Accidental release

Any unintended release of regulated plant material into the environment, food and/or feed chains. For the purposes of these Guidelines, any breach of the authorized terms and conditions for reproductive isolation of the confined trial site shall be considered an accidental release. Accidental release also includes the spillage, theft, or encroachment by unauthorized persons of regulated GE plant material during transportation, storage within a contained facility, or during any other activity associated with the conduct of a confined field trial. Any accidental release shall be subject to risk assessment, and any necessary corrective actions shall be at the cost of the applicant or permitted party.

Acute Oral Toxicity

Refers to those adverse effects occurring following oral administration of a single dose of a substance, or multiple doses given within 24 hours.

Allergen

An allergen is a usually harmless substance capable of triggering a response that starts in the immune system and results in an allergic reaction.

Allergy

An allergy is a chronic condition involving an abnormal reaction to an ordinarily harmless substance called an allergen.

Anthesis

The time of flowering or pollination. Anthesis is complete when flowering or pollination is complete.

Anti- nutrient

Substance that interferes with the utilization of one or more nutrients by the body (e.g., oxalate and phytate, which prevent calcium absorption).

Applicant

The Applicant must be a permanent resident of India or must designate an Authorized Signatory (AS) who is a permanent resident of India. Where an AS is used, there must be a formal, legal agreement indicating the AS is acting on behalf of the Applicant and both under the jurisdiction of any Court of Law of India.

A copy of this agreement must be submitted to the Regulatory Authorities along with the confined field trial application. The Applicant need not be the breeder/developer or owner of the regulated plant, in which case a signed statement is required from the breeder/developer or owner authorizing representation by the Applicant or the designated AS. All correspondence with respect to the application for a confined field trial, including the notification of authorization, will be addressed to the Applicant, or when appropriate, the AS.

Biocide

A general term for any agent that kills organisms

Biotechnology

The application of scientific and engineering principles to the processing of materials by biological agents to produce goods and services

Breach

Any contravention or violation of any term and/or condition of authorization of a confined field trial will be considered a breach under these guidelines.

Cartagena Protocol

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international agreement that aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from modern biotechnology, which may have adverse effects on biological diversity, also taking into account risks to human health. It was adopted on 29 January 2000 and entered into force on 11 September 2003. [1]

Codex

Alimentarius

Commission

An international regulatory body (part of the FAO) responsible for the definition of a set of international food standards. The Commission periodically determines and publishes a list of food ingredients and maximum allowable levels (the Codex Alimentarius) deemed to be safe for human consumption.

Comparability exercise

Comparison of a Similar Biologic with a Reference Biologic with the goal to establish Similarity in safety, efficacy and quality.

Confined Field Trial

A confined field trial is a field experiment of a regulated GE plant under terms and conditions that are intended to mitigate the establishment and spread of the plant. A single confined field trial may be comprised of one or more varieties/hybrids of a single event of a single plant species that are subject to the same terms and conditions of confinement which include, but are not limited to, reproductive isolation, site monitoring, and post-harvest land use restrictions. The field trials are categorized into two types: Biosafety Research Level I and Biosafety Research Level II trials.

Construct

An engineered DNA fragment containing, but not limited to, the DNA sequences to be integrated into the genome of the target plant.

Containment

The term “containment” is used to describe safe methods for managing infectious agents and/or regulated GMOs/LMOs/rDNA material in the laboratory environment where they are being handled or maintained.

Conventional counterpart

It means the related non-genetically engineered plant variety, its components and/or products for which there is experience of established safety based on common use as food.

Delayed Death

Means that an animal does not die or appear moribund within 48 hours but dies later during the 14-day observation period.

Donor organism

Means the organism from which genetic material is obtained for transfer to the recipient organism.

Dose

Is the amount of test substance administered and is expressed as weight of test substance per unit weight of test animal (e.g., mg/kg).

Drug

Drug includes (as defined in Drugs and Cosmetics Act, 1940).

i. all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;

ii. such substances (other than food) intended to affect the structure or any function of human body or intended to be used for the destruction of (vermin) or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;

iii. All substances intended for use as components of a drug including empty gelatine capsules; and

iv. Such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.

Drug product

The dosage form in the final immediate packaging intended for marketing. A pharmaceutical product type that contains a drug substance, generally in association with excipients.

Drug substance

Any substance or mixture of substances intended to be used in the manufacture of a drug(medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.

Early termination

Any termination of a confined field trial before the anticipated completion date

Evident Toxicity

Is a general term describing clear signs of toxicity following the administration of test substance, such that at the next highest fixed dose either severe pain and enduring signs of severe distress, moribund status (criteria are presented in the OECD Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation), or probable mortality in most animals can be expected.

Clinical signs that may be indicative of toxicity include, but are not limited to: rapid weight loss; diarrhoea (if debilitating); progressive dermatitis; rough hair coat; hunched posture; lethargy or persistent recumbency; labored breathing; nasal discharge; jaundice or anaemia; neurological signs; bleeding from any orifice; self-induced trauma; any condition interfering with eating or drinking (e.g., difficulty moving); or excessive or prolonged hyperthermia or hypothermia.

Facility

The whole of the space that is to be certified by the Regulator to a specific level of containment.

Facility In-charge

The person designated by the permitted party as responsible for the storage (before or at planting, during planting and after harvest) of regulated, genetically engineered plant material.

Genetic

Engineering (GE)

The technique by which heritable material, which does not usually occur or will not occur naturally in the organism or cell concerned, generated outside the organism or the cell is inserted into said cell or organism. It shall also mean the formation of new combinations of genetic material by incorporation of a cell into a host cell, where they occur naturally (self-cloning) as well as modification of an organism or in a cell by deletion and removal of parts of the heritable material

GE Plant

A plant in which the genetic material has been changed through in vitro nucleic acid techniques, including recombinant-deoxyribonucleic acid (r-DNA) and direct injection of nucleic acid into cells or organelles.

Immunogenicity

The ability of a substance to trigger an immune response or reaction (e.g., development of specific antibodies, T cell response, allergic or anaphylactic reaction).

Import permit

An official document authorizing importation of a consignment in accordance with specified phytosanitary requirements.

Impurity

Any component present in the drug substance or drug product that is not the desired product, a product-related substance, or excipient including buffer components. It may be either processor product-related.

Incident

This means unintended release, breach of containment, spill or occupational exposure to GMOs/LMOs/rDNA materials.

Isolation distance

A mandated distance used to spatially separate a confined field trial from the nearest plant of the same or any sexually compatible species. Minimum spatial isolation distances vary depending on the reproductive biology of the plant species, and minimum distances for a number of plant species have been established by the RCGM.

LD₅₀

Median lethal oral dose is a statistically derived single dose of a substance that can beexpected to cause death in 50 per cent of animals when administered by the oral route. The LD50 value is expressed in terms of weight of test substance per unit weight of test animal (mg/kg).

Limit Dose

Refers to a dose at an upper limitation on testing (e.g., limit dose of 2000 mg/kg body weight or when this cannot be achieved in the recommended volume for administration, the dose used should be the maximum possible based on the solubility of the protein).

Manufacture

in relation to any drug includes any process or part of a process for producing, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug with a view to its sale or distribution but does not include the compounding or dispensing in the ordinary course of retail business; and “to manufacture” shall be construed accordingly.

Moribund

Being in a state of dying or inability to survive, even if treated.

Pharmacovigilance

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems.

Physical landmarks

Landmarks used to identify or designate boundaries of a confined field trial site (e.g., telephone poles, fences, alleys or roads).

Plant material

Propagable material (e.g., seed, transplants, tubers, rhizomes, shoots, budwood, whole plant), and non-propagable material (e.g., leaves, devitalized material).

Post-harvest period

A period of time that follows the harvest or termination of a confined field trial when restrictions are imposed on the use of the trial site.

Prohibited plant

Plants of any species that are sexually compatible with the regulated plant under fieldconditions, including volunteers that may arise in the isolation area during the conduct of confined field trials

Propagable

Any plant or plant part that can be used in the field to regenerate a whole plant under field conditions

Protocol

The step-by-step experiments proposed to describe or solve a scientific problem, or the defined steps of a specific procedure. [17]

Reference Biologic

A Reference Biologic is used as the comparator for comparability studies with the Similar Biologic in order to show Similarity in terms of safety, efficacy and quality. The Reference Biologic should be licensed / approved in India or ICH countries and should be the innovator s product. The Reference Biologic should be licensed based on a full safety, efficacy and quality data. Therefore another Similar Biologic cannot be considered as a choice for Reference Biologic

Regulatory Authority

As regards confined field trials, RCGM is the regulatory authority responsible for authorizing Biosafety Research Level I trials and GEAC is the regulatory authority responsible for authorizing Biosafety Research Level II trials.

Reproductive isolation

Refers to the means used to prevent movement of plant material, particularly pollen,from a confined field trial site.

Sexually compatible

Ability of a plant to cross-pollinate with other cultivated plants of the same species, orwith wild plants of a related species, and form viable hybrids without human intervention.

Similar

Absence of a relevant difference in the parameter of interest.

Similar Biologic

A Similar Biologic product is that which is similar in terms of quality, safety and efficacy to an approved Reference Biological product based on comparability.

Stress

Non-optimal conditions for growth. Stresses may be imposed by biotic (pathogens, pests) or abiotic (environment, such as heat, drought, etc.) factors.

Trial site

The area where one or more confined field trials of the same plant species may be grown. For example, three confined field trials of cotton surrounded by a shared 50 m isolation area would constitute a single trial site.

Trial site location

The geographic location of a confined trial site, e.g. village, address and plot number.

Trial-in-Charge

The technical person designated by the Permitted Party as responsible for management of the field trial, ensuring compliance with the terms and conditions of a confined field trial authorization and providing information required by Regulatory Authorities. The Trial-in-Charge must, at a minimum, be an agriculture graduate.

Volunteers

Self-sown plants of the same species as the regulated plant that may germinate and grow on the trial site and/or within the isolation distance.