2019

STANDARDS OUTLOOK

What’s Cooking?

Food Safety Modernization Act is a
public health imperative

by Les Schnoll

according to recent data from the Centers for Disease Control and Prevention (CDC), every year about 48 million people get sick, 128,000 are hospitalized, and 3,000 die in the United States from foodborne diseases.

Hardly a day goes by when there isn’t a recall of food contaminated by a variety of microorganisms, oftentimes E. coli or salmonella. The foodborne illnesses caused by these contaminated products do not just result in stomachaches. They can cause chronic diseases, such as arthritis and kidney failure, or even death.

People who are immune-compromised (for example, infants and children, pregnant women, older individuals and those undergoing chemotherapy) are more susceptible, and the effects are more severe. These facts signify a tremendous public health burden that is largely preventable.

The U.S. Federal Drug Administration (FDA) Food Safety Modernization Act (FSMA or Public Law 111-353), an 89-page document, was signed into law by President Barack Obama in early 2011. It enables the FDA to better protect public health and safety by strengthening the food safety system. It allows the agency to focus more on preventing food safety problems rather than reacting to problems after they occur.

The law also provides the FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention and risk-based food safety standards and to better respond to and contain problems when they do occur.

The FSMA also gives the FDA important new tools to hold imported foods to the same standards as domestic foods and directs the FDA to build an integrated national food safety system in partnership with state and local authorities.

The law is another milestone in food safety—the latest step to supplement hazard analysis and critical control point programs that have been mandated for a variety of commodities.

Why it’s important

Why was the law needed? Can’t we just improve the quality of the food chain and be more careful? Unfortunately, there are three scenarios that make an easy fix unlikely and untenable:

  1. About 15% of the U.S. food supply is imported. This increasing globalization of the food chain requires that the United States take a stronger role in helping other countries manage their sanitation levels and the care with which those commodities are treated.
  2. The food supply is more complex and high tech than in the past. There is more food in the marketplace, and there are new hazards in foods that we have not previously seen.
  3. Demographics are shifting, and the population of individuals who are at risk from foodborne illnesses has increased by 30%, according to the CDC and World Health Organization.

What is so historic about the FSMA is that it involves creation of a new food safety system and implements a broad prevention mandate and accountability, plus a new system of import oversight. It emphasizes partnerships and farm-to-table responsibility and was developed through a broad coalition.

Building this new food safety system based on prevention will take time, and the FDA is creating a process for accomplishing this. Congress has established specific implementation dates in its legislation. Some authorizations, such as the FDA’s new authority to order companies to recall food, will go into effect quickly. Others require the FDA to prepare and issue regulations and guidance documents.

The funding the agency gets each year, which affects staffing and vital operations, will also influence how quickly the FDA can put this legislation into effect. The FDA, however, is committed to implementing the requirements through an open, transparent process with opportunity for input from all stakeholders.

The FDA’s key new authorities and mandates through the FSMA are prevention, authority to prevent intentional contamination, mandatory produce safety standards, inspection and compliance, response, imports and enhanced partnerships.

Prevention

For the first time, FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply.

Mandatory preventive controls for food facilities. Food facilities are required to implement written preventive control plans.

This involves evaluating the hazards that could affect food safety, specifying what preventive steps—controls—will be put into place to significantly minimize or prevent the hazards, specifying how the facility will monitor these controls to ensure they are working, maintaining routine records of the monitoring and specifying what actions the facility will take to correct problems that arise.

The timetable for these provisions is that a final rule is due within 18 months of enactment.

Authority to prevent intentional contamination. The FDA must issue regulations to protect against the intentional adulteration of food, including the establishment of science-based mitigation strategies to prepare and protect the food supply chain at specific vulnerable points.

The final rule regarding intentional contamination is due within 18 months of enactment.

Mandatory produce safety standards. The FDA must establish science-based minimum standards for the safe production and harvesting of fruits and vegetables. Those standards must consider naturally occurring hazards and those that may be introduced either unintentionally or intentionally during processing.

They also must address materials added to the soil (such as compost), hygiene, packaging, temperature controls and animals in the growing area and water. This final rule is due within two years of enactment.

Inspection and compliance

The FSMA recognizes that preventive control standards improve food safety only to the extent that producers and processors comply with them. Therefore, the FDA must provide oversight, ensure compliance with requirements and respond effectively when problems emerge.

The FSMA provides the FDA with important new tools for inspection and compliance, including:

  • Mandated inspection frequency. The FSMA establishes a mandated inspection frequency based on risk and requires the frequency of inspection to increase immediately. All high-risk domestic facilities must be inspected within five years of enactment and no less than every three years thereafter. Within one year of enactment, the law directs the agency to inspect at least 600 foreign facilities and double those inspections every year for the next five years.
  • Records access. The FDA will have access to records, including industry food safety plans and those that firms will be required to keep to document implementation of their plans.
  • Testing by accredited laboratories. The FSMA requires certain food testing to be performed by accredited laboratories and directs the FDA to establish a program for laboratory accreditation to ensure that U.S. food testing laboratories meet quality standards.

This compliance and inspection program must be established within two years of enactment.

Response

The FSMA recognizes that the FDA must have the tools to respond effectively when problems emerge despite preventive controls. New authorities provided by the law include:

  • Mandatory recall. The FSMA provides the FDA with authority to issue mandatory recalls when companies fail to voluntarily recall unsafe food after being asked to do so by the FDA.
  • Expanded administrative detention. The FSMA provides the FDA with a more flexible standard for administratively detaining products that are potentially in violation of the law.
  • Suspension of registration. The FDA can suspend registration of a facility if it determines the food poses a reasonable probability of serious adverse health consequences or death. A facility that is under suspension is prohibited from distributing food. This provision is effective six months after enactment.
  • Enhanced product tracing abilities. The FDA is directed to establish a system that will enhance its ability to track and trace domestic and imported foods. In addition, the FDA is directed to establish pilot projects to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or control a foodborne illness outbreak. A pilot for this program must be implemented within nine months of enactment.
  • Additional recordkeeping for high-risk foods. The FDA is directed to issue proposed rulemaking to establish recordkeeping requirements for facilities that manufacture, process, pack or hold foods that are designated as high risk. Implementation is due within two years of enactment.
     

Imports

The FSMA gives the FDA unprecedented authority to better ensure that imported products meet U.S. standards and are safe for consumers. New authorities include:

  • Importer accountability. For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe. Implementation is due within one year of enactment.
  • Voluntary qualified importer program. The FDA must establish a voluntary program for importers that provides for expedited review and entry of foods from participating importers. Eligibility is limited to importers offering food from certified facilities. Implementation is due within 18 months of enactment.
  • Third-party certification. The FSMA establishes a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards. This certification may be used to facilitate the entry of imports. A system for FDA recognition of accreditation bodies is due within two years of enactment.
  • Certification for high-risk foods. The FDA has the authority to require that high-risk imported foods be accompanied by a credible third-party certification or other assurance of compliance as a condition of entry into the United States.
  • Authority to deny entry. The FDA can refuse entry of food from a foreign facility into the United States if the FDA is denied access by the facility or the country in which the facility is located.
     

Enhanced partnerships

The FSMA builds a formal system of collaboration with other government agencies, both domestic and foreign. In doing so, the statute explicitly recognizes that all food safety agencies must work together in an integrated way to achieve the desired public health goals. Examples of enhanced collaboration include:

  • State and local capacity building. The FDA must develop and implement strategies to leverage and enhance the food safety and defense capacities of state and local agencies. The FSMA provides the agency a new multiyear grant mechanism to facilitate investment in states’ capacity to more efficiently achieve national food safety goals.
  • Foreign capacity building. The law directs the FDA to develop a comprehensive plan to expand the capacity of foreign governments and their industries.
  • Reliance on inspections by other agencies. The FDA is explicitly authorized to rely on inspections of other federal, state and local agencies to meet its increased inspection mandate for domestic facilities. The FSMA also allows the FDA to enter into interagency agreements to leverage resources with respect to the inspection of seafood facilities, both domestic and foreign, as well as seafood imports.
     

Public confidence

Companies that produce, manufacture, import, distribute, store or market food are urged to evaluate the implications and benefits of the law for their business activities, regulatory compliance programs, and related legal and business risk management systems.

The FSMA requires strengthening of existing collaboration among all food safety agencies, whether federal, state, local or foreign. Among other provisions, the legislation directs the secretary of health and human services to improve training of state and local food safety officials and authorizes grants for training, conducting inspections, building capacity of labs and food safety programs, and other food safety activities.

Building and leveraging the capacity of these food safety partners is how we can have a well-integrated, national food safety system that is effective, efficient, and provides an increased level of comfort to the public.


Les Schnoll has more than 35 years of experience in industries regulated by the Food and Drug Administration. He is a senior member of ASQ and an ASQ-certified quality engineer, auditor and manager. A former member of the U.S. Technical Advisory Group to International Organization for Standardization technical committee 176, Schnoll wrote The Regulatory Compliance Almanac (Paton Press, 2001, 2008). He is currently the principal of Quality Docs LLC, providing quality and regulatory consulting services to the FDA-regulated industries. He also teaches several courses in the master’s degree programs in regulatory affairs at Arizona State University in Phoenix and Northeastern University in Boston.


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