Registration of New and Novel Feed Products in Canada: A Practical Perspective

Transcription

1 Registration of New and Novel Feed Products in Canada: A Practical Perspective Ag West Bio Plant Bioindustrial Oils Workshop March 6,7, 2013 Dr. Colleen Christensen, Executive Director Feeds Innovation Institute University of Saskatchewan Connecting technology to value-added to create economic impact.

2 Objective: To provide an overview of how feeds are registered in Canada a) Context of the registration system b) Nomenclature c) Steps of the process d) Actual examples (of what to do and what not to do!) e) Costs f) Timelines To keep your attention!

3 Overview of the CFIA THE CFIA'S LEGISLATIVE AUTHORITY CFIA Wide Agriculture and Agri-Food Administrative Monetary Penalties Act Canadian Food Inspection Agency Act Food Canada Agricultural Products Act Consumer Packaging and Labelling Act (as it relates to food) Fish Inspection Act Food and Drugs Act (as it relates to food) Meat Inspection Act Plant Fertilizers Act Plant Breeders' Rights Act Plant Protection Act Seeds Act Animal Health of Animals Act Feeds Act Seeds Act

4 Overview of the CFIA Minister of Agriculture Canadian Food Inspection Agency Minister of Health Health Canada (Human food) Food Plant Animal Harmonization between offices a) Plants with Novel Traits (PNT) packages submitted to the Plant Biotech Office (PBO) are sent to the Feeds Division and Health Canada for review Examples of shared activities a) Human health claims are vetted by Health Canada (omega 3 in feed requesting milk or egg claims) b) Tolerance level, toxicity level calculations by Health Canada

5 Animal Feed Division (CFIA), Bilateral Meetings, RDIMS # v4 Feed Regulatory Renewal CFIA s Interests - Feed Program contributes to all three of Agency s strategic outcomes CFIA is also administrator, enforcer and change agent of Regulations. Control of livestock feed contributes to safety of food products (meat, milk and eggs) Feeds must be nutritionally sound and safe for animals to consume Safe / Sustainable Plant & Animal Resource Base Public Health Risks Minimized / Managed Consumer Protection / Market Access Control of livestock feed contributes to zoonotic disease transmission prevention (e.g. BSE) Feed labelling requirements contribute to consumer protection no false claims, product must be fit for purpose

6 Feeds Nomeclature Oilseed meals are ingredients Ingredients can be new or novel, but plant bioindustrial oilseed meals will always be classified as novel Schedule IV and V The intended uses of bioindustrial oilseed meals can either be as a protein source or an energy source

7 Options to register bioindustrial oilseed meals Research Exemption then Ingredient Registration is for an ingredient not a mixed or complete feed

8 New vs Novel New = category 2 e.g. binders, amino acids, minerals Novel = category 3 e.g. new bioindustrial oilseed meals

9 Novel Feed Definition Novel feeds from plant sources include any plants and products/by-products derived there from that: are not approved as livestock feed in Canada (not listed in Schedule IV or V of the Feeds Regulations) e.g. papaya; and/or contain a novel trait e.g. herbicide tolerant soybean

10 Schedules IV and V Schedules IV and V of the Feeds Act list all of the approved feed ingredients in Canada Schedule IV lists feed ingredients, minerals, additives; Schedule V lists flavourings Schedules IV and V are listed on Justice Canada s website as they are legislature An up to date list can be obtained from the Feeds Division December 2012 list has 162 pages with ~ 10 ingredients/page The EU and the USA have similar lists

11 Protein Source vs. Energy Source All animal diets contain 5-10 ingredients, including minerals, vitamins, medications When nutritionists are planning/formulating a diet they consider plant feed ingredients as either a source of energy for the animal or a source of protein Your bioindustrial oilseed meal will almost always be a protein source if it is a hexane extracted meal and the protein content is 32-42% protein and it is used at an incorporation rate < 20% *** protein content, fat content, fiber content and incorporation rate

12 Steps of the Process All information needed to register a feed is in Regulatory Guidance #1 RG read the other related CFIA documents (e.g. camelina guidance document) My intention: pass on practical tips to speed up the process minimize wasted efforts and cost

13 Regulatory Pipeline Trends Increase in the number of Canadian field trials for PNTs, many of which could be novel feeds Source: CFIA-Animal Feed Division Update for CAHPRAC April 27th, 2010

14 Average # Of Days Under Review Average # Of Days On Hold Regulatory Pipeline Trends 2009 average is 291 days under review with an additional 144 days on hold for info requests Avg. time under review, avg. time on hold, and % of submissions that required additional info requests have all increased in the past 3 years novel feed requests in 2011 Source: CFIA-Animal Feed Division Update for CAHPRAC April 27th, 2010

15 Steps of the process Review the website information and write out as much information as you have and as many questions as you have Go to Ottawa and meet with the portfolio managers pre submission consultation phase Obtain a research exemption ($450 + tax) *Need chemistry and a literature review Do all of your animal experiments Write up the whole package Apply for approval ($400 + tax)

16 Novel Feed Ingredient Approval Require both a safety and efficacy review in order to obtain approval If enough is known chemically about the makeup of your bioindustrial oilseed meal a literature review (5-20 pages) may be enough to describe the safety Otherwise, safety can also be demonstrated by feeding an animal and observing no adverse reactions Efficacy is proven by feeding an increasing doses of your bioindustrial oilseed meal and determining which level of incorporation demonstrates the optimum feed conversation (gain:feed, yeild:feed (ie. #eggs or milk yield))

17 Apply for a Research Exemption first You need an exemption to conduct animal trials to obtain the data needed for the full portfolio The information that you have written in a biology document is not the right information

18 Information for the Research Exemption Document T S2 answer all of their questions Describe your manufacturing process we are using the same process by which canola meal is made we are using food grade additives Draw a flow chart, write out the manufacturing information in 3-5 pages Regulators want to know that you know all of the details of time/temp, equipment, and all additives, do not make any assumptions regarding the regulators knowledge

19 Real example question on manufacturing additives: The CFIA Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products ( does not contain Nalco 1825 amine. However, the Reference List contains two Nalco products named, Custamine 1825 and Tri-Act Clarify if one of these two products is what you are using as a boiler chemical during the manufacturing of.. spent ~ 2 hours tracking down who might know what chemical additive was actually used. I called the CFIA employee first to determine what evidence she/he would accept as proof. A MSDS sheet was negotiated as acceptable proof of which additive was used.

20 Real example of how NOT to write My original application had a detailed description of the manufacturing process, however I had started the description with The seeds will be cleaned prior to delivery to the manufacturing facility. CFIA response: We have reviewed the manufacturing description provided It is stated that the seeds are cleaned, but it is not stated what is used to clean the seeds. Second version: During the cleaning step, all unwanted weed, seeds, or other material were removed prior to processing by physical separation. No agents were added to the seeds for cleaning.

21 Information for the Research Exemption Need to provide the chemistry from three separate lots of the new bioindustrial oilseed meal Provide Certificates of Analysis for the analyses Ensure that all possible nutrient and anti-nutritional compounds are analyzed a) Protein, fat, fiber, moisture, ash = ~ $250 x 3 b) Glucosinolates, erucic acid, sinapines, tannins, phytates = ~$ x 3 c) Your bioindustrial oilseed has a high level of?, what is the impact if an animal ingests it? (ie Russian dandelion has a high rubber and inulin content) d) Heavy metals (brassicas are hyperaccumulators), pesticide residues Describe what is in your meal, what the literature describes for your type of plant, what % you are proposing to use it at, describes the risks involved with that level (i.e. you are arguing for the safety of your product) Be clear on whether the test animals (or their milk/eggs) will go into the human food chain. If the regulators do not accept your safety assessment, the animals must be euthanized and go to the landfill Probably 5-10 pages in length

22 Real example: Sinapines in Camelina Meal The sinapine content in the cold pressed camelina meal (CPCM) ( %) is less than that published in the literature. The assay used to measure sinapine for CPCM is a NMR based assay which analyzes total phenylpropanoid choline ester content in situ (i.e. no extraction involved in protocol). In Matthaus and Angelini (2005) the sinapine content in camelina was measured by chromotography following a number of extraction steps. Utilizing the extraction assay, Matthaus and Angelini (2005) measured 7.0 mg/g of sinapine in the seed. In brown egg laying hens, sinapine is hydrolyzed and choline is converted to trimethylamine, which gives a fishy smell to the eggs (Matthaus and Angelini 2005). The incorporation rate where this taint smell occurs is at levels greater than 1g of sinapine/kg of the ration (Matthaus and Angelini 2005). There is no published literature describing an impact of sinapine on broiler performance, however sinapine does have a bitter taste. In this trial, feed intake will be monitored to determine if there are negative impacts of CPCM on palatability of the feed ration. Sinapine is only an anti-nutritional in brown egg laying hens Sinapines are not relevant to cows, pigs, broiler chickens

23 Description of the animal trial Work closely with whomever is doing the trial The animal trial does not have to occur in an academic institution, but the people conducting the trial need to know what they are doing, and create data sheets with all information (USA requires GLP and GCP, Canada does not) Describe null hypothesis, experimental design, statistical design, # of animals, stage of life, what outcomes you will be measuring, e.g. a) Feed conversion gain:feed, yield:feed b) Hormone levels (thyroid is sensitive to glucosinolates) c) Organ size (stunted growth or pathology?) d) Deads

24 Research Exemption Approval Letter Your letter will provide approval to proceed, location, dates, overview of the experimental details Give a copy of the letter to whomever is making the feed (feedmills are regularly inspected and will not want to work with your product unless you have this letter) You do not have to share the results with the CFIA, but presumably you are conducting the approval trials and you will be sharing

25 Ingredient Application Package 1/eng/ / ?1 The following items are essential in order for any application to be accepted for evaluation: Covering letter Application form Proposed product label (five copies) - All ingredients must be approved as per Schedules IV and V - Acceptable feed claims (no drug or veterinary biological claims should appear on the label) Supporting data (for Category 2 and 3 Feeds, only) Application fee Any omissions will result in the return of the submission. Every submission is screened within 10 days of receipt and if any of the above-mentioned information is missing or incorrect, the Animal Feed Division will return the complete submission package, including any fees sent, with a letter of explanation. The application package is like a thesis. Include: literature review, materials and methods, results, conclusions It will be pages long and will include copies of the raw data as well as the description of all of the scientific evidence.

26 Outcome of the application process: You will receive an approval letter Sometime that year the Schedule IV will be updated and everyone will have public access to your product description Every 3 years you ll need to renew your product registration ($40)

27 Costs Costs of doing the chemistry Costs of preparing the portfolio (often done by consultants) Cost of conducting animal trials. Product has to be fed separately to all species. Duration of trial is what would occur in a commercial setting (i.e. using the length of an animal s life) a) Beef cattle: background and finishing: $240,000 x 3 b) Dairy cattle: double square latin design: $60,000 x 3 c) Swine: grower-finisher: $120,000 x 3 d) Broilers: days: $80,000 x 3 e) Layers: 10 months: $100,000 x 3

28 Timelines Goal of this presentation: To reduce the number of days on hold. Your files will be put on hold for a period of 60 days Average # Of Days Under Review average is 291 days under review with an additional 144 days on hold for info requests Source: CFIA-Animal Feed Division Update for CAHPRAC April 27th, 2010

29 Modernization of the Feeds Division Feed Regulatory Modernization Working Group January 22/23, 2013 workshop on ingredients Second workshop on process controls/haccp etc New framework by end of April 2013 *** Jan 2013 discussion included removing the requirement for efficacy testing for low risk ingredients 1/9 recommendations from the Animal Nutrition Association of Canada d_ingredients_final.pdf Proposed situation would be similar to recent changes to fertilizer, similar to the environment prior to CFIA (i.e. rapeseed)????

30 1972 no double lows 1978 introduction of double lows

31 Conclusion Practical advice to minimize the days on hold and average registration duration Business intelligence to plan budget, timelines and fit with the rest of operations A new framework for the Feeds Division should be approved by April 2013, so get involved in the next consultation period!

32 Colleen Christensen, PhD, PAg Executive Director Feeds Innovation Institute, U of Saskatchewan Colleen.Christensen@usask.ca (306)

33 What is FII? The Feeds Innovation Institute is a commercialization centre within the College of Agriculture and Bioresources at the U of S. FII commercializes U of S research by working to develop and administer applied research networks which work closely with companies. FII commercializes UofS research infrastructure by conducting fee-for-service work in the areas of nutritional chemistry and animal performance trials.

34 What does FII do? Provide an interface between industry and academia assist in developing business processes so that successful interaction can occur Fee-for-service work service projects Research network development and administration Provide connections for industry and government to the correct university person and vice-versa!

35 FII Uniqueness Only one similar industry oriented entity within the UofS system - Business Services of Edwards School of Business No similar organizations in Western Canada GOAL To get stuff out into the real world - Achieving this goal means listening and involving industry as full partners throughout all activities