Archival Records Choose from a variety of guides, records and indexes of people, places, history and legislation. (2) Except as provided in 66.116 for voluntary disclosure, a label shall not bear a disclosure that a food is a bioengineered food or contains a bioengineered food ingredient if the records maintained in accordance with 66.302 demonstrate that the food is not a bioengineered food or does not contain a bioengineered food ingredient. This has resulted in an estimate that is closer to the GMA estimate. In addition, Section IV.A.1 further details AMS's position on recordkeeping. AMS Response: AMS finds it unnecessary to define the term found in nature. AMS received no compelling arguments to define the term and believes that attempting to do so may cause confusion in light of the rapid pace of innovation. This table of contents is a navigational tool, processed from the Another group of commenters stated that this should be done through a supplemental proposed rule that provides the public with an additional opportunity to provide public comments.. Some commenters requested AMS clarify disclosure and recordkeeping requirements for foods included on the commercially available, but not highly adopted list, be more narrowly focused on cultivars directly the result of bioengineering. A few commenters asked AMS to establish a specific time period within which the agency would respond to requests for adoption of factors or conditions, as well as a time period for regulated entities to attain compliance with adopted factors or conditions. AMS Response: AMS notes that FDA and FSIS use the same method for determining predominance of ingredients by weight. These voluntary programs label highly refined products derived from bioengineering as GMO's. AMS anticipates that maintaining an ingredients-based list would be resource-intensive, difficult to maintain, and would likely become obsolete in short order. 11/09/2022, 193 AMS notes that FDA (and FSIS depending on the food at issue) retain authority over absence claims. Commenters suggested that the disclosure be concise, large enough to read, easily located, and intelligible. Many of these commenters suggested that the alternatives AMS provided promoted bioengineering or provided the BE food disclosure in a misleading or confusing manner. Comment: Several commenters supported the proposed disclosure requirements for food sold in bulk containers, stating that such disclosure is necessary to allow consumers to easily identify and understand the bioengineered status of the food. AMS Response: We appreciate that several commenters would like to extend the BE disclosure to food for animals. The amended Act is clear that it is the food manufacturer that selects the disclosure option that it wants to use to make the required disclosure. Comment: One commenter supports the 5% threshold, but believes it should be measured using the percent based on volume of the BE substance in the ingredient, rather than ingredient weight. The second, published on June 20, 2018 (83 FR 28547), made a correction to the Initial Regulatory Flexibility Analysis contained in the NPRM to clarify that the proposed rule was not expected to have a significant economic impact on a substantial number of small business entities. 1639b(a). (2010) Monitoring GM soybean along the industrial soybean oil extraction and refining processes by PCR techniques. The telephone number must be available at all times of the day and must clearly provide bioengineered food information to the caller. However, some commenters expressed concern that voluntary disclosures could potentially be false or misleading, while others stated that voluntary disclosures could lead to a fractured system where individual companies make different choices regarding the exact same ingredients and consumers would not know what such disclosure really means. [FR Doc. The commenters state that it would be prudent to mirror that level to support regulatory certainty in the international food supply chain. Some commenters, however, thought a crops-based list would be easier for regulated entities to use and noted that a crops list, unlike an ingredients list, could be updated and verified using adoption rates and field data. Bioengineered substance means substance that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature. The final rule maintains this definition of small food manufacturer. The proposed rule also sought comment on the process for seeking a determination on the adoption of other factors or conditions. The amended Act also authorizes the Secretary to determine the amounts of a bioengineered substance that may be present in food, as appropriate, in order for the food to be a bioengineered food. 7 U.S.C. 1639b(c)(1). The first proposed option (Alternative 1-A) would establish that food in which an ingredient contains a BE substance that is inadvertent or technically unavoidable, and accounts for no more than five percent (5%) of the specific ingredient, would not be subject to disclosure as a result of that one ingredient. Section IV.A.1 further details AMS's position on recordkeeping. AMS solicited comments on three disclosure options for small and very small packages: (1) A modified version of the electronic or digital link disclosure (scan for info); (2) a modified version of the text (text for info); and (3) a modified version of the phone number (call for info). If other countries have a BE labeling program, AMS is also working to develop mutual recognition agreements where the requirements of countries with similar labeling requirements may be recognized in the United States. For information regarding recordkeeping flexibilities, see our responses to other comments in the Paperwork Reduction Act section. Section III.A.4 of this rule provides a more detailed rationale regarding AMS's position on placement of the BE disclosure. Food Control 16: 753-759 (Greiner study). Some commenters stressed that the NBFDS should state that products exempt from disclosure as bioengineered, such as products from animals fed bioengineered animal food, cannot by default qualify for an absence claim. They explained that consumers have a right to know that the food they are buying is bioengineered and should have access to this information as soon as possible. Additionally, several commenters expressed concern that adopting Position 1 could negatively impact trade. That said, as we have stated previously, nothing in this disclosure standard conveys information about the health, safety, or environmental attributes of BE food compared to non-BE counterparts. We also believe the timeframes in the final rule provide reasonable notice to regulated entities to produce records. Regulated entities are in the best position to know whether disclosure is not required for the ingredients in their products, including, for example, because records verify the products are sourced from non-bioengineered crops or other sources, the ingredients have been subjected to refinement processes validated to remove genetic material, or analytical testing results demonstrate the absence of modified genetic material. (1) Description of the requested factor or condition. The detectability of rDNA may vary by crop and by refining method. Some of these commenters noted that a store could install its own scanners to allow consumers to access electronic or digital link disclosures, but a subset of such commenters stated that such scanners would need to be installed within easy access to all shelves throughout the store, and not just near check-out counters, in order to be comparable to on-package labeling. AMS Response: On analysis of comments and other data, including studies, AMS concludes impacts to producers are mitigated by exemptions for qualifying small and very small entities, by offsetting efficiencies of a uniform standard, and by consideration to international norms and trade. As such, AMS does not specify the records that must be maintained, but allows regulated entities discretion in determining what records will demonstrate compliance. These Start Printed Page 65835commenters proposed that a narrow focus on the presence of genetic material creates a differentiation based on rDNA that some could use to imply a safety issue with the rDNA. legal research should verify their results against an official edition of 1639b(c)(4). Several commenters expressed concern this potential confusion could impact them personally, as many have experienced health-related issues after consuming products made with GMO ingredients. Under SBA's definition of small firms within the each 6-digit NAICS code expected to be impacted by the rule164,329, or 98 percent of 166,975 total firms. In order to incorporate technological changes in industry into this mandatory labeling standard, AMS believes it needs to retain maximum flexibility. For the modified version of the text message, 66.112(b) allows regulated entities to utilize the text message in 66.108, but replace the statement Text [number] for more bioengineered food information with Text [number] for info. AMS believes that shortening the statement may make the text message disclosure small enough to fit on small and very small packages. Distilled spirits, wines, or malt beverages as defined by the Federal Alcohol Administration Act (FAA Act) are foods under the FDCA but are not subject to the NBFDS because they are subject to the labeling provisions of the FAA Act rather than the labeling requirements of the FDCA. The NPRM solicited comments on an array of issues pertaining to the threshold exemption. In addition, the terms regulated entity, marketing and promotional information, principal display panel, small package, very small package, and small food manufacturer, are also discussed. . to be labeled as a bioengineered food. Highly refined products have undergone processes that removed genetic material such that it cannot be detected using common testing methods. With respect to apples, AMS understands that most apple varieties are not known to be bioengineered. Contributors from diverse backgrounds, including consumers, food manufacturers and retailers, farmers and processors, State and foreign governments, and various associations and other interested groups representing consumers and industry submitted over 112,000 responses. Because food and dietary supplement manufacturers are in the manufacturing sector, they are both defined by number of employees for purposes of SBA size categorization. The amended Act requires the electronic or digital link to provide the bioengineering disclosure on the first product information page accessed through the link, without any marketing and promotional information. Comment: A few commenters stated that number of employees was an equally if not more suitable criterion than receipts for a small business. These comments explained how consumers deserve to know when the food they are buying is bioengineered, regardless of whether it was purchased in a restaurant or in a grocery store. Requirements on how the disclosure must appear on food labels and packaging remain the same as proposed in the NPRM. Commenters stated that the inclusion of the phrase . AMS Response: Based on the amended Act, AMS believes that the electronic or digital link disclosure requires that the bioengineering disclosure be on the first product information page.
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