The Food Safety Modernization Act Produce Rule addresses many issues with regard produce food safety. One issue not addressed is the issue of biological soil amendments of animal origin (i.e. manure). When issuing the rule, the Food and Drug Administration (FDA) chose to leave blank those portions of the rule dealing with the required interval between manure application and harvest of covered crops pending a comprehensive risk assessment by the agency.
FDA has initiated its comprehensive risk assessment process by publishing a request for scientific data, information, and comments in the Federal Register on March 4. There will, most likely, be other requests for comments as FDA investigates the issue and incorporates its findings into the produce rule.
In January 2016, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, otherwise known as the Produce Rule, became law. This rule, as part of the Food Safety and Modernization Act, sets a standard for produce food safety. Not all growers are covered by the rule. An excellent flowchart to help determine coverage may be found at http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM472499.pdf. For those growers who are covered by the rule, there is a training requirement. Growers will have from 2-4 years, depending on farm size (defined by gross sales), to comply with training requirements.
The general requirement of the produce rule is that all personnel who handle covered produce (i.e. commodities covered under the rule) or food contact surfaces or are engaged in supervision of those personnel must receive adequate training, appropriate to the person’s duties, upon hiring and at least once annually thereafter. The rule goes on to say that personnel must have a combination of education, training, and experience necessary to perform their assigned duties in a manner that assures compliance with the rule. Training must be conducted in a manner that is easily understood by personnel being trained. The rule also requires that training be repeated as necessary and appropriate in light of observations or information indicating that personnel are not meeting standards established by the rule.
At a minimum, training should include:
1. Principles of food hygiene and food safety.
2. The importance of health and personal hygiene for all personnel and visitors, including the recognition of symptoms of a health condition that is reasonably likely to result in contamination of produce or food contact surfaces.
3. Standards established in the produce rule that are applicable to the employee’s job responsibilities.
Additionally, for those workers who are involved in harvest activities, training should include:
1. Recognition of produce that should not be harvested due to potential contamination with known or reasonably foreseeable hazards.
2. Inspection of harvest containers and equipment to ensure proper function and cleanliness.
3. Correction and reporting of problems with harvest containers and equipment.
Also, at least one supervisor or responsible party per farm must have successfully completed food safety training at least equivalent to that received under the standardized curriculum recognized as adequate by the FDA. The standardized curriculum has been developed by the Produce Safety Alliance (PSA). Presently, as stated in the produce rule, FDA intends that the PSA curriculum will be the only curriculum officially recognized by FDA. The rule does allow for other curricula to be used as long as it is equivalent to the PSA curriculum. Presently, no mechanism exists to assure the equivalency of other curricula to the officially recognized curriculum.
Currently, PSA has delayed all training programs until September 2016. This was done in order to allow FDA time to review the official curriculum. Once training begins, training for those who are delivering the curriculum will commence. In Indiana, at least eight individuals have started the process of becoming certified lead trainers who are able to offer this curriculum on a statewide basis. Once PSA resumes trainings, certifications will be completed and trainings will be offered shortly thereafter.
As stated previously, each covered farm will need to have at least one supervisor or responsible party complete training. The rule does not take into account any previous trainings that growers may have had. Based on the most current information that I have, trainings will be managed through the Association of Food and Drug Officials (AFDO). Pricing will be $50 for registration and materials and $35 for a certificate at the conclusion of the training.
As we gear up for the 2016 season, please feel free to contact me at (812) 886-0198 or firstname.lastname@example.org if you have any questions concerning food safety training. I am available to discuss training issues and to assist with any on-farm training needs that you may have.
In January 2016, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, otherwise known as the Produce Rule, became law. This rule, as part of the Food Safety and Modernization Act, sets a standard for produce food safety. Not all growers are covered by the rule. An excellent flowchart to help determine coverage may be found at http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM472499.pdf. Those growers who are covered by the rule will have from 2-4 years, depending on farm size (defined by gross sales), to be in compliance. All growers will then receive an additional 2 years to comply with the water testing component of the rule.
The water testing component of the produce rule requires growers to regularly test irrigation water. Growers irrigating with surface water (ponds, lakes, streams, ditches) are required to collect and test 20 samples over a two-year period in order to establish a baseline. Once the baseline is established, 5 samples must be collected and tested every year thereafter. Growers using underground water sources (i.e. wells) will be required to initially collect and test 5 samples over a one-year period in order to establish a baseline. Once the baseline is established, below ground water sources will need to be tested once annually.
When writing the produce rule, the Food and Drug Administration (FDA) chose to use generic E. coli as an indicator of water quality. Indicators, while not human pathogens, are used to indicate the potential for contamination with a human pathogen. The reasoning is that if the indicator organisms are present, there is a reasonable likelihood that human pathogens may also be present. As a result, water samples collected by growers who are covered by the produce rule will need to be tested for generic E. coli, in addition to any other tests the grower may require.
For all irrigation water, the geometric mean of sample results cannot exceed 126 colony forming units (CFU) of generic E. coli per 100 ml of water. Additionally, the statistical threshold value cannot exceed 410 CFU generic E. coli per 100 ml. In the case of surface water, the initial 20 samples will be used to confirm that the irrigation water meets quality standards. After baseline establishment, growers will use the most current year’s test results (5 samples) and the 15 most recent test results from previous years to create a rolling dataset of 20 test results from which new threshold calculations are performed annually. In the case of irrigation water from below-ground sources, an initial 4 samples will be used to confirm that the irrigation water meets quality standards. After baseline establishment, growers will use the previous year’s test results (1 sample) and the 3 most recent test results to create a rolling dataset of 4 test results from which new threshold calculations are performed annually.
This standard applies to all water applied to the crop prior to harvest. In writing the produce rule, FDA chose not to differentiate between methods of irrigation. Consequently, the water testing requirement and thresholds apply whether growers utilize drip or overhead irrigation. In cases where growers’ test results exceed the thresholds, the issue must be addressed and corrected. Growers have the following options:
1. Allowing time for microbial die-off in the field between irrigation and harvest. Growers may assume a 0.5 log reduction per day in microbe levels.
2. Treating the water or water source with an approved sanitizer
3. Finding an alternative water source that meets requirements.
Water used for postharvest must be potable, which means no detectable generic E. coli. It is the responsibility of each farm to be able to demonstrate that their postharvest water meets this quality standard. In the case of farms using well water for packing lines or for other postharvest uses, they will need to document that the water is of sufficient quality by having the well tested in accordance with the procedures for underground water. This means collecting an initial four samples over a one-year period, establishing a baseline, and then testing one sample annually. Growers who are using well water for postharvest are advised to begin this process as early as possible in the growing season in order to establish their baseline prior to this season’s harvest. In establishing the baseline, tests from last season may be used, as long as all the tests are taken within a one year period.
Please feel free to contact me at 812-886-0198 or email@example.com should you have any questions about water testing or any other components of the produce rule.
In November 2015 the Food and Drug Administration (FDA) published the final version of Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption, otherwise known as the Produce Rule, in the Federal Register. Sixty days later, in January 2016, the rule became law. The Produce Rule is one of several new regulations mandated by the Food Safety Modernization Act (FSMA), which was signed into law in January 2011.
1. What is the value of my produce sales? Growers whose produce sales have averaged $25,000 or less for the past three years are not covered by this rule.
2. What crops am I growing? FDA has listed several crops that are rarely consumed raw. Examples of these crops are winter squash and potatoes. These crops are exempt from coverage.
3. What is the value of all my food sales? Growers whose total food sales (including agronomic crops and livestock) have averaged $500,000 or less over the past three years may receive a qualified exemption.
4. How am I marketing my crops? In order to receive a qualified exemption, over one-half of food sales must be to a qualified end user, defined as the end consumer or a restaurant or retail food establishment located in the same state or the same Indiana reservation that produced the food or not more than 275 miles from the farm that produced the food.
5. Am I producing any crops for personal consumption? Crops grown for personal consumption (i.e. not for sale into the public food supply) are not covered by the Produce Rule
6. Am I producing crops for processing? Crops grown for processing receive a qualified exemption, although certain conditions must be met to insure that crops are, in fact, being processed in a manner that adequately reduces pathogens.
Growers should remember that regardless of whether or not they are covered by the Produce Rule, there is never an exemption from liability. All growers who sell produce into the public food supply face the same liability, regardless of Produce Rule coverage, should the unthinkable happen and a foodborne illness outbreak is traced to their farm. As a result, all growers are reminded to use Good Agricultural Practices in the upcoming season as a means of reducing the risk of a foodborne pathogens contaminating produce on their farm.
Purdue University is pleased to offer Indiana fruit and vegetable farmers a farm walk-through with a private food safety consultant. This opportunity is open to any farm that sells fresh produce and has attended a produce safety educational program. A consultant paid by Purdue will visit your farm to walk through and address your specific farm and packinghouse food safety questions. Growers who participated in the consulting program in 2015 reported it was very helpful. Funds for the consulting come from a grant from the Indiana State Department of Agriculture through the USDA Specialty Crops Block Grant Program.
The grant also includes funds for audit cost-sharing for Indiana fruit and vegetable growers who receive passing scores on their third party food safety audits. The audit cost-share program will reimburse at least 40% of the cost of a third party food safety audit, up to a maximum reimbursement of $750 per farm.
To apply for consulting or audit cost-share, fill out and return the application by May 1, 2016. Applications may be downloaded from ag.purdue.edu/hla/foodsafety/Documents/PurdueFoodSafetyCostshareConsultApp2016.pdf, or applicants may fill out the online form at tinyurl.com/fs-cost-share-2016.
In addition to these programs, Purdue food safety Extension experts Amanda Deering and Scott Monroe are available to conduct mock-audits for produce farms on request. Contact Scott at 812-886-0198 at Amanda at 765-494-0512.
For more information contact Liz Maynard at 219-548-3674 or firstname.lastname@example.org.
There are certain questions within our culture for which there are simply no good answers. For example, how many times have we heard the classic question, “If a tree falls in a woods and there’s no one to hear it, does it still make a sound?” One question I’ve been asked recently, for which the answer is equally elusive, is “How long must I wait to grow vegetables after applying manure to the field?” With the 2015 season quickly winding down, it will soon be time to start making plans for next year’s crops. Part of those plans will undoubtedly include the question of manure use.
While manure is a good source of plant nutrients and organic matter, it may also contain human pathogens that can be transferred onto fresh fruits and vegetables. After manure is applied to a field, the bacterial community in the manure changes as it adapts to conditions in the soil. Given all the variables involved, exactly what happens to the bacteria is anyone’s guess. Soil type, manure type, soil moisture levels, and temperature all play a role in how quickly manure degrades and the bacterial community changes. While research is starting to shed some light on the issue, the fate of human pathogens in manure applied to the soil is still poorly understood. This was noted by FDA in their latest draft of the Proposed Rule for Produce Safety. Publications supplemental to the proposed rule stated that:
“The agency is deferring its decision on an appropriate time interval [between manure application and crop harvest] until it pursues certain actions. These include conducting a risk assessment and extensive research to strengthen scientific support for any future proposal, working with the U.S. Department of Agriculture and other stakeholders.” (FSMA Proposed Rule for Produce Safety: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm)
The National Organic Program specifies an interval of 120 days between the application of raw manure and harvest for crops that come in contact with the soil and an interval of 90 days for crops that do not come in contact with the soil. These serve as good general guidelines, but the intervals were not developed to assure food safety.
Remember, in addition to any general guidelines, always follow the guidance given by your particular audit protocol or food safety plan.
Those using properly composted manure may apply it at any time, taking care to avoid application to the edible parts of the plants. Those producing crops with edible parts underground may also want to avoid applying composted manure while crops are in the field. Proper composting in this context involves a high-temperature process that kills most human pathogens. The high temperatures must be documented, along with other details of the composting process. A summary of what is involved in producing compost may be found at: http://content.ces.ncsu.edu/compost-production-and-use-in-sustainable-farming-systems.pdf.
Unless you have documentation that manure was composted properly, it should be treated as nothing more than aged raw manure, and there should be an interval of several months between application and harvest of a fruit or vegetable crop.
In addition to composting, other heat and chemical treatments can reduce pathogens in manure. Often manure treated with these methods is sold commercially as a bagged or bulk product. Growers using such products should get information about the manure treatment from the supplier, and ask specifically whether the treatment is documented to kill human pathogens.
One of the best ways to utilize manure is to apply it in the fall. A fall application, followed by incorporation and a cover crop, is a good way to insure a lengthy application-to-harvest window. One additional advantage is that fall-applying manure cuts one more job from what is, for most people, an increasingly hectic spring season. For those wishing to use a fall manure application, Purdue’s Midwest Cover Crops Field Guide (ID-433, https://mdc.itap.purdue.edu/item.asp?Item_Number=ID-433) can provide valuable cover crop information. Purdue’s Manure Management Planner, although designed for field crops, can help with estimating nutrient content from various manures (http://www.purdue.edu/agsoftware/mmp/).
An additional option may be to simply use manure only on agronomic crops. As a whole, the Midwest is a very strong agronomic region. Corn and soybeans are still the main crops. Where possible, growers can use this to their advantage by applying manure to agronomic crops in the year before fields are rotated into vegetables. This gives an interval of a year or more and growers can still reap some benefits (increased organic matter, plant nutrients, etc.) from the manure application, with reduced risk to their vegetable crops.
If you must apply manure in the spring, avoid planting short-season crops in fields that have received an application. Long season vegetables, such as staked tomatoes, whose edible parts do not contact the ground, carry the least risk of being contaminated with a foodborne pathogen. Other options would be to grow late-season crops that normally are not consumed, such as pumpkins or gourds. Yet another option would be crops that are cooked prior to eating, such as sweet corn.
Across the state, growers have worked hard to incorporate food safety into the culture of their farms. Paying attention to how and when manure is applied is a good way to reduce the risk of a future outbreak.
Recently the USDA announced the addition of a new third-party auditing service that will be available through the Ag Marketing Service (AMS). The service, called “GroupGAP”, will be available in the spring of 2016. The expansion of the service follows multi-year piloting and testing of the program.
Under the GroupGAP program, independent farms may organize under a central entity, such as a food hub or grower cooperative, to create a food safety system. Participating farms are responsible for collectively developing food safety practices and collecting required documentation. Entities will also be responsible for providing their own internal auditing services. They will also participate in an external audit by USDA-AMS Specialty Crops Inspection Service.
Recently, I’ve gotten a few similar calls from vegetable growers. The call usually starts out with the grower saying, “My buyer tells me that I need to get a food safety certification – what is that?” I’m hoping that with this entry I can start to de-mystify the process.
The term “Food Safety Certification” can have different meanings, depending on what the buyer is requesting. My experience is that buyers frequently don’t know what they are actually asking for and are requesting action on your part due to a request or concern expressed by customers further down the marketing channel. The first recommendation I give growers when I get this type of call is to contact their buyer and find out EXACTLY what is being requested.
Industry and state and federal regulatory agencies are all a part of the produce food safety landscape. The following is a quick run-down of the role each currently plays:
Industry – In the absence of government regulation, the produce industry as a whole has moved to address food safety issues. Frequently, this means a third-party certification. Several entities have developed proprietary food safety audit protocols. Examples of protocols include PrimusGFS and GlobalGAP. The general process is that a grower selects a protocol and auditing company (sometimes the same entity), the grower writes a food safety plan and establishes a food safety program based on that protocol, and finally the grower undergoes a voluntary third-party audit to insure that the written plan is being followed. Passing the audit earns the grower a third-party food safety certification.
State Regulatory Agencies – In Indiana, the Indiana State Department of Health (ISDH) is the agency that regulates produce food safety. Their produce protection program has two requirements. First, all operations that are selling produce on a wholesale basis must register with the department. Registration involves simply filling out a form and submitting it to ISDH. This requirement has actually been in place since the 1930’s as part of the Indiana Food, Drug, and Cosmetic Act and really adds no new regulatory burden to growers. The second requirement is that growers who sell on a wholesale basis and register with the department must show proof of Good Agricultural Practices (GAPs) training. ISDH recognizes trainings such as the Purdue GAPs A-Z workshops and other introductory level trainings as meeting their requirements.
Federal Agencies – The Food and Drug Administration (FDA) is responsible for regulating produce food safety. At the time of this writing, it is anticipated that FDA will soon release the final version of the Produce Rule, mandated by the Food Safety and Modernization Act of 2011 (FSMA). The rule will require certain operations to provide proof of food safety training, but will not require farms to undergo third party audits.
The USDA Ag Marketing Service does not regulate fresh produce safety, but does provide food safety audits for growers. Growers may choose from several audit protocols that USDA staff are trained to provide. Passing a food safety audit from USDA provides a grower with a third-party certification.
Given the number of groups and agencies involved in produce food safety, and the inconsistent terminology, it is easy to see where communication break-downs can occur. Also, buyers may be new to food safety and may not fully understand what they are requesting. That’s why it is critical that growers ask buyers to spell out exactly what they are requesting. If the buyer wants a third-party certification, the next step is to find out what protocol(s) the buyer will accept. Each buyer has specific audit protocols that are preferred or accepted. For instance, one buyer may only accept an audit benchmarked by the Global Food Safety Initiative (GFSI). Another may accept a USDA Harmonized GAPs Audit. Find out what your buyer will accept before you start spending time and money to implement a specific program.
If the buyer is simply needing proof of GAPs training, any recognized introductory training will do. Participants who complete an introductory GAPs training course are generally given a certificate of attendance or a certificate of completion. Receiving a certificate of attendance is not the same as being third-party certified!
A buyer using the term “certification,” may also be asking for proof that one has registered with ISDH.
While incredibly important, produce food safety comes with a price. Preparing for and passing an audit to obtain third-party certification can be very costly. GAPs training may also come with an expense. Consequently, clear communication is essential in order to understand exactly what is required. Asking the right questions of buyers will help to avoid situations where excess time and money are spent to fulfill the wrong expectations.
By J. Scott Monroe, Food Safety Educator, Purdue Extension
Purdue University and the Illiana Watermelon Association (IWA) are offering food safety audit cost-share programs to Indiana fruit and vegetable growers this year. Funds for the programs come from a grant from the Indiana State Department of Agriculture through the USDA Specialty Crops Block Grant Program. Through the Purdue program, Indiana fruit and vegetable growers who receive passing scores on their third party food safety audits are eligible for reimbursement of 40% of their audit cost, up to a maximum of $400 per farm. Through the Illiana Watermelon Association program IWA members may receive reimbursement for 75% of an audit cost (up to $1,500) if a preferred audit-provider is used, or 60% (up to $1,200) if a non-preferred provider is used. Producers of any fruit or vegetable wishing to take advantage of the IWA program may join the IWA.
To apply for cost-sharing, complete and return the appropriate application by July 1. The Purdue application may be down-loaded from https://ag.purdue.edu/hla/foodsafety/documents/PurdueFoodSafetyCostshareConsultApp.pdf, or filled out online at http://tinyurl.com/audit-cost-share. The IWA application is available at http://www.illianawatermelon.org/Documents/2015/Audit%20reimb%20application.pdf. Producers may receive reimbursement from only one of the programs. To receive reimbursement, documentation of audit results and cost must be submitted to Purdue or IWA after the audit is complete.
The program also provides the opportunity for growers to have a walk-through of their farm with a private food safety consultant contracted by Purdue. The private food safety consultant may also address specific farm and packinghouse food safety questions and issues. This opportunity is open to any grower, whether or not they participate in either audit cost-share program. To request a consultant visit, use the application for the Purdue cost-share program and return by July 1.
For more information, contact Scott Monroe at 812- 886-0198 (office) or 765-427-9910 (cell).
J. Scott Monroe - Food Safety Educator, Purdue Extension
Jennifer Stefancik - Extension Educator-HHS, Purdue Extension Daviess County
Karel Kirschner - Extension Educator-HHS, Purdue Extension Knox County
Summer has once again returned to the area. With the weather continuing to warm up, gardens will soon be bursting forth with nature’s bounty. As we all enjoy fresh produce from the garden and work to preserve food for the winter that we know will return, it is important to manage produce in such a way that we don’t create opportunities for the introduction of foodborne pathogens. Following a few simple steps can reduce the risk of microbial contamination.
In the garden, care should be taken to minimize the presence of both wild and domestic animals. Dogs, deer, and other wildlife can introduce foodborne pathogens. It is also a good idea for everyone to wash their hands before picking or otherwise handling produce. Placing harvested produce into clean containers (ideally cleaned before each harvest) can also reduce contamination risk. Gardeners should have one or two containers that they keep clean and use exclusively for holding harvested produce. Irrigating from a clean water source (such as a municipal system or well) is a good way to reduce the risk of contamination.
Whether items are from the garden or the local produce stands or farmer’s markets, fresh produce should be preserved as quickly as possible. The time to start thinking about preserving produce is prior to harvest. Start by checking your equipment and supplies. Proper equipment in good condition is required for safe, high quality home canned food. A pressure canner is essential for canning low-acid vegetables (pH less than 4.6), meats, fish, and poultry. Two basic types are available. One has a dial gauge to indicate the pressure inside the canner; the other has a metal weighted gauge. Dial gauges must be tested for accuracy before each canning season. For information on testing a dial gauge, call your county Extension Office. Check the rubber gasket if your canner has one; it should be flexible and soft, not brittle, sticky or cracked. Also make sure any small pipes or vent ports with openings are clean and open all the way through.
A boiling water canner is needed for canning other foods such as fruits, pickles, jellies and jams. The canner should be deep enough to allow at least one to two inches of water to boil over the tops of the jars. Both types of canners should have a rack in the bottom to keep jars off the bottom of the canner. Inventory your jars and decide if you need to buy new jars this year. Inspect those you have for nicks, cracks or chips, especially around the top sealing edge. Nicks can prevent lids from sealing. Very old jars can weaken with age and repeated use, causing them to break under pressure and heat. Consider investing in new jars if you need to, and watch for specials at the stores. New jars are a better investment over time than buying used jars at yard sales or flea markets. Mason-type jars specifically designed for home canning are best. Jars that use two-piece self-sealing metal lids are the recommended container in USDA guidelines. A "must" every canning season is new flat lids. Used lids should be thrown away. The screw bands are re-usable if they are not bent, dented or rusted.
A final must is reliable, up-to-date canning instructions. Publications and information are available at your county Extension Office, or the National Center for Home Food
Preservation website (http://nchfp.uga.edu/
). The most recently revised edition of the USDA Complete Guide to Home Canning is dated 2009; all recommendations in this book are current. To order, visit the Purdue University Education Store (https://mdc.itap.purdue.edu/
). The University of Georgia Cooperative Extension Service also sells "So Easy to Preserve", a comprehensive book with information on all types of home food preservation. The order form for the book can be printed from (www.soeasytopreserve.com
) . Directions for payment and mailing or faxing orders are on that order form.
Be sure to look at the instructions for what you want to preserve well before you are ready to prepare the food. You may need time to purchase some ingredients and small pieces of equipment that are necessary to prepare the food exactly as the directions indicate. For example, there are a few products listed in the USDA Complete Guide to Home Canning (starches) that are only available through mail order for most locations. Planning ahead can save you time, money, and frustration with home canning. Make it a happy, successful canning season by getting prepared.
This summer, Purdue Extension will be offering Hands-On workshops for making Jams and Jellies (May 21), Salsa (July 30), and Vegetables (Aug 20). Contact Jennifer Stefancik at email@example.com
or Karel Kirschner at firstname.lastname@example.org
for more information. Cost is $10 per class and class size is limited!