UNITED STATES FOOD SAFETY LAW DEVELOPMENTS OF INTEREST FOR EUROPEAN FOOD COMPANIES

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UNITED STATES FOOD SAFETY LAW DEVELOPMENTS OF INTEREST FOR EUROPEAN FOOD COMPANIES
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                    UNITED STATES FOOD SAFETY LAW
                      DEVELOPMENTS OF INTEREST
                    FOR EUROPEAN FOOD COMPANIES
                                                          food safety

                                                   MAILE HERMIDA, ANNA GLINKE

T
              he food safety laws in the      globalization of the food system. About      A food safety plan must have the follo-
              United States have changed      48 million people in the U.S. (1 in 6)       wing components:
              significantly in recent years.   get sick, 128,000 are hospitalized, and
              The FDA Food Safety Mo-         3,000 die each year from foodborne di-       š Hazard Analysis The hazard analysis
              dernization Act (FSMA)          seases, according to recent data from the       must identify and evaluate known or
was signed into law in 2011, after which      Centers for Disease Control and Preven-         reasonably foreseeable biological, chemi-
the U.S. Food and Drug Administration         tion. The goal of FSMA is to shift the          cal, and physical hazards. If any of these
(FDA) spent several years developing          focus from responding to foodborne ill-         hazards is determined to be significant
and finalizing implementing regulations.       ness to preventing it.                          enough that it is a “hazard requiring
Most of the regulations under FSMA                                                            a preventive control,” then the facility
are now being enforced, and FDA is            FDA has finalized seven major rules to           must identify and implement preventive
focusing considerable efforts on its in-      implement FSMA. The underlying focus            controls to significantly minimize or pre-
spectional activities. The FSMA regula-       of the regulations is on ensuring that all      vent the identified hazards.
tions apply to food companies that sell       of the parties in the global food supply
FDA-regulated food in the United States,      chain are responsible for managing the       š Preventive Controls The rule includes
with very few exceptions, so companies        food safety risks within their control.         several types of preventive controls:
in Germany and Austria are covered by                                                       š Process controls (e.g., cooking, ref-
these new requirements as applicable                 II. Overview of                            rigerating, and acidifying foods);
to their operations. In this article, we                                                    š Food allergen controls (i.e., controls
survey the key requirements under the                Key Regulations                            for allergen cross-contact and to en-
FSMA regulations, provide updates on          Below is a summary of each of the seven           sure allergens are appropriately lis-
FDA’s implementation and inspection           major FSMA regulations, their require-            ted on labels);
activities, and conclude with recommen-       ments, and how they affect companies          š Sanitation controls (i.e., procedures,
dations for actions to take to ensure you     in Germany and Austria that sell food in          practices, and processes to ensure
are in compliance. Note that FDA does         the United States.                                that the facility is maintained in a
not regulate meat and poultry products,                                                         sanitary condition to minimize or
so U.S. requirements for those foods are      1. Preventive Controls for Human Food             prevent hazards such as environ-
beyond the scope of this article.             In general, the Preventive Controls for           mental pathogens); and
                                              Human Food (PCHF) rule applies to             š Other Controls (i.e., controls that
                                              all facilities that are required to regis-        are not described above but are
 I. Background on FSMA                        ter with FDA. These facilities must de-           necessary to ensure that a hazard re-
Congress enacted FSMA in response to          velop and implement a Food Safety Plan            quiring a preventive control will be
a number of significant food safety is-        (FSP). This is similar to, but has some           significantly minimized or preven-
sues in the United States and increasing      key differences from, a HACCP plan.               ted).

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š Management Components To ensure               notify the public when necessary, to        lified to perform their assigned duties.
   that the controls are being met, faci-        conduct effectiveness checks, and to        This means that they must have the
   lities must implement procedures for          appropriately dispose of recalled pro-      necessary combination of education,
   monitoring, corrective actions, and           duct.                                       training, and/or experience necessary
   verification of the preventive controls.    There also are significant recordkeeping       to manufacture, process, pack, or hold
   Verification includes activities such       requirements related to the Food Safety       food that is clean and safe. Individuals
   as calibration, validation, records re-     Plan, as well as requirements for reana-      also must receive training in the prin-
   views, environmental monitoring, and        lysis.                                        ciples of food hygiene and food safety.
   product testing, as appropriate.            You also should be aware that there are       Second, whoever is responsible for pre-
                                               some significant differences between          paring the Food Safety Plan and per-
š Supply Chain Program If a supplier          FDA’s expectations and the standards          forming certain key activities under the
   is responsible for controlling a “ha-       under European and law. For example,          plan must be a “Preventive Controls
   zard requiring a preventive cont-           FDA has a very strict policy for listeria     Qualified Individual” (PCQI). This sta-
   rol,” then a supply chain program           in ready-to-eat foods. The supplier ve-       tus can be attained either by attending
   is required. FDA has issued detailed        rification regulations are another area        a training program equivalent to a stan-
   requirements for how to adequately          with significant differences that war-        dardized curriculum developed by FDA
   perform supplier verification in these      rants careful attention.                      (such as the training programs offered
   situations, which differ significantly                                                    through the Food Safety Preventive
   from the way that companies have            In addition to issuing the above regula-      Controls Alliance), or based on educati-
   historically performed supplier verifi-     tions, FDA “modernized” the current           on and experience.
   cation voluntarily. Careful attention       Good Manufacturing Practice (cGMP)
   is needed for this part of the regula-      regulations. In particular, the regulations   The compliance dates for the PCHF
   tion. In particular, be aware that just     now specifically address allergen cross-con-   regulation have passed, and FDA is ac-
   obtaining your supplier’s third-party       tact and include a provision for holding      tively performing inspections. These in-
   audit certificate is not sufficient to be   and distribution of human food by-pro-        spections are occurring domestically and
   in compliance.                              ducts that are used for animal food.          internationally. Note that foreign inspec-
                                                                                             tions are preceded with written notice,
š Recall Plan If the hazard analysis          Finally, there are new training require-      and are scheduled in advance. There can
   identifies a hazard requiring a preven-     ments for all personnel, and specialized      be significant consequences related to
   tive control, the facility must have a      training requirements for personnel with      refusal or failure of a foreign inspection,
   written recall plan that describes the      responsibility for development and im-        including delayed or rejected imports to
   procedures to perform a recall of the       plementing the Food Safety Plan. First,       the United States. If an inspection results
   product. The recall plan must include       all employees who manufacture, pro-           in a Form 483, this means that FDA has
   procedures to notify consignees, to         cess, pack, or hold food must be qua-         identified deficiencies during the inspec-

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tion. It is imperative to respond in wri-            number of exposures; how fast              4. Foreign Supplier Verification Pro-
ting to a Form 483 within 15 business                the food moves through the dis-         gram The Foreign Supplier Verification
days of when it is issued, and advisable             tribution system; potential agents      Program (FSVP) requires someone in
to work with experienced legal counsel               of concern and the infectious/let-      the United States to verify the safety of
to ensure that your response is sufficient.          hal dose of each; and the possible      the food being imported. FSVP cannot
                                                     number of illnesses and deaths.         be performed by someone outside of
  2. Preventive Controls for Animal              š The degree of physical access to        the United States. The legal responsibi-
Food The Preventive Controls for Ani-                the product. Issues to be consi-        lity for FSVP falls on the person in the
mal Food (PCAF) rule is parallel to the              dered would include the presence        U.S. who owns the food, has purchased
PCHF rule, except that the rule applies              of such physical barriers as gates,     the food, or has agreed in writing to
to food made for animals. You should                 railings, doors, lids, seals, and       purchase the food – i.e., the “importer.”
be aware that FDA expects that animal                shields.                                Note that “importer” for FSVP is de-
food will be free of pathogens, just like        š The ability to successfully conta-      fined differently than the term “importer
human food. However, the allergen re-                minate the product.                     of record,” which is used in other U.S.
quirements for human food do not ap-                                                         regulations. This identity of the FSVP
ply to animal food. Instead, FDA is fo-        š Mitigation Strategies Mitigation          importer party will vary depending on
cused on issues of specific interest for            strategies should be identified and        your own situation.
animals, such as nutrient deficiencies             implemented at each actionable
or toxicities (e.g., inadequate thiamine           process step to provide assurances           The FSVP importer must do the follo-
in cat food, excessive vitamin D in dog            that vulnerabilities will be minimi-      wing:
food, and excessive copper in food for             zed or prevented. The mitigation          š Hazard Analysis The importer is re-
sheep). As part of this rulemaking, FDA            strategies are tailored to the facility      quired to identify and evaluate – ba-
also issued cGMP regulations for animal            and its procedures.                          sed on experience, illness data, scienti-
food. Most of the compliance dates for                                                          fic reports and other information – the
the PCAF regulation have passed, and           š Mitigation Strategy Management               known or reasonably foreseeable ha-
FDA has started conducting inspections.            Components These are steps that              zards for each type of food it imports
                                                   must be taken to ensure the proper           to determine if there are any hazards
  3. Intentional Adulteration This rule            implementation of each mitigation            requiring a control. The importer can
represents the first time that companies            strategy. Specifically, there are requi-      rely on another entity (such as the fo-
are required to create a Food Defense              rements related to food defense mo-          reign supplier) to conduct the hazard
Plan to address intentional adulteration.          nitoring, food defense corrective ac-        analysis, so long as the importer re-
With some exceptions, this rule applies            tions, and food defense verification.         views and assesses the relevant docu-
to both domestic and foreign compa-           The first compliance date for the In-             mentation.
nies that are required to register with       tentional Adulteration rule is July 26,
the FDA. The Food Defense Plan must           2019, which applies to the largest com-        š Evaluation of Food Risk and Sup-
identify vulnerabilities and actionable       panies. FDA was scheduled to begin                plier Performance The importer must
process steps, mitigation strategies, and     routine inspections of larger businesses          evaluate (1) the hazard analysis, (2)
procedures for food defense monitoring,       in March 2020, but these inspections              the entity that will be significantly
corrective actions and verification. Re-       were delayed in response to the CO-               minimizing or preventing the hazards
analysis is required every three years or     VID-19 pandemic. Routine inspections              (e.g., whether the hazard is cont-
when certain criteria are met, including      for smaller businesses will begin in              rolled by the foreign supplier or the
mitigation strategies that are determined     March 2021. When routine inspections              supplier’s own supplier), (3) the for-
to be improperly implemented. More            begin, FDA has said they will consist of          eign supplier’s procedures, processes,
details are provided below:                   “quick checks” that will occur during             and practices related to the safety of
                                              regularly scheduled food safety inspec-           food, (4) applicable FDA food safety
 š Vulnerability Assessment Facilities      tions. These “quick checks” allow FDA             regulations, and information regar-
     must identify vulnerabilities and        to verify that the facility has satisfied          ding the foreign supplier’s compliance,
     actionable process steps for each        the basic requirements of the rule by             (5) the foreign supplier’s food safety
     type of food manufactured, proces-       preparing a Food Defense Plan and may             history, including the responsiveness
     sed, packed or held. For each point,     also provide some educational materi-             of the foreign supplier in correcting
     step, or procedure in the facility’s     als. Note that there are numerous trai-           past problems, and (6) other factors
     process, these elements must be          ning programs available for the various           as necessary, including storage and
     evaluated:                               aspects of this regulation. Because this          transportation practices. The impor-
    š The severity and scale of the po-     is a complex regulation that does not             ter can rely on another entity (other
        tential impact on public health.      mirror any preexisting regulations, it is         than the foreign supplier) to perform
        This would include such consi-        prudent to pay careful attention to these         this evaluation, so long as the importer
        derations as the volume of pro-       requirements and developing an imple-             reviews and assesses the relevant docu-
        duct; the number of servings, the     mentation strategy.                               mentation.

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š Verification Activities Based upon the       bering System (DUNS) number, which             š Domesticated and Wild Animals
   evaluation of risk that was conducted,       serves as their UFI for FSVP.                      The rule includes standards related
   the importer must establish and fol-                                                            to intrusion by domesticated and
   low written procedures to ensure that        Most of the compliance dates have pas-             wild animals at farms. Farmers are
   it only imports from approved foreign        sed for FSVP, and FDA is actively per-             required to take all measures reaso-
   suppliers. The importer also must            forming inspections of the FSVP impor-             nably necessary to identify and not
   conduct appropriate supplier verifica-       ters. Note that because these inspections          harvest produce that is likely to be
   tion activities. The verification activity   occur in the United States and FSVP                contaminated. However, farms are
   options include:                             importers must be domestic, FDA will               not required to exclude animals
 š Annual on-site audits of the sup-          never perform an FSVP inspection of a              from outdoor growing areas, dest-
      plier’s facility. Note that an on-site    foreign company or outside of the U.S.             roy animal habitat, or clear borders
      audit can be a second-party audit                                                            around growing or drainage areas.
      or a third-party audit. Such audits        5. Produce Safety FDA’s Produce Safety
      are generally required when there         rule established, for the first time, scien-    š Worker Training and Health and
      is a reasonable probability that ex-      ce-based minimum standards for the                 Hygiene Requirements for health
      posure to a hazard controlled by the      safe growing, harvesting, packing, and             and hygiene include taking measu-
      foreign supplier will result in serious   holding of fruits and vegetables grown             res to prevent contamination of pro-
      adverse health consequences or de-        for human consumption in the United                duce and food-contact surfaces by
      ath to humans or animals (called a        States. The rule applies to all produce            ill or infected persons, using hygi-
      SAHCODHA hazard);                         that will be consumed in the United Sta-           enic practices when contacting pro-
 š Sampling and testing (e.g., perfor-        tes, regardless of whether it is grown do-         duce or food-contact surfaces, and
      ming testing upon receipt of the          mestically or internationally. There are           taking measures to prevent visitors
      food, or receiving a Certificate of        two key exemptions from the rule:                  from contaminating produce and/or
      Analysis); or                              š Produce commodities that FDA                  food-contact surfaces.
 š A review of the supplier’s relevant             has identified as rarely consumed
      food safety records.                           raw – i.e., asparagus; black beans,       š Equipment, Tools and Buildings The
                                                     great Northern beans, kidney be-              rule establishes standards related
An importer can rely on another entity               ans, lima beans, navy beans, and              to equipment, tools and buildings
(other than the foreign supplier) to de-             pinto beans; garden beets (roots and          to prevent these sources, and inade-
termine and perform appropriate sup-                 tops) and sugar beets; cashews; sour          quate sanitation, from contamina-
plier verification activities, so long as the        cherries; chickpeas; cocoa beans;             ting produce. This section of the rule
importer reviews and assesses the rele-              coffee beans; collards; sweet corn;           covers, for example, greenhouses,
vant documentation.                                  cranberries; dates; dill (seeds and           germination chambers, and other
                                                     weed); eggplants; figs; ginger; horse-         such structures, as well as toilet and
š Corrective Actions Importers must                 radish; hazelnuts; lentils; okra; pea-        hand-washing facilities. Required
   promptly take appropriate corrective              nuts; pecans; peppermint; potatoes;           measures to prevent contamination
   actions if they determine that there is           pumpkins; winter squash; sweet po-            of covered produce and food contact
   a food safety problem or the foreign              tatoes; and water chestnuts; and              surfaces include, for example, appro-
   supplier is out of compliance. The            š Produce that receives commercial              priate storage, maintenance, and cle-
   appropriate corrective measure will               processing that adequately reduces            aning of equipment and tools.
   depend on the circumstances, but                  the presence of microorganisms of
   could include discontinuing use of the            public health significance, under         š Sprouts There are specific requi-
   foreign supplier.                                 certain conditions.                           rements to help prevent the con-
                                                                                                   tamination of sprouts, which are
Note that there are a number of ex-               The following is a summary of the key            particularly at risk for microbial
emptions from the FSVP regulations,             substantive requirements under the rule:           contamination.
as well as modified requirements for             š Agricultural Water The rule estab-
certain types of food. For example, the              lishes requirements for agricultural     The compliance dates have passed for
FSVP regulations do not apply to foods               water related to water quality and       most farms and FDA has started per-
produced under FDA’s seafood or juice                testing. FDA is currently reconside-     forming inspections until the spring of
HACCP regulations.                                   ring these requirements, however,        2019 to allow time for more guidance,
                                                     and has extended the compliance          training, technical assistance, and plan-
Upon entry to the U.S., FDA determi-                 dates for this part of the rule.         ning.
nes who is responsible for FSVP as the           š Biological Soil Amendments The
importer based on the “unique facility               rule has requirements relating to the      6. Accredited Third-Party Certifica-
identifier” (UFI) provided on the import              use of raw manure and stabilized         tion The rule on Accredited Third-Par-
documentation. The importer must ob-                 compost as biological soil amend-        ty Certification establishes a volun-
tain and provide a Data Universal Num-               ments.                                   tary program for the accreditation of

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third-party certification bodies, also        food testing must be performed by labo-          2. Traceability FSMA also requires
known as third-party auditors, to con-        ratories accredited by an FDA-recognized      FDA to issue a proposed rule addressing
duct food safety audits and issue certifi-     accreditation body. Second, results of tes-   traceability. Specifically, FSMA requires
cations of foreign entities and the foods     ting conducted under the rule would be        FDA to designate a list of “high-risk”
for humans and animals they produce.          required to be sent directly to FDA. Third,   foods, and then engage in rulemaking
FSMA specifies two uses for certifica-          it would establish model laboratory stan-     to establish recordkeeping require-
tions under this program:                     dards. Finally, it would establish a public   ments for facilities that manufacture,
š Certifications may be used by impor-       registry of accreditation bodies and ac-      process, pack, or hold designated high-
   ters to help establish eligibility for     credited laboratories. The Proposed Rule      risk foods. The designation for high-risk
   participation in the Voluntary Quali-      would apply to an “owner or consignee”        foods must be based on:
   fied Importer Program (VQIP), which        that is required to use an accredited la-     š the known safety risks of a particular
   is a fee-based program that offers ex-     boratory to conduct food testing under           food, including the history and se-
   pedited entry reviews.                     the regulation. FDA defines this term to          verity of foodborne illness outbreaks
š FDA can also require in specific, limi-    mean “any person with an ownership or            attributed to such food, taking into
   ted circumstances that a food offered      consignment interest” in the food product        consideration foodborne illness data
   for import be accompanied by a certi-      or environment that triggers the need for        collected by the Centers for Disease
   fication from an accredited third-par-     testing under this proposed regulation.          Control and Prevention (CDC);
   ty certification body.                     As part of a settlement agreement with a      š the likelihood that a particular food
                                              consumer group seeking to compel FDA             has a high potential risk for microbio-
This rule is unlikely to affect most for-     to satisfy its obligations under FSMA, the       logical or chemical contamination or
eign companies, unless they are produ-        agency has agreed to issue a Final Rule by       would support the growth of pathoge-
cing food that will be imported under         February 4, 2022.                                nic microorganisms due to the nature
VQIP.                                                                                          of the food or the processes used to
                                              šUse of Accredited Laboratories Use             produce such food;
    7. Sanitary Food Transportation             of an accredited laboratory would           š the point in the manufacturing pro-
FDA’s Sanitary Food Transportation rule         be required when testing is conduc-            cess of the food where contamination
aims to prevent practices during trans-         ted on behalf of an owner or con-              is most likely to occur;
portation that create food safety risks,        signee in the following situations:         š the likelihood of contamination and
such as failure to properly refrigerate         (1) for nine specific existing regu-           steps taken during the manufacturing
food, inadequate cleaning of vehicles           latory testing requirements that ap-           process to reduce the possibility of
between loads, and failure to properly          ply to bottled water, shell eggs, and          contamination;
protect food. The rule establishes requi-       sprouts; when FDA issues a “food            š the likelihood that consuming a par-
rements for shippers, loaders, carriers by      testing order”; (2) to address an              ticular food will result in a foodbor-
motor or rail vehicle, and receivers invol-     identified or suspected food safety            ne illness due to contamination of the
ved in transporting human and animal            problem and presented to FDA as                food; and
food to use sanitary practices to ensure        part of evidence for a hearing pri-         š the likely or known severity, including
the safety of that food. The requirements       or to the issuance of a mandatory              health and economic impacts, of a
do not apply to transportation by ship or       food recall order, as part of a cor-           foodborne illness attributed to a par-
air because of limitations in the law. The      rective action plan after an order             ticular food.
rule only applies to transportation within      suspending the registration of a
the United States, and thus only applies to     food facility, or as part of evidence       The purpose of the recordkeeping requi-
U.S. transport legs for imported food.          submitted for an appeal of an ad-           rements is to facilitate the quick identifi-
                                                ministrative detention order; (3) in        cation of recipients of food to prevent or
      III. Forthcoming                          support of admission of an article          mitigate a foodborne illness outbreak.
                                                of food under section 801(a) of the         FDA will issue the list of high-risk foods
     FSMA Regulations                           Federal Food, Drug, and Cosmetic            and a Proposed Rule by September 8,
FDA is in the process of implementing           Act, which allows FDA to refuse             2020, and a Final Rule by November
two additional regulations. When fina-           admission of food for reasons in-           7, 2022. Once the Final Rule is issued,
lized, these regulations also will affect       cluding if the food “appears” to be         FDA will publish on its website the list
German and Austrian businesses selling          adulterated, misbranded, or ma-             of high-risk foods.
food to the United States.                      nufactured, processed, or packed
                                                under insanitary conditions; (4) as               IV. Recommended
  1. Laboratory Accreditation On No-            required by FDA in a food testing
vember 4, 2019, FDA issued the Labora-          order, which is a new regulatory                     Action Steps
tory Accreditation for Analyses of Foods        tool the agency proposes establis-          FSMA is a significant development that
Proposed Rule. The key components of            hing under the rule; or (5) to sup-         all German and Austrian companies
the Proposed Rule mirror Section 202 of         port removal from import alert th-          selling food in the US need to under-
FSMA. First, it would require that certain      rough successful consecutive testing.       stand. Below we set out key recommen-

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dations to help you with FSMA com-               for the FSVP importer to be in                be prudent to monitor FDA’s re-
pliance.                                         compliance.                                   cordkeeping requirements for those
                                                                                               foods, because they could ultima-
    All FSMA Rules Work with expe-              Intentional Adulteration:                      tely serve as the foundation for tra-
rienced legal counsel or consultants to       š Carefully review the regulation and          ceability throughout the entire food
ensure you understand FDA’s expec-                FDA’s guidance documents to beco-            system.
tations and how they apply for your               me familiar with the agency’s expec-
operation. Ignorance or misunderstan-             tations.                                     Zusammenfassung Der Food
dings are not excuses that will help you      š Participate in the various available     Safety Modernization Act (kurz:
when FDA comes to inspect.                        training programs to develop the         „FSMA“) stellt die größte Reform
                                                  necessary expertise to build your        des US-amerikanischen Lebensmittel-
   Preventive Controls for Human                  Food Defense Plan.                       sicherheitsrechts seit den 1930er Jahren
Food and Preventive Controls for Ani-         š Develop and implement a Food De-         dar. Das Gesetz ist im Jahr 2011 in Re-
mal Food:                                         fense Plan.                              aktion auf eine Reihe von Lebensmittel-
 š Ensure that someone in your com-                                                      skandalen, bei denen auch Verbraucher
     pany is a Preventive Controls Qua-         Produce Safety:                            zu Schaden gekommen waren, verab-
     lified Individual, or identify a PCQI     š Review FDA’s regulations and gui-        schiedet worden. Mittlerweile sind fast
     to assist you with your Food Safety          dance to ensure you understand the       alle Übergangsfristen abgelaufen. Der
     Plan as a consultant.                        regulation.                              FSMA verpflichtet Lebensmittelunter-
 š Develop a Food Safety Plan, which        š Attend training programs related to      nehmen in größerem Umfang als bis-
     may involve performing a gap ana-            the regulation to deepen your un-        lang zur Einrichtung von präventiven
     lysis to identify opportunities to           derstanding of the rule.                 Kontrollmechanismen, und er erwei-
     modify your HACCP plan to com-           š Train personnel on FDA’s expecta-        tert die Eingriffsbefugnisse der Food
     ply with FSMA.                               tions.                                   and Drug Administration („FDA“)
 š For human foods, put a strong            š If you qualify for an exemption ba-      erheblich. US-amerikanische Lebens-
     emphasis on environmental monito-            sed on commercial processing of          mittelunternehmen müssen im Rahmen
     ring for pathogens, if you make rea-         your produce, ensure you meet the        eines „Foreign Supplier Verification
     dy-to-eat foods, and allergen cont-          requirements under the rule related      Program“ auch gewährleisten, dass ihre
     rols, if you make foods containing           to the exemption.                        Lieferanten die neuen Vorschriften be-
     any of the “big 8” allergens in the                                                   achten. Europäische Unternehmen, die
     United States (i.e., milk, eggs, fish,      Accredited Third-Party Certification:       Lebensmittel in die USA exportieren,
     crustacean shellfish, tree nuts, pea-     š Consult with your U.S. importer          müssen daher ihre Prozesse überprü-
     nuts, wheat, and soybean).                   as to whether they are considering       fen und an ihren Produktionsstandor-
 š Review your supplier verification            participating in VQIP and/or may         ten einen Mitarbeiter zum „Preventive
     program to assess whether it is con-         require your facility to obtain a cer-   Controls Qualified Individual (PCQI)“
     sistent with the requirements in the         tification under this program.            ausbilden, der für die Beachtung des
     regulations. In particular, be aware                                                  FSMA verantwortlich ist. Die FDA
     that just having a third-party audit       Sanitary Food Transportation:              führt auch bereits Inspektionen in eu-
     of your supplier is not sufficient to    š If you are shipping food to the U.S.     ropäischen Betrieben zur Überprüfung
     be in compliance.                            that will be further transported in      der FSMA-Compliance durch. Bei ei-
 š Stay abreast of FDA’s guidance do-           the same shipping container once it      nem Verstoß drohen Abmahnungen
     cuments, as the agency is exercising         arrives, be sure you are familiar with   und Importwarnungen, die das US-Ge-
     “enforcement discretion” for some            the requirements under this rule and     schäft empfindlich treffen können.
     provisions of the regulations through        how it applies to your shipments         Dieser Beitrag erläutert die neuen Re-
     guidance and also has issued recom-          once they are in U.S. commerce.          gelungen und gibt Empfehlungen zur
     mendations to assist with compliance.                                                 Umsetzung in europäischen Unterneh-
                                                Laboratory Accreditation                   men.
   FSVP:                                      š Keep an eye out for FDA’s final re-
 šEnsure you know who is respon-                gulation, and assess the implication     Maile Hermida, Attorney at law, Hogan
    sible for performing FSVP for                 of the final regulation’s require-       Lovells US LLP, Washington
    the foods you are sending to the              ments for your testing programs.
    United States. You will need to                                                        Rechtsanwältin Dr. Anna Glinke,
    work with this entity to ensure             Traceability                               Hogan Lovells International LLP,
    they have the necessary informa-           š Monitor for FDA’s release of the list    Düsseldorf
    tion to verify the safety of your             of designated high-risk foods and
    products. Be aware that just pro-             Proposed Rule. Even if the foods         Der Beitrag ist zuerst in der ZLR
    viding them with a third-party                you produce are not designated as        4/2019 erschienen und wurde nun
    (e.g., GFSI) audit is not enough              high-risk under the proposal, it will    adaptiert.

                                                                        volume 44 | 05./06. 2020 ERNÄHRUNG | NUTRITION
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