February 4, 2014

High-Risk Foods Identification, Food Safety, Product Tracing, Food Defense, Preventive Controls

Food and Drug Administration (FDA) must designate high-risk foods that require additional recordkeeping to enable rapid and effective track and trace, (product tracing), during a foodborne illness outbreak or other event.


Announced TODAY, FDA plans to:

1.    Publish a list of these high-risk foods (HRFs) and

2.    Issue a proposed rule under section 204(d)(1) of the FDA Food Safety Modernization Act (FSMA) to establish the recordkeeping requirements for the designated HRFs.


Designation of HRFs must be based on the historical public record of any outbreaks and cases of foodborne disease, as well as a number of vulnerable food- and processing-related factors associated with that HRF.


A product tracingsystem involves documenting the production and distribution chain of products so that in the case of an outbreak or evidence of contaminated food, a product can be traced back to a common source or its distribution channels.


When an outbreak of foodborne illness occurs or contaminated product is identified, product tracing systems enable government agencies and those who produce and sell food to remove a product from the marketplace and alert the public if a product has already been distributed.


Many producers, manufacturers and retailers have product tracing systems in place, but they vary depending on the amount of information the system records, how far forward or backwards in the supply chain the system tracks, technologies used to maintain records and the precision with which a system can pinpoint a product’s movement.


Food Defense is the effort to protect the food supply against intentional contamination due to sabotage, terrorism, counterfeiting, or other illegal, intentionally harmful means. Potential contaminants include biological, chemical and radiological hazards that are generally not found in foods or their production environment. Food defense differs from food safety, which is the effort to prevent unintentional contamination of food products by agents reasonably likely to occur in the food supply (e.g., E. coli, Salmonella, Listeria).


FSMA now requires FDA to issue regulations to protect against the intentional adulteration of food. For example, FDA is required to issue regulations specifying appropriate science-based mitigation strategies or measures to prepare and protect the food supply chain from intentional adulteration at specific vulnerable points, as appropriate.


In addition, FSMA requires FDA to issue regulations regarding food hazards, including those hazards that may be intentionally introduced, to establish standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of preventive controls.


Further, FSMA requires FDA to issue regulations to establish science-based minimum standards for the safe production and harvesting of raw fruits and vegetables to minimize the risk of serious adverse health consequences or death, including from hazards that may be intentionally introduced. This shift from the current system challenges the agency and its stakeholders to manage substantive information gathering, analyze available data and engage stakeholders to better understand the benefits and costs of such regulation.


Prior to FSMA, there were no requirements that food facilities implement mitigation strategies or measures to protect against intentional contamination. FDA has guidance, tools, and resources for industry on food defense. The guidance represents the agency’s current thinking on the measures that food establishments may take to minimize the risk that food under their control will be subject to intentional contamination. For more information on the guidance, tools, and resources available to industry, visit the FDA Food Defense page.


The FDA is extending the comment period for its ‘‘Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals’’ document (the proposed preventive controls rule for food for animals) to March 31, 2014.


You may submit Electronic comments to the Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments.


FDA is granting an extension of the comment period to March 31, 2014, for the proposed preventive controls rule. To satisfy requirements of the FDA Food Safety Modernization Act (FSMA), FDA drafted a document entitled, ‘Qualitative Risk Assessment of Risk of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm’’ to provide a science-based risk analysis of those activity/ animal food combinations that would be considered low risk.


FDA used the results of the draft to propose to exempt certain animal food facilities (i.e., those that are small or very small businesses that are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities identified as low-risk activity/animal food combinations) from the proposed requirements of the Federal Food, Drug, and Cosmetic Act for hazard analysis and risk-based preventive controls (the proposed preventive controls rule).


FDA is providing additional time to allow interested persons an opportunity to consider the interrelationship between this proposed rule and the proposed rules entitled ‘‘Foreign Supplier Verification Programs for Importers of Food for Humans and Animals’’ (78 FR 45729, July 29, 2013) and ‘‘Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications’’ (78 FR 45782, July 29, 2013).


Interested persons may submit either electronic comments regarding the proposed rule to http://www.regulations.gov.

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