Regulatory Updates

Bovine Spongiform Encephalopathy (BSE) Import Policy for Bovine Animals and their Products and By-products

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Distribution date: 22 April 2010 | Final date for Comment: 14 June 2010

The notification amends Canada's BSE import policy for bovine animals and their products. There are a number of changes and additions to this directive. The main proposed changes are highlighted below. The proposed amendments take into account Canada's utilization of the OIE classification for country BSE risk categorization. The list of the BSE status of OIE members within the proposed import policy is that of the Terrestrial Animal Health Code (May 2009). The list will be updated annually to reflect any changes in the status of OIE classification for country BSE risk categorization. The CFIA will not routinely carry out independent assessments regarding a country's BSE categorization. The proposed amendments also reflect the CFIA and Health Canada's legislative and policy requirements for the removal of Specified Risk Material (SRM) from all cattle at slaughter. SRM is any of the skull, brain, trigeminal ganglia, eyes, tonsils, spinal cord and dorsal root ganglia of cattle aged 30 months or older, and the distal ileum of cattle of all ages. All removed SRM are to be diverted away from the products for human consumption and from the animal food supply. The requirement to remove all SRM from cattle does not apply to products originating from a country that is designated as having negligible risk of BSE.

Products Covered: Bovine origin products (ICS Codes: 65.020, 67.020, 67.040 and 67.120)

Regulation Type: Revision to Regular Notification

Animal diseases Food safety Animal feed Animal health Human health Pest- or Disease- free Regions / Regionalization Zoonoses Bovine Spongiform Encephalopathy (BSE) Transmissible Spongiform Encephalopathy (TSE)

La República de Ecuador comunica con relación al Reglamento Técnico RTE INEN 020 para "Fósforos sean de fabricación nacional o importados, que se comercialicen en la República del Ecuador”, del Instituto Ecuatoriano de Normalización, notificado mediante el documento identificado con la signatura G/TBT/N/ECU/15 del 29 de septiembre de 2006, que éste ha sido expedido mediante la Resolución N° 016-2008 del 19 de mayo de 2008, publicado en el Registro Oficial Spto. Nº 465 del 12 de noviembre de 2008. ; ; Texto disponible en el Ministerio de Industrias y Productividad; Subsecretaría de Comercio e Inversiones; Organismo Nacional encargado de la Notificación: ; Responsable: Econ. Arturo Barbosa G. ; Avdas. Eloy Alfaro y Amazinas, 2º Piso, Edif. MAGAP ; Quito, Ecuador ; ; Tel: (+593-2) 2566041, Ext. 284 ; Fax: (+593-2) 2504922 ; Punto de Contacto: abarbosa@mipro.gov.ec ;

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Distribution date: 21 April 2010

Products Covered: HS tariff subheading 360

Regulation Type: Addendum to Regular Notification

Beverages: Bottled Water; Reopening of the Comment Period

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Distribution date: 21 April 2010 | Final date for Comment: 01 June 2010

FDA is reopening the comment period for a 1993 proposed rule that proposed establishment of an allowable level in bottled water for the chemical di(2-ethylhexyl)phthalate (DEHP). FDA is seeking further comment on finalizing the allowable level for DEHP in the bottled water quality standard.

Products Covered: Bottled water (HS Code: 2201)

Regulation Type: Regular notification

Human health Beverages Food safety Contaminants

Regulations Amending the Food and Drug Regulations (1610 - Food Additives)

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Distribution date: 20 April 2010

The proposed amendments notified in the following documents G/SPS/N/CAN/195 (dated 6 January 2004) G/SPS/N/CAN/266 (dated 23 June 2006) G/SPS/N/CAN/270 (dated 14 August 2006) G/SPS/N/CAN/273 (dated 15 September 2006) G/SPS/N/CAN/278 (dated 8 January 2007) were adopted 23 February 2010 as the Regulations Amending the Food and Drug Regulations (1610 - Food Additives). These amendments to the Regulations enable the use of the enzymes pullulanase, glucose oxidase, invertase and xylanase produced from new genetically modified or conventional sources of micro-organisms, as noted in the Regulations. These Regulations entered into force on 23 February 2010.

Products Covered:

Regulation Type: Addendum to Regular Notification

Adoption/publication/entry into force of reg.

Proyecto de Resolución del Instituto Colombiano Agropecuario - ICA "Por medio de la cual se prohíbe la importación, comercialización y uso de dietilestilbestrol en la producción de insumos veterinarios, así como su administración en cualquier especie animal" (Draft Resolution of the Colombian Agricultural Institute (ICA) "Prohibiting the importation and marketing of diethylstilbestrol, its use in the production of veterinary inputs and its administration to any species of animal").

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Distribution date: 20 April 2010 | Final date for Comment: 14 July 2010

Prohibition, notification and period of validity.

Products Covered: Diethylstilbestrol (DES)

Regulation Type: Regular notification

Food safety Animal health Human health Veterinary drugs

Regulations Amending the Food and Drug Regulations (1610 - Food Additives)

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Distribution date: 20 April 2010

The proposed amendments notified in the following documents: G/SPS/N/CAN/195 (dated 6 January 2004) G/SPS/N/CAN/266 (dated 23 June 2006) G/SPS/N/CAN/270 (dated 14 August 2006) G/SPS/N/CAN/273 (dated 15 September 2006) G/SPS/N/CAN/278 (dated 8 January 2007) were adopted 23 February 2010 as the Regulations Amending the Food and Drug Regulations (1610 - Food Additives). These amendments to the Regulations enable the use of the enzymes pullulanase, glucose oxidase, invertase and xylanase produced from new genetically modified or conventional sources of micro-organisms, as noted in the Regulations. These Regulations entered into force on 23 February 2010.

Products Covered:

Regulation Type: Addendum to Regular Notification

Adoption/publication/entry into force of reg.

Polychlorinated Biphenyls (PCBs); Reassessment of Use Authorizations (23 pages, in English)

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Distribution date: 19 April 2010 | Final date for Comment: 18 June 2010

EPA is issuing an ANPRM for the use and distribution in commerce of certain classes of PCBs and PCB items and certain other areas of the PCB regulations under the Toxic Substances Control Act (TSCA). EPA is reassessing its TSCA PCB use and distribution in commerce regulations to address: The use, distribution in commerce, marking, and storage for reuse of liquid PCBs in electric and non-electric equipment; the use of the 50 parts per million (ppm) level for excluded PCB products; the use of non-liquid PCBs; the use and distribution in commerce of PCBs in porous surfaces; and the marking of PCB articles in use. Also in this document, EPA is also reassessing the definitions of “excluded manufacturing process,” “quantifiable level/level of detection,” and “recycled PCBs.” EPA is soliciting comments on these and other areas of the PCB use regulations. EPA is not soliciting comments on the PCB disposal regulations in this document.

Products Covered: Polychlorinated Biphenyls (PCBs) (HS Chapter 29; ICS: 13.020, 71.080

Regulation Type: Regular notification

Arrêté interministériel réglementant les conditions d'octroi d'agrément et du contrôle sanitaire des établissements se livrant au traitement et à la commercialisation du guano (Interministerial Order regulating the conditions for the granting of approval to and the sanitary control of establishments engaged in the treatment and marketing of guano)

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Distribution date: 13 April 2010 | Final date for Comment: 12 June 2010

Definition of the requirements to be met by establishments seeking to obtain authorization to place on the local market or to export domestically produced guano.

Products Covered: Guano (bat guano and seabird guano)

Regulation Type: Regular notification

Human health Plant health

Hazardous Materials Regulations: Combustible Liquids: Advance notice of proposed rulemaking (ANPRM) ; (8 pages, English) ;

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Distribution date: 09 April 2010 | Final date for Comment: 08 June 2010

PHMSA is considering amendments to the Hazardous Materials Regulations (HMR) as they apply to the transportation of combustible liquids. Specifically, we are considering whether to harmonize the domestic regulations applicable to the transportation of combustible liquids with international transportation standards. In addition, we are examining ways to revise, clarify, or relax certain regulatory requirements to facilitate the transportation of these materials while maintaining an adequate level of safety. The intent of this ANPRM is to invite public comments on how to accomplish these goals, provide an opportunity for comment on amendments PHMSA is considering, and present a forum for the public to offer additional recommendations for the safe transportation of combustible liquids.

Products Covered: Combustible liquids (HS 36, ICS 03.220, 13.300, 75.160)

Regulation Type: Regular notification

AGENCY: Food and Drug Administration, HHS ; ; ACTION: Final Rule ; ; SUMMARY: The Food and Drug Administration (FDA) is amending the color additive regulations to increase the permitted use level of bismuth citrate as a color additive in cosmetics intended for coloring hair on the scalp. This action is in response to a petition filed by Combe, Inc. ; ; DATES: This rule is effective April 27, 2010; except as to any provisions that may be stayed by the filing of proper objections. Submit electronic or written objections and requests for a hearing by April 26, 2010. See section VII of this document for information on the filing of objections. ; ; ; URL: ; http://edocket.access.gpo.gov/2010/2010-6731.htm ; http://edocket.access.gpo.gov/2010/pdf/2010-6731.pdf ; ;

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Distribution date: 07 April 2010

Products Covered: Hair Dyes (HS:  32-US1; ICS:  71.100)

Regulation Type: Addendum to Regular Notification

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