Health regulators generally have a more permissive approach to raw fruits and vegetables relative to any other product sold by a direct farm business. However, if a direct farm business (DFB) wants to sell value added products, such as canned goods and juices, it is a different story. Because these items have a long and sordid history of harboring dangerous bacteria, Illinois Department of Public Health (IDPH) has significant concerns about safety in production. Consequently, all processed products must be prepared in approved facilities and most processes will have to undergo pre-approval by IDPH.

Before covering the regulations that pertain to each group, one should understand the difference between raw and processed foods. The Illinois Food, Drug and Cosmetic act (IL-FDCA) defines a raw agricultural commodity as “any food in its raw or natural state, including all fruits that are washed, colored or otherwise treated in their unpeeled natural form before marketing” (410 ILCS 620/2.18). IDPH defines “processing" to mean manufacturing, compounding, intermixing or preparing food products for sale or for customer service (77 IAC 750.10, 77 IAC 760.20). An example of this difference is raw versus processed lettuce – a washed head of lettuce is raw, while bagged salad mix is processed. A good rule of thumb would be that if you want to sell your produce in any form other than how it came off the plant or out of the ground, it may be “processed” and subject to additional regulations.

Unprocessed Fruits, Vegetables and Mushrooms

Probably the most common way to sell fruits and vegetables is as raw, unprocessed commodities. If a DFB is selling raw, unprocessed fruits and vegetables, the regulations limit pesticide residues and a prohibit selling rotten or filthy food. Additionally, the Illinois Department of Public Health (IDPH) has specific guidelines for selling mushrooms.

Under the IL-FDCA, a raw agricultural commodity is adulterated if it “bears or contains a pesticide chemical which is unsafe within the meaning of Section 408(a) of the Federal [Food Drug and Cosmetic] Act” (410 ILCS 620/10(a)(2)(B)). Under section 408 of the Federal Food Dug and Cosmetic Act (F-FDCA) (21 U.S.C. 346a), the Federal Environmental Protection Agency (EPA) sets tolerance levels for pesticides on and in foods.  Using notice and comment rulemaking, the EPA establishes the tolerance level for each pesticide based on the potential risks to human health posed by that pesticide. EPA lists tolerance levels for over 1,000 pesticides; therefore it is impossible for this guide to cover all the standards. However, there are several ways a farmer can determine the tolerance levels for pesticides they are using. One method is to look the pesticide up in the Code of Federal Regulations (CFR) (40 C.F.R. Part 180). EPA maintains a website, that explains how to search the CFR to determine the tolerance level for a particular crop. Another EPA website contains general information on pesticides by family, commodity type, and crop type. The site also has a database to look up tolerance levels for particular pesticides, which users can search using pesticides’ common names.

If a food consists in whole or in part of a diseased, contaminated, filthy, putrid or decomposed substance, or if it is otherwise unfit for food, it is adulterated under the IL-FDCA (410 ILCS 620/10(a)(3)). This legal distinction, in general terms, means food should not be rotten or contaminated with animal feces. As many direct farm businesses build their customer base through delivery of superior products and rely on reputation, common business sense would eliminate many of these potential violations. Nonetheless, it merits mentioning because this legal standard applies to both raw and processed foods.

A special subset of vegetable that a DFB may wish to sell is mushrooms. There are no regulations for selling mushrooms, but IDPH Technical Information Bulletin # 26 provides guidance for selling mushrooms to the public. The technical bulletin only allows the sale of domesticated button, portobello, and crimini mushrooms (cultivated Agaricus species), oyster mushrooms (Hiratake) (Pleurotus species), straw mushrooms (Volvariella volvacea), wood ears (Auricularia auricular), enokis (Flammulina velutipes), shiitakes (Lentinus edodes), morels (Morchella species), and hen of the woods (Grifola frondos). To sell cultivated mushrooms, IDPH must regulate the growing, harvesting and processing operation, but the technical bulletin does not provide any guidance on what constitutes acceptable growing, harvesting and processing operations.

The technical bulletin generally prohibits the sale of wild mushrooms that occur naturally on your land. However, morels (Morchella species) may be sold if they show no sign of spoilage and have not been cut, cooked, processed or soaked in any liquids. Retailers must also provide a clear and conspicuous consumer advisory, which can be a sign or on a label, that states at a minimum:

NOTICE

These mushrooms have been picked in the wild and have not been approved as safe to eat by any expert or regulatory agency. Persons who suspect they have mushroom poisoning should seek medical care immediately if any of the following symptoms occur after consuming wild mushrooms: gastrointestinal irritation, abdominal pain, vomiting, diarrhea, sweating, dizziness, weakness, or hallucinations.

It is strongly recommended to thoroughly cook these mushrooms prior to consumption.

Processed Fruits and Vegetables

As discussed above the difference between raw and processed food is slight. Beyond washing and packing, there are several popular processing methods a DFB may employ to create “value-added” products, such as drying, canning, jarring, and pressing into a juice or other beverage. IDPH strictly regulates these activities for safety. Although the Federal Food and Drug Administration provides some guidance, IDPH at the state level does not have written documents available to processors that clearly delineate what constitutes “safe.” As a result, individual regulators make independent “judgment calls” during the permitting process. Therefore, “safe practice” could mean different things between different regulators and different regions. Moreover, standards, and therefore processing requirements, could change as regulators come and go. The bottom line is that careful cooperation is required between the DFB and local public health inspectors during the approval process.

In addition to inspection and permitting, many processed foods must have labels containing particular information. For instance, processed foods must conform to their standards of identity (if any) and bear labels giving the common name of the food. Product labels also must list all ingredients (410 ILCS 620/11(g) and (h)). Packaged foods must have labels identifying the manufacturer, packer or distributor and an accurate accounting of the quantity of the contents (921 U.S.C. 343(e); 410 ILCS 620/11(e)). In addition, federal regulations require foods processed with sulfites to disclose the presence of a sulfating agent (21 C.F.R. § 130.9). IDPH inspectors should advise food processors of any labeling requirements or restrictions that apply to their particular product.

Dried Fruit

 Drying fruit may be the simplest means of processing produce into a value added product, which has the added benefit of longer storage times and the possibility of mixing into trail mixes. To dry fruits and mix them into value-added products, IDPH must inspect and permit the facility. IDPH does not have to pre-approve the recipe or process, but labels or signs must disclose additives and ingredients. IDPH also may check products to ensure they are safe and do not contain undisclosed or deleterious substances.

Some fruit drying processes may use products such as sulfites or FD&C Yellow # 5, which are food and color additives under the IL-FDCA (410 ILCS 620/2.19, 620/2.20). The act deems these additives unsafe unless there is a regulation specifying the permissible quantity of the added substance and its use (410 ILCS 620/13(a)) and adopts the federal regulations of food and color additives (410 ILCS 620/21). If a product requires a processing agent, the simplest approach is to consult a local regulator to determine use restrictions and residue limits. Alternatively, information on allowable food additives is available through FDA’s “Everything Added to Food Database”, which is available here. Lists of FDA approved color additives are available in 21 C.F.R. Parts 73 and 74.

Canning, Jarring, Pickling

Another popular way to create value added products for fruits and vegetables is jellies, jams, fruit butters, pickles and salsas. These methods, which can create anaerobic conditions conducive to the growth of dangerous microbes such as botulism, represent a significant public health concern. Therefore, IDPH exercises strict oversight of these goods. To make any of these products a producer will have to have, at minimum, a certified commercial kitchen and IDPH pre-approval of recipes and production processes. IDPH may require on-going testing of product.

Illinois’ regulations require processing under conditions that minimize the potential for undesirable bacterial or other microbiological growth, toxin formation, or deterioration or contamination of the processed product or ingredients (77 IAC 730.7060).  The regulation states  “[t]his may require careful monitoring of such physical factors as time, temperature, humidity, pressure, flow-rate and such processing operations as freezing, dehydration, heat processing, and refrigeration to assure that mechanical break-downs, time delays, temperature fluctuations, and other factors do not contribute to the decomposition or contamination of the processed products” (id.). However, IDPH has not published technical guidance documents to clarify when these processes may be necessary. Because the IL-FDCA incorporates federal standards of identity and quality for foods sold in Illinois (410 ILCS 620/9), FDA’s guidance regarding standards of identity, which specify production methods for certain foods, provides at least some relevant information for food processors.[1]

Juice & Cider

Like all foods, juice and cider processing facilities must undergo inspection and approval by IDPH. However, rather than IDPH pre-approval of production processes, juice processors must comply with federally mandated Hazard Analysis and Critical Control Point (HAACP, pronounced Ha-sip) procedures, even if only selling the product intrastate (21 C.F.R. Part 120).[2] The HACCP rules require producers to develop a written analysis that identifies points in the production process where microbial, toxic, chemical, physical or other hazards may contaminate the juice, and a written plan for preventing hazards reasonably likely to occur (21 C.F.R. §§ 120.7 and 8). The developer of the written analysis and plan must have specialized HACCP training (21 C.F.R. § 120.13). For more information on the juice HACCP, see FDA’s Guidance for Industry: Juice HACCP; Small Industry Compliance Guide here.

Processers who sell their own produce as juice directly do not have to comply with the HACCP rule, so long as they store, prepare, package, serve, and vend their product exclusively and directly to consumers (21 C.F.R. 120.3(j)). They must comply with HACCP, however, if they sell to other retailers or if anyone else stores, prepares or packages their juice. If a processor is exempt from HACCP, they must still comply with FDA’s other rules. There are standards of identity proscribing minimum contents and allowable ingredients for canned fruit juices and vegetable juices (21 C.F.R. Parts 146 and 156). Additionally, FDA’s labeling rule (21 C.F.R. 101.17(g)) requires a warning label for juices that have not been pasteurized or otherwise treated to kill pathogens. The statement must read:

WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems.

Wine, Beer and Spirits

Once an operation begins pressing juice, it may be a natural progression to ferment wine, beer or spirits. Like all other foods, these products fall under the jurisdiction of the IDPH, which must inspect and permit their operation. However, these operations also are subject to oversight by the Federal Alcohol and Tobacco Trade and Tax Bureau (TTB) (27 U.S.C. §§ 201 et seq.; C.F.R. Title 27) and state and local liquor control commissions (235 ILCS 5; 11 IAC Part 100). The Illinois Board of Tourism’s website, which has a library of guides and marketing tools for wineries, is a valuable resource for individuals interested in producing and selling alcoholic beverages. Although they focus on wine, many of their resources provide information that may be useful to producers of beer and liquors.

At the federal level, TTB requires producers to obtain several permits prior to commencing operations and submit annual forms and taxes. Forms are available through TTB’s website or in a packet by calling 1-800-398-2282. TTB also provides packets of information tailored to particular manufacturers here.

Local and county liquor control commissions vary in their permit requirements. Manufacturers and retailers generally must obtain local permits before obtaining the state level permit (235 ILCS 5/4). At the state level,  the Illinois Liquor Control Commission (ILCC) issues additional required permits for manufacturing, retailing and other activities related to alcoholic beverages, such as off-site tastings (235 ILC 5/3-12). Permit applications are available here. The ILCC also provides guidance to licensees on complying with Illinois’ liquor laws, which is available as a packet or in individual pamphlets here. Many of the ILCC permits require proof of insurance and bonds, proof of local permits, and proof of federal permits.

Illinois’ alcohol distribution system complicates sales and distribution. Generally, Illinois has what is known as a three-tier distribution system that requires manufacturers to contract with distributors, who in turn contract with retailers, who may sell the product to the end consumer. However, there are some exceptions that allow producers to sell directly to consumers in specific instances.

Wineries generally must sell their wine through licensed distributors (235 ILCS 5/5-1(a)). Small wineries that produce less than 25,000 gallons may distribute some of their wine to retailers directly (235 ILCS 5/3-12(a)(17)). To do so, they must obtain a self distribution exemption and may not sell more than 5,000 gallons to retail licensees per year. Winemakers may also sell wine directly to consumers at the winery or show rooms by obtaining a wine maker’s premises license (235 ILCS 5/5-1(i)). Illinois law also allows wineries to ship up to 12 cases directly to a consumer, but the winery must obtain an Illinois Winery Shipper’s license (235 ILCS 5/5-1(r)). The cost of licenses varies according to production size and intended sales methods. Producers should contact the ILCC or their local liquor control office for assistance in identifying which permits to apply for.

Like wineries, beer breweries generally sell through distributors. However, breweries may also act as their own distributors by obtaining distributors licenses (235 ILCS 5/5-2(a)). These permits limit sales of beer for off-premises consumption to 50,000 gallons per year. Brewers may also sell directly to consumers on the premises if they obtain a brew pub license (235 ILCs 5/5-1(n)). If a brewer chooses to contract with a distributor to deliver to retailers, they must comply with the Illinois Beer Industry Fair Dealing Act (815 ILCS 720). The act severely limits when a brewery can terminate or refuse to renew a contract with a distributor (815 ILCS 720/3 and 720/4), and limits breweries rights to prevent the distributor from selling their distribution rights to another company (815 ILCS 720/6).

Other Considerations for Fruits and Vegetables

There are a couple other issues that may arise for fruits and vegetables which other sections of the guide cover. When marketing goods, producers may wish to make certain health or nutrient content claims. The FDA, however, regulates such claims. For details, see Advertising/Marketing, in Chapter ____. Organic production and marketing must follow additional rules. Chapter X, on Organics, explains the requirements of organic production and certification. Finally, the Weights & Measures section of Chapter _______ covers additional marketing rules.

Have you…

- Determined what the residue limits are for any pesticides on the product?

- If you are intending to raise or gather mushrooms, consulted with IDPH?

- If you are processing raw fruits and vegetables, obtained an IDPH inspection and permit for your processing facility? Do you need pre-approval of recipes or processes?

- Are you pressing juice? If so, you need to undergo HACCP training and develop a written HACCP plan or hire a trained professional to do so for you.

- Thinking about selling alcohol? Look into the all the permits you need to get from federal, state and local agencies and be aware of what order they need to be done in and how much they will cost (some can run into the thousands). Also be aware of whether you can sell directly or will need to contract with a distributor.

[1] FDA regulations for canning and jarring are in various parts of Title 21 of the Code of Federal Regulations, including Part 113, Thermally processed low-acid foods packaged in hermetically sealed containers; Part 114, acidified food; Part 145, Canned fruits; Part 150, Fruit butters, jellies, preserves, and related products; Part 152, Fruit pies; and Part 155, Canned Vegetables.

[2] The FDA’s authority over food is generally limited to foods shipped in interstate commerce (21 U.S.C. § 331). However, FDA asserts authority to enforce the HACCP rules under the Public Health Services Act (21 U.S.C. §§ 241, 242l, 254) because juice is a vehicle for transmitting food borne illnesses (see 66 Fed. Reg. 6137, 6148, 6158-6160 (Jan. 19, 2001). 

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