PAKISTAN BIOSAFETY RULES, 2005

PAKISTAN BIOSAFETY RULES, 2005

(Islamabad, Tuesday, April 26, 2005)

NOTIFICATION

Islamabad, the 21st April , 2005

S.R.O. (I) 336(I)/2005-In exercise of the powers conferred by section 31 of the Pakistan

Environmental Protection Act, 1997 (XXXIV of 1997), the Federal Government is pleased to make the

following rules, namely: -

1. Short title and commencement.-(1) These rules may be called the Pakistan Biosafety Rules, 2005.

(2) They shall come into force at once.

2. Application.- These rules shall be applicable to-

(a) manufacture, import and storage of micro-organism and gene technological products for

research whether conducted in laboratories of teaching and research, research and

development institutes or private companies involved in the uses and applications of

genetically modified organisms and products thereof.

(b) all work involved in the field trial of genetically manipulated plants, animals (including

poultry and marine life), micro-organisms and cells; and

(c) import, export, sale and purchase of living modified organism, substances or cells and

products thereof  for commercial purposes.

3. Definitions.-(I) In these rules, unless there is anything repugnant in the subject or context.-

a) “act” means the Pakistan Environmental Protection Act, 1997 (XXXIV of 1997);

b)  “applicant” means any person including an artificial judicial person, seeking license for

activities related with application of these rules;

c)  “Biosafety” means the mechanism developed through policy and procedures to ensure the

environmentally safe application of biotechnology;

d) “biosafety guidelines” means the Pakistan Biosafety Guidelines notified by the Ministry of

Environment;

e) “commercial release” means any intentional introduction of living modified organisms into the

environment through sale or purchase;

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f) “contained use” means any operation or activity, undertaken within a facility, installation or

other physical structure, which involves living modified organisms, substances or cells and

products thereof and controlled in a manner that limit their contact with, and their impact on,

the external environment and the general population;

g)  “deliberate release” means any intentional transfer of living modified organisms to the

environment or nature, irrespective of the way in which it is done;

h) “experimental release” means any intentional introduction into the environment of living

modified organisms, with containment measures and which is not used for commercialization;

i) “export” means the intentional transboundary movement from Pakistan to another country;

j) “import” means the international transboundary movement into Pakistan from another country;

k) “Institutional Biosafety Committee ” means the committee constituted under rule 8;

l) “intentional introduction into the environment” means any deliberate release of living modified

organisms subject to these rules that is not “contained use”, including release for experimental

purposes but does not include living modified organisms imported for direct use for food or

feed or for processing;

m) “licence” means the licence granted by the Federal Agency under section 14 of the Act;

n)  “living modified organism or genetically modified organisms” means living cells or

organisms, substances, cells and products thereof whose genetic material has been altered or

modified by any variety of techniques of modern biotechnology to make them capable of

producing new substances or perform new functions;

o) “living organisms” means any biological entity capable of transferring or replicating genetic

material, including sterile organisms, viruses and viroids;

p) “modern biotechnology” means the application of-

i. in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA)

and direct injection of nucleic acid into cells or organelles; or

ii. fusion of cells beyond  the taxonomic family,

to overcome natural physiological reproductive or recombination barriers and that are not

techniques used in traditional breeding and selection;

q) “National Biosafety Committee” means the committee constituted under rule 4; and (r)

“Technical Advisory Committee” means the committee constituted under rule 6.

4. Establishment of National Bio-safety Committee.-(1) The Federal Government shall, by

notification in the official Gazette, establish a National Biosafety Committee consisting of the following

members namely:-

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a) Secretary, Ministry of Environment     Chairperson

b) Member (Biosciences), Pakistan Atomic Energy Commission  Member

c) Chairpersons of concerned Institutional Biosafety Committees Members

d) Representatives of Provincial Governments    Members

e) Representatives of Government of AJK    Member

f) Chairman, PARC       Member

g) Representative Ministry of Food & Agriculture   Member

h) Representative Ministry of Health     Member

i) Representative Ministry of Science and Technology   Member

j) Representative Ministry of Education    Member

k) Director-General, Department of Plant Protection   Member

l) Director-General, Pakistan EPA     Member

(2) The Director-General, Pakistan EPA, shall act as Secretary of the National Bio-safety

Committee

(3) The Committee may co-opt any other member as deemed necessary for its functioning.

(4)  The members of the Committee, other than ex-officio members, shall hold office for a term of

three years extendable to another term of three years with the approval of the Chairperson

(5) The Committee shall frame its own rules and procedures.

(6) The Committee shall hold meetings as and when deemed necessary, provided that not less than

four meetings shall be held in a year.

5. Functions of National Biosafety Committee._ (1) The National Biosafety Committee shall

perform the following functions:namely:-

a) to establish standards and procedures for risk assessment and labeling of living modified

organisms, substances or cells and products thereof.

b) to consider application(s) for import, export or commercial release of living modified

organisms, and on the recommendations of Technical Advisory Committee allow release

or reject applications after reviewing the risk assessment carried out in accordance with

the biosafety guidelines, the procedures established under clause (a) and  any other

reliable information.

c) to ban or restrict import, export, sale, purchase or trading of any living modified organism

causing or likely  to cause risk to public health, safety or environment.

d) to develop linkages  with foreign biosafety committees and relevant agencies to ensure

that genetic manipulation practices in Pakistan address international biosafety concerns

and observe universal codes of conduct.

e) to cooperate with other relevant federal or provincial authorities overseeing the import

and release of living organisms and formulate guidelines for the identification, inspection

and regulation of transgenic species exotic organisms and others.

f) to restrain on the advice of Technical Advisory Committee any person, authority or

institute involved with genetic manipulation experiments of potential hazards.

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g) to facilitate exchange of technical expertise to various research institutions and regulatory

agencies in setting up appropriate experimental conditions.

h) to Facilitate all levels of supervision of genetic manipulation work by assisting other

regulatory bodies including Institutional Biosafety Committees, in establishing pertinent

codes disciplines and guidelines for the appraisal of biohazards and the management of

bio- safeguards.

i) to coordinate efforts of Institutional Biosafety Committees and inform and educate the

public on biosafety issues and on proposed national policies.

j) to ensure that laboratory, field work and commercial release of genetically modified

organisms and their products conforms to the national biosafety guidelines.

k) to prepare and provide to Institutional Biosafety Committees the various notifications and

assessment forms, biosafety guidelines, related documents and assorted signs for

facilities.

l) to inform the various institutions engaged in genetic manipulation work about new

developments in biosafety so as to avoid exposure of laboratory personnel, the

community or the environment to undue risks.

m) to coordinate efforts between pertinent government agencies and private organizations to

maintain safety levels in biotechnological work and to prepare them for biological

emergencies.

n) to certify high-level laboratories, plant glass houses and animal houses intended for use in

high-risk work. Upon request by the institution, and at the earliest convenience, the

National Biosafety Committee may inspect a facility and either issue certification, or

recommend additional precautions, if elements of the facility are determined to be

inadequate to support the types of risk/hazard companying work requiring such physical

containment.

o) to inspect high-level laboratories and containment facilities on a regular basis. The

National Biosafety Committee may inspect laboratories and facilities of containment level

C2. PH2. C2A, as specified in the bio safety guidelines, equivalent or higher at any time

subsequent to certification without prior notice.

p) to inspect systems equipment and instruments governing ambient biosafety levels in

genetic manipulation laboratories.

q) to keep information of commercial significance confidential from public domain if so

requested in writing by applicant, person or institution or organization.

r) to monitor the safety related aspects of on going research projects and achievements

involving genetically engineered organisms/hazardous substances or cells and products

thereof.

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6. Technical Advisory Committee:- (1) The Federal Government shall, by notification in the

official Gazette, establish a Technical Advisory Committee consisting of the following:

i)   Director-General, Pakistan EPA         Chairperson

ii) Director, National Institute for Bio Technology and    Vice Chairperson

Genetic Engineering, Faisalabad.

iii)  Executive Director, Pakistan Medical Research Council(PMRC) Member

iv)  Director, Pakistan Council of Industrial and     Member

Scientific Research (PCSIR)

v)  Director, Health Services Academy (HAS)    Member

vi)  Executive Director, National Institute of Health    Member

vii)  Representative, Pakistan Atomic Energy Commission, Islamabad Member

viii) Representative, Centre for Molecular Genetics, University of Karachi Member

ix)  Representative, Centre for Applied and Molecular Biology, Lahore  Member

x)  Representative, National Commission on Biotechnology  Member

xi) Relevant technical representative Animal Sciences PARC  Member

xii) Relevant technical representative Plant Sciences PARC   Member

xiii) Director, Pakistan Environmental Protection Agency, Islamabad   Member/Secretary

xiv) Two experts from private sector/civil society    Members

(2) The Director, Pakistan Environmental Protection Agency shall act as Secretary of the

Technical Advisory Committee.

(3) The Committee may co-opt any technical representative from any province.

7. Functions of Technical Advisory Committee.- The following are the functions of the

Technical Advisory Committee, namely:-

a) to examine applications and recommend to National Biosafety Committee on

permitting or otherwise laboratory work, field work or release of living modified

organism, substances, cells, and products thereof;

b) to review and control of safety measures adopted while handling large scale use of

genetically engineered organisms/classified organisms in research, developmental

and industrial production activities;

c) to review research methodologies in genetic engineering and recombinant DNA

work at the international level and assess the associated risks to guide relevant

institutions;

d) to monitoring release of engineered organisms or products into environment and to

oversee field applications and experimental field trials;

e) to provide information or data inputs to National Biosafety Committee upon

surveillance of approved projects under industrial production, and in case of

environmental releases with respect to safety risks and accidents; and

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f) to supervise directly or through any person authorized in this behalf the

implementation of the terms and conditions laid down in connection with the

approvals accorded by the National Biosafety Committee.

8. Institutional Biosafety Committees.- (1) The head of the institution related to biotechnology

shall notify Institutional Biosafety Committee with the following minimum composition:

a) Head of the institution      Chairperson

b) Subject expert (s)         Members

c) Social Scientist/economist (for social impact)    Member

d) Representative of civil society      Member

9. Functions of Institutional Biosafety Committee ._ (1) The Committee shall perform the

following functions, namely:-

a) to assist in the activities of National Biosafety Committee and Technical Advisory

Committee;

b) to assist researchers in undertaking risk assessment, organizing training programmes and

harmonizing experimental conditions with biosafety guidelines;

c) to determine additional safeguards and draft supplementary operating instructions for work

at the institution, in line with and addressing the specific risks and concerns uncovered;

d) to evaluate the qualifications of researchers involved in biotechnological projects and assess

whether each retains a thorough understanding of good microbiological practices necessary

for the supervision of students, assistants and junior personnel;

e) to monitor all regulated work under progress within the institution and counsel the

proponents on issues of biosafety and on compliance with biosafety guidelines on a regular

basis, or as requested;

f) to serve, where appropriate as a gateway for the flow of information, ideas and opinions

between the National Biosafety Committee  and the research teams;

g) to maintain and update a directory of all personnel engaged in activities at every biosafety

level and to instruct new personnel on the correct laboratory or field practices, emergency

procedures and equipment operation at the relevant level;

h) to ensure health of laboratory and field personnel as may deem necessary from medical

records;

i) to liaise with National Biosafety Committee and Technical Advisory Committee on import,

export, manufacture, process, use or sale of any genetically modified organisms/substances

or cells and products thereof for the purpose of research;

j) to withhold funds and or use administrative authority to immediately refrain programmes if

biosafety guidelines are violated;

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k) to prepare and implement the institutional emergency and response plan according to the

details provided in the manuals and guidelines prepared by National Biosafety Committee;

l) to assess all projects referred to it, and on the basis of the information provided and the

risks forecast determine under which category of work the proposals fall and whether to

endorse the work proposed;

m) to maintain records of approved project proposals for laboratory genetic manipulation work

(including notification for project exemption) and the assessments;

n) to forward summaries of all project proposals submitted for IBC notification, and the

assessments to the Technical Advisory Committee for records and information or for

review and recommendation in the case of proposals for Risk Category 2 and 3 work;

o)  to undertake risk assessment, in cooperation with the research teams as necessary, to

determine the appropriate containment and biosafety conditions, operating procedures and

emergency safeguards for Risk Category 2 and 3 genetic manipulation work, and for the

housing, storage or movement of regulated material and also the waste;

p)  to prepare, in conjunction with the research teams, specific contingency plans after

undertaking risk assessments and reviewing project proposals;

q)  to enforce, with particular emphasis on Risk Category 3 work, all recommendations, and

ensure that the conditions of National Biosafety Committee have been acknowledged and

promptly addressed;

r) to inspect and certify, before use in genetic manipulation work. C1 level laboratories,

conventional animal houses, PH 1 plant glass houses, and quarantine and medical facilitates

for infected animals; and

s) to monitor and access the containment features of and the working conditions within all

laboratories, plant glass houses and animal houses supporting the institution’s work, to

ensure that the various facilities are maintained at the standards and requirements delineated

in Appendices 4 through 11 of biosafety guidelines.

10. The Bio-Safety Officer (BSO)._ (1) Institutions and organizations engaged in biotechnology

or genetic manipulation work shall appoint or designate a Bio-Safety Officer (s) well conversant with

bio-safety issues and emergency counter-measures to perform the following functions; namely

a) to assist and liaison with Institutional Biosafety Committee.

b) to review in conjunction with the Institutional Biosafety Committee and on a regular

basis operating procedures and biosafety records, and to assay the integrity of

containment facilities and safety equipment or utilities; and

c) to advise on all matters pertaining to risk and biosafety, health of personnel,

contingencies at work and infractions of  biosafety guidelines.

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11. Prohibition and Licence requirements.-(1) No person shall import, export, sell, purchase or

trade living modified organisms, substances or cells and products thereof for any purposes, without the

prior obtaining  of licence from the Federal Agency.

(2) Applicants seeking licence for activities shall submit an application prepared in conformity

with the requirements of the Biosafety Guidelines to the Federal Agency accompanied with a

prescribed fee.

(3) Any person to whom a licence has been granted shall notify the Federal Agency and the

National Biosafety Committee of any change in or addition to the information already submitted.

12. Confidential Information.- Information designated as confidential by the applicant shall be

protected from disclosure inconformity with Article 21 of the Cartagena Protocol as set forth in the

biosafety guidelines.

13.  Risk Assessments and Risk Management.-(1)The National Biosafety Committee shall ensure

that risk assessment is carried out in accordance with the biosafety guidelines for all activities that

require licence.

(2) Risk assessment, including the auditing of risk assessments and evaluation of proposed risk

management measures, and field trials shall be carried out on a case-by-case basis in a scientifically

sound manner, in accordance with Article 15 and Annex III of the Cartagena Protocol as set forth in

the biosafety guidelines.

14. Decision-making and Communication of Decision.-(1) A final decision shall be made and

communicated to the applicant within;

a) sixty days for Risk Category 2 and 3 contained use activities (as specified in the

biosafety guidelines);

b)   ninety days for experimental releases; and

c)   one hundred and twenty days for commercialization.

(2) Decisions shall be based on information set forth in the application, scientific risk assessment

and prior field experience with the living modified organisms in Pakistan.

(3) Final decisions shall be recorded in a decision document as described in the biosafety

guidelines. No person shall vary the purpose of the licence activity as set forth in the decision

document unless he obtains a licence.

(4) The licence granted by the Federal Agency under rule 11 shall not take effect until the applicant

executes an undertaking in which the applicant assumes the legal duty to comply with applicable

provisions of the biosafety guidelines in existence as of the date of the licence.

15. Grant of Licence-(1) All grants of licence under rules 11 shall be subjected to terms and

conditions as to the labeling, control to be exercised by the applicant, supervision, restriction on use,

the layout of the enterprise and as to the submission of information or any other condition deemed

appropriate by the Federal Agency.

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(2) All approvals of the Federal Agency shall be for a specified period not exceeding four years at

the first instance renewable for two years at a time. The Federal Agency shall have powers to revoke

such approval in the following situations; namely: -

(a) if there is any new information as to the harmful effects of the genetically

engineered organisms or cells.

(b) if the genetically engineered organisms or cells cause such  damage to

the environment, nature or health as could not be envisaged when the

approval was given, or

(c) non compliance of any condition stipulated by the Federal Agency

16. Application for re-examination.- (1) Any applicant may file application with the National

Biosafety Committee for re-examination after a minimum time of six months if the applicant considers

that-

(a) a change in circumstances has occurred that may have a material effect on  the outcome

of the risk assessment upon which the decision was based; or

(b) additional scientific or technical information has become available that may have a

material effect on the decision including any conditions, limitations or requirements

imposed under an authorization.

17.  Special Requirements for Import and Export of Living Modified Organisms.-(1) Living

modified organisms, substances or cells and products thereof imported for contained use, for

intentional introduction into the environment, or for direct use as food or feed or for processing shall

be identified in accordance with the requirements of Article 18 of the Cartagena Protocol as set forth in

the biosafety guidelines and such import, where required, shall be in accordance with these rules and

the National Plant Quarantine Regulations aligned with International Plant Protection Convention. All

such imports will also be governed by the provision of Import Trade and Procedures Order (IT&PO)

and Export Policy and Procedures Order (EPPO).

(2) Any person proposing to export living modified organisms, substances or cells and products

thereof shall provide all information including risk assessment and field trials to the exporting country.

and such export, where required, shall be in accordance with these rules and the National Plant

Quarantine Regulations aligned with International Plant Protection Convention. All such exports will

also be governed by the provision of IT&PO and EPPO.

18. Transition and Reviews.- Activities that were ongoing pursuant to the pre-existing regulatory

system at the date of the entry into force of these rules shall be subject to the review procedure set forth

in rule 11 but may continue until such time as a final decision is provided to the applicant. Any

application pending at the date of the entry into force of these rules shall be subject to the provision of

these rules.

19. Production: - Production in which living modified engineered organisms, substances or cells

or products thereof or microorganism are generated or used shall not be commenced except with the

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consent of National Biosafety Committee. This shall also apply to production taking place in

connection with development, testing and experiments.

20. Deliberate or unintentional release.-(1) Deliberate or unintentional release of living modified

organisms or hazardous microorganisms, substances or cells and products thereof including deliberate

release for the purpose of experiment is not allowed.

(2) National Biosafety Committee on the recommendations of the Technical Advisory Committee

may in special cases give approval of deliberate release.

21. Permission and approval for certain substances:- Substances and products, which contain

genetically engineered organisms or cells or microorganisms shall not be produced, sold, imported or

used except with the approval of National Biosafety Committee and in accordance with sub-rule (2) of

rule 20.

22. Permission and approval for food stuffs.- Food stuffs, ingredients in food stuffs and

additives including processing aids containing or consisting of living modified organisms, substances

or cells and products thereof shall not be produced, sold, imported or used except with the approval of

the National Biosafety Committee and in accordance with sub-rule (2) of rule 20.

23. Responsibility to notify interruptions or accidents.-(1) Any person, institution or

organization whether obtained licence under rule 11 or not shall immediately notify the Technical

Advisory Committee of any interruption of operations or accidents that may lead to discharges of

genetically engineered organisms or cells which may be harmful to the environment, nature or health

or involve any danger thereto.

(2) Any notice given under sub-rule (1) above shall not lessen the duty of the person who is

responsible to try effectively to minimize or prevent the effects of interruptions of operations of

accidents.

24. Preparation of Off-site emergency Plan by the Technical Advisory Committee.-

(1) Technical Advisory Committee may prepare an off-site emergency plan for emergencies

relating to a possible major accident and prepare a plan of action in consultation with all concerned.

(2) For the purpose of enabling the Technical Advisory Committee to prepare the emergency plan

required under sub-rule(1), the person, institute or organization shall provide the Technical Advisory

Committee with such information relating to the handling of hazardous micro-organisms/genetically

engineered organisms under his control as the Technical Advisory Committee may require including

the nature, extent and likely off-site effects of a possible major accident and the Technical Advisory

Committee shall provide the person, institute or organization with any information related to off-side

emergency plan.

25. Information and Inspections .-(1) Any person seeking licence or who has obtained licence

under rules 11 shall at the direction of Technical Advisory Committee submit all such information

deemed necessary for its functioning.

(2) The National Biosafety Committee or its authorized officer may at any reasonable time inspect or

verify compliance of any condition  laid down in the licence issued under rule 11.

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26. Fees.- (1) The Technical Advisory Committee may fix a fee with the approval of National

Biosafety Committee to cover, in whole or in part, the expenses incurred by the authorities in

connection with approvals, examinations, supervision and control.

27. Powers to give directions.- (1) The Federal Government may give any written direction which

shall be binding on the National Biosafety Committee or the Technical Advisory Committee or the

Institutional Biosafety Committees to comply with.

Sd/-

(NOOR ZAMAN)

Section Officer (Admn-I)

File [2(7)95-Bio.]