Food Safety Modernization Act & Produce Safety Rule Compliance

Overview

The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.​

All farms that are growing, harvesting, packing, or holding produce must register their farm. Learn how to register here.

FSMA final rules

FSMA is comprised of several Final Rules that address different areas of food safety:

• Final Rule on Produce Safety — The rule establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. Key requirements focus on agricultural water; biological soil amendments; sprouts; domesticated and wild animals; worker training, health, and hygiene; and equipment, tools, building.
• Final Rule for Preventive Controls for Animal Food —The rule establishes Good Manufacturing Practices (GMPs), requires Hazard Analysis and Critical Control Points (HACCP) for animal feed, and mandates a recall plan. There is an exemption to this rule for fully integrated farming operations.
• Final Rule on Sanitary Transportation of Human and Animal Food —The rule applies to shippers, receivers, loaders, and carriers who transport food in the U.S. by motor or rail vehicle. All transportation activities performed by a farm are excluded from the rule, but farms are still subject to the Food, Drug and Cosmetic Act provisions that prohibit the holding of food under insanitary conditions.
• Final Rule for Preventive Controls for Human Food — The rule requires manufacturing and/or processing facilities to establish and implement HACCP. This rule does not apply to operations meeting the definition of “farm.”
• Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration — The rule applies to domestic and foreign companies that are required to register under the Federal Food, Drug, and Cosmetic (FD&C) Act.  Companies must do vulnerability assessments and implement mitigation strategies to provide assurances that vulnerabilities will be minimized or prevented. Farms are not required to register and are not covered by this rule.
• Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals — The 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 has no impact on Maryland farmers—other than assuring that produce or other food imported from foreign countries must meet the same food safety standards as U.S. growers and processors​.
• Final Rule on Accredited Third-Party Certification​ —The rule addresses requirements for accreditation bodies and third-party certification bodies seeking accreditation. The certification body would be used by importers to establish eligibility for participation in the Voluntary Qualified Importer Program which offers expedited review and entry of food.  FDA may also require certification in certain circumstances to prevent potentially harmful food from reaching the U.S. This rule has no impact on Maryland farmers.

On-Farm Readiness Reviews

Readiness Reviews are offered without charge to help farmers better understand and meet the requirements of the federal Food Safety Modernization Act Produce Safety Rule. To request a review, please fill out and submit an On-Farm Readiness Review Request form - PDF - 139.93 KB.

Resources

• Produce Safety Alliance
• Produce Safety Rule Compliance Resources - DOCX - 457.39 KB
• Produce Safety worker training documents - ZIP - 46.96 MB
• FDA: Frequently Asked Questions on FSMA
• FDA: FSMA Rules & Guidance for Industry
• FDA: FSMA Training
• Food Safety Preventive Controls Alliance (FSPCA)
• Sprout Safety Alliance
• Testing Labs, Extension Offices, and Soil Conservation District Offices map​
• USDA: Food Safety Modernization Act
• University of Maryland Agriculture Law Initiative