United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2003_register executive 2010-09-23 article Rules and Regulations D09002ee1c817b2e5 D09002ee1c817b377 United States Environmental Protection Agency originator org United States Government Agency or Subagency EPA is issuing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for Burkholderia cepacia complex (Bcc), a group of naturally-occurring microorganisms. Bcc microorganisms, when encountered in sufficient numbers through an appropriate route of exposure by a member of a sensitive population, such as a cystic fibrosis (CF) patient, have the potential to cause a severe infection, resulting in significantly increased rates of mortality. This rule would require persons who intend to manufacture, import, or process any individual member of Bcc for a significant new use to notify EPA at least 90 days before commencing the manufacturing (including import) or processing of Bcc for a use designated by this SNUR as a significant new use. The required notice would provide EPA with the opportunity to evaluate the intended new use and associated activities and, if necessary, to prohibit or limit that activity before it occurs. 68 FR 35315 https://www.govinfo.gov/app/details/FR-2003-06-13/03-15010 03-15010 fr13jn03-22 RIN 2070-AD43 6560-50-S OPPT-2002-0041 FRL-7200-3 https://www.govinfo.gov/app/details/FR-2003-06-13/03-15010 https://www.govinfo.gov/content/pkg/FR-2003-06-13/html/03-15010.htm https://www.govinfo.gov/content/pkg/FR-2003-06-13/pdf/03-15010.pdf Environmental Protection Chemicals Hazardous Substances Reporting and Recordkeeping Requirements 6 p. 35315 35320 68 FR 35315 Title 40 Part 725 40 CFR Part 725 RIN 2070-AD43 Burkholderia Cepacia Complex; Significant New Use Rule; Federal Register Vol. 68, Issue RULE 03-15010 ENVIRONMENTAL PROTECTION AGENCY 2003-08-12 OPPT-2002-0041 FRL-7200-3 6560-50-S 03-15010 Final rule.

EPA is issuing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for Burkholderia cepacia complex (Bcc), a group of naturally-occurring microorganisms. Bcc microorganisms, when encountered in sufficient numbers through an appropriate route of exposure by a member of a sensitive population, such as a cystic fibrosis (CF) patient, have the potential to cause a severe infection, resulting in significantly increased rates of mortality. This rule would require persons who intend to manufacture, import, or process any individual member of Bcc for a significant new use to notify EPA at least 90 days before commencing the manufacturing (including import) or processing of Bcc for a use designated by this SNUR as a significant new use. The required notice would provide EPA with the opportunity to evaluate the intended new use and associated activities and, if necessary, to prohibit or limit that activity before it occurs.

This final rule is effective on August 12, 2003. For general information contact: Barbara Cunningham, Director, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- Environmental Protection Chemicals Hazardous Substances Reporting and Recordkeeping Requirements Toxic substances: Significant new uses Burkholderia cepacia complex, alwood.jim@epa.gov TSCA-Hotline@epa.gov http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr725_00.html http://www.epa.gov/edocket/ http://www.epa.gov/fedrgstr/ www.epa.gov/opptsfrs/home/guidelin.htm Vol. 68, no. 114 Office of the Federal Register, National Archives and Records Administration 2003-06-13 continuing daily deposited born digital 272 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2003-06-13 P0b002ee1809c29e5 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13jn03 https://www.govinfo.gov/app/details/FR-2003-06-13 https://www.govinfo.gov/content/pkg/FR-2003-06-13/pdf/FR-2003-06-13.pdf https://www.govinfo.gov/content/pkg/FR-2003-06-13/xml/FR-2003-06-13.xml fdlp 35265 35524 DGPO 2010-09-23 2024-06-07 FR-2003-06-13 machine generated eng FR FR-2003-06-13 68 114