Overview: FDA strengthens food safety foundation
“Preventing problems before they cause harm is not only common sense, it is the key to food safety in the 21st century,” says FDA Commissioner Margaret A.
Hamburg, M.D. “We cannot afford to wait until people become ill to realize there is a problem.”
Summary page: The New Food Safety Modernization Act
Key link: Get FSMA updates by email
PT.3.4 When will FDA begin developing recordkeeping requirements for high-risk foods, as directed by FSMA?
Once the product tracing pilots are completed, and other data are gathered, the Agency will begin the development of a proposed rule.
PT.3.5 Will FDA expand requirements for recordkeeping requirements to foods that are not designated as high risk?
No. FSMA specifies that additional recordkeeping requirements developed under section 204 must apply only to high risk foods. FDA will be seeking input from stakeholders in considering whether to develop voluntary guidance for foods beyond those designated as high risk to enhance product tracing in the supply chain.
PT.3.6 Will FDA recommend certain product tracing technologies either for the pilot or for future regulations and potential guidance?
FDA does not plan to recommend specific software or systems at any of these stages. Rather, FDA will focus on the elements of a product tracing system that enable rapid and effective tracing of food products. Under section 204, FDA is not permitted to prescribe specific technologies to maintain records in the context of the additional recordkeeping requirements for high-risk foods.
Summary: Produce Safety Standards
Produce Safety Standards: Entire proposed rule
Can you believe? 547 pages
Produce Safety Standards: Analysis of economic impact
Key takeaway: 388 pages!
Summary page: Preventive control standards
Along with the proposed rule, FDA is announcing the availability of, and requesting comment on, a draft qualitative risk assessment, Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm (PDF: 660KB), designed to provide a science-based risk analysis of those on-farm activity/food combinations that would be considered not reasonably likely to introduce hazards that are reasonably likely to cause serious adverse health consequences. Interested persons may submit written comments regarding the draft risk assessment by visiting http://www.regulations.gov.