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Proposed Regulations Impacting Trade and Exports
NIST is the home of the U.S. Inquiry Point to the World Trade Organization's Technical Barriers to Trade Agreement. The Inquiry Point monitors TBT activity globally; its Notify U.S. database reports on proposed technical regulations and standards in advance of adoption and implementation. 
| Country |
Notification |
Topic |
Date issued |
Comment Deadline |
| Canada |
CAN/361 |
Human blood
Canada
Human blood
Blood and blood components are currently regulated as drugs by a combination of provisions that are not specific to blood, found in several Divisions of Part C of the Food and Drug Regulations (FDR).
The purpose of this initiative is to introduce in the Food and Drugs Act (FDA) specific Regulations for human blood and its components intended for transfusion or for further manufacturing into human drugs. The proposed regulatory framework would address the safety, efficacy and quality of blood and its components with requirements related to the donor suitability assessment, collection, testing, labelling, storage, distribution and importation, for all establishments performing these activities. The proposed regulatory initiative would consolidate the existing requirements in new Regulations specific for blood and its components, apply to all establishments that perform any of the regulated activities, and apply the level of oversight that is commensurate with the level of risk of the activities performed by each establishment. |
3/22/2012 |
5/24/2012 |
| Canada |
CAN/357 |
Radio communications Equipment
Canada
Radio communications Equipment
Notice is hereby given by Industry Canada that the following radio standards specifications (RSSs) come into force effective immediately:
- Radio Standards Specification RSS-111, Issue 4: Broadband Public Safety Equipment Operating in the Band 4940-4990 MHz, which sets out the requirements for certification of radio transmitters and receivers in the band 4940-4990 MHz for public safety applications;
- Radio Standards Specification RSS-182, Issue 5: Maritime Radio Transmitters and Receivers in the Band 156-162.5 MHz, which sets out the requirements for certification of radio transmitters and receivers in the maritime service in the band 156-162.5 MHz; and
- Radio Standards Specification RSS-288, Issue 1: Global Maritime Distress and Safety System (GMDSS), which sets out the requirements for certification of the shipborne radio communication equipment that meets the requirements of the GMDSS.
RSS-111 was updated to clarify the requirements for equipment with multiple transmitters. RSS-182 was updated to provide the new requirements regarding the Automatic Identification
System (AIS SART). RSS-288 was renumbered from RSS-188 to reflect the numbering convention for licence-exempt equipment and to include the new requirements from international standards. |
2/14/2012 |
5/27/2012 |
| Canada |
CAN/362 |
Explosives
Canada
Explosives
The Explosives Regulations are out of date and make it difficult for regulatees to determine their obligations in order to comply with the Regulations. Several areas of industrial safety and security must be enhanced to be in line with industry best practices such as quality management systems and personnel training, and certain gaps must be filled in order to ensure an appropriate level of safety and security for the industry, its workers, and the public at large.
Modernization of the Regulations requires a complete rewrite of the legal text, and introduces a minimal number of new requirements. The Explosives Act and Regulations are outdated. The modernized Regulations would better reflect modern industry practices and standards.
With the exception of regulatory requirements related to the implementation of outstanding obligations under the Public Safety Act, the modernization initiative does not introduce new requirements other than changes to reflect modern practices. The most important changes being made are:
- Enhanced management of operating procedures for processes and better staff training;
- Requirement of fire safety plans and, under certain circumstances, of decommissioning plans;
- Tighter control on the packaging of consumer fireworks (e.g. roman candles, fountains);
- Distribution of safety information to consumers;
- Clarification of requirements applicable to retail sales establishments (e.g. requirement of displays for sale for consumer fireworks);
- Clarification and strengthening of requirements applicable to the use of consumer fireworks; and
- New packaging standards to be met by sellers of industrial explosives (e.g. sellers must mark licence or authorization number on inner packaging).
As well, the security of explosives is to be strengthened by:
- introducing a regime of export and in transit transportation permits and requiring importers and exporters to provide additional information;
- requiring a tracking and communication system in vehicles carrying large quantities of explosives;
- lowering magazine storage exemption limits, which will vary by type of explosive;
- requiring security plans detailing measures to be taken to prevent and react to security incidents;
- requiring a key control plan for licensed magazines; and
- requiring security screening of personnel who could have access to high hazard explosives types E (high explosives), I (initiation systems) and D (military and law enforcement explosives). |
4/4/2012 |
5/31/2012 |
| Canada |
CAN/363 |
On-road heavy-duty vehicles and engines
Canada
On-road heavy-duty vehicles and engines
Greenhouse gases (GHGs) are primary contributors to climate change. The most significant sources of GHG emissions are anthropogenic, mostly as a result of combustion of fossil fuels. The emissions of GHGs have been increasing significantly since the industrial revolution and this trend is likely to continue if no action is taken.
Transportation is one of the largest sources of GHG emissions in Canada, accounting for about 28% of total emissions in 2009. Heavy-duty vehicles accounted for around 7% of total GHG emissions or 24% of transportation emissions. Accordingly, taking action to reduce emissions from new on-road heavy-duty vehicles is an essential element of the Government of Canada's strategy to reduce air pollutant and GHG emissions to protect the environment and the health of Canadians.
The objective of the proposed Heavy-Duty Vehicles Greenhouse Gas Emission Regulations (the proposed Regulations), under CEPA 1999, is to reduce GHG emissions by establishing mandatory GHG emission standards for new on-road heavy-duty vehicles and engines of the 2014 and later model years that are aligned with U.S. standards. The development of common North America standards will provide a level playing field that will lead North American manufacturers to produce more advanced vehicles, which enhances their competitiveness.
The proposed Regulations would introduce progressively more stringent GHG emission standards for new on-road heavy-duty vehicles and engines that would align with the national GHG emission standards and test procedures of the United States Environmental Protection Agency for the 2014 and later model years. The proposed Regulations would apply to companies manufacturing and importing new on-road heavy-duty vehicles and engines for the purpose of sale into Canada. It would reduce greenhouse gas emissions from the whole range of new on-road heavy-duty vehicles from full-size pick-up trucks and vans to road tractors (i.e., semi-trucks) and buses, as well as a wide variety of vocational vehicles such as: freight, delivery, service, cement, garbage and dump trucks. The standards in the proposed Regulations would address emissions of CO2, N2O and CH4 from heavy-duty vehicles and engines and would also include measures to require reductions in leakage of the hydrofluorocarbon refrigerant used in cabin air-conditioning systems.
The proposed Regulations also include provisions that establish compliance flexibilities designed to provide appropriate lead-time for technological improvements and a smooth transition to a more stringent regulatory program. These flexibilities include a CO2 credit system for generating, banking and trading emission credits that could be used to offset any emission deficits incurred. Credits would be obtained by companies whose fleet emission levels fall below the applicable standard, while deficits would be incurred by companies whose fleet emissions exceed the applicable standard. Flexibilities also include additional credits for vehicles with advanced and innovative technology vehicles. Companies would also be required to submit annual reports and to maintain records relating to the GHG emission performance of their fleets. |
4/23/2012 |
6/13/2012 |
| Canada |
CAN/364 |
Prescription status of medicinal ingredients for human use and for veterinary use
Canada
Prescription status of medicinal ingredients for human use and for veterinary use
As part of the Jobs, Growth and Long-term Prosperity Act, the government of Canada is making amendments to the Food and Drugs Act to streamline the regulatory process to establish the prescription status of a drug while maintaining the same scientific rigour based on well-established and publicly available criteria.
These amendments found in Division 19 of Part 4 will permit the Minister of Health to establish a list of prescription drugs or classes of prescription drugs and to provide that the list may be incorporated by reference.
The proposed changes to the Food and Drug Act will make the process of assigning prescription status more efficient by removing the requirement for a regulatory amendment and maintaining the list of prescription drugs administratively.
These changes will not affect the way the sale, direct to consumer advertising, or importation of prescription drugs is managed in Canada. This new approach will not impact the safety and efficacy of drugs in Canada. All drug submissions to Health Canada will continue to be subject to rigorous safety, efficacy and quality assessments prior to approval. |
5/8/2012 |
7/2/2012 |
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