About APCS
A Program for Stewardship of Plant Molecular Farming Products Expressing Animal Proteins in Crops used for Food and Feed
Purpose: The Animal Protein Crop Stewardship (APCS) program outlines a comprehensive set of activities to be implemented by developers where at least one of the recombinant animal proteins expressed in the plant is a known major food allergen, and a subset of practices to be implemented for products that are not a known major food allergen but may present properties that could impact grain grading or may have considerations for vegetarian, halal, kosher or other qualified diets.
Introduction: The production of genetically modified (GM) plants that express animal proteins intended for human consumption, also known as plant molecular farming, represents an innovation which has the potential to provide additional market opportunities for farmers and diversify available protein sources.
The unique nature of these plants presents potential new considerations that can be addressed through the development and implementation of tailored stewardship practices. This may include a closed-loop system (CLS) or similarly appropriate stewardship practices based on the properties of the product. Appropriate stewardship practices are an important foundational component for the responsible commercialization of these products.
The APCS Program outlined here is designed specifically for these types of products, comprising guidance for activities throughout the product life cycle. The life cycle begins with the concept in the lab and contained facilities, continues through field plantings, and extends to post-harvest storage, movement and processing activities, through product discontinuation. The purpose of this program is to enhance traceability and control for these types of products by developers or others handling or using such products at every step of the product life cycle and supply chain. This is accomplished by implementing appropriate stewardship activities to enable responsible use and identify relevant critical control points (CCPs).
Leveraging industry best practices developed over decades for the stewardship of GM crops provides a solid foundation for this framework. Building on that solid foundation, this framework enables a developer to construct stewardship practices that are fit-for-purpose for this class of agricultural products by taking into account current industry guides and stewardship practices with appropriate practices, processes, controls, and technologies tailored to these products. The proper design and implementation of such practices will enable the developer to create and commercialize its products in a responsible manner, increase grower and consumer access to these products, and benefit stakeholders across the value chain.
Successfully implementing the APCS program will equip a developer with tools to maximize appropriate product placement and maintain product identity of its materials, and to enable products to be brought to market at scale. This framework establishes a uniform and consistently applied approach to assist in the responsible production of these agricultural products across the industry. Ultimately, this will benefit not just the biotechnology industry, but also the farmers, consumers, and the environment that these innovative products aim to serve.
Objective: The APCS program establishes industry guidance for the development, growing and processing of products expressing animal proteins in crops intended to be used for food and feed. This program incorporates a third-party auditing component that will cover the practices to be adopted by developers.
Scope: This document provides a summary of the program for the responsible production of products that express animal proteins intended for human consumption in crops used for food or feed including but not limited to grains, oilseeds and tubers. This program is applicable to all stages of the product life cycle, from initial research concept through development, contained facilities, field plantings, post-harvest storage, movement and processing activities, through product discontinuation.
Animal Protein Crop Stewardship - Framework
Commitment to Appropriate Controls, Procedures, Processes, and Technologies
The production of these products may introduce considerations that extend beyond the scope of current industry best practices for traditional biotechnology products. This program will focus on stewardship activities that should be considered across the plant product life cycle (see Figure 1). There is a special focus on the management of the on-farm activities in the “Seed Production” and “Crop Production” phase of the life cycle, as well as on the “Crop Utilization” phase through the management of the marketable plant parts, including but not limited to grain and tubers produced from these crops. These are important considerations for the responsible stewardship of these products.
For these products, a tailored approach may be developed by layering appropriate processes, controls, and technologies as part of implementing established industry guidance at various stages of the life cycle, from research and discovery to the first introduction into the environment, through food and co-product processing. Depending on the protein type – allergen or non-allergen – the full, or a subset of activities should be undertaken. The Product Flow Chart can be used to help determine the appropriate set of practices for each set of products (see Figure 2).
The practices outlined in the program address appropriate stewardship components that should be considered by a developer, where applicable, to mitigate the potential impacts associated with product development and commercialization. The program documents and guidance include notations on the practices which are applicable only to a developer utilizing an allergenic animal protein and those which are applicable to all developers.
This program includes guides dedicated to general stewardship principles and incident response that are applicable across all product development and commercialization modules. After this, and to accommodate different business models, the program follows the stages of the product life cycle and maintaining plant product integrity across those stages.
