COVID-19 Regulatory Developments: Update 19
The outbreak of the COVID-19 pandemic has resulted in countries adapting their regulatory landscape to accommodate and mitigate the unprecedented disruptions to companies and individuals. Through regular updates, Compliance & Risks will closely monitor the situation and inform our clients of the latest global regulatory developments in relation to COVID-19 relevant to their topics, along with updates on items which may be of interest outside our topics.
EH&S Occupational Health and Safety
On 29 October 2020, the EU Commission issued a roadmap for a Strategic Framework on Health and Safety at Work for the period 2021-2027. The roadmap is currently open for a four week public consultation period. The strategy aims at maintaining and improving high occupational health and safety (OHS) standards for workers across the Union taking into account the new circumstances of the pandemic and the need to prepare for upcoming new crisis and threats, by reducing accidents at work and work-related diseases. The new strategy should trigger the adoption or revision of national OH&S strategies with a view to support a coherent policy framework and coordinated actions of Member States and stakeholders across the EU. Interested parties must submit their feedback via the following webpage.
On 23 October 2020, the Oregon Occupational Safety and Health (OSHA) released a fourth draft infectious disease rule to reflect recent revisions to the Oregon Health Authority guidance on face coverings. The rule is applicable to all workplaces and workers subject to the Oregon OSHA’s jurisdiction. Employers will be required to quickly adapt to the new requirements by developing and implementing a COVID-19 exposure risk assessment and an infection control plan within a month following the adoption of the rule. The exposure assessment shall be conducted “without regard” to the use of personal protective equipment and face coverings. All workplaces shall organize work activities and workflow in such a way as to ensure six-foot physical distancing between employees unless it can be demonstrated that physical distancing is not feasible for certain activities. Face masks, face coverings or face shields shall be provided at no cost to all employees. Further details may be found here.
The Oregon Health Authority has, once again, updated its state-wide guidance on face coverings. The guidance only concerns a limited number of businesses. The Health Authority now strongly recommends the use of face masks, face coverings or face shields in all indoor work areas unless employees, contractors or volunteers do not have a job which requires interacting with the public or other co-workers, and a minimum six feet social distance can be maintained between individuals. Businesses and persons responsible for public and private workplaces shall provide masks, face coverings or face shields to their employees. OSHA recommends the use of face masks and clarifies that face shields alone should be limited to situations when wearing a mask or a face covering is not feasible, for example, due to a medical condition.
At Federal level, the U.S. Occupational Safety and Health Administration (OSHA) has revised its COVID-19 Frequently Asked Questions (“FAQ”) to further clarify the reporting obligations of employers for work-related fatality or in-patient hospitalization for employees with confirmed, work-related COVID-19 cases.
Turkey has amended its national Labor Law No. 4857 to introduce temporary layoff protection in the context of COVID-19. As per new Article 10, the termination of any type of employment agreement, whether under the scope of the Labor Law or not, is prohibited from 17 November 2020 until 17 January 2021. Exceptions are allowed in specific circumstances where employee behavior contradicts the rules of ethics and goodwill, or in the specific cases provided for under Article 25(II) of the Labor Law. In addition to this, entitlements of furlough have been extended for an additional two month period ending on 17 January 2021.
In Ontario, Workplace Safety & Prevention Services has developed a short questionnaire to assist workplaces in pre-screening visitors for symptoms of COVID-19. With this respect, WSPS has also developed a guide to help determine whether face coverings are appropriate in the workplace. The Ontarian Ministry of Labor, Training and Skills Development has updated the Health & Safety Prevention Poster to outline the rights and responsibilities incumbent on workers, supervisors and employers respectively under the Occupational Health and Safety Act.
Ontario Regulation 364/20 as amended by Ontario Regulation 530/20 requires businesses or organizations that remain open during the pandemic to operate in compliance with the advice, recommendations and instructions issued by the Office of the Chief Medical Officer of Health on screening individuals. The instruction of the Chief Medical Officer includes the recommendations set out in COVID-19 Screening Tool for Workplaces (Businesses and Organizations). Failure to use the tool will give rise to significant fines.
On 20 October 2020, Ontario introduced Bill 218, Supporting Ontario’s Recovery and Municipal Elections Act, 2020, to provide Ontario businesses with protection against lawsuits relating to COVID-19 infection or exposure. If passed, liability protection against COVID-19 related lawsuits would apply to businesses and workers who “acted or made a good faith effort” to follow public health guidelines and laws. The Bill includes a number of exceptions. It specifically excludes circumstances where the act or omission of a person constitutes a gross negligence. Moreover, the Bill does not preclude causes of actions resulting from the act or omission of a person whose operation was required to close under an existing law. Protection from liability would not apply to actions brought by a worker employed by a Schedule 1 employer or Schedule 2 employer within the meaning of the Workplace Safety and Insurance Act, 1997. Broad exceptions also include exposures (actual or potential) or infections “that occurred in the course, or as a result of, employment with a person or in the performance of work for or supply of services to a person”.
Temporary and permanent legislative amendments were passed in May 2020 under the Ontario Business Corporations Act and the Corporations Act to help businesses continue to operate while enforcing physical distancing. These changes enable corporations to call and hold virtual meetings. These amendments also provide individuals, corporations and other businesses with flexibility to defer annual meetings, and utilize electronic signature on documents filed with the Ministry of Government and Consumer Services. These temporary legislative provisions have been extended to allow corporations to hold virtual meetings until 31 May 2021. Further information may be found here.
U.S employers shall consider reviewing their screening tools and health and safety protocols to account for the new definition of ‘close contact’ in the updated guidance of the U.S. Centers for Disease Control (CDC). The CDC has significantly broadened the notion of ‘close contact’ to include any person who “was within 6 feet of an infected person for a cumulative total of 15 minutes or more over a 24-hour period* starting from 2 days before illness onset (or, for asymptomatic patients, 2 days prior to test specimen collection) until the time the patient is isolated”. The definition of ‘a close contact’ was initially limited to any person who “spent at least 15 consecutive minutes within six feet of an infected person, starting from 2 days before illness onset (or, for asymptomatic patients, 2 days prior to test specimen collection) until the time the patient is isolated”. The main implication of this new definition is that employers would be obliged to amend their screening tools and re-organize work activities in such a way as to prevent physical interactions within 6 feet for a cumulative (and not consecutive) 15 minutes or more over a 24 hour period.
According to CDC, the new definition infers that a person would be considered as a ‘close contact’ if he/she was within six feet of an infected person three times for five minutes in the last 24 hours. Factors to consider when defining close contact include: “proximity (closer distance likely increases exposure risk), the duration of exposure (longer exposure time likely increases exposure risk), whether the infected individual has symptoms (the period around onset of symptoms is associated with the highest levels of viral shedding), if the infected person was likely to generate respiratory aerosols (e.g., was coughing, singing, shouting), and other environmental factors (crowding, adequacy of ventilation, whether exposure was indoors or outdoors).”
Three additional Bills were approved in Michigan to protect employers from liability related to COVID-19 claims and prohibit adverse actions against employees who were absent from work because of COVID-19. House Bill 6032 prohibits an employee who tested positive for COVID-19 or display one or more of the principle symptoms from reporting to work until he/she has received a negative test or until both of the following conditions are satisfied: 1) three days have passed since the employee’s symptoms have ended, and 2) seven days have passed since the date of the employee’s symptoms first appeared or the date the employee received the positive test for COVID-19. The Bill similarly prohibits employees who have had close contact with an individual who has tested positive or displays one or more symptoms from reporting to work under certain circumstances. With this respect, close contact is defined as a person who was within approximately 6 feet of an infected individual for 15 minutes or longer. Finally, the Act provides employees with a degree of protection against discharge, discipline or retaliation if the employee complies with the requirement not to report to work due to COVID-19, opposes a violation of this law, or reports health violations related to COVID-19.
House Bill 6030, the COVID-19 Response and Reopening Liability Assurance Act, lays down requirements for immunity from liability for certain tort claims alleging COVID-19 exposure. Employers shall be immune from liability if they complied with all federal, state, and local statutes, rules, regulations, executive orders, and agency orders in effect at the time of the conduct or risk that allegedly caused harm. “An isolated, de minimis deviation from strict compliance” with such regulations or orders within the meaning of this Act does not preclude liability immunity. The act applies retroactively to any claim or cause of action that arose after 1 March 2020. House Bill 6031 amends the Michigan Occupational Safety and Health Act with a view to establish conditions for immunity from civil liability for an employer whose employee is exposed to COVID-19.
The Canadian Centre for Occupational Health and Safety has announced the launch of a customizable tool kit to help workplaces operate safely and prevent the spread of infection during the pandemic. The tool is designed to accompany the COVID-19 Workplace Health and Safety Guide and provides one-stop access to a series of resources on disinfection procedures, screening, face coverings, employers’ responsibilities, and exposure assessments. Resources of the COVID-19 tool kit can be found on the CCOHS website.
On 7 October 2020, the Colombian Ministry of Labor issued a Circular to inform employers about their obligations to evaluate and prevent psychosocial risk factors and mental disorders in workers in the context of COVID-19. As part of this evaluation, employers are required, among other things, to consider and assess the psychological aspects of working from home and implement actions to identify, evaluate, monitor and prevent psychosocial risk factors. In so doing, they shall comply with the assessment tools issued by the Ministry of Labor.
The Australian Government issued two additional guidance’s on working from home and restriction risk and transition to usual workplaces. As many workers are progressively returning to work, the Australian regulator expects employers and workplaces to carry out risk assessments and develop transition plans. The transition plans should aim at ensuring that employees are physically and mentally supported and can safely return to their usual workplace.
Peru is providing additional labor protection to pregnant women in the workplace during the national state of emergency. A new Law of 17 September 2020 obliges employers to identify and organize remote working for pregnant and breastfeeding employees who are at risk of contracting COVID-19. Where remote working is not feasible, employers shall assign pregnant women and nursing mothers tasks that are compatible with the functions they originally performed or otherwise offer preferential leave with possibility of subsequent compensation.
In Uruguay, a new law requires the use of adequate face masks and face protection devices that allow lip reading mandatory in companies, offices and organizations where workers interact with individuals who rely on lip reading to understand their interlocutor.
Single-use Plastic and Personal Protective Equipment
On 7 October 2020, the Canadian Ministry of Environment and Climate Change released a list of single-use plastic items candidate for a ban or restriction as part of the Government’s plan to achieve “zero plastic waste by 2030” . This announcement was made in parallel with the release of a discussion paper on a proposed integrated management approach to plastic products and a regulatory impact assessment adding plastic manufactured items to the list of toxic substances in Schedule 1 to the Canadian Environmental Protection Act. The Government confirmed that single-use PPE such as face masks, gowns and gloves, which are critical in the fight against COVID-19, will be duly considered for exemptions from management measures under the integrated management plan. The Government is seeking public comments on the proposed integrated management framework no later than 9 December 2020. Parties wishing to comment on any aspect of the discussion paper should submit their written comments to the Director of the Plastics and Marine Litter Division of ECCC at firstname.lastname@example.org
Chile has postponed the date of application of its new energy efficiency standard for interior lighting products. Lamps which do not meet the energy performance requirement of 40lm/W, as set out under Resolution No. 10/2020, may still be marketed until 1 May 2021. The initial compliance deadline was 1 January 2021. The decision was published in a resolution issued by the Ministry of Energy on 3 October 2020.
Wireless and Telecommunication Equipment
ANATEL, the National Telecommunications Agency of Brazil, has extended until 30 December 2020 the instructions contained in Official Letter No. 134/20, 194/20 and 384/20 which make the process of maintaining the certificates issued by the Agency more flexible in the context of COVID-19. Official Letter 134/20 and 194/20 – 384/20 authorized the maintenance of certificates based on the presentation of the necessary declarations for the conduct of the certification process, photos and test reports.
EH&S: Environment – Energy Efficiency (Buildings)
The Australian Building Ministers have delayed the adoption of the National Construction Code (NCC) to 2022. The new Code is now expected to be adopted from 1 September 2022. The period of public review will also be adjusted to reflect the delay in the adoption process. The Australian Building Code Boards announced the following key dates:
- May – July 2021: NCC 2022 Public Comment Draft released for public consultation
- May 2022: NCC 2022 Preview published at ncc.abcb.gov.au
Medical Devices and Personal Protective Equipment
Taiwan has developed labelling requirements on country origin for imported non-medical masks.
The Chinese National Medical Products Administration has decided to extend the trial period to pilot its unique device identification (UDI) program for an additional three months, ending on 1 January 2021.
The Health Sciences Authority of Singapore also announced the introduction of a phased implementation plan for Unique Device Identification (UDI) in Singapore. The announcement was made on 19 October 2020. One of the reason underlying the adoption of UDI is to improve the traceability of medical devices and identification of patients treated with specific devices impacted by recalls, failures or serious adverse events. Singapore would accept UDI barcodes affixed to the label of devices marketed to the US and, or European Union. The phase 1 of the implementation plan is scheduled to start in 2022 and would only affect high risk implantable medical devices. The three subsequent phases for medium risk devices will be implemented two years after each phase. Low risk medical device of class A would be exempt from UDI requirements.
Two draft Tanzanian standards on surgical face masks and reusable fabric face masks were notified and published by WTO on 12 October 2020. The first standard specifies the performance requirements, sampling and test methods applicable to surgical face masks intended to limit the transmission of infective agents from staff to patients during surgical procedures. The second standard contains performance requirements, sampling and test methods for reusable fabric face masks intended for general public use. Requirements encompass technical aspects relating to design and manufacturing, fiber composition, use of dyes and pigments, and bacterial filtration efficiency.
On 28 October 2020, the WTO published another notification from Botswana on a new national standard on alcohol-based hand sanitizers.
The Environmental Protection Agency has announced its intention to fast-track the registration of new products adding residual efficacy claims in the context of COVID-19. According to the EPA, products with extended or long-lasting residual effect claims that qualify for an expedited review fall into two major categories; (1) disinfectants that also provide residual efficacy, and (2) supplemental residual antimicrobial products (e.g., coatings, paints, solid surfaces) that do not meet EPA’s standards for disinfectants but are intended to be used as a supplement to standard List N disinfectants.
The FDA has rolled out its Accreditation Scheme for Conformity Assessment (ASCA) Pilot program and published three additional guidance in this respect. ASCA Pilot is intended to simplify testing requirements for medical devices and “increase consistency and predictability in the FDA’s approach to assessing conformance with FDA-recognized consensus standards and test methods eligible for inclusion in the ASCA Pilot in medical device premarket reviews”.
Three new technical guidance on Pan-Canadian approach to COVID-19 Testing and Screening have been put forward by the Government of Canada in early October.
The European Union has revealed the content of its upcoming package of COVID-19 measures. In a Communication published on 28 October 2020, the Commission announced its intent to place a strong emphasis on effective and rapid testing. An emergency support instrument of €100 million will be allocated to purchase rapid antigen tests and distribute them to Member States. The EU has also committed to support the roll out of national tracing apps and connect them to the European Federation Gateway Service. New Joint Procurements are under way for tests and medical equipment used for vaccination purposes including vaccine carriers, waste containers, injecting devices, disinfectants, personal protective equipment and anesthetic. Reduced rate or exemptions of VAT on test kits are being considered by the Commission. Furthermore, the suspension of VAT on imported medical equipment, initially authorized on 3 April 2020, will also be extended until the end of April 2021.