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

How is HARPC Different From HACCP?

How is HARPC Different From HACCP

HACCP and HARPC share more than just four letters. They’re both food safety standards based on prevention, but they do differ on execution. Their differences and their similarities aren’t as important as the way they fit together for most food processors, though. A HARPC plan shouldn’t be considered as a replacement, but as a necessary upgrade to the conventional HACCP plan. Understanding how the systems fit together is the first step toward implementing both.

HACCP

HARPC

(1) Is the preventative approach based on a standard, guideline or a set of laws?
Based on a guideline recommended by CODEX and NACMCF Based on FSMA act and principally, the Final Rule for Preventive Controls for Human Food
(2) What food safety risks are considered using the preventative approach?
Conventional – Biological, Chemical, and Physical Beyond the conventional risks for actual and potential food safety hazards
(3) What is the goal of the preventative approach?
To prevent, eliminate (or) reduce hazards to a safe level (in that priority) Preventive controls that prevent or significantly minimize “known or reasonably foreseeable” risks
(4) Who is primarily responsible for the development and maintenance of the preventive plan?
Primarily, a competent HACCP coordinator with assistance from multidisciplinary team Trained Preventive Controls Qualified Individual (PCQI) as described in the FSMA Act
(5) At what frequency is the preventive plan being reviewed by the facility?
At least once a year, or when required At least once in 3 years, or when required
(6) The plan is mandatory for what type of establishments?
For FDA and USDA mandated establishments, or when required for certification purposes For all establishments along the food supply chain that serve U.S. consumers, unless exempted
(7) The plan is excluded or exempted for what type of establishments?
Unless mandated or required for certification, HACCP is voluntary, and GMPs are mandatory Exemption list is provided by FDA, but this does not exempt facilities from following at least CGMPs
(8) Who is the interested party here? For whom is the plan for?
Stakeholders: auditors, inspectors, and customers The FDA
(9) What is the documented approach for making the preventive plan?
12 Steps of HACCP (includes 7 Principles) 7 Steps of Developing a HARPC Plan

HARPC as an Upgrade to HACCP

HACCP, or Hazard Analysis Critical Control Points, is already widely used due to requirements from retailers, auditing standards, and inspectors, though the USDA and the FDA only mandate it for meat, seafood, and juice products. As a global standard conceptualized the 1960s, HACCP has been continually developed and updated. HACCP requires a multi-disciplinary team for implementation and follows prescriptive steps.

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