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eFOODLab_International_03_2014

3/14 eFOOD-Lab international 19 • Utilize the HACCP-like concepts of monitoring, corrective actions, verification and validation controls for all critical control points and preventive control measures. It is important to point out here, that all the items in the last bullet above will require that the food processing plant have these programs and their preventive controls identified in writing and once US FDA finalizes this regulation, they will have access to both the written programs and the plant records supporting these programs. Of particular interest to non-US based food processors shipping into the US marketplace or intending to do so, are the finalization of the Foreign Supplier Verification Program (FSVP) and the Third Party Certification Program (TPCP). These together establish methods for non-US food processing plants to demonstrate to their importer in the US that they comply with all parts of FSMA and its seven (7) regulations. Another way to look at it, is all food plants marketing food to the US consumer must demonstrate FSMA compliance or they will not be allowed to ship food or food ingredients into the US market (Note: In most cases, unprocessed agricultural products are not covered under FSMA, except for produce). Just as many of us were starting to understand what the seven (7) proposed regulations might require if finalized according to the dead- Current GMPs & Preventive Controls for Human Food Comment Period Closure 12/15/14 Final Publication By 8/30/15 Main Points (HA – Hazard Analysis; PC – Preventive Controls) 1. Farms exempt from HA & PC development even if they pack & dry RAC for others. 2. Change criteria for HA & PC from “reasonably likely to occur” to “significant hazard” based on severity & probability (see Table 6 for examples-p70). 3. Written procedure for finished product testing. 4. Written procedures for environmental monitoring. 5. Written procedures for supplier control program 6. Include intentionally introduced economic hazards in HA Current GMPs & Preventive Controls for Animal Food Comment Period Closure 12/15/14 Final Publication By 8/30/15 1. Human food processors already complying with human food requirements & cGMPs would not have to implement additional PCs or GMPs related to supplying animal foods as a byproduct (part 507 including HA & PC not required). 2. Change criteria for HA & PC from “reasonably likely to occur” to “significant hazard” based on severity & probability (see Table 6 for examples-p70). 3. Written procedure for finished product testing. 4. Written procedures for environmental monitoring. 5. Written procedures for supplier control program 6. Include intentionally introduced economic hazards in HA Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Comment Period Closure 12/15/14 Final Publication By 10/31/15 1. Delete requirements for compliance status review. 2. Change criteria for HA & PC from “reasonably likely to occur” to “reasonably foreseeable hazards” to identify “significant hazard” based on a person knowledgeable about the safe manufacturing, processing, packing and holding of food. 3. Consider intentionally introduced economic hazards 4. Importer required to consider the following in accepting suppliers & appropriate verification activities. a. Entity applying hazard controls b. Foreign supplier’s procedures, processes & practices related to the safety of the food. c. Foreign suppliers history of compliance with FDA’s applicable regulations & whether they are under any type of FDA regulatory action. 5. Importer can utilize only foreign suppliers they have approved based on written supplier verification program. 6. Importer’s FSVP needs to provide assurances that the foreign supplier produces food consistent with FSMA’s PCs. Assurances could include: a. On-site audits b. Sampling & testing of the food c. Review of foreign supplier’s food safety records 7. SAHCODHA* hazards require imported to conduct audit of foreign supplier prior to import and annually thereafter 8. Farms not subject to Produce reg. must provide biennial written assurance of complying with the FD & C Act. 9. If importers in compliance with PC regulation, then they are deemed to be in compliance with FSVP *Serious Adverse Health Consequences or Death to Humans or Animals Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption(Produce Rule) Comment Period Closure 12/15/14 Final Publication By 10/31/15 1. Modifying exemption dollar amount ($25,00 on 3 yr average), as well as definitions for small & very small farms. 2. Modify definitions for “covered activity”, “harvesting”, “holding”, & “packing”. 3. Flexibility to achieve EPA micro requirements for water used to grow produce: a. Geometric mean not to exceed 126 cfu for Escherichia coli/100 ml b. Statistical threshold of samples 410 cfu of generic ecoli/100 ml Or by other measures including type of application and time of application. 4. More flexibility in accepting micro. die-off rates (0.5 logs) using time between last water application and storage or use of commercial washing 5. Farms can test own water supplies


eFOODLab_International_03_2014
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