New Rules Help Drive Organic Foods

December 2001

More and more, consumers are demanding foods that are made with natural ingredients and are certified organic. Today, this niche market is among the fastest-growing segments of the food industry with continued growth predicted for the future. As the consumer push for natural and organic foods expands and grows, there has been a greater infiltration of these types of products in the ranks of the conventional, further-processed, frozen and convenient foods. Conventional retailers are readily opening their aisles and freezers to natural and organic SKUs, driving conventional marketers and manufacturers to seriously consider further-processed organic foods for the mass consumer market. Organic ingredients are more readily available and the federal government has finally defined the rules for “organic.”

Up until this year, the industry has relied on individual state regulations and independent certifying agencies to define and validate organic ingredients, products and processors. And although there was some uniformity under this previous system from a domestic and international standpoint, now, one set of standardized rules allows for continued market growth and development of organic products. Developers, marketers and manufacturers considering these products need to have a good understanding of the new regulations to achieve success in designing, processing and distributing organic foods that are in compliance with the new regulations.

In accordance with the Organic Foods Production Act of 1990, The Department of Agriculture finalized regulations for a National Organic Program effective Feb. 21, 2001. These regulations can be found in the Code of Federal Regulations (CFR) Title 7 Agriculture, Chapter I Agricultural Marketing Service, Part 205 National Organic Program.
Setting up organic controls

Before delving into the actual regulations, it is important to understand the overall concept of an organic product and the organic processor who manufactures the product. From the standpoint of the conventional processor, a whole new array of control systems must be developed if organic products are being considered for production in a plant. Before the processor can achieve certification for the manufacture of organic products, it must put systems in place for the documentation and isolation of organic ingredients and products. In addition, it must assure the prevention of cross-contamination with nonorganic ingredients and products. Conceptually, a processor treats the production of organic products much like kosher products.

However, to pass an organic-certification audit as a processor requires that the quality systems and cGMP (current Good Manufacturing Practices) programs be stepped up. Setting up a comprehensive Total Quality Management (TQM) program that incorporates the implementation of a Hazard Analysis Critical Control Points (HACCP) system is the first step to obtaining certification as an organic processor.

To get started, the manufacturer seeking organic certification should consider the documentation and the implementation of the following requirements for certification.

• An organic processor must have a system in place that documents that the suppliers of its organic ingredients have valid certification for the ingredients shipped into the plant.
• A plan must be in place that documents the unit operations, checkpoints, systems and procedures necessary to assure that the process meets specific organic standards. Further, the plan must describe the procedures that will prevent the cross-contamination of the organic ingredients, processing and finished products.
• A defined system must be in place that tracks and documents the organic product from raw materials through labeling and distribution.
• Standard operating procedures should document and define the materials and procedures for the pest and sanitation programs used in the plant.

New regulation compliance
Organic certification is one step; compliance with the regulations is another. Title 7 CFR, Part 205, The National Organic Program sets the organic standards. Subpart A of these regulations lists all the definitions of terms used throughout the document. One term of special interest is the definition of “Excluded Methods” that states: “A variety of methods used to genetically modify organisms or influence their growth and development by means that are not possible under natural conditions or processes and are not considered compatible with organic production. Such methods include cell fusion, microencapsulation and macroencapsulation, and recombinant DNA technology (including gene deletion, gene doubling, introducing a foreign gene, and changing the position of genes when achieved by recombinant DNA technology). Such methods do not include the use of traditional breeding, conjugation, fermentation, hybridization, in vitro fertilization, or tissue culture.”

Subpart B discusses the applicability of organic certification. The handling or production of crops, livestock, livestock products or other agricultural products intended to be sold, labeled or represented as “100% organic,” “organic” or “made with organic-specified ingredients or food groups” are required to be certified in accordance with these regulations. Operations that are already certified by a certifying agent and then become accredited under these regulations within 18 months from Feb. 20, 2001 will be certified under the Act until the next anniversary date of organic certification. Exemptions to certification include retail food establishments that handle organically produced products but do not process them, and retail food establishments who process and serve ready-to-eat organic food. Subpart B also discusses the record-keeping requirements for certified operations and defines the allowed and prohibited substances, methods and ingredients in organic production and handling.

Subpart C of the regulations defines the organic production and handling requirements for entities that must be certified. Specific sections cover the requirements for land, seed, crops, livestock and feed. The basis for an organic production and handling plan approved by an accredited certifying agent is defined. The organic handling requirements define the unit operations that can be used during production to retard spoilage and prepare the product for the market. Standards are set for facility pest management and the prevention of comingling and contact with prohibited substances. This is a critical part of these regulations for the processor.

The market information, labels and labeling criteria are defined in Subpart D of the regulations and set the standards for further-processed organic foods. Companies should use this part of the regulations as their “bible” when it comes to the design and labeling of organic products. A product labeled, sold or represented as “100% organic” must contain 100% organically produced ingredients on a weight or volume basis as appropriate, excluding water or salt.

A product labeled, sold or represented as “organic” must contain 95% organically produced ingredients on a weight or volume basis as appropriate, excluding water or salt. Be careful here; the nonorganic ingredients have specific limitations spelled out in this part of the regulations. A product labeled, sold or represented as “made with organic…(specified ingredients or food groups)” must contain at least 70% organically produced ingredients on a weight or volume basis as appropriate, excluding water or salt. Again, the nonorganic ingredients have specific limitations spelled out in this part of the regulations.
All of the details are laid out in this regulation: how to calculate the percent of organic ingredients; what is acceptable as far as the nonorganic ingredients; what is unacceptable as processes used on these ingredients; and how to use a USDA seal, logo, or other identifying marks on packaging to certify the organic nature of the product. Every company’s label designer must know these requirements.

The next two subparts, E and F, discuss the requirements for certification and accreditation of certifying agents respectively. Subpart G is titled “Administrative, The National List of Allowed and Prohibited Substances.” This subpart defines the synthetic and non-synthetic substances that you can and cannot use in organic crop production, livestock production, and ingredients in or on processed products labeled as organic or made with organic ingredients. Again, this part of the regulations is critical in the design and development of all organic products. If there is any question regarding what can be used as an ingredient or process aid, users can refer to this section for an answer.

The remainder of the subparts cover a variety of topics, including: State Organic Programs; Fees; Compliance; Inspection and Testing, Reporting, and Inclusion from Sale; and Adverse Action Appeal Process.

Every company considering entering the market with further-processed organic foods needs to fully assess these regulations prior to embarking on any product-development program. A complete understanding of the quality systems, controls, regulations and processes will provide a road map for the development of a line of packaged organic products that are safe, have consistent quality and comply with the National Organic Program.

Philip H. Katz is president of Canton, MA-based Shuster Laboratories, one of the leading independent food-product R&D and testing facilities in the world. The company provides manufacturers and marketers of natural/organic and functional foods with comprehensive product-formulation, product-quality and consumer-acceptability services. Katz can be reached at 800/444-8705 or via email at phil.katz@shusterlabs.com.

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