Food Safety Modernization Act and Puerto Rico

nutriment encumbrance Modernization carry and Puerto anti-racketeering lawResearch Paper victuals recourse Modernization piece (FSMA) An Assessment of Puerto anti-racketeering laws sustenance effort Readiness and Prep ardnessAbstr practise advance IdeaThe successful development and implementation of compliance policies and activities in the intellectual nourishment industry could be directly associated with the access to culture and downstairsstanding of the law. Discussions and culture found in the literature almost the in completelyude of the pabulum caoutchouc Modernization Act (FSMA) implementation has been in the first place conducted within the coupled States. nevertheless, express mail teaching is available approximately the impact of this revolutionary law in one of the U.S. territories, the Commonwealth of Puerto anti-racketeering law. On this research study FDA Official Inspected governments in Puerto anti-racketeering law were questioned about their readiness and prep ardness for FSMA using an on-line come off tool. The purpose of this research is to obtain selective information that derriere allow to evaluated if the miss of access to FSMA information and language barriers possess a direct tack together that limits the readiness and prep bedness of the FSMA implementation in Puerto Rico.In take place embroil results and conclusion headings/sectionsChapter I IntroductionIntroductionFSMA implementation represents a ample challenge that urges nutrition manufacturers to revise their victuals synthetic rubber systems and make decisions about resource allocation to reduce diet safety risks in their operations. This novel law had been building with several years of high-profile victuals recalls, diet for thoughtborne complaint outbreak, and consumers advisories (3).Discussions and information found in the literature about the impact of the implementation of FSMA has been brinyly conducted within the join St ates. However, limited information is available about the impact of this untested law on the aliment industry in anformer(a)(prenominal)wise U.S. territories.On this research study the information collected allow to test the readiness and prep ardness on FSMA in one of the U.S. territories, the Commonwealth of Puerto Rico. The island of Puerto Rico is dissever of the Greater Antilles and since 1898 has been part of the United States (1). This unique status requires that pabulum manufacturers in Puerto Rico comply with all federal regulations that cover the sustenance industry (2).It is important to chthonianstand that the challenges faced by fare manufacturers in Puerto Rico are not unalike from their counterparts in the United States. FDA Commissioner Margaret A. Hamburg say that FSMA calls for the strengthening of existing collaboration among all food safety agencies whether they are federal official, state, local, territorial, tribal, or impertinent. Building and l everaging the capacity of these food safety partners is how we advise overhear a well-integrated, national food safety system that is as effective and efficient as it can be (12) (13).In hunting lodge to achieve these statements it is imperative to collect information, actually not available, about food manufactures readiness and preparedness in Puerto Rico for the implementation of the different requirements accomplished on FSMA. This task represents a big challenge specific topics about the requirements of the FSMA law are outside the scope of this research study. Taking this bound in regard, two research questions are intended to be cover by this study.Is the lack of access to FSMA information limiting readiness of food manufacturers in Puerto Rico?Is the lack of infrastanding due to language barriers among food manufacturers limiting FSMA preparedness?The participants were defined using the FDA Official Inventory Establishment (OIE) leaning of food manufacturers in Puert o Rico (Appendix 1). An online survey was utilise as the instrument to obtain information. The survey questionnaire was distributed among the participants by e-mail and descriptive statistics was used to summarize and analyze the data obtained from the survey. Findings, recommendations and future directions volition be discussed to peck more about the food manufacturing industry in Puerto Rico.FSMA Rule RequirementsThe aliment safeguard Modernization Act (FSMA) is the most significant amendment of United States food law since passage of the 1938 viands, Drug, and Cosmetic Act (3). It pass on impact all domestic and import food products that are not under the legal power of the U.S. Department of Agriculture nutriment Safety and Inspection Service (USDA-FSIS). FSMA was gestural into law on January 4, 2011 and since then food manufacturers waste been called upon to start preparing their companies to be in compliance with the new law requirements.FDA identified five mark ci strons where its leave was enhanced. The first element is focusing on pr howeverting food borne illness by requiring mandatory celebrateive visualises, Hazard abridgment Risk contraceptive sways (HARPC), for food facilities and mandatory kindle safety standards, and as well as giving the potential to prevent intentional adulteration. The difference from the Hazard Analysis and Critical Control Points (HACCP) entree is that HARPC is slightly broader requiring identification and overcomes of hazards generally, not just critical control points (3). The minute of arc is by providing the ability to increase FDA direction frequency establish on risk high-risk facilities will be identified. Third, ability to move to problems when emerge including authority to conduct mandatory recall for all products, authority to detain products that are in violation, and by suspending facilitys registration. Before, FDA was required to have credible evidence or information than an article of food presents a little terror of serious adverse health consequences or death to humans or animals with FSMA FDA have the authority to detain an article if the agency has reason to commit that the article of food is adulterated or misbranded (3). The fourth element identified is new requirements for imported products by requiring importers to verify their foreign suppliers have adequate preventive controls. The last element considered is the enhanced of partnerships between FDA by improving training of state, local, and tribal food safety ordaineds (25). In addition, FDA will enhance the partnerships with other food agencies and private entities (24).The FDA is responsible for more than 50 regulations, bearlines, and studies under FSMA, this included seven foundational rules required to fully implement it (See confuse 1) (25).Among the 7 different rules included in FSMA the well-known part one hundred ten that covers incumbent hefty Manufacturing Practices was removed an d replaced it. Now part 117 will covers Good Manufacturing Practice and Hazard Analysis and Risk Controls for Human food and for Growing, Harvesting, packing material and Holdings of Produce for Human Consumption.In addition, it is expected by law that all high-risk domestic firms subsequently the law enactment be inspected in a period of five years and no less than both three years thereafter (3).The FSMA legislations purpose is to renovate the existing turn up to food safety by enabling stakeholders to concentrate on preventive controls rather than simply reacting to food safety events (4). Legislative requirements of FSMA can be challenging, especially for subaltern food facilities affected by the regulations immediately or in the near future (4). The new recordkeeping requirements will be science- base and based on the know safety risk of a particular food, including the accounting and severity of outbreak, and factors related with the likelihood on foodborne illnesses (3) . Small and very down(p) plants do not have robust programs in place when examined with larger plants. Historically, small businesses have not had extensive experience with prevalent food safety management systems and standards much(prenominal) as ISO 22000 2005, SQF code (Safe Quality Food Institute), GFSI guidelines (Global Food Safety Initiative) or HACCP (4). weapons platforms that in most cases larger plants are more familiarized (4). In addition, FDA has recognized that small food facilities will likely face financial concerns in the implementation of the preventive control requirements of FSMA because they lack experience with HACCP-based models (4). Nevertheless, the new food safety requirements are the aforementioned(prenominal) regardless of coat, unless they are partially or fully exempted based on the operations conducted in the facility (5). Small plants and very small plants direct to comply within a period of two to three years, respectively, after the publica tion of the final rule (see table 2) (5).Historical Background and Food Regulatory Structure in Puerto RicoThe island of Puerto Rico is similar in size to Connecticut, encompassing 3,492 square miles. The nation is about 3.4 million and the main language is Spanish. The island has 6 urban centers designated as Standard Metropolitan field of honors (SMAs) by the U.S. count Bureau (6) (7).Puerto Rico and the US Virgin Islands are under the jurisdiction of the FDA San Juan District office located in the capital area of Puerto Rico. This office is the smallest of the FDAs 20 districts, was established back in 1911 and was officially named in 1971. This office reports to the regional Field Office, Southeast Region in Atlanta, GA (19). In 2013, FDA reported that they regulated 1,500 facilities, approximately half of them from the food industry (8). FDA in San Juan works closely with the local Health Department environmental Health Food Division, which is in charge of the inspection o f food manufacturing facilities. As other states in the U.S. (20), this agency establishes specific regulatory requirements and issues the mandatory hygienic license that covers food operations in the island. In 2016, the Association of Food and Drug Officials (AFDO), under contract to the FDA, shared data on the progress of FDA Food Code adoptions by States, Territories, and Indian Health Service. They reported that Puerto Rico adopted the Food Code version 2009 based in their population (21).Food Regulatory requirements in Puerto Rico are also promulgated by the Puerto Rico Health Department in Departamento de Salud de Puerto Rico Reglamento widely distributed de Salud Ambiental No. 6090 4 de febrero de 2000 (18). On this regulations, the CFR tittle 21 is mentioned as the elementary reference for compliance. However, in addition of the regulation established in the CFR patronage 21 there is specific requirements established in Puerto Rico for food products label language, annu al license certificationXXXX In addition, there are other agencies in the island that are or may be involve on food safety oversight. The State Department of Agriculture has regulations thru the program of Inspeccion de Mercado that covers produce, coffee berry and eggs (22).Also, the Departamento de Asuntos al Consumidor (DACO) protect consumers from being deceiving (23). They are involve on informing recalls of imported products marketed in the Island, inspect and removed expired products from shelves and have the authority to enforce civil penalties. Also, they are involving on the inspection of box of meat, fruits, vegetable and others food products by enforcing the Reglamento de Empaque (23).It is important to mention that the USDA-FSIS is responsible for ensuring that meat, poultry, and processed egg products produced in Puerto Rico are safe, whole whatever, and accurately labeled. Puerto Rico establishments are under the jurisdiction of the FSISs Atlanta, Georgia District (14). Data obtained from the USDA-FSIS in Puerto Rico showed that eighty seven establishments are inspected by FSIS thirty four of them under dual jurisdiction with FDA. This means that thirty nine percentageage of these establishments have to comply at some point based on their size with FSMA requirements (15) (appendix 2).Puerto Rico is highly dependent on importations ninety three percent of the food consumed in the island is imported. This is also passing important to take in consideration since one of the part of FSMA cover importations and foreign supplier verification. Importers will need to institute risk-based foreign supplier verification programs to assure that imported foods are compliance with the new requirements of the law (3).Although much information can be found related to FSMA, information about the impact of this new law in Puerto Rico is limited. An in-depth literature review showed nothing specifically related to Puerto Rico.Recent U.S. keep abreasts Outcom esSeveral surveys in the U.S. have al do been conducted, viewing specific topics on FSMA readiness and preparedness. One of the recent surveys in 2016 was conducted by Sparta Systems Inc. They conduct an online survey about FSMA readiness and compliance strategy. About 153 food and beverage professionals in the U.S. participated in this survey. The results showed that 61% of the participants felt confident that their organizations are prepared for FSMA. Approximately 20% of the respondents from medium-sized companies disagreed that their organizations were ready for FSMA according to additional conclusion from the survey (9a) (9b).Safety Chain Software and The Acheson Group (TAG) also conducted a survey in 2016. They used an online survey that received more than cd respondents, including food processors and manufacturers, produce growers/packagers/shippers, warehouse and distribution companies, animal food manufacturers, domestic suppliers, foodservice companies, retailers, impor t manufacturers, and import and domestic brokers (10b). More than two-thirds of respondents (68 percent) said they were somewhat ready for FSMA. Only 25 percent of respondents indicated they were ready for FSMA, while 6 percent said they werent ready at all. (10a)(10b).These findings indicate that education and preparation for FSMA die hard a challenge for some food manufacturers in the U.S. particularly for medium, small and very small processors.Why its importantThere are many another(prenominal) reasons of the importance of complying with the implementation of this new law. But for to make this task achievable it is important to make sure that the information is accessible and understandable by the regulated firms that fall under the law. The ultimately responsible following the different steps that compose this chain is the food manufacturer. The decisions made by them in order to be in compliance will be critical more than ever.Traditional inspecting styles will change becom ing more inspection -oriented and enforcement-minded (). Practices that were usually acceptable it maybe not enough to comply with these new inspections styles (). Firms that receive a Warning Letter following an FDA inspections, will be charged for the follow-up inspection (). In addition, if the firm is enforced by an injunction it will be required to close until corrective actions are completed and re-inspected by FDA, at the firm expense. It is important to note that even after being permitted to reopen, the firm remains under court supervision for the foreseeable future (). Moreover, FDA are resurrecting enforcement actions like criminal liability under the Park doctrine. The application of the doctrine establishes that corporate officials can be held criminally liable for violations of the FDC Act in areas of the company under the officials control, even if the official did not intend for the violations to occur ().If information on FSMA is not pronto accessible it can limiti ng readiness of food manufacturers in Puerto Rico that can severely delay their compliance. Also, language may be a barrier on food manufacturers that can limiting FSMA preparedness. Considering that side of meat is part of the educational curriculum of schools in Puerto Rico, contradictorily in 2000 the US Census showed that 45.1 percent of the total of the population of 481,410 people do not give tongue to English (26). This number could have been changed thru the years but Spanish stills is the main language used by the governmental offices in Puerto Rico and the population.Survey Instrument DescriptionThe survey instrument used was similar to the ones already used to obtain information from food manufacturers in the U.S.Taking into consideration that the main spoken language is Spanish, questions were provided in both, Spanish and English.The survey begins with a 5-minutes educational video from FDA about FSMA implementation to help participants be introduced into the topic. a fter completing the video, the participants will complete 16 questions in Likert and multiple extract formats. The questionnaire is divided into the following three parts Company and Respondent Profile, FSMA and Resources Preferences. (Appendix 3)sampling SelectionThe initial target population based on the OEI list submitted by FDA includes 786 firms (Appendix 2). Nevertheless, this number drastically changes because data include establishments reporting a last inspection dated in 1970. Furthermore, several firms appear duplicated on the list with exactly the same address information. Water and Ice Plants were also excluded for the purpose of the study. A further research, conducted me to a list NAME in the FDA webpage that seems to be more updated. This list included firms that were inspected for the period of 2008 2016. At the end, the try used were considering firms that have their last inspection date from 2008.The only accomplish information of the firm provided in the list was the address and phone number. Industry groups in Puerto Rico, MIDA and PRIDCO, and the Food Industry Forum (FIF) were ghosted and provide me with additional information by sharing their members list that include the e-mails information. Also, information found on the webpages PR Supply Chain On-Line and Hecho en Puerto Rico where extremely helpful to retrieve and validate food manufacturers contact information (16)(17).However some firms have been found that closed business at some point during 2008 2016 which was the period selected. At the end, the final revised number that their contact information can be validated roughly finished in 179 inspected firms.Data CollectionThe survey was classified as exempt by the Institutional Review Board (IRB) (appendix 2). It was open from February 14 to March 20, 2017 (proposed decision date). A total of 179 FDA food inspected firms were invited via e-mail to participate in the survey. From the 179 firms invited 23 e-mails bounced out a nd 1 opted out. Only 3 firms responded during the period of February 14 to February 27. A second invitation was sent on March 3, something that may affect the companionship on the first invitation is that field line and message were sent in English taking this premise in consideration second invitation subject line and message were sent in Spanish (on progress). In addition, some firms were contacted by phone to encourage them to participate in the survey.Data AnalysisThe analytical procedure used to evaluate the data collected was descriptive statistical methods. (Waiting for data)By been FSMA compliant food firms should be able to be give way prepared to respond to situations that emerge in the day to day. They should lurch from reactive and corrective minded to preventive minded by creating heavy food safety plans and HARCP programs.Future directions may include a second project that can be used as a follow-up in conjunction with regulatory agencies in Puerto Rico to evaluat e and compare the progress of the FSMA implementation among Food Manufacturers. Classification of the industry will be important to organize strategies by focusing on high-risk operations and offer a better guidance to food manufactures.Development of educational strategies such as guidelines, videos, workshops, and educational campaigns may be developed. Better allocating local and federal economical resources food manufacturers with limited resources can be better assisted.Regulatory agencies in Puerto Rico can unify efforts toward food safety compliance to create a strategy. Puerto Rico can used models from other states in U.S. that compiled information of food agencies in their area in a webpage creating a roadmap for food firms making the information easily accessible to food firms. Food regulatory agencies must enforce their partnership between agencies, recognise and share available resources between the agencies. Also, it is needed the establishment of periodic revisions an d psychoanalysis of recorded data to evaluate the progress of the firms. The use of new media tools such webpages and phone apps can expedite the delivering or retrieving of information from food manufacturers in the island. This will help to maintain open communication and keep information updated ensuring the availability of accurate data when it is needed.References(1) Ayala, C. J., Bernabe, R. (2007). Puerto Rico in the American ampere-second A history since 1898. Chapel Hill University of North Carolina Press.(2) Code of Federal Regulations, Title 21, Food and Drug Pt 1403, App. A, page 282 Revised as of April 1, 2011(3) Fortin, N. D. (2011). The United States FDA food safety modernization act The key new requirements. European Food and Feed Law Review EFFL, 6(5), 260-268. Retrieved from http//ezproxy.msu.edu.proxy1.cl.msu.edu/login?url=http//search.proquest.com.proxy1.cl.msu.edu/docview/903529133?accountid=12598(4) Grover, A. K., Chopra, S., Mosher, G. A. (2016). Food safe ty modernization act A fibre management approach to identify and prioritize factors affecting adoption of preventive controls among small food facilities. Food Control, 66, 241-249. doi10.1016/j.foodcont.2016.02.001(5) Food and Drug judicature, 2015 Food and Drug AdministrationFSMA proposed rule for preventive controls for human food(2015, February 21) Retrieved from http//www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm(6) United States Council for Puerto Rico Statehoodhttp//www.prstatehood.com/about-pr/index.asp(7) United States Census Bureau 2015 Puerto Rico Population Estimateshttp//factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?src=bkmk(8) FDA-Island Office Protects Consumers Near and distanthttp//www.fda.gov/forconsumers/consumerupdates/ucm370079.htm(9a) Sparta Systems Survey Finds Food Beverage Companies Confident in FDA Regulation Preparedness-May 5, 2016http//www.spartasystems.com/about-us/press-releases/press-archive/press-releases-2016/sp arta-systems%E2%80%99-survey-finds-food-beverage-compa(9b) Sparta Systems Food Quality and Safety Survey 2016http//marketo.spartasystems.com/rs/084-QBA-512/images/Food_Survey_Results_Report_2016.pdf(10a) Food Engineering ar you ready for the FSMA final rules? April 25, 2016http//www.foodengineeringmag.com/articles/95479-are-you-ready-for-the-fsma-final-rules(10b) 2016 FSMA Readiness Compliance Strategyhttp//marketing.safetychain.com/acton/attachment/2194/f-01d9/1/-/-/-/-/2016%20FSMA%20Readiness%20%26%20Compliance%20Strategy%20Survey%20Report%20Sponsored%20by%20SafetyChain%20and%20TAG.pdf?sid=TV2K3Vrv8uFV(11) Kumar, R. (2014). Research methodology A step-by-step guide for beginners (4th ed.). London SAGE. Chapter 12(12) Strauss, D. M. (2011). An analysis of the FDA food safety modernization act Protection for consumers and boon for business. Food and Drug Law Journal, 66(3), 353(13) Margaret A. Hamburg. Food Safety Modernization Act Putting the Focus on Prevention, Jan. 3. 2011, h ttps//obamawhitehouse.archives.gov/blog/2011/01/03/food-safety-modernization-act-putting-focus-prevention(14) The Food Safety and Inspection Service in Puerto Rico https//www.fsis.usda.gov/wps/wcm/connect/8d8574dc-4d0a-4b36-8667-039d8f5f6aac/PR.pdf? advanced=AJPERES(15) Data enviada por OEIO Sepulveda-Evans, J.R. and Lindsay, W.M. (2011),Managing for Quality and Performance Excellence, 8th ed., South-Western Cengage Learning, Mason, OH, pp. 554-555.-Cobb, C. (2000), Knowledge management and quality systems,The 54th Annual Quality Congress Proceedings, 2000, American Society for Quality, pp. 276-287.-Teskey, S., Nassar, M. and Buciarelli, R. (2010),Food Safety beyond the Standards How to Build a Culture of Food Safety to Protect Your Customers and Your gull , Delloite and Touche LLP, available at www.deloitte.com/assets/DcomCanada/Local%20Assets/Documents/Consulting/call%20for%20papers/ca_en_ers_FoodSafety_230910.pdf (accessed March 5,2012).(16) http//hechoenpr.com/directorio-de-se rvicios-y-productos/(17) https//www.prsupplychainonline.com/PRSCO/search.jsf(18) http//cayey.upr.edu/wp-content/uploads/sites/10/2016/07/REGLAMENTO-GENERAL-SALUD-AMBIENTAL.pdf(19) ORA Regional Field Office, Southeast Region, Atlanta, GA Organizational Chart https//www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm351289.htm(20) State sell and Food Service Codes and Regulations by Statehttps//www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/ucm122814.htm(21) FDA- Real show up in Food Code Adoption 02/22/2016 (last visited 02/26/2017)https//www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/UCM476819.pdf(22) Departamento de Agricultura de Puerto Rico Inspeccin de Mercadoshttp//www2.pr.gov/agencias/Agricultura/SAIA/InspeccionMercados/Pages/Leyes-y-Reglamentos.aspx(23) Departamento de Asuntos del Consumidor DACOhttp//daco.pr.gov/sobre-nosotros(24) Susan A. Schneider, Notes on Food Law An Overview of the Food Safety Modernization Act, October 10, 2011 2011 Ark. L. Notes 650(25) Rene Johnson, Congressional Research Service, Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353) December 2016(26) Fishman, J. A., Garcia, O. (2011). Handbook of language ethnic identity. 2 The success-failure continuum in language and ethnic identity efforts. Chapter 9 Learning English in Puerto Rico An Approach-Avoidance Conflict? Oxford Oxford University Press.Table 1 Seven Foundational Rules inevitable to Fully Implement FSMA Congressional Research Service Implementation, December 16, 2016(1) hindrance Controls for Human Food Requires that food facilities have safety plans that set forrader how they will identify and minimize hazards (FSMA 103).(2) Preventive Controls for Animal Food Establishes Current Good Manufacturing Practices and preventive controls for food for animals (FSMA 103).(3) Produce Safety Establishes science-based standards for growing, harvesting, packing, and holding produce on domest ic and foreign farms (FSMA 105(a)).(4) Foreign Supplier Verification Program Importers will be required to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of U.S. food producers (FSMA 301(a)).(5) Third Party certification Establishes a program for the accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities producing food for humans or animals (FSMA 307).(6) Sanitary Transportation Requires those who transport food to use sanitary practices to ensure the safety of food (FSMA 111).(7) Intentional alloy Requires domestic and foreign facilities to address vulnerable processes in their operations to prevent acts intended to cause large-scale public harm (FSMA 106(b))Table 2Classification of food facilities as per the