Regulations last checked for updates: Nov 22, 2024
Title 7 - Agriculture last revised: Nov 20, 2024
§ 66.100 - General.
(a) Responsibility for disclosure. (1) For a food that is packaged prior to receipt by a retailer, the food manufacturer or importer is responsible for ensuring that the food label bears a bioengineered food disclosure in accordance with this part.
(2) If a retailer packages a food or sells a food in bulk, that retailer is responsible for ensuring that the food bears a bioengineered food disclosure in accordance with this part.
(b) Type of disclosure. If a food must bear a bioengineered food disclosure under this part, the disclosure must be in one of the forms described in this paragraph (b), except as provided in §§ 66.110 and 66.112.
(1) A text disclosure in accordance with § 66.102.
(2) A symbol disclosure in accordance with § 66.104.
(3) An electronic or digital link disclosure in accordance with § 66.106.
(4) A text message disclosure in accordance with § 66.108.
(c) Appearance of disclosure. The required disclosure must be of sufficient size and clarity to appear prominently and conspicuously on the label, making it likely to be read and understood by the consumer under ordinary shopping conditions.
(d) Placement of the disclosure. Except as provided in § 66.114 for bulk food, the disclosure must be placed on the label in one of the manners described in this paragraph (d).
(1) The disclosure is placed in the information panel directly adjacent to the statement identifying the name and location of the handler, distributor, packer, manufacturer, importer, or any statement disclosing similar information.
(2) The disclosure is placed in the principal display panel.
(3) The disclosure is placed in an alternate panel likely to be seen by a consumer under ordinary shopping conditions if there is insufficient space to place the disclosure on the information panel or the principal display panel.
(e) Uniform Resource Locator (URL). Except for disclosures made by small manufacturers and for disclosures on very small packages, a bioengineered food disclosure may not include an internet website URL that is not embedded in an electronic or digital link.
§ 66.102 - Text disclosure.
A text disclosure must bear the text as described in this section. A text disclosure may use a plural form if applicable, e.g. if a food product includes more than one bioengineered food, then “bioengineered foods” or “bioengineered food ingredients” may be used.
(a) Bioengineered foods. If a food (including any ingredient produced from such food) is on the List of Bioengineered Foods, and records maintained by a regulated entity demonstrate that the food is bioengineered, the text disclosure must be one of the following, as applicable:
(1) “Bioengineered food” for bioengineered food that is a raw agricultural commodity or processed food that contains only bioengineered food ingredients; or
(2) “Contains a bioengineered food ingredient” for multi-ingredient food that is not described in paragraph (a)(1) of this section but contains one or more bioengineered food ingredients.
(b) Predominant language in U.S. Food subject to disclosure that is distributed solely in a U.S. territory may be labeled with statements equivalent to those required in this part, using the predominant language used in that territory.
§ 66.104 - Symbol disclosure.
A symbol disclosure must replicate the form and design of Figure 1 to this section.
(a) The symbol is a circle with a green circumference, and a white outer band. The bottom portion of the circle contains an arch, filled in green to the bottom of the circle. The arch contains two light green terrace lines, sloping downward from left to right. On the left side of the arch is a stem arching towards the center of the circle, ending in a four-pointed starburst. The stem contains two leaves originating on the upper side of the stem and pointing towards the top of the circle. In the background of the leaves, at the top of the circle and to the left of center, is approximately one-half of a circle filled in yellow. The remainder of the circle is filled in light blue. The symbol must contain the words “BIOENGINEERED.”
(b) If a food (including any ingredient produced from such food) is on the List of Bioengineered Foods, and records maintained by a regulated entity demonstrate that the food is bioengineered, or do not demonstrate whether the food is bioengineered, the symbol disclosure must be the following:
(c) The symbol may be printed in black and white.
(d) Nothing can be added to or removed from the bioengineered food symbol design except as allowed in this part.
§ 66.106 - Electronic or digital link disclosure.
If a required bioengineered food disclosure is made through an electronic or digital link printed on the label, the disclosure must comply with the requirements described in this section.
(a) Accompanying statement. (1) An electronic or digital disclosure must be accompanied by, and be placed directly above or below, this statement: “Scan here for more food information” or equivalent language that only reflects technological changes (e.g., “Scan anywhere on package for more food information” or “Scan icon for more food information”).
(2) The electronic or digital disclosure must also be accompanied by a telephone number that will provide the bioengineered food disclosure to the consumer, regardless of the time of day. The telephone number instructions must be in close proximity to the digital link and the accompanying statement described in paragraph (a)(1) of this section, must indicate that calling the telephone number will provide more food information, and must be accompanied by the statement “Call [1-000-000-0000] for more food information.”
(b) Product information page. When the electronic or digital link is accessed, the link must go directly to the product information page for display on the electronic or digital device. The product information page must comply with the requirements described in this paragraph (b).
(1) The product information page must be the first screen to appear on an electronic or digital device after the link is accessed as directed.
(2) The product information page must include a bioengineered food disclosure that is consistent with § 66.102 or § 66.104.
(3) The product information page must exclude marketing and promotional information.
(4) The electronic or digital link disclosure may not collect, analyze, or sell any personally identifiable information about consumers or the devices of consumers; however, if this information must be collected to carry out the purposes of this part, the information must be deleted immediately and not used for any other purpose.
§ 66.108 - Text message disclosure.
The regulated entity must not charge a person any fee to access the bioengineered food information through text message and must comply with the requirements described in this section.
(a) The label must include this statement “Text [command word] to [number] for bioengineered food information.” The number must be a number, including a short code, that sends an immediate response to the consumer's mobile device.
(b) The response must be a one-time response and the only information in the response must be the appropriate bioengineered food disclosure described in § 66.102 or § 66.116.
(c) The response must exclude marketing and promotional information.
(d) A regulated entity that selects the text message option must comply with the requirements of this paragraph (d).
(1) The regulated entity must not collect, analyze, or sell any personally identifiable information about consumers or the devices of consumers.
(2) The regulated entity must not use any information related to the text message option for any marketing purposes.
(3) If any information must be collected to carry out the purposes of this part, the information must be deleted as soon as possible and not be used for any other purpose.
§ 66.109 - Required disclosure with actual knowledge.
Notwithstanding any provision in this subpart, if a food manufacturer (other than a very small food manufacturer), a retailer, or an importer has actual knowledge that the food is a bioengineered food or contains a bioengineered food ingredient, it must disclose that the food is bioengineered or contains a bioengineered food ingredient, as applicable, using appropriate text, symbol, electronic or digital link disclosure, or text message.
§ 66.110 - Small food manufacturers.
A small food manufacturer must make the required bioengineered food disclosure using one of the bioengineered food disclosure options permitted under §§ 66.102, 66.104, 66.106, and 66.108 or as described in this section.
(a) The label bears the statement: “Call for more food information,” which accompanies a telephone number that will provide the bioengineered food disclosure to the consumer, regardless of the time of day. Disclosure via telephone number must include a bioengineered food disclosure that is consistent with § 66.102 in audio form and may be pre-recorded.
(b) The label bears the statement: “Visit [URL of the website] for more food information,” which accompanies a website that meets the requirements of § 66.106(b). Disclosure via website must include a bioengineered food disclosure that is consistent with § 66.102 or § 66.104 in written form.
§ 66.112 - Small and very small packages.
In addition to the disclosures described in this subpart, for food in small and very small packages, the required disclosure may be in the form described in paragraph (a), (b), or (c) of this section.
(a) The label bears the electronic or digital disclosure described in § 66.106, and replaces the statement and phone number required in § 66.106(a) with the statement “Scan for info.”
(b) The label bears a number or short code as described in § 66.108(a), and replaces the statement with “Text for info.”
(c) The label bears a phone number as described in § 66.110(a), and replaces the statement with “Call for info.”
(d) For very small packages only, if the label includes a preexisting Uniform Resource Locator for a website or a telephone number that a consumer can use to obtain food information, that website or telephone number may also be used for the required bioengineered food disclosure, provided that the disclosure is consistent with § 66.102 or § 66.104 in written or audio form, as applicable.
§ 66.114 - Food sold in bulk containers.
(a) Bioengineered food sold in bulk containers (e.g., display case, bin, carton, and barrel), used at the retail level to present product to consumers, including a display at a fresh seafood counter, must use one of the disclosure options described in § 66.102, § 66.104, § 66.106, or § 66.108.
(b) The disclosure must appear on signage or other materials (e.g., placard, sign, label, sticker, band, twist tie, or other similar format) that allows consumers to easily identify and understand the bioengineered status of the food.
§ 66.116 - Voluntary disclosure.
(a) Disclosure of bioengineered food by exempt entities. If a food on the List of Bioengineered Foods is subject to disclosure, a very small food manufacturer, restaurant, or similar retail food establishment may voluntarily provide that disclosure. The disclosure must be in one or more of the forms described in this paragraph (a).
(1) A text disclosure, in accordance with § 66.102.
(2) A symbol disclosure, in accordance with § 66.104.
(3) An electronic or digital link disclosure, in accordance with § 66.106.
(4) A text message disclosure, in accordance with § 66.108.
(5) Appropriate small manufacturer and small and very small package disclosure options, in accordance with §§ 66.110 and 66.112.
(b) Disclosure of foods derived from bioengineering. For foods or food ingredients that do not meet paragraph (1) of the definition of bioengineered food in § 66.1, that do not qualify as a factor or condition under paragraph (2) of the definition of bioengineered food in § 66.1, that are not exempt from disclosure under § 66.5, and that are derived from a food on the List of Bioengineered Foods, regulated entities may disclose such foods with one of the disclosures described in this paragraph (b).
(1) A text disclosure with the following statement: “derived from bioengineering” or “ingredient(s) derived from a bioengineered source.” The word “ingredient(s)” may be replaced with the name of the specific crop(s) or food ingredient(s).
(2) A symbol disclosure using the following symbol:
(3) An electronic or digital link disclosure, in accordance with § 66.106, provided that the disclosure is the text described in paragraph (b)(1) of this section or the symbol in Figure 1 to this section.
(4) A text message disclosure, in accordance with § 66.108, provided that the response is the text described in paragraph (b)(1) of this section or the symbol in Figure 1 to this section.
(5) Appropriate small manufacturer and small and very small package disclosure options, in accordance with §§ 66.110 and 66.112, provided that the disclosure is the text described in paragraph (b)(1) of this section or the symbol in Figure 1 to this section.
(c) Appearance of disclosure. The disclosure should be of sufficient size and clarity to appear prominently and conspicuously on the label, making it likely to be read and understood by the consumer under ordinary shopping conditions.
(d) Recordkeeping. Reasonable and customary records should be maintained to verify disclosures made under this section, in accordance with § 66.302.
§ 66.118 - Other claims.
Nothing in this subpart will prohibit regulated entities from making other claims regarding bioengineered foods, provided that such claims are consistent with applicable Federal law.
source: 83 FR 65871, Dec. 21, 2018, unless otherwise noted.
cite as: 7 CFR 66.110