The US Food and Drug Administration establishes action levels for a wide range of toxins and poisons in a wide range of food products. For seafood products such as Dungeness crab, these toxin thresholds are documented in Appendix 5: FDA and EPA Safety Levels in Regulations and Guidance (PDF) in FDAās Fish and Fishery Guide, June 2022 Edition.
The Crab Evisceration Program applies to processors who receive, hold, or eviscerate Dungeness crab or rock crab caught in areas under an Evisceration Order (EO) in California. Specific to handling crab during a bioxtoxin event under an EO:
What is an Evisceration Order?
When domoic acid levels exceed action levels in Dungeness or rock crab viscera, but not the meat, an Evisceration Order is issued by CDPH to authorize the evisceration of crab caught in specific biotoxin management areas. Removing the viscera in the contaminated crab will reduce the significant hazard to control public health risk.
CDPH works in collaboration with the California Department of Fish and Wildlife (CDFW) and Office of Environmental Health Hazards Assessment (OEHHA) for the biotoxin management areas.
What are the requirements to lift a crab evisceration order?
There are two possible scenarios that could end an Evisceration Order.
- When the viscera from two consecutive crab sample sets, tested minimum seven (7) days apart, are found ā¤30ppm for domoic acid, CDPH lifts the Evisceration Order. Note that when viscera is ā¤30ppm, no meat testing is needed. Each sample set consists of 6 crab, and each is tested individually.
- When one or more viscera samples from a set is detected above action level (>30ppm) and the meat is also above action level (ā„20ppm) for domoic acid, then the biotoxin management area is closed to harvest. Any crab caught in the area is considered adulterated and cannot be sold, offered for sale, delivered or donated. Evisceration is not allowed.
How does evisceration affect domoic acid?
Current testing data indicate that the viscera (internal organs, also known as ābutterā or āgutsā) of crabs usually contains higher levels of domoic acid than the meat. By removing the viscera, the level of domoic acid in crab may be reduced to an acceptable level. After evisceration, crab may be sold if the domoic acid level in meat is below action level (< 20ppm).
What is an āapproved processorāā?
An approved processor is a person or entity registered with the CDPH to receive, hold, or eviscerate Dungeness crab or rock crab under an Evisceration Order.
This applies to primary processors and secondary processors who will eviscerate, repack, relabel, or otherwise change the market form of the crab.
How do I become an approved processor?
To become an approved processor, you will need:
- Apply for a Processed Food Registration (PFR) and fee if you are not already registered.
- Apply for an Crab Evisceration Registration.
- Pay $350 fee for reviewing and approving the evisceration Hazard Analysis & Critical
Control Point (HACCP) plan. - Receive crab caught from CA waters from a CDFW licensed commercial fishers.
- Have an evisceration HACCP plan approved by CDPH.
- Have written Recall Procedures.
- Have labeling procedures to identify harvest location, harvest date, or lot code or any combination of these to allow effective product traceability.
- Renew your PFR and Evisceration Registration annually.
āIf I already have a Processed Food Registration with CDPH, do I still need to apply for the Crab Evisceration Registration?
Yes, you need to apply for an Evisceration Registration even if you already have the Processed Food Registration. The Crab Evisceration Registration is required for all firms that want to receive, hold, or eviscerate Dungeness crab or rock crab, and processors that repack or relable the eviscerated crab meat from crab harvested from areas under EO. A separate application is required for each location.
Will CDPH have templates or sample HACCP plans?
Yes, CDPH will have templates to assist approved processors after they apply.
What recordkeeping practices are required for approved processors?
Approved processors must maintain records of supplier information, harvest location, quantity received, production data, distribution details, and HACCP documentation. These records must be available for inspection by the Department.
What steps must an Approved Processor follow when receiving Dungeness or rock crab under a Department Evisceration Order?
Approved Processors must receive CA crab only from CDFW licensed commercial fishers. They must also document that the crab are from areas authorized by the Department for evisceration. Also see question 10 above.
CA crab caught under an EO must be eviscerated in CA by a CDPH Approved Processor before leaving the state. A list of CDPH Approved Processors will be posted on our website.
What are the fees associated with the eviscerated crab program? Would CDPH charge HACCP fee every year since HACCP plans have to be reassessed annually?
Processors must pay non-refundable fees for their Processed Food Registration and additional fees for the initial review and approval of their Eviscerated Crab Hazard Analysis Critical Control Point (HACCP) plan. CDPH would not charge the HACCP review fee for the annual HACCP reassessment. This fee would be charged if the processor made changes to the HACCP plan and required CDPH review and approval.
What happens if a biotoxin management area is closed?
If a biotoxin management area is closed, crab from that area may not be donated, sold, or processed.
When an EO is issued, when is harvest affected?
If under an Evisceration Order, crab must be eviscerated starting at 12:01 a.m. on the harvest date.
What are the labeling requirements for eviscerated crab?
Eviscerated crab in bulk packaging for further processing must display the lot code, product name, processor name and location, and weight or quantity. Retail packaging must comply with FDA labeling standardsā, including displaying the lot code on the principal display panel.
What are the potential penalties for non-compliance with eviscerated crab regulations?
Penalties for non-compliance include, but are not limited to, embargoed products, re- inspection fees, administrative penalties, suspension or revocation of evisceration registration. Infractions include falsifying records, making false statements on applications, failing to disclose necessary information, and altering registration documents.
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