess is that most companies would say “yes” because at least once some amount of chemical would have met one of these activities.
8. Timing of the effective date. EPA is proposing very extensive expansion and changes to the IUR and cannot expect companies to be able to respond in the proposed time frame.
9. Frequency of reporting. A simple annual site volume report may be reasonable, but not the whole of Parts II and III. Alternatively, with a 5 year reporting schedule, perhaps an open-ended question on whether there have been significant changes since the last reporting period would suffice.
10. Drop the reporting threshold to 10,000 lbs. It’s not clear what the advantage would be. Perhaps if EPA is concerned with aggregate quantities it can start on a company basis and require reporting if the total company (parent) production/import exceeds 25,000 lbs (or even higher) report.
11. Expand reporting elements to be more like PMNs. NO! Information collection is not free. EPA must have a basis for collecting information under the present TSCA.
12. Processor reporting. It would be a big mistake to simply expand reporting under IUR to processors. While it would be most useful to collect use and exposure information from processors, the complexities of the marketplace in terms of supply chains, company sophistication and knowledge about chemical composition make such rulemaking a serious undertaking. EPA should work closely with processors, as well as chemical manufacturers and distributors, to design a practical program to collect sufficient information about the smallest set of chemicals and number of companies reasonable. Even 100 chemicals is a large number given the variety and number of companies who would meet the definition of “processor.” Processors who are not manufacturers have a very limited familiarity with TSCA and would require extensive communication efforts on any new rule. I strongly recommend piloting any information collection effort on a small number of chemicals and/or uses and consider carefully tailoring information to the concern at hand.
 This was the original concept of the 8(a) “Level A” (now PAIR) to be followed by Levels B and C rules to collect the relevant data on selected chemicals on a menu basis. [Note to readers: This was my brainchild when I worked at EPA eons ago. Probably no one left there who remembers - except maybe Office Director Wendy Cleland-Hamnett]
Read Full Post »