[Type text]

COMMENTS

on

CHAMP – THE TSCA INVENTORY RESET AND INORGANIC HIGH PRODUCTION VOLUME CHALLENGE PROGRAM
73 Fed. Reg. 70640-70643 (November 21, 2008)
DOCKET NOs. EPA-HQ-OPPT-2 008-0785 & EPA-HQ-OPPT-2008-0807

Daniel Newton Manager, Government Relations

January 23, 2009

SOCMA 1850 M Street, NW Suite 700 Washington, DC 200362 Introduction Since 1921, the Synthetic Organic Ch emical Manufacturers Association (SOCMA) has been the leading trade asso ciation representing specialty and batch chemical manufacturers and importers—an in novative, entrepreneurial and customerdriven sector of the chemical industry. Around 90% of SOCMA’s approximately 300 members are small businesses, according to the relevant Small Business Administration size standards. While some large companie s are also members of the association, represented primarily through th eir specialty chemical divisi ons and related businesses, SOCMA principally speaks for and serves ba tch, custom and small chemical companies. Specialty chemicals are materials with highl y specialized physical or performance functions, which are the result of certain atoms being attached to a molecule in very specific locations. The specialty chemical economic sector is critical to most other manufacturing industries and, therefore, all region al economies. Specialty
chemicals are used in the deve lopment of most every other t ype of product, whether as a building block, raw material, performance additive, ingredient or processing material. Specialty chemicals differ from commodity chemicals in that a specialty chemical may have only one or two uses, while commodity chemicals may have dozens of different applications for each chemical. While commodity chemicals make up most of the production volume (by weight) in the globa l marketplace, specialty chemicals make up most of the diversity (numbe r of different chemicals) in commerce at a ny given time.
Another term associated with SOCMA is batch manufacturing . Commodity chemicals are typically produced in continuous processes, 24 hours a day, 7 days a week. Specialty chemicals, because of their complex chemistries and narrowly focused applications, are frequently produced batc h-by-batch in a reaction vessel. Since continuous processes employ continuous feeds and yields , the production volume is usually far greater, per chemical, than for batch processes. The main difference, however, is that a batch process is not neces sarily automated, and the chemical reaction (which yields the desired product) has a di stinct beginning and ending for each batch.3 SOCMA is in the unique position of represen ting the most diverse chemistries in the industry. This technical expertise allows SOCMA to provide insights that are scientifically based and drawn from real-wor ld experience, not just theory. SOCMA’s staff and member company re presentatives are routinely consulted for their unique technical perspectives and practicality. SOCM A makes its resources av ailable to industry partners, government and other stakeholders interested in chemistry and engineering.

General Comments SOCMA is pleased to submit comments on EPA’s two proposed enhancements to ChAMP: the TSCA Inventory Reset a nd the Inorganic Hi gh Production Volume Challenge Program (IHPV). SOCMA suppor ts ChAMP and looks forward to its continued progress. SOCMA views this appr oach to assessing and managing chemicals as the most reasonable going forward, not only in meeting the United States’ SPP commitments, but more importantly in prot ecting human health a nd the environment. SOCMA hopes to see it contin ue without being altered or impacted by any other activities or programs. As an overall comment, SOCMA would like EPA to consider how the two proposed enhancements should rank in priority with some of the other efforts that are already underway under ChAMP, such as the hazard-based prioritizations (HBPs) and risk-based prioritizations (RBPs). SOCMA vi ews the latter efforts as higher priority and hopes to see more of these prioritizations in the near future. Also, SOCMA would like to
see international efforts leve raged as much as possible in order to avoid redundancy and minimize industry and Agency burdens. The following comments will first address EPA’s specific requests, by addressing the questions posed in the EPA doc ument posted on the ChAMP website, Background Discussion Piece: EPA’s TSCA Inventory Reset , dated November 25, 2008. SOCMA will then offer brief comments on additional foreseeable issues regarding the reset and
end with brief comments on the IHPV Pr ogram. SOCMA hopes its suggestions will make EPA’s proposed enhancements more manageable and effective.4 TSCA Inventory Reset EPA Request for Comments
In EPA’s Background Discussion Piece: EPA’ s TSCA Inventory Reset , Section 9, comments were requested on the following specific questions:

a. Should EPA continue with the certific ation idea under TSCA section 8(b) or the alternative approach of a reporting rule under TSCA section 8(a)? SOCMA believes that the TSCA 8(a) approach should not be used, for several reasons. First, the statute requires it to have a small business exclusion, which means that the resulting data would be inherently uncertain. 1 Second, the TSCA 8(a) approach would be more demanding of EPA’s resources because it would require rulemaking. The TSCA 8(a) appr oach does not make sense as it is inconsistent with EPA’s objective, does not provide a level pl aying field and is not protective of human health and the environment. Therefore, SOCMA views the TSCA 8(b) approach as more appropriate.

b. What should be done with chemicals th at have not been manufactured within
a certain timeframe? Should EPA consid er a SNUR alternative or stick with a PMN requirement?For chemicals that have not been manufactured or imported in the to-bedetermined timeframe, SOCMA believes that requiring a PM N is the proper approach. For one thing, it is unclear what purpos e EPA would accomplish by leaving on the inventory such “inactive” chemicals, especially if persons could
not manufacture them anew without so me further action having to occur under Section 5 (and potentially Section 12(b)). Moreover, the SNUR approach would not be substance specific and is lik ely to be much more burdensome and
restrictive. SOCMA does believe, however, that an expedited process for inventory re-eligibility should be availa ble for delisted inventory chemicals that were the subject of effective PMNs.

1 See 15 U.S.C. § 2607(a)(1)(A) (Section 8(a) ru les must apply to “each person (other than a small manufacturer or processor) who manufactures or processes or proposes to manufacture or process a chemical substance. . . .”). Section 8(a) also has an exclusion for small quantities of chemicals manufactur ed or processed for scientific purposes, id
., creating yet anot her loophole.5 It is important to use a timeframe of 5 years – no less – for the initial reset.

c. How should EPA address chemicals that are processed only? SOCMA believes that processors should be held to the same requirements as
manufacturers in this case. TSCA doe s not generally excu se processors of chemical substances, who still have ma ny responsibilities for TSCA compliance. The statute and EPA rules pl ace primary responsibility for certain requirements on importers and manufacturers, but even in many SNURS, it is clearly stated that should the manufacturers and importers fail to meet their responsibilities, then it falls on the processors to meet the requirements. Likewise in the case of the Inventory reset, a processor should have to take action should his supplier fail to meet the certification requirement. SOCMA supports EPA’s proposal of a separate, processor-only r ound of reporting as was used during creation of the initial inventory.

d. Should there be exceptions for delisting, say if a person expects to manufacture in the future, but has not within the to-be-determined
timeframe? There needs to be a specific deadline based upon actual comme rcial activity; the reset should not be based upon theoreti cal activity. Again, SOCMA believes a look back timeframe of 5 years is appropriate.

e. Should there be a time-limited process for corrections of errors made during
certification? Is there a process envisioned as worthy of using? SOCMA believes there should be an opportunity to correct errors – after all, what purpose would EPA serve by resetting th e inventory to c ontain incorrect information? At least 60 days of review should be adequate and should be allowed based upon the published reset list to provide opportunity for correcting errors, regardless of source. This should include adding substances and correcting
substance identifications.6 SOCMA notes that the Information Quality Act and EPA’s implementing guidelines 2 may require EPA to correct factua l errors in the Inventory in any

event.

Additional Comments

• Regarding the certification phase of the reset effort, there needs to be an appropriate timeframe set for companies to accomplish this. SOCMA would like
to see this done before the next IUR and a timeframe of at least 6 months allotted to accomplish this.

• EPA needs to address the status of chem icals for which PMNs have gone through the new chemical review process, but manufacture of which has not yet been commenced. SOCMA suggests that manufact ure of such chemicals would have to commence within 5 years of PMN effectiveness for such chemicals to be eligible for introduction into the inventory. It is importa nt to note, however, that SOCMA believes an expedited process fo r inventory re-eligibility should be
available for such chemicals should this timeframe be exceeded. As noted above, such a process should also be available to delisted inventory chemicals that were the subject of effective PMNs.

• In regards to future reset efforts, SO CMA suggests that they be conducted in conjunction with every other Inventory Update Rule (IUR); that is every 10 years. This would eliminate unnecessary use of Agency resources and be the least burdensome way to implement the periodic reset idea. Inorganic High Production Volume Program (IHPV)
General Comments

• SOCMA is supportive of an IHPV Program but believes that it should only be pursued after the gaps in the existing HPV program are corrected. Once these

2 These guidelines are available at http://www.epa.gov/quality/informationguidelines /documents/EPA_InfoQualityGuideline s.pdf. These should be little question that the inventory is “inf luential” scientific information, subject to the most demanding standards for quality.7 gaps are addressed, the IHPV Program should have a fixed time period for response and have the same requirements and rules.

• SOCMA would like to see a 3 year program.

• SOCMA fully supports the Agency’s call to “vigorously” issu e Section 4 test
rules in cases where chemi cals lack sponsorships or where sponsors are inactive in providing data.

• SOCMA is also pleased to hear that EPA plans on fully utilizing international efforts where opportunities are present. In particular, SOCMA believes EPA should use REACH HPV datasets where they will come into ex istence on a timely basis, since, as EPA notes, they will “mor e than meet IHPV Challenge needs.” It may well make sense to limit the IHPV Challenge to those inorganic chemicals that no one has prereg istered under REACH. In summary, SOCMA supports this enha ncement and believes that a sound framework for the IHPV program will consider stakeholder comments on the gaps of the HPV program. Also, active issuan ce of test rules applied as necessary, and ut ilization of international work, will help ensure a successful program.
Conclusion SOCMA appreciates the opportunity to submit comments on the EPA’s proposed enhancements to ChAMP. SOCMA believes that these enhancements are reasonable, but again, hopes that they are appropriately prioritiz ed so as not to impair EPA’s progress in issuing risk- and hazard-based prioritizations – which are, after all, the ultimate goal of the ChAMP program. SOCMA is pleased to the see the Agency continuing to further implement ChAMP and believes that it is the best approach to the assessment and management of chemicals going forward. For questions, clarifications and further information, please contact Daniel Newt on at 202-721-4100 or newtond@socma.com.