May 2017 Agriculture/FarmFoodSafety/2017-01pr

Farm Food Safety Laws: FSMA vs. GAP Shawn Olsen and Karin Allen

The FDA Food Safety Modernization Act (FSMA) includes a Produce Safety Rule that became final in November, 2015 (U.S. Food and Drug Administration, 2015). The rule establishes minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. All covered growers will need to comply with FSMA as it is a federal law. More information on coverage and exemptions can be found on the FDA website (www.fda.gov/FSMA).

Good Agricultural Practices (GAP), which includes Good Handling Practices (GHP), was formally implemented by USDA and FDA in 2002 (USDA,

AMS, FV, Specialty Crops Inspection Division, 2014). GAP is a voluntary audit program designed to verify that produce is grown, packed, handled, and stored as safely as possible. There are different GAP audit protocols such as harmonized GAP, Global GAP, and GroupGAP that may have slightly different requirements. GAP auditors come from private companies, state departments of agriculture, and USDA. Many produce buyers are now requiring that growers be GAP certified and may require a specific GAP protocol. The USDA website is a good place to start learning about GAP (https://www.ams.usda.gov/services/auditing/gap-ghp).

Figure 1. Irrigation water testing is important in FSMA and GAP.

The FSMA and GAP programs have many similar requirements but also some differences. The Produce Safety Alliance (2017) provides an extensive list of university and industry resources to help write a farm food safety plan. Some

components of FSMA are still being evaluated by the FDA and the agency may provide more specific guidance on some practices in the future. The table below compares different criteria of FSMA and GAP.

CRITERIA FSMA GAP Scope U.S. Global Structure Law, specific rules Voluntary, broad scope Audit Unannounced Announced & unannounced Auditor FDA or State contracted Dept. of Ag Private companies, state Dept. of

Ag, USDA Proponent FDA law, consumers Grocery store produce buyers,

consumers Exemptions Farms with <$25K total produce sales are

exempt. Others may be eligible for a qualified exemption, based on total food sales and the percentage of customers that are considered qualified end users

Driven by buyers

Covered produce All produce covered unless specified by the FDA as “rarely consumed raw.” Sprouts have additional requirements.

All produce being sold to buyer

Food safety plan with risk assessment, operating procedures, and record keeping

Hazard analysis similar to food safety and preventive controls for hazard analysis.

Documented plan required

Designated food safety officer

Required Required

Traceability n/a Documented plan Pesticide residue testing

n/a Required in GlobalGAP

Mock recall n/a Required Worker health and hygiene plan

FDA accepted training for at least one food safety manager. Employees who contact produce must be trained annually to follow good hygiene and sanitation practices with documented trainings.

Designated food safety manager. Employees who contact produce must be trained to follow good hygiene and sanitation practices with documented trainings.

Irrigation water assessment

Surface water: 20 samples over 2-4 years to develop baseline of generic E. coli, then five samples per season. Ground water: Four samples over 1 year to develop baseline of generic E. coli, then one sample per season.

Generally three water tests/year for generic E. coli.

Postharvest water use—washing, cooling, icing

Culinary or potable water. No detectable E. coli.

Culinary or potable water. No detectable E. coli.

Sewage treatment n/a Review of farm septic system and nearby sewage plants.

Animals, wildlife Visible examination of contamination during the growing season of all growing areas and all produce to be harvested regardless of

Visible examination of contamination during the growing season of all growing areas and all

method. Must have a documented corrective action plan and keep a record of examination.

produce to be harvested regardless of method. Record of examination.

Treated manure or other compost of animal origin

Must use one of two FDA suggested treatments, or provide documentation showing that another method results in compost of the same microbiological quality.

Manure and/or biosolids must be properly treated or composted using a documented process. Test results should be maintained.

Raw manure Rule is currently under development. FDA recommends following organic rule in the interim—90 days before harvest of produce that does not come in contact with the ground and 120 day interval for product that contacts the ground.

Two weeks before planting or incorporated 120+ days before harvest.

Soils n/a Review of previous land use and flood-prone areas.

Field sanitation and hygiene

Field inspection records. Pre-harvest field assessment and field sanitation units.

Field harvesting and transportation

Equipment and tools should be cleaned, and if possible sanitized. Record of cleaning and sanitizing activities should be kept.

Harvesting containers and harvesting equipment are clean. Light bulbs and glass are protected from breakage.

Harvested product covered during transport

n/a Required

Variances States, tribes, or foreign countries may request variances related to ag water, microbial die-off rate, etc.

As per selected GAP protocol or buyer.

Frequency of audit Depends on size, anywhere from yearly to every 10+ years.

Annually +

Figure 2. Field information signs encourage good hygiene.

Figure 3. Pesticides should be stored in a secure facility.

Figure 4. Wood containers can be used if they are kept clean and in good repair, but easily sanitized plastic container or bin liners are preferable.

Figure 5. Restroom and hand washing facilities are an important part of farm food safety. Handwashing stations should have water, single use paper towels, and soap.

Summary

GAP requirements not included in FSMA:

• Documented Farm Food Safety Plan—FSMA recommends, but does not require.

• Designated food safety officer—but this person would ideally be the one attending the FDA-approved course. A current list of training courses can be viewed on the Produce Safety Alliance website (https://producesafetyalliance.cornell.edu/).

• Traceability records—but, some on-farm food processing activities require traceability.

• Pesticide residue testing. • Mock recall plan. • Farm sewage treatment is done properly.

Recommended additions to a GAP plan that will help with FSMA compliance:

• Test five surface water samples per year, for total E. coli by EPA method 1603.

• Have one or more employees responsible for farm food safety attend a Produce Safety Alliance training.

• Develop a farm-specific food safety training program for employees.

• Evaluate and document your current composting techniques against FDA requirements.

It is anticipated that future regulations and protocols may align FSMA and GAP into one program, but for now growers need to be aware of both programs and meet their requirements.

References

Maughan, T., Drost, D., Olsen, S., & Black, B. (2016). Good agricultural practices (GAP): certification basics. Retrieved from http://digitalcommons.usu.edu/extension_curall/1127/

National Sustainable Agriculture Coalition. (2016). Am I affected by new food safety rules under the Food Safety Modernization Act? A flowchart for farmers and food businesses. Retrieved from http://sustainableagriculture.net/fsma

Produce Safety Alliance. (2017). Farm food safety plan writing resources. Retrieved from

https://producesafetyalliance.cornell.edu/resources/farm-food-safety-plan-writing-resources

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, 21 Code of Federal Regulations § 112 (2017).

Tripp, P. (2015). Expert tip: I’m GAPs certified. Am I also FSMA compliant? Retrieved from https://www.carolinafarmstewards.org/expert-tip-im-gaps-certified-am-i-also-fsma-compliant/

Tocco, P. (2014). FSMA and GAP are not the same. Retrieved from http://msue.anr.msu.edu/news/fsma and gap are not the same

U.S. Food & Drug Administration. (2015). Key requirements: Final rule on produce safety. Retrieved from www.fda.gov/FSMA

USDA, AMS, FV, Specialty Crops Inspection Division. (2014). USDA good agricultural practices, good handling practices audit verification checklist. Retrieved from www.ams.usda.gov/gapghp

Viswanathan, S. (2014). FSMA and GFSI: Alignment and gaps. Retrieved from https://foodsafetyteach.com

FIGURE CREDITS

1 Photo by Taun Beddes

2,3 Photos by Shawn Olsen

4 Courtesy of pixabay.com

5 Courtesy of University of Minnesota

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