Control of production and use of Genetically modified crops to produce oil, starch, protein 9
Running Head: Regulatory Impact Analysis Study 1
REGULATORY IMPACT ANALYSIS STATEMENT ON CONTROL OF PRODUCTION AND USE OF GENETIC MODIFIED CROPS TO PRODUCE OILS, STARCH, FIBER, PROTEIN OR OTHER CHEMICALS FOR INDUSTRIAL PROCESSES.
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ISSUES
The Government of Canada is proposing to amend a regulation which will control the production and use of Modified Genetic Crops to produce oil, starch, fiber, protein or other chemicals for industrial processes.
The present state is that the markets have flooded with this product which is not safe for human consumption at the long run. Food and Drug Regulations (FDR) are yet to undergo amendments that will enable this federal agency to execute its mandate as required.
The borders also have gaps that allow easy penetration of genetically modified crops into the market. This also means exports of the same have a paved way into Canadian markets simply because of laxity from the authority mandated to check and control exports through screening and inspections (Waltz 2017).
Background
Food and Drug Regulations and composition standards
Food and Drug Regulations (FDR) and the Food and Drugs Act (FDA) spell out requirements about health and safety standards, production and processing requirements that apply to food. More than 200 food composition standards have been prescribed under the Food and Drug Regulations. The Food standards should be composed of purity and quality; when we talk of Genetics, it is something else far from quality since there is an alteration in genes during production. Crops which are produced under this environment and have undergone some modification cannot be termed as standardized crops. It will only qualify to be standardized if it will comply with the requirements of these regulations (FDR)/(FDA).
Standards will provide consumers with safe crops and fake products and help them make productive decisions when making a purchase.
The requirements of these standards always apply when imports and exports are taken in or outside Canada for safety purposes.
Industries
The Canadian industries have experienced changes due to mergers and acquisition over the past years making changes in structures and environment which they initially operated. The consumer rate is also high in terms of consumption of starch, oil, fiber, and protein as they consist of the human diet for a healthy lifestyle.
Objectives
The core objective of the proposal is to amend a regulation to control production and use of genetically modified crops in the production of various products such as oil, starch, fiber, proteins and other chemicals used in food processing. This objective is geared to
1) Reducing Genetic Modified crop products into the market by allowing relevant agencies to execute their role diligently through transparency and in an integral manner.
2) Protecting the interest of the public by ensuring their safety and health is maintained.
3) Reducing counterfeit and duplication through standardization of product about additives that is safe for consumption with zero effects.
4) Enabling product to be labeled as per the content during production to describe the consumer
Labeling amendment is proposed to allow Food and Drug Regulation to be able to protect the health of Canadians inclusively through the provision of relevant information on the label to make an informed decision during purchasing.
Description
Definition of genetic modification
Also known as genetic engineering is the modification of organisms’ genes directly using biotechnology to alter their characteristics in terms of maturity and growth, size and shape. This alteration of genes is proposed not to be used in the production of crops and not to allow processing of goods using raw materials from genetically modified crops (Diduck 2016).
Canadian Food Inspection Agency should review its guidance on policies related to food standards.
Proteins
Canadian Food Inspection Agency (CFIA) designed guidance and policy. The guidance clarifies the term “Proteins” to mean an element found in food which is essential for bodybuilding as they provide tissues with energy and acts as a fuel source (Bernstein 2017).
Under the FDR, subsection B.01.3059 (1) states; ‘No person shall, on the label of or in any advertisement of food, make a representation, express or implied, respecting a protein unless food meets the conditions set out in column 2 of the 8 of the table following section B.01.513 for the subject “source of proteins” set out in column 1.“if the term “complete protein” is used, it must be in conjunction with and meet the requirements of a “source of proteins” claim. Meaning, there must be no intervening materials to alter the source of proteins acclaim wording. (FDA 2016)
Also, it is not allowed to advertise a commodity to the public by referring to the protein as of high quality; rather, a percentage can be used to emphasize on that matter.
Starch
This is a carbohydrate that consists of a large number of glucose essential for energy in living things.
Fiber
Found in vegetables, fruits, barley and legumes that are essential to lower cholesterol and stabilize blood sugar.
Processing Aids
These are substances used during the manufacturing and processing of food. Some of these substances have been produced from these genetically modified organisms (Nassr 2017). The proposed amendment will incorporate removal of genetic substances used as processing aids. This will allow products to meet the required standards.
Benefits and costs
The benefit-cost is used to assess the potential impact in term of cost and benefits. The proposed regulations on GMOs will apply to both imports and exports into Canada. Industries will use FDR guidelines and policies in discharging their duties. The impact in terms of cost will affect the following stakeholders
1- General public/consumers
2-Government (FDA/CFIA)
3-Farmers
4- Manufacturers/Industries
Qualitative Benefits
- a) Support product development
The proposal will reduce confusion in terms of standardization.
- b) Protection of human health
Products will not be produced from genetically modified raw products which affect the human body (allergy, diseases) (Hellmuth 2017).
- c) Removal of unsafe standards
The move is tailored at removing genetic engineered crops away from the market.
- d) Product quality
Product quality will be supported when the market will be at its top in performance.
- e) Prevention of adverse reactions to product content
Increased awareness related to products that are as a result of genetic engineered. Increased awareness due to new standards related to natural use of crops in the processing of certain products will improve medical care by reducing adverse complications proceeded by regulatory amendments being implemented.
Monetized cost
Product reformulation
It will require additional labor when testing the products to check if they meet the standard.
“One for one ”Rule
“one for one ” Rule applies as the regulatory amendments proposed will impose an additional administrative cost which is associated with adapting the new regulatory requirements.
A standard cost model was adopted with an assumption noted below.
- Cost of learning
An estimate of 600 food processing industries stakeholders will have to know the detail pertaining proposed regulatory requirements to predict the impact on the industries.
Small business lens
The small business lens was used. Under the Treasury Board of Canada Secretariat, they defined small business to be having less than 100 employees. An estimate of1000 small business will be affected by the proposed amendments
Consultation
Canadian Food Inspection Agency conducted a survey online to seek the views of the public on issues to do with genetic modification. This was to derive detailed understanding from stakeholders and to gain that knowledge from their views on the changes proposed, challenges gaps or any further recommendations that may be inclusive The stakeholder who made the consultation a success include customers/public, health experts, members of the board from different industries, legal experts. Although some respondents provided a mixed reaction (Zanabria 2018).
World Trade Organization issued a notification during the consultation which provided Canada’s international trading partners with the opportunity to provide comments on proposed regulatory requirement standards.
There was strong support received for
-Repealing the standards of production and doing away with the processing of genetically modified crops during processing of oil, starch, proteins, and other chemical elements.
-Inspecting on any import or export in and out of the country to ensure human safety.
-Maintaining the status quo for cereal grains and other crops.
-Allowing processed products to be labeled according to the set standards of Food and Drugs Regulations.
– Not advocating for genetic engineering labs being established in the country as some productions could pave into the markets.
Regulatory cooperation
Federal Responsibilities
FDA and FDR are the agencies tasked to establishing a standard for safety and nutritional quality of food, enforced by the Canadian Food Inspection Agency (CFIA).
International
Currently, there is no international standard when it comes to manufacturing of industrial processes; some countries still allow engineered genetic products and do not have enough regulations to control how manufacturing industries operate. With the proposed amendments, all imports will be required to comply with the proposed regulatory requirements.
Rationale
Proposed amendments directed to Food and Drug Regulation will enable the Government of Canada to plan well for its citizens and achieve its goals of securing people’s health and safety.
Implementation, enforcement and service delivery
The proposed amendments will come into effect after they are registered and published in the Canadian Gazette. The new transition period will be adopted as soon as the above requirements expire. CFIA operational procedure will be amended to ensure ongoing monitoring and inspection of both domestic and imported products comply with the country regulations.
Contacts
Consumer Protection and Market
Fairness Division
Director
Kathy Twardek
Canadian Food Inspection Agency
1400 Merivale Road,
Canada, Ontario
K1A0Y9
Telephone: 613-773-5489
Fax: 613-773-5489
References
Anderson, P. A., Nassr, A., Currier, B. L., Sebastian, A. S., Arnold, P. M., Fehlings, M. G., … & Riew, K. D. (2017). Evaluation of adverse events in Total disc replacement: a meta-analysis of FDA summary of safety and effectiveness data. Global spine journal, 7(1_suppl), 76S-83S.
Franco-Arellano, B., Bernstein, J. T., Norsen, S., Schermel, A., & L’Abbé, M. R. (2017). Assessing nutrition and other claims on food labels: a repeated cross-sectional analysis of the Canadian food supply. BMC Nutrition, 3(1), 74.
Kim-Hellmuth, S., Bechheim, M., Pütz, B., Mohammadi, P., Nédélec, Y., Giangreco, N., … & Boor, P. (2017). Genetic regulatory effects modified by immune activation contribute to autoimmune disease associations — nature Communications, 8(1), 266.
Mikulsen, M., & Diduck, A. P. (2016). Towards an integrated approach to disaster management and food safety governance. International Journal of Disaster Risk Reduction, 15, 116-124.
Racicot, M., Zanabria, R., Leroux, A., Ng, S., Cormier, M., Tiwari, A., … & Holley, R. (2018). Quantifying the impact of food safety criteria included in the Canadian Food Inspection Agency risk assessment model for food establishments through Expert Elicitation. Food control, 92, 450-463.
Van Tassel, D., O’Reilly, J. T., Johnson III, J. F., & Asebey, E. (2016). Food and Drug Law. Food and Drug Law, in Developments in Administrative Law & Regulatory Practice, 344-381.
Waltz, E. (2017). First genetically engineered salmon sold in Canada. Nature News, 548(7666), 148.