The practice of producing organically grown agricultural products has existed for several decades in the United States and has evolved from a small-scale and localized system into a highly organized and global production and marketing system. These changes motivated the organic industry to establish standards for organic production and marketing.
Initially, private organizations and some states developed third-party certification systems. Under these systems, inspectors employed by either private organizations or state governments would certify farm and food operations as organic under certain requirements. However, each organization and state that ran an organic certification system had different organic standards. While the third-party certification system was a positive development for the organic industry, many third parties refused to recognize products that were certified by other certifying organizations because of differing standards. Therefore, organic producers found it hard to get their products into the marketplace, especially across state lines. The inability to adequately prevent instances of fraud was another major obstacle.
Congress responded to these problems by enacting the Organic Foods Production Act (OFPA), 7 U.S.C. §§ 6501et esq. The OFPA was enacted to create “national standards governing the marketing of [organically produced] agricultural products,” to assure consumers that “organically produced products meet a consistent standard,” and to facilitate “interstate commerce in fresh and processed [organically produced] food.” 7 U.S.C. § 6501. On December 21, 2000, the Agricultural Marketing Service (AMS), an agency within the United States Department of Agriculture (USDA), published a final rule which established the regulations implementing the OFPA. See 7 C.F.R. § 205. The combination of the OFPA and the organic regulations make up the National Organic Program (NOP). Since October 21, 2002, producers and handlers that sell, label, or represent agricultural products as organic must comply with the NOP.
Both the OFPA and the regulations define certain terms. Although the OFPA and the regulations define many terms, it is important to understand the meaning of a select few as they are used in this body of law.
The OFPA defines a “producer” as any person engaged in the business of growing or producing food or feed. See 7 U.S.C. § 6502(19). This differs from “handlers” which both the OFPA and the regulations define as any person engaged in the business of selling, processing, or packaging agricultural products. See id. §6502(9); see 7 C.F.R. § 205.2. However, the term handler does not include those who sell, transport, or deliver organic crops from a producer to a handler, in other words, the middlemen are not considered handlers. See id.
The OFPA and its regulations define an “agricultural product” as any agricultural commodity in raw or processed form. See 7 U.S.C. § 6502(1); see 7 C.F.R. § 205.2. The term “agricultural product” also includes any product derived from livestock that is marketed for either human or livestock consumption. See id.
Finally, the OFPA and its regulations define “processing” as “cooking, baking, curing, heating, drying, mixing, grinding, churning, separating, extracting, slaughtering, cutting, fermenting, distilling, eviscerating, preserving, dehydrating, freezing, chilling, or otherwise manufacturing and includes the packaging, canning, jarring, or otherwise enclosing food in a container.” See 7 U.S.C. § 6502(18); see also 7 C.F.R. § 205.2.
Although the NOP requirements apply to most organic operations, the regulations allow for a few exemptions. An exemption is granted to those who would ordinarily fall under the regulation, but the regulation explicitly offers leave from liability.
Although exempted organic operations are not required to comply with NOP certification requirements before labeling their products as organic, they must still comply with other NOP requirements. Some NOP requirements that exempted operations must still adhere to include applicable organic production and handling requirements, see 7 C.F.R. § 205.200 et seq.; using the correct organic labeling, see id. § 205.300 et seq.; and keeping accurate records. Id. § 205.101(i).
Eight types of organic operations are exempt from the NOP certification requirements. These exempt operations include those that: (1) have a gross annual income from organic product sales totaling $5,000 or less; (2) are retail food establishments that handle but do not process organic products; (3) are retail food establishments that process, at the point of final sale, products certified as “100 percent organic,” “organic,” or “made with organic specified ingredients or food groups; (4) are handling operations that only handle products containing 70 percent organic ingredients or that only identify organic ingredients in the ingredients list of packaged products; (5) do not handle but receive, store, and/or prepare for shipment organic products that are enclosed in sealed, tamper-evident packages prior to being received and remains in the same package; (6) do not handle but buy, sell, receive, store, and/or prepare for shipment organic products already labeled for retail sale that are enclosed in a sealed, tamper-evident package and remains in the same package; (7) do not handle but is a Customs broker only conducting customs business; or (8) do not handle but only arrange for the shipping, storing, transport, or movement of organic products. 7 C.F.R. § 205.101.
Non-exempt organic producers and handlers must comply with the NOP organic production and handling standards found in Subpart C of the regulations. The production and handling standards set forth requirements for organic system plans, crop production, livestock production, and organic handling.
An “organic system plan” is an organic production or handling operation plan that the producer or handler and the certifying agent agreed upon and includes a written plan concerning all aspects of agricultural production or handling. 7 C.F.R. § 205.2. Some of the more notable requirements of an organic system plan include a description of the practices and procedures and the monitoring practices and procedures that will be performed and maintained along with how often they are performed, a description of the recordkeeping system implemented, and a description of the management practices established to prevent commingling of organic and nonorganic products. For a complete list of requirements, please refer to 7 C.F.R. § 205.201. Producers also have the option to substitute a plan prepared for another Federal, State, or local government regulatory program for the organic system plan so long as the plan meets all the requirements of 7 C.F.R. § 205.201.
The organic production and handling requirements that govern crop production include land management; soil fertility and crop nutrient management practices; seeds and planting stock use; crop rotation; crop pest, weed, and disease management; and the harvesting of “wild crops.” 7 C.F.R. §§ 205.202 – 207. Although the NOP sets soil fertility standards, crops grown without soil can still be certified organic. See Ctr. for Food Safety v. Vilsack, No. 21-15883 (9 th Cir. Sep. 22, 2022).
The requirements that govern livestock production include livestock origins, livestock feed, livestock health care practices, livestock living conditions, and pasture practice standards. 7 C.F.R. §§ 205.236–40. However, there may be changes to these requirements. On August 9, 2022, USDA’s AMS published proposed amendments to the organic livestock and poultry production requirements. See 87 Fed. Reg. 48562. The proposed rule will add new provisions for livestock handling and transport for slaughter and avian living conditions along with expanding and clarifying the existing requirements for livestock care and production practices and mammalian living conditions. Id. The proposed rule describes that potentially affected entities may include: (1) individuals or business entities that are considering organic certification for a new or existing livestock farm or slaughter facility; (2) existing livestock farms and slaughter facilities that are currently certified organic under the USDA organic regulations; and (3) certifying agents accredited by the USDA to certify organic livestock operations and organic livestock handling operations. Id. To fully determine what individuals or businesses may be affected, refer to the proposed rule at 87 Fed. Reg. 48562.
There are also handler specific standards outlines in Subpart C. The organic handling standards set forth requirements for managing pests and for preventing the commingling and contact of organic products with prohibited substances. 7 C.F.R. §§ 205.270-272. The last section of Subpart C describes the requirements for imports into the United States. 7 C.F.R. § 205.273.
Subpart D of the organic regulations sets forth standards, requirements, and restrictions that govern the labeling and use of marketing information for organically produced products. 7 C.F.R. §§ 205.300 et esq. This section of the regulations aims to prevent abuses in the marketing of organic products and to assure consumers that organic products and ingredients are labeled in a consistent, reliable, and predictable manner.
In particular, this subpart explains the difference between the labeling terms “100% Organic”, “Organic”, and “made with organic ingredients”. Only products that are solely derived from organically produced ingredients can bear the label “100% organic”. 7 C.F.R. § 205.301(b). When 95% of the ingredients of a product are certified organic, the product may carry an “Organic” label. 7 C.F.R. § 205.301(c). When 70% or more of a product’s ingredients were organically produced, the product may state “made with organic (specified ingredients or food group(s))”, but the label must specify which ingredients or food groups are organic. 7 C.F.R. § 205.301(d).
Subpart D also explains how to: calculate the percentage of organic composition in a product; label livestock feed; label nonretail containers used for shipping and storing organic products; label organic products that are sold, labeled, or represented as “100 percent organic,” “organic,” and “made with organic (specified ingredients or food group(s)) at the point of retail sale but are not sold in a packaged container; label products produced on exempted and excluded operations; and use the USDA organic seal on products. 7 C.F.R. §§ 205.302, 306-311.
Subpart E of the organic regulations governs the certification process. “Certification” is when a certifying agent determines that an operation has complied with all applicable NOP requirements. 7 C.F.R. § 250.2. A “certifying agent” is “[a]ny entity accredited by the Secretary for the purpose of certifying a production or handling operation as a certified [organic] production or handling operation.” Id. Certification is documented by a certificate of organic operation. Id. The organic regulations set forth general requirements for applying for certification, how certifying agents should review applications, how certifying agents should conduct on-site inspections, and how certifying agents should grant and deny certifications. 7 C.F.R. § 205.400-406.
The OFPA established the National Organic Standards Board (NOSB). 7 U.S.C. § 6518. The NOSB is a Federal Advisory Board comprised of fifteen public volunteers from across the organic community. Id. § 6518(b). The NOSB reviews and makes recommendations on various issues involving the production, handling, and processing of organic products. Most notably, the NOSB assists with developing and amending the “National List of Allowed and Prohibited Substances” set forth by the NOP. The National List identifies synesthetic substances that organic producers may use and natural substances that organic producers may not use. Id. § 6517. The National List is based upon recommendations submitted to the Secretary of Agriculture by the NOSB. Id. § 6517(d)(1). Any person may petition the NOSB to consider whether a substance should be listed as allowed or prohibited on the National List. See 7 C.F.R. § 205.607(a).
Any state may create a state organic program (SOP) for production and handling operations within that state. The SOP is subject to certain conditions set by the NOP. The SOP must comply with all NOP requirements, although it may contain additional requirements that are more restrictive than NOP requirements “because of environmental conditions or the necessity of specific production or handling practices particular to the State or region of the United States.” 7 U.S.C. § 6507(a)-(b)(1). Any additional or more restrictive requirements in the SOP must further the purposes of the NOP. Thus, the SOP must be consistent with NOP and must not be “discriminatory towards agricultural commodities organically produced in other States.” Id. § 6507(b)(2)(A)-(C). The Secretary of Agriculture must approve the SOP before it can be implemented by the state.