NCFC urges that any food safety legislation and regulations be based on sound science—they should also be risk-based and commodity specific. American consumers must have confidence that their food is safe and that the best science is being used to ensure the most wholesome product possible.
As the implementation of the food safety law continues, we must ensure food safety regulations enhance our nation’s food safety, while avoiding negative impacts to farmer cooperatives and their producer members. NCFC will continue to educate members of Congress and the Administration on this important issue, highlighting that America’s farmers and ranchers are committed to providing a safe and affordable food supply for consumers globally.
In early 2013, the Food and Drug Administration (FDA) began the process of implementing the Food Safety Modernization Act (FSMA). Since then, FDA has released all seven of the major proposed rules to implement FSMA. After reviewing stakeholder comments, FDA decided significant changes were needed in key provisions of four of the major proposed rules; the Human Preventive Controls, Produce Safety, Foreign Supplier and Animal Feed rules. Due to the significance of these changes, FDA released revised rule language in the fall of 2014 and allowed the public to comment on the revised provisions of those four rules. Currently, five of the seven rules have been finalized and the remaining final rules will be published spring 2016, based on court ordered deadlines.
The first two rules FDA finalized, the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food rule (Human Preventive Controls rule) and the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals rule (Animal Feed rule), were published on September 10, 2015.
The Human Preventive Controls final rule requires covered facilities to create and implement a food safety plan composed of a hazard analysis and risk-based preventive controls. The final rule also updated and clarified binding provisions under the Current Good Manufacturing Practices (CGMPs). Compliance dates are staggered over several years based on size with some businesses expected to comply with the new regulation as early as September 2016.
|Business Size||CGMPs & Preventive Controls Compliance Dates|
|Very Small Businesses (averaging less than $1 million per year, adjusted for inflation, in both annual sales of human food plus the market value of human food manufactured, processed, packed or held without sale)||Three Years *Except for records to support its status as a small business (January 1, 2016)|
|Businesses Subject to the Pasteurized Milk Ordinance (extended time to allow for changes to the PMO safety standards that incorporate the requirements of this rule)||Three Years|
|Small Businesses (less than 500 full-time equivalent employees)||Two Years|
|All Other Businesses||One Year|
|Business Classification ||Compliance Date for Supply Chain Program |
|If receiving facility is a small business and its supplier will not be subject to the human preventive controls rule or the produce safety rule||Two Years|
|If receiving facility is a small business and its supplier will be subject to the human preventive controls rule or the produce safety rule||Two Years OR six months after the supplier is required to comply with the applicable rule, whichever is later|
|If receiving facility is not a small or very small business and its supplier will not be subject to the human preventive controls rule or the produce safety rule||18 Months|
|If receiving facility is not a small or very small business and its supplier will be subject to the human preventive controls rule or the produce safety rule||Six Months after the supplier is required to comply with the applicable rule|
The Animal Feed final rule, similar to the Human Preventive Controls rule, requires covered facilities to create and implement a food safety plan composed of a hazard analysis and risk-based preventive controls. The final rule sets requirements for a written food safety plan and baseline CGMP standards for producing animal food.
|Business Size||CGMP Compliance Date||Preventive Controls Compliance Date|
|Business other than small and very small||One Year||Two Years|
|Small business (less than 500 full-time equivalent employees)||Two Years||Three Years|
|Very small business (averaging less than $2,500,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed, or held without sale (e.g., held for a fee or supplied to a farm without sale).||Three Years||Four Years *Except for records to support its status as a very small business (January 1, 2017)|
The next three final rules, the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule (Produce Safety rule), the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals rule (Foreign Supplier rule) and the Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications rule (Accreditation rule) were published on November 27, 2015.
The Produce Safety final rule involves enforceable science- and risk-based safety standards for the production and harvesting of produce on-farms. This regulation is significant as it is the first time the FDA has regulated on-farm activity. The final rule imposes new standards for growers on water quality, testing, manure use, worker training, and the presence of animals in production fields. However, there are exemptions for produce rarely consumed raw, produce used for personal or on-farm consumption, and farms with produce sales of $25,000 or less.
|Compliance dates for covered actives (except for those involving spouts) after the effective date if the final rule are: |
|Size of Covered Farm:||Compliance Date:|
|Very small businesses (businesses with more than $25,000 but no more than $250,000 in average annual produce sales during the previous three year period)||Four Years|
|Small businesses (businesses with more than $250,000 but no more than $500,000 in average annual produce sales during the previous three year period)||Three Years|
|All other farms||Two Years|
|The compliance dates for certain aspects of the water quality standards, and related testing and recordkeeping provisions, allow for an additional two years beyond each of these compliance dates.|
The Foreign Supplier final rule would require importers to ensure that food brought into the United States is in compliance with our domestic food safety standards, including identifying and evaluating potential hazards and properly labeling food allergens.
Importers must comply with the Foreign Supplier Verification Program regulations by May 2017. For the importation of food from a supplier that is subject to the Preventive Controls or Produce Safety rules, the compliance date is six months after the foreign supplier is required to meet those relevant regulations. For an importer that is a manufacturer or processor, subject to the supply-chain program provisions in the Preventive Controls rule, they will need to comply by the date specified in those provisions.
The Accreditation final rule establishes a voluntary program for the accreditation of third-party certification bodies or auditors to preform food safety audits and certify facilities abroad. Foreign entities may use certifications to qualify for participation in the Voluntary Qualified Importer Program (VQIP), which allows for expedited review and entry of products into the U.S. The certifications also ensure the safety of the food foreign entities are shipping to U.S. consumers. Compliance dates are contingent on FDA finalizing the Model Accreditation Standards guidance and user fees for accreditation and certification bodies.
FDA then finalized the Sanitary Transportation of Human and Animal Food (Sanitary Transportation rule) on April 6, 2017. The final rule requires those who transport food to use sanitary transportation practices, such as proper refrigeration, adequate vehicle cleaning between loads and protecting food from the elements, to ensure the safety of food being transported. The rule will impact shippers, loaders, motor and rail vehicle carriers and receivers transporting human and animal food. Some firms will be required to comply as early as one year after publication of the rule in the Federal Register (April 6, 2017).
The last rule to be finalized was the Focused Mitigation Strategies to Protect Food Against Intentional Adulteration rule (Intentional Adulteration rule). The rule was announced May 26, 2016. The focus of the final rule is to protect food from the threat of intentional adulteration including acts of terrorism or actions by disgruntled employees. As the Agency notes, the likelihood of such acts are minimal, however, if carried out they would have a wide ranging impact. Therefore, the FDA believes this proactive approach to mitigate risks is important to protect the public’s safety and avoid economic disruption.
The rule primarily covers large companies and does not apply to farms. FDA acknowledges that many of the food facilities covered by this final rule will also have to comply with other FSMA regulations. To account for this, FDA is offering a lengthier compliance timeline for the Intentional Adulteration rule. Large companies will have three years to comply and smaller companies will have an additional one to two years depending on their size.
|Business Size||Compliance Timeline|
|Very Small Businesses—a business averaging under $10,000,000/year (adjusted for inflation) during the three-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale||(modified requirements only) Five years after the publication of the final rule|
|Small Businesses—a business employing fewer than 500 persons||Four years after the publication of the final rule|
|Other Businesses—a business that is not small or very small and does not qualify for exemptions||Three years after the publication of the final rule|
NCFC continues to work with the Agency and our members to ensure a successful implementation of the law.