Regulatory Corner

As this article was being written on July 30, the House of Representatives passed the Food Safety Enhancement Act (FSEA) of 2009 (H.R. 2749) which contains provisions with far-reaching consequences for the food industry in general, and the spice and seasoning industry specifically. A summary of the key components of the legislation is listed at the end of this article.

Wixon’s VP of Quality & Technical Services, Tim Sonntag, has been an active participant in meeting with legislative staff of key Senate and House members who sit on the respective committee’s in both Congressional houses that are responsible for establishing legislation that, under Executive Order from President Obama, improve the safety of America’s food supply in light of the number of significant food safety recalls and food poisoning outbreaks that have occurred over the last several years. Tim has made numerous visits to the lawmakers' Capitol Hill offices over the last two years as a member and current chairman of the American Spice Trade Association's (ASTA) Government Relations Committee, specifically to help educate the lawmakers on the impact some of the proposed regulations will have on the spice and seasoning industry specifically and the food industry in general.

ASTA’s work, along with the work of some other aligned trade associations, resulted in the approved House bill having a significant number of compromise measures that eliminated or limited some proposed requirements that would have been either impractical, over burdensome or would not impact the safety of the food supply. Some of these key concessions were in the areas of traceability, food company user fees, country of origin labeling, FDA authority to require a company to revise its preventative controls and the requirement to have all imports certified by the FDA.

With the Senate currently prioritizing health care over food safety legislation, it appears that the Senate version of the food safety bill sponsored by Sen. Durbin (D-IL), called the FDA Food Safety Modernization Act (FDA FSMA), will not be amended and acted on in the Senate until late 2009. Once the Senate proposes and passes their bill, a joint committee consisting of key members from both the House and Senate will be formed and they will be charged with putting together a compromise bill that will ultimately be sent to the President to sign.

With the House bill having already passed committee and close to being voted on by the House, Tim and several other representatives of ASTA, together with other members of the Food Safety Coalition of trade associations like the Grocery Manufacturers Association (GMA), the National Fisheries Institute (NFI) and the United Fresh Produce Association (UFPA), traveled to Washington on July 17 to meet with Senate Congressional staff to discuss the Senate bill, which the Food Safety Coalition prefers over the FSEA in the House. The goal of these meetings for the 18 food industry representatives from a wide variety of food companies throughout the supply chain was to meet with the legislative staff from 20 key congressional offices that are very involved in shaping the food safety legislation in the Senate and to educate them on the key components of the House bill (FSEA) that the Food Safety Coalition of trade associations opposes and why those provisions will not improve the safety of the American food supply. The group also met with two consumer groups and discussed why some of the specific requirements they have pushed in the FSEA will not improve food safety and, in fact, may negatively impact food safety like the provision that requires mandatory reporting of all positive pathogen test results to the FDA.

In addition to these meetings, one of the five groups of food industry representatives, including Tim Sonntag, attended a meeting at the White House executive office building with the Obama Administration's Chief Policy Analyst for the Office of Information and Regulatory Affairs (OIRA), among others, at the Office of Management and Budget (OMB) who is responsible for working on the legislation under the Administration's food safety executive order. The function of the OIRA is to review proposed legislation, perform a risk/benefit analysis on the impact of the legislation on federal agencies, businesses and consumers and to coordinate meetings with other federal offices, committees, agencies, associations or groups in order to not only build meaningful legislation that meets the intent of the executive order but also meets the budgetary requirements without being overly burdensome on either the food regulatory agencies or the food industry, while at the same time affording consumers a safe and wholesome food supply. In effect, the OIRA and OMB are responsible to make sure that legislation that is passed under an executive order is relevant. The executive staff were very interested in our position against the mandatory reporting of all positive pathogen test results to the FDA and seemed to understand the arguments that providing positive results out of the context of the organization’s food safety plan, it's plant and equipment layout, and the corrective actions taken by the company would result in valuable FDA resources being spent on tasks that would not improve food safety. Additionally, they were equally disturbed that this requirement may in fact prevent many smaller food companies with limited resources from implementing true corrective action-based food safety systems for fear of having to report any positive results to the FDA. The staff at OIRA seemed to understand that a clearly defined, risk-based food safety program is how food safety in the U.S. will improve and not by having legislation that mandates positive test results being supplied to the regulatory agencies. In addition, they asked about other provisions in some of the proposed legislation that would have little impact on food safety from our perspective, so we briefly discussed traceability, country of origin labeling and mandates requiring annual inspection of international vendors by food companies as other examples of items being legislated with little foresight into either the feasibility of the mandate or the effect it would have on improving the safety of the U.S. food supply. At the conclusion of this meeting, the topic of future meetings between the groups were discussed to more clearly help the OIRA and OMB understand the implications of other requirements on the food industry in both pieces of food safety legislation. This is certainly something that the Food Safety Coalition will take part in because as the Chief Policy Analyst mentioned “the offices of OIRA specifically, and OMB in general, are 'obscure, but powerful' offices that play a major part in the formulating of the final legislation that is being proposed in response to the President’s Executive Order." As part of the Food Safety Coalition, ASTA as a group representing and the entire spice and seasoning industry will continue to attend these meetings and be represented by Tim Sonntag as ASTA’s Government Relations Committee Chair because the food industry needs to continue to meet with these officials as they clearly play an important role in the legislative and regulatory process and they are responsible for making the content of the final bill to be signed by President Obama relevant.

Summary of the Food Safety Enhancement Act of 2009

Amends the Federal Food, Drug, and Cosmetic Act to set forth provisions governing food safety. Requires each food facility to:
(1) conduct a hazard analysis;
(2) implement preventative controls; and
(3) implement a food safety plan.

Requires the Secretary of Health and Human Services to:
(1) issue science-based performance standards to minimize the hazards from foodborne contaminants;
(2) establish science-based standards for raw agricultural commodities;
(3) inspect facilities at a frequency determined pursuant to a risk-based schedule;
(4) establish a food tracing system;
(5) assess fees relating to food facility reinspection and food recall; and
(6) establish a program for accreditation of labs that perform analytical testing of food for import or export.

Authorizes the Secretary to:
(1) order an immediate cessation of distribution, or a recall, of food;
(2) establish an importer verification program; and
(3) quarantine food in any geographic area within the United States.

Defines the term "color additive" to include carbon monoxide that may affect the color of fresh meat, poultry products, or seafood. Requires country of origin labeling on food and annual registration of importers. Provides for unique identifiers for food facilities and food importers. Deems a food to be adulterated if an inspection is delayed or refused. Requires the Secretary to establish a corps of inspectors dedicated to inspections of foreign food facilities. Sets forth provisions governing the reorganization of Food and Drug Administration (FDA) field laboratories and district offices. Gives the Commissioner of Food and Drugs subpoena authority with respect to a food proceeding. Establishes whistleblower protections.

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