On May 19, President Trump issued an Executive Order (EO) authorizing federal agencies to provide regulatory relief to support the economic response to the COVID-19 outbreak. Specifically, the EO allows agencies to rescind, modify, waive, or provide exemptions from regulatory and other requirements that may impede economic recovery, consistent with applicable law and protection of the public health and safety. Since March, federal agencies have responded to the COVID-19 outbreak by taking hundreds of administrative actions, many of which provided flexibility regarding regulatory requirements, in an effort to address the spread of the virus and its impacts. With focus shifting to overcoming the effect the virus has had on the economy, the EO notably requires agencies to review those regulatory standards that they have temporarily rescinded or otherwise modified and determine which, if any, would promote economic recovery if made permanent. The EO also requires agencies to more broadly review current and prospective regulatory priorities and identify those that may inhibit economic recovery. Finally, the EO recommends that agencies provide compliance guidance to businesses and commit to fairness in administrative enforcement and adjudication.
The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) recently issued a Memorandum of Understanding (MOU) regarding the potential use of the Defense Production Act (DPA) with regard to FDA-regulated food. Importantly, USDA retains its DPA authority for products subject to FDA jurisdiction. The MOU, however, establishes that FDA will be responsible for monitoring the continued functioning of the FDA-regulated food production sector, bringing issues to USDA’s attention should FDA believe that USDA may need to exercise its DPA authorities to address a situation. The MOU is intended to supplement preparedness efforts and directs FDA to take the lead for FDA-regulated industry and monitor the food supply, work with stakeholders to identify and assess potential supply chain disruptions, issue applicable guidance for workers, and educate stakeholders about the potential for use of DPA authority. To the extent FDA identifies disruptions to the supply or other issues, both Agencies will work together to discuss appropriate action, including potentially invoking USDA’s DPA-delegated authorities. The MOU does not actually take any action under the DPA—it does not reflect action by USDA expanding the scope of the President’s invocation of the DPA beyond the meat and poultry sectors, nor does it constitute an order under the DPA.
On May 19, 2020, the Occupational Safety and Health Administration (OSHA) issued Revised Enforcement Guidance (Guidance) requiring employers to investigate whether employee COVID-19 infections are “work-related” for the purpose of determining whether a record must be made of such infections. This Guidance, which is effective on May 26, 2020, backtracks from OSHA’s prior April 10 guidance which had previously relaxed recordkeeping obligations on all non-healthcare, emergency response, or correctional institution employers for COVID-19 illnesses.
As background, OSHA requires employers to make a record of a COVID-19 infection if: (1) the case is a confirmed case of COVID-19; (2) the case is work-related as defined by 29 CFR § 1904.5 (an injury or illness is work-related if an event or exposure in the work environment either caused or contributed to the resulting condition or significantly aggravated a pre-existing injury or illness); and (3) the case involves one or more of the general recording criteria set forth in 29 CFR § 1904.7 (an injury or illness is recordable if it results in: death, days away from work, restricted work or transfer to another job, medical treatment beyond first aid, loss of consciousness or if it is otherwise diagnosed by a medical professional as a significant injury or illness). Certain circumstances, such as work-related fatalities, must not only be recorded, but reported to OSHA.
In light of the difficulty of determining whether workers contracted COVID-19 due to exposures at work, in an April 10, 2020 memorandum, OSHA exercised its “enforcement discretion” to not require work-relatedness determinations to be made by non-healthcare/emergency response/correctional institution employers unless (a) there is objective evidence a COVID-19 case may be work related (e.g., a number of cases developing among workers who work closely together without an alternative explanation; and (b) the evidence was reasonably available to the employer.
OSHA now requires all employers (except employers who have less than 10 employees or employers who are otherwise partially exempt from OSHA’s recordkeeping obligations) to make work-relatedness determinations. The Guidance specifically requires an employer to make a “good faith and reasonable inquiry” into whether it is more likely than not that exposure in the workplace played a causal role with respect to a particular case of COVID-19. If it is, then the exposure should be deemed “work-related” and is potentially recordable. In determining the adequacy of the employer’s inquiry, OSHA will consider the following:
- The reasonableness of the employer’s investigation into work-relatedness. Employers are not “expected to undertake extensive medical inquiries,” but should “(1) to ask the employee how he believes he contracted the COVID-19 illness; (2) while respecting employee privacy, discuss with the employee his work and out-of-work activities that may have led to the COVID-19 illness; and (3) review the employee’s work environment for potential SARS-CoV-2 exposure,” including reviewing co-worker COVID-19 infections.
- The evidence available to the employer. In determining the reasonableness of an investigation, OSHA will focus on “the information reasonably available to the employer at the time it made its work-relatedness determination” but will also consider later information learned by the employer. Thus, an employer may wish to revisit work-relatedness determinations based on new information learned.
- The evidence that a COVID-19 illness was contracted at work. OSHA has explained that work-relatedness is more likely where:
- Several cases develop among workers who work closely together and there is no alternative explanation.
- A COVID-19 infection is contracted shortly after lengthy, close exposure to a particular customer or coworker who has a confirmed case of COVID-19 and there is no alternative explanation.
- An employee’s job duties include having frequent, close exposure to the general public in a locality with ongoing community transmission and there is no alternative explanation.
- By contrast, work-relatedness is less likely where:
- An employee is the only worker to contract COVID-19 in her vicinity and her job duties do not include having frequent contact with the general public, regardless of the rate of community spread.
- An employee, outside the workplace, closely and frequently associates with someone (e.g., a family member, significant other, or close friend) who (1) has COVID-19; (2) is not a coworker, and (3) exposes the employee during the period in which the individual is likely infectious.
- OSHA will give due weight to any evidence of causation, pertaining to the employee illness at issue, provided by medical providers, public health authorities, or the employee herself.
Employers should ensure they are prepared to conduct this inquiry into COVID-19 infections in the workplace. For more information regarding this development or other issues relating to COVID-19, please contact one of the authors of this article or the Hogan Lovells lawyer with whom you work.
The Centers for Disease Control and Prevention (CDC) has issued Interim Guidance from CDC and the Occupational Safety and Health Administration (OSHA), Manufacturing Workers and Employers (the Interim Guidance), which provides recommendations related to COVID-19 transmission considerations for manufacturing workers and employers. This Interim Guidance is in most parts the same as the previously issued CDC/OSHA joint interim guidance for meat and poultry workers and employers, with only a few minor additions. Of note, the Interim Guidance lists an expanded set of potential COVID-19 symptoms to use when screening workers: fever, cough, or shortness of breath or difficulty breathing, fever, chills, repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell. The Interim Guidance applies to a number of manufacturing industries, including food processing facilities.
As part of the COVID-19 “lockdown measures” in Dubai, all dine-in restaurants, cafés, and food establishments were temporarily closed as of 25 March 2020. As from 24 April 2020, the Dubai government began the process of easing certain lockdown measures. This facilitated the reopening of food establishments, subject to certain restrictions. This alert provides an overview of the various precautionary measures for food establishments in the wake of the UAE lockdown restrictions easing.
On 15 May 2020, the German Federal Council approved a new regulation by the Federal Ministry of Food and Agriculture. The regulation provides for a ban of sweetened baby and infant tea and new information obligations for such products.
Ban on sugar
According to the Federal Ministry of Food and Agriculture it is necessary to prohibit baby and infant tea containing sugar, honey, malt extract or other syrups or thick juices obtained from vegetable raw materials, fruit juice, fruit juice powder or fruit nectar.
The Federal Council also approved a recommendation of its Committee for Agricultural Policy and Consumer Protection requesting the Federal Government to consider an extension of the ban to include other sweeteners, e.g. stevia and maltodextrin.
New information obligations
In addition, manufacturers should add to the packaging of the teas a statement advising that teas for babies and infants should not be sweetened by the consumer with sugar or other sweetening additives. Further, the packaging should indicate at which age the tea can be used. This age must not be less than four months of age.
Health protection as motive
The Federal Ministry of Food and Agriculture’s motives are referring to studies associating the consumption of sugar in baby and infant age with the consumption of sugar in later childhood and adolescence. The ministry expects the new measures to make a significant contribution to reducing sugar consumption by babies and infants and thus to protect their (future) health (counteracting obesity and dental caries etc.).
Almost 30 years ago, warnings in connection with infant tea products were discussed in an important decision by the German Supreme Court (judgment of 12 November 1991, case ref. VI ZR 7/91). The Supreme Court held that the manufacturer has a duty to warn about potential damage caused by dental caries due to the “nursing bottle syndrome” – a consequence of teeth having been flushed by a sweet liquid over a longer period of time – in an explicit way. A second judgment by the Supreme Court in 1994 (case ref. VI ZR 41/93) in connection with such products clarified that a manufacturer has to adapt content and scope of instructions to the least informed and thus most vulnerable group of product users.
Compliance with European laws?
It is questionable if the measures adopted are compliant with EU laws.
It is more than difficult to reconcile this German special regulation with the European principles of the free movement of goods and mutual recognition as it clearly impedes the free movement of goods within the EU – and therewith clearly contradicts to the aim of the Mutual Recognition Regulation (EU) 2019/515.
Moreover, baby and infant tea products fall within the broad definition of complementary foods, which is regulated by primarily applicable EU law (Art. 2 para. 2 lit. f) Regulation (EU) 609/2013). At the latest when a – so far missing – European implementing regulation comes into force, the German special regulation is likely to become obsolete. The adoption of a delegated regulation on complementary foods at European level is, however, not be expected in the near future, so that the German legislator could argue that a national regulation in the meantime is justified for the protection of health.
From the manufacturer’s point of view, it is desirable that the EU lawmakers adopt a regulation in the near future in order to prevent different national regulations by the Member States.
The California Department of Public Health (CDPH) recently issued a COVID-19 Industry Guidance intended for facilities that process or pack meat, dairy, or produce to support a safe and clean environment for workers. In general, the recommendations provided by CDPH are generally consistent with the interim guidance for meat and poultry processing workers and employers issued by the Center for Disease Control and Prevention (CDC) and Occupational Safety and Health Administration (OSHA), although the documents are not identical. In contrast to the CDC/OSHA Interim Guidance, which is specific to meat and poultry employers, the CDPH Guidance is wider in scope and applies to packers and processors of meat, dairy, and produce.
This memorandum provides a general overview of the topics covered in the CPDH guidance.
The U.S. Food and Drug Administration (FDA) recently provided an update regarding its plans for conducting routine surveillance inspections of domestic and foreign facilities during the COVID-19 pandemic. FDA announced in March that it would temporarily postpone foreign and domestic inspections, with the exception of certain “mission-critical” inspections, as identified on a case-by-case basis. In its most recent update, FDA Commissioner Stephen Hahn M.D. stated that the agency’s current approach will continue as local, national, and international conditions warrant.
The U.S. Food and Drug Administration (FDA) has issued two resources for retail food establishments that are reopening after closing or partially closing in response to COVID-19. The resources include a Food Safety Checklist with considerations for retail food establishments when restarting or resuming operations and an infographic identifying best practices for reopening during the COVID-19 pandemic. Much of the guidance will be familiar. In light of the evolving nature of the COVID-19 pandemic, FDA recommendations warrant a particular review and possible modification to companies’ existing policies and practices. In addition to FDA’s guidance, retail food establishments should be cognizant of any state or local requirements for retail food establishments as they reopen, and FDA encourages retail food establishments to partner with their local health authorities to discuss specific requirements for retail food establishments prior to reopening.
The United States Department of Agriculture (USDA) recently updated its Frequently Asked Questions (FAQs) webpage regarding COVID-19 to include a section on President Trump’s Executive Order (EO) invoking the Defense Production Act (DPA) for Meat and Poultry Processors. These FAQs address the role USDA plays in implementing the EO, what meat and poultry plants should do under the EO, and the potential actions USDA may take to ensure meat and poultry processors continue operations consistent with federal guidance issued by the Centers for Disease Control and Prevention (CDC) and the Department of Labor’s (DOL) Occupational Health and Safety Administration (OSHA). Notably, USDA recommends meat and poultry plants that are closed follow the OSHA/CDC guidance specific to the meat and poultry industry. Further, if necessary, USDA may issue orders under the EO and the DPA requiring meat and poultry establishments to fulfill their contracts. Below, we provide the FAQs released by USDA.