BRAI Bill - WHY NOT A NATIONAL BIOSAFETY PROTECTION AUTHORITY?

Response to the Biotechnology Regulatory Authority of India Bill 2009 crafted by the Dept of Biotechnology,Government of India
February 14, 2010
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RESPONSE TO THE PROPOSED
BIOTECHNOLOGY REGULATORY AUTHORITY OF INDIA BILL, 2009:
WHY NOT A NATIONAL BIOSAFETY PROTECTION AUTHORITY?
The purpose of any regulation around Genetic Engineering and related modern biotechnology
applications flows from the inherent risks and hazards associated with these technologies.
India does not have a separate statute to govern the regulation of GMOs in our food and farming
systems. This means that we have only executive orders/rules under the Environment Protection
Act 1986 and these rules are easily changeable and altered by the regulators whereas having a
proper statute would ensure that frequent, undemocratic changes in rules, guidelines and
protocols will not be made too easily.
Requisite components of any biotech regulatory regime
Any regulatory regime around GMOs should have the primary mandate of protecting health of
people and the environment from the risks of modern biotechnology. It should necessarily have
the following principles as cornerstones of the legislation:
• Precautionary Principle as the central guiding principle
• Going in for the GM option only in case other alternatives are missing
• Separating out very clearly the phases of contained research and deliberate release and
distinct regulatory mechanisms for both, in a sequential fashion
• No conflicting interests to be allowed anywhere in the regulation and decision-making
• Transparent functioning: information disclosure and public/independent scrutiny
• Democratic functioning including public participation – even here, data to be put out in
the public domain and public participation included before the decision-making process
and not just informing after a decision is made
• Risk assessment – (a) prescribing rigorous, scientific protocols and asking the crop
developer to take up studies and then do independent analysis of the dossier supplied by
the crop developer and evaluate/review of the same; (b) to also take up independent
testing by having all facilities and institutional structures in place for the same and
evaluating the results
• Risk management – including monitoring, reviewing, revoking of approvals
• Liability – including penal clauses, redressal and remediation
• Labeling regime for informed choices – this covers traceability and identity preservation
requirements
• Oversight and appellate mechanisms
• In the case of India, given that it is a federal structure and given that Agriculture is a
state subject, special clauses which allow the state governments to form their own
regulatory systems and mechanisms
Further, the law should be governed by principles like Polluter Pays, Inter-generational equity (a
key principle in environmental jurisprudence now which covers conservation of options,
conservation of quality and conservation of access, for present and future generations) etc.
In countries like Norway, the law also has provisions to answer questions like “Is this ethically
and socially justifiable?”, before a GMO is cleared. That would automatically include socio-
economic and ethical concerns within the regulatory regime.
Almost everything listed above, as ideal pre-requisites of any statute governing modern
biotechnology applications in our food and farming systems, are missing in the Indian regulatory
system right now.
Response to the Biotechnology Regulatory Authority of India Bill 2009 crafted by the Dept of Biotechnology,
Government of India by Kavitha Kuruganti, February 14, 2010
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The lack of a proper statute and the absence of a credible regulatory regime is something that
everyone is concerned about and using the opportunity of the current debate generated around
Bt Brinjal, the Department of Biotechnology is trying to introduce a BIOTECHNOLOGY
REGULATORY AUTHORITY OF INDIA (BRAI) BILL soon.
The following are the important concerns around this Bill.
1. The mandate of this Bill in its current version is for the “establishment of the
Biotechnology Regulatory Authority of India to regulate the research, transport, import,
manufacture and use of organisms and products of modern biotechnology and for
matters connected therewith or incidental thereto in order to promote the safe use of
modern biotechnology by enhancing the effectiveness and efficiency of regulatory
procedures”.
The Bill therefore pre-supposes a clearing house/facilitator/approver role to the Authority
of applications that it would receive and that is sought to be made into the main purpose
of this legislation.
However, this very mandate is wrong and assumes that an inherently unsafe technology
can be made safe by making the regulation effective and efficient! The main purpose
of Biotechnology Regulation should be “to protect the health (human and
animal) and environment of India from the risks posed by modern
biotechnology and its applications”. To that extent, this Bill should be called
by some other name like “Gene Technology and Biosafety Protection Act,
2010”.
It is worthwhile to remember here that that the need for an independent and credible regulatory
regime was articulated by the 2004 Task Force Report on Agricultural Biotechnology and this
report clearly pointed out that the following should be the bottom line for any biotechnology
regulatory policy: the safety of the environment, the well being of farming families, the
ecological and economic sustainability of farming systems, the health and nutrition
security of consumers, safeguarding of home and external trade and the biosecurity
of the nation”. These important aspects or cornerstones do not find any place in the
draft Bill sought to be introduced.
2. This so-called autonomous regulatory authority should NOT be housed under the Ministry
of Science & Technology or more specifically within the Department of Biotechnology
(the draft Bill emerged from the DBT). This will be a major conflict of interest in itself and
if it is housed under this Ministry, the mandate itself becomes questionable. This
Authority should be under the Ministry of Environment & Forests or under the
Ministry of Health & Family Welfare.
3. This statute should not in any way take away from the Constitutional
authority that state governments have over their Agriculture and Health in the
Indian federal structure. However, the current Bill envisages only an advisory role
for the state governments in the form of “State Biotechnology Regulatory Advisory
Committees” with no decision-making powers. Worse, as per Section 87 (2), it asks for
a repealing of any law in force for the time being in any State corresponding to
this Act (including any licensing authority that the state government’s concerned
agencies might have under any other Law). Section 81 also expressly states that this Act
will have an over-riding effect (on other Acts). This is simply not acceptable on at
least two counts: this ignores the constitutional powers that state governments have
Response to the Biotechnology Regulatory Authority of India Bill 2009 crafted by the Dept of Biotechnology,
Government of India by Kavitha Kuruganti, February 14, 2010
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over their Agriculture & Health; it also ignores and could impinge on or override the
somewhat progressive legislations like Biological Diversity Act, with a mandate also to
conserve and sustainably use biological diversity.
4. The proposed legislation also makes modern biotechnology regulation into only a
technical risk assessment and risk management. It ignores the bottom line set out in
the Task Force report on Agri-Biotechnology and operationalising the same.
5. The legislation, instead of expressly having clauses on information disclosure,
that too before decision-making and independent or public scrutiny, has brought in
clauses on retaining Confidential Commercial Information. As past experience in
India has shown, this cannot be left to the discretion of the officials in the Authority and
all product development and biosafety-related information has to be pro-actively
disclosed and placed in the public domain before decision-making.
6. It is also important to operationalise in this statute some key principles, as
part of the regulations to be notified, that should be guiding decision-making
in this area: (a) Precautionary principle; (b) Inter-generational equity; (c)
Going in for the GM option only in case other alternatives are missing. This third
principle is what eminent molecular biologist and Supreme Court observer in the apex
regulatory authority right now had proposed too, as the first parameter for assessment
of a GMO. “ascertain after careful analysis of existing information (and, if need be,
relevant new information that could be generated within a short period) that there are no
alternatives to the GMO and that the GMO will, if it meets the stipulated requirements,
bring substantial benefit to the country and to one or more classes of its citizens. And if
the GMO is truly required, carry out rigorous risk assessment”. Dr Bhargava has then
gone on to lay down what such a risk assessment should consist of. Therefore, every
application has to be rejected or accepted based on this main parameter right at the
beginning.
7. Final decision-making, especially in the case of environmental release cannot be left to
technical experts alone. An alternate structure is proposed in Point 13 for this.
8. Chapter V: Risk assessment cannot be left to the proposed three Divisions, Risk
Assessment (and Enforcement Unit with its Monitoring Officers) and Products Ruling
Committee for a ‘science-based evaluation of the application’ whether it is for import or
manufacture or for any other purpose. As the Supreme Court observer had pointed out
time and again, there is a need for independent testing itself and independent testing
facilities. Risk assessment should therefore consist of an evaluation of the
biosafety dossier submitted by the crop/product developer including
mandatory independent, public scrutiny but also independent testing for
further verification of results. Any proposed Authority should have the testing
capabilities established for this.
9. Risk Management aspects have been neglected in the proposed legislation. It
is not enough to have an Enforcement Unit with empowered Monitoring Officers. There
should be clear clauses for reviewing of approvals and permissions, timebound
permissions in each case and clauses for revoking and cancellations of
approvals.
10. For some inexplicable reason, a Risk Assessment Unit is brought into the picture for
the applications pertaining to research, transport or import which is supposed to present
its “clear assessment” to the Authority and further, a Products Ruling Committee is
Response to the Biotechnology Regulatory Authority of India Bill 2009 crafted by the Dept of Biotechnology,
Government of India by Kavitha Kuruganti, February 14, 2010
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brought into the picture for manufacture or use of GMOs and products thereof, for
making recommendations to the Authority. This clearly assumes that import may not
pose much threat and this may not be the case for large scale imports or GMOs getting
imported (not just products thereof). There is no need for a Risk Assessment Unit and a
Products Ruling Committee separate from each other. There can be only one Risk
Assessment Unit and no Ruling should be allowed by anyone who is supposed to assess
and evaluate. This Unit is only required to place its assessment report and
recommendations.
11. It would be important to make a distinction for regulation of contained use
and deliberate environmental release. There should be a sequential mode of
regulation of any GMO, from contained use or containment to environment release, if at
all. The environmental release should be permitted ONLY after biosafety has been
conclusively established as per the Risk Assessment Unit.
12. The final decision on environmental releases of GMOs (manufacture and use)
should come from the Inter-Ministerial Products Ruling Committee – the inter-
ministerial body in the current proposals only has an advisory role. However, it should
have the final decision-making authority, along with the Chairperson of the Authority, the
three Chief Regulatory Officers who should head the three different Risk Assessment
Units. Decision-making has to be from a broad-based body which studies aspects beyond
technical biosafety too and should have an inter-ministerial composition for the obvious
reason that GMOs in our food and farming systems have implications beyond biosafety.
13. The following structure for the National Biosafety Protection Authority is
demanded – that all contained use applications be routinely processed by the 3-
member Authority (Chairperson PLUS two members), based on risk assessment and
independent testing wherever required by the concerned Division. The Enforcement Unit
with its Monitoring Officers also has a role during this phase.
However, for all deliberate environmental releases, especially pertaining to Division 1
(Agriculture, Fisheries, Animals and Forestry), such approvals may come only from the
Inter-Ministerial Product Rulings Committee, based on recommendations by the
concerned Division on proof of biosafety, after both science-based evaluation of the
applicant’s data as well as mandatory independent testing and through public
participation mechanisms in addition to consideration of other parameters that are to be
evaluated (beyond biosafety).
Response to the Biotechnology Regulatory Authority of India Bill 2009 crafted by the Dept of Biotechnology,
Government of India by Kavitha Kuruganti, February 14, 2010
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14. The proposed legislation has no clauses on public participation. The Cartagena Protocol
on Biosafety’s (under the Convention on Biological Diversity) Article 23.2 says that
‘Parties…shall consult the public in decision-making process regarding living modified
organisms…’ and India is a signatory to this. Any statute on this matter should
have systemic mechanisms built for public participation in decision-making
including having representatives from credible and committed farmers’ and consumers’
groups in the decision-making bodies, apart from larger public consultations.
15. Chapter XIII on Offences & Penalties: It is not clear who Section 61 related to False or
Misleading Information will be applicable to! Any person producing any document that is
known to be false or misleading, it says. If this is not specifically meant for applicants to
the National Biosafety Protection Authority, then this is to be construed as harassment of
the public! Similarly, Section (63) is completely objectionable and is meant to
harass civil society groups concerned about the application of this hazardous
technology. This clause says: Whoever, without any evidence or scientific record
misleads the public about safety of GMOs and products thereof shall be punished with
imprisonment and fine!
16. In fact, the liability clauses in this proposed legislation are very weak. To begin
with, there need not be any distinction made between companies, universities, society,
trust, government departments etc. The penal clauses should apply uniformly. Two, the
legislation should have express clauses on Redressal or Compensation and
Remediation or Cleaning up. The legislation should also have a clause that makes the
crop developer solely liable for any leakage, contamination and so on throughout every
stage of the product development cycle. Further, the penalty of one year imprisonment
and two lakh rupees fine is no deterrent and this should be made more rigorous.
17. Chapter VI pertains to provisions related to Import of Organisms and Products
thereof. Here, apart from authorization to detain imported packages suspected to contain
organisms and products thereof, there should be an express provision for
Importer’s Declaration & Certification at the time of import that the
Chairperson, National Biosafety Protection Authority PLUS 2 members
Inter-ministerial Products Ruling Committee
1. Division on Agriculture,
Forestry,
Animals & Fisheries
2. Division on Human &
Veterinary Health
3. Division on industrial &
environmental applications
Biotechnology Advisory Council
Risk Assessment Unit
Enforcement Unit
Risk Assessment
Unit
Enforcement Unit
Risk Assessment
Unit
Enforcement Unit
Independent testing
facilities
Response to the Biotechnology Regulatory Authority of India Bill 2009 crafted by the Dept of Biotechnology,
Government of India by Kavitha Kuruganti, February 14, 2010
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consignment does not contain any GMOs or products thereof, for every
consignment coming into India.
18. Provisions related to Biotech Regulatory Appellate Tribunal: As pointed out in
response to the 2008 draft NBRA Bill, to appeal within 30 days after a decision is made
by the Authority may not be possible for everyone and there is absolutely no reason why
this provision should be incorporated into Section 42 (1). This Tribunal should be more
broad based and consist of people beyond certain technical expertise. Further Section 55
(1) on Jurisdiction, Powers and Authority of the Appellate Tribunal where the Tribunal is
expected to have jurisdiction over all civil cases where a substantial question related to
modern biotechnology is involved is not fair for the ongoing PILs on the issue. The
Appellate Tribunal should pick up cases which come in appeal to it only. Further, Section
55 (3) with its time bar of two years from the date of the cause of action for an appeal
on a substantial question is not to be allowed. There should be no time bar, for the
simple reason that some unpredictable effects might start showing up any time beyond
two years too.
19. Section 56’s clauses related to the Tribunal not being guided by Code of Civil Procedure
1908 but by principles of natural justice, not bound by the rules of evidence contained in
the Indian Evidence Act 1872 and its proceedings deemed to be judicial proceedings
under particular sections of Indian Penal Code and some Chapter of Criminal Procedure
Code have to be studied further by legal experts.
20. The amendments being proposed to the Food Safety & Standards Authority (FSSA) Act
2006, so that no provisions of this Act may apply to FSSA needs to be revisited,
especially given that the labeling regime comes under the FSSA and a narrow definition
of GM food under FSSA will leave out many GM foods from a labeling regime.
21. Under Chapter X on Notification of Laboratories, it is not at all acceptable that non-
accredited labs may also be notified “having regard to the emerging nature of modern
biotechnology and facilities and equipment in labs”. If it is such an emerging technology,
one just has to wait!
22. Welcome clauses in this proposed Bill: Restriction on employment after cessation of
office for different posts for at least two years from the Authority and its Tribunal etc.,
are welcome moves.