Genetically Modified Organisms Amendment Act

This section amends and adds definitions for GMO-related terms such as accident, activity, release, contained use, and user.

This section sets up the Executive Council for Genetically Modified Organisms and lets the Minister appoint its members and alternates.

This section says section 4 of the principal Act is being substituted, but the replacement text is not included here.

The Council must advise the Minister on genetically modified organisms and ensure related activities comply with this Act.

The Council is given wide powers and duties for GMO permit applications, accident response, notifications, coordination, and guidelines.

Council decisions must be made by consensus, and the Council must call a special meeting when required by the specified triggers.

The registrar must check applications, manage permits, keep a register, arrange inspections, stop non-compliant activities, send permit applications and documents to the Council, and share specified information with the Biosafety Clearing-House.

This section amends section 10 so that two persons must be from the public sector, with one knowledgeable about ecological matters and genetically modified organisms and the other knowledgeable about the potential impact of genetically modified organisms on human and animal health.

The Committee may advise officials and bodies on organism modification matters, and may seek input from knowledgeable scientists on genetic modification issues.

The Minister, with the concurrence of the Minister of Finance, may determine the remuneration paid to committee and subcommittee members and certain other members.

This section amends the principal Act by replacing paragraph text about seizure of items, notice to owners or controllers, and removal of seized items at the person's cost.

Users must take appropriate measures to avoid harmful impacts from genetically modified organisms, and users are generally liable for damage caused by GMO-related activities.

The Council may recover costs, and affected people may appeal a costs order.

The section amends application-content requirements for genetically modified organism matters.

This section changes appeal-board procedure, including appointment timing, ministerial designation of a chairperson, the board’s decision-making powers, and publication of decisions.

This section amends section 20 of the principal Act by changing permit-related wording and adding topics about risk assessments, environmental impact assessments, accident-notification information, and the Biosafety Clearing-House.

This section replaces rules so that a person must not break the Act or any rule made under it, must respond to lawful questions from specified officials, and must not give false or misleading information.

This section substitutes the long title of the principal Act with a title about measures for genetically modified organisms, including responsible development, protection of the environment and health, risk evaluation, and notification procedures.

This section says the Act starts on a date fixed by the President through a proclamation in the Gazette.

Each Party must take necessary and appropriate legal, administrative, and other measures to implement its obligations under this Protocol.

The Parties must ensure activities involving living modified organisms reduce or prevent risks to biological diversity and consider risks to human health.

This provision says the Protocol does not change states’ sovereignty and related maritime rights, or navigation freedoms under international law.

A Party may take more protective action for biodiversity conservation and sustainable use than the Protocol requires, if the action fits the Protocol’s objective and provisions and complies with other international law obligations.

The Parties are encouraged to consider available expertise, instruments, and work from international forums on risks to human health. The section also defines key terms and says the Protocol does not apply to human pharmaceuticals covered by other international agreements or organizations.

The advance informed agreement procedure does not apply to living modified organisms that are in transit.

The Party may risk-assess living modified organisms before import decisions and set contained-use standards within its jurisdiction. The advance informed agreement procedure does not apply to transboundary movement of living modified organisms for contained use if it follows the Party of import’s standards.

The advance informed agreement procedure applies before the first intentional transboundary movement of living modified organisms for intentional introduction into the environment, subject to Articles 5 and 6.

This provision says Article I1 applies before the first transboundary movement of living modified organisms intended for direct use as food or feed, or for processing.

The advance informed agreement procedure does not apply to certain intentional transboundary movements of living modified organisms, and the Party of export must notify the Party of import’s competent national authority in writing before such movement.

The Party of export must ensure there is a legal requirement for the accuracy of information provided by the exporter.

The Party of import must acknowledge receipt of the notification in writing to the notifier within 90 days of receiving it.

The acknowledgement must state the date of receipt, whether the notification appears to contain the Article 8 information, and whether to proceed under the domestic regulatory framework or Article 10.

The domestic regulatory framework referred to here must be consistent with this Protocol.

If the Party of import fails to acknowledge receipt of a notification, that failure does not count as consent to an intentional transboundary movement.

Decisions taken by the Party of i m p r t must be in accordance with Article 15.

The Party of import must inform the notifier, within the period referred to in Article 9, whether the intentional transboundary movement may proceed.

The Party of import must send its decision in writing to the notifier and the Biosafety Clearing-House.

A decision under paragraph 3 must state the reasons on which it is based, except where consent is unconditional.

If the Party does not communicate its decision within 270 days after receipt of the notification, that failure does not count as consent to the intentional transboundary movement.

If scientific certainty is lacking, that does not stop the Party of import from deciding on the import of the living modified organism.

A Party must inform the Parties through the Biosafety Clearing-House within 15 days after making a final decision on domestic use or placing on the market of a living modified organism in the stated cases.

The Party must provide a written copy of the information to the national focal point of each Party that has told the Secretariat it does not have access to the Biosafety Clearing-House.

The decision-making party under paragraph 1 must ensure there is a legal requirement that the applicant’s information is accurate.

Any Party may request additional information from the authority identified in paragraph (b) of Annex 11.

A Party may decide on imports of certain living modified organisms, if its domestic rules are consistent with the Protocol’s objective.

Each Pany must make available certain national laws, regulations, and guidelines to the Biosafety Clearing-House, if available.

A developing country Party or a Party with an economy in transition may declare, through the Biosafety Clearing-House, that certain pre-import decisions will follow a risk assessment and be made within 270 days.

If a Party does not communicate its decision, that silence does not count as consent or refusal for the import of a living modified organism for food, feed, or processing, unless the Party says otherwise.

A lack of scientific certainty does not stop a Party from deciding whether to allow import of a living modified organism for direct use as food or feed, or for processing.

A Party may state its need for financial and technical assistance and capacity-building for certain living modified organisms, and the Parties must cooperate to meet those needs.

A Party may review and change a transboundary movement decision when new scientific information or potential adverse effects justify it, while considering human health risks.

The Party of export or the notifier may ask the Party of import to review a decision under Article 10 if circumstances have changed or new relevant scientific or technical information is available.

The Party of iinport must reply in writing to the request within 90 days and explain its decision.

The party of import may, at its discretion, require an assessment for subsequent imports.

A Party may, if adequate safety measures are in place, pre-notify the Biosafety Clearing-House of certain intentional cross-border movements and exempt some living modified organism imports from the advance informed agreement procedure.

Notifications under paragraph 1 must use the information specified in Annex 1.

Parties may make certain bilateral, regional, or multilateral agreements and arrangements about international transboundary movements of living modified organisms, if they fit the Protocol’s objective and do not reduce protection below the Protocol level.

The Parties must inform each other, through the Biosafety Clexing-House, about certain bilateral, regional, and multilateral agreements and arrangements they entered into.

This provision says the Protocol does not affect certain movements made under agreements or arrangements between the parties to those agreements or arrangements.

Any Party may decide that its domestic regulations apply to specific imports, and must notify the Biosafety Clearing-House of that decision.

The Party or import must ensure risk assessments are carried out for decisions made under Article 10.

The notifier must make the cost or risk assessment if the party of impact requires it.

The Parties must establish and maintain mechanisms, measures, and strategies to regulate, manage, and control risks linked to living modified organisms.

Measures based on risk assessment must be imposed as necessary to prevent adverse effects of a living modified organism on conservation and sustainable use of biological diversity, while also considering risks to human health, in the territory of the Party of import.

Each Party must take appropriate measures to prevent international movements of living modified organisms.

Each Party should ensure living modified organisms are observed for an appropriate period before intended use.

Parties must cooperate to identify living modified organisms or traits that may harm biodiversity and human health, and to take appropriate treatment measures.

Each Party must take appropriate measures to notify affected or potentially affected States, the Biosafety Clearing-House, and sometimes relevant international organizations, after certain releases involving a living modified organism.

Each Party must provide the Biosafety Clearing-House with its contact-point details for receiving notifications under this Article.

A notification under paragraph 1 must include specified information about the living modified organism, the release, possible adverse effects, other relevant information, and a contact point.

Each Party must immediately consult affected or potentially affected States after a release, and must require safe handling, packaging, and transport of certain living modified organisms.

Each Party must require documentation for certain living modified organisms to clearly identify them and include specified handling and contact information.

The Conference of the Parties must consider whether to develop standards for identification, handling, packaging, and transport practices, and do so in consultation with other relevant international bodies.

Each Party must designate a national focal point and one or more competent national authorities; it may use one entity for both roles.

Each Party must tell the Secretariat who its focal point and competent national authority are, and update that information when it changes.

The Secretariat must promptly tell the Parties about certain notifications it receives and make that information available through the Biosafety Clearing-House.

The Clearing-House must act as the means for making information available and provide access to relevant Parties and, where possible, other biosafety information exchange mechanisms.

Each Party must provide specified information to the Biosafety Clearing-House, subject to protection of confidential information.

The Conference of the Parties, acting as the meeting of the Parties to the Protocol, must consider and decide the Biosafety'Cleatin~-House operating arrangements at its first meeting and keep them under review afterward.

The Party of import must let the notifier identify confidential information submitted under the Protocol procedures or required for the advance informed agreement procedure, and must give a justification on request in such cases.

The Party of import must consult the notifier and, before disclosing the information, tell the notifier of its decision and give reasons on request, plus an opportunity for consultation and internal review.

Each Party must protect confidential information received under the Protocol.

The party of import must not use the information for a commercial purpose unless the notifier gives written consent.

If a notifier withdraws a notification, the Party of import must keep commercial and industrial information confidential.

Some information is not confidential, including the notifier’s name and address, a general description of the living modified organism, the risk-assessment summary, and emergency-response methods and plans.

The Parties must cooperate to build biosafety-related human and institutional capacity, including biotechnology where needed, to help implement the protocol.

In cooperation on biosafety capacity-building, the parties must take the needs of developing countries, especially least developed countries and small island developing States, fully into account.

The Parties must promote public awareness, education, and participation about the safe transfer, handling, and use of living modified organisms, and cooperate with other States and international bodies as appropriate.

The Parties must consult the public on decisions about living modified organisms and make the results public, while respecting confidential information under Article 21.

Each P m y should try to inform the public about how to access the Biosafety Clearing-House.

Transboundary movements of living modified organisms must be consistent with the Protocol’s objective, and Parties may make bilateral, regional, or multilateral agreements about those movements.

The Parties must encourage non-Parties to follow this Protocol and provide appropriate information to the Biosafety Clearing-House about certain living modified organisms.

Each Party must adopt domestic measures to prevent, and where appropriate minimize, illegal transboundary movements of living modified organisms.

In an illegal transit case, the party of origin is to dispose of the matter, apparently by repatriation or destruction, at its request.

Each Party must make available information about cases of illegal transboundary movements that relate to it.

The Parties may consider certain non-economic impacts when deciding on imports under the Protocol or related domestic measures, as long as they act consistently with international obligations.

The Parties are encouraged to cooperate on research and information exchange about the socio-economic impacts of living modified organisms, especially for indigenous and local communities.

When considering financial resources for implementing this Protocol, the Parties must take into account Article 20 of the Convention.

The financial mechanism under Article 21 of the Convention is the financial mechanism for this Protocol, operating through the institutional structure assigned to it.

When giving guidance on the financial mechanism, the Conference of the Parties serving as the meeting of the Parties must take developing-country financial needs into account, especially for least developed and small island developing States.

Parties must take into account the needs of developing country Parties, especially least developed and small island developing States, and Parties with economies in transition, when identifying and implementing capacity-building requirements for implementing the Protocol.

Guidance to the financial mechanism and relevant Conference of the Parties decisions applies, as adapted as necessary, to this Article.

Developed country Parties may provide financial and technological resources, and developing country Parties and Parties with economies in transition may avail themselves of such resources, through bilateral, regional, or multilateral channels.

The Conference of the Parties must serve as the meeting of the Parties to this Protocol.

Non-Parties to the Protocol that are Parties to the Convention may attend meetings as observers.

If the Conference of the Parties is acting as the meeting of the Parties to the Protocol, a bureau member representing a Convention party that is not yet a Protocol party must be replaced by a member elected from among the Protocol parties.

The Protocol’s meeting of Parties must review implementation, make needed decisions, and carry out the functions assigned to it.

The Convention’s rules of procedure and financial rules apply to this Protocol, except where the Parties decide otherwise by consensus.

The Secretariat must convene the first meeting, and later ordinary meetings must be held together with ordinary meetings of the Conference of the Parties unless the Parties decide אחרת.

Extraordinary meetings must be held when the body deems them necessary or when a Party requests one in writing and the request is supported by at least one third of the Parties within six months.

Certain international and qualified bodies may attend as observers at the relevant meetings, and observer admission/participation is subject to the rules of procedure and possible objection by one third of Parties present.

A subsidiary body established by or under the Convention may serve the Protocol, if the Parties acting as the meeting of the Parties decide so.

Non-Parties to the Protocol may attend relevant subsidiary-body meetings as observers, and Protocol decisions are made only by Protocol Parties.

If the subsidiary body is acting on matters concerning this Protocol, a bureau member representing a Convention Party that is not a Protocol Party must be replaced by a member elected from among the Protocol Parties.

The secretariat established by Article 24 of the Convention must serve as the secretariat for this Protocol.

Article 24(1) of the Convention on the functions of the Secretariat applies, mutatis mutandis, to this Protocol.

Parties must pay the distinct secretariat costs, monitor implementation, and report to the Conference of the Parties; the Conference must also set up compliance procedures and budget arrangements at its first meeting.

The Conference of the Parties must review the Protocol’s effectiveness five years after it enters into force, and then at least every five years.

This Protocol enters into force 90 days after the fiftieth instrument of ratification, acceptance, approval, or accession is deposited.

This Protocol enters into force for a ratifying, accepting, approving, or acceding State or regional economic integration organization on the later of 90 days after deposit of its instrument or the date the Convention enters into force for it.

An instrument deposited by a regional economic integration organization is not counted as additional to the 25 instruments deposited by member States.

A Party may withdraw from the Protocol after two years from the date it entered into force for that Party, by notifying the Depositary.

A withdrawal takes effect on expiry, one year after the Depositary receives it, or later if the notification says so.

This provision says risk assessment under the Protocol is meant to identify and evaluate possible adverse effects of living modified organisms on biodiversity and human health.

Risk assessment should be carried out in a scientifically sound and transparent manner.

Lack of scientific knowledge or consensus should not be treated as meaning there is a particular level of risk, no risk, or an acceptable risk.

Risk assessment should be done case by case, and the information needed can vary depending on the organism, its intended use, and the receiving environment.

During risk assessment, additional information about specific subjects may be needed and requested.

This provision lists the steps for risk assessment of a living modified organism, including checking characteristics, likelihood, consequences, overall risk, and possible risk management or monitoring.

Risk assessment must take account of the relevant technical and scientific details for the listed biological subjects and the receiving environment.