{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/2.2-5503.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/2.2-5503.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/2.2-5503.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/2.2-5503.html"}],"law_id":84406,"edition_id":1,"section_id":84406,"structure_id":15529,"section_number":"2.2-5503","catch_line":"Requirements for regulated introduction","history":"1994, c. 472, \u00a7 2.1-772; 2001, c. 844.","full_text":"Except as provided under \u00a7 2.2-5502, no person may commence a regulated introduction unless the person:\n\n1\n\nProvides to the Department all of the following information within seven days after the person submits or should have submitted the information specified in subdivisions 1 a and 1 b to a federal regulator, whichever is sooner:\n\t\t\ta. A copy of all information that the person is required to submit to the federal regulator and that is not confidential information; and\n\t\t\tb. A summary of any confidential information that the person submits or is required to submit to a federal regulator. The summary shall provide sufficient information to enable the Department to exercise its notice and comment functions under &#xA7;&#xA7; 2.2-5504 and 2.2-5505, to provide public notice pursuant to &#xA7; 2.2-5504, and to prepare comments pursuant to &#xA7; 2.2-5505, and shall have minimal extraneous and irrelevant information. The summary shall also provide sufficient information to enable the locality in which the introduction is proposed to be made to exercise its comment function under &#xA7; 2.2-5505.2\n\nProvides such additional information, if any, as is necessary to enable the Department to fulfill any functions it undertakes, on a case-by-case basis, under &#xA7; 2.2-5505.","order_by":null,"text":{"0":{"id":302532,"text":"Except as provided under \u00a7 2.2-5502, no person may commence a regulated introduction unless the person:","type":"section","prefixes":[""],"prefix":"","entire_prefix":"","prefix_anchor":"","level":1,"next_prefix":"1"},"1":{"id":302533,"text":"Provides to the Department all of the following information within seven days after the person submits or should have submitted the information specified in subdivisions 1 a and 1 b to a federal regulator, whichever is sooner:\n\t\t\ta. A copy of all information that the person is required to submit to the federal regulator and that is not confidential information; and\n\t\t\tb. A summary of any confidential information that the person submits or is required to submit to a federal regulator. The summary shall provide sufficient information to enable the Department to exercise its notice and comment functions under &#xA7;&#xA7; 2.2-5504 and 2.2-5505, to provide public notice pursuant to &#xA7; 2.2-5504, and to prepare comments pursuant to &#xA7; 2.2-5505, and shall have minimal extraneous and irrelevant information. The summary shall also provide sufficient information to enable the locality in which the introduction is proposed to be made to exercise its comment function under &#xA7; 2.2-5505.","type":"section","prefixes":["1"],"prefix":"1","entire_prefix":"1","prefix_anchor":"1","level":1,"prior_prefix":"","next_prefix":"2"},"2":{"id":302534,"text":"Provides such additional information, if any, as is necessary to enable the Department to fulfill any functions it undertakes, on a case-by-case basis, under &#xA7; 2.2-5505.","type":"section","prefixes":["2"],"prefix":"2","entire_prefix":"2","prefix_anchor":"2","level":1,"prior_prefix":"1"}},"ancestry":[{"id":15529,"edition_id":1,"name":"Virginia Biotechnology Research Act","identifier":"55","label":"chapter","depth":4,"order_by":1,"parent_id":12751,"metadata":{},"date_created":"2026-06-26 03:55:59","date_modified":"2026-06-26 03:55:59","permalink":{"id":177941,"object_type":"structure","relational_id":15529,"identifier":"55","token":"2.2\/II\/B\/55","url":"\/2.2\/II\/B\/55\/","edition_id":1,"permalink":0,"preferred":1}},{"id":12751,"edition_id":1,"name":"Transaction of Public Business","identifier":"B","label":"part","depth":3,"order_by":1,"parent_id":12750,"metadata":{},"date_created":"2026-06-26 03:43:51","date_modified":"2026-06-26 03:43:51","permalink":{"id":176445,"object_type":"structure","relational_id":12751,"identifier":"B","token":"2.2\/II\/B","url":"\/2.2\/II\/B\/","edition_id":1,"permalink":0,"preferred":1}},{"id":12750,"edition_id":1,"name":"Administration of State Government","identifier":"II","label":"subtitle","depth":2,"order_by":1,"parent_id":12749,"metadata":{},"date_created":"2026-06-26 03:43:51","date_modified":"2026-06-26 03:43:51","permalink":{"id":176253,"object_type":"structure","relational_id":12750,"identifier":"II","token":"2.2\/II","url":"\/2.2\/II\/","edition_id":1,"permalink":0,"preferred":1}},{"id":12749,"edition_id":1,"name":"Administration of Government","identifier":"2.2","label":"title","depth":1,"order_by":1,"parent_id":null,"metadata":{},"date_created":"2026-06-26 03:43:51","date_modified":"2026-06-26 03:43:51","permalink":{"id":171453,"object_type":"structure","relational_id":12749,"identifier":"2.2","token":"2.2","url":"\/2.2\/","edition_id":1,"permalink":0,"preferred":1}}],"structure_contents":[{"id":59399,"structure_id":15529,"section_number":"2.2-5500","catch_line":"Purpose","url":"\/2.2-5500\/","token":"2.2\/II\/B\/55\/2.2-5500","metadata":false},{"id":62425,"structure_id":15529,"section_number":"2.2-5501","catch_line":"Definitions","url":"\/2.2-5501\/","token":"2.2\/II\/B\/55\/2.2-5501","metadata":false},{"id":59259,"structure_id":15529,"section_number":"2.2-5502","catch_line":"Exemptions from chapter to be determined by Department","url":"\/2.2-5502\/","token":"2.2\/II\/B\/55\/2.2-5502","metadata":false},{"id":84406,"structure_id":15529,"section_number":"2.2-5503","catch_line":"Requirements for regulated introduction","url":"\/2.2-5503\/","token":"2.2\/II\/B\/55\/2.2-5503","metadata":false},{"id":86467,"structure_id":15529,"section_number":"2.2-5504","catch_line":"Public notice of proposed regulated introduction","url":"\/2.2-5504\/","token":"2.2\/II\/B\/55\/2.2-5504","metadata":false},{"id":72976,"structure_id":15529,"section_number":"2.2-5505","catch_line":"Comment on proposed regulated introduction","url":"\/2.2-5505\/","token":"2.2\/II\/B\/55\/2.2-5505","metadata":false},{"id":59221,"structure_id":15529,"section_number":"2.2-5506","catch_line":"Confidential business information; Department to establish procedures","url":"\/2.2-5506\/","token":"2.2\/II\/B\/55\/2.2-5506","metadata":false},{"id":68975,"structure_id":15529,"section_number":"2.2-5507","catch_line":"Enforcement","url":"\/2.2-5507\/","token":"2.2\/II\/B\/55\/2.2-5507","metadata":false},{"id":61086,"structure_id":15529,"section_number":"2.2-5508","catch_line":"Penalties","url":"\/2.2-5508\/","token":"2.2\/II\/B\/55\/2.2-5508","metadata":false},{"id":60378,"structure_id":15529,"section_number":"2.2-5509","catch_line":"Limitation on local regulation","url":"\/2.2-5509\/","token":"2.2\/II\/B\/55\/2.2-5509","metadata":false}],"previous_section":{"id":59259,"structure_id":15529,"section_number":"2.2-5502","catch_line":"Exemptions from chapter to be determined by Department","url":"\/2.2-5502\/","token":"2.2\/II\/B\/55\/2.2-5502","metadata":false},"next_section":{"id":86467,"structure_id":15529,"section_number":"2.2-5504","catch_line":"Public notice of proposed regulated introduction","url":"\/2.2-5504\/","token":"2.2\/II\/B\/55\/2.2-5504","metadata":false},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/2.2-5503\/","history_text":"<p>This law was first created in 1994. The record of its establishment is cataloged in chapter <a href=\"https:\/\/legacylis.virginia.gov\/cgi-bin\/legp604.exe?941+ful+CHAP0472\">472<\/a> of that year\u2019s edition of \u201cActs of Assembly,\u201d the annual state publication listing all changes made to the Code of Virginia in that year. It has been modified 1 time. Those modifications are cataloged by \u201cThe Acts of Assembly,\u201d a state publication, by year and chapter. Those modifications that can be read on the General Assembly\u2019s website will be linked accordingly. That modification is as follows: in 2001, chapter <a href=\"https:\/\/legacylis.virginia.gov\/cgi-bin\/legp604.exe?011+ful+CHAP0844\">844<\/a>.<\/p>","references":[{"id":86467,"section_number":"2.2-5504","catch_line":"Public notice of proposed regulated introduction","order_by":null,"url":"\/2.2-5504\/"},{"id":72976,"section_number":"2.2-5505","catch_line":"Comment on proposed regulated introduction","order_by":null,"url":"\/2.2-5505\/"},{"id":59221,"section_number":"2.2-5506","catch_line":"Confidential business information; Department to establish procedures","order_by":null,"url":"\/2.2-5506\/"},{"id":68975,"section_number":"2.2-5507","catch_line":"Enforcement","order_by":null,"url":"\/2.2-5507\/"},{"id":61086,"section_number":"2.2-5508","catch_line":"Penalties","order_by":null,"url":"\/2.2-5508\/"}],"refers_to":[{"id":59259,"section_number":"2.2-5502","catch_line":"Exemptions from chapter to be determined by Department","order_by":null,"url":"\/2.2-5502\/"},{"id":86467,"section_number":"2.2-5504","catch_line":"Public notice of proposed regulated introduction","order_by":null,"url":"\/2.2-5504\/"},{"id":72976,"section_number":"2.2-5505","catch_line":"Comment on proposed regulated introduction","order_by":null,"url":"\/2.2-5505\/"}],"permalink":{"id":177955,"object_type":"law","relational_id":84406,"identifier":"2.2-5503","token":"2.2\/II\/B\/55\/2.2-5503","url":"\/2.2-5503\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/2.2-5503\/","token":"2.2\/II\/B\/55\/2.2-5503","dublin_core":{"Title":"Requirements for regulated introduction","Type":"Text","Format":"text\/html","Identifier":"\u00a7 2.2-5503","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t<section><p>Except as provided under \u00a7&nbsp;<a class=\"law\" title=\"Exemptions from chapter to be determined by Department\" href=\"\/2.2-5502\/\">2.2-5502<\/a>, no person may commence a <span class=\"dictionary\">regulated introduction<\/span> unless the person:<\/p><\/section>\n\t\t\t\t\t\t<section id=\"1\"><p><span class=\"prefix-number\">1.<\/span> Provides to the <span class=\"dictionary\">Department<\/span> all of the following information within seven days after the person submits or should have submitted the information specified in subdivisions 1 a and 1 b to a <span class=\"dictionary\">federal regulator<\/span>, whichever is sooner:\n\t\t\ta. A copy of all information that the person is required to submit to the <span class=\"dictionary\">federal regulator<\/span> and that is not confidential information; and\n\t\t\tb. A summary of any confidential information that the person submits or is required to submit to a <span class=\"dictionary\">federal regulator<\/span>. The summary shall provide sufficient information to enable the <span class=\"dictionary\">Department<\/span> to exercise its notice and comment functions under &#xA7;&#xA7; <a class=\"law\" title=\"Public notice of proposed regulated introduction\" href=\"\/2.2-5504\/\">2.2-5504<\/a> and <a class=\"law\" title=\"Comment on proposed regulated introduction\" href=\"\/2.2-5505\/\">2.2-5505<\/a>, to provide public notice pursuant to &#xA7; <a class=\"law\" title=\"Public notice of proposed regulated introduction\" href=\"\/2.2-5504\/\">2.2-5504<\/a>, and to prepare comments pursuant to &#xA7; <a class=\"law\" title=\"Comment on proposed regulated introduction\" href=\"\/2.2-5505\/\">2.2-5505<\/a>, and shall have minimal extraneous and irrelevant information. The summary shall also provide sufficient information to enable the <span class=\"dictionary\">locality<\/span> in which the introduction is proposed to be made to exercise its comment function under &#xA7; <a class=\"law\" title=\"Comment on proposed regulated introduction\" href=\"\/2.2-5505\/\">2.2-5505<\/a>. <a id=\"paragraph-302533\" class=\"section-permalink\" href=\"https:\/\/vacode.org\/2.2-5503\/#1\"><i class=\"fa fa-link\"><\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t<section id=\"2\"><p><span class=\"prefix-number\">2.<\/span> Provides such additional information, if any, as is necessary to enable the <span class=\"dictionary\">Department<\/span> to fulfill any functions it undertakes, on a case-by-case basis, under &#xA7; <a class=\"law\" title=\"Comment on proposed regulated introduction\" href=\"\/2.2-5505\/\">2.2-5505<\/a>. <a id=\"paragraph-302534\" class=\"section-permalink\" href=\"https:\/\/vacode.org\/2.2-5503\/#2\"><i class=\"fa fa-link\"><\/i><\/a><\/p><\/section>","plain_text":"                                 CODE OF VIRGINIA\n\nREQUIREMENTS FOR REGULATED INTRODUCTION (\u00a7 2.2-5503)\n\nExcept as provided under \u00a7 2.2-5502, no person may commence a regulated\nintroduction unless the person:\n\n1. Provides to the Department all of the following information within seven days\nafter the person submits or should have submitted the information specified in\nsubdivisions 1 a and 1 b to a federal regulator, whichever is sooner:\n\t\t\ta. A copy of all information that the person is required to submit to the\nfederal regulator and that is not confidential information; and\n\t\t\tb. A summary of any confidential information that the person submits or is\nrequired to submit to a federal regulator. The summary shall provide sufficient\ninformation to enable the Department to exercise its notice and comment\nfunctions under &#xA7;&#xA7; 2.2-5504 and 2.2-5505, to provide public notice\npursuant to &#xA7; 2.2-5504, and to prepare comments pursuant to &#xA7;\n2.2-5505, and shall have minimal extraneous and irrelevant information. The\nsummary shall also provide sufficient information to enable the locality in\nwhich the introduction is proposed to be made to exercise its comment function\nunder &#xA7; 2.2-5505.\n\n2. Provides such additional information, if any, as is necessary to enable the\nDepartment to fulfill any functions it undertakes, on a case-by-case basis,\nunder &#xA7; 2.2-5505.\n\nHISTORY: 1994, c. 472, \u00a7 2.1-772; 2001, c. 844.","edition":{"id":1,"name":"2025","slug":"2025","date_created":"2026-06-21 22:39:22","date_modified":"2026-06-21 22:39:22","current":1,"order_by":1,"last_import":null}}