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Inventory of National Practices on Standards, Technical Regulations
and Conformity Assessment in the Western Hemisphere


III. Technical Regulations Entities

Antigua & Barbuda

Argentina
Standards are developed by the IRAM (Argentine Standardization Institute), within a regime of technical cooperation agreements for the study of standards.
Technical regulations are developed by the Ministries, State Secretariats, and other agencies under them. Technical regulations and provisions inherent to the regulated market include laws, decrees, resolutions, etc., that emanate from the different branches of government, Ministries, municipal governments, and authorized agencies.
These provisions refer to goods, services, and in some cases installations; in general they treat issues related to health, safety, the environment, and consumer information and protection.

Bahamas
Information Technology
Regulatory Agencies: The Bahamas Telecommunications Corporation and the Broadcasting Corporation of the Bahamas.
Chemicals
Regulatory Agencies: The Department of Environmental Health Services and the Department of Agriculture. The standards required by the regulation are internationally recognized.
Building
Regulatory Agency: The Ministry of Works. Regulatory requirements are contained in the building code of the Bahamas. The Building Code is internationally recognized.
Drugs
Regulatory Agencies: The Ministry of Health, and the Department of Environmental Health. There are no internationally recognized standards for drug approval. Drug's safety and efficiency is reviewed prior to permitting drugs to be marketed. These regulatory agencies accept standards used by other economies. Importing agencies must supply self certification by manufacturers, as well as testing and inspection results from approved bodies, e.g., FDA's approval for drugs manufactured in the USA.
Environment
Regulatory Agencies: The Department of Environmental Health and the Department of Agriculture. Standards required by the regulation are internationally recognized.
Medical Devices
Regulatory Agency: The Ministry of Health and Environment. No local standards exist. The Ministry of Health and Environment accepts standards used by other economies.
Transportation Equipment: Motor Vehicles
Regulatory Agency: The Road Traffic Department and Ministry of Transport. Although the standards required by the regulations are internationally recognized, no formal arrangements exist. The regulatory agencies accept standards used by other economies.
Food; Processed Foods
Regulatory Agencies: The Department of Agriculture and the Department of Environmental Health. International standards are adopted or adapted to elaborate national standards. No international recognition agreement exists. The regulatory agencies accept standards used by other economies. Products such as meats must be certified by the Foreign Government agencies, e.g., USDA for the USA.
Food: Unprocessed Food
Regulatory Agencies: The Department of Agriculture, under the authority of the Public Market and Slaughterhouse Act and the plant protection act. The Department of Environmental Health under the authority of the Health Service Act.
International standards are used in the drafting of regulations and local standards. The regulatory agencies accept standards used by other economies. Meats and/or poultry must be inspected by the relevant authority in the exporting country.
Consumer Protection
Regulatory Agency: Consumer affairs section, Ministry of Finance. No local standards exist. Activities are in the area of price control. Standards used by other economies are generally accepted.

Barbados

Belize
Mandatory Technical Regulations
Chemicals
Pesticides are the responsibility of the Pesticide Control Board which is governmental body. The Registered and Restricted Pesticide Regulations under the Pesticide Control Act 1985 requires the registration of pesticides. Other chemicals are not regulated.
Information Technology and Communication Equipment
The Telecommunication Act of 1987 assigns responsibility for the regulation of information technology and communication to the government department, Office of Telecommunications.
Construction
The Ministry of Housing and Planning and specifically the Department of Housing and planning is responsible for the regulation of this sector under the Housing and Town Planning legislation of Belize. The building code for the City of Belize is different from that for the towns of the country, however enforcement and monitoring are the responsibility of the government department, Department of Housing and Planning. The building codes are mandatory.
Environment
The Department of Environment (DOE) is the assigned government department responsible for the regulation of the environment under the Environment Protection Act of 1992. Since the enactment of that legislation, the Environment Impact Assessment Regulation of 1995 has come into force. All the environment requirements are on international standards.
Transport
The Department of Transport has been empowered by the Motor Vehicle and Road Traffic Act 1990 for the regulation of transport within Belize.
Consumer Protection, Health and Safety
This responsibility is shared by at least three governmental departments within the respective Ministries, namely: Ministry of Health, Ministry of Agriculture and Fisheries and the ministry of Trade and Industry. The Public Health Department enforces the Food and Drug Act which ensures that sound food is available to the population. Phytosanitary Certificates are required for all agricultural products before importation into Belize.

Bolivia
Technical regulations are developed and issued by a competent authority, i.e. the Ministries, State Secretariats, and services under them, depending on the issue and the competence assigned by law. The authorizing legislation is National Law No. 1493 of 1993, "Law on Ministries," and its regulation, Supreme Decree No. 23660 of 1993, Organization of the Ministries. The Law on Municipalities enables the Departmental Mayoralties to develop and oversee technical regulations. At present the Secretariat for Industry is developing a mechanism to ensure that the development of technical regulations follows a common procedure, whatever the competent organ, by external request or by consideration of the authority. This mechanism will be based on the principles established in the WTO agreement on Technical Barriers to Trade.

Brazil
The Resolution of the National Council of Metrology, Standardization and Industrial Quality - CONMETRO _ 05, of 4/September/1995, names INMETRO as Brazil's enquiry point with responsibility for supporting the process of technical regulation. Technical regulations are developed and issued by the competent bodies as follows:
Information Technology: the National Policy on Information Technology is the responsibility of the Ministry of Science and Technology.
Chemicals: the chemical products used in the agricultural sector are the responsibility of the Ministry of Agriculture; the chemicals used in the preparation of explosives are the responsibility of the Army. Production, transport and commercial activities involve the Ministry of the Environment, Water Resources and Legal Amazon, the Ministry of Health and the Ministry of Labor.
Drugs and pharmaceutical products are the responsibility of the Ministries of Health and of Agriculture (products for veterinary use).
Environment: the Ministry of the Environment, Water Resources and Legal Amazon is in charge of environmental protection, prevention of the contamination of plant and animal life, chemical substances, industrial residuals, mining, protection of the atmosphere and noise pollution.
Medical Equipment is the responsibility of the Ministry of Health and of INMETRO.
Transportation Equipment is the responsibility of the Ministry of Transport, Ministry of the Environment, Water Resources and Legal Amazon, Ministry of Industry, Commerce and Tourism (through INMETRO).
Food is the responsibility of the Ministry of Agriculture and the Ministry of Health.
Consumer Protection: the National Policy on consumer relations, consumers' rights, product quality and services, prevention and reparation of damages, commercial practices and contractual protection are regulated by the Federal Government under the coordination of the Ministry of Justice (LAW _ 8078, 11/September/1990).

Canada
Chemicals
The relevant legislation for Chemicals (not otherwise subject to the Explosives Act, Food and Drugs Act, Pest Control Products Act or Atomic Energy Control Act) is the Hazardous Products Act which is administered by Health Canada. The Product Safety Bureau in the Health Protection Branch of Health Canada is responsible for developing and enforcing separate regulations for chemicals used by consumers and chemicals used in the workplace. The provinces have complimentary regulations and also cooperate with this federal department in the administration and enforcement of the Controlled Products Regulations which apply to hazardous chemicals used in the workplace. The Pest Management Regulatory Agency, which is also a part of Health Canada, develops regulations for Pest control products under the Pest Control Products Act.

Relationship to international standards
Relevant international standards such as those developed by the OECD have been referenced in the regulations to the greatest extent possible.

Conformance Requirements
No pre-approval of labels or Material Safety Data sheets (MSDs) is required under the Hazardous Products Act, The Controlled Products Regulations prescribe the notification requirements for hazardous workplace materials imported into Canada which do not comply with the label and MSDS requirements.

Information Technology and Telecommunications Equipment
The control of Information Technology and Telecommunications (IT&T) equipment is governed by the Telecommunications Act, the Radio Communications Act and Interference-causing equipment regulations which are administered by the Director General, Spectrum Engineering Branch of Industry Canada (IC).

Relationship to international standards
International standards from ISO, ITU and IEC are used whenever possible. However for areas such as for network protection, where international standards do not exist, domestic standards are developed.

In the area of terminal attachment, other countries standards are not accepted. For Electromagnetic Compatibility (EMC), the US/FCC Part 15 and CISPR-22 are considered as equivalent. In the area of safety the UL 459 standard and the US/Canada binational standard (IEC 950) are accepted.

Conformity assessment
In general Telecommunications equipment such as telephones, modems, facsimile machines, PBX equipment, Centrex service equipment, trunk-to-station tie lines equipment and off-premises station apparatus must be certified by Industry Canada and bear a conforming label before they can be attached to the telephone network. Certification is obtained on a Type basis or on an individual equipment basis by demonstrating compliance to mandatory requirements such as for prevention of harm to network, user safety etc. Compliance to mandatory requirements is demonstrated for a particular type of equipment by the applicant submitting test results, from an Industry Canada approved test laboratory, of tests conducted against applicable standards. Test laboratory can be an approved third party lab or a lab in the manufactures premises which has been approved by Industry Canada. Telecommunications and Information Technology equipment must also meet mandatory requirements for Electromagnetic Interference. Self certification is allowed in the area of EMI requirements. For safety requirements, third party certification from a certification organization accredited by the Standards Council of Canada (SCC), is required.

Building
The Canadian Constitution assigns the responsibility for regulation of buildings to the provinces and territories. Among other things, this gives the provinces and territories the authority to establish its own building codes as well as to define the qualifications of who may design and construct buildings. This responsibility is usually assigned to such ministries as Municipal Affairs, Labour or Housing. The federal government's role is to encourage uniformity in building regulations by facilitating model technical requirements through a national consensus process and by providing a national resource in construction research. The result is the National model codes including the National Building Code (NBC) which forms the basis for all provincial and territorial building codes and regulations. The NBC is prepared by the Canadian Commission on Building and Fire Codes (CCBFC); a Committee supported by the National Research Council (NRC). NRC publishes the National Building Code, the National Fire Code, the National Plumbing Code and the National Energy Codes. In such a system, where one level of government enforces requirements essentially produced by another, a high degree of consultation and participation by both parties is essential, particularly at the policy level.

Relationship to international standards
The NBC references over 200 standards produced by Canadian and US standards development organizations. References of standards in building codes changes the status of the standard from voluntary to mandatory. Materials and components must meet standards referenced in the NBC or provide the equivalent performance expected by the Code. Although preference is given to Canadian Standards, there is nothing to prohibit the referencing of acceptable international standards.

Conformity Assessment
The process of assessing conformity to building code requirements during construction is the responsibility of the provincial, territorial, or municipal authority having jurisdiction and the supervising professional designers. Those persons responsible for ensuring that a material, appliance, system or equipment meets the performance requirements of this Code have several means available to assist them. These means vary from on-site inspection to the use of certification services provided by accredited third party organizations.

Federal involvement in conformity assessment is essentially one of service to assist the provincial and territorial authorities. For example, the Standards Council of Canada operates accreditation programs for testing, standards development, certification and quality registration organizations. NRC's Canadian Construction Materials Centre (CCMC) offers evaluation services that verify that new and innovative proprietary products will perform their intended functions in a building by determining equivalency of performance to the intent of a Code requirement.

Drugs
The control of pharmaceuticals at the federal level is governed by two pieces of legislation: the Food and Drugs Act and Regulations and the National Narcotic Control Act and Regulations which are administered by the Drugs Directorate, Health Protection Branch of Health Canada. One of the main objectives of the Drugs Directorate is to protect the health of Canadians by assessing, effectively and efficiently, the benefits and risks of pharmaceuticals, including biologics. This is accomplished by preparing and communicating standards for development and use of pharmaceuticals and then by assessing products and facilities against those standards for safety and effectiveness.

Relationship to international standards
The regulations are based on international standards. Canada is committed to the principles of international regulatory harmonization, and supports the activities of the International Conference on Harmonization of the Technical Requirements for Drugs (ICH) and participates as an observer on the ICH Steering Committee since November 1991.

Standards of other countries
- Exchange of Pharmaceutical Evaluation Reports: pharmaceutical evaluation reports are exchanged with the Australian Therapeutic Goods Administration and as well Canada participates bilaterally with 13 other countries in the Scheme for the Mutual Recognition of Evaluation Reports on Pharmaceutical Products under the European Union. The purpose of the Scheme is to facilitate the registration of pharmaceutical products through the exchange of evaluation reports between members. The Scheme aims to eliminate the duplicate evaluation of scientific data required for registration and contributes to international cooperation by mutually recognizing the evaluations reports of the members.

- Intergovernmental Liaison with Drug Regulatory Agencies: annual tripartite meetings are held on a wide range of topics with the United States and the United Kingdom, and trilateral meetings are held annually with the United States and Mexico. Canada is also a member of the Council for the International Organization of Medical Sciences (CIOMS) Working Group II established to explore the development of harmonized or standardized approaches to safety update summaries. The Drugs Directorate has observer status on the International Conference on Harmonization (ICH).

- Joint Reviews: two AIDS drugs were simultaneously approved by the Drugs Directorate and the U.S. Food and Drug Administration (FDA) as part of a joint review. These joint reviews have demonstrated that the sharing of data and the parallel evaluation of submissions is an effective way to facilitate the approval of new drugs. The Drugs Directorate is now exploring with the FDA the possibility of integrating review functions, where feasible.

Conformance Requirements
All pharmaceutical products require to be pre approved prior to their sale in Canada. In general the review process includes distinct steps such as Filing of Information by the Applicant, Screening of the Information for completeness and Review of the Submission.

Information requirements vary, depending on the nature of application such as for a New Drug or Changes to be made to an existing drug etc. Requirements may include information indicating compliance to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

Medical Devices
Medical devices are regulated under the Canadian Food and Drugs Act and Medical Devices Regulations. The Act and Regulations are administered by Health Canada through the Environmental Health Directorate, Health Protection Branch of the Medical Devices Bureau. This Act and its Regulations are Federal requirements which apply to all medical devices advertised, imported for sale, sold or offered for sale in Canada. Provincial requirements may impose additional requirements over and above those at the Federal level. For example, the use of medical devices in hospitals is a Provincial responsibility. Provinces may require specific types of medical devices used in hospitals and health institutions to meet specific Canadian Standards Association (CSA) standards or labelling standards. Also, hospital accreditation systems may require that devices meet specific standards.

Relationship to international standards
The current Medical Devices Regulations have begun to make reference to international standards (e.g. requirements for pacemakers). National standards [Canadian Standards Association (CSA) and Canadian General Standards Board (CGSB)] are incorporated into these Regulations. It is proposed to amend the Regulations to require medical devices to comply with ISO 9001, Quality Systems - Model for quality assurance in design/development, production, installation and servicing. Regulations will also use international standards whenever possible.

Standards of other countries
Under the Act and Regulations medical devices are not approved by the Federal government prior to their sale in Canada. For specific devices listed in Part V of the Regulations, a notice of compliance must be issued prior to the sale of the device in Canada. The onus is on the manufacturer of the medical device to ensure that their product is in compliance with the Act and Regulations at the time it is advertised, imported for sale, sold or offered in Canada. The manufacturer must conduct tests respecting their product and the tests must indicate that the benefits claimed to be attainable from the use of the product and the Performance characteristics of the product are justified. Manufacturers may refer to standards and the compliance of their device to those standards in order to indicate their compliance with the Act and Regulations.

Certification issued by other countries
No formal conformance arrangements with other countries are available respecting medical devices at this time. Mutual Recognition of Conformity Assessment Agreements are currently being explored. It is the manufacturers responsibility under the Act and Regulations to ensure that their device is in compliance at the time it is sold in Canada. Inspectors named under the Act are responsible for the enforcement of the Act and Regulations. In practice, regulatory authorities may not waive any of the requirements under the Act or Regulations. However certifications issued in other economies can be used by the manufacturer to substantiate their claim that their device is in compliance with the Canadian Act and Regulations.

Environment While Canada's Constitution divides powers of government between the federal and provincial governments, there is no explicit division of responsibility for protection of the environment. Thus, the constitutional authorities that support the federal presence include interprovincial and international trade and commerce, sea coast and inland fisheries, navigation and shipping, federal lands, Indians and lands reserved for Indians, census and statistics, and interprovincial and international transportation as well as criminal law and peace, order and good government powers. The provinces -- and through legislation called the Interpretation Act, Canada's two territories -- have responsibility for natural resources, civil and property rights, and local works.

At the federal level, the regulatory agency responsible for protection of the environment and enhancement of its quality is Environment Canada. It administers legislation and regulations dealing with environmental protection, prevention of pollution, and preservation of wildlife, in particular migrating and endangered species as well as environmental assessment. Provinces and territories also have Ministries or Departments known by titles such as Environment or Natural Resources. Those provincial and territorial ministries or departments also administer laws, regulations and permit or licensing systems. The federal, provincial and territorial governments try to work together. All three recognize that their laws and actions are all critical to the protection of the environment, prevention of pollution and sustainable development. In Canada, Aboriginal Peoples are also increasingly assuming greater management of their everyday affairs, and their responsibilities range from small scale projects to self-government regimes which have been negotiated with the Government of Canada and will continue to be negotiated under 1995 document "Aboriginal Self-Government -- The Government of Canada's Approach to Implementation of the Inherent Right and the Negotiation of Aboriginal Self-Government". Areas in which aboriginal governments will be able to negotiate to assume authority are protection of the environment, prevention of pollution and management of wildlife species. Relationship of Canadian Environmental Laws to the International Area
As the federal government has jurisdiction over international matters, federal legislation normally implements the commitments that Canada has agreed to internationally under treaties, conventions and protocols. Examples of the international commitments that Canada has implemented, is in the process of implementing or will implement through its domestic legislation are:

- The London Convention, 1972, with respect to disposal of wastes at sea
- Convention on International Trade in Endangered Species
- Basel Convention on the Transboundary Movement of Hazardous Wastes
- Montreal Protocol on Substances that Deplete the Ozone Layer
- Canada-U.S. Agreement an Air Quality
- Convention on Biological Diversity
- Agenda 21, the action plan and declaration following the 1992 United Nations Conference on Environment and Development
- Commitments under the United Nations Environment Program in relation to export of toxic substances

Transport Equipment
Transport Canada, a department of the Federal Government of Canada, is the federal agency responsible for the administration and enforcement of the Motor Vehicle Safety Act and Regulations.
Regulations on the safe use and control of vehicles on provincial highways fall within provincial jurisdiction.

Relationship to international standards
Under the Motor Vehicles Safety Act and Regulations standards referenced in the legislation are mainly US standards such as Society of Automotive Engineers (SAE), American Society for Testing and Materials (ASTM) and Department of Transportation (DOT) of the USA. There are no recognized international standards in this area.

Standards of other countries
Standards used by other countries are acceptable where agreements exist or when they provide the same level of safety. The federal regulations reference standards from various organizations making them mandatory.

Conformity requirements
The responsibility rests with the manufacturer or his representative to ensure compliance with the requirements of the Act and Regulations.

Food
The mandate for food inspection is shared among three federal departments: Health Canada, Fisheries and Oceans (DFO) and Agriculture and Agri-Food Canada (AAFC). Each department is accountable for specific responsibilities as set out in their respective legislation. Health Canada has primary responsibility in ensuring the health, safety and nutritional requirements for food sold in Canada and they administer the Food and Drugs Act and Regulations which contain standards relating to safety and fraud of food sold in Canada. Other federal statutes containing food standards are administered by Agriculture and Agri-Food Canada and Fisheries and Oceans. These statutes are intended primarily to enhance the marketability of food products through a combination of safety, quality and grading standards. AAFC is responsible for the Meat Inspection Act and the Canada Agricultural Products Act and administers the food labelling and fraud provisions of the Food and Drug Act. DFO has the sole statutory mandate for controlling the import, export and domestic marketing of all fish and fishery products as legislated under the Fish Inspection Act and Regulations. AAFC and DFO also administer applicable sections of the Consumer Packaging and Labelling Act and Regulations. The food safety standards contained in the statutes of DFO and AAFC complement or further define the food safety standards set out in the food and Drugs Act. AAFC is also responsible for regulating agricultural inputs. The legislation relating to these inputs are the Feeds Act, the Fertilizer Act and the Seeds Act. Provinces may set additional standards for food for sale within provinces. The federal government has primary regulatory responsibility for the import and export of food.

Relationship to international standards
The Food and Drug Regulations prescribe standards of composition for approximately 325 foods and also list permitted food additives as well as limits for contaminants such as pesticide residues, heavy metals and veterinary drug residues. Many of these requirements are consistent with the international standards such as Codex but a large number are also unique to Canada. The Fish Inspection Regulations, Meat Inspection Regulations and the Regulations under the Canada Agricultural Products Act prescribe standards for agricultural commodities. To the extent possible these standards are consistent with international standards.

Standards of other countries
The regulations under federal acts, including the Food and Drugs Act, Consumer Packaging and Labelling Act, the Meat Inspection Act and the Canada Agricultural Products Act, the Feeds Act, the Fertilizer Act and Seeds Act are legal requirements. Standards of other countries cannot be accepted unless they are the same or equivalent. DFO does not accept fish product standards used by other countries unless there is an agreement that such standards are deemed equivalent to Canadian standards.

Conformance requirements
Imported food products must comply with the relevant requirements found in Canadian regulations. In most cases, Canadian regulations do not provide for discretionary powers to waive some of these requirements for imported products. The legal agent for foods marketed in Canada (e.g. importer) has the responsibility for ensuring compliance with regulatory requirements.

The federal government operates an import inspection system in order to verify that imports comply with Canadian standards. Most food imports do not require non-safety related certification. When mandatory certification is required, usually a government issued certificate is mandatory.

Mutual Recognition of Conformity Assessment Procedures
At this time, there are no formal arrangements between Health Canada and other countries relative to the certification of food products being imported into Canada. However, certification of compliance with Canadian requirements by a foreign economy would be taken into account in the degree of import monitoring/inspection. A Mutual Recognition Agreement has been negotiated with Australia for the inspection and certification of fishery products based on equivalency between our two countries. Unilateral agreements have been established with a number of foreign countries meeting Canadian standards. At this time AAFC does not have any formal mutual recognition agreements, though the principle of equivalency is commonly used.

Energy - Gas-fired appliances
There is no national regulatory agency for this area. Regulation of fuel-fired equipment is a provincial responsibility. There are provincial regulatory requirements for this area. The standards referenced in the provincial regulations are standards prepared by the Canadian Gas Association (CGA), the Canadian Standards Association (CSA) and Underwriters' Laboratories of Canada (ULC).

Relationship to international standards
There are no recognized international standards for this area.

Standards of other countries
Standards of other countries are accepted whenever they are found to be equivalent.

Conformance requirements
Provinces require mandatory certification to approved standards. The Canadian Gas Association (CGA) has been designated as a certifying body under provincial and territorial legislation. In some provincial regulations, the Underwriters' Laboratories of Canada and the Canadian Standards Association are also accredited to test gas appliances against applicable standards.

Energy - Electrical Safety
There is no national regulatory body in this area. The electrical safety of products is the responsibility of provincial governments. There are no provincial regulations for electrical products which reference electrical standards. The standards referenced in the provincial regulations are standards contained in the Canadian Electrical Code published by the Canadian Standards Association (CSA).

Relationship to international standards
There are no recognized international standards in this area.

Standards of other countries
Standards used by other countries are accepted whenever they are found to be equivalent.

Conformance requirements
Legislation in each of the ten provinces makes it mandatory that all electrical equipment be safety certified as proof of compliance with the relevant standards of the Canadian Electrical Code.

Certification of other countries
The responsibility lies with the provincial regulatory agencies.

Energy - Energy Efficiency
The federal department of Natural Resources Canada (Energy Demand Branch) is responsible for administering the Energy Efficiency Act and corresponding regulations. These regulations under the authority of the Energy Efficiency Act require minimum energy efficiency levels for residential refrigerators; freezers; electric ranges and ovens; dishwashers; clothes washers; room and central air conditioners; natural gas, electric and oil fired water heaters; natural gas furnaces; air, ground, water and internal water-loop heat pumps; lamp ballasts; and electric motors. It also stipulates energy efficiency ignition design for natural gas ranges and ovens. Requirements are planned for lamps and other HVAC products. The provinces of British Columbia, Nova Scotia, Ontario, Québec and New Brunswick also have complimentary legislation which sets out energy efficiency requirements.

Relationship to international standards
The standards that are referenced in the Energy Efficiency Regulations are National Standards of Canada published by the Canadian Gas Association (CGA) and the Canadian Standards Association (CSA). CGA and CSA standards are also presently referenced in the Efficiency Standards Regulation of the provinces which have Energy Efficiency Regulations.

Standards of other countries
Standards of other countries are accepted whenever they are found to be equivalent.

Conformance requirements
Energy using products have to be certified by certification organizations that have been accredited by the Standards Council of Canada. Provincial certification, for small producers and niche market importers is also available. As for conformance to provincial regulations, the provincial regulatory body should be consulted.

Trade Measuring Devices
Measuring devices used in trade (e.g. Electricity and Gas Meters, Gasoline Dispensers, Scales, etc.) Are subject to the Weights and Measures Act and Electricity and Gas Inspection Act which are administered by the Legal Metrology Branch of Industry Canada (IC). There is no similar legislation at the provincial or municipal level.

Relationship to international standards
Canada is a member of the OIML (Organization Internationale de Metrologie Legale) and the Legal Metrology Branch of Industry Canada participates in the development of the OIML technical standards. Those standards, which usually refer to the design, conception, installation and performance of measuring devices, are used whenever possible.

Conformance requirements
Trade measuring devices are required to be type approved according to requirements of the Weights and Measures Act and the Electricity and Gas Inspection Act.

Owners of trade measuring devices have the responsibility for ensuring compliance to the regulatory requirements. The Legal Metrology Branch monitors the compliance to the regulations by conducting inspections and by accrediting organizations that can perform inspections.

Arrangements with other organizations
The Legal Metrology Branch and the Office of Weights and Measures of the U.S. National Institute of Standards and Technology have a Mutual Recognition Agreement on type approval of specific type of devices since April 1994. This agreement allows both countries to perform type approval evaluation for each others markets.

Consumer Products (non Food)
Health Canada is responsible for regulating consumer products, under the Hazardous Products Act. Industry Canada is responsible for regulating consumer products under the Consumer Packaging and Labelling Act, the Textile Labelling Act and the Precious Metals Marking Act. Agricultures and Agri-Food Canada, however, is designated to enforce certain food requirements outlined in the Consumer Packaging and Labelling Act. These three agencies are all federal government departments. Health Canada administers the Radiation Emitting Devices Act and Regulations which regulated the design, construction, functioning and warning symbols of the devices. Some of the Products covered under the regulations are TV, X-ray machines, micro-wave ovens, laser equipment and sun lamps.There are some provincial requirements for the cleanliness of stuffing materials in some textile products in four provinces, namely Ontario, Quebec, Manitoba and Alberta.

Relationship to international standards
The Hazardous Products Act currently makes reference to CSA, ASTM and OECD standards to the greater extent possible. The consumer Packaging and Labelling Act does not reference international standards although the regulations are consistent with practices in many countries. International standards are used as a guide when writing the regulations, although they are not referenced. The standards referenced in the Textile Labelling Act are CGSB, ASTM, BSI and ISO standards.

Conformance requirements
The responsibility for conformance with applicable regulations for most consumer products that fall under the Consumer Packaging and Labelling Act, the Textile Labelling Act and the Precious Metals Marking Act rests with the manufacturer or importer. The responsibility for conformance with applicable regulations for all consumer products under the Hazardous Products Act rests with the manufacturer or importer. Health Canada monitors products to ensure compliance with regulations, voluntary guidelines and policies. Health Canada - Products Safety Bureau administers the Hazardous Products Act and has a Memorandum of Understanding with the United States Consumer Products Safety Commission for harmonization of consumer product safety standards.

Commodities Sold on the Basis of Measure
The weights and Measures Act establishes net quality requirements for commodities sold on the basis of measure. This legislation, administered by the Legal Metrology Branch of Industry Canada, does not apply to commodities subject to net quantity requirements set out In other federal legislation. It applies mostly to non-consumer packages and commodities sold from bulk.

Relationship to international standards
The net quantity requirements set out in the Weights and Measures Regulations are consistent with the OIML (Organisation Internationale de Metrologie Legale) recommendation R87.

Conformance requirements
Traders have the responsibility for ensuring compliance to the regulatory requirements. The Legal Metrology Branch monitors the compliance to the regulations by conducting inspections.

Chile
In Chile, technical regulations are issued by the Ministries and the Services under them that are directly related to regulation, whether through Decrees, Supreme Decrees, Resolutions, or Exempt Resolutions. The authority to regulate has been granted by Law, in most cases the Organic Law of the Ministry or Service in question.

These technical regulations originate with the initiative of the regulatory authority itself or actors interested in issuance of a regulation, and they are proposed to the authority, who then makes a decision. Technical regulations are limited, in general, to issues relating to health, safety, environment, and consumer information and protection.

Colombia
The Ministries and offices beneath or linked to them at the national level as well as the municipal offices, secretariats, and oversight entities at the regional level are authorized by law to issue technical regulations.

The entities that issue national-level technical regulations are:
- Ministry of Mines and Energy
- Ministry of the Environment
- Ministry of Agriculture
- Ministry of Communications
- Ministry of Economic Development
- Ministry of Transportation
- Ministry of Public Health
- Ministry of Foreign Trade
- Ministry of Labor and Social Security
- Ministry of Industry and Commerce
- Institute for the Oversight of Drugs and Food (INVIMA)
- Colombian Agricultural Institute (ICA)
- Telecommunications Regulatory Commission
- Superintendency of Public Services

Agriculture: The products used in the agricultural sector are regulated. The regulating entities in this area are the Ministry of Agriculture and the Colombian Agricultural Institute (ICA).

Information Technology and Telecommunications Equipment: the regulating entities in this area are the Ministry of Communications, the Telecommunications Regulatory Commission and the Superintendency of Public Services.

Construction: the regulating entities in this area are the Ministry of Economic Development, the Ministry of Transportation and the National Council on Standards and Quality.

Pharmaceuticals, Medical Equipment, Food: regulated by the Ministry of Public Health.

In addition, the requirements for the protection of health and security not covered above are regulated by the National Council on Standards and Qualities, for all goods and services that relate to the international system of units; metrology; materials, products or procedures that entail a risk to safety, protection of life, human, animal, and plant health; as well as the prevention of practices that may induce to error and criteria that foster the improvement of the environment and ecosystems and preserve natural resources. The requirements are established when Colombian technical standards, elaborated by the ICONTEC, become officially obligatory.

To harmonize the procedures to be followed in the issuance of technical regulations and to guarantee that the issuance of such technical regulations applicable to goods and services matches the requirements of international standards, Decree 1112 was issued in June/1996.

Costa Rica
The organizations in charge of developing and implementing technical regulations include the ONNUM and government institutions with technical regulatory functions depending on the product in question: Department of Narcotic Drugs, Controls, and Records, Department of Food Control, Department of Control and Registration of Toxic Substances and Labor Medicine, General Bureau for Agricultural Protection, Department of Registration, Quality Control, and Oversight of Veterinary Medicines, the National Office of Seeds, and the Department of Environmental Protection. All resulting technical regulations elaborated by these various government departments are subsequently channeled through the National Body of Technical Regulations.

Dominica

Dominican Republic

Ecuador
Offices responsible for promulgating technical regulations:
At the national (federal) level: The Ministries of the Central Government.
At the subnational (regional) level: The Municipal Governments and autonomous regional agencies. These offices are supervised and funded by the central government.

Among the main laws that govern the development and adoption of technical regulations, mention can be made of the following:
- Health codes
- Law on Pesticides and related products
- Law on Weights and Measures
- Law for Consumer Defense
- Law on Energy. Regulation 3380
- Law on Special Consumption

The government's objectives in promulgating national technical regulations are to safeguard health, safety, the environment, and fair play in the market. The requirements of the product are in relation to performance, design, and description. Technical regulations are not defined for manufacturing processes.

El Salvador
Work is under way to prepare Technical Regulations.

Grenada

Guatemala
In Guatemala, technical regulations are issued by the Guatemalan Commission on Standards and by the Ministries directly related to their enforcement, either by decree or resolution. The agencies that enforce technical regulations in Guatemala are as follows:
- The Department of Drug Registration and Control, Division of Drug and Food Registration and Control, General Bureau of Public Health and Social Assistance Services, of the central government.
- The Department of Food Registration and Control, Division of Drug and Food Registration and Control, General Bureau of Public Health and Social Assistance Services, of the central government.
- Technical Plant Health Bureau, of the General Bureau of Agricultural Services (DIGESA), the Ministry of Agriculture, Livestock, and Food, of the central government.
- Department of Control of Veterinary Products, Technical Bureau of Animal Health, Ministry of Agriculture, Livestock, and Food, of the central government.
- General Bureau of Hydrocarbons, Ministry of Energy and Mines, of the central government.
- General Bureau of Nuclear Energy, Ministry of Energy and Mines, of the central government.

Guyana

Haiti
Obligatory technical regulations exist for coffee, under the control of the Ministere du Commerce et de l'Industrie/DCOPC, and for sanitary requirements, under the control of the Code d'hygiene (1954). The inspection agency is the Ministere de la Sante Publique et de la Population. The technical regulations are similar to international standards (for coffee) and to regional standards (for sanitary requirements).

Honduras

Jamaica

Mexico
In Mexico, the technical regulations are developed by official agencies, according to their area of competence and in accordance with Article 38 of the Metrology and Standardization Law. The agencies and their respective areas of competence are as follows:
- Department of Social Development: Construction Services and Security;
- Department of Energy: Preservation and Rational Use of Energy Resources; Electric Installations; Nuclear Security;
- Department of Commerce and Industrial Promotion: Private and Commercial Information Security and Commercial Practices;
- Department of Agriculture, Livestock and Rural Development: Protection, Promotion and Rational Use of Forest, Plant and Animal Resources; Zoo-sanitary Protection; Phytosanitary Protection;
- Department of Communication and Transport: Communication and Information Technology; Land Transportation; Air Transport; Maritime Transport;
- Department of Health: Regulation and Sanitary Promotion; Health Services;
- Department of Labor and Social Welfare: Security, Hygiene and Work Environment;
- Department of Tourism: Tourism;
- Department of Environment, Natural Resources and Fishing: Environmental Protection; Fishing.

Panama
The General Bureau for Standards and Industrial Technology (DGNTI) of the Ministry of Commerce and Industry of Panama is responsible for coordinating technical standardization in all areas, establishing sectoral structures as necessary. The DGNTI coordinates the Technical Committees, which study and discuss the standard, which is made official by the Ministry of Commerce and Industry, and then officially published. At this time there are technical regulations for public entities which, depending on the issue in question, may be ministries, municipalities, or decentralized institutions.

Agrochemicals:
- Ministry of Health, through the Office of Pharmacies and Drugs.
- Ministry of Agricultural Development - Agricultural Quarantine.
Technological Information and Telecommunications Equipment:
- National Telecommunications Institute (INTEL, S.A.)
- Ministry of Government and Justice, through the National Bureau for Communications Media.
Construction:
- Ministry of Housing.
- Municipal government of Panama City, through the Municipal Engineering Bureau.
Pharmaceuticals:
- Ministry of Health, through the Office of Pharmacies and Drugs.
- Specialized Institute for Analysis (IEA).
Environment:
- National Institute for Renewable Natural Resources.
Transportation:
- Ministry of Government and Justice, through the General Bureau for Overland Transportation and Communication.
Foods
: - Ministry of Health, through the Office for Control of Foods and Veterinary Oversight.
Energy:
- Institute for Hydraulic Resources and Electrification (IRHE).
Consumer Protection:
- Ministry of Commerce and Industry, through the General Bureau for Consumer Protection and the General Bureau of Standards and Industrial Technology.
Health and Safety:
- Social Security Fund, through the Bureau for Occupational Health.
- Ministry of Government and Justice, through the Panama City Fire Department and its Security Office.

All the above-mentioned institutions participate directly in the preparation of the COPANIT National Standards, for at some point, and depending on the issue faced, they are all part of the technical standardization committees.

Paraguay
The INTN (National Institute of Technology and Standardization) is the national standards office. To meet its objectives the INTN has set up a Technical Standards Department with a basic organizational framework that enables it to perform its functions efficiently. The Department of Technical Standards coordinates national, regional, and international regulatory activity.

Peru
In Peru, technical regulations are issued by the Ministries and offices under them that have regulatory functions, through Supreme Decrees or Ministerial Resolutions. The regulatory authority is granted by law, for the purposes of protecting the health and integrity of the population, protecting the environment, and ensuring the defense of the nation. The various sectors of the government are autonomous in framing their technical regulations, but must abide by national legislation on free trade, and shall not unduly burden commerce to meet legislative objectives.

Saint Lucia

Trinidad & Tobago
Technical regulations (compulsory standards) are developed by TTBS for non-food items to protect the health and safety of consumers; to require that information be given to consumers and for the protection of the environment. Technical regulations are developed by the Chemistry Food and Drugs Division for foods, drugs and cosmetics.

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.

Uruguay
In Uruguay the establishment of standards, technical regulations, and methods of conformity assessment, as in the vast majority of countries, involves the participation of both official and private entities. From the official standpoint, the establishment of standards is not limited to technical regulations and conformity assessment activities, since standards initially voluntary can become binding not only through the participation of official entities in their design, but also in the express will to enforce them through national and departmental decrees and resolutions.

Of the official entities, the following merit specific mention:
Ministry of Housing, Land Management, and Environment (MVOTMA)
Ministry of Public Health (MSP)
Ministry of Livestock, Agriculture and Fisheries (MGAP)
Ministry of National Defense (MDN)
Ministry of Transportation and Public Works (MTOP)
Ministry of Industry, Energy, and Mining (MIEM)
National Administration of Fuel, Alcohol, and Cement (ANCAP)
Departmental Governments (IIMM)
Technological Laboratory of Uruguay (LATU)

Each of the aforementioned agencies participates in one way or another in the preparation of standards, rules, and technical regulations and in establishing conformity assessment systems. Regulatory authority with respect to food hygiene and health is vested exclusively in the Ministry of Public Health (MSP) and the Ministry of Livestock, Agriculture, and Fisheries (MGAP).

The Technological Laboratory of Uruguay (LATU) is responsible for issuing decrees on the mandatory quality certification of several export products (food, industrial items, consumer goods, etc.), as well as for the qualification of plants for food preparation.

Venezuela
Technical regulations and provisions inherent to the regulated market include laws, decrees, resolutions, etc. that emanate from the different branches of government, ministries, municipal governments and decentralized institutions. These regulations and provisions refer to goods, services and in some cases installations, as well as measures affecting health, safety, the environment and consumer information and protection.

 
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