The FDA Food Safety Modernization Act (FSMA)

The food safety law passed by Congress on December 21, 2010 aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. Key facts about this legislation are presented below.

Key Facts

The burden of foodborne illness is considerable. Every year, 1 out of 6 people in the United States—48 million people—suffers from foodborne illness, more than a hundred thousand are hospitalized, and thousands die.
Following are some of the important food safety enhancements included in the legislation.

Preventive controls

For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply.

• The legislation transforms FDA’s approach to food safety from a system that far too often responds to outbreaks rather than prevents them. It does so by requiring food facilities to evaluate the 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.
• It also requires FDA to establish science-based standards for the safe production and harvesting of fruits and vegetables to minimize the risk of serious illnesses or death.
• This new ability to hold food companies accountable for preventing contamination is a significant milestone in the efforts to modernize the food safety system.

Inspection and Compliance

The legislation recognizes that inspection is an important means of holding industry accountable for their responsibility to produce safe product. FDA will meet this expectation by:

• Applying its inspection resources in a risk-based manner.
• Innovating in its inspection approaches to be the most efficient and effective with existing resources.

Imported Food Safety

The legislation provides significant enhancements to FDA’s ability to achieve greater oversight of the millions of food products coming into the United States from other countries each year. An estimated 15 percent of the U.S. food supply is imported, including 60 percent of fresh fruits and vegetables and 80 percent of seafood.
More specifically, relative to import food safety, the legislation:

• requires importers to perform supplier verification activities to ensure imported food is safe;

• authorizes FDA to refuse admission to imported food if the foreign facility or country refuses to allow an FDA inspection;
• authorizes FDA to require certification, based on risk criteria, that the imported food is in compliance with food safety requirements;
• provides an incentive for importers to take additional food safety measures by directing FDA to establish a voluntary program through which imports may receive expedited review of their shipments if the importer has taken certain measures to assure the safety of the food.

Response

For the first time, FDA will have mandatory recall authority for all food products. While FDA expects that it will only need to invoke this authority infrequently since the food industry is largely compliant with FDA’s requests for voluntary recalls, this new authority is a critical improvement in FDA’s ability to protect the public health.

Enhanced Partnerships

The legislation recognizes the importance of strengthening existing collaboration among all food safety agencies—Federal, state, local, territorial, tribal, and foreign—to achieve our public health goals.

It also recognizes the importance of building the capacity of state, local, territorial and tribal food safety programs. Among other provisions, it directs the Secretary to improve training of state, local, territorial and tribal food safety officials and authorizes grants for training, conducting inspections, building capacity of labs and food safety programs, and other food safety activities.

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CDC Reports 1 in 6 Get Sick from Foodborne Illnesses Each Year

New estimates more precise

About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according new estimates from the Centers for Disease Control and Prevention (CDC). The figures are the most accurate to date due to better data and methods used. The data have been published in two articles in the journal Emerging Infectious Diseases.

The papers provide the most accurate picture yet of what foodborne pathogens are causing the most illness, as well as estimating the proportion of foodborne illness without a known cause. The reports are the first comprehensive estimates since 1999 and are CDC’s first to estimate illnesses caused solely by foods eaten in the United States.

“We’ve made progress in better understanding the burden of foodborne illness and unfortunately, far too many people continue to get sick from the food they eat,’ said CDC Director Thomas Frieden, MD, MPH “These estimates provide valuable information to help CDC and its partners set priorities and further reduce illnesses from food.”

CDC’s new estimates are lower than in the 1999 report. The difference is largely the result of improvements in the quality and quantity of the data used and new methods used to estimate foodborne-disease. For example, it is now known that most norovirus is not spread by the foodborne route, which has reduced the estimate of foodborne norovirus from 9.2 to approximately 5.5 million cases per year. Because of data and method improvements, the 1999 and current estimates cannot be compared to measure trends.

CDC’s FoodNet surveillance system data, which tracks trends among common foodborne pathogens, has documented a decrease of 20 percent in illnesses from key pathogens during the past 10 years. However, these FoodNet pathogens make up only a small proportion of the illnesses included in the new estimates.

Of the total estimate of 48 million illnesses annually, CDC estimates that 9.4 million illnesses are due to 31 known foodborne pathogens. The remaining 38 million illnesses result from unspecified agents, which include known agents without enough data to make specific estimates, agents not yet recognized as causing foodborne illness, and agents not yet discovered. In both the 1999 and current estimates, unspecified agents were responsible for roughly 80 percent of estimated illnesses.

“Foodborne illnesses and deaths are preventable, and as such, are unacceptable,” said FDA Commissioner Margaret A. Hamburg, MD “We must, and can, do better by intensifying our efforts to implement measures that are prevention-oriented and science-based. We are moving down this path as quickly as possible under current authorities but eagerly await passage of new food safety legislation that would provide us with new and long overdue tools to further modernize our food safety program.”

Among the additional findings for foodborne illness due to known pathogens:

• Salmonella was the leading cause of estimated hospitalizations and deaths, responsible for about 28 percent of deaths and 35 percent of hospitalizations due to known pathogens transmitted by food.
• About 90 percent of estimated illnesses, hospitalizations, and deaths were due to seven pathogens: Salmonella, norovirus, Campylobacter, Toxoplasma, E.col O157, Listeria and Clostridium perfringens.
• Nearly 60 percent of estimated illnesses, but a much smaller proportion of severe illness, was caused by norovirus.

“People expect food to nourish them, not to harm them. So we need to intensify efforts to decrease the number of illnesses and deaths due to foodborne diseases,” said Christopher Braden, MD, director of CDC’s Division of Foodborne, Waterborne, and Environmental Diseases. “We now know more than ever what pathogens are causing the most harm, and we will continue our work to help protect people from these illnesses. Much that remains unknown about how and why people get sick and we are committed to learning more in the future.”

CDC continues to encourage consumers to take an active role in preventing foodborne infection by following safe food-handling and preparation tips of separating meats and produce while preparing foods, cooking meat and poultry to the right temperatures, promptly chilling leftovers, and avoiding unpasteurized milk and cheese and raw oysters.

The full report is available online at www.cdc.gov/eid. For more detailed information on the estimates and methods, please visit www.cdc.gov/foodborneburden. To learn more about foodborne illness trends, visit the FoodNet site at www.cdc.gov/FoodNet/. To learn about how to prevent foodborne illness, visit www.foodsafety.gov.

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Questions and Answers on the Food Safety Modernization Act

How big a problem is foodborne illness in this country?

About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.

Why is this law needed?

Foodborne illness is largely preventable if everyone in today’s global food chain could be held responsible and accountable at each step for controlling hazards that can cause illness. Under the new law, FDA will now have new prevention-focused tools and a clear regulatory framework to help make substantial improvements in our approach to food safety. For example, for the first time, FDA has a legislative mandate to require comprehensive, preventive-based controls across the food supply chain. Preventive controls include steps that a food facility would take to prevent or significantly minimize the likelihood of problems occurring. The new law also significantly enhances FDA’s ability to achieve greater oversight of the millions of food products coming into the United States from other countries each year.

What are the major elements of the law?

The elements can be divided into five key areas:

• Preventive controls. For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply.

• Inspection and Compliance. The legislation recognizes that inspection is an important means of holding industry accountable for its responsibility to   produce safe food; thus, the law specifies how often FDA should inspect food producers. FDA is committed to applying its inspection resources in a risk-based manner and adopting innovative inspection approaches.

• Imported Food Safety. FDA has new tools to ensure that those imported foods meet U.S. standards and are safe for our consumers. For example, for the first time, importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety, and FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with U.S. food safety standards.

• Response. For the first time, FDA will have mandatory recall authority for all food products. FDA expects that it will only need to invoke this authority infrequently since the food industry largely honors our requests for voluntary recalls.

• Enhanced Partnerships. The legislation recognizes the importance of strengthening existing collaboration among all food safety agencies—U.S. federal, state, local, territorial, tribal and foreign—to achieve our public health goals. For example, it directs FDA to improve training of state, local, territorial and tribal food safety officials.

How long will it take before our food system is made safer?

A long-term process will be needed to build a new food safety system based on prevention. Congress has established specific implementation dates in the legislation. Some authorities will go into effect quickly, such as mandatory recall authority, and others require FDA to prepare and issue regulations and guidance documents. FDA is committed to implementing the requirements through an open process with opportunity for input from all stakeholders.

Does FDA have sufficient funding to implement the new rule?

The funding we have available through the annual budget cycle and fees impacts the number of FTEs we have and will be a factor in the way that FDA handles its significant and far-ranging activities, including the way that this legislation is implemented. For example, the inspection schedule in the legislation would increase the burden on FDA’s inspection functions. Without additional funding, FDA will be challenged in implementing the legislation fully without compromising other key functions. We look forward to working with Congress and our partners to ensure that FDA is funded sufficiently to achieve our food safety and food defense goals.

How will this law make imported food safer?

U.S. consumers enjoy the benefit of imported foods from more than 150 countries. The Food Safety Modernization Act (FSMA) gives FDA new tools to ensure that those imported foods meet U.S. standards and are safe for U.S. consumers. New authorities under the Act include:

• importer accountability—importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety;
• third party certification—FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with U.S. food safety standards;
• high risk foods—FDA now has the authority to require that high-risk imported foods be accompanied by a credible third-party certification as a condition of admission into this country;
• additional resources are directed toward foreign inspections;
• FDA now has the authority to refuse entry into the U.S. of a food that has refused U.S. inspection.

FDA expects to hold briefings on the new legislation for its colleagues in embassies in Washington, and to brief the World Trade Organization on the new legislation.

How does this Act change the way FDA regulates foods?

This new law puts prevention up front for FDA. For the first time, FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply. Under the Act, implementation of mandatory preventive controls for food facilities and compliance with mandatory produce safety standards will be required. FDA is in the process of developing a proposed rule that will establish science-based minimum standards for the safe production and harvesting of fruits and vegetables and will address soil amendments, worker health and hygiene, packaging, temperature controls, water, and other issues. Food facilities will be required to implement a written preventive control plan, provide for the monitoring of the performance of those controls, and specify the corrective actions the facility will take when necessary.

Provided by FDA U.S. Food and Drug Administration, www.fda.gov.