|Food Safety and Inspection
United States Department of Agriculture
Washington, D.C. 20250-3700
Key Facts: HACCP Final Rule
A number of comments received on the proposed Pathogen Reduction and HACCP Systems rule raised concerns about the impact of the rule on small businesses. Comments submitted by all parties, including small plants, on all aspects of the rule were carefully considered when putting together the rule in its final form. Several important changes, which the agency made to strengthen food safety and improve the rule's effectiveness, while minimizing its cost impacts generally, have also significantly reduced the final rule's economic impact on small business.
The changes still accomplish the rule's original objectives and strengthen the new food safety system. The changes bring more meat and poultry products under HACCP earlier than the proposed rule and minimize the impact on small business by reducing the rule's economic burden and giving small plants more time, training, and assistance. The net result is a final rule that maintains a comprehensive approach to a preventive control system that achieves a variety of objectives that will improve food safety.
The issues raised by smaller plants--the lack of sufficient time, training, and preparation to implement HACCP and the additional costs associated with daily testing, antimicrobial treatments, and cooling requirements--have all been addressed in the final rule.
In accordance with Small Business Administration guidelines, the definition of small business has been expanded to encompass establishments with 500 or fewer but 10 or more employees.
A new category for very small businesses has been added and is defined as an establishment with fewer than 10 employees or annual sales of less than $2.5 million.
Size and amount of sales, not process type, will determine the implementation date. Larger plants will come under HACCP sooner, while smaller plants will be given more time to implement and comply with the new regulation. Because large slaughter plants account for 75 percent of slaughter production, most of the Nation's meat and poultry supply will come under HACCP-based process control one year earlier than originally proposed.
Small plants will have 30 months to develop and implement HACCP plans and very small plants will have 42 months. At the same time, all plants must implement SOPs for sanitation and all slaughter plants, regardless of size, must institute E. coli microbial testing to verify process control for fecal contamination in 6 months.
All plants will have 180 days--rather than the originally proposed 90 days--to develop and implement sanitation standard operating procedures.
Microbial testing requirements have been revised to ensure their scientific integrity and validity, based on review of comments and input from scientific conferences and meetings held during the comment period. Microbial testing for slaughter process control will be based on generic E. coli rather than Salmonella. One side benefit is that E. coli testing is easier and much less expensive.
Extending the effective compliance dates for microbial testing requirements will lessen their economic and regulatory impact on smaller slaughter plants by allowing plants more time to prepare.
Testing for all plants will not be required daily, as was initially proposed, but will be based on production volume. Plants with very low production will only have to sample for a limited time each year.
The Agency agreed with comments urging that a volume-based procedure--rather than one based on type of product--would be a more effective approach and improve the role of E. coli testing, benefiting everyone and reducing the cost burden to smaller operations.
FSIS will conduct testing for Salmonella to ensure slaughter and ground product plants are meeting performance standards under HACCP.
Only one HACCP-trained person will be required for each plant.
Time and temperature controls and antimicrobial treatments are not required. The time and temperature (or cooling) requirements originally proposed for raw products need more scientific input and public comment. FSIS plans to broaden the consideration of cooling requirements to remedy problems in plants, during transportation, in storage and in retail establishments. This critical issue will be considered in an extended and expanded rulemaking. The agency also concluded separate requirements for antimicrobial treatments were unnecessary, since plants can use them when necessary to meet performance criteria and standards.
The HACCP demonstration projects requested by small and very small plants will be conducted during the two-year period following the rule's publication at sites nationwide to show how HACCP systems work for various products under operating conditions. Some of the demonstrations will address issues unique to very small establishments.
HACCP guidance materials to be made available to all plants include a Guidebook for the Preparation of HACCP Plans, a Hazards and Preventive Measures Guide, and 13 generic HACCP models addressing process categories in the regulation. These materials should be particularly helpful to small and very small businesses. Additional guidance materials addressing other parts of the final rule are also available.
FSIS will hold a 3-day HACCP implementation conference in Washington, D.C. about 60 days after the rule is published, as well as regional implementation conferences throughout the United States.
Consultation with small and very small business (and all other affected parties) will continue. Extensive preparatory meetings, material, sample HACCP protocols and plans, audio, video or computer training aids, guidelines, notices, pamphlets and training will be provided at least six months before any establishment must begin work on its hazard analysis and HACCP plan. Recommendations for any additional material, protocols, and training will be requested from all parties.
The annual estimated cost of implementing the final rule is about $76 to $89 million per year, or slightly more than 1/10 of a cent per pound of meat and poultry. This is significantly lower than the annual estimated cost of implementing the proposed rule, which was about $244.5 million per year, or slightly more than 2/10 of a cent per pound of meat and poultry.
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