This Week's Top Story

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This Week's Other Stories:

EDITORIAL COMMENT: The Idiotic, Dangerous War On Salt

OTHER NEWS: Flat Creek Lodge Moves From Raw Milk To Pasteurized Cheese, Upgrades Facility

OTHER NEWS: Full-Fat Dairy Associated With Lower Risk Of Developing Diabetes, Other Metablic Diseases

GUEST COLUMNIST:  
In Their Own Words:
La Clare Farm by John Umhoefer

COMPANY PROFILE:  
NYC’s Newest Cheese Cave Created In 1850s Underground Lagering Tunnels
Crown Finish Caves Partners With Parish Hill Creamery’s Peter Dixon For Aging Venture

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FDA Releases Updated Preventive Controls, Other FSMA Proposals

Agency Will Accept Comments For 75 Days Starting On Sept. 29; ‘Very Small Business’ Would Have Sales Under $1 Million

The US Food and Drug Administration (FDA) today proposed revisions to four major proposed rules required under the Food Safety Modernization Act (FSMA).

The four updated proposals released today include: preventive controls for human food; preventive controls for animal food; produce safety; and the Foreign Supplier Verification Program. FDA said it was issuing updated proposals based on extensive outreach and public comment.

FDA is accepting comments for 75 days after the publication date. The comment period starts September 29, 2014.

In the original proposed rule for Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food, released in January of 2013, FDA had proposed to amend the CGMP requirements to modernize them and to add requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for human food.

Key revisions to that preventive controls proposed rule include:
• Farms that pack or hold food from other farms are not subject to the preventive controls rule. Farms that conduct additional processing or manufacturing may be subject to the preventive controls rule for those activities.

• A “very small business” would be defined as firms having less than $1 million in total annual sales of human food, adjusted for inflation. Previously, three options were proposed: annual sales of $250,000, $500,000 and $1 million.

• The proposed revisions would establish procedures to guide FDA in withdrawing an exemption for a qualified facility for food safety reasons as specified in the proposed rule. FDA first may consider alternatives to protect public health and would provide advance notification to the facility and an opportunity for the facility to respond. FDA must provide an additional 60 days (for a total of 120 days) after the receipt of the order for a facility whose exemption is withdrawn to comply with the full requirements for hazard analysis and risk-based preventive controls.

• Product testing, environmental monitoring, supplier controls proposed. While these potential provisions were referenced in the preamble of the proposed rule, they were not included in the regulatory text. FDA is now providing an opportunity for input on specific language and seeking comment on whether to include it in the final rule.

FDA is seeking comment on whether the preventive controls for human food should require: a facility, as appropriate to the facility, the food, and the nature of the preventive control, to conduct product testing to verify implementation and effectiveness of preventive controls; and a facility, as appropriate to the facility, the food, and the nature of the preventive control, to conduct environmental monitoring to verify implementation and effectiveness of preventive controls if contami ...more