FDA is considering a semi-quantitative risk model that would be data-driven and comprehensive, flexible enough to be adapted to a number of different hazards, and applicable to a wide variety of foods.
Hampton, Virginia (PRWEB) February 05, 2014
On February 4, 2014, the U.S. Food and Drug Administration (FDA) published a draft approach to identifying high-risk foods in accordance with section 204 of the U.S. Food Safety Modernization Act (FSMA).
In 2011, the U.S. Congress passed the FSMA with the purpose of changing the approach of FDA policies from that of "reactive" to "proactive." In the past, FDA spent much of its efforts mitigating the effects of food-borne crises. Under FSMA, FDA will ideally prevent food-borne crises from ever occurring. A critical component of this effort is the ability to trace products once contamination is discovered, so that consumers can be warned and affected products recalled. There is wide variance in the amount and quality of traceability information maintained by manufacturers and distributors of food products.
To improve the ability of FDA to respond to such outbreaks, Section 204 of FSMA requires FDA to publish a notice of proposed rule-making to establish record-keeping requirements for high risk foods to help in tracing products. The draft published is the first step made by FDA towards meeting this FSMA requirement.
The most recent action taken by the agency is related to this requirement. FDA has issued a Draft Approach for Designating High-Risk Foods [HRF] as required by Section 204 of FSMA, identifying the factors upon which FSMA requires the designation be based.
These criteria include:
- Known safety risks,
- History of outbreaks,
- Innate potential risk for microbiological or chemical contamination,
- Points in the manufacturing process at which contamination may occur and steps can be taken to control and/or reduce it,
- Likelihood of illness after consumption of a contaminated food, and severity of health and economic impacts related to the foodborne illness.
FDA is considering a semi-quantitative risk model that would be data-driven and comprehensive, flexible enough to be adapted to a number of different hazards, and applicable to a wide variety of foods. FDA intends to incorporate comments, additional data received from stakeholders, and additional external input for the risk model and the eventual list of HRF. Once the list of HRF is determined, it will be published in conjunction with a proposed rule for the additional recordkeeping requirements for such food products.
FDA is opening up a comment period, beginning February 4, 2014, to solicit input from stakeholders and industry regarding the methodology by which foods will be designated "high risk." [1 Comments must be submitted by April 7, 2014. You may submit comments on the Draft Approach for Designating High-Risk Foods as required by Section 204 of FSMA identified by Docket No. FDA-2014-N-0053, at http://www.regulations.gov/. Tweet Registrar Corp (@RegistrarCorp) if you have specific questions. Or, for any questions related to U.S. FDA Regulations, please contact Registrar Corp 24/7 at http://www.registrarcorp.com or call us at +1-757-224-0177.
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