News

September 2017 Update

Animal Foods: Meet the Preventive Control Regulation, but not FDA Investigators

The Food Safety Modernization Act’s (FSMA’s) staggered implementation continues with two new compliance events for the animal food industry starting yesterday, September 18, 2017.

  • “Large” Facilities (500 or more employees) must comply with the Hazard Analysis and Risk-based Preventive Control Rule (referred to as PCR or HARPC). This regulation requires a facility to conduct a hazard analysis and implement appropriate controls for the significant hazards.
  • Small Facilities (fewer than 500 employees) must comply with the Current Good Manufacturing Practices (cGMPs) requirements. This regulation establishes baseline standards for the sanitary manufacturing of animal food – large facilities had to comply with this requirement starting last year.

While the compliance date is September 2017, FDA indicated that they will not start inspecting animal food facilities for compliance with the Preventive Control Rule until fall of 2018 – a year later. Relatedly, that is also when FDA will first start inspecting affected animal food importers for compliance with the Foreign Supplier Verification Program (FSVP) too.

While this gap may be confusing, we believe practical reasons can explain this gap between the compliance date and the inspection dates. Until FSMA, non-medicated animal foods along with cosmetics were the only two primary FDA commodities not subject to a cGMP requirement. By way of context, FDA’s human food cGMPs are over 30 years old with industry and FDA well trained on the requirements. On top of this rich history, FSMA added the Preventive Control Rule, whose root concepts have been explored by FDA in various forms since the mid-1990s. During that time the food industry has become quite familiar with the concepts and conducted independent research into various issues.

Animal foods, on the other hand, over a few short years needed to develop both cGMPs and PCRs regulations (which admittedly mirrors human food regulations closely) and determine how they apply in an animal food context. While FDA refers more heavily to the industry’s desire for more clarity, it is “new terrority for all of us [including FDA].” CVM and their inspectors (the smallest group in FDA) need to additionally train their staff on these issues. This all takes time.

Manufacturers should not take this year-long interlude to do nothing. Rather they need to implement PCR now and be prepared whenever the FDA inspection comes. A firm’s understanding and implementation of the requirement is essential for creating a positive first impression that will set the tone with FDA from then well into the future.

Our staff at FDAImports.com and the attorneys at Benjamin L. England & Associates are here to help you navigate through the maze of PCR implementation and prepare you for the inspections to come. Contact us today! 

July 2017 Update

FDA Implementing FSMA: Program Realignment Building a Firm Foundation

 

 

 

 

 

 

FDA is full-speed ahead with rolling out the Food Safety Modernization Act (commonly referred to as “FSMA”).  With FSMA, FDA seeks to overhaul the U.S. regime for food safety – from a regime that reacted to safety outbreaks to one that seeks to preventive them. A key pillar in this preventive model is the Hazard Analysis and Risk-based Preventive Controls Rule (HARPC or PCR). This rule requires food facilities to develop and implement Food Safety Plans that control for food safety hazards. FDA staggered the compliance dates for this regulation; however, the “large” companies had to start complying almost a year ago (August 2016).

Since the first compliance date for HARPC, FDA has been silent about any enforcement activities.

This is not surprising – notably the first Warning Letter for Dietary Supplement cGMPs did not occur until almost two years after the first compliance date. “However, FDA’s silence should not be interpreted as non-action by the Agency,” cautions John F. Johnson, attorney with Benjamin L. England & Associates, sister firm of FDAImports.com.

FDA’s Program Realignment

Rather FDA has been hard at work implementing Program Realignment, which took effect in May 2017. FDA’s Program Realignment is larger than FSMA and concerns reorganizing FDA’s field operations (frontline inspection and enforcement staff) from generalists who handle all FDA commodities into specialist groups that handle just one commodity (such as just foods). This allows the FDA staff to become more familiar with the unique aspects of the commodity.

Mr. Johnson explains, “This specialist expertise is essential for implementing FSMA”. First, HARPC requires the industry to conduct hazard analyses and then implement appropriate controls for those hazards. FDA must have the knowledge and expertise to analyze and critique a facility’s decisions. Second, FDA intends to enforce FSMA through more real-time compliance decisions – as compared to conducting an inspection and not raising issues until weeks or months later. Under the new FSMA approach, FDA desires to make certain compliance decisions during the inspection and/or issue a “deficiency letter” within days of the inspection.

Thus to accomplish FDA’s goals for FSMA compliance and enforcement, FDA needs a highly trained front-line staff that specializes in the food regulations, policies, and science. FDA’s Program Realignment provides a firm foundation for FDA to build this new inspection and compliance corps for enforcing FSMA.

Learn more about the Preventive Control Rule:

On Wednesday July 26th attorney John F. Johnson of FDAImports.com, LLC and industry veteran Holly Mockus of Alchemy Academy will be hosting a FREE Webinar titled “FDA’s Preventive Controls Rule: Common Misconceptions Revealed.” The webinar will follow their expertise on how companies can fully comply with the changes made under FSMA in the past year.

For more insight into how these policies will and have already impacted your company and information about things to come REGISTER TODAY!

May 2016 Update

Hazard Analysis and Risk-Based Preventive Controls is an important provision within the U.S. Food Safety Modernization Act. U.S. Food and Drug Administration released the final regulation for Hazards Analysis and Risk-Based Preventive Controls. In this video FDAImports.com Founder and CEO, Benjamin England, discusses some key aspects of the regulation and what impact they could have for industry. HARPC.com is a project of Maryland based consulting firm, FDAImports.com.

January 2013 Update

Hazard Analysis and Risk-Based Preventive Controls is an important provision within the U.S. Food Safety Modernization Act. On January 4th, 2013 the U.S. Food and Drug Administration released the Proposed Regulations for HARPC with final regulations coming in May. In this video FDAImports.com Founder and CEO, Benjamin England, discusses some key aspects of the Proposed Regulations and what impact they could have for industry. HARPC.com is a project of Maryland based consulting firm, FDAImports.com.

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