Bio-Safe America, Inc. — Hazardous Materials Safety Interpretation

Page 1US.Department 400 Seventh Street, S.W. of Transportation Washington, D.C 20590 Research and Special Programs Administration DEC | 6 1999 Ms. Samantha Burdick Ref. No. 99-0192 Office Manager Bio-Safe America, Inc. 4301 32nd Street West, Suite C-16 Bradenton, Florida 34205 Dear Ms. Burdick: This is in response to your letter dated July 12, 1999, requesting clarification of the packaging exceptions in 49 CFR 173.134(b)(3) for "Regulated Medical Waste, 6.2, UN 3291, PG I'" in the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Your understanding of the exceptions in § 173.134(b)(3) is correct. As provided by § 173.134(b)(3), a regulated medical waste that is transported by a private or contract carrier is excepted from: (1) the "INFECTIOUS SUBSTANCE" label, if the-outer packaging is marked with a "BIOHAZARD" marking conforming to 29 CFR 1910.1030, and (2) for other than a waste culture or stock of an infectious substance, the specific packaging requirements in § 173.197, if packaged in a rigid, non-bulk package conforming to §§ 173.24 and 173.24a, and 29 CFR 1910.1030. I hope this satisfies your request. Sincerely, Delmer F. Billings Chief, Standards Development Office of Hazardous Materials Standards 173.13 990192#

Page 2Boothe July 12,1999 §173.134 Mr. Edward Mazzullo, Director 99-0192 US DOT/RSPA 400 7% Street S.W. Washington, D.C. 20590 Dear Mr. Mazzullo: I am wating in reference to the US DOT regulations pertaining to containers manufacture or the transportation of regulated medical waste. I was referred to you by Mr. Arthu Pollack in the standards division in regard to obtaining a letter from your office regatding certain exceptions to the packaging requirements. CFR 49 Parts 100-185 set forth the regulations for transportation of all hazardous materials, including regulated medical waste. Bio-Safe America, Inc. is a medical waste transporter and, packaging and marking requirements for various types of carriers and different types of theretore, must comply with these regulations. However, there are exceptions to the substances being transported. Part 173.197 sets forth the packaging regulations for regulated medical waste. In this section, minimum construction standards are established, testing and certification procedures are discussed (specific testing procedures are located in parts 173.24 and 173.242), and UN Standard Packaging (UN markings, numbers) is defined. However, part 173.134 sets forth EXCEPTIONS to the packaging requirements for regulated medical waste in part 173.197. Based on our interpretation of the regulations, we believe that our boxes do not require testing or certification based on several of these exceptions. I have indicated below those that apply to Bio-Safc Amrica, Inc. directly. The specific exceptions are as follows: 173.134 Packaging Exceptions A Regulated Medical Waste that is transported by a private or contract carrier (Bio-Safe America is a contract carrier) is excepted from: 1. Infectious Substance label, if the outer packaging is marked with a "biohazard" marking (Bio-Safe America's boxes have always been printed with the international biohazard symbol and the word "biohazard"). requirements that Bio-Safe America's containers comply with. BIO-SAFE AMERICA, INC. 4301 32ND STREET WEST, SUITE C-16 BRADENTON, FL 34205#

Page 3-2- July 12,1999 Parts 173.24 and 173.24a set forth General Non-Specification and Specification Packaging Requirments for hazardous materials: 1. There will be no identifiable leakage. 2. The effectiveness of the package will not be substantially reduced due to temperature changes or weather conditions. 3. Inner packaging (bags) must be secured to prevent leakage. Under normal use and conditions, Bio-Safe America's boxes meet all of the above specifications. Based on this information, it is our understanding that our containers are not subject to UN Standard Packaging requirements, including testing and certification, UN markings, and identification numbers. individuals in your department, including Ms. Helen Engrum and Mr. Arthur Pollack, both As part of my research in this matter, I have had several telephone conversations with regulatory specialists. I also spoke with Mr. Phil Olsen at the office of the Associate Administrator, Mr. Alan Roberts. After I had explained our situation to them, each of these individuals verbally agreed with our interpretation of the exceptions in the regulations. I am now, however, in need of written clarification of this information from your office. Please call me at 941-755-1921 with any questions or comments regarding this matter. If possible, please fax your response to this inquiry to my attention at 941-753-1416. Thank you for your time and attention in this matter. Sincerely, Sinteth Samantha Burdick Office Manager#