Regulatory Updates

Distribution date: 12 September 2007

The Draft Normative Instruction notified as G/SPS/N/BRA/226 (criteria for the use of non-agglutinating antibody vaccines against bovine Brucellosis) was adopted as a final text, published as Normative Instruction Nº 33, on 24 August 2007, in the Official Gazette Nº 166 from 28 August 2007, section 1, pages 6 and 7. Date of entry into force: 28 August 2007. The full text is available only in Portuguese and can be downloaded at: http://extranet.agricultura.gov.br/sislegis-consulta/consultarLegislacao.do?operacao=visualizar&id=18064 E-mail: cgomc@agricultura.gov.br

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 05 September 2007

With regard to the notification G/SPS/N/TPKM/114 dated 16 August 2007, the dates of adoption and entry into force of the proposed veterinary drug residue limits of ractopamine in foods have been extended until the time to be decided later.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 03 September 2007 | Final date for Comment: 20 September 2007

The US Food and Drug Administration (FDA) published a final rule in the Federal Register on August 22, 2007 (72 FR 46895), amending the food additive regulations in §172.735 (21 CFR 172.735) to provide for the safe use of glycerol ester of tall oil rosin to adjust the density of citrus oils used in the preparation of beverages. The additive may be used at a level not to exceed 100 ppm of the finished beverage and will be a substitute for glycerol ester of wood or gum rosin, which are already permitted for this use. The rule also amended §172.735 by providing for the use of steam stripping as a purification method for producing glycerol ester of wood rosin, gum rosin, or tall oil rosin. This action is in response to a petition from Georgia-Pacific Resins, Inc. The complete text of the Final Rule in the Federal Register, 72 FR 46895 (available in English), can be found on the Internet at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-16558.pdf. Any person who will be adversely affected by this regulation may file written or electronic objections and requests for a hearing with the Division of Dockets Management by 20 September 2007. Submit written objections and requests for a hearing identified by Docket No. 2006F-0059, by any of the following methods: . Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. . Agency Web site: http://www.fda.gov/dockets/ecomments. Follow the instructions for submitting comments on the agency Web site. . Fax: 301-827-6870 . Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All submissions received must include the agency name and docket number for this rulemaking. All objections received will be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal information provided. For further information contact: Blondell Anderson, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1304.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 03 September 2007

EPA is proposing an exemption to the phaseout of methyl bromide to meet the needs of 2008 critical uses. Specifically, EPA is proposing uses that qualify for the 2008 critical use exemption and the amount of methyl bromide that may be produced, imported, or supplied from existing stocks for those uses in 2008. EPA is taking action under the authority of the Clean Air Act to reflect recent consensus decisions taken by the Parties to the Montreal Protocol on Substances that Deplete the Ozone Layer (Protocol) at the 18th Meeting of the Parties (MOP). EPA is seeking comment on the list of critical uses and on EPA's determination of the amounts of methyl bromide needed to satisfy those uses.

Products Covered: Ozone Depleting Substances (HS:  3808; ICS: 13)

Regulation Type: Regular notification

Distribution date: 03 September 2007

The notified Emergency Technical Regulation contains thirteen (13) titles, thirty-six (36) articles, eight (8) transitional and final provisions and five (5) annexes and covers technical issues relating to the manufacture, importation, distribution and marketing of toxic or hazardous toys and office supplies.

Products Covered: 1. Toys 9503.00.10.00 Wheeled toys designed to be ridden by children (for example, tricycles, cars, baby-walkers and similar wheeled toys);  dolls' carriages 9503.00.29.00 Dolls, whether or not dressed 9503.00.21.00   Garments and accessories therefor, footwear and headgear  9503.00.40.00   Puzzles of all kinds 9503.00.30.00 Reduced-size ("scale") model assembly kits and similar recreational models, working or not  9503.00.91.00 Electric trains, including tracks, signals and other accessories therefor  9503.00.92.00 Other constructional toys 9503.00.93.00 Toys representing animals or non-human creatures 9503.00.94.00 Musical instruments and apparatus  9503.00.9

Regulation Type: Regular notification

Distribution date: 03 September 2007

The Food and Drug Administration (FDA) is issuing a proposed rule that would amend the final monograph (FM) for over-the-counter (OTC) sunscreen drug products as part of FDA's ongoing review of OTC drug products. This amendment addresses formulation, labelling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection. FDA proposes to add combinations of avobenzone with zinc oxide and avobenzone with ensulizole as permitted combinations of active sunscreen ingredients in the FM. FDA is issuing this proposed rule after considering public comments and new data and information that have come to FDA's attention. This rule proposes to lift the stays of 21 CFR 347.20(d) and 21 CFR Part 352 when FDA publishes a final rule based on this proposed rule.

Products Covered: Sunscreen Drug Products (HS:  3304.10-99;  ICS:  13, 71.100)

Regulation Type: Regular notification

Distribution date: 23 August 2007 | Final date for Comment: 22 October 2007

- To amend MRLs for antibiotics in Foods - To establish additional standards for impotence drug-like substance (thiosildenafil , dimethylthiosildenafil , acetylvardenafil ) - To establish Maximum Levels for heavy metal in Fishes and mollusk

Products Covered: Food products

Regulation Type: Regular notification

Distribution date: 16 August 2007 | Final date for Comment: 21 August 2007

To establish the residue limits for veterinary drug ractopamine on the muscle, fat, liver and kidney of cattle and pigs.

Products Covered: Ractopamine

Regulation Type: Regular notification

Distribution date: 07 August 2007

The Draft Normative Instruction notified as G/SPS/N/BRA/128 (technical regulation for research, development, production, evaluation, registration and permit renewal, trade and use of vaccine against canine visceral leishmaniasis) was adopted as a final text, published as Interministerial Normative Instruction Nº 31, on 9 July 2007, in the Official Gazette Nº 131 from 10 July 2007, section 1, pages 1 to 3. The full text is available only in Portuguese and can be downloaded at: http://extranet.agricultura.gov.br/sislegis-consulta/consultarLegislacao.do?operacao=visualizar&id=17939 E-mail: cgomc@agricultura.gov.br

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 03 August 2007

Health Canada has received submissions to amend the Food and Drug Regulations to permit new uses or new levels of use of the following food additives that are already listed in the Tables to Division 16 of Part B of these Regulations: - calcium sulphate as a binding agent in a blend of prepared fish or meat as described in paragraph B.21.006(n) of the Regulations, for example surimi, to enhance the gel forming capabilities of the product throughout its shelf life, at a maximum level of use of 0.06%; and - to increase the permitted level of use of sorbitol in a blend of prepared fish or meat as described in paragraph B.21.006(n) of the Regulations to provide the desired sweetening effect; the level would be increased from 3.5% to 6.0%. As a means to improve the responsiveness of the regulatory system, Interim Marketing Authorizations (IMA) were issued to permit the immediate use of these food additives. They were published in the "Government Notices" section of the Canada Gazette, Part I, as follows: - on 30 anuary 1999, for calcium sulphate in surimi; and - on 25 August 2001, for sorbitol in a blend of prepared fish and prepared meat as described in paragraph B.21.006(n). These IMAs were issued prior to June 2002, the date when Canada began to notify its IMAs. At the time that these IMAs were issued, it was anticipated that WTO notification would occur later when the appropriate regulatory amendments were published in the Canada Gazette, Part I. However, in July 2006, the Canadian regulatory process was modified to permit regulatory amendments having low significance when assessed against a triage framework to proceed directly to final approval and publication in Canada Gazette, Part II. The IMAs noted above are enabling measures as they allow the sale of additional foods containing the food additive, or the sale of food containing the food additive at higher levels than previously permitted. No concerns or issues have been identified by Canada's trading partners since the IMAs were issued. Accordingly, these regulatory amendments were considered to be of low significance and were permitted to proceed directly to the Canada Gazette, Part II. Therefore, the Food and Drug Regulations have been amended to permit the use of the food additives mentioned above in the specified applications. These IMAs were revoked on 2 May 2007, the date on which these amendments came into force.

Products Covered: Food additives (ICS: 67.220)

Regulation Type: Regular notification