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 tracing
system 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.
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.
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
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,
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
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.
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
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
to Conduct Food Safety Audits and to Issue Certifications’’ (78 FR 45782, July
Interested persons may submit either electronic comments regarding the
proposed rule to http:// www.regulations.gov.
Labels: California Ag News, FDA CHURNING OUT REGULATORY ANNOUNCEMENTS, Food Defense, Food Safety, High-Risk Foods Identification, Preventive Controls, Product Tracing