The FSMA gives the Food and Drug Administration (“FDA”) authority to regulate food grown, harvested, or processed in the US or elsewhere. The FDA has the duty to better protect public health preventing ex ante rather than curing ex post stronger control over the manufacturing process. The FSMA reregulated the role that the FDA plays, awarding it with new authority which includes the right to issue a mandatory recall (when and if the manufacturer or importer fails to conduct a voluntary recall) and the right to detain articles of food that they have reason to believe are adulterated or misbranded.

The Act is organized into three areas: (a) Preventive Control; (b) Foreign Supplier Verification Program; (c) Accredited Third Party Certification.

(a) Preventive Control Rules: Human Food

Food facilities must prepare a food safety plan that is updated at least one every three years. A person termed as “A preventive controls qualified individual” who has completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system, must prepare or oversee the preparation of the food safety plan. The facilities that are covered must establish a food safety system that includes: Hazard analysis; Preventive control; and Oversight and management.

(b) Foreign Supplier Verification program (FSVP)

An importer who is the U.S owner or consignee of food offered for import into the U.S. and the U.S agency or representative of a foreign owner of a consignee at the time of entry has to comply with the requirements of FSMA. The importers are subject to all the product safety rules, the preventive controls, the risk assessment and supplier verification activities
required by the domestic market with the below additions:

• Importers are required to develop, maintain and follow a FSVP for each food brought into the U.S from a supplier.
• Importers who establish and verify compliance under the Current Good Manufacturing Practices regulations will not be required to comply with most FSVP standard.
• A written assurance that from the Customer that he/ she is compliant with the requirements states above is required.

Imported food not covered by the FSVP include: Juice; Fish and fishery products which are subject to FDA’s hazard Analysis and Critical Control Point regulations; Food for research and personal consumption; Alcoholic beverages; Food that is imported for processing and future export; Certain canned food; and products regulated by the U.S Department of Agriculture (USDA).

(c) Accredited Third-Party Certification

Third party certification bodies conduct food safety audits and issue certifications to foreign facilities for foods for human and animal consumption they produce. Foreign entities may use certification for two purposes: a) To establish eligibility for participation in the Voluntary Qualifies Importer Program (VQIP), which offers expedited review and entry of food; b) 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.

Requirements for recognized accreditation bodies (private or public/governmental entities) are:

• Assess third party-certification bodies for accreditation, including observing a representative sample of the prospective certification body’s work;
• Monitor performance of the third-party certification bodies it accredits, including periodically conducting on-site observations, and notifying the FDA of any change in, or withdrawal of, accreditations it has granted;
• Assess and correct any problems in their own performance;
• Submit monitoring and self-assessment reports and other notifications to the FDA;
• Maintain and provide the FDA access to records required to be kept under the program.

Which are the FSMA Compliance Dates?

FSVP importer whose foreign supplier is not subject to the PC or produce safety rules: May 30, 2017.
FSVP importer whose foreign supplier is required to comply with the PC rule for human food. Compliance dates when foreign suppliers are in these categories:

• Small businesses (Less than 500 employees): March 19, 2018.
• Qualified Facilities (including Very Small Businesses): March 18, 2019.
• Suppliers subject to the Pasteurized Milk Ordinance: March 18, 2019.
• “All Other” Businesses Suppliers: May 30, 2017.

FSVP importers of animal food whose foreign supplier is subject to the current good manufacturing practices (“CGMP”) requirements in subpart B of 21 CFR part 507 in the PC rule for animal food. Compliance dates when foreign suppliers are in these categories:

• Small Businesses as defined: March 19, 2018.
• Qualified Facilities (including Very Small Businesses): March 18, 2019.
• “All Other” Businesses: May 30, 2017.

FSVP importer whose foreign supplier is required to comply with the animal food preventive controls requirements in subpart C of part 507 of the PC rule for animal food, but that is not required to comply with the CGMP requirements in subpart B of 21 CFR part 507. Compliance dates when foreign suppliers are in these categories:

• Small Businesses: March 18, 2019.
• Qualified Facilities (including Very Small Businesses): March 17, 2020.
• “All Other” Businesses: March 19, 2018.

FSVP importer whose foreign supplier is required to comply with the produce safety rule, except for the requirements applicable to sprouts in subpart M of 21 CFR part 112. Compliance dates when foreign suppliers are in these categories:

• Small Businesses: July 29, 2019.
• Very Small Businesses: July 27, 2020.
• “All Other” Businesses: July 26, 2018.

FSVP importer whose foreign supplier is required to comply with the requirements in the produce safety rule applicable to sprouts in subpart M of 21 CFR part 112. Compliance dates when foreign suppliers are in these categories:

• Small Businesses: July 26, 2018.
• Very Small Businesses: July 29, 2019.
• “All Other” Businesses: July 26, 2017.

FSVP importer whose foreign supplier is subject to the produce safety rule and eligible for a qualified exemption (other than when the foreign supplier is a farm producing sprouts). Compliance dates when foreign suppliers are in these categories:

• Small Businesses: July 29, 2019.
• Very Small Businesses: July 27, 2020.

FSVP importer whose foreign supplier is a farm producing sprouts that is eligible for a qualified exemption under the produce safety rule. Compliance dates when foreign suppliers are in these categories:

• Small Businesses: July 26, 2018.
• Very Small Businesses: July 29, 2019.

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