SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005

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1 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 COVANCE LABORATORIES INC. 55 East Hamblin Ave. Battle Creek, MI Hollis Cloninger Phone: BIOLOGICAL Valid to: August 31, 2019 Certificate Number: In recognition of the successful completion of the A2LA evaluation process (including an assessment of the laboratory's compliance with the A2LA Food Testing Program Requirements, containing the 2015 AOAC International Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements and Pharmaceuticals ), accreditation is granted to this laboratory to perform the following tests on food and dietary supplements: Test Method Test and Technology Test Method Reference Quantitative Microbiology MP-APCPET Aerobic Plate Count by Petrifilm AOAC , AOAC (Modified) MP-APC Aerobic Plate Count Maturin, L., and Peeler, J.T., Chapter 3- Aerobic Plate Count, Bacteriological Analytical Manual, Eighth Ed., Revision A., U.S. Food and Drug Administration: Silver Spring, MD (1998) Revised Jan (Modified). MP-BCMYP Bacillus cereus Counts by BAM Tallent, S. M. Rhodehamel, E.J., Harmon, S. M., and Bennett, R. W., Chapter 14 Bacillus cereus Bacteriological Analytical Manual, Eighth Ed., Revision A, U.S. Food and Drug Administration: Silver Spring, MD (1998). Revised Feb MP-ECMPN Coliform/Escherichia coli MPN Feng, P., Weagant, S. D., Grant, M. A., and Burkhardt, W., Chapter 4 Enumeration of Escherichia coli and the Coliform Bacteria, Bacteriological Analytical Manual, Eighth Ed., Revision A, U. S. Food and Drug Administration: Silver Spring, MD (1998), Revised Feb (Modified). (A2LA Cert. No ) 10/31/2017 Page 1 of 6

2 MP-ECMPN (cont) Coliform/Escherichia coli MPN Blodgett, R., Appendix 2: Most Probable Number from Serial Dilutions, Bacteriological Analytical Manual, Eighth Ed., Revision A, U. S. Food and Drug Administration: Silver Spring, MD (1998), Revised Oct Powers, E. M., and Latt, T. G., Simplified 48-hour IMVic Test: An Agar Plate Method, Applied and Environmental Microbiology 34 (3): (1977). MP-ECPET Coliform/E. coli Plate Count by Petrifilm AOAC MP-COLIPET Coliform Plate Count by Petrifilm AOAC: , MP-ENTPET Enterobacteriaceae Count by Petrifilm AOAC MP-SABP Staphylococcus aureaus (Baird-Parker) Bacteriological Analytical Manual online, Staphylococcus aureus, Chapter 12 Food and Drug Administration, AOAC International: Gaithersburg, Maryland (January 2001). MP-SAPET S. aureaus Plate Count by Petrifilm AOAC: , MP-YM_SPRD Yeast and Mold Counts(Compendium) Compendium of Methods for the (Compendium) Examination of Foods, Yeasts and Molds, 4 th Edition, Chapter 20, American Public Health Association: Washington D.C., (2001). MP-YMPET Yeast and Mold Counts by Petrifilm AOAC (A2LA Cert. No ) 10/31/2017 Page 2 of 6

3 Qualitative Microbiology MP-ALG_ELISA Allergen Residue by ELISA Neogen Veratox MP-EO157BAX E. coli by BAX PCR Detection United States Department of Agriculture, MLG 5A.02, FSIS Procedure for the use of Escherichia coli O157:H7 Screening Tests, USDA-FSIS: Washington, DC (01 Oct. 2010) Chemists, RI Certificate No , BAX System PCR Assay for Screening E. coli O157:H7 MP and the BAX System MP media, AOAC Research Institute: Dupont Qualicon BAX System User Guide, Part Number 2CQ v2.7, Dupont Qualicon, Wilmington, DE, USA Institute: Chemists, RI Certificate No , BAX System PCR Assay for Screening E. coli O157:H7 MP and the BAX System MP media, AOAC Research Institute: Dupont Qualicon BAX System User Guide, Part Number 2CQ v2.7, Dupont Qualicon, Wilmington, DE, USA MP-EO157VIDAS E. coli by ELFA Method Association Francaise de Normalisation (AFNOR), NF Validation Certificate. BIO 12/25-05/09, VIDAS UP E. coli O157 including H7 (VIDAS ECPT), Ref. EN ISO 16654, AFNOR: France AOAC RI Validated Protocol (A2LA Cert. No ) 10/31/2017 Page 3 of 6

4 MP-LMONATLAS MP-LISTBAX MP-LISTVIDAS MP-LMONCONF Listeria monocytogenes Detection by Atlas Listeria species and Listeria monocytogenes by BAX PCR Detection Listeria species and L. monocytogenes by ELFA method Listeria species and L. monocytogenes Confirmation Detection by Atlas Chemists, Research Institute Performance Tested Method No , AOAC Research Institute: Chemists, Research Institute Performance Tested Method No , AOAC Research Institute: FSIS Procedure for the Use of a Listeria monocytogenes by BAX Listeria monocytogenes Polymerase PCR Detection Chain Reaction (PCR) Screening Test MLG 8A.04, USDA Microbiological Laboratory Guidelines, 03 Aug Dupont Qualicon BAX System User Guide, Part Number 2CQ V3.3, FSIS Procedure for the Use of a L. monocytogenes and Listeria monocytogenes Polymerase by ELFA method Chain Reaction (PCR) Screening Test MLG 8A.04, USDA Microbiological Laboratory Guidelines, 03 Aug AOAC: , , AOAC RI Validated Protocol Isolation and Identification of L. monocytogenes Confirmation Listeria monocytogenes from Red Meat, Poultry, Egg and Environmental Samples MLG 8.07, USDA Microbiological Laboratory Guidelines. 03 Aug 2009 Bacteriological Analytical Manual, 8th Edition, Revision A, Chapter 10. Detection and Enumeration of Listeria monocytogenes (A2LA Cert. No ) 10/31/2017 Page 4 of 6

5 MP-LISTATLAS Genus Listeria Species Detection by Atlas Detection by Atlas Chemists, Research Institute Performance Tested Method No , AOAC Research Institute: Atlas Listeria Detection Assay, Part Number PRT Rev. C, Roka Bioscience, Inc., Warren, NJ, USA Matrix Summary: Whey Protein Concentrate (WPC-80) Atlas Listeria LSP Detection Assay. Roka Bioscience, Inc., Warren, NJ, USA Matrix Summary: Low Moisture Mozzarella Cheese Atlas Listeria LSP Detection Assay. Roka Bioscience, Inc., Warren, NJ, USA MP-GLUTENRIDA S-ELISA Quantitative Test AOAC MP-SALBAX-MA Salmonella by (BAX) PCR Detection AOAC ; Dupont Qualicon BAX PCR Detection System User Guide, Part Number 2CQ V3.3, MP-MSALVIDAS Salmonella by VIDAS Official Method No , Salmonella in a Variety of Food VIDAS Salmonella (SLM) Easy Salmonella Method, Official Methods of Analysis of AOAC INTERNATIONAL [online]. (accessed 22 Jan 2013) (A2LA Cert. No ) 10/31/2017 Page 5 of 6

6 MP-SALATLAS Salmonella Detection by Atlas Chemists, by Atlas Research Institute Performance Tested Methods No AOAC. Research Institute: Gaithersburg, MD. Atlas Salmonella Detection Assay, Part Number PRT Rev. D, 2014 Roka Bioscience, Inc., Warren, NJ, USA. Matrix Summary: Dry Pet Food Kibble Atlas Salmonella SEN Detection Assay. Roka Bioscience, Inc., Warren, NJ, USA. Matrix Summary: Whey Protein Concentrate (WPC-80) Atlas Salmonella SEN Detection Assay. Roka Bioscience Inc. Warren, NJ, USA. Matrix Summary: Low Moisture Mozzarella Cheese Atlas Salmonella SEN Detection Assay. Roka Bioscience, Inc. Warren, NJ, USA Matrix Summary: Deproteinized Whey Powder Atlas Salmonella SEN Detection Assay. Roka Bioscience, Inc., Warren, NJ, USA. Matrix Summary: Instant 90 Whey Protein Powder Atlas Salmonella SEN DetectionAssay. Roka Bioscience, Inc., Warren, NJ, USA. (A2LA Cert. No ) 10/31/2017 Page 6 of 6

Accredited Laboratory A2LA has accredited COVANCE LABORATORIES INC.

Standard ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories.

This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint

7 Accredited Laboratory A2LA has accredited COVANCE LABORATORIES INC. Battle Creek, MI for technical competence in the field of Biological Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories. This laboratory also meets the requirements of A2LA R204 - Specific Requirements - Food and Pharmaceutical Testing Laboratory Accreditation Program. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communiqué dated 8 January 2009). Presented this 31 st day of October President and CEO For the Accreditation Council Certificate Number Valid to August 31, 2019 For the tests to which this accreditation applies, please refer to the laboratory s Biological Scope of Accreditation.

SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005. COVANCE LABORATORIES INC Wright St Madison, WI Hollis Cloninger Phone:

SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 COVANCE LABORATORIES INC. 2102 Wright St Madison, WI 53704 Hollis Cloninger Phone: 608 210-5501 BIOLOGICAL Valid To: November 30, 2017 Certificate Number: 2918.05