More than five years after the FDA’s Food Safety Modernization Act (FSMA) was signed into law, the first compliance dates are among us.
What is FSMA?
FSMA is often referred to as the most sweeping reform of U.S. food safety laws in more than 70 years. It was signed into law by President Obama on Jan. 4, 2011.
According to the FDA, data from the Centers for Disease Control and Prevention shows that about 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized and 3,000 die each year from foodborne diseases. FSMA aims ensure food is safe by shifting focus from responding to contamination to actually preventing it.
The law has seven foundational rules that impact both human and animal food producers and importers, including requirements such as writing and implementing a preventative control plan and new inspection guidelines.
As a result, many small and large food companies are working hard to align their businesses with new requirements to meet coming compliance dates, with the first for large companies in September 2016.
Below we give a brief overview of some of the key elements of FSMA, how it’s being implemented, compliance dates and resources to help you understand how FSMA applies to your business.
The Elements of FSMA
According to the FDA, FSMA has five major elements that include various mandates and authorities:
- Preventative Controls
- Inspection and Compliance
- Imported Food Safety
- Enhanced Partnerships
Get a closer look at each of these elements here.
The 7 Rules of FSMA
As previously mentioned, FSMA is comprised of seven foundational rules:
- Preventative Controls for Human Food, which requires food facilities to have safety plans detailing how they will identify and minimize hazards.
- Preventative Controls for Animal Food, which establishes Current Good Manufacturing Practices (CGMP) and preventive controls for animal food.
- Produce Safety, which establishes science-based standards for growing, harvesting, packing and holding produce on both domestic and foreign farms.
- Foreign Supplier Verification Program (FSVP), which requires importers to verify that food brought into the country has been produced in a way that meets the same requirements U.S. food companies are subject to.
- Third Party Certification, which establishes a program where qualified third parties can certify foreign food facilities comply with U.S. food safety standards.
- Sanitary Transportation, which requires food transporters to use sanitary processes to ensure food safety.
- Food Defense/Intentional Adulteration, which requires both foreign and domestic food facilities to address vulnerable steps in their processes to prevent acts that are intended to cause large-scale public harm.
FSMA Compliance Dates
For many food processing companies, understanding when FSMA compliance deadlines take effect is challenging. There are a number of nuances and exceptions to be aware of, and the FDA has also issued some extensions and clarifications in recent months.
Generally speaking, compliance dates for various requirements are staggered one to five years from when the final rule was published, and depend on the size and type of business. The first compliance dates for large businesses are coming up in mid-September 2016.
The National Grain and Feed Association (NGFA) did a wonderful job summarizing big compliance dates. Their table is featured below.
|Final Rule||Date Issued||Compliance Date
Very Small Business
|CGMP and Preventative Controls for Human Food||Sep. 17, 2015||Sept. 19, 2016||Sept. 18, 2017||Sept. 17, 2018|
|CGMP and Preventative Controls for Animal Food||Sept. 17, 2015||Sept. 19, 2016 (CGMP)
Sept. 18, 2017 (PCs)
|Sept. 18, 2017 (CGMP)
Sept. 17, 2018 (PCs)
|Sept. 17, 2018 (CGMP)
Sept. 17, 2019 (PCs)
|Produce Safety||Nov. 27, 2015||Jan. 26, 2018||Jan. 26, 2019||Jan. 26, 2020|
|Foreign Supplier Verification Program||Nov. 27, 2015||>May 27, 2017||Not applicable||Not applicable|
|Third Party Accreditation and Certification||Nov. 27, 2015||Requirements go into effect after FDA publishes Model Accreditation Standards|
|Sanitary Transportation of Human and Animal Food||April 6, 2016||April 6, 2017||April 6, 2018||Not applicable|
|Food Defense/Intentional Adulteration||May 27, 2016||July 26, 2019||July 26, 2020||July 26,2021|
See the NGFA’s full PDF on compliance dates.
Another extensive resource comes from Trace Grains, a document management retailer. Their article So … What Are the Exact Compliance Dates for FSMA Rules? includes much of the same information as above, as well as additional links that will allow you to dig into the rules and requirements specific to your business.
However, as mentioned above, the FDA issued some compliance date extensions and clarifications on Aug. 23, 2016. For example, compliance dates were extended for certain provisions concerning written customer assurances under four of the seven rules.
One of the best ways to keep up with FSMA updates is to subscribe to Constituent Updates, which also includes other updates from the Center for Food Safety and Applied Nutrition.
Additional Resources on FSMA
If you’re looking for additional resources to learn about FSMA and how it relates to your facility, below are some more resources:
- Frequently Asked Questions on FSMA (FDA)
- Fact Sheets & Presentations (FDA)
- The Law, Rules & Guidance (FDA)
- FMSA Roundup: An Overview of the FDA’s Seven Major Rules (FoodOnline)
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