Regulatory Updates
TITLE: Safer Consumer Product Alternatives ; ; AGENCY: State of California, Department of Toxic Substances Control (DTSC) ; ; ACTION: Revised Text of Proposed Regulation and Extension of Comment Period ; ; SUMMARY: Pursuant to Government Code section 11346.8(c), notice is hereby given that the Department of Toxic Substances Control (DTSC) has revised the text of the proposed regulations which establish the process for identifying and prioritizing consumer products and their chemicals of concern, evaluating their alternatives, and imposing regulatory responses, by adding chapter 55 to division 4.5 of title 22, California Code of Regulations, and amending the Table of Contents. A written comment period for these revisions to the proposed regulations text has been established commencing on 29 January 2013, and closing on 28 February 2013. ; ; DTSC mailed the original text and made it available for public review and comment on 27 July 2012. A public hearing was held on 10 September 2012, during which DTSC accepted written and oral testimony. In addition, written comments were accepted during the 45-day public comment period, which was extended by 30 days and ended 11 October 2012. DTSC has now made post-hearing changes to the proposed text. It considers these new changes to the rulemaking to be "sufficiently related changes", as defined in Title 1, California Code of Regulations, section 42. ; ; Copies of the revised text are posted to DTSC's Internet site at: http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/index.cfm and http://www.dtsc.ca.gov/SCPRegulations.cfm or may be obtained from Krysia Von Burg of DTSC's Regulations Section at (916) 324-2810. Additions to the originally proposed text are underlined, and text deleted from the originally proposed text is shown as strikeout. ; ; Notice is given that any interested persons may submit comments regarding the revisions to the originally proposed text to DTSC by email to gcregs@dtsc.ca.gov, fax (916) 323-5542, or by mail to: ; ; Krysia Von Burg ; Department of Toxic Substances Control ; Regulations Section ; PO Box 806 ; Sacramento, CA 95812-0806 ; ; All comments must be received by DTSC by 5:00 P.M. PST on 28 February 2013, regardless of the form of transmission. ; ; URLs: ; http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/upload/SCP-Revised-Text.pdf ; http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/upload/SCP-Summary-of-Changes.pdf ;
Distribution date: 07 February 2013
Products Covered: Chemicals (HS Chapter 38; ICS 71.100)
Regulation Type: Addendum to Regular Notification
TITLE: Safer Consumer Product Alternatives ; ; AGENCY: State of California, Department of Toxic Substances Control (DTSC) ; ; ACTION: Revised Text of Proposed Regulation and Extension of Comment Period ; ; SUMMARY: Pursuant to Government Code section 11346.8(c), notice is hereby given that the Department of Toxic Substances Control (DTSC) has revised the text of the proposed regulations which establish the process for identifying and prioritizing consumer products and their chemicals of concern, evaluating their alternatives, and imposing regulatory responses, by adding chapter 55 to division 4.5 of title 22, California Code of Regulations, and amending the Table of Contents. A written comment period for these revisions to the proposed regulations text has been established commencing on 29 January 2013, and closing on 28 February 2013. ; ; DTSC mailed the original text and made it available for public review and comment on 27 July 2012. A public hearing was held on 10 September 2012, during which DTSC accepted written and oral testimony. In addition, written comments were accepted during the 45-day public comment period, which was extended by 30 days and ended 11 October 2012. DTSC has now made post-hearing changes to the proposed text. It considers these new changes to the rulemaking to be "sufficiently related changes", as defined in Title 1, California Code of Regulations, section 42. ; ; Copies of the revised text are posted to DTSC's Internet site at: http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/index.cfm and http://www.dtsc.ca.gov/SCPRegulations.cfm or may be obtained from Krysia Von Burg of DTSC's Regulations Section at (916) 324-2810. Additions to the originally proposed text are underlined, and text deleted from the originally proposed text is shown as strikeout. ; ; Notice is given that any interested persons may submit comments regarding the revisions to the originally proposed text to DTSC by email to gcregs@dtsc.ca.gov, fax (916) 323-5542, or by mail to: ; ; Krysia Von Burg ; Department of Toxic Substances Control ; Regulations Section ; PO Box 806 ; Sacramento, CA 95812-0806 ; ; All comments must be received by DTSC by 5:00 P.M. PST on 28 February 2013, regardless of the form of transmission. ; ; URLs: ; http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/upload/SCP-Revised-Text.pdf ; http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/upload/SCP-Summary-of-Changes.pdf ;
Distribution date: 07 February 2013
Products Covered: Chemicals (HS Chapter 38; ICS 71.100)
Regulation Type: Addendum to Regular Notification
TITLE: Labeling of Pesticide Products and Devices for Export; Clarification of Requirements ; ; AGENCY: Environmental Protection Agency (EPA) ; ; ACTION: Final rule ; ; SUMMARY: EPA is revising the regulations on the labeling of pesticide products and devices intended solely for export. Specifically, EPA is restructuring the current regulations to clarify which provisions apply under various circumstances. EPA is also increasing specificity in the regulations by requiring that people who transfer unregistered pesticide products between registered establishments operated by the same producer within the United States must also comply with the requirements of this part if those products are intended solely for export at the time of such transfer. EPA believes that this requirement is necessary to ensure appropriate handling of such products as they move in commerce before they actually leave the United States. ; ; DATES: This final rule is effective 19 March 2013. The compliance date for the requirement to label unregistered pesticide products intended solely for export that are being shipped between registered establishments operated by the same producer is 21 January 2014. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2013-01-18/html/2013-01055.htm ; http://www.gpo.gov/fdsys/pkg/FR-2013-01-18/pdf/2013-01055.pdf ;
Distribution date: 31 January 2013
Products Covered: Pesticides (HS 3808; ICS 13.020, 13.300, 65.100.01)
Regulation Type: Addendum to Regular Notification
TITLE: Labeling of Pesticide Products and Devices for Export; Clarification of Requirements ; ; AGENCY: Environmental Protection Agency (EPA) ; ; ACTION: Final rule ; ; SUMMARY: EPA is revising the regulations on the labeling of pesticide products and devices intended solely for export. Specifically, EPA is restructuring the current regulations to clarify which provisions apply under various circumstances. EPA is also increasing specificity in the regulations by requiring that people who transfer unregistered pesticide products between registered establishments operated by the same producer within the United States must also comply with the requirements of this part if those products are intended solely for export at the time of such transfer. EPA believes that this requirement is necessary to ensure appropriate handling of such products as they move in commerce before they actually leave the United States. ; ; DATES: This final rule is effective 19 March 2013. The compliance date for the requirement to label unregistered pesticide products intended solely for export that are being shipped between registered establishments operated by the same producer is 21 January 2014. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2013-01-18/html/2013-01055.htm ; http://www.gpo.gov/fdsys/pkg/FR-2013-01-18/pdf/2013-01055.pdf ;
Distribution date: 31 January 2013
Products Covered: Pesticides (HS 3808; ICS 13.020, 13.300, 65.100.01)
Regulation Type: Addendum to Regular Notification
Draft Ministry of Public Health (MOPH) Measure on entitled "Food Additives (No. 4): Steviol glycoside"
Distribution date: 31 January 2013 | Final date for Comment: 11 February 2013
In response to international requests regarding the Draft Ministry of Public Health Notification, entitled "Food Additives (No. 4): Steviol glycoside", notification G/SPS/N/THA/211, an extension period is provided until 11 February 2013.
Products Covered:
Regulation Type: Addendum to Regular Notification
Draft Ministry of Public Health (MOPH) Measure on entitled "Food Additives (No. 4): Steviol glycoside"
Distribution date: 31 January 2013 | Final date for Comment: 11 February 2013
In response to international requests regarding the Draft Ministry of Public Health Notification, entitled "Food Additives (No. 4): Steviol glycoside", notification G/SPS/N/THA/211, an extension period is provided until 11 February 2013.
Products Covered:
Regulation Type: Addendum to Regular Notification
TITLE: Current Good Manufacturing Practice Requirements for Combination Products ; ; AGENCY: Food and Drug Administration (FDA), Department of Health and Human Services (HHS) ; ; ACTION: Final rule ; ; SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing this regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for single-entity and co-packaged combination products. ; ; DATES: This rule is effective 22 July 2013. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2013-01-22/html/2013-01068.htm ; http://www.gpo.gov/fdsys/pkg/FR-2013-01-22/pdf/2013-01068.pdf ; ;
Distribution date: 31 January 2013
Products Covered: Combination products (HS: 3004, 9018.11-90) (ICS: 71.100, 13.020)
Regulation Type: Addendum to Regular Notification
TITLE: Current Good Manufacturing Practice Requirements for Combination Products ; ; AGENCY: Food and Drug Administration (FDA), Department of Health and Human Services (HHS) ; ; ACTION: Final rule ; ; SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing this regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for single-entity and co-packaged combination products. ; ; DATES: This rule is effective 22 July 2013. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2013-01-22/html/2013-01068.htm ; http://www.gpo.gov/fdsys/pkg/FR-2013-01-22/pdf/2013-01068.pdf ; ;
Distribution date: 31 January 2013
Products Covered: Combination products (HS: 3004, 9018.11-90) (ICS: 71.100, 13.020)
Regulation Type: Addendum to Regular Notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Law (Revision of agricultural chemical residue standards)
Distribution date: 28 January 2013 | Final date for Comment: 29 March 2013
Proposed maximum residue limits (MRLs) for the following agricultural chemicals. Pesticides: Phenthoate and Spirodiclofen
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06 and 02.08) - Dairy produce, birds' eggs and natural honey (HS Code: 04.01) - Products of animal origin, not elsewhere specified or included (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07 and 12.10) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Law (Revision of agricultural chemical residue standards)
Distribution date: 28 January 2013 | Final date for Comment: 29 March 2013
Proposed maximum residue limits (MRLs) for the following agricultural chemicals. Pesticides: Phenthoate and Spirodiclofen
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06 and 02.08) - Dairy produce, birds' eggs and natural honey (HS Code: 04.01) - Products of animal origin, not elsewhere specified or included (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07 and 12.10) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
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