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In-Depth Standards Resources
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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/379 |
Passenger cars and light trucks (13.040, 43.080, 43.100)
Canada
Passenger cars and light trucks (13.040, 43.080, 43.100)
Greenhouse gases (GHGs) are primary contributors to climate change. The most significant sources of anthropogenic GHG emissions are a result of the combustion of fossil fuels, including gasoline and diesel. The Government of Canada has a plan to reduce national GHG emissions based on a sector-by-sector regulatory approach.
The transportation sector is a significant source of GHG emissions in Canada, accounting for 24% of total emissions in 2010. In that year, passenger automobiles and light trucks (hereinafter referred to as light-duty vehicles) accounted for approximately 13% of Canada's total GHG emissions or 53% of transportation emissions. Taking action to reduce GHG emissions from new light-duty vehicles is an important element of the Government's plan to introduce an integrated, nationally consistent approach to reduce GHG emissions.
The proposed Regulations Amending the Passenger Automobile and Light Truck Greenhouse Gas Emission Regulations (2017-2025) [hereinafter referred to as the proposed Regulations] would build on the success of the current Regulations covering model years 2011 through 2016. The proposed Regulations have been developed in collaboration with the United States Environmental Protection Agency (U.S. EPA) to ensure alignment of Canada's regulations with those of the United States in a manner that is consistent with the authorities provided under the Canadian Environmental Protection Act, 1999 (CEPA 1999). The proposed Regulations would continue to apply to companies that manufacture or import new light-duty vehicles into Canada for the purpose of sale to the first retail purchaser. Similar to the current Regulations, the proposed Regulations would establish progressively more stringent annual fleet average GHG emission standards over the 2017 to 2025 model years, while providing companies with flexibility mechanisms to allow them to comply in a cost-effective manner.
Note: In October 2010, the Government of Canada published the final Passenger Automobile and Light Truck Greenhouse Gas Emission Regulations (herein referred to as the current Regulations) covering new vehicles of model years 2011 through 2016, under CEPA 1999 (notified as G/TBT/N/CAN/312/Add.1). These Regulations prescribe progressively more stringent annual emission standards for new light-duty vehicles of model years 2011 to 2016, in alignment with those of the United States.
Also in October 2010, the Government of Canada published a Notice of Intent to continue working with the United States and build upon the standards already in place to develop more stringent GHG emission standards for new light-duty vehicles of model years 2017 and beyond. The NOI was notified as G/TBT/N/CAN/312/Add.2. |
1/8/2013 |
2/21/2013 |
Canada |
CAN/380 |
Prescription status of medicinal ingredients for human use
Canada
Prescription status of medicinal ingredients for human use
The Food and Drug Regulations (Subsection C.01.040 (b)) prohibit manufacturers or importers from selling a drug for human use that contains arsenic or any of its salts or derivatives. Clinical trials showed that arsenic trioxide is highly effective when used as a treatment for patients with relapsed acute promyelocytic leukemia (APL).
This proposal would exempt the sale of a drug that contains arsenic trioxide as a medicinal ingredient from the prohibition contained in subsection C.01.040 (b) of the Regulations.
This amendment would also add arsenic trioxide when used as a medicinal ingredient to Part I of Schedule F to the Regulations. Schedule F to the Food and Drug Regulations lists medicinal ingredients that are required to be sold pursuant to a prescription when sold as a drug in Canada. Arsenic trioxide is proposed to be sold pursuant to prescription because direct supervision by a practitioner is required along with routine medical monitoring. As with all antineoplastic agents, there are potential or known undesirable or severe side effects at normal therapeutic dosage levels.
Market approval for arsenic trioxide pursuant to a prescription has been granted by the United States Food and Drug Administration, the European Medicines Agency and the Therapeutic Goods Administration of Australia.
7 |
1/8/2013 |
2/28/2013 |
Canada |
CAN/381 |
Controlled substances (HS 1211)
Canada
Controlled substances (HS 1211)
Marihuana (cannabis) is categorized as a controlled substance, regulated in Canada under the Controlled Drugs and Substances Act (CDSA).
In 2001, the Marihuana Medical Access Regulations (MMAR) were promulgated. The MMAR sets out a scheme for Canadians to access marihuana for medical purposes, if they have the support of a medical practitioner.
Growth in Program participation has had unintended consequences for the administration of the MMAR, but more importantly, for public health, safety and security as a result of authorizing individuals to produce marihuana in private dwellings.
The proposed Marihuana for Medical Purposes Regulations (MMPR) would authorize the following key activities:
- the possession of dried marihuana by individuals who have the support of an authorized health care practitioner to use marihuana for medical purposes;
- the production of dried marihuana by licensed producers only; and
- the direct sale and distribution of dried marihuana by specific regulated parties to individuals who are eligible to possess it.
Security requirements would be in place for the production site and key personnel of the licensed producer. Standards for packaging, transportation and record-keeping would contribute to achieving security objectives. Quality and sanitation standards appropriate for a product for medical use will be in place.
Licensed producers would be permitted to engage in the import or export of marihuana if they have obtained an import or export permit from Health Canada. The import/export permit scheme would be similar to that for other controlled substances and is intended to maintain control over the movement of controlled substances, consistent with Canada's obligations under international conventions on the control of narcotic drugs and psychotropic substances.
The proposed MMPR include a number of consequential changes to the MMAR, as well as two transitional registration schemes, that would allow for gradual transition to the new regulatory regime. The MMAR would be repealed on 31 March 2014. |
1/8/2013 |
2/28/2013 |
Canada |
CAN/382 |
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
Schedule F to the Food and Drug Regulations
lists medicinal ingredients that are required to be sold pursuant to a prescription when sold as a drug in Canada. Currently, adding or removing medicinal ingredients to Schedule F requires changes to regulations following a well-established scientific review process.
Following the targeted amendments to the Food and Drugs Act that were signed into law on
29 June 2012 as part of the Jobs, Growth and Long-term Prosperity Act (Bill C-38), the
Government of Canada now has the ability to streamline the regulatory process to establish
the prescription status of a drug while maintaining the same scientific rigor based on well-established and publicly available criteria. This was previously notified under G/TBT/N/CAN/364.
Regulatory amendments are required to bring into force of the recent legislative updates. The
proposed regulations would repeal Schedule F and incorporate a web-based Prescription Drug
List (PDL) that is to be established by the Minister in accordance with the enabling
amendments to the Food and Drugs Act. They would also provide the scientific criteria the
Minister must consider in maintaining the PDL. The proposed overarching scientific criteria
would support the existing Schedule F criteria and ensure that the scientific basis for
assigning prescription status remain the same.
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. |
1/11/2013 |
3/7/2013 |
Canada |
CAN/383 |
Radiocommunications equipment
Canada
Radiocommunications equipment
Notice is hereby given by Industry Canada that the following Radio Standards Specifications (RSSs) come into force effective immediately: -Radio Standards Specification RSS-132, Issue 3: Cellular Telephone Systems Operating in the Bands 824-849 MHz and 869-894 MHz, which sets out the certification requirements for transmitters and receivers for cellular telephone systems in the bands 824-849 MHz and 869-894 MHz; and -Radio Standards Specification RSS-133, Issue 6: 2 GHz Personal Communications Services, which sets out the certification requirements for transmitters and receivers used in radiocommunications systems to provide personal communications services (PCS) in the bands 1850-1915 MHz and 1930-1995 MHz. |
2/7/2013 |
5/26/2013 |
For full access to notifications, please visit Notify U.S.
Workshops and Events
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