Source: https://www.jdsupra.com/legalnews/many-more-questions-than-answers-in-78548/
Timestamp: 2018-09-25 15:56:32
Document Index: 339550042

Matched Legal Cases: ['§1', '§ 66', '§ 66', '§ 66', '§ 66', '§ 66', '§ 66', '§ 66', '§ 66']

Many More Questions Than Answers in USDA’s Proposed Rule for “Bioengineered” Food | King & Spalding - JDSupra
In May 2018, the Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture (USDA) finally issued a proposed rule1 (BE Proposed Rule) to begin implementation of the National Bioengineered Food Disclosure Standard (NBFDS),2 which became law in July 2016. The purpose of the NBFDS and implementing regulations is to provide uniform information to consumers about bioengineered (BE) food and BE food ingredients. The timing of the rulemaking is long overdue.
Following the NBFDS, AMS’s BE Proposed Rule requires disclosure of the presence of BE food, where “bioengineered food” is defined as food that “contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.”3 A food that is an “incidental additive” is expressly excluded from the scope of the definition.4 The proposed definition adopts the statutory definition “without further interpretation of what ‘bioengineering’ means.”5 AMS clearly acknowledges that this approach leaves open significant questions about the scope of the definition, including two conflicting positions about whether highly refined foods and ingredients are within or outside the scope of the definition, as well as the meaning of “conventional breeding” and “found in nature.”6
To aid food manufacturers in determining applicability of the disclosure requirement, AMS has proposed the use of two lists that will presumptively trigger the disclosure requirement for any “listed” food.7 A commercially available BE food will be identified in one of the two lists based on whether it has an adoption rate of more or less than 85% in the U.S., as determined by the Economic Research Service (ERS). Specifically, commercially available BE foods with an adoption rate of 85% or more will be included in the “list of commercially available bioengineered foods with a high adoption rate,” while the BE foods that fall below this threshold will be identified in the “list of commercially available bioengineered foods not highly adopted.”8 These lists will be published and maintained on AMS’s website, and will be reviewed and updated annually through public notification by AMS.9
Affected and Exempted Foods
The proposed BE food disclosure requirement is limited to human food that is subject to the labeling requirements of (a) the Federal Food, Drug, and Cosmetic Act (FDCA) or (b) the Federal Meat Inspection Act, Poultry Products Inspection Act, or Egg Products Inspection Act if the most predominant ingredient in the food (i) would independently be subject to FDCA labeling requirements or (ii) is broth, stock, water, or a similar solution and the second-most predominant ingredient would independently be subject to FDCA labeling requirements.10
Under the NBFDS and the BE Proposed Rule, the following foods are not subject to the disclosure requirement: incidental additives, pet food and animal feed, food derived from animals that consumed BE feed (i.e., feed produced from, containing, or consisting of a BE substance), and organic food.11 Another category of food exempt from the disclosure requirement—that remains to be decided—is food “in which an ingredient contains a bioengineered substance that is inadvertent or technically unavoidable, and accounts for no more than” either 5% or 0.9% by weight of the ingredient, or food in which the ingredient(s) containing a bioengineered substance account(s) for no more than 5% of the total weight of the food in final form. As evidenced by these three very different alternatives, AMS has not yet determined the appropriate thresholds for this exemption.
Lastly, the BE Proposed Rule also exempts from the disclosure requirements restaurants (or similar retail food establishments) and very small food manufacturers.12
Food manufacturers can choose one of four forms of disclosure to satisfy the NBFDS and the BE Proposed Rule. By acknowledging that the food chain is complex, and many food manufacturers could source BE and non-BE foods for their products, AMS’s approach “attempts to avoid imposing additional costs on regulated entities by offering flexibility.” Accordingly, the disclosures account for differences between high adoption and non-high adoption list foods, and permit a variety of disclosure statements, as appropriate, for non-high adoption foods.
A text disclosure may be used in singular or plural form for BE foods based on their “list” status, as follows:
• May be a bioengineered food;
• May contain a bioengineered food ingredient;
• Bioengineered food; or
• Contains a bioengineered food ingredient
A symbol may also be used to identify BE food. In the preamble to the proposed rule, AMS makes clear that nothing in the disclosure requirement is meant to disparage BE foods from a health, safety, or environmental perspective.13 Indeed, the proposed rule includes three alternate symbols—one of which will be selected by AMS—seemingly designed to avoid suggesting BE food is more or less safe than non-BE food, and arguably the symbols attempt to spin BE status in a positive light. These symbols are presented as follows, including the additional text “bioengineered” and “may be bioengineered food,” which AMS is considering but has not decided:
3. Electronic or digital link
If an electronic or digital link disclosure is used, it must be accompanied by the statement “scan here for more food information” or equivalent language that reflects technological changes. Once scanned, the link must go directly to the product information page, where a BE food disclosure must appear, either by text or symbol (according to requirements for those forms of disclosure). Additionally, due to concerns about accessibility, AMS is requiring the electronic digital link disclosure to be accompanied by a telephone number that consumers can call at any time, alongside a statement reading “Call for more food information.”
Finally, the proposed rule allows a BE food label to include the statement “Text [short code number] for more food information.” The only information in response to such text message must be one of the text disclosures discussed in the first option above.
Note that the BE Proposed Rule permits shortened text requirements for small and very small packages and also contains special rules for foods sold in bulk containers. In addition, small food manufacturers may utilize additional disclosure methods, including a telephone number and website, to comply with the NBFDS.
The BE disclosure must be placed on the information panel or principal display panel (PDP). An alternate panel may be used if neither the information panel nor the PDP can accommodate the disclosure. In addition, the disclosure must be of sufficient size and clarity to be easily read and must appear prominently and conspicuously on the food label.14
The BE Proposed Rule requires food manufacturers to maintain records that are customary or reasonable to demonstrate compliance with disclosure requirements.15 These records must be maintained for two years after the date the food is sold or distributed for retail sale.16 If a food is on one of the AMS BE food lists, but does not make a BE food disclosure, records must document verification that the food is not a BE food and/or does not contain any BE food ingredient. When AMS requests access to records, the BE Proposed Rule permits an entity five days to respond to the request. If AMS needs access to records at the entity’s place of business, AMS will provide three business days’ notice.
Any interested person may submit a complaint to the AMS regarding a violation of the NBFDS disclosure requirement. If an investigation is warranted, AMS will conduct an audit of the relevant records. AMS will make its findings available to the audited entity, which may request a hearing if it has any objections. Importantly, at the conclusion of the audit or hearing (if one is requested), AMS will make public the summary of the audit results.17
AMS has proposed that when the final BE disclosure rule is published, the compliance date be January 1, 2020, with a delayed compliance date of January 1, 2021, for small and very small food manufacturers.18 The timing is purposeful, intended to align with FDA’s compliance dates for final rules on changes to nutrition labeling and serving sizes, presumably to aid food manufacturers in cost-efficient labeling updates. In another nod to supporting food manufacturers’ efforts, AMS has proposed to permit food manufacturers to use up their current food label inventories. Specifically, regulated entities may use labels printed by the initial compliance date (regardless of whether they comply with the NBFDS), until the regulated entity uses up remaining label inventories or until January 1, 2022, whichever date occurs first.19
The BE Proposed Rule appears to reflect AMS’s recognition of industry concerns and interests. The USDA adhered closely to the NBFDS with a goal of minimizing compliance costs for industry, while still seeking to address consumer interest in access to BE information. As evidenced in the proposed rule, there are several “alternative” proposals and many more questions that remain to be decided before AMS can publish a final rule. Nevertheless, it is clear that AMS is now proceeding expeditiously. The comment period for the proposed rule closed July 3. The lack of an extension of time to comment is unusual in rulemaking for food labeling and likely evidences AMS’s desire to proceed to a final rule without delay.
1 See Proposed Rule; National Bioengineered Food Disclosure Standard [Docket No. AMS–TM–17–0050], 83 Fed. Reg. 19860 (May 4, 2018) (to be codified at 7 C.F.R Pt. 66).
2 National Bioengineered Food Disclosure Standard, Pub. L. No. 114-216, §1, 7 USC 1639 (2016) available at https://congress.gov/114/plaws/publ216/PLAW-114publ216.pdf.
3 BE Proposed Rule, 83 Fed. Reg. at 19885 (§ 66.1).
5Id. at 19862.
6Id. at 19862-64.
7 Id. at 19864-65 and 19885 (§ 66.1).
9Id. at 19864-65 and 19886 (§ 66.7).
10Id. at 19885-86 (§ 66.3).
11Id. at 19861-68.
12Id. at 19885 (defining “small manufacturers” as having annual gross receipts between $2.5 million and $10 million, and “very small manufacturers” as having annual gross receipts below $2.5 million).
13Id. at 19860.
14 Id. at 19886 (§ 66.100(d)).
15 Id. at 19889 (§ 66.302(a)(1)).
16 Id. (§ 66.302(a)(3)).
17 Id. at 19889 (§ 66.406).
18 Id. at 19879; see also id. at 19885 (defining “small manufacturers” as having annual gross receipts between $2.5 million and $10 million, and “very small manufacturers” as having annual gross receipts below $2.5 million).
19 Id. at 19879.
The Beginning of the National Bioengineered Food Disclosure Standard