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Food Safety Modernization Act (FSMA)

The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on January  4, 2015 enables FDA to better protect public health by strengthening the food safety system by focusing on preventative controls.  The law also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur.  The law applies to food for humans as well as for animals. The regulations enforcing the law and the effective compliance dates differ for human food and for animal food and depending on the size of the food facility. Three main components of the law for pet food manufacturers  are Good Manufacturing Practices (CGMPs) a Hazard Anaylsis and Critical Control Point (HACCP) plan, which may be necessary depending on the size of the business, and if you import foods, compliance with a Foreign Supplier Verification Program. Additional requirements include the retention of records and registration of food facilities to be provided and updated by registering with the FDA, that was initially required under the Bioterrorism Act and control procedures for transporters.

FSMA Final Rule for Preventive Controls for Animal Food 

The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food rule is  final, and compliance dates for some businesses began in September 2016. See this Compliance Guide for Industry for further details on CGMPs and HACCP.

Key Requirements

1. Current Good Manufacturing Practices (CGMPs) established for animal food production.  The FDA has finalized baseline CGMP standards for producing safe animal food that take into consideration the unique aspects of the animal food industry and provide flexibility for the wide diversity in types of animal food facilities. For more detailson the requirements please see the FDA's Small Entity Compliance Guide What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals 

2. Covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. The rule sets requirements for 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).
  • Preventive controls: These measures are required to ensure that hazards requiring a preventive control will be minimized or prevented.
  • Oversight and management of preventive controls: The final rule provides flexibility in the steps needed to ensure that preventive controls are effective and to correct problems that may arise.
  • 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, proper refrigeration could be documented with either affirmative records demonstrating temperature is controlled or "exception records" demonstrating loss of temperature control.
  • Verification: These activities are required to ensure that preventive controls are consistently implemented and effective. They include validating with scientific evidence that the control is capable of effectively controlling an identified hazard; confirming implementation and effectiveness; and verifying that monitoring and corrective actions (if necessary) are being conducted. Product testing and environmental monitoring are possible verification activities but are only 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.
  • Recall plan: Every facility that produces animal food with a hazard requiring a preventive control must have a recall plan. 
 Foreign Supplier Verification Program (FSVP)

FSVP requires importers to verify that their foreign suppliers of food for human and animal consumption meet applicable FDA safety standards.  More specifically, FSVP requires that importers verify that their suppliers are producing food using processes and procedures that offer the same level of public health protection as the preventive controls (PC) requirements in the preventive controls and current good manufacturing practices rules for human food and animal food and produce safety FSMA rules, and that the food is not adulterated and properly labeled with respect to allergens. The FDA has set up an accredited Third Party Certification program to conduct inspections at foreign facilities. Here is a talking point discussion on the FSVP from the FDA on: What Do Importers Need to Know?

Compliance Dates

Businesses have a staggered number of years after publication of the final rule to comply, based on business size. In addition, there will be staggered compliance between the CGMP requirements and the Preventive Control Requirements

Preventive Controls for Animal Feed 8-30-15=  1 year after final rule 8-30-16

Small Business Compliance Period (less than 500 employees business-wide) Preventive Controls for Animal Feed 8-30-15 = 2 years from final rule 8-30-17

Very Small Business Compliance Period (business has annual food sales below the applicable limit) PC Animal Feed < $2.5M 8-30-15= 3 years from final rule 8-30-18

 

 Additional Information:

Frequently Asked Questions about FSMA

FSMA Training

FSMA Technical Assistance Network