FDA Food Safety Modernization Act

Senators Jon Tester and Kay Hagan sponsored two amendments that removed farmers, ranchers and local 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.[18]

The amendment offered protections for operations (a.k.a. “qualified facilities”) that sell 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.[19] 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.[19] 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.[19]

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.[20] 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.[20]

The legislation affects every aspect of the U.S. food system, from farmers to manufacturers to importers.[21] 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[21] 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[21] 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.[21]

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

• Mandatory preventive controls for food facilities
  • Food facilities are required to implement a written Hazard Analysis and Risk-based Preventive Controls (HARPC) 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. Animal food manufacturers must implement current Good Manufacturing Practices and Preventive Controls.(Final rule published September 17, 2015)[22]

• 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, 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)[22]

• Radiological hazards
  • For the first time, firms must explicitly consider radioactive contamination as part of their hazard analysis, under chemical safety. The FDA does not anticipate that this will be a hazard that requires continuous monitoring with a Geiger counter. Rather, as an example, a firm that uses spring water in its products should consider having the water tested regularly for the presence of dissolved radon, tritium and heavy metal contaminants.

• 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. (Final rule due 18 months following enactment)[22] This is the first time language involving Food Defense has been incorporated into law.

The FSMA recognizes that preventive control standards improve food safety only to the extent that producers and processors comply with them. FSMA provides the FDA with new authority to conduct inspections and ensure compliance.

The 2011 fiscal year report on foreign food inspections by the FDA.[23]

• 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 the FDA to inspect at least 600 foreign facilities and double those inspections every year for the next five years.[22] 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.[24]

• 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 the 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)

• Visual inspection
  • During an unannounced inspection by the FDA, a visual inspection will be conducted. During the inspection they will look at the building and equipment to see if there is any possibility of food contamination. The will probe into poor welds, condensation leaks especially over open product lines.

• Swabbing of environment
  • During their cursory walk, the agent will also look for any areas and niches that they feel may be a harborage point for bacteria. The agents can and will take anywhere form 150- 200 swabs depending on how big the facility is. The agent will also take raw material samples as well as finished product. It is advised that the company does not take companion samples because this can double the chances of a lab error, and does not look good if the FDA's samples come up negative and the facilities positive and vice versa.[25]

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.[26] Small farms that sell locally or sell less than $500,000 a year are exempt from these new rules.[27] New authorities include:

• Mandatory recall
  • The FSMA provides the FDA with authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to 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 (administrative detention is the procedure the FDA uses to keep suspect food from being moved).
• Suspension of registration
  • The FDA can suspend registration of a facility if it determines that the food poses a SOMEWHAT 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
  • The 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
  • The 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).

The FSMA gives the 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 the FDA to recognize accreditation bodies is due 2 years after 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 U.S.

• 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, among other things, importers offering food from certified facilities. (Implementation due 18 months after enactment)

• Authority to deny entry
  • The FDA can refuse entry into the U.S. of food from a foreign facility if the FDA is denied access by the facility or the country in which the facility is located.

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

The FSMA also includes provisions that protect employees who try to prevent food safety problems. Section 402 of the FSMA prohibits employers engaged in the manufacture, processing, packing, transporting, distribution, reception, holding or importation of food from retaliating against employees who disclose violations of the Federal Food, Drug, and Cosmetic Act. This particular portion of the FSMA is administered by the U.S. Department of Labor.[28]

In 2012, the FDA was sued by consumer groups the Center for Food Safety (CFS) and the Center for Environmental Health for its failure to meet deadlines.[30] In settling the litigation, the agency agreed to deadlines in 2015 and 2016 for certain rules.[30]

The first public comment period occurred in 2013, and the agency received tens of thousands of comments in that period.[31] The FDA previously submitted their proposed regulations to the Office of Management and Budget (OMB) for review, and in that process the OMB weakened the regulations in a variety of ways.[32]

The FDA has planned to make available to the general public and to Congress significant progress they have made towards implementing the FSMA.[33] 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.[34] The list includes tomatoes, frozen Kung Pao-style dishes, jarred peanut butter, and dry, packaged peanut/spice.[34] Tomatoes both sliced and whole were chosen because of the significant number of outbreaks recorded; mirroring a multifaceted food supply chain. It was recommended by majority of the food industry associations as the number one food product to be used in the pilot program.[34]

The Frozen Kung Pao-style dishes contain ingredients such as chicken, red pepper spice and peanut products which are foods that are involved in outbreaks, and for this reason were included in the pilot project.[34] In addition, it is supplied to diverse food chain distribution channels which could involve imported and domestic products.[34] To increase the intricacy of the pilot project, the jarred peanut butter and dry, packaged spice peanut were included.[34] That summer, the pilot projects results were expected to be accomplished with hopes of developing a complete product tracing system with the information received.[34]

The Safety Act was signed into law along with the Government Performance and Results Modernization Act of 2010. The cost for the first five years was projected to be $1.4 billion, without being fully funded at that time.[35]

On October 22, 2012, the updated food facility registration system by the US FDA was made available. This update required all facilities previously registered prior to October 1, 2012, to renew registration. Failure to do so became a prohibited act, leading to refusal of entry for foreign products and illegal trade for domestic facilities.[36] Every 2 years in even numbered years, every registered facility would be required to renew its registration between October 1 and December 31. Registration would be accepted by fax, mail and electronics means on the FDA food facility registration website.

As of January 22, 2014, there were 195,518 food facilities registered with the FDA.[37]

There has been criticism that the FDA's proposed rule[42] would be prohibitively expensive on the practice of alcoholic beverage facilities selling spent grain to farmers for animal food.[43] Under current law, alcoholic beverages, such as beer, wine, cider and spirits, are exempt from the FDA's normal oversight of food products.[44] The FDA will open up the rule to comments again this summer and then revise the proposal, which is due to be finalized by August 2015.[43]

The proposed rules regulate the "good manufacturing practice in manufacturing, processing, packing or holding of animal food" and "require that certain facilities establish and implement hazard analysis and risk-based preventive controls for food for animals", but animal food at alcoholic beverage facilities would not be exempt pursuant to section 116 of FSMA[45] since "those spent grains are not alcoholic beverages themselves, and they are not in a prepackaged form that prevents any direct human contact with the food".[46]

As of September 18, 2018, all brewers need to be in compliance with the Food Safety Modernization Act (FSMA).

Under the final rules the FDA is obligated to inspect every brewery in the USA over the next few years.

The FDA inspector will inspect and observe every level of the brewers operations.

They may and will review all record keeping files and are allowed to make copies and photographs for their records.

If the brewing facility fails the FDA inspection they will not only get fined but a stricter re-inspection will be required at a cost of over $200 per hour payable by the inspected brewer.

The USA brewing industry is legally obliged to provide a safe for consumption product and to ensure safety throughout the supply and manufacturing chain.

Brewing beer generally creates a much safer product than non-alcoholic beverages and foods, naturally protected from certain mycotoxins and bacteria, however it can still be contaminated by foreign bodies and chemicals at various stages within the manufacturing process.