•,'
mapubltt ot toe asDtltppineS
House of Representatives
asatdEtln a©tllS, ®ueSlm ¢ttp
Nineteenth Congress
First Regular Session
HousE`B.IL`L:-No.  6 1 1 7
*     T'ME;
Introduced by Representative Florencio Gabriel "Ben" G. Noel and Representative
Josephine Veronique "Jaye" Lacson-Noel
EXPLANATORY NOTH
The  recent COVID-19 pandemic  and the  African  Swine  Fever,  two  unprecedented
events in the past two years, exposed the world's unpreparedness in handling viral diseases,
which led to numerous losses of jobs, economic growth opportunities, and most importantly,
lives. In the Philippines, its impact's footprints are still visible, but similar events in the future
are definitely preventable. Further, these two events have exposed the gaps in our government
programs and policies and emphasized the need to establish a virology and vaccine institute.
Outbreaks like COVID-19 could have been prevented or handled more efficiently in
the presence of a national virology laboratory that will conduct surveillance, diagnosis and
monitoring of viral diseases in hulnans, plants and animals. Issues like the recent pandemic
and other non-human related viruses should be handled with urgency, enough funding, and
with the best instruments.
As the government strive to address the situation and save more lives, we must learn
from  these  experiences,  identify  gaps  in  government  response  mechanisms,  and be  more
proactive in preparing for other similar crises in the future.
In the long term, investing heavily on bealth research initiatives should be pursued.
Therefore, to better prepare the country for future similar emergencies and protect our people's
health  and welfare,  this proposed measure  seeks  to  institutionalize the  establishment of a
Virology  Institute under the  Department of Science  and Technology.  It  shall  serve  as  the
premier research and development institute in the field of virology, encompassing all areas in
viruses and viral diseases in humans, plants, and animals. The virology institute will capacitate


the country to conduct scientific research initiatives on preventing and treating various viruses
and diseases. It shall also act as a venue for scientists, both in the Philippines and abroad, to
work collaboratively to study viruses of agricultural, industrial, clinical, and environmental
importance.
This  bill  seeks  to  establish  a reliable national virology laboratory that  shall play  a
critical role in surveillance, diagnosis and monitoring of viral diseases in humans, plants and
animals  as well  as  in the understanding of the  genetic  changes  in their viral  genome  as  a
prerequisite for a strong public health response to emerging, re-emerging and existing viral
diseases in order to raise the level of health of the Filipino and improve their social, economic
and cultural conditions.
In view of the foregoing, approval of this bill is earnestly sought.
iiE=EiiiE
FLORENCI0 GABRIEL "BEM" G. NOEL
Representative
An-Waray Partylist
Malabon, Lone District
2


mepub[ic ot toe asbtlipptneg
House of Representatives
asdtoSan 3BtllS, ®ue?oit ¢tty
Nineteenth Congress
First Regular Session
Housi`B`|L-L`No.6117
Representative Florencio Gabriel ``Bem" G. Noel and Representative Josephine Veronique
"Jaye" Lacson-Noel
AN ACT
PROVIDING FOR THE FRAMEWORK FOR THE ESTABLISHMHNT AND
0PHRATI0N 0F VIROLOGY LABORATORIES IN THE PHILIPPINES,
CRHATING FOR THH pURPoSE THn VIROLOGY SclnNcn AND
THCHNOLOG¥ INSTITUTn oF Tlm PHILIPplNES, AppRopRIATING FUNDs
TIIEREFOR AND FOR OTHER PURPOSES
Be it enacted by the Senate and the House Of Representatives Of the Philippines in Congress
assembled:
CHAPTER I
GENERAL PROVISIONS
Section 1. Short Title. -This A.ct st\alll be krLo"rn as the "Virology Institute Of the Philippines
pup) Act"
Sec. 2. Doc/arcz/i.o# a/Po/I.c};.  -  It is hereby declared the policy of the State to protect and
promote the right to health of every Filipino by ensuring that they are proactively protected
from diseases. It is recognized that the establishment of an institute that will conduct research
and development activities/in-depth study on the viruses affecting the lives of its people and
resources  is vital  for the protection of the health of its people  and the preservation of the
national life.
Towards this end, it is also hereby declared the policy of the State to establish a reliable national
virology laboratory that shall play a critical role in surveillance, diagnosis and monitoring of
viral diseases humans, plants and animals as well as in the understanding of the genetic changes
in their viral genome as a prerequisite for a strong public health response to emerging, re-
3


emerging and existing viral diseases in order tl raise the level of health of the Filipino and
improve their social, economic and cultural conditions.
It  is  hereby  further  declared  the  policy  of the  State  that  a  systematic  approach  to  the
improvement of our health system requires the establishment of an institution equipped with
the  necessary  capacity,  competency,  latitude  and  authority  to  decisively  and  scientifically
respond to the demands of public health and public health emergencies, crises and situations
brought about by viral infections and regulate the operation of other virology laboratories in
order  to  prevent  possible  public  health  threats     resulting  from  the  operation  of  these
laboratories.
Sec. 2 (a). Oky.ecfj.1;elf - This Act seeks to establish a Virology hstitute that shall focus on the
following key development areas for virology science and technology applications to ensure
the state's sustained progress:
(a)  To protect and promote the right to health of the people and instill health consciousness
among them;
(b) Research  on  viruses  using  a  modem  approach  such  as  molecular  biology  and  its
application or biotechnology;
(c) Development of diagnostics, vaccines, and therapeutics (Molecular Biotechnology);
(d) International cooperation and network of databases of virus infections;
(e) Operation of a virus bank, virus genome laboratory, and virus reference laboratory to
focus   on   viruses   circulating   in   the   Philippines   for   disease   prevention   and
epidemiological studies; and
(I)  Operation  of a virus high  contairment laboratory dedicated to  the  study  of highly
infectious and highly pathogenic viruses.
See. 3. De¢#jfi.o# a/fer#!s. - As used in this Act, the following terms shall mean:
(a)  "Bz.osa/edy"   is   the   application   of  safety  precautions   that  reduce   a   laboratory
personnel's   risk   of  exposure   to   a   potentially   infectious   microbe   and   limit
contamination of the work environment and ultimately the community;
(b) Bz.oscz/edy /eve/s  are  c7z.VI.dad I.#to /o#r  /4J.  Each  level  has  specific  controls  for the
contairment  of microbes  and  biological  agents  based  on  internationally-accepted
safety  standards.  The  primary  risk  that  determines  the  levels  of containment  are
infectivity, severity of disease transmissibility and the nature of the work conducted;
(c)  "Cw//wre medz.win " or  "growlfe  medz.win "  is  a liquid or gel designed to  support the
growth of microorganisms;
(d)  ``Dz'agros#.cL5 " relates to methods, tests, techniques,  and tools in viral diagnosis for
humans, animals, and plants;
(e)  "Disi.#/ecfz.o7!"    is    the    process    using    chemical    compounds    to    exterminate
microorganisms but does not necessarily kill all microorganisms especially resistant
bacterial spores;
4


®   "J#/ecfi.o#s wczsfe " has been defined to include biological waste, cultures and stocks,
pathological waste, and sharps. Each of these categories has a proper disposal method.
Infectious wastes must either be incinerated or treated prior to disposal.
The following are the infectious wastes:
i.       Bz.oJogz.ccz/ wcrsJe includes blood and blood products, excretions, exudates,
ii.
secretions,suctioningandotherbodyfluidsthatcamotbedirectlydiscarded
into the municipal sewer system, but excludes articles contaminated with
fully absorbed or dried blood. Biological waste must either be incinerated,
sterilized with steam in a dedicated autoclave as described below, or treated
by some other nationally recognized method which has been approved and
formally adopted by the Department of Environment and Natural Resources
(DENR). After treatment, biological waste may be treated as normal refuse.
Cw/fwres  ¢#d sfocds  include  etiologic  agents  and  associated  biologicals,
including  specimen  cultures  and  dishes  and  devices  used  to  transfer,
inoculate  and mix  cultures.  The  definition  also  includes  wastes  from  the
production of biologicals, serums, and discarded live or attenuated vaccines.
Cultures and stocks must be treated in the same way as biological waste.
iii.       P¢Jfoo/ogz.co/  wczsfe   includes  biopsy  materials,   all   human  tissues,   and
anatomical  parts  from  surgery  and  other  procedures.  It  also  includes
carcasses  and bedding from animals  and plants  exposed to pathogens  in
research,  but  does  not   include  teeth  or  preservative   agents   such   as
formaldehyde. Pathological waste must be incinerated.
iv.       Slfearpr includes needles, scalpel blades, lancets, glass tubes that could be
broken during handling and syringes that have been removed from their
original sterile containers. Sharps must be incinerated.
(g)  "Kz.f "  or  "resf  fu.f "  is  a  commercially  packaged  system  of the  principal  or  key
components  of an analytical method used to determine the presence of a specific
analyte(s) in a given matrix (es). Test kits include directions for their use and are often
self-contained, complete analytical systems; but they may require supporting supplies
and equipment.  The key components  frequently represent proprietary elements or
reagents that may be readily prepared only by the producer of the kit. This "Kit" or
"Test kit" must be approved by an appropriate government agency in the Philippines
before its actual use.
(h)  "Perso#a/ profecfz.ve  eg%zpme#f "  rppEJ  consists  of garments  placed  to  protect  a
laboratory scientist, worker or any other person from getting infected by a viral agent.
It consists of standard precautions:  gloves, masks and gowns. When working with
blood or airborne high infections, it shall also include face protection, goggles and
masks or faces shields, gloves or coveralls, head cover and rubber boots;
(i)   "Reclge#f "  is  any natural  or synthetic  substance used  in  a chemical  or biological
reaction in order to produce, identify, or measure another substance;
¢)  Rz.s4 Growp J vz.r"sex  are microorganism that is unlikely to  cause human, plant or
animal disease (e.g. Adeno-associated Virus (AAV) types I -4). These vinises shall be
studied in basic virology laboratories;
5


(k) Rz.sk  Growp  2  vz.r#ses  (moderate  individual  risk,  low  community  risk)  are  viral
pathogens that can cause human, plant or animal disease but are unlikely to be a
serious hazard to laboratory workers, the community, livestock or the environment.
Laboratory  exposures  to  these  group  of viruses  may  cause  serious  infection,  but
effective treatment and preventive measures are available and the risk of spread of
infection is limited. Assay systems using these vinises shall be done in biosafety level
2  laboratories.  Examples  include herpes viruses,  foot-and-  mouth  disease  viruses,
adenoviruses and unconventional slow viruses;
(I)  Risfr Growp 3 vz.7"ses (high individual risk, low community risk) are viral pathogens
that usually cause serious  human,  plant or animal  disease  but does not  ordinarily
spread from one infected individual to another. Effective treatment and preventive
measures  are  available  against these  group  of viruses.  Assay  systems using these
viruses shall be conducted in biosafety level 3 laboratories. Examples include human
immunodeficiency  vrfus  (HIV),  hepatitis  8  virus  (IIBV),  hantaviruses,  Japanese
encephalitis virus (JEV), rabies, rift valley fever and yellow fever virus;
(in)jtz.s4 Groap 4 vz.ruses (high individual and community risk) are viral pathogens that
usually  cause  serious  human,  plant  or  animal  disease  and  that  can  be  readily
transmitted from one individual to another, directly or indirectly. Effective treatment
and preventive measures  are not usually  available  against these  group  of viruses.
Assay systems using these viruses  shall be made in biosafety level 4 laboratories.
Examples include Lassa fever, filoviruses, smallpox, Crimean- Congo hemorrhagic
fever, avian influenza viruses, Nipah virus, Russian spring-summer encephalitis and
Kyasanur forest disease viruses;
(n)  "Scro/og)/"  is  the  scientific   study  or  diagnostic   examination  of  blood  serum,
especially  with  regard  to  the  response  of  the  immune  system  to  pathogens  or
introduced substances;
(o)  "S7#eczr" is a specimen for microscopic study, the material being spread thinly and
unevenly across the slide with a swab or loop, or with the edge of another slide;
a)  ``Sferz./j.zafz.oH " is the process of exteminating all microorganisms within or outside
an object or material using extreme chemical or physical;
(q)  "77!erczpew/I.as " shall include anti-viral, nanotechnology treatment approach, nucleic
acid-based treatment, remedial agents, drugs for the treatment of viral diseases and
infections for humans, animals, and plants;
(r)   "rl.isLTwe Cw/Jwre " refers to a collection of laboratory techniques and methods in which
frogments  of a tissue  (human,  plant  or animal  tissue)  are  introduced  into  a new,
artificial environment, where they continue to function or grow;
(s)  "yczcc}.7Ies"  are  products  that  induce  or  stimulate  active  acquired  immunity  by
producing antibodies to a specific infectious agent. It helps the body's immune system
to recognize and fight pathogens like viruses or bacteria; and
(t)   "yz.roJog}/" is the  scientific  discipline  concerned with the  study of the biology  of
viruses    and    viral    diseases,    including    the    distribution,    pathogenicity,    viral
cytopathicity, biochemistry, physiology, molecular biology, biotechnology, ecology,
tropism,  spillover  or  interspecies  transmission,  evolution,  and  clinical  aspects  of
viruses.


CHAPTHR 11
VIROLOGY SCIENCE AND TECHNOLOGY
INSTITUTE 0F THH PHILIPPINES
See. 4. Creation Of a Virology Science and Technology Institute Of the Philippines (VIP). -To
cany out the provisions of this Act, a research and development institute under the Department
of Science and Technology (DOST) called the Virology Science and Technology Institute
of the Philippines (VIP) shall be created.
The DOST, in coordination with the Department of Agriculture (DA) and the Department of
Health (DOH), shall promulgate policies for and exercise supervision and control over VIP.
The VIP shall serve as the premier research and development institute in the field of virology,
encompassing all areas in viruses and viral diseases in humans, plants, and animals. It shall
act as a venue for scientists, both here and abroad, to work collaboratively to study viruses of
agricultural , industrial , clinical, and environmental importance.
The Institute shall establish strategic partnerships with the world's leading scientists, virology
centers, and institutes and conduct innovative and pioneering researches that will advance the
frontiers of virology in the country.
See. S. Scope and Coverage Of Virology Science and Technology. -For p:i]r'poses of tlriLs ALct,
the scope and coverage of the Institute shall be the extensive, ground-breaking, pioneering and
original  research  projects  on  the  study  of viruses  for  agricultural,  industrial,  clinical  and
environmental importance, contagious and non-contagious viral diseases from the standpoint
of preventive medicine  in humans,  animals  and plants,  improving human,  zoological  and
botanical health and welfare by suppressing infectious and non-infectious viral diseases, and
clarifying  and  supporting  the  scientific  background  of viruses  in  relation  to  zoological,
botanical and human health and medical administration of the government: Provided, That the
Institute shall be the national reference laboratory for all zoonotic and botanical infections
involving viral etiology.
See. 6.   Org¢#z.z¢Jz.o#cz/ Sfrztcf#re - The VIP shall be an attached agency of the DOST for
purposes of policy and program coordination, and to ensure alignment in national policies and
priorities.
It shall be headed by a Director-General and two (2) Deputy Directors-General, in charge
of (i) Research and Development, and (ii) Support, Policy, and Linkages.
The Director-General, who shall have a rank of an undersecretary and shall be appointed by
the President of the Philippines upon the recommendation of the Advisory Board created under
Section 6 (a) of this Act. The Director-General shall be assisted by a Deputy Directors-General,
who sball have a rank of an assistant secretary, and shall be appointed by the President of the
Philippines upon the recommendation of the Advisory Council.
7


The  VIP  shall  be  composed  of the  Office  of the  Director-General,  Office  of the  Deputy
Director-General for Research and Development, Office of the Deputy Director-General for
Support, Policy, and Linkages and the following divisions:
a.    Virus Research;
b.   Diagnostics and Therapeutics Research;
c.    Vaccines Research;
d.   Technical services and Training;
e.   Policy, Planning, and Linkages; and
f.    Finance and Administration.
The Deputy Director-General for Research and Development shall head the Virus Research,
Diagnostics  and  Therapeutics  Research,  and  Vaccines  Research  Divisions.   The  Deputy
Director-General  for  Support,  Policy,  and Linkages  shall  head the  Technical  Services  and
Tralning, Policy, Planning, and Linkages, and Finance and Administration Divisions.
Subject to the approval of the Department of Budget and Management (DBM), the VIP shall
determine  its  organizational  structure  and  create  new  divisions  or  units  as  it  may  deem
necessary and shall appoint officers and employees of the VIP following the civil service laws,
rules, and regulations.
For  this  purpose,  the  Institute  shall  draw  up  the  necessary  position,  qualifications,  and
standards   for  its  personnel  following  the  civil   service  law,  rules,  and  regulations,   in
consultation with the DBM.
See. 6 ® Qualifications Of the VIP Director-General and Deputy Directors-General. -The
VIP and Deputy Directors-General shall be appointed by the President of the Philippines, upon
the recommendation of the DOST Secretary.
The Director-General, with a rank of Undersecretary, shall be a qualified expert possessing at
least a Master's degree in Biology, Microbiology, and/or an allied discipline; p7-e/ercb/y with
a doctorate degree in medical sciences and/or in virology-related discipline with ten (10) years
of experience  in  diagnostic  virology.  He  or  she  shall  have  overall  responsibility  for  the
activities, including the supervision of all the staff working in the VIP and the President of the
Philippines the results of the various diagnostic assays and research studies performed in the
Institute.
Each of the Deputy Directors-General of the VIP shall have a rank of Assistant Secretary. The
Deputy Directors-General shall possess at least the education background qualification for the
VIP Director-General position.
The Director-General and the Deputy Directors-General of the VIP shall be appointed by the
President for a term of seven (7) years, pursuant to civil service laws, rules, and regulations.
Of those first appointed, the Director-General shall hold office for a term of seven (7) years,
one Deputy Director-General shall hold office for a term of five (5) years, and the other Deputy
Director-General shall have a temi of three (3) years.


Sec. 7. Powers aHd Fw#cfz.o#s. -The Institute shall be the principal laboratory of the country in
providing quality virology laboratory investigation, research and technical coordination of the
entire network of the virology laboratories in the Philippines. The VIP shall also serve as the
lead convener of the virology research agenda as part of the National Unified Health Research
Agenda OVUHRA), as defined and mandated under Republic Act No. 10532, otherwise known
as the "Philippine National Health Research System Act of 2013".
Furthermore,  the  VIP  may  enter  into  a  memorandum  of agreement  or  memorandum  of
understanding with international partners, with the concurrence of the Secretary of Science and
Technology and/or Secretary of Agriculture.
The Institute shall perform the following functions:
(a)  Conduct  basic  and  applied  research  projects  on  zoological,  botanical  and  human
infectious, non-infectious and other intractable diseases of viral etiology with primary
focus  on their characterization,  vector/reservoir transmission,  viral  ecology,  clinical
virology,  pathogenesis,  pathophysiology,  and  host  immune  response  to  these  viral
pathogens;
a) Provide  reference  services  including  all  that  are  necessary  for  ensuring  the  assay
systems  for  diseases  of viral  etiology,  industrial  and  technological  implications  of
virology  and  services  involving  the  storing  and  supplying  pathogenic  and  non-
pathogenic viral agents and their vectors and hosts, standardizing reagents, preparing
and supplying reference materials needed for the diagnosis and surveillance of plant,
animal  and  human  diseases,  educating  professional  technicians,  and  information
exchange;
(c)  Establish testing, reference and biosafety levels  1,  2,  3,  and 4 research laboratories
which  are  fully  compliant  with  the  provisions  of this  Act  and  the  internationally
accepted guidelines in the establishment and operation of the same;
(d) Conduct viral  disease  surveillance program,  collection,  analysis,  and  feedback  and
distribution of information on diseases of viral etiology;
(e)  Comprehensively coordinate  the planning  and  implementation of research projects,
approve liaison and coordination with relevant governmental agencies, and coordinate
research proj ects with other research institutions ;
(I)  Provide technical advice to national authorities on the progress, needs and aspirations
of the virology laboratory network in the country and to regulate the operation of the
Same;
(g) Assist national authorities in the planning, organization and supervision of the virology
laboratory network;
(h) Develop technical/training material for use in laboratories in the network to enhance
their quality;
(i)  Assess the needs and impart training to the staff of other virology laboratories in the
country in quality testing for viral pathogens;
a)  Validate reagents and kits that may be used nationally;
9


(k) Validate   new   technologies   that   may   become   available   and   recommend   their
implementation in the country;
(I)  Develop minimum standards, standard operating procedures and research protocols for
virology laboratories and assist virology laboratories in their inplementation of the
Same;
(in)Develop, in consultation with the DOH, DA, other relevant government agencies, the
academe,  and  private  entelprises  engaged  in  the  industry  of virology,  a  national
database of viruses and laboratory results;
(n) Organize  external  quality  assessment  schemes  to periodically  assess  the  quality  of
testing in networks and suggest remedial measures to those laboratories that show poor
performance;
(o) Undertake research to improve the quality and cost-effectiveness of virology laboratory
services in the country;
®) Collaborate  with  the  World  Health  Organization  (WIIO)  and  other  international
agencies  in  virology  research  and  technical  matters  pertaining  to  improvement  of
laboratories;
(q) Create  within  the  Institute  various  divisions  that  will  spearhead  basic  and  applied
molecular biological research and reference activities in arbovirology, emerging and
reemerging  viral  diseases,  neurovirology,  herpes  virology,  enteric  virology,  tumor
virology,  hepatitis  virology,  acute  viral  respiratory  infections  and  cytokines,  viral
genomics  and  molecular  genetics  and  biosafety  control  studies  of viruses,  among
others;
(r)  Promulgate rules and regulations regarding the management and operation of virology
laboratories in the country as well as its rules of engagement;
(s)  Collect fees in connection with the exercise of its regulatory powers;
(t)  Apply for, receive, and accept bequests, grants,  and donation of funds,  equipment,
materials and services needed for the attainment of its objectives;
(u) Provide grants, research fund, materials and equipment for the conduct of virology
research by both public and private higher education institutions;
(v) Order the suspension or closure of virology laboratories and prosecution of individuals
and corporations for violations of this Act;
(w) Establish an editorial office of a refereedjoumal ofvirology, to publish it, and a library
which shall collect and preserve books, joumals and other reference materials in the
field of virology; and
(x) Perform such other related activities as may be assigned by the DOST.
See. 8. Orgr#z.z¢fz.o# cI#cJ Perso##e/. - The Institute shall have its technical and administrative
support staff as well as consultants as may be necessary. Such consultants may be drawn from
the public and private sectors on consultancy or contractual basis and shall be granted honoraria
or allowances at such amounts as may be determined in accordance with existing rules and
regulations.
10


All   laboratory   workers   shall   undergo   periodic   training   to   increase   their   laboratory
competencies.  Attendance to  conferences,  seminars  and trainings  shall be  given  additional
service credits.
See. 8 (al) Engagement Of Balik Scientists and Foreign Experts - The lmsti"te may enga,ge
Balik  Scientists  and  foreign  experts  following  the  terms  of reference  and  compensation
structure
See. 9. 4dvz.gory Boa!rd -The Institute shall have an Advisory Board composed of the following
officials or their representatives :
(a) The Secretary of Science and Technology, Chairman;
(b) The Secretary of Health, Co-Chairman;
(c) The Secretary of Agriculture, Co-Chairman; and
(d) Ten (10) members from the academe who must have distinguished themselves in
the field of medical virology, genomics, plant virology, animal virology epidemiology, genetic
engineering  and  other  related  disciplines  and  shall  be  appointed  by  the  President  of the
Philippines.
Sec. 10. rrfl#s/er a/Bz.o"edz.ccz/ Rese¢rch Fw#cfz.o#s. - All offices and units under the DOST
system that are handling matters related to virology shall be transferred to the VIP. The transfer
of an office  or unit  shall  include  the  functions,  appropriations,  funds,  records,  equipment,
facilities, choses in action, rights, other assets, and liabilities, if any, of the transferred office
or unit as well as the personnel thereof, as may be necessary.
Furthermore, all functions in the DOH involving biomedical research in virology and in the
DA involving animal and plant virology shall be transferred to the Institute together with their
applicable  appropriations,  records,  equipment,  property  and  such  persormel  as  may  be
necessary.
Notwithstanding  the  provisions  of this  law,  the  Research  Institute  for  Tropical  Medicine
(RITM) shall retain its existing mandate on reference laboratories for public health purposes,
as stipulated in relevant laws and mles.
See.11.  yz.ro/og}; jteseclrch Fw#d -There is hereby created a Virology Research Fund to be
used exclusively for the implementation of the Virology Institute Strategic Plan, and shall be
administered by the VIP following existing government budgeting, accounting, and auditing
rules and regulations. The Fund shall be sourced from the following:
a.    The initial amount of Two Billion Pesos (P2,000,000,000.00) to be taken from the current
fiscal year's appropriation, in case the General Appropriation Act (GAA) was approved
before this law is enacted; Provided an amount which shall not be less than One Billion
11


`1r`
pesos    (P1,000,000,000.00)    shall    be    annually    included    in    subsequent    General
Appropriations Acts ;
b.   The income produced from its operations, technology transfer, and licensing agreements;
and
c.    Loans, contributions, grants, bequests, gifts, and donations whether from local or foreign
sources; Provided, that acceptance of grants, bequests, contributions, and donations from
foreign   governments   shall  be   subject  to  the   approval   of  the   President  upon  the
recommendation of the Secretary of the DOST and Secretary of the Department of Foreign
Affairs (DFA).
See. 11 (a) Use a/J#co"e -The VIP shall be authorized to use all of the income generated
from its operations, as well as donations, bequests, and grants for the upgrading of its physical
and human resources, and for the augmentation of its budget, in case of a shortfall.
CHAPHR Ill
VIROLOGY LABORATORY OPERATIONS
See.  12.  Physical  structure  Of virology  laboratories.   -  AIL  newly  consrfucted  virology
laboratories shall be located in separate, multi-storied buildings.
A virology laboratory shall be situated at the end of a corridor in a building where other
laboratories are located in order to restrict entry of visitors, prevent contamination and facilitate
malntaining biosafety standards. In cases of existing laboratories, they shall be separated from
other areas and facilities that are open to unrestricted staff movement within the building.
Sec. 13. Esse#fz.a!//eclf#res a/a vz.ro/og)/ Jabor¢Jory. - Apart from the biosafety requirements,
the following shall be the minimum essential features that must to be incorporated in the design
of a virology laboratory:
(a) Adequate  space  shall be provided for the  safe  conduct of laboratory work and for
cleaning and maintenance. Designated cubicles, rooms or areas shall be available to
carry out different activities, e.g. office rooms, specimen collection cubicle, specimen
reception and processing room,  serology  laboratory,  cell  culture cubicle,  molecular
diagnostic laboratory comprising three cubicles, cold room, dark room for fluorescent
microscopy,   common   equipment   room,   media   preparation   room,   washing   and
sterilization section, store room, toilets and lunch room;
(b) Each laboratory room shall have a space for housing a biosafety level 2 cabinet, one
workbench, a sink, discard bins, wall cabinets to store consumables, a centrifuge, an
incubator and a refrigerator;
(c)  The entire laboratory shall be climate-controlled to maintain a dust-free environment
and an ambient temperature of 22-25  °c.  Least cell  culture cubicles, virus handling
cubicles, the serology lab and the molecular biology labs shall also be air conditioned;
(d) Walls, ceilings and floors shall be smooth, easy to clean, impermeable to liquids and
resistant to chemicals and disinfectants normally used in the laboratory. Floors shall be
slip- resistant;
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(e)  Bench-tops shall be impervious to water and resistant to disinfectants, acids, alkalis,
organic solvents and moderate heat;
(f)  Illumination shall be adequate for all activities. Undesirable reflections and glare shall
be avoided;
(g) Laboratory furniture shall be sturdy. Open spaces between and under benches, cabinets
and equipment shall be accessible to cleaning;
(h) Storage space shall be adequate to hold supplies for immediate use and thus prevent
clutter on bench tops and in aisles. Additional long-term storage space conveniently
located within or outside the laboratory area shall also be provided;
(i)  All doors shall have vision panels, appropriate fire ratings and self-closing;
a)  Facilities  for storing outer garments, personal  items,  pantry and restrooms  shall be
provided outside the laboratory working area;
(k) Hand-washing basins with running tap water shall be provided in each laboratory room,
preferably  near the  exit  door.  A  dependable  supply  of good  quality water shall  be
essential.  There must be no  cross-connections  between  sources  of laboratory water
supply and drinking water supplies;
(I)  There shall be reliable and adequate electricity supply and emergency lighting for safe
exits.  A  stand-by  generator shall  be  available  at  least  for some  equipment  such  as
incubators, biosafety cabinets, freezers etc.; and
(in) Safety systems shall cover fire, electrical emergencies, emergency shower and eyewash
facilities including systems for avoiding overcrowding and too much equipment, pest
control   and   prevention   particularly   rodents   and   arthropods   and   prevention   of
unauthorized entry into the laboratory areas.
Sec.  14. Egwz.pme#f a#d swpp/I.es.  - The virology laboratory shall have adequate equipment
which shall take into account certain general principles, including:
(a)  The equipment,  facilities  and supplies must be designed to prevent or limit contact
between the operator and the  infectious material (e.g.  biosafety cabinets,  electronic
pipetting aids, etc.);
(b) The equipment and facilities must be made of materials that are impermeable to liquids,
resistant to corrosion and meet internationally-accepted structural requirements;
(c) The equipment and facilities must be free of sharp edges, burrs and unguarded moving
Parts;
(d) The equipment and facilities must be designed, constructed and installed to facilitate
simple operation and provide for ease of maintenance, cleaning, decontamination and
certification testing; and
(e)  Glassware and other breakable materials must be avoided wherever possible. Essential
and  desirable  equipment  required  for  a  virology  laboratory  must  conforin  with
standards set by the Institute and internationally-recognized manuals and guidelines for
virology laboratory operations.
See. 15. Bz.ascz/edy reg"J.rements a//¢boraforz.es. - The biosafety infrastructure shall be designed
on the basis of risk assessment for handling specific pathogeus. The desired biosafety levels
13


shall be established on the basis of professional judgement based on risk assessment and on
intemationally-accepted guidelines on the handling and management of specific viral agents,
(a) In addition to the minimum essential features stipulated in Section 12, a biosafety level
2 laboratory shall have the following minimum requirements:
1 .   Inward airflow ventilation or controlled ventilating system;
2.   On-site Autoclave: and
3.   Biological safety cabinets.
(b) In addition to the minimum essential features stipulated in Section 12, biosafety level
3 and 4 laboratories shall have the following minimum requirements:
1.   Isolation of laboratory;
2.   Room sealable for decontamination;
3.   Inward  airflow  ventilation,   controlled  ventilating   system  and  HEPA-
filtered;
4.   Double-door entry;
5.    Airlock;
6.   Airlock with shower;
7.   Anteroom;
8.   Anteroom with shower;
9.   Effluent treatment;
10. On site, jn-laboratory and double-ended Autoclave;
11. Biological safety cabinets; and
12. Personal safety monitoring capability.
(c) Biosafety level 3 and 4 laboratories must be separated from general traffic flow and
accessed through an anteroom (with double door entry or basic laboratory - Biosafety
Level 2) or an airlock.
(d)  An autoclave must available within the facility for decontamination of wastes prior to
disposal.
(e) A sink with hands-free operation must available.
®  Inward directional airflow must be established and all work with infectious materials
must conducted within a biological safety cabinet.
See. 16. Handling Of viruses  and specimens  containing viruses.  -Unless tine reco;r][u[][+ended
biosafety level facilities are available, the laboratory should not handle a particular virus. In
situations where there is an outbreak of a viral illness and the required biosafety levels are not
available, the specimen shall be collected and referred to the nearest laboratory that has the
required  biosafety  laboratory.  Specimens  collected  from  patients  who  are  suspected  of
suffering from viral infections caused by agents under risk groups  3  or 4  shall be directly
forwarded to the reference laboratory or the Institute which has the required facilities for the
handling such agents.
See.  T].  Minimum  staff  requirement  for  a  virology  laboratory.  -The  rmjlirl"um  shalff
requirements for a virology laboratory shall include :
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(a)  A g"a/z/}ed v].7io/ogz.sJ possessing a postgraduate qualification in virology with at least
three (3) years of experience in diagnostic virology shall be the Chief of the laboratory.
He  shall  have  overall  responsibility  for  the  activities  of the  laboratory  and  shall
supervise all the staff working in it.  In addition, he shall be directly responsible for
reporting results of the various diagnostic assays performed in the laboratory;
(b) Two (2)/.ci#z.or mz.crobz.a/ogisfs possessing a master's degree in medical, animal or plant
microbiology with one to two (2) years of experience in diagnostic virology. These
microbiologists  shall  be  responsible  for the  day-to-day  operation  of the  laboratory
including the supervision of technical staff who carry out the various diagnostic tests,
stock management and procurement of laboratory supplies and diagnostic kits, quality
control and quality assurance;
(c)  Two (2) /¢boro}ory fech7co/ogz.sis possessing a bachelor's degree in medical technology,
one to be trained in cell culture and virus isolation methods and the other to be trained
in  serology.  The  technicians  shall  be responsible  for  specimen processing,  testing,
laboratory safety, malntenance of laboratory records and media preparation; and
(d) One (1) or two (2:) laboratory supportive staf f :
The  duties  and responsibilities  of all  the  staff shall  be  clearly  outlined  and they  shall  be
provided with periodic training to upgrade the knowledge and skills of the laboratory operation
and  management  to  ensure  that  the  laboratory  is  abreast  with  contemporary  diagnostic
methodology as well as maintain quality in the services rendered.
See.18. Use Of personal protective equipment in virology laboratories. -SpectaLlly desig[\ed
coveralls which afford protection up to the neck, facemasks or fiill face respirators and gloves
shall be used at all times in the virology laboratory. Additional personal protective equipment
shall be used when handling highly pathogenic viruses.
Sec.  19. j4me#i./I.es.  -  Hand basins  must be provided in  each  laboratory.  Lockers  for staff
clothing must be available outside but near the laboratory rooms. Pantry/rooms for eating and
drinking must be provided close to laboratory rooms.
Sec. 20. Heal/ffa a/Sftzjor -Pre-employment medical examination for all staff shall be made.
Medical monitoring for workers in biosafety level 3 and 4 laboratories shall also be conducted
regularly. The scope of the monitoring shall depend on the agent being handled. Women who
work with viruses must disclose their pregnancy as soon as possible. Individual evaluation of
the risks involved in continued employment in the virology laboratory must also be done.
Sec.  21. Medl.ca/ Swrvez.//cz%ce.  -  A system that records  and follows up  all  cases  of illness
among laboratory staff to ascertain the source of infection and initiate any follow up action
shall be developed.
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See. 2;2. Accidents. -
(a)  All accidents causing personal injury with or without exposure to infectious agents
shall be reported to the supervisor or safety officer. Records should be kept of all staff
sicknesses, injuries and accidents, and of x-rays and immunization;
(b) A qualified first-aid provider must be present at all times in the laboratory. He/she
must receive additional training in dealing with exposure to and ingestion of infectious,
toxic and corrosive chemicals;
(c)  A well sign-posted standard first aid kit for minor injuries must be in a conspicuous
location inside the laboratory; and
(d) Standard operating procedures for management of post-exposure prophylaxis must be
in place.
CHAPTER IV
LABORATORy WASTH MANAGnMENT
See. 23. A4l¢#¢geme#f o/£obora!fory Wa[sfe. - Laboratory waste shall be segregated into color-
coded  containers  corresponding those  for incineration,  for autoclaving,  normal  household
waste and for soiled linens.
The following practical methods shall be used in treating contaminated laboratory waste:
(a)  Sterilization  by  autoclaving  using  timed  exposure  of  materials  to  steann  above
atmospheric pressure at temperatures above 100 °C.
a) Chemical disinfection which is regarded as the first line defense, especially in the case
of discarded  bench  equipment,  and  which  should  be  followed  by  autoclaving  or
incineration.   Chemical   disinfection   shall   use   clear   sodium   hypochlorite,   clear
phenolics, alcohols and aldehydes.
(c)  Incineration involves the transport of waste materials  off-site for disposal using an
incinerator.
(d) Other  internationally-accepted  forms  of disinfection  and  decontamination  shall  be
employed in effectively preventing accidents and contamination.
Sec. 24. J"/ecfj.ows Wasfe - Infectious wastes shall be segregated from general wastes as they
need to be autoclaved or incinerated before being removed from the area in which they are
generated.
See. 25. jzo„/z.#e Co#/¢"z.#¢/ed Jycrs/es. - Laboratory workers shall take care to segregate their
wastes from general wastes. General wastes shall be decontaminated prior to removal from
the   area   in   which   they   are   generated.   Intemationally-accepted   altemative   means   of
decontamination to autoclaving or incineration may be used, provided they are effective.
See. 26. A4l¢#¢gemeHf a/sfoczxps wasfe. -All sharps waste shall be segregated from other wastes
and placed in dedicated and labelled single-use rigid containers immediately after use. Shalps
waste containers shall not be compacted or emptied into ordinary waste streams.
16


See. Z] . Labelling Of wastes. -
(a) All wastes shall be identified with an appropriate type of label which shall remain
attached to the waste. The label shall state the nature of waste material, the department,
date, and the name of the person responsible for the waste.
(b) In transporting wastes through buildings and across campus, the main consideration
shall be the  non-exposure  of anyone to the risks  from the  contaminated material.
Containers shall be leak-proof.
(c) Wastes shall be decontaminated as far as is practical before removal from the area of
generation. All laboratories shall have access to local autoclave and other appropriate
decontamination facilities so as to minimize the need to transport contaminated wastes
around laboratories.
CRAPTER V
QUALITY SYSTHMS IN VIROLOGY LABORATORIES
See. 28. gwcz/I.fy systems. - A quality system shall be instituted in all virology laboratories. It
shall be comprehensive and shall cover all aspects from the decision to collect the specimen
to the interpretation of results. Systematic efforts through organizational structure and efficient
utilization of resources shall be used implement all the steps that shall assure generation of
quality reports by the laboratory. It shall aim at consistency, reproducibility, traceability and
efficaciousness of the laboratory services.
See.  29.  Docwme#fa!fz.o#.   -  Routine  procedures   shall  be  described  in  written  Standard
Operating Procedures (sops). They shall be reviewed regularly and modified, if necessary.
The modified versions shall be signed and dated by the laboratory director. The most recent
version of sops shall be available directly at the work place. The old versions shall be kept in
the laboratory and shall be archived if required. The records shall be stored for long periods
of time but  shall  be  available  for prompt retrieval.  Safe  archiving of all records  shall be
ensured.
Archiving of the source documents and other essential documents shall be done in such a way
that data are kept in an integer state and can neither be lost nor altered to achieve this goal.
Records of usage, maintenance and calibration shall be kept in the laboratory and shall be
routinely monitored.  Reports  of the tests  shall be released  only after proper  scrutiny  and
documentation of the scrutiny with the signature and date by the laboratory supervisor.
See. 30. SJfl#dard Oper¢fz.ng Procedwre /SOPJ. -SOP is one of the most important documents
in a diagnostic laboratory. Apart from providing the complete details of how exactly a test or
a procedure is carried out in a laboratory, the SOP shall provide information on specimen
collection, laboratory safety instructions, purpose and limitations of the procedure, turnaround
times, interpretation of results, and above all, the line of authority. The procedure manual used
in the laboratory shall be complete enough in detail in order that any laboratory scientist can
perform the procedure without additional infomation. One copy of the manual shall be readily
17


available to bench personnel, and another copy shall be stored separately in case of accidents.
A document control system shall be instituted to ensure that up-to-date document are used.
See. 31. g#cz/z.fy Co#J7io/ Cfeecds 4reasT. -The following, among others, shall be the minimum
critical quality control check areas:
(a)  Specimen transport. Viral  specimens held for short periods  shall be refrigerated,
while those for longer periods shall be frozen at -200C or -700C;
(b) Transport media. The composition and type of viral transport media can affect viral
isolation rates. Culture media shall be a balanced isotonic solution at physiological pH.
It shall contain a substance that will stabilize the virus such as gelatin, fetal calf serum
or bovine serum albumin, and antibiotics against bacteria and fungi. The swab shall be
made of a material that is non-toxic to viruses;
(c)  Smears. Smears must contain a reasonable number of cells, be of a reasonable size,
and not mixed with blood or pus in order to avoid non-specjfic staining;
(d) Specimens for serology. Excessively hemolyzed, lipaemic, bacterially contaminated,
or leaking specimens shall be rejected. Sera shall be heat inactivated depending on the
tests to be performed. In the event of a specimen being rejected, the sender shall be
informed,  preferably  by  an  oral  report  followed  by  a  written  one.  Extenuating
circumstances may warrant the acceptance of a substandard specimen;
(e)  Tissue culture and media. Within a given cell line, there may be significant variations
in sensitivity to virus isolation which may depend on the particular cell line or clone
and  the  passage  number.  Information  on  a  particular  cell  line  shall  be  recorded
accurately including the source, type, passage number, con fluency and cell condition.
These back-up systems shall include freezing and storage of low passage cells at -70
°C liquid nitrogen tanks, use of paired stock flasks or carrying of a parallel set of stock
flasks using a separate set of tissue culture reagents and glassware;
Other quality control procedures that may aid in minimizing the risk of contamination
shall include the exclusion of laboratory with infectious diseases from handling tissue
culture, and separate laboratory apparel, reagents and glassware for tissue culture. Cell
lines shall be handled separately and the cabinet shall be decontaminated in between
uses;
®  Media. Following filter sterilization, aliquots of the media shall be taken and checked
for bacteriological or fungal contamination. These samples shall be examined daily for
five  days  and  must  be  free  from  contamination.  Aliquots  of all  other  medium
components such as fetal calf serum and L-glutamine shall also be checked. New lots
of medium and fetal calf serum that have passed the sterility check shall be monitored
for their ability to support cell growth;
(g) Reagents  and  Kits.   Reagents  and  kits   shall  only  be  ordered  from  reputable
manufacturers  and  dealers  with  reliable  transportation  systems.  Upon  receipt,  the
reagents shall be checked for obvious breakage or contamination. The quantity, source,
18


lot number and date of receipt shall be entered in a logbook and the reagents stored
according to the manufacturer's storage specifications.
When new lots of any reagent are opened, the date shall be noted on the container.
Caution shall be exercised in the case of kits as different components of a kit may
require different storage conditions and have different expiration dates; and
(h) Instruments.   Laboratory   instruments   shall   be   subjected  to   routine   preventive
maintenance and checked and calibrated on a regular basis. Some of these checks may
be performed by laboratory staff and entered into a logbook. The following shall be
the minimum routine laboratory malntenance and performance checks on instruments:
(i)
i.       Incubators:   daily   temperature,   C02   and   humidity   checks.   Weekly
decontamination of interior;
ii.       Safety cabinets: daily air pressure check and cleaning ofuv lamp. Work
surface should be decontaminated after each  use.  Annual  checks  for air
velocity   and   filter   integrity   and   paraldehyde   decontamination,   as
applicable;
iii.       Microscopes: daily cleaning of objectives and stage, log oflamp usage and
annual  overhaul.  Refrigerators  and  freezers:  daily  temperature  check;
annual check of compressor and reffigerant levels;
iv.       Water baths: daily temperature checks, weekly decontamination;
v.      Refrigerated  centrifuges:  weekly  decontamination,  annual  inspection  of
motor, speed calibration and drive system;
vi.      Autoclaves: daily temperature check and monthly spore strip testing;
vii.      pH meters: single reference buffer check before each use, multiple point
check monthly; and
viii.       Pipetting devices: gravimetric volume check monthly; annual overhaul.
Sec. 32. CoHfz.#wz.#gpro/essz.o#a/ ed#ccrfz.o#. - All virology laboratories shall regularly provide
local and intemational education and training to its laboratory workers at the expense of the
laboratory.
See. 33. J7cceHfz.veg a/ /oborczfory worifers.  -The DOST shall device a scheme which shall
provide incentives to laboratory workers in virology laboratories whose outputs result in high-
impact medical, agricultural, technological and industrial innovations.
Sec. 34. j4ssessmeHf a/gtJ¢/z.ty Sysfe7#. -The quality system shall be assessed either through
an onsite inspection (audit) or by sending known but undisclosed material to the laboratories
for testing (quality assessment scheme). The latter can be done within the Institute by internal
staff (intemal quality assessment scheme - IQAS) or through an extemal agency (extemal
quality assessment scheme- EQAS).
19


CHAPTER VI
PENALTY PROVISIONS
See. 3S. Penalties. -
(a)  In addition to those already penalized by existing laws, the following acts or omissions
shall be punishable by imprisonment of at least twelve (12) years and one (1) day to
twenty   (20)  years   or  a  fine  of  not  less  than  Five   Hundred  Thousand  pesos
(P500,000.00)  but  not  more  than  flve  million  pesos  (P5,000,000),  or  both,  such
imprisonment and fine, at the discretion of the court:
i.    Any person who  introduces  high-risk viral pathogens  into the  domestic
environment without obtaining a permit, in violation Section 15 of this Act.
ii.   Any person who refuses, interferes with, or evades an inspection for the
safety control of high-risk viral pathogens;
iii.  Any  person  who  neglects  to  apply  for  permit  for  the  operation  of the
virology laboratory;
iv.  Any  person  who  makes  a  false  statement,  presents  false  materials  or
documents, or intentionally omits or conceals any fact, in violation of any
of the provision of this Act;
a) In addition to those already penalized by existing laws, the following acts or omissions
shall be punishable by imprisonment of at least six (6) years and one ( 1) day to twelve
(12) years or a fine of not less than One Hundred Thousand pesos (Ploo,000.00) but
not more than One Million pesos (P1,000,000) or both, such imprisonment and fine,
at the discretion of the court:
i.      Any person who operates a virology laboratory in violation of sections 12,
13,14 and 15 of this Act.
ii.       Any person who disposes laboratory waste in violation of sections 23, 24,
25, 26 and 27 of this Act;
(c)  In addition to those already penalized by existing laws, the following acts or omissions
shall be punishable by imprisonment of at least six (6) months and one (I) day to six
(6) years or a fine of not less than One Hundred Thousand pesos (P100,000.00) but
not   more   than   Five   Hundred   Thousand   pesos   (P500,000.00),   or   both,   such
imprisonment and fine, at the discretion of the court:
i.       Any person who operates a virology laboratory in violation of sections 16,17,
18,19, 20, 21 and 22 of this Act.
ii.      Any person who operates a virology laboratory in violation of sections 28, 29,
30, 31, 32, 33 and 34 of this Act;
See. 36. Joz."f Pe#fl/fy. - Where a representative of a corporation, or an agent or an employee
of, or any other person employed by, a corporation or individual commits any violation of the
provisions of this Act in connection with the business of the corporation or individual, in
addition to the punishment of such violator, the corporation or individual shall be punished by
a fine under the respective provisions of Section 35.
20


1,,
/J,,
See.  37. ,4c7mz.7".strczJz've.  - In  addition to those  already penalized by existing  laws,  the  any
government official or employee who, by act or omission, violates any provision of this Act
shall be perpetually disqualified from holding public office with forfeiture of benefits in favor
of the State.
CHAPTER VII
OTHER PROVISIONS
See.  S8.  Congressional  Overnight  Committee  on  the  Virology  Science  and  Technology
J"sfz./wfe  a/ ffee Pfez./zzxpz.7!es-To  monitor the  implementation  of this  Act,  there  shall  be  a
Congressional Oversight Committee on the Virology Science and Technology Institute of the
Philippines, composed of the Chair and four (4) members of the House Committee on Science
and Technology, Chair of the House Committees on Health and Agriculture and Food and the
Chair and four (4) members of the Senate Committee on Science and Technology, and the
Chair of the Committees on Health and Demography and Agriculture,  Food and Agrarian
Reform. No part of this Act shall be construed as to limit the oversight powers inherently or
actually possessed by the same committees.
Sec.  39.  Sf¢j##g.  ~The  Secretary  of Science  and  Technology,  in  consultation  with  the
Department of Budget and Management (DBML shall determine the organizational structures,
qualification standards, stafling pattern and compensation of the newly created Institute and
other positions which are established under this Act in accordance with existing laws, rules
and regulations.
See.  40. j4pprapriafz.o#s.  -   The sum of Two  Billion Pesos  (P2,000,000,000.00)  is hereby
appropriated as an initial operating fund for the operation of the VIP, taken from the current
fiscal year's appropriation.  Thereafter, the amount needed for its armual operation shall be
included in the General Appropriation Act.
Sec. 41. Jmp/eme7cfz.#g Rc{Jes a#d Regc¢/¢Jz.o#s. -The Secretary of Health and the Secretary of
Agriculture, in coordination with the Secretary of Science and Technology, shall promulgate
the necessary rules and regulations within One Hundred Twenty ( 120) working days from the
effectivity of this Act.
Sec.  42.  Sep¢rczbz./I.ty  C/¢wSe.  -  If any  portion  or provision  of this  Act  is  subsequently
declared invalid or unconstitutional, other provisions hereof which are not affected thereby
shall remain in full force and effect.
See. 43. Repeo/I."g CJ¢ase. - All other laws,  acts, presidential decrees,  executive orders,
presidential  proclamations,  issuances,  mles  and  regulations,  or  parts  thereof  which  are
contrary to or inconsistent with any of the provisions of this Act are hereby repealed, amended,
or modified accordingly.
See. 44. E#ec/!.vz.fy. -This Act shall take effect fifteen (15) days after its publication in the
Official Gazette or in at least two (2) newspapers of general circulation.
21


'  ,`  i .
Approved,
22