UNITED STATES FOOD SAFETY LAW DEVELOPMENTS OF INTEREST FOR EUROPEAN FOOD COMPANIES
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48 recht law UNITED STATES FOOD SAFETY LAW DEVELOPMENTS OF INTEREST FOR EUROPEAN FOOD COMPANIES food safety MAILE HERMIDA, ANNA GLINKE T he food safety laws in the globalization of the food system. About A food safety plan must have the follo- United States have changed 48 million people in the U.S. (1 in 6) wing components: significantly in recent years. get sick, 128,000 are hospitalized, and The FDA Food Safety Mo- 3,000 die each year from foodborne di- š Hazard Analysis The hazard analysis dernization Act (FSMA) seases, according to recent data from the must identify and evaluate known or was signed into law in 2011, after which Centers for Disease Control and Preven- reasonably foreseeable biological, chemi- the U.S. Food and Drug Administration tion. The goal of FSMA is to shift the cal, and physical hazards. If any of these (FDA) spent several years developing focus from responding to foodborne ill- hazards is determined to be significant and finalizing implementing regulations. ness to preventing it. enough that it is a “hazard requiring Most of the regulations under FSMA a preventive control,” then the facility are now being enforced, and FDA is FDA has finalized seven major rules to must identify and implement preventive focusing considerable efforts on its in- implement FSMA. The underlying focus controls to significantly minimize or pre- spectional activities. The FSMA regula- of the regulations is on ensuring that all vent the identified hazards. tions apply to food companies that sell of the parties in the global food supply FDA-regulated food in the United States, chain are responsible for managing the š Preventive Controls The rule includes with very few exceptions, so companies food safety risks within their control. several types of preventive controls: in Germany and Austria are covered by š Process controls (e.g., cooking, ref- these new requirements as applicable II. Overview of rigerating, and acidifying foods); to their operations. In this article, we š Food allergen controls (i.e., controls survey the key requirements under the Key Regulations for allergen cross-contact and to en- FSMA regulations, provide updates on Below is a summary of each of the seven sure allergens are appropriately lis- FDA’s implementation and inspection major FSMA regulations, their require- ted on labels); activities, and conclude with recommen- ments, and how they affect companies š Sanitation controls (i.e., procedures, dations for actions to take to ensure you in Germany and Austria that sell food in practices, and processes to ensure are in compliance. Note that FDA does the United States. that the facility is maintained in a not regulate meat and poultry products, sanitary condition to minimize or so U.S. requirements for those foods are 1. Preventive Controls for Human Food prevent hazards such as environ- beyond the scope of this article. In general, the Preventive Controls for mental pathogens); and Human Food (PCHF) rule applies to š Other Controls (i.e., controls that all facilities that are required to regis- are not described above but are I. Background on FSMA ter with FDA. These facilities must de- necessary to ensure that a hazard re- Congress enacted FSMA in response to velop and implement a Food Safety Plan quiring a preventive control will be a number of significant food safety is- (FSP). This is similar to, but has some significantly minimized or preven- sues in the United States and increasing key differences from, a HACCP plan. ted). ERNÄHRUNG | NUTRITION volume 44 | 05./06. 2020
49 recht law © ADOBE STOCK – DUSANPETKOVIC1 š Management Components To ensure notify the public when necessary, to lified to perform their assigned duties. that the controls are being met, faci- conduct effectiveness checks, and to This means that they must have the lities must implement procedures for appropriately dispose of recalled pro- necessary combination of education, monitoring, corrective actions, and duct. training, and/or experience necessary verification of the preventive controls. There also are significant recordkeeping to manufacture, process, pack, or hold Verification includes activities such requirements related to the Food Safety food that is clean and safe. Individuals as calibration, validation, records re- Plan, as well as requirements for reana- also must receive training in the prin- views, environmental monitoring, and lysis. ciples of food hygiene and food safety. product testing, as appropriate. You also should be aware that there are Second, whoever is responsible for pre- some significant differences between paring the Food Safety Plan and per- š Supply Chain Program If a supplier FDA’s expectations and the standards forming certain key activities under the is responsible for controlling a “ha- under European and law. For example, plan must be a “Preventive Controls zard requiring a preventive cont- FDA has a very strict policy for listeria Qualified Individual” (PCQI). This sta- rol,” then a supply chain program in ready-to-eat foods. The supplier ve- tus can be attained either by attending is required. FDA has issued detailed rification regulations are another area a training program equivalent to a stan- requirements for how to adequately with significant differences that war- dardized curriculum developed by FDA perform supplier verification in these rants careful attention. (such as the training programs offered situations, which differ significantly through the Food Safety Preventive from the way that companies have In addition to issuing the above regula- Controls Alliance), or based on educati- historically performed supplier verifi- tions, FDA “modernized” the current on and experience. cation voluntarily. Careful attention Good Manufacturing Practice (cGMP) is needed for this part of the regula- regulations. In particular, the regulations The compliance dates for the PCHF tion. In particular, be aware that just now specifically address allergen cross-con- regulation have passed, and FDA is ac- obtaining your supplier’s third-party tact and include a provision for holding tively performing inspections. These in- audit certificate is not sufficient to be and distribution of human food by-pro- spections are occurring domestically and in compliance. ducts that are used for animal food. internationally. Note that foreign inspec- tions are preceded with written notice, š Recall Plan If the hazard analysis Finally, there are new training require- and are scheduled in advance. There can identifies a hazard requiring a preven- ments for all personnel, and specialized be significant consequences related to tive control, the facility must have a training requirements for personnel with refusal or failure of a foreign inspection, written recall plan that describes the responsibility for development and im- including delayed or rejected imports to procedures to perform a recall of the plementing the Food Safety Plan. First, the United States. If an inspection results product. The recall plan must include all employees who manufacture, pro- in a Form 483, this means that FDA has procedures to notify consignees, to cess, pack, or hold food must be qua- identified deficiencies during the inspec- volume 44 | 05./06. 2020 ERNÄHRUNG | NUTRITION
50 recht law tion. It is imperative to respond in wri- number of exposures; how fast 4. Foreign Supplier Verification Pro- ting to a Form 483 within 15 business the food moves through the dis- gram The Foreign Supplier Verification days of when it is issued, and advisable tribution system; potential agents Program (FSVP) requires someone in to work with experienced legal counsel of concern and the infectious/let- the United States to verify the safety of to ensure that your response is sufficient. hal dose of each; and the possible the food being imported. FSVP cannot number of illnesses and deaths. be performed by someone outside of 2. Preventive Controls for Animal š The degree of physical access to the United States. The legal responsibi- Food The Preventive Controls for Ani- the product. Issues to be consi- lity for FSVP falls on the person in the mal Food (PCAF) rule is parallel to the dered would include the presence U.S. who owns the food, has purchased PCHF rule, except that the rule applies of such physical barriers as gates, the food, or has agreed in writing to to food made for animals. You should railings, doors, lids, seals, and purchase the food – i.e., the “importer.” be aware that FDA expects that animal shields. Note that “importer” for FSVP is de- food will be free of pathogens, just like š The ability to successfully conta- fined differently than the term “importer human food. However, the allergen re- minate the product. of record,” which is used in other U.S. quirements for human food do not ap- regulations. This identity of the FSVP ply to animal food. Instead, FDA is fo- š Mitigation Strategies Mitigation importer party will vary depending on cused on issues of specific interest for strategies should be identified and your own situation. animals, such as nutrient deficiencies implemented at each actionable or toxicities (e.g., inadequate thiamine process step to provide assurances The FSVP importer must do the follo- in cat food, excessive vitamin D in dog that vulnerabilities will be minimi- wing: food, and excessive copper in food for zed or prevented. The mitigation š Hazard Analysis The importer is re- sheep). As part of this rulemaking, FDA strategies are tailored to the facility quired to identify and evaluate – ba- also issued cGMP regulations for animal and its procedures. sed on experience, illness data, scienti- food. Most of the compliance dates for fic reports and other information – the the PCAF regulation have passed, and š Mitigation Strategy Management known or reasonably foreseeable ha- FDA has started conducting inspections. Components These are steps that zards for each type of food it imports must be taken to ensure the proper to determine if there are any hazards 3. Intentional Adulteration This rule implementation of each mitigation requiring a control. The importer can represents the first time that companies strategy. Specifically, there are requi- rely on another entity (such as the fo- are required to create a Food Defense rements related to food defense mo- reign supplier) to conduct the hazard Plan to address intentional adulteration. nitoring, food defense corrective ac- analysis, so long as the importer re- With some exceptions, this rule applies tions, and food defense verification. views and assesses the relevant docu- to both domestic and foreign compa- The first compliance date for the In- mentation. nies that are required to register with tentional Adulteration rule is July 26, the FDA. The Food Defense Plan must 2019, which applies to the largest com- š Evaluation of Food Risk and Sup- identify vulnerabilities and actionable panies. FDA was scheduled to begin plier Performance The importer must process steps, mitigation strategies, and routine inspections of larger businesses evaluate (1) the hazard analysis, (2) procedures for food defense monitoring, in March 2020, but these inspections the entity that will be significantly corrective actions and verification. Re- were delayed in response to the CO- minimizing or preventing the hazards analysis is required every three years or VID-19 pandemic. Routine inspections (e.g., whether the hazard is cont- when certain criteria are met, including for smaller businesses will begin in rolled by the foreign supplier or the mitigation strategies that are determined March 2021. When routine inspections supplier’s own supplier), (3) the for- to be improperly implemented. More begin, FDA has said they will consist of eign supplier’s procedures, processes, details are provided below: “quick checks” that will occur during and practices related to the safety of regularly scheduled food safety inspec- food, (4) applicable FDA food safety š Vulnerability Assessment Facilities tions. These “quick checks” allow FDA regulations, and information regar- must identify vulnerabilities and to verify that the facility has satisfied ding the foreign supplier’s compliance, actionable process steps for each the basic requirements of the rule by (5) the foreign supplier’s food safety type of food manufactured, proces- preparing a Food Defense Plan and may history, including the responsiveness sed, packed or held. For each point, also provide some educational materi- of the foreign supplier in correcting step, or procedure in the facility’s als. Note that there are numerous trai- past problems, and (6) other factors process, these elements must be ning programs available for the various as necessary, including storage and evaluated: aspects of this regulation. Because this transportation practices. The impor- š The severity and scale of the po- is a complex regulation that does not ter can rely on another entity (other tential impact on public health. mirror any preexisting regulations, it is than the foreign supplier) to perform This would include such consi- prudent to pay careful attention to these this evaluation, so long as the importer derations as the volume of pro- requirements and developing an imple- reviews and assesses the relevant docu- duct; the number of servings, the mentation strategy. mentation. ERNÄHRUNG | NUTRITION volume 44 | 05./06. 2020
51 recht law š Verification Activities Based upon the bering System (DUNS) number, which š Domesticated and Wild Animals evaluation of risk that was conducted, serves as their UFI for FSVP. The rule includes standards related the importer must establish and fol- to intrusion by domesticated and low written procedures to ensure that Most of the compliance dates have pas- wild animals at farms. Farmers are it only imports from approved foreign sed for FSVP, and FDA is actively per- required to take all measures reaso- suppliers. The importer also must forming inspections of the FSVP impor- nably necessary to identify and not conduct appropriate supplier verifica- ters. Note that because these inspections harvest produce that is likely to be tion activities. The verification activity occur in the United States and FSVP contaminated. However, farms are options include: importers must be domestic, FDA will not required to exclude animals š Annual on-site audits of the sup- never perform an FSVP inspection of a from outdoor growing areas, dest- plier’s facility. Note that an on-site foreign company or outside of the U.S. roy animal habitat, or clear borders audit can be a second-party audit around growing or drainage areas. or a third-party audit. Such audits 5. Produce Safety FDA’s Produce Safety are generally required when there rule established, for the first time, scien- š Worker Training and Health and is a reasonable probability that ex- ce-based minimum standards for the Hygiene Requirements for health posure to a hazard controlled by the safe growing, harvesting, packing, and and hygiene include taking measu- foreign supplier will result in serious holding of fruits and vegetables grown res to prevent contamination of pro- adverse health consequences or de- for human consumption in the United duce and food-contact surfaces by ath to humans or animals (called a States. The rule applies to all produce ill or infected persons, using hygi- SAHCODHA hazard); that will be consumed in the United Sta- enic practices when contacting pro- š Sampling and testing (e.g., perfor- tes, regardless of whether it is grown do- duce or food-contact surfaces, and ming testing upon receipt of the mestically or internationally. There are taking measures to prevent visitors food, or receiving a Certificate of two key exemptions from the rule: from contaminating produce and/or Analysis); or š Produce commodities that FDA food-contact surfaces. š A review of the supplier’s relevant has identified as rarely consumed food safety records. raw – i.e., asparagus; black beans, š Equipment, Tools and Buildings The great Northern beans, kidney be- rule establishes standards related An importer can rely on another entity ans, lima beans, navy beans, and to equipment, tools and buildings (other than the foreign supplier) to de- pinto beans; garden beets (roots and to prevent these sources, and inade- termine and perform appropriate sup- tops) and sugar beets; cashews; sour quate sanitation, from contamina- plier verification activities, so long as the cherries; chickpeas; cocoa beans; ting produce. This section of the rule importer reviews and assesses the rele- coffee beans; collards; sweet corn; covers, for example, greenhouses, vant documentation. cranberries; dates; dill (seeds and germination chambers, and other weed); eggplants; figs; ginger; horse- such structures, as well as toilet and š Corrective Actions Importers must radish; hazelnuts; lentils; okra; pea- hand-washing facilities. Required promptly take appropriate corrective nuts; pecans; peppermint; potatoes; measures to prevent contamination actions if they determine that there is pumpkins; winter squash; sweet po- of covered produce and food contact a food safety problem or the foreign tatoes; and water chestnuts; and surfaces include, for example, appro- supplier is out of compliance. The š Produce that receives commercial priate storage, maintenance, and cle- appropriate corrective measure will processing that adequately reduces aning of equipment and tools. depend on the circumstances, but the presence of microorganisms of could include discontinuing use of the public health significance, under š Sprouts There are specific requi- foreign supplier. certain conditions. rements to help prevent the con- tamination of sprouts, which are Note that there are a number of ex- The following is a summary of the key particularly at risk for microbial emptions from the FSVP regulations, substantive requirements under the rule: contamination. as well as modified requirements for š Agricultural Water The rule estab- certain types of food. For example, the lishes requirements for agricultural The compliance dates have passed for FSVP regulations do not apply to foods water related to water quality and most farms and FDA has started per- produced under FDA’s seafood or juice testing. FDA is currently reconside- forming inspections until the spring of HACCP regulations. ring these requirements, however, 2019 to allow time for more guidance, and has extended the compliance training, technical assistance, and plan- Upon entry to the U.S., FDA determi- dates for this part of the rule. ning. nes who is responsible for FSVP as the š Biological Soil Amendments The importer based on the “unique facility rule has requirements relating to the 6. Accredited Third-Party Certifica- identifier” (UFI) provided on the import use of raw manure and stabilized tion The rule on Accredited Third-Par- documentation. The importer must ob- compost as biological soil amend- ty Certification establishes a volun- tain and provide a Data Universal Num- ments. tary program for the accreditation of volume 44 | 05./06. 2020 ERNÄHRUNG | NUTRITION
52 recht law third-party certification bodies, also food testing must be performed by labo- 2. Traceability FSMA also requires known as third-party auditors, to con- ratories accredited by an FDA-recognized FDA to issue a proposed rule addressing duct food safety audits and issue certifi- accreditation body. Second, results of tes- traceability. Specifically, FSMA requires cations of foreign entities and the foods ting conducted under the rule would be FDA to designate a list of “high-risk” for humans and animals they produce. required to be sent directly to FDA. Third, foods, and then engage in rulemaking FSMA specifies two uses for certifica- it would establish model laboratory stan- to establish recordkeeping require- tions under this program: dards. Finally, it would establish a public ments for facilities that manufacture, š Certifications may be used by impor- registry of accreditation bodies and ac- process, pack, or hold designated high- ters to help establish eligibility for credited laboratories. The Proposed Rule risk foods. The designation for high-risk participation in the Voluntary Quali- would apply to an “owner or consignee” foods must be based on: fied Importer Program (VQIP), which that is required to use an accredited la- š the known safety risks of a particular is a fee-based program that offers ex- boratory to conduct food testing under food, including the history and se- pedited entry reviews. the regulation. FDA defines this term to verity of foodborne illness outbreaks š FDA can also require in specific, limi- mean “any person with an ownership or attributed to such food, taking into ted circumstances that a food offered consignment interest” in the food product consideration foodborne illness data for import be accompanied by a certi- or environment that triggers the need for collected by the Centers for Disease fication from an accredited third-par- testing under this proposed regulation. Control and Prevention (CDC); ty certification body. As part of a settlement agreement with a š the likelihood that a particular food consumer group seeking to compel FDA has a high potential risk for microbio- This rule is unlikely to affect most for- to satisfy its obligations under FSMA, the logical or chemical contamination or eign companies, unless they are produ- agency has agreed to issue a Final Rule by would support the growth of pathoge- cing food that will be imported under February 4, 2022. nic microorganisms due to the nature VQIP. of the food or the processes used to šUse of Accredited Laboratories Use produce such food; 7. Sanitary Food Transportation of an accredited laboratory would š the point in the manufacturing pro- FDA’s Sanitary Food Transportation rule be required when testing is conduc- cess of the food where contamination aims to prevent practices during trans- ted on behalf of an owner or con- is most likely to occur; portation that create food safety risks, signee in the following situations: š the likelihood of contamination and such as failure to properly refrigerate (1) for nine specific existing regu- steps taken during the manufacturing food, inadequate cleaning of vehicles latory testing requirements that ap- process to reduce the possibility of between loads, and failure to properly ply to bottled water, shell eggs, and contamination; protect food. The rule establishes requi- sprouts; when FDA issues a “food š the likelihood that consuming a par- rements for shippers, loaders, carriers by testing order”; (2) to address an ticular food will result in a foodbor- motor or rail vehicle, and receivers invol- identified or suspected food safety ne illness due to contamination of the ved in transporting human and animal problem and presented to FDA as food; and food to use sanitary practices to ensure part of evidence for a hearing pri- š the likely or known severity, including the safety of that food. The requirements or to the issuance of a mandatory health and economic impacts, of a do not apply to transportation by ship or food recall order, as part of a cor- foodborne illness attributed to a par- air because of limitations in the law. The rective action plan after an order ticular food. rule only applies to transportation within suspending the registration of a the United States, and thus only applies to food facility, or as part of evidence The purpose of the recordkeeping requi- U.S. transport legs for imported food. submitted for an appeal of an ad- rements is to facilitate the quick identifi- ministrative detention order; (3) in cation of recipients of food to prevent or III. Forthcoming support of admission of an article mitigate a foodborne illness outbreak. of food under section 801(a) of the FDA will issue the list of high-risk foods FSMA Regulations Federal Food, Drug, and Cosmetic and a Proposed Rule by September 8, FDA is in the process of implementing Act, which allows FDA to refuse 2020, and a Final Rule by November two additional regulations. When fina- admission of food for reasons in- 7, 2022. Once the Final Rule is issued, lized, these regulations also will affect cluding if the food “appears” to be FDA will publish on its website the list German and Austrian businesses selling adulterated, misbranded, or ma- of high-risk foods. food to the United States. nufactured, processed, or packed under insanitary conditions; (4) as IV. Recommended 1. Laboratory Accreditation On No- required by FDA in a food testing vember 4, 2019, FDA issued the Labora- order, which is a new regulatory Action Steps tory Accreditation for Analyses of Foods tool the agency proposes establis- FSMA is a significant development that Proposed Rule. The key components of hing under the rule; or (5) to sup- all German and Austrian companies the Proposed Rule mirror Section 202 of port removal from import alert th- selling food in the US need to under- FSMA. First, it would require that certain rough successful consecutive testing. stand. Below we set out key recommen- ERNÄHRUNG | NUTRITION volume 44 | 05./06. 2020
53 recht law dations to help you with FSMA com- for the FSVP importer to be in be prudent to monitor FDA’s re- pliance. compliance. cordkeeping requirements for those foods, because they could ultima- All FSMA Rules Work with expe- Intentional Adulteration: tely serve as the foundation for tra- rienced legal counsel or consultants to š Carefully review the regulation and ceability throughout the entire food ensure you understand FDA’s expec- FDA’s guidance documents to beco- system. tations and how they apply for your me familiar with the agency’s expec- operation. Ignorance or misunderstan- tations. Zusammenfassung Der Food dings are not excuses that will help you š Participate in the various available Safety Modernization Act (kurz: when FDA comes to inspect. training programs to develop the „FSMA“) stellt die größte Reform necessary expertise to build your des US-amerikanischen Lebensmittel- Preventive Controls for Human Food Defense Plan. sicherheitsrechts seit den 1930er Jahren Food and Preventive Controls for Ani- š Develop and implement a Food De- dar. Das Gesetz ist im Jahr 2011 in Re- mal Food: fense Plan. aktion auf eine Reihe von Lebensmittel- š Ensure that someone in your com- skandalen, bei denen auch Verbraucher pany is a Preventive Controls Qua- Produce Safety: zu Schaden gekommen waren, verab- lified Individual, or identify a PCQI š Review FDA’s regulations and gui- schiedet worden. Mittlerweile sind fast to assist you with your Food Safety dance to ensure you understand the alle Übergangsfristen abgelaufen. Der Plan as a consultant. regulation. FSMA verpflichtet Lebensmittelunter- š Develop a Food Safety Plan, which š Attend training programs related to nehmen in größerem Umfang als bis- may involve performing a gap ana- the regulation to deepen your un- lang zur Einrichtung von präventiven lysis to identify opportunities to derstanding of the rule. Kontrollmechanismen, und er erwei- modify your HACCP plan to com- š Train personnel on FDA’s expecta- tert die Eingriffsbefugnisse der Food ply with FSMA. tions. and Drug Administration („FDA“) š For human foods, put a strong š If you qualify for an exemption ba- erheblich. US-amerikanische Lebens- emphasis on environmental monito- sed on commercial processing of mittelunternehmen müssen im Rahmen ring for pathogens, if you make rea- your produce, ensure you meet the eines „Foreign Supplier Verification dy-to-eat foods, and allergen cont- requirements under the rule related Program“ auch gewährleisten, dass ihre rols, if you make foods containing to the exemption. Lieferanten die neuen Vorschriften be- any of the “big 8” allergens in the achten. Europäische Unternehmen, die United States (i.e., milk, eggs, fish, Accredited Third-Party Certification: Lebensmittel in die USA exportieren, crustacean shellfish, tree nuts, pea- š Consult with your U.S. importer müssen daher ihre Prozesse überprü- nuts, wheat, and soybean). as to whether they are considering fen und an ihren Produktionsstandor- š Review your supplier verification participating in VQIP and/or may ten einen Mitarbeiter zum „Preventive program to assess whether it is con- require your facility to obtain a cer- Controls Qualified Individual (PCQI)“ sistent with the requirements in the tification under this program. ausbilden, der für die Beachtung des regulations. In particular, be aware FSMA verantwortlich ist. Die FDA that just having a third-party audit Sanitary Food Transportation: führt auch bereits Inspektionen in eu- of your supplier is not sufficient to š If you are shipping food to the U.S. ropäischen Betrieben zur Überprüfung be in compliance. that will be further transported in der FSMA-Compliance durch. Bei ei- š Stay abreast of FDA’s guidance do- the same shipping container once it nem Verstoß drohen Abmahnungen cuments, as the agency is exercising arrives, be sure you are familiar with und Importwarnungen, die das US-Ge- “enforcement discretion” for some the requirements under this rule and schäft empfindlich treffen können. provisions of the regulations through how it applies to your shipments Dieser Beitrag erläutert die neuen Re- guidance and also has issued recom- once they are in U.S. commerce. gelungen und gibt Empfehlungen zur mendations to assist with compliance. Umsetzung in europäischen Unterneh- Laboratory Accreditation men. FSVP: š Keep an eye out for FDA’s final re- šEnsure you know who is respon- gulation, and assess the implication Maile Hermida, Attorney at law, Hogan sible for performing FSVP for of the final regulation’s require- Lovells US LLP, Washington the foods you are sending to the ments for your testing programs. United States. You will need to Rechtsanwältin Dr. Anna Glinke, work with this entity to ensure Traceability Hogan Lovells International LLP, they have the necessary informa- š Monitor for FDA’s release of the list Düsseldorf tion to verify the safety of your of designated high-risk foods and products. Be aware that just pro- Proposed Rule. Even if the foods Der Beitrag ist zuerst in der ZLR viding them with a third-party you produce are not designated as 4/2019 erschienen und wurde nun (e.g., GFSI) audit is not enough high-risk under the proposal, it will adaptiert. volume 44 | 05./06. 2020 ERNÄHRUNG | NUTRITION
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