What is FSMA?

History

The FDA’s Food Safety Modernization Act (FSMA) is being called the most sweeping reform of U.S. food safety laws in more than 70 years. It was originally signed into law by President Obama on January 4, 2011, and in the years since, FDA has been working to develop the final rules that the act requires them to implement. The focus of the act is more effective prevention of food safety issues in the U.S. food supply. FSMA is a comprehensive top-to-bottom overhaul of the United States food safety regulatory framework. FSMA will touch every segment of the produce business supply chain from farm-to-fork. The U.S. Food and Drug Administration (FDA) has proposed seven major regulations. The proposed regulations will affect how produce is grown, packed, processed, shipped and imported into the U.S.

The Food Safety Modernization Act is changing the culture of the food safety system in the United States. FSMA shifts the focus of the FDA to ensuring food safety through prevention of microbial contamination rather than just reacting to the problem after it has already occurred. With new changes in food safety regulations also come new compliance challenges for the food industry. Growers, producers, harvesters and processors need to fully comprehend the rules in order to overcome the challenges associated with FSMA. The Food Safety Modernization Act will require a multitude of standards to be met and procedures to be followed in order to comply with the law, below are a few noteworthy comments to help you in your journey to FSMA compliance.

Understanding FSMA

One of the first challenges that companies will face when diving into FSMA is understanding the law and the rules which will implement it. These include preventive controls specific requirements for imported foods, food safety inspections, the sanitary transportation of foods and compliance timelines. Establishing where each rule fits, and which rules apply to food facilities can be overwhelming at first. Doing a gap analysis is a good idea for this first challenge, as it will let a company know their current standing and what future steps to take. Safe Food Alliance is working to make this transition easier for the food industry by pursuing FDA-approved training on the Produce Safety and Preventive Controls Rules. This will allow Safe Food Alliance to offer public and onsite training, as well as consultation services, for companies needing guidance-look for these classes in the coming year!

The Rules


Preventive Controls for Human Food

Overview

The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food is now final, and compliance dates for some businesses begin in September 2016 (see ‘Compliance Dates’ below). This rule creates new requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for human food. The final rule implements the requirements of FSMA for covered facilities to establish and implement a food safety system that includes a hazard analysis and risk-based preventive controls. Specifically, the rule establishes requirements for: a written food safety plan, hazard analysis, preventive controls, monitoring, corrective actions and corrections, verification, supply-chain program, recall plan, and associated records.

Implementation Schedule

Company Type Publication Date Compliance Basis Compliance Deadline
General Compliance Period 8/30/2015 1 Year After Final Rule 9/30/2016
Small Business Compliance Period (less than 500 employees business-wide) 8/30/2015 2 Years After Final Rule 9/30/2017
Very Small Business Compliance Period (annual business food sales below applicable limit) 8/30/2015 3 Years After Final Rule 9/30/2018

Services We Can Provide

  • Environmental Monitoring Testing
  • Product Testing
  • Water Testing
  • Hazard Analysis and Risk-Based Preventive Controls
  • Custom FSMA Compliance Training & Consulting
  • Preventive Controls Qualified Individual Training

If you would like more information about any of the above services, contact us and we’ll get back to you as quickly as possible.

Produce Safety Standards

Overview

The FDA Food Safety Modernization Act (FSMA) Produce Safety rule is now final, and the earliest compliance dates for some farms begin one year after the effective date of the final rule (see ‘Compliance Dates’ below). 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.

For more information on the Produce Safety rule, visit the FDA’s webpage (http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm) or contact Safe Food Alliance at foodsafety@safefoodalliance.com or (916) 561-5900.

Implementation Schedule

Company Type Publication Date Compliance Basis Compliance Deadline
General Compliance Period 10/31/2015 *2 Years + 60 Days From Final Rule 12/31/2017
Small Business Compliance Period (less than 500 employees business-wide) 10/31/2015 *3 Years + 60 Days From Final Rule 12/31/2018
Very Small Business Compliance Period (annual business food sales below applicable limit) 10/31/2015 *4 Years + 60 Days From Final Rule 12/31/2019

*All farms have an additional 2 years to comply with certain water-related requirements.

Services We Can Provide

  • Water Testing
  • Microbiological Testing on all food commodities
  • Pesticide Testing
  • Food Safety Training & Consulting
    • Produce Safety Qualified Individual Training
    • On-Farm Food Safety Plan
    • Gap Analysis of farm activities

If you would like more information about any of the above services, contact us and we’ll get back to you as quickly as possible.

Foreign Supplier Verification Program

Overview

The FDA FSMA rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is now final, and compliance dates for some businesses begin in April of 2017 (see ‘Compliance Dates’ below). The final 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 is the product of a significant level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local, tribal, and international regulatory counterparts, academia and other stakeholders.

For more information on the Foreign Supplier Verification rule, visit the FDA webpage here. (http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361902.htm) or contact Safe Food Alliance at foodsafety@safefoodalliance.com or (916) 561-5900.

Implementation Schedule

Company Type Publication Date Compliance Basis Compliance Deadline
General Compliance Period 10/31/2015 *18 Months From Final Rule 4/31/2017
Small Business Compliance Period (less than 500 employees business-wide) 10/31/2015 * *
Very Small Business Compliance Period (annual business food sales below applicable limit) 10/31/2015 *18 Months From Final Rule 4/31/2017

*All importers must comply with FSVP requirements 18 months after the final rule OR 6 months after their foreign suppliers’ reach their FSMA compliance deadlines, whichever is later.

Services We Can Provide

  • Environmental Monitoring Testing
  • Product Testing
  • Water Testing
  • Hazard Analysis and Risk-Based Preventive Controls
  • Custom FSMA Compliance Training & Consulting
  • Preventive Controls Qualified Individual Training

If you would like more information about any of the above services, contact us and we’ll get back to you as quickly as possible.

Accreditation of Third Party Auditors

Overview

The FDA FSMA rule on the Accredited Third-Party Certification is now final. This rule, proposed in July 2013, establishes a voluntary program for the accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. These requirements will help ensure the competence and independence of the accreditation bodies and third-party certification bodies participating in the program.

For more information on the Accreditation of Third Party Auditor, visit the FDA webpage here. (http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361903.htm) or contact Safe Food Alliance at foodsafety@safefoodalliance.com or (916) 561-5900.

Implementation Schedule

Company Type Publication Date Compliance Basis Compliance Deadline
General Compliance Period 10/31/2015 *After Model Accreditation Standards
Small Business Compliance Period (less than 500 employees business-wide) ** ** **
Very Small Business Compliance Period (annual business food sales below applicable limit) ** ** **

*3rd Party Accreditation and Certification’s provisions are effective immediately following the final rule, but can only be implemented after publication of Model Accreditation Standards.

**If there is no special compliance period noted, then follow the General Compliance Period Rule.

Sanitary Transport of Food and Feed

Overview

The FDA’s final rule, released on April 5th, requires those who transport food to use sanitary transportation practices to ensure the safety of that food.

The final rule, required by the Food Safety Modernization Act (FSMA), is intended to help maintain the safety of both human and animal food during transportation by establishing criteria for vehicle and transportation equipment conditions and practices, and training and record keeping.

Implementation Schedule

Company Type Publication Date Compliance Basis Compliance Deadline
General Compliance Period April 5, 2016 1 Year From Final Rule April 2017
Small Business Compliance Period (less than 500 employees business-wide) April 5, 2016 2 Years From Final Rule April 2018
Very Small Business Compliance Period (annual business food sales below applicable limit) April 5, 2016 * *

*If there is no special compliance period noted, then follow the General Compliance Period Rule.

Intentional Contamination/Food Defense

Overview

FDA’s proposed rule on food defense would require domestic and foreign facilities to address vulnerable processes in their operations to prevent acts on the food supply intended to cause large-scale public harm. The proposed rule, which is required by the FDA FSMA, would require the largest food businesses to have a written food defense plan that addresses significant vulnerabilities in a food operation.

Implementation Schedule

Company Type Publication Date Compliance Basis Compliance Deadline
General Compliance Period 1 Year + 60 Days From Final Rule
Small Business Compliance Period (less than 500 employees business-wide) 2 Years + 60 Days From Final Rule
Very Small Business Compliance Period (annual business food sales below applicable limit) 3 Years + 60 Days From Final Rule