FSMA Clarification is Good News


The National Sustainable Agriculture Coalition (NSAC) welcomed the issuance of the Food and Drug Administration’s (FDA) final rule amending the Food Safety Modernization Act (FSMA) requirements for food facility registration this week. The local and regional farm and food community has long awaited this final rule, which provides much-needed clarity for direct marketing farms and food enterprises, preventing undue regulation of these businesses.

By redefining the term “retail food establishments”, the FDA provides clear distinctions between which farms and related businesses are subject to “food facility” registration under the Preventive Controls Rule, and which are not. Thanks to this new language, farmers and small food enterprises primarily selling value-added products directly to consumers can now rest assured that they are not subject to food facility registration requirements or regulations.

“For family farmers, one of the most concerning things about the new FSMA rules has been this confusion over classification of farms and registration requirements,” said NSAC Policy Specialist Sophia Kruszewski. “Conflicting and misleading guidance on farms that do or do not qualify as retail food establishments has been the order of the day for over a decade. Congress settled the matter in FSMA in 2010. We are pleased to see FDA finalize this long overdue clarification, and on first glance are optimistic that the final rule reflects the intent of Congress to shield local food producers who directly market to consumers from ill-fitting federal requirements.”

In FSMA, Congress clarified that sales through direct-to-consumer sales platforms like roadside stands, farmers markets, and community-supported agriculture (CSAs) operations were included within the exemption for retail food establishments. This amendment was sponsored by Senator Jon Tester (D-MT) and former Senator Kay Hagan (D-NC) and was strongly backed by NSAC.

The clarification serves two important purposes. First, it reinforces that CSAs, farmers markets, roadside stands, and other direct-to-consumer operations that sell the majority of their food directly to consumers are not food facilities, do not have to register with FDA as facilities, and therefore are not subject to the Preventive Controls Rule.

Second, it clarifies that the location of the direct sales does not trigger the facility definition – for example, delivering a CSA box to an off-farm location where customers could pick up their boxes would not make that location a “facility”. Neither, as the final rule makes clear, would use of an off-farm commercial kitchen to process value-added goods.


(From news reports)

Free Agriculture Water Food Safety Testing

Iowa State University Extension and Outreach food safety specialists will be providing free agricultural water food safety testing for up to 100 hobby gardeners and very small fruit and vegetable producers in Iowa for an upcoming ISU Extension and Outreach research project titled “Educating Iowans about the importance of water food safety when growing fruits and vegetables.”

Food and Drug Administration’s Food Safety Modernization Act Produce Rule requires fruit and vegetable growers to test all agricultural water that is used for handwashing and during the growing, harvesting, and processing of fruits and vegetables.  This rule requires that this agricultural water must have less than 126 colony forming units of generic Escherichia coli for safe production.

The ISU Extension research team wants to assist hobby gardeners and very small farmers with testing their agricultural water utilized within their fruit and vegetable garden or farm.  The first 100 agricultural water samples will be sampled for the presence and quantity of generic Escherichia coli at no cost.  Only one agricultural water sample per garden/farm and growers must be located in Iowa.  All sample criteria must accompany the sample.

To participate, three items are needed:
1.    Two sample of at least 500 mL of agricultural water from an untreated surface source (e.g. pond, lagoon, rain barrel, etc.) or untreated ground (e.g. well) source provided.
o    Collect in a sterile container (such as a specimen cup from a doctor office or an unused emptied water bottle)
2.    The use of this agricultural water (e.g. handwashing, drip irrigation, overhead irrigation, produce rinsing)
3.    Indicate the market the fruits and vegetables will be sold or given to (e.g. food pantry, grocer, restaurant, farmers market, hospital, school, etc.)

Please send the items with your contact information including name, address, phone number and email to:
Attn: Angela Shaw
2312 Food Science Building
Ames, IA 50011

If you have any questions, contact ISU Extension food safety specialists Angela Shaw, angelaml@iastate.edu.

This research project is funded by Iowa State University Human Science Extension and Outreach.

Coordinated Audits

Question: How much does a USDA GAP audit cost in Iowa?

Third party Good Agricultural Practices (GAP) certification is expensive for small-scale farmers. Because of the low number of Iowa farms requiring certification, auditors come from out-of-state. The most common certification body used in Iowa at this time is the USDA Agriculture Marketing Service, and auditors will come from Illinois, Missouri or Texas. USDA GAP audits of Iowa farms can exceed $1000 per year.

There have been conversations in Iowa about training people to be state auditors to lower the travel costs associated with an audit.  However, different buyers may request audits from different certification standards and training auditors to more than one standard is prohibitive and not feasible. For example, one buyer might require a USDA GAP audit while another might require a Primus GAP audit.

Several approaches to make audits more affordable have been studied in Iowa. One approach requires neighboring farms to work together.

Called “coordinated audits”, farms in certain areas (generally within 100 miles) will work together to schedule the auditor to visit their farms in the same day or adjacent days. In northeast Iowa, an auditor could visit 2-3 small farms in a day when the farms are 30-40 miles from each other.

This effort to coordinate the auditor’s time results in the travel costs being shared between the farms. Farms practicing “audit coordination” have seen their audit costs cut in half – $500-600 per farm.

When coupled with a GAP cost-share program, where farmers can receive $400-500 in cost-share, GAP certification becomes more realistic.

For more information about coordinated audits, talk to your neighbors, or contact Teresa Wiemerslage at wiemer@iastate.edu. Most Iowa audits take place in August and September.


FAQ: Irrigation Water Quality

Question: My well water test came back high for coliform bacteria but negative for E.coli, is the water okay to use for irrigation?

Answer: It depends on the bacteria level. Look at your test results for the concentration number.

Your irrigation water should be tested specifically for fecal coliforms and generic E. coli, and the test used should not be a simple positive/negative but should determine the number of E. coli present. Typically Iowa farmers will use the University of Iowa Hygienic lab for water testing.

While the presence of generic E. coli does not correlate directly with the likelihood of pathogens being present, it does suggest that the water has been exposed to fecal matter that may contain pathogens. We test for indicators as it is a more cost effective activity than testing for all possible pathogens. Thresholds exist for water quality for different uses: zero E. coli are allowed for wash water and drinking; higher levels are permissible for irrigation water as that water is often impacted by UV rays and drying.

For irrigation water coming in direct contact with the edible portion of a plant, if the average is below 126 MPN/100 mL and highest single sample is below 235 MPN/100 mL then your water is acceptable for agricultural use (EPA, 1986). For water not coming in direct contact with the edible portion of a plant, if the average is below 126 MPN/100 mL and highest single sample is below 576 MPN/100 mL then your water is acceptable for agricultural use. If either number exceeds those tolerances, then you need to take remedial action.

NOTE: Most testing labs will return results as MPN/100 mL but some will report in CFU/100 mL. These measures are equivalent, so regardless of the measurement units, you are looking for the same thresholds (126/235 or 126/576).

Don’t forget to keep your results in your food safety manual.

Remember it is important to choose the highest quality source possible for agricultural irrigation. Water can be contaminated by sediment, agricultural runoff, chemicals, or any of the major microbial contaminants, such as bacteria, viruses, or parasitic organisms. The water tests mentioned above only test for fecal bacteria. Irrigation methods that reduce water contact with produce such as drip are recommended over overhead irrigation.

Source: GAPs for Small Diversified Farms, North Carolina State University and Carolina Farm Stewardship Association.

GAP Cost-share Grants Available for Iowa Growers

Iowa fruit and vegetable farmers can apply for a cost-share grant to assist with the costs of independent food safety certification of an operation’s good agricultural practices (GAPs).

The program is available through the Iowa Food Hub with support from an Iowa Department of Agriculture and Land Stewardship (IDALS) Specialty Crop Block Grant.  The program is available to any Iowa grower.

To be eligible, growers must have a third-party audit from an approved government agency or company that verifies GAP or GHP efforts, the audit must be conducted in 2016 or 2017 and the grower must submit an application to participate in the program prior to the audit. The audit can be for farm review, field harvest and field packing activities, packing house facility, storage and transportation, and traceback. Qualified applicants may receive up to a maximum of $600 per year to cover the costs of one successful audit.

“Cost-share funds help farmers with their on-farm food safety efforts, which are critical to marketing their farm products,” said Teresa Wiemerslage, ISU Extension Regional Program Coordinator.  “I am glad we were able to secure these funds to assist our growers. Funds are available to farmers on a first-come, first-served basis.”

A business/individual is eligible to apply for reimbursement as soon as their USDA GAP audit has been approved. Applicants must fully complete the necessary application and be able to show verification of audit approval. Qualified applicants may only receive funding for one successful audit per calendar year.  Reimbursements will not be given for costs associated with a failed audit.

Participation in the GAP and GHP audit program is voluntary. The cost share program is designed to help defray some of the costs related to a successful audit.  USDA audits for Iowa produce farms have ranged in price from $525 to $1200 per year.

For more information about on-farm food safety or GAP certification, contact Teresa Wiemerslage at wiemer@iastate.edu or 563-794-0599.

Does the FSMA Produce Rule apply to me?

Growers may have a lot of questions about the Food Safety Modernization Act’s Produce Rule now that it is final.

The goal of the produce safety rule is to prevent food safety risks in the growing, harvesting, packing and holding of fresh produce. The rule sets standards for personnel qualifications and training; health and hygiene; agricultural water; biological soil amendments of animal origin; domesticated and wild animals; growing, harvesting, packing and holding activities; equipment, tools and building; and recordkeeping.

The rule was effective beginning Jan. 26, 2016, but farms will need to be in full compliance at different times depending on their operations. Michigan State University Extension has created this chart to show compliance deadlines for different-sized farms.

Click here to find out if your farm is subject to the produce rule, exempt or qualified exempt.

Exempt growers must have records on file supporting their eligibility as an exempt farm by Jan. 26, 2016. These growers must also review their status annually and maintain records of this review and their continued eligibility.

Whether you have one year or five before you need to comply, now is the time to start reviewing your food safety practices. For assistance, contact an Iowa GAPs team member.

FSMA and GAP are not the same

With the advent of the Food Safety Modernization Act (FSMA), we now have a uniform minimum standard of food safety that the overwhelming majority of fresh produce growers must adhere to. The key with FSMA is that it is a minimum requirement. The burden to demonstrate compliance will fall to the producers, and a documented farm food-safety program will be the best way.

In Iowa, we have focused our training on USDA GAP/GHP standard. Currently, USDA teams are working to make the GAP/GHP standard FSMA compliant, and those changes are expected later this year. This is good news for those farms who have implemented GAP plans on their farms. I think we can agree that modifying a current plan is easier than creating one from scratch!

Additionally, FMSA will not eliminate buyer imposed programs for food safety  that are already in place. Even if a farm is FSMA compliant, they may still need to be certified under one or more GAPs to sell to certain buyers.

There are several different “brands” of GAP certification, each with their own special requirements and certification agency. The type of GAP certification required is wholly the choice of the produce buying company. In some cases, a grower may need two or more certifications to sell to several different buyers.

The good news is that often food safety is the same, irrespective of the audit that a grower needs to perform. The food safety manual for a particular audit will be virtually the same for another audit under two different GAP brands. This saves time upfront when a grower needs more than one audit.

If you have specific questions about GAPs or have difficulty tailoring GAPs to your farm, contact the Iowa GAPs team for assistance.

Article adapted from Michigan State University Extension.

Harvest Crew of One

On large, commercial vegetable farms the harvest crew has the responsibly to pick, pack and bring in the product from the field. Employees are trained in food safety so they understand handwashing and sanitary handling. Harvesting is the only activity they do. The crew does not weed, trellis, cull or prune while harvesting. Harvesting is its own activity.

On Iowa’s smaller produce farms, the harvest crew may be a handful of people – or only one or two people on the really small farms. But the concept of the “harvest crew” should still apply. Harvesting is its own activity.

For best food safety management, the harvesting activities need to be the primary focus of the field worker during that time. Hands and equipment are washed, and product is collected and moved to the packing area or cold storage quickly. Distractions should be avoided.

Conduct a pre-harvest walk-through (assessment) to look for wildlife damage and create a plan for harvest. The assessment can also help you identify other items to add to the to-do list after harvesting – fixing the fence, weeding the cucumbers, staking the tomatoes. Leave your phone in the packing area to help you focus on the task at hand (and motivate you to finish quickly). Once the harvest is complete and the food is transferred to the holding facility, your attention can shift to the other tasks for the day.

ISU Named Regional Center for FMSA Training

The U.S. Food & Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) will transform the nation’s food safety system into one that is based on the prevention of foodborne illness. It will be a system in which the food industry systematically puts in place measures proven effective in preventing contamination. Thus, food industry training will be an important component of successful implementation.

In 2015, recognizing the need for food safety training for small farm owners and food processors, the FDA and USDA’s National Institute of Food and Agriculture (NIFA) announced the National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Grant Program, intended to provide funding so that these critical groups receive training, education and technical assistance consistent with standards being established under FSMA. Grants issued through this program will fund a National Coordination Center (NCC) and four Regional Centers (RCs), which will be involved in both key components of training—primarily facilitating training delivery but also, in certain situations, facilitating curricula development targeted to specific audiences.

National Coordination Center: International Food Protection Training Institute (IFPTI) of Battle Creek, Michigan

Regional Centers:

University of Florida, Gainesville, FL received the grant to establish the Southern Training, Education, Extension, Outreach, and Technical Assistance Center to Enhance Produce Safety.

Oregon State University, Corvallis, OR received the grant to establish the Western Training, Education, Extension, Outreach, and Technical Assistance Center to Enhance Food Safety.

Iowa State University has received the grant to establish the North Central Regional Center for Food Safety Training, Education, Extension, Outreach and Technical Assistance

University of Vermont and State Agricultural College has received the grant to establish the Northeast Center for Food Safety, Training, Education, Extension, Outreach and Technical Assistance.

The goal of FSMA training programs will be the outcome – advancing knowledge among food producers to meet FSMA requirements. Specifically, the regional centers will be charged with understanding and communicating the landscape of training opportunities available to target businesses in their region. They will identify any need to develop or tailor curricula to meet specific unmet regional needs and/or to target a specific audience. These centers will work with representatives from non-governmental and community-based organizations, as well as representatives from cooperative extension services, food hubs, local farm cooperatives and other entities that can address specific needs of the communities they serve.

For more information on the FDA’s training strategy for FSMA, please see: FSMA Training

Wash Water Management

FAQ:  Can the used water draining from the hand- and produce-washing sinks flow via gutters in the concrete floor to an exterior outlet?

100_2154Wastewater drainage should not promote cross contamination. If you are using an open gutter or tube, the water could splash and contaminate the floor or other surfaces. People or equipment could contribute to the contamination by walking or moving through the wet areas.

If the wastewater is moving through a closed pipe or channel, then the potential for contamination is greatly reduced. Be sure any piping is not a tripping hazard for workers.

Perform regular maintenance on floor drains to make sure they are free from debris.

dry wellWhere is the wash water going after the packing area? Local governments may require that wash water be put through a septic system, but avoid hooking it up to your home’s septic. The huge amount of water you use in the packing shed may overwhelm your septic system. Most growers just run the water from the packing shed off to a non-production area, storage tank, dry well, or settling area. Think about traffic flow and make sure that people and equipment are not crossing through wet areas.