May 9, 2013
 Profile of Chemical Users Coalition

 Perspective on Recent EPA Initiatives

 Chemical Action Plans and Workplan Chemicals

 ChemView Information Portal

 Transparency Projects

 Recent GAO Report

 Downstream Industry TSCA Issues

 Longer-term Policy Interests
 Formed in 2010 to represent a critical downstream 

perspective on chemical management

 Manufacturing operations – not retailers, service providers 

or brand names without domestic manufacturing

 Mix of companies across industries – find common ground

 Limited membership, but major industry leaders

 8 companies; almost $600 B in global sales

 Aligning ability to innovate with environmental 

protection is common theme of activities

 Will engage EPA, Administration, Congress as needed
 Positive elements of new existing chemical program

 Having an agenda –Action Plan, Workplan list

▪ Provides greater certainty for planning purposes

▪ We need reliable expectations over 5+ year timeframes

 Agenda appears calibrated to what EPA will do

▪ Appears to match EPA intent, resources, capabilities

▪ Good to avoid “menu” lists that go beyond program’s abilities

▪ Ex: EPA National Priority List, TSCA Master Testing List, ChAMP concept

▪ Such lists are less valuable for planning, stewardship activity

 Initial assessments have targeted scope

▪ Areas of potential risk where TSCA might be able to fill a gap

▪ Provides early signal of relevance to downstream industries
 Important to maintain agenda over time

 Establishes program consistency and continuity

 Concern: recent change in agenda for 2013 assessments

▪ Does it signal ongoing annual shifts in agenda?

▪ Does it return to TSCA history of unpredictability?

 Process suggestions

 Identify early point of contact for individual assessments

▪ Would allow for direct communication, information flow

 Identify steps in existing chemical process

▪ What follows screening assessments?

▪ Points of public comment, interaction?
 Defining “Uses” in Screening Assessments

 “Use” as end-use applications – preferred approach

▪ Example: paint strippers for NMP, methylene chloride

▪ Facilitates exposure assessment, identifying management options

 “Use” as a general chemical function – less desirable

▪ Example: “fire retardant” category is a function that is desired for a 

variety of materials in a variety of technical applications

▪ Specific applications determine likely exposures; technology of 

applications determines practical choices

 Evaluation of non-substitution technology options?

 Engage industry on design, exposure control options
 Priority issue: approach to articles under TSCA

 Article regulation should not be a “default” approach

▪ As a general matter, articles are not the main business of TSCA

▪ But “targeted” article regulation may be needed in some cases

 Determinations that should precede article regulation

▪ Cannot address objective by regulation of substances/mixtures

▪ Clear nexus between article and U.S. exposures causing risk

▪ Articles of concern likely to be distributed in the U.S.

- Implementation issues for articles need greater clarity

- Clarify “use” definitions; example of “consumer use” confusion

- Reasonable screening measures for chemicals in articles?
 ChemView Information Portal

 First reaction is very positive

▪ Regulatory information addresses a key downstream concern

▪ Access to TSCA data helps chemical evaluation activities

 Priorities for inclusion in site

▪ Include all TSCA requirements, including export and Section 8

▪ Presence on Inventory, with CAS, PMN, Accession identifier

▪ Allow for searches by PMN number, Accession number

▪ Indicator of pending SNUR (with planned restrictions)

▪ Include proposed rules – ability to comment + direct impact

▪ Sunset dates for data submission, link to data submitted
 Issues to address in ChemView development

 Data quality: EPA assessments

▪ Mix of documents with different purposes, developed over time, 

based on evolving sets of underlying data

▪ Consider ways to assure users see best available data

▪ Dates on assessments, sequence documents so best available data must be 

viewed first, pop-up notices about existence of more recent information

 CBI concerns will arise with additions and information links

▪ Need process for stakeholder vetting to address any CBI issues

 Ongoing beta testing of site with general public

▪ Site holds very useful information, but it is complex

▪ Understanding public use, reaction can guide better design
 Transparency Initiatives

 As users of chemical data, we appreciate effective access 

to information; but we also know that CBI protection is 

essential for us to be competitive

▪ B to B data-sharing vs. public domain information is a key issue

 Favor approach emphasizing effective system for case by 

case CBI claims; most adaptable to the many contexts 

where competitive intelligence challenges arise

▪ Adding rigor (e.g., upfront substantiation) may be needed

▪ Mandatory disclosure provision raise more concerns, particularly 

when EPA expands interpretation of key terms (e.g., health and 

safety study) to include process and chemical function data
 Perspective on protection of R&D information

 Chemical ID should be protectable, if substantiated

▪ Low exposure to public; less compelling disclosure need 

▪ CBI value is at its highest; provides roadmap to innovation

 This pattern can reverse at commercialization stage

▪ But that depends on specifics of chemical and technology

▪ Can be sorted out in case by case CBI determinations

 Perspective on protection of mixture information

 Toxicity testing of a mixture has limited value to users

▪ Important if mixture is used, but B to B sharing is often adequate

▪ Generally don’t rely on such tests to evaluate constituent toxicity
 Recommendations on Transparency Policies

 Case by case CBI determinations are preferred

 Processors, users should be allowed to participate in CBI 

claim and appeal process for use/exposure information

▪ Upstream chemical producer may not be party in interest

 Protecting chemical identification at R&D stage is critical

 Protecting names of chemicals in a mixture when a 

mixture is tested should be allowed

 Engage stakeholders on value of data to be disclosed

▪ Assumptions about value of data may be inaccurate
 Support Agency response on Processor Reporting

 Mirrors comment CUC filed on CDR rule

 Processors may hold key information on exposure, but the 

context determines when they are the best source

▪ Factors include EPA data needs, length of supply chain, number of 

parties at each step, sophistication of parties, existing industry 

networks for sharing data, experience with EPA collaboration

 Obtaining more detailed exposure data beyond CDR is 

best accomplished through a case by case approach

▪ Possibly by industries, product categories, pathways for release to 

the environment, specific geographies

▪ Where feasible, voluntary action tends to be timely and effective
 TSCA impact on downstream industries

 Regulation as processors, importers, exporters, etc.

▪ But dependent on suppliers for chemical-specific information

 Supplier compliance issues can disrupt operations

 Challenge: TSCA applicability to materials supplied

 Often provided materials that are mixtures or are 

identified by names not used in TSCA rules

▪ CAS number ID vs. PMN numbers (in SNUR)

▪ MSDS chemical names vs. TSCA substance names

 Proprietary chemical ID information masked by suppliers
 Supplier notice about TSCA obligations is uneven

 More consistency on TSCA Inventory status

 SNUR, reporting obligations not always noted

 Particularly when supplier is distributor/broker

 Long lag times for public notice about SNURs

 Recent EPA actions have included PMN’s filed in 1990’s

 Some chemicals have been in commerce for several years 

before downstream companies learn of SNUR

 Direct final process creates a narrow window to respond
 TSCA rules do not offer effective pathways to 

determine what TSCA rules apply to a chemical

 Bona fide request process is too slow and requires 

unrelated information (e.g., filing date for PMN)

 SNUR “safe harbor” provision (721.5(c)) is not useful; 

requires companies to “document” lack of knowledge that 

a SNUR applies; document that you don’t know?

 CUC polled members on most effective approach

 Top priority: online check of regulatory status, by chemical

 Direct alignment with capability of ChemView, so ongoing 

CUC interest in developing site to support compliance
 Additional measure that would be helpful

 Export notification: posted updates on chemicals covered

▪ Identify changes since prior update

 Issue SNUR actions on a more timely basis

 Bona fide request tailored for processors

▪ Would be used mainly for R&D purposes for chemicals not yet in 

commerce (prior to Notice of Commencement)

▪ Request would be to determine whether the substance is facing 

controls (e.g., restrictions on use, volume, discharge to water)

▪ Certification of intent to process (not manufacture) submission

 Update training materials for importers (e.g., CDR role)

▪ Consider translation to assist global supplier networks
 Speed to market (efficiency in new chemical review)

 Critical need to maintain global competitiveness

 Concerns about policy/resource changes that affect speed

 Interested in any streamlining efforts

 Consistency of policy, information across borders

 Global companies facing diverse regulatory systems

 US should not defer to policies that are not risk-based

▪ But opportunities for practical alignment of standards exist

▪ Mutual acceptance of data and assessments are also possible

 Similar need to align across state borders