3.248.  The United States has numerous laws and regulations pertaining to food safety, animal health, and plant health. Major, and long-standing, pieces of SPS legislation include the Federal Food, Drug and Cosmetic Act (FFDCA), the Federal Meat Inspection Act, the Poultry Products Inspection Act, the Egg Products Inspection Act, the Plant Protection Act, the Animal Health Protection Act, and the Federal Insecticide, Fungicide, and the Rodenticide Act.[448] Since the promulgation of the FDA Food Safety Modernization Act (FSMA) in 2011, the United States has not made a comparable large-scale update to its SPS legislation. However, some changes took place during the review period in relation with implementing regulations which accompany this overall regulatory framework (see below)

3.249.  According to the product and the type of risk inherent to products, responsibilities for the development, implementation, and enforcement of SPS measures are split among federal agencies.[449] In general, SPS measures are subject to the same administrative rulemaking procedures as technical regulations (see above). FDA is responsible for the regulation of a broad range of products, including food (except food products regulated by the Department of Agriculture); food additives; dietary supplements; human and veterinary drugs; medical devices; human biologics; tobacco; and cosmetics, including imported goods.[450] FSIS within the Department of Agriculture (USDA) is responsible for ensuring a safe, wholesome, and correctly labelled and packaged commercial supply of meat, poultry, Siluriformes fish and fish products (catfish), and some egg products in the United States, including imported goods.[451] The Animal and Plant Health Inspection Service (APHIS) at USDA protects the health of U.S. agriculture and natural resources against invasive pests and diseases, and regulates genetically engineered crops while promoting exports of U.S. plant and animal products.[452] In cases where requirements by APHIS and FSIS simultaneously apply to imported goods, APHIS evaluates the animal and plant health risks while FSIS ensures the enforcement of food safety requirements. The responsibilities of EPA include, inter alia, the registration of pesticides, including herbicides and fungicides, and the establishment of tolerances (maximum residue limits (MRLs)) for pesticides in food.[453]

3.250.  Other agencies involved in SPS issues include the Agricultural Marketing Service, the Agricultural Research Service, and the National Institute of Food and Agriculture in the Department of Agriculture, the Centers for Disease Control and Prevention in the Department of Health and Human Services, the National Oceanic and Atmospheric Administration in the Department of Commerce, CBP in the Department of Homeland Security, and the Alcohol and Tobacco Tax and Trade Bureau in the Department of the Treasury

3.251.  Agencies have jurisdiction over imported products at the time of entry and after the products have entered the country. When a food does not meet FDA food safety requirements, such as when the food contains organisms of public health significance, foreign objects, or a major food allergen, firms may recall products[454]; on average, some 1,000 recalls of FDA‑regulated products have been conducted every year since 2018. Of these recalls, 248 were related to imported human food and animal feed.[455] Since July 2018, the FDA has reported nearly 45,000 import refusals at the border.[456] In case of a refusal, the owner or consignee is entitled to an informal hearing regarding the admissibility of the product and can submit a plan to bring the product into compliance. A non‑compliant product must be re-exported or destroyed within 90 days of FDA's notice of intent to refuse the goods. Similarly, whenever a health hazard situation with a reasonable probability that the use of the product will cause serious, adverse health consequences or death arises, FSIS recommends the voluntary recall of the product.[457] From January 2018 to January 2022, there were 330 recalls, and 38 recalls involved imported meat, poultry, or egg products. Compared to the period 2015‑19, there were fewer recalls in 2020 and 2021; factors including societal disruptions and consumer behavior during the pandemic, explain this decrease

3.252.  Regarding the enforcement of APHIS regulations, CBP plays a key role at U.S. ports of entry and its staff inspects shipments of imported agricultural products to certify that the required animal or plant health import permits and SPS documentation accompany each shipment. In 2020, CBP reported the daily discovery of 250 pests and 3,091 materials (plant, meat, animal by‑product, or soil) for quarantine at U.S. ports of entry.[458] To meet increased requirements, the Protecting America's Food and Agriculture Act of 2019, P.L. 116-122, authorized CBP to recruit 240 additional agriculture specialists above the current level (2,600 specialists in March 2020); these specialists conduct the SPS-related inspections on imports at the 328 ports of entry covered by CBP

3.253.  EPA establishes tolerances for each crop's use of pesticides and notifies its Notices of Filings (NOF) in the Federal Register.[459] The tolerances for meat, poultry, and certain egg products are enforced by USDA, while FDA enforces them for other foods. The application fees for the registration of pesticides rose by 5% in 2020 and will increase by an additional 5% in 2022 as instructed by the Pesticide Registration Improvement Extension Act of 2018

3.254.  Equivalence determinations of an exporting country's regulatory food safety inspection system for products regulated by FSIS are a prerequisite for trade with the United States. The only FDA‑regulated food products requiring an assessment as a precondition to import into the United States are Grade A dairy products and raw bivalve molluscan shellfish. On 24 September 2020, FDA announced its first-ever equivalence determination, which recognizes the control systems of Spain and the Netherlands on raw bivalve molluscan shellfish as equivalent to the U.S. National Shellfish Sanitation Program.[460] Imports from Spanish and Dutch establishments listed by FDA on the Interstate Certified Shellfish Shippers List are now allowed. FSIS has also determined equivalent certified and approved producers in 34 countries and the product scope of these equivalences varies from country to country. Following a regulatory change in 2019, a single list of eligible foreign countries to import FSIS-regulated goods is kept on the FSIS website.[461] During the review period, FSIS notified the adoption of seven equivalence determinations on poultry products, Siluriformes fish and fish products, and egg products. FDA has also concluded Systems Recognition Arrangements with food safety agencies in three trading partners. The authorities indicate that these arrangements do not constitute trade‑facilitating measures and that they are not the same as equivalence determinations.[462]

3.255.  The FSMA requires that U.S. importers develop a Foreign Supplier Verification Programs (FSVP) for each type of human and animal food product and each foreign supplier they import to confirm that the imported good complies with FDA requirements, has the same level of public health protection as in the United States, including preventive controls, produce safety regulations, and controls against adulteration or misbranding. On 10 May 2021, FDA launched the FSVP Importer Portal for FSVP Records Submission as a means for importers to upload FSVP records electronically to FDA.[463] More specifically, the FSVP rule requires importers to perform risk-based foreign supplier verification activities to verify that: (i) the food is produced in a manner that provides the same level of public health protection concerning hazard analysis and risk-based preventive controls, or standards for the safe production and harvesting of certain fruits and vegetables than U.S.‑produced food; (ii) the food is not adulterated; and (iii) the human food is not misbranded (concerning food allergen labelling). Moreover, U.S. importers may request to participate in the Voluntary Qualified Importer Program (VQIP), an expedited review and entry program for food. Four U.S. importers are approved to participate in VQIP for fiscal year 2022 (1 October 2021‑30 September 2022).[464]

3.256.  On 1 August 2018, new U.S. standards for barley under the U.S. Grain Standards Act entered into force.[465] In June 2019, APHIS issued a final rule clarifying and further detailing the criteria to be used when assessing risks related to plant pests for the importation, interstate movement, and release of biological control organisms.[466] On 18 May 2020, APHIS made public the first comprehensive revision of regulations on genetically engineered organisms since 1987 to facilitate the development of genetically engineered organisms that are unlikely to pose plant pest risks.[467] On 17 September 2020, the regulations governing the importation of cattle and bison in regards to bovine tuberculosis and brucellosis were amended.[468] In December 2020, FDA issued a final regulation for accreditation of laboratories that perform food testing. When fully implemented, laboratory analysis of food for import purposes or when subject to food testing orders will be required to be performed by accredited laboratories.[469] In April 2021, label requirements for allergens in food products were extended to sesame (P.L. 117-11)

3.257.  In line with the 2018 Agriculture Improvement Act, P.L. 115-334 (also known as the 2018 Farm Bill), APHIS maintains a list of animal and plant diseases and pests of concern posing a significant risk to U.S. food and agriculture resources and developed emergency response plans for these diseases and pests.[470] This list is in addition to other disease, pest, or health statuses lists kept by APHIS's Plant Protection and Quarantine (PPQ) and Veterinary Services (VS) for specific purposes, such as the U.S. Regulated Plant Pest List, the National List of Reportable Animal Diseases, or lists of APHIS‑recognized animal health statuses of regions

3.258.  In July 2020, FDA outlined the steps to create a more digital, traceable, and safer human and animal food system over the next decade. Through tech-enabled technology, smarter tools, and approaches for prevention and outbreak response, and an adaptation to new emerging business models and retail modernization, FDA seeks to keep promoting a food safety culture. Other agencies have also embraced the modernization of their systems, policies, and approaches in their respective strategic plans.[471]

3.259.  In March 2020, APHIS launched the Veterinary Services Permitting Assistant (VSPA), a search tool designed to guide applicants in determining their import requirements for animal products.[472] Since September 2021, VSPA covers requirements on live animals and it is expected that in the future, all permits will be processed only through APHIS eFile, a more comprehensive platform replacing the previous APHIS ePermit platform. Since 2018, APHIS has contributed to and supported the development and launch of the International Plant Protection Convention (IPPC) global ePhyto system and started exchanging electronic phytosanitary certificates. Currently, 30 trading partners send ePhyto certificates to APHIS while 59 trading partners receive ePhyto certificates issued by APHIS.[473] To facilitate clearance of imported plants and plant products during the COVID‑19 emergency, APHIS and CBP have accepted digital phytosanitary certificates including since March 2020.[474] This measure was extended until through 31 March 2022

3.260.  In September 2020, FDA launched a renewed Food Safety Partnership with its Mexican counterparts, i.e. the National Service of Agro-Alimentary Health, Safety and Quality (SENASICA) and the Federal Commission for Protection against Sanitary Risk (COFEPRIS), which builds upon a pre‑existing partnership on fresh produce safety established in 2014 and extends the scope of covered products to all human foods.[475] In this framework, authorities aim at enabling core elements of tech‑enabled traceability and increasing data sharing to improve cross-border responses to outbreaks of foodborne illnesses

3.261.  The Multilateral Affairs Division at USDA's Foreign Agricultural Service serves as the national enquiry point and notification authority under the WTO SPS Agreement.[476] The U.S. Codex Office, housed in USDA's Trade and Foreign Agricultural Affairs, coordinates the U.S. representation at the Codex Alimentarius Commission[477], while APHIS is the contact point for the World Organisation for Animal Health (OIE) and the International Plant Protection Convention (IPPC)

3.262.  During the period July 2018‑March 2022, the United States submitted 365 SPS notifications to the WTO (including 6 corrigenda to earlier notifications) and 65 emergency notifications (including 50 addenda to earlier notifications). The main objective or rationale for notifications remain food safety (80.0%) and plant protection (14.5%).[478] One of every seven notifications (14%) indicates a related international standard or guideline[479]; however, harmonization with international standards is not always reported, as was the case for example of 2021 EPA regulations related to the Codex Alimentarius Commission.[480]

3.263.  During the period under review, three new specific trade concerns (STCs) were raised in the WTO SPS Committee relating to measures maintained by the United States.[481] In addition, three previously raised concerns continued to be discussed in the SPS Committee; one of them raised by the European Union concerning beef exports was reported as partially resolved.[482] During the same period, the United States used the SPS Committee to raise or support 20 new STCs regarding measures maintained by other Members. In February 2018, the SPS Agreement was cited in a request for consultation concerning U.S. measures on pangasius seafood products.[483] The United States takes part as a third party of two dispute settlement proceedings with reference to the SPS Agreement initiated during the review period.[484]

3.228.  In the United States, the private sector leads the development of voluntary consensus standards (VCS), which are based on needs or concerns identified by industry, government, and consumers.[424] The American National Standards Institute (ANSI), a private non‑profit organization, has a central role in coordinating the private sector in this demand-driven system, but does not develop standards. This responsibility is entrusted to the hundreds of standards developing organizations (SDOs) located within the United States. The United States considers any VCS developed in accordance with the Committee Decision on International Standards[425] to be an international standard under the WTO TBT Agreement regardless of the specific SDO or its location. The ANSI Essential Requirements: Due Process Requirements for American National Standards (Essential Requirements) serve as guidelines to develop VCSs and include principles for openness, balance, lack of dominance, due process, consensus, and the right to appeal. The procedural requirements outlined in the Essential Requirements align closely with the criteria for VCS outlined in the Office of Management and Budget (OMB) Circular A-119 (discussed below) and also with the principles outlined in the Committee Decision on International Standards. Moreover, ANSI was also in charge of the process of reviewing and updating the U.S. Standards Strategy, whose fifth update was completed in December 2020 with the participation of all stakeholders

3.229.  The National Institute of Standards and Technology (NIST), within USDOC, aims to promote U.S. innovation and industrial competitiveness by advancing measurement science, standards, and technology. The Standards Coordination Office (SCO) at NIST serves as the WTO TBT Enquiry Point and is the notification authority of the United States under the WTO TBT Agreement.[426] The SCO manages and operates Notify U.S., a free, web-based email registration service, disseminating notifications of other WTO Members to domestic stakeholders and providing them with an opportunity to review and comment on foreign regulations. Comments and queries on notified proposed U.S. measures are forwarded by the TBT Enquiry Point to the relevant U.S. regulatory agency upon receipt. Under the National Technology Transfer and Advancement Act (NTTAA), NIST coordinates government conformity assessment activities with the private sector to reduce unnecessary duplication and complexity.[427] NIST maintains a reference collection of technical regulations, specifications, test methods, codes, and recommended practices, and produces the U.S. Standard Reference Data (SRD).[428]

3.230.  SDOs that adhere to the Essential Requirements may be accredited by ANSI to develop American National Standards (ANS) related to products, processes, services, systems, or personnel. In March 2022, there were 237 ANSI-accredited standard developers (ASDs)[429]; 18 organizations became ASDs during the review period. By the same date, ANSI listed more than 13,600 standards developed by ASDs[430], of which 1,075 new standards were issued between July 2018 and March 2022. In addition to the thousands of VCS developed by SDOs, consortia standards also help to fill the need for standards used by industry, especially in technology areas where a more rapid development pace is needed to meet market needs

3.231.  In the United States, technical regulations can be established at the federal or sub-federal level, and rely heavily on VCS developed by the private sector making them mandatory by reference; technical regulations cover mostly products but can also concern processes or services. While Congress can establish product regulations legislatively, it usually delegates enabling legislation to regulatory agencies, generally pursuant to broad guidance as to the factors to be considered and policy goals to be achieved. The majority of rulemaking involves three steps: issuance of a notice of proposed rulemaking soliciting public comment, agency consideration of all relevant information, and the issuance of a final rule after consideration of the relevant information. Executive Order (E.O.) 13563 requires the use of the Internet for the consultation procedure and the publication of rules to the extent possible and establishes a 60-day period for consultations. Any interested person can submit petitions for reconsideration after final rules have been issued. All final rules may be judicially reviewed. All regulations issued by agencies as final rules are subject to Congressional review under the Congressional Review Act (CRA)

3.232.  Title IV of the Trade Agreements Act (TAA) of 1979 (P.L. 96-39), as amended, provides the legal basis on which the WTO TBT Agreement and the SPS Agreement are implemented. In addition to enabling legislation, various other requirements govern the development and issuance of technical regulations by the Federal Government, including other statutes and Presidential E.O.s that impose procedural requirements intended to ensure reasoned and fair decision-making, as well as Circulars from the OMB. Consequently, the legal framework for the preparation of technical regulations and adoption of standards is also prescribed by the Administrative Procedure Act (APA) (P.L. 79‑404), the National Technology Transfer and Advancement Act (NTTAA) (P.L. 104‑113), U.S. Office of Management and Budget Circular A-119, and E.O.s 12866 (Regulatory Planning and Review), 13563 (Improving Regulation and Regulatory Review)[431], 13609 (Promoting International Regulatory Cooperation), and 13610 (Identifying and Reducing Regulatory Burdens). E.O. 13771 (Reducing Regulation and Controlling Regulatory Costs) and E.O. 13777 (Enforcing the Regulatory Reform Agenda) were revoked by E.O. 13992 (Revocation of Certain Executive Orders Concerning Federal Regulation), issued on 20 January 2021

3.233.  OMB's Office of Information and Regulatory Affairs (OIRA) is responsible for regulatory oversight and leads interagency review of significant regulation pursuant to E.O. 12866.[432] The agency or agencies responsible for developing technical regulations depend on the product in question. Agencies may adopt technical regulations only after thoroughly analyzing their potential impact, typically by means of an assessment and comparison of either the benefits and costs or the cost-effectiveness of alternative regulatory approaches. OIRA keeps an updated repository of ongoing reviews and those completed since 1981. Final rules are published in the Federal Register and codified in the Code of Federal Regulations; a unified agenda for regulatory and deregulatory actions is also available on OIRA's website.[433] A memorandum, issued on 20 January 2021, initiated consultations to improve and modernize the regulatory review.[434]

3.234.  E.O. 13609 aims at promoting international regulatory cooperation between the United States and its foreign trading partners to avoid unnecessary impediments for U.S. businesses to export and compete internationally. While USTR has statutory authority in the area of trade policy, the Interagency Regulatory Working Group serves, where appropriate, as a forum to discuss international regulatory cooperation activities in which the United States is engaged such as in the Asia‑Pacific Economic Cooperation (APEC), the U.S.-Canada Regulatory Cooperation Council, the OECD Regulatory Policy Committee, and other bilateral and regional engagements

3.235.  The TAA restricts government agencies from engaging in any standards-related activity that creates unnecessary obstacles to the foreign commerce of the United States and ensures that imported goods are treated no less favorably than like domestic products in the application of standards-related activities. The NTTAA directs federal agencies and departments to use VCS, both domestic and international, in lieu of government-developed requirements in regulations, to meet their objectives and reaffirms principles already expressed in Circular A-119. The NTTAA further directs the agencies to participate in the development of such standards to ensure that VCSs reflect government needs and to reduce government reliance on government‑unique standards. To keep track of the use of government-unique standards used in technical regulations, the NIST publishes an annual report based on developments provided by 22 agencies for the fiscal year 2019.[435] Circular A-119 also encourages federal agencies, in line with their missions, to participate in SDOs

3.236.  Agencies are not required to rely only on VCSs available free of cost for their rules; however, a principle of "reasonable availability" of the information is applied.[436] Federal agencies are also required, when developing technical regulations, to take into account international standards and, if appropriate, base their regulations on those international standards. Title IV of the TAA of 1979 as amended (19 U.S.C. 2531) provides that the reasons for which it may not be appropriate to base a U.S. technical regulation on an international standard include, but are not limited to, the protection of human health or safety, animal or plant life or health, or the environment

3.237.  The Internet of Things (IoT) Cybersecurity Improvement Act of 2020, P.L. 116-207, enacted in December 2020, required NIST and the OMB to take steps to increase the cybersecurity of IoT devices. NIST subsequently developed a series of guidelines, through an open comment and review process, for the use and management of IoT devices by federal agencies.[437]

3.238.  In March 2020, the FDA issued a final rule for new health warnings on cigarette packages and advertisements to increase public awareness of lesser-known, but serious negative health consequences of cigarette smoking.[438]

3.239.  Since the beginning of the pandemic, numerous Emergency Use Authorizations (EUAs) were issued by the FDA under Section 564 of the Federal Food, Drug, and Cosmetic Act (21 USC, Chapter 9), covering more than 400 test and sample collection devices, 119 ventilators and accessories, 11 COVID‑19 treatments, and 3 vaccines. In 2021, more than 600 drug development programs were in the planning stages, a new guidance for conducting clinical trials was issued to facilitate the response to COVID‑19, and in addition, the FDA dealt with some numerous reports of fraudulent products related to COVID‑19

3.240.  The U.S. conformity assessment system utilizes a variety of mechanisms depending on the product and assessed risk. Standards and technical regulations that rely on supplier's self‑declaration are also supported, to a large extent, through product-liability laws. It is generally the responsibility of the supplier (producer or importer) to ensure compliance with existing technical regulations or with standards when such compliance is required by the purchaser. In the case of imports, it is primarily the responsibility of importers representing foreign manufacturers to meet technical regulations and to ensure that permits, if required, have been obtained in advance of the goods arriving in the United States. For some products, a declaration or proof of conformity or compliance must be submitted by the manufacturer or the importer upon or prior to importation

3.241.  When assessment of conformity to a technical regulation is required, it may be done by the Federal Government, state or local governments, or an independent testing authority where the Government gives official recognition through accreditation or similar measures. CBP, in cooperation with other agencies responsible for regulated products, such as the Consumer Product Safety Commission (CPSC), is responsible for enforcing technical regulations at the border, and taking enforcement actions when such regulations are violated, including refusing admission. The CPSC has jurisdiction over many types of consumer products. However, some types of consumer products are covered by other federal agencies. For example, automobiles, trucks, and motorcycles are within the jurisdiction of the Department of Transportation (DOT); food, drugs, and cosmetics are covered by the Food and Drug Administration (FDA); pesticides and fungicides are monitored by the Environmental Protection Agency (EPA); boats by the U.S. Coast Guard; and chemicals by the U.S. Chemical Safety and Hazard Investigation Board (CSB).[439] Assessment of conformity with SPS requirements, especially for plants and animal products, is generally carried out by APHIS and Food Safety and Inspection Service (FSIS) inspectors located at the borders. The CPSC also controls labelling requirements, such as those of the Federal Hazardous Substances Act (FHSA), which requires precautionary labelling on the immediate container of hazardous household products

3.242.  Accreditation procedures of conformity assessment bodies (CABs) vary depending on each standard or technical regulation following a risk-based approach. U.S. requirements generally follow the standards issued by the Committee on Conformity Assessment at the International Organization for Standardization (ISO CASCO)

3.243.  Between July 2018 and March 2022, the United States submitted 1,290 TBT notifications concerning proposed and final measures to the WTO. More than 300 notifications were submitted the last two years: 370 in 2020 and 393 in 2021. TBT notifications per year were only higher in 2016.[440] During the review period, the notifications covered both federal- and state‑level regulations; 113 notifications covered the latter. More than half (53.4%) of all notifications were amendments to previous notifications, while 36.3% of all notifications were regular ones; only 20 urgent notifications were submitted since July 2018, accounting for 1.6% of all notifications

3.244.  Overall, 980 notifications (76.0%) relate to technical regulations (out of which 110 at the state level) and 255 notifications (19.8%) relate to conformity assessment procedures (out of which 28 at the state level). An increasing number of notifications, 18.4% of all notifications during the period under review, simultaneously refer to technical regulations and conformity assessment procedures. Moreover, an increasing proportion of notifications (19.1% over the review period, or 246 notifications) does not specify its relationship with a specific article of the TBT Agreement.[441] Based on standardization fields reported in the notifications following the International Classification of Standards (ICS), at least two ICS fields are mentioned in 70.9% of up from 51.9% in the previous review period.[442] At the same time, regulations aimed at attaining several objectives also increased, from 15.6% to 48.8%. The most frequent objectives are the protection of the environment (49.3%), the protection of human health or safety (38.4%), the prevention of deceptive practices and consumer protection (26.0%), and consumer information and labelling (16.3%)

3.245.  During the review period, 12 specific trade concerns (STCs) relating to measures maintained by the United States were raised in the TBT Committee; 1 STC raised before the review period was reiterated since July 2018. The United States actively participates in the TBT Committee and has raised or supported 82 new STCs against its trade partners. There is a dispute against U.S. measures concerning the origin marking requirement applicable to goods produced in Hong Kong, China.[443] The United States is participating as a third party in two disputes with reference to the TBT Agreement.[444]

3.246.  ANSI represents the United States at ISO and, through its U.S. National Committee, it coordinates the U.S. engagement in the International Electrotechnical Commission (IEC). The Department of State, the Department of Commerce, and the Federal Communications Commission are the U.S. representatives at the International Telecommunication Union (ITU). Moreover, the United States is a member of the International Maritime Organization (IMO), and the International Civil Aviation Organization (ICAO), participating in the respective standards development activities of these organizations. The United States also participates in other regional organizations and fora related to standards.[445] In addition, most of the bilateral FTAs that the United States has concluded incorporate provisions reaffirming the adherence to obligations under the TBT Agreement, as well as decisions and recommendations adopted by the TBT Committee (e.g. Chapter 11 of the USMCA)

3.247.  The United States has concluded mutual recognition agreements (MRAs) covering different sectors with numerous foreign partners, including two MRAs with the United Kingdom in 2021. MRA implementation varies for each partner, even within a common or regional arrangement, regarding the recognition level of CABs[446] and the product coverage. In the area of telecommunications equipment, MRAs are implemented with some APEC members (Australia; Canada; Chinese Taipei; Hong Kong, China; the Republic of Korea; Malaysia; New Zealand; Singapore; and Viet Nam), the European Union, some EFTA States (Norway, Iceland, and Liechtenstein), and other trading partners (Israel, Japan, Mexico, and the United Kingdom). MRA signatories designate their accredited CABs to the Federal Communication Commission (FCC) while the NIST, through its Telecom MRA Program Office, serves as the designated authority for U.S. CABs.[447] The MRA with the EFTA States also covers recreational craft, while the MRA with the European Union extends to electrical safety, recreational craft, medical devices, and pharmaceutical Good Manufacturing Practices (GMPs). The coverage of this latter sector in the U.S.‑EU MRA was amended in 2017. Pharmaceutical GMPs are also part of the recent MRA with the United Kingdom. The United States has also signed separate MRAs with the European Union, EFTA, and the United Kingdom for marine safety equipment