Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Kari Miller
An effective strategy requires recruiting qualified personnel familiar with the process and technology
Dario Lirio
Modernization is critical to enhance patient experience and boost clinical trial productivity
Alexander Khomich
Healthcare software opens up opportunities for clinics in both management and patient care
Gary Shorter
Pharma needs to adapt and evolve with the changing environment of life science data
Etienne Nichols
Quality management system regulation explained

More Features

FDA Compliance News
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains
An invite from Alcon Laboratories
Intended to harmonize domestic and international requirements

More News

Tamar June

FDA Compliance

FDA Proposals Take a Fresh Look at Some Stale Food Issues

Comment on FDA's proposed amendments to the Food Safety Modernization Act

Published: Tuesday, October 7, 2014 - 10:18

The landmark Food Safety Modernization Act (FSMA) just keeps getting more and more important. Earlier this month, the Food and Drug Administration (FDA) unveiled four proposed amendments that will likely make a tough law even tougher.

The FSMA, signed into law in January 2011, is designed to tighten food safety regulations and shift the focus to a proactive mindset and away from FDA’s relatively reactive approach in years past. The FDA has now proposed seven rules to implement the FSMA. This new wave of proposed revisions target four areas: produce safety, preventive controls for human food, preventive controls for animal food, and the foreign supplier verification program.

The action follows FDA’s May 2014 announcement that it was engaging in the rule-making and guidance-development processes required to establish the new prevention-oriented standards. FDA implementation teams have developed a slew of ideas for how the agency can better oversee the food industry, strengthen the global food-safety system, and enhance protection of public health. Planning has also begun for the next phase of FSMA implementation, which involves advancing new public health-prevention standards and implementing the strategic and risk-based industry oversight framework at the heart of the FSMA.

In just part of what could go into effect next year, the FDA calls for revisions to the foreign-supplier verification proposed rule. It aims to give importers more flexibility to determine appropriate supplier verification measures based on risk and previous experience with their suppliers.

Arguably, one of the more important FDA proposals is a new call to develop current good manufacturing practices (cGMPs) more applicable to the animal food industry to provide flexibility for wider diversity in the types of animal food facilities and establish standards for producing safe animal food.

However, human-food processors already complying with FDA human-food safety requirements, such as brewers, would not need to implement additional preventive controls or cGMPs when supplying a byproduct (e.g., wet-spent grains, fruit or vegetable peels, liquid whey) for animal food, except for proposed cGMPs to prevent physical and chemical contamination when holding and distributing the byproduct (e.g., ensuring the byproduct isn’t co-mingled with garbage). That noted, further processing a byproduct for use as animal food (e.g., drying, heat treating, making pellets) would still require compliance with the preventive controls for animal-food rules.

FDA’s new amendments would also make exemptions a bit clearer and raise the requirements defining a “very small business.” To be considered “very small”, a firm must post less than $2.5 million in total annual sales of animal food, adjusted for inflation. FDA expects that exemption to apply to slightly more than 4,000 facilities.

The proposed rules also address some supplier issues. The FDA wants new controls addressing those occasions when the receiving facility’s hazard analysis identifies a significant hazard for a raw material or ingredient, and that hazard is controlled before the facility receives the raw material or ingredient from the supplier.

If these new FDA proposals become the law of the land, the facility would have flexibility to determine the appropriate verification activity (e.g., onsite audit, sampling and testing, review of supplier’s records) unless there is reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals.

Industry and any other interested parties have some time to weigh in on the FDA’s proposals. The FDA is accepting comments on the revisions of the four proposed amendments for 75 days, which started the week of Sept. 29, 2014, while continuing to review comments already received on the sections of the proposed rules that are going to change. The agency will consider all comments before issuing final rules sometime next year.

First published Sept. 24, 2014, on the AssurX blog.

Discuss

About The Author

Tamar June’s picture

Tamar June

Tamar June is vice president of strategic marketing and product manager for AssurX Inc., a provider of enterprise quality and compliance systems to a variety of industries including medical device, pharmaceutical, biotech, electronics, aerospace and contact manufacturing. She has spent the past 17 years in both manufacturing and information technology.