September 21, 2020
“Organic” Certification: An Overview of the Legal Framework
In 1990, Congress passed the Organic Foods Production
70% organic material may use the term “organic,” but may
Act (OFPA), 7 U.S.C. §§ 6501–6522, “to establish national
apply it only to specific ingredients, not the entire product
standards governing the marketing of certain agricultural
(e.g., “organic” may precede each organically produced
products as organically produced products.” OFPA, enacted
ingredient in a list of ingredients). Id. §§ 205.303–205.309.
as part of the 1990 Omnibus Farm Bill, authorized the
Labels for “100% organic” and “organic” products may
Secretary of Agriculture to establish regulations,
also use the USDA organic seal. Id. § 205.311.
administered by the Agricultural Marketing Service (AMS)
within the U.S. Department of Agriculture (USDA), for
“Organic” and Bioengineering Claims
certifying products as organic under the National Organic
Under OFPA, an “organic” certification for products with
Program (NOP). Id. § 6503. The Secretary may also
70% to 100% organic content allows producers and
authorize states to operate their own programs with
handlers to “make a claim regarding the absence of
requirements equivalent to or more restrictive than the
bioengineering in the food,” including “non-GMO” and
federal program. Id. § 6507. This In Focus summarizes the
“not bioengineered.” 7 U.S.C. § 6524. To make these
organic certification framework and highlights some
claims, the products must not be produced with methods “to
proposed regulatory changes.
genetically modify organisms or influence their growth and
development by means that are not possible under natural
What Qualifies as “Organic”?
conditions or processes and are not considered compatible
“Organic” may be used to describe products produced and
with organic production.” 7 C.F.R. §§ 205.2, 205.105(e).
handled (1) “without the use of synthetic chemicals,”
except as permitted by law; (2) on land to which prohibited
Designating Prohibited Substances
substances have not been applied in the three years before
Producers and handlers of organic products cannot use
harvest; and (3) “in compliance with an organic plan”
prohibited substances in their operations. Id. § 205.400. The
approved by a certifying agent. Id. § 6504.
Secretary, on recommendation from the National Organic
Standards Board (NOSB), designates these substances on
Eligible Products
the National List, which itemizes all permitted synthetic
All products within the statutory definition of “agricultural
substances and prohibited natural substances. 7 U.S.C.
product” may obtain organic certification. This definition
§ 6517; 7 C.F.R. §§ 205.600–205.607. The NOSB consists
encompasses raw and processed products, and products
of fifteen individuals designated by the Secretary. 7 U.S.C.
derived from livestock for human or livestock consumption.
§ 6518(b). Prohibited substances may be permitted if they
Livestock includes “cattle, sheep, goats, swine, poultry,
(1) would not harm human health or the environment;
equine animals used for food or in the production of food,”
(2) are necessary in the operation due to unavailability of
fish, and “other nonplant life.” Id. §§ 6502(1), (11); 7
natural substitutes; and (3) are consistent with organic
C.F.R. § 205.2.
farming and handling. Id. § 6517(c); 7 C.F.R. § 205.600(b).
Natural substances may be prohibited if they harm human
Describing a Product as “Organic”
health or the environment and their use would be
The term “organic” may be used to describe or label
“inconsistent with organic farming or handling.” 7 U.S.C.
products in four configurations: (1) “100 percent organic”;
§ 6517. When the NOSB considers recommendations for
(2) “organic”; (3) “made with organic (specified ingredients
the National List, it assesses how the substances may
or food groups)”; and (4) by designating specific
interact with other materials used in farming systems; the
ingredients as “organic” if the product contains less than
substance’s toxicity; probability of environmental
70% organic material. 7 C.F.R. § 205.301.
contamination; effects on human health and the
agroecosystem; existence of alternative substances; and
“100 percent organic” refers to products consisting entirely
compatibility with sustainable agriculture. Id. § 6518(m).
of organically produced ingredients. “Organic” refers to
The NOSB must obtain scientific evaluations of the
products that contain at least 95% organically produced
relevant substances before making final recommendations.
products by weight or fluid volume, excluding water and
Id. § 6518(k).
salt. The remaining 5% must be (1) organically produced
ingredients, “unless not commercially available in organic
Certifying Organic Plans
form,” or (2) “nonagricultural substances or nonorganically
Operations seeking to describe their products as organic
produced agricultural products produced consistent with the
typically must obtain certification of an organic plan. These
National List.” “Made with organic (specified ingredients
plans must outline how the operations will comply with all
or food groups)” refers to products with at least 70%
regulatory requirements. First, the plans must show how the
organically produced ingredients; the remaining 30% must
operations will avoid prohibited substances, primarily by
meet other production requirements. Products with less than
listing the materials and operational or monitoring
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“Organic” Certification: An Overview of the Legal Framework
procedures they intend to use. Id. § 6506(a); 7 C.F.R. §
same rules as for U.S.-produced and handled products. 7
205.201. Second, the plans must meet commodity-specific
C.F.R. § 205.300(c).
requirements. For example, farms seeking to certify crops
as organic must provide for pest and erosion control,
Foreign certifying agents in the exporting countries may
practice crop rotation, and implement other practices to
conduct the certification process. The Secretary may
protect soil conditions. 7 C.F.R. §§ 205.202–205.206.
accredit foreign certifying agents in several ways. First,
Organic livestock producers must keep animals “under
they may be designated in the same manner as U.S.-based
continuous organic management from the last third of
agents. Second, the Secretary may determine that their
gestation or hatching” by using organic feed and
qualifications are equivalent to those required under U.S.
establishing procedures to address animal health and
law. Third, the Secretary may recognize their authority if
pasture conditions. Id. §§ 205.236–205.240.
the agent was acting under an equivalency agreement. Id. §
205.500. Such agreements allow products certified in
Review of Proposed Plans
accordance with another country’s standards to be sold in
A certifying agent reviews the proposed plans and conducts
the United States as “organic” and vice-versa. The United
onsite inspections. Inspections are used to verify that an
States has equivalency agreements with Canada, the
operation seeking approval is capable of or is complying
European Union, Japan, the Republic of Korea,
with program requirements. Id. § 205.403. Certifying
Switzerland, and Taiwan. The United States also has
agents are officials or private entities the Secretary
recognition agreements with India, Israel, and New
authorizes to conduct these reviews. They must possess
Zealand, which allow these governments to certify that their
“sufficient expertise in organic farming and handling
agents meet U.S. accreditation standards for purposes of
techniques as determined by the Secretary” and apply for
certifying imports to the United States.
accreditation. Their applications must demonstrate their
capacity to comply with all requirements, and must attest
Enforcement of Certification Requirements
that they will comply with recordkeeping, conflict of
An organic operation’s failure to comply with the
interest, and other administrative provisions. 7 U.S.C.
regulations may lead to suspension or revocation of
§ 6514(b); 7 C.F.R. § 205.501. Agents also have an
certification as well as civil or criminal penalties. Id.
obligation to employ third parties (e.g., inspectors) and
§ 205.660. A person who knowingly sells or labels products
annually review their performance “to correct any
as organic not in accordance with the regulations may be
deficiencies in certification services.” 7 C.F.R.
subject to a civil penalty of up to $964 for a first offense or
§ 205.501(a). The Secretary may suspend agents’
of at least $1,872 for subsequent offenses. A person who
accreditations for noncompliance. 7 U.S.C. § 6515(i); 7
makes a false statement to the Secretary, a state official, or
C.F.R. §§ 205.510(e), 205.665.
certifying agent may be imprisoned for up to five years,
fined, or both. 7 U.S.C. § 6519(c); 7 C.F.R. § 205.100(c).
The Secretary’s decisions on proposed organic plans must
be in writing and any denial must state the reasons for
Proposed Regulatory Changes
rejection. If an agent declines to approve a plan, a producer
On August 5, 2020, AMS issued a proposed rule to amend
or handler may try to correct the deficiencies, request
its regulations, primarily to address enforcement. 85 Fed.
mediation, or file an administrative appeal. 7 C.F.R.
Reg. 47,536. For example, the proposed rule would require
§§ 205.402–205.405. An adverse decision may be
certifying agents to perform unannounced inspections on
challenged in the federal district courts. 7 U.S.C. § 6520(b).
5% of the operations they review and prohibit certification
of operations where such inspections are infeasible. It
Exemptions from Certification Requirements
would also require agents to inspect all operations annually;
Certain entities are exempt from certification. Operations
complete supply chain audits; and issue certificates only
with less than $5,000 in annual gross agricultural income
from USDA’s electronic database. The proposed rule would
from organic sales need not apply for certification, although
impose experience and training requirements on inspectors
they must adhere to certain production, handling, and
and certification review personnel, and seeks to address
labeling rules. Some handling operations, including retail
concerns about improperly certified imports. For instance, it
food establishments, are exempt if they deal with only
would require imports to be linked to an NOP import
specified types of products, such as products with less than
certificate or equivalent data source (e.g., third-party export
70% organic ingredients or prepackaged products.
system) and require shipping or storage containers to list
However, they must comply with labeling and
certain data, including the appropriate organic designation
recordkeeping requirements, among others. Id. § 6505(d); 7
(e.g., 100% organic) and certifying agent. It would also
C.F.R. § 205.101.
codify USDA’s practice for determining that a foreign
country’s certification program is equivalent to U.S.
Certification of Imported Products
standards.
OFPA allows imported products to use “organic” on
products sold in the United States if the Secretary
If Congress seeks to revise the NOP standards or practices
determines the products were handled and produced in
that currently apply, or that might apply if the proposed
accordance with safeguards and guidelines “that are at least
regulations take effect, it could consider adding greater
equivalent” to those applicable to U.S. products. 7 U.S.C.
statutory detail to the certification standards for domestic
§ 6505(b). AMS’s regulations stipulate that imported
and/or imported products. Congress could also consider
products must generally be certified in accordance with the
whether to change or supplement AMS’s enforcement
authorities and resources to strengthen the NOP.
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“Organic” Certification: An Overview of the Legal Framework

IF11652
Nina M. Hart, Legislative Attorney


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