Regulatory Updates
TITLE: Elemental Mercury Used in Barometers, Manometers, Hygrometers, and Psychrometers; Significant New Use Rule ; ; AGENCY: Environmental Protection Agency (EPA) ; ; ACTION: Final Rule ; ; SUMMARY: EPA is promulgating a significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA) for elemental mercury use in barometers, manometers, hygrometers, and psychrometers. This action will require persons who intend to manufacture (including import) or process elemental mercury for an activity that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. ; ; DATES: This final rule is effective 29 June 2012. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-30/html/2012-13071.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-30/pdf/2012-13071.pdf ;
Distribution date: 12 June 2012
Products Covered: Elemental mercury (HS 2805.40, ICS 13.020, 71.100)
Regulation Type: Addendum to Regular Notification
TITLE: Elemental Mercury Used in Barometers, Manometers, Hygrometers, and Psychrometers; Significant New Use Rule ; ; AGENCY: Environmental Protection Agency (EPA) ; ; ACTION: Final Rule ; ; SUMMARY: EPA is promulgating a significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA) for elemental mercury use in barometers, manometers, hygrometers, and psychrometers. This action will require persons who intend to manufacture (including import) or process elemental mercury for an activity that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. ; ; DATES: This final rule is effective 29 June 2012. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-30/html/2012-13071.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-30/pdf/2012-13071.pdf ;
Distribution date: 12 June 2012
Products Covered: Elemental mercury (HS 2805.40, ICS 13.020, 71.100)
Regulation Type: Addendum to Regular Notification
TITLE: Amendments to Sterility Test Requirements for Biological Products ; ; AGENCY: Food and Drug Administration (FDA), Department of Health and Human Services (HHS) ; ; ACTION: Final rule ; ; SUMMARY: The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products. ; ; DATES: This rule is effective 4 June 2012. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-03/html/2012-10649.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-03/pdf/2012-10649.pdf ; ;
Distribution date: 08 June 2012
Products Covered: Biological products (HS 3002, 3003, 3004, ICS 11.080, 11.100, 11.120)
Regulation Type: Addendum to Regular Notification
TITLE: Amendments to Sterility Test Requirements for Biological Products ; ; AGENCY: Food and Drug Administration (FDA), Department of Health and Human Services (HHS) ; ; ACTION: Final rule ; ; SUMMARY: The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products. ; ; DATES: This rule is effective 4 June 2012. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-03/html/2012-10649.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-03/pdf/2012-10649.pdf ; ;
Distribution date: 08 June 2012
Products Covered: Biological products (HS 3002, 3003, 3004, ICS 11.080, 11.100, 11.120)
Regulation Type: Addendum to Regular Notification
TITLE: Amendments to Sterility Test Requirements for Biological Products ; ; AGENCY: Food and Drug Administration (FDA), Department of Health and Human Services (HHS) ; ; ACTION: Final rule; correction ; ; SUMMARY: The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of 3 May 2012 (77 FR 26162). The final rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The rule was published with an inaccurate citation in the codified section of the rule. This notice corrects that error. ; ; DATES: Effective 4 June 2012. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-24/html/2012-12594.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-24/pdf/2012-12594.pdf ;
Distribution date: 08 June 2012
Products Covered: Biological products (HS 3002, 3003, 3004, ICS 11.080, 11.100, 11.120)
Regulation Type: Corrigendum to Regular Notification
TITLE: Amendments to Sterility Test Requirements for Biological Products ; ; AGENCY: Food and Drug Administration (FDA), Department of Health and Human Services (HHS) ; ; ACTION: Final rule; correction ; ; SUMMARY: The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of 3 May 2012 (77 FR 26162). The final rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The rule was published with an inaccurate citation in the codified section of the rule. This notice corrects that error. ; ; DATES: Effective 4 June 2012. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-24/html/2012-12594.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-24/pdf/2012-12594.pdf ;
Distribution date: 08 June 2012
Products Covered: Biological products (HS 3002, 3003, 3004, ICS 11.080, 11.100, 11.120)
Regulation Type: Corrigendum to Regular Notification
Law No. 10465, date 29.09.2011 "On Veterinary Service in the Republic of Albania" .
Distribution date: 05 June 2012
The purposes of this law are: 1. To protect and improve the health of terrestrial and aquatic animals. 2. To establish the procedures for prevention, monitoring, diagnoses, treatment and eradication of animal diseases. 3. To protect public health against zoonotic diseases transmitted from animals as well as from harmful residues in animal products used for human consumption. 4. To ensure implementation of the sanitary-veterinary measures on the products of animal origin, produced at farm level, raw materials, pastures, water and drinking places for animals. 5. To protect the reproduction health of animals and to ensure the increase of production as well as animal breeding. 6. To protect the environment from infections, poisons, animal wastes and pollutions (biological, physical, chemical, radiobiological) with harmful consequences to animal and human health. 7. To establish the procedures of training and information of the veterinarians, animal owners or keepers and the public on veterinary matters. 8. To protect animals against torture and to provide their welfare. 9. To protect wild animals. 10. To ensure safe disposal of dead animals and their carcasses, confiscates, animal wastes and by-products not for human consumption. 11. To establish obligations of farmers, physical and legal persons, in implementation of this law. This law has the following objectives: 1. Establishing of the main principles for the protection of animal health and welfare in compliance with the international standards of the International Animal Health Organization (OIE) and of the European Union; 2. Arranging, organizing, financing of the Veterinary Service, definition of responsibilities, rules and procedures of the Veterinary Service in the protection of animal health and welfare; 3. Protection of the public health in the Republic of Albania from zoonotic diseases transmitable by animals, approximating the EU legislation. This law has the following chapters: Chapter I: General Provisions. Chapter II: Identification and registration of animals and livestock farms. Chapter III: Protection of animal health and control (based on EU Directive 92/119/EC). Chapter IV: Animal Welfare (based on several EU Directives and Regulations such as Council Directive 98/58; Council Directive 86/609; Council Regulation 1099/2009; Council Regulation 1/2005). Chapter V: Disposal of animal products not for human consumption and environment protection. Chapter VI: Monitoring plan of residues and medicated feed (based on EU Directive 96/22 and EU Directive 96/23). Chapter VII: Veterinary Medicinal Products (based on EU Directive 2001/82). Chapter VIII: Organization and performing of veterinary medicine practice. Chapter IX: State veterinary laboratories and veterinary professional education. Chapter X: Organization and competencies of the Veterinary Service. CHAPTER XI: Final dispositions.
Products Covered: Live animals, food products of animal origin, animal by-product, feed, veterinary medicinal products
Regulation Type: Regular notification
Law No. 10465, date 29.09.2011 "On Veterinary Service in the Republic of Albania" .
Distribution date: 05 June 2012
The purposes of this law are: 1. To protect and improve the health of terrestrial and aquatic animals. 2. To establish the procedures for prevention, monitoring, diagnoses, treatment and eradication of animal diseases. 3. To protect public health against zoonotic diseases transmitted from animals as well as from harmful residues in animal products used for human consumption. 4. To ensure implementation of the sanitary-veterinary measures on the products of animal origin, produced at farm level, raw materials, pastures, water and drinking places for animals. 5. To protect the reproduction health of animals and to ensure the increase of production as well as animal breeding. 6. To protect the environment from infections, poisons, animal wastes and pollutions (biological, physical, chemical, radiobiological) with harmful consequences to animal and human health. 7. To establish the procedures of training and information of the veterinarians, animal owners or keepers and the public on veterinary matters. 8. To protect animals against torture and to provide their welfare. 9. To protect wild animals. 10. To ensure safe disposal of dead animals and their carcasses, confiscates, animal wastes and by-products not for human consumption. 11. To establish obligations of farmers, physical and legal persons, in implementation of this law. This law has the following objectives: 1. Establishing of the main principles for the protection of animal health and welfare in compliance with the international standards of the International Animal Health Organization (OIE) and of the European Union; 2. Arranging, organizing, financing of the Veterinary Service, definition of responsibilities, rules and procedures of the Veterinary Service in the protection of animal health and welfare; 3. Protection of the public health in the Republic of Albania from zoonotic diseases transmitable by animals, approximating the EU legislation. This law has the following chapters: Chapter I: General Provisions. Chapter II: Identification and registration of animals and livestock farms. Chapter III: Protection of animal health and control (based on EU Directive 92/119/EC). Chapter IV: Animal Welfare (based on several EU Directives and Regulations such as Council Directive 98/58; Council Directive 86/609; Council Regulation 1099/2009; Council Regulation 1/2005). Chapter V: Disposal of animal products not for human consumption and environment protection. Chapter VI: Monitoring plan of residues and medicated feed (based on EU Directive 96/22 and EU Directive 96/23). Chapter VII: Veterinary Medicinal Products (based on EU Directive 2001/82). Chapter VIII: Organization and performing of veterinary medicine practice. Chapter IX: State veterinary laboratories and veterinary professional education. Chapter X: Organization and competencies of the Veterinary Service. CHAPTER XI: Final dispositions.
Products Covered: Live animals, food products of animal origin, animal by-product, feed, veterinary medicinal products
Regulation Type: Regular notification
Partial amendment to the Minimum Requirements for Biological Products (1 page , available in English)
Distribution date: 30 May 2012 | Final date for Comment: 19 June 2012
The Minimum Requirements for Biological Products shall be partially amended to revise the standard for the Blood Products.
Products Covered: Drugs(HS: 30)
Regulation Type: Regular notification
Partial amendment to the Minimum Requirements for Biological Products (1 page , available in English)
Distribution date: 30 May 2012 | Final date for Comment: 19 June 2012
The Minimum Requirements for Biological Products shall be partially amended to revise the standard for the Blood Products.
Products Covered: Drugs(HS: 30)
Regulation Type: Regular notification
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