{"id":363,"date":"2024-11-21T21:17:39","date_gmt":"2024-11-21T21:17:39","guid":{"rendered":"https:\/\/blogs.cdfa.ca.gov\/CFRP\/?p=363"},"modified":"2024-11-21T21:17:39","modified_gmt":"2024-11-21T21:17:39","slug":"innovative-products-update-and-labeling-and-use-of-bovaer10-in-california","status":"publish","type":"post","link":"https:\/\/blogs.cdfa.ca.gov\/CFRP\/index.php\/2024\/11\/21\/innovative-products-update-and-labeling-and-use-of-bovaer10-in-california\/","title":{"rendered":"Innovative Products Update and Labeling and Use of Bovaer\u00ae10 in California"},"content":{"rendered":"\n<p>The Commercial Feed Regulatory Program (CFRP) has released a <a href=\"https:\/\/www.cdfa.ca.gov\/is\/ffldrs\/pdfs\/NTI_Labeling_Use_of_Bovaer_10_20241104.pdf\">Notice to Industry<\/a> regarding the labeling and use of Bovaer\u00ae10 in commercial feed in California.<\/p>\n\n\n\n<p>In 2023, the U.S. Food and Drug Administration (FDA) launched an <a href=\"https:\/\/www.fda.gov\/animal-veterinary\/products\/animal-and-veterinary-innovation-agenda\">Animal and Veterinary Innovation Agenda<\/a> that has helped shape future direction for innovative products. California relies on FDA\u2019s federal review and evaluation process for these new and novel products that have demonstrated progress toward climate goals. Elanco Animal Health\u2019s Bovaer\u00ae 10 is intended for the reduction of methane emissions in lactating dairy cattle and one of the first of these innovative products that has undergone FDA review for safety and efficacy. This provides agriculture an additional tool to be part of the overall methane reduction strategy.&nbsp;&nbsp;<\/p>\n\n\n\n<p>On October 3, CDFA\u2019s Feed Inspection Advisory Board and its Technical Advisory Subcommittee met to discuss labeling and use of products with enforcement discretion from FDA, and specifically, Elanco\u2019s Bovaer\u00ae 10. They reviewed and supported the <a href=\"https:\/\/www.cdfa.ca.gov\/is\/ffldrs\/pdfs\/cfrp_process_for_evaluation_of_products_under_fda_enforcement_discretion.pdf\" data-type=\"link\" data-id=\"https:\/\/www.cdfa.ca.gov\/is\/ffldrs\/pdfs\/cfrp_process_for_evaluation_of_products_under_fda_enforcement_discretion.pdf\">CFRP\u2019s five-step process<\/a> to evaluate products\/ingredients under FDA enforcement discretion for safe and effective labeling and use in California. Regarding Bovaer\u00ae 10, they reviewed information provided to CDFA\u2019s Milk and Dairy Food Safety Branch and CFRP including the <a href=\"https:\/\/www.fda.gov\/media\/178913\/download?attachment\">FDA Center for Veterinary Medicine enforcement discretion letter to Elanco for 3-NOP<\/a>. After conducting a review of submitted information and materials, CDFA has no current objection to the sale or use of Bovaer\u00ae 10 in California, provided it adheres to California-specific labeling requirements, it is used in accordance with its labeling, and that CDFA and FDA continue to have no questions or public health concerns regarding its safety.<\/p>\n\n\n\n<p>California\u2019s climate goals include the reduction of methane emissions to 40% below 2013 levels by 2030, as codified in SB 1383 (Lara, 2016). CDFA\u2019s <a href=\"https:\/\/www.cdfa.ca.gov\/oefi\/enteric\/\">Enteric Methane Emission Reduction Programs<\/a> in the Office of Environmental Farming and Innovation are assisting the department in working towards this goal. Advancements in enteric methane reduction offer real opportunities for agricultural producers to utilize while contributing toward California\u2019s reputation as a leader in climate-smart agriculture.<\/p>\n\n\n\n<p><a id=\"_msocom_1\"><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Commercial Feed Regulatory Program (CFRP) has released a Notice to Industry regarding the labeling and use of Bovaer\u00ae10 in commercial feed in California. In 2023, the U.S. Food and Drug Administration (FDA) launched an Animal and Veterinary Innovation Agenda that has helped shape future direction for innovative products. California relies on FDA\u2019s federal review and evaluation process for these &hellip;<\/p>\n<div class=\"m-y-md text-right\"><a href=\"https:\/\/blogs.cdfa.ca.gov\/CFRP\/index.php\/2024\/11\/21\/innovative-products-update-and-labeling-and-use-of-bovaer10-in-california\/\" class=\"btn btn-primary\" aria-label=\"Continue reading the blog post...\">Read More<\/a><\/div>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[45,44],"tags":[49,5,74],"class_list":["post-363","post","type-post","status-publish","format-standard","hentry","category-commercial-feed","category-notice-to-industry","tag-commercial-feed","tag-guidance","tag-labeling"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/blogs.cdfa.ca.gov\/CFRP\/index.php\/wp-json\/wp\/v2\/posts\/363","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.cdfa.ca.gov\/CFRP\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.cdfa.ca.gov\/CFRP\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.cdfa.ca.gov\/CFRP\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.cdfa.ca.gov\/CFRP\/index.php\/wp-json\/wp\/v2\/comments?post=363"}],"version-history":[{"count":2,"href":"https:\/\/blogs.cdfa.ca.gov\/CFRP\/index.php\/wp-json\/wp\/v2\/posts\/363\/revisions"}],"predecessor-version":[{"id":367,"href":"https:\/\/blogs.cdfa.ca.gov\/CFRP\/index.php\/wp-json\/wp\/v2\/posts\/363\/revisions\/367"}],"wp:attachment":[{"href":"https:\/\/blogs.cdfa.ca.gov\/CFRP\/index.php\/wp-json\/wp\/v2\/media?parent=363"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.cdfa.ca.gov\/CFRP\/index.php\/wp-json\/wp\/v2\/categories?post=363"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.cdfa.ca.gov\/CFRP\/index.php\/wp-json\/wp\/v2\/tags?post=363"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}