FDA Food Safety Modernization Act

Last updated

FDA Food Safety Modernization Act
Great Seal of the United States (obverse).svg
Long titleTo amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply.
Acronyms (colloquial)FSMA
Enacted bythe 111th United States Congress
EffectiveJanuary 4, 2011
Citations
Public law 111-353
Codification
Acts amended Federal Food, Drug, and Cosmetic Act
Titles amended 21 U.S.C.: Food and Drugs
U.S.C. sections created301 et seq.
Legislative history

The Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama on January 4, 2011. The FSMA has given the Food and Drug Administration (FDA) new authority to regulate the way foods are grown, harvested and processed. The law grants the FDA a number of new powers, including mandatory recall authority, which the agency had sought for many years. The FSMA requires the 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.

Contents

The law was prompted after many reported incidents of foodborne illnesses during the first decade of the 2000s and was largely crafted by members of the Grocery Manufacturers Association. 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. [1] It is also the first piece of legislation to address intentional adulteration and Food Defense. [2]

Background

The U.S. Centers for Disease Control and Prevention (CDC) estimated in 2011 that each year 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases. [3] [4] 31 pathogens are notorious for causing foodborne illness. [3] Unspecified agents have insufficient data to estimate with certainty the agent-specific burden. Known agents that have not been identified as causing foodborne illness include microbes, chemicals, or other substance known to be in food. The ability for these known agents to cause illness has not been proven so they remain unidentified. Considering 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. [5] The FDA Food Safety Modernization Act (FSMA), enables FDA to better protect public health by strengthening the food safety system. It enables the FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. [4]

Estimated annual number of domestically acquired, food borne illnesses, hospitalizations, and deaths due to 31 pathogens and unspecified agents transmitted through food, United States. [3]
Food borne AgentsEstimated 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 pathogens9.4 million

(6.6–12.7 million)

2055,961

(39,534–75,741)

441,351

(712–2,268)

44
Unspecified agents38.4 million

(19.8–61.2 million)

8071,878

(9,924–157,340)

561,686

(369–3,338)

56
Total47.8 million

(28.7–71.1 million)

100127,839

(62,529–215,562)

1003,037

(1,492–4,983)

100

In 1998, the FDA announced a publication entitled "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables" in response to President Clinton's 1997 "Initiative to Ensure the Safety of Imported and Domestic Fruits and Vegetables". [6] They resulted in Good Agricultural Practices (GAP) and Good Handling Practices (GHP) certifications that became de facto industry requirements, but were not enforceable. [7]

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. [8] 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. [8]

Under the new law, the FDA will now have new prevention-focused tools and a clear regulatory framework to help make substantial improvements in their approach to food safety. [4] For example, for the first time, the 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 the FDA's ability to achieve greater oversight of the millions of food products coming into the United States from other countries each year.

Legislative history

The events of September 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. [9] 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. [10] 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. [10]

President Obama signs FSMA into law. Obama signs FSMA into Law.jpg
President Obama signs FSMA into law.

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. [11] 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. [12] Attempts to add the bill to the continuing resolution for government funding were scrapped over the objection of Senator Tom Coburn. [13] Eventually, however, the Senate moved on December 19, 2010, to pass the fixed bill by unanimous consent by a voice vote. [12] The House went on to approve the bill by a vote of 215 to 144 on December 21, 2010. [14] [15] President Barack Obama signed the bill into law on Tuesday, January 4, 2011. [16]

Although this bill is meant to address food safety, there are, according to food safety advocate Bill Marler, some issues with its effectiveness. Many facilities, such as farms, restaurants, and nonprofit food establishments in which food is prepared for or served directly to the consumer are exempt from the requirements of the bill. Also exempt are facilities that produce food solely for non-human animals. [17]

Tester-Hagan Amendment

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]

Provisions

Impact and fees

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]

Prevention

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.

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 the FDA with new authority to conduct inspections and ensure compliance.

The 2011 fiscal year report on foreign food inspections by the FDA. 2011 Fiscal year Foreign Food Inspection chart by FDA.png
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. [26] Small farms that sell locally or sell less than $500,000 a year are exempt from these new rules. [27] New authorities include:

Additional information on imported goods

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:

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:

Employee protections

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]

Implementation

With the Act in place, the FDA began the rulemaking process to codify how to enforce the new laws. [10]

Effective June 12, 2011, many food companies became required to develop food safety plans based on an evaluation of hazards related to food manufactured, processed, packed or held in all registered facilities. [29] Following a hazard analysis, firms were required to 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. [29]

Even after completion of the rulemaking process, it was estimated that time would be required for the FDA to become fully equipped to enforce the new laws. The agency estimated that it would require at least 1,000 more inspectors and $1.4 billion over the following five years, with uncertainty that Congress would appropriate such funds given the economic climate at the time, and calls for spending cuts. [10]

Rules

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]

FSMA progress report

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]

Funding

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]

Food facility registration

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]

Reaction and controversy

Large trade organizations joined public health advocates in supporting the bill, while groups aligned with individuals and small farms generally opposed it. [38] However, after Senate adoption of Jon Tester's amendment, which allows for the possible exemption of producers that sell less than $500,000 a year, [39] many large food companies objected, arguing that the exemption puts consumers at risk. [40]

A year after enactment the agency had fallen behind on expected progress. It has yet to implement "a specific timetable for issuing" a process to create rule for science-based produce standards, has not completed rules for foreign supplier verification, and must still create a guidance that will help schools and childcare programs lessen allergy risks for school-age children. [41]

A similar set of New Zealand rules, Food Bill 160–2, has been towards passage since 2010. The primary effects expected are to tie New Zealand to Codex Alimentarius and the World Trade Organization permanently, although those international agreements will be constantly adjusted. Despite its 366 pages, Food Bill 160-2 cannot directly resolve many threats to food safety, as there is no added Produce traceability nor methods to control Antibiotic resistance.

Alcoholic beverage facilities exemption

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[ when? ] 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.

See also

Related Research Articles

<span class="mw-page-title-main">Food and Drug Administration</span> United States federal agency

The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

<span class="mw-page-title-main">Hazard analysis and critical control points</span> Systematic preventive approach to food safety

Hazard analysis and critical control points, or HACCP, is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe and designs measures to reduce these risks to a safe level. In this manner, HACCP attempts to avoid hazards rather than attempting to inspect finished products for the effects of those hazards. The HACCP system can be used at all stages of a food chain, from food production and preparation processes including packaging, distribution, etc. The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) require mandatory HACCP programs for juice and meat as an effective approach to food safety and protecting public health. Meat HACCP systems are regulated by the USDA, while seafood and juice are regulated by the FDA. All other food companies in the United States that are required to register with the FDA under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, as well as firms outside the US that export food to the US, are transitioning to mandatory hazard analysis and risk-based preventive controls (HARPC) plans.

<span class="mw-page-title-main">Federal Food, Drug, and Cosmetic Act of 1938</span> Acts of the United States Congress

The United States Federal Food, Drug, and Cosmetic Act is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.

<span class="mw-page-title-main">Toxic Substances Control Act of 1976</span> United States federal law

The Toxic Substances Control Act (TSCA) is a United States law, passed by the 94th United States Congress in 1976 and administered by the United States Environmental Protection Agency (EPA), that regulates chemicals not regulated by other U.S. federal statutes, including chemicals already in commerce and the introduction of new chemicals. When the TSCA was put into place, all existing chemicals were considered to be safe for use and subsequently grandfathered in. Its three main objectives are to assess and regulate new commercial chemicals before they enter the market, to regulate chemicals already existing in 1976 that posed an "unreasonable risk of injury to health or the environment", as for example PCBs, lead, mercury and radon, and to regulate these chemicals' distribution and use.

The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, reported, and archived. These principles apply to the non-clinical safety testing of substances found in various products to ensure the quality and integrity of the safety data submitted to regulatory authorities globally.

<span class="mw-page-title-main">Food policy</span> Area of public policy

Food policy is the area of public policy concerning how food is produced, processed, distributed, purchased, or provided. Food policies are designed to influence the operation of the food and agriculture system balanced with ensuring human health needs. This often includes decision-making around production and processing techniques, marketing, availability, utilization, and consumption of food, in the interest of meeting or furthering social objectives. Food policy can be promulgated on any level, from local to global, and by a government agency, business, or organization. Food policymakers engage in activities such as regulation of food-related industries, establishing eligibility standards for food assistance programs for the poor, ensuring safety of the food supply, food labeling, and even the qualifications of a product to be considered organic.

<span class="mw-page-title-main">Public Health Security and Bioterrorism Preparedness and Response Act of 2002</span>

Signed into effect on 12 June 2002, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PHSBPRA) was signed by the President, the Department of Health and Human Services (DHHS) and the U.S. Department of Agriculture (USDA).

<span class="mw-page-title-main">Food safety</span> Scientific discipline

Food safety is used as a scientific method/discipline describing handling, preparation, and storage of food in ways that prevent foodborne illness. The occurrence of two or more cases of a similar illness resulting from the ingestion of a common food is known as a food-borne disease outbreak. This includes a number of routines that should be followed to avoid potential health hazards. In this way, food safety often overlaps with food defense to prevent harm to consumers. The tracks within this line of thought are safety between industry and the market and then between the market and the consumer. In considering industry-to-market practices, food safety considerations include the origins of food including the practices relating to food labeling, food hygiene, food additives and pesticide residues, as well as policies on biotechnology and food and guidelines for the management of governmental import and export inspection and certification systems for foods. In considering market-to-consumer practices, the usual thought is that food ought to be safe in the market and the concern is safe delivery and preparation of the food for the consumer. Food safety, nutrition and food security are closely related. Unhealthy food creates a cycle of disease and malnutrition that affects infants and adults as well.

A food code is the organic body and systematized basic standards relating to food, condiments, stimulants and drink and beverages, their concerned raw materials, utensils and equipment use and domestic consumption.

Adulteration is a legal offense and when the food fails to meet the legal standards set by the government, it is said to have been Adulterated Food. One form of adulteration is the addition of another substance to a food item in order to increase the quantity of the food item in raw form or prepared form, which results in the loss of the actual quality of the food item. These substances may be either available food items or non-food items. Among meat and meat products some of the items used to adulterate are water or ice, carcasses, or carcasses of animals other than the animal meant to be consumed. In the case of seafood, adulteration may refer to species substitution (mislabeling), which replaces the species identified on the product label with another species, or undisclosed processing methods, in which treatments such as additives, excessive glazing, or short-weighting are not disclosed to the consumer.

<span class="mw-page-title-main">Food and Drug Administration Modernization Act of 1997</span> US law

The United States Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act. This act is related to the regulation of food, drugs, devices, and biological products by the FDA. These changes were made in order to recognize the changes in the way the FDA would be operating in the 21st century. The main focus of this is the acknowledgment in the advancement of technological, trade, and public health complexities.

<span class="mw-page-title-main">Michael R. Taylor</span> American politician

Michael R. Taylor is an American lawyer who has played leadership roles in the US Food and Drug Administration, agrochemical company Monsanto, and law firm King & Spalding. He currently co-chairs the board of STOP Foodborne Illness, a non-profit that supports victims of serious illness and their families in efforts to strengthen food safety culture and practices in government and industry.

<span class="mw-page-title-main">Food Safety and Inspection Service</span> U.S. federal government agency

The Food Safety and Inspection Service (FSIS), an agency of the United States Department of Agriculture (USDA), is the public health regulatory agency responsible for ensuring that United States' commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged. The FSIS draws its authority from the Federal Meat Inspection Act of 1906, the Poultry Products Inspection Act of 1957 and the Egg Products Inspection Act of 1970. The FSIS also acts as a national health department and is responsible for the safety of public food-related establishments as well as business investigation.

<span class="mw-page-title-main">Pesticide regulation in the United States</span>

Pesticide regulation in the United States is primarily a responsibility of the Environmental Protection Agency (EPA). In America, it was not till the 1950s that pesticides were regulated in terms of their safety. The Pesticides Control Amendment (PCA) of 1954 was the first time Congress passed guidance regarding the establishment of safe limits for pesticide residues on food. It authorized the Food and Drug Administration (FDA) to ban pesticides they determined to be unsafe if they were sprayed directly on food. The Food Additives Amendment, which included the Delaney Clause, prohibited the pesticide residues from any carcinogenic pesticides in processed food. In 1959, pesticides were required to be registered.

Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled. Consumers and health professionals report any adverse event caused by the device to MedWatch program for reporting significant adverse events or product problems with medical products.

<span class="mw-page-title-main">Food and Drug Administration Safety and Innovation Act</span> Piece of American regulatory legislation

The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also creates the breakthrough therapy designation program and extends the priority review voucher program to make eligible rare pediatric diseases. The measure was passed by 96 senators voting for and one voting against.

Food defense is the protection of food products from intentional contamination or adulteration by biological, chemical, physical, or radiological agents introduced for the purpose of causing harm. It addresses additional concerns including physical, personnel and operational security.

<span class="mw-page-title-main">Hazard analysis and risk-based preventive controls</span> Food safety regulations

Hazard analysis and risk-based preventive controls or HARPC is a successor to the Hazard analysis and critical control points (HACCP) food safety system, mandated in the United States by the FDA Food Safety Modernization Act (FSMA) of 2010.

Genetic engineering in North America is any genetic engineering activities in North America

<span class="mw-page-title-main">Food safety in the United States</span>

Food safety in the United States relates to the processing, packaging, and storage of food in a way that prevents food-borne illness within the United States. The beginning of regulation on food safety in the United States started in the early 1900s, when several outbreaks sparked the need for litigation managing food in the food industry. Over the next few decades, the United States created several government agencies in an effort to better understand contaminants in food and to regulate these impurities. Many laws regarding food safety in the United States have been created and amended since the beginning of the 1900s. Food makers and their products are inspected and regulated by the Food and Drug Administration and the Department of Agriculture.

References

  1. ↑ "House Approves Food-Safety Bill; Law Would Expand FDA's Power". The Washington Post. July 31, 2009. Retrieved January 1, 2011.
  2. ↑ "FSMA Proposed Rule for Focused Mitigation Strategies to Protect Food Against Intentional Adulteration". FDA. March 11, 2022.
  3. 1 2 3 "CDC Estimates of Foodborne Illness in the United States". Centers for Disease Control and Prevention. Retrieved December 28, 2013.
  4. 1 2 3 "Background on the FDA Food Safety Modernization Act". U.S. Food and Drug Administration. Retrieved June 6, 2011.
  5. ↑ "FDA Food Safety Modernization Act Overview" . Retrieved April 16, 2012.
  6. ↑ "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables". Center for Food Safety and Applied Nutrition . October 26, 1998.63 FR 58055
  7. ↑ Thomas, Courtney I. P. (2014). In Food We Trust: The Politics of Purity in American Food Regulation. University of Nebraska Press. pp. 131–134. ISBN   9780803276420.
  8. 1 2 "Food Bill Aims to Improve". U.S. Food and Drug Administration. Retrieved November 19, 2011.
  9. ↑ "Bioterrorism Act of 2002". U.S. Food and Drug Administration. Retrieved December 1, 2011.
  10. 1 2 3 4 "The FDA Food Safety Modernization Act. What do the new laws mean for small farms and producers?". New England Farmers Union. Retrieved December 1, 2011.[ permanent dead link ]
  11. ↑ "Roll Call Votes 111th Congress - 2nd Session". United States Senate. Retrieved January 1, 2011.
  12. 1 2 "Senate OKs food safety measure – Meredith Shiner". Politico.Com. Retrieved January 1, 2011.
  13. ↑ Falkenstein, Drew (December 18, 2010). "In Lame Duck Flux, Food Safety Bill All But Dead". Foodsafetynews.com. Retrieved January 1, 2011.
  14. ↑ "Final Vote Results for Roll Call 661". Office of the Clerk of the U.S. House of Representatives. December 21, 2013. Retrieved December 27, 2013.
  15. ↑ "House Vote 661 – Passes Food Safety Bill". The New York Times. Archived from the original on December 27, 2013. Retrieved December 26, 2013.
  16. ↑ "Inside United Fresh". United Fresh. January 6, 2011. Retrieved December 27, 2013.
  17. ↑ "A Friday and Saturday night read - H.R. 2749 - Food Safety Enhancement Act 2009 - So, what's really in it?". marlerblog.com. August 2009.
  18. ↑ "S. 510 Food Safety Modernization Act Healthy Local Foods Amendment" (PDF). Western Organization of Resource Councils. Archived from the original (PDF) on November 27, 2014. Retrieved November 25, 2011.
  19. 1 2 3 "The Tester – Hagen Amendment to S. 510 protects food safety and small farmers". Marler Blog. Retrieved November 25, 2001.
  20. 1 2 "Food Safety Actction Alert". National Sustainable Agriculture Coalition. October 2010. Retrieved December 1, 2011.
  21. 1 2 3 4 Layton, Lyndsey (July 31, 2009). "House Approves Food-Safety Bill; Law Would Expand FDA's Power". The Washington Post. Retrieved November 20, 2011.
  22. 1 2 3 4 "Food Safety Legislation Key Facts". U.S. Food and Drug Administration. Retrieved April 26, 2011.
  23. ↑ "About FDA". U.S. Food and Drug Administration. Retrieved April 19, 2012.
  24. ↑ "The Food Safety Modernization Act: A New Paradigm for Importers and Global Partnerships". Quality Assurance & Food Safety Magazine. Retrieved April 15, 2012.
  25. ↑ Mushrush, Laura (March 23, 2017). "Three things to expect during unannounced FDA inspections". Food Safety News. Retrieved April 19, 2017.
  26. ↑ "Food-safety measure passes Senate in Sunday surprise". The Washington Post. December 19, 2010. Retrieved January 1, 2011.
  27. ↑ Sutton, Betty (January 4, 2011). "H.R.2751 - 111th Congress (2009-2010): FDA Food Safety Modernization Act". www.congress.gov. Retrieved June 10, 2022.
  28. ↑ "H.R. 2751 - Federal Food, Drug, and Cosmetic Act Amendment With Respect To The Safety Of The Food Supply". Library of Congress THOMAS. January 5, 2010. Archived from the original on April 8, 2013. Retrieved January 7, 2013.
  29. 1 2 "FDA Food Safety Modernization Act: Marking a New Era in U.S. Food Safety". Food Safety Magazine. Archived from the original on December 9, 2011. Retrieved December 1, 2011.
  30. 1 2 "FSMA Gets New Deadlines for Final Rules | Food Safety News". February 21, 2014. Retrieved September 18, 2016.
  31. ↑ "New Food Safety Rules: Food Safety Modernization Act (FSMA) | Small Farms Programs". smallfarms.oregonstate.edu. Archived from the original on August 26, 2016. Retrieved September 18, 2016.
  32. ↑ "Documents Show OMB Weakened FDA's Food Safety Rules | Food Safety News". March 25, 2013. Retrieved September 18, 2016.
  33. ↑ "FDA Progress Report on Implementing the Food Safety Modernization Act: January – March 2012" (PDF). FDA FSMA. Retrieved April 29, 2012.
  34. 1 2 3 4 5 6 7 "Rapid Tracing of Food Products Prevents illness". FDA Transparency Blog. Archived from the original on April 29, 2012. Retrieved April 29, 2012.
  35. ↑ "President Obama Signs Landmark Food Safety Bill". Center for Effective Government. January 4, 2011.
  36. ↑ "21 Code of Federal Regulations (CFR) 1.241". Code of Federal Regulations (CFR). Retrieved November 14, 2012.
  37. ↑ "2014 U.S. FDA Food Facility Registration Data". Registrar Corp. Retrieved June 27, 2014.
  38. ↑ "FDA Food Safety Modernization Act - Senate Vote: On Passage | Total Campaign Contributions". MapLight. December 31, 2010. Archived from the original on July 10, 2012. Retrieved May 29, 2012.
  39. ↑ "Senate passes Food Safety Act with Tester's amendment | Indy Blog". Missoulanews.bigskypress.com. November 30, 2010. Archived from the original on March 6, 2012. Retrieved May 29, 2012.
  40. ↑ Salahi, Lara (December 1, 2010). "Senate Votes for Food Safety Overhaul". ABC News. Retrieved May 29, 2012.
  41. ↑ Bottemiller, Helena (January 20, 2012). "The Food Safety Modernization Act - One Year Later". Food Safety News .
  42. ↑ 78 FR 64735 (October 29, 2013)
  43. 1 2 Terry, Lynne (April 18, 2014). "Beer prices could go up under FDA rule that angers farmers, brewers". The Oregonian .
  44. ↑ Scully, Sean. "After outcry, FDA to revise proposed rules on brewery grain as feed". The Press Democrat . Archived from the original on April 22, 2014. Retrieved April 21, 2014.
  45. ↑ 21 U.S.C.   § 2206
  46. ↑ Klein, Jeffrey (November 8, 2013). "FDA's Proposed Rules May Affect Breweries and Distilleries". LaszloLaw.

Further reading

This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.