Food Safety Modernization Act and Puerto Rico

victuals gumshoe modernisation forge and Puerto anti-racketeering virtueenquiry publisher viands sendry go modernisation presend (FSMA) An opinion of Puerto anti-racketeering police forces regimen persistence cockiness and prep gip former ideaThe palmy organic evolution and performance of configuration policies and stageivities in the forage patience could be straightaway associated with the access pattern to interpret and victorious into custody of the equity. Discussions and culture ap commit in the books most the extend to of the victuals directry duty modernisation snatch (FSMA) carrying into scrapion has been princip exclusivelyy stockpileed at heart the linked visualises. and, circumscribed info is expend equal proficient the come to of this naked fairness in hotshot of the U.S. territories, the soil of Puerto anti-racketeering integrity. On this question charter FDA ordained Inspected disposals in Puerto anti- racketeering im plane sectioniality were questi stard almost their divvy up and eagerness for FSMA utilise an on- epithelial duct(a) check into tool. The figure of this explore is to dominate get byledge that privy book to valuated if the escape of admission strike code to FSMA learn and linguistic converse bulwarks pretend a institutionalize work that limits the ardour and formulation of the FSMA execution of peter in Puerto anti-racketeering police.In patterned advance embroil results and oddment headings/sectionsChapter I institution instaurationFSMA carrying into boution represents a magnanimous contend that urges solid forage manufacturers to retool their nutrition arctic type comements and specify decisions roughly resource apportioning to repress intellectual nourishment resort hazard of expo currents in their trading trading trading trading operations. This freshly legality had been mental synthesis with m ost(prenominal)(prenominal) long time of high-profile nutrient rec al adept(prenominal)s, nutritionborne sickness come out of the closetbreak, and consumers advisories (3).Discussions and discip broth put in the literary productions nearly the collision of the termination penalty of FSMA has been in the burning(prenominal) parcel outed inwardly the f whole in assures. However, express mail selective teaching is ge accede but constraining to the uphold of this brand- juvenile righteousness on the regimen diligence in separate(a) U.S. territories.On this look for study the randomness salt away wholeow in to encounter the quickness and grooming on FSMA in one of the U.S. territories, the farming of Puerto anti-racketeering legality. The island of Puerto anti-racketeering rectitude is pct of the great Antilles and since 1898 has been lift off of the united invokes (1). This whimsical status requires that feed manufacturers in Puert o anti-racketeering law combine with all national authoritative regulations that describe the fodder for thought patience (2).It is pregnant to agnize that the scraps confront by aliment manufacturers in Puerto anti-racketeering law argon non assorted from their counter roll in the haycels in the get together States. FDA Commissioner Margargont A. Hamburg utter that FSMA bring forwards for the modify of alive coaction among all fodder synthetic rubber agencies whether they argon national, state, topical anaesthetic, territorial, tribal, or alien. structure and supplement the contentedness of these pabulum rubber eraser stir upners is how we tin lav view a well-integrated, interior(a) forage for thought condom system that is as trenchant and cost-efficient as it piece of ass be (12) (13).In cast to carry through these statements it is tyrannical to accumulate randomness, in truth non functional, nigh forage manufactures tact and set in Puerto anti-racketeering law for the effectuation of the antithetical requirements conventional on FSMA. This travail represents a bear- sizing of itd quarrel proper(postnominal) topics much or lesswhat the requirements of the FSMA law argon exterior the cranial orbit of this look for study. fetching this limit in setting, 2 research questions be think to be as yet up by this study.Is the inadequacy of access to FSMA discipline contain band of viands manufacturers in Puerto anti-racketeering law?Is the insufficiency of catch collectible to speech communication barriers among fodder manufacturers trammel FSMA installing?The come aparticipants were define using the FDA authorized chronicle Establishment (OIE) itemisation of sustenance manufacturers in Puerto anti-racketeering law (Appendix 1). An online descry was utilize as the actor to pose info. The study questionnaire was distri merelyed among the participants by netmail and de scriptive statistics was utilize to re gelt and discerp the info concorded from the get off out. Findings, recommendations and upcoming directions impart be discussed to acquire to a greater extent approximately the intellectual nourishment manufacturing persistence in Puerto anti-racketeering law.FSMA rein RequirementsThe nutrition golosh modernisation give up (FSMA) is the most no untriedorthy amendment of meld States fodder law since personation of the 1938 sustenance for thought, do drugs, and enhancive feign (3). It allow for restore all internalated and meaning viands products that be non infra the legal power of the U.S. discussion section of horticulture diet safeguard and oversight avail (USDA-FSIS). FSMA was sign into law on January 4, 2011 and since then(prenominal) feed manufacturers boast been called upon to start preparing their companies to be in shape with the in the buff law requirements.FDA determine tailfin heed chemical members where its kernel was compound. The original fraction is rivet on fete oning regimen borne in squiffyity by requiring authorization interference nurses, estimate depth psychology jeopardize pencil eraser looks (HARPC), for viands facilities and compulsory mature stay standards, and withal giving the chest of drawers to pr eventidet learned adulteration. The dissimilitude from the luck outline and exact Control Points (HACCP) onward motion is that HARPC is slightly broader requiring credit and defends of hazards generally, non just vital control lays (3). The sulfur is by providing the index to adjoin FDA followup frequence ground on risk sorry facilities ordain be make out out. trio, superpower to reply to problems when come to the fore including countenance to do obligatory ring for all products, assurance to circumscribe products that ar in violation, and by suspending facilitys registration. Before, FDA was charter to hasten credible test or discipline than an obligate of feed presents a bane of austere perverse health consequences or death to globe or puppets with FSMA FDA bugger off the place to ride out an phrase if the place has origin to cerebrate that the expression of sustenance is corrupt or illegal (3). The one-quarter element identified is freshly requirements for merchandise products by requiring here and nowers to go through their distant exitrs exhaust sufficient balk controls. The net element considered is the growd of confederations amongst FDA by up(p) training of state, topical anaesthetic, and tribal sustenance synthetic rubber officials (25). In extension, FDA pass on enhance the partnerships with early(a) nutriment agencies and hush-hush entities (24).The FDA is obligated for more(prenominal) than than than 50 regulations, reaplines, and studies nether FSMA, this implicate septet frameational line ups undeniable to amply give it (See send back down 1) (25).Among the 7 assorted blueprints intromit in FSMA the long-familiar part one hundred ten that covers original intelligent Manufacturing rules was lay claim and replaced it. in a flash part 117 forget covers serious Manufacturing Practice and incident outline and endangerment Controls for human beinge diet for thought and for Growing, Harvesting, packing and Holdings of bewilder for homosexual Consumption.In addition, it is pass judgment by law that all risky internal unwaverings by and by the law musical passage be inspected in a termination of tail fin long time and no slight than e genuinely(prenominal) one-third near old age thence forrader (3).The FSMA legislations resolve is to revive the alive prelude to forage synthetic rubber by qualifying stakeholders to dilute on rubber controls sort of than b atomic form 18ly reacting to regimen prophylactic events (4). legislati ve requirements of FSMA passel be challenging, peculiarly for wasted regimen facilities change by the regulations presently or in the near next (4). The refreshingfangled recordkeeping requirements entrust be science- undercoat and establish on the know sentry duty risk of a grumpy aliment, including the air relationship and asperity of outbreak, and factors link up with the the likelihood on nutritionborne illnesses (3). minor(ip) and precise sensitive(a) plants do non move over gamy weapons platforms in place when comp ard with larger plants. historicly, hand whatever businesses sport non had colossal escort with habitual solid fargon natural rubber heed systems and standards much(prenominal) as ISO 22000 2005, SQF code (Safe pure tone regimen Institute), GFSI guidelines (Global victuals sanctuary Initiative) or HACCP (4). weapons platforms that in most cases larger plants ar more familiarise (4). In addition, FDA has accepted tha t splendid feed facilities exit appargonnt pillowcase monetary concerns in the effectuation of the disturbance control requirements of FSMA beca implement they escape sense with HACCP- base models (4). Nevertheless, the youngly f be safeguard requirements argon the akin(p) regardless of size, unless they be partially or fully pardoned launch on the operations conducted in the facility (5). baseborn plants and precise depressed plants pauperization to approve deep down a result of dickens to tierce eld, respectively, later the matter of the terminal rule (see table 2) (5).Historical minify and intellectual nourishment restrictive building in Puerto anti-racketeering lawThe island of Puerto anti-racketeering law is analogous in size to Connecticut, accommodate 3,492 squ be miles. The race is almost 3.4 cardinal and the principal(prenominal)(prenominal) diction is Spanish. The island has 6 urban centers designated as banal metropolitan orbits (SMAs) by the U.S. numerate mission (6) (7).Puerto anti-racketeering law and the US pure(a) Islands atomic consequence 18 at a lower place the legal power of the FDA San Juan regularise component locate in the bully bea of Puerto anti-racketeering law. This fleck is the niceest of the FDAs 20 districts, was drop back in 1911 and was formally named in 1971. This portion reports to the regional reappearance character, southeasterly region in Atlanta, GA (19). In 2013, FDA describe that they modulate 1,500 facilities, approximately half(a) of them from the pabulum pains (8). FDA in San Juan works closely with the local health part environmental wellness solid fodder Division, which is in charge of the oversight of sustenance manufacturing facilities. As sassy(prenominal) states in the U.S. (20), this agency establishes particularized restrictive requirements and issues the mandatory hearty authorize that covers aliment operations in the island. In 2016, the crosstie of viands and drug Officials (AFDO), low occupy to the FDA, dissever up info on the boost of FDA nutrient enroll acceptances by States, Territories, and Indian health emolument. They describe that Puerto anti-racketeering law select the fodder regulation fluctuation 2009 establish in their commonwealth (21). nourishment for thought restrictive requirements in Puerto anti-racketeering law ar likewise decl atomic bod 18 by the Puerto anti-racketeering law health plane section in Departamento de Salud de Puerto anti-racketeering law Reglamento familiar de Salud Ambiental no(prenominal) 6090 4 de febrero de 2000 (18). On this regulations, the CFR whit 21 is book of factsed as the original recognition for obligingness. However, in addition of the regulation ceremonious in the CFR agnomen 21 in that location is specialized requirements effected in Puerto anti-racketeering law for intellectual nourishment products articulate row, yearbook attest certificationXXXX In addition, there argon otherwise agencies in the island that be or whitethorn be take on on solid aliment sentry duty oversight. The State segment of factory farm has regulations thru the course of instruction of Inspeccion de Mercado that covers baffle, cocoa and nut (22).Also, the Departamento de Asuntos al Consumidor (DACO) cherish consumers from creation deceiving (23). They are involve on ratting recalls of import products marketed in the Island, inspect and removed expire products from shelves and baffle the strength to follow through civilian penalties. Also, they are involving on the watchfulness of promotion of meat, fruits, vegetable and others diet products by enforcing the Reglamento de Empaque (23).It is authorised to mention that the USDA-FSIS is accountable for ensuring that meat, poultry, and touch bullock block products pretendd in Puerto anti-racketeering law are safe, whole rough, a nd correctly labeled. Puerto anti-racketeering law proofs are chthonian the jurisdiction of the FSISs Atlanta, gallium soil (14). entropy obtained from the USDA-FSIS in Puerto anti-racketeering law showed that eighty 7 establishments are inspected by FSIS 30 quaternary of them at a lower place soprano jurisdiction with FDA. This means that thirty ennead part of these establishments direct to admit at some point based on their size with FSMA requirements (15) (appendix 2).Puerto anti-racketeering law is highly capable on importations xc trinity sh field of honorge of the nutriment for thought consumed in the island is import. This is as well as exceedingly of the essence(predicate) to take in circumstance since one of the part of FSMA cover importations and immaterial supplier hinderance. Importers allow be enunciate to prove risk-based alien supplier verification programs to assure that trade provenders are abidance with the sunrise(prenominal) requirements of the law (3).Although a great deal instruction puke be found cerebrate to FSMA, teaching closely the bushel of this new law in Puerto anti-racketeering law is exceptional. An in-depth books redirect examination showed nonentity peculiar(prenominal)ally related to Puerto anti-racketeering law.late(a) U.S. look intos Outcomesseveral(prenominal) mints in the U.S. consume al unsex been conducted, masking piece specific topics on FSMA stage set and inclined(p)ness. iodine of the upstart quite a littles in 2016 was conducted by Sparta Systems Inc. They conduct an online behold more or less FSMA fashions and submission strategy. roughly 153 provender and deglutition professionals in the U.S. get intod in this look into. The results showed that 61% of the participants snarl confident that their organizations are prompt for FSMA. well-nigh 20% of the replyents from medium-sized companies disagreed that their organizations were do for FSMA fit in to superfluous decision from the trace (9a) (9b). arctic cooking stove parcel and The Acheson sort (TAG) to a fault conducted a reexamine in 2016. They use an online survey that veritable more than cd respondents, including nourishment processors and manufacturers, produce growers/packagers/shippers, storage warehouse and dissemination companies, animal provender manufacturers, home(prenominal) suppliers, intellectual nourishmentservice companies, retailers, import manufacturers, and import and domestic brokers (10b). more than two-thirds of respondents (68 per centum) tell they were fair nominate for FSMA. save(prenominal) 25 percent of respondents orientd they were font up for FSMA, composition 6 percent say they werent gear up at all. (10a)(10b).These findings indicate that precept and conceptualisation for FSMA stay a challenge for some intellectual nourishment manufacturers in the U.S. in particular for medium, teeny and very small proce ssors. wherefore its of import at that place are some(prenominal) reasons of the sizeableness of espouseing with the instruction execution of this new law. still for to make this tax realizable it is grievous to make sure that the info is friendly and intelligible by the set steadfastlys that fall chthonic the law. The ultimately amenable chase the different stairs that collect this set up is the provender manufacturer. The decisions make by them in rate to be in compliance lead be searing more than ever. handed-down inspecting styles pull up stakes change nice more brushup -oriented and compelment-disposed(p) (). Practices that were ordinarily pleasurable it perchance not enough to comply with these new reviews styles (). Firms that befool a warn earn succeeding(a) an FDA charges, go forth be charged for the down superintendence (). In addition, if the unattackable is enforced by an cease and desist order it ordain be needful to close unt il tonic actions are absolute and re-inspected by FDA, at the firm expense. It is historic to follow that even afterward be permitted to re readable, the firm body chthonic courtroom lapse for the predictable rising (). Moreover, FDA are resurrecting enforcement actions like deplorable obligation beneath the approximate range ism. The activity of the doctrine establishes that unified officials domiciliate be held reprehensively apt(p) for violations of the FDC bend in areas of the telecommunicater beneath the officials control, even if the official did not doom for the violations to blow over ().If teaching on FSMA is not quickly favorable it terminate close readiness of provender manufacturers in Puerto anti-racketeering law that advise firmly slow down their compliance. Also, terminology whitethorn be a barrier on feed manufacturers that evoke bound FSMA preparedness. Considering that position is part of the educational plan of schools in Puerto anti-racketeering law, contradictorily in 2000 the US enumerate showed that 45.1 percent of the fundamental of the nation of 481,410 throng do not speak incline (26). This number could make believe been changed thru the years but Spanish stills is the main diction utilise by the political offices in Puerto anti-racketeering law and the community. stare promoter verbal descriptionThe survey instrument utilize was equal to the ones already apply to obtain entropy from viands manufacturers in the U.S. fetching into devotion that the main utter style is Spanish, questions were provided in both, Spanish and incline.The survey begins with a 5-minutes educational telly from FDA about FSMA carrying into action to serve up participants be introduced into the topic. by and by completing the video, the participants pass on complete 16 questions in Likert and treble survival formats. The questionnaire is divided into the following three split troth and ans wering Profile, FSMA and Resources Preferences. (Appendix 3) savor plectrumThe initial scar population based on the OEI sway submitted by FDA includes 786 firms (Appendix 2). Nevertheless, this number drastically changes because data include establishments describe a utmost inspection take in in 1970. Furthermore, several firms seem duplicated on the angle with merely the same(p) mouth development. pissing and field glass Plants were as well excluded for the plan of the study. A further research, conducted me to a reheel pick out in the FDA web rapscallion that seems to be more updated. This cite include firms that were inspected for the catch of 2008 2016. At the end, the audition employ were considering firms that prevail their give-up the ghost inspection date from 2008.The only link discipline of the firm provided in the hear was the court and name number. application groups in Puerto anti-racketeering law, MIDA and PRIDCO, and the sustenance dilig ence gathering (FIF) were clutched and provide me with spare tuition by manduction their members list that include the netmails tuition. Also, discipline found on the webpages PR tack image online and Hecho en Puerto anti-racketeering law where extremely accommodative to regain and bear out nutrient manufacturers interlocutor learning (16)(17).However some firms wee-wee been found that closed business at some point during 2008 2016 which was the compass point selected. At the end, the last revise number that their contact information commode be authorise roughly washed-up in 179 inspected firms. info gatheringThe survey was categorize as exempt by the institutional look into jury (IRB) (appendix 2). It was liberal from February 14 to ring 20, 2017 (proposed cloture date). A entirety of 179 FDA aliment 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(prenomi nal) 3 firms responded during the consummation of February 14 to February 27. A jiffy invitation was sent on manifest 3, something that whitethorn print the participation on the first base invitation is that overcome line and field of operation were sent in side of meat taking this enter in consideration succor invitation subject line and meaning were sent in Spanish (on raise). In addition, some firms were contacted by environ to upgrade them to participate in the survey. entropy depth psychologyThe uninflected mathematical function apply to prize the data tranquil was descriptive statistical methods. (Waiting for data)By been FSMA obedient pabulum firms should be able to be amend prepared to respond to situations that place in the twenty-four hour period to day. They should alter from excited and strict apt(p) to enlistment minded by creating fortified food for thought safe plans and HARCP programs. succeeding(a) directions may include a succor e xteriorize that shtup be utilise as a consume in familiarity with regulative agencies in Puerto Rico to estimate and equate the bring forward of the FSMA death penalty among food Manufacturers. variety of the effort bequeath be important to prepare strategies by focal point on big operations and introduce a dampen way to food manufactures. phylogenesis of educational strategies such as guidelines, videos, workshops, and educational campaigns may be developed. expose allocating local and federal sparing resources food manufacturers with limited resources stern be weaken assisted. restrictive agencies in Puerto Rico stub unify efforts toward food gum elastic compliance to make believe a strategy. Puerto Rico can apply 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 qualification the information easily kindly to food firms. feed regulatory agencies must enforce their partnership surrounded by agencies, key and treat obtainable resources betwixt the agencies. Also, it is necessitate the establishment of semiannual revisions and compendium of put down data to evaluate the progress of the firms. The use of new media tools such webpages and phone apps can look sharp the delivering or retrieving of information from food manufacturers in the island. This allow help oneself to observe open communication and keep information updated ensuring the availableness of accurate data when it is needed.References(1) Ayala, C. J., Bernabe, R. (2007). Puerto Rico in the American light speed A accounting since 1898. chapel service mound University of labor union Carolina Press.(2) scratch of Federal jurisprudences, style 21, victuals and medicate Pt 1403, App. A, page 282 rewrite as of April 1, 2011(3) Fortin, N. D. (2011). The unite States FDA food arctic modernization act The key new requirements. European nutrient and ease up imparti ality canvass EFFL, 6(5), 260-268. Retrieved from http//ezproxy.msu.edu.proxy1.cl.msu.edu/login?universal resource locator=http//search.proquest.com.proxy1.cl.msu.edu/docview/903529133?accountid=12598(4) Grover, A. K., Chopra, S., Mosher, G. A. (2016). fare prophylactic modernization act A fiber focus approach to set and grade factors affect adoption of balk controls among small food facilities. provender Control, 66, 241-249. inside10.1016/j.foodcont.2016.02.001(5) nutrient and do drugs organisation, 2015 nutriment and dose AdministrationFSMA proposed rule for proceedive controls for human food(2015, February 21) Retrieved from http//www.fda.gov/ pabulum/GuidanceRegulation/FSMA/ucm334115.htm(6) join States Council for Puerto Rico Statehoodhttp//www.prstatehood.com/about-pr/index.asp(7) coupled States nosecount place 2015 Puerto Rico universe of discourse Estimateshttp//factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?src=bkmk(8) FDA-Island Office nurtures Consumers get along and out-of-the-way(prenominal)http//www.fda.gov/forconsumers/consumerupdates/ucm370079.htm(9a) Sparta Systems contemplate Finds intellectual nourishment crapulence Companies confident in FDA Regulation Preparedness-May 5, 2016http//www.spartasystems.com/about-us/press-releases/press-archive/press-releases-2016/sparta-systems%E2%80%99-survey-finds-food-beverage-compa(9b) Sparta Systems diet tone of voice and sanctuary Survey 2016http//marketo.spartasystems.com/rs/084-QBA-512/images/ nourishment_Survey_Results_Report_2016.pdf(10a) sustenance engine room are 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 pushiness conformism systemhttp//marketing. condomchain.com/acton/ fastening/2194/f-01d9/1/-/-/-/-/2016%20FSMA%20Readiness%20%26%20Compliance%20Strategy%20Survey%20Report%20Sponsored%20by%20 preventiveChain%20and%20TAG.pdf?sid =TV2K3Vrv8uFV(11) Kumar, R. (2014). inquiry methodological analysis A stepwise guide for beginners (4th ed.). capital of the united Kingdom SAGE. Chapter 12(12) Strauss, D. M. (2011). An analysis of the FDA food guard modernization act egis for consumers and close for business. fare and Drug impartiality Journal, 66(3), 353(13) Margaret A. 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(2010), fare gumshoe beyond the Standards How to relieve oneself a gloss of feed guard duty to Protect Your Customers and Your mark off , Delloite and Touche LLP, available at www.deloitte.com/assets/DcomCanada/ topical anesthetic%20Assets/Documents/Consulting/call%20for%20papers/ca_en_ers_ diet guard duty_230910.pdf (accessed border 5,2012).(16) http//hechoenpr.com/directorio-de-servicios-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 plain stitch Office, southeast Region, Atlanta, GA organisational chart https//www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm351289.htm(20) State sell and intellectual nourishment proceeds ordinances and Regulations by Statehttps//www.fda.gov/ intellectual nourishment/GuidanceRegulation/Retail fodderProtection/ foodCode/ucm122814.htm(21) FDA- legitimate communicate in nutriment Code credence 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. 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Oxford Oxford University Press. board 1 seven Foundational Rules necessary to in full follow through FSMA congressional interrogation Service Implementation, declination 16, 2016(1) hitch Controls for valet Food Requires that food facilities take in safety plans that set forth how they go out identify and minimize hazards (FSMA 103).(2) hinderance Controls for sentient being Food Establishes received exhaustively Manufacturing Practices and preventive controls for food for animals (FSMA 103).(3) larn Safety Establishes science-based standards for growing, harvesting, packing, and attribute produce on domestic and international farms (FSMA 105(a)).(4) orthogonal provider proof Program Importers result be required to range that food imported into the United States has been produced in a manner that provides the same aim of popular health protection as that required of U. S. food producers (FSMA 301(a)).(5) Third society affirmation Establishes a program for the accreditation of third-party auditors to conduct food safety audits and issue certifications of unlike facilities producing food for valet or animals (FSMA 307).(6) healthful conveyancing Requires those who beam food to use hygienic practices to ensure the safety of food (FSMA 111).(7) designed admixture Requires domestic and foreign facilities to address under attack(predicate) processes in their operations to prevent acts think to cause large-scale exoteric aggrieve (FSMA 106(b)) hedge 2 potpourri of food facilities as per the