Download Fact Sheet on Livestock Cloning in the United States

Fact Sheet on Livestock Cloning in the United States Livestock cloning is being commercialized around the world Today, producers use livestock cloning for several reasons, including the following: a. To improve product safety and quality by distributing superior genotypes more broadly b. For improved animal health and reducing environmental impact of livestock production by selecting the healthiest animals, improving feed efficiency and reducing environmental impact c. “Rescuing” genetics lost due to early death or an animal health event d. Adding to the gene pool by cloning steers, barrows, or geldings for reproductive purposes. Commercial cloning entities exist in the United States, Argentina, Brazil, Australia, South Africa, Canada, South Korea and China. ViaGen, Trans Ova Genetics and Bovance produce cloned livestock in the U.S. Our companies produce cloned animals (cattle, pigs, and horses) for clients; we do not own or manage the clones or their offspring. A client contracts for our services to produce a genetic copy of the donor animal and we deliver the animal to them at 30‐90 days of age, depending on species. The products from cloned animals and their offspring are safe The U.S. Food and Drug Administration (FDA) risk assessment clearly states: “Thus, edible products from healthy clones that meet existing requirements for meat and milk in commerce pose no increased food consumption risk(s) relative to comparable products from sexually‐derived animals. “Edible products derived from the progeny of clones pose no additional food consumption risk(s) relative to corresponding products from other animals based on underlying biological assumptions1, evidence from model systems2, and consistent empirical observations3.” The European Food Safety Authority4 scientific opinion states: “There is no indication that differences exist in terms of food safety for meat and milk of clones and their progeny compared with those from conventionally bred animals. Such a conclusion is based on the assumption that meat and milk are derived from healthy animals which are subject to relevant food safety controls.” This safety determination is reinforced by other scientific opinions, including NAS 20025, New Zealand Food Safety Authority6, and Japan’s Food Safety Commission7 1
FDA Risk Assessment, Chapter 1: Executive Summary pages 14‐15: “for health of progeny animals (explained in Chapter IV) is that passage through the process of creating the cells that ultimately become ova and sperm naturally resets epigenetic signals for gene expression, and effectively “clears” the genome of incomplete or inappropriate signals.” 2
FDA Risk Assessment, Chapter 1: Executive Summary page 15: “This assumption has been supported by empirical evidence in the mouse model system, which clearly indicates that phenotypic alterations noted in the parent clones are not passed to their sexually‐derived progeny.” 3
FDA Risk Assessment, Chapter 1: Executive Summary page 15: “Detailed observations of the progeny of bovine and swine clones demonstrate that these progeny are born healthy, develop normally, and do not exhibit any of the anomalies observed in clones. One extensive dataset on the progeny of swine clones providing direct data on the composition of their meat indicates that these animals are essentially indistinguishable from the comparable progeny of non‐clone animals.” 4
http://www.efsa.europa.eu/en/ahawtopics/topic/cloning.htm 5
National Academies of Science and National Research Council. Animal Biotechnology ‐ Science‐Based Concerns. 2002. Washington, DC, National Academies Press. http://www.nap.edu/openbook.php?isbn=0309084393 6
http://www.nzfsa.govt.nz/policy‐law/publications/policy‐statements/food‐cloned‐animals/food‐from‐cloned‐animals‐final.htm 7
http://www.fsc.go.jp/english/evaluationreports/hy_abstract_clone.pdf 1 10/18/2010 The offspring of cloned animals are not clones; there is no reason to track them or exclude them from the food supply A clone has the same genetic material as the original animal. The offspring of a clone is the result of a conventional sexual mating5, whether that mating be natural or using assisted reproductive technology (artificial insemination, ET, IVF). This mating results in the sharing of genetic material between the two parents that create the offspring. The fact does not change whether you are talking about the first generation, the second generation or the tenth generation offspring produced from a cloned animal. The U.S. FDA has found no reason to regulate, while USDA requests a continued voluntary moratorium The U.S. Food and Drug Administration (FDA), during the development and review of its risk assessment on the safety of foods from cloned animals and their offspring, requested all U.S. livestock cloning companies voluntarily withhold the products of clones from commercial markets. At the completion of the risk assessment in 2008, FDA determined there was no need to regulate and lifted the voluntary moratorium. However, the U.S. Department of Agriculture (USDA) requested the industry continue to abide by this “voluntary moratorium” on products from clones entering the marketplace during a transition period to broader commercialization. The offspring (progeny) of clones are specifically excluded from the voluntary moratorium. We continue to comply with this request. Our Supply Chain Management program is stronger than a “voluntary moratorium” In December 2007, ViaGen and Trans Ova Genetics announced a Supply Chain Management (SCM) program for our cattle and pig clones. The SCM program was developed in consultation and cooperation with all segments of the food industry. The program includes the components of identification and registration, education, affidavits, and a marketing incentive. While USDA has not publicly referenced the voluntary moratorium in over two years, the SCM program, which is formal and supported by the U.S. livestock and meat industries, recognizes the USDA request. The SCM program is stronger than the voluntary moratorium alone because it requires identification and registration of the cattle or pig clones, and includes the marketing incentive. Identification allows for a meat or milk processor to query the online registry to see if the animal in question is a clone, and to segregate that animal from meat or milk products if that is the company’s desire. The identification portion of the SCM program also receives annual auditing by USDA’s Agricultural Marketing Service as part of a Process Verified Program (PVP) claim maintained by ViaGen. Our companies also collect a deposit when a client contract is signed. This provides a strong incentive for the client to market or dispose of the animal appropriately. When the clone has died or reached the end of its reproductive life, the animal may be euthanized, butchered for personal consumption, or sold to a company for whom the clone status is not an issue. When proper documentation is submitted to Bovance, Trans Ova or ViaGen that the animal has been dealt with appropriately, the deposit is returned to the client. The deposit is roughly twice the average value of a cull cow/bull or cull sow/boar in order to provide a strong incentive to the owner. How is cloning applied in the U.S.? Today, producers are using livestock cloning for several reasons, including to improve product safety and quality by distributing superior genotypes more broadly; for improved animal health and reducing the environmental impact of livestock production by selecting the healthiest animals. This improves 2 10/18/2010 feed efficiency and reduces impact on the environment; “rescuing” genetics lost due to early death, an animal health event, or injury, and adding to the gene pool by cloning steers, barrows, or geldings for reproductive purposes. Specific examples on the value achieved by the use of this technology in the different segments include the following: Cloning and Pig Improvement The pork industry is built upon a genetic foundation continually improved through managed breeding programs. Pork producers benefit from a steady supply of superior genotypes selected for optimal production, meat quality and economic return. Packers and processors have access to consistent, high quality products tailored to meet consumer needs and pocketbooks. The existence of technically sophisticated approaches to breeding is a reflection of the biology of pigs, i.e. short gestation periods, heavy reliance on assisted reproductive technology, and multiple offspring per pregnancy. Additionally, the integrated nature of the production industry provides economies of scale that can bear the cost of paying for technology driven breeding programs. The value of cloning to the commercial pig industry is in the ability to use truly elite animals that exist in every program as commercial sires rather than as grandparents of commercial sires, i.e. to reduce the genetic lag between the top of the pyramid and the base of the pyramid. By identifying the few boars whose performance places them in the top 1% of all boars each year and cloning them, adding value across a wider population of progeny for producers. Genomic Selection and Cloning – Impact on the Dairy Industry Selection for economically important traits in plants and animals is usually achieved by evaluating performance of the progeny of individuals produced in the breeding program. Breeders have worked for years to increase the accuracy of selection through the use of DNA markers. The impact has been limited, in large part due to the limited number of markers available. The ability to sequence entire genomes quickly and efficiently has increased the number of DNA markers that can be used and, in dairy particularly, is set to have a major impact on dairy breeding. The ability to accurately determine the breeding value of an animal at birth creates the opportunity to radically reduce the genetic lag in dairy. Rather than having to wait until a bull is five or six years old before estimating his genetic merit, bulls will be DNA tested at birth and a molecular breeding value assigned. Dairy breeders will begin to collect and sell semen from young bulls as soon as they reach sexual maturity, reducing genetic lag by four to five years. However, cloning will play an important role in enabling dairy breeders to recognize the full potential of genomic selection through the following: 1) Enabling them to select only the top few percent of bulls and thus increase genetic gain, and 2) overcoming the problem of less volume and (relatively) poor quality semen typically produced by young bulls. To gain full advantage of the ability to select early, breeders will clone the best bulls as soon as they are born and the molecular tests are completed. Semen from the cloned bulls will be available to the market one year after the original bull. Cloning Potential in Beef Currently, the technology is employed primarily by seedstock and purebred breeders to replicate animals with very high genetic merit in order to maximize the impact of those animals 3 10/18/2010 on breed performance. For example, N Bar Primrose 2424 is an Angus cow whose progeny have been among the top performers in the breed. The original genetic donor died several years ago, but her genetics remain in high demand among Angus breeders because of her proven ability to produce elite offspring. 2424 is the dam of the bull N Bar Emulation EXT, the leading sire of Angus registrations for seven consecutive years – who was cloned as well. Using embryo transfer (by collecting her embryos and transferring them to recipient cows), a single donor cow can only produce approximately 50 offspring during her breeding life. Cloning is the only reproductive method enabling breeders to multiply the best female animals and increase the impact of her genetics. Through cloning, the Angus breed will be able to continue using this highly desirable genetic line. The Angus breed provides another example of the value of cloning technology. During 2008, three recessive genetic abnormalities were identified within the breed. Many top pedigrees were found to be carriers of one or more of the negative traits and breeders began searching for alternative bloodlines to use in their programs. Three top performing Angus females (Ideal 4465 of 6807, Basin Lucy 178E, and N Bar Primrose 2424) were determined to be free of the genetic abnormalities and demand for their genetics increased significantly. An additional complication was that two of the animals, Basin Lucy 178E and N Bar Primrose 2424, were already deceased. Fortunately, their owners had stored cells of the animals and have utilized cloning. Today a copy of each has been born and delivered to their owners. Industry acceptance of the technology was illustrated as cloned heifers of each of the females mentioned (4465, 178E and 2424) were sold at elite Angus sales held in 2009 and 2010 during the National Western Stock Show in Denver, Colorado, the largest cattle show in the United States. 4 10/18/2010