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Regulatory Reform: The FDA Announces Release of Two of the FSMA Proposed Rules

January 16, 2013


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The Food Safety Modernization Act (FSMA) is the most sweeping reform of the Food and Drug Administration’s (FDA) food safety authority in more than 70 years. This act gives FDA new and enhanced mandates and authorities to protect consumers and promote public health.

The FDA has published two of the proposed rules under FSMA, which are commonly referred to as “Preventive Controls for Human Food” and “Produce Safety Rule.

The FDA indicated that additional proposed rules for foreign supplier verification will be coming shortly, and future proposed rules for preventive controls for animal food and feed and accreditation of third-party auditors for imported food will be issued at a later date.

There will be a 120-day comment period after the rule is published in the Federal Register (currently scheduled for publication on January 16, 2013).

Both rules would be effective 60 days after the final rule is published. Compliance dates are listed under each proposed rule.

Proposed rule under FSMA for preventive controls for human food: Current good manufacturing practice and hazard analysis and risk-based preventive controls for human food

Summary

  • The proposed rule applies to facilities that manufacture, process, pack, or hold human food. In general, the proposed rule would apply to facilities that are required to register with the FDA under the current food registration regulations and applies to many domestic and foreign firms.
  • It requires covered facilities to have a written food safety plan, that which includes the following:
    • Hazard analysis (identify potential hazards)
    • Risk-based preventive controls (steps to address potential hazards)
    • Monitoring procedures (verify that the steps are working)
    • Corrective actions, verification, and outline how to correct any problems that arise
    • Record-keeping

The proposed hazard analysis and risk-based preventive control requirements are similar to Hazard Analysis and Critical Control Points systems.

Compliance dates for preventive controls for human food
Size of business FDA proposed definitions Time to comply
Very small business <$250,000 or
<$500,000 or
<$1,000,000
(total annual sales of food, adjusted for inflation)
3 years after publication of final rule
Small business <500 persons; does not qualify for other exemption 2 years after publication of final rule
Other businesses Not small or very small; does not qualify for other exemptions 1 year after publication of final rule

Proposed rule under FSMA for produce: Standards for the growing, harvesting, packing, and holding of produce for human consumption

The FDA acknowledges that produce is an essential component of a healthy diet. Its analysis indicates there were 131 outbreaks associated with contaminated produce between 1996 and 2010, causing more than 14,000 illnesses and 34 deaths.

Summary

  • The proposed rule will establish science-based standards for growing, harvesting, packing, and holding produce on domestic and foreign farms. The proposed rule covers most fruits and vegetables while they are in their raw or natural (unprocessed) state. It would not apply to raw agricultural commodities that are rarely consumed raw (e.g., potatoes) and those destined for commercial processing, such as canning (e.g., green beans).
  • The standards in the proposed rule are associated with:
    • Agricultural water. The rule proposes that all agricultural water be safe and of adequate sanitary quality for its intended use, and has achieved microbiological standards and testing requirements.
    • Biological soil amendments of animal origin. The rule proposes specific time intervals between the application of a biological soil amendment and crop harvest. It also has provisions pertaining to the handling and storage of biological soil amendments. It also requires verification of processes.
    • Health and hygiene. The rule proposes basic hygienic practices to prevent bacteria, viruses, and parasites that are frequently transmitted from person to person and from person to food.
    • Animals in growing area. The rule proposes that farms take reasonable measures to prevent pathogens from being introduced onto the produce and not harvest produce that is visibly contaminated.
    • Equipment, tools, and buildings. The rule also proposes standards for sanitation used for produce operations on farms and for certain equipment, tools, buildings, and sanitation.
  • Exemptions: As required by congress, farms would be partially exempt from the proposed rule if they meet the following two requirements:
    • Food sales averaging less than $500,000 per year during last three years (adjusted for inflation)
    • Sales to qualified end users (consumer, restaurant or retail food establishment located in the same state as the farm or not more than 275 miles away from the farm) must exceed their sales to others

The FDA may withdraw this exemption if the farm is directly linked to an outbreak or if the FDA determines it is necessary to protect public health.

  • Alternatives and variances: A farm may establish alternatives to certain requirements to water and biological soil amendments if the alternative is scientifically established to provide the same amount of protection as the requirement in the proposed rule. A state or foreign country can request a variance from some or all provisions of the proposed rule if they can demonstrate that the practices under the proposed variance will provide the same level of public health protection as the requirements of the proposed rule.
Compliance dates for product safety rule
Size of business FDA proposed definitions Time to comply
Very small business No more than $250,000 in annual sales during previous three years 4 years after effective date to comply; 6 years for some water requirements
Small business No more than $500,000 in annual sales during previous three years 3 years after effective date to comply; 5 years for some water requirements
Other businesses Not small or very small 2 years after effective date to comply; 4 years for some water requirements

You may also go to the following links to view the prepublication documents in the Federal Register:

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (2013-00125)
A Proposed Rule by the FDA to be published on January 16, 2013

Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (2013-00123)
A Proposed Rule by the FDA to be published on January 16, 2013

Other relevant references

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