Are You a Farm or a Processor?
New regulations under the Food Safety Modernization Act (FSMA) coming into effect in 2016 will impact both farms and food processers. Smaller operations have longer to comply, but market forces will drive everyone to meet these new requirements. Where does your operation fall under FSMA? It all depends if your business is designated as a “farm” or a “processor.” Do you make “processed food” then your operation is covered under 21 CFR Part 117 or do you make a “raw agricultural product” that is consumed as a ready-to-eat food, then you’re covered under Part 112? Unfortunately, depending upon what you do, your business might have to comply with both. For example, harvesting and packing fresh berries is covered under Part 112 but freezing berries is under Part 117, and both are ready to eat foods. Manufacturing/processing specifies packing, and holding, but even with this, the distinction between what a farm is and what conventional farm activities are, and how these meld into processing activities is not all that clear.
Here we will compare 21 CFR Parts 112 for produce safety and 117 cGMPs (current Good Manufacturing Practices) for processed food to help you determine what rule does your operation fall under and what you may have to do that is different than what you are doing now.
Major Changes Under FSMA for Farmers – Producers of Raw Agricultural Products that are ready-to-eat
Food has a much broader definition and FDA is reaching down to regulate farm activities. Farmers must have plan for controlling microbes of public health significance and know and document who along the value chain controls a food safety hazard if it is not their operations. Farmers must have trained people on staff to manage food safety and be able to document that anyone who has a role in growing, harvesting and packaging agricultural products that are to be consumed raw have had training to do their job correctly. Environmental testing will become a fact of life. Very proscriptive requirements are being put in place for agricultural water safety and the safety of water used for harvesting and other on-farm uses. There are process and microbial specifications for biological soil amendments. And records – lots and lots of records. Compliance for larger operations, those with sales >$500K/yr, is 2017.
Major Changes Under FSMA for Food Processors
There are several new factors affecting food processors. Facilities that process foods must have a food safety expert, called a preventive controls qualified individual, to manage a detailed, written food safety program. There are specific provisions for allergen control and labeling for foods and also for the control of environmental pathogens in ready-to-eat foods.
All processors must now have a preventive controls based food safety plan with detailed verification and monitoring. Processors must also take the physical conditions of their facility into account as part of risk based hazard analysis, this will determine whether a product is at higher risk for example if a facility or equipment within it is hard to clean or zoning is less than ideal. Control programs are now required for undesirable (not just pathogenic) microorganisms that could lead to illness, radiological hazards, unapproved additives, color additives, and economic adulteration for processed food. The term “undesirable microorganisms” includes those microorganisms that: are pathogens, subject food to decomposition, indicate that food is contaminated with filth, or otherwise may cause food to be adulterated.
For Farmers – It’s All About the Water
An initial water quality profile for surface water must be conducted that will involve a minimum of 20 tests for generic E. coli over the first 2 to 4 years to establish microbial water quality profile. This will be the basis for determining if the irrigation water is suitable for fruits or vegetables that are eaten raw. Ground water will require an annual test. If not able to meet water quality criteria, a farmer can show that bacteria “die off” at a certain rate between the last irrigation period and harvest or between harvest and end of storage.
What is a Farm?
There are three categories of farm: primary production, secondary activities, and mixed (§1.227). A primary production farm is an operation under one management in one general (location) but not necessarily contiguous physical location, devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. The term “farm” includes operations that also do the following things:
- pack or hold raw agricultural commodities;
- pack or hold processed food, provided that all processed food is either consumed on that farm or another farm under the same management;
- Manufactures or processes food, provided that: all food used is consumed on that farm or another farm under the same management; or if the processing consists only of drying/Secondary farm activities involve an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of raw agricultural commodities, provided that the primary production farms(s) that grows, harvests and/or raises the majority of the raw agricultural commodities harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm. Mixed-type facility means an establishment that engages in both activities that are exempt from registration (e.g. farming) and activities that require the establishment to be registered (e.g. processing). Mixed type facilities must register with the FDA just as food processors do. dehydrating grapes to produce raisins, and packaging and labeling raisins without additional processing such as slicing); treatment to manipulate the ripening of raw agricultural commodities (such as by treating produce with ethylene gas), and packaging and labeling treated raw agricultural commodities, without additional manufacturing/processing; or packaging and labeling raw agricultural commodities.
A Secondary activities farm is an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of raw agricultural commodities, provided that the primary production farms(s) that grow(s), harvest(s) the majority of the raw agricultural commodities harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm.
A mixed-type facility engages in both farming and processing. Because it is a processor, it must register with the FDA.
Who is a Food Processor? At what point does a farm become a food processing facility?
A food manufacturer or processor makes food from one or more ingredients, synthesizes, prepares, treats, modifies or manipulates food, food crops or ingredients. Examples of manufacturing/processing activities include: baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying dehydrating grapes to produce raisins), evaporating, eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, irradiating, labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate ripening, trimming, washing or waxing or transforms a raw agricultural commodity into a processed food. The manufacturer is the last facility that manufactured or processed the food even if the food has a label added or is packed at another facility. I have highlighted some of the terms above because these overlap with farm activities that are outlined below that are likely to cause confusion for anyone trying to comply with these new regulation since many of these activities could be conducted on a farm as a traditional farm activity (see below).
The FDA lists common farm activities. For example, harvesting applies to farms and farm mixed-type facilities and means activities that are traditionally performed on farms for the purpose of removing raw agricultural commodities from the place they were grown or raised and preparing them for use as foods. Harvesting is limited to activities performed on raw agricultural commodities, or on processed foods created by drying/dehydrating a raw agricultural commodity (like raisins) without additional manufacturing or processing activities besides these occurring on the farm. Examples of harvesting activities include: Cooling, field coring, filtering, gathering, hulling, removing stems and husks, shelling, sifting, threshing, trimming of outer leaves and washing. Note here that there could be an overlap of “farm” activities with “processing” activities, and the distinction is whether or not these activities are ones that are conventionally conducted on a farm or not.
Farms can also hold or store foods. Holding means storage of food and also includes activities performed incidental to storage of a food (e.g., activities performed for the safe or effective storage of that foods, such as fumigating food during storage, and drying/dehydrating raw agricultural commodities when the drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or alfalfa)). Holding also includes activities performed as a practical necessity for the distribution of that foods (such as blending of the same raw agricultural commodity and breaking down pallets), but does not include activities that transform the raw agricultural commodity into a processed food as defined in § 201 (gg) of the Federal Food Drug and Cosmetic Act. Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators and liquid storage tanks.
What are the new food safety requirements that apply to ready-to-eat foods such as fresh produce?
A ready-to-eat food (RTE food) means any food that is normally eaten in its raw state or any other food that is likely to be eaten without further processing or cooking that would significantly minimize biological hazards, specifically microbial contamination. Produce is commonly consumed raw and includes any fruit or vegetable (including mixes of intact fruits and vegetables) and includes mushrooms, sprouts (irrespective of seed source), peanuts, tree nuts, and herbs. A fruit is the edible reproductive body of a seed plant or tree nut (such as apple, orange, and almond) such that fruit means the harvestable or harvested part of a plant developed from a flower. A vegetable is the edible part of an herbaceous plant (such as cabbage or potato) or fleshy fruiting body of a fungus (such as white button or shiitake) grown for an edible part such that vegetable means the harvestable or harvested part of any plant or fungus whose fruit, fleshy fruiting bodies, seeds, roots, tubers, bulbs, stems, leaves, or flower parts are used as food and includes mushrooms, sprouts, and herbs (such as basil or cilantro). Grains are not produce.
The Produce Safety Rule will be the new normal for raw fruits and vegetables
The Produce Safety Rule regulates covered activities for covered produce (Table 1). Covered activities include growing, harvesting, packing, or holding covered produce on a farm. Covered activity also includes manufacturing/ processing of covered produce on a farm, but only to the extent that such activities are performed on raw agricultural commodities and only to the extent that such activities fall within the meaning of “farm” activities. If you produce any of these foods in Table 1, then your operation is covered under the Produce Safety Rule.
The FDA divided produce up according to their assessment of whether or not a product was likely to be consumed raw. Table 2 lists the items from the definition of covered produce (although I have highlighted items I know are commonly consumed raw, you may notice more, despite consideration of fad raw and paleo diets). Regardless of how good the rationale is behind putting these particular items on the excluded list, if it is in Table 2, it is exempt from the Produce Safety Rule requirements. Also exempt is produce that is produced by an individual for personal consumption or produced for consumption on the farm or another farm under the same management. Produce destined for further processing that has a ‘kill step’ such as juice production or canning.
Are there exemptions if you are selling your fruits or vegetables to a processor?
If you will be seeking and exemption from the Produce Rule because your fruits or vegetables will be further processed, the following guidelines will apply. First the processor to whom you are transferring your produce must be applying a processing step to significantly reduce or eliminate microbes of public health significance. Examples of these types of commercial processing are thermal processing (juice and acidified foods), treating with a validated process to eliminate spore-forming microorganisms (such as processing to produce tomato paste or shelf-stable tomatoes), and processing such as refining, distilling, or otherwise manufacturing/processing produce into products such as sugar, oil, spirits, wine, beer or similar products – note, freezing and refrigeration are not on this list. If your customer is not performing the kill step, then you are required to follow the food down the supply chain to the business that is.
To seek an exemption from the Produce Safety Rule requirements, you must disclose in documents accompanying the produce, in accordance with the practice of the trade, that the food is “not processed to adequately reduce the presence of microorganisms of public health significance;” AND you must either:
- Annually obtain written assurance, subject from the customer that performs the commercial processing (that involves the kill step) that the customer has established and is following procedures (identified in the written assurance) that adequately reduce the presence of microorganisms of public health significance; or
- Annually obtain written assurance from your customerthat an entity in the distribution chain subsequent to your customer will perform commercial processing and that the customer: (A) Will disclose in documents accompanying the food, in accordance with the practice of the trade, that the food is “not processed to adequately reduce the presence of micro (B) Will only sell to another entity that agrees, in writing, it will either: (1) Follow procedures (identified in a written assurance) that adequately reduce the presence of microorganisms of public health significance; or (2) Obtain a similar written assurance from its customer that the produce will receive commercial processing, and that there will be disclosure in documents accompanying the food, in accordance with the practice of the trade, that the food is “not processed to adequately reduce the presence of microorganisms of public health significance”.
What are the general requirements for produce safety and what must I do to comply?
The new law requires farmers to take appropriate measures to minimize the risk of serious adverse health consequences or death from the use of, or exposure to fresh produce eaten raw or without a kill step, including measures reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards onto the produce, and provide reasonable assurances that the produce is not adulterated.
Biological hazards such as microbes, parasites, protozoa or viruses that are known to be or have the potential to be associated with the farm or the food need to be controlled. The Produce Safety Rule focuses on biological hazards only, issues such as chemical residues or physical hazards are still important but are not specifically addressed in this new regulation. These new rules focus on control of environmental pathogens –these are microbes capable of surviving and persisting within the manufacturing, processing, packing, or holding environment potentially contaminating a ready-to-eat food and causing foodborne illness if the food. Examples of environmental pathogens include Listeria monocytogenes and Salmonella spp. but not spores of pathogenic sporeforming bacteria. Under the Produce Safety rule, specified testing for E coli 0157:H7, Salmonella spp., Listeria monocytogenes for some products.
A comparison of food safety programs for produce items, and for processed food are provided below in Table 3.
For farms, control programs for covered produce under Part 112 include the following: Water quality monitoring, worker hygiene, animal control, food safety based design and sanitation of buildings, equipment, tools, instruments. There are new requirements for safety of biological soil amendments such as compost, monitoring and records programs for various aspects of the food safety plan, worker training record and verification of effectiveness of control programs. Recall and traceability programs are highly recommended. Allergen control programs may also be important to growers if there is a potential for an allergen, for example, peanut or tree nut meat or shells to come into contact with produce.
There are specific training requirements for individuals handling fresh produce. All personnel (including temporary, part time, seasonal, and contracted personnel) who handle covered produce or food contact surfaces, or who are engaged in the supervision thereof, must receive adequate training, as appropriate to the person’s duties, upon hiring, and periodically thereafter, at least once annually. Also, all personnel (including temporary, part time, seasonal, and contracted personnel) who handle covered produce or food contact surfaces, or who are engaged in the supervision of others performing these activities, must have a combination of education, training, and experience necessary to perform their assigned duties properly. Training for individuals must be conducted in a manner that is easily understood by the people being trained. Training must be repeated as necessary and appropriate in light of observations or information indicating that personnel are not meeting the necessary standards. At least one supervisor or responsible party for a farming operation must have successfully completed food safety training at least equivalent to that received under standardized curriculum recognized as adequate by the FDA
For food processors the requirements are a bit extensive. Processors must have plans for: sanitation, good manufacturing practices, conduct a Hazard Analysis and Risk Based Preventive Controls analysis and prepare a Plan, validate preventive control, verify that the food safety plan has been implemented and is effective for controlling hazards, understand the defect action levels for the food they produce, have a supply chain management program in place when required, a written recall program, documented worker training, and provisions for periodic food safety audits.
New provisions apply to HACCP based programs. These must now be redeveloped based upon preventive controls which would include process control critical limits but also other precautions that would be taken to ensure food safety. Preventive controls for processed food (§ 117.3) are defined as those risk-based, reasonably appropriate procedures, practices, and processes that as person knowledgeable about the safe manufacturing, processing, packing, or holding food would employ to significantly minimize or prevent the hazard identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.
As for produce, individuals manufacturing, processing, packing, or holding food must have proper training. The management of a food processing establishment must ensure that all individuals are qualified to perform their assigned duties. Each individual engaged in manufacturing, processing, packing, or holding food (including temporary or seasonal personnel) or who supervises others must: have the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe as appropriate to the individual’s assigned duties; and must receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility and the individual’s assigned duties. In addition facilities must have a preventive controls qualified individual (§ 117.3) on staff who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA or is otherwise qualified through job experience to develop and apply a food safety systems. This preventive controls qualified individual must do or oversee the following:
- Preparation of the food safety plan (§117.126 (a)(2));
- Validation of the preventive controls (§117.160 (c) (5)):
- Written justification for validation to be performed in a timeframe that exceeds the first 90 calendar days of production of the applicable foods;
- Determination that validation is not required (§117.160 (c) (5));
- >Review of records (§117.165(a)(4)):
- Written justification for review of records of monitoring and corrective actions within a timeframe that exceeds 7 working days;
- Reanalysis of the food safety plan (§117.170(d)):
- >Determination that reanalysis can be completed, and additional preventive controls validated; as appropriate to the nature of the preventive control and its role in the facility’s food safety system, in a timeframe that exceeds the first 90 calendar days of production of the applicable food safety plan
For many operations these new requirements will require re-tasking and retraining and potentially hiring new staff in order to meet the new requirements.
In summary, a number of new regulations are coming in to effect for both produce and processed food. The compliance deadlines are coming up fast, particularly for processors but also for farming operations. Much of this work will involve validating and verifying that operations are conducted to minimize foodborne contamination and involve water testing programs for microbial contamination, microbial control steps during processing and handling, allergen controls (where appropriate), worker training, and ensuring that monitoring of food safety controls are in place whether these are environmental, process, sanitation or GMP controls. There are new responsibilities for managing food safety along the supply chain and mandatory written recall plans. University Extension is ramping up to provide training programs and technical assistance to help you with compliance. Please contact us if you need assistance.
You can watch Dr. Rasco explain this and other presentations by food safety specialists here: http://whatcom.wsu.edu/ag/edu/sfc/2015presentations.html#fs