May 13, 2013 - Electronic distribution of SDS&hellips;May 13, 2013 - Electronic distribution of SDS&hellips;
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Karl E. Luke, PhD Diagnostic Hybrids, Inc. [acquired by Quidel Corp in 2010]
1055 East State Street, Suite 100
Athens, OH 45701
Dear Dr. Luke:
Thank you for your March 18, 2013, letter to the
Occupational Safety and Health Administration (OSHA) Regional Office. Your
letter was forwarded to OSHA's Directorate of Enforcement Programs to be
answered. Your questions concerned the distribution requirements for Safety
Data Sheets under the revised Hazard Communication standard (HCS 2012), (29 CFR 1910.1200. This letter constitutes OSHA's interpretation only of the
requirements herein, and may not be applicable to any questions not delineated
within your original correspondence. Your paraphrased question and our
response is below.
Background:Diagnostic Hybrids (DHI) manufactures in vitro
diagnostic medical devices for professional use in testing facilities. DHI
recently uploaded all of DHI's Safety Data Sheets (SDSs) to the website to make
them accessible to all of its customers. DHI also includes an 'e-labeling'
product information card with each shipment to inform the customers that the
SDSs are available on the DHI website.
Question: Would the 'e-labeling' product information card
meet the requirements of 29 CFR 1910.1200(g)(6)(ii) to provide the SDS with the shipped
containers or prior to the first shipment?
Response: No. The use of the 'e-labeling' product
information card would not be compliant with 29 CFR 1910.1200(g)(6)(ii). While
OSHA allows for the use of electronic distribution of SDSs, the system you
proposed does not meet all the requirements OSHA has outlined for electronic
distribution of SDSs.
The manufacturer
must ensure that the downstream user has
agreed to this type of information access, ("opt-in").
The manufacturer
cannot require the downstream user to
purchase new technology in order to obtain the SDS.
The manufacturer
must ensure that some positive and
verifiable form of notification (such as a letter or email) is provided with
all the information necessary to access the SDS(s).
The manufacturer
must ensure that some positive and
verifiable form of notification is provided to ensure that the downstream user
is aware when SDSs are updated.
To this end, downstream users must choose whether they would
like to receive SDSs electronically through your e-labeling system and be able
to "opt-out" at any time. Once a downstream user "opts-out" you must provide
them a hard-copy of the SDS as part of their next shipment. If the downstream
user elects to receive SDSs electronically, you are required to provide them
with information on how to access SDSs and to notify users when SDSs are
updated. Also, please note that all SDSs must be provided at no cost to the
downstream user, regardless of whether they are shipped as hard-copies or
provided electronically. In addition, the use of electronic distribution of
SDSs does not eliminate the manufacturer or importer's requirement under 29 CFR
1910.1200(g)(6)(iv) to provide an SDS (hard-copy) upon request by the
distributor or employer.
Thank you for your interest in occupational safety and
health. We hope you find this information helpful. OSHA's
requirements are set by statute, standards, and regulations. Our letters
of interpretation do not create new or additional requirements but rather
explain these requirements and how they apply to particular
circumstances. This letter constitutes OSHA's interpretation of the
requirements discussed. From time to time, letters are affected when the
Agency updates a standard, a legal decision impacts a standard, or changes in
technology affect the interpretation. To assure that you are using the correct
information and guidance, please consult OSHA's website at https://www.osha.gov. If you have further
questions, please feel free to contact the Directorate of Enforcement Programs
at (202) 693-2100.