Proposed amendments

Public authorities are pushing the food industry as well as the feed industry to develop all-inclusive quality management systems and to improve safety. This is essential in attempting to regain consumers trust in food (Rohr et al., 2005). Organic agriculture and food processes are widely practiced in developed countries, seeking the development of a 

Various different sets of criteria are used to interpret the quality of a food product. The term acceptability is a practical approach when comparing it to the quality limit . Below this limit a product is then rejected. The acceptance limit is mainly defined by economic and physiological factors, whereas the quality of a product is basically defined by its fundamental characteristics. For food products such as fruits and vegetables, properties such as color, firmness, and taste will change over time. Shelf life is calculated as the time before the product qualities drop below the acceptance limit under standardized storage conditions (Tijskens, 2000 Rico et al., 2007). 

In the USDA-FSIS compliance guidelines (USDA-FSIS, 1999, 2001) for chilling of thermally processed meat and poultry products it is stated that the products should be  

OPTION 2 Chilled from 48 to 12.7°C in 6 h with continued cooling to 4.4°C, with the stipulation that the product not be shipped until the temperature reaches 4.4°C (Juneja and Thippareddi, 2004) 

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COM(97j738 Proposal amending 76/769/EEC on the laws relating to restrictions on the marketing and use of... 

This proposed amendment forbids the United States or any State to deny or abridge the right to vote on account of sex. If adopted, it will make several millions of female voters, totally inexperienced in political affairs, quite generally dependent upon the other sex, all incapable (5) of performing military duty and without the power to enforce the laws which their numerical strength may enable them to make, and comparatively very few of whom wish to assume the irksome and responsible political duties which this measure thrusts upon them. 

PhUip Morris et al. (1998) Comments before the Massachusetts Department of Public Health on proposed amendments to regulations entitled cigarette and smokeless tobacco products Reports of added constituents and nicotine ratings. October 2 1998. Massachusetts Department of Public Health. Boston, Massachusetts... 

On the basis of the details referred to in Article 6(3) and in accordance with Article 7, the Ethics Committee shall give an opinion within a maximum of 35 days of the date of receipt of the proposed amendment in good and due form. If this opinion is unfavourable, the sponsor may not implement the amendment to the protocol. If the opinion of the Ethics Committee is favourable and the competent authorities of the Member States have raised no... 

In June, 1984, the EU Commission proposed amending Directive 81/602 to allow the use of natural hormones, and in July the EU Council president requested the European Parliament for an opinion on this proposal. In October, 1985, the European Parliament adopted a resolution on the Commission s proposal. The resolution claimed that scientific information about the five hormonal substances was far from complete and that considerable doubt therefore exists about the desirability of their use and of their effect on human health. It endorsed a ban on zeranol and trenbolone on the grounds that their safety has not been conclusively proven, and rejected the proposed authorization of the three natural hormones except for therapeutic purposes. 

As anticipated, the Biii proposed amendments to the Patent Act it aiso included some related amendments to the Food and Drug Act. 

The FDA in their proposed amendments to the CGMPs [17] have designated that the following unit operations are considered critical and therefore their processing variables must be controlled and not disregarded ... 

U.S. Food and Drug Administration. CGMP Proposed Amendment of Certain Requirements for Finished Pharmaceuticals, 21 CFR Parts 210 and 211, Rockville, MD (1996). 

It seems that the only potentially problematic element here may be criterion (5) thus, a clear explanation would be needed as to why the proposed amendments do not amount to undue favour for certain undertakings/activities, leading to concerns under the EC Treaty s rules on State aid. If the point were to redress such differentiation at present, then this would seem possibly to fit within criterion (5). 

For various reasons, groups such as the American Association of Pharmaceutical Chemists, the National Association of Medicinal Products, and the National Association of Druggists had opposed the bill in its initial form and lobbied actively for a number of modifications resulting in submission of a final form in 1913. Following considerable debate between House and Senate committees over proposed amendments, the Harrison Narcotics Act was passed on December 14, 1914, and went into effect March 1, 1915. Enforcement was assigned to the Bureau of Internal Revenue within the Treasury Department. 

A State Party may propose amendments to this Convention. The proposed amendment shall be submitted to the depositary who shall circulate it immediately to all other State Parties. 

If a majority of the State Parties request the depositary to convene a conference to consider the proposed amendments, the depositary shall invite all State Parties to attend such a conference to begin not sooner than thirty days after the invitations are issued. Any amendment adopted at the conference by a two-thirds majority of all State Parties shall be laid down in a protocol which is open to signature in Vienna and New York by all State Parties. 

Article VII (Amendments) gives each State party the right to propose amendments to the Treaty, the Protocol or the annexes to the Protocol at any time after the Treaty s entry into force. The proposed amendment requires the approval of a majority of State Parties at an amendment conference with no party casting a negative vote. 

Department of Health and Human Services. (1998) Laxative Drug Products for Over-the-Counter Human Use Proposed Amendment to the Tentative Final Monograph. Federal Register. 63, 33592-33595. 

In 1991, a proposed amendment was proposed that would have established a sales cap after which... 

UK submits proposed amendment to the NAP to the Commission following finalisation of Updated Energy Projections November 2004... 

Initial notification to the Commission Provisional NAP in April 2004, with proposed amendments in November 2004... 

Within three months of notification of a national allocation plan by a Member State under paragraph 1, the Commission may reject that plan, or any aspect thereof, on the basis that it is incompatible with the criteria listed in Annex III or with Article 10. The Member State shall only take a decision under Article 11(1) or (2) if proposed amendments are accepted by the Commission. Reasons shall be given for any rejection decision by the Commission. 

A proposal to amend the procedure, to make provision for the review of a Quahty Manual (in place of a Laboratory Information File (LIF)) and to include an inventory audit was discussed. The Committee agreed that the proposed amended procedure be presented to the WHO Legal Counsel for comments before finalization. 

The Committee was informed that there had been a move towards the prequalification of manufacturers of APIs. The focus so far had been on ARVs, antituberculosis and antimalarial substances. A proposed amendment of the WHO GMP guidelines for APIs had been discussed previously but had not been adopted by the Committee. The Committee recommended that ... 

In response, the IEC must give an opinion within a maximum of 35 days of receipt. If this opinion is unfavorable, the sponsor is disallowed from implementing the amendment to the protocol under these circumstances the sponsor should either take account of the grounds for non acceptance and adapt the proposed amendment accordingly or should withdraw the proposed amendment. But, if the IEC and CA approve the amendment, the sponsor is clear to proceed with its clinical application. 

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