Procedures for Obtaining a Shellfish Handling and Marketing Certificate (SHMC)
The California Department of Public Health (Department) is the State Shellfish Control Authority. California Health and Safety Code (HSC) Section 112205 and Title 17 of the California Code of Regulations 7707 requires wholesale businesses that maintain ownership of raw molluscan shellfish (oysters, clams, mussels, and whole scallops) to be certified by the California Department of Public Health, Food and Drug Branch (FDB).
The SHMC is not required for firms that handle crustacean shellfish, such as crab, shrimp, and lobster. Those firms are required to have a Processed Food Registration (PFR). If you are unsure whether your operation is required to have a SHMC, please email SeafoodReporting@cdph.ca.gov.
SHMC Application
The first step towards certification is to submit a fully completed application form with the required fees. Application may be obtained from our Seafood and Shellfish Safety webpage, and should be submitted 30 to 60 days before purchasing and distributing raw molluscan shellfish (live, shucked or frozen). A separate application is required for each location.
- Any incomplete and/or illegible applications will be returned to the applicant.
- The application fee is non-refundable and non-transferable to other locations, persons, or business entities.
- Facility address is the processing plant, warehouse, or office in California where an inspection can be conducted.
- Mailing address can be the facility, corporate headquarters, or other office where business mail is received. License certificates and all correspondence from FDB will be sent to the “mailing address” identified on the application.
- Certification is valid for one calendar year and expires on March 31st regardless of when the application is submitted.
- A change of facility/business ownership will invalidate the certification. The new owner must apply for a new certification, prior to the onset of operations.
- Please keep a copy of the completed application and payment check for your records.
Pursuant to HSC 110474, the registration fee owed by a person who is required to hold one or more licenses, registrations, or certificates issued by the Department shall be the fee for the single highest cost license, registration, or certificate only. For example, if a business is required to obtain both a SHMC and PFR, where the PFR fee is less than the SHMC, the business must pay for the SHMC and the PFR license fee will be excused. The business must still apply for the PFR and pay for the Seafood HACCP fee ($250), and Food safety fee ($100) that are associated with the PFR, because these fees are not covered by HSC 110474.
Key Requirements for Certification
- You are required to have and implement food safety controls under a Seafood Hazard Analysis Critical Control Points (HACCP) plan pursuant to Title 21 Code of Federal Regulations (CFR) Part 123.
- Proof of personnel trained in seafood HACCP principles will be required, along with a copy of your shellfish HACCP plan(s).
Pre-Certification Inspection
Once your application and check have been processed by FDB, you will be contacted by our inspectional staff to schedule the pre-certification inspection. An inspection ensures that the business is in compliance with the California Health & Safety Code, the applicable provisions of the Code of Federal Regulations, and the National Shellfish Sanitation Program (NSSP). These include Good Manufacturing Practices, Seafood HACCP Regulations and shellfish labeling requirements. The inspection verifies that appropriate operations are employed to ensure that shellfish and handling activities are safe and suitable for human consumption. Inspections typically include the following areas:
Business and Product Information will be reviewed to ensure that the business has the infrastructure to employ reasonable controls to prevent foodborne illnesses, provide training for employees, identify and segregate ill employees from contact with food, and ensure an environment that meets current standards and requirements. Examples include:
- Organizational structure
- Supervision expertise
- Shellfish sources
- Product distribution
- Dealers that want to sell and ship shellfish out of California must be listed on the Interstate Certified Shellfish Shippers List (ICSSL). These Dealers can only obtain shellfish from other ICSSL Dealers and are inspected more frequently.
- Dealers that will only distribute shellfish within California can be listed on the CA ONLY Shellfish Shippers List. They cannot sell or ship shellfish out of California.
- Traceability and written Recall procedures
Production and Process Controls will be reviewed to
ensure that critical control points in the handling process are consistently met,
and adequate science-based barriers exist to prevent pathogen growth and toxin
formation. Examples include:
- Shellfish receiving and inspection procedures
- Storage methods
- Appropriate measures to prevent shellfish commingling
- Temperature measuring instruments and calibration procedures
- Effective recordkeeping and traceability of raw molluscan shellfish by lot
Sanitation Control Procedures will be reviewed to ensure that all shellfish handling and storage is completed without cross-contamination, on clean/sanitized food contact surfaces, following hygienic practices, utilizing potable water, while excluding pests and other sources of contamination. Examples include:
- Sanitation inspections
- Cleaning procedures
- Sanitizing procedures
- Equipment and building maintenance
- Pest control program
- Allergen control program
Shellfish Tagging and Labeling will be reviewed to
ensure NSSP tagging requirements are reviewed and only conducted by specific
certified operations. Examples include:
- Tags and labels constructed of waterproof materials
- Written with indelible ink
- Correct information obtained and transferred
- Appropriate measures to prevent shellfish commingling
If deficiencies are identified during the inspection process, then issuance of the SHMC certificate will be delayed until compliance is achieved. When your firm is found to be in compliance, a SHMC certificate will usually be issued, and your company name will be placed on either the ICSSL or the CA ONLY Shellfish Shippers List.
Any inspection that results in violations or deficiencies being discovered may subject your firm to a re-inspection to verify that corrective actions have occurred. FDB cannot certify a company that is not in compliance with the minimal safety standards for the commercial distribution of raw molluscan shellfish.
After the issuance of the SHMC, routine inspections will be conducted. These inspections are not scheduled in advance.
Food and Drug Branch
1-800-495-3232
FDBfood@cdph.ca.gov