Notice of Intent to List a Chemical by the "Formally Required to be Labeled or Identified" Mechanism: Chloramphenicol Sodium Succinate

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list the chemical identified in the table below as known to the State to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 19861.  This action is being proposed under the “formally required to be labeled or identified” listing mechanism2

Chemical

CAS No.

Toxicological Endpoint

Reference

Chloramphenicol sodium succinate

982-57-0

Cancer

NLM (2012);
APP (2008)

Background on listing via the formally required to be labeled or Identified mechanism:  A chemical must be listed under the Proposition 653 and its implementing regulations (Section 259024) when a state or federal agency has formally required it to be labeled or identified as causing cancer or reproductive toxicity. 
According to Section 25902(b):

  • “‘[F]ormally required’ means that a mandatory instruction, order, condition, or similar command, has been issued in accordance with established policies and procedures of an agency of the state or federal government to a person or legal entity outside of the agency.  The action of such agency may be directed at one or more persons or legal entities and may include formal requirements of general application;”
  • “‘[L]abeled’ means that a warning message about the carcinogenicity or reproductive toxicity of a chemical is printed, stamped, written, or in any other manner placed upon the container in which the chemical is present or its outer or inner packaging including any material inserted with, attached to, or otherwise accompanying such a chemical;”
  • “‘[I]dentified’ means that a required message about the carcinogenicity or reproductive toxicity of the chemical is to be disclosed in any manner to a person or legal entity other than the person or legal entity who is required to make such disclosure”; and
  • “As causing cancer” means:  “For chemicals that cause cancer, the required label or identification uses any words or phrases intended to communicate a risk of cancer or tumors.” 

OEHHA is the lead agency for Proposition 65 implementation.  After a state or federal agency has required that a chemical be labeled or identified as causing cancer or reproductive toxicity, OEHHA evaluates whether listing under Proposition 65 is required pursuant to the definitions set out in Section 25902.

OEHHA’s determination:  Chloramphenicol sodium succinate has been identified or labeled to communicate a risk of cancer (NLM, 2012; APP, 2008) in accordance with formal requirements by the U.S. Food and Drug Administration (FDA). 

Language from the FDA-approved product labels which meets the requirements of Section 25902 is quoted below:

Chloramphenicol sodium succinate

Cancer Endpoint (Under boxed Warning)

Under boxed Warning:  “Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia and granulocytopenia) are known to occur after the administration of chloramphenicol.  In addition, there have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia.  Blood dyscrasias have occurred after both short term and prolonged therapy with this drug. Chloramphenicol must not be used when less potentially dangerous agents will be effective, as described in the INDICATIONS section.  It must not be used in the treatment of trivial infections or where it is not indicated, as in colds, influenza, infections of the throat; or as a prophylactic agent to prevent bacterial infections.

Request for comments:  OEHHA is requesting comments as to whether this chemical meets the criteria set forth in the Proposition 65 regulations for listings via the formally required to be labeled or identified mechanism (Section 25902).  Because these are ministerial listings, comments should be limited to whether FDA requires that chloramphenicol sodium succinate be labeled to communicate a risk of cancer or tumors.  OEHHA cannot consider scientific arguments concerning the weight or quality of the evidence considered by FDA when it established the labeling requirement and will not respond to such comments if they are submitted.  

In order to be considered, OEHHA must receive comments by 5:00 p.m. on TUEDAY, SEPTEMBER 3, 2013.  We encourage you to submit comments in electronic form, rather than in paper form.  Comments transmitted by e-mail should be addressed to P65Public.Comments@oehha.ca.gov.  Please include “chloramphenicol sodium succinate” in the subject line.  Comments submitted in paper form may be mailed, faxed, or delivered in person to the address below.

Mailing Address: 
Office of Environmental Health Hazard Assessment
P.O. Box 4010, MS-19B
Sacramento, California 95812-4010

Street Address:1001 I Street
Sacramento, California 95814

Comments received during the public comment period will be posted on the OEHHA web site after the close of the comment period.

Public Comments

Comment period closed Sept. 3, 2013. No comments received.

Footnotes and References

APP, a division of Fresenius Kabi U.S.A. LLC (APP, 2008).  Label for the drug Chloramphenicol sodium succinate.  [Accessed on July 9, 2013].

National Library of Medicine DailyMed web site (NLM, 2012).  NLM, National Institutes of Health, Health and Human Services, Bethesda Maryland.  Label for the drug Chloramphenicol sodium succinate.  Available at:  http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=aed29594-211d-49ef-813f-131975a8d0e3 [Accessed on July 9, 2013].

1Commonly known as Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986 is codified in Health and Safety Code section 25249.5 et seq.

2 See Health and Safety Code section 25249.8(b) and Title 27, Cal. Code of Regs., section 25902.

3 See Health and Safety Code section 25249.8(b).

4 All referenced sections are from Title 27 of the Cal. Code of Regulations.