- Standard Number:
OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov.
February 6, 1998
Environmental Affairs Assistant
Braun Medical Inc.
824 Twelfth Avenue
P.O. Box 4027
Bethlehem, PA 18018-0027
Peter J. Brady
Dear Ms. Millington;
This is in reply to your letter, dated January 22, 1998, concerning whether methylene chloride used as a solvent or bonding agent is covered by the "formulation of products" stay for the methylene chloride standard listed in the Federal Register of December 18, 1997. As confirmed with our national office, the December 18, 1997 stay would not cover this usage of methylene chloride.
OSHA standards and policies are accessible on the Internet. OSHA's web site address is "www.osha.gov." Please contact this office if we may be of further assistance.
KENNETH W. GERECKE
Assistant Regional Administrator
January 22, 1998
Occupational Safety and Health Administration (OSHA)
ATTN: George J. Torachick Jr.
850 North Sth Street
Allentown, PA 18102
Dear Mr. Tomchick:
Pursuant to my conversation with Mr. Scott Shimandle from your OSHA office in Allentown, PA. on Friday January 16, 1998, I am formally requesting written confirmation as to B. Braun/McGaw's (formerly B. Braun Medical Inc.) eligibility under recently published partial stay of start up dates for compliance to the Methylene Chloride Standard.
B. Braun/McGaw is a disposable medical device manufacturer that has over 4,000 different items that are manufactured at the facility located in Allentown, Pa. In order for this request to be processed, B. Braun/McGaw provides you with the following example of the formulation of an item that contain Methylene Chloride. This particular extension set is used in patients requiring IV antibiotic therapy, Nutritional Support, and rapid administration of solutions.
Six inch piece of PVC tubing is dipped into Methylene Chloride and the T-fitting is attached to the end of the tubing. On the opposite end of the tubing, a female adapter is attached using the same process described above. The product is then packaged, sterilized and ready for shipment. The Methylene Chloride serves as a solvent or bonding agent in this assembly process thereby allowing B. Braun/McGaw to provide our customer with a useable IV extension set. This serves as just one example of many products that are assembled using either (a) 75/25% mixture of Methylene Chloride and Tetrahydrofuran, (b) 75/25% mixture of Tetrahydrofuran and Methylene Chloride or (c) a 100% solution of Methylene Chloride.
I hope that this example demonstrates the importance of Methylene Chloride's contribution to the formulation, manufacturing and assembly of a majority of B. Braun/McGaw's final products. Without the use of Methylene Chloride, B. Braun/McGaw would not be able to produce a marketable product. For this reason, B. Braun/McGaw has served as a member of the Halogenated Solvents Industrial Alliance (HSIA) and has supported their attempts at obtaining the partial stay to the Methylene Chloride standard.
As discussed with Mr. Scott Shimandle, both Scott and I feel that B. Braun/McGaw's does fall under the scope of an employer engaged in the formulation of products containing Methylene Chloride.
It would be greatly appreciated if you could confirm in writing B. Braun/McGaw's eligibility under this stay. If there are any questions concerning our production process and/or our use of Methylene Chloride that could clarify your determination of our eligibility, please do not hesitate to contact me at any time.
I look forward to hearing from you shortly.
Environmental Affairs Assistant
Medical & Scientific Affairs