Regulatory Updates

Distribution date: 04 February 2011

EPA proposes to declare a prion (i.e., proteinaceous infectious particle) a “pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and to amend its regulations to expressly include prion within the regulatory definition of pest. EPA currently considers a prion to be a pest under FIFRA, so a product intended to reduce the infectivity of any prion on inanimate surfaces (i.e., a “prion-related product”) is considered to be a pesticide and regulated as such. Any company seeking to distribute or sell a pesticide product regulated under FIFRA must obtain a section 3 registration, section 24(c) registration, or a section 18 emergency exemption before it can be distributed or sold in the United States. This proposed rule would codify the Agency's current interpretation of FIFRA, and provides interested parties the opportunity to comment about how it is adding prion to the list of pests in the regulatory definition of pest. This amendment, together with the formal declaration that a prion is a pest, will eliminate any confusion about the status of prion-related products under FIFRA. Codifying the Agency's current interpretation of FIFRA will not change the manner in which EPA currently regulates prion-related products under FIFRA sections 3, 24(c) and 18. Regulating prion-related products under FIFRA is appropriate for protecting human health and the environment against unreasonable adverse effects and ensuring that such products are effective. ;

Products Covered: Pesticides (HS 3808; ICS 13.020, 65.100)

Regulation Type: Regular notification

Distribution date: 04 February 2011

EPA proposes to declare a prion (i.e., proteinaceous infectious particle) a “pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and to amend its regulations to expressly include prion within the regulatory definition of pest. EPA currently considers a prion to be a pest under FIFRA, so a product intended to reduce the infectivity of any prion on inanimate surfaces (i.e., a “prion-related product”) is considered to be a pesticide and regulated as such. Any company seeking to distribute or sell a pesticide product regulated under FIFRA must obtain a section 3 registration, section 24(c) registration, or a section 18 emergency exemption before it can be distributed or sold in the United States. This proposed rule would codify the Agency's current interpretation of FIFRA, and provides interested parties the opportunity to comment about how it is adding prion to the list of pests in the regulatory definition of pest. This amendment, together with the formal declaration that a prion is a pest, will eliminate any confusion about the status of prion-related products under FIFRA. Codifying the Agency's current interpretation of FIFRA will not change the manner in which EPA currently regulates prion-related products under FIFRA sections 3, 24(c) and 18. Regulating prion-related products under FIFRA is appropriate for protecting human health and the environment against unreasonable adverse effects and ensuring that such products are effective. ;

Products Covered: Pesticides (HS 3808; ICS 13.020, 65.100)

Regulation Type: Regular notification

Distribution date: 03 February 2011 | Final date for Comment: 04 April 2011

Article 4.2 of this standard is mandatory, the remaining ones are recommended. The mandatory contents are the prescribed requirements which should be met by fluted medicament fully mixed with antioxidant.

Products Covered: Fireworks and firecrackers ICS: 71.100.30 HS: 36041000

Regulation Type: Regular notification

Distribution date: 03 February 2011 | Final date for Comment: 04 April 2011

Article 4.2 of this standard is mandatory, the remaining ones are recommended. The mandatory contents are the prescribed requirements which should be met by fluted medicament fully mixed with antioxidant.

Products Covered: Fireworks and firecrackers ICS: 71.100.30 HS: 36041000

Regulation Type: Regular notification

Distribution date: 03 February 2011 | Final date for Comment: 04 April 2011

This standard specifies the classifications, requirements, test methods, inspection rules, package, marking, storage and transportation for black powder used in fireworks and firecrackers. This standard applies to the production, sale, acceptance and storage of black powder used in fireworks and firecrackers. It doesn’t apply to black powder for civil explosive and military gunpowder.

Products Covered: Fireworks and firecrackers ICS: 71.100.30 HS: 36041000

Regulation Type: Regular notification

Distribution date: 03 February 2011 | Final date for Comment: 04 April 2011

This standard specifies the classifications, requirements, test methods, inspection rules, package, marking, storage and transportation for black powder used in fireworks and firecrackers. This standard applies to the production, sale, acceptance and storage of black powder used in fireworks and firecrackers. It doesn’t apply to black powder for civil explosive and military gunpowder.

Products Covered: Fireworks and firecrackers ICS: 71.100.30 HS: 36041000

Regulation Type: Regular notification

Distribution date: 03 February 2011 | Final date for Comment: 04 April 2011

Chapters 4 and 6 of this standard are mandatory, the rest ones are recommended. The mandatory contents are the requirements, marking, packaging, transportation and storage of virulent arsenic trioxide. ;

Products Covered: Arsenic trioxide, ICS: 71.060

Regulation Type: Regular notification

Distribution date: 03 February 2011 | Final date for Comment: 04 April 2011

Chapters 4 and 6 of this standard are mandatory, the rest ones are recommended. The mandatory contents are the requirements, marking, packaging, transportation and storage of virulent arsenic trioxide. ;

Products Covered: Arsenic trioxide, ICS: 71.060

Regulation Type: Regular notification

Distribution date: 01 February 2011 | Final date for Comment: 13 March 2011

Draft technical regulation which establishes the criteria to indicate the label’s or tag’s description and quantitative content for products to be marketed. It revokes the Ministerial Act Nº 27, 27 January 1989.

Products Covered: Paints and varnishes (including enamels and lacquers) based on synthetic polymers or chemically modified natural polymers, dispersed or dissolved in a non-aqueous médium (HS 3208); Paints and varnishes (including enamels and lacquers) based on synthetic polymers or chemically modified natural polymers, dispersed or dissolved in an aqueous médium ( HS 3209).

Regulation Type: Regular notification

Distribution date: 01 February 2011 | Final date for Comment: 13 March 2011

Draft technical regulation which establishes the criteria to indicate the label’s or tag’s description and quantitative content for products to be marketed. It revokes the Ministerial Act Nº 27, 27 January 1989.

Products Covered: Paints and varnishes (including enamels and lacquers) based on synthetic polymers or chemically modified natural polymers, dispersed or dissolved in a non-aqueous médium (HS 3208); Paints and varnishes (including enamels and lacquers) based on synthetic polymers or chemically modified natural polymers, dispersed or dissolved in an aqueous médium ( HS 3209).

Regulation Type: Regular notification