FOOD SAFETY ASSESSMENT IN SITUATIONS OF LOW-LEVEL PRESENCE OF RECOMBINANT-DNA PLANT MATERIALS IN FOOD AND FEED

WHEREAS, products derived from modern biotechnology, including
genetically modified (GM) commodities for food and feed or processing
are globally traded;

WHEREAS, countries in accordance with their national priorities and
needs have adopted biosafety legislation, rules and regulations, and
other measures so as to enjoy fully the benefits of modern biotechnology
while safeguarding the health of humans and animals and safety of the
environment;

WHEREAS, Department of Agriculture Administrative Order No. 8, series
2002 (DA AO 8), “Rules and Regulations on the Importation and Release
into the Environment of Plants and Plant Products Derived from the Use
of Modern Biotechnology”, regulates the use of products of modern
agricultural biotechnology that are intended for commercial release
including recombinant-DNA products for direct use for food and feed or
for processing;

WHEREAS, the cornerstone of a decision making for the issuance of a
biosafety permit for direct use as food and feed or for processing under
DA AO No. 8 is a food safety assessment/risk assessment conducted in
accordance with internationally accepted principles and practices
including those of the Cartagena Protocol on Biosafety, the Codex
Principles for the Risk Assessment of Foods Derived from Modern
Biotechnology (CAC/GL 44-2003) and the Codex Guideline for the Conduct
of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants,
or otherwise known as the Codex Plant Guideline (CAC/GL 45-2003);

WHEREAS, the DA adopted the Codex Principles for the Risk Assessment
of Food Derived from Modern Biotechnology (CAC/GL 44-2003) and the Codex
Guideline for the Conduct of Food Safety Assessment of Foods Derived
From Recombinant-DNA Plants (CAC/GL 45-2003) on 13 October 2008 through
DA AO No. 31 series of 2008;

WHEREAS, DA AO No. 8 has established the Approval Registry of Plant
Products for Direct Use as Food and Feed or for Processing, currently
maintained by the Department of Agriculture-Bureau of Plant Industry;

WHEREAS, there have been occasions of unauthorized low-level presence of recombinant-DNA material in countries of import;

WHEREAS, the unauthorized presence in low levels of recombinant-DNA
plant materials in commercial food and feed can be traced to several
factors, including natural pollen flow, emergence of volunteer plants
from previously harvested GM crops, discontinued GM products where
discontinuance is not due to safety reasons, handling, processing and
transport of GM commodities. Hence, there is a need to identify the
risks posed by such recombinant-DNA plant material;

WHEREAS, such presence in low levels of unauthorized recombinant-DNA
plant material in food and feed, by its nature, is transient, temporary
or occasional; exists in non-commercial levels; and can be detected and
measured through threshold levels;

WHEREAS, the 31st Session of the Codex Alimentarius Commission
adopted Annex 3 to the Codex Plant Guideline, “Food Safety Assessment in
Situations of Low-Level Presence of Recombinant-DNA Plant Material in
Food”;

WHEREAS, low level presence of recombinant-DNA plant material under
Annex 3 refers to the occasional presence in low levels of
recombinant-DNA plant material present in food in importing countries
in which the food safety of the relevant recombinant-DNA plants has not
been determined but which have passed a foods safety assessment in one
or more countries according to the Codex Plant Guideline;

WHEREAS, Annex 3 to the Codex Plant Guidelines provides that food
safety assessment in situations of low-level presence may not require
a full or complete comparison of the characteristics of a
recombinant-DNA plant or plant product with its conventional counterpart
as in the Codex Plant Guideline;

WHEREAS, this Administrative Order does not cover recombinant-DNA
plant and plant products denied approval by Department of Agriculture’s
regulatory agencies for the reason that these products pose significant
risks to human, animal, plant or the environment health;

WHEREAS, there is a need to ensure consumer protection in terms of
human and animal health, environmental safety, and food safety by
utilizing the Annex to the Codex Plant Guideline in assessing the safety
of low-level presence of recombinant-DNA plant materials in food and
feed;

NOW, THEREFORE, I, ARTHUR C. YAP, Secretary of the Department of
Agriculture, in accordance with the Consumer Act of the Philippines and
Section 19, Chapter 4, Title IV, Book IV of Executive Order No. 292,
Series of 1987, do hereby issue this Order:

Adopting Annex 3 to the Codex Plant Guideline, “Food Safety Assessment in Situations of Low-Level Presence of Recombinant -DNA Plant Material in Food”, for
the conduct of food safety assessment in situations of low-level
presence of recombinant-DNA plant materials in food and feed;

Directing the concerned policy and regulatory offices of the
Department to clarify issues and formulate guidelines necessary to
implement this Order under the leadership of the Office of Policy and
Planning; and Implementing an institutional capability building program
for DA regulatory agencies to enhance their technical capacities to
undertake appropriate regulatory action.

This Order shall take effect thirty (30) days after its publication in a national newspaper of general circulation.

Adopted: 05 Jan. 2009

(SGD.) ATTY. ARTHUR C. YAP
Secretary