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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 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 must undergo pre-approval by IDPH.

Before describing the regulations that pertain to each group, it is important to 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 produce sold in any form other than how it came off the plant or out of the ground  may be “processed” and subject to additional regulations.

I.  Unprocessed Fruits, Vegetables, and Mushrooms

Probably the most common way to sell fruits and vegetables is as raw, unprocessed commodities.  If a direct farm business 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.

Federal Law Requirements  

As noted, the Food and Drug Administration is the federal agency charged with ensuring the safety of food commodities sold in the United States.  However, until recently, the FDA did not impose formal rules on unprocessed fruits and vegetables at the farm level, because it did not have the statutory authority to do so.  Instead, the FDA was limited to publishing non-binding guidance documents on best practices for the growing, harvesting, and processing of fresh fruits and vegetables. 

This has changed with the passage in early 2011 of the Food Safety Modernization Act (FSMA), the most significant food safety legislation since the 1938 passage of the FFDCA.  The intent of the FSMA is to close some of the gaps in the existing food safety system.  Key additions/revisions to the existing food safety framework include:

The ability of FDA to mandate food safety measures at the farm level for fruit and vegetable production.  Previously, agricultural production (i.e., farming) was the exclusive purview of the USDA, with very limited exceptions such as shell egg production.  But Section 105 of the FSMA directs the FDA, by way of formal rulemaking, to “establish minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death” (H.R. 2751 § 105 (to be codified at 21 U.S.C. § 419(a)(1)(A)). 

 

As of this writing (March 2011), these rules have not yet been formalized, but the law states that the FDA’s rules should: (1) be sufficiently flexible so as to apply to fruit and vegetable producers of all sizes, including those that sell directly to consumers; (2) include, with respect to growing, harvesting, sorting, packing, and storage operations, “science-based minimum standards related to soil amendments, hygiene, packaging, temperature controls, animals in the growing area, and water;” and (3) not conflict with or duplicate requirements of the National Organic Program.

 

The FDA already has established such standards by way of its Good Agricultural Practices (GAP) Guide  for fruit and vegetable production, though this Guide is not law and compliance is therefore voluntary.  However, fruit and vegetable producers who wish to get an idea of what FDA’s rules might eventually look like or who wish to reduce the risk of bacterial contamination in their produce may find the Guide to be a helpful resource for altering or refining growing and production processes. 

 

FDA authority to create a system of hazard analysis risk and risk based prevention control (HACCP) in all food processing facilities: A Hazard Analysis and Critical Control Point (HACCP) system is a prevention-based food-safety system designed to prevent, reduce to acceptable levels, or eliminate the microbial, chemical, and physical hazards associated with food production.  HACCP’s main advantage is that it is a proactive rather than reactive method of containing contamination.  It is the food producer’s responsibility to identify critical points in the production process that are susceptible to contamination and then develop and follow a written plan that addresses and effectively controls those risks.

 

To that end, Section 103 of the FSMA requires food processing, packing, and holding facilities to develop and carry out HACCP plans that: (1) identify, in writing, “known or reasonably foreseeable hazards” associated with the facility, including natural toxins (such as Salmonella and E. coli), (2) identify and implement preventative controls, including at critical control points, to significantly minimize or prevent the identified hazards, and (3) take corrective actions if the preventative controls are not properly implemented or are found to be ineffective.  The statute also imposes detailed monitoring, plan re-verification, and recordkeeping requirements. 

 

Exemption for small producers:  After intense lobbying by small farm and local food advocates, the Senate passed the Tester-Hagen Amendment to the FSMA as a compromise to minimize the financial impact of compliance with many of the new statute’s provisions.  Specifically, Congress exempted small farms (less than $500,000 in total sales) engaged in direct-farm marketing (so long as 50% of total farm sales were in direct sales to  consumers or restaurants in the same state or within a 275-mile radius).  Congress included a similar exemption for these entities from the HACCP requirements. 

 

What the changes in the law mean for direct farm business producers:  The FDA authority to impose on-farm safety measures is limited to fresh fruit and vegetable production, not grains or oilseeds.  The HACCP requirements apply to food processing facilities.  The definition of a facility specifically exempts farms, unless the farm engages in some type of processing, such as milling of wheat for flour. [1]  However, farms processing harvested goods for use on the same farm (e.g., milling own wheat for personal use) are exempted from the definition of a “facility.”  Therefore, unless the farm is creating a value added product (e.g., engaging in some form of processing) and delivering this product off the premises, the farm is not a facility and thus not subject to the HACCP rules.   Food processing facilities, on the other hand, should carefully monitor the development of implementing regulations as several elements of the FMSA may apply and require operational changing and documentation of food safety procedures.

That being said, many direct farm business producers will fall within the small farm exemption to the law and therefore will not need to comply with the new rules.  FDA produce safety is currently a moving area of law, and producers who are unsure of their status should contact an attorney for specific guidance. 

State Law Requirements  

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 § 408(a) of the Federal [Food Drug and Cosmetic] Act” (410 ILCS 620/10(a)(2)(B)).  Under § 408 of the Federal Food, Drug, 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 more than 1,000 pesticides, so it is impossible for this Guide to cover all the standards.  However, there are several ways farmers can determine the tolerance levels for pesticides they are using.  One method is to look up the pesticide 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 the common names of pesticides.

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.

            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 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.

II.  Processed Fruits and Vegetables

As discussed above, the difference between raw and processed food can sometimes be slight.  Beyond washing and packing, there are several popular processing methods a direct farm business may use 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 direct farm businesses should cooperate with local public health inspectors during the approval process to ensure that no violations occur. 

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 must also list all ingredients (410 ILCS 620/11(g) and (h)).  Packaged foods must have labels that identify the manufacturer, packer, or distributor and that contain an accurate accounting of the quantity of the contents (21 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.  Before a direct farm business may dry fruits and mix them into value-added products such as trail mix, IDPH must inspect and permit the processing 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 defined as food and color additives under the IL-FDCA (410 ILCS 620/2.19, 620/2.20).  The Act deems these additives to be unsafe unless there is a regulation specifying the permissible quantity of the added substance and its use (410 ILCS 620/13(a)); it also adopts the federal regulations of food and color additives (410 ILCS 620/21(d)).  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 online.  Lists of FDA approved color additives are available in 21 C.F.R. Parts 73 and 74.

Canning, Jarring, Pickling

Jellies, jams, fruit butters, pickles, and salsas are all popular value-added fruit and vegetable products.   However, the methods used to create them primarily canning, jarring, and pickling can create anaerobic conditions conducive to the growth of dangerous microbes such as botulism and therefore represent a significant public health concern.  As a result, IDPH exercises strict oversight of these goods.  To make any of these products, a producer will need, at minimum, a certified commercial kitchen and IDPH pre-approval of recipes and production processes. IDPH may also require on-going product testing.

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: “This 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.[2]   The USDA also has a Complete Guide to Home Canning  that contains helpful tips to ensure safe canning processes. 

Juice and Cider

Like all foods, juice and cider processing facilities must undergo inspection and approval by IDPH.  However, rather than undergoing IDPH pre-approval of production processes, juice processors must instead comply with federally-mandated Hazard Analysis and Critical Control Point (HACCP, pronounced “ha-sip”) procedures, even if they are only selling the product intrastate (21 C.F.R. Part 120).[3]   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, as well as a written plan for preventing hazards reasonably likely to occur (21 C.F.R. §§ 120.7 and 120.8). 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, the FDA has issued Guidance for Industry: Juice HACCP; Small Industry Compliance Guide, which is available online.    

Processers who sell their own produce directly to consumers as juice 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, including 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.

Penn State Extension has produced an excellent publication, My Food Venture Risk Management Plan, which can help small producers assess and mitigate the risks associated with producing and selling value-added and processed foods.  The guide is available on the Penn State Extension website. 

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 the Board of Tourism focuses on wine, many of their resources provide information that may be useful to producers of beer and liquors as well.

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 online packets of information tailored to particular manufacturers. 

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 on the ILCC website.   The ILCC also provides guidance to licensees on complying with Illinois’ liquor laws, which is available as a packet or in individual pamphlets online.  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 the circumstances under which a brewery can terminate or refuse to renew a contract with a distributor (815 ILCS 720/3 and 720/4).  It also limits a brewery’s right to prevent the distributor from selling their distribution rights to another company (815 ILCS 720/6).

Other Considerations for Fruits and Vegetables

Other sections of this Guide cover several additional issues that might arise when a direct farm business chooses to grow and sell fruits and vegetables.  First, producers may wish to make certain health or nutrient claims when marketing their goods.  These statements are regulated by the FDA and are discussed further in the “Marketing and Managing” chapter.  Second, organic production and marketing must follow additional rules, which are outlined in the “Organic Marketing” chapter.  Finally, the “Weights & Measures” section of the “Marketing and Managing” chapter covers additional marketing rules applicable to direct farm businesses.   

  • Have you determined what the residue limits are for any pesticides on the product?
  • If you are intending to raise or gather mushrooms, have you consulted with IDPH?
  • If you are processing raw fruits and vegetables, have you 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.
  • Are you thinking about selling alcohol? Look into the all the permits you need to get from federal, state and local agencies, be aware the order in which they must be completed, and investigate 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.

 Key Contact Information

U.S. Environmental Protection Agency's National Pesticide Information Center

Ph: 1-800-858-7378

Illinois Division of Public Health, Division of Foods, Drugs, and Dairies

Ph: 217-785-2439 (main)

Regional office contact search: http://www.idph.state.il.us/local/map.htm

U.S. Dept. of the Treasury, Alcohol and Tobacco Tax and Trade Bureau (TTB)

Ph: 877-882-3277 (general info)

Illinois Liquor Control Commission

Chicago office: 312-814-2206

Springfield office: 217-782-2136

email: ilcc_info@mail.state.il.us

 


[1] Specifically, current law defines a “facility” as “any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food.  Such term does not include farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels….”  21 U.S.C. § 350d(b)(1).

[2] 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.

[3] 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). 


Continue to Grains, Cereals & Oilseeds  arrow.jpg

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 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 must undergo pre-approval by IDPH.

Text Box:  Before describing the regulations that pertain to each group, it is important to 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 produce sold in any form other than how it came off the plant or out of the ground  may be “processed” and subject to additional regulations.

I.                Unprocessed Fruits, Vegetables and Mushrooms

Probably the most common way to sell fruits and vegetables is as raw, unprocessed commodities. If a direct farm business 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.

Federal Law Requirements

As noted, the federal Food and Drug Administration is the federal agency charged with ensuring the safety of food commodities sold in the United States.   However, until recently, the FDA imposed no formal rules on unprocessed fruits and vegetables at the farm level, simply because it did not have the statutory authority to do so. Instead, the FDA was limited to publishing non-binding guidance documents on best practices for the growing, harvesting, and processing of fresh fruits and vegetables. 

This has changed with the passage in early 2011 of the Food Safety Modernization Act (FSMA), the most significant food safety legislation since the 1938 passage for the FFDCA.  The intent of the FSMA is to close some of the gaps in the existing food safety system.  Key additions/revisions to the existing food safety framework include:

The ability of FDA to mandate food safety measures at the farm level for fruit and vegetable production.   Previously, agricultural production (i.e., farming) was the exclusive purview of the USDA, with very limited exceptions such as shell egg production.  But Section 105 of the FSMA directs the FDA, by way of formal rulemaking, to “establish minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death” (H.R. 2751 § 105 (to be codified at 21 U.S.C. § 419(a)(1)(A)). 

 

As of this writing (March 2011), these rules have not yet been formalized, but the law states that FDA’s rules should be (1) sufficiently flexible so as to apply to fruit and vegetable producers of all sizes, including those that sell directly to consumers; (2) include, with respect to growing, harvesting, sorting, packing, and storage operations, “science-based minimum standards related to soil amendments, hygiene, packaging, temperature controls, animals in the growing area, and water,” (3) not conflict with or duplicate requirements of the National Organic Program.

 

The FDA already has established such standards by way of its Good Agricultural Practices (GAP) Guide[1] for fruit and vegetable production, though this Guide is not law and compliance is therefore voluntary.  However, fruit and vegetable producers who wish to get an idea of what FDA’s rules might eventually look like – or who wish to reduce the risk of bacterial contamination in their produce – may find the Guide to be a helpful resource for altering or refining growing and production processes. 

 

FDA authority to create a system of hazard analysis risk and risk based prevention control (HACCP) in all food processing facilities:  A Hazard Analysis and Critical Control Point (HACCP) system is a prevention-based food-safety system designed to prevent, reduce to acceptable levels, or eliminate the microbial, chemical, and physical hazards associated with food production.  HACCP’s main advantage is that it is a proactive rather than reactive method of containing contamination: it is the food producer’s responsibility to identify critical points in the production process that are susceptible to contamination and then develop and follow a written plan that addresses and effectively controls those risks.

 

To that end, Section 103 of the FSMA requires food processing, packing, and holding facilities to develop and carry out HACCP plans that (1) identify, in writing, “known or reasonably foreseeable hazards” associated with the facility, including natural toxins (such as Salmonella and E. coli), (2) identify and implement preventative controls, including at critical control points, to significantly minimize or prevent the identified hazards, and (3) take corrective actions if the preventative controls are not properly implemented or are found to be ineffective.  The statute also imposes detailed monitoring, plan re-verification, and recordkeeping requirements. 

 

Exemption for small producers:  After intense lobbying by small farm and local food advocates, the Senate passed the Tester-Hagen Amendment to the FSMA as a compromise to minimize the financial impact of compliance with many of the new statute’s provisions.  Specifically, Congress exempted small farms (less than $500,000 in total sales) engaged in direct-farm marketing (so long as 50% of total farm sales were in direct sales to  consumers or restaurants in the same state or within a 275-mile radius). Congress included a similar exemption for these entities from the HACCP requirements. 

 

What the changes in the law mean for direct farm business producers:    The FDA authority to impose on-farm safety measures is limited to fresh fruit and vegetable production, not grains or oilseeds.  The HACCP requirements apply to food processing facilities.  The definition of a facility specifically exempts farms, unless the farm engages in some type of processing, such as milling of wheat for flour.[2]  However, farms processing harvested goods for use on the same farm (e.g., milling own wheat for personal use) are exempted from the definition of a “facility.”  Therefore, unless the farm is creating a value added product (e.g., engaging in some form of processing) and delivering this product off the premises, the farm is not a facility and thus not subject to the HACCP rules.   Food processing facilities, on the other hand, should carefully monitor the development of implementing regulations as several elements of the FMSA may apply and require operational changing and documentation of food safety procedures.

That being said, many direct farm business producers will fall within the small farm exemption to the law and therefore will not need to comply with the new rules.  FDA produce safety is currently a moving area of law, and producers who are unsure of their status should contact an attorney for specific guidance. 

 

 

State Law Requirements

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, Drug, 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 more than 1,000 pesticides, so it is impossible for this Guide to cover all the standards.  However, there are several ways farmers can determine the tolerance levels for pesticides they are using.  One method is to look up the pesticide in the Code of Federal Regulations (CFR) (40 C.F.R. Part 180). EPA maintains a website[3] that explains how to search the CFR to determine the tolerance level for a particular crop. Another EPA website[4] 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 the common names of pesticides.

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.

Text Box:               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 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.

II.              Processed Fruits and Vegetables

As discussed above, the difference between raw and processed food can sometimes be slight. Beyond washing and packing, there are several popular processing methods a direct farm business may use 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 direct farm businesses should cooperate with local public health inspectors during the approval process to ensure that no violations occur. 

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 must also list all ingredients (410 ILCS 620/11(g) and (h)).  Packaged foods must have labels that identify the manufacturer, packer or distributor and that contain an accurate accounting of the quantity of the contents (21 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. Before a direct farm business may dry fruits and mix them into value-added products such as trail mix, IDPH must inspect and permit the processing 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 defined as food and color additives under the IL-FDCA (410 ILCS 620/2.19, 620/2.20).  The Act deems these additives to be unsafe unless there is a regulation specifying the permissible quantity of the added substance and its use (410 ILCS 620/13(a)); it also adopts the federal regulations of food and color additives (410 ILCS 620/21(d)).  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 online.[5]   Lists of FDA approved color additives are available in 21 C.F.R. Parts 73 and 74.

Canning, Jarring, Pickling

Jellies, jams, fruit butters, pickles and salsas are all popular value-added fruit and vegetable products.   However, the methods used to create them – primarily canning, jarring, and pickling - can create anaerobic conditions conducive to the growth of dangerous microbes such as botulism and therefore represent a significant public health concern.  As a result, IDPH exercises strict oversight of these goods.  To make any of these products, a producer will need, at minimum, a certified commercial kitchen and IDPH pre-approval of recipes and production processes. IDPH may also require on-going product testing.

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:   “This 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.[6]   The USDA also has a Complete Guide to Home Canning[7] that contains helpful tips to ensure safe canning processes. 

Juice and Cider

Like all foods, juice and cider processing facilities must undergo inspection and approval by IDPH.  However, rather than undergoing IDPH pre-approval of production processes, juice processors must instead comply with federally-mandated Hazard Analysis and Critical Control Point (HACCP, pronounced “ha-sip”) procedures, even if they are only selling the product intrastate (21 C.F.R. Part 120).[8] 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, as well as a written plan for preventing hazards reasonably likely to occur (21 C.F.R. §§ 120.7 and 120.8). 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, the FDA has issued Guidance for Industry: Juice HACCP; Small Industry Compliance Guide, which is available online.[9]   

Processers who sell their own produce directly to consumers as juice 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, including 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.

Penn State Extension has produced an excellent publication, My Food Venture Risk Management Plan, which can help small producers assess and mitigate the risks associated with producing and selling value-added and processed foods.  The guide is available on the Penn State Extension website.[10]

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,[11] 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 the Board of Tourism focuses on wine, many of their resources provide information that may be useful to producers of beer and liquors as well.

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[12] or in a packet by calling 1-800-398-2282.  TTB also provides online packets of information[13] tailored to particular manufacturers. 

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 on the ILCC website.[14]  The ILCC also provides guidance to licensees on complying with Illinois’ liquor laws, which is available as a packet or in individual pamphlets online.[15]  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 the circumstances under which a brewery can terminate or refuse to renew a contract with a distributor (815 ILCS 720/3 and 720/4).  It also limits a brewery’s right to prevent the distributor from selling their distribution rights to another company (815 ILCS 720/6).

Other Considerations for Fruits and Vegetables

Other sections of this Guide cover several additional issues that might arise when a direct farm business chooses to grow and sell fruits and vegetables.    First, producers may wish to make certain health or nutrient claims when marketing their goods.  These statements are regulated by the FDA and are discussed further in the “Marketing and Managing” chapter.  Second, organic production and marketing must follow additional rules, which are outlined in the “Organic Marketing” chapter.  Finally, the “Weights & Measures” section of the “Marketing and Managing” chapter covers additional marketing rules applicable to direct farm businesses.



[1] http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/UCM169112.pdf

[2] Specifically, current law defines a “facility” as “any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food.  Such term does not include farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels….”  21 U.S.C. § 350d(b)(1). 

[3] http://www.epa.gov/opp00001/food/viewtols.htm

[4] http://www.epa.gov/opp00001/regulating/part-180.html

[5] http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=eafusListing

[6] 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). 

[7] http://www.uga.edu/nchfp/publications/publications_usda.html  

[8] 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). 

 

[9] http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Juice/ucm072637.htm

[10] http://extension.psu.edu/m/farm-business/resources/publications/my-food-venture-risk-management-plan/view

[11] http://www.illinoiswine.com/index.html

[12] http://www.ttb.gov/forms/index.shtml

[13] http://www.ttb.gov/applications/index.shtml#Manufacturers