Regulatory
REGULATORY NEWS FOR WEEK OF JULY 23, 2020
Canadian Federal News
GUI-0005 is a revised version of the currently posted document replacing PIC/S Annex 1: Explanatory Notes for Industry on the Preparation of a Site Master File document (January 18, 2008). GUI-0005 will be implemented effective immediately as it will help you prepare a site master file.
This guide is based on the Pharmaceutical Inspection Cooperation Scheme (PIC/S) document Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File (SMF) (PE 008-4). This guide reflects changes necessary to adapt the text of the PIC/s document to meet Canadian requirements.
Work on the Canadian Environmental Protection Act, 1999 (CEPA) reform and renewal of the Chemicals Management Plan (CMP) is continuing. The Government of Canada, through public statements such as Ministerial Mandate letters (also here), has committed to strengthening CEPA.
This work remains focused along the lines described in the June 2018 Follow-Up Report to the House of Commons Standing Committee on Environment and Sustainable Development on the Canadian Environmental Protection Act, 1999. Since the publication of that Report, there have been a number of changes in Canada and throughout the world resulting from the COVID-19 pandemic. In light of this, we are reaching out to see if any of these changes have affected your views on CEPA reform or CMP renewal.
Please let us know if you have any comments or concerns regarding the reform of CEPA or CMP renewal at this time by sending an email to [email protected].
The Minister of the Environment hereby varies Significant New Activity Notice No. 16528, pursuant to subsection 110(2) of the Canadian Environmental Protection Act, 1999, in accordance with the Annex.
It is proposed to conclude that MEA, DEEA, LME, DEA, LDE, CDE, CADEA, TADEA, TEA, TIPA and BATEA do not meet the criteria under paragraph 64(c) of CEPA, as they are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.
While exposure of the general population to DEA, LDE, CDE and TEA is not of concern at current levels, these substances are associated with human health effects of concern. Therefore, there may be concerns if exposure were to increase. Follow-up activities to track changes in exposure or commercial use patterns are under consideration.
Stakeholders are encouraged to provide, during the 60-day public comment period on the draft screening assessment, any information pertaining to the substances that may help inform the choice of follow-up activity. This could include information on new or planned import, manufacture or use of the substances, if the information has not previously been submitted to the ministers.
The Canada–United States–Mexico Agreement (CUSMA)—aka, “the new NAFTA”—creates big advantages for small and medium‑sized enterprises (SMEs). Rules of origin have changed in a few other sectors as well. Clients are encouraged to review the Annex to Chapter 4 for information on rules of origin that may be applicable to their goods.
This notice is to inform importers and brokers that the Canadian Food Inspection Agency has successfully updated the Automated Import Reference System (AIRS) to include the Safe Food for Canadians (SFC) licence requirement for the Manufactured food commodities that now require a SFC licence. However, as announced on April 7, 2020, the CFIA will not prioritize compliance activities related to these requirements during the pandemic.
Due to the numerous changes to the AIRS database, we encourage the users to consult AIRS to view the most recent updates to the CFIA regulated food products and to obtain pertinent information. For those importers/brokers using the AIRS Verification Service (AVS), AVS currently reflects all updated AIRS information. For more information regarding the HS codes being changed, see Changes to harmonized system (HS) codes.
Canadian Provincial News
Bill 32, the Restoring Balance in Alberta’s Workplaces Act would support economic recovery, restore balance in the workplace and get Albertans back to work. If passed, Bill 32 will provide employees and employers with clearer and more transparent rules promoting fairness and productivity, including more clarity about rest periods and temporary layoff notices. More than 5,000 responses were gathered from Albertans during our employment standards engagement.
Automated Speed Enforcement (ASE) is an automated system that uses a camera and a speed measurement device to detect and capture images of vehicles travelling in excess of the posted speed limit. It is designed to work in tandem with other methods and strategies, including engineering measures, education initiatives and traditional police enforcement. ASE is focused on altering driver behaviour to decrease speeding and increase safety.
Effective July 1, 2020, Regulation 833 is amended by O. Reg. 449/19 to reflect the adoption of new or revised occupational exposure limits (OELs) or listings for 36 chemical substances based on recommendations by the American Conference of Governmental Industrial Hygienists (ACGIH). An overview of these changes is given below:
- addition of listings for 7 substances in regulation: boron trichloride, calcium silicate (naturally occurring as wollastonite), hard metals (containing cobalt and tungsten carbide), simazine, acetamide, cadusafos, and folpet
- revisions to exposure limits or listings for 19 substances currently regulated: boron tribromide, boron trifluoride, n-butyl acetate, sec-butyl acetate, tert-butyl acetate, isobutyl acetate, cyanogen, propoxur, triorthocresyl phosphate, warfarin, captafol, β-chloroprene, ethylene glycol, furfural, furfuryl alcohol, hexylene glycol, phthalic anhydride, stearates, and tungsten
- removal of listing and OEL for 1 substance: calcium silicate (synthetic nonfibrous)
- addition or removal of notations for 9 substances: acetylene, butane (all isomers), 2,4-D, ethane, hydrogen, liquefied petroleum gas, methyl acetylene, methyl acetylene-propadiene mixture, and propane
In addition to the changes noted above, effective January 1, 2020, the ministry has updated the frequency of medical surveillance for asbestos-exposed workers subject to O. Reg. 278/05, in order to harmonize these requirements with provisions that apply to asbestos-exposed workers subject to O. Reg. 490/09. For more information read the amending regulation, O. Reg. 450/19.
The Ontario government is providing employers with a new general workplace guide, which will help them develop a safety plan to better protect workers, customers and clients. The new guide will help each employer create a safety plan that is right for their own unique workplace. It includes information on the use of face coverings, as well as applying controls in the workplace, from most important to least important. It also includes information on what personal protective equipment may be needed for workers.
he Ontario government has released a new online tool that provides the people of Ontario and businesses with information about highway projects in their communities, including the status of projects that are already underway and major construction projects slated for the future. The new online tool is part of the government’s plan to keep highways safe and reliable, while supporting economic growth and job creation across the province.
Your responsibility as an employer is to take every reasonable precaution to ensure the health and safety of your employees. Ensuring that your employees and supervisors understand their responsibilities to minimize exposure to COVID-19 is essential for maintaining a safe workplace. You’re also obligated to ensure your entire team understands and complies with the safety measures you have put in place. No matter what your risk level and choice of measures, training, communication and documentation are critical to prevent the transmission of COVID-19
US News
The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has undertaken a public service messaging effort to remind workers that the agency is committed to ensuring their safety and health during the coronavirus pandemic.
OSHA is using public service audio announcements in English and Spanish, as well as bilingual digital and print billboard messaging, to encourage employees to contact OSHA with their concerns about workplace safety amid the coronavirus pandemic. Billboards will appear in states under federal OSHA jurisdiction.
U.S. Environmental Protection Agency (EPA) Administrator Andrew Wheeler joined Liz Claman on Fox Business to discuss deregulation and environmental progress. To date, EPA has finalized 64 deregulatory actions, saving an estimated $94 billion while combined emissions of criteria pollutants and their precursors dropped 7% under President Trump.
The U.S. Environmental Protection Agency (EPA) took another important step toward implementing Administrator Andrew Wheeler’s directive to reduce animal testing by releasing a new guidance that reduces unnecessary testing on fish.
The U.S. Environmental Protection Agency (EPA) is correcting existing regulatory language for the Toxics Release Inventory (TRI) Program. EPA is making corrections that update identifiers, formulas, and names for certain TRI-listed chemicals, and updating the text that identifies which chemicals the 0.1 percent de minimis concentration applies to in order to remedy a cross-reference to a no-longer-accurate Occupational Safety and Health Administration (OSHA) regulatory citation. These corrections maintain previous regulatory actions and do not alter existing reporting requirements or impact compliance burdens or costs. This final rule is effective on 14 July 2020.
International News
New substance evaluation conclusion documents are now available on ECHA’s website for:
- Di-tert-butyl peroxide (EC 203-733-6, CAS 110-05-4), added to the CoRAP list in 2016 and evaluated by Netherlands; and
- Biphenyl (EC 202-163-5, CAS 92-52-4), added to the CoRAP list in 2013 and evaluated by Portugal.
The progressive substitution of SVHCs with suitable alternatives is one of the key objectives of authorization under REACH. Substitution is directly linked with the main objectives of REACH – ensuring a high level of protection for human health and the environment. It also contributes to the overarching EU objectives for a non-toxic environment and a circular economy by progressively replacing harmful substances with more sustainable alternatives. Of the 131 received answers, 34 % (45) indicated that their company had already substituted the use(s) of a substance of concern, while 26 % (34) were in the process of substituting and 29 % (38) had plans to substitute in the future. Finally, 11 % of the respondents (14) indicated that they had no plans to substitute.
Other Relevant Information
Safety Share
The COVID-19 global pandemic has created new challenges for workplaces and workplace inspections are changing to adapt to the new reality and the risk posed to workers. Amy Campbell, Health and Safety Program Manager at the Canadian Centre for Occupational Health and Safety, discusses how workplace inspections have changed during the current pandemic.
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