# RCS, Inc. - Ohio — Hazardous Materials Safety Interpretation

**Citation:** 02-0309  
**Type / status:** guidance / guidance  
**Agency:** Pipeline and Hazardous Materials Safety Administration  
**Effective:** Not stated  
**Published:** 2003-01-02

02-0309 response to RCS, Inc. - Ohio concerning 171.8.

## Document text

<<<PAGE 1>>>

us anorion
JAN M2 2003
400 Seventh St., S.W.
Research and
Washington, D.C. 20590
Special Programs
Administration
Mr. Jeff Henderson
RCS, Inc. - Ohio
Reference No.: 02-0309
950 Taylor Station Road
Gahanna, OH 43230
Dear Mr. Henderson:
This is in response to your letter concerning the exceptions for Consumer commodities, ORM-D,
under the Hazardous Materials Regulations (HMR; 49 FR Parts 171-180). Specifically, you
ask if your products, Intravenous starting kits and Dressing change kits, that contain an alcohol
that the swabs contain 2 to 10 mL of alcohol or alcohol and iodine solution and are packaged in a
pad and/or an iodine/alcohol swab may be shipped as Consumer commodity, ORM-D. You state
hermetically sealed pouch. The pouch contains free liquid when manufactured. These products
are shipped to hospitals and health care facilities.
In general terms, a consumer commodity, as defined in 49 CFR 171.8, is a material that is
packaged and distributed in a form intended or suitable for sale through retail sales agencies or
instrumentalities for consumption by individuals for purposes of personal care or household use.
The definition includes materials that are suitable for retail sale even if not specifically so
intended and which may, in fact, be used in some other fashion. It is the opinion of this office
"Consumer commodity, ORM-D."
that the Intravenous starting kits and Dressing change kits would qualify for shipment as
I hope this satisfies your request.
Sincerely,
Hollez. mitkell
Hattie L. Mitchell
Chief, Regulatory Review and Reinvention
Office of Hazardous Materiais Standards
020309
171.8

<<<PAGE 2>>>

Corbin
RCS
$171.8c)
Consummer Commodite
November 26, 2002
02 - 0309
Research and Special Programs Administration
400 7* Street SW
DHM-10.
Washington D.C. 20590-0001
Attn: Edward Mazzullo-Director of the Office of Hazardous Materials Standards..
Re: Letter of Interpretation under the Consumer Commodity Definition
Dear Mr. Mazzullo,
The following, requests a letter of interpretation regarding the applicability of the
defirition of a Consumer Commodity as stated in 49 CFR 171.8. RCS, Inc's
products, requesting interpretation, are Intravenous (IV) Starting Kits and
client, Becton Dickinson, manufactures and ships medical products.
Dressing Change Kits, which contain an Alcohol pad and/or an lodine/Alcohol
Swab.:
These. products are shipped to hospitals and health care facilities for
patient care purposes
Alcohol. and lodine Swabs consist of 2 ml to 10ml of alcohol or alcohol and
iodine solution.
The swabs are packaged in a hermetically sealed pouch and
contain free liquid when manufactured. These products are regarded by the FDA
*as being Generally Regarded as Safe an Effective (GRASE) under the Tentative"
Final Monograph for Health-care Antiseptic Drug Products.
specialized use in changing patient dressing or starting an IV.
Dressing Change Kits and IV Starting Kits are prepackaged products for
Within the
prepackaged kits are Alcohol or Alcohol and lodine Swabs identical to those
with a Tyvek lid to maintain sterility and prevent breakage during transport or
outlined above. IV Start Kits are packaged in a thick plastic pouch and sealed
handling. Dress Change Kits are packaged in rigid plastic trays and sealed with
•a plastic pouch to prevent breakage during transportation and handling.
A letter of interpretation is requested to allow for shipment of the above products
as Consumer Commodity, ORM-D materials. While the above products are
manufactured and intended for clinical use, the type of packaging utilized for the
• products can be suitable in household use or personal care.
"Under the current definition, a Consumer Commodity means a material that is
packaged and distributed in a form intended or suitable for sale through retail

<<<PAGE 3>>>

sales agencies or instrumentalities for consumption by individuals for purposes of
personal care or household use. This term also includes drugs and medicines
It is the opinion. of Becton Dickinson and RCS, Inc. that the above mentioned
products can
• classified as Consumer Commodity, ORM-D materials.
Therefore, it is requested that a letter of interpretation be formed to acknowledge
If the above products may be shipped as a Consumer Commodity, ORM-D
materials.
Additional information regarding the above products can be obtained from the
following sources:
Becton Dickinson
Rand Pugmire
Jeff. Henderson
RCS, Inc.
9450 South State St.
950 Taylor Station Rd, St M
Phone: 801-565-2550
Sandy, UT 84070
Phone: 614-552-8530 x 31
Gahanna, OH 43230
Fax: 801-565-2749
Fax: 61.4-552-8541
send a hard copy to the above fax numbers and addresses. Your cooperation
Upon determination and completion of a letter of interpretation, please fax and:
and timeliness is greaty appreciated.:
Sincerely
Jeff Henderson
Technical Consultant
RCS, Inc.

## Provenance

- Official: Yes
- Source: <https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2002/020309.pdf>
- Source ID: `phmsa`
- SHA-256: `4028e7498de073d8ebb6d60247f6caf61d92292fb6b765fc3f3b689c5888be35`
- Retrieved: 2026-08-20T00:59:31.977Z
- Exported: 2026-08-23T07:49:11.057Z
- Document slug: `phmsa-interpretation-02-0309`

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