Food Safety Food Safety Issues Related to Street VendorsModernization Act and Puerto Rico

Research Paper

Food Safety Modernization Act (FSMA): An Assess


Street food vending forms a very important segment of the unauthorized sector of food industry. As a result of rapidly growing economy and better employment opportunities in urban areas, urban sector attracts a large proportion of population for employment and results in settlement of this section in other areas of big cities and development of suburbs. This growth is expected to increase significantly with the increasing urbanization & population growth, especially in developing countries. Due to this transition, food habits of people are getting affected. In India during recent years there is an increasing trend in the sale and consumption of foods on the roadside. Though Street food vending is found around the world, but it has variations within both regions and cultures.

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Nowadays street food is becoming very popular and is in demand because it saves one’s time and energy as it is ready to eat, street foods reflect the traditional local culture and is one of the best ways to experience the real cuisine of any community. The Street vended foods include foods without any preparation, ready to eat food and foods cooked on the site. A part from this street food is appreciated for the taste, flavour they offer at low, affordable price to the general population. (Bhowmick, 2005) Street vended foods include foods as diverse as meat, fish, fruits, vegetables, grains, cereals, frozen produce and beverages. Street foods may be sold in places or found in clusters around public places, such as the market or fair, place of work, schools & colleges, railway stations, hospital and bus terminals and may be vended from roadside makeshift stalls, carts or small establishments by hawkers or vendors .

According to food and agricultural Organisation (F A O), 2.5 million people eat street food daily. The national policy for urban street vendors/hawkers of India notes that street vendors, roughly estimated to be 10 million, constitute approximately 2% of the metro populations. FAO defines street vended foods as “Ready – to – eat foods and beverages prepared and/ or sold by vendors and hawkers especially in street and & other similar public place (FAO 1988). According to National policy on urban street vendors, street vendor is broadly defined as a person who offers goods for sale to the public without having a permanent built up structure but with a temporary static structure or mobile stall (or head load). Street vendors may be stationary by occupying space on the pavements or other public /private areas or may be mobile in the sense that move from place to place carrying their wares on push carts or in cycles or baskets on their heads ,or may sell their wares in moving trains, bus etc. (National policy on urban street vendors,2004). The rising popularity of street food vending, besides its social support system for the under privileged urban population is it’s easily accessibility; variety in taste, low cost fresh and often nutritious attributes. People spend almost 50% of their income on food; among low income groups this figure may go up to 70% (Bhandari).

A study conducted in India in the city of Varanasi, observed that about 42% of working men and women in the age groups of 25-45 and 61% of the students in the age group of 14 -21 consumed food from the street vendors rather carrying foods from home to the workplace . About 82% of people of all age groups prefer to go to street vendors against 18% only who prefer to go to the restaurants in the evening (Mishra2007) FAO and WHO recognising this spiralling Asian trend, has promoted documents on “ Food safety requirements for street vended foods” and also on “ Training aspects “ of safe food for small operator and inspectors. Presently countries like Singapore, Thailand and Malaysia have put together a structured national program to promote food safety in street vended food.

IMPORTANCE of street foods

The concept of traditional street food has acquired new dimensions in developed countries with food streets/ food centres emerging as new tourist attractions. Though street food culture pervades almost all countries of developed regions, the Asian street food is considered as the best in the world.

The Time magazine survey of 2004 and the CNN report of March 2012 find Asia’s 10 greatest street food cities and tell us how the street food make those cities economically bustling and socially charming. Malaysia’s Penang, Taiwan’s Taipei, Thailand’s Bangkok, Japan’sFuloka, Vietnam’s Hanoi, Korea’s Seoul, Singapore, China’s Xian, Philippines’s Manila and Cambodia’s Phnom Penh find their places in this list of 10 top Asian street food cities.

Street foods play a very important role in providing inexpensive and nutritious foods, particularly for millions in the middle and lower income groups. The FAO and the WHO have carried out several studies on street foods in different countries of Asia, Africa and Latin America. Besides their convenience and employment potential, the greatest factor in their favour is the fact that they can provide per capita calorie and protein requirements within a cost of around $1(wilnaro). It also plays an important social- economic role in terms of employment potential and in serving the food and nutritional requirements of consumers at the affordable prices. It requires a low capital investment, offers a chance for self employment and provides business opportunities for developing entrepreneurs. It also contributes to local and national economic growth by supporting local agricultural producers and food processors. Thus the socioeconomic significance of street foods is immense.

Street foods are an attractive experience of varied foods for tourists. In developing countries, making and vending street food provides a regular source of income for vast number of men and particularly women, who lack education or skills. Also the street food vendors are valuable, because it is a large significant area supporting the livelihood of millions of the urban poor. Nothing represents the rich tapestry of India’s multi cultural fabric better than street food. The cuisine of a place speaks volume about the weather; cultural life style and habit of the people. The convenience and low price make street food the most favoured choice. Many itinerant workers who do not have proper housing and cooking facilities have no option but to depend upon street foods.

Risk factors involved

Food borne illness associated with the consumption of street vended foods has been reported in several places in India. Multiple lines of evidence reveal that foods exposed for sale on the roadsides may become contaminated either by spoilage or pathogenic microorganisms (Bryans 1992:A shenafi;1995;WHO,1984) Food can easily be adulterated to defraud the consumer and deprive him of his money’s worth. According to WHO (1989), Food handling personnel play an important role in ensuring food safety throughout the chain of food production and storage. Mishandling and disregard of hygiene measures on the part of the food vendors may enable pathogenic bacteria to come into contact with food and in some cases survive and multiply in sufficient numbers to cause illness in the consumer.Tamberker,reported that poor hygiene of vendors resulted in higher contamination(66.6%), reducing to (33.4%) where hygiene was fare. This higher contamination can be due to dirty clothing, unhygienic handling and serving practices, contaminated hands and lack of knowledge of hygienic practices.

Many foods are highly perishable. They are easily contaminated when produced in an unhealthy and unclean environment. Microbiological contamination and spoilage of food needs to be prevented through good handling practice (Ham bridge). More often than not, the microbiological quality of street foods, especially that of prepared dishes and drinks is below standard, indicating inappropriate sanitary and hygienic practices during preparation and handling. Most of the foods are not well protected from flies, which carry food borne pathogens. Food borne pathogens are recognized as a major health hazard associated with street foods. Salmonella species is a post modern pathogen, which belongs to important food contaminating bacteria, causing a high number of human infections worldwide.

Consumption of raw or inadequately processed animal foods can have a significant public health risk as such foods are frequently contaminated with pathogens and occasionally with toxic chemicals. Similarly vegetables, fruits and grains may carry hazardous contaminants. Further, unsanitary environmental conditions like proximity of the establishment to sewers or garbage dumps, pollution from traffic add to the public health risks associated with street foods. Additional hazards may also be in the form of use of improper food additives (often unauthorized colouring), myotoxins, heavy metals and other contaminants (such as pesticide residues) in street foods. Infrastructure developments are relatively limited with restricted access to potable water, toilets, refrigeration and washing and waste disposal facilities.

Food Safety Practices—effects on public health

With the increasing pace of globalisation and tourism, the safety of street food has become one of the major concerns of public health. There is difficulty in controlling the large numbers of street food vending operations because of their diversity, mobility and temporary nature. Food safety issues have been the most wanted intervention in the field of nutrition all over the world. Safety of the street food is an important aspect in the field of nutrition security. Ensuring food quality and food safety is equally significant for the welfare of an individual, a community and a nation. Since this is an unorganised sector, there is felt need of generating government’s initiation for its development. There is also a need of generating food and personal hygiene and ensuring an effective system of regular health examination of vendors and regular sample collection of food they are serving to the customers. In spite of numerous advantages offered by street foods, there are also several health hazards associated with this sector of the economy. Many human illnesses are food related, because of lack of basic infrastructure and services, such as nutritional status and economic well-being are affected by food carrying pathogenic organisms and their toxins and by poisonous chemicals. Appropriate location and condition of vending stalls, observation of personal hygiene by vendors, employing washed and clean utensils, using potable water and proper drainage and waste disposal are some steps to be taken which can lead to hygiene and safe food. In India, traditional methods of processing and packaging, improper holding temperature, poor personal hygiene of food handlers are still observed during food marketing and sales. Consumption of raw inadequately processed animal foods can have a significant public health risk as such foods are frequently contaminated with pathogens and occasionally with toxic chemicals. Similarly vegetables fruits and grains may carry hazardous contaminants. There are also problems with the use of unauthorized food colours and some other additives, as well as chemical contamination from the environment.

Various studies have been also done to observe the personal hygiene, health and food handling practices like (vendors not wearing clean clothes, are dirty, chewing tobacco during food handling and do not wipe hands after every service of food.). Bhasker (2004) reported that defective personal hygiene can facilitate the transmission of pathogenic bacteria found in environment and on people’s hands via food to humans. Handling with bare may result in cross contaminants, hence introduction of microbes on safe food (FAO’1997). Paulson D.S (1994) also reported that outbreaks are generally caused by foods due to poor personal hygiene of the vendors, during preparation or storage of food. Unhygienic surrounding like sewerage, improper waste disposal system and inadequate water supply attract flies and houseflies which further increase food contamination as reported by Chumber, 2007. To instil professional face to street food operators, the street food safety management needs a Hazard Analysis Critical Control Point (HACCP) and the prerequisite system as good manufacturing practices (GMPs) and good hygiene practices.(GHPs). Following Table reports current hazards and critical control points observed at the main steps along the street food production chain.

Table—Hazards and critical control points identified at different steps of street food production chain

Step Hazards ( Biological) Critical control points
Primary Production:

Raw food stuff

Initial Contamination Raw food stuffs from illegal sources and bad quality.

Contamination of raw food stuffs by different elements

Storage: Growth of bacteria from initial contamination Storage in inadequate containers or stores without protection from rodents and flies.

Contamination by excrements and other food wastes

Fragmentation and conditioning Growth of bacteria Addition of illegal ingredients.

Further contamination via hands

Processing :

Precooking/ preparation

Cross contamination and survival of bacteria

Initial contaminants occur in unlock foods

Bad separation of raw products with cooked foods.

Contamination via hands or in other ways.

Inadequate washing of raw food before preparation

Vending :

Cooking/cooling/ Reheating

Survival of pathogens & spores.

Production of toxins

Inefficient cooking or reheating temperature.

Cross contamination.

Inefficient holding temp.

Exposure / Vending:

Serving / Consumption

Contamination and growth of bacteria and spores.

Production of toxins

Bad protection from file and dust.

Bad handling.

Source:Chirag Gadi

Microbial hazards and their solution, critical points, practical control processing measures and monitoring procedures as well as principles of food microbiology and food safety need to be incorporated for the safe street food preparation.

Standards or Criteria to maintain while handling the food.

The standards of street food safety can be upgraded by the vendors through implementation of some basic good practices with respect to hygiene and food handling. Standards for food handler requirements such as hand-washing, working attire, personal hygiene and personal behaviour should be maintained. Standards for food-vending equipment; which must be food grade ,easy to clean and sanitize, standards for food serving such as safe food cover and packaging, regular hygiene and sanitation inspection and monitoring of good food handling practices should always be maintained. Kinton and Ceserani(1996) recommended that food stuffs of all kinds should be kept covered as much as possible to prevent contamination from dust and flies.

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The food safety and standards Authority of India (FSSAI) has started engaging with the national association of street vendors of India in systematizing and professionalising street foods across cities in the wider interests of ensuring public health and protecting livelihood of street food vendors. Also FSSAI is in the process of developing guidelines and regulations to ensure food safety and safe street foods for state governments to implement. The Food safety and standards Authority of India has prepared a checklist, guidelines and prerequisite for registration of medium to small food –vending establishment to ensure food safety and upgrading of existing conditions of eating establishments. Several agencies at the level of the state governments, the department of public health, commerce, consumer affairs and food processing, the local municipalities and the police administration have identified roles and responsibilities in these guidelines and regulations that are expected to be executed to ensure safe street foods.

Microbial hazards and their solution, critical points, practical control processing measures and monitoring procedures as well as principles of food processing microbiology and food safety need to be incorporated for the safe street food preparation. Appropriate location and conditions of vending stalls, observation of personal hygiene by vendors, employing washed and clean utensils, using potable water and proper drainage and waste disposal are some steps to be taken which can lead to hygiene and safe food.

Policy issues for provision of safe food

Adapting the five keys to safer food to address the street food sector (WHO,2011). WHO has developed few measures for street food vendors based on the principles of five keys to safe food. These can be incorporated and taught in Indian scenario. These are:

Key 1: keep clean

Key 2: raw and cooked food should be kept separated.

Key 3: destroy hazards when possible.

Key 4: keep microorganisms in food from growing.

Key 5: use safe water and raw material.

The Ministry of Food processing industries has proposed schemes for “’Safe Food Towns’’ and safe food streets’’. These schemes aim to upgrade the quality of street food by promoting Indian cuisines at affordable rates in locations of tourist importance through upgrading and creation of common


Keeping in view the scale of operation of such enterprises, it is quite a challenge to bring about improvements in the street food scenario. Policing action has to be coupled with training. Local bodies have also to provide facilities for safe water supply, garbage disposal etc. The HACCP approach can be applied to keep down hazards to consumers.(Raj.k.Malik)

ment of Puerto Rico’s Food Industry Readiness and Preparedness


Preliminary Idea

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).

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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).

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.

  1. Is the lack of access to FSMA information limiting readiness of food manufacturers in Puerto Rico?
  2. 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.

FSMA Rule Requirements

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.

Recent U.S. Surveys Outcomes

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.

Why it’s important

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)

Sample Selection

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.

Data Collection

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.

Data Analysis

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

(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

(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,

(14) The Food Safety and Inspection Service in Puerto Rico

(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.

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(19) ORA Regional Field Office, Southeast Region, Atlanta, GA Organizational Chart

(20) State Retail and Food Service Codes and Regulations by State

(21) FDA- Real Progress in Food Code Adoption 02/22/2016 (last visited 02/26/2017)

(22) Departamento de Agricultura de Puerto Rico – Inspección de Mercados

(23) Departamento de Asuntos del Consumidor DACO

(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) Renée 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 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))

Table 2

Classification of food facilities as per the


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