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From: Food Quality & Safety magazine, February/March 2007

REPORT: ISO Standards Big Catch for Seafood Industry

by Steven Wilson

The U.S. Department of Commerce and the National Oceanic and Atmospheric Administration (NOAA) provides the voluntary Seafood Inspection Program, which offers a variety of professional inspection services that assure compliance with all applicable food regulations.

To augment this volunteer program, regulators now required the implementation of two ISO standards, 9001, which addresses HACCP from a quality perspective, and 22000, the food safety management standard, in all approved facilities in the Seafood Inspection Program. The rating criteria and supporting documentation was finalized by May 2006. The matter of how best to implement these food safety and quality strategies is currently being determined in a series of meetings between industry and agency personne.1

While ISO implementation was equally embraced by industry and regulatory agencies, the logistics of that integration continue to bring debate over acceptance as well as how program participants located outside the United States would adjust. Although it is international in scope, many firms outside of the United States needed its implementation sooner rather than later.

The Global Seafood Community

Although figures vary, at least 60 percent and as much as 80 percent of the seafood products consumed in the United States are derived from imported products. In the case of shrimp, the figures indicate over 90 percent of the product consumed in the United States was imported. Imports cover numerous species, product forms, and levels of further processing. Many of the imports originate from countries varying highly in the infrastructure, capabilities, and food system controls.

As inspection of the process is more effective for a commodity than end-item inspection, these figures clearly provide evidence that inspection of seafood firms overseas would be indicated. Also, since similar figures are found in many other countries, whatever system is in place must meet international requirements and concerns, and it must also have strong integrity for acceptance by the consumer. This mandated adoption of internationally recognized system standards and, although CODEX Alimentarius had standardized trade between nations, the ISO had standardized the buyer-supplier relationship.

Voluntary Inspection

Perhaps the first step to implementation is to become familiar with the Seafood Inspection Program, which continues to offer product quality evaluation, grading and certification services on a product lot basis. Benefits include the ability to apply official marks, such as the U.S. Grade A, Processed Under Federal Inspection (PUFI), and lot inspection marks.

The services provided by the Seafood Inspection Program include the following:

  • Establishment/vessel sanitation inspection;
  • Process and product inspection and product grading;
  • Product lot inspection;
  • Laboratory analysis;
  • Training and consultation.

These services can be provided nationwide, in U.S. territories, and with the exception of product certification, in foreign countries as well. All types of establishments such as vessels, processing plants, and retail facilities may receive these services. All edible product forms ranging from whole fish to formulated products, as well as fish meal products used for animal foods, are eligible for inspection and certification. The official government forms and certificates issued by USDC inspectors are legal documents recognized in any U.S. court.

In fiscal year 2005, the Seafood Inspection Program inspected a total volume of 1.34 billion pounds of fish and fishery products. This represents approximately one-fifth of the seafood consumed in the United States.

Contracts for in-plant services numbered over 330, approximately 10 percent of the total processing establishments in the U.S. However, approximately 2,500 firms utilized the services of the program. All this was accomplished with a total budget of $17.9 million.

The Agricultural Marketing Act of 1946 as amended provides the authority for the Seafood Inspection Program to provide its services. The act was established for the purpose of agricultural products, including fishery products “may be marketed to the best advantage, that trading may be facilitated, and that consumers may be able to obtain the quality product which they desire….”

The act also enables the assessment and collection of fees, “as will be reasonable and as nearly as may be to cover the cost of the service rendered….” The programs developed from the act are to be available to all areas of the industry, domestic and foreign.

ISO 9001 Benefits

One of the services offered by ISO 9001 is the HACCP Quality Management Program (HACCP QMP). This program is a comprehensive program with emphasis on product safety, plant and food hygiene, economic integrity, and product quality. Firms participating in this program operate their approved quality system and are audited at a defined frequency by Seafood Inspection Program personnel. Audits are based upon the firm’s adherence to their approved plan. Firms who do not follow their plan well and take responsibility for corrections and improvement typically are audited more frequently. If a firm can maintain their system, they can be audited as little as once every three months. In return, compliant firms may place inspection marks on any product that meets the program’s requirements. With the only other alternative being a full time inspector during all processing of the identified product, a firm could save greatly on inspection costs.

In January 2000, the Seafood Inspection Program made changes to the HACCP QMP that further defined the quality system to be implemented. This quality system, based upon ISO Standard 9001:2000, would provide greater definition of the quality system and its controls for all products covered under the contract with the firm. Adoption of ISO 9001 would also allow firms to compete more effectively on the global market. Products leaving participating firms bearing an inspection mark or being advertised as inspected would be required to implement these changes. The firm’s quality plan now required the HACCP plan focus on food safety and be in a format conducive to inspection by the USFDA. However, it was also now required for firms to provide the program written hazard analyses for covered products, written sanitation standard operating procedures (SOPs), defect analyses, defect action plans, and a quality manual, which would define the quality policies and general procedures of the firm with regard to maintaining the quality of the applicable products.

Implementation would not be easy as the ISO 9001 standard had a poor reputation in the food industry. Many industry members were highly suspicious and were convinced a high increase in forms and written procedures would be enacted, making the system difficult to follow. The number and depth of written procedures that would be required were also in question. Others feared the increased demands on the system would result in a reduced focus on food safety.

Although seafood safety was directly a concern of the USDA and each state, a number of the Seafood Inspection Program participants used the program to further document and verify their adherence to food safety. As the program utilized a rating system with various levels of deficiencies based upon criticality of the issue, adding more “checkboxes” would only make it more difficult to achieve a high rating, which could ultimately affect the frequency of audits on the firm. In general the seafood industry was asking the question, “why is this necessary?”

The plan for implementation of these changes included time for the seafood industry and program participants to accept them and adapt their systems. To address the concerns of the seafood industry, a number of face-to-face meetings were held across the country at times convenient for industry members to participate. Similar meetings were held in the evenings with inspection personnel, as they would be integral to the successful implementation of the program. All questions and concerns were discussed fully. The meetings emphasized that these changes were specific to the HACCP QMP program and that firms would be given up to 18 months to implement the necessary changes. To ease the process, plan development and reengineering was provided to all firms. In fact, the current plans were assigned to Seafood Inspection Program personnel and a draft plan was developed with the necessary updates. This plan was then brought to the firm to illustrate the ease and minimal changes necessary. However, the concerns were still strong in the industry and the original timeline of 18 months ultimately extended to a total of four years. Even with all the fears of the industry, the HACCP QMP program now had a stronger place in global seafood markets and was widely accepted by many governments and buyers worldwide.

Application of ISO 22000

The official publication of the food safety management standard ISO 22000 that came in late 2005 provided another opportunity for the Seafood Inspection Program to further enhance its international acceptance.

ISO 22000 provides a number of advantages to food processors wishing to improve their food safety management system. The system approach of the standard, with its compatibility to ISO 9001 would be a great advantage. In addition, the ISO 22000 was written to try and alleviate the myriad of different audit program requirements by buyers that are currently present.

The benefit of ISO 22000 is that it is designed specifically to address CODEX requirements and it is specific to the food industry. Firms adopting the standard would now be on an even playing field with many other firms across international lines. Further, buyers could be assured, with proper outside auditing, that products from these firms would meet their food safety needs. As the standard was written in similar terms to that of ISO 9001, implementation within the HACCP QMP would be nearly seamless. These firms already have most of the elements covered with just a few changes. Therefore, there would be no effect on the audit frequency as concerned the industry previously. But to be most effective in positioning firms in the Seafood Inspection Program internationally, ISO 22000 would have to be adopted in all approved facilities, not just those in the HACCP Quality Management Program.

Adopting ISO 22000 as the standard of the Seafood Inspection Program brought up the same concerns. Although the frequency of audits would not be an issue, the same concern on increased paperwork was initially raised. ISO 22000 was drafted so that minimum documentation would be required. It is anticipated that little additional procedures would be required of program participants. But firms in the program were not accustomed to the controls described in the increased focus on management commitment being of foremost concern. An unnecessary focus on prerequisite programs was also highlighted as possible.

The decision to implement ISO 22000 in all approved facilities in the Seafood Inspection Program was made in January 2006. The rating criteria and supporting documentation was finalized by May 2006. It was determined that again a series of meetings with industry and agency personnel would enhance the change. However, there were some differences in implementation. First, meetings were held with an agency personnel focus group. This led to valuable information regarding acceptance of the changes as it was determined agency personnel fully supported the new standard. This was much different than with the adoption of ISO 9001. Also, it was decided that those program participants located outside the United States would be required to implement the changes earlier than domestic firms. The standard is international in scope and many of the firms outside of the United States needed its implementation sooner rather than later.

The first plants outside of the United States have already been assessed to the standard and it was found that the additional procedures and documentation were highly minimal due to the current requirements of the Seafood Inspection Program. Therefore, a deadline has been established for overseas commencement of the new requirement of October 1, 2006 and domestic commencement on January 1, 2007. Again, the participants will be given assistance in process development and templates for all required forms and procedures will be provided to ease the burden. Full implementation will be required within 18 months of commencement. The early results indicate high support by agency personnel and industry for the standard. With little change in the firm’s system required, successful implementation is expected.

Steven Wilson is chief quality officer of the Seafood Inspection Program under the United States Department of Commerce. He can be reached at 301-713-2355 or



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