Food Protection Connection: Food Safety Modernization Act

(reprinted from Dietary Manager, February 2011)

The biggest overhaul of the US food system in the past 70 years was just signed by President Obama—the Food and Drug Administration (FDA) Food Safety Modernization Act of 2010 (FSMA). This Act will give greater oversight and power to FDA when it comes to preventing foodborne illness. On the heels of the Centers for Disease Control and Prevention (CDC) announcement of new updated statistics for foodborne illness, the FDA now finds itself in the spotlight. CDC announced in mid December that the old foodborne illness statistics of 76 million ill, 325,000 hospitalized, and 5,000 deaths annually was being updated to 48 million, 128,000 and 3,000, respectively. Why? It is not necessarily because we are doing better at controlling causes of foodborne illness, but because we have more defined and accurate methods of statistical analysis and more documented statistics to use when making analysis. All reports warn not to compare the old statistics to the new more accurate statistics.

We can now say that the federal government has taken significant tangible steps towards truly attempting to reduce the likelihood of foodborne illness through preventative controls, inspection and compliance efficiencies, increased import safety, enhanced authority and improved partnerships with state, local, federal, and tribal food safety officials. However, the 234 page Food Safety Modernization Act comes with a huge price tag of $1.4 billion to fully fund the Act. The funding through the annual budget cycles and registration fees collected will impact how FDA will handle the significant and monstrous task of implementing this Act. Without the funding, FDA will be challenged in implementing this legislation without compromising crucial factors required by the Act. The Act does, however, make significant efforts not to burden small business and agricultural businesses through exemptions. These exceptions or guidelines will eventually be promulgated in Regulation, but don’t expect to see the full effects of the Act for months or years to come.

Margaret Hamburg, MD, the Commissioner of Food and Drugs, states “The idea of prevention is not new. FDA has established prevention-oriented standards and rules for seafood, juice, and eggs, as has the U.S. Department of Agriculture for meat and poultry, and many in the food industry have pioneered “best practices” for prevention. What’s new is the recognition that, for all the strengths of the American food system, a breakdown at any point on the farm-to-table spectrum can cause catastrophic harm to the health of consumers and great disruption and economic loss to the food industry.” She further comments the preventative measures need to be controlled by looking at the whole picture and make everyone from farm to fork, domestically and internationally, responsible for prevention. The intent of the Modernization Act is to address this prevention and control.

This Act will not directly affect retail food operations across the country in most instances. Its intent and focus is on the safety and preventative controls of imported foods, farms, and manufactured/processed food. It is the enhancement of governmental oversight of the nation’s food producer’s safety system not necessarily the retail food safety system, which is regulated by state, local, and tribal governments.

In general the Act will provide:

• Food recall power: Now voluntary, FDA will now have mandatory recall powers over all foods that might pose a significant health threat.
• Fees for re-inspections: FDA will have the right to establish re-inspection or recall fees.
• Updated performance standards: Significant food threats (contaminants and disease) will need to be reported by FDA every two years at minimum. FDA will also publish new science-based guidelines and regulations for food production facilities.
• Increased access to records: FDA will gain expanded access to food production records, upon request, for tracking purposes or if there is a potential significant health threat.
• Power to suspend: FDA may suspend a food production facility if a possible health risk is suspected. There will be a new registration process, every two years. Failure to comply may result in suspension.
• Risk and hazard prevention: Food facilities must, through a plan (HACCP), inform FDA of the risks/hazards in their operations, implement and monitor effective measures to prevent contamination, and have a plan in place to take any corrective actions that are necessary. Food companies will be held accountable for preventing ontamination. These requirements would not apply to farms, restaurants, other retail food establishments, nonprofit food establishments in which food is prepared for or served directly to the consumer, or fishing vessels.
• Produce safety standards: FDA will be able to, through science based studies, set standards for producing and harvesting fresh produce/raw agricultural commodities. There is an exemption in the Act for small food processors and small local farms that may be unable to reach standards intended for larger companies. These exemptions will be written in detail in Regulation.
• Regulations on food unfit for human consumption: In conjunction with Homeland Security, regulation would be issued to prevent food companies from knowingly using illegal additives, chemicals, or other substances in their food.
• Food allergy management: In conjunction with the Department of Education, FDA will develop food allergy management guidelines. Schools and early childhood programs that voluntarily comply with the guidelines could benefit from grant funding.
• Response and recovery: In conjunction with Homeland Security, FDA will develop specific rapid response and recovery guidance in the case of a foodborne illness outbreak. Additionally, grocery stores will be responsible for informing consumers of specific food recalls through consumer notifications.
• Inspection frequency: Risk based priority will be utilized to determine inspection frequency, however, high risk food production facilities will be inspected every three years and low risk every 7 years. FDA will also be required to report to Congress its frequency and cost of inspections.
• Tracking produce: The produce industry will assist FDA in creating a new method of tracking and tracing produce in a timely manner in case of any recalls.
• Imported food certifications: The Act will require importers to ensure imported foods are safe by obtaining letters of food safety guarantee and/or supplier verification for high-risk food imports. imports without this guarantee could be rejected from entry into the US; however, there are incentives. Importers that take additional food safety measures to assure the safety of the food could receive expedited review of their shipments into the country.
• Establish foreign offices: FDA must establish offices in at least five foreign countries that export food to the US to increase oversight.
• Foreign regulatory power: A country that is importing food to the US will be required to allow FDA to review its food safety practices.
• Foreign inspection frequency: FDA inspections of foreign food facilities must double each year for the next five years. The Act additionally authorized FDA to decline admission to imported food if the foreign facility or country refuses to allow an FDA inspection of its facility.
• Funds for staffing: Incremental funding will be provided to FDA to support staffing needs in order to implement the Act.
• Whistleblower protection: Any food production company employee will be protected when providing information regarding potential desecrations to the FSMA.
• Enhanced partnerships: To strengthen existing collaborations among food safety agencies at the Federal, state, local or territorial, tribal or foreign governments, the FDA is directed to improve training of such agencies by authorizing grants for training, conducting inspections, laboratory enhancements and building food safety programs and activities across the United States.

Exemptions

Although certainly all exemptions in the Act are not listed in the article, here are a few that stand out:

The FSMA specifically does not include food items regulated by the Department of Agriculture. Therefore, the Act does not address the safety of meat, poultry, or processed eggs.

FACILITIES are defined as businesses that store, hold, manufacture, or process food. Since the passage of the Bioterrorism Act of 2002, all facilities must register with the FDA. This is still the case in the FSMA. Farms and retail food establishments are exempt, but these were narrowly defined under the Bioterrorism Act.

The Act, through an amendment, clarifies that businesses that sell more than half of their products directly to individual consumers are exempt as retail food establishments even if they process the food at a different location than where the sale occurs, such as a farmers market or farm stand. Additionally, there are exemptions for small and very small facilities with regards to the requirement for HACCP plans.

FARMS: small-scale, direct-marketing farms are exempt from the provisions of some sections of the Act relating to the produce safety standards in which FDA would regulate growing and harvesting practices. exempt farms are those with sales of less than $500,000 (averaged over three years, and adjusted for inflation) and that sell more than half to qualifying end users. ‘Qualifying end users’ are individual consumers (with no limitation on location) or restaurants and retail establishments that are either in-state or within 275 miles of the facility (i.e. the farm in this case).

Concerns for Grocery Stores
In order to take a farm to fork approach, there are some requirements for grocery stores within the Act. The majority of obligations for a retail food (grocery) store will revolve around consumer notifications.

• The FSMA requires grocery stores to maintain records as to certain foods (produced on a farm and sold to a grocery store by the owner, operator, or agent in charge of the farm), documenting the farm that was the source of such food.
• The FDA will be required to prepare a report of critical information with respect to articles (except fruits and vegetables that are raw agricultural commodities) in a one-page standardized summary. This summary will be posted on the web site of the FDA, in a format to be easily printed by a grocery store for purposes of consumer notification.
• If a grocery store sold a “reportable food” that is the subject of the posting, and such store is part of a chain of establishments with 15 or more physical locations, then the store, not later than 24 hours after the summary was published, must prominently display each summary or the information from such summary for 14 days. The FDA will publish a list of acceptable locations and manners for the stores to choose from.
• It is important to note that knowing and willful failure to comply with the notification requirement set forth above will be a "prohibited act."

Many reviewers of the Act agree it would appear that the largest burden willl likely fall on mid-sized businesses. Large supersized industries (farms to processing plants) most likely already have many of these controls in place and will certainly have the resources available to comply with the Act. Many small and very small facilities have exemptions within the Act that will lessen their burden. It is the mid-sized businesses that will have to pay for the increased monitoring, recordkeeping, and inspection requirements included in the Act. Many mid-sized facilities will have a lot of work to do to become compliant with the FSMA. However, until FDA promulgates regulations under this Act, facilities will truly not know their cost and responsibilities.

What will the average consumer notice once this Act is fully implemented? Safer food, increased cost of food, more jobs, heightened awareness of food concerns, reduced foodborne illness? No one knows just yet. But, if consumers would realize improved peace of mind from knowing that our food supply is and will remain the safest in the world.

by Melissa Vaccaro, MS, CHO
Melissa Vaccaro, MS, CHO is a Food Program Specialist for the PA Department of Agriculture and an Executive Board Member for the Central Atlantic States Association of Food Drug Officials (CASA). Contact her at mvaccaro@state.pa.us.