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.     

The impact of food regulation on the food supply chain

Food regulation in the main is aimed at protecting the consumer's health, increasing economic viability, harmonizing well-being and engendering fair trade on foods within and between nations. Consumers nowadays are faced with food or food ingredients that may derive from distant countries or continents, and with a less transparent food supply. Safety concerns must cover the range of different food chains relevant to a certain food product or product group, including all relevant producers, manufacturing sites and food service establishments within a country as well as those importing into the country. Hazard analysis at critical control points (HACCP), good manufacturing practice (GMP) and good hygiene practice (GHP) are major components of the safety management systems in the food supply chain. Principally, "a hazard" is a biological, chemical or physical agent in, or condition of, food that has the potential to cause an adverse health effect. The likelihood of occurrence and severity of the same is important for the assessment of the risk presented by the hazard to the food supply chain. The Government's regulatory mechanisms in accordance with the WTO agreements (HACCPs, sanitary and phytosanitary measures, etc.) oversee the analyses of public health problems and their association to the food supply. Under the WTO SPS Agreements and the codes of practices issued by the Codex Alimentarius Commission, there now exists a benchmark for international harmonization that guarantee the trade of safe food. Inevitably, food safety is still mainly the responsibility of the consumer.     

Scientific issues related to Codex Alimentarius goals: a review of principles, with examples

The Codex Alimentarius provides the food standards and guidelines recognized by the World Trade Organization as the primary authority for use in settlement of related trade disputes. Codex bases its decisions primarily on scientific principles and evidence, although other legitimate factors such as economic and societal values may be considered. Codex has two primary aims: to protect consumers' health and assure fair practices in food trade. Codex documents may provide templates for individual nations but are not binding for domestic policies. Despite many advances over the last couple of decades, misunderstandings and controversies have interfered with important aspects of progress which Codex needs to accomplish, especially in the areas of claims of benefits related to food or nutrient consumption and the establishment of the safety of these items. Claims for health benefits should be based on the totality of available scientific evidence, including observational data collected from large populations as well as the results from randomized clinical trials. Safety should be evaluated by risk assessment on high quality experimental data, with anecdotal information having a lesser role. Regulatory policy would be improved if "history of safe use" were to be better defined and described.     

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)     

Harmonisation of food consumption data format for dietary exposure assessments of chemicals analysed in raw agricultural commodities

In this paper, we present an approach to format national food consumption data at raw agricultural commodity (RAC) level. In this way, the data is both formatted in a harmonised way given the comparability of RACs between countries, and suitable to assess the dietary exposure to chemicals analysed in RACs at a European level. In this approach, consumption data needs to be converted to edible part of RAC (e-RAC) level using a RAC conversion database. To subsequently use this data in exposure assessments, both e-RACs and RACs analysed in chemical control programmes should be classified via a uniform system. Furthermore, chemical concentrations in RACs may need to be converted to e-RAC level using processing factors. To illustrate the use of this approach, we describe how the Dutch RAC conversion database was used to convert consumption data of four national consumption surveys to e-RAC level, and the use of the FAO/WHO Codex Classification system of Foods and Animal Feeds to harmonise the classification. We demonstrate that this approach works well for pesticides and glycoalkaloids, and is an essential step forward in the harmonisation of risk assessment procedures within Europe when addressing chemicals analysed in RACs by all national food control systems.     

The role of science in international trade law

While the General Agreement on Tariffs and Trade addressed overt barriers to international trade, the current focus of international trade rules has shifted to less obvious, but in many cases no less restrictive, barriers to trade, such as protectionist measures adopted under the guise of health and safety standards. The new agreements established under the World Trade Organization ("WTO"), including the Agreement on the Application of Sanitary and Phytosanitary Measures ("SPS Agreement"), the Agreement on Technical Barriers to Trade ("TBT Agreement"), provide important tools that can be invoked by governments and used by stakeholders to address regulatory barriers that were once thought outside the purview of international trade rules. Non-science based regulations can be and have been successfully challenged under the SPS and TBT Agreements, which prohibit WTO Members from maintaining laws or regulations that adversely affect trade unless such measures are scientifically justified. Stakeholders should use to the fullest extent possible international trade rules to eliminate non-science based regulations that adversely affect trade in the goods that they produce.     

Food allergy and intolerance: an international chemical safety perspective

Chemical safety is concerned with the assessment of human health (and environmental) risks and their management. The safety of chemicals in food, present as normal constituents, intentional additives, contaminants or residues is part of chemical safety. Morbidity and mortality due to allergenic chemicals and allergic hypersensitization are being addressed on a global basis. As part of this, international efforts are being made to establish the prevalence of respiratory and dermal allergies in all countries and it is timely to extend this to food allergies. A number of international organizations are involved in the assessment of chemical risk and risk management. Information exchange is a vital part of these processes. The International Programme on Chemical Safety is an example of a cooperative programme of three organizations with close links and coordination with other bodies and organizations concerned with safe and sustainable use of chemicals.     

Regulation of Herbal and Homeopathic Medicines

Currently, national and international regulations for herbal products and homeopathic remedies are subject to extensive review and revision. This is a result of increased consumer demand and a growth in the international marketing of these products. New legislation addresses issues such as concerns regarding product quality, accessibility, depletion of sources of plants leading to extinction, and toxic effects of some medicinal herbs. Evidence-based medicine has increased the need for demonstrable efficacy and safety. Homeopathic products are safe and generally conform to proscribed quality standards but proving therapeutic effectiveness has been controversial. The long-term future for this widely used system of complementary medicine requires more research with positive outcomes. More quality research is required on the efficacy and safety of many herbal health products. Approaches to regulation and licensing of herbal and homeopathic products vary among countries and cultures. There is a need for greater international harmonization and homogeneity. Canada has adopted legislation introducing a Natural Health Products Directorate responsible for a wide range of complementary medicines including herbal and homeopathic products. The objective is to provide ready access to these therapeutic agents while ensuring quality, safety, and efficacy. Products that provide health benefits and resemble food are considered as Functional Foods under food legislation. Regulators in the European Union (EU) are developing legislation to facilitate international trade in herbal and homeopathic products within the Union. Member countries have their own laws, which must be adapted to conform to those of the central parliament. Australia regulates herbal products and homeopathic remedies under the Therapeutic Products Act, 1989, where they are considered as medicines. Homeopathic agents constitute a special section, with modified standards. Countries which accept homeopathic therapy generally acknowledge compendial standards in major national homeopathic pharmacopoeias. This inhibits licensing approval for any new product or delivery system not in the compendia. The US categorizes most herbal products as supplements under the Dietary Supplement Health Education Act of 1994. There is postmarket notification and the US FDA has to demonstrate any problem with safety. The World Health Organization (WHO) is promoting standards for regulating Traditional Medicine, including quality, safety, and efficacy. Important therapeutic systems covered by WHO include those of China, Japan (Kampo) and India (Ayurveda). New regulations for herbal products will enable the consumer to make informed choices based upon improved research data, quality standards, and product labeling.     

New trends in the development of occupational exposure limits for airborne chemicals in China

Occupational exposure limits (OELs) are well established in many countries, which serve occupational professionals as benchmarks of industrial hygiene practice at workplaces worldwide. Starting in the mid-1950s, the central government of China began promulgating OELs for hazardous substances at workplaces. This paper discusses the historical basis, philosophical principles and schematic protocols of developing and setting OELs in China. The underlying principles include: (1) protection of human health being the first and the most important criterion; (2) the use of quantitative epidemiological studies in humans being given top priority; (3) integration and full use of all information sources, including animal experimental data for new chemicals or chemicals with new toxicity concerns; (4) considerations of socioeconomic and technological feasibilities in the country; and (5) amending existing standards based on new evidence. The strategy of the World Health Organization's "Two-step Procedure" is applied to convert health-based recommendations to law-based operational OELs, with considerations for national technological and socioeconomic conditions and priorities. As a result of the recent passage of the new law Occupational Diseases Prevention and Control Act of the People's Republic of China (ODPCAct), an official document Occupational Exposure Limits for Hazardous Agents in the Workplace containing a comprehensive list of new and amended OELs has been issued, which has now become one of the most essential regulations affiliated with the ODPCAct. This paper provides a brief summary of the salient features of the new law ODPCAct and the principles and processes of developing or amending OELs. This paper also discusses the challenges that lie ahead in enforcing the new regulations in China.     

Balancing risks

Regulatory policies designed to reduce the health risk of environmental and/or synthetic chemicals generally aim for zero or negligible levels. Foods, on the other hand, especially those with a long history in the human diet, have been treated as essentially safe, even though they too contain various chemicals including nutrients. The recent debate on the presence in food of acrylamide, a possible human carcinogen, is likely to shake up the traditional paradigm held by regulatory agencies on chemical health risks. The current stance on the safety of acrylamide in food seems to be an extension of the traditional approach to assessment of environmental and/or synthetic chemicals. However, even foods which have long been a part of the human diet contain components that do not necessarily meet the safety margins applied to environmental and/or synthetic chemicals. In the future, a greater understanding of the effect of these agents on biological systems as well as the development of analytical methods for testing will result in many questions being raised concerning chemicals in foods, such as acrylamide which is under scrutiny today. Regulatory policies currently employ various standards for controlling chemical risk. These standards are dependent upon the labeling of the chemical in question, e.g., whether carcinogenic or non-carcinogenic, synthetic or natural, or whether a food or industrial chemical. Regardless of labeling, all chemicals to which we are exposed should be evaluated on an equal footing. Then, according to the level of the identified health risk, regulations could or could not be applied based on local circumstances, e.g., public acceptance, voluntary risk vs. involuntary risk, etc. In order to create a standardized system for chemical risk assessment, the introduction of uniform measures is essential. Loss of life expectancy (LLE) is one possible measure to assess chemical health risk. When LLE has been used, animal toxicity data have indicated that an ad libitum diet intake has considerably more impact on health risk than the acrylamide concentration of the ingested food. Reassessing the health effects of chemicals with a system of uniform measures could reveal many risks that need to be preferentially addressed above and beyond keeping minor toxicants to zero or negligible levels. Recognition of such risks may result in changes that conflict with existing regulations. In any case, whether consciously or unconsciously, people have always been exposed to a certain degree of chemical risk in their daily life. Based on the premise that the public can accept some degree of chemical risk in balance with other risks in their lives, regulatory bodies should be able to take a flexible and effective approach. In order to efficiently and comprehensively maximize the protection of our health against potential harm from chemicals using limited public resources, it is now time for regulatory agencies to restructure their policy frameworks across categories for controlling chemical health risks.     

国家药品标准物质供应工作现状与探讨

目的 探讨国家药品标准物质供应工作发展方向.方法 介绍国家药品标准物质供应工作现状,探讨需要加强和改进的方面.结果与结论 随着我国药品标准物质工作的不断发展,国家药品标准物质供应会更快捷、更先进、更完善,并逐步确立在国际市场上的地位,为保证人类用药安全起到积极的作用.     

Significance of regulation limits in mycotoxin contamination in Asia and risk management programs at the national level

Mycotoxins are the secondary metabolites produced from toxigenic fungi recognized as major food and feed contaminants. They are a source of grave concern in food contamination, resulting in mycotoxicosis in humans and animals. To date, many regulations on the allowable levels of each mycotoxin have been established in several countries. Consumers and food producers expect that toxin contamination in food and feed, based on government regulations and guideline levels, should have no adverse consequences on human and animal health. This review is an extension of the discussions during the international seminar entitled Risk Assessment and Risk Management of Mycotoxins for Food Safety in Asia, which was jointly organized by Kasetsart University (Thailand) and the Food and Fertilizer Technology Center for the Asian and Pacific Region (Taiwan) and held in Chonburi, Thailand, in September 2011. In this review, we discuss the recent findings on mycotoxins in food and feed, with emphasis on aflatoxins, fumonisins, ochratoxins, and zearalenone, as well as the national management programs that will supply a wider knowledge base for establishing appropriate control measures for mycotoxins in Asian countries. However, we believe that continuing support from national governments and regional communities is essential to encourage and fund activities that contribute to a reliable exposure risk assessment and risk management of mycotoxins in the region, and also to improve our understanding and practices in order to protect consumers from the health threat posed by mycotoxin contamination.     

Overview on legislation and scientific approaches for risk assessment of combined exposure to multiple chemicals: the potential EuroMix contribution

Abstract

This article reviews the current legislative requirements for risk assessment of combined exposure to multiple chemicals via multiple exposure routes, focusing on human health and particularly on food-related chemicals. The aim is to identify regulatory needs and current approaches for this type of risk assessment as well as challenges of the implementation of appropriate and harmonized guidance at international level. It provides an overview of the current legal requirements in the European Union (EU), the United States and Canada. Substantial differences were identified in the legal requirements for risk assessment of combined exposure to multiple chemicals and its implementation between EU and non-EU countries and across several regulatory sectors. Frameworks currently proposed and in use for assessing risks from combined exposure to multiple chemicals via multiple routes and different durations of exposure are summarized. In order to avoid significant discrepancies between regulatory sectors or countries, the approach for assessing risks of combined exposure should be based on similar principles for all types of chemicals. OECD and EFSA identified the development of harmonized methodologies for combined exposure to multiple chemicals as a key priority area. The Horizon 2020 project “EuroMix” aims to contribute to the further development of internationally harmonized approaches for such risk assessments by the development of an integrated test strategy using in vitro and in silico tests verified for chemical mixtures based on more appropriate data on potential combined effects. These approaches and testing strategies should be integrated in a scientifically based weight of evidence approach to account for complexity and uncertainty, to improve risk assessment.     

Review of chinese environmental risk assessment regulations and case studies

Environmental risk assessment is an essential step in the development of solutions for pollution problems and new environmental regulations. An assessment system for environmental risks has been developed in China in recent decades. However, many of the Chinese technical guidelines, standards, and regulations were directly adapted from those of developed countries, and were not based on the Chinese environmental and socioeconomic context. Although existing environmental regulations for pollutants are usually obtained by extrapolations from high-dose toxicological data to low-dose scenarios using linear-non-threshold (LNT) models, toxicologists have argued that J-shaped or inverse J-shaped curves may dominate the dose-response relationships for environmental pollutants at low doses because low exposures stimulate biological protective mechanisms that are ineffective at higher doses. The costs of regulations based on LNT and J-shaped models could therefore be dramatically different. Since economic factors strongly affect the decision-making process, particularly for developing countries, it is time to strengthen basic research to provide more scientific support for Chinese environmental regulations. In this paper, we summarize current Chinese environmental policies and standards and the application of environmental risk assessment in China, and recommend a more scientific approach to the development of Chinese regulations.     

Programs of safety surveillance and control of fishery products.

In the United States, fishery product safety at the federal level falls primarily under the authority of the Food and Drug Administration. However, other federal agencies play an important role. The Environmental Protection Agency is responsible for setting and recommending pesticide limits in seafood, and the National Marine Fisheries Service operates a voluntary inspection program. The Centers for Disease Control is responsible for the collection and evaluation of data characterizing the source of seafood-borne illness. Individual states also play a dominant role in the control of seafood-borne risk because of the important differences in consumption and contaminant levels across regions of the country. State public health, environmental protection, and resource management agencies have developed programs designed to mitigate that risk. Because of the complication and variability of the fishery industry, an effective safety system can be developed based on partnership among federal and state agencies, in which state governments retain the dominant role and the federal government develops and updates guidance programs and provides oversight. The international community has developed practices and protocols impacting the regulation of seafood safety in the United States. In view of developing trade agreements, the international community should address the criteria of setting equivalent contaminant levels and consider the option of establishing import contract criteria for fishery products.     

监管法规协调背景下医疗器械国际标准转化研究与思考

目的：我国医疗器械产业蓬勃发展,医疗器械国际竞争力持续提高,国际医疗器械监管法规协调进程不断发展,科学合理转化国际标准,持续提升我国医疗器械标准与国际标准的一致性程度,进一步推进我国医疗器械标准与国际接轨,是提高我国医疗器械监管国际化水平的重要内容,对促进医疗器械国际贸易、提高医疗器械质量和技术水平,助力医疗器械科学监管具有重要的意义。方法：通过对我国医疗器械转化国际标准工作的回顾性研究,系统分析了医疗器械转化国际标准工作的现状、未转化国际标准的原因及存在的问题, 提出了促进我国医疗器械标准化工作高质量发展的机制和措施。结果与结论：研究提出了加强国际标准转化的政策引领,探索国际标准转化的机制创新,继续强化国际标准的跟踪、比对研究,加强监督考核和人才建设的具体措施,将有利于进一步提升我国医疗器械标准与国际标准的一致性程度,推动我国医疗器械标准化工作高质量发展。     

Safety evaluation of food flavorings

Food flavorings are an essential element in foods. Flavorings are a unique class of food ingredients and excluded from the legislative definition of a food additive because they are regulated by flavor legislation and not food additive legislation. Flavoring ingredients naturally present in foods, have simple chemical structures, low toxicity, and are used in very low levels in foods and beverages resulting in very low levels of human exposure or consumption. Today, the overwhelming regulatory trend is a positive list of flavoring substances, e.g. substances not listed are prohibited. Flavoring substances are added to the list following a safety evaluation based on the conditions of intended use by qualified experts. The basic principles for assessing the safety of flavoring ingredients will be discussed with emphasis on the safety evaluation of flavoring ingredients by the Food and Agriculture Organization (FAO) and World Health Organization (WHO) Joint Expert Committee on Food Additives (JECFA) and the US Flavor and Extract Manufacturers Expert Panel (FEXPAN). The main components of the JECFA evaluation process include chemical structure, human intake (exposure), metabolism to innocuous or harmless substances, and toxicity concerns consistent with JECFA principles. The Flavor and Extract Manufacturers Association (FEMA) evaluation is very similar to the JECFA procedure. Both the JECFA and FEMA evaluation procedures are widely recognized and the results are accepted by many countries. This implies that there is no need for developing countries to conduct their own toxicological assessment of flavoring ingredients unless it is an unique ingredient in one country, but it is helpful to survey intake or exposure assessment. The global safety program established by the International Organization of Flavor Industry (IOFI) resulting in one worldwide open positive list of flavoring substances will be reviewed.     

某二甲醚生产项目职业病危害控制效果评价

目的检测某二甲醚生产项目职业病危害因素,提出职业病防治的关键目标,探讨相应的防护对策。方法选择某二甲醚生产项目进行职业病危害因素调查并对职业病危害因素进行检测。结果检测9个噪声作业点,3个接噪作业工种,合格率100％;2种有毒物质的测试结果全部符合国家标准。结论该项目主要的职业病危害因素均可得到有效控制,从职业卫生角度分析,该建设项目是可行的。     

The work of OECD in the harmonization of the testing and control of chemicals

The 24 Member countries of the Organization for Economic Co-operation and Development (OECD) have over the past few years reached agreement on several issues relating to the assessment of chemicals. The subjects on which agreement has been reached include guidelines for the testing of chemicals, good laboratory practice, mutual acceptance of data, and data interpretation guides. The agreement on mutual acceptance of data within OECD Member countries ensures that data generated on a chemical in one country (using OECD test guidelines and in accordance with OECD principles of good laboratory practice) will be accepted in other OECD Member countries for purposes of assessment related to protection of human health and the environment. This agreement will reduce repeated testing of the same chemical in different (OECD) countries, will result in more cost-efficient use of test facilities and specialist manpower, and, not least, will result in a significant reduction in the number of animals (and species) used in biological testing. It is hoped that other international organizations, and countries that are not members of OECD, will adopt the same approach. Reference to some other OECD activities intended to facilitate the transfer of information on chemicals between Member countries whilst maintaining proprietary rights and confidentiality is included in this review.     

Ensuring quality of in vitro alternative test methods: issues and answers

Many in vitro and ex vivo methods have been developed or are under development to reduce or replace animal usage in toxicity tests. Consistent with the goal of obtaining scientifically sound test data for hazard and risk assessment of chemicals, changes are being made in current policies and procedures to facilitate the acceptance of data developed using these methods. National and international organizations are developing policies and standards for scientific practice to assure quality in implementation of in vitro methods. Consensus is developing in the scientific community for the quality control measures needed for in vitro methods; including appropriate controls, data reporting elements, and benchmarks to be identified in test guidelines so that the potential risks of chemicals can be reviewed and reliably assessed. Additional guidance to the OECD's Good Laboratory Practice principles [Organization for Economic Cooperation and Development (. Advisory Document of the Working Group on Good Laboratory Practice: The Application of the Principles of GLP to in vitro Studies. OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Number 14 (ENV/JM/MONO(2004)26). Paris, France] will help to ensure that in vitro tests used for regulatory purposes are reproducible, credible, and acceptable. Generic test guidelines incorporating performance standards are being written to allow acceptance of proprietary test methods by regulatory agencies and to provide assurance that any in vitro system performs over time in a manner that is consistent with the test system as it was originally validated.