[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-2008-0785 & EPA-HQ-OPPT-2008-0807 

Daniel Newton 

Manager, Government Relations 

January 23, 2009 

SOCMA 

1850 M Street, NW 

Suite 700 

Washington, DC 20036 
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Introduction 

Since 1921, the Synthetic Organic Chemical Manufacturers Association 

(SOCMA) has been the leading trade association representing specialty and batch 

chemical manufacturers and importers—an innovative, 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 companies are also members of the association, 

represented primarily through their specialty chemical divisions and related businesses, 

SOCMA principally speaks for and serves batch, custom and small chemical companies. 

Specialty chemicals are materials with highly 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 regional economies. Specialty 

chemicals are used in the development of most every other type 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 global marketplace, specialty chemicals make 

up most of the diversity (number of different chemicals) in commerce at any 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 batch-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 necessarily automated, and the chemical reaction 

(which yields the desired product) has a distinct beginning and ending for each batch. 
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SOCMA is in the unique position of representing the most diverse chemistries in 

the industry. This technical expertise allows SOCMA to provide insights that are 

scientifically based and drawn from real-world experience, not just theory. SOCMA’s 

staff and member company representatives are routinely consulted for their unique 

technical perspectives and practicality. SOCMA makes its resources available 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 and the Inorganic High Production Volume 

Challenge Program (IHPV). SOCMA supports ChAMP and looks forward to its 

continued progress. SOCMA views this approach to assessing and managing chemicals 

as the most reasonable going forward, not only in meeting the United States’ SPP 

commitments, but more importantly in protecting human health and the environment. 

SOCMA hopes to see it continue 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 views 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 leveraged 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 document 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 Program. SOCMA hopes its suggestions will 

make EPA’s proposed enhancements more manageable and effective. 
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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 certification 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) approach does not make sense as it is 

inconsistent with EPA’s objective, does not provide a level playing 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 that have not been manufactured within 

a certain timeframe? Should EPA consider 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 PMN is the proper 

approach. For one thing, it is unclear what purpose EPA would accomplish by 

leaving on the inventory such “inactive” chemicals, especially if persons could 

not manufacture them anew without some further action having to occur under 

Section 5 (and potentially Section 12(b)). Moreover, the SNUR approach would 

not be substance specific and is likely to be much more burdensome and 

restrictive. SOCMA does believe, however, that an expedited process for 

inventory re-eligibility should be available for delisted inventory chemicals that 

were the subject of effective PMNs. 

 

1 See 15 U.S.C. § 2607(a)(1)(A) (Section 8(a) rules 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 manufactured or processed for scientific purposes, id., 

creating yet another loophole. 
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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 does not generally excuse processors of 

chemical substances, who still have many responsibilities for TSCA compliance. 

The statute and EPA rules place 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 round 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 commercial activity; the 

reset should not be based upon theoretical 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 the inventory to contain 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. 
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SOCMA notes that the Information Quality Act and EPA’s implementing 

guidelines2 may require EPA to correct factual 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 chemicals for which PMNs have gone through 

the new chemical review process, but manufacture of which has not yet been 

commenced. SOCMA suggests that manufacture 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 important to note, however, that 

SOCMA believes an expedited process for 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, SOCMA 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 “influential” scientific 

information, subject to the most demanding standards for quality. 
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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” issue Section 4 test 

rules in cases where chemicals 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 existence on a timely 

basis, since, as EPA notes, they will “more than meet IHPV Challenge needs.” It 

may well make sense to limit the IHPV Challenge to those inorganic chemicals 

that no one has preregistered under REACH. 

In summary, SOCMA supports this enhancement and believes that a sound 

framework for the IHPV program will consider stakeholder comments on the gaps of the 

HPV program. Also, active issuance of test rules applied as necessary, and utilization 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 prioritized 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 Newton at 202-721-4100 or newtond@socma.com.