"Draft Commission Decision Concerning the Non-inclusion of cresylic acid, dichlorophen, imazamethabenz, kasugamicin and polyoxin as Active Substances in Annex I to Directive 91/414/EEC and the Withdrawal of Authorizations for Plant Protection Products Containing these Active Substances" (available in English, 6 pages).

Distribution date: 13 July 2004
Provides that cresylic acid, dichlorophen, imazamethabenz, kasugamicin and polyoxin are not included in the positive Community list and that Member States have to withdraw authorizations for plant protection products containing cresylic acid, dichlorophen, imazamethabenz, kasugamicin and polyoxin.
Products Covered: Cereals (CN Headings 1001, 1002, 1003, 1004, 1005, 1006, 1007, 1008), citrus fruits (CN 08.05), certain fruiting vegetables under CN headings 0702 to 0713; cucurbits (CN 0807), pome fruits (CN 0808), stone fruits (CN 0809), strawberries, currants and other berries (CN 0810), cotton (CN 52), tobacco (CN 2401).
Regulation Type: Regular notification
"Draft Commission Decision Concerning the Non-inclusion of cresylic acid, dichlorophen, imazamethabenz, kasugamicin and polyoxin as Active Substances in Annex I to Directive 91/414/EEC and the Withdrawal of Authorizations for Plant Protection Products Containing these Active Substances" (available in English, 6 pages).

Distribution date: 13 July 2004
Provides that cresylic acid, dichlorophen, imazamethabenz, kasugamicin and polyoxin are not included in the positive Community list and that Member States have to withdraw authorizations for plant protection products containing cresylic acid, dichlorophen, imazamethabenz, kasugamicin and polyoxin.
Products Covered: Cereals (CN Headings 1001, 1002, 1003, 1004, 1005, 1006, 1007, 1008), citrus fruits (CN 08.05), certain fruiting vegetables under CN headings 0702 to 0713; cucurbits (CN 0807), pome fruits (CN 0808), stone fruits (CN 0809), strawberries, currants and other berries (CN 0810), cotton (CN 52), tobacco (CN 2401).
Regulation Type: Regular notification
Standards for Pesticide Containers and Containment (3 Pages, in English)

Distribution date: 06 July 2004
On February 11, 1994, EPA published a proposed rule in the Federal Register proposing container design and residue removal requirements for refillable and non-refillable pesticide containers and standards for pesticide containment structures (59 FR 6712). Subsequently, EPA issued a supplemental notice in the Federal Register partially reopening the comment period on several specific issues (64 FR 56918, October 21, 1999). Because significant time has passed since the publication of the proposed rule and the supplemental notice, EPA believes it is appropriate to reopen the comment period prior to preparing a final rule. Specifically, EPA is reopening the comment period to obtain public input on the proposed requirements which would not have been available or could not have been addressed at the time of either the notice of proposed rulemaking in 1994 or the supplemental notice in 1999. EPA is reopening the comment period for the following proposed rule to solicit public input on issues or technology relating to the proposed requirements that would not have been available or could not have been addressed in comments submitted during previous public comment opportunities.
Products Covered: Pesticide Containers and Containment (HS Chapter 3808) (ICS 23.020)
Regulation Type: Regular notification
Standards for Pesticide Containers and Containment (3 Pages, in English)

Distribution date: 06 July 2004
On February 11, 1994, EPA published a proposed rule in the Federal Register proposing container design and residue removal requirements for refillable and non-refillable pesticide containers and standards for pesticide containment structures (59 FR 6712). Subsequently, EPA issued a supplemental notice in the Federal Register partially reopening the comment period on several specific issues (64 FR 56918, October 21, 1999). Because significant time has passed since the publication of the proposed rule and the supplemental notice, EPA believes it is appropriate to reopen the comment period prior to preparing a final rule. Specifically, EPA is reopening the comment period to obtain public input on the proposed requirements which would not have been available or could not have been addressed at the time of either the notice of proposed rulemaking in 1994 or the supplemental notice in 1999. EPA is reopening the comment period for the following proposed rule to solicit public input on issues or technology relating to the proposed requirements that would not have been available or could not have been addressed in comments submitted during previous public comment opportunities.
Products Covered: Pesticide Containers and Containment (HS Chapter 3808) (ICS 23.020)
Regulation Type: Regular notification
Draft TIS 528-2547 (2004) Hot Rolled Flat Carbon Steel of Commercial and Drawing Qualities (17 pages, available in Thai language)

Distribution date: 06 July 2004
The Thai Industrial Standards Institute (TISI) has proposed to withdraw TIS 528-2540(1997) which is a mandatory standard and replace it with TIS 5282547(2004). The standard classifies hot rolled flat carbon steel into four grades based on its application as HR 1 for commercial quality, HR 2 for drawing quality, HR 3 for deep drawing quality and HR 4 for extra deep drawing quality. Specifies basic mass, dimension and tolerances on thickness, width and length, permissible variations and outofsquareness, chemical composition, appearance, tensile strength and elongation and bending. Includes marking, labelling, sampling and criteria for conformity, and testing.
Products Covered: Steels (HS Chapter 7208, ICS: 77.080.20)
Regulation Type: Regular notification
Draft TIS 528-2547 (2004) Hot Rolled Flat Carbon Steel of Commercial and Drawing Qualities (17 pages, available in Thai language)

Distribution date: 06 July 2004
The Thai Industrial Standards Institute (TISI) has proposed to withdraw TIS 528-2540(1997) which is a mandatory standard and replace it with TIS 5282547(2004). The standard classifies hot rolled flat carbon steel into four grades based on its application as HR 1 for commercial quality, HR 2 for drawing quality, HR 3 for deep drawing quality and HR 4 for extra deep drawing quality. Specifies basic mass, dimension and tolerances on thickness, width and length, permissible variations and outofsquareness, chemical composition, appearance, tensile strength and elongation and bending. Includes marking, labelling, sampling and criteria for conformity, and testing.
Products Covered: Steels (HS Chapter 7208, ICS: 77.080.20)
Regulation Type: Regular notification
Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application (9 Pages, in English)

Distribution date: 21 June 2004
The Food and Drug Administration (FDA) is proposing to revise its regulations on its acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) as support for an IND or marketing application for a drug or biological product. We are proposing to replace the requirement that such studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki (Declaration) with a requirement that the studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC). The proposed rule is intended to update the standards for the acceptance of non IND foreign studies and to help ensure the quality and integrity of data obtained from such studies.
Products Covered: Pharmaceutical Clinical Studies (HS Chapter 3004) (ICS 11.120)
Regulation Type: Regular notification
Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application (9 Pages, in English)

Distribution date: 21 June 2004
The Food and Drug Administration (FDA) is proposing to revise its regulations on its acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) as support for an IND or marketing application for a drug or biological product. We are proposing to replace the requirement that such studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki (Declaration) with a requirement that the studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC). The proposed rule is intended to update the standards for the acceptance of non IND foreign studies and to help ensure the quality and integrity of data obtained from such studies.
Products Covered: Pharmaceutical Clinical Studies (HS Chapter 3004) (ICS 11.120)
Regulation Type: Regular notification
Proposed Amendment of the Standards and Specifications of Foods (available in Korean, 7 pages).

Distribution date: 17 June 2004
The KFDA has proposed the following revision to the Standards and Specifications of Foods: Establishment of the maximum residue limits (MRLs) in fowl and duck meat for enrofloxacin; and Revision of analytical method for nitrofurans metaborites and bioassay method for antibiotics in fishes and crustaceans
Products Covered: Products that have enrofloxacin, nitrofurans metaborites and antibiotics
Regulation Type: Regular notification
Proposed Amendment of the Standards and Specifications of Foods (available in Korean, 7 pages).

Distribution date: 17 June 2004
The KFDA has proposed the following revision to the Standards and Specifications of Foods: Establishment of the maximum residue limits (MRLs) in fowl and duck meat for enrofloxacin; and Revision of analytical method for nitrofurans metaborites and bioassay method for antibiotics in fishes and crustaceans
Products Covered: Products that have enrofloxacin, nitrofurans metaborites and antibiotics
Regulation Type: Regular notification
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