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Dileep Thatte

FDA Compliance

The Food Safety Modernization Act in a Nutshell

Producing safe food doesn’t just make sense. It’s the law.

Published: Tuesday, November 26, 2019 - 12:02

According to information from the Centers for Disease Control and Prevention (CDC), every year 48 million people in the United States get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases. That means one in six people in the United States get sick from contaminated food every 12 months. These statistics are important to take note of and address because the U.S. food supply also represents a huge economic asset, contributing almost $1 trillion to the national gross domestic product (GDP) each year.

Manufacturers have an important role to play in preventing foodborne illnesses through responsibilities outlined in the 2011 Food Safety Modernization Act (FSMA). The act overhauled regulations regarding food production and gave the Food and Drug Administration (FDA) more authority to oversee and enforce supply chains. The FSMA shifts the focus from responding to foodborne illnesses to preventing them and affects almost every business that must register with the FDA. If you’re still wondering how the FSMA impacts your manufacturing business, we’ve answered the most frequently asked questions below.

What is the Food Safety Modernization Act?

The FDA finalized seven major rules to implement the FSMA. The rules translate the act into specific actions at each point in the global supply chain to reduce contamination and make it easier to implement the changes. Those seven rules are:

1. Preventive controls for human food. Human food facilities registered with the FDA must implement a written plan that identifies hazards and outlines appropriate preventive controls.
2. Preventive controls for animal food. Animal food facilities registered with the FDA must implement a written plan that identifies hazards and outlines appropriate preventive controls.
3. Produce safety. This rule establishes minimum standards for growing, harvesting, packing, and storing produce.
4. Foreign supplier verification program—Importers must verify that their global suppliers comply with FDA regulations.
5. Third-party certification. This accredits third-party certification bodies to administer voluntary consultative and regulatory audits to help companies prepare for regulatory audits or achieve certifications.
6. Food defense (intentional adulteration). Food facilities registered with the FDA must develop a plan that assesses contamination vulnerabilities and document a mitigation strategy for each vulnerability.
7. Sanitary transportation. The FSMA inlcudes new requirements for companies that transport food, including shippers, receivers, loaders, and carriers

Whom does the FSMA affect?

FSMA rules apply only to foods regulated by the FDA. Granted, this is a significant chunk of the U.S. food supply, about 75 percent. The other 25 percent is regulated by other agencies, such as the United States Department of Agriculture (USDA), which oversees meat, poultry, and many dairy products. So, if you manufacture meat, poultry or dairy products regulated by the USDA or another agency, then the FSMA does not apply to you.

What is covered by the FSMA are commercial farms, packing operations, and food processing facilities. Basically, if you have to register with the FDA as a food manufacturing facility, then the odds are extremely high that you need to comply with the FSMA. That being said, there are some exemptions made for facilities that don’t fit the FDA’s definitions for these categories, or that don’t meet certain thresholds for sales and ownership percentages; check the FSMA if you’re not sure whether or not you qualify.

But not everyone who grows or processes products overseen by the FDA is automatically affected by the FSMA. Home gardeners and food preservers aren’t covered by the law, and neither are direct-to-consumer sales at restaurants, retail food establishments, farmers markets, and so on. These sales may be covered by state and/or local laws, however. To learn about nonfederal laws that may impact your food business, start by consulting the Association of Food and Drug Officials’ Directory of State and Local Officials.

Hazard analysis and critical control points (HACCP) are management systems tailored to the manufacturing of specific food products, such as juice and seafood. Please note that if your business already has a HACCP plan in place, the FSMA applies to you as well. Your HACCP plan will need to be updated and enhanced in order to be fully compliant with the FSMA.

When did the FSMA take effect?

The FSMA was passed by Congress in December 2010 and signed into law by President Obama on Jan. 4, 2011. However, it took the FDA several years to finalize what the FSMA regulations would look like in practice, which did not occur until 2015.

Compliance dates vary depending on the safety rule in question and the size of the operation. In a nutshell, large companies with more than 500 employees needed to achieve compliance in 2016, while small business with fewer than 500 employees were due in 2017. Very small businesses are defined by different sales thresholds depending on the rule, but most compliance dates for them were in 2018. The Grocery Manufacturers Association offers a handy chart with compliance dates broken down by rule and company size.

What could noncompliance do to my business?

Because the FSMA is a law, violations may be treated as criminal acts. If the FDA finds violations of the FSMA, it will issue a warning letter and publish it publicly on its website. Facilities have 15 days to comply with the warning letter; the FDA may reinspect the plant to ensure compliance, and issue fees to cover the costs of the second inspection.

The FDA could issue a food recall order if the contamination is pervasive, and it has the authority to assess and collect fees related to the recall. If the health hazard to the public is great enough, the FDA may even seize the contaminated food item. In especially severe cases, the FDA may arrest responsible parties, conduct an extended audit of company practices, or even suspend the registration of food facilities (which can lead to temporary or permanent shutdown).

However, consequences aren’t enacted only by the FDA. It takes time, money, and effort to redo processes to ensure compliance, if they aren’t done properly in the first place. In the event of a recall, illness and negative media attention can erode a company’s reputation, decreasing consumer trust and profits. This can lead to a loss of market share and competitive advantage. Consumers can also sue companies in the case of wrongful death or illness related to foodborne illnesses.

How do I comply?

Compliance looks different for each business depending on the size and purpose of the facility, as well as what products it makes.

If you’ve got questions (and you’re not alone), your best bet is to reach out to an advisor familiar with the FSMA who can identify the rules that pertain to you and offer strategies for compliance based on experience.

Your local MEP Center, part of the MEP National Network, which is designed to provide U.S. manufacturers with access to qualified experts in critical fields affecting manufacturing, can help you navigate FSMA as well as state and local food laws. There is a MEP center in every state and Puerto Rico with representatives no more than three hours away from any manufacturing facility.

First published Oct. 17, 2019, on the Manufacturing Innovation blog.

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About The Author

Dileep Thatte’s picture

Dileep Thatte

Dileep Thatte is a manager with the National Institute of Standards and Technology, Manufacturing Extension Partnership.