Document ID: EPA-HQ-OPPT-2023-0376-0257
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2023-11-24T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
                                       
                             OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
MEMORANDUM FOR THE RECORD

RE:  	Meeting with the Medical Imaging and Technology Association (MITA) on PIP (3:1) in the Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h)
List of Contents
 Meeting Summary
 Attendees
 Contact
Meeting Summary

On February 23, 2022, representatives from EPA met with representatives and member companies from the Medical Imaging and Technology Association (MITA), a trade association representing manufacturers of medical devices. MITA expanded on a letter they had sent on December 21, 2021date to EPA regarding jurisdictional overlap between the U.S. Food and Drug Administration (FDA) and Toxic Substances Control Act (TSCA) uses of phenol, isopropylated phosphate (3:1) (PIP (3:1)) (CASRN 68937-41-7) in the manufacture of medical devices. MITA was following up on the issue in their letter regarding their confusion on EPA's inclusion of medical technology (specifically Covid-19 vaccine equipment) as rationale for the compliance date extension for PIP (3:1) in certain articles. MITA presented their analysis of how any chemical substance used for medical devices is statutorily excluded from the jurisdiction of the TSCA, as well as requested feedback from EPA on how compliance and enforcement would distinguish between continuing use/import that would be allowed under the FDA but not under TSCA. EPA requested that MITA follow up with a letter delineating specific enforcement concerns that could then be shared with EPA and indicated that EPA would prepare a written response to points about jurisdiction MITA may raise in that letter.
 Attendees
EPA:  
Mark Hartman
Sheila Canavan
Susanna Blair
Brian Symmes
Tanya Mottley 
Joel Wolf
Niva Kramek
Gabriela Rossner  

MITA:
Laura Srebnik
Denise Mousouris 
GE Healthcare:
James Vetro 
Fujifilm:
Jan Carlock
Jill Rathburn 
Philips:
Hans van der Wel 
United Imaging Healthcare:
Paul Biggins
Mark Weyna