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.

FSIS Tells Ground Poultry Producers to Reassess Their Food Safety Plans

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) issued a press release on Wednesday, December 5, 2012, announcing that companies producing raw ground chicken and turkey and similar products will be required to reassess their sanitation procedures and pathogen control plans over the next few months. Specifically, over the next 90 days, producers of raw ground chicken and turkey must conduct a thorough examination of its current Hazard Analysis and Critical Control Points (HACCP) to confirm its ability to identify hazards and better prevent foodborne illness. After the 90 day period, FSIS inspection program personnel will begin verifying that establishments that manufacture raw ground turkey or chicken products have indeed reassessed their HACCP plans.

FSIS will be documenting whether establishments made any changes to their HACCP plans in response to the required reassessment and will later evaluate those changes. Later, the agency intends to publish guidance materials for the industry on best practices to reduce Salmonella in ground and comminuted (further processed by mechanical separation or deboning and chopped, flaked, minced or broken down) poultry.

In making this announcement, officials at FSIS are hoping to lower the prevalence of Salmonella contamination within these types of products. This attention to the ground poultry product industry with a focus on Salmonella comes as a response to recent outbreaks that have sickened hundreds across the country in the past few years. Just in the last two years there have been two major Salmonella outbreaks associated with ground poultry products that affected consumers nationwide.

In conducting these reassessments, FSIS is advising companies to look at, among other things, the following:

[E]stablishments should evaluate the adequacy of their sanitation procedures for processing equipment, including grinders, blenders, pipes, and other components and surfaces in contact with the product. Thus, Sanitation SOPs, other prerequisite programs, or HACCP plans should address procedures that ensure that all slaughter and further processing equipment, employee hands, tools, and clothing, and food contact surfaces are maintained in a sanitary manner to minimize the potential for cross contamination within and among lots of production. In addition, FSIS expects establishments to ensure that slaughter and dressing procedures are designed to prevent contamination to the maximum extent possible. Such procedures should, at a minimum, be designed to limit the exterior contamination of birds before exsanguination, as well as minimize digestive tract content spillage during dressing process.

Other FSIS recommendations include validating cooking instructions, examining lotting practices that minimize contact between lots, and requiring suppliers to show that they have used a Salmonella intervention step.

In FSIS’s notice, the agency also announced that it will be expanding the Salmonella verification sampling program to include other raw comminuted poultry products, in addition to ground product; it will be increasing the sample size for laboratory analysis from 25 grams to 325 grams to provide consistency as the Agency moves toward analyzing samples for Salmonella and Campylobacter; and it will be conducting sampling to determine the prevalence of Salmonella in raw comminuted poultry products.

Although these new procedures are intended for producers of ground or comminuted chicken and turkey products, FSIS is recommending that manufacturers of comminuted products derived from cattle, hogs, and sheep or comminuted poultry products derived from poultry other than chicken or turkeys also consider assessing whether their food safety systems present food safety vulnerabilities.

More on the FSMA and the "Tester Amendment"

Earlier this week, I presented a webinar to the American Cheese Society entitled the "Food Safety Modernization Act and Product Liability." A link to the presentation is here. The presentation covered a number of topics and included a discussion of the so-called "Tester Amendment" to FSMA.

The "Tester Amendment" in section 103 of FSMA "exempts" from the hazard analysis and risk-based preventative controls requirements in section 103 certain "Qualified Facilities." To be a "Qualified Facility" you have to either (1) be a "Very Small Business" or (2) have "Limited Annual Monetary Value of Sales."

FSMA leaves it to FDA to define by regulation a "Very Small Business," so we have little guidance now on what this means.

FSMA does define what it means to have "Limited Annual Monetary Value of Sales":

a. You have average annual sales (over three years) of less than $500,000 (adjusted for inflation); and
b. Your sales to "Qualified End Users" exceed sales to others.

"Qualified End Users" mean consumers or restaurants/retailers located in the same state or within 275 miles from your facility who are selling directly to consumers.

BUT even if you qualify for the exemption to the hazard analysis and risk-based preventative controls, understand that it is not truly an exemption. Even qualified facilities will still have to provide documentation to FDA that either:

a. demonstrates you have “identified potential hazards associated with the food being produced” and “implementing” and “monitoring” preventative controls; or

b. “as specified” by FDA shows compliance with “State, local, county, or other applicable non-Federal food safety law.

A "Qualified Facility" also must provide to FDA “Documentation, as specified by FDA in a guidance document that the facility is a qualified facility.”

Hazard analysis and risk-based preventative controls provision of section 103 of FSMA will become effective in June 2012 irregardless of whether FDA completes its rule-making process.

Beyond Statistics: What the FDA's RFR Report Means for Food Manufacturers

Last week, the FDA issued its first annual report on the Reportable Food Registry (RFR). The report provides statistics on the first year of the RFR (2240 entries, 229 "primary reports," a breakdown of the report by hazards, etc.).

Beyond the statistics, the FDA report should be noted by food companies for two reasons:

  1. Food Safety Plans

FDA Deputy Commissioner for Foods Michael Taylor says that “[s]everal key U.S. industries are already re-evaluating their hazard and preventive controls, core principles of the Food Safety Modernization Act recently passed by Congress. We also anticipate improved reporting as we continue our vigorous outreach to food facilities through federal, state, local and foreign agencies, to help us expand the positive effect of the RFR on the safety of the U.S. food supply.”

The new hazard analysis and preventative controls requirements in the Food Safety Modernization Act (FSMA) are not effective for 18 months following passage. Deputy Commissioner Taylor's comments suggest that industry standards may already be moving in that direction . To mitigate exposure and risk, FDA enforcement actions, product liability claims, supply chain contract claims and recalls, food manufacturers may want to consider updating and/or creating food safety plans that address the hazard analysis and preventative controls prescribed by the FSMA.

  1. Allergen Controls

The FDA reports undeclared allergens/intolerances accounted for 34.9 percent of the primary reports. Industry experts assert that the FDA believes that the industry does not in general have good control over the issue of undeclared allergens. These experts believe that the FDA will give special attention to the issue of undeclared allergens/intolerances in promulgating regulations under the FSMA's requirements for hazard analysis and preventative controls (see point 1 above). In anticipation of the FDA's concern, manufacturers should consider now how they can change manufacturing processes to address the undeclared allergen issue.