CATER Mask
Decisions
February 12, 2021
Administration
to Lean on
Medical Supply
Companies to
Include Masks
from Small
Manufacturers
ASTM Standards
are a Good
Starting Point
Toward More
Effective Masks
President Biden
Stresses Mask
Use Until 2022
People have to
be Viewed As
Pollution
Sources to be
Controlled by a
Central System
Bureau Veritas can Provide Safe Bubble Validation
CDC Releases Its
School Guidance
______________________________________________________________________________
Administration
to Lean on
Medical Supply
Companies to
Include Masks
from Small
Manufacturers
The White House
on Thursday
stepped into the
fragmented
market for
disposable
virus-filtering
N95 masks,
moving to
connect medical
supply companies
with mask
manufacturers
who say they are
loaded with
inventory but
can’t find
buyers — even in
the midst of a
pandemic in
which doctors
and nurses are
desperate for
the protective
gear.
President
Biden’s
coronavirus
response
coordinator,
Jeffrey D.
Zients,
intervened after
reading about
the mask
manufacturers’
dilemma on
Thursday in an
article in The
New York Times.
“We will do all
we can to get
frontline
workers the
personal
protective
equipment they
need, including
breaking down
barriers for N95
manufacturers,”
Mr. Zients said
in a statement,
adding that he
had “reached out
to all of the
major medical
distributors to
start connecting
them with these
new N95 mask
manufacturers.”
A senior
administration
official said
members of Mr.
Zients’ team had
talked with
three top
medical
suppliers:
AmerisourceBergen,
Cardinal Health
and McKesson
Corporation.
Nearly two dozen
small American
companies have
recently jumped
into the
business of
making N95s but
are sitting on
extra supply, in
part because of
ingrained
purchasing
habits of
hospital
systems,
competition from
China and bans
on mask
advertising by
companies like
Facebook and
Google, which
were trying to
thwart price
gouging early in
the pandemic.
Mr. Zients said
the White House
intended to work
with “online
retailers to
ensure they are
making more of
these products
available to
their
customers.”
One mask
manufacturer,
Luis Arguello
Jr., said he had
30 million masks
for sale. After
the pandemic
exposed a huge
need for
protective
equipment and
China closed its
inventory to the
world, his
family-run
business,
DemeTech, began
making masks in
its factories in
Miami. It
invested tens of
millions of
dollars in new
machinery and
then navigated a
nine-month federal
approval process that
allows the masks
to be marketed.
“It’s insane
that we can’t
get these masks
to the people
who desperately
need them,” he
said.
The mask
shortage has
been one of the
most visible
failures of the
federal response
to the pandemic.
One mask company
executive, Mike
Bowen of
Prestige
Ameritech,
testified on
Capitol Hill
last year that
he had been
warning for
years that the
United States
was too
dependent on
China for mask
supply.
ASTM Standards
are a Good
Starting Point
Toward More
Effective Masks
The new
standards are
likely to be
published early
next week.
The draft
guidance
includes both
single use and
reusable masks
and outlines
specific
requirements for
evaluating the
performance of
reusable masks.
Dr. Donald
Milton, a
professor of
environmental
health at the
University of
Maryland who
studies how
viruses are
transmitted,
believes these
standards will
fill a major
regulatory gap.
"You've got all
these knockoff
masks coming in.
They're not very
good, claiming
to be N95 and
they're not. So
having some
benchmarks is a
step in the
right
direction," he
told CNN.
"This is
desperately
needed because
people have no
guidance at all
right now,"
Linsey Marr, a
professor of
civil and
environmental
engineering at
Virginia Tech
with expertise
in airborne
transmission of
viruses, air
quality and
nanotechnology,
told CNN.
If the standards
are adopted,
each mask would
come with a set
of user
instructions
that describe
proper sizing,
fit and cleaning
protocol. The
standards
strictly
prohibit the use
of vents, valves
or any feature
that allows
people to blow
out or breathe
in unfiltered
air.
The draft
guidelines would
also require
manufacturers to
test their
facial coverings
in accredited
labs to certify
performance,
register their
products and use
the outlined
labeling system
to use the ASTM
labeling
designations.
Perhaps the most
important change
ASTM is
proposing is a
labeling system.
Consumers in
stores would be
able to evaluate
the quality of
masks on store
shelves from the
labeling on the
packaging. If a
mask has ASTM
labeling, it
could ensure the
customer that
product has met
the testing and
quality
requirements.
The drafted ASTM
standard
labeling
requirements
would indicate
results of two
testing
criteria:
breathability
and filtration
efficiency.
Typically, when
a mask has a
higher
filtration, it
results in more
resistance and
can make it
harder to
breathe.
According to the
ASTM draft
guidelines, a
lower
performance,
level one
designation
would require
the product to
filter 20% of
particles --
something that
would make the
mask easy to
breathe through,
but that would
provide less
protection. A
level two
certification
would designate
high performance
filtration of at
least 50% of
particles but
would provide
less
breathability.
"The use of the
'levels' defines
a classification
system intended
to aid in
understanding
potential
tradeoffs for
higher levels of
filtration
efficiency with
airflow
(breathing)
resistance,"
Jonathan
Szalajda, deputy
director at the
National
Personal
Protective
Technology
Laboratory, told
CNN in a
statement.
Milton believes
information on
breathability
would be an
important
consideration
for consumers
with chronic
lung or heart
disease and
other conditions
that might
require easier
breathability in
a mask.
"It gives people
information to
make decisions
on what they
want, and what
level of
protection they
feel they need,"
Milton told CNN.
ASTM's main test
-- whether a
mask can filter
out particles
measuring 0.3
microns. Why
this size? It's
a hard one to
stop, and if a
mask can handle
a particle that
size, it can
stop droplets
most likely to
carry viruses
and bacteria.
Marr understands
why 20% and 50%
protection
benchmarks might
seem low to the
public but
believes the
actual
performance
against the
virus could
surpass 50%.
"That criteria
is for a certain
size particle
that is really
the hardest size
to filter out,"
she told CNN.
"It's very
likely that the
virus is mostly
in particles
that are larger
than that
critical size,
the test size."
But while
experts grow
increasingly
concerned at the
growing spread
of more
transmissible
coronavirus
variants, some
believe the
draft mask
guidelines need
to require a
higher level of
protection to
slow the spread
and protect
people.
"The first
iteration may
not be where you
want it to be,
but it's a step
in the right
direction to
have some
quality levels
here," Milton
told CNN. "I
would like to
see a level
three on the
higher end."
"If you would
have asked me
this in November
last year, I
would have said
this is okay,"
Marr told CNN.
"But now with,
with the more
transmissible
variants. I'm
more concerned.
I think it's a
higher level of
certification...I
would like to
see another
level of
performance like
80%."
Several European
countries have
already required
people wear
masks with a
minimum
filtration
efficacy of
80-90% against
0.3-micron
particles.
Germany, Austria
and France have
mandated the
public to wear
high filtration
masks on public
transport,
shopping or in
public areas.
While she hopes
for the addition
of a higher
level of
protection added
to these
guidelines, Marr
believes that if
approved, the
standards will
have an impact
because
consumers want
and need
guidance.
"I think if
these standards
are out, there
will be a demand
for the highest
level of
protection that
ASTM is willing
to have a level
for," she told
CNN. "The
manufacturers, I
think, will step
up and provide
that."
Currently, only
medical-grade
masks and
respirators must
meet standards.
These include
the N95 masks,
which are
regulated by the
US Food and Drug
Administration,
National
Institute for
Occupational
Safety and
Health (NIOSH)
and the
Occupational
Safety and
Health
Administration
(OSHA) for fit,
filtration
efficiency,
flammability and
other qualities.
President Biden
Stresses Mask
Use Until 2022
President Biden
on Thursday
stressed the
importance of wearing
masks until
at least 2022 to
save lives —
despite
declaring the US
will have enough
supply of
vaccines by the
summer to
inoculate 300
million
Americans.
The president
told reporters
during a visit
to the National
Institutes of
Health complex
that he would
not take his
mask off even
though he was
standing more
than 10 feet
away from Dr.
Anthony Fauci
and NIH Director
Dr. Francis
Collins.
“You know that
wearing this
mask through the
next year here
can save lives —
a significant
number of
lives,” Biden
said. “And so I
apologize if you
don’t hear me as
clearly as you,
maybe you
should.”
Biden warned
that the country
is still “in the
teeth of this
pandemic” with
new, highly
contagious
variants
spreading.
“January of 2021
was the
deadliest month
we’ve had. We
lost over
100,000 —
100,000 of our
fellow
citizens. We’re
on track to
cross 500,000
dead Americans
this next
month,” he
said.
“The new strains
emerging create
immense
challenges, and
masking is still
the easiest
thing to do to
save lives. But
we need everyone
to mask up.
“I know it’s a
pain in the
neck, but it’s a
patriotic
responsibility. We’re
in the middle of
a war with this
virus. It’s a
patriotic
responsibility —
not only if you
care about your
family, if you
care about your
fellow
Americans.”
However, with
more than 26
million jabs
delivered in
Biden’s first
three weeks in
office, the US
is on pace to
exceed his goal
of administering
100 million
doses in his
first 100 days.
“Just this
afternoon, we
signed the final
contracts for
100 million more
Moderna and 100
million more
Pfizer
vaccines. And
we’re also able
to move up the
delivery dates
with an
additional 200
million vaccines
to the end of
July — faster
than we
expected,” the
president said
Thursday.
People have to
be Viewed As
Pollution
Sources to be
Controlled by a
Central System
People create
100% of the
COVID
contamination.
So it is not
surprising that
tight fitting
efficient masks
are the solution
to the problem.
But masks also
have to be
considered in
every
air
cleanliness
initiative.
The average
person has two
colds per year
and is therefore
infectious for
5% of the time.
In the
average building
5% of the people
are causing
close to 100% of
the infections
if they are not
wearing masks.
How would you
rate a dust
collection
system which
processes air
from all the
sources except
the one which
creates the
pollution? An
HVAC system
where infectious
people don’t
wear masks is
the equivalent.
When pick up of
dust at the
source is
difficult, it is
called fugitive
dust and will
need to be
captured by an
air cleaning
system which is
very large and
costly.
This fugitive
dust air
cleaning system
is similar to
the filter cubes
installed by
Mann +Hummel at
polluted
traffic
intersections in
Germany. These
cubes reduce the
pollutant load
on the
pedestrians. But
you have to ask
how inconvenient
is it to wear
masks
and does
this
inconvenience
justify the cost
of cleaning the
outdoor air?
The filter cubes
are a good
solution for
a few
busy
intersections
but
prohibitively
costly as a
general
cleanliness
tool.
The cleanroom
industry has
already
identified
people as the
largest
contamination
source and has
gone to great
lengths to
minimize their
impact.
Indoor and
outdoor air
cleanliness
initiatives need
to consider
masks as one of
the components
in pollutant
minimization.
Our thinking
about masks is
similar to that
on seat belts
and air bags
decades ago.
Unless there is
a little
inconvenience
your car is not
going to be a
safe
environment.
This does not
mean that there
shouldn’t be
large
investments to
see that the air
is not polluted.
But in
certain cities
ambient
air pollution
under
certain climatic
conditions or
due to
wildfires,
volcanoes or
dust storms will
be excessive and
masks will be
needed.
Bureau
Veritas can
Provide Safe
Bubble
Validation
McIlvaine has
recommended the
safe bubble
approach. It
entails
maintaining a
low COVID risk
environment.
Bureau Veritas
can provide the
auditing.
It partners with
clients to build
a custom
continuity
program to
mitigate
COVID-19 risk
and ensure
safety.
CDC Releases Its
School Guidance
The Centers for
Disease Control
and Prevention released
its
much-anticipated,
updated guidance Friday
to help school
leaders decide
how to safely
bring students
back into
classrooms
and/or keep them
there. Rather
than a political
push to reopen
schools, the
update is a
measured,
data-driven
effort to expand
on old
recommendations
and advise
school leaders
on how to
"layer" the most
effective safety
precautions:
masking,
physical
distancing,
handwashing and
respiratory
etiquette,
ventilation and
building
cleaning, and
contact tracing.
For politicians,
parents and
school leaders
looking for a
clear greenlight
to reopen
schools, this is
not it.
"CDC is not
mandating that
schools reopen,"
CDC Director Dr.
Rochelle
Walensky said
Friday on a
phone briefing
with reporters.
Instead, the CDC
goes to great
lengths to
explain that
proper
mitigation can
help keep kids
and staff safe
at school, even
in hard-hit
communities,
though it also
warns that
schools lulled
into a false
sense of
security because
of low community
transmission
rates could
still spread the
virus if they
don't enforce
mask-wearing and
socially
distanced
classrooms.
The updated
guidance comes
as President
Biden tries to
make good on his
promise to help
more K-8 schools
reopen within
his first 100
days in office.
School reopening
has become a
potent political
battle between
parents and
educators. In
Washington,
Republicans have
used it to
criticize the
Biden
administration
for bowing to
pressure from a
powerful
interest group,
teachers unions,
rather than
listening to
scientists and
the concerns of
parents.
The update
offers a few key
changes to
earlier
language,
including a
color-coded
chart that
divides schools'
reopening
options into
four zones:
blue, yellow,
orange and red.
Districts with
low community
spread of the
coronavirus
(blue, 0-9 new
cases per
100,000 in past
7 days) or
moderate
transmission
(yellow, 10-49
new cases) are
encouraged to
consider
reopening for
full, in-person
learning.
Schools in areas
with substantial
transmission
(orange, 50-99
new cases per
100,000) may
still consider a
limited
reopening, as
long as they can
layer multiple
safety
strategies in
the classroom.
In hard-hit
communities
(red, more than
100 new cases
per 100,000)
elementary
schools may
consider limited
reopening, with
physical
distancing
required, but
the CDC
recommends
middle and high
schools be
virtual-only
unless
mitigation
strategies can
be met.
The guidance
also
incorporates
several recent,
forceful
statements by
CDC scientists.
"School should
be the last
places closed
and the first
places open,"
Walensky said
recently,
a line that
officially
appears in
Friday's
guidance: "K-12
schools should
be the last
settings to
close after all
other mitigation
measures in the
community have
been employed,
and the first to
reopen.
There is
detailed
guidance on
masks
Universal and
correct use of
masks
Core principle
for masks:
Require
consistent and
correct use of
face masks, by
all students,
teachers, and
staff to prevent
SARS-CoV-2
transmission
through
respiratory
droplets. Masks
should be worn
at all times, by
all persons in
school
facilities, with
exceptions for
certain persons
who, because of
a disability,
cannot wear a
mask or wear a
mask safely, or
for certain
settings such as
while eating or
drinking. Masks
should be
required in all
classroom and
non-classroom
settings,
including
hallways, school
offices,
restrooms, gyms,
auditoriums,
etc.
• Mask
policies for all
students,
teachers, and
staff set the
expectation that
individuals will
use masks
throughout the
school.
• Most
students,
including those
with
disabilities,
can tolerate and
safely wear a
mask. However, a
narrow subset of
students with
disabilities may
not be able to
wear a mask or
cannot safely
wear a mask.
Those who cannot
safely wear a
mask – for
example, a
person with a
disability who,
for reasons
related to the
disability,
would be
physically
unable to remove
a mask without
assistance if
breathing
becomes
obstructed –
should not be
required to wear
one. For the
remaining
portion of the
subset, schools
should make
individualized
determinations
as required by
Federal
disability laws
in order to
determine if an
exception to the
mask requirement
is necessary and
appropriate for
a particular
student. If a
child with a
disability
cannot wear a
mask, maintain
physical
distance, or
adhere to other
public health
requirements,
the student is
still entitled
to an
appropriate
education, which
in some
circumstances
may need to be
provided
virtually.
• If
visitors are
permitted in
school, they
should be
required to wear
masks at all
times and should
maintain at
least 6 feet of
distance from
others.
• Schools should
encourage
modeling of
correct and
consistent mask
use by school
leaders, local
leaders, and
others respected
in the
community.
• The
most effective
fabrics for
cloth masks are
tightly woven
such as cotton
and cotton
blends,
breathable, and
in two or three
fabric layers.
Masks with
exhalation
valves or vents,
those that use
loosely woven
fabrics, and
ones that do not
fit properly are
not recommended
