REGULATORY COOPERATION COUNCIL – Part Two

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Appendix 1: General Proposals on Regulatory Alignment

Although the RCC consultations submission proposals can be organized into four main themes (as described earlier and detailed in Annex 2), submissions also identified many other areas for enhanced regulatory alignment. Listed in the following is a summary of these recommendations.

Process and Approach to Regulatory Alignment

General Approach

In assessing priorities, quantify the potential benefits and risks of various options in order to maximize cost reductions and gains in economic growth while ensuring continued strong protection of public health and safety.

Use principles of rationalization and coherence, common sense implementation, and avoidance of unintended consequences to examine issues brought to the RCC.

Ensure that efforts designed to enhance alignment do not inadvertently create new barriers to trade for Canadian industries or cause disruption in domestic markets.

Insist that sound science and robust information support regulatory decision making.

Ensure that each government demonstrates transparency in drafting policy and regulatory initiatives.

Encourage greater continuity in North America regulatory activity and approaches, and expedite processes and rule making to match the speed of business in the global economy.

Undertake a complete review of all non-customs requirements for importing and exporting between countries, with the goal of aligning import and export requirements, and eliminate requirements where there are no identified health and safety or security concerns.

Single Window to Government

Align regulations and regulatory reporting processes across government agencies and departments, including implementing single-window reporting.

Develop one-window application processes, with subsequent approvals honoured by both countries.

Establishing Working Groups

Create an industry-government working group to discuss issues that might lend themselves to fairly rapid harmonization and mutual acceptance.

Recommend establishing working groups that focus on the following key sectors of our bi-national economy: agriculture, transportation, energy, and health and consumer products.

Establish a senior-level committee to provide oversight and coordinate cross-jurisdictional implementation of the RCC Joint Action Plan.

Information Sharing

Coordinate information gathering, data analysis and distribution activities to reduce duplication, enhance efficiency and foster cooperation across the Canada-U.S. border.

Establish clear procedures on how information may be shared and used by U.S. officials.

Ensure appropriate levels of privacy protection, in compliance with Canadian laws (e.g., the Personal Information Protection and Electronic Documents Act, or PIPEDA).

Ensure adequate protection of commercially sensitive data.

Develop common standards for secure information technology.

Horizontal Issues

Foster regulatory cooperation and alignment relating to nanotechnology.

Facilitate subsequent imports of the same product once initial requirements have been met (without having to fill out the same paperwork every time).

Eliminate redundant testing and certification requirements for previously examined products.

Review NAFTA's rules of origin requirements to facilitate compliance, especially for small businesses.

Roll back regulations and fees that impede supply chains.

Mandate the Standards Council of Canada and its U.S. counterpart to develop a standards and conformity assessment harmonization agenda.

Include a transparency clause in future trade agreements that would require the competent authority to notify any other competent authority whose responsibilities or workers may be affected by a Mutual Recognition Agreement being negotiated or changed.

Within Canada, revise the Competition Bureau's guidelines on using "Made in Canada" labelling for consumer products in order to align with requirements that apply to food products.

Other

Exempt Canada from the U.S. Foreign Account Tax Compliance Act.


Appendix 2: Specific Proposals by Sector

Agriculture and Food

Food Safety Systems

Develop common approaches to food safety requirements and policies, aligning new regulations and guidance—specifically, implementation of the U.S. Food Safety Modernization Act requirements.

Mutually recognize food safety systems.

Improve the effectiveness of meat-safety-system equivalency agreements (i.e., eliminate or minimize re-inspections of product and microbial testing at the border).

Accept industry-led standards and programs that are based on international standards (e.g., the Hazard Analysis Critical Control Point, or HACCP).

Harmonize approvals for food-safety-enhancing products and technology used in processing (e.g., packaging materials, anti-microbial interventions, testing methodologies and processes, sanitation, and maintenance chemicals and equipment).

Biotechnology

Establish a joint review process or a Mutual Recognition Agreement for biotechnology product approvals to facilitate synchronized approvals.

Establish a common policy for dealing with low level presence (LLP) of unapproved biotechnology products (e.g., harmonized risk assessments and acceptance of LLP already commercially available in the other country).

Agricultural Inputs

Building on significant collaboration to date, align pre-market approval processes and data requirements for crop protection products (i.e., pesticides, seed treatments) to facilitate joint reviews and assessments and improve re-evaluation and re-registration processes.

Resolve discrepancies in maximum residue limits for crop protection products.

Modify the U.S. Environmental Protection Agency (EPA) notice-of-arrival process to remove the advance notification requirement for products that are already EPA-registered.

Harmonize the approval process for veterinary drugs, including the establishment of maximum residue limits.

Labelling, Packaging and Product Content

Align nutritional labelling formats and content (e.g., nutrient definitions, required values, daily recommended intakes).

Harmonize approaches to allowed health claims.

Align standards for discretionary fortification of foods.

Develop uniform labelling requirements (e.g., quality specifications, method of production claims, glycemic index labelling).

Adopt a common approach to the nomenclature of meat cuts.

Eliminate or amend U.S. mandatory country-of-origin labelling requirements.

Align container size requirements (infant food, bottled and canned goods).

Export Certification

Implement complementary electronic certification systems in Canada and the U.S. for agricultural products.

Eliminate Canada's requirement for a veterinarian's signature on export certificates for meat and poultry products.

Animal and Plant Health

Agree on zoning for foreign animal diseases, with greater recognition of each country's ability to verify the absence of disease and its control.

Align traceability requirements for live animals.

Mutually recognize phytosanitary and zoosanitary inspections.

Harmonize crop pests and weed seeds regulations and standards to address the issue of the requirement to maintain the identity of screenings from bulk shipments.

Restore and/or facilitate market access for the following:

• Canadian small ruminants (sheep, goats);
• U.S. live hogs for slaughter in Canada; and
• Beef-containing pet food from Canada.

Harmonize livestock transportation standards training for truckers.

Animal Feed and Pet Food

Align product requirements for market authorization for animal feed ingredients and additives to facilitate joint Canada-U.S. U.S. animal feed product registration, in particular for high-risk ingredients.

Align definitions of specified risk materials to alleviate pet food ingredient supply pressures between Canada and the U.S.

Reduce border-crossing times for pet food from Canada to the U.S. by allowing pre-clearance and improving service standards for import permits.

Other

Adjust user fees of the U.S. Animal and Plant Health Inspection Service.

Address inequity created by the Marine Mammal Protection Act, which prevents Canadian access to the U.S. market relating to seal products, although products from Alaska move freely through U.S. markets.

Develop a protocol to manage agri-food trade during an emergency (e.g., pandemic).

Align financial risk mitigation tools for commercial transactions for fresh produce.

Adopt common approaches to bulk produce shipment requirements, removing the requirement for Ministerial exemptions.

Eliminate the monopoly of the Canadian Wheat Board.

Environment and Energy

Foster closer collaboration on climate policy through the following:

• Aligning greenhouse gas emission standards for vehicles and engines;
• Developing a broad bilateral energy and environment accord; and
• Harmonizing energy efficiency standards, e.g., developing a consistent approach to performance requirements, conformity assessment, and labelling of electrical and electronics products.

Harmonize regulations to support electric and other alternative energy vehicles.

Align chemicals management processes, including reviewing, permitting, labelling, reporting and timelines for implementation.

Streamline permissions for and construction of new cross-border energy infrastructure, e.g., a single Canada-U.S. regime for permitting oil and gas pipelines.

Ensure common approaches to nuclear liability, in the event of litigation arising from nuclear incidents.

Avoid policies that discriminate against particular fuel sources, such as low-carbon fuel standards (for types of crude oil) or renewable electricity standards (for large-scale hydro).

Transportation

Motor Vehicles

Establish a robust, enduring process to establish safety regulations that meet the needs of both countries, including a formal framework to coordinate research efforts and monitor progress.

Implement one set of common rules and regulations across North America for vehicle safety and emissions standards.

Align testing and certification requirements. There is a lack of reciprocal recognition of certification.

Align regulatory mechanisms for chemicals management for the vehicle manufacturing sector.

Align the Canada Motor Vehicle Safety Standards and the U.S. Federal Motor Vehicle Safety Standards and Regulations.

Work cooperatively in developing new standards and codes related to clean technologies for light-duty vehicles and heavy-duty vehicles with respect to liquefied natural gas, aerodynamic devices and electric vehicles.

Trucking

Align the different requirements for safety and hours of operation.

Align the different requirements for weight and dimension.

Revise regulations regarding in-transit shipments. If the carrier belongs to a customs supply chain security program, only high-level cargo descriptions should be required.

Review immigration laws and interpretations to enable a driver to move empty trailers in another jurisdiction to the pickup point of an export load to enhance efficiency.

Review proposed rules regarding sleep apnea.

Review rules regarding container residue.

Align regulations relating to the use of boat tails on transport trailers.

Marine

Harmonize safety, environmental and regulatory standards across both countries.

Harmonize and streamline reporting and vessel clearance requirements between both countries.

Align Canadian and U.S. marine security regulations.

Align small vessels construction standards (capacity labels).

Remove user fees as barriers to trade.

Increase icebreaking assets.

Streamline pilotage services.

Remedy the situation regarding double scanning or no scanning of ocean containers.

Give consideration to seaway infrastructure (maintenance, technology and research).

Regarding the Great Lakes and St. Lawrence region:

• Streamline reporting requirements for marine shipments within the Great Lakes region.
• Mutually recognize regulatory oversight regimes relating to Canadian and U.S. flagged vessels operating on the Great Lakes and the St. Lawrence Seaway;
• Harmonize environmental (ballast water management) and emissions requirements across the Great Lakes and the St. Lawrence Seaway; and
• Harmonize and streamline pilotage services.

Seek reciprocity for the Seafarer's Identification Document.

Align construction standards for pleasure craft (small vessels).

Harmonize ballast water regulations and remedy the State of New York's implemented ballast water management discharge standards.

Harmonize regulations for ship emissions, taking into account fleet requirements.

Air

Recommend that Canada and the U.S. sign a formal partnership on NextGen.

Streamline and harmonize security and facilitation protocols and align passenger baggage screening regulations.

Streamline and automate pre-enrollment border clearance processes.

Streamline regulations for passenger pre-clearance, watch lists and exit immigration controls.

Align cargo security regulations.

Dangerous Goods

Harmonize shipping requirements for dangerous or hazardous materials relating to shipping names, packaging and labelling, including mutual recognition for tank repairs.

Rail

Regarding locomotive emissions, align regulations on locomotive air contaminants and greenhouse gas emissions.

Health and Consumer Products

Leverage Canadian and American scientific capacities by aligning research, review and approval processes to reduce duplication:


• Establish a joint electronic submission gateway for pharmaceutical products.

• Establish a mutual reliance agreement for sharing scientific analyses that support regulatory decision making while protecting trade secrets and confidential business information.

• Establish mutual reliance on equivalent good manufacturing practices in each country.

• Mutually recognize product claims that can be substantiated scientifically by the manufacturer.

• Deem as acceptable in Canada and the U.S. consumer health products that meet U.S. Food and Drug Administration and Health Canada requirements.

Standardize regulatory classifications and definitions for therapeutic and personal care products.

Align with the American over-the-counter monograph system as an official reference for personal-care imported products and develop common monographs for therapeutic products.

Establish mutual recognition regarding inspections and certification:

• Establish mutual reliance on each country's good manufacturing processes and collaborate on ensuring any third-party country's compliance and enforcement to avoid duplicative inspections.

Establish uniform labelling requirements, including alignment of the following:

• Health claims;
• Medicinal ingredients;
• Ingredient nomenclature;
• Warnings and classifications;
• Expiration dating practices; and
• Lot number configuration.

Standardize security packaging closures based on product risk.

Align toy safety regulations and standards with international or bilateral norms, especially relating to the following:

• Lead levels;
• Testing methodology;
• Magnets or magnetic compounds;
• Mechanical and electrical hazards;
• Acoustics; and
• Flammability.

Synchronize hazard classification and communication standards for chemicals and hazardous materials:

• Align regulations relating to hazard classification (including types of hazard statements that must be on a controlled product label, hazard symbols, and requirements associated with mandatory hazard communication information);

• Ensure synchronicity in regulatory changes and harmonization of labelling elements to the U.S. Occupational Safety and Health Administration and the Canadian Workplace Hazardous Materials Information System during implementation of the Globally Harmonized System (GHS) for the Classification and Labelling of Chemicals; and

• Standardize the format of material safety data sheets through the formal recognition of GHS Material Safety Data Sheets.

Coordinate standard setting with respect to the following:

• The development of common standards in new and emerging areas; and
• The equivalency of existing standards.

Align exemptions relating to export controls for products covered by the International Traffic in Arms Regulations (ITAR) by pursuing a clear exemption in the ITAR for a Canadian company that is registered under the Controlled Goods Program.

Align export controls regarding cryptography products and equipment.

Foster alignment in product safety, including the following:

• Alignment of global mandatory incident requirements;

• synchronized required reporting period; and

• common approach to privacy issues.

Foster North American alignment with respect to the creation and management of common standards and regulations for electrical and plumbing products.

Appendix 3: Organizations That Provided Consultation Submissions

The following companies and associations provided comments to the RCC consultation process, or provided input to consultations by the Beyond the Border Working Group on issues relevant to the work of the RCC:

• 3M Canada
• Aerospace Industries Association of Canada
• Animal Nutrition Association of Canada
• Association of Canadian Port Authorities
• Association of Equipment Manufacturers
• Association of International Automobile Manufacturers of Canada
• Bayer CropScience Canada
• Borderpol
• Canada's Research-Based Pharmaceutical Companies
• Canadian Appliance Manufacturers Association
• Canadian Association of Importers and Exporters (I.E. Canada)
• Canadian Business Aviation Association
• Canadian Cattlemen's Association
• Canadian Chamber of Commerce
• Canadian Civil Liberties Association
• Canadian Consumer Specialty Products Association
• Canadian Cosmetic, Toiletry and Fragrance Association, together with the U.S. Personal Care Products Council and the Mexican Cámara Nacional de la Industria de Productos Cosméticos
• Canadian Council of Chief Executives
• Canadian Energy Pipeline Association
• Canadian Federation of Agriculture
• Canadian Federation of Independent Business
• Canadian Gas Association
• Canadian Generic Pharmaceutical Association
• Canadian Horticultural Council
• Canadian Institute of Plumbing and Heating
• Canadian International Freight Forwarders Association Inc.
• Canadian Manufacturers and Exporters
• Canadian Manufacturing Coalition
• Canadian Meat Council, together with the American Meat Institute
• Canadian Nuclear Association
• Canadian Oilseed Processors Association
• Canadian Parks and Wilderness Society
• Canadian Pork Council
• Canadian Produce Marketing Association
• Canadian Propane Association
• Canadian Shipowners Association
• Canadian Society of Customs Brokers
• Canadian Supply Chain Food Safety Coalition
• Canadian Toy Association, together with the Toy Industry Association Inc.
• Canadian Trucking Alliance
• Canadian Vehicle Manufacturers' Association
• Canola Council of Canada
• Capilano Rock and Gem
• Certified General Accountants Association of Canada
• Chamber of Marine Commerce
• Consumer Health Products Canada
• Council of Great Lakes Industries
• CropLife Canada
• Electro-Federation Canada
• Fisheries Council of Canada
• Food and Consumer Products of Canada
• Food Processors of Canada
• Fraser Institute
• International Air Transport Association
• National Airlines Council of Canada
• National Marine Manufacturers Association
• Pacific NorthWest Economic Region
• Public Border Operators Association
• Pulse Canada
• Railway Association of Canada
• Retail Council of Canada
• St. Lawrence Seaway Management Corporation
• Shipping Federation of Canada
• Standards Council of Canada
• Tea Association of Canada
• The Conference Board of Canada
• Wild Bird Trading Company Ltd.