As a fundamental overarching comment, Merck opposes the adoption of the current 16VAC25-220, Revised Proposed Permanent Standard for Infectious Disease Prevention of the SARS-CoV-2 Virus That Causes COVID-19. Merck believes that a more appropriate approach is to continue with a Temporary Standard with a suitable extension process with defined end dates. This could be accomplished with six-month renewals of a Temporary Standard (allowing for updates as necessary) with reevaluation of applicability and necessity at the end of each six-month term.

Comments on specific text are below.

In Section 16VAC25-220-30 Definitions;

The definition of Face Covering has been updated to include only washable fabric masks. Merck’s pharmaceutical operations are regulated by the Food and Drug Administration (FDA) which does not permit the use of washable fabric masks in many of our manufacturing areas. The use of fabric masks has the potential to introduce fibers into sterile production areas and can be a mechanism for the transmission of contaminate microorganisms to pharmaceutical product. Rather, Merck’s Elkton Facility uses disposable sterile masks, consistent with FDA requirements. These disposable sterile masks visually look like a Surgical/Medical Procedure Mask but are not FDA approved (as referenced in the definition of Surgical/Medical Procedure Mask in Section 16VAC25-220-30 Definitions). These disposable sterile masks are considered Face Coverings by Merck, and as such are designated as Face Coverings in our COVID specific Hazard Assessments. The new proposed language in the definition of Face Covering appears to exclude the approach Merck has taken for Face Coverings in its pharmaceutical production areas. This is a significant issue that requires clarification. Our recommendation is to address the words “washable” and “fabric” to allow appropriate flexibility to use these disposable sterile masks as Face Coverings while meeting FDA manufacturing requirements. Importantly, utilizing FDA approved Surgical/Medical Procedure Masks as face coverings under the Virginia regulations would unnecessarily remove them from the inventories for hospital use. Merck does not believe this is an appropriate allocation of these critical resources. As such Merck is requesting that the definition be clarified such that disposable masks, that are not necessarily FDA approved Surgical/Medical Procedure Masks, are designated as an acceptable form of Face Covering.

In Sections 16VAC25-220-40 Mandatory Requirements for all Employers

Section 16VAC25-220-40 B.8 the new language regarding employer reporting of COVID positive cases “present at the place of employment within 2 days prior to symptom onset (or positive test if the employee is asymptomatic) until 10 days after onset (or positive test)”  is now inconsistent with the language in the subsections that follow, i.e., Sections 16VAC25-220-40 B.8.d. & e. These sections (Sections 16VAC25-220-40 B.8.d. & e) still contain the language “present at the place of employment within a 14-day period testing positive for SARS-CoV-2 virus during that 14-day time period.” This requirement requires clarification such that the new language in Section 16VAC25-220-40 B.8 is clearly applicable in Sections 16VAC25-220-40 B.8.d. & e.

Sections 16VAC25-220-40 B.8.d. & e.; The 24 - hour reporting requirement for VDH and DOLI requires modification. The private personal information necessary for this reporting requires coordination between three groups within Merck: Health Services, Human Resources, and Environmental Health & Safety. It is not feasible to staff these three functions 24 hours per day/7 days per week. This makes reporting over weekends and holiday periods extremely challenging. It is not clear that VDH or DOLI are using this information in any way that necessitates reporting within 24 hours. Merck believes that reporting by the “next business day”  will alleviate an unnecessary reporting burden, protect personal information that should not be handled by individuals outside the groups listed above, and provide VDH and DOLI with the necessary information in an appropriate period of time.

Section 16VAC25-220-40 B.8.d.; The term “Declared Emergency” requires definition. Who implements and communicates a “Declared Emergency” in the future? A clear definition and defined process is needed.

Sections 16VAC25-220-40 B.8.e.; Unlike subsection d above, there appears to be no end to this reporting requirement or reimplementation based on necessity. At a minimum, the same language in subsection d needs to be included in subsection e so it is not an “in perpetuity” requirement.