Nanotechnology, Impact on Animal Drugs and Feeds. Dragan Momcilovic, DVM, PhD, DACT Center for Veterinary Medicine AAFCO August 2, 2008

Transcription

1 Nanotechnology, Impact on Animal Drugs and Feeds Dragan Momcilovic, DVM, PhD, DACT Center for Veterinary Medicine AAFCO August 2, 2008

2 Woodrow Wilson Center for International Scholars WASHINGTON Few domestic policy areas that the new administration must address will have greater long-range consequences than nanotechnology a new technology that has been compared with the industrial revolution in terms of its impact on society. If the right decisions are made, nanotechnology will bring vast improvements to almost every area of daily living. If the wrong decisions are made, the American economy, human health and the environment will suffer.

3

4 There's Plenty of Room at the Bottom An Invitation to Enter a New Field of Physics by Richard P. Feynman

5

6 ~2nm

7 Nanogold

8 Introduction Outline Terminology Size that matters Definition Examples of nanoparticles CVM s role New animal drug approval process Technical sections for an animal drug approval Animal feeds Technical sections for a food additive petition Type of product - feeds Summary

9 Terminology Nanotechnology The study of phenomena and manipulation of materials at atomic, molecular and macromolecular scales, where properties differ significantly from those at a larger scale Nanoscale Having one or more dimensions of the order of 100 nm or less Nanoparticle Particle with one or more dimensions at the nanoscale.

10 Size that matters A nanometer is a billionth of a meter A human hair is about 80,000 nanometers in width

11 1x10-9 m v 1x10 9 m 1x10-9 m 1x10 9 m 1m

12 1x10 9 m 0.38x10 9 m 1x10 9 m

13 1x10-9 m - 1x10-7 m nm

14 Size that matters Definition: NNI definition: Nanotechnology is the understanding and control of matter at dimensions of roughly 1 to 100 nanometers, where unique phenomena enable novel applications

15 1x10-9 m - 1x10-7 m nm

16 1x10-9 m - 1x10-7 m Glucose ~1nm Parvovirus ~26nm Rotavirus ~60-80nm nm

17 Examples of Nanoparticles nanotubes

18 Micro-GC nanotube sensor array Nature 452, 904 (17 April 2008)

19 Examples of Nanoparticles nanotubes fullerenes quantum dots

20 Renal clearance of quantum dots Kidney elimination Organic coating ZnS CdSe <5.5 nm >5.5 nm Liver elimination nm nm Choi et al., Nature Biotechnology. 25:

21 What does CVM do? CVM is responsible for assuring that animal drugs and medicated feeds are safe and effective and that food from treated animals is safe to eat

22 CVM Drug Feed Medicated Feed Animals Humans

23 Drug Approval To have an approved animal drug means that: Product is safe and effective for intended use The methods, facilities, and controls used for the manufacturing, processing, and packaging of the drug are adequate to preserve its identity, strength, quality, and purity NADA = New Animal Drug Application

24 The Federal Food, Drug, and Cosmetic Act mandates that a new animal drug may not be sold in interstate commerce unless it is the subject of a New Animal Drug Application (NADA)

25 Technical sections for an Animal Drug Approval Effectiveness Target Animal Safety Human Food Safety Chemistry, Manufacturing, and Controls Environmental Assessment Labeling Freedom of Information Summary

26 Effectiveness Same effectiveness criteria as conventional drug: substantial evidence of effectiveness Independent substantiation Inferential value This may include laboratory and field studies Also use information from effectiveness studies for safety evaluations

27 Target Animal Safety Same overall safety criteria must show drug is safe when used as labeled Additional variables/procedures in TAS studies may be necessary for a specific product (based on pilot work, published literature on similar product/nanomaterial nanomaterial)

28 User Safety Any unique concerns to humans who administer the product to animals? Contact with animal drug product before administration, during administration, and after administration Veterinarian, animal owner, and others that may contact treated animal

29 Human Food Safety If drug for food animal, must show when animal products are safe for human consumption May require new detection methods for determining tissue residues Toxicology need appropriate assays and studies

30 Human Food Safety Slaughter Authorizations (pre-approval) Only applies to animals used in studies that will enter the food supply Need to provide information to support a request Authorizations and withdrawal times based on available data

31 Chemistry, Manufacturing, and Controls Ensure the methods, facilities, and controls used for the manufacturing, processing, and packaging of the drug are adequate to preserve its identity, strength, quality, and purity Need to confirm formulation May need new methods Validate methods for determining particle attributes in formulation Methods for manufacturing controls

32 Environmental May give more consideration to a product before determining if an EA is necessary or granting categorical exclusion Existing categorical exclusions (from the requirement to prepare an EA) may not apply May need more information in decision process (formulation and particle sizes) Existing test methods may need to be altered due to unique properties of some nanomaterials

33 Labeling Labeling of FDA-regulated products must be truthful, not misleading, and containing material information Current state of the science does not indicate unique safety concerns Recommendation Address on a product-by by-product basis whether labeling must or may contain information on the use of nanomaterials

34 Animal Feeds

35 Animal Feeds Generally Recognized as Safe (GRAS) Otherwise Permitted (e.g., AAFCO) Food Additive Petition (FAP)

36 Technical Sections for a Food Additive Petition Utility Target Animal Safety Human Food Safety Chemistry, Manufacturing, and Controls Environmental Safety Labeling Proposed Regulation

37 Types of Products - Feeds Medicated Feed Articles like drugs Feed Additives new platforms Toxin binding Matrix with nanomaterials Enhanced delivery of vitamins, mineral, and nutrients Packaging Antimicrobial Longer shelf life

38 Nanoproduct Drug Feed Medicated Feed Animals Humans

39 Due to a high surface area, the nanoparticles can interact strongly with all the components of the food matrix. Simon and Joner J. Food Nutr. Res. 47:51-59

40 Modernising the rules on food additives and labelling of azo dyes Nanotechnology if the production process of an additive is changed, for example via a change in particle size through nanotechnology, a fresh authorization process, including a safety evaluation, must be carried out IPR false/default_en.htm

41 Summary Overall premarket approval process is similar to a conventional drug, but the use of nanoscale materials in animal drugs does present new issues New methods, validate existing methods Methods may be product specific Current regulations allow CVM to consider the potential novel properties of products containing nanoscale materials May issue new guidance as appropriate

42 JC Meyer et al. Nature 454, (2008) doi: /nature07094