Celebrating FSMA’s 10th Anniversary: What have we achieved, and what’s to come in 2021?

blue workstation

Ten years ago, on January 4th, President Obama signed into law the Food Safety Modernization Act (FSMA). This act enables the FDA to better protect public health by focusing more on preventing food safety problems rather than simply reacting to them. Looking through a decade of U.S. regulatory challenges and achievements, so far, seven FSMA Final Rules and several guidelines have been published, and most food industries are already complying with the relevant requirements. Other FSMA compliance date deadlines to look out for are as follows:

FSMA Final Rule

Applicability

Compliance Date Deadline




Produce Safety

Other Produce – Small Farms (remaining water requirements)

Jan. 26, 2021

Other Produce – Very Small Farms (remaining water requirements)

Jan. 26, 2022

Small Farms – Non-sprout agricultural water requirements

Jan. 26, 2023

Very Small Farms – Non-sprout agricultural water requirements

Jan. 26, 2024

Intentional Adulteration

Very Small Businesses

July 26, 2021

 

For more current information on FSMA compliance requirements, visit the FDA’s website.

The battle is still far from being won – allergen labeling and management remains the top cited cause for product recalls, and contamination by Listeria monocytogenes and Salmonella continue to be the leading causes of foodborne illness outbreaks. These trends indicate that regulatory agencies, industry stakeholders, and allied groups should continue to make a concerted effort in providing safe and wholesome food to consumers. In light of increased hospitalizations during the ongoing pandemic, controlling for allergens and contaminants are even more critical as we face an already strained healthcare system. 

This year should see significant activities centered around strengthening industry requirements toward FSMA compliance. The following are some of the recent developments to potentially keep track of:

  1. Collaboration and Integration within Agencies: Expect more open communication among North American regulatory agencies such as the FDA, FSIS, and the CFIA and stakeholders. One such collaborative initiative that has been spearheaded by these organizations is on Salmonella reduction efforts in meat, poultry, and produce to meet Healthy People 2030 global targets. 
  2. Digitization of Food Safety Processes and Systems: To meet increasing record-keeping requirements, industries will make a greater effort to move away from physical paperwork and towards digitization and the use of AI and Data analytics technologies. Companies should be able to take advantage of real-time, block-chain, or predictive capabilities to help in hazard prevention, but these systems must also meet the 21 CFR 11 requirements on electronic record-keeping.
  3. Preparing for a New Era of Smarter Food Safety: The FDA’s Blueprint was launched in July last year as the agency’s masterplan towards creating a more digital, traceable, safer, and FSMA-based food network system that should help bend the curve of foodborne illnesses in the U.S. We should expect more developments for this initiative in 2021.
  4. Traceability as a Preventive Approach: The ability to trace and track the source of foodborne illnesses to be able to better prevent future outbreaks has become one of the FDA’s priorities. This year we look forward to the finalization of FSMA’s proposed Rule for Food Traceability, which should mandate additional record-keeping requirements for certain high-risk foods.
  5. Enhanced Focus on Sanitation Controls: With sanitation being elevated to one of the hazard analysis risk-based preventive controls, there should be an increased industry focus toward an integrated sanitation approach. Such an approach should also include the selection, cleaning, storage, and maintenance of cleaning tools, as such equipment can also become vectors of contamination in a food plant.

For more updates on the FDA’s Viewpoint on FSMA progress and the path forward, visit the FDA’s website.

References:

Focus on FSMA: Looking Forward to a Year of Produce Safety Improvements

Produce safety changes in 2020

According to the World Health Organization, low consumption of fresh fruits and vegetables has been shown to be a significant risk factor potentially contributing to cancer, heart disease, and strokes around the globe. Indeed, nutrition experts have recommended a minimum individual daily intake of 400 g of various fresh produce commodities.1 However, eating fresh fruits and vegetables isn’t without risk, as there are minimal processing steps (such as washing, cutting, and packing) even when they’re not just eaten raw. This can and does increase the chances of produce cross-contamination that may result in foodborne illnesses.

Last year, in 2019, a significant number of disease outbreaks and recalls were linked to the produce sector. Some of the key food safety incidents that made headlines were on:

  • Multi-state coli O157:H7 outbreak associated with romaine lettuce from Salinas growing region in California, that led to about 138 reported illnesses and 72 hospitalizations;
  • Nationwide recall of Ready-to-eat (RTE) vegetable products from various retail outlets due to potential risk of Listeria monocytogenes found in produce sourced from a common supplier;
  • Outbreak of Salmonella Uganda infections (reported in nine U.S. States) linked to whole, fresh papayas imported from a Mexican farm.

Not surprisingly, the U.S. is currently a net importer of fresh produce.2 Just over half of the fresh fruit and almost a third of fresh vegetables consumed by the American public are imported from other countries such as Mexico, Chile, and Canada. The risks to food and produce safety are greatly aggravated if suppliers do not have adequate preventive food safety controls in place. Thus, it became imperative for the U.S. federal government to enact the 2011 Food Safety Modernization Act (FSMA), which basically provides the FDA with a proactive authority to regulate the way foods are sourced or grown, harvested, processed, stored, and transported for interstate or international commerce.3

In 2020, we should expect stakeholders to build upon the existing regulatory framework or initiatives in order to foster better Produce Safety improvements, and with a collaborative objective of providing safe and wholesome food to the public. Some of the key things coming in this arena are as follows:

1. Produce Safety Rule compliance date for very small farms is nearing:

The FSMA Final Rule on Produce Safety was published on January 26, 2016, with the aim of providing minimum food safety standards for growing, harvesting, packing and holding of fruits and vegetables.4 Most of the compliance deadlines have passed, but then the compliance date for the very small produce farms (other than sprouts – which has a separate compliance date) shall be January 27, 2020.

2. Supplier traceability challenges should make industry adopt smarter food safety technologies:

To enable a faster foodborne outbreak response in the interest of public health, more reliable information, better processes and updated technologies will be required by industry to track the source and destinations of contaminated produce. According to Frank Yiannas, the FDA deputy commissioner for food safety, facilitating the adoption of newer traceability technologies (such as blockchain) in the produce sector will usher in a New Era of Smarter Food Safety that is people-led, FSMA-based, and technology enabled.5

3. Sanitation and hygiene will become a greater produce sector focus:

There will be an enhanced requirement to strengthen the foundation of Good Agricultural Practices and the key risk-based sanitation programs on farms that should help prevent microbial contamination of the marketable produce, associated food recalls, and foodborne disease outbreaks. Examples of these practices include ensuring worker health and hygiene; overall plant sanitation and cleaning; organizing growing, harvesting, packing, and holding activities; ensuring the proper quality of agricultural water and soil amendments; and properly maintaining equipment, tools, and buildings. Moreover, it has been generally estimated that poor sanitary conditions at a plant or site is responsible for at least one-third of North American food recalls, and a lot of direct and indirect expenses could be avoided through proper sanitation strategies.6

Remco can help the food industry, as a well as the produce sector, with the right selection, storage, care and maintenance criteria for sanitation and material handling implements that are required for a sanitary and more hygienic food production environment. More information about our tools are available at https://remcoproducts.com/products/.

 

Selected References:

(1) WHO: Global Strategy on Diet, Physical Activity and Health – https://www.who.int/dietphysicalactivity/fruit/index1.html

(2) The U.S. Trade Situation for Fruit and Vegetable Products – https://fas.org/sgp/crs/misc/RL34468.pdf

(3) FDA Food Safety Modernization Act – https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/food-safety-modernization-act-fsma

(4) FSMA Final Rule On Produce Safety – https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-produce-safety

(5) New Era of Smarter Food Safety – https://www.fda.gov/food/food-industry/new-era-smarter-food-safety

(6) Evaluating FDA Food Recalls with Sanitation as a Root Cause – https://www.vikan.com/media/8428/2019_iafp-poster_amitmkheradia-us.pdf