United States
Chemicals
Regulatory Agencies: the Environmental Protection Agency (EPA); the Department of Labor's (DOL), Occupational Safety and Health Administration (OSHA). They are Federal Government Agencies.
EPA: In order to control local pollution, some states have enacted controls on use of certain chemicals (e.g., solvent use in California which have had a significant impact on solvent and other chemical use in paints and coatings) that have had national impact.
OSHA: State governments that operate their own workplace safety and health programs are required to have programs that are at least as effective as the Federal OSHA program. In 1987, OSHA issued its mandatory Hazard Communication Standard (HCS) (29 CFR 1910.1200). The primary purpose of the HCS is to ensure that all chemicals are evaluated to determine their hazards and that information concerning toxic substances used in the workplace is passed on to employees. Under the HCS, chemical importers are required to provide employers with Material Safety Data Sheets (MSDSs) and labels for each hazardous chemical. OSHA has established requirements for information that should be contained on labels and MSDSs, but has not specified a format. Therefore, importers could employ the format used to develop labels and MSDSs in their country, so long as the label and MSDSs contain the information required by OSHA. OSHA has played an active role in the negotiations for harmonization of chemical hazard communication requirements between different countries, in an effort to facilitate trade.
Information Technology
Regulatory Agency: the Federal Communications Commission (FCC).
As far as video-display terminals (VDTs) are concerned, there are no federal government technical regulations but state level requirements do exist. Additionally, public sector unions at federal, state, and local levels have negotiated regulations as have some private unions.
The FCC's standards limiting radio noise generated by information technology equipment (ITE) are very similar to those contained in CISPR Pub.22. (CISPR is the International Special Committee on Radio Interference, and operates as a special committee in the IEC). In addition, the FCC recently agreed to accept measurements on ITE showing compliance with either the existing FCC specifications or the CISPR Pub. 22 specifications, with some minor additions. Thus, equipment that is tested for compliance with CISPR (which is the basis for the European EMC requirements and is used elsewhere in the world as well) can be tested once to show compliance with EMC requirements. The FCC does not accept any other standards; however acceptance of the CISPR standard also means acceptance of the EC standard.
Most ITE is subject to supplier's declaration of conformity (at the FCC, it is called verification). However, personal computers and personal computer peripherals are subject to FCC certification. While FCC certifications are based on testing done by laboratories throughout the world, only the FCC is able at this time to issue certification. Certification requirements are not waived. In addition, ITE that attaches to the telephone lines are also subject to testing and FCC authorization under the "registration" program, which is intended to protect the telephone network from harm.
Building
Regulatory Agency: U.S. Department of Housing and Urban Development (HUD)'s Federal Housing Administration (FHA). Regulatory requirements for building are very localized in the United States. Local regulations are based on the model building codes. Some of the model building codes are internationally recognized. The BOCA (Building Official and Code Administrators) Building Code, for example, is accepted in Canada; the Uniform Building Code is translated into Japanese, and is used by the Army Corp of Engineers in its work in other countries.
Drugs
Regulatory Agency: the Food and Drug Administration (FDA) under the jurisdiction of Department of Health and Human Services (DHHS) -- Federal Government agency. There are no internationally recognized standards for drug approval. Most economies require some review of drug safety and efficacy prior to permitting drugs to be marketed. A few economies will waive or abbreviate this review for drugs that have been approved for market in specified economies. Efforts to harmonize the data elements to be reviewed are being undertaken in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The World Health Organization has a standard for Good Manufacturing Practices for Pharmaceuticals (quality assurance requirements), which is currently under revision.
In general the regulatory agencies do not accept standards used by other economies. In a few instances, under a bilateral agreement, inspections are conducted by a counterpart regulatory agency and a report provided to FDA. Sponsors of a drug must submit applications and completely satisfy all agency requirements prior to placing the drug on the market. Manufacturing facilities are inspected at least once every two years. There is no discretion to waive requirements, but inspections may be scheduled more frequently than every two years at the agency's discretion, based on the regulatory history of the facility. Drugs approved abroad but not marketed in the U.S. are likely to be regarded as new drugs under U.S. law. A new drug will be admitted only if the FDA has approved a New Drug Application (NDA) for it.
Medical Devices
Regulatory Agencies: the Food and Drug Administration (FDA), the Center for Disease Control (CDC), and the National Institute of Occupational Safety and Health (NIOSH). These three agencies are under the jurisdiction of the Department of Health and Human Services. In addition, some medical devices generate and use radio frequency energy to function (e.g. ultrasonic devices, magnetic resonance imaging devices). These devices (unless used by consumers directly) are subject to FCC radio noise requirements.
U.S. law allows states to apply to the FDA for exemptions from Federal regulatory pre-emption. Therefore, there exists potential for state requirements covering medical devices. FDA's Good Manufacturing Practices (GMP) regulations presently in effect are similar to most parts of the ISO 9001 Quality Assurance Standard. Currently proposed revisions would make the regulation fully compatible with that international standard. In general, the regulatory agencies do not accept standards used by other economies. In one instance, under a bilateral agreement, inspections are conducted by a counterpart regulatory agency and a report provided to FDA.
- Conformance Arrangements:
FDA: Manufacturers are required to register, list, and submit appropriate market entry documentation before introducing medical devices into the market. They are also required to comply with the GMP regulations.
FCC: Medical devices (unless used by consumers directly) which generate and use radio frequency energy to function that are subject to FCC radio noise requirements must be manufacturer self-certified. Consumer devices must be FCC certified.
At the present time the U.S. economy does not accept certification issued in other economies. Since 1990, however, FDA has had explicit legal authority to enter into mutual recognition agreements for medical devices regulation, especially for Good Manufacturing Practices, so this type of cooperation can be expected to expand to additional bilateral agreements.
Environment
Regulatory Agency: the Environmental Protection Agency (EPA); the Occupational Safety and Health Administration (OSHA) -- Federal Government agencies. State and local governments usually have the right to impose regulations that are more stringent than those set by the EPA and/or OSHA.
OSHA: State governments that operate their own workplace safety and health programs are required to have programs that are at least as effective as the Federal OSHA program. OSHA recently issued its Process Safety Management (PMS) regulation for highly hazardous chemicals. The major objective of PMS is to prevent unwanted releases of hazardous chemicals especially into locations that could expose employees and others to serious hazards. An effective PMS program requires a systematic approach to evaluating the whole chemical process. OSHA has also developed a regulation of Hazardous Waste Operation and Emergency Response (HAZWOPER). Employers are responsible for ensuring that they comply with both standards. Neither regulation would likely affect international trade.
EPA: In order to control local pollution, some states have enacted controls on use of certain chemicals (e.g., solvent use in California which have had a significant impact on solvent and other chemical use in paints and coatings) that have had national impact. Individual permits establish emissions or effluent limits, measurement methodologies, product registration, reporting requirements, record-keeping, on-site inspections. National regulations generally give the local permit issuing authority significant flexibility in setting permit conditions.
EPA's measurement standards are generally internationally recognized as evidenced by OIML and ISO adoption. Standards of performance, or acceptable contamination levels are often internationally recognized. Similarly, U.S. standards of performance when based on engineering capabilities may conflict with similar standards in other economies. Bi- and multi-lateral agreements codify the mutual acceptance of standards between the United States and other economies. One such agreement is the Great Lakes Agreement between the United States and Canada restricting the contamination of the Great Lakes. The London Dumping Convention is an example of a multilateral agreement restricting the amount of contamination which can be introduced into the ocean. EPA generally does not accept certification issued in other economies. However, it will accept pesticide measurement data conforming to its Good Laboratory Practice, which is essentially the same as that of the EC -- after performing laboratory audits (i.e., on a lab-by-lab basis data is accepted).
Transportation Equipment: Motor Vehicles
Regulatory Agencies: the Environmental Protection Agency (EPA). The National Highway Traffic Safety Administration (NHTSA) and the Federal Highway Administration (FHA) and the Federal Transit Administration (FTA) -- all under the jurisdiction of the Department of Transportation (DOT) (Federal Government Agencies).
In those areas not preempted by Federal Motor Vehicle Safety Standards (FMVSS), the individual states are free to regulate. Individual states may have safety standards imposing a higher level of performance than the applicable FMVSS as long as they apply only to vehicles procured for use by the state or its political subdivisions. The FMVSS are regulations that have the force of law. They often incorporate by reference, Society of Automotive Engineers (SAE) standards as well as other voluntary standards developed by organizations such as ANSI and the ISO. Each FMVSS specifies the test conditions and procedures NHTSA uses to determine compliance. Manufacturers are permitted to use any means to evaluate their products that will show they exercised "due care" in certifying compliance. While NHTSA will not judge what constitutes "due care" in advance of the actual circumstances in which a noncompliance occurs, it is possible that another country's certification of compliance with a nearly identical requirement would constitute "due care".
The Safety Act establishes a "self certification" process under which each manufacturer (or importer) is responsible for certifying that its products meet all applicable safety standards. If either the manufacturer or NHTSA determines that a vehicle or item of equipment does not comply with an applicable safety standard, the manufacturer is required to recall the product and remedy the defect free of charge. In addition, the manufacturer may be subject to civil penalties. Under the Act, the NHTSA has discretion to grant petitions for temporary exemptions from any or all FMVSS so long as the petitions meet certain statutory criteria.
DOT/NHTSA adopts and amends all standards and regulations under its authority using the rulemaking procedures of the Administrative Procedures Act (APA). A standard or regulation used by other economies could be adopted by the U.S. only after following these procedures and a final rule is issued. Manufacturers are required to certify that the vehicles they manufacture meet applicable federal and state standards.
EPA checks conformance with the standards and many states and local governments have on-going vehicle emissions inspection systems to ensure continued compliance with the standards. In order to lessen air pollution, the State of California has established more stringent motor vehicle emissions regulations than are in effect nationally and these regulations have stimulated the development of less polluting vehicles.
Transportation Equipment: Refrigerated Transportation
Regulatory Agencies: U.S. Department of Agriculture (USDA), Agricultural Marketing Service (AMS), Marketing and Transportation Division -- Federal Government agency U.S. ATP (Agreement on the International Carriage of Perishable Foodstuffs Act) certificates are recognized by the 21 countries that are contracting parties to the Agreement under reciprocal arrangement. Approved equipment requires an authorized ATP certification plate and distinguishing mark along with a manufacturer's plate. USDA issues a certificate based on reports of private sector testing. USDA maintains the authority to spot check and witness testing. Acceptance of certificates issued in other economies is between the buyer and seller.
Food: Processed Foods
Regulatory Agencies: the Food and Drug Administration (FDA) under the jurisdiction of the Department of Health and Human Services. The Agricultural Marketing Service (AMS) and the Food Safety and Inspection Service (FSIS) - the FSIS has authority over all products from cattle, sheep, swine, goats, horses, mules and other equines, chickens, turkeys, ducks, geese, and guineas; this includes processed products containing more than 3 percent raw (2 percent cooked) meat or poultry - under the jurisdiction of the U.S. Department of Agriculture (USDA). The Environmental Protection Agency (EPA).
Under the AMS' area of coverage, states regulate the quality of fluid milk. Standards may be recognized internationally by other economies if a recognition agreement exists. Under a recognition agreement, AMS can accept standards used in other economies for egg products if the product is processed in a facility approved by AMS and certified by the foreign government. For egg products, testing/inspection by approved bodies is accepted when it is documented on a government certificate. There is no discretionary power to waive any requirements.
Under the EPA's area of coverage several large states have established food purity standards which are more stringent than federal standards that national manufacturers have adopted. Maximum allowable levels of pesticide contamination are established by EPA (as mandated by the Food, Drug and Cosmetic Act) and conformance enforced by USDA or FDA, depending on the particular food type. In some instances, a total prohibition is enforced (Delaney Amendment to the Federal Food, Drug and Cosmetic Act). These levels are accepted internationally. In general, pesticide levels in imported foods are treated identically to domestic foods. While other economies' standards are not readily accepted, when they do match or are more stringent than the U.S.'s standards, they are accepted. EPA consults internationally when establishing maximum allowable pesticide residue levels through the WHO/FAO Codex Committee on Pesticides Residues.
Under the FSIS' area of coverage, the standards required by the Federal Meat Inspection Act and the Poultry Products Inspection Act are recognized internationally; however some countries have fewer requirements and others may have additional requirements. FSIS recognizes countries as eligible to export meat and/or poultry to the United States when such countries maintain an inspection system which is equivalent to that of the United States. At least once a year, the head of the foreign inspection system certifies the names and establishments numbers of the meat and/or poultry plants that comply with the U.S. equal to requirements. Each shipment must be accompanied by a certificate indicating that it is in compliance with at least equal to requirements. Also, the foreign countries must maintain residue testing programs which are equivalent to those of the United States (this requires laboratories with well-trained personnel and adequate testing equipment). The regulations also require periodic review of the foreign inspection system in operation by representatives of FSIS. There are no discretionary powers for regulatory authorities to waive any of the requirements.
Food: Unprocessed Food
Regulatory Agencies: USDA's Animal and Plant Health Inspection Service (APHIS), Food Safety and Inspection Service (FSIS), and the Agricultural Marketing Service (AMS); Food and Drug Administration (FDA); Environmental Protection Agency (EPA); DOC's National Oceanic and Atmospheric Administration (NOAA) the National Marine Fisheries Service (NMFS).
APHIS scientist and policy analysts involved in the drafting of regulations take into consideration relevant international plant or animal health standards. Whenever possible, APHIS tries to maintain consistency with these international standards. APHIS adheres to IPPC standards for certifying plant-related exports. Phytosanitary certificates issued by APHIS also comply with standards established by the IPPC.
Under the FSIS' are of coverage, the standards required by the Federal Meat Inspection Act and the Poultry Products Inspection Act are recognized internationally; however some countries have fewer requirements and others may have additional requirements. FSIS recognizes countries as eligible to export meat and/or poultry to the United States when such countries maintain an inspection system which is equivalent to that of the United States. At least once a year, the head of the foreign inspection system certifies the names and establishments numbers of the meat and/or poultry plants that comply with the U.S. equivalent requirements. Each shipment must be accompanied by a certificate indicating that it is in compliance with equivalent requirements. Also, the foreign countries must maintain residue testing programs which are equivalent to those of the United States. (This requires laboratories with well-trained personnel and adequate testing equipment). The regulations also require periodic review of the foreign inspection system in operation by representatives of FSIS. There are no discretionary powers for regulatory authorities to waive any of the requirements.
Under the AMS' area of coverage some states have minimum quality requirements for fresh fruits and vegetables produced in those States. U.S. food quality standards are generally not internationally recognized either because no international standards exist, or due to differences in geography, climate, and processing techniques. Quality standards for cotton are internationally recognized. There is limited acceptance by U.S. regulatory agencies of food standards used by other economies. Restrictions to acceptance depend on the commodity, equivalency to U.S. standards, existence of reciprocal agreements, and whether verified by government certification. Only USDA can certify to U.S. grade standards. There is no discretionary powers to waive any requirements. USDA may accept other economies standards and certification under agreement for some commodities provided the body is approved and verified with a government certificate. USDA reserves the right to monitor imports.
Under the EPA's area of coverage several large states have established food purity standards which are more stringent than federal standards that national manufacturers have adopted. Maximum allowable levels of pesticide contamination are established by EPA (as mandated by the Food, Drug and Cosmetic Act) and conformance enforced by USDA or FDA, depending on the particular food type. In some instances, a total prohibition is enforced (Delaney Amendment to the Federal Food, Drug and Cosmetic Act). These levels are accepted internationally. FDA also regulates unprocessed food as to other forms of contamination, e.g., bacteria and heavy metals, and unappropriate additives.
Energy
Note: "Energy" impacts many areas other than just power production and transmission. Among other things, it includes or impacts contaminated material removal and disposal; decontamination and decommissioning of contaminated facilities; water, air and ground quality; transportation; certification of personnel; quality assurance; standards development and use, etc. Both voluntary standards and mandatory regulations are involved. A more precise response can be given, if required, for a particular product or service.
Federal Government agencies: the Departments of Energy (DOE), Commerce (DOC), Labor (DOL/OSHA), Transportation (DOT), and Agriculture (USDA); the Environmental Protection Agency (EPA); Nuclear Regulatory Commission (NRC); Interstate Commerce Commission (ICC); U.S. Army Corps of Engineers.
State Government agencies: Federation of State Commissions on Regulatory Matters (represents states rules, regulations and standards concerning many energy-related matters); State Departments of Environmental Control.
Each state and local government has laws, regulations and rules that implement national and local standards and conformance requirements. Each product and service must be examined specifically for the activity to be undertaken to determine which requirements apply. The standards and regulations often reflect the requirements specified in international standards, however the difference may be significant on a case-by-case basis. In general the regulatory agencies don't accept standards used by other economies. Products and services must meet U.S. regulations. The conformance arrangements that apply are dependent upon the product or service in question. There is no centralized accreditation or certification authority within the federal government or with the various states.
Regulatory authorities do not generally waive any requirements. Users must demonstrate compliance through permits, reports, monitoring and sampling. Many requirements are met through self evaluation and supplier's declaration of conformity. Certification is generally recognized with Canada (through agreement). This occurs on a mutual recognition basis and may apply to other countries in selected areas (such as pressure vessels).
Consumer Protection
Regulatory Agency: Consumer Product Safety Commission (CPSC), an independent federal regulatory agency.
CPSC standards are not internationally recognized. CPSC standards address documented risks of injuries occurring in the United States which are associated with specific consumer products. In some case, the variation between CPSC and internationally recognized regulations may be significant. CPSC does not accept standards used by other economies. Products sold in the United States must meet the requirements of applicable CPSC regulations.
Certification of compliance by a U.S. manufacturer or importer is required for products subject to consumer product safety standards issued under provisions of the Consumer Product Safety Act. These products include, but are not limited to, architectural glazing materials, citizens band base station antennas, disposable lighters (effective July 12, 1994), and power lawn mowers. U.S. importers must issue a certificate of compliance based on a test of each product or a reasonable testing program. Tests to support the certificate may be performed by the importer or a third party. Testing may be performed outside the United States, unless otherwise specified. CPSC tests products for enforcement purposes only.
Health and Safety Regulations Not Included Elsewhere
The Occupational Safety and Health Administration (OSHA) is responsible for enforcing workplace safety and health laws. The Mine Safety and Health Administration (MSHA) is responsible for mine safety. Both are agencies of the U.S. Department of Labor - Federal Government. States that operate their own workplace safety and health programs are required to have programs that are at least as effective as the Federal OSHA program.
OSHA is recognized as a leader in the field and many countries have asked for technical assistance when developing their standards. There are, however, many variations from one country to the next. OSHA operates a program for accrediting third party certification bodies (Nationally Recognized Testing Laboratories -- NRTLs) which certify compliance with OSHA standards and regulations.
Most states in which significant mining activities occur have mining laws requiring certain mining equipment and products to meet the health and/or safety requirements of MSHA and to be certified/approved by MSHA as a condition of use in the mines of the state. In one instance a state requires MSHA approval of mining equipment and products prior to consideration for certification in the states own program. In this instance, the state imposes additional certification requirements beyond those necessary for the MSHA certification. The standards required by the MSHA approval/certification regulations are not uniformly recognized internationally. MSHA equipment and product safety approval/certification standards are highly specialized and were implemented as early as 1913. Because of different mining conditions and philosophies in the United States, these regulations developed independently. Current Mining regulations in the United States preclude adoption of any standard which will result in a diminution of safety from those standards now in place. The variations between international regulations is often minor and MSHA is actively exploring mechanisms to harmonize equipment and product approval/certification requirements. Currently MSHA does not accept approval/certification standards used and certifications issued by other countries.
MSHA requires the equipment/product compliance with published standards describing the technical requirements which must be met for approval/certification. MSHA currently has two separate approval programs in place. One requires that MSHA receive all documentation supporting the application for equipment/product approval and perform all testing and follow-up quality assurance auditing. The applicant is charged a fee equated to the cost incurred by MSHA. The other program requires that the applicant or a third party laboratory perform the equipment/product testing, provide evidence of test results to MSHA and certify to the validity of the tests. MSHA completes the evaluation and issues the approval/certification and conducts follow-up quality assurance auditing. This also is a fee program. MSHA has no significant discretionary powers to waive some or all of the requirements.
