Food Safety and Modernization Act

Food Safety Modernization Act

Long title	It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.
Acronyms (colloquial)	FSMA
Citations
Public law	P.L. 111-353

The Food Safety Modernization Act of 2010 (H.R. 2751) was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. The Food Safety Modernization Act (FSMA) has given the Food and Drug Administration (FDA) new authorities to regulate the way foods are grown, harvested and processed. The law grants FDA a number of new powers, including mandatory recall authority, which the agency has sought for many years. The FSMA requires FDA to undertake more than a dozen rulemakings and issue at least 10 guidance documents, as well as a host of reports, plans, strategies, standards, notices, and other tasks.

The law was prompted after many reported incidents of food-borne illnesses during the 2000s (decade). Tainted food has cost the food industry billions of dollars in recalls, lost sales and legal expenses.

This bill is similar to the Food Safety Enhancement Act which passed the House in 2009. It is considered the first major piece of federal legislation addressing food safety since 1938.

President Obama signs FSMA into law.

Need for the Food Safety and Modernization Act

Due to lack of food regulations, food-borne illnesses are on the rise. About 48 million people (one in six Americans) get sick, 128,000 are hospitalized, and about 3,000 die each year from food borne diseases, according to recent data from the Center for Disease Control and Prevention. These food borne pathogens have been classified into 2 distinct types: known and unknown. As indicated by the CDC’s discovery, over 30 known pathogens are notorious for making people fall sick. The unknown food borne pathogens are unspecified agents existing in food but not yet proven to be the reason for sickness. However, this group of pathogens has been distinguished by the symptoms they cause in people such as gastric flu or acute gastroenteritis. This is a significant public health burden that can be largely preventable. Considering the fact that, about 30% of the population is at risk for food borne sicknesses, over 14% of food supply to the United States is imported from other countries, and also new and more food items are becoming more complex or intricate, the FSMA was indeed needed. The FDA Food Safety Modernization Act (FSMA), enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur.

Table 1. Estimated annual number of domestically acquired, food borne illnesses, hospitalizations, and deaths due to 31 pathogens and unspecified agents transmitted through food, United States

Food borne Agents	Estimated annual number of illnesses (90% credible interval)	%	Estimated annual number of hospitalizations (90% credible interval)	%	Estimated annual number of deaths (90% credible interval)	%
31 known pathogens	9.4 million (6.6–12.7 million)	20	55,961 (39,534–75,741)	44	1,351 (712–2,268)	44
Unspecified agents	38.4 million (19.8–61.2 million)	80	71,878 (9,924–157,340)	56	1,686 (369–3,338)	56
Total	47.8 million (28.7–71.1 million)	100	127,839 (62,529–215,562)	100	3,037 (1,492–4,983)	100

Over the past few years, high-profile outbreaks related to various foods, from spinach and peanut products to eggs, have underscored the need to make continuous improvements in food safety. Under this law The FDA will be allowed to mandate a system that is based on science and addresses the hazards from farm to table. This means that the FDA has the power to oversee how foods are produced and how they are maintained in food markets. This puts greater emphasis on preventing food-borne illness. The reasoning is simple: The better the system handles producing, processing, transporting, and preparing foods, the safer our food supply will be.

Under the new law, FDA will now have new prevention-focused tools and a clear regulatory framework to help make substantial improvements in their 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.

The Effects of the FSMA

The legislation affects every aspect of the U.S. food system, from farmers to manufacturers to importers. It places significant responsibilities on farmers and food processors to prevent contamination—a departure from the country's reactive tradition, which has relied on government inspectors to catch tainted food after the fact The legislation requires food producers and importers to pay an annual $500 registration fee, which would help fund stepped-up FDA inspections, enforcement and related activities such as food-safety research About 360,000 facilities in the United States and abroad would be subject to the fees. The Congressional Budget Office reported that the fees would not cover the cost of the new system, leaving the FDA to incur a net cost of $2.2 billion over five years.

Legislative history

The events of Sep 11, 2001 reinforced the need to enhance the security of the United States. Congress responded by passing the Public Health Security and Bioterrorism Preparedness Response Act, 'the Bioterrorism Act', which President Bush signed into law June 12, 2002. The Bioterrorism Act of 2002 granted the FDA administrative detention authority over food items if there is credible evidence or information that indicates the food presents a threat of serious adverse health consequences or death to humans or animals. The new (FSMA) law broadens that authority, allowing for administrative detention based on ‘reason to believe’ that the food item has been misbranded or adulterated’ and thus violates a legal standard for the product.

The first version of the law, the Food Safety Enhancement Act, passed the house on June 9, 2009. However, negotiations with the Senate led to the final product, the 'Food Safety and Modernization Act.' The bill was passed by the Senate in November 2010 by a vote of 73–25. However, because of a tax provision added to the bill, (which is constitutionally required to begin in the House), the vote did not count. There was concern that with the short time left in the lame-duck session, the bill would not get the time needed to be voted on and passed. Attempts to add the bill to the continuing resolution for government funding were scraped over the objection of Senator Tom Coburn. Eventually, however, the Senate moved on December 19, 2010 to pass the fixed bill by unanimous consent by a voice vote. The House went on to approve the bill by a vote of 215 to 144 on December 21, 2010. President Barack Obama signed the bill into law on Tuesday, January 4, 2011.

Components of the Law

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 a written preventive controls plan. This involves: (1) evaluating the hazards that could affect food safety, (2) specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards, (3) specifying how the facility will monitor these controls to ensure they are working, (4) maintaining routine records of the monitoring, and (5) specifying what actions the facility will take to correct problems that arise. (Final rule due 18 months following enactment)

• Mandatory produce safety standards

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, and must address soil amendments (materials added to the soil such as compost), hygiene, packaging, temperature controls, animals in the growing area and water. (Final regulation due about 2 years following enactment)

• Authority to prevent intentional contamination

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. (Final rule due 18 months following 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. FSMA provides FDA with new authority to conduct inspections and ensure compliance.

• Mandated inspection frequency

The FSMA establishes a mandated inspection frequency, based on risk, for food facilities 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 FDA to inspect at least 600 foreign facilities and double those inspections every year for the next five years. To accomplish this projected goal, the USFDA and other agencies in the United States will work in partnership or collaborate with foreign governing bodies for help, due to lack of resources to meet the demand.

• Records access

FDA will have access to records, including industry food safety plans and the records firms will be required to keep documenting implementation of their plans.

• Testing by accredited laboratories

The FSMA requires certain food testing to be carried out by accredited laboratories and directs FDA to establish a program for laboratory accreditation to ensure that U.S. food testing laboratories meet high- quality standards. (Establishment of accreditation program due 2 years after enactment)

Chart 1. The Number of Foreign Food Inspections Recorded each Month for the 2011 Fiscal Year

The 2011 fiscal year report on foreign food inspections by the FDA.

Response to contaminants/ violations

The bill gives the FDA the authority to recall food in the case of contamination or illness. In addition, it requires farms to track their food and implement plans to deal with recalls or outbreaks of disease. FDA officials will also be given access to food growers records in the case of an outbreak. The bill also requires food importers to verify that they meet US food safety standards. Small farms that sell locally or sell less than $500,000 a year are exempt from these new rules. New authorities include:

• Mandatory recall

The FSMA provides FDA with authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to by FDA.

• Expanded administrative detention

The FSMA provides FDA with a more flexible standard for administratively detaining products that are potentially in violation of the law (administrative detention is the procedure FDA uses to keep suspect food from being moved).

• Suspension of registration

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. (Effective 6 months after enactment)

• Enhanced product tracing abilities

FDA is directed to establish a system that will enhance its ability to track and trace both domestic and imported foods. In addition, 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. (Implementation of pilots due 9 months after enactment)

• Additional Record keeping for High Risk Foods

FDA is directed to issue proposed rule making to establish record keeping requirements for facilities that manufacture, process, pack, or hold foods that the Secretary designates as high-risk foods. (Implementation due 2 years after enactment).

Additional information on imported goods

The FSMA gives FDA authority to better ensure that imported products meet U.S. standards and are safe for U.S. consumers, with the vision that imported foods should be held to the same standards as domestic foods. These standards will be met by implementing the following components:

• 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. (Final regulation and guidance due 1 year following 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. (Establishment of a system for FDA to recognize accreditation bodies is due 2 years after enactment)

• Certification for high risk foods

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 U.S.

• Voluntary qualified importer program

FDA must establish a voluntary program for importers that provides for expedited review and entry of foods from participating importers. Eligibility is limited to, among other things, importers offering food from certified facilities. (Implementation due 18 months after enactment)

• Authority to deny entry

FDA can refuse entry into the U.S. of food from a foreign facility if 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 our public health goals. The following are examples of enhanced collaboration:

• State and local capacity building

FDA must develop and implement strategies to leverage and enhance the food safety and defense capacities of State and local agencies. The FSMA provides FDA with a new multi-year grant mechanism to facilitate investment in State capacity to more efficiently achieve national food safety goals.

• Foreign capacity building

The law directs FDA to develop a comprehensive plan to expand the capacity of foreign governments and their industries. One component of the plan is to address training of foreign governments and food producers on U.S. food safety requirements.

• Reliance on inspections by other agencies

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 FDA to enter into inter-agency agreements to leverage resources with respect to the inspection of seafood facilities, both domestic and foreign, as well as seafood imports.

Implementation

Now that the Act is in place, the FDA must begin the rulemaking process to codify how they intend to enforce the new laws.

One of the greatest challenges of the law will be the implementation of new requirements for FDA registered food facilities to conduct a hazard analysis and develop preventive control plans. Effective June 12, 2011, many food companies will be required to develop food safety plans based on an evaluation of hazards related to food manufactured, processed, packed or held in all registered facilities. Following a hazard analysis, firms must identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards. Examples of preventive controls include sanitation procedures for food contact surfaces; employee hygiene training; environmental monitoring to verify pathogen controls; a recall plan; supplier verification activities; and a food allergen control program.

Even after the rulemaking process is complete, it will likely be some time before the FDA is fully equipped to enforce the new laws. The agency estimates that it will need at least 1,000 more inspectors and $1.4 billion over the next five years, and it is certainly not a sure thing that Congress will appropriate such funds given the current economic climate and calls for spending cuts and smaller government.

FSMA Progress Report

Now, the FDA has planned to make available to the general public and to Congress significant progress they have made towards implementing the FSMA. In March 2012, the FDA’s Senior Advisor, Coordinated Outbreak Response and Evaluation Network, Sherri McGarry, on a blog reported the types of foods to be used in the pilot project on tracing products to prevent illnesses. The list includes Tomatoes, Frozen Kung Pao-style dishes, and Jarred peanut butter and dry, packaged peanut/spice. Tomatoes both sliced and whole was chosen because of the significant number of outbreaks recorded; it mirrors a multifaceted food supply chain and it was recognized by majority of the food industry associations as the number one food product to be used in the pilot program.

The Frozen Kung Pao-style dishes have ingredients such as chicken, red pepper spice and peanut products which are foods that are involved in outbreaks, for this reason they are in the pilot project. In addition, it is supplied to diverse food chain distribution channels which could be involved in imported and domestic products. To increase the intricacy of the pilot project, the jarred peanut butter and dry, packaged spice peanut were included. This summer, the pilot projects results will be accomplished with hopes of developing a complete product tracing system with the information received.

Tester-Hagen Amendment

Senators Jon Tester and Kay Hagan sponsored two amendments that removed vital local food growers and processors from federal oversight, leaving them –as they currently are – within the existing regulatory framework of state and local health and sanitation laws and rules.

The amendment will offer protections for operations (a.k.a. “qualified facilities”) that make less than $500,000 a year and sell most (greater than 50%) of their products directly to consumers in the same state and within a 400-mile radius. The amendment also applies to all operations that the FDA classified as a "very small business." Small, local farmers would not necessarily need to comply with some of the requirements and produce safety regulations implemented under S. 510. Instead, these small-scale producers (like those who sell their goods at farmers' markets or roadside stands) would continue to be regulated by local and state entities. In addition, consumers would know whom they are buying from either by direct sales or clear labeling .

Farmers who qualify must provide documentation that the farm is in compliance with state regulations.Documentation may include licenses, inspection reports, or other evidence that the farm is in compliance with State, local, county, or other applicable non-Federal food safety law. The farm must also prominently and conspicuously display the name and address of farm/facility on its label. For foods without a label then by poster, sign, or placard, at the point of purchase or, in the case of Internet sales, in an electronic notice, or in the case of sales to stores and restaurants, on the invoice.

External links

• Ensuring Food Safety - White Paper from GE Intelligent Platforms