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

A Year in Regulations: Key Food Safety Developments for 2019 and 2020

With the new year just around the corner, it’s time to reflect on what changed in 2019 and what’s to come for 2020 in the world of food safety. Significant foodborne illness outbreaks and recalls this year put an increased focus on farm-to-fork accountability. For many food processors, this meant reevaluating their facility’s food safety efforts and those of their suppliers.

  • Foreign material contamination forced a recall of over 11 million pounds of frozen and RTE chicken strips
  • Salmonella Uganda infections spread and are potentially related to whole, fresh papayas
  • An coli O157:H7 outbreak linked to Romaine lettuce

The following five trends should influence the food safety landscape in North America next year:

1. Regulatory performance metrics should drive FSMA implementation – The FDA has launched a food safety dashboard, FDA-TRACK, to help evaluate how well the FSMA rules are being implemented, and whether there is any need for improvement from the industry to control foodborne outbreaks, recalls and product contamination. More information about this agency-wide program is available on the FDA’s website.

2. There will be a focus on modernizing food production lines – As an example, FSIS-USDA just announced a final rule for facilitating the establishment of a New Swine Slaughter Inspection System aimed at allowing for food safety innovations while not compromising the goal of protecting public health.

3. Regulations will increasingly influence regional food safety developments – In the U.S., phased implementation of the Food Safety Modernization Act (FSMA) through targeted FDA’s Final Rules has been making its mark. Meanwhile, Canada’s Safe Food for Canadians Regulations (SFCR), came into force on January 15th of this year. We should expect to see closer collaboration between the FDA and the CFIA in order to streamline and align their food safety systems to ensure a seamless regional trade partnership. Explore our recent white paper on Canada’s SFCR in our Knowledge Center.

4. Hygienic design will be a much bigger industry focus – A new working group has just started their work on integrating hygienic design elements with the existing GFSI requirements (with a globalized farm-to-fork food safety approach) under scope K, covering food processing/handling equipment and facilities. This will facilitate the eventual adoption of hygienic design elements by the industry as it’s implemented in GFSI-benchmarked standards like BRC and SQF.

5. We will be entering a New Smarter Era of Food Safety, and maybe sooner than expected – Frank Yiannas, the FDA deputy commissioner for Food Policy & Response, has been spearheading the agency’s efforts to develop a strategic plan on leveraging technology, smarter tools, and best practices for creating a more digital, traceable, and safer food safety system. Through Frank’s previous professional work experience with Disney and Walmart, he has aptly evaluated that implementing such a novel regulatory approach requires continuous collaboration and communication with the industry and relevant stakeholders. A brief summary of the FDA’s approach is available on their website.

2020-2021 Compliance Dates to Remember:

 Type

Details

Compliance Date

GFSI-based standard

FSSC 22000 Version 5

Auditable from Jan. 1, 2020

 

 

 

 

 

U.S. FSMA Final Rules

PRODUCE SAFETY rule compliance for all produce types (for all farm sizes); other produce (remaining water requirements for large farms); other produce (very small farms except certain water requirements)

 

Jan. 27, 2020

FOREIGN SUPPLIER VERIFICATION PROGRAM rule compliance for importers of animal food whose foreign supplier is a qualified facility (including very small businesses) subject to PCAF, PC but not CGMP requirements

 

March 17, 2020

INTENTIONAL ADULTERATION rule for small businesses

July 27, 2020

FOREIGN SUPPLIER VERIFICATION PROGRAM rule compliance for importers whose very small business foreign supplier is subject to the Produce Safety rule

 

July 27, 2020

 

 

 

Canadian SFCR Compliance

Written Preventive Control Plan for fresh fruit and vegetables facilities

Jan. 15, 2020

Licensing, traceability and written Preventive Control Plan compliance for other food facilities (except meat, fish, eggs, dairy, processed fruits or vegetables, honey, maple products, and fresh fruits & vegetables) with gross income >CDN100K and >5 employees

 

July 15, 2020

 

Licensing and traceability requirements compliance for other food facilities with gross income >CDN100K and <5 employees

July 15, 2020

 

Written Preventive Control Plan compliance for other food facilities with gross income >CDN100K and <5 employees

July 15, 2021

Licensing and traceability requirements compliance for other food facilities with gross income of <=CDN100K

July 15, 2020

Preventive Controls compliance for other food facilities with gross income of <=CDN100K

July 15, 2021

 Remco believes that using the right sanitary implements – and through their selection, storage, care, and maintenance – has a vital role in maintaining a cleaner and safer food production environment. Our line of food-safe offerings includes color-coded material handling and cleaning tools like scoops, tubs, brushes, squeegees, and more. Additional information about our products is available at remcoproducts.com/products/.

 

Links for Additional Information:

Professionals at the Food Safety Consortium Endorse FDA’s Vision of a ‘New Era of Smarter Food Safety’

Remco is proud to have participated and exhibited in the 2019 Food Safety Consortium Conference & Expo. Over 400 food safety professionals and about 50 exhibitors attended this leading educational and networking event, and some of the key sessions covered were on:

  • Salmonella detection and control;
  • FSSC 22000 v.5;
  • Data-driven, smart food safety management systems;
  • Role of water activity in FSMA regulations;
  • Aggressive approach to sanitation: planning for a decontamination event;
  • Sanitary design as the generation next of food safety;
  • Innovative food safety technologies;
  • Monitoring and controlling environmental pathogens; and,
  • Creating effective training programs for food manufacturers.

The keynote speaker at this leading conference was Frank Yiannas, FDA’s deputy commissioner for food policy and response, who provided a vital overview on the ‘New Era of Smarter Food Safety.’ Frank shared the FDA’s 21st century vision of promoting better, interconnected food safety systems that are FSMA-based, technology-enabled, digital, collaborative, people-led, consumer-focused, and with the enhanced traceability features. He also talked about the recent inclusion of FSMA Performance Measures within FDA-TRACK*, which is the agency’s performance management program that monitors, analyzes and reports results (on a quarterly basis) from key FDA performance data, projects and initiatives.

Remco also virtually participated in the Food Safety Public Meeting on the FDA’s blueprint for a “New Era of Smarter Food Safety” that took place in Washington DC on October 21, which was well attended by regulators, industry stakeholders, academia, consumer advocacy groups, and the media.  The FDA have requested formal comments from the stakeholders, and the details are available at: https://www.federalregister.gov/documents/2019/09/18/2019-20229/a-new-era-of-smarter-food-safety-public-meeting-request-for-comments.

Remco shares the vision of promoting smarter food safety by providing the end-users with high quality color-coded material handling tools like scoops, tubs, scrapers, mixing paddles, and much more. As a Vikan company, we also distribute innovative, hygienically designed cleaning tools and solutions (e.g. brushes, brooms, squeegees etc.) to food producers and manufacturers based in North America. For further information, kindly visit us at: https://remcoproducts.com/.

Note:

Food Safety Consortium Conference & Expo is one of the food safety industry’s premier event organized by Innovative Publishing Co. LLC, a publishing house for Med-Tech-Intelligence, Food-Safety- Tech, and Cannabis-Industry-Journal. More information is available at: https://foodsafetyconsortium.org/.

The New Era of Smarter Food Safety Initiative is the FDA’s strategic blueprint on how the agency plans to leverage technology and other tools in order to create a digital, traceable and safer food safety system. More information is available at: https://www.fda.gov/food/food-industry/new-era-smarter-food-safety.

* About FDA-TRACK: https://www.fda.gov/about-fda/fda-track-agency-wide-program-performance/about-fda-track

The Importance of Hand Washing in the Food Industry

Hygienic nail brush being used in hand washing
Handwashing in the food industry is one of the first lines of defense in food safety. Along with being a consumer health risk, inadequate personal hygiene can lead to costly and reputation-destroying recalls. However, it’s not just the responsibility of individual employees to ensure proper handwashing procedures are followed. Managers must cultivate a culture of food safety where taking time-off from lines to wash up is encouraged. Facilities also must be equipped with adequate hand washing stations.

Not only will setting the scene and creating the culture for effective handwashing help protect consumers, it will also help protect your business.

When to Wash

Employees knowing when to wash their hands is just as important as knowing how to properly wash them. High-visibility signs posted around the facility can teach and remind employees about handwashing. 

Signs posted around the facility make for great reminders, but the topic should also be covered in training seminars. Don’t forget to translate instructions in whatever languages required to communicate with all of your employees.

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FDA Inspection Checklist

Remco Products presents Food Industry Counsel’s FDA Inspection Checklist as a part of our commitment to bringing our audience the best information in the food industry. We don’t endorse any legal services or provide legal advice. For legal services or advice, please consult your attorney.  You can also contact Shawn Stevens, the author of this post, at stevens@foodindustrycounsel.com.

What to do Before, During and After Your Next FDA Inspection

Food Industry Counsel, LLC is pleased to provide you with the most comprehensive and useful FDA Inspection Checklist available. With the passage of the Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) was given the mission of overhauling the safety of the nation’s food supply. The new FSMA regulations written by FDA are now coming into effect, and the agency is now aggressively enforcing its new rules during routine inspections. Within the coming years, FDA Investigators will conduct an onsite inspection of every food facility in the U.S.

Here are FDA’s new enforcement priorities during routine unannounced inspections:

(1) To carefully critique each company’s written food safety programs and verification records to ensure they are compliant with the new FSMA requirements;

(2) To conduct extensive Zone 1, Zone 2, Zone 3 and Zone 4 microbiological sampling inside all food facilities to find evidence of pathogenic contamination;

Continue reading “FDA Inspection Checklist”