The U.S. Food & Drug Administration (FDA) today has released for public comment a proposed rule on Preventive Controls for Human Food and a proposed rule on Standards for Produce Safety.  These rules are two of the proposed rules established by the 2011 FDA Food Safety Modernization Act.  FDA said that future proposed rules will address preventive controls for animal food and accreditation of third-party auditors.

Proposed Rule for Preventive Controls for Human Food

The proposed rule on preventive controls for human food would apply to facilities that manufacture, process, pack or hold human food. In general, with some exceptions, the new preventive control provisions would apply to facilities that are required to register with FDA under FDA’s current food facility registration regulations.

The rule proposes each covered facility to prepare and implement a written food safety plan, which would include the following:

  • hazard analysis;
  • risk-based preventive controls;
  • monitoring procedures;
  • corrective actions; verification; and
  • record keeping.

The proposed hazard analysis and risk-based preventive control requirements are similar to Hazard Analysis and Critical Control Points (HACCP) systems already in place in the meat and poultry industry.

For more information, click here.

Proposed Standards for Produce Safety

The proposed produce rule covers all fruits and vegetables except those rarely consumed raw, produced for personal consumption, or destined for commercial processing that will reduce microorganisms of public health concern. The proposed rule focuses on areas of risk, most noticeably:

  • agricultural water;
  • biological soil amendments;
  • health and hygiene;
  • equipment, tools and buildings; and
  • domesticated and wild animals.

FDA points out that pathogens can be introduced into fruit and vegetable production systems via animal feces. Where there is a reasonable probability that animals could contaminate produce, says the agency, the rule proposes farms be required to take reasonable measures to prevent pathogens from being introduced onto the produce and not harvest produce that is visibly contaminated with animal excreta.

For more information about the proposed standards for produce safety, including limitations on coverage, effective and compliance dates, click here.