Food Safety Modernization Act (FSMA) About 48 million people in the U.S. (1 in 6) 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.

is transforming the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it. Congress enacted FSMA in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system.

What is FSMA (Food Safety Modernization Act) and HARPC?

FDA has finalized nine major rules to implement FSMA, recognizing that ensuring the safety of the food supply is a shared responsibility among many different points in the global supply chain for both human and animal food. The FSMA rules are designed to make clear specific actions that must be taken at each of these points to prevent contamination.

What is the purpose of the FSMA?

CDC and the Food Safety Modernization Act The U.S. Food and Drug Administration (FDA) is charged with implementing most of the laws, rules and guidance that are part of the (FSMA), but CDC plays a key role. The act, signed into law in 2011, seeks to protect public health more effectively by strengthening the food safety system.

FSMA focuses on preventing food safety problems before they occur and recognizes the importance of strong foodborne illness and outbreak surveillance systems. Rapidly detecting and responding to foodborne disease outbreaks is crucial to stop outbreaks, prevent them from happening, and ultimately decrease the burden of foodborne illness.

FSMA directs CDC to enhance foodborne illness surveillance systems through improved collection, analysis, and reporting of foodborne illness data. CDC supports FSMA with four key activities:

Creation and management of Integrated Food Safety Centers of Excellence with academic partners at state health departments to serve as resources for local, state and federal public health professionals to detect and respond to foodborne illnesses and outbreaks Implementation of activities to improve the collection, analysis, and reporting of foodborne surveillance data supported by guidance from a multidisciplinary working group Development and dissemination of guidelines to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs.

The Integrated Food Safety Centers of Excellence provide assistance and training to other state and local health departments to build their capacity to track and investigate foodborne disease. CDC surveillance data and outbreak investigations support FDA’s work of designing data-driven preventive controls and food safety standards. CDC developed and disseminated guidelines to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs. : CDC and the Food Safety Modernization Act

Who has responsibility to ensure the safety of food UK?

The Food Standards Agency is an independent government department for England, Wales, and Northern Ireland that protects public health and consumers in the food industry. The FSA says that, as a food business, you must ensure you have food safety management procedures in place to keep consumers safe and comply with food hygiene and food standards. But who is responsible for food safety in catering, hospitality and other organisations that sell food? Is it the business owner? Or food handlers, managers, and supervisors on the ground floor? Read on to find out.

What is the difference between Haccp and FSMA?

The Risk-Based Approach to Food Safety and the HACCP Concept – Great strides were taken in the twentieth century to assure the safety of the U.S. food system. A series of federal food safety laws culminated with the passage of the Federal Food, Drug, and Cosmetics Act (FD&C) in 1938,

• Among the provisions of the Act, the U.S.
• Food and Drug Administration (FDA) was given the authority to investigate illnesses or outbreaks attributed to manufactured foods and to inspect food processing facilities and warehouses for compliance with federal food safety standards.
• Periodic visits by government sanitarians and end-point product testing were thereafter relied upon for assurances of the safety of food products.

If someone became ill from eating a food product or if contamination was found during an inspection, the usual practice was for the government to request that the food company destroy or recall the product. However, over time it became clear to many that the existing resources available for on-site inspections were not adequate to oversee a growing and continually changing food industry.

A new approach was needed that placed more responsibility on manufacturers to identify potential food safety hazards for their unique products and processes, develop ways to prevent them from occurring before they become a problem, and to document that all practices and policies are consistently implemented.

The Hazard Analysis Critical Control Point (HACCP) food safety management system has emerged as a better alternative to the inspect and test approach and is now the globally accepted system for assuring buyers, the public, and regulators that they have taken all possible measures to reduce or eliminate potential food safety hazards in their operations.

• HACCP is a systematic and proactive way to consider risks at each step of a manufacturing process and then develop control measures to prevent or reduce food safety risks to acceptable levels.
• Risk-based, preventive approaches to food safety began in the 1960s when the National Aeronautics and Space Administration (NASA) adapted “zero defect” engineering and quality assurance systems for assuring the safety of food taken into outer space.

These included applications of “Modes of Failure” concepts that require a thorough understanding of the product and the process in order to predict when a food safety “hazard” can occur. In 1985, the National Academy of Sciences (NAS) recommended that HACCP be incorporated into U.S.

Food regulations. The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) then developed uniform procedures for developing food safety plans known as the seven HACCP principles 21, Worldwide consensus on the utility of HACCP for maintaining the safety of the global food supply was achieved in 2003 when the World Health Organization’s (WHO) Codex Alimentarius Committee on Food Hygiene issued Hazard Analysis Critical Control Point guidelines for international trade 5,

Soon after, the European Union (EU), Canada, Australia, and Japan issued regulations requiring food businesses within their jurisdiction to develop and implement food safety plans based on the NACMCF and Codex HACCP frameworks 3, Over the last three decades, U.S.

government agencies have issued a succession of regulations that required HACCP plan development for certain types of foods. In 1995, all U.S. seafood processing facilities were mandated by the Food and Drug Administration (FDA) to develop HACCP plans 6, Soon after, the United States Department of Agriculture (USDA) required meat and poultry establishments to write HACCP plans 7,

In 2001, after a series of food borne illness outbreaks attributed to unpasteurized juice products, FDA directed wholesale juice and cider processors to implement HACCP plans in their operations 8, In the U.S., full adoption of the HACCP approach for assuring the safety of food came in 2011 when Congress passed, and the president signed into law, the Food Safety Modernization Act (FSMA),

• The law is said to be the most sweeping reform of the U.S.
• Food regulatory system since the 1938 FD&C Act was enacted.
• FSMA adopts the risk-based, preventive approach of HACCP and expands upon it to address potential hazards that have emerged with the development of modern food production and processing practices.

The law grants new authority to the U.S. Food and Drug Administration (FDA) to establish and enforce food safety standards encompassing the entire U.S. food system, including farms that grow, harvest, pack, and hold fresh produce; facilities that process, manufacturer, pack, or hold human or animal food; and shippers and receivers involved in transporting human and animal food.

• The seven regulations issued under FSMA and a brief description of the scope of each are shown in Table 1,
• Complete information on each regulation can be accessed on the FDA’s FSMA website,
• The FSMA regulation that has the greatest impact on the food processing and manufacturing industry is “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” 9, often abbreviated to simply the “Preventive Controls Rule”.

Table 1. Definitions of terms used in HACCP 21 and HARPC in the FDA Preventive Controls Rule 2,16 Collection and evaluation of scientific and technical information to determine whether the food safety plan can effectively control significant hazards.

What kind of controls does FSMA require?

FOOD SAFETY PLAN – In general, you are a covered facility if you are required to register with FDA under section 415 of the Federal Food, Drug, and Cosmetic (FD&C) Act. Covered facilities are required to have and implement a written food safety plan that includes:

Hazard analysis: The first step is hazard identification, which must consider known or reasonably foreseeable biological, chemical, and physical hazards. These hazards could be present because they occur naturally, are unintentionally introduced, or are intentionally introduced for economic gain (if they affect the safety of the food). If the hazard analysis reveals one or more hazards that require a preventive control, the facility must have and implement written preventive controls for the identified hazards.

Preventive controls : Facilities have the flexibility to tailor preventive controls to address hazards that occur in the products they manufacture. The preventive controls, which must be written, must be implemented to ensure that any hazards requiring a preventive control will be significantly minimized or prevented and help ensure that the food is not adulterated. The rule includes the following preventive controls:

Process controls include procedures that ensure the control parameters are met. Process controls can include operations such as cooking, refrigerating, and acidifying foods. They must include parameters and values (e.g., critical limits), as appropriate to the nature of the applicable control and its role in the facility’s food safety system. Food allergen controls are written procedures the facility must have and implement to control allergen cross-contact and ensure allergens are appropriately listed on the labels of packaged food products. Sanitation controls are procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition to minimize or prevent hazards such as environmental pathogens, hazards from employees handling food, and food allergen hazards. Other Controls are controls that are not described above but are necessary to ensure that a hazard requiring a preventive control will be significantly minimized or prevented.

Oversight and management of preventive controls: Once a facility has identified a preventive control for a hazard, the facility must make sure that the controls are being met.

Monitoring : These procedures are designed to provide assurance that preventive controls are consistently performed. Monitoring is conducted as appropriate to the preventive control. For example, monitoring of a heat process to kill pathogens would include recording temperature values. Monitoring must be documented. Corrections : These are steps taken, in a timely manner, to identify and correct a minor, isolated problem that occurs during food production. Corrective actions : These include actions to identify and correct a problem implementing a preventive control, reduce the likelihood the problem will recur, evaluate affected food for safety, and prevent that food from entering commerce if you cannot ensure that the affected food is not adulterated. Corrective actions must be documented with records. Verification : These activities are required to ensure that preventive controls are consistently implemented and effective in minimizing hazards. Examples of verification activities include scientifically validating process preventive controls to ensure that the control measure is capable of effectively controlling an identified hazard and calibrating (or checking the accuracy of) process monitoring and verification instruments such as thermometers. Verification activities also include reviewing records to ensure that monitoring and corrective actions (if necessary) are being conducted. Verification activities must be documented. Product testing and environmental monitoring are also possible verification activities, required as appropriate to the food, facility, nature of the preventive control, and the role of that control in the facility’s food safety system. Environmental monitoring is required if the contamination of a ready-to-eat food with an environmental pathogen is a hazard the facility identified as requiring a preventive control.

Supply chain program: Manufacturers must have and implement a risk-based supply chain program if the hazard analysis identifies a hazard that (1) requires a preventive control and (2) the control will be applied in the facility’s supply chain.

Facilities do not need to have a supply-chain program if they control the hazard in their own facility, or if a subsequent entity (such as another processor) will control the hazard, and the facility follows applicable requirements. Manufacturers are responsible for ensuring that raw materials and other ingredients requiring a supply-chain-applied control are received only from approved suppliers, or on a temporary basis from unapproved suppliers whose materials are subject to verification activities before being accepted for use. (Suppliers are approved by the facility after the facility considers several factors, such as a hazard analysis of the food, the entity that will be controlling that hazard, and supplier performance.) Another entity in the supply chain, such as a broker or distributor, can conduct supplier verification activities, but the receiving facility must review and assess that entity’s documentation that they verified the supplier’s control of the hazard.

Recall plan: If the hazard analysis identifies a hazard requiring a preventive control, the facility must have a written recall plan that describes the procedures to perform a recall of the product. The recall plan must include procedures to notify consignees, to notify the public when necessary, to conduct effectiveness checks and to appropriately dispose of recalled product.

Does FSMA require HACCP?

What is the difference between a HACCP Plan and a FSMA Food Safety Plan? First of all, HACCP stands for Hazard Analysis and Critical Control Points. According to the USDA, HACCP is a “systematic approach to the identification, evaluation, and control of food safety hazards.” Basically, the approach centers on identifying the key steps (the “control points”) in food processing where safety risks can be eliminated or reduced to an acceptable level.

So, what is the difference between a Food Safety Plan and a HACCP plan? According to Dr. Mark Morgan Professor of Food Processing and Extension Specialist at UT Knoxville, a Food Safety Plan, under the Preventive Controls for Human Foods Rules of the Food Safety Modernization Act (FSMA) is a replacement or extension of HACCP.

Dr. Morgan explains “the difference between a Food Safety Plan (under FSMA) and a HACCP plan is that a Food Safety Plan includes: process preventive controls, sanitation preventive controls, allergen preventive controls, and supply chain preventive controls to address potential hazards.

1. The HACCP program only has critical control points (CCPs) which are essentially equivalent to process preventive controls.
2. When referring to Grade A milk processing, the PMO covers biological hazards.
3. So, a Food Safety Plan is only needed (required by FDA) to address chemical and physical hazards.
4. For other dairy products, not part of the PMO, a Food Safety Plan must cover all potential hazards, biological, chemical, and physical.” When does a dairy processor need a HACCP plan vs.

a Food Safety Plan? According to Paul Wadham at the Tennessee Department of Agriculture, the FDA requires a Food Safety Plan for dairy processors that sell across state lines and are included on the Interstate Milk Shippers (IMS) list. Dr. Morgan notes that “Food Safety Plans are now required for essentially any food regulated by FDA except those that have specific regulations such as PMO, juice HACCP, Seafood HACCP, and Meat HACCP, etc.

• Also, there is an exemption under FSMA for “qualified facilities”.
• This is a complex part of the regulation (21 CFR part 117 subpart D) but basically, someone can claim to be exempt based on being a ‘small’ processor.” The most common situation where a dairy processor would need a HACCP plan is when they are also processing juice.

Producing juice or juice drinks can be a great way to fill out the production schedule for a dairy processor who has unused plant capacity. But doing so requires submitting to FDA inspection and abiding by the Juice HACCP Regulation (). Dairy processors who need to develop or update a Food Safety Plan that complies with FSMA should take the Preventive Controls for Human Foods Course ().

• By passing this course, a person can become a Preventive Controls Qualified Individual (PCQI).
• Having a PCQI on staff or under contract is one of the requirements to implement a Food Safety Plan under FSMA.
• For those who are looking to expand their product offerings to juice, a short course on HACCP is also available at many universities including UT ().

: What is the difference between a HACCP Plan and a FSMA Food Safety Plan?

What is FDA approval?

FDA Approval: What it means – FDA approval of a drug means that data on the drug’s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population. The drug approval process takes place within a structured framework that includes:

Analysis of the target condition and available treatments —FDA reviewers analyze the condition or illness for which the drug is intended and evaluate the current treatment landscape, which provide the context for weighing the drug’s risks and benefits. For example, a drug intended to treat patients with a life-threatening disease for which no other therapy exists may be considered to have benefits that outweigh the risks even if those risks would be considered unacceptable for a condition that is not life threatening. Assessment of benefits and risks from clinical data —FDA reviewers evaluate clinical benefit and risk information submitted by the drug maker, taking into account any uncertainties that may result from imperfect or incomplete data. Generally, the agency expects that the drug maker will submit results from two well-designed clinical trials, to be sure that the findings from the first trial are not the result of chance or bias. In certain cases, especially if the disease is rare and multiple trials may not be feasible, convincing evidence from one clinical trial may be enough. Evidence that the drug will benefit the target population should outweigh any risks and uncertainties. Strategies for managing risks —All drugs have risks. Risk management strategies include an FDA-approved drug label, which clearly describes the drug’s benefits and risks, and how the risks can be detected and managed. Sometimes, more effort is needed to manage risks. In these cases, a drug maker may need to implement a Risk Management and Mitigation Strategy (REMS).

Although many of the FDA’s risk-benefit assessments and decisions are straightforward, sometimes the benefits and risks are uncertain and may be difficult to interpret or predict. The agency and the drug maker may reach different conclusions after analyzing the same data, or there may be differences of opinion among members of the FDA’s review team.

As a science-led organization, FDA uses the best scientific and technological information available to make decisions through a deliberative process. Accelerated Approval In some cases, the approval of a new drug is expedited. Accelerated Approval can be applied to promising therapies that treat a serious or life-threatening condition and provide therapeutic benefit over available therapies.

This approach allows for the approval of a drug that demonstrates an effect on a “surrogate endpoint” that is reasonably likely to predict clinical benefit, or on a clinical endpoint that occurs earlier but may not be as robust as the standard endpoint used for approval.

This approval pathway is especially useful when the drug is meant to treat a disease whose course is long, and an extended period of time is needed to measure its effect. After the drug enters the market, the drug maker is required to conduct post-marketing clinical trials to verify and describe the drug’s benefit.

If further trials fail to verify the predicted clinical benefit, FDA may withdraw approval. Since the Accelerated Approval pathway was established in 1992, many drugs that treat life-threatening diseases have successfully been brought to market this way and have made a significant impact on disease course.

Why do we need FDA approval?

The FDA approves new human drugs and biological products. – New drugs and biological products for people must be FDA approved before they are marketed in interstate commerce. This means that a company must demonstrate that its drug or biological product is safe and effective for the intended use, and that it can manufacture the product to federal quality standards.

• If the FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the risks for the intended use.
• Some examples of biological products that require approval are therapeutic proteins, vaccines, allergenic products, cellular and gene therapies, and products manufactured from plasma.

Manufacturers must also prove that they are able to make the drug or biological product according to federal quality standards. The FDA does not develop products before approving them. Instead, FDA experts conduct a careful evaluation of the results of laboratory, animal, and human clinical testing done by manufacturers.

A directory of approved and unapproved finished drugs on the market. A complete list of licensed biological products.

What is a food safety policy?

What is a food safety policy? – A food safety policy is your organisation’s commitment to providing safe and suitable food. Food safety is important as it helps to protect your consumers from the risk of food borne illnesses. It also helps to prevent consumers from risks of health–related conditions such as allergy and even death.

Is HACCP the same as food safety?

Hazard Analysis and Critical Control Points (HACCP) is a preventive food safety strategy that is a systematic approach to the identification and assessment of the risk of hazards from a particular food or food production process or practice and the control of those hazards that are reasonably likely to occur.

What is the first step of a HACCP plan?

HACCP PRINCIPLES – HACCP is a systematic approach to the identification, evaluation, and control of food safety hazards based on the following seven principles: Principle 1: Conduct a hazard analysis. Principle 2: Determine the critical control points (CCPs).

What is the objective of FSMA 2000?

The Financial Services and Markets Act 2000 ( c 8 ) is an Act of the Parliament of the United Kingdom that created the Financial Services Authority (FSA) as a regulator for insurance, investment business and banking, and the Financial Ombudsman Service to resolve disputes as a free alternative to the courts.

What are FSMA process preventive controls?

Learn about the FSMA Produce Safety and Preventive Controls for Human Food Rules (Video) – Are your produce crops or processed food products covered under the Food Safety Modernization Act (FSMA). In this 28-minute video, you will learn if your farm or food business is affected by FSMA. Details on the Produce Safety and Preventive Controls for Human Foods rules are also covered. Watch the video >>

What is the FSMA financial promotion restriction?

The effect of section 21 of the Act (Restrictions on financial promotion) is that in the course of business, an unauthorised person must not communicate an invitation or inducement to engage in investment activity or to engage in claims management activity unless either the content of the communication is approved for

What is the downside of FSMA?

The Pros and Cons of FSMA – On the positive side, most health advocates recognize that FSMA is a genuinely progressive piece of legislation with many new benefits and powers. Since its passage:

The FDA at long last has shifted its regulatory approach from reacting to food safety problems to preventing them. FSMA articulates food safety objectives that were once vague, and clarifies compliance expectations through guidance and training. Food safety management systems ( FSMS ) are now mandatory, rather than optional. The FDA’s ability to identify, track, and trace particular strains of pathogens back to their sources has improved due to new testing methods. The FDA can now suspend a facility’s registration and shut down its operations if it does not respond swiftly and effectively to a food safety concern that puts the public at risk.

On the negative side, FSMA has obvious weaknesses:

The FDA is incapable of full enforcement for lack of funding, staffing, inspections, and education. The FDA must, therefore, rely on other agencies for enforcement assistance, increasingly complexity, redundancy, and gaps in communication. High-risk foods, such as fresh produce, still require much better requirements for product tracking. Many small operations are exempt from FSMA. FSMA is weak regarding newer, more nuanced methods of food delivery.

Jack Gloop