Analyzing International Animal Biotech Regulations for the Philippines' Future

The Philippines is one of the leading countries in Southeast Asia in the field of biotechnology. However, the country needs to catch up with laws and regulations concerning animal biotechnology. Analyzing the animal biotech regulations in other countries will help create policies that the Philippines needs. 

ISAAA Inc., in partnership with Winrock International through the Building Safe Agricultural Food Enterprises (B-SAFE) Project, held a webinar titled Navigating the Landscape: A Look at Animal Biotech Regulations in Brazil and Canada on April 11, 2024, via Zoom. The webinar aimed to create an understanding of and capacitate Philippine regulators to craft policy approaches that are consistent with international standards. 

Ms. Ma. Lorelie U. Agbagala, Assistant Scientist and Head Secretariat of the National Committee on Biosafety of the Philippines and the DOST Biosafety Committees opened the activity. In her opening remarks, Ms. Agbagala mentioned that the Philippines has been at the forefront of biosafety regulation in crops and, more recently, has ventured into developing biosafety guidelines for biotech animals. However, as the country threads into new territories, there may be apprehensions in society regarding the regulation of genetically modified (GM) animals. Hence, the webinar holds immense significance in raising awareness and knowledge, and fostering understanding of biotechnology applications in livestock and agriculture. Ms. Agabagala also emphasized that the webinar’s main objective was to provide valuable insights into how regulatory frameworks can facilitate the safe and responsible deployment of biotechnology products in the country. 

Biosafety regulation for GM animals in Brazil 

The first speaker, Dr. Maria Lucia Dagli, a regulator at the National Technical Committee on Biosafety (CTNBio), Ministry of Science and Technology in Brazil, introduced CTNBio as a commission that defines and analyzes GMOs. She provided an overview of Brazil's biosafety regulation for GM livestock.  

Dr. Dagli emphasized that the Brazilian model of GMO regulation is science-based and has a robust and transparent technical assessment of GM products. She mentioned some important normative solutions, such as RN34 and RN18, which provide the risk classes of GMOs and their respective biosafety levels. Dr. Dagli provided examples of gene-edited animals not considered GMOs, such as hornless cattle and tilapia. 

Biosafety regulation for GM fish in Canada 

Ms. Chantal March, the Director of Quality and Regulatory Compliance at AquaBounty in Canada, presented their experiences in Canada's regulation of GM fish. She highlighted the three primary government departments responsible for regulating GM animals in Canada, with specific responsibilities and requirements for assessing the products. These government departments include Environment and Climate Change Canada for New Substances Regulations, Health Canada for Novel Food Regulations, and the Canadian Food Inspection Agency for Novel Feed Regulations. 

New substances have specific data requirements that must be provided to Environment and Climate Change Canada. These include characterization of the animal, biological and ecological properties, and environmental exposure. Hazards must also be considered, such as indirect human health hazards and environmental hazards.  

Ms. March defined novel food as a “product that is new or changed compared to existing foods.” Meanwhile, novel feed was described as “feeds composed of or derived from a plant, animal, or microorganism that contain a novel trait and/or are not approved as livestock feed in Canada.” She also highlighted five key steps to regulatory success: defining your product, pre-submission consultation, continued communication, quality data and documentation, and recognition of economic opportunities. 

Open Discussion 

Most of the attendees were regulatory officers, so most of the questions were about the assessment and approval process of GMOs. Based on the open discussion, only CTNBio decides in Brazil if the product is safe for humans, the environment, and other animals. Meanwhile, in Canada, companies will need three approvals. Environment Canada determines if the product has a negative impact on the environment. Health Canada will state if they have no objection to the sale of the product in the marketplace. CFIA will give approval for the product as a novel feed. 

Ms. March also mentioned that cultural and societal elements, such as ethics, sustainability, and animal welfare, are now part of some of the reviews in Canada. Meanwhile, in Brazil, the risk assessment is science-based. However, they also analyze other aspects, like animal welfare, in the overall evaluation of the product.  

The program ended with remarks from Dr. Paul Limson, Director of the Philippine Agriculture and Fisheries Biotechnology Program of the Department of Agriculture (DA Biotech). Dr. Limson said, animal biotechnology shows great promise for enhancing the quality of life for humans and animals. Through advancements in genetic engineering, animals with improved traits have been developed, and they have the potential to benefit society in various ways. Dr. Limson mentioned that efforts are underway to establish regulatory policies for animal biotech products, focusing on evidence-based analysis to govern the development and utilization of these technologies before their actual implementation. He also reminded the audience that it is not only about ensuring the safety of the food supply and protecting the environment but also upholding the ethical obligations to the animals themselves.  

For inquiries about the event, email meetings@isaaa.org.

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