{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,9,14]],"date-time":"2023-09-14T06:44:04Z","timestamp":1694673844649},"reference-count":24,"publisher":"Wiley","issue":"s4","license":[{"start":{"date-parts":[[2012,7,25]],"date-time":"2012-07-25T00:00:00Z","timestamp":1343174400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Reprod Domestic Animals"],"published-print":{"date-parts":[[2012,8]]},"abstract":"<jats:title>Contents<\/jats:title><jats:p>Animal biotechnology represents one subset of tools among a larger set of technologies for potential use to meet increasing world demands for food. Assisted reproductive technologies (ART) such as artificial insemination and embryo transfer continue to make positive contributions in food animal production. The US Food and Drug Administration (FDA) performed a comprehensive risk assessment to identify potential food consumption or animal health risks associated with animal cloning, an emerging ART. At that time, FDA concluded that animal cloning posed no unique risks either to animal health or to food consumption, and food from animal clones and their sexually reproduced offspring required no additional federal regulation beyond that applicable to conventionally bred animals of the species examined. At this time, no new information has arisen that would necessitate a change in FDA\u2019s conclusions on food from animal clones or their sexually reproduced offspring. Use of recombinant DNA technologies to produce genetically engineered (GE) animals represents another emerging technology with potential to impact food animal production. In its regulation of GE animals, FDA follows a cumulative, risk\u2010based approach to address scientific questions related to the GE animals. FDA evaluates data and information on the safety, effectiveness and stability of the GE event. FDA carries out its review at several levels (e.g. molecular biology, animal safety, food safety, environmental safety and claim validation). GE animal sponsors provide data to address risk questions for each level. This manuscript discusses FDA\u2019s role in evaluation of animal cloning and GE animals.<\/jats:p>","DOI":"10.1111\/j.1439-0531.2012.02066.x","type":"journal-article","created":{"date-parts":[[2012,7,25]],"date-time":"2012-07-25T08:06:59Z","timestamp":1343203619000},"page":"127-133","source":"Crossref","is-referenced-by-count":0,"title":["Agency Perspectives on Food Safety for the Products of Animal Biotechnology"],"prefix":"10.1111","volume":"47","author":[{"given":"HJ","family":"Howard","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"KM","family":"Jones","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L","family":"Rudenko","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2012,7,25]]},"reference":[{"key":"e_1_2_7_2_1","volume-title":"Foods Derived From Modern Biotechnology","author":"Codex Alimentarius","year":"2009"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2006.03.014"},{"key":"e_1_2_7_4_1","unstructured":"European Food Safety Authority 2008:Food safety animal health and welfare and environmental impact of animals derived from cloning by somatic cell nucleus transfer (SCNT) and their offspring and products obtained from those animals. Available:http:\/\/www.efsa.europa.eu\/en\/efsajournal\/doc\/767.pdf. (accessed 14 November 2011)."},{"key":"e_1_2_7_5_1","unstructured":"FAO 2002:World agriculture: towards 2015\/2030 \u2013 summary report. Available:ftp:\/\/ftp.fao.org\/docrep\/fao\/004\/y3557e\/y3557e.pdf. (accessed 20 December 2011)."},{"key":"e_1_2_7_6_1","unstructured":"FAO 2008:The state of food insecurity in the world in 2008. Available:ftp:\/\/ftp.fao.org\/docrep\/fao\/011\/i0291e\/i0291e00.pdf. (accessed 21 January 2012)."},{"key":"e_1_2_7_7_1","unstructured":"FAO 2009:How to feed the world in 2050. Available:http:\/\/www.fao.org\/fileadmin\/templates\/wsfs\/docs\/expert_paper\/How_to_Feed_the_World_in_2050.pdf. (accessed 19 December 2011)."},{"key":"e_1_2_7_8_1","unstructured":"FAO.2011 World Livestock 2011: livestock in food security. Available:http:\/\/www.fao.org\/docrep\/014\/i2373e\/i2373e.pdf. (accessed 19 December 2011)."},{"key":"e_1_2_7_9_1","unstructured":"FDA 2008a:Animal cloning: a risk assessment. Available:http:\/\/www.fda.gov\/downloads\/AnimalVeterinary\/SafetyHealth\/AnimalCloning\/UCM124756.pdf. (accessed 15 December 2011)."},{"key":"e_1_2_7_10_1","unstructured":"FDA 2008b:Guidance for Industry #179 \u2013 Use of animal clones and clone progeny for human food and animal feed. Available:http:\/\/www.fda.gov\/downloads\/AnimalVeterinary\/GuidanceComplianceEnforcement\/GuidanceforIndustry\/UCM052469.pdf. (accessed 15 December 2011)."},{"key":"e_1_2_7_11_1","unstructured":"FDA 2009:Guidance for Industry #187 \u2013 Regulation of genetically engineered animals containing heritable recombinant DNA constructs. Available:http:\/\/www.fda.gov\/downloads\/AnimalVeterinary\/GuidanceComplianceEnforcement\/GuidanceforIndustry\/UCM113903.pdf. (accessed 15 December 2011)."},{"key":"e_1_2_7_12_1","unstructured":"Food Standards Australia New Zealand 2003:Review on the current status of the extent and use of cloning in animal production in Australia and New Zealand. Available:http:\/\/www.foodstandards.gov.au\/_srcfiles\/Cloning_Review_Final_June%202003.pdf. (accessed 15 November 2011)."},{"key":"e_1_2_7_13_1","unstructured":"Food Standards Australia New Zealand 2010:Food derived from cloned animals and their offspring. Available:http:\/\/www.foodstandards.gov.au\/scienceandeducation\/factsheets\/factsheets2010\/foodderivedfromclone4908.cfm. (accessed 15 November 2011)."},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1177\/003591576505800503"},{"key":"e_1_2_7_15_1","unstructured":"IETS 2008:Health assessment and care for animals involved in the cloning process. Available:http:\/\/iets.org\/pdf\/HASAC\u2010HealthAssessmentCare.pdf. (accessed 16 December 2011)."},{"key":"e_1_2_7_16_1","unstructured":"ItoY WatanabeS 2011:Characteristics of milk\/meat derived from progeny of somatic cell cloned cattle.National Institute of Livestock and Grassland Science Japan. Available:http:\/\/www.nilgs.affrc.go.jp\/pub\/shiryou\/mem\u2010nilgs11.pdf. (accessed 11 December 2011)."},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.2105\/AJPH.2004.044727"},{"key":"e_1_2_7_18_1","unstructured":"New Zealand Food Safety Authority no date:Food from cloned animals. Available:http:\/\/www.foodsafety.govt.nz\/elibrary\/industry\/Food_From\u2010Background_Research.htm. (accessed 30 November 2011)."},{"key":"e_1_2_7_19_1","volume-title":"Animal Biotechnology: Science\u2010Based Concerns","author":"NRC","year":"2002"},{"key":"e_1_2_7_20_1","volume-title":"A New Biology for the 21st Century","author":"NRC","year":"2009"},{"key":"e_1_2_7_21_1","unstructured":"One Health \u2013 One Medicine 2009:\u201cOne Health \u2013 One Medicine\u201d: linking human animal and environmental health. In:KaplanB HahnLH MonathTP(eds):Veterinaria Italiana45 9\u2013211."},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.theriogenology.2006.09.033"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1089\/1536230041372427"},{"key":"e_1_2_7_24_1","unstructured":"USDA Foreign Agricultural Service 2011:Global Agricultural Information Network Report. Available:http:\/\/gain.fas.usda.gov\/Recent%20GAIN%20Publications\/Agricultural%20Biotechnology%20Annual_Buenos%20Aires_Paraguay_7\u201018\u20102011.pdf. (accessed 15 July 2011)."},{"key":"e_1_2_7_25_1","unstructured":"WatanabeS 2011:Somatic cell cloned cattle and their progeny produced in Japan: a report for animal health and characteristics of animal products.National Institute of Livestock and Grassland Science Japan Available:http:\/\/www.nilgs.affrc.go.jp\/pub\/shiryou\/mem\u2010nilgs12.pdf. (accessed 11 December 2011)."}],"container-title":["Reproduction in Domestic Animals"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fj.1439-0531.2012.02066.x","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/j.1439-0531.2012.02066.x","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,13]],"date-time":"2023-09-13T23:45:41Z","timestamp":1694648741000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/j.1439-0531.2012.02066.x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,7,25]]},"references-count":24,"journal-issue":{"issue":"s4","published-print":{"date-parts":[[2012,8]]}},"alternative-id":["10.1111\/j.1439-0531.2012.02066.x"],"URL":"https:\/\/doi.org\/10.1111\/j.1439-0531.2012.02066.x","archive":["Portico"],"relation":{},"ISSN":["0936-6768","1439-0531"],"issn-type":[{"value":"0936-6768","type":"print"},{"value":"1439-0531","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,7,25]]}}}