Preventive Controls for Human Food

The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final, and compliance dates for some businesses began 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. For example, flexibility has been built into key requirements, including control of the supply chain, and the definition of farms— which are exempt from these regulations— has significantly changed to reflect modern farming practices.

Related Links

• FDA Final Rule for Preventative Controls for Human Food Factsheet

Training Options

• Food Safety Preventive Controls Alliance Training
• Preventive Controls Qualified Individual Training
• GMPs Part 117 Online Course

Preventive Controls for Animal Food

The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food rule is now final, and compliance dates for some businesses began 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 October 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 preventive controls proposals.

Related Links

• Final Rule for Preventive Controls for Animal Food Factsheet

Produce Safety

What is the FSMA Produce Safety Rule?

The Produce Safety Rule is part of the FDA Food Safety Modernization Act (FSMA) that was passed by President Obama on January 4, 2011. This regulation focuses on setting the first-ever federal regulatory standards for the production, harvest, and handling of fruits and vegetables, in an effort to prevent microbial contamination and reduce foodborne illnesses associated with fresh produce. The Produce Safety Rule was made available publicly on November 13, 2015 and was published in the Federal Register on November 27, 2015.

What does the FSMA Produce Safety Rule cover?

The Produce Safety Rule, outlined in Section 105 of FSMA, establishes science-based minimum standards for safe production and harvesting of fresh fruits and vegetables. These standards are based on a foundation of Good Agricultural Practices (GAPs).

The rule is divided into several parts, including standards for:

• Worker health, hygiene, and training
• Agricultural water, both for production and post-harvest uses
• Biological soil amendments (e.g., compost, manure)
• Domesticated and wild animals
• Equipment, tools, buildings, and sanitation
• Production of sprouts*

*The Sprout Safety Alliance, based at the Illinois Institute of Technology, is developing a core curriculum, training and outreach programs for stakeholders in the sprout production community to enhance the industry's understanding and implementation of best practices for improving sprout safety, and requirements for sprout producers included in the FSMA Produce Safety Rule.

Will my farm be subject to the regulation?

If you grow, pack, process, or sell fresh produce, this regulation may apply to you. Review § 112.1—112.7 of the regulation to determine if your farm and the commodities you grow are subject to the regulation. You can also refer to the FDA’s factsheet on coverage, exclusions, and exemptions to help you determine whether you are subject to the regulation.

Here are a few key exemptions and exclusions:

• The rule does not apply to certain specified produce commodities that are rarely consumed raw. You can find the list of produce not covered by the regulation in § 112.2.
• The rule does not apply to produce that is used for personal or on-farm consumption, or that is not a Raw Agricultural Commodity (RAC).
• The rule provides an exemption for produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance (e.g., via a “kill step”) as long as certain disclosures are made and written assurances are received, with appropriate documentation.
• The rule does not cover produce farms that have an average annual value of produce sold during the previous 3-year period of $25,000 or less.
• The rule provides a qualified exemption and modified requirements for farms that meet two requirements: (1) the farm must have food sales averaging less than $500,000 per year during the previous 3 years; and (2) the farm’s sales to qualified end-users must exceed sales to others.

A qualified end-user is either: (1) the consumer of the food or (2) a restaurant or retail food establishment that is located in the same State or the same Indian reservation as the farm or not more than 275 miles away. Instead, these farms are required to include their name and complete business address either on the label of the produce that would otherwise be covered (if a label is required under the FD&C Act and its implementing regulations) or to display the same information at the point-of-purchase. These farms are also required to establish and keep certain documentation (See § 112.7).

Related Links

• FSMA Final Rule on Produce Safety Factsheet

Training Options

• Produce Safety Alliance - Training Information to help with Compliance

Foreign Supplier Verification Program

The FDA FSMA rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals became final January 26, 2016, and compliance dates for some businesses begin over the following 18 months.

The final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. This rule is the product of a significant level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local, tribal and international regulatory counterparts, academia and other stakeholders. The FDA first proposed this rule in July 2013.

After input received during the comment period and during numerous engagements that included public meetings, webinars, and listening sessions, the FDA issued a supplemental notice of proposed rulemaking in September 2014. The proposed revisions included providing importers flexibility in determining appropriate verification measures based on food and supplier risks, while acknowledging the greater risk to public health posed by the most serious hazards in foods.

The final rule has elements of both the original and supplemental proposals, with the addition of greater flexibility in meeting certain requirements to better reflect modern supply and distribution chains. For example, importers can meet key FSVP obligations by relying on analyses, evaluations and activities performed by other entities in certain circumstances, as long as those importers review and assess the corresponding documentation.

The FDA is responsible for ensuring that importers meet the FSVP requirements, and will also provide guidance, outreach and training.

Related Links

• FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Factsheet

Training Options

• Foreign Supplier Verification Program Workshop

Third Party Certification

The FDA FSMA rule on the Accredited Third-Party Certification is now final.

This rule, proposed in July 2013, establishes a voluntary program for the accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. These requirements will help ensure the competence and independence of the accreditation bodies and third-party certification bodies participating in the program.

Foreign entities may use certifications for two purposes:

• Certifications may be used by importers to establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food.
• To prevent potentially harmful food from reaching U.S. consumers, the FDA can also require in specific circumstances that a food offered for import be accompanied by a certification from an accredited third-party certification body.

Related Links

• FSMA Final Rule on Accredited Third-Party Certification Factsheet

Sanitary Transportation

The FDA Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food is now final, advancing FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation. The earliest compliance dates for some firms begin one year after publication of the final rule in the Federal Register.

This rule is one of seven foundational rules proposed since January 2013 to create a modern, risk-based framework for food safety. The goal of this rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food.

The rule builds on safeguards envisioned in the 2005 Sanitary Food Transportation Act (SFTA). Because of illness outbreaks resulting from human and animal food contaminated during transportation, and incidents and reports of unsanitary transportation practices, there have long been concerns about the need for regulations to ensure that foods are being transported in a safe manner.

The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. The requirements do not apply to transportation by ship or air because of limitations in the law.

Specifically, the FSMA rule establishes requirements for vehicles and transportation equipment, transportation operations, records, training and waivers.

Related Links

• FSMA Final Rule on Sanitary Transportation of Human and Animal Food Factsheet
• FSMA Webinar: Final Rule on Sanitary Transportation of Human and Animal Food

Intentional Adulteration

The FDA Food Safety Modernization Act (FSMA) final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Such acts, while not likely to occur, could cause illness, death, economic disruption of the food supply absent mitigation strategies.

Rather than targeting specific foods or hazards, this rule requires mitigation (risk-reducing) strategies for processes in certain registered food facilities.

The proposed rule was issued in December 2013. The changes in the final rule are largely designed to provide either more information, where stakeholders requested it, or greater flexibility for food facilities in determining how they will assess their facilities, implement mitigation strategies, and ensure that the mitigation strategies are working as intended.

In developing the rule, FDA interacted with the intelligence community and considered vulnerability assessments conducted in collaboration with the food industry.

While acts of intentional adulteration may many other forms, including acts of disgruntled employees or economically motivated adulteration, the goal of this rule is to prevent acts intended to cause wide-scale harm. Economic adulteration is addressed in the final preventive controls rules for human and animal foods.

Related Links

• FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration Factsheet
• Presentation on the Final Rule for Intentional Adulteration

Training Options

• Intentional Adulteration Vulnerability Assessment Course