Regulatory Updates

Distribution date: 19 July 2007

Proposes a national reactivity-based volatile organic compound (VOC) emissions regulation for the aerosol coatings (aerosol spray paints) category under section 183(e) of the Clean Air Act (CAA). The proposed standards implement section 183(e) of the CAA, as amended in 1990, which requires the Administrator to control VOC emissions from certain categories of consumer and commercial products for purposes of minimizing VOC emissions contributing to ozone formation and causing non-attainment. This regulation will establish a nationwide reactivity-based standard for aerosol coatings. States have promulgated rules for the aerosol coatings category based upon reductions of VOC by mass; however, the Agency believes that a national rule based upon the relative reactivity approach may achieve more reduction in ozone formation than can be achieved by a mass-based approach for this specific product category. EPA believes that this rule will better control a product's contribution to ozone formation by encouraging the use of less reactive VOC ingredients, rather than treating all VOC in a product alike through the traditional mass-based approach. EPA is also proposing to revise EPA's regulatory definition of VOC exempt compounds for purposes of this regulation in order to account for all the reactive compounds in aerosol coatings that contribute to ozone formation. Therefore, compounds that would not be VOC under the otherwise applicable definition will count towards a product's reactivity limits under this proposed regulation. The initial listing of product categories and schedule for regulation was published on March 23, 1995 (60 FR 15264). This proposed action announces EPA's final decision to list aerosol coatings for regulation under group III of the consumer and commercial product category for which regulations are mandated under section 183 (e) of the Act.

Products Covered: Aerosol spray coatings (HS:  29;  ICS:  87.040, 87.060, 71.100, 71.080, 13.020)

Regulation Type: Regular notification

Distribution date: 13 July 2007 | Final date for Comment: 31 August 2007

To establish sanitation standard for food use detergents

Products Covered: Food Use Detergents

Regulation Type: Regular notification

Distribution date: 09 July 2007

The Food and Drug Administration (FDA) is proposing to reclassify the device, tissue adhesive for the topical approximation of skin, from class III (premarket approval) into class II (special controls). Tissue adhesives for non-topical uses would remain in class III and continue to require premarket approval applications (PMAs). FDA is proposing this reclassification in accordance with the Federal Food, Drug, and Cosmetic Act.

Products Covered: Tissue adhesive; (HS:  3006.10;  ICS:  11.040)

Regulation Type: Regular notification

Distribution date: 09 July 2007

The change and supplement to the Rules will enable Slovenia to consider also the maximum pesticide residual levels (MRL) as defined nationally in other EU countries. In general, considering the uncertainty of the measurement of 50% that covers the inter-laboratory variability between the laboratories and is recommended to be used by regulatory authorities in cases of enforcement of the decision. Competence of the inspectors is defined more evidently.

Products Covered: HS:  3808; ICS:  65.100

Regulation Type: Regular notification

Distribution date: 03 July 2007

Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC. (OJ L 125, 23.5.1996, p. 3- 9) prohibits the use of oestradiol 17  and its ester like derivatives to include therapeutic and zootechnical use in farm animals as well as other five hormones (testosterone, progesterone, trembolone acetate, zeranol and melengestrol acetate) for growth promotion purposes in farm animals, on a provisional basis. The latest modification of this Directive was notified in Document G/SPS/N/EEC/102/Rev.1/Add.1 (dated 23 October 2003). A consolidated text (EN/FR/ES) is available from the links indicted below: http://eur-lex.europa.eu/LexUriServ/site/en/consleg/1996/L/01996L0022-20031014-en.pdf http://eur-lex.europa.eu/LexUriServ/site/fr/consleg/1996/L/01996L0022-20031014-fr.pdf http://eur-lex.europa.eu/LexUriServ/site/es/consleg/1996/L/01996L0022-20031014-es.pdf Now, the European Commission, in document COM(2007) 292 final, 2007/0102 (COD) notifies a Proposal for a Directive of the European Parliament and of the Council amending Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyreostatic action and of beta agonists. This proposal prohibits completely the use of oestradiol 17β in food-producing animals and removes pet animals from the scope of the Council Directive 96/22/EC. The text (ENG/FRA/ESP) is available in the following links http://eur-lex.europa.eu/LexUriServ/site/en/com/2007/com2007_0292en01.pdf http://eur-lex.europa.eu/LexUriServ/site/fr/com/2007/com2007_0292fr01.pdf http://eur-lex.europa.eu/LexUriServ/site/es/com/2007/com2007_0292es01.pdf Proposed date of adoption: End of 2008. Note: This proposal follows the co-decision procedure (Article 251 of the EC Treaty). Information of its progress through the European Parliament and the Council is available from Pre-Lex, at the links indicated below (ENG/FRA/ESP): http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=en&DosId=195794 http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=fr&DosId=195794 http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=es&DosId=195794 Proposed date of application: Cannot be given at this stage of the co-decision procedure (see above). Final date for comments: 60 days after date of notification

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 03 July 2007

Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC. (OJ L 125, 23.5.1996, p. 3- 9) prohibits the use of oestradiol 17  and its ester like derivatives to include therapeutic and zootechnical use in farm animals as well as other five hormones (testosterone, progesterone, trembolone acetate, zeranol and melengestrol acetate) for growth promotion purposes in farm animals, on a provisional basis. The latest modification of this Directive was notified in Document G/SPS/N/EEC/102/Rev.1/Add.1 (dated 23 October 2003). A consolidated text (EN/FR/ES) is available from the links indicted below: http://eur-lex.europa.eu/LexUriServ/site/en/consleg/1996/L/01996L0022-20031014-en.pdf http://eur-lex.europa.eu/LexUriServ/site/fr/consleg/1996/L/01996L0022-20031014-fr.pdf http://eur-lex.europa.eu/LexUriServ/site/es/consleg/1996/L/01996L0022-20031014-es.pdf Now, the European Commission, in document COM(2007) 292 final, 2007/0102 (COD) notifies a Proposal for a Directive of the European Parliament and of the Council amending Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyreostatic action and of beta agonists. This proposal prohibits completely the use of oestradiol 17β in food-producing animals and removes pet animals from the scope of the Council Directive 96/22/EC. The text (ENG/FRA/ESP) is available in the following links http://eur-lex.europa.eu/LexUriServ/site/en/com/2007/com2007_0292en01.pdf http://eur-lex.europa.eu/LexUriServ/site/fr/com/2007/com2007_0292fr01.pdf http://eur-lex.europa.eu/LexUriServ/site/es/com/2007/com2007_0292es01.pdf Proposed date of adoption: End of 2008. Note: This proposal follows the co-decision procedure (Article 251 of the EC Treaty). Information of its progress through the European Parliament and the Council is available from Pre-Lex, at the links indicated below (ENG/FRA/ESP): http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=en&DosId=195794 http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=fr&DosId=195794 http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=es&DosId=195794 Proposed date of application: Cannot be given at this stage of the co-decision procedure (see above). Final date for comments: 60 days after date of notification

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 29 June 2007 | Final date for Comment: 28 August 2007

Withdrawal of the maximum residue limits for avoparcin (Feed additive and veterinary drug) on all commodities listed under Item 3.

Products Covered: Cattle (muscle, fat, liver, kidney and other edible offal), pig (muscle, fat, liver, kidney and other edible offal), other terrestrial mammals (muscle, fat, liver, kidney and other edible offal), milk, chicken (muscle, fat, liver, kidney and other edible offal), other poultry (muscle, fat, liver, kidney and other edible offal)

Regulation Type: Regular notification

Distribution date: 29 June 2007 | Final date for Comment: 28 August 2007

Withdrawal of the maximum residue limits for avoparcin (Feed additive and veterinary drug) on all commodities listed under Item 3.

Products Covered: Cattle (muscle, fat, liver, kidney and other edible offal), pig (muscle, fat, liver, kidney and other edible offal), other terrestrial mammals (muscle, fat, liver, kidney and other edible offal), milk, chicken (muscle, fat, liver, kidney and other edible offal), other poultry (muscle, fat, liver, kidney and other edible offal)

Regulation Type: Regular notification

Distribution date: 29 June 2007 | Final date for Comment: 28 August 2007

Establishment of maximum residue limits for veterinary drug, difloxacin, in foods

Products Covered: Pig (muscle, fat, liver, kidney and other edible offal)

Regulation Type: Regular notification

Distribution date: 29 June 2007 | Final date for Comment: 28 August 2007

Establishment of maximum residue limits for veterinary drug, difloxacin, in foods

Products Covered: Pig (muscle, fat, liver, kidney and other edible offal)

Regulation Type: Regular notification