COVID-19 Regulatory Developments: Update 8
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.
The increasing use of digital contract tracing technologies during COVID-19 inevitably encroaches upon the principles of data protection law. In order to maintain some levels of data security and privacy protection, the US Senator Roger Wicker, R-Miss together with the Chairman of the Senate Committee on Commerce, Science, and Transportation and a number of co-sponsors announced their intention to introduce a new data privacy law, the COVID-19 Consumer Data Protection Act. The Bill establishes data protection and safety requirements on companies handling personal data relating to individuals’ health conditions, geolocation and proximity for the purpose of tracing contacts.
The US Senate Committee on Commerce, Science and Transportation argued that the legislation would provide all Americans with “more transparency, choice, and control over the collection and use of their personal health, geolocation, and proximity data”. The proposal prohibits unlawful collection, processing and transfer of personal data without the express consent of individuals. It also confers data subjects the right to opt out of the collection, processing or transfer of their personal data, geolocation or proximity information. Businesses would also be obliged to disclose information on how personal data will be handled and provide transparency reports to inform the general public on their data collection activities during the pandemic. While the chance of the Bill to become a law might be low, private entities and public bodies may want to consider the requirements before engaging in contact tracing in the work place to assess employees’ exposure to the virus.
The Chilean Senate has also introduced a bill amending the provisions of Data Protection Law 19.628 in relation to the processing of sensitive data for the duration of the emergency.
In France, the French Data Protection Authority (CNIL) recalled certain fundamental principles and updated its occupational guidance on the processing of personal data in the work place. The guidance is mainly directed at employers and reminds them of their legal obligations under the French Labor Code. The CNIL stresses that the disruptions caused by COVID-19 in no way affects employers’ obligation to ensure the health and safety of their employees. Employers are obliged to implement risk prevention measures, provide information and offer appropriate training to their employees. With respect to data protection, employers may only process data that are strictly necessary to satisfy their legal and contractual obligations, that is, necessary for implementing internal organizational measures to prevent contamination. As such, employers may only collect and process information relating to the date, identity of the person and the fact that this person indicated that he or she has been contaminated or suspect such contamination and adopt organizational measures accordingly. Additionally, employers shall remind employees who work in close contact with each other to report any contamination or suspicion of contamination in the work place. They shall also facilitate transmission of such information by setting up dedicated and secure channels, promote remote working methods and encourage the use of occupational medicine.
A further announcement was published on 14 May by the European Chemicals Agency to introduce flexibility in the time limits available to businesses for submitting contributions to consultations on REACH restriction proposals. No specific time frame for comments has been given by the Agency. However, companies and other entities seeking to submit their comments on ongoing REACH consultations or SEAC draft opinions should do so in due course in order to enable ECHA Committees to meet the legal deadlines for submitting their opinions to the European Commission.
Chemicals in EH&S: Environment – Occupational Health and Safety
In India, the National Disaster Management Authority has issued a series of guidelines for restarting manufacturing industries after lockdown. The guidelines are mainly directed to operators and supervisors in charge of servicing or maintaining electrical, mechanical or chemical equipment. They cover aspects relating to the storage of products, raw materials and manufacturing processes. The document further refers to additional guidelines on chemicals management which should be relevant to the chemical industry:
1. Guidelines on Chemical Disasters, 2007
2. Guidelines on Management of Chemical (Terrorism) Disasters, 2009
3. Strengthening of Safety and Security For Transportation of POL Tankers, 2010.
The Manufacture, Storage and Import of Hazardous Chemical Rules, 1989 under the Environment Protection Act, 1086 provide the statutory requirements for these industries.
On 23 April 2020, Environment and Climate Change Canada announced the extension of the greenhouse gas emissions reporting (GHG) deadline for covered facilities from June 1 to 31 July 2020. To align with the federal extension of time limit for reporting GHG emissions, Ontario has amended its Regulation on Greenhouse Gas Emissions: Quantification, Reporting and Verification (Reg 390/18). The amendment provides temporary relief by allowing for extensions of the deadlines to submit the 2019 GHG reporting and verification statements. The changes also suspend or delay the requirement for site visits by third-party verifiers for 2019 in certain circumstances. The information notice on the amendment and deferral of reporting deadlines is available here.
Wireless and Electromagnetic Compatibility
The Chilean Undersecretary of Telecommunication informed the Reduced Scope Equipment Certification companies that the undersecretary has decided to leave the 2020 Certification Protocol without effect until further notice. The Certifying companies shall comply with current regulations through the Protocol previously in force which was published under Resolution No. 1985, 2017 approving the Technical Standard on Short Range Telecommunication Equipment. Further information is available here.
The European Commission has developed a proposal for a Regulation laying down temporary measures concerning the validity of certain certificates, licences and authorizations and postponing certain periodic checks and training for motor vehicles and drivers. The proposal intends to relieve the transport sector from practical hurdles and administrative barriers by extending deadlines and introducing flexibility under certain transport legislation. The proposal is not limited to transport by road and supports the aviation, rail, maritime, inland navigation sector.
The Commission proposes to extend time limits for carrying out roadworthiness tests for motor vehicles and trailers under Directive 2014/45/EU. Roadworthiness tests that are due to be carried out between 1 March 2020 and 31 August 2020 may be carried out at a later date, but not later than six months after the original time limit. The certificates should remain valid accordingly. The proposal also extends the time limit of renewal and validity of railway safety certificates and authorizations to ensure the proper functioning and operation of railway undertakings and infrastructures.
Medical Supplies and Personal Protective Equipment (PPE)
Belgium has reduced the VAT rate for hydro alcoholic gel and face masks in Belgium. VAT benefits will apply until 31 December 2020 to hydro-alcoholic gel and face masks with the following combined nomenclature codes: 4818 90 10 00, 4818 90 90 00, 6307 90 98 10, 6307 909891, 6307 90 98 99 and 9020 00 00 10.
This initiative is not specific to Belgium. On 3 April 2020, the European Commission already decided to waive VAT and customs duties on the import of PPE from non-EU countries. To this effect, the EU Commission has developed guidance to support uniform implementation of the Union Customs Code during the emergency crisis. The relief of VAT and custom duties at the EU level will remain in place until 31 July 2020 and may be extended if necessary after consultation with Member States. While this initiative is timely, such measures are however limited to goods that are declared for consumption by public bodies, charities and governmental organizations. In a press communique, the European Apparel and Textile Confederation urged the European Commission to extend the exemption to private companies which are in better place to quickly answer the demand for PPE and other medical devices.
An export authorization will now be required prior to exporting certain categories of PPE outside Norway. On 28 April 2020, the Ministry of Health and Care Services adopted Regulation No. 882 making the export of PPE subject to prior authorization by the Health Directorate. The measure amends previous Regulation No. 239 on measures to ensure the supply of medicines, medical equipment and PPE in order to implement Regulation (EU) 2020/528. As of 28 April 2020, an export license shall be established for the following protective equipment:
- Protective spectacles and visors covered by CN Code ex 9004 90 10 and ex 9004 90 90 meeting the following description: protection against potentially infectious material; encircling the eyes and surroundings; compatible with different models of FFP masks and facial masks; transparent lens; reusable (can be cleaned and disinfected) or single-use items
- Mouth and nasal protection equipment (CN Codes: ex 6307 90 98 and ex 9020 00 00). This category encompasses Filtering Facepiece masks classified under FFP1, FFP2 and FFP3, and medical/surgical masks
- Protective garments (CN Code ex 3926 20 00, ex 4015 90 00, ex 6113 00, ex 6114, ex 6210 10 10, ex 6210 10 92, ex 6210 10 98, ex 6210 20 00, ex 6210 30 00, ex 6210 40 00, ex 6210 50 00, ex 6211 32 10, ex 6211 32 90, ex 6211 33 10, ex 6211 33 90, ex 6211 39 00, ex 6211 42 10, ex 6211 42 90, ex 6211 43 10, ex 6211 43 90, ex 6211 49 00, ex 9020 00 00)
The Canadian Government has stressed that keeping Canadians safe remains a top priority and announced the relief of customs duty for eligible medical goods and PPE imported on or after 5 May 2020. The relief can be claimed at the time of importation or within two years of the date of importation. Canada Border Service Agency issued a Notice which in its Annex I provides the list and description of goods based on tariff classification which are eligible for relief of custom duties under the Certain Goods Remission Order (COVID-19), SOR 2020-101.
On 7 May 2020, the US Federal Drug Administration amended the Emergency Use Authorization (EUA) for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators. The revised EUA modifies one of the eligibility criteria for respirators, the criterion for authorization based on review of test reports from recognized independent test laboratories submitted to the FDA by the manufacturer or importer. The FDA removed from the scope of Annex I those respirators that had been authorized under this criterion. This decision came as a result of repeated failures to demonstrate a minimum particulate filtration efficiency of 95% in the testing conducted by NIOSH. Respirators that were removed from Appendix A are no longer eligible under the EUA and no longer authorized to be marketed or distributed in the United States as respirators. For further information, please consult the FDA’s Letter to Health Care Providers.