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Les Schnoll

FDA Compliance

The Food Safety Modernization Act: A Public Health Imperative

Why the new legislation is necessary

Published: Tuesday, August 30, 2011 - 15:59

According to recent data from the Centers for Disease Control and Prevention, every year about 48 million people get sick, 128,000 are hospitalized, and 3,000 die from food-borne diseases. Hardly a day goes by where there isn’t another recall of food contaminated with a variety of microorganisms, primarily Salmonella species. The food-borne illnesses caused by these contaminated products do not just result in stomachaches; they can also cause chronic diseases such as arthritis and kidney failure. These data signify a tremendous public health burden, one that is largely preventable.

Just before Christmas of 2010, the U.S. House of Representatives and the Senate passed the Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), which President Obama signed into law on Jan. 4, 2011. The FSMA (Public Law 111-353), an 89-page document, enables the FDA to better protect public health and safety by strengthening the food safety system. It enables 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. In addition, the law 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 (HACCP) programs that have been mandated for a variety of commodities.

So why was the law needed? Can’t we just “tighten up” the food chain and be more careful? Unfortunately, there are several scenarios that make an easy fix unlikely and untenable. First, approximately 15 percent of the U.S. food supply is imported; this increasing globalization of the food chain requires that we take a stronger role in helping other countries manage their sanitation levels and the care with which those commodities are treated. Second, 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 had not previously seen. Finally, according to the World Health Organization, demographics are shifting, and the population of individuals who are a “risk” for food-borne illnesses (mostly older people and young children) has increased by 30 percent.

What is so historic about the FSMA? It involves creation of a new food safety system; implements a broad prevention mandate and accountability, as well as a new system of import oversight; it emphasizes partnerships and farm-to-table responsibility; and was developed through a broad coalition. However, 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 the legislation—some authorities will go into effect quickly (such as FDA’s new authority to order companies to recall food), and others require the FDA to prepare and issue regulations and guidance documents. The funding that the agency gets each year, which affects staffing and vital operations, will also affect how quickly the FDA can put this legislation into effect. The agency is committed to implementing the requirements through an open, transparent process with opportunity for input from all stakeholders.

Several of the FDA’s key new authorities and mandates through the FSMA are as follows (information provided by the FDA website).

Prevention

For the first time, the FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply. This mandate includes:
• Mandatory preventive controls for food facilities: Food facilities are required to implement written preventive controls plans. This involves evaluating the hazards that could affect food safety, specifying what preventive steps (i.e., controls) will be put in 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 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, as well as those that may be introduced either unintentionally or intentionally during processing, and must address soil amendments (materials added to the soil such as compost), hygiene, packaging, temperature controls, animals in the growing area, and water. The 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 the records that firms will be required to keep that 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 program must be established within two years of enactment.

Response

The FSMA recognizes that 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 that 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 both 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 food-borne 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 record-keeping requirements for facilities that manufacture, process, pack, or hold foods that are designated as high-risk foods. 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 need to 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 with a new, multiyear grant mechanism to facilitate investment in a state’s 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.

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About The Author

Les Schnoll’s picture

Les Schnoll

Les Schnoll has 35 years of experience in industries regulated by the Food and Drug Administration (FDA). He is a senior member of the American Society for Quality (ASQ) and an ASQ-certified quality engineer, auditor, and manager. Schnoll also holds a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS). As a member of the U.S. technical advisory group to ISO technical committee 176, Schnoll is the author of The Regulatory Compliance Almanac (Paton Press, 2001, 2008), and The CE Mark: Understanding the Medical Device Directives (Paton Press, 2007). He is currently the principal of Quality Docs LLC, providing quality and regulatory consulting services to the FDA-regulated industries. Schnoll is also an instructor in the regulatory affairs master’s degree programs at Arizona State University and Northeastern University.

Comments

Food Safety

This is a step in the right direction.  FDA regulates food and drugs but not meat.  Meat is regulated through USDA. 


The 15% occurrence of problems with imported foods is significant and clearly requests action to be taken to safeguard our citizens.  It is unfortunate that some producers and food handlers do not use best practices to process their products, either through lack of knowledge, economics, or priority.  By standardizing the necessary practices for food handling throughout the food chain, we are educating and insuring our food supply.  It's too bad we couldn't be more self regulating but this is the result. 

Factory farms

I find it interesting that they mention high risk foods, vegetables and fruits but there is no comment about the factory farming, salmonella is an animal food product related illness.  If fruits and vegetables are getting contaminated it is most likely thru contact with animal products.  We slaughter a ridiculous amount of land animals every year so I find it appalling that they seems to have more interest in going after the 600 foreign food facilities then focusing on the 6 major slaughter houses in the U.S.A.    The bill is great in theory but has poor follow thru and I believe this is an issue that cannot wait to be addressed.   I feel sorry for the inspectors that have a huge pile of work ahead of them, good luck brining the really issues that face the food industry to light.

Causes of food un-safety

You listed 2 main reasons for the problems with the food supply and the need for more government regulations: Global Supply and "High Tech" food.  Supporting and buying local food eliminates most of these problems.  That is why I am part of a Community Supported Agriculture.  A local farmer, who I know by name and have seen her farm grows, much of what I eat.  If I have a problem, I know where she lives, and she knows it.  She is very careful and provides only good, safe, freah food.  If she doesn't she will be out of business next year.  You can't say that for the factory farm!  There may have been local problems with unsanitary food in the years past, but it was very local and didn't involve millions of pounds distributed all over the country.  Local  is best!