Food Safety Modernization Act (FSMA): An Assessment of Puerto Rico’s Food Industry Readiness and Preparedness
The successful development and implementation of compliance policies and activities in the food industry could be directly associated with the access to information and understanding of the law. Discussions and information found in the literature about the impact of the Food Safety Modernization Act (FSMA) implementation has been mainly conducted within the United States. However, limited information is available about the impact of this new law in one of the U.S. territories, the Commonwealth of Puerto Rico. On this research study FDA Official Inspected Establishments in Puerto Rico were questioned about their readiness and preparedness for FSMA using an on-line survey tool. The purpose of this research is to obtain information that can allow to evaluated if the lack of access to FSMA information and language barriers have a direct effect that limits the readiness and preparedness of the FSMA implementation in Puerto Rico.
In progress: include results and conclusion headings/sections
Chapter I: Introduction
FSMA implementation represents a big challenge that urges food manufacturers to revise their food safety systems and make decisions about resource allocation to reduce food safety risks in their operations. This new law had been building with several years of high-profile food recalls, foodborne illness outbreak, and consumer’s advisories (3).
Discussions and information found in the literature about the impact of the implementation of FSMA has been mainly conducted within the United States. However, limited information is available about the impact of this new law on the food industry in other U.S. territories.
On this research study the information collected allow to examine the readiness and preparedness on FSMA in one of the U.S. territories, the Commonwealth of Puerto Rico. The island of Puerto Rico is part of the Greater Antilles and since 1898 has been part of the United States (1). This unique status requires that food manufacturers in Puerto Rico comply with all federal regulations that cover the food industry (2).
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It is important to understand that the challenges faced by food manufacturers in Puerto Rico are not different from their counterparts in the United States. FDA Commissioner Margaret A. Hamburg stated that FSMA calls for the strengthening of existing collaboration among all food safety agencies whether they are Federal, state, local, territorial, tribal, or foreign. “Building and leveraging the capacity of these food safety partners is how we can have a well-integrated, national food safety system that is as effective and efficient as it can be” (12) (13).
In order 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 established 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 limitation in consideration, two research questions are intended to be covered by this study.
- Is the lack of access to FSMA information limiting readiness of food manufacturers in Puerto Rico?
- Is the lack of understanding due to language barriers among food manufacturers limiting FSMA preparedness?
The participants were defined using the FDA Official Inventory Establishment (OIE) list of food manufacturers in Puerto Rico (Appendix 1). An online survey was used 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 will be discussed to learn more about the food manufacturing industry in Puerto Rico.
The Food Safety Modernization Act (FSMA) is the most significant amendment of United States food law since passage of the 1938 Food, Drug, and Cosmetic Act (3). It will impact all domestic and imported food products that are not under the jurisdiction of the U.S. Department of Agriculture Food Safety and Inspection Service (USDA-FSIS). FSMA was signed into law on January 4, 2011 and since then food manufacturers have been called upon to start preparing their companies to be in compliance with the new law requirements.
FDA identified five key elements where its authority was enhanced. The first element is focusing on preventing food borne illness by requiring mandatory preventive controls, Hazard Analysis Risk Preventive Controls (HARPC), for food facilities and mandatory produce safety standards, and also giving the authority to prevent intentional adulteration. The difference from the Hazard Analysis and Critical Control Points (HACCP) approach is that HARPC is slightly broader requiring identification and controls of hazards generally, not just critical control points (3). The second is by providing the ability to increase FDA inspection frequency based on risk; high-risk facilities will be identified. Third, ability to respond to problems when emerge including authority to conduct mandatory recall for all products, authority to detain products that are in violation, and by suspending facility’s registration. Before, FDA was required to have “credible evidence” or “information” than an article of food “presents a threat 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 believe” 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 officials (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, guidelines, and studies under FSMA, this included seven “foundational” rules required to fully implement it (See table 1) (25).
Among the 7 different rules included in FSMA the well-known part 110 that covers Current Good Manufacturing Practices was removed and replaced it. Now part 117 will covers Good Manufacturing Practice and Hazard Analysis and Risk Controls for Human food and for Growing, Harvesting, Packing and Holdings of Produce for Human Consumption.
In addition, it is expected by law that all high-risk domestic firms after the law enactment be inspected in a period of five years and no less than every three years thereafter (3).
The FSMA legislation’s purpose is to renovate the existing approach 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 small food facilities affected by the regulations immediately or in the near future (4). The new recordkeeping requirements will be science-based and based on the know safety risk of a particular food, including the history and severity of outbreak, and factors related with the likelihood on foodborne illnesses (3). Small and very small plants do not have robust programs in place when compared with larger plants. Historically, small businesses have not had extensive experience with prevalent food safety management systems and standards such as ISO 22000: 2005, SQF code (Safe Quality Food Institute), GFSI guidelines (Global Food Safety Initiative) or HACCP (4). Programs 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 same regardless of size, unless they are partially or fully exempted based on the operations conducted in the facility (5). Small plants and very small plants need to comply within a period of two to three years, respectively, after the publication of the final rule (see table 2) (5).
Historical Background and Food Regulatory Structure in Puerto Rico
The island of Puerto Rico is similar in size to Connecticut, encompassing 3,492 square miles. The population is about 3.4 million and the main language is Spanish. The island has 6 urban centers designated as Standard Metropolitan areas (SMAs) by the U.S. Census 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 FDA’s 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 of food manufacturing facilities. As other states in the U.S. (20), this agency establishes specific regulatory requirements and issues the mandatory sanitary 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 General de Salud Ambiental No. 6090 4 de febrero de 2000 (18). On this regulations, the CFR tittle 21 is mentioned as the primary reference for compliance. However, in addition of the regulation established in the CFR title 21 there is specific requirements established in Puerto Rico for food products label language, annual 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 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 packaging 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, wholesome, and accurately labeled. Puerto Rico establishments are under the jurisdiction of the FSIS’s 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 percent 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 extremely 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.
Several surveys in the U.S. have already been conducted, covering 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 finding 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 400 respondents, including food processors and manufacturers, produce growers/packagers/shippers, warehouse and distribution companies, animal food manufacturers, domestic suppliers, foodservice companies, retailers, import 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 weren’t ready at all. (10a)(10b).
These findings indicate that education and preparation for FSMA remain a challenge for some food manufacturers in the U.S. particularly for medium, small and very small processors.
There are many 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 becoming 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 FD&C Act in areas of the company under the official’s control, even if the official did not intend for the violations to occur ().
If information on FSMA is not readily accessible it can limiting 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 English 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 speak 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 Description
The 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. After completing the video, the participants will complete 16 questions in Likert and multiple selection formats. The questionnaire is divided into the following three parts: Company and Respondent Profile, FSMA and Resources Preferences. (Appendix 3)
The 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 sample used were considering firms that have their last inspection date from 2008.
The only contact 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 contacted 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.
The survey was classified as exempt by the Institutional Review Board (IRB) (appendix 2). It was open from February 14 to March 20, 2017 (proposed closing 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 and 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 participation on the first invitation is that subject 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.
The 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 better prepared to respond to situations that emerge in the day to day. They should switch from reactive and corrective minded to preventive minded by creating strong 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 evaluate 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, identify and share available resources between the agencies. Also, it is needed the establishment of periodic revisions and analysis 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.
(1) Ayala, C. J., & Bernabe, R. (2007). Puerto Rico in the American century: 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 safety modernization act: A quality management approach to identify and prioritize factors affecting adoption of preventive controls among small food facilities. Food Control, 66, 241-249. doi:10.1016/j.foodcont.2016.02.001
(5) Food and Drug Administration, 2015 Food and Drug Administration
FSMA 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 Statehood
(7) United States Census Bureau – 2015 Puerto Rico Population Estimates
(8) FDA-Island Office Protects Consumers Near and Far
(9a) Sparta Systems’ Survey Finds Food & Beverage Companies Confident in FDA Regulation Preparedness-May 5, 2016
(9b) Sparta Systems Food Quality and Safety Survey 2016
(10a) Food Engineering – Are you ready for the FSMA final rules? April 25, 2016
(10b) 2016 FSMA Readiness & Compliance Strategy
(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, https://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?MOD=AJPERES
(15) Data enviada por OEIO Sepulveda
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(19) ORA Regional Field Office, Southeast Region, Atlanta, GA Organizational Chart https://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm351289.htm
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Seven “Foundational” Rules Required to Fully Implement FSMA
Congressional Research Service Implementation, December 16, 2016
(1) Preventive Controls for Human Food: Requires that food facilities have safety plans that set forth 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 domestic 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 Adulteration: 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))
Classification of food facilities as per the
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