Interpretation Response #08-0290 ([Sensitech, Inc.] [Mr. Henry Ames])

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date: 12/17/2008

Company Name: Sensitech, Inc.

Individual Name: Mr. Henry Ames

Location State: MA Country: US

View the Interpretation Document

Response text:

December 17, 2008

Mr. Henry Ames

Director of Strategic Marketing

Sensitech, Inc.

800 Cummings Center, Suite 258x

Beverly, MA 01915

Ref. No.: 08-0290

Dear Mr. Ames:

This is in response to your inquiry, submitted by email, dated December 1, 2008, and subsequent emails and phone conversations, concerning the compliance of certain temperature and humidity monitoring devices marketed by Sensitech with requirements of the Hazardous Material Regulations (HMR; 49 CFR Parts 171-180), particularly with regard to the provisions of Special Provision (SP) 188 of § 172.102(c)(1).

You described these monitoring devices as incorporating small, primary lithium batteries and provided information on each type of battery, with regard to lithium content, and compliance with applicable regulatory standards such as SP 188 and the UN Manual of Tests and Criteria, and on the test regimen (electromagnetic compatibility testing, vibration testing, shock testing, and water resistance and submersion testing) to which each type of device has been subjected. Using your nomenclature, the products are described as VaxAlert, FreezeAlert, TempTale 4 (TT4), TT4 USB, TT4 RF, TagAlert, TTMini, and TT4 Dry Ice. You indicated the devices are used to monitor temperature- and humidity-sensitive products, many of which are pharmaceuticals, and may be attached to pallets or packages, placed inside a package, or built into a packaging containing these products.

You indicated there is some confusion as to whether these cargo monitoring devices are subject to the HMR. The devices are offered for transport and transported in commerce; thus, to the extent they contain hazardous materials, they are subject to applicable provisions of the HMR.

Based on the information you have provided, we agree with your assessment that these devices qualify for the exceptions provided for small lithium batteries under SP 188. Specifically, the batteries conform to the provisions in paragraph a(2) as they are contained in equipment and meet the quantity and net weight limits specified. Therefore, the devices are not prohibited for transport aboard passenger aircraft nor are they subject to the marking requirement of paragraph a(1). Moreover, the batteries conform to the lithium content limitations of paragraphs b and c, and it appears that all battery types meet, or will meet by

October 1, 2009, the test requirements of paragraph d. The batteries are separated so as to prevent short circuits and contained in equipment in conformance with the requirements of paragraph e. Finally, based on the information you provided concerning the test regimen to which the devices are subject, the devices conform to the requirements of § 173.21 of the HMR, in that they do not appear likely to create sparks or generate a dangerous quantity of heat and, thus, meet the requirements of paragraph g. Paragraphs f and h do not apply to your situation.

With regard to your request that certain information contained in your submissions not be made available for public release, please see 49 CFR 105.30 for the procedure for requesting confidential treatment. Also, note that the HMR do not address electromagnetic compatibility requirements, which fall under the Federal Aviation Regulations. If you have questions concerning those requirements, they should be addressed to the Federal Aviation Administration.

I trust this satisfies your inquiry. If we can be of further assistance, please contact us.

Sincerely,

Edward T. Mazzullo

Director, Office of Hazardous Materials Standards

Pipeline and Hazardous Materials Safety Administration

172.102 SP 188, 173.21

Regulation Sections