Behind the standard – FDA



Third Party FDA Certification Keeping food safe for human consumption is a major issue worldwide, regardless of where they were made, whether they are conventional or organic products, whether the company is large or small, or whether it is manufactured or processed production. The health of consumers is the most important thing. Over the years, different standards and laws have been developed for the food industry at the international level; which are endorsed by government agencies, experts in food safety and private councils formed by leaders. One of the organizations that has been most concerned with safeguarding consumer health is the Food and Drug Administration, better known as FDA for its acronym. The U.S. Food and Drug Administration is a federal Consumer Protection Agency and is one of the oldest in the United States. FDA has its origins in the analysis of food products in around 1848, but it is not until 1930 when it is known by its current name, FDA, for its acronym, which is Food and Drug Administration. FDA is the government agency of the United States responsible for regulating food, medicines, cosmetics, medical devices, biological products and blood derivatives intended for human or animal consumption. This agency is part of a division of the Department of Health and Human Services, which in turn represents one of the 15 ministries of the Government of the United States of America. Its functions are distributed throughout the 50 states of this country, including the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa and other territories that are part of the United States. FDA needs arms, they need extensions to be monitoring. There are many crossings of products to the United States; so, through this development that has been done with agents, which is a legal issue, which is a legal document, the CFR 21. This allows accreditation bodies to take care of the rights and, in that sense, these accreditation bodies give permits to certification bodies in any other part of the world, the one who wishes to bring products to the United States meets certain characteristics. This makes it possible to bring safer products to the United States or, if any anomaly is detected, all the traceability mechanisms necessary to identify the product are carried out and that the corresponding faults are investigated, or the resulting rulings to those products that are in the United States. Its main objectives are to protect and promote public health through the promotion of product innovation, as well as to provide the public with scientific information that allows them to use the regulated drugs and foods correctly, to improve their health. FDA also inspects facilities that conduct studies for people such as clinical trial labs, as well as laboratories that do studies with animals or micro-organism when they are used to request the approval of a medical product. It also evaluates all products that are imported on the U.S. border. There are about 64 scopes that FDA will have to extend and give permission to the accrediting entities and in turn the accrediting entities to the certification bodies. At the moment, there are two accreditation bodies that together have 10 released scopes. Among the main ones, there is human consumption, which is the code 117, but there are also some other interesting as primary production and pet food. More scopes are opening up for the greater monitoring, because essentially what FDA is looking for at the end is to make sure that any product is finally being monitored. FDA launched these major scopes, they are 64, 3 were released first, then 5, and now we have 10 and, surely, in a given period of time, no longer than a couple of years the 64 scopes will be released by FDA to an accrediting body and that accrediting body such as we are. Even that development project was determined that the FDA in which is the issue of the law FISMA would authorize accreditation bodies and those accreditation bodies authorize certification bodies, for the case of the role we play, to ensure that these suppliers are monitored. Another aspect of its jurisprudence in food is the regulation of the content in the labeling; however, because this regulation relates to the First Amendment, FDA must balance public health concerns with the right to freedom of expression. One of the most important laws that the United States Government has implemented to protect the safety of food consumed by its inhabitants, both inside the country and abroad, is the law of modernization of food safety, better known as FSMA act, which was promulgated in January 2011. This law is the final product of significant quantities of frequent food incidents at the national and international level, including insufficient controls and regulations on human consumption products. Faced with this, the U.S. government determined to strengthen these requirements to ensure that any type of entry that was a risk factor had greater control. United States certainly has several departments that control those powers concerning exporting their products but in this case, particularly the FSMA act one of the main mechanisms is to attack the whole food chain issue and make sure that any food found within the United States complies with certain rules. It is a very extensive rule, it is a very extensive legal issue but in the first instance the goal is to make sure that any product that is in the United States complies with certain rules. The FSMA law is considered the most radical on food safety and has as its main objective to change the corrective approach by responding to food security failures, by a preventive approach, implementing programs to prevent such failures from happening. In order to ensure the formation of programs that meet the needs of those who must comply with the new FSMA law, regardless of its size, nature or location, FDA is touring a long and arduous path in which it works with public and private partners at the international level, ensuring that everyone involved in the supply chain knows and has the resources available for training and education, including the way to access them. Companies that must be concerned or required to comply with those FSMA act requirements are those whose products end up in the United States. In that sense, there are some companies that are clearly exporting. However, there are marketers that have their products in the United States and the company does not realize that the additional commercial entity has its products in that country. In such a form that they do not realize, as producers, that their products are in United States. Also, by being monitored to comply with all the FSMA act, depending on the scope that corresponds to these companies. It is essential that agencies, that companies, make sure whether their products are being brought or not into the United States For organizations that must comply with the FISMA law, it will not be enough to have a HACCP plan or to have a management system recognized before the GFSI, since they must implement preventive controls and develop a safety plan that documents the monitoring, corrective actions, and verification of these controls that will be focused on prevention and demonstrate the compliance of organizations with the implementation of a HARPC program. The FSMA act includes, for example, among some of its regulations, the preventive controls for human food, the preventive controls for the feeding of animals; It contains specific requirements for foreign suppliers and, well, it also contains specific requirements for importers as well as the identification of qualified individuals in preventive controls. Many companies have already implemented these elements in their programs or food security management systems however, it is very important to know the differences between the requirements of the FSMA act and what is established. It brought us many benefits since it opened the doors to other markets in which we could reach the American market and have more customers, have an increase in sales. and, by sequence, more work here at that plant I think one of the benefits, surely of the most important, is that it brings this need to re-evaluate the entire supply chain, the whole process, to identify which are the most appropriate preventative controls that generate a much more robust system. The FSMA Act also establishes a voluntary program for the accreditation of third-party certification bodies, better known as third-party auditors. With the purpose of conducting safety audits and issuing certificates of external entities for food for human and animal consumption. All requirements for this accredited third-party certification rule are available or are set forth in the CFR 21 Part 1 Subpart M. That is where it is defined in practically all the regulations that should be followed by a certification body or an accreditation body to comply with this part or with this rule. These requirements are intended to help ensure the competence and independence of accreditation bodies and the third-party certification bodies that make up the program. According to the United Nations for Food and Agriculture, populations in 37 countries, 28 of which are in Africa, face food insecurity; for this reason, currently, many international regulations such as the FSMA act have set standards on the production, storage, distribution and preparation of food in the manufacturer companies. Still thus, food safety remains a major global challenge that is even more necessary in those areas that suffer from extreme levels of poverty and where access to basic services is limited.

1 Comment

  1. buen vídeo!

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