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Codex committee on veterinary drug residues.

There has been widespread international concern over residues of veterinary drugs in food. However, until recently, there was little international cooperation in trying to find solutions to the problem. Many nations have taken steps to control the increased use of veterinary drugs, but the rules governing their use vary widely from country to country. Sharing of scientific expertise and other resources between countries would markedly improve this situation. With the need for international cooperation mounting, concerned drug regulators from 20 countries met in 1982 and again in 1984 to discuss international use of veterinary drugs. The group repeatedly called for a Codex committee on veterinary drug residues. At its 1983 meeting in Rome the Codex Alimentarius Commission convened an Expert Consultation to consider the need for a new committee. That international group of experts strongly agreed that a standing committee under the sponsorship of the commission should be established. In July of 1985, the commission unanimously voted to establish a new Committee on Residues of Veterinary Drugs in Food. The United States was chosen as host country. The committee will work closely with several existing Codex committees, but it has a clear mandate of its own. Its responsibilities will include establishing a list of priority drugs for review, recommending maximum residue levels, developing codes of practice, and reviewing analytical methods used to control veterinary drug residues. This fall, a new Codex committee has met for the first time--the Codex Committee on Residues of Veterinary Drugs in Food.(ABSTRACT TRUNCATED AT 250 WORDS)

Agriculture

Codex Committee on Pesticide Residues--a plan for improved participation by governments.

The Codex Committee on Pesticide Residues (CCPR), which is responsible for establishing maximum residue limits (MRLs) for pesticides on food, has a vital role in protecting the public health and facilitating international trade. Codex MRLs are based on scientific evaluations by expert panels that constitute the Joint FAO/WHO Meeting on Pesticide Residues (JMPR). These panelists estimate an acceptable daily intake for a pesticide and expected level of residue remaining in food when the pesticide is used according to good agricultural practice. The goals of the CCPR are not being fully achieved. Governments are generally not accepting Codex MRLs; instead, technical and procedural aspects of the JMPR and CCPR process are being criticized. The CCPR is responding to valid criticisms of the process; however, governments may still lack the will to seek harmonization of pesticide limits for food in international trade. Overcoming this problem will be difficult, but not impossible. A plan of action is proposed that allows countries to selectively accept Codex MRLs, increase the number of chemicals in the JMPR/CCPR system for evaluation, and be responsive to both their consumers and their food producers without compromising national health and safety standards and competitive trade advantages.

Food Contamination

Codex alimentarius approach to pesticide residue standards.

To protect consumers' health, most countries have maximum legal limits for pesticide residues in foods. Trade difficulties can arise when limits differ between countries. The Codex Alimentarius Commission was established in 1962 to implement the Joint FAO/WHO Food Standards Programme, the purpose of which is to protect consumer health and ensure fair practices in international food trade. The Codex Committee on Pesticide Residues (CCPR), an intergovernmental body which advises the Commission on matters related to pesticide residues, is responsible for establishing maximum residue limits (MRLs) for pesticides in foods and feeds that move in international trade. Codex MRLs are based on residue data obtained mainly from supervised trials that reflect approved pesticide use in accordance with "good agricultural practice." MRLs must be toxicologically acceptable in terms of estimated pesticide intake by consumers. CCPR Working Groups examine problems related to establishing and implementing MRLs, including sampling and methods of analysis. Despite time and effort expended, acceptance and application of Codex MRLs face many problems in international trade.

Food Contamination

Collaborative study of the Food Chemicals Codex method for the determination of the neutralizing value of sodium aluminum phosphate.

Fifteen laboratories participated in a collaborative study to evaluate the Food Chemicals Codex method for the determination of the neutralizing value of sodium aluminum phosphate. The AOAC method for determining the neutralizing value of sodium acid pyrophosphate, sec. 8.010, was also included in the study. The precisions of the Food chemicals Codex method, based on the between-replicate standard deviation and on one collaborator making one determination, are 1.16 and 3.66, respectively. The Food Chemicals Codex method for the determination of the neutralizing value of sodium aluminum phosphate has been adopted as official first action.

Aluminum

[The Austrian penal code and the Codex Ur-nammu--a comparison from the forensic medicine viewpoint].

A comparison between the Mesopotamian Law (Codex Ur-nammu) and the Austrian Penal Code reveals the long-sightedness of the founder of the 3rd dynasty from Ur, called Ur-nammu. It seems extremely remarkable that at those remote times (3rd Millenium B. C.) body injuries were satisfied by simple money-penalties. The Codex Ur-nammu therefore not only represents on exceedingly piece of work from the historical point of view but also from the point of view from Legal Medicine.

Austria

Pharmacopoeia as quality codex for the manufacturers.

Three are the basic features of a medicine legally introduced on the market: efficacy, safety and quality. With regarding to drugs listed in a national or international pharmacopoeia, the ratio between efficacy and safety, within the range of dosage established by the codex, must be considered as official by the industry. As far as quality is concerned, the pharmacopoeia plays a fundamental role in establishing methods of analysis and technical control intended as official reference in case of controversy. The quality of drugs, pharmaceutical adjuvants or preparations listed in a modern pharmacopoeia must be considered by the industry as the minimum level of the acceptable standard for medical use, to ensure efficacy under proper storage conditions. In fact, the specifications are largely based upon suggestions made by manufacturers. Pharmaceutical specialties, being registered by Health Authorities following suitable documentation, do not have to be subjected to the standards established by the pharmacopoeia for new drugs or formulation adjuvants. The constant effort of the manufacturers to minimize risks leads to optimum quality levels, considering that samples used for control by the Health Authorities are usually picked from commercial packages containing a small number of units. To ensure statistical compliance of every sample with official pharmacopoeial standards, manufacturers are forced to exercise the highest care in every process of production and packaging. There cannot possibly be a guarantee that every single unit at the consumer's disposal will actually comply with the quality level established by a modern pharmacopoeia. Optimum quality level in every package of medical products can be achieved by following the "Good Manufacturing Practice" sponsored by the WHO; this goal requires skilled people and sophisticated equipment. The practice of quality control as an essential part of the manufacturing process in a wide range of pharmaceuticals, provides an excellent experience that may be useful to the pharmacopoeial commissions. Therefore a closer co-operation between health officials and industry's experts must be considered the best way to improve the specifications, to speed-up the revision of monographs and to collect reports on stability tests. The part of a modern pharmacopoeia, devoted to tests and standards appears today as the most important for the pharmaceutical industry because, when a controversy arises about drugs, the official methods established by the pharmacopoeia play a fundamental role in the enforcement of law. The task of compiling each new edition of a modern pharmacopoeia is becoming increasingly difficult; to speed revision any time a problem arises, the revision committees may seek advice from the numerous experts of the pharmaceutical industry thus achieving a most profitable collaboration.

International Cooperation

Deep immune profiling of intrahepatic cholangiocarcinoma with CODEX multiplexed imaging.

BACKGROUND: Intrahepatic cholangiocarcinoma (iCCA) may be genomically subclassified by the presence of potentially actionable molecular aberrations, of which pathogenic alterations in isocitrate dehydrogenase (IDH)1 and fibroblast growth factor receptor (FGFR)2 are the most frequently observed. The impact of these molecular alterations on the tumor immune microenvironment remains incompletely understood. METHODS: We performed a high-parameter spatial immune phenotyping of iCCA samples with pathogenic FGFR2 or IDH1 alterations and FGFR2/IDH1 wild-type controls at the single-cell level using CO-Detection by indEXing. RESULTS: A total of 24 tumors were examined. Tumors with FGFR2 alterations were characterized by fewer CD8+ T cells and "M2-like" macrophages but higher levels of polymorphonuclear myeloid-derived suppressor cells as compared to FGFR2 wild-type tumors. Spatial relationships between polymorphonuclear myeloid-derived suppressor cells and multiple other cell types in the tumor microenvironment (including tumor cells, CD4+, and CD8+ T cells) were enriched in tumors with FGFR2 alterations. Tumors with IDH1 mutations had a trend toward more fibroblasts and were characterized by a closer proximity of tumor cells to CD4+ T cells, and between macrophages and multiple structural tumor microenvironment components as compared to other subtypes. CONCLUSIONS: iCCAs with pathogenic FGFR2 fusions/rearrangements and IDH1 mutations have distinct immunophenotypes. Tailoring immunotherapeutic approaches to specific molecular subsets could improve treatment outcomes across the divergent molecularly defined iCCA subtypes.

Humans