Interpretation Response #15-0090 ([Inova Diagnostics] [Allison Fowler])
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
Response Publish Date:
Company Name: Inova Diagnostics
Individual Name: Allison Fowler
Location State: CA Country: US
View the Interpretation Document
Response text:
Allison E. Fowler
EH & S Manager, BSO, CHO
Inova Diagnostics
9900 Old Grove Road
San Diego, CA 92131
Ref. No. 15-0090
Dear Ms. Fowler:
This responds to your May 6, 2015 request for clarification on the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Specifically, you ask if the following scenario is compliant with § 178.601(g)(1), Variation 1.
You state that you had a certification for a low density polyethylene (LDPE) plastic inner packaging/bottle that passed the testing/certification criteria and proved capability. This certification has since expired. You have a current certification that tested a high density polyethylene (HDPE) plastic (re: inner packaging bottle type), and it references HDPE, LDPE and PPCO on the certification under materials/bottle type. You ask if you comply with § 178.601(g)(1), Variation 1, using an LDPE bottle type for inner packaging under the current certification.
You believe that because the previous certification proved capability of LDPE and the current certification for HDPE proves capability, an equivalent level of performance is maintained on the basis of: (1) the inner packagings are of equivalent size/volume; (2) the inner packagings are of similar design to the tested inner packagings (i.e., shape-round); and (3) the material of construction of the inner packagings (re: plastic) offers resistance to impact and stacking forces equal to or greater than that of the originally tested inner packaging. Therefore, you believe the LDPE plastic inner packaging included under the HDPE certification may be used without further testing of the packaging in accordance with § 178.601(g)(1), Variation 1.
Your understanding is correct. Use of the LDPE plastic inner packagings complies with requirements in § 178.601(g)(1), Variation 1. Provided the inner packagings are of similar design (i.e., shape) and the material of construction offers the same or greater impact resistance than that of the originally tested inner packaging, further testing of a tested design type is not necessary and the LDPE inner packagings may be used. Moreover, provided an equivalent level of performance can be ascertained, you may use the LDPE inner packagings instead of the HDPE inner packagings under Variation 1.
I hope this answers your inquiry. If you need additional assistance, please contact this Office at 202-366-8553.
Sincerely,
Dirk Der Kinderen
Acting Chief, Standards Development Branch
Standards and Rulemaking Division
178.601(g)(1)
Regulation Sections
| Section | Subject |
|---|---|
| 178.601 | General requirements |