Protection of Stratospheric Ozone: Listing of Ozone Depleting Substitutes in Foam Blowing (9 pages, in English)

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Distribution date: 10 November 2005 | Final date for Comment: 22 April 2025

Today the Environmental Protection Agency (EPA) is proposing to determine that HCFC-22 and HCFC-142b are unacceptable for use in the foam sector under the Significant New Alternatives Policy (SNAP) Program under section 612 of the Clean Air Act. The SNAP program reviews alternatives to Class I and Class II ozone depleting substances and approves use of alternatives which do not present a greater risk to public health and the environment than the substance they replace or than other available substitutes. Specifically, EPA is taking two actions. First, in response to a court decision upholding a challenge to EPA's July 2002 final rule finding HCFC-22 and HCFC-142b acceptable subject to Narrowed Use Limits in three foam end uses, we are proposing to find HCFC-22 and HCFC-142b unacceptable as substitutes for HCFC-141b in the foam end uses of commercial refrigeration, sandwich panels, slabstock and "other" foams. Second, in the July 2002 final rule, EPA withdrew a proposed action to find HCFC-22 and HCFC-142b unacceptable as substitutes for CFCs in all foam end uses. We are now issuing a new proposal to find HCFC-22 and HCFC-142b unacceptable as substitutes for CFCs in all foam end uses.

Products Covered: Ozone Depleting Substances (HS Chapter:  3824;  ICS:  13)

Regulation Type: Regular notification

Protection of Stratospheric Ozone: Listing of Ozone Depleting Substitutes in Foam Blowing (9 pages, in English)

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Distribution date: 10 November 2005 | Final date for Comment: 22 April 2025

Today the Environmental Protection Agency (EPA) is proposing to determine that HCFC-22 and HCFC-142b are unacceptable for use in the foam sector under the Significant New Alternatives Policy (SNAP) Program under section 612 of the Clean Air Act. The SNAP program reviews alternatives to Class I and Class II ozone depleting substances and approves use of alternatives which do not present a greater risk to public health and the environment than the substance they replace or than other available substitutes. Specifically, EPA is taking two actions. First, in response to a court decision upholding a challenge to EPA's July 2002 final rule finding HCFC-22 and HCFC-142b acceptable subject to Narrowed Use Limits in three foam end uses, we are proposing to find HCFC-22 and HCFC-142b unacceptable as substitutes for HCFC-141b in the foam end uses of commercial refrigeration, sandwich panels, slabstock and "other" foams. Second, in the July 2002 final rule, EPA withdrew a proposed action to find HCFC-22 and HCFC-142b unacceptable as substitutes for CFCs in all foam end uses. We are now issuing a new proposal to find HCFC-22 and HCFC-142b unacceptable as substitutes for CFCs in all foam end uses.

Products Covered: Ozone Depleting Substances (HS Chapter:  3824;  ICS:  13)

Regulation Type: Regular notification

Normative Instruction Nº 28, issued on 26 September 2005, published in the "Diário Oficial da União" Nº 193 (Federal Official Journal) from 6 October 2005, section 1, page 13 (Available only in Portuguese, a single page). The text may be downloaded from the following Internet site: http://oc4j.agricultura.gov.br/agrolegis/do/consultaLei?op=viewTextual&codigo=13473

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Distribution date: 16 November 2005 | Final date for Comment: 22 April 2025

Draft normative instruction that approves the “Technical regulation for research, development, production, evaluation, registration and permit renewal, trade and use of vaccine against canine visceral leishmaniasis.

Products Covered: Vaccine against Canine Visceral Leishmaniasis

Regulation Type: Regular notification

Animal diseases Animal health Zoonoses Veterinary drugs

Normative Instruction Nº 28, issued on 26 September 2005, published in the "Diário Oficial da União" Nº 193 (Federal Official Journal) from 6 October 2005, section 1, page 13 (Available only in Portuguese, a single page). The text may be downloaded from the following Internet site: http://oc4j.agricultura.gov.br/agrolegis/do/consultaLei?op=viewTextual&codigo=13473

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Distribution date: 16 November 2005 | Final date for Comment: 22 April 2025

Draft normative instruction that approves the “Technical regulation for research, development, production, evaluation, registration and permit renewal, trade and use of vaccine against canine visceral leishmaniasis.

Products Covered: Vaccine against Canine Visceral Leishmaniasis

Regulation Type: Regular notification

Animal diseases Animal health Zoonoses Veterinary drugs

Ordinance on the simplified authorization procedure and the reporting obligation for medicines, (19 pages and additional annex, available in German, French and Italian)

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Distribution date: 16 November 2005 | Final date for Comment: 22 April 2025

Products Covered: Medicines

Regulation Type: Regular notification

Ordinance on the simplified authorization procedure and the reporting obligation for medicines, (19 pages and additional annex, available in German, French and Italian)

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Distribution date: 16 November 2005 | Final date for Comment: 22 April 2025

Products Covered: Medicines

Regulation Type: Regular notification

Ordinance on complementary and herbal medicinal products, 37 pages and additional annexes, (available in German, French and Italian).

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Distribution date: 16 November 2005 | Final date for Comment: 22 April 2025

Products Covered: Complementary and herbal medicinal products

Regulation Type: Regular notification

Ordinance on complementary and herbal medicinal products, 37 pages and additional annexes, (available in German, French and Italian).

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Distribution date: 16 November 2005 | Final date for Comment: 22 April 2025

Products Covered: Complementary and herbal medicinal products

Regulation Type: Regular notification

Administrative Resolution No. 009/2005 (2 pages, in Spanish).

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Distribution date: 16 November 2005 | Final date for Comment: 22 April 2025

This Resolution prohibits the use throughout national territory of veterinary products and inputs containing chloramphenicol, given the scientific evidence showing the genotoxicity of the product as well as the problems associated with aplastic anaemias, blood dyscrasias and hypersensitivity phenomena in humans. The Resolution cancels veterinary products and inputs containing chloramphenicol within Bolivia; such products can therefore not be imported into the country. It does not apply to chloramphenicol-based products for collyria and topical use in dogs, cats, ornamental birds, horses and other species not intended for human consumption.

Products Covered: Veterinary products and inputs containing chloramphenicol throughout national territory

Regulation Type: Regular notification

Food safety Animal health Human health Veterinary drugs Maximum residue limits (MRLs)

Administrative Resolution No. 009/2005 (2 pages, in Spanish).

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Distribution date: 16 November 2005 | Final date for Comment: 22 April 2025

This Resolution prohibits the use throughout national territory of veterinary products and inputs containing chloramphenicol, given the scientific evidence showing the genotoxicity of the product as well as the problems associated with aplastic anaemias, blood dyscrasias and hypersensitivity phenomena in humans. The Resolution cancels veterinary products and inputs containing chloramphenicol within Bolivia; such products can therefore not be imported into the country. It does not apply to chloramphenicol-based products for collyria and topical use in dogs, cats, ornamental birds, horses and other species not intended for human consumption.

Products Covered: Veterinary products and inputs containing chloramphenicol throughout national territory

Regulation Type: Regular notification

Food safety Animal health Human health Veterinary drugs Maximum residue limits (MRLs)

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