The FDA recently released new final Food Safety Modernization Act (FSMA) rules. These rules are the result of amendments made to the original proposals, based on comments and criticisms in public forums. Below are important details of two rules. You can find a full explanation of each new rule here.
1. Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
The FSVP rule outlines certain risk-based activities importers must perform to ensure that imported foods have been produced in adherence to applicable U.S. safety standards.
Below are six key requirements the FSVP rule establishes:
- Scope—An FSVP is a program importers must have in place to verify that their foreign suppliers are producing food with the same level of public health protection as applicable preventive controls and regulations. Importers that are also manufacturers/processors are deemed in compliance with supply-chain program requirements under the preventive controls rule if:
- They are in compliance with the supply-chain program requirements under the preventive controls rules.
- They implement preventive controls for hazards in the food based on requirements in the preventive controls rules.
- They are not required to implement preventive controls in certain circumstances including:
- When the type of food (e.g., such as coffee beans) could not be consumed without application of a preventive control.
- When the customer will be significantly minimizing or preventing identified hazards and they comply with requirements for disclosures and written assurances.
- Hazard analysis—Importers must identify and evaluate reasonably foreseeable hazards for each type of food they import. Their analysis must assess the likelihood of the hazard and the severity of harm that may result, and include the following factors:
- Formulation of the food
- Condition, function and design of the establishment and equipment of a typical entity that produces the food
- Raw materials and other ingredients
- Transportation practices
- Harvesting, raising, manufacturing, processing and packing procedures
- Packaging and labeling activities
- Storage and distribution
- Intended or reasonably foreseeable use
- Sanitation, including employee hygiene
- Evaluation of food risk and supplier performance—An importer must evaluate factors like:
- The hazard analysis
- The supplier and its food safety history
- Applicable FDA food safety regulations
- Supplier verification—The importer must follow written procedures to ensure that it only imports from approved foreign suppliers and conducts appropriate supplier verification activities. Importers have the flexibility to tailor supplier verification activities to unique food risks and supplier characteristics. The options include:
- Annual on-site audits of the supplier’s facility, which is required when there is a reasonable exposure to a hazard controlled by the foreign supplier that will result in serious adverse health consequences or death to humans or animals (called a SAHCODHA hazard)
- Sampling and testing
- A review of the supplier’s relevant food safety records
- Corrective actions—Importers must take appropriate corrective actions if they determine a foreign supplier has not used processes or procedures that comply with applicable preventive controls or regulations.
- Exemptions and modified standards—There are several modifications and exemptions to the FSVP rule, including:
- Modified requirements for very small importers and importers of food from certain small suppliers
- Modified requirements pertaining to a foreign supplier in a country whose food safety system is recognized as comparable or equivalent to that of the United States
- Exemptions for certain categories of imported food, including:
- Juice, fish and fishery products
- Food for research or evaluation
- Food for personal consumption
- Alcoholic beverages and certain ingredients for use in alcoholic beverages
- Food imported for processing and future export
- Low-acid canned foods (LACF) with respect to microbiological hazards covered by other regulations
- Certain meat, poultry and egg products regulated by the USDA at the time of importation
- The latest date importers must comply with the FSVP regulations is 18 months after the publication of the final rule.
- For importation of food from a supplier subject to the preventive controls or produce safety rules: six months after the foreign supplier is required to meet the relevant regulations.
- For an importer that is a manufacturer or processor subject to provisions in the preventive controls regulations: the date it has to comply with those provisions.
2. Accredited Third-Party Certification Final Rule
The Accredited Third-Party Certification rule establishes a voluntary program for the accreditation of third-party certification bodies, or auditors, to conduct food safety audits and issue certifications of foreign facilities and the foods they produce.
Below are four key features of the Third-Party Certification rule:
- Scope—This rule establishes the framework, procedures and requirements for accreditation bodies seeking recognition by the FDA, as well as requirements for third-party certification bodies seeking accreditation. These requirements cover:
- Legal authority
- Conflict-of-interest safeguards
- Quality assurance
- Record procedures
- Requirements for recognized accreditation bodies—Recognized accreditation bodies will be required to:
- Assess third-party certification bodies for accreditation
- Monitor the performance of the third-party certification bodies it accredits
- Assess and correct any problems in their own performance and submit monitoring and self-assessment reports to the FDA
- Maintain and provide the FDA access to required records
- Requirements for third-party certification bodies—Third-party certification bodies are required to perform unannounced facility audits, as well as:
- Ensure their audit agents are competent and objective
- Verify the effectiveness of corrective actions
- Assess and correct any problems in their own performance and provide the FDA required records
- Related FDA actions—The FDA provides draft recommendations on the qualifications that third-party certification bodies should have in education and experience. Those recommendations can be found in the Model Accreditation Standards draft guidance document.
The mandatory certification authority under the FSMA does not apply to:
- Alcoholic beverages manufactured by foreign facilities
- Meat, poultry and egg products subject to USDA oversight at the time of importation
Note: This program is not yet in effect, but the FDA intends to implement it as soon as possible after publication of the final Model Accreditation Standards guidance, and the final user fee rule.
If you have more questions about the new FSMA final rules, email me at email@example.com.
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