Philippine Biotech Regulations

Learning Outcomes

1.  To understand the concept of risk assessment and management

2.  To be familiar with how biotechnology is regulated in the Philippines using the example of GMOs

3.  To analyze how other biotechnologies should be regulated

Learning Outcome #1

1.  To understand the concept of risk assessment and management

Technology

Public

Regulatory System

Risk Assessment

Regulations

Risk Assessment

Risk management in regulatory frameworks: towards a better management of risks

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One benefit of this tool is that it prevents its users from quantifying consequences that are in fact unquantifiable, such as loss of life or health. It also helps policymakers compare risks that occur in widely different areas and develops a government-wide approach to risk management.

Once the risks have been ranked by both probability and consequences, the organization needs to assign a level of criticality to every combination of probability and consequences (such as “high probability and high impact” – a critical risk). This allows us to develop the kind of matrix illustrated in Figure 2.6.

Figure 2.6 An example of the “probability – impact” matrix for risk ranking

Very low consequences

Low consequences

Medium consequences

High consequences

Very high consequences

Very low probability Low risk Low risk Low risk Low risk Medium risk

Low probability Low risk Low risk Low risk Medium risk Medium risk

Medium probability Low risk Low risk Medium risk Medium risk Critical risk

High probability Low risk Medium risk Medium risk Critical risk Critical risk

Very high probability Low risk Medium risk Critical risk Critical risk Critical risk

The organization can then use the matrix to rank all the risks it has previously identified.

There are many other methods for risk evaluation, most of which can be used to analyse any risk. A few such methods are described in the following box:

Some methods for risk evaluation

“Event trees” are one of the most widely used methods in system risk analysis. The method involves performing an inductive failure analysis to determine the causes and consequences of a possible single future failure for the overall system risk or reliability. “Event tree analysis” (ETA) uses similar logic and mathematics as “fault tree analysis”, but the approach is different. The latter uses a deductive approach (from system failure to its reasons), while ETA uses the inductive approach (from basic failure to its consequences). For example, fault tree analysis would allow us to assess how our business would be affected in the event of an earthquake, whereas event tree analysis could be used to determine the possible causes of a faulty production consignment.

“Layers of protection analysis” (LOPA) is still another method – this time semi-quantitative – for estimating the risks associated with an undesirable event or scenario. It analyses whether there are sufficient measures to control or mitigate the risk.

Other quantitative methods that can be used for risk evaluation include Markov

United Nations Economic Commission for Europe, 20120

Risk Management

Risk Tolerance

•  Do nothing and accept the risk

Risk Transfer

•  transfer the risk to another party or parties

Risk Avoidance

•  renounce or discontinue the activity

Risk Mitigation

•  minimize the consequences and/or likelihood of the risk

Learning Outcome #2

2.  To be familiar with how biotechnology is regulated in the Philippines using the example of GMOs

Regulatory Systems

Cartagena Protocol NCBP

Who’s In? Who’s Out?

Philippine System for Cartagena Protocol

National Focal Point

BCH Emergency

Regulatory Systems

Cartagena Protocol NCBP

National Committee on Biosafety of the Philippines

1990 2006

NCBP Organization

Page | 14

Biosafety Organizational Structure In the Philippines

The DOST Undersecretary for R & D serves as Chair of the NCBP and the members

include the ex-officio members who are representatives of DA, DENR, and DOH who are designated by their respective Secretaries, four scientists with specialization in the biological sciences, environmental sciences, physical sciences, and social sciences, and two community representatives. The DOST’s Office of the Undersecretary for R & D serves as the Secretariat of the NCBP with the member departments providing additional staff support as the need arises.

The Institutional Biosafety Committees (IBCs) are required to be established in institutions

involved in genetic engineering and/or hazardous biological work and are tasked to evaluate and monitor the biosafety aspects of their biological researches. The IBC shall be composed of at least five members— at least three scientists with expertise in biotechnology or related fields and have the capacity to assess and monitor properly any work involving GMOs and potentially harmful and exotic species (PHES) and two community representatives who are not affiliated with the institution and shall represent the interest of the surrounding community with respect to health and protection of the environment as stated in the Philippine Biosafety Guidelines (NCBP 1991). The list of nominees for IBC membership of an institution has to be approved by the NCBP. Minimum requirement is the submission of the curriculum vitae of the nominees for review by the NCBP.

The NCBP creates a Scientific and Technical Review Panel (STRP) when needed to

conduct a scientific review or evaluation of biosafety proposals independent of the NCBP. Members of the STRP are experts in fields relevant to the proposal being evaluated.

Fig. 1. Organizational Structure of the NCBP.

DOST

DOH

DENR

DA

NCBP

SECRETARIAT

STRP

IBC’s

BCT

E.O. 514, s. 2006

Stages of Approval

Contained use

Confined environmental release

Large scale release

Commercial release

Use for feed, food and processing

APPLICATION TO RELEASE FOR PROPAGATION

Applicant

BPI

Sufficient in Form &

Substance?

STRP Evaluation and risk assessment

For conduct of public consultation

5 day process/ evaluation period

YES NO

Submit: •  5 copies of Application Form •  supporting documents (technical dossier; copy of PIS; & BPI certification that reg.art. has undergone satisfactory field testing in the Phils.

APPROVED

DENIED

90 day period

Applicant Shall publish PIS in 2 papers, & invite comments w/in 30-day pd.

60 day grace period to correct defects

30 day period

BAFPS

FPA

BAI

If pest-protected plant

In all instances

If intended as feed

Risk Assessment

No person shall be allowed to import or release into the environment any regulated article without a satisfactory risk assessment conducted in accordance with the rules. The assessor summarizes the possible risks due to the GMO and recommends the mitigating measures or risk management strategies

The Bt Corn Experience

Bt corn event2 MON 810 •  first biotechnology material that has so far gone

through the entire biosafety regulation process •  first GMO approved for commercial release in

the Philippines

The Bt Corn Experience

4 stages of biosafety assessment: 1.  glasshouse trial phase (1996 and 1997)* 2.  limited field trial stage (1999-2000) 3.  multi-location field trial phase (2001-2002) 4.  processing of the application before

commercialization (2002)

* portions of the trial were conducted in the US

Major Findings: Safe to Grow?

1. Seed dormancy, seed survival, and the time to maturity of Bt corn were comparable to non-Bt corn 2. No gene transfer to wild relatives due to spatial, ecological, temporal, and cytological isolation

Major Findings: Environmentally Safe?

1.  No differences in the insect population between these Bt and non-Bt corn farms

2.  Bt toxin easily degrades in the soil 3.  Bt has been previously used as biological control

pesticide against the diamond back 4.  ACB was found to be naturally bound to develop

resistance

Major Findings: Safe to Eat?

1. Same chemical/nutritional composition with non-Bt corn 2. No sources of toxicants or allergens found 3. No effect when fed on broilers; plant DNA not found in animals 4. Humans and animals have no receptors for the Bt toxin; acidic human digestive tract degrades the Bt toxin

Risk Mitigation Strategies

•  Segregation, security, and labeling for stored or transported GM materials

•  Isolation of field trial sites for GM crops; contingency plan in case of accidental release

•  DA-BPI created a multi-sectoral Technical Working Group on Insect Resistance Management (IRM)

•  Post-harvest land use restriction and monitoring of one or more years, depending on the crop species.

•  The permit to propagate or commercialize Bt corn was issued for only five years, but can be renewed if no adverse effects are observed

•  Was NCBP’s first encounter with those opposed to modern biotechnology

•  Forced NCBP and scientists to explain biotechnology to laymen

•  Highlighted the fact that biosafety is not only science-based risk assessment, but involves other issues which NCBP is ill-equipped to handle

•  NCBP was later criticized because: •  Risk management measures required of the applicant

were too strict •  It took a long time to approve the application •  It was very expensive for the applicant

The Bt Corn Experience Jose Maria A. Ochave, Former Member and Legal Adviser, NCBP

Philippine Regulations

•  One of the first Asian countries to establish a biotechnology R&D program •  Model for GMO regulatory policy for other

developing countries •  Regulations recognized as science-based,

thorough and transparent •  Regulations have allowed the propagation of GE

corn for over a decade with no environmental and health issues

Biotech Regulatory Systems

Table 3. Comparison of biosafety guidelines under different regulatory regimes

Areas Philippines Indonesia Malaysia Vietnam Japan Norway US Mexico

Use of existing legislation 9 9 9 9 9 9 8 9 Mandatory pre-market approval 9 9 9 9 9 9 9 8 Established safety standards 9 9 9 9 9 9 9 8 Transparency (regulatory process) 9 8 8 8 9 9 9 9 Transparency (data) 9 8 8 9 8 8 9 8 Public information (application) 9 8 8 8 8 9 9 8 Use of external scientific experts 9 9 8 8 8 9 9 9 Post-approval monitoring 9 8 8 8 8 8 9 8

The implementation of the PBG has evolved through the years. As more experience is gained by the regulators and the scientists through exposure to actual field conditions and literature, risk assessments have become more realistic and less stringent. Also, GMO evaluation has taken on a wider and deeper perspective. Gene flow and the effects on non-target organisms, biodiversity, ecosystems and the food chain have become important concerns in addition to toxicity, nutritional value and allergenicity (Ramirez 2004).

Moreover, the efficiency of regulators has improved over the years. The period for processing applications for field trials declined from eleven months (September 1998 to August 1999) in the case of MON 810 Bt corn to five months (July to November 2002) in the case of the field trial application of Bt 11 maize and six months in the case of glyphosate-tolerant corn or NK 603 and Bt corn Herculex I (NCBP 2004). The shortened processing time is reflective of the regulators’ learning curve.

Efforts to make the PBRS truly CPB-compliant are underway. The Philippines is among the many developing countries that receive assistance from the UNEP/GEF to formulate a national biosafety framework (NBF) based on the provisions of the CPB. Some structural and operational changes to the PBG have been introduced in the proposed NBF. Under the NBF, the National Committee on Biosafety of the Philippines (NCBP) will become a policy-making body and all the biosafety regulation tasks will be performed by the regulatory agencies i.e., the DA, Department of Environment and Natural Resources (DENR), and Department of Health (DOH).

Like the PBG, the NBF is consistent with the national policy to promote the safe and responsible use of biotechnology and the principles of sustainable development. The NBF expressly states that it adopts the precautionary principle, science-based, balanced approach to risk assessment by taking into consideration the potential risks and benefits of biotechnology application as well as the interests of major stakeholders. The other major features of the NBF that articulate the provisions of the CPB are those concerning availability of remedies through administrative and judicial proceedings and the inclusion of socio-economic, cultural, and ethical considerations.

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Research report, 1608-5434 ; 2005-RR13

Learning Outcomes

3.  To analyze how other biotechnologies should be regulated

Grp 2: vaccines

Grp 3: gene

therapy

Grp 1: biofuels

Grp 4: bioplastics

Grp 5: marine drugs

Group report, max 10min per presentation Suggest a regulatory process involving authority agencies of the

Philippine government for the intended technology and present the flowchart. Identify 3 medium or critical risks associated with the technology and recommend a risk mitigation strategy for each.

4 3 2 1

Content All the required elements are presented.

Most of the required elements are presented.

Some of the required elements are presented.

None or few of the required elements are presented.

Comprehension Report reflects a strong understanding of the concepts learned/discussed.

Report reflects a good understanding of the concepts learned/discussed.

Report reflects some understanding of the concepts learned/discussed.

Report reflects weak understanding of the concepts learned/discussed.

Analysis Report shows a clear relationship between various factors, and appropriate conclusions or feasible recommendations were drawn.

Report shows some relationship between various factors, and appropriate conclusions or feasible recommendations were drawn.

Report shows some relationship between various factors, but some conclusions were not appropriate or recommendations were not feasible.

Report fails to show the relationship between various factors, or conclusions were not appropriate or recommendations were not feasible.

Pragmatism All ideas have been given careful thought to be sensible and realistic (based more on practical rather than theoretical considerations).

Most ideas have been given careful thought to be sensible and realistic (based more on practical rather than theoretical considerations).

Some ideas have been given careful thought to be sensible and realistic (based more on practical rather than theoretical considerations).

Few or none of the ideas have been given careful thought to be sensible and realistic (based more on practical rather than theoretical considerations).

Presentation Report is well organized and clear, and time is properly managed.

Report is well organized and clear, but slightly overtime.

Report is mostly well organized and clear, and time is properly managed.

Organization and clarity of report or time management needs improvement.