Register Today for FDA's Public Meetings on Two Major FSMA Proposed Rules

Earlier this year, the Food and Drug Administration (FDA) made some progress toward implementing the Food Safety Modernization Act (FSMA) by issuing two new proposed food safety rules. Specifically, the agency published proposed rules to establish standards for (1) growing, harvesting, packing, and holding of produce for human consumption (the “Produce Safety Rule”) and for (2) current good manufacturing practice and hazard analysis and risk-based preventive controls for human food (the “Preventive Controls for Human Food Rule”).

These two proposed rules are just the first step for establishing the framework for the modern food safety system called for by FSMA. Eventually, the FDA intends to release additional proposed rules addressing importer foreign supplier verification, preventive controls for animal food, and accreditation of third party auditors. A helpful overview of the proposed Produce Safety Rule and the Preventive Controls for Human Food Rule can be found here.

The FDA is currently in the process of soliciting comments on the proposed rules from industry stakeholders. The public may offer comments to the proposed rules over the course of the next several weeks. To facilitate that process FDA is planning to host two additional public meetings in Chicago, IL and Portland, OR in March. These meetings are the second and third in a series of public meetings announced in the January 31, 2013 Federal Register Notice and on FDA’s FSMA website. The first public meeting will be held February 28-March 1, 2013, at the U.S. Department of Agriculture in Washington, DC.

Stakeholders will be permitted to submit oral comments during the public meetings. In addition, the meetings aim to inform the public about the FDA rulemaking process (including how to submit comments, data and other information to the rulemaking dockets), and respond to questions about the proposed rules. 

In Chicago, the forum will be held on March 11-12, 2013 at The Westin on Michigan Avenue. The meeting in Portland will take place on March 27-28, 2013 at Crown Plaza Portland Downtown Convention Center. To register for either event visit FDA’s registration page: http://ppleventreg.com/FDA-FoodSafety-IL-OR/.

FDA Releases Two New Proposed Food Safety Rules

On January 4, 2013, exactly two years after the Food Safety Modernization Act (FSMA) was signed into law by President Obama, the Food and Drug Administration (FDA) published two new proposed food safety rules that will be available for public comment for the next 120 days.

The first rule on “Preventive Controls for Human Food” sets safety requirements for facilities that process, package or store food to be sold in the United States, whether produced at a foreign or domestic-based facility, for human consumption. A separate rule will be issued for animal food in the near future. The rule will require that food facilities implement “preventive controls,” a science-based set of measures intended to prevent foodborne illness similar to Hazard Analysis and Critical Control Points (HACCP) systems that are already required by FDA for juice and seafood processors. Each covered facility would be tasked with preparing and implementing a written food safety plan, which would include the following:

  • Hazard analysis;
  • Risk based preventive controls;
  • Monitoring procedures;
  • Corrective actions; verification; and
  • Recordkeeping. 

The FDA is also seeking public comment on a second proposed rule, which proposes enforceable safety standards for the production and harvesting of produce on farms.

This proposed “Standards for Produce Safety” rule proposes science- and risk-based standards that would address the major areas of concern for the fruit and vegetable industry including:

  • Irrigation and other agricultural water;
  • Farm worker hygiene;
  • Manure and other additions to the soil;
  • Intrusion of animals in the growing fields;
  • Sanitation conditions affecting buildings, equipment and tools.

FDA indicated that the effective date of both proposed rules would be 60 days after the final rule is published. However, in order to allow all businesses, particularly small and very small facilities, adequate time to comply with the new requirements of the rule, FDA plans to adjust the compliance dates based on the facility’s size.

Although many in the food industry believe these rules are long overdue, FDA notes that it conducted extensive outreach to the produce industry, the consumer community, other government agencies and the international community. Since January 2011, FDA staff have toured farms and facilities of all sizes nationwide and participated in hundreds of meetings and presentations with global regulatory partners, industry stakeholders, consumer groups, farmers, state and local officials, and the research community. The goal was to develop proposed rules that could be applied to small and large food facilities alike.

FDA intends to release additional proposed rules addressing importer foreign supplier verification, preventive controls for animal food, and accreditation of third party auditors.

The attorneys at Stoel Rives will be providing more details about the proposed rules implementing FSMA here at the Food Liability Law Blog in the coming weeks. Stay tuned.

Acrylamide Unlikely To Cause Health Effects According To IFIC

The International Food Information Council’s expert panel, organized for the January 26, 2012 press webinar, found that acrylamide cannot be shown to pose any health risks.   Acrylamide, which is also listed as a Prop 65 chemical was thought to be a carcinogen based on tests performed on rats at high doses.  A study that included approximately 40 human epidemiological studies reviewed levels in food and none of which conclusively associated acrylamide with any increased heath risks.

Most notably, acrylamide is produced by browning or burning foods.  It is also thought to be in coffee and many baked goods. Plant-based foods that are rich in carbohydrates may form acrylamide when baked, fried or roasted –French fries, potato chips, other fried and baked snack foods, coffee, roasted grain-based coffee substitutes, roasted asparagus, canned sweet potatoes and pumpkin, canned black olives, roasted nuts, prune juice, breakfast cereals, crackers, cookies, breads, and toast all may contain varying amounts of acrylamide.  Foods that have been boiled or steamed do not contain acrylamide.

Next Generation Sequencing for the Food Industry

More and more, it is becoming true that nothing drives detection and prevention of food-borne illness than technology (and, of course, with advancements in detection come potential increases in exposure to legal liability). No technological advancement may be more significant than Next Generation Sequencing ("Next Gen Sequencing").  

I've recently had the opportunity to spend time learning about Next Gen Sequencing with Dr. Andrew Benson, a genetic microbiologist at the University of Nebraska’s Department of Food Science and Technology. Dr. Benson has received large research grants to harness the power of Next Gen sequencing. If you’re interested in the field, take a look at this short video, where Dr. Benson explains the technology, and check out the information on the CAGE (Core for Applied Genomics and Ecology) website.

As described on the CAGE website, this Next Gen technology “allows a single machine to accomplish in 48 hours what used to take an entire room full of machines and an army of
staff a month to achieve.”

Dr. Benson and others at CAGE explain further that:

Having such a powerful diagnostic technique now challenges us to rethink completely how we might go about risk assessment. Instead of looking for a single “indicator organism” in a food sample, we can now look at the entire population of microorganisms in a food sample and ask if the community of organisms present is the expected species that normally occupy that food or if the sample contains numbers of unexpected species, and in particular those species that are unique to fecal or soil environments. Thus, our assessment of “risk” is now based on the entire population, including the most abundant species of fecal and soil communities. Because our assessment is based on the entire composition, multiple species that are unique to feces or soil can be used in the determination, making the assessment much more accurate and robust. Moreover, the assessment is not limited to “risk” as we can also determine if the microbial community in a food sample has shifted toward spoilage (which gives us shelf-life predictions) or is consistent with “good” organoleptic properties of the food. The list of applications goes on and on.

Discoveries using this technology are happening at astonishing speed. PFGE testing, now considered the "gold standard" and generic E.coli testing may soon seem old fashioned and crude.