U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. CPG Sec 540.250 Clams, Mussels, Oysters, Fresh, Frozen or Canned - Paralytic Shellfish Poison
  1. Search for FDA Guidance Documents


CPG Sec 540.250 Clams, Mussels, Oysters, Fresh, Frozen or Canned - Paralytic Shellfish Poison November 2005

Issued by:
Guidance Issuing Office
Office of Regulatory Affairs
Center for Food Safety and Applied Nutrition


Paralytic shellfish poison is a marine biotoxin, produced in single celled marine protozoa of the order Dinoflagellata. This poison accumulates in the tissue of bivalve shellfish that have ingested certain species of dinoflagellates of the genus Gonvaulax or closely related genera.

Toxin levels in shellfish are associated with algal "blooms" of toxic dinoflagellates in shellfish growing waters of the Pacific Coast and the Bay of Fundy region.

Ordinary cooking does not insure safety of shellfish since the poison is very stable and is not destroyed completely by the usual heat treatments.


The following represents criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605):

Actionable if one sub from a lot shows paralytic shellfish poison value of 80 micrograms, or more, per 100 grams meat when bioanalyzed by current Association of Official Analytical Chemists procedure.

Articles meeting the above criterion represent a potential health hazard. Consequently, recall is the action of choice. Notify CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) immediately if articles meeting the above criterion are encountered.

Notify CFSAN's Office of Seafood (HFS-415) immediately when articles containing any detectable levels of paralytic shellfish poison are encountered.

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 10/30/89, 3/95, 5/2005
Updated: 11/29/2005

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Back to Top