Chemical Regulatory Updates – Latest Global Changes

TITLE: Safer Consumer Products ; ; AGENCY: California Department of Toxic Substances Control ; ; ACTION: Notice of Public Availability of Documents Added to the Rulemaking File and Extension of Comment ; ; SUMMARY: Notice is hereby given, pursuant to Government Code section 11347.1, subdivision (b), that the Department of Toxic Substances Control (DTSC) has added the following documents to the Safer Consumer Products rulemaking file, which was published in the California Regulatory Notice Register (Z-2012-0717-04) on July 27, 2012: ; ; (1) External Scientific Peer Review Reports ; DTSC has added nine external scientific peer review reports to the rulemaking file. DTSC has complied with Health and Safety Code section 57004, regarding submission of the scientific portions of the January 29, 2013, post-hearing changes to the proposed safer consumer product regulations to an external scientific peer review. The documents were submitted to scientific peer reviewers through the University of California. Their written reports, which contain an evaluation of the scientific basis of the post-hearing changes to the proposed regulations, have been added to the rulemaking file. ; ; (2) California Environmental Policy Council Resolution ; DTSC has also added to the rulemaking file the California Environmental Policy Council (Council) resolution adopted on February 28, 2013. Health and Safety Code section 25252.5, subject to a specified exception, requires DTSC to prepare, and submit to the Council for review, a multimedia life cycle evaluation prior to adopting these regulations. However, the law provides an exception to this requirement if the Council conclusively determines that the regulations will not have any significant adverse impacts on public health or the environment. During the February 28, 2013, meeting of the Council written and oral testimony was accepted on the issue described herein. The Council unanimously made a conclusive determination that the adoption of these regulations would not have a significant adverse impact on public health or the environment. Thus, DTSC is not required to prepare a multimedia life cycle evaluation for these regulations. ; ; A public comment period for the documents added to the rulemaking file, as described above, will commence on 13 March 2013, and close at 5 p.m. on 28 March 2013. ; ; Interested persons may submit comments by e-mail to gcregs@dtsc.ca.gov, by fax to ; (916) 324-1808, or by mail to: ; ; Ms. Jackie Buttle ; Acting Regulations Coordinator ; Department of Toxic Substances Control ; P.O. Box 806 ; Sacramento, CA 95812-0806 ; ; URLs: ; http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/index.cfm ; http://www.dtsc.ca.gov/SCPRegulations.cfm ;

Distribution date: 22 March 2013

Products Covered: Chemicals (HS Chapter 38; ICS 71.100)

Regulation Type: Addendum to Regular Notification

TITLE: Safer Consumer Products ; ; AGENCY: California Department of Toxic Substances Control ; ; ACTION: Notice of Public Availability of Documents Added to the Rulemaking File and Extension of Comment ; ; SUMMARY: Notice is hereby given, pursuant to Government Code section 11347.1, subdivision (b), that the Department of Toxic Substances Control (DTSC) has added the following documents to the Safer Consumer Products rulemaking file, which was published in the California Regulatory Notice Register (Z-2012-0717-04) on July 27, 2012: ; ; (1) External Scientific Peer Review Reports ; DTSC has added nine external scientific peer review reports to the rulemaking file. DTSC has complied with Health and Safety Code section 57004, regarding submission of the scientific portions of the January 29, 2013, post-hearing changes to the proposed safer consumer product regulations to an external scientific peer review. The documents were submitted to scientific peer reviewers through the University of California. Their written reports, which contain an evaluation of the scientific basis of the post-hearing changes to the proposed regulations, have been added to the rulemaking file. ; ; (2) California Environmental Policy Council Resolution ; DTSC has also added to the rulemaking file the California Environmental Policy Council (Council) resolution adopted on February 28, 2013. Health and Safety Code section 25252.5, subject to a specified exception, requires DTSC to prepare, and submit to the Council for review, a multimedia life cycle evaluation prior to adopting these regulations. However, the law provides an exception to this requirement if the Council conclusively determines that the regulations will not have any significant adverse impacts on public health or the environment. During the February 28, 2013, meeting of the Council written and oral testimony was accepted on the issue described herein. The Council unanimously made a conclusive determination that the adoption of these regulations would not have a significant adverse impact on public health or the environment. Thus, DTSC is not required to prepare a multimedia life cycle evaluation for these regulations. ; ; A public comment period for the documents added to the rulemaking file, as described above, will commence on 13 March 2013, and close at 5 p.m. on 28 March 2013. ; ; Interested persons may submit comments by e-mail to gcregs@dtsc.ca.gov, by fax to ; (916) 324-1808, or by mail to: ; ; Ms. Jackie Buttle ; Acting Regulations Coordinator ; Department of Toxic Substances Control ; P.O. Box 806 ; Sacramento, CA 95812-0806 ; ; URLs: ; http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/index.cfm ; http://www.dtsc.ca.gov/SCPRegulations.cfm ;

Distribution date: 22 March 2013

Products Covered: Chemicals (HS Chapter 38; ICS 71.100)

Regulation Type: Addendum to Regular Notification

TITLE: Use of Materials Derived From Cattle in Human Food and Cosmetics ; ; AGENCY: Food and Drug Administration (FDA), Health and Human Services (HHS) ; ; ACTION: Interim final rule; reopening of the comment period ; ; SUMMARY: The Food and Drug Administration (FDA or we) is reopening the comment period for the interim final rule entitled Use of Materials Derived From Cattle in Human Food and Cosmetics that published in the Federal Register of 14 July 2004 (69 FR 42256). The interim final rule prohibited the use of certain cattle material to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. In the Federal Register of 7 September 2005 (70 FR 53063), we amended the interim final rule to make changes, including providing that the small intestine of cattle, formerly prohibited cattle material, could be used in human food and cosmetics if the distal ileum was removed by a specified procedure or one that the establishment could demonstrate is equally effective in ensuring complete removal of the distal ileum. Since 2005, peer-reviewed studies have been published showing the presence of infectivity in the proximal ileum, jejunum, ileocecal junction, and colon of cattle with BSE. Therefore, we are reopening the comment period for the interim final rule to give interested parties an opportunity to comment on the new studies concerning infectivity in parts of the small intestine other than the distal ileum. ; ; DATES: Submit either electronic or written comments by 3 May 2013. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2013-03-04/html/2013-04869.htm ; http://www.gpo.gov/fdsys/pkg/FR-2013-03-04/pdf/2013-04869.pdf ;

Distribution date: 20 March 2013

Products Covered: Human foods, cosmetics (HS 33-3, 2106) (ICS 71.100, 67.040, 07.100)

Regulation Type: Addendum to Regular Notification

Food standards

TITLE: Use of Materials Derived From Cattle in Human Food and Cosmetics ; ; AGENCY: Food and Drug Administration (FDA), Health and Human Services (HHS) ; ; ACTION: Interim final rule; reopening of the comment period ; ; SUMMARY: The Food and Drug Administration (FDA or we) is reopening the comment period for the interim final rule entitled Use of Materials Derived From Cattle in Human Food and Cosmetics that published in the Federal Register of 14 July 2004 (69 FR 42256). The interim final rule prohibited the use of certain cattle material to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. In the Federal Register of 7 September 2005 (70 FR 53063), we amended the interim final rule to make changes, including providing that the small intestine of cattle, formerly prohibited cattle material, could be used in human food and cosmetics if the distal ileum was removed by a specified procedure or one that the establishment could demonstrate is equally effective in ensuring complete removal of the distal ileum. Since 2005, peer-reviewed studies have been published showing the presence of infectivity in the proximal ileum, jejunum, ileocecal junction, and colon of cattle with BSE. Therefore, we are reopening the comment period for the interim final rule to give interested parties an opportunity to comment on the new studies concerning infectivity in parts of the small intestine other than the distal ileum. ; ; DATES: Submit either electronic or written comments by 3 May 2013. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2013-03-04/html/2013-04869.htm ; http://www.gpo.gov/fdsys/pkg/FR-2013-03-04/pdf/2013-04869.pdf ;

Distribution date: 20 March 2013

Products Covered: Human foods, cosmetics (HS 33-3, 2106) (ICS 71.100, 67.040, 07.100)

Regulation Type: Addendum to Regular Notification

Food standards