This presentation is all about Biosafety - Rules & Regulations at both National & International levels.... All you need to know about BIOSAFETY ... The ppt will allow you to access the vast Biological procedures around globe.

1. Mr. Abhirup Ganguli
Assistant Professor
Dept. of Biotechnology
Swami Vivekananda Institute of Modern Sciences

2.  The Cartagena Protocol on Biosafety to the Convention on
Biological Diversity is an international treaty governing the
movements of living modified organisms (LMOs) resulting from
modern biotechnology from one country to another.
 It was adopted on 29 January 2000 as a supplementary agreement
to the Convention on Biological Diversity and entered into force
on 11 September 2003.
 The Biosafety Protocol makes clear that products from new
technologies must be based on the precautionary principle and
allow developing nations to balance public health against
economic benefits.
 It will for example let countries ban imports of a genetically
modified organisms if they feel there is not enough scientific
evidence that the product is safe and requires exporters to label
shipments containing genetically altered commodities such as
corn or cotton.

3.  In accordance with the precautionary approach,
contained in Principle 15 of the Rio Declaration on
Environment and Development, the objective of the
Protocol is to contribute to ensuring an adequate level
of protection in the field of the safe transfer, handling
and use of 'living modified organisms resulting from
modern biotechnology' that may have adverse effects
on the conservation and sustainable use of biological
diversity, taking also into account risks to human
health, and specifically focusing on transboundary
movements (Article 1 of the Protocol, SCBD 2000).

4.  The protocol defines a 'living modified organism' as any living
organism that possesses a novel combination of genetic material
obtained through the use of modern biotechnology, and 'living
organism' means any biological entity capable of transferring or
replicating genetic material, including sterile organisms, viruses and
viroids.
 'Modern biotechnology' is defined in the Protocol to mean the
application of in vitro nucleic acid techniques, or fusion of cells beyond
the taxonomic family, that overcome natural physiological reproductive
or recombination barriers and are not techniques used in traditional
breeding and selection.
 'Living modified organism (LMO) Products' are defined as processed
material that are of living modified organism origin, containing
detectable novel combinations of replicable genetic material obtained
through the use of modern biotechnology (for instance, flour from GM
maize).

5.  'Living modified organism intended for
direct use as food or feed, or for processing
(LMO-FFP)' are agricultural commodities
from GM crops.
 Overall the term 'living modified organisms'
is equivalent to genetically modified
organism - the Protocol did not make any
distinction between these terms and did not
use the term 'genetically modified
organism’.

6.  One of the outcomes of the United Nations
Conference on Environment and Development (also
known as the Earth Summit) held in Rio de Janeiro,
Brazil, in June 1992, was the adoption of the Rio
Declaration on Environment and Development, which
contains 27 principles to underpin sustainable
development.
 Commonly known as the precautionary principle,
Principle 15 states that "In order to protect the
environment, the precautionary approach shall be
widely applied by States according to their capabilities.
Where there are threats of serious or irreversible
damage, lack of full scientific certainty shall not be
used as a reason for postponing cost-effective
measures to prevent environmental degradation."

7.  Elements of the precautionary approach are reflected in a
number of the provisions of the Protocol, such as:
1. The preamble, reaffirming "the precautionary approach
contained in Principle 15 of the Rio Declaration on
environment and Development";
2. Article 1, indicating that the objective of the Protocol is "in
accordance with the precautionary approach contained in
Principle 15 of the Rio Declaration on Environment and
Development";
3. Article 10.6 and 11.8, which states "Lack of scientific
certainty due to insufficient relevant scientific information
and knowledge regarding the extent of the potential adverse
effects of an LMO on biodiversity, taking into account risks
to human health, shall not prevent a Party of import from
taking a decision, as appropriate, with regard to the import
of the LMO in question, in order to avoid or minimize such
potential adverse effects."; and
4. Annex III on risk assessment, which notes that "Lack of
scientific knowledge or scientific consensus should not
necessarily be interpreted as indicating a particular level of
risk, an absence of risk, or an acceptable risk."

8.  The Protocol applies to the transboundary
movement, transit, handling and use of all
living modified organisms that may have
adverse effects on the conservation and
sustainable use of biological diversity,
taking also into account risks to human
health (Article 4 of the Protocol, SCBD
2000).

9.  The governing body of the Protocol is called the
Conference of the Parties to the Convention serving as
the meeting of the Parties to the Protocol (also the COP-
MOP). The main function of this body is to review the
implementation of the Protocol and make decisions
necessary to promote its effective operation.
 Decisions under the Protocol can only be taken by Parties
to the Protocol. Parties to the Convention that are not
Parties to the Protocol may only participate as observers in
the proceedings of meetings of the COP-MOP.
 The Protocol addresses the obligations of Parties in
relation to the transboundary movements of LMOs to and
from non-Parties to the Protocol. The transboundary
movements between Parties and non-Parties must be
carried out in a manner that is consistent with the objective
of the Protocol. Parties are required to encourage non-
Parties to adhere to the Protocol and to contribute
information to the Biosafety Clearing-House.

10.  A number of agreements under the World Trade Organization
(WTO), such as the Agreement on the Application of Sanitary
and Phytosanitary Measures (SPS Agreement) and the
Agreement on Technical Barriers to Trade (TBT Agreement),
and the Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPs), contain provisions that are relevant
to the Protocol. The Protocol states in its preamble that
parties:
1. Recognize that trade and environment agreements should
be mutually supportive;
2. Emphasize that the Protocol is not interpreted as implying a
change in the rights and obligations under any existing
agreements; and
3. Understand that the above recital is not intended to
subordinate the Protocol to other international agreements.

11.  The Protocol promotes biosafety by establishing rules and
procedures for the safe transfer, handling, and use of LMOs, with
specific focus on transboundary movements of LMOs.
 It features a set of procedures including one for LMOs that are to
be intentionally introduced into the environment called the
advance informed agreement procedure, and one for LMOs that
are intended to be used directly as food or feed or for processing.
 Parties to the Protocol must ensure that LMOs are handled,
packaged and transported under conditions of safety.
 Furthermore, the shipment of LMOs subject to transboundary
movement must be accompanied by appropriate documentation
specifying, among other things, identity of LMOs and contact
point for further information.
 These procedures and requirements are designed to provide
importing Parties with the necessary information needed for
making informed decisions about whether or not to accept LMO
imports and for handling them in a safe manner.

12.  The Party of import makes its decisions in accordance with
scientifically sound risk assessments.
 The Protocol sets out principles and methodologies on how
to conduct a risk assessment.
 In case of insufficient relevant scientific information and
knowledge, the Party of import may use precaution in
making their decisions on import.
 Parties may also take into account, consistent with their
international obligations, socio-economic considerations
in reaching decisions on import of LMOs.
 Parties must also adopt measures for managing any risks
identified by the risk assessment, and they must take
necessary steps in the event of accidental release of LMOs.
 To facilitate its implementation, the Protocol establishes a
Biosafety Clearing-House for Parties to exchange
information, and contains a number of important
provisions, including capacity-building, a financial
mechanism, compliance procedures, and requirements for
public awareness and participation.

13. Advance Informed Agreement:
 The "Advance Informed Agreement" (AIA) procedure applies to
the first intentional transboundary movement of LMOs for
intentional introduction into the environment of the Party of
import. It includes four components: notification by the Party of
export or the exporter, acknowledgment of receipt of notification
by the Party of import, the decision procedure, and opportunity
for review of decisions.
 The purpose of this procedure is to ensure that importing
countries have both the opportunity and the capacity to assess
risks that may be associated with the LMO before agreeing to its
import.
 The Party of import must indicate the reasons on which its
decisions are based (unless consent is unconditional).
 A Party of import may, at any time, in light of new scientific
information, review and change a decision. A Party of export or a
notifier may also request the Party of import to review its
decisions.

14.  However, the Protocol's AIA procedure does not apply
to certain categories of LMOs:
 LMOs in transit;
 LMOs destined for contained use;
 LMOs intended for direct use as food or feed or for
processing
 While the Protocol's AIA procedure does not apply to
certain categories of LMOs, Parties have the right to
regulate the importation on the basis of domestic
legislation. There are also allowances in the Protocol to
declare certain LMOs exempt from application of the
AIA procedure.

15.  LMOs intended for direct use as food or feed, or processing
(LMOs-FFP) represent a large category of agricultural
commodities. The Protocol, instead of using the AIA procedure,
establishes a more simplified procedure for the transboundary
movement of LMOs-FFP.
 Under this procedure, A Party must inform other Parties
through the Biosafety Clearing-House, within 15 days, of its
decision regarding domestic use of LMOs that may be subject to
transboundary movement.
 Decisions by the Party of import on whether or not to accept the
import of LMOs-FFP are taken under its domestic regulatory
framework that is consistent with the objective of the Protocol.
 A developing country Party or a Party with an economy in
transition may, in the absence of a domestic regulatory
framework, declare through the Biosafety Clearing-House that
its decisions on the first import of LMOs-FFP will be taken in
accordance with risk assessment as set out in the Protocol and
time frame for decision-making.

16.  The Protocol provides for practical requirements that are
deemed to contribute to the safe movement of LMOs.
 Parties are required to take measures for the safe handling,
packaging and transportation of LMOs that are subject to
transboundary movement.
 The Protocol specifies requirements on identification by setting
out what information must be provided in documentation that
should accompany transboundary shipments of LMOs.
 It also leaves room for possible future development of standards
for handling, packaging, transport and identification of LMOs by
the meeting of the Parties to the Protocol.
 Each Party is required to take measures ensuring that LMOs
subject to intentional transboundary movement are
accompanied by documentation identifying the LMOs and
providing contact details of persons responsible for such
movement.

17.  The details of these requirements vary according to the
intended use of the LMOs, and, in the case of LMOs
for food, feed or for processing, they should be further
addressed by the governing body of the Protocol.
(Article 18 of the Protocol, SCBD 2000).
 The first meeting of the Parties adopted decisions
outlining identification requirements for different
categories of LMOs (Decision BS-I/6, SCBD 2004).
 However, the second meeting of the Parties failed to
reach agreement on the detailed requirements to
identify LMOs intended for direct use as food, feed or
for processing and reconsider this issue at its third
meeting in March 2006.

18.  The Protocol established a Biosafety Clearing-House
(BCH), in order to facilitate the exchange of scientific,
technical, environmental and legal information on,
and experience with, living modified organisms; and
to assist Parties to implement the Protocol (Article 20
of the Protocol, SCBD 2000).
 It was established in a phased manner, and the first
meeting of the Parties approved the transition from
the pilot phase to the fully operational phase, and
adopted modalities for its operations (Decision BS-I/3,
SCBD 2004).

19.  The use of Biotechnology creates profound ethical questions .
i. Its use in reproduction & genetic screening brings unique questions of
discrimination , exploitation of women .
ii. Should we become architects of life itself ? Should biotechnology be
allowed to play GOD ? Crossing the species boundaries in genetic
exchanges which have resulted into inserting animal genes into human
or human genes into animals and inserting plant genes into
microorganisms & other species is not correct .
iii. Patenting genetically engineered animal is equating it to status of
manufactured product. Will living things have no more intrinsic value
than automobiles & garments or any other commodity ?
iv. Will diagnostic procedures undermine individual privacy ?
v. The failure to label genetically engineered foods means that persons
who follow religious dietary restrictions will be unable to ensure
compliance with their beliefs . The genes from prohibited foods could
be engineered into other foods .Thus genetic material whose
consumption violates religious restrictions may be present in vegetable ,
fruit , etc. Consumer will not know which processed foods are
genetically engineered . Vegetarians will be forced inadvertently to take
food containing genetic material from insects , fish , pigs or other
animals . Religious & ethical beliefs will be greatly disturbed.

20. vi. Would mothers be willing to buy infant formula with
bioengineered ingredients extracted from udders of
transgenic cow ? (Human lactoferrin & human lysozyme are
expressed in cow’s milk.)
vii. 70% of public feel that , introducing animal genes into plants
is ‘unacceptable’. 90% feel that human genes should not be
introduced into animals & 98% people want genetically
engineered (bovine growth hormone) bGH-milk labeled so
that they can avoid it .
viii. Should humans be genetically engineered ? Gene therapy
should be restricted to the alleviation of genetic diseases in
individual patients & should not be used to change or enhance
normal human traits. Genetic modification of reproductive
cells or the germ cells which give rise to them should not at
present be attempted.
ix. Attempts to patent human DNA sequences which is our
common heritage is an ugly side of research on Human
genome .

21.  The use of Biotechnology creates socio-
economical dislocation in many instance.
 It acts at National as well as International level .
 The most serious aspect of Biotechnology is
perhaps lack of supervision , lack of regulation
& secrecy & overcoming of legal hurdles
incorrectly.
 Patenting , testing the production in couple
which are ignorant of effects , illegal release of
genetically engineered organisms and many
still requires more attention .

22.  The ability to manufacture chemical or biological
threats is relatively much easier and its availability
more widespread that nuclear weapons.
 Because of this, many believe any future terrorist
attacks might be done with biological weapons
similar to anthrax.
 Though seemingly a new threat, similar weaponry
has been the subject of debate for decades.
 Here we discuss the subject of many of those
debates, the ethical implications of its use and
development.

23.  “Biological warfare is the intentional use of disease-causing
microorganisms or other entities that can replicate
themselves (e.g., viruses, infectious nucleic acids and
prions) against humans, animals or plants for hostile
purposes”.
 Furthermore, “it may also involve the use of toxins:
poisonous substances produced by living
organisms…plants…and animals.
 If they are utilized for warfare purpose, the synthetically
manufactured counterparts of these toxins are biological
weapons”.
 Delivery of such substances can be as easy as sending it via
mail, as in the anthrax example, or as sophisticated as
mounting a chemical warhead onto a missile.
 Other possible means of delivery include introducing a
substance to a water supply or through air dispersal in the
form of gas.
 Here we will use the terms “biological weapons” and
“chemical weapons” interchangeably.

24.  Among the most important issues is the issue of biological
weapon use. In some respects, its use is similar to a nuclear
weapon.
 Both are capable of mass destruction and, in the case of
poisonous gases, “can disable living creatures when carried by
winds to areas far beyond the immediate impact zone” (fallout
in nuclear terms).
 Both are “militarily very effective” .
 As such, the ethical discussion of chemical weapons closely
resembles the ethical discussion of nuclear weapons.
 Under the CWC guidelines, the following scenario is unlikely to
happen because of restrictions on the production of chemical
weaponry but it is an ethical issue regarding the use of it and its
moral implications.

25.  Nicholas Fotion gives the example of a fascist
nation under a Nazi-like regime known to practice
genocide.
 “Its military forces need only to overcome [the
other nation’s forces] to gather another two
hundred million people” to murder.
 “If [they] are successful, it will likely send at least
ten million people to their deaths,” and will likely
mean success for their military campaign.
 Their only weakness would be against chemical
weaponry.
 Would the use of chemical weapons by the nation
being invaded by ethically responsible?
 Nearly any view, not only utilitarian, would say
that by almost any means, stopping genocide of
such scale is paramount.

26.  Does this apply to current times – would the use of chemical weapons
against terrorist groups be the most effective way of eradicating such a
threat? It is difficult to say.
 The issues that arise are issues similar to nuclear use, but perhaps on a
smaller scale.
 On the other hand, to reduce the potential for civilian casualties as a
result of “fallout,” traditional means of war appear more effective.
 Perhaps equally important is the issue of chemical weapon
development.
 This topic, however, is a little trickier.
 Biotechnology is applied commercially every day.
 The dual-use potential of most technology involved in the research and
development of biotechnology complicates the issue.
 “Dual-use” means that anything made for the public could also be used
by the military or vice versa .
 Researching vaccines means researching, and possibly the
development of, weapon agents.
 Is this ethically responsible?

27. Introduction :
 All countries which have active biotechnology
programs have mechanisms for safety regulations.
 Regulations were introduced initially on a national
basis but there is now a move towards
standardization.
 Current regulations covering the industrial use of
genetically modified organisms (GMOs) are being
added to by regulation designed to control the
impact on worker safety & the environment of any
hazardous biological substance or organism .

28. Most regulations are based on a so called “case by case”
approach ; this means that for each biotechnological
experiment outside the laboratory approval has to be
obtained from a national commission .
 The govt. of India’s biosafety guidelines on GMOs have
been prematurely put to a severe test . The Indian biosafety
rules require that a state biotechnology coordination
committee must be constituted in each state to inspect ,
investigate , and extract penalties for violations of the
statutory provisions .
 However , most states did not constitute these committees
because GEAC so far has not given approval for any
commercial release .

29. Transgenic Research trials :
 India is one of the few countries in Asia that has
instituted biosafety regulations. In India , a number of
research projects involving GMOs , with both
contained & field trials, are already in progress .
 The annual report from the Department of
Biotechnology (DBT) has listed two field trials .
 The first is by Proagro PGS India Ltd. Which imported
transgenic mustard from Plant Genetic System (PGS)
in Belgium .
 They started the field trial in 1994 at Gurgaon
(Haryana) & Bangalore (Karnataka).

30. Institutional framework :
 India’s Biosafety & rDNA Guidelines (1990) falls under the
Environment (Protection) Act of 1986 .
 In 1994 , after India signed the Biodiversity Convention, the DBT
revised its earlier guidelines to accommodate the safe handling
of GMOs in research, application & technology transfer .
 There is no permanent secretariat to monitor the trials instead
regulations are implemented by various adhoc committees . The
most important committees are :-
i. Institutional Biosafety Committees (IBSC) – implementation
of guidelines
ii. Review Committee on Genetic Manipulation (RCGM) –
issuing permits
iii. Genetic Engineering Approval Committee (GEAC) –
monitoring large scale & commercial use of transgenic
material .
 These bodies have statutory authority .
 Members are mainly from scientific community & staff of DBT
& the Ministry of Environment & Forestry .

31. 1. Country : US
 The US Food & Drug Administration (FDA) ensures the safety
of most domestic & imported foods in US market , except meat
& poultry , which are regulated by US Dept. of Agriculture .
 In USA no mandatory risk assessment requirements for GMOs
exist , the proposed Premarket Notice Concerning
Bioengineered Foods will require companies to submit
information on safety considerations before marketing GM
foods .
2. Country : European Union
 The EU has set up stringent import regime for GMOs
worldwide .
 Mandatory labeling requirements for food & its ingredients
which contain GMOs , have been in place .
 They have recently been further tightened under new
traceability & labeling regulations adopted in July 2003 .

32.  A good manufacturing practice (GMP) is a production and
testing practice that helps to ensure a quality product.
 Many countries have legislated that pharmaceutical and medical
device companies must follow GMP procedures, and have
created their own GMP guidelines that correspond with their
legislation.
 Basic concepts of all of these guidelines remain more or less
similar to the ultimate goals of safeguarding the health of the
patient as well as producing good quality medicine, medical
devices or active pharmaceutical products.
 In the U.S. a drug may be deemed adulterated if it passes all of
the specifications tests but is found to be manufactured in a
condition which violates current good manufacturing guidelines.


33. Although there are a number of them, all guidelines
follow a few basic principles:
 Manufacturing processes are clearly defined and controlled. All
critical processes are validated to ensure consistency and
compliance with specifications.
 Manufacturing processes are controlled, and any changes to the
process are evaluated. Changes that have an impact on the quality
of the drug are validated as necessary.
 Instructions and procedures are written in clear and unambiguous
language. (Good Documentation Practices)
 Operators are trained to carry out and document procedures.
 Records are made, manually or by instruments, during manufacture
that demonstrate that all the steps required by the defined
procedures and instructions were in fact taken and that the
quantity and quality of the drug was as expected. Deviations are
investigated and documented.
 Records of manufacture (including distribution) that enable the
complete history of a batch to be traced are retained in a
comprehensible and accessible form.
 The distribution of the drugs minimizes any risk to their quality.

34.  A system is available for recalling any batch of drug
from sale or supply.
 Complaints about marketed drugs are examined, the
causes of quality defects are investigated, and
appropriate measures are taken with respect to the
defective drugs and to prevent recurrence.
 Therefore, complying with GMP is a mandatory aspect
in pharmaceutical manufacturing.
 GMP guidelines are not prescriptive instructions on
how to manufacture products.
 They are a series of general principles that must be
observed during manufacturing.
 When a company is setting up its quality program and
manufacturing process, there may be many ways it can
fulfill GMP requirements.
 is the company's responsibility to determine the most
effective and efficient quality process.

35.  GMPs are enforced in the United States by the US FDA, under
Section 501(B) of the 1938 Food, Drug, and Cosmetic Act (21
USCS § 351).
 The regulations use the phrase "current good manufacturing
practices" (cGMP) to describe these guidelines.
 Courts may theoretically hold that a drug product
is adulterated even if there is no specific regulatory requirement
that was violated as long as the process was not performed
according to industry standards.
 As of June 2010, a different set of cGMP requirements apply to all
manufacturers of dietary supplements.
 The World Health Organization (WHO) version of GMP is used
by pharmaceutical regulators and the pharmaceutical
industry in over one hundred countries worldwide, primarily in
the developing world.
 The European Union's GMP (EU-GMP) enforces similar
requirements to WHO GMP, as does the Food and Drug
Administration's version in the US.

36.  Similar GMPs are used in other countries,
with Australia, Canada, Japan, Singapore, Philippines and
others having highly developed/sophisticated GMP
requirements.
 In the United Kingdom, the Medicines Act (1968) covers
most aspects of GMP in what is commonly referred to as
"The Orange Guide", which is named so because of the
color of its cover; it is officially known as Rules and
Guidance for Pharmaceutical Manufacturers and
Distributors.
 Since the 1999 publication of GMPs for Active
Pharmaceutical Ingredients, by the International
Conference on Harmonization (ICH), GMPs now apply in
those countries and trade groupings that are signatories to
ICH (the EU, Japan and the U.S.), and applies in other
countries (e.g., Australia, Canada, Singapore) which adopt
ICH guidelines for the manufacture and testing of active
raw materials.

37.  Within the European Union, GMP inspections are performed by
National Regulatory Agencies (e.g., GMP inspections are performed
in the United Kingdom by the Medicines and Healthcare products
Regulatory Agency (MHRA)); in the Republic of Korea (South
Korea) by the Korea Food & Drug Administration (KFDA); in
Australia by the Therapeutical Goods Administration (TGA); in
Bangladesh by the Drug Administration (DGDA); in South Africa by
the Medicines Control Council (MCC); in Brazil by the Agência
Nacional de Vigilância Sanitária (National Health Surveillance
Agency Brazil) (ANVISA); in Iran, in India GMP inspections are
carried out by state FDA and these FDA report to Central Drugs
Standard Control Organization and Pakistan by the Ministry of
Health; Nigeria has NAFDACand by similar national organizations
worldwide.
 Each of the inspectorates carry out routine GMP inspections to
ensure that drug products are produced safely and correctly;
additionally, many countries perform pre-approval inspections
(PAI) for GMP compliance prior to the approval of a new drug for
marketing.

38.  Regulatory agencies (including the FDA in the
U.S. and regulatory agencies in many European
nations) are authorized to conduct
unannounced inspections, though some are
scheduled.
 FDA routine domestic inspections are usually
unannounced, but must be conducted
according to 704(A) of the FD&C Act (21 USCS
§ 374), which requires that they are performed
at a "reasonable time".
 Courts have held that any time the firm is open
for business is a reasonable time for an
inspection.

39.  In the experimental (non-clinical) research arena, the phrase good
laboratory practice or GLP specifically refers to a quality system
of management controls for research laboratories and organizations
to try to ensure the uniformity, consistency, reliability,
reproducibility, quality, and integrity of chemical (including
pharmaceuticals) non-clinical safety tests; from physio-chemical
properties through acute to chronic toxicity tests .
 The original GLP regulatory mandate was promulgated in 1978 by
US-FDA (though they may have got it from the New Zealand
medicines agency) and published in the Federal Register 43 FR
59985-60020.
 It was followed a few years later by US-EPA, and (as outlined in
the Organization for Economic Co-operation and
Development (OECD) Principles of GLP in 1992) the OECD has
since help promulgate it to many countries, helping them place it
into their national regulations.

40. Defination :
 Good Laboratory Practice (GLP) embodies a set of principles that
provides a framework within which laboratory studies are
planned, performed, monitored, recorded, reported and archived.
These studies are undertaken to generate data by which the
hazards and risks to users, consumers and third parties,
including the environment, can be assessed for pharmaceuticals
(only preclinical studies), agrochemicals, cosmetics, food
additives, feed additives and contaminants, novel foods, biocides,
detergents etc.... GLP helps assure regulatory authorities that the
data submitted are a true reflection of the results obtained during
the study and can therefore be relied upon when making
risk/safety assessments.
 ***GLP, a data quality system, should not be confused with
standards for laboratory safety - appropriate gloves, glasses
& clothing to handle lab materials safely.***

41. THANK YOU