The New TADA

              COUNTERING BRAI 2009: (Biotechnology Regulatory Authority of India Bill )

1.By-Passing Supreme Court Jurisdiction-The establishment of a completely new jurisdiction authority; “Biotechnology Regulatory Appellate Tribunal” for an area like “food”which concerns 100 % of the population as it deals with most primary need,is grossly irresponsible and underhanded manipulation of the right of the people to a fair and just judiciary.

BRAI । Chapter 15 । Biotechnology Regulatory Appellate Tribunal । Section 42-43 ।

42. (/) Any person aggrieved by a decision or order or directions of the Authority under this Act, may, within a period of thirty days from the date on which the decision or order or direction is communicated to him, file an appeal to the Biotechnology Regulatory Appellate Tribunal. (2)Every such appeal shall be preferred in such form and manner along with such fees and contain such particulars as may be prescribed. 43.The Central Government shall, by notification, establish with effect rom such date as may be specified therein, an Appellate Tribunal to be known as the Biotechnology Regulatory Appellate Tribunal to exercise the jurisdiction, powers and authority conferred on such Tribunal by or under this Act.

2. Over-riding authority of Centre over State - Chapter 1 ; Section 2 & Chapter 15 ; Section 81 - These sections propose the introduction of an over-riding authority by the Union (Central) Government over all State governments in India over matters of Agriculture & Pest Control.This is in direct violation of the Provisions of the State having the right to govern matters pertaining to Agriculture & Pesticides,as listed in the Constitution in Article 246.

The Constitution Of India 1949 । Article 246 ।

Subject matter of laws made by Parliament and by the Legislatures of States (1) Notwithstanding anything in clauses ( 2 ) and ( 3 ), Parliament has exclusive power to make laws with respect to any of the matters enumerated in List I in the Seventh Schedule (in this Constitution referred to as the Union List) (2) Notwithstanding anything in clause ( 3 ), Parliament, and, subject to clause ( 1 ), the Legislature of any State also, have power to make laws with respect to any of the matters enumerated in List III in the Seventh Schedule (in this Constitution referred to as the Concurrent List) (4) Parliament has power to make laws with respect to any matter for any part of the territory of India not included (in a State) notwithstanding that such matter is a matter enumerated in the State List

BRAI । Chapter 1 । Preliminary । Section 2 । It is hereby declared that it is expedient in the public interest that the control by Union. Union should take under its control the regulation of organisms, products and processes of modern biotechnology industry.

BRAI । Chapter 15 । Miscellaneous । Section 81 । Save as otherwise provided, the provisions of this Act shall have effect, notwithstanding anything inconsistent therewith contained in any other law for the time being in force or in any instrument having effect by virtue of any law other than this Act.

3. Violation of Freedom of Speech - Chapter 13 ; Section 63, is in direct Violation of Provision for Freedom of Speech & Expression for all citizens as listed in the Article 19 of the Constitution.

The Constitution Of India 1949 । Article 19 ।

I.All citizens shall have the right - 

A. to freedom of speech and expression;

B. to assemble peaceably and without arms; 

C. to form associations or unions;

BRAI । Offenses & Penalties । Chapter 13 । Section 63 । Whoever, without any evidence or scientific record misleads the public about the safety of the organisms and products specified in Part I or Part II or Part III of the Schedule I, shall be punished with imprisonment for a term which shall not be less than six months but

which may extend to one year and with fine which may extend to two lakh rupees or with both.

4. Draconian Law - Chapter 13 ; Section 63,as above, list’s a draconian sentence of imprisonment where the language used for penalty “imprisonment for a term which shall not be less than six months” can only be compared with the Laws like TADA (Terrorist & Disruptive Activities ‘Prevention’ Act,1987 ). It poses serious and fundamental questions for a democratic country as ours where regular Laws have clause for Offense & Penalty as, “imprisonment for a term which shall up to six months”.

5. No  Offense for Concealment - Chapter 13 ; Sec 61 lists No Offense for Concealment or Omission of Information (pertaining to adverse effects of GM technology ) This is indeed a very serious cause for concern and another reason why the BRAI should be considered unlawful in its scope.

BRAI । Offenses & Penalties । Chapter 13 । Section 61 । If a person, in connection with a requirement or direction under this Punishment for false Act, provides any

information or produces any document that the person knows is false or misleading, he shall be punishable with imprisonment for a term which may extend to three months and also with fine which may extend to five lakh rupees.

6. No Penal Provision for Risk - Incase of contamination from leakage whilst conducting Clinical/Field Trials no penal provision is given under Chapter 13 ; Sec 62. Further,even the definition of “clinical trial” only includes ‘humans’,hence the provision for offenses under this Section do not account for the clinical or field trials on animals or plants.Hence as history is a witness,the Case of BT Cotton,where Agricultural Fields were infiltrated with BT- Cotton seeds ,even before the approval of BT-Cotton,any future events of this kind would not be punishable if this Bill becomes law.

BRAI । Offenses & Penalties । Chapter 13 । Section 62 । (/) Whoever, himself or by any other person on his behalf, conducts clinical trials with organisms or products specified in Part II of Schedule 1, in contravention of section 33 shall be punished with imprisonment for a term which shall not be less than five years but which may

extend to ten years and with fine which may extend to ten lakh rupees or with both.

BRAI । Clinical Trial or Field Trial । Chapter 7 । Section 33 । No person shall conduct, clinical trials in respect of any organisms or products specified in Part II of

Schedule I, or, field trials in respect of any organisms or products specified in Part I and Part III of Schedule 1: Provided that the Authority may having regard to the health care needs or development of agriculture sector, permit clinical trial of organisms and products specified in Part II of Schedule I, or field trials in respect to any organism or products specified in Part I and Part III of Schedule I with such safeguards as it may consider necessary and which may be specified by the regulations.

BRAI । Chapter 1 । Preliminary । Section 3 । (g) "clinical trial" means systematic study of any new organism or product specified in Schedule I in human for the purpose of generating data for discovering or verifying its clinical, pharmacological (including pharmacodynamic and pharmacokinetic) biological,

or, adverse effects with the objective of determining safety, efficacy or tolerance of that organism or product

7. Proposed amendments to the Drugs and Cosmetics Act 1940,shockingly leave the GM food or Organism out of it’s ambit .

SCHEDULE II PART I

AMENDMENTS TO THE DRUGS AND COSMETICS ACT, 1940 2. After section 37, the following section shall be inserted, namely:— "37A. Nothing contained in this section shall apply to the genetically modified or engineered organisms or any matter or thing connected with it to which are covered under the Biotechnology Regulatory Authority of India Act, 2009.".

Critique of Biotechnology Regulatory Authority of India Bill 2009, Alliance for GM Free & Safe Foods, Chandigarh

8. Proposed amendments to the Food Safety and Standards Act 2006,shockingly leave the GM food or Organism out of it’s ambit .

SCHEDULE II

   PART II

AMENDMENTS TO THE FOOD SAFETY AND STANDARDS ACT, 2006 3, After section 98, the following section shall be inserted, namely:— "98A. Nothing contained in this section shall apply to the genetically modified or engineered organisms or any matter or thing connected with it to which are covered under the Biotechnology Regulatory Authority of India Act, 2009.".

9. Conflict of Interest - Proposed Bill,BRAI has been developed by the Department of Biotechnology,under the Ministry of Science and Technology ,the very Objective of whom is to Promote Biotechnology,this obvious Conflict of Interest has serious ramifications and such vested interests are questionable.

10. Beyond the Scope of RTI Act 2005 - Chapter 1 ; Sec 3(g) is over-riding the provisions of RTI (Right to Information) Act 2005.Under RTI Act ,2005 ; Sec 8 states exemption from disclosure of information if the information sought is perceived to be a “Trade Secret”.Under BRAI,an attempt is being made to deny accessibility to information under RTI Act to the citizens,by defining “Confidential Information”as either a “Trade Secret” or “Any Other Information”.BRAI further defines “Such Other Information” as pertaining to all Genetically Modified or Engineered Organisms and Food (and Food Products).This implies a total denial & blockage of Right to Information on any and all matters relating to testing,production,usage, of GM organisms/food,as other information will cover everything else that doesn’t come under trade secret,leaving absolutely no provision for public accountability or responsibility.

BRAI । Chapter 1 । Preliminary । Section 3 । (h) "confidential commercial information" means,—

(/) a trade secret or any other information which has a commercial or other value which would be, or could reasonably be expected to be, destroyed or diminished if such information was disclosed; or (if) such other information which relates to lawful commercial or financial affairs of a person, organization or undertaking dealing with organisms or products specified under Part I or Part II or Part III of Schedule I which, if disclosed, could adversely affect such person, organization or undertaking;

SCHEDULE I

P ART I

  1. Organisms and products mentioned under sub-paragraph (a) to (c) of this Part which shall be regulated by the Authority. (a) Any genetically engineered plant, animal, micro-organism, virus or other animate organism that may have application in agriculture, fisheries (including aquaculture), forestry or food production; (b) Any genetically engineered plant, animal, micro-organism, virus or other animate organism used as food; (c)Any animal clones that may have application in agriculture, fisheries or food production.

PART II

 2. Organisms and products mentioned under (a) to (i) of this Part which shall be regulated by the Authority. (a) DNA vaccines intended to induce or increase an antigen specific immune response for prophylactic or therapeutic immunization, regardless of the composition or method of manufacture; (b) Vaccines for use in humans or animals that contain living genetically engineered organisms; (c) Cellular products, including products composed of human, bacterial or animal cells (such as pancreatic islet cells for transplantation), or rom physical parts of those cells (such as whole cells, cell fragments, or other components intended for use as preventative or therapeutic vaccines); 

(d) Recombinant gene therapy products including nucleic acids, viruses, or genetically engineered micro-organisms that mediate their effect by transcription and/or translation of the transferred genetic material, and/or by integrating into the host genome. Cells may be modified in these ways ex vivo for subsequent administration to the recipient, or altered in vivo by gene therapy products administered directly to the recipient. (e) Transgenic blood or plasma derived products. (/) Stem cell based products. (g) RNA interference (RNAi) based products. (h) Products of synthetic biology for human or animal use. (i)Any products that include as a component a product rom categories (a) to (h) above.

PART III 

3. Organisms and products mentioned under this Part which shall be regulated by the Authority. Any genetically engineered plant, animal, micro-organism, virus or other animate organism that may be released into the environment, excluding the provisions of Parts I and II of this Schedule, or have application in industrial production or manufacturing processes.

11. Lack of Serious Restriction on Board Members re-employment - The restriction of Employment on members and Chairman of the Biotechnology Regulatory Authority of India,after cessation of office,is very irresponsible as it is merely for a period of two years,whereas matters relating to GM,on an average easily cover ten years.This leaves plenty of loopholes for manipulation upon re-employment after the said restriction of two years.

BRAI । Chapter 2 । Biotechnology Regulatory Authority of India । Section10 । (7)The Chairperson/Member, ceasing to hold office

(a) for a period of two years from the date on which they cease to hold office, accept any employment in, or connected with the management or administration of, any person which has been associated with or granted authorization for research, transport or import of organisms or products or manufacture or use of organisms and products under this Act:

Critique of Biotechnology Regulatory Authority of India Bill 2009, Alliance for GM Free & Safe Foods, Chandigarh

Provided that nothing contained in this section shall apply to any employment under the Central Government or a State Government or local authority or in any statutory authority or any corporation established by or under any Central, State or Provincial Act or a Government company as defined in section 617 of the Companies Act, 1956; or (b) act, for or on behalf of any person or organization in connection with any specific proceeding or transaction or negotiation or a case to which the Authority is a party and with respect to which the Chairperson or such Member before cessation of his office had acted for, or provided advice to, the Authority; or

(c) give advice to any person (including his client, business associate or employer) using information which was obtained in his capacity as the Chairperson or a Member and being not available or cannot be made available to the public; or (d) for a period of two years from his last day in office, enter into a contract of service with, accept an appointment to a board of directors of, or accept an offer of employment with, an entity with which he had direct and significant official dealings during his term of office as such without the due approval of the Central Government.

12. Attempt to limit participation of Advisory Council-By the very mention of no provisionof“T&D(Travel& Allowance)” for attendance of Meetings by members of the Advisory council,this proposed BRAI bill attempts to limit the participation by Advisory council members in any democratic discussion process.This is a clearly in stark contrast with usual provision of T & D for government meetings practiced throughout India as a norm.

BRAI । Chapter 3 । Inter-Ministerial Advisory Board and Biotechnology Advisory Council । 15 । (7) The expenses for attending the meeting of the Inter-Ministerial Advisory Board (including travel expenses or any other allowances) shall be borne by the

respective Ministries, Departments, Councils, office. Directorate and Authorities, whom they represent under clauses (a) to (q) of sub-section(2)-

13. Glaring Contradictions within BRAI - An attempt to mislead the public is made as on one hand the BRAI under Section 86 clearly states no interference in jurisdiction of Drug and Cosmetics Act,1940 and Food Safety and Standards Act 2006. While on the other hand,amendments made under BRAI ,sec.37(a) for Drug and Cosmetics Act,1940 and sec.98(a) Food Safety and Standards Act 2006,provide for the over-riding authority of BRAI over both these acts and completely obliterates the scope of independent jurisdiction of these acts over GM organism and food ( or/and food products).

BRAI । Chapter 15 । Miscellaneous । Section 86 । The provisions of this Act shall be in addition to the provisions of the Drugs and Cosmetics Act, 1940 and Food

Safety and Standards Act, and, nothing in this Act shall affect any jurisdiction, powers and functions required to be exercised or performed by the Authority in relation to any area falling within the jurisdiction of the Authority under this Act.