The National Bioengineered Food Disclosure Standard: Overview and Select Considerations

Summary: In July 2016, Congress enacted P.L. 114-216 (2016 Act), comprehensive legislation to govern the labeling of bioengineered foods. The 2016 Act required the U.S. Department of Agriculture (USDA) to establish the National Bioengineered Food Disclosure Standard ( the Standard ) . The Standard regulates labeling of bioengineered foods, a term defined in the 2016 Act. The act does not address or define other terms that some members of the public might associate with bioengineered foods, such as genetically engineered (GE), genetically modified , and genetically modified organism (GMO). The Standard guides the mandatory labeling of foods to indicate the presence of GE ingredients. As such, foods meeting requirements identified in the Standard must bear a bioengineered disclosure. Implementation began on January 1, 2020, and mandatory compliance begins on January 1, 2022.

Summary: The Standard provides details under the three key issues of applicability, disclosure options, and administrative provisions:

Summary: Applicability discusses the definition of bioengineered food and the USDA-maintained List of Bioengineered Foods (List). The Standard applies to foods that are or may be derived from bioengineered ingredients, with some exclusions and exemptions. It does not apply to refined products, such as oils or sugars, that derive from GE plants but no longer contain detectable modified deoxyribonucleic acid (DNA). Many groups interpret the Standard as not applying to foods derived from gene editing and other new technologies that do not use recombinant DNA. The Standard exempts from disclosure foods served in restaurants. Some have endorsed such exclusions and exemptions, and others have criticized them. Disclosure Options outlines acceptable disclosure options for regulated entities, as well as additional options available for specific entities and types of food packages. Most regulated entities may disclose by text, symbol (pictured above), electronic or digital link, or text message. In some cases, a telephone number or website address may be acceptable. Some groups have praised the flexibility that this range of options provides regulated entities, while others have criticized these options as confusing. Administrative Provisions reviews compliance dates, recordkeeping requirements, and enforcement mechanisms, which include audits, examinations, hearings, and release of public findings. The 2016 Act provided few enforcement mechanisms to promote compliance. The Standard establishes how USDA may investigate accusations of non-compliance and how it may publicly release its findings.

Summary: The Standard does not affect how foods derived from biotechnology are regulated for safety and approval for human consumption. The Coordinated Framework for Regulation of Biotechnology , a policy the White House issued in 1986, continues to govern how federal agencies, including USDA, evaluate and approve products developed using modern biotechnology. More generally, USDA and the U.S. Food and Drug Administration (FDA) continue to ensure that foods sold in the United States are safe and properly labeled.

Summary: USDA's Agricultural Marketing Service (AMS) developed the Standard within a broader societal context. Before the 2016 Act, some members of the public had demanded mandatory labeling of the presence of GE ingredients in foods, based on the consumer's right to know. Other members of the public had opposed any GE labeling because of the scientific consensus that GE foods are safe to eat and concern that labeling may introduce unwarranted doubts about food safety. Before the 2016 Act, several states had enacted GE labeling laws, creating concerns among industry and consumer groups. In response, Congress debated this and other federal GE labeling legislation. GE labeling programs may be voluntary or mandatory and may indicate the presence or absence of GE ingredients. Several voluntary labeling programs predate the Standard's mandatory labeling requirements. Public and private programs for the voluntary labeling of foods continue to indicate the absence of GE ingredients in foods. These include the Non-GMO Project and the USDA National Organic Program.

Summary: Future considerations for Congress may include ongoing questions consumers may have concerning what it means for a food to be labeled as bioengineered , how regulated entities will respond to the Standard's new requirements, how USDA will implement its responsibilities under the Standard, potential market impacts as demand for GE versus non-GE foods may change, and how the Standard aligns with international labeling requirements. Congress may choose to monitor implementation of the new Standard in accordance with its oversight responsibilities.

The United States has been a global leader in developing advanced genetic technologies and applying them to crops and livestock. Federal regulators first approved a genetically engineered (GE) food, the Flavr Savr tomato, for sale in 1994. As additional GE crops gained federal approval, farmers rapidly adopted them. Today, about 90% of canola, corn, cotton, soybean, and sugarbeet acres in the United States are planted with GE varieties. GE foods predominantly enter commerce as processed foods and food ingredients (e.g., soybean oil, corn syrup, and sugar). Some members of the public seek to avoid consuming GE foods, as advances in biotechnology have outpaced their acceptance.

In July 2016, Congress enacted P.L. 114-216 (the 2016 Act), requiring the U.S. Department of Agriculture (USDA) to establish a National Bioengineered Food Disclosure Standard (the Standard) within two years. The 2016 Act followed decades of societal debate about genetic engineering, and it marked the first time that the federal government would require the disclosure of GE foods to consumers. (The 2016 Act defined these as bioengineered foods .) With the 2016 Act, the United States joined more than 60 countries that require some form of GE labeling , or on-package disclosure of GE foods or food ingredients.

The Standard provides a mandatory national standard for disclosure of the presence of bioengineered foods and food ingredients to consumers. It details who is responsible for making disclosures, what they must look like, and when they are and are not required. The Standard provides U.S. food manufacturers, importers, and retailers with a voluntary compliance period and a mandatory compliance deadline. The more than 126,000 comments that USDA received during the rulemaking process demonstrate significant public interest in its formulation. USDA released the final rule in December 2018, and phased implementation began in January 2020.

Stakeholder reactions to the final Standard have been mixed. Several organizations immediately criticized the final rule, while others supported it. The Organic Trade Association (OTA), the Center for Food Safety (CFS), the Non-GMO Project, and the Institute for Agriculture and Trade Policy (IATP) each released statements with critical comments. OTA remarked that it is "deeply disappointed in the U.S. Department of Agriculture's final GMO labeling rule and calls on companies to voluntarily act on their own to provide full disclosures on their food products about GMO content." CFS stated that "the USDA has betrayed the public trust by denying Americans the right to know how their food is produce[d]." The Non-GMO Project commented that it "is disappointed by the content of the final rule, which jeopardizes GMO transparency for Americans." IATP stated that "unfortunately, the final rule fails to fix the most egregious provisions of the draft rule and is practically useless in conveying accurate information about food ingredients to consumers while they are shopping."

In contrast, the National Corn Growers Association (NCGA), the American Soybean Association (ASA), and the Food Marketing Institute (FMI) provided supportive comments. NCGA commented that "America's corn farmers need a consistent, transparent system to provide consumers with information without stigmatizing important, safe technology. Thus, we are pleased with the issuance of these rules and look forward to reviewing the details in the coming days." ASA stated, "we believe that it allows transparency for consumers while following the intent of Congress that only food that contains modified genetic material be required to be labeled bioengineered under the law, with food companies having the option of providing additional information if they choose." FMI stated, "the rule provides a consistent way to provide transparency regarding the foods we sell and allow[s] our customers across the country the means to learn more about grocery products containing bioengineered ingredients."

This report provides background information on agricultural biotechnology; reviews major provisions of the Standard (related to applicability, disclosure options, and administrative provisions); and concludes with potential considerations for Congress. The Appendix provides definitions of select scientific and related terms used in this report.

People have been changing plants, animals, and other edible organisms since before agriculture began more than 10,000 years ago. Before people planted crops and raised farm animals, hunting and gathering changed the genetic composition of species. The pace of these changes accelerated with the onset of agriculture. Selective breeding helped create and improve agricultural varieties to meet farmer and consumer needs. Conventional (traditional) breeding created hybrid varieties with enhanced size, growth rate, and other valuable characteristics. Since the mid-20 th century, laboratory-based breeding techniques have further strengthened the ability to modify agricultural varieties. In recent decades, genetic engineering has allowed for increasingly specific genetic manipulation. These techniques can change plants and animals in ways that, with conventional breeding, would not be possible or could take decades to achieve.

The public has come to recognize plants and animals altered through modern biotechnology and genetic engineering as genetically modified organisms (GMOs) . Scientific and federal government experts identify the term g enetically modified as more general than genetically engineered , and as such genetically modified may include conventional breeding. In this report, genetic engineering refers to genetic modification techniques other than conventional breeding.

The Standard addresses food labeling, and it does not change how foods derived from biotechnology are regulated for safety and approval for human or animal consumption. The federal government's 1986 Coordinated Framework for Regulation of Biotechnology (the Coordinated Framework) governs how USDA, the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) apply existing statutes to evaluate biotechnology products. USDA regulates plants under the Plant Protection Act (7 U.S.C. Â§7701 et seq.). FDA regulates food, animal feed additives, and human and animal drugs, primarily under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Â§301 et seq.) and the Public Health Service Act (42 U.S.C. Â§201 et seq.). EPA registers and approves the use of pesticides, including those incorporated into plants through biotechnology, under the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. Â§136 et seq.). A key principle of the Coordinated Framework is to regulate products according to their characteristics and unique features rather than the processes used to develop them.

More generally, FDA and the USDA Animal and Plant Health Inspection Service (APHIS) have responsibilities for assuring that foods sold in the United States are safe, with respect to human and agricultural health, and properly labeled. FDA released a policy statement on GE foods in 1992, indicating that in most cases they are "substantially similar" to non-GE foods and do not require additional regulation or labeling beyond what is required for comparable non-GE foods. A legal decision in 2000 upheld this policy. FDA requires labeling of GE foods that (1) have nutritional characteristics that differ from comparable non-GE foods, (2) contain GE material from known allergenic sources, or (3) have elevated levels of toxic compounds. This labeling is not required to indicate the GE status of the food.

APHIS reviews GE organisms on the basis of whether they pose plant pest risks to agriculture. In 2019, the agency issued a proposed rule to exempt several categories of GE plants from review, citing 30 years of evidence indicating that "genetically engineering a plant with a plant pest as a vector, vector agent, or donor does not in and of itself result in a GE plant that presents a plant pest risk." The proposed rule further stated that new GE technologies, such as gene editing, do not engage with plant pests in any way.

The National Bioengineered Food Disclosure Standard

The Standard provides a mandatory national standard for disclosure of the presence of bioengineered foods and food ingredients to consumers. It provides U.S. food manufacturers, importers, and retailers with a voluntary compliance period and a mandatory compliance deadline.

Following enactment of the 2016 Act, USDA delegated development and implementation of the Standard to the USDA Agricultural Marketing Service (AMS), which oversees many other USDA food-labeling programs, including mandatory Country of Origin Labeling (COOL), the voluntary National Organic Program (NOP), and the voluntary Process Verified Program (PVP). AMS developed the Standard through federal rulemaking, and issued the final rule in December 2018. The final rule defines key terms and interprets issues arising from the 2016 Act. The text box below includes terms defined in the Standard.

The Standard identifies regulated entities as the food manufacturers, importers, and retailers responsible for making disclosures under the Standard. All regulated entities must comply with the Standard by January 1, 2022, although disclosures may begin during the voluntary compliance period, which started on January 1, 2020.

As required for economically significant regulations, AMS prepared and published a regulatory impact analysis (RIA) of the Standard. The RIA estimates that implementation will cost between $570 million and $3.9 billion in the first year, and between $52 million and $118 million in each following year. It attributes most first year costs to those incurred by manufacturers analyzing the applicability of the rule and their compliance with the rule ($401 million to $3.1 billion). After the first year, the RIA attributes most ongoing costs to regulated entities avoiding mandatory disclosures by verifying that foods are not subject to the Standard ($0 to $59 million) and replacing bioengineered ingredients with non-bioengineered ingredients ($41 million to $44 million). The RIA estimates annual financial benefits of $190 million to $565 million, mostly attributed to costs avoided: the costs of complying with a patchwork of state laws, which are avoided and by implementation of the federal Standard. The RIA does not anticipate that the new Standard will provide any benefits to human health or the environment.

Key provisions of the Standard, along with associated issues raised by stakeholders, are identified below within three categories: (1) applicability, (2) disclosure options, and (3) administrative provisions. Many components of the Standard remain controversial. Public reactions are discussed after each category.

The Standard addresses its applicability to specific types of foods and types of entities involved in the manufacture, sale, and distribution of food. These issues were debated in policy discussions about GE food labeling, and they range from how the Standard defines a bioengineered food to which entities must comply with the Standard and which are exempt.

Bioengineered Food Definition and Exclusions

The 2016 Act defined bioengineering , with respect to food, as a food "(A) that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and (B) for which the modification could not otherwise be obtained through conventional breeding or found in nature." It did not identify any specific technologies that would meet the definition of bioengineering . The 2016 Act specified that bioengineering referred to foods "intended for human consumption," and the act left open the possibility that USDA could use additional similar terms in the Standard.

When issuing the Standard, USDA added detail to some statutory definitions and did not provide explicit definition of some other terms. While the Standard builds on the definition of bioengineering by describing the applicability of term, it does not define component parts of the definition, including conventional breeding or found in nature . Nor does it specify whether foods developed through specific technologies, such as gene editing, require disclosure to consumers. The Standard requires use of the term bioengineering rather than similar terms, such as genetic engineering , genetically modified , or GMO .

The final rule sets boundaries for the foods that require disclosure. Based on the definition of bioengineering in the 2016 Act, AMS determined that certain products that derive from GE sources do not require labeling. The Standard identifies these exclusions in its definition of bioengineered food . They include animal feed, which is not considered food because it is not intended for human consumption; foods in which modified DNA is not detectable (e.g., refined oils and sugars); and incidental additives, as described in 21 C.F.R. 101.100(a)(3). The Standard expressly exempts other foods and substances described below. The text box at the end of this section summarizes exclusions and exemptions from the Standard.

The Standard identifies five exemptions from disclosure. The 2016 Act explicitly identified two of these: food served at restaurants or similar retail food establishments, and food produced by very small food manufacturers. The act called for the Standard to set a third exemption: foods containing an amount of a bioengineered substance below a certain threshold. The final two exemptions are for foods derived from animals solely because they consumed bioengineered feed, and food certified under the USDA National Organic Program (NOP).

Food Served in a Restaurant or Similar Retail Food Establishment

The 2016 Act exempts from disclosure food served in a restaurant or similar retail food establishment . The Standard defines this term as follows:

A cafeteria, lunch room, food stand, food truck, transportation carrier (such as a train or airplane), saloon, tavern, bar, lounge, other similar establishment operated as an enterprise engaged in the business of selling prepared food to the public, or salad bars, delicatessens, and other food enterprises located within retail establishments that provide ready-to-eat foods that are consumed either on or outside of the retailer's premises.

The 2016 Act exempts from disclosure food produced by a very small food manufacturer . The Standard defines this term as "any food manufacturer with annual receipts of less than $2,500,000."

Foods with Unintentional Bioengineered Ingredients Under a Presence Threshold

The 2016 Act called for USDA 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." The Standard exempts "food in which no ingredient intentionally contains a bioengineered (BE) substance, with an allowance for inadvertent or technically unavoidable BE presence of up to five percent (5%) for each ingredient."

Foods Derived from Animals That Consumed Bioengineered Feed

The 2016 Act specified that the Standard should not consider food derived from animals to be bioengineered food solely because those animals consumed bioengineered feed. The Standard exempts such foods. Food products such as meat, eggs, or milk derived from animals that consumed bioengineered feed do not require disclosure solely because the animals consumed bioengineered feed.

The 2016 Act specified that NOP certification "shall be considered sufficient to make a claim regarding the absence of bioengineering in the food, such as 'not bioengineered,' 'non-GMO,' or another similar claim." The Standard explicitly exempts foods certified under NOP. NOP is a voluntary food labeling program managed by AMS and operated as a public-private partnership. NOP certifies that agricultural products have been produced using approved organic methods listed in statute. Among NOP's diverse criteria, genetic engineering is an excluded method: NOP-certified products may not be produced or handled with genetic engineering. Thus, such products are not bioengineered and are exempted from the Standard.

The 2016 Act directed USDA to establish "such requirements and procedures as the Secretary [of Agriculture] determines necessary to carry out the standard." During rulemaking, AMS requested public comment on the utility of maintaining a list of potentially regulated foods, for entities to consult when determining whether a food is subject to disclosure. The final Standard includes a List of Bioengineered Foods (the List), that identifies foods that are available in a bioengineered form. While there are bioengineered and non-bioengineered versions of all foods on the List, only the bioengineered versions may require disclosure. The final rule details how AMS considered including on the List, but ultimately did not include, enzymes, yeasts, and other microorganisms produced in controlled environments. The rule states that regulated entities would need to make determinations on whether these substances require recordkeeping or disclosure on a case-by-case basis.

AMS also publishes the List and associated details on its website. Beginning in early 2020, AMS plans to update the List annually, with associated opportunities for public comment. AMS plans to notify the public of the review via the Federal Register and the AMS website. If needed, AMS plans to update the List through the federal rulemaking process. See the text box below for foods on the List as of January 2020.

Public Response to Applicability Provisions of the Standard

The Standard's definition of bioengineered food , and what it applies to, remains controversial. Some areas of disagreement among stakeholders include the use of bioengineered rather than alternative terms, the definition's treatment of gene editing and new genetic technologies, the definition's treatment of refined food products, and the disclosure threshold for inadvertent or technically unavoidable presence of GE ingredients. Some farmer and industry groups have praised the Standard, contending that it provides consumers and regulated entities with needed consistency and transparency. Some advocates of stricter GE labeling argue that it is too permissive because many foods they consider genetically engineered do not require disclosure. These issues are addressed below.

Alternative terms. The terminology used in the Standard has been a point of contention. While USDA had statutory authority to use alternative terms to bioengineered , it did not do so . Some stakeholder groups argue that most consumers are unfamiliar with the term bioengineered . They assert that using other terms, such as GMO , genetically modifi ed organism , or genetically engineered , would be less confusing for consumers. Other groups contend that the Standard's language is precise.

Gene editing and n ew genetic technologies. The Standard's definition of bioengineered food does not identify specific technologies used to create such foods. AMS states that the Standard's definition "focuses primarily on the products of technology, not the technology itself." During rulemaking, some stakeholders had called for the Standard to explicitly address the status of foods derived from new genetic technologies that may not meet the statutory definition of bioengineering . For example, foods derived from gene editing may not meet the statutory definition of bioengineering if (a) they do not contain recombinant DNA or (b) AMS considers that that their modifications could be achieved through conventional breeding or found in nature. Other new genetic technologies may arise that do not meet the Standard's definition of bioengineering for these or other reasons.

Because the Standard does not address specific technologies, consumers and regulated entities may lack clarity about whether or not foods derived from new genetic technologies must be disclosed under the Standard. In the absence of this information, many have interpreted the bioengineering definition as broadly excluding foods derived from gene editing. Under this interpretation, gene-edited foods would not require disclosure. Other interpretations of the Standard simply note that the final rule does not explicitly address gene editing or other new genetic technologies. Advocates of stricter GE labeling requirements contend that even though gene-edited foods seem to be excluded from the Standard's definition of bio engineering , such foods meet the common understanding of genetic engineering and therefore should be required to bear disclosures.

R efined foods exclusion. The Standard excludes refined food products that do not contain detectable amounts of modified DNA from required disclosure. Food without detectable modified genetic material does not meet the statutory definition of bioengineered . Examples include soybean oil, canola oil, and refined sugar. The Standard does not require regulated entities to test every product for the presence of detectable modified genetic material. Rather, manufacturers, importers, and retailers can demonstrate the absence of modified genetic material with records of a validated refining process. Some groups that favor a more expansive definition of bioengineered foods argue that consumers want to know whether the foods they eat derive from GE plants and animals, and thus the Standard should have required disclosures for these refined foods. In contrast, some industry groups, including the Consumer Brands Association (formerly the Grocery Manufacturers Association), commended the Standard for providing regulated entities with the option to voluntarily disclose such foods if desired.

Disclosure threshold. The Standard does not require disclosures for foods with up to 5% presence, per ingredient, of unintentional or technically unavoidable bioengineered substances. In comparison, the European Union applies a threshold of 0.9% per ingredient, and Australia and New Zealand use a threshold of 1% per ingredient. Foods in Japan must be labeled if a GE ingredient is among the top three ingredients and accounts for more 5% of the total product by weight. AMS selected the 5% threshold for the Standard to "appropriately balance providing disclosure to consumers with the realities of the food supply chain." Some advocates of stricter GE labeling, such as OTA, argue that the threshold in the Standard is too high and is "inconsistent with accepted private standards, most of our major global trading partners and unacceptable to consumers."

The Standard identifies permissible options for on-package disclosure of bioengineered foods. All disclosures 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." Regulated entities must place the disclosure in one of three places: within the information panel close to details about the manufacturer, on the principle display panel, or on another panel the consumer is likely to see. In most cases, only one form of disclosure is required per package. Some disclosure options are available to all regulated entities for required disclosures (text, symbol, electronic or digital link, and/or text message), while others are available only to small food manufacturers (telephone number or website address) or in cases of voluntary disclosure (voluntary version of the BE disclosure symbol). Each option is described below.

The 2016 Act specified that the Standard should provide several types of disclosure options. The final rule gives additional detail to their implementation.

Text. "Bioengineered food" is the required text to disclose foods for which all ingredients either meet the definition of bioengineered food or lack records that indicate whether or not they are bioengineered. "Contains a bioengineered food ingredient" is the text required to disclose multi-ingredient foods for which some ingredients are not bioengineered while others are bioengineered or are of undetermined status. For foods distributed solely within a U.S. territory where the predominant language is not English, the appropriate text disclosure may be displayed in the territory's predominant language.

Symbol. Regulated entities may use color or black-and-white versions of the disclosure symbols shown in Figure 1 . The symbol that incorporates the word bioengineered is for products that require disclosure. The symbol that incorporates the phrase derived from bioengineering may be placed voluntarily on packages of food that do not meet the bioengineered food definition but contain food that is derived from bioengineered food (such as refined foods without detectable modified DNA). Disclosures must not be false or misleading. Entities that are exempt from mandatory disclosure (e.g., very small food manufacturers and restaurants) may make voluntary disclosures using the appropriate symbol.

Electronic or digital link . Entities may disclose bioengineered food via electronic or digital links, which are codes that consumers can scan to access more information. Current examples include Quick Response (QR) codes and digital watermarks that consumers may scan with a smart phone or in-store scanner. The code may embed product information or a link to a website with this information presented on the first webpage. The 2016 Act and the Standard require that any electronic or digital link disclosure on a package must be accompanied by the text "Scan here for more food information" or equivalent language consistent with technological changes. They also require that such disclosures be accompanied by a telephone number that consumers may call to receive additional information.

Providing disclosure via these technologies was among the most controversial aspects of the 2016 Act. In the 2016 Act, Congress required USDA to solicit public comment and conduct a study to determine if electronic or digital links would provide consumers with sufficient access to information while shopping. If USDA were to determine that these disclosure methods were insufficient in this regard, then the Standard would need to provide additional disclosure options.

AMS contracted with Deloitte Consulting to conduct the study. The resulting report identified several challenges that would need to be overcome for consumers to access information through digital or electronic link disclosures. AMS determined that the Deloitte study indicated that electronic and digital links would not provide consumers with sufficient access to this information.

Text message . In response to public comments and the results of the Deloitte study, the Standard adopts disclosure by text message as an option in addition to those identified in the 2016 Act. Regulated entities choosing this option must include a clear statement on the food package describing how to receive a text message.

Disclosure Options for Small Food Manufacturers

The Standard defines a small food manufacturer as one with annual receipts of between $2.5 million and $10 million. As directed in the 2016 Act, the Standard allows small food manufacturers to select from additional disclosure options. These consist of providing a telephone number or an internet website address to allow consumers to access more information. Such disclosures must be accompanied by the text "Call [number] for more food information" or "Visit [Uniform Resource Locator of the website] for more food information."

Alternative Disclosure Options for Specific Circumstances

The Standard specifies additional considerations for small and very small packages as well as food sold in bulk containers. The additional disclosure options for small packages mirror the standard options but allow for abbreviated on-package text: "Scan for info," "Text [number] for info," and "Call [number] for info." For very small packages, regulated entities may use a label's preexisting telephone number or website address in lieu of other disclosures. Retailers are responsible for disclosures for food sold in bulk containers (e.g., display case, bin, carton, and barrel), and they must use the primary disclosure options.

The Standard allows for voluntary disclosure in some cases. Exempt entities (very small food manufacturers and restaurants and similar retail food establishments) may voluntarily disclose bioengineered foods and food ingredients using any of the options provided. Additionally, the Standard permits both regulated and exempt entities to voluntarily disclose foods that do not require mandatory disclosure. Such foods include refined foods that derive from bioengineered foods but do not have detectable modified DNA. Voluntary disclosures should indicate that ingredients are "derived from bioengineering" rather than "bioengineered." The Standard does not permit voluntary disclosure in most other circumstances.

Public Response to Disclosure Options of the Standard

During the rulemaking process for the Standard, some advocates for strict GE labeling provisions were seeking a single, easily identifiable, on-package disclosure. These respondents have criticized the disclosure options in the Standard as confusing and uninformative. In contrast, some other groups sought flexible disclosure options that regulated entities could adapt easily to different circumstances. Such industry groups have supported the disclosure options in the Standard as informative and flexible enough for manufacturers to meet.

Among critics, the Organic Trade Association (OTA) argued that the Standard does not provide for meaningful disclosure. It stated that the Standard "allows for the option of digital/electronic disclosures rather than requiring on-pack plain English text disclosure" and that the "stylized GMO symbol with a four-pointed starburst does not reflect a neutral symbol as Congress intended and is misleading." The Center for Food Safety (CFS) found that "both disclosure methods [electronic and digital disclosure], as well as 800 numbers, are unwieldy, time-consuming, and clearly designed to inhibit rather than facilitate access to GE content information."

The International Dairy Foods Association (IDFA) provided a mixed reaction, approving of some aspects of the Standard while further stating, "the rule does not provide the level of transparency IDFA and consumers were hoping for." Among other perceived limitations, IDFA added that the Standard does not require disclosure of highly refined ingredients deriving from GE foods, although it allows for voluntary disclosure of these products.

Among supporters of the Standard, the Food Marketing Institute and the National Corn Growers Association welcomed the disclosure consistency that the Standard provides.

The Standard's inclusion of a voluntary disclosure option elicited mixed responses. While the Consumer Brands Association praised this option, the Center for Science in the Public Interest (CSPI) commented that voluntary disclosure could introduce confusion. CSPI identified the potential for consumers to encounter a single type of product, derived from bioengineering, that one company chose to voluntarily disclose and another company did not. OTA called on food companies to voluntarily disclose all foods produced with genetic engineering.

Stakeholders have also focused on the administrative provisions of the Standard. Key administrative issues include the speed at which regulated entities must comply with the Standard, recordkeeping requirements and burdens, and the enforceability of the Standard. These topics are addressed below.

The 2016 Act did not specify compliance dates for the Standard. The final rule allows for phased implementation before requiring all regulated entities to comply with the Standard (see Table 1 ). It sets January 1, 2020, as the date on which most regulated entities may begin implementation. Small food manufacturers have an additional year to begin implementation, with a start date of January 1, 2021. All regulated entities must fully comply with the Standard by January 1, 2022.

In the RIA, AMS commented that it provides the List of Bioengineered Foods to "simplify and minimize analysis and recordkeeping burden on regulated entities." The Standard requires regulated entities that sell foods on the List, including both bioengineered and non-bioengineered versions, to maintain records documenting whether or not those foods or their ingredients are bioengineered. The Standard does not require potentially regulated entities to maintain records for foods that are not on the List unless they know that a food is bioengineered. This situation could occur if AMS has not yet identified the food as commercially available and has not yet added the food to the List. In such cases, the entity must disclose the food and must maintain records.

Regulated entities may determine what records to keep and how to manage them, as long as they contain sufficient detail for AMS to understand and audit them under the Standard. Entities must maintain these records for two years after sale or distribution of the food.

Failure to make a required disclosure is prohibited under the 2016 Act. However, the act limited the scope of potential enforcement mechanisms and remained silent on others. The 2016 Act explicitly prohibited USDA from recalling food for known or suspected violations of the Standard. It did not address or authorize potential civil penalties for violations. The act allowed USDA to enforce compliance through records audits, examinations, hearings, and public disclosure of findings.

The Standard identifies procedures for carrying out these enforcement mechanisms. AMS does not continuously and proactively verify compliance with the Standard. Rather, the Standard creates a mechanism for the public to file statements or complaints to the AMS Administrator about possible violations of the Standard, and it outlines how AMS may respond to these written statements or complaints. If AMS determines that a complaint warrants further investigation, AMS may audit or examine the records of the entity responsible for disclosure and make its findings available to the entity. The entity may then request a hearing if it objects to the findings. The Standard allows for AMS to revise the findings if warranted and provides that AMS will make the final results of the investigation publicly available.

Public Response to Administrative Provisions of the Standard

While most stakeholder responses to the final Standard have focused on applicability and disclosure options, some interested groups have commented on its administrative provisions. Before release of the Standard, advocates of strict GE labeling had called for an early start to the mandatory compliance period. However, some industry groups supported the delay of mandatory compliance, citing the need to allow sufficient time for regulated entities to adjust labels and recordkeeping procedures. Echoing comments that AMS received during the federal rulemaking process, some critics of the Standard have continued to assert that its enforcement mechanisms are weak.

The National Bioengineered Food Disclosure Standard was developed within a broader societal context. State-level approaches to GE labeling predated the federal 2016 Act. These were driven by public interest in knowing the GE status of their foods. In addition, some private and federal voluntary labeling programs that provide information on the GE status of foods are expected to continue after implementation of the Standard.

Public Opinion and State-Level GE Labeling Before the Standard

When foods containing GE ingredients were first introduced in the 1990s, some members of the public called for banning them based on concerns about potential harm to human health. Research has repeatedly found no difference between foods developed with and without genetic engineering, in terms of the health and safety of the people consuming them.

Even so, some consumers remain concerned about genetic engineering, citing health, personal preference, religious, economic system, and other objections. Moving on from calls to ban GE foods for human health reasons, many consumers began to demand a government role in making GE foods easily identifiable via GE labeling. Before establishment of the Standard, some surveys reported that the majority of consumers wanted GE foods to be labeled. Various proposed GE labeling laws and initiatives at the state and federal levels provided for mandatory or voluntary labeling. Mandatory labeling requires companies to disclose the presence of GE ingredients. Voluntary labeling can allow companies to certify the absence of GE ingredients (as discussed in " Continuing Voluntary Labeling Programs and GE-Absence Claims ") or to disclose the presence of GE ingredients.

The 2016 Act preempted state laws and initiatives and instituted mandatory labeling of the presence of GE ingredients in foods. In the years preceding the introduction and passage of the 2016 Act, state laws and ballot initiatives on GE labeling began to proliferate. In 2014, Vermont became the first state to enact a mandatory GE labeling law, with an effective date of July 1, 2016. Other states enacted similar laws, while others still considered similar legislation or voted on state ballot initiatives. Michigan and North Dakota enacted legislation urging the U.S. Congress to pass a uniform GE labeling standard.

Most GE labeling proponents strongly supported mandatory labeling standards, citing consumers' right to know, even if safety were not an issue. Some GE labeling opponents argued that no scientific basis existed for requiring mandatory GE labeling, and that such labeling may unnecessarily introduce doubt about the quality or safety of labeled foods and could cause costly and unnecessary market disruption. Before the 2016 Act, some GE labeling proponents and opponents called for a federal law to preempt development of an uncertain and confusing patchwork of state laws with different GE labeling requirements.

In the absence of federal legislation in 2015, USDA experimented with adapting an existing voluntary USDA labeling program to meet consumer and producer interests in GE labeling. That year, AMS used its Process Verified Program (PVP) to certify the absence of GE ingredients in food products from a single company, which had requested this service. Some anticipated that this would lead to a voluntary USDA program to certify the absence of GE ingredients in foods. GE-labeling proponents responded that, although this would be a step in the right direction, a voluntary program would fail to meet consumer demands, and only mandatory labeling would do so. This application of PVP to certify the absence of GE ingredients in foods did not expand beyond a single company.

Continuing Voluntary Labeling Programs and GE-Absence Claims

Voluntary labeling programs that identify the absence of GE ingredients predate legislation to require mandatory labels on foods that contain GE ingredients. On-package symbols from these private and public-private programs indicate to consumers that foods do not contain GE ingredients. They may either make a direct GE-absence claim (certifying that the food does not contain GE ingredients) or indicate that the food was produced with processes that do not include genetic engineering (e.g., certified organic production methods). Food producers and manufacturers may choose to opt into these programs and to bear associated costs.

One example is the Non-GMO Project, which a non-profit organization manages to provide third-party verification for processed foods that do not contain GE ingredients. Companies sign agreements with the Non-GMO Project to have their processes reviewed and to have any high-risk products tested by third-party laboratories. Once the Non-GMO Project verifies a company's processes and products, the company can display the Non-GMO Project Verified symbol on its food packaging. This symbol on food packaging makes a GE-absence claim.

Another example is the USDA National Organic Program (NOP), a public-private program for voluntary labeling that, among other things, indicates the absence of GE ingredients. NOP, which is administered by AMS, certifies that agricultural products have been produced using approved organic methods listed in statute. Genetic engineering is an excluded method: NOP-certified products may not be produced or handled with genetic engineering. The NOP symbol indicates that a food meets diverse criteria, including production methods that exclude genetic engineering.

These voluntary labeling programs are expected to continue after implementation of the Standard. They differ from the Standard's voluntary disclosure option , which permits voluntary disclosure of foods that derive from bioengineering yet no longer have the characteristics of bioengineered foods, and is discussed in this report's section on " Voluntary Disclosure ." The voluntary labeling programs provide opportunities to identify foods that affirmatively do not derive from bioengineering. The Standard does not address GE-absence claims, and the final rule states that FDA (and the USDA Food Safety and Inspection Service, depending on the food at issue) "retain authority over absence claims."

Implementation of the Standard over the next two years and beyond will affect consumers, regulated entities, and AMS. Many potential issues arising from the Standard will become clear only as implementation continues. The below text summarizes potential and stated concerns related to applicability, disclosure options, administrative provisions, and other issues. Congress may choose to monitor the new Standard's implementation in accordance with its oversight responsibilities.

A key question for Congress is whether AMS's implementation of the 2016 Act meets congressional intent regarding the scope of applicability and the degree of disclosure required. In the final rule, AMS asserted that it balanced flexibility for regulated entities and information to consumers regarding the bioengineered status of their foods. Stakeholders who question AMS's decisions in the rulemaking process, as described above, may question the extent to which AMS's implementation aligns with congressional intent.

Applicability. Groups that have criticized the definition of bioengineered in the 2016 Act may call on Congress to amend the definition to include highly refined products derived from GE organisms and/or include products that do not meet the current definition, such as those derived from gene editing and other new technologies. Other interested groups may continue to advocate for a definition that restricts the number and types of foods to which the definition applies.

AMS has committed to maintaining and updating the List through annual public reviews, and on an interim basis as needed. Such reviews can provide opportunities to add to the List any bioengineered food products that have entered commerce. Additionally, during these reviews, stakeholders with differing views may encourage the agency to adopt either a more expansive or a more restrictive listing of bioengineered foods.

Disclosure. Another issue in the context of disclosure is the degree of familiarity with the required labels that consumers may have. Consumers unfamiliar with the term bioengineered may have questions about what this means on foods bearing disclosure. Public reaction to implementation of the various types of disclosure may generate calls for these options to be revised based on their success or failure to provide consumers with easily accessible and useful information.

Administrative provisions. An issue for potential consideration is the extent to which additional federal resources will be required to implement the Standard in both the voluntary and mandatory compliance periods. In its regulatory impact analysis (RIA), AMS broadly estimated that it may need $2 million annually to implement the Standard, without differentiating potential expenses during the voluntary and mandatory compliance periods. AMS proposed that it would use such funds to update the List; conduct audits and hearings; manage complaints and inquiries; and provide training, education, outreach and programmatic support.

AMS may need to assign staff and develop new processes to implement the Standard's provisions related to audits, examinations, hearings, and publications of findings. Congress may be asked to consider allocating new resources to support continued implementation of the new Standard.

In addition, Congress may assess the cost and administrative overhead that regulated entities expend to identify and maintain records on foods subject to disclosure and to adjust labels on food packaging. Estimates for administrative costs to regulated entities, which AMS presents in its RIA, range from a lower bound of $459 million to an upper bound of nearly $3.6 billion for the first year. AMS anticipates that these costs will greatly reduce in subsequent years as potentially regulated entities replace bioengineered ingredients with non-bioengineered ingredients.

Regarding enforcement, the rule largely relies on a public notification mechanism to influence the compliance of regulated entities and correct violations of the Standard. Stakeholders may or may not view this mechanism as successful, depending on the extent and frequency of any such violations. Interested parties may petition Congress to strengthen existing enforcement mechanisms or identify new ones to enhance compliance with the new Standard.

Market demand for bioengineered versus non-bioengineered products . In the RIA, AMS indicates that it cannot accurately predict how consumers will react to bioengineered disclosures on food labels. Consumers may avoid foods labeled as bioengineered, they may prefer them, or such labels may make no difference to consumer purchasing behaviors. In the RIA, AMS assumes that manufacturers will avoid labeling 20% of their products as bioengineered, by replacing bioengineered with non-bioengineered ingredients, due to potential consumer reactions. AMS selected 20% for purposes of estimating costs and benefits in the RIA following consideration of existing studies and surveys of consumer behavior and consideration of the requirements of the Standard. Depending on how consumers respond, implementation of the Standard may influence manufacturer and retailer demand for bioengineered and non-bioengineered foods. Congress may respond to stakeholder concerns about any market shifts resulting from the Standard.

Interactions with international trade. Unexpected issues may arise as implementation begins. For example, AMS states that it does not expect the Standard to impact foreign trade. However, it also notes that the USDA Foreign Agriculture Service is prepared to work closely with foreign countries that export food and agricultural products to the United States, to facilitate their understanding of the Standard. If trade issues arise, Congress may choose to address harmonization of labeling requirements with foreign trading partners by amending applicability, disclosure, or administrative requirements in the 2016 Act, or by other means.

Appendix. Glossary of Select Scientific and Related Terms

Many terms are used when describing human alterations of plants and animals over time. Unless otherwise noted, the definitions in this glossary derive from USDA's online Agricultural Biotechnology Glossary and are used for the purposes of this report.

Agricultural b iotechnology. A range of tools, including traditional breeding techniques, that alter living organisms, or parts of organisms, to make or modify products; improve plants or animals; or develop microorganisms for specific agricultural uses. Modern biotechnology today includes the tools of genetic engineering.

Conventional breeding. Undefined in USDA's Agricultural Biotechnology Glossar y. USDA defines the similar term, traditional breeding , as "modification of plants and animals through selective breeding. Practices used in traditional plant breeding may include aspects of biotechnology such as tissue culture and mutational breeding."

Gene editing. A technique that allows researchers to alter the DNA of organisms to insert, delete, or modify a gene or gene sequences to silence, enhance, or otherwise change an organism's specific genetic characteristics.

GE labeling. On-package disclosure of genetically engineered foods or food ingredients.

Genetically engineered (GE) . Produced through genetic engineering.

Genetic engineering. Manipulation of an organism's genes by introducing, eliminating or rearranging specific genes using the methods of modern molecular biology, particularly those techniques referred to as recombinant DNA techniques.

Genetic modification. The production of heritable improvements in plants or animals for specific uses, via either genetic engineering or other more traditional methods. Some countries other than the United States use this term to refer specifically to genetic engineering.

Genetically modified organism ( GMO). An organism produced through genetic modification.

Recombinant DNA. A molecule of DNA formed by joining different DNA segments using recombinant DNA technology.

Recombinant DNA technology. Procedures used to join together DNA segments in a cell-free system (e.g., in a test tube outside living cells or organisms). Under appropriate conditions, a recombinant DNA molecule can be introduced into a cell and copy itself (replicate), either as an independent entity (autonomously) or as an integral part of a cellular chromosome.

Selective breeding . Making deliberate crosses or matings of organisms so the offspring will have particular desired characteristics derived from one or both of the parents.

Transgenic organism. An organism resulting from the insertion of genetic material from another organism using recombinant DNA techniques.

Variety. A subdivision of a species for taxonomic classification also referred to as a "cultivar." A variety is a group of individual plants that is uniform, stable, and distinct genetically from other groups of individuals in the same species.


Occupational Safety and Health Administration (OSHA): Emergency Temporary Standards (ETS) and COVID-19

Summary: The Occupational Safety and Health Administration (OSHA) does not currently have a specific standard that protects healthcare or other workers from airborne or aerosol transmission of disease or diseases transmitted by airborne droplets. Some in Congress, and some groups representing healthcare, meat and poultry processing, and other workers, are calling on OSHA to promulgate an emergency temporary standard (ETS) to protect workers from exposure to SARS-Cov-2, the virus that causes Coronavirus Disease 2019 (COVID-19). The Occupational Safety and Health Act of 1970 (OSH Act) gives OSHA the ability to promulgate an ETS that would remain in effect for up to six months without going through the normal review and comment process of rulemaking. OSHA, however, has rarely used this authority in the pastânot since the courts struck down its ETS on asbestos in 1983.

Summary: The California Division of Occupational Safety and Health (Cal/OSHA), which operates California's state occupational safety and health plan, has had an aerosol transmissible disease (ATD) standard since 2009. This standard includes, among other provisions, the requirement that employers provide covered employees with respirators, rather than surgical masks, when these workers interact with ATDs, such as known or suspected COVID-19 cases. Also, according to the Cal/OSHA ATD standard, certain procedures require the use of powered air purifying respirators (PAPR). Both OSHA and Cal/OSHA have issued enforcement guidance to address situations when the shortage of respirators may impede an employer's ability to comply with existing standards.

Summary: H.R. 6139 , the COVID-19 Health Care Worker Protection Act of 2020, would require OSHA to promulgate an ETS on COVID-19 that incorporates both the Cal/OSHA ATD standard and the Centers for Disease Control and Prevention's (CDC's) 2007 guidelines on occupational exposure to infectious agents in healthcare settings. The CDC's 2007 guidelines generally require stricter controls than its interim guidance on COVID-19 exposure. The provisions of H.R. 6139 were incorporated into the version of H.R. 6201 , the Families First Coronavirus Response Act, as introduced in the House. However, the OSHA ETS provisions were not included in the version of legislation that passed the House and the Senate and was signed into law as P.L. 116-127 .

Summary: H.R. 6379 , as introduced in the House, also includes a requirement for an OSHA ETS and permanent standard to address COVID-19 exposure, with similar provisions in S. 3584 . H.R. 6559 includes the requirements for an ETS and permanent standard, clarifies the requirement that employers must report work-related COVID-19 cases, and expands protections for whistleblowers. The provisions of H.R. 6559 were included in H.R. 6800 , the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act) passed by the House on May 15, 2020.

Summary: A group representing hospitals claims that because SARS-Cov-2 is primarily transmitted by airborne droplets and surface contacts, surgical masks are sufficient protection for workers coming into routine contact with COVID-19 cases, and that the shortage of respirators may adversely impact some hospitals' patient capacities if stricter requirements to provide personal protective equipment (PPE) to employees were to be enacted.

Occupational Safety and Health Administration Standards

Section 6 of the Occupational Safety and Health Act of 1970 (OSH Act) grants the Occupational Safety and Health Administration (OSHA) of the Department of Labor (DOL) the authority to promulgate, modify, or revoke occupational safety and health standards that apply to private sector employers, the United States Postal Service, and the federal government as an employer. In addition, Section 5(a)(1) of the OSH Act, commonly referred to as the General Duty Clause, requires that all employers under OSHA's jurisdiction provide workplaces free of "recognized hazards that are causing or are likely to cause death or serious physical harm" to their employees. OSHA has the authority to enforce employer compliance with its standards and with the General Duty Clause through the issuance of abatement orders, citations, and civil monetary penalties. The OSH Act does not cover state or local government agencies or units. Thus, certain entities that may be affected by Coronavirus Disease 2019 (COVID-19), such as state and local government hospitals, local fire departments and emergency medical services, state prisons and county jails, and public schools, are not covered by the OSH Act or subject to OSHA regulation or enforcement.

Section 18 of the OSH Act authorizes states to establish their own occupational safety and health plans and preempt standards established and enforced by OSHA. OSHA must approve state plans if they are "at least as effective" as OSHA's standards and enforcement. If a state adopts a state plan, it also must cover state and local government entities not covered by OSHA. Currently, 21 states and Puerto Rico have state plans that cover all employers, and 5 states and the U.S. Virgin Islands have state plans that cover only state and local government employers not covered by the OSH Act. In the remaining states, state and local government employers are not covered by OSHA standards or enforcement. State plans may incorporate OSHA standards by reference, or states may adopt their own standards that are at least as effective as OSHA's standards.

OSHA may promulgate occupational safety and health standards on its own initiative or in response to petitions submitted to the agency by various government agencies, the public, or employer and employee groups. OSHA is not required, however, to respond to a petition for a standard or to promulgate a standard in response to a petition. OSHA may also consult with one of the two statutory standing advisory committeesâthe National Advisory Committee on Occupational Safety and Health (NACOSH) or the Advisory Committee on Construction Safety and Health (ACCSH)âor an ad-hoc advisory committee for assistance in developing a standard.

OSHA's rulemaking process for the promulgation of standards is largely governed by the provisions of the Administrative Procedure Act (APA) and Section 6(b) of the OSH Act. Under the APA informal rulemaking process, federal agencies, including OSHA, are required to provide notice of proposed rules through the publication of a Notice of Proposed Rulemaking in the Federal Register and provide the public a period of time to provide comments on the proposed rules.

Section 7(b) of the OSH Act mirrors the APA in that it requires notice and comment in the rulemaking process. After publishing a proposed standard, the public must be given a period of at least 30 days to provide comments. In addition, any person may submit written objections to the proposed standard and may request a public hearing on the standard.

Section 6(e) of the OSH Act requires OSHA to publish in the Federal Register a statement of the reasons the agency is taking action whenever it promulgates a standard, conducts other rulemaking, or takes certain additional actions, including issuing an order, compromising on a penalty amount, or settling an issued penalty.

Other Relevant Laws and Executive Order 12866

In addition to the APA and OSH Act, other federal laws that generally apply to OSHA rulemaking include the Paperwork Reduction Act, Regulatory Flexibility Act, Congressional Review Act, Information Quality Act, and Small Business Regulatory Enforcement Fairness Act (SBREFA). Also, Executive Order 12866, issued by President Clinton in 1993, requires agencies to submit certain regulatory actions to the Office of Management and Budget (OMB) and Office of Information and Regulatory Affairs (OIRA) for review before promulgation.

OSHA rulemaking for new standards has historically been a relatively time-consuming process. In 2012, at the request of Congress, the Government Accountability Office (GAO) reviewed 59 significant OSHA standards promulgated between 1981 (after the enactments of the Paperwork Reduction Act and Regulatory Flexibility Act) and 2010. For these standards, OSHA's average time between beginning formal consideration of the standardâeither through publishing a Request for Information or Advanced Notice of Proposed Rulemaking in the Federal Register or placing the rulemaking on its semiannual regulatory agendaâand promulgation of the standard was 93 months (7 years, 9 months). Once the Notice of Proposed Rulemaking was published for these 59 standards, the average time until promulgation of the standard was 39 months (3 years, 3 months).

In 2012, OSHA's Directorate of Standards and Guidance published a flowchart of the OSHA rulemaking process on the agency's website. This flowchart includes estimated duration ranges for a variety of rulemaking actions, beginning with pre-rule activitiesâsuch as developing the idea for the standard and meeting with stakeholdersâand ending with promulgation of the standard. The flowchart also includes an estimated duration range for post-promulgation activities, such as judicial review. The estimated time from the start of preliminary rulemaking to the promulgation of a standard ranges from 52 months (4 years, 4 months) to 138 months (11 years, 6 months). After a Notice of Proposed Rulemaking is published in the Federal Register, the estimated length of time until the standard is promulgated ranges from 26 months (2 years, 2 months) to 63 months (5 years, 3 months).

Table 1 provides OSHA's estimated timelines for six major pre-rulemaking and rulemaking activities leading to the promulgation of a standard.

Both the APA and the OSH Act provide for judicial review of OSHA standards. Section 7(f) of the OSH Act provides that any person who is "adversely affected" by a standard may file, within 60 days of its promulgation, a petition challenging the standard with the U.S. Court of Appeals for the circuit in which the person lives or maintains his or her principal place of business. A petition for judicial review does not automatically stay the implementation or enforcement of the standard. However, the court may order such a stay. OSHA estimates that post-promulgation activities, including judicial review, can take between 4 and 12 months after the standard is promulgated.

Section 6(c) of the OSH Act provides the authority for OSHA to issue an Emergency Temporary Standard (ETS) without having to go through the normal rulemaking process. OSHA may promulgate an ETS without supplying any notice or opportunity for public comment or public hearings. An ETS is immediately effective upon publication in the Federal Register . Upon promulgation of an ETS, OSHA is required to begin the full rulemaking process for a permanent standard with the ETS serving as the proposed standard for this rulemaking. An ETS is valid until superseded by a permanent standard, which OSHA must promulgate within six months of publishing the ETS in the Federal Register . An ETS must include a statement of reasons for the action in the same manner as required for a permanent standard. State plans are required to adopt or adhere to an ETS, although the OSH Act is not clear on how quickly a state plan must come into compliance with an ETS.

Section 6(c)(1) of the OSH Act requires that both of the following determinations be made in order for OSHA to promulgate an ETS:

that employees are exposed to grave danger from exposure to substances or agents determined to be toxic or physically harmful or from new hazards, and that such emergency standard is necessary to protect employees from such danger.

The term grave danger , used in the first mandatory determination for an ETS, is not defined in statute or regulation. The legislative history demonstrates the intent of Congress that the ETS process "not be utilized to circumvent the regular standard-setting process," but the history is unclear as to how Congress intended the term grave danger to be defined.

In addition, although the federal courts have ruled on challenges to previous ETS promulgations, the courts have provided no clear guidance as to what constitutes a grave danger. In 1984, the U.S. Court of Appeals for the Fifth Circuit in Asbestos Info. Ass'n v. OSHA issued a stay and invalidated OSHA's November 1983 ETS lowering the permissible exposure limit for asbestos in the workplace. In its decision, the court stated that "gravity of danger is a policy decision committed to OSHA, not to the courts." The court, however, ultimately rejected the ETS, in part on the grounds that OSHA did not provide sufficient support for its claim that 80 workers would ultimately die because of exposures to asbestos during the six-month life of the ETS.

In addition to addressing a grave danger to employees, an ETS must also be necessary to protect employees from that danger. In Asbestos Info. Ass'n , the court invalidated the asbestos ETS for the additional reason that OSHA had not demonstrated the necessity of the ETS. The court cited, among other factors, the duplication between the respirator requirements of the ETS and OSHA's existing standards requiring respirator use. The court dismissed OSHA's argument that the ETS was necessary because the agency felt that the existing respiratory standards were "unenforceable absent actual monitoring to show that ambient asbestos particles are so far above the permissible limit that respirators are necessary to bring employees' exposure within the PEL of 2.0 f/cc." The court determined that "fear of a successful judicial challenge to enforcement of OSHA's permanent standard regarding respirator use hardly justifies resort to the most dramatic weapon in OSHA's enforcement arsenal."

Although OSHA has not promulgated an ETS since the 1983 asbestos standard, it has since determined the necessity of an ETS. In 2006, the agency considered a petition from the United Food and Commercial Workers (UFCW) and International Brotherhood of Teamsters (IBT) for an ETS on diacetyl. The UFCW and IBT petitioned OSHA for the ETS after the National Institute for Occupational Safety and Health (NIOSH) and other researchers found that airborne exposure to diacetyl, then commonly used as an artificial butter flavoring in microwave popcorn and a flavoring in other food and beverage products, was linked to the lung disease bronchiolitis obliterans , now commonly referred to as "popcorn lung." According to GAO's 2012 report on OSHA's standard-setting processes, OSHA informed GAO that although the agency may have been able to issue an ETS based on the grave danger posed by diacetyl, the actions taken by the food and beverage industries, including reducing or removing diacetyl from products, made it less likely that the necessity requirement could be met.

Section 6(c)(2) of the OSH Act provides that an ETS is effective until superseded by a permanent standard promulgated pursuant to the normal rulemaking provisions of the OSH Act. Section 6(c)(3) of the OSH Act requires OSHA to promulgate a permanent standard within six months of promulgating the ETS. As shown earlier in this report, six months is well outside of historical and currently expected time frames for developing and promulgating a standard under the notice and comment provisions of the APA and OSH Act, as well as under other relevant federal laws and executive orders. This dichotomy between the statutory mandate to promulgate a standard and the timelines that, based on historical precedent, other provisions in the OSH Act might realistically require for such promulgation raises the question of whether or not OSHA could extend an ETS's duration without going through the normal rulemaking process. The statute and legislative history do not clearly address this question.

OSHA has used its ETS authority sparingly in its history and not since the asbestos ETS promulgated in 1983. As shown in Table A-1 in the Appendix, of the nine times OSHA has issued an ETS, the courts have fully vacated or stayed the ETS in four cases and partially vacated the ETS in one case. Of the five cases that were not challenged or that were fully or partially upheld by the courts, OSHA issued a permanent standard either within the six months required by the statute or within several months of the six-month period and always within one year of the promulgation of the ETS. Each of these cases, however, occurred before 1980, when a combination of additional federal laws and court decisions added additional procedural requirements to the OSHA rulemaking process. OSHA did not attempt to extend the ETS's expiration date in any of these cases.

Although the courts have not ruled directly on an attempt by OSHA to solely extend the life of an ETS, in 1974, the U.S. Court Appeals for the Fifth Circuit held in Florida Peach Growers Ass ' n v. United States Department of Labor that OSHA was within its authority to amend an ETS without going through the normal rulemaking process. The court stated that "it is inconceivable that Congress, having granted the Secretary the authority to react quickly in fast-breaking emergency situations, intended to limit his ability to react to developments subsequent to his initial response." The court also recognized the difficulty OSHA may have in promulgating a standard within six months due to the notice and comment requirements of the OSH Act, stating that in the case of OSHA seeking to amend an ETS to expand its focus, "adherence to subsection (b) procedures would not be in the best interest of employees, whom the Act is designed to protect. Such lengthy procedures could all too easily consume all of the temporary standard's six months life"

Currently, no OSHA standard directly covers exposure to airborne or aerosol diseases in the workplace. As a result, OSHA is limited in its ability to enforce protections for healthcare and other workers who may be exposed to SARS-Cov-2, the virus that causes COVID-19.

OSHA may enforce the General Duty Clause in the absence of a standard, if it can be determined that an employer has failed to provide a worksite free of "recognized hazards" that are "causing or are likely to cause death or serious physical harm" to workers. In addition, OSHA's standards for the use of personal protective equipment (PPE) may apply in cases in which workers require eye, face, hand, or respiratory protection against COVID-19 exposure.

National Institute for Occupational Safety and Health Certification

The OSHA respiratory protection standard requires the use of respirators certified by NIOSH in cases in which engineering controls, such as ventilation or enclosure of hazards, are insufficient to protect workers from breathing contaminated air. Surgical masks, procedure masks, and dust masks are not considered respirators. NIOSH certifies respirators pursuant to federal regulations. For nonpowered respirators, such as filtering face piece respirators commonly used in healthcare and construction, NIOSH classifies respirators based on their efficiency at filtering airborne particles and their ability to protect against oil particles. Under the NIOSH classification system, the letter (N, R, or P) indicates the level of oil protection as follows: Nâno oil protection; Râoil resistant; and Pâoil proof. The number following the letter indicates the efficiency rating of the respirator as follows: 95âfilters 95% of airborne particles; 97âfilters 97% of airborne particles; and 100âfilters 99.7% of airborne particles. Thus an N95 respirator, the most common type, is one that does not protect against oil particles and filters out 95% of airborne particles. An R or P respirator can be used in place of an N respirator.

A respirator that is past its manufacturer-designated shelf life is no longer considered to be certified by NIOSH. However, in response to potential shortages in respirators, NIOSH has tested and approved certain models of respirators for certified use beyond their manufacturer-designated shelf lives.

Respirators designed for certain medical and surgical uses are subject to both certification by NIOSH (for oil protection and efficiency) and regulation by the Food and Drug Administration (FDA) as medical devices. In general, respirators with exhalation valves cannot be used in surgical and certain medical settings because, although the presence of an exhalation valve does not affect the respirator's protection afforded the user, it may allow unfiltered air from the user into a sterile field. On March 2, 2020, FDA issued an Emergency Use Authorization (EUA) to approve for use in medical settings certain NIOSH-certified respirators not previously regulated by FDA.

CDC Interim Guidance on Respiratory Protection

On March 10, 2020, the Centers for Disease Control and Prevention (CDC) updated its interim guidance for the protection of healthcare workers against exposure to COVID-19 to permit healthcare workers caring for known or suspected COVID-19 cases to use "facemasks" when respirators are not available or are in limited supply. This differs from the CDC's 2007 guidelines for control of infectious agents in healthcare settings, which required the use of respirators for treatment of known or suspected cases. CDC states that respirators should be prioritized for use in medical procedures likely to generate respiratory aerosols. Before this interim guidance was released, Representative Bobby Scott, Chairman of the House Committee on Education and Labor, and Representative Alma Adams, Chair of the Subcommittee on Workforce Protections, sent a letter to Secretary of Health and Human Services (HHS) Alex M. Azar II expressing their opposition to this change in the interim standard.

The OSHA respiratory protection standard requires that the employer provide a medical evaluation to the employee to determine if the employee is physiologically able to use a respirator. This medical evaluation must be completed before any fit testing. For respirators designed to fit tightly against the face, the specific type and model of respirator that an employee is to use must be fit tested in accordance with the procedures provided in Appendix A of the OSHA respiratory protection standard to ensure there is a complete seal around the respirator when worn. Once an employee has been fit tested for a respirator, he or she is required to be fit tested annually or whenever the model of respirator, but not the actual respirator itself, is changed. Each time an individual uses a respirator, he or she is required to perform a check of the seal of the respirator to his or her face in accordance with the procedures provided in Appendix B of the standard. On March 14, 2020, OSHA issued guidance permitting employers to suspend annual fit testing of respirators for employees that have already been fit tested on the same model respirator.

Temporary OSHA Enforcement Guidance on the Respiratory Protection Standard

In response to shortages of respirators and other PPE during the national response to the COVID-19 pandemic, OSHA has issued three sets of temporary enforcement guidance to permit the following exceptions to the respiratory protection standard:

1. Employers may suspend annual fit testing of respirators for employees that have already been fit tested on the same model respirator; 2. Employers may permit the use of expired respirators and the extended use or reuse of respirators, provided the respirator maintains its structural integrity and is not damaged, soiled, or contaminated (e.g., with blood, oil, or paint); and 3. Employers may permit the use of respirators not certified by NIOSH, but approved under standards used by the following countries or jurisdictions, in accordance with the protection equivalency tables provided in Appendices A and B of the enforcement guidance document: Australia, Brazil, European Union, Japan, Mexico, People's Republic of China, and Republic of Korea.

Cal/OSHA Aerosol Transmissible Disease Standard

Although no OSHA standard specifically covers aerosol or airborne disease transmission, the California Division of Occupational Safety and Health (Cal/OSHA), under its state plan, promulgated its aerosol transmissible disease (ATD) standard in 2009. The ATD standard covers most healthcare workers, laboratory workers, as well as workers in correctional facilities, homeless shelters, and drug treatment programs. Under the ATD standard, SARS-Cov-2, the virus that causes COVID-19, is classified as a disease or pathogen requiring airborne isolation. This classification subjects the virus to stricter control standards than diseases requiring only droplet precautions, such as seasonal influenza. The key requirements of the ATD standard include

written ATD exposure control plan and procedures, training of all employees on COVID-19 exposure, use of PPE, and procedures if exposed to COVID-19, engineering and work practice controls to control COVID-19 exposure, including the use of airborne isolation rooms, provision of medical services to employees, including removal of exposed employees, specific requirements for laboratory workers, and PPE requirements.

Cal/OSHA Aerosol Transmissible Disease PPE Requirements

The Cal/OSHA ATD standard requires that employers provide employees PPE, including gloves, gowns or coveralls, eye protection, and respirators certified by NIOSH at least at the N95 level whenever workers

enter or work in an airborne isolation room or area with a case or suspected case; are present during procedures or services on a case or suspected case; repair, replace, or maintain air systems or equipment that may contain pathogens; decontaminate an area that is or was occupied by a case or suspected case; are present during aerosol generating procedures on cadavers of cases or suspected cases; transport a case or suspected case within a facility or within a vehicle when the patient is not masked; and are working with a viable virus in the laboratory.

In addition, a powered air purifying respirator (PAPR) with a high-efficiency particulate air (HEPA) filter must be used whenever a worker performs a high- hazard procedure on a known or suspected COVID-19 case. High-hazard procedures are those in which "the potential for being exposed to aerosol transmissible pathogens is increased due to the reasonably anticipated generation of aerosolized pathogens"âthey include intubation, airway suction, and caring for patients on positive pressure ventilation. Emergency medical services (EMS) workers may use N100, R100, or P100 respirators in place of PAPRs.

Cal/OSHA has issued interim guidance in response to shortages of respirators in the state due to the COVID-19 pandemic response. Under this interim guidance, if the supply of N95 respirators or PAPRs are insufficient to meet current or anticipated needs, surgical masks may be used for low-hazard patient contacts that would otherwise require the use of respirators, and respirators may be used for high-hazard procedures that would otherwise require the use of PAPRs.

OSHA Infectious Disease Standard Rulemaking

In 2010, OSHA published a Request for Information in the Federal Register seeking public comments on strategies to control exposure to infectious diseases in healthcare workplaces. After collecting public comments and holding public meetings, OSHA completed the SBREFA process in 2014. Since then, however, no public actions have occurred on this rulemaking; since spring 2017, this rulemaking has been listed as a "long-term action" in DOL's semiannual regulatory agenda.

Congressional Activity to Require an OSHA Emergency Temporary Standard onÂ COVID-19

On March 5, 2020, Representative Scott, chairman of the House Committee on Education and Labor, and Representative Adams, chair of the Subcommittee on Workforce Protections, sent a letter to Secretary of Labor Eugene Scalia calling on OSHA to promulgate an ETS to address COVID-19 exposure among healthcare workers. This letter followed a January 2020 letter requesting that OSHA reopen its rulemaking on the infectious disease standard and begin to formulate for possible future promulgation an ETS to address COVID-19 exposure. Senator Patty Murray, ranking member of the Senate Committee on Health, Education, Labor, and Pensions and a group of Democratic Senators sent a similar letter to the Secretary of Labor calling for an OSHA ETS.

In addition, in March 2020, David Michaels, who served as the Assistant Secretary of Labor for Occupational Safety and Health during the Obama Administration, wrote an op-ed in The Atlantic calling on OSHA to promulgate a COVID-19 ETS. On March 6, 2020, the AFL-CIO and 22 other unions petitioned OSHA for an ETS on COVID-19 that would cover all workers with potential exposures. National Nurses United submitted a similar petition requesting that OSHA promulgate an ETS based largely on the Cal/OSHA ATD standard. On May 4, 2020, the Center for Food Safety and Food Chain Workers Alliance submitted a petition requesting that OSHA promulgate an ETS to protect meat and poultry processing workers from COVID-19 exposure in the workplace. On May 18, 2020, the AFL-CIO petitioned the U.S. Court of Appeals for the D.C. Circuit for a writ of mandamus to compel OSHA to promulgate a COVID-19 ETS.

H.R. 6139, the COVID-19 Health Care Worker Protection Act ofÂ 2020

On March 9, 2020, Representative Scott introduced H.R. 6139 , the COVID-19 Health Care Worker Protection Act of 2020. This bill would require OSHA to promulgate a COVID-19 ETS within one month of enactment. The ETS would be required to cover healthcare workers and any workers in sectors determined by the CDC or OSHA to be at an elevated risk of COVID-19 exposure. The ETS would be required to include an exposure control plan provision and be, at a minimum, based on CDC's 2007 guidance and any updates to this guidance. The ETS would also be required to provide no less protection than any state standard on novel pathogens, thus requiring OSHA to include the elements of the Cal/OSHA ATD standard in this ETS. Title II of the bill would provide that hospitals and skilled nursing facilities that receive Medicare funding and that are owned by state or local government units and not subject to state plans would be required to comply with the ETS.

P.L. 116-127, the Families First Coronavirus Response Act

The provisions of H.R. 6139 were included as Division C of H.R. 6201 , the Families First Coronavirus Response Act, as introduced in the House. The American Hospital Association (AHA) issued an alert to its members expressing its opposition to the OSHA ETS provisions in the bill. Specifically, the AHA opposed the requirement that the ETS be based on the CDC's 2007 guidance. The AHA stated that unlike severe acute respiratory syndrome (SARS), which was transmitted through the air, COVID-19 transmission is through droplets and surface contacts. Thus, the requirement of the 2007 CDC guidance that N95 respirators, rather than surgical masks, be used for patient contact is not necessary to protect healthcare workers from COVID-19, and the use of surgical masks is consistent with World Health Organization guidance. The AHA also claimed that shortages of available respirators could reduce the capacity of hospitals to treat COVID-19 patients, due to a lack of respirators for staff. The OSHA ETS provisions were not included in the version of the legislation that was passed by the House and the Senate and signed into law as P.L. 116-127 .

H.R. 6379, the Take Responsibility for Workers and Families Act

Division D of H.R. 6379 , the Take Responsibility for Workers and Families Act, as introduced in the House on March 23, 2020, includes the requirement that OSHA promulgate an ETS on COVID-19 within seven days of enactment and a permanent COVID-19 standard within 24 months of enactment to cover healthcare workers, firefighters and emergency response workers, and workers in other occupations that CDC or OSHA determines to have an elevated risk of COVID-19 exposure. Division D of H.R. 6379 would amend the OSH Act, for the purposes of the ETS only, such that state and local government employers in states without state plans would be covered by the ETS. The provisions of Division D of H.R. 6379 were also included in S. 3584 , the COVIDâ19 Workers First Protection Act of 2020, as introduced in the Senate.

This legislation would specifically provide that the ETS would remain in force until the permanent standard is promulgated and explicitly exempts the ETS from the Regulatory Flexibility Act, Paperwork Reduction Act, and Executive Order 12866. OSHA would be granted enforcement discretion in cases in which it is not feasible for an employer to fully comply with the ETS (such as a case in which PPE is unavailable) if the employer is exercising due diligence to comply and implementing alternative means to protect employees.

Like the provisions in H.R. 6139 and the version of H.R. 6201 introduced in the House, this ETS and permanent standard would be required to include an exposure control plan and provide no less protection than any state standard on novel pathogens, thus requiring OSHA to include the elements of the Cal/OSHA ATD standard in this ETS and permanent standard. Although the ETS provisions in H.R. 6139 and H.R. 6201 required that the ETS be based on the 2007 CDC guidance, specific reference to the 2007 guidance is not included in this legislation. Rather, the ETS and permanent standard would have to incorporate, as appropriate, "guidelines issued by the Centers for Disease Control and Prevention, and the National Institute for Occupational Safety and Health, which are designed to prevent the transmission of infectious agents in healthcare settings" and scientific research on novel pathogens.

States with occupational safety and health plans would be required to adopt the ETS, or their own ETSs at least as effective as the ETS, within 14 days of the legislation's enactment.

H.R. 6559, the COVID-19 Every Worker Protection Act of 2020

H.R. 6559 , the COVID-19 Every Worker Protection Act of 2020, was introduced in the House by Representative Scott on April 21, 2020. This legislation includes the ETS and permanent standard provisions of Division D of H.R. 6379 and S. 3584 and would require that these standards cover healthcare workers, emergency medical responders, and "other employees at occupational risk" of COVID-19 exposure. This legislation also adds two provisions that clarify the requirements for employers to record work-related COVID-19 infections and strengthen the protections against retaliation and discrimination offered to whistleblowers.

Sections 8(c) and 24(a) of the OSH Act require employers to maintain records of occupational injuries and illnesses in accordance with OSHA regulations. OSHA's reporting and recordkeeping regulations require that employers with 10 or more employees must keep records of work-related injuries and illnesses that result in lost work time for employees or that require medical care beyond first aid. Employers must also report to OSHA, within 8 hours, any workplace fatality, and within 24 hours, any injury or illness that results in in-patient hospitalization, amputation, or loss of an eye. Employers in certain industries determined by OSHA to have lower occupational safety and health hazards are listed in the regulations as being exempt from the recordkeeping requirements but not the requirement to report serious injuries, illnesses, and deaths to OSHA. Offices of physicians, dentists, other health practitioners, and outpatient medical clinics are included in the industries that are exempt from the recordkeeping requirements.

OSHA regulations require the employer to determine if an employee's injury or illness is related to his or her work and thus subject to the recordkeeping requirements. The regulations provide a presumption that an injury or illness that occurs in the workplace is work-related and recordable, unless one of the exemptions provided in the regulations applies. One of the listed exemptions is as follows:

The illness is the common cold or flu (Note: contagious diseases such as tuberculosis, brucellosis, hepatitis A, or plague are considered work-related if the employee is infected at work).

Because of the nature of COVID-19 transmission, which can occur in the community as well as the workplace, it can be difficult to determine the exact source of any person's COVID-19 transmission. This may make it difficult for employers to determine if an employee's COVID-19 is subject to the recordkeeping requirements.

On April 10, 2020, OSHA issued enforcement guidance on how cases of COVID-19 should be treated under the recordkeeping requirements. This guidance states that COVID-19 cases are recordable if they are work-related.

Under this guidance, employers in the following industry groups must fully comply with the recordkeeping regulations, including the requirement to determine if COVID-19 cases are work-related:

healthcare; emergency response, including firefighting, emergency medical services, and law enforcement; and correctional institutions.

For all other employers, however, OSHA will only require employers to determine if COVID-19 cases are work-related and subject to the recordkeeping requirements if the following two conditions are met:

1. There is objective evidence that a COVID-19 case may be work-related. This could include, for example, a number of cases developing among workers who work closely together without an alternative explanation; and 2. The evidence of work-relatedness was reasonably available to the employer. For purposes of this guidance, examples of reasonably available evidence include information given to the employer by employees, as well as information that an employer learns regarding its employees' health and safety in the ordinary course of managing its business and employees.

H.R. 6559 would require that the ETS and permanent standard established pursuant to the legislation include the requirement for the recording and reporting of all COVID-19 cases in accordance with OSHA regulations in place at the time of enactment. By referencing the regulations in place rather than the guidance, this provision would serve to supersede OSHA's guidance and apply the requirement to determine the work-relatedness of COVID-19 cases to all employers covered by the recordkeeping regulations.

Section 11(c) of the OSH Act prohibits any person from retaliating or discriminating against any employee who exercises certain rights provided by the OSH Act. Commonly referred to as the whistleblower protection provision, this provision protects any employee who takes any of the following actions:

files a complaint with OSHA related to a violation of the OSH Act; causes an OSHA proceeding, such as an investigation, to be instituted; testifies or is about to testify in any OSHA proceeding; and exercises on his or her own behalf, or on behalf of others, any other rights afforded by the OSH Act.

Other rights afforded by the OSH Act that are covered by the whistleblower protection provision include the right to inform the employer about unsafe work conditions; the right to access material safety data sheets or other information required to be made available by the employer; and the right to report a work-related injury, illness, or death to OSHA. In limited cases, the employee has the right to refuse to work if conditions reasonably present a risk of serious injury or death and there is not sufficient time to eliminate the danger through other means.

H.R. 6559 would require that the ETS and permanent standard promulgated pursuant to the legislation expand the protections for whistleblowers. The following additional activities taken by employees would grant them protection from retaliation and discrimination from employers and agents of employers:

reporting to the employer; a local, state, or federal agency; or the media; or on a social media platform; the following: a violation of the ETS or permanent standard promulgated pursuant to the legislation; a violation of the infectious disease control plan required by the ETS or permanent standard; or a good-faith concern about an infectious disease hazard in the workplace; seeking assistance from the employer or a local, state, or federal agency with such a report; and using personally supplied PPE with a higher level of protection than offered by the employer.

H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act)

The provisions of H.R. 6559 , including the provisions relating to recordkeeping and whistleblower protections, were included as Title III of Division L of H.R. 6800 , the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act). H.R. 6800 was passed by the House on May 1 5, 2020.