Raj K. Malik is a former Chief of the Food Quality and Standards Service, Food Policy and Nutrition Division, FAO, Rome.
Consumer and industry involvement
Food control system
Approach for action
Food and agriculture form a major sector of most economies in terms of gross domestic product, employment and foreign exchange earnings. In developing countries, people spend almost 50 percent of their income on food; among lower-income households this figure may rise above 70 percent (Malik, 1981). As incomes increase, a large proportion of the additional money (50 percent and above) will be spent on food (Sen, 1985). Thus, when food quality is jeopardized, consumers may not get their money's worth and may suffer in economic terms.
Consumer protection from food hazards is necessary, as many human illnesses are food related. Nutritional status and economic well-being are affected by food carrying pathogenic organisms and their toxins or poisonous chemicals. Food is easily contaminated when produced in an unhealthy or unclean environment. Many foods are highly perishable, while others contain natural toxicants. Many need extra care for their protection. Microbiological contamination and spoilage of food should be prevented, and the use of pesticides, fungicides, food additives, veterinary drugs that leave residues and numerous other chemicals that can contaminate food should be controlled. As food can be easily adulterated or contaminated through environmental pollution, safe practices need to be ensured when food is procured, handled, processed, stored and distributed.
Food control is mandatory to ensure the quality, safety and nutritional value of food and to protect the consumer's health. It prohibits the sale of food not of the nature, substance or quality demanded by the purchaser. Food control is, therefore, a policing activity. However, it is now well recognized that rather than being a hindrance in the production, processing and marketing of food, food control can stimulate the food industry along sound scientific lines and promote food trade.
Before reaching consumers, food passes through a complex system involving production (crop cultivation, animal husbandry, etc.), postharvest handling, processing, storage, transport, distribution and sale through large or small retail outlets. Until recently, many foods were produced locally and prepared at home; now the greater complexity and dynamism of the food sector has increased the potential for hazards to consumers. Food control applies to this entire system, helping to introduce good manufacturing practices, to maintain efficiency and to prevent food wastage, contamination and rejection in the marketplace. The incidence and severity of food-borne illnesses directly reflect the shortcomings in the food control system. Even where effective food control is exercised, food-borne illnesses still occur because of improper food handling in eating places and in the home. Age-old customs and deeply ingrained practices can prevent the control of hazards in the food supply.1 A family's health and welfare are affected by the skill and knowledge used in the marketplace as well as in the kitchen.
1 Increasingly, it is recognized that promoting food safety through changes in food habits may require redefining the role of food. While educating consumers to handle food properly within the home is crucial, this issue is beyond the scope of this article.
International trade in food is growing very rapidly. For many countries, food exports are the main source of foreign exchange. Most national authorities as well as food industries realize that exported food must meet the quality and safety requirements of importing countries or the Codex Alimentarius Commission's International Food Standards. Therefore, many national food control authorities protect not only local consumers but also consumers who purchase their countries' food exports.
While it is well understood that hazards should be kept to a minimum, very few countries have reliable statistics on food-borne diseases. In spite of underreporting of the incidence of food-borne diseases, food control officials, food scientists and toxicologists have attempted to categorize and prioritize food hazards (Wodicka, 1982; National Research Council, USA, 1987). This ranking appears to be quite valid in both developed and developing countries and is as follows:
· microbiological hazards,
· nutritional inadequacies,
· natural toxicants and environmental contaminants,
· hazards from improper use of pesticides and food additives,
There have been no worldwide surveys to determine the order in which consumers rank their concerns related to food. However, studies from some industrialized countries found that the number-one concern is chemicals in food: pesticide residues and food additives (Knauer, 1984). The educated middle class in developing countries who receive their information from the industrialized world probably share these concerns. Newspapers and television circulate stories about chemicals in food, often magnifying the extent of the hazards and their importance. It is commonly perceived that these problems outweigh microbiological hazards. Inadequate information on the criteria and the methodology for safety evaluation of chemicals in food by the food control authorities only adds to this concern.
The consumers' second major concern, particularly in developing countries, is food adulteration. Filth and extraneous matter can often be seen by the consumer, and food control authorities, consumer organizations and the media announce adulteration incidents. While in the industrialized world most food is packaged before sale, in many developing countries retail food is often sold from bulk containers with the consumer purchasing relatively small quantities. This practice permits tampering with food and introduces food handling and contamination problems.
Another concern, particularly over the last few decades, concerns the "purity" of food products. There may be a preference for so-called "organic" foods -foods produced without the use of chemical fertilizers, pesticides, additives, etc., which are perceived to be safer and more nutritious. This trend is growing rapidly, particularly among wealthier consumers.
Some consumers are mindful of foods regarded as "natural" versus "artificial". Ingredients perceived as harmful and added colours are other major consumer concerns. Consumers fear that food colouring may mask the inferior quality of a food product and/or be harmful. In many cases the food control authorities are unable to prevent the use of prohibited colours and other additives. This adds to the stigma of chemicals in food.
There is growing awareness about pollution and environmental contaminants. In many developing countries the individual consumer is blissfully unaware of the hazards from these sources, which can be quite serious. The same is true of natural toxicants and mycotoxins.
Most food-borne diseases that are of major global significance are contracted through microbiological contamination. Serious food-borne diseases are, generally speaking, more prevalent in developing countries, and their effects are more severe where nutritional status is poor. Many people are aware that such infections are acquired from contaminated food and water, poor personal hygiene and unsanitary living conditions. Yet, the ubiquitous nature of such illnesses has made them less conspicuous. This may explain why food-borne diseases receive so little attention from consumers. Alternatively, consumers may feel that they can cope with this problem by themselves, although this is doubtful.
Last but not least is the question of trust in the national food control system. Absence of trust may or may not be due to the public's lack of information. Sometimes transparency is lacking, which leads to misunderstanding by industry and consumers. Allegations of malpractice in the food control system spread very fast. While consumers recognize the responsibility of the government and the food industry, most trust only themselves to be sure that the food they buy is safe and of the quality they demand. Many consumers, particularly in industrialized countries and among the educated middle class in developing countries, feel that nutrition and food safety recommendations are the subject of scientific controversy. Therefore, they prefer to make an informed choice rather than allowing the government to make it for them.
The absence of organization among consumers constrains their ability to protect their own interests in food control. While there has been quite rapid growth of consumer groups and non-governmental organizations (NGOs) in developing countries, the overall impression is that of a fragmented effort. Some groups analyse consumer products and inform and guide their members, while others promote enactment and enforcement of consumer legislation including that relating to food. There are groups that conduct market surveys and advise their members on the best buys; many handle complaints. A few are also engaged in training activities.
Food control authorities have difficulty deciding which organization should be given representation. Sometimes the interests of one group regarding a particular class of food or a food-related problem have come into conflict with the interests of another. The net result is that both lose their impact. As group participation is a voluntary activity, the personalities, drive and integrity of a group's leaders make a tremendous difference in the group's effectiveness.
Of course there are still developing countries where there is no consumer movement and where only a few individuals from educational institutes show an active interest in consumer problems. Most of the time they are quite passive. At the international level the International Organization of Consumers Unions (IOCU) has done considerable work to create greater awareness for strengthening national consumer movements.
In comparison to consumers, the industry and trade organizations have more resources and are in a better position to participate in food control decisions. However, industry may be unacquainted with the workings of the regulatory agency and may have doubts that its cooperation is needed.
Scientific knowledge and evidence
A serious constraint to consumer participation in decision-making is consumers' lack of scientific knowledge and information about food quality and safety criteria. Current food laws are unclear about what "safe" means, and there is public confusion and ambiguity about how the concept of safety applies in a given case. Based on risk assessment, a food control authority's task is to reduce risk to the fullest extent possible but not to engage in visionary or impractical efforts to eliminate it. In scientific terms there is no such thing as "absolute safety" or "zero risk". Yet this concept may be difficult to comprehend. It is understandable that a consumer organization would use the zero-risk approach to bargain for risk reduction within practical limits. Beyond that, this approach can only harm the food system with resultant damage to the interests of consumers, industry and the national economy.
Much can be done to educate consumers about the field of food safety evaluation. This calls for information from food science and technology, toxicology and other related subjects including the applicable regulatory mechanisms. It is assumed that the consumer organizations will have the capacity to absorb such information for the common good.
While industry is well equipped with laboratories, qualified scientific personnel, etc., consumer organizations may lack scientific evidence and data of their own to support their point of view. Consumer organizations in developing countries usually rely upon information from industrialized countries, although this may not be relevant to their situation. The consumer organizations could strengthen their scientific expertise through association with institutes specializing in food science, home science, agriculture, public health and nutrition. However, these institutes do not always find it profitable to get involved in consumer affairs.
Industry and trade associations should establish technical committees and expert groups that can appreciate the problems of food safety and consumer protection, prepare scientific evidence and present their case to the food control authorities. Many associations lack technical experts who can give advice about how to conform with national regulations regarding production, marketing and distribution of food.
Legislation and consumers' rights
In addition to food laws, there has been national legislation which protects consumers on such matters as health, environment and trade. Legislation on consumer protection per se has been approved in many countries recently. Unfortunately, consumers are not aware of their rights and this prevents them from deriving full advantage from these measures. The consumer is not at fault for this; the plethora of legislation may produce confusion. At times the gains from one type of legislation may be significantly diluted under another.
When several agencies are involved in food control and there is no coordination or clear division of responsibility, both the consumer and the industry suffer. Lack of uniformity of regulations and duplication of inspections confuse industry and increase its costs as well as those of government, and ultimately consumers pay for this.
Lack of understanding
Consumer movements have traditionally been concerned with the question of which product or technology is best rather than the question of why it is so. They seldom look into the compulsions and motives of those who sell or market foods. This creates a gulf between the interests of the consumers and those of trade and industry. If consumers were to look beyond the product and appreciate the complexities of the food system in their country, they would also realize the system has inadequacies with which the industry must cope. Both consumers and industry would benefit from more dialogue. Allowing the processing and marketing of food to improve over time without undue economic disruption or health risk to the consumer would be helpful.
In many countries, trust and cooperation between industry and the regulatory authority are lacking and any contact between the two is viewed with suspicion. While understandable, this distrust does not protect the interests of the consumer or those of the national economy. With improved cooperation the majority of businesses will comply with food regulations, as it is in their own interest to do so.
All countries share the objectives of promoting a safe and honestly presented food supply and protecting consumers from health hazards and commercial fraud. Achieving these objectives requires a food control system based on a fundamental food law, accompanied by detailed regulations and administered by an efficient food control organization. When food legislation is enacted and the first bricks of the food control organization are laid, the importance of industry and consumer participation must be recognized. This does not mean that the food control compliance policies have to please industry, but industry's involvement in developing policies is advantageous and facilitates implementation. Similarly, active participation by consumers with objective and adequate information enhances consumer confidence in the national food control system. Thus a government's willingness to involve consumer and industry interests in food control is the first policy decision to be made.
Representation of industry and consumer
Once involvement of consumers and industry is accepted, the food control law should reflect this. For instance, a statutory provision for an advisory or coordinating committee or a board to advise on matters arising from the administration of the food act can be created.2 This body should determine policy matters, and various ministries, industries, consumers, NGOs and academia should be represented. Subgroups should have consumer and industry representatives as well. The advisory committee or board should report to the minister concerned and in most cases these reports should be published.
2 See model food law in FAO/WHO, 1976.
Where an advisory committee does not exist, industry and consumer views are ensured through regulations. Once the principle is accepted, the mechanism may vary from country to country. Thus, before a major policy change, prescription or amendment of food standards is made, the industry and consumers have the opportunity to comment and provide additional data on the subject, public level. In fact, a third opportunity occurs when there is a review of the comments for a final decision. Therefore, this is a more effective and comprehensive way to integrate consumer and industry interests in food control. Such an arrangement optimizes resource utilization and better satisfies consumer concerns as well as industry needs. Thus compliance improves and consumer protection and satisfaction are enhanced.
The statutory provision of an advisory or coordinating body in the food legislation of the country is highly recommended for various reasons. There is an opportunity for participation at the committee level when a proposal is discussed, and a second chance when comments on a proposal are solicited at the general.
Wherever consumers and industry are well organized and have among themselves good and agreed-upon channels of communication, their proper representation on the food control advisory or coordinating committee does not pose a problem for the government. Because of their common interest, industry organizations usually have one or more confederations at the national level. Consumer groups may not have such alliances; in this case they may serve as representatives on a rotational basis. There is a possibility that representation may be politically influenced. It is always good in the long run for the food control authorities to obtain representation from active groups who have at their disposal members or advisers with the most scientific expertise. In some countries, it may be necessary to apply geographic criteria in determining representation. It is important to recall that the purpose of such participation will be served only if it is representative and the participants have the necessary background qualifications to be effective.
Compliance policies are not necessarily meant to be popular, but to ensure their effectiveness they should be supported from various sectors. Developing these policies requires substantial effort and can be achieved only if the food control authority has a solid and enduring relationship with industry and consumer interests. While the compliance policies have to be directed towards the overall national development goals, the strategies available to achieve those goals will vary according to the local situation. Integration of consumer and industry interests in local decision-making can often facilitate the development of cost-effective strategies for implementing policies.
An open environment for scientifically based decisions should be fostered by the food control authority. The problem and its proposed solution should be thoroughly examined. Objective presentation and discussion of the facts with regard to industry and trade practices, potential hazards to consumers, risk assessment, socio-cultural issues and economic impact of the proposal at the individual or the national level builds confidence between the food control authorities and various interests. The role of consumers, NGOs and industry is particularly vital for proper risk management. Extraneous issues, often political in nature, should be excluded or kept to the barest minimum; otherwise the trust in the food control system is easily destroyed. It is crucial that the integrity of the food control system be carefully guarded.
Because of concerns that negative information will cause unnecessary worry and harm, many food control agencies do not disclose the information they collect on particular foods and food handling practices, Occasionally a brief statement on the subject is made in the country's legislative body, but this does not inform policy-makers or the public as effectively as a published report which is brought out in the open and widely distributed. If information is published, it could, in the long run, provoke comments and elicit assistance from consumer and industry groups as well as the scientific community. This, in turn, promotes government responsiveness to the public in general.
More open discussion should help to generate additional resources and strengthen and improve the food control system. The country would benefit from wider dissémination of information in an appropriate form on subjects such as incidence of food-borne illnesses and poisonings; incidence of spoilage, destruction of contaminated foods and the resultant economic losses; health hazards from street food vending; and rejections in the export trade. Food control authorities must expand and strengthen their communication network with industry, consumers and academia and use all current fora within the agency or outside for proper dissémination of scientific information relating to food control problems.
A food control organization in its basic form consists of three elements; inspectorate, analysts and management. The inspectorate is responsible for inspecting food premises, collecting samples and evidence of infringement of food laws or regulations, assisting in prosecution and advising industry. Analysts examine food samples sent to the laboratories and prepare analytical and evaluation reports which could form the basis for further action against those who flout the law; they also carry out monitoring and research work. Management supervises and administers the food control agency, develops compliance policies and takes legal or other follow-up actions. Quite often the organization functions at the national, provincial and/or local levels.
Consumer and industry affairs unit
Few countries have a well-established office of consumer and industry affairs to interact with consumers and industry on a regular basis. This is a serious lacuna, since these groups need opportunities to express their views and should have a say in how the system functions. In response to increasing pressure from consumer associations and growing awareness of the need for industry cooperation, several food control organizations have created units to deal exclusively with issues concerning these groups. In most developing countries, such arrangements are still quite nebulous and ineffective, and their impact on the efficiency of the national food control system is minimal.
A modern food control organization should provide a separate unit specifically for consumer and industry affairs at the central level. Its shape, location and size will depend upon the country's situation, the organizational structure of the food control system, the resources available and, most importantly, a clear understanding of its anticipated role. To function properly, it must have qualified personnel who possess a sound understanding of national food control policies and regulatory requirements as well as the technical competence to advise or consult with consumer and industry groups and deal with their problems. They must be able to assist in consumer education and have a flair for maintaining public relations for the organization. This unit should be directly responsible to the higher levels of management at the national level and should be able to draw upon other departments of the food control organization and government health, education and information programmes. This will enable it to present a coherent, objective and positive image of trust and openness to the public and to carry out its functions in a cost-effective manner.
Where personnel and financial resources are limited and the food control organization itself is rudimentary, a reference point within the organization can be designated to develop a mechanism for interaction with consumer and industry interests. To have an impact, a staff of at least two qualified persons would be required. With the development of the national economy, growth of the consumer movement and expansion of the food industry base in the country, this unit could be strengthened along with the food control organization.
The functions and responsibilities of a consumer and industry affairs unit are crucial and require considerable thought and planning by food control authorities. They may be divided into the four broad areas described below.
Soliciting and coordinating public advice. Major proposals for changes in compliance policy, amendments to food standards or residue limits, changes in labelling provisions, etc. are published officially, and representatives of consumer, industry, trade, non-governmental and other organizations may submit their views by a particular date. These comments are evaluated within the organization and if necessary after a public hearing or an expert committee review. The role of consumers, industry and academia is very important at this stage; the consumer affairs unit should be in contact with them and should solicit their views orally or in writing. Summaries of these views should be presented within the review process. The unit should participate in the organization's policy development by coordinating consumer and industry involvement in vital decision-making processes and should assist in setting priorities for the organization.
Informing and educating the public. Active cooperation and pooling of resources from ministries of agriculture, food, health, industry, commerce, consumer affairs, etc. are needed to provide consumers with information. A major function of the consumer and industry affairs unit in preparing public information is the enlistment of support from other agencies, individuals and the community.
Education and information activities could include the publication of fact sheets, newsletters and bulletins on the quality, safety and nutritional value of foods, consumer protection and food production and trade issues for the general public or specific target groups. The planning, production and evaluation of audiovisual materials can be coordinated with government programmes in areas such as health education, community development and agricultural extension. Written and audiovisual materials that highlight the food control agency's particular objectives can be distributed. Educational materials can raise awareness of the science of food safety evaluation, addressing risk assessment and management issues which have a bearing on national food supply and protection of the consumer. Consumers should be made aware of nutritional quality and labelling requirements so they can make informed choices. Information should be disseminated about product recalls, emergencies, national calamities and other situations involving imminent danger to the health of the consumer or about situations of gross fraudulent practices affecting consumer interests. The unit should collaborate with television, radio and newspapers which can carry food control messages to consumers and industry. The unit can publish newsletters or reports summarizing charges, judgements, decrees and court orders issued under the food law, indicating, where appropriate, the follow-up remedial actions taken by the food control agency.
Community outreach programmes. Seeking direct participation in the agency's programme of work greatly helps to strengthen the bond between the agency and the community, This also generates political support and, in turn, could bring in greater resources for the agency. Such activities could involve keeping mailing lists of consumer organizations, industry associations, NGOs and academics and collecting information on their roles and expertise. An assessment of the influence of these groups on public opinion can be made. Assistance can be provided in selecting and training consumer and industry representatives to the relevant committees or expert groups of the agency. Consumer and industry groups can be informed of opportunities for participation in the agency's decision-making processes. Consumer committees and industry groups can be organized to strengthen their professional roles in development, education and monitoring, and assistance can be given in identifying resources for the same purposes.
Formal seminars or workshops on food safety, quality and nutrition-related subjects, for both consumers and industry, can be carried out. Educational institutions engaged in food science, nutrition, home economics, agriculture and public health can be provided with information for their course syllabi. Their assistance can be sought for informing consumers, and they can cooperate in social audits in specific areas of concern to consumers. These institutions can be involved in surveys related to food consumption and consumer habits and preferences, and the information can be disseminated through workshops and seminars.
Community action programmes can be developed to improve food hygiene and safety of street foods. Competitions, awards, exhibitions, etc. can be held to promote consumer protection. Outreach programmes can provide access to laboratory testing of food products for consumer organizations, free or on a reasonably subsidized basis, and can keep abreast of industry practices that may affect consumer interests. They should share knowledge with industry to facilitate development of more realistic regulations and compliance policies and the introduction of good manufacturing practices (GMPs). Industry should realize that voluntary compliance is the best way to prevent legislation and regulations that can put it out of business.
Complaints and grievances. Consumer complaints and grievances call for expeditious handling, and a responsive system with easy access to justice builds a good image for the agency. With the recently promulgated consumer protection acts in many countries, a separate machinery has been set up for redressing grievances from consumers. However, this is outside the scope of the food control agency's work. Even though a country may have a ministry of consumer affairs or consumer protection councils and well-established machinery for redressal of grievances for general consumer protection, food control agencies are advised to have a system for looking into consumer complaints dealing with subjects covered under the food control legislation. The consumer and industry affairs unit could have a key role in the redressal of grievances from consumers on selected food safety and economic fraud issues. The consumer with a grievance can be given a method or a choice of methods by which to seek such redress. While the choice is left to the consumer, it has been observed that litigation, for which the consumer has to pay, is rarely the first preference. This means that the agency can have an informal role in the redressal of grievances.
In general terms the consumer and industry affairs unit should develop, manage and monitor a programme for handling consumer complaints and enquiries and initiate follow-up actions, i.e. inspection and investigation relating to the complaint, initiation of product recall and information procedures with regard to unsafe or adulterated products, etc. It should widely advertise the name, address and phone number of the person or persons to be contacted in case of a complaint; answer phone calls from the public; promote informal redressal of the grievance through contacts with the industry associations concerned, when appropriate, or recommend legal action where necessary. Finally, it can provide information and advice for the agency's decision-making and compliance policy development processes.
A systematic and methodical approach is necessary to integrate consumer and industry interests in food control. This can be discussed in terms of formal or statutory representation, infrastructure development and programme development.
Formal or statutory representation
As a regulatory activity the food control organization should establish well-designed and well-publicized procedures for receiving and considering consumer and industry inputs at the policy-making level. There should be verification that the food laws or regulations make a provision for an advisory or coordinating body at the national level, with representation of consumer and industry interests. The statutory requirements and procedures for making or amending various food regulations should provide for advance notice and seek public inputs before the regulations are finalized, and the provisions should be practical, allowing sufficient time for the response of consumers, industry and academia. Depending upon the legal requirements of the country and the nature of the proposal, the whole process of an amendment to a regulation or standard may sometimes take a year or even more.
PROCEDURES FOR SEEKING PUBLIC VIEWS ON FOOD CONTROL
· Consider the' agency's proposal (after risk assessment as necessary) at the advisory or coordinating committee level
· Notify the public of the proposal and seek comments from interested parties, giving them sufficient notice to respond:
· Assist in the coordination of such responses
· Consolidate responses and review them within the agency
· If necessary, convene a public hearing or an expert group or committee discussion
· Review and finalize the proposal at the advisory or coordinating committee level
· Notify the public of the final proposal, including the date at which it comes into force
To enable the organization to cope with its obligations concerning consumer and industry interests, an appropriate infrastructure is needed. A plan of work should be determined with goals for each activity depending upon priorities, agency objectives and resources. The foremost priority should be the consolidation of responses resulting from statutory public notifications.
PROCEDURES FOR INFRASTRUCTURE DEVELOPMENT WITHIN A FOOD CONTROL ORGANIZATION
· Explain why the establishment of an office or unit of consumer and industry affairs as an entity within the overall food control management system is essential
· Indicate personnel and financial resources needed, given that inspection and investigation work must continue I
· Establish the functions and responsibilities of the office; describe reporting, evaluation, and feedback requirements
· Recruit and train staff and provide for audiovisual and other training-equipment
Certain basic but specific steps need to be followed to prepare the consumer and industry affairs unit or office to take up the functions and activities listed above. Introductory messages about the purpose of the office should be made which seek cooperation of the consumer and industry groups. Priorities will need to be identified in relation to agency objectives, planning strategies, channel selection, materials and target audiences. One or two projects should be prepared for implementation. The programme staff should collaborate with other health and community extension workers. Educational programmes and educational and audiovisual materials should be prepared; these should be pre-tested to assess their effectiveness. Communication strategies should be drafted. When necessary, the programmes can be revised.
If followed consistently, such an approach by food control authorities can meet the objectives of effective integration of consumer and industry interests in food control. This collaboration will be to the benefit of overall national development.
FAO/WHO. 1976. Guidelines for developing an effective national food control system. Rome.
Knauer, V.H. 1984. Keynote address to the Second National Conference for Food Protection, United States, Department of Health and Human Services.
Malik, R.K. 1981. Food; a priority for consumer protection in Asia and the Pacific Region. Food and Nutrition, 7(2):18-23.
National Research Council, USA. 1987. Food protection in the Americas, A report on the Inter-American Conference on Food Protection, August 1985. Washington, DC. National Academy Press.
Sen, B.R. 1985. Development through food: a strategy for surplus utilization. In Food aid for development, FAO Economic and Social Development Series No. 34. Rome, FAO.
Wodicka, V. 1982. An overview of food risks/hazards. Presented at the Food and Drug Officials Sponsored Symposium on Food Toxicology, Spring Workshop, New Orleans, Louisiana, USA.