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Accordingly, 66.5(e) is revised to read Food certified under the National Organic Program. In addition, AMS confirms that food certified under other international regulations with which the NOP has established recognition or equivalency agreements would be exempt from the NBFDS. Some commenters argued that the USDA study, conducted by Deloitte, on access to bioengineering disclosures using electronic and digital link disclosures showed that the alternatives to on-package labeling (QR codes, website URLs, text messaging numbers, and other alternatives) will be ineffective and are discriminatory. As described in the Preamble and in 66.9, regulated entities can demonstrate that their food products do not contain modified genetic material in multiple ways. AMS intends to rely on customary business records. 7 U.S.C. Commenters argued against equating U.S. planted acreage with human food production and commercial availability in the United States, explaining that a large percentage of highly adopted bioengineered crops are used for animal feed, and that U.S. planted acreage does not necessarily reflect the prevalence of bioengineered foods available on the market. AMS notes that FDA (and FSIS depending on the food at issue) retain authority over absence claims. A few commenters suggested taking a more flexible approach, which would allow interested parties to submit comments on an appropriate time period as part of the list revision process. Another commenter suggests the rule may not need to require a mutual recognition agreement when a prior processing agreement exists between the U.S. and a foreign country, unless a BE ingredient is introduced to a product during processing in that foreign country. The annualized net benefit from replacing the Vermont BE labeling law would be between $40 million and $49 million at a three percent discount rate and between $70 million and $84 million at a seven percent discount rate. Manufacturer commenters also urged AMS to allow the use of labels compliant with the preempted State GMO labeling laws during the compliance period. J. 1639b(b)(2)(A). Commenters noted that scientific methods may advance to where today's undetectable genetic material may be detectable using future technologies. The principal display panel typically includes the statement of identity and the net quantity statement, in addition to other marketing claims. Additionally, the timelines to produce records are consistent with other marketing labels administered by AMS. A few commenters warned against overreliance on the views of interested stakeholders in the proposed revision process, encouraging AMS to rely primarily on evidence-based criteria for list updates. All rights reserved. None of the approximately 14,000 responses received on the NPRM were identified as being submitted from Tribal representatives. Updates to the List of Bioengineered Foods. Commenters further suggest such implied issues could lead consumers to believe foods and food ingredients containing genetic material are different in a way that necessitates informing consumers. Instead, they justified their position based on consumer interest and popular understanding of how common BE agricultural crops are grown, not whether the food or ingredient contains modified genetic material. In addition, AMS believes using a fixed 18-month compliance period for all changes to the list will prove more workable than setting applicable compliance periods on an ad hoc basis as part of the annual notice process for list revision. Comment: Some commenters favoring voluntary disclosure urged AMS not to limit voluntary claims. Five States Put Abortion Questions on the Ballot; Health Care and How to Rehearse Your Closing Argument & Avoid Stumbling Over Your DPR Announces Agreement with Amazon to Pay Nearly Five Million Less Cumbrous Conversions In Sight For California Corporations, Weekly Bankruptcy Alert - November 7, 2022. In addition, AMS believes that, to the degree regulated entities are currently tracking the use of BE and non-BE foods for voluntary disclosure, most customary records only indicate the presence or absence of a BE substance and not necessarily the amount. Some commenters believe BE labeling requirements on BE products on the highly adopted or not highly adopted lists are appropriate and what Congress intended. The amended Act directs USDA to promulgate regulations regarding foods required to bear a disclosure indicating that the food is or may be bioengineered. Entities seeking to use absence claims should ensure that such claims are in compliance with all applicable Federal laws and are otherwise truthful and not misleading. For other exempt foodssuch as those derived from animals fed BE foodanother commenter strongly agrees no records should be required from the entity producing these products. Some comments provided alternative symbols and others suggested general ideas that AMS should incorporate, such as more neutral colors or images. Applying the FDA exemptions (annual sales of no more than $500,000) at 21 CFR 101.9(j)(1)(i) and 101.36(h)(1) as described above would exempt 45 percent of firms, only one percent of products, and less than 0.5 percent of sales for food manufacturers, and only 17 percent of firms and about 0.1 percent of products and sales for dietary supplement manufacturers. AMS requested public comments on the definition of bioengineered food. The statutory definition of bioengineering describes food that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques. In the NPRM, we proposed two interpretations of this definition; Position 1 proposed that highly refined products do not contain genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques and therefore are not bioengineered food, while Position 2 proposed that all foods produced from bioengineering, including refined and highly refined products, are bioengineered food. Therefore, an entity utilizing the voluntary disclosure provisions must comply with the disclosure requirements for text, symbol, digital or electronic link, or text Start Printed Page 65859message disclosure, as applicable. 1639(1). Section 66.1's incorporation of the incidental additives factor and condition into the NBFDS thus references the FDA labeling requirement at 21 CFR 101.100(a)(3), which, among other things, outlines the circumstances in which incidental additives need not be labeled as ingredients and describes the types of substances constituting incidental additives. To the extent that secondary direct additives do not constitute incidental additives not subject to FDCA labeling requirements, then such additives would be subject to BE disclosure. The commenters state that it would be prudent to mirror that level to support regulatory certainty in the international food supply chain. As part of the process for list maintenance and revision, AMS will, in consultation with the U.S. Government agencies responsible for the oversight of biotechnology products, consider new and emerging technologies and whether foods resulting from those technologies meet the definition of bioengineered food.. BE crops and non-BE crops are often grown in close proximity and, depending on the crop, cross-pollination may occur. AMS Response: AMS anticipates that enzymes, yeasts, and similar organisms will frequently be excluded from the disclosure requirement, either because they will meet the requirements of the incidental additive factor or condition or because they meet some other NBFDS provision permitting nondisclosure (such as 66.1 and 66.9 regarding foods with no detectable genetic material). Those commenters urged AMS to allow a shorter compliance period for label use-up. For example, if a regulated entity does not make a disclosure for a food containing a soy ingredient, it could maintain supplier records demonstrating non-BE soybeans were used in a product or records showing the soy ingredient accounts for less than 0.9% of total product weight. Very small package means food packages that have a total surface area of less than 12 square inches. Task Force and OMB Issue New Guidance on Federal Contractor Vaccine Weekly IRS Roundup October 31 November 4, 2022. They said this could discourage consumers from purchasing products with BE labels. Provisions for making findings and allowing for appeals hearings in response to the findings were proposed. The DOJ is ramping up enforcement with the first ever False Claims Act settlement with a lender of Paycheck Protection Programs, PPP funds. For example, eggs used in a baked good, where the eggs come from a chicken fed feed produced from BE corn and soy, would not be considered bioengineered solely on the basis of the chicken's feed. The NPRM described a process to update the List on an annual basis. Consistent with the statutory requirement, where the regulated entity has actual knowledge that the food or food ingredient is bioengineered, the regulated entity must maintain records for that food or food ingredient, even if the food is not on the List of Bioengineered Foods. documents in the last year, by the Veterans Affairs Department Accordingly, AMS has provided for voluntary disclosure of such foods. 9. At the top of the circle, to the left of center, in the background of the leaves, is a portion of a yellow circle that resembles a sun. AMS Response: AMS has adopted Position 1 based on the plain language of the amended Act. Such information may allow AMS to align the NBFDS with the standards of other Federal agencies or foreign governments, which may facilitate interstate commerce and trade by allowing for recognition of compatible standards. The NPRM solicited comments on the scope of this definition. In both cases, since the exemptions are smaller than assumed in the GMA study, it is reasonable to expect that the number of exempted food products would also be smaller. (c) The Administrator may consider other relevant information, including whether the requested factor or condition is compatible with the food labeling requirements of other agencies or countries, as part of the evaluation. AMS Response: A threshold substantially lower than 5% per ingredient may not be practical or achievable in production systems across a range of commodity groups. OMB Circular A-4 admonishes agencies to focus on opportunity costs, the real expenditure of society's resources, and to avoid counting transfers as benefits or costs. 1503 & 1507. Electronic or Digital Link Disclosure, 14. AMS's interest is to facilitate imports and exports under arrangements where BE labeling is consistent with the NBFDS. Some commenters stated that the exemption for very small food manufacturers be extended to small retailers. heating) serve to degrade and eliminate DNA. Those periods are comparable to the extended compliance date of January 1, 2020, for FDA's Nutrition Facts and Supplement Facts Label and Serving Size final rules, which is approximately 3.5 years after FDA published the final rules. (d) At the conclusion of the audit or examination of records or similar activity, AMS will make the findings available to the entity that was the subject of the investigation. Comment: A few commenters stressed that testing for BE content should not be a requirement. AMS also requested comments on using list maintenance to evaluate whether a particular crop meets the definition of bioengineering in light of emerging technologies; on whether enzymes, yeasts, and other foods produced in a controlled environment should be included on the lists; and on the treatment of foods produced in other countries. The NPRM outlined AMS's proposed requirements and procedures for the new Standard to be codified at 7 CFR part 66 and requested public comment on several regulatory alternatives offered for consideration. FDA's method of determining predominance relies on weight of the ingredients, as does FSIS's. As part of the NPRM, AMS sought comments on the study, as well as the proposed text message disclosure option, should the Secretary determine, after reviewing the study and comments, that consumers would not have sufficient access to the bioengineering disclosure through electronic or digital disclosure methods. This implication, in conjunction with the Secretary's authority to consider establishing consistency between the NBFDS and the Organic Foods Production Act, permits a regulatory exemption for products certified under Start Printed Page 65825the NOP. Trusted and independent source of local, national and world news. A request or petition must be submitted in accordance with 66.204. Conversely, other commenters who also conducted research on consumer response to the proposed symbols and text options, believed adding the word bioengineered would provide consumers with more information than a symbol with the acronym BE.. The NBFDS provides a mandatory, uniform disclosure standard for BE foodas defined in this rule, by which uniform information is provided to consumers. By also permitting that the disclosure may appear on the principal display panel, AMS acknowledges that some regulated entities may want to increase transparency or highlight specific traits from the BE food in tandem with the BE food disclosure. Regardless of the type of disclosure used, regulated entities can generally look to the List of Bioengineered Foods to determine if the food is required to have a BE disclosure. Industry Minimum Wage Increases On The Ballot in Some California New York Federal Court Decision Creates Doubt Over Use of 28 U.S.C Tis the Season to Find a New Job: New Trends that Make it Easier for Up In Smoke CA Court of Appeal Dismisses Prop 65 Case Against Water Privacy Considerations for the End of 2022. These commenters stated this approach would be consistent with how state laws on BE disclosure treated enzymes. on The NPRM stated that implicit in the statutory provision is that certified organic foods are not subject to BE disclosure. Consumers in low-income rural areas already lacking connective capabilities equivalent to urban areas would be especially burdened. This will improve the understanding of the symbol, as many comments explained that they did not understand what the acronym BE stood for. Many of those in opposition believed the term found in nature itself was nebulous, misleading, and not adequately defined by science. AMS Response: AMS acknowledges the burden frequent relabeling and repackaging would place on regulated entities. Conversely, foods may be removed from the List if they are no Start Printed Page 65820longer produced from a technology that meets the definition of bioengineered food. In other cases, some varieties may meet the definition, while others do not. A number of comments suggested that Alternative 1-C subverted the amended Act by allowing the intentional use of a BE substance into food products without requiring labeling. Comment: Some commenters believed adding the word bioengineered to the symbol was unnecessary and that other symbols used on food (e.g. AMS also notes that any electronic or digital link disclosure utilized by small food manufacturers must take the same steps as larger manufacturers to protect personally identifiable information about consumers.