Document ID: EPA-HQ-OPPT-2015-0234-0012
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2016-05-23T04:00Z

Good afternoon and thank you for the opportunity to provide comments on the TSCA Work Plan Chemicals Assessment Process.  My name is Steve Risotto; I am a Senior Director at the American Chemistry Council and have been involved in petitions to the Agency regarding the identification of 2 chemicals as priorities under the Work Plan program within the last year.  My comments today focus on general concerns about the prioritization process the Agency used to identify the Work Plan chemicals list, using the evidence for these 2 petitioned chemicals for illustration.

In 2011, the Office of Pollution Prevention and Toxics announced its intent to establish a two-step process to " [quote] identify potential chemicals for near-term review and assignment under TSCA." [unquote]  In February 2012, the Toxics Office released a Methods Document that outlined the prioritization process and identified - for the very first time - 83 chemicals for assessment.  The Methods Document included numerical scores for Hazard, Exposure, and Persistence and Bioaccumulation for each of the listed chemicals, but provided little explanation for the scores beyond a general discussion of the methodology used by the Agency.

In October 2014, OPPT released an update to the Methods Document that removed several substances from the list of Work Plan chemicals because 

   * they no longer presented exposure potential from consumer or commercial use,
   * their hazards are well characterized and EPA has a strong risk reduction effort in place, or 
   * exposure to the chemical was limited to the workplace and controlled by regulations issued by the Occupational Safety and Health Administration.

As these conclusions apply equally to several other substances that were left on the Work Plan list  -  it doesn't appear that EPA conducted a thorough review.  Other chemicals were added to the list in 2014 based on a conclusion that the potential for exposure was greater than originally concluded  -  in spite of the fact that for some of the chemicals nothing had apparently changed.

Neither the 2012 Methods Document nor the 2014 Update was made available for public review and comment prior to its release.  The Toxics Office has provided no subsequent opportunity for stakeholders to provide information on a Work Plan chemical prior to an Agency decision on what actions to take on that chemical.  Waiting until the problem formulation stage to accept comment on whether a Work Plan chemical has - in EPA's words - the "highest potential for exposure and hazard" is too late and is not consistent with Agency guidelines for information quality and transparency; nor is this approach conducive to an efficient and effective program for prioritizing public health concerns.

Because no other avenue existed, ACC submitted petitions under the Information Quality Act relating to the Work Plan listing of two chemicals used exclusively as intermediates in the production of other materials.  The first chemical  -  phthalic anhydride  -  is used as a reactant in the production of phthalate plasticizers and various resins.  The second substance  -  ethylene dichloride or EDC  -  is used exclusively in the production of vinyl chloride monomer used in the manufacture of polyvinyl chloride.

OPPT assigned both of these chemicals the highest score possible for potential exposure suggesting that  - 

   * One - there is widespread exposures through the use of consumer and commercial products despite the fact that neither substance is used in these products, and

   * Secondly - that data exist indicating the presence of both substances in biota and the environment despite the fact that no such data exist for phthalic anhydride and that the Center for Disease Control and Prevention failed to find detectable levels of EDC in the blood of over 4,000 individuals sampled between 2003 and 2006 as part of its biomonitoring program.

Earlier this year, the Toxics Office announced its intent to start the problem formulation stage for EDC and 6 other chlorinated organic substances.  Like EDC, 5 of the other 6 substances are used exclusively in intermediate applications and present minimal exposure potential.  Rather than attempt to formulate a problem that doesn't exist for these chemicals, we strongly encourage OPPT - with the assistance of this Committee - to review the initial basis for their listing in the Work Plan. 

As part of this Committee's activities, it is critical that you carefully evaluate the process OPPT used to identify the Work Plan chemicals in its 2012 Methods Document and 2014 Update to ensure that the process is transparent and scientifically sound.  To aid in this review we recommend that  - 

   * EPA establish a public docket for the Work Plan chemicals program that will make available all of the information the Agency used for listing the identified chemicals and provide an opportunity for public input on the listing decisions; and
   * OPPT and this Committee conduct a comprehensive refresh of the Work Plan chemicals list to ensure that substances are appropriately prioritized before the Toxics Office initiates any additional steps under the program.

Thank you for your attention.