Food Safety Modernization Act

Why Preventive Controls?

According to the FDA, “About 48 million people or 1 in 6 Americans get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable”. Thus FDA’s new food low for US imports and local manufacturing, Food Safety Modernization Act (FSMA), signed into law by President Obama on January 4th 2011, enables FDA to better protect public health by strengthening the food safety system which enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. Building a new food safety system based on prevention will take time, and FDA is creating a process for getting this work done where Congress has established specific implementation dates in the legislation. The FSMA is starting to rule from 1st January 2016, where importers from many part of the world as well as local manufacturers now need to update their systems against new compliances of FSMA.  

FDA is committed to implementing the requirements through an open process with opportunity for input from all stakeholders. The following are among FDA's key new prevention authorities and mandates. Specific implementation dates specified in the law are noted in parentheses:

For the first time, FDA will have a legislative mandate to require comprehensive, science based preventive controls across the food supply. This mandate includes:

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)

Preventive Controls for Human Food

Since the FDA’s, Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final, and compliance dates for some businesses begin in September 2016. This final rule is the product of an unprecedented level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local and tribal regulatory counterparts, academia and other stakeholders. This outreach began before the rule was proposed in January 2013. In response to input received during the comment period and during hundreds of engagements that included public meetings, webinars, listening sessions, and visits to farms and food facilities across the country, the FDA issued a supplemental notice of proposed rulemaking in September 2014. The proposed revisions were designed to make the originally proposed rule more practical, flexible, and effective for industry, while still advancing the FDA’s food safety goals. The final rule has elements of both the original and supplemental proposals, in addition to new requirements that are the outgrowth of public input received during the comment period for both proposals.

The final rule largely reflects the January 2013 original proposed rule as modified by the September 2014 supplemental proposed rule, but with modifications and few new requirements in response to public input. For example, additional flexibility has been built into key requirements, including supply chain   controls,   and   the   definition of "farms" which are exempt from preventive controls requirements.

The final rule creates certain new requirements for the production of human food by registered food facilities, and revises previous requirements, in three key ways:

First, the final rule modernizes FDA's long-standing current good manufacturing practice (CGMP) regulations, which govern the manufacturing, processing, packing, or holding  of human food. Importantly, it imposes minimum training requirements for all employees involved in manufacturing, processing, packing, or holding food (including temporary and seasonal employees).  All such employees must be "qualified individuals" (i.e., must have education, training, or experience appropriate to perform their assigned duties) and must receive training in the principles of food hygiene and food safety.

Second, the final rule requires that covered facilities to establish and implement hazard analysis and risk-based preventive controls for human food. In general, these requirements apply to establishments that are required to register with FDA as a food "facility." This portion of the final rule requires registered food facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the control of those hazards, unless an exemption applies.  Facilities must also monitor their preventive controls, conduct verification activities to ensure the preventive controls are effective, take appropriate corrective actions, and maintain records documenting these actions.

Third, the final rule clarifies the scope of the exemption for farms in FDA's current food facility registration regulations, and makes corresponding revisions to FDA's current regulations for the establishment, maintenance, and availability of records. These revisions affect who is subject to the existing regulations for registration and recordkeeping, as well as the new requirements for hazard analysis and risk-based preventive controls established in the final rule. The definition of "farm" now includes both "primary production farms" and "secondary activities farms," the latter being an off-farm operation engaged in harvesting, packing or holding raw agricultural commodities in which the primary production farm that provides most of the raw agricultural commodities owns a majority interest.

The new preventive controls requirements, implementing section 418 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), include the following requirements:

Covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls.

The final rule sets requirements for a written food safety plan that includes:

Hazard analysis;

Preventive controls; and

Oversight and management of preventive controls, including:

Monitoring;

Corrective actions and corrections; and

Verification;

A covered facility also would be required to maintain associated records and have a recall plan.

The definition of a "farm" is clarified to cover two types of farm operations:

Primary Production Farm; and

Secondary Activities Farm;

Operations defined as farms are not subject to the preventive controls final rule.

Primary  Production  and  Secondary  Activities  Farms  conducting  activities  on  produce  covered  by  the Produce Safety final rule will be required to comply with that final rule.

The supply chain program is made more flexible, with separate compliance dates established.