Spray Dried Porcine Blood Products Are Safe Porcine Epidemic Diarrhea Virus February 11, 2014 The North American Spray Dried Blood and Plasma Producers (NASDBPP; Table 1) are committed to producing safe, high-quality blood products for use in feeds for commercial livestock and companion animals. Recent publicity concerning the transmission of Porcine Epidemic Diarrhea virus (PEDv) has resulted in questions about the potential role of spray dried porcine plasma and porcine red cells in the spread of this disease. Based on current scientific evidence, the NASDBPP concludes that properly sourced, collected and processed porcine blood and porcine blood products are safe and do not contribute to the spread of PEDv. In 1994, the NASDBPP member companies developed Good Manufacturing Practices (GMPs) to assure the proper sourcing, collecting and processing of animal blood and blood products to maintain safety. These GMPs provide multiple safeguards for the safety and quality of spray-dried blood and plasma products. The members actively support continued research into the causes and control of this and other diseases. Current scientific evidence indicates collection and manufacturing processes ensure spray dried bovine or porcine blood and bovine or porcine plasma products are safe feed ingredients. Characteristics of PED Porcine Epidemic Diarrhea virus is classified in the Coronaviridae family. Clinically, PEDv infection is similar to transmissible gastroenteritis (TGE), which is also a Coronavirus. PEDv is an RNA enveloped virus ranging in diameter from 90 to 190 nm. PEDv is stable at low temperatures in neutral ph. o 39.0 o F (4.0 o C) at ph between 5.0 and 9.0 o 98.5 o F (37 o C) at ph between 6.5 and 7.5 High temperatures inactivate PEDv o 140 o F (60 o C) for 30 min o 160 o F (71 o C) for 10 min PEDv is inactivated by most virucidal disinfectants (Pospischil et al., 2002) o sodium hydroxide (2%), o formalin (1%), o sodium carbonate (4%), o ionic and non-ionic detergents o lipid solvents such as chloroform Spray Drying has been shown to inactivate many viruses (Table 2). The NASDBPP has supported research documenting that spray drying inactivates many different viruses. Porcine Reproductive and Respiratory Syndrome virus (PRRSv) is an envelope virus with stability characteristics very similar to PEDv. Spray drying has been shown to inactivate PRRSv (Polo et al., 2005). In addition, spray drying has been shown to inactivate Pseudorabies virus (Polo et al., 2005) and Swine Vesicular Disease virus (Pujols et al., 2007). Spray dried blood products are heated to over 175 o F (80 o C) throughout substance well above temperatures shown to inactivate PEDv. 1
Spray drying is recognized by international government agencies as an effective heat treatment to inactivate PEDv. Department for Environmental, Food and Rural Affairs (DEFRA) International Disease Monitoring (IDM) team stated that spray drying and heat treatment used in the manufacture of blood products were effective to inactivate PEDv (VITT/1200 PED in USA; 24/07/2013). Many viruses do not survive in a dry environment Recent data has demonstrated that when inoculated in dry feed, PEDv did not survive past 7 days when held at room temperature. In contrast, in a liquid slurry (5 g feed mixed with 10 ml water), PEDv survived 28 days. Spray dried blood products have a moisture content of 8% and a water activity < 0.60. Typically, spray dried blood products will be held for a minimum of 7 10 days pending QA analysis with an additional 2 weeks to move through commercial channels. Depending on inventory levels and demand, typical product age will range from 1 month to 2 years. Envelope viruses, like PEDv, do not survive in dry environments; therefore, PEDv would not be expected to survive in spray dried blood products. The presence of viral genome in spray dried blood product does not mean that feeding the ingredient will transmit the disease. It is common for commercial porcine plasma to test positive for the presence of Porcine Circovirus (PCV2) DNA. However, pigs did not become infected with PCV2 when fed a diet containing high levels of porcine plasma with high titers for PCV2 DNA (Pujols et al., 2008; Shen et al., 2011; Polo et al., 2013). Rovira, 2013, released data demonstrating that pigs did not become infected when fed a diet PCR positive for PEDv. PCR testing does not reflect infectivity. Manufacturing standards: The NASDBPP has developed manufacturing standards ensuring that spray dried blood products are collected in a hygienic manner and processed in such a way to prevent contamination. Blood is collected only from healthy animals fit for slaughter for human consumption in federally inspected slaughter houses. During collection blood is immediately pumped through a closed system to a processing room isolated from the slaughter area. Blood is transported in dedicated tankers to a remote spray drying facility. Packaging material is new. In summary, envelope viruses, like PEDv, are inactivated by heat treatment and do not survive in dry environments. Spray drying has been shown to inactivate many viruses including envelope viruses. International Scientific Review Committees recognize spray drying inactivates PEDv. PCR testing for PEDv does not determine if a feed ingredient is infective. The NASDBPP has developed manufacturing standards insuring that spray dried blood products are collected in a hygienic manner and processed in such a way to prevent contamination. Spray dried porcine plasma and spray dried porcine blood cells are safe, high-quality feed ingredients for livestock and companion animal feed. 2
References: Benfield DA, Collins JE, Dee SA, Halbur PG, Joo HS, Lager KM, Mengeling WL, Murtaugh MP, Rossow KD, Stevenson GW, Zimmerman JJ. Porcine Reproductive and Respiratory Syndrome. In: Straw BE, D Allaire S, Mengeling WL, Taylor DJ, eds. Diseases of Swine, 8th ed. Ames: Iowa State University Press; 1999:201-232. DEFRA - Department for Environment, Food and Rural Affairs Veterinary & Science Policy Advice International Disease Monitoring. Reference: VITT/1200 PED in USA Date: 24/07/2013 Emerson SU, Arankalle VA, Purcell RH. Thermal stability of hepatitis E virus. J. Infect. Dis. 2005;192:930-933. House JA, House CA. Vesicular Diseases. In: Straw BE, D Allaire S, Mengeling WL, Taylor DJ, eds. Diseases of Swine, 8th ed. Ames: Iowa State University Press; 1999:327-340. Kluge JP, Beran GW, Hill HT, Platt KB. Pseudorabies (Aujeszky s Disease). In: Straw BE, D Allaire S, Mengeling WL, Taylor DJ, eds. Diseases of Swine, 8th ed. Ames: Iowa State University Press; 1999:233-246. Lukert PD, Allan GM. Porcine Circovirus. In: Straw BE, D Allaire S, Mengeling WL, Taylor DJ, eds. Diseases of Swine, 8th ed. Ames: Iowa State University Press; 1999:119-124. Martin H, Le Potier MF, Maris P. Virucidal efficacy of nine commercial disinfectants against porcine circovirus type 2. Vet J. 2008;177:388-393. Mengeling WL. Porcine Parvovirus. In: Straw BE, D Allaire S, Mengeling WL, Taylor DJ, eds. Diseases of Swine, 8th ed. Ames: Iowa State University Press; 1999:187-200. National Pork Board PED Research Update. Environmental Stability of PEDV. Project 2. Update 11-13-13. Pensaert MB. Porcine Epidemic Diarrhea. In: Straw BE, D Allaire S, Mengeling WL, Taylor DJ, eds. Diseases of Swine, 8th ed. Ames: Iowa State University Press; 1999:179-186. Polo, J., J. D. Quigley, L. E. Russell, J. M. Campbell, J. Pujols, and P. D. Lukert. 2005. Efficacy of spray-drying to reduce infectivity of Pseudorabies and PRRS viruses and seroconversion in pigs fed diets containing spray-dried animal plasma. J. Anim. Sci. 83:1933-1938. Polo, J., T. Opriessnig, K.C. O Neill, C. Rodríguez, L.E. Russell, J.M. Campbell, J. Crenshaw, J. Segalés and J. Pujols. 2013. Neutralizing antibodies against porcine circovirus type 2 in liquid pooled plasma contribute to the biosafety of commercially manufactured spray-dried porcine plasma. J. Anim. Sci. 91:2192-2198. Pospischil, A., A. Stuedli, and M. Kiupel, 2002. Update on porcine epidemic diarrhea. J Swine Health Prod. 10(2):81 85. Pujols, J. R. Rosell, L. Russell, J. Campbell, J. Crenshaw, E. Weaver, C. Rodriguez, J. Rodenas, and J. Polo. 2007. Inactivation of swine vesicular disease virus in porcine plasma by spraydrying. Proc. Amer. Assoc. Swine Vet., p 281-283. 3
Pujols, J., S. Lopez-Soria, J. Segalés, M. Fort, M. Sibila, R. Rosell, D. Solanes, L. Russell, J. Campbell, J. Crenshaw, E. Weaver, and J. Polo. 2008. Lack of transmission of porcine circovirus type 2 to weanling pigs by feeding them spray-dried porcine plasma. Vet. Rec. 163:536-538. Royer RL, Nawagigul P, Halbur PG, Paul PS. Susceptibility of porcine circovirus type 2 to commercial and laboratory disinfectants. J Swine Health Prod. 2001;9:281-284. Rovira, A. 2013. Porcine Epidemic Diarrhea Virus Bioassay. Center for Veterinary Medicine. University of Minnesota. Saif LJ, Wesley RD. Transmissible Gastroenteritis and Porcine Respiratory Coronavirus. In: Straw BE, D Allaire S, Mengeling WL, Taylor DJ, eds. Diseases of Swine, 8th ed. Ames: Iowa State University Press; 1999:295-326. Shen, H.G., S. Schalk, P.G. Halbur, J.M. Campbell, L.E. Russell and T. Opriessnig. 2011. Commercially produced spray-dried porcine plasma contains high levels of porcine circovirus type 2 (PCV2) DNA but did not transmit PCV2 when fed to naïve pigs. J. Anim. Sci. 89:1930-1938. Van Oirschot JT. Classical Swine Fever (Hog Cholera). In: Straw BE, D Allaire S, Mengeling WL, Taylor DJ, eds. Diseases of Swine, 8th ed. Ames: Iowa State University Press; 1999:159-172. Welch J, Bieneck C, Gomperts E, Simmonds P. Resistance of porcine circovirus and chicken anemia virus to virus inactivation procedures used for blood products. Transfusion. 2006;46:1951-1958. 4
Table 1. North American Spray Dried Blood and Plasma Protein Producers Company APC, Inc Hemotech Sonac USA Merrick s, Inc. Proliant Sanimal, Inc. Address 2425 SE Oak Tree Ct Ankeny, IA 50021 601 Carlson Pkwy. Suite 400 Minnetonka, MN 1299 E Maple St, Maquoketa, IA 52060 654 Bridge St. P.O. Box 99 Union City, WI 53962 2425 SE Oak Tree Ct Ankeny, IA 50021 9900 6e Rue Montreal, Quebec H1C 1G2 5
Table 2. Thermal and solvent resistance of select swine viruses Thermal Solvent Virus Family Genome Envelope Size (nm) resistance resistance PRRSV Arterividae ssrna Yes 50-65 + + PRV Herpesviridae ssdna Yes 150-180 + + PEDV Coronaviridae ssrna Yes 90-190 + + TGEV Coronaviridae ssrna Yes 60-160 + + CSFV Flaviviridae ssrna Yes 40-50 ++ + FMDV Picornaviridae ssrna No 22-30 ++ ++ SVDV Picornaviridae ssrna No 22-30 +++ ++++ Hepatitis E Hepeviridae ssrna No 32-34 +++ ++++ PPV Parvoviridae ssdna No 18-26 ++++ ++++ PCV2 Circoviridae ssdna No 17 ++++ ++++ As number of + increases, the degree of thermal or solvent resistance of the virus increases. List of references: Disease of Swine, 8 th ed., Chapters: 8, 14, 16, 17, 18, 19, 24, 25; Emerson et al., 2005; Martin et al., 2008; Welch et al., 2006; Royer et al., 2001. 6