

From: 	Chris Sarsony, HDR|e[2]M

To: 	Amy Hambrick, U.S. Environmental Protection Agency

Re:  	August 7, 2009 Meeting Between the U.S. EPA and Accellent Inc. regarding the Halogenated Solvent Cleaning Reconsideration

Date: 	August 21, 2009
                                       

      On August 7, 2009, a teleconference meeting was held between the U.S. Environmental Protection Agency (EPA) and representatives from Accellent Inc - a narrow tube manufacturer.  The meeting participants are listed below.

                                     Name
                                 Organization
Tim Benner
EPA/ORD
Wendy Cooper
Accellent Inc.
Susmita Dubey
EPA/OGC
Robin Dunkins
EPA/OAQPS
Amy Hambrick
EPA/OAQPS
Ann Johnson
EPA/OPEI
Carol McCabe
Representing Accellent Inc.
Dennis Pagano
EPA/OAQPS
Chris Sarsony
HDR|e[2]M Inc.
Larry Sorrels
EPA/OAQPS
Kim Teal
EPA/OAQPS


Meeting Agenda (see attachment for detailed agenda):
1.	Introductions and Meeting Purpose
2.	Issues for Discussion
3.	Open Discussion	

Meeting Summary:

1. Introduction and Meeting Purpose

Ms. Hambrick of the U.S. EPA began the meeting with introductions and by stating the purpose for the meeting.  The meeting was to follow up to Accellent's February 3, 2009 public comments on the October 20, 2008, Proposed Notice of Reconsideration and Request for Public Comment for Halogenated Solvent Cleaning (73 FR 62384).  Specifically, EPA wanted to obtain clarification and additional details regarding Accellent's products, manufacturing process, halogenated solvent cleaning machines, and trichloroethylene (TCE) emission controls.  

Ms. Hambrick indicated that a meeting summary would be developed for the meeting and this summary would be made available to the public in the docket.  

2. Issues for Discussion

   a. What size are the medical device tubes that Accellent manufactures at the Collegeville, PA facility?
      
      Some of the narrow tubing that Accellent makes are as thin as a human hair (see Accellent's public comment letter and the Meeting Summary for the 1/28/09 meeting between Accellent and EPA for additional details.).  Other tube manufacturers specialize in much thicker tubes.
      
   b. Is it only the medical device tubes that present problems for Accellent in complying with the proposed limit of 60,000 kg methylene chloride equivalents (MC EQ) (Options 2 and 3 of the October 20, 2008 proposal)?
      
      There are several factors that make the cleaning process at Accellent unique: 
         * The extreme narrowness of the tubing they manufacture;
         * The high standards of cleanliness that are required for implantable devices; and 
         * The long lengths of coiled tubing that are cleaned.  

      Although they do make a variety of products, most of their tubing does enter the body.  All of their tubing, regardless of end use, is cleaned on the same line.  Accellent does not segregate its products during the cleaning process based on end use.
      
   c. Is stainless steel used in larger tubes?
      
      The majority of their products are made of stainless steel.  However, they do also use other specialty metals.   
      
   d. Does Accellent have recent data they can share with us that show their system operating with the carbon adsorption systems (CAS)?
      
      Accellent indicated that, because their CAS are retrofit systems, it has been difficult to obtain a high capture efficiency.  The control of the air going through the CAS is very good, but they are currently working on increasing the capture efficiency of the systems.  [The overall efficiency is equal to the capture efficiency of the CAS multiplied by the control efficiency of the CAS.]  The overall control efficiency that was guaranteed by the manufacturer of the CAS is in the 20% to 30% range.  
      
      Even with the capture efficiency issues, Accellent has seen significant reductions in their TCE emissions as a result of installing the two CAS.  They have recently agreed voluntarily to have their PA TCE emission limit lowered from 94 tons/year to 45 tons/year.
      
In 2006, prior to installation of the two CAS, Accellent stated that their TCE emissions were 68 tons.  In 2008, after installation of the CAS, Accellent stated that their TCE emissions were about 39 tons.  That is a reduction in TCE emissions of 29 tons or 42% from their 2006 baseline. (Accellent also indicated that it has observed a maximum percent control efficiency in the low 50's for Plant 2, though not on a continuous basis, and has observed  a maximum percent control efficiency in the lower 60's for Plant 1.)  Observed control efficiencies  are variable, and are not achieved on a continuous basis, though Accellent continues to optimize system operation.
      
   e. Is Accellent the only facility that manufactures medical device narrow tubes?
      
      There may be some other companies that manufacture tubing for medical devices, but
      Accellent is the primary manufacturer (i.e., has the greatest market share) in the U.S. of narrow tubing that is used in implantable devices.
        
   f. Can we get a copy of the slides presented to EPA in January of this year?
      
      Accellent will send EPA an electronic copy of the presentation.  
      
   g. Accellent's comments outline that it would not be feasible to install vacuum technology.  Could you explain to us why this is the case?  What was the basis for this statement?
   
      Accellent indicated that they investigated switching to vacuum-to-vacuum cleaning technology in 2006.  At that time, they determined that vacuum-to-vacuum cleaning technology would be prohibitively expensive for their operations and would also not be technically feasible.  Specifically, the costs were so high because they determined that, in order to meet current production levels, they would need two new vacuum-to-vacuum cleaning machines for each existing open top cleaning machine.  In addition, they found that the vacuum-to-vacuum machines were all end loading units at that time.  Loading a 40-foot tube into an end loading machine requires a significant amount of space.  In order to accommodate the additional machines and the end loading design, Accellent would have to construct a new facility at a cost of greater than >$10 million.  This cost is in addition to the cost of the new vacuum-to-vacuum machines themselves.  
      
      In addition to the cost concerns, Accellent also determined that they would be unable to purge their large coils of tubing of contaminants and solvent in a vacuum-to-vacuum cleaning machine.      
      
      Accellent stressed that over the years they have actively explored alternative cleaning technologies and their decision to invest $2 million in CAS was well researched ahead of time.   
      
   h. Is n-propyl bromide (nPB) the only alternative solvent that has been tried at Accellent?  What procedures did Accellent conduct to determine that nPB would not work, i.e., what is the basis for determining that TCE was the only solvent that would meet the performance specifications for your processes?   What are the specific Food and Drug Administration (FDA) requirements for approving alternative cleaning solvents for the tubing used for medical devices?  Do you have a point of contact at FDA that we can contact to gain a better firsthand understanding of their requirements?
      
      Accellent has conducted bench scale cleaning trials using nPB.  The results of these trials indicated that nPB does not achieve the required level of cleanliness for their products.  The bench scale tests indicated that tubing cleaned with nPB contained residual contaminants that could cause product failure.  In their presentation to EPA in February of this year, Accellent presented photos of rusted and pitted tubing that was cleaned using nPB by a competitor.  Accellent indicated that such product failures are unacceptable when dealing with implantable medical devices.  
      
      Accellent indicated that some other manufacturers of narrow tube have been able to switch to nPB because they are manufacturing different tubing products with a larger diameter and different standards of cleanliness.
      
      Accellent indicated that they may have looked at using methylene chloride at one time, but they would have to check to verify this.  Currently, Accellent does not know of any solvent other than TCE that will achieve the required level of cleanliness for their products.  
      
      The FDA process for approving changes in the manufacturing process for medical devices can take several years.  In addition, there can be a lengthy client approval process.  Accellent will send EPA some information on the FDA approval process and a contact name at the FDA.  
      
      
   i. How is Accellent's process different than competitors who have added vacuum cleaning systems?

      See 2g. above.
      
3. Open Discussion
                                       
   Accellent indicated that they prefer Option 1 in the October 20, 2008 proposal, because Accellent believes that the rule, as promulgated provides an ample margin of safety, as required by the statute.  Accellent does not believe that additional requirements beyond the original NESHAP should be imposed for narrow tube manufacturers.
   
   When asked whether it might be beneficial if the EPA were to subcategorize the ultra small medical tubing from narrow tubing, Accellent indicated that it may be beneficial as long as the structure of the requirements do not restrict their ability to expand their product base and increase their production in the future.  Subcategorization should not adversely affect Accellent's ability to manufacture non-medical products.
   
   Accellent indicated that they have 15 or 16 facilities, but that all of their solvent vapor cleaning operations subject to the NESHAP are consolidated at the facility in Collegeville, PA.  Accellent indicated that they could not farm out their cleaning operations to other facilities, because the other facilities do not have solvent cleaning capabilities.  
   
   EPA asked Accellent if they could provide any additional details on their manufacturing and cleaning operations.  Accellent indicated that some of their tube products are cleaned in both of their cleaning machines in series, and some of their products are cleaned in only one of the cleaning machines.  Accellent indicated that Plant 1 cleans the smallest tubes.  Accellent's manufacturing line runs 24 hours a day/5 days a week and reduced hours on weekends.  
   
   EPA asked Accellent if they could achieve greater TCE emission reductions if given more time.  Accellent indicated that, other than continuing to improve the capture efficiency of their CAS, they have done everything they can to reduce their TCE emissions.   
       
   
   
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                               AttachmentsAgenda
          EPA Halogenated Solvent Reconsideration Proposal Workgroup
                            Meeting with Accellent
                                August 7, 2009
                             11:00 am to 12:00 pm
                  Conference Line: 919-541-4332/ Room: E141B
                                       
   1. Introductions & Meeting Purpose
   
         a. Introduce meeting participants
         
         b. To discuss new information that the Accellent and other commenters provided on the Halogenated Solvent Proposed Rule regarding technologies used by certain narrow tube solvent cleaning machines located at facilities.

   2. Issues for Discussion. 

         a. What size are the medical device tubes?
         b. Is it only the medical device tubes that present problems?
         c. Is stainless steel used in larger tubes?
         d. Does Accellent have recent data they can share with us that show their system operating with the CAS?
         e. Is Accellent the only facility that manufactures medical device narrow tubes?
         f. Can we get a copy of the slides presented to EPA in January of this year?
         g. Accellent's comments outline that it would not be feasible to install vacuum technology.  Could you explain to us why this is the case?  What was the basis for this statement?
         h. Is nPB the only alternative solvent that has been tried at Accellent?  What procedures did Accellent conduct to determine that nPB would not work, i.e., what is the basis for determining that TCE was the only solvent that would meet the performance specifications for your processes?   What are the specific FDA requirements for approving alternative cleaning solvents for the tubing used for medical devices?  Do you have a point of contact at FDA that we can contact to gain a better firsthand understanding of their requirements?
         i. How is Accellent's process different than competitors who have added vacuum cleaning systems?
         
   3. Open discussion for any additional questions or discussion points

   4. Meeting adjourned.  Thank you! 



                                        

