May 1998 - Revised from March 1996
On December 18, 1997 the long anticipated regulation for a new
method of inspection for food safety in the seafood and
aquaculture industry became effective and enforceable by the U.
S. Food & Drug Administration (FDA). The new system is named
"HACCP" for the proven concept of Hazard Analysis and
Critical Control Point programs designed to prevent and control
food safety problems. Justification for the program was based on
continuing concerns for seafood-borne illnesses, public
expectations, industry requests, and market trends in both
domestic and international settings. Regulatory response
considered HACCP as the most cost-effective way to ensure seafood
safety. HACCP relies on more industry self-regulation through
"preventative maintenance" with regulatory oversight.
WHO MUST COMPLY ?
Processors - firms either in the United
States or in a foreign country, engaged in handling, storing,
preparing, heading, eviscerating, shucking, freezing, changing
into different market forms, manufacturing, preserving, packing,
labeling, dockside unloading, or holding fish and fishery
Importers - U.S. owners or consignee at the
time of entry into the United States, or the U.S. agent or
representative of the foreign owner at time of entry. Foreign
processors will be influenced indirectly through requirements for
U.S. importers to ensure their suppliers comply with HACCP
programs equivalent to that for domestic processors.
Products Involved - fresh or saltwater fish,
crustaceans, all mollusks, alligators, frogs, aquatic turtles,
jellyfish, sea cucumbers, sea urchins, other aquatic animal life
except mammals and birds, and the roe from these animals, if
intended for human consumption. A fishery product includes fish
or shellfish as the characterizing ingredient.
Exempted - harvesting or transporting the
involved products without otherwise processing, retail operations
and practices such as heading, eviscerating, or freezing intended
solely to prepare [involved products] for holding on board a
harvest vessel. Note, harvesters and transporters can be
influenced indirectly through a processors' product and shipping
specifications as relate to their HACCP Plans.
WHAT IS REQUIRED ?
Prerequisite Programs (before installing
HACCP Plans shall be required in addition to the existing requirements for:
Current Good Manufacturing Practices (GMP's: 21 CFR 110)
Sanitary Standard Operating Procedures (SSOP)
related regulations to prevent economic fraud
Written HACCP Plans shall be prepared based on hazard analysis for food safety for each location where the involved products are "processed" and for each kind of involved product(s). Contents of the written HACCP Plan include:
1. List of the food safety hazards "reasonably likely" to occur.
2. List of the critical control points (CCP's).
3. List of the critical limits that must be met at each CCP.
4. Monitoring procedures for each CCP.
5. Any pre-determined corrective action plans
6. List of the verification procedures to assure the HACCP Plan is adequate.
7. Record keeping system to document the monitoring of the
CCP's. Includes dating and signature requirements
Sanitation Control Records for the SSOP
Each "processor" shall maintain sanitation control
records that, at a minimum, document the monitoring and
corrections for the conditions and practices during processing
with sufficient frequency to ensure conformance with sanitation
standard operating procedures (SSOP's) and good manufacturing
practices (GMP's). SSOP monitoring requirements include dating
and signatures to accompany monitoring and respective corrective
FDA issued the final rule for HACCP
inspection for fish and fishery products. They are responsible
for the enforcement in accordance with the Federal Food, Drug and
Cosmetic Act. In the absence of an appropriate HACCP program can
be considered adulterated and subject to regulatory actions and
State regulatory authorities will be adopting
the federal mandate and assisting with enforcement as done for
similar food regulations applicable to food processing and
importing. In Florida, the primary regulatory authorities for
seafood and aquacultured product processing are the Department of
Environmental Protection (for blue crabs and mollusks) and the
Department of Agriculture & Consumer Services (for other
National Marine Fisheries Service (NMFS) will
continue to maintain their voluntary fee-for-services inspection
program which includes an experienced HACCP element. Their HACCP
services are not mandatory.
According to FDA's new HACCP regulation, at a minimum, the
following functions 'shall' be performed by an individual(s)
trained in the application of HACCP principles to fish and
fishery product processing:
Developing the HACCP Plan
Reassessing and adjusting the HACCP Plan in accordance with corrective actions and verifications
Performing record reviews
Training should be equivalent to that available through a
standardized curriculum recognized as adequate by the U.S. FDA.
Currently this curriculum is the 2˝ day training program
developed by the national "Seafood HACCP Alliance".
This program will be offered through the regional affiliates of
the Association of Food & Drug Officials (AFDO) utilizing
established trainers from academic, industry and regulatory
programs about the nation. Job experience and other training
formats can qualify an individual to perform the required
functions if it has provided knowledge at least equivalent to
that provided through the standardized curriculum. The trained
individual need not be an employee of the processor.
SEAFOOD HACCP ALLIANCE and TRAINING MATERIALS
The National Sea Grant College Program funded the development of the Seafood HACCP Alliance for education and training services. The initial Alliance consists of members of the three principle federal agencies; FDA, USDA and NMFS, various State agencies through the Association of Food & Drug Officials regional affiliates, the Interstate Shellfish Sanitation Conference, and various Sea Grant College programs from coastal states. The Alliance has developed and pilot-tested a HACCP Core Curriculum to accompany their Compendium of Methods and FDA's new Fishery Products Hazard Guide. These materials are
+ - available to support training programs.
Basic Seafood HACCP Training Manual (with models) and FDA's
accompanying "Fisheries' Products Guide":
NC Sea Grant College Program, Box 8605, N.C. State University,
Raleigh, North Caorlina 27695-8605, 919/515-2454
Alliance's "Compendium of Fishery Product Processing
Methods, Hazards and Controls":
Internet Address- http://www-seafood.ucdavis.edu/haccp/compendium/compend.htm
This HACCP brief is a condensed version based on the final
rule, "Procedures for the Safe and Sanitary Processing and
Importing of Fish and Fishery Products" issued in the
federal register (Vol. 60 No. 242) on December 18, 1995. The
actual rule should be referenced for accuracy and more detail.
The brief was first compiled 2/7/96 and revised 5/5/98 by:
Artwork and contents of this
site Copyright© 1998 by the Florida Sea Grant College Program
and may not be used without permission.
Aquatic Food Products Program Mail:
c/o Steve Otwell and Victor Garrido Food Science & Human Nutrition Department
352/392-4221 University of Florida
Fax 352/392-8594 P.O. Box 110370
E-mail Otwell@gnv.ifas.ufl.edu Gainesville, FL 32611-0370