The implementation of FSMA (the Food Safety Modernization Act) affects everyone in the food and beverage industry. The first final rules went into effect at the end of August, and the last will finalize in May 2016. No matter what your business size or which of the rules apply to you, here are the resources and planning tools you'll need to guide you every step of the way.
Terms
Current Good Manufacturing Practices (CGMP), Preventive Control (PC), Voluntary Qualified Importer Program (VQIP)
General Resources
FSMA Fact Sheet: This 2-page document provides key facts on the 2010 law passed by Congress.
Operational Strategy for Implementing FSMA: This page outlines operational strategy for implementing FSMA, including enterprise-level collaboration, and appendices with guiding principles for each major element.
What's New at FSMA: This page maintains the latest FSMA updates and resources from the FDA. It's a centralized place for webinars, meeting notes, and document links.
Regulations
Preventive Controls for Human Food
Key Components
The focus of this rule is on hazard analysis and preventive controls. CGMPs are updated and clarified. Farms are not subject to preventive control monitoring rules. Be sure to check for separate supply-chain program compliance dates.
Implementation Timeline
- Final rule – August 31, 2015
- Very small businesses (less than $1m in business per year) – 3 years (except for records to support its status as a very small business: January 1, 2016)
- Businesses subject to the Pasteurized Milk Ordinance – 3 years
- Small businesses (fewer than 500 FTE) – 2 years
- All other businesses – 1 year
Additional Resources
- The Grocery Manufacturers Association (GMA) resource page on the Preventive Control rule
Preventive Controls for Animal Food
Key Components
This rule establishes CGMPs for animal food production. Covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. Separate supply-chain compliance dates apply. Operations meeting the definition of “farm” under the Preventive Controls for Human Food are not subject to this rule, nor are feed mills associated with farms meeting one of those two definitions.
Implementation Timeline
- Final rule – August 31, 2015
- Very small businesses (less than $2.5m/yr) – 3 years (CGMP), 4 years (PC)
- Small businesses (fewer than 500 FTE) – 2 years (CGMP), 3 years (PC)
- All other businesses – 1 year (CGMP), 2 years (PC)
Additional Resources
- National Sustainable Agriculture Coalition: What is the Preventive Controls Rule?
- Federal Register: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Final Rule
Produce Safety
Key Components
This rule increases the flexibility of the standards governing water quality and testing, gives further study to manure strategy, and better defines covered farms. It also clarifies the process for withdrawal of qualified exemptions and provisions on wild animals.
Implementation Timeline
- Final rule: October 31, 2015
- Very small businesses ($2500-$250k/yr) – 4 years
- Small businesses ($250k-$500k/yr) – 3 years
- All other farms – 2 years
- Water quality standards – additional 2 years beyond all compliance dates
Additional Resources
- FDA PowerPoint: Produce Safety Rule Implementation
- Produce Marketing Association's FSMA Resource Page
Foreign Supplier Verification Program
Key Components
This program provides for hazard analysis and supplier verification and emphasizes consistency with other proposed FSMA rules. Its broader evaluation of risks requires importers to consider factors such as the nature of hazards in food and foreign suppliers' procedures, processes, and practices related to food safety.
Implementation Timeline
- Final rule: October 31, 2015
- All businesses – 18 months after final rule
- Exception: “For the importation of food that is also subject to the preventive controls and produce safety rules, the importer would be required to comply with FSVP regulations six months after the foreign supplier is required to comply with preventive controls or produce safety regulations. The compliance dates for those regulations vary, depending on the rule and size of the operation.”
Additional Resources
- Trace Gains webinar: Preparing for FSMA's Foreign Supplier Verification Program
- Voice of Food Retail's FSMA blog series on the FSVP
- FSVP.com
Accreditation of Third-Party Auditors
Key Components:
This proposed rule sets eligibility requirements for accreditation bodies, as well as eligibility requirements for third-party auditors. It also authorizes the Voluntary Qualified Importer Program (VQIP), which provides for expedited review and entry of food into the United States.
Implementation Timeline:
- Final rule: October 31, 2015
- From fda.gov: “The FDA intends to implement this program as soon as possible after publication of the final rule and the final Model Accreditation Standards, which will be published separately. Accreditation bodies could begin to apply for recognition when the program goes into effect, and third-party auditors could seek accreditation after one or more FDA-recognized accreditation bodies begin accepting applications.”
Additional Resources:
- FDA's Voluntary Qualified Importer Program (DRAFT)
- Model Accreditation Standards (DRAFT) for Third-Party Auditor/Certification Body Accreditation for Food Safety Audits
Sanitary Transportation of Food
Key Components
This proposed rule “addresses the sanitary transportation of both human and animal food traveling via motor or rail vehicle by establishing criteria for the safe transportation of food.” Specifically, it establishes requirements for transportation equipment and operations, exchange of information, training, records, and waivers.
Implementation Timeline
- Final rule: March 31, 2016
- Very small businesses (less than $10,000,000/year) – 3 years
- Small businesses (fewer than 500 FTE) – 2 years
- All other businesses – 1 year
Additional Resources
Intentional Adulteration
Key Components
This rule identifies and protects key activities most vulnerable to forms of adulteration intended to cause large-scale public harm. It includes a written “Food Defense Plan” with specific components that each facility covered by the rule will be required to complete.
Implementation Timeline:
- Final rule: May 31, 2016
- Very small businesses (less than $10,000,000/year) – 3 years
- Small businesses (fewer than 500 FTE) – 2 years
- All other businesses – 1 year
Additional Resources:
- FDA Law Blog: FSMA and Intentional Adulteration: FDA Issues Proposed Rule and Signals Approach to Economically Motivated Adulteration
- Food Fraud Resources website
The Global Food Safety Initiative
The GFSI is a private organization maintained by the Consumer Goods Forum, which benchmarks food safety and farm assurance standards for manufacturers worldwide. GFSI certification will help to drive food safety initiatives and processes toward FSMA compliance, but it's important to understand that there are differences as well.
Here are some additional resources that help to clarify the relationship between GFSI and FSMA
- The GFSI website
- A three-part webcast series discussing how GFSI schemes align with and prepare you for FSMA
- A Quality Assurance and Food Safety article: GFSI Certified. FSMA Compliant.
- OnTrak with FSMA: a webinar series (PowerPoint) hosted by ReposiTrak
- A Food Quality and Safety article by Susan Moyers, Ph.D
We will update this guide regularly as additional resources become available.
