Regulatory
REGULATORY NEWS FOR WEEK OF MAY 21, 2020
Canadian Federal News
Health Canada continues to work closely with the Public Health Agency of Canada, which is leading the COVID-19 public health response and pandemic planning as well as with provincial, territorial and international partners to monitor and respond to this evolving situation.
Health Canada is aware of challenges encountered when shipping medications as shipping modes and routes have been affected by the COVID-19 pandemic. This may lead to Canadian suppliers having to use new shipping modes or routes. Please ensure such changes are evaluated in accordance with Quality Risk Management (QRM) principles and consider the following:
- Evaluate the new shipping route/mode to determine potential risks and potential extreme environmental conditions.
- Review known information about the product, such as all stability data and freeze/thaw and high temperature cycling studies, where available. Note: If wholesalers do not have access to such information, they should seek guidance and recommendations from their suppliers.
- Apply mitigation strategies for any identified risks. This should include a consideration to increase temperature monitoring points throughout the load to better assess transportation conditions.
- Review and update your risk evaluations periodically.
Health Canada is aware that, due to the pandemic, you may be experiencing additional challenges such as; unavailability of temperature mapped vehicles and containers, a potential lack of warehouse space, and a lack of personnel to conduct required qualification and calibration activities. Please consider the following to mitigate these challenges:
- Conduct a QRM assessment to determine if distribution equipment and facilities can be used in an expedited manner with limited qualification and validation. In such cases, additional mitigation steps (e.g. increased temperature monitoring) may be required. Any remaining qualification and validation work should be completed as soon as possible.
- Defer periodic calibration requirements when there is a minimal risk of failure per a QRM assessment. You should continue to check devices periodically to ensure they are working within established temperature and humidity limits.
During the pandemic, you may have a significant number of staff working from home and quality and service consultants not able to visit sites. Health Canada understands that this is creating difficulty as not all companies have the appropriate controls in place for electronic signatures as per Good manufacturing practices guide for drug products (GUI-0001). In response to such challenges, Health Canada will not object to the implementation of electronic records and systems that do not fully meet Good manufacturing practices guide for drug products (GUI-0001) provided that steps are taken to ensure their authenticity. Examples of such steps include:
- Ensure all electronic signatures are controlled and fully attributable to the person signing the record.
- Ensure all personnel understand the meaning of electronic signatures.
- Ensure all electronic signatures are dated. Electronic signatures should also be time-stamped, where possible.
Important: It remains the responsibility of the Canadian Quality Control department to ensure all drug product complies with the Food and Drugs Act, the Food and Drug Regulations and applicable marketing authorizations.
According to Statistics Canada, demand for hand sanitizer increased by 735% for the week ending March 14, 2020, relative to the same period last year[1]. Additionally, a large number of companies that were not manufacturing hand sanitizers and disinfectants had expressed interest in doing so to support the COVID-19 response efforts. To support this, Health Canada introduced a number of interim policy measures to boost supply of these products in Canada.
In light of the short-term success in meeting an unprecedented demand and urgent need for disinfectants and hand sanitizers during the COVID-19 pandemic, this interim measure on bilingual labelling is being lifted. Effective immediately, all new Canadian manufacturers are required to use bilingual labelling on their hand sanitizer products. Canadian manufacturers of hand sanitizers who are currently licensed and are using unilingual labelling under this interim measure will be required to adopt bilingual labelling no later than June 8, 2020, consistent with the Natural Health Product Regulations (NHPR).
Canadian Provincial News
On May 3, a ministerial order took effect that temporarily amends the OHS Code during the COVID-19 public emergency. This amendment lists specific respirator standards, approved for use in other countries, that employers can use without needing to request an approval.
WorkSafeBC has released industry-specific guidance and resources for employers resuming operations as part of phase 2 of the provincial government’s restart plan.
58 new inspectors will join the hundreds of existing provincial labour inspectors on the ground. The inspectors, which include workers from the Technical Standards and Safety Authority (TSSA) and the Ontario College of Trades (OCOT), will be tasked with communicating COVID-19 safety guidelines to essential workplaces or enforcing emergency measures, including physical distancing and the closure of non-essential businesses.
Protecting employees in the face of unprecedented demand for personal protective equipment (PPE) is a challenge facing workplaces in every industry sector. N95 protectors are not so much masks as “particulate filtering facepiece respirators.” These single-use, disposable respirators filter airborne particulates and aerosols in the air around us, whereas the blue surgical masks and cloth masks prevent wearers from ejecting particles of saliva, and reduce the probability that users will touch their face. Regardless of the PPE you choose, it’s effective only if people wear it correctly. Ensure PPE training includes the fit, use, care, putting on and taking off, maintenance, cleaning and limitations of the PPE. Provide and maintain appropriate containers for disposal of used PPE.
US News
The U.S. Environmental Protection Agency (EPA) took the next step to implement an important per- and polyfluoroalkyl substances (PFAS) requirement of the National Defense Authorization Act (NDAA). The NDAA added 172 PFAS to the list of chemicals required to be reported to the Toxics Release Inventory (TRI) and established a 100-pound reporting threshold for these substances. The agency is publishing a final rule that officially incorporates these requirements into the Code of Federal Regulations for TRI.
The Environmental Protection Agency (EPA) s proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances which are the subject of premanufacture notices (PMNs). This action would require persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use by this proposed rule. This action would further require that persons not commence manufacture or processing for the significant new use until they have submitted a Significant New Use Notice, and EPA has conducted a review of the notice, made an appropriate determination on the notice under TSCA, and has taken any risk management actions as are required as a result of that determination. DATES: Comments must be received on or before June 18, 2020.
The Federal Motor Carrier Safety Administration (FMCSA) hereby declares that a national emergency continues to exist that warrants extension of Emergency Declaration No. 2020-002 issued on March 13, 2020, expanded on March 18, 2020, and extended and further expanded on April 8, 2020. This extension continues the exemption granted from Parts 390 through 399 of the Federal Motor Carrier Safety Regulations (FMCSRs) for the fifty States and the District of Columbia. This Declaration extends the exemption through June 14, 2020.
The U.S. Department of Transportation’s Federal Motor Carrier Safety Administration (FMCSA) today published a final rule updating hours of service (HOS) rules to increase safety on America’s roadways by updating existing regulations for commercial motor vehicle (CMV) drivers.
Based on the detailed public comments and input from the American people, FMCSA’s final rule on hours of service offers four key revisions to the existing HOS rules:
- The Agency will increase safety and flexibility for the 30-minute break rule by requiring a break after 8 hours of consecutive driving and allowing the break to be satisfied by a driver using on-duty, not driving status, rather than off-duty status.
- The Agency will modify the sleeper-berth exception to allow drivers to split their required 10 hours off duty into two periods: an 8/2 split, or a 7/3 split—with neither period counting against the driver’s 14‑hour driving window.
- The Agency will modify the adverse driving conditions exception by extending by two hours the maximum window during which driving is permitted.
- The Agency will change the short-haul exception available to certain commercial drivers by lengthening the drivers’ maximum on‑duty period from 12 to 14 hours and extending the distance limit within which the driver may operate from 100 air miles to 150 air miles.
International News
To speed up identifying and managing the risks of hazardous chemicals, ECHA is screening structurally similar substances in groups. Last year, the Agency together with national authorities reviewed around 220 high-volume substances of which 56 % needed more hazard data.
Our step by step guide on how to categorise your chemical importation or manufacture (introduction) is now available for you to read and download.
Other Relevant Information
Safety Share
If you’re up for the challenge, complete the activities below. You’ll be an expert in no time. We love to see young scientists in action. Share photos of your progress on social media using #JuniorCFIA and show us what you’re up to!
Canadian Centre for Occupational Health and Safety – Use these tools to help you plan, prepare, prevent and protect against infectious disease outbreaks and pandemics.
According to NFPA, cooking equipment is the leading cause of U.S. home fires overall, annually contributing to nearly half (49 percent) of all home fires. NFPA estimates show that between 2014 and 2018, an annual average of 10,600 home fires involving grills, hibachis, or barbecues, resulting in 10 civilian deaths, 160 civilian injuries, and $149 million in direct property damage. July is the peak month for grilling fires, followed by June, May, and August.
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