FSMA Final Rules: Foreign Supplier Verification, Accredited Third Party Certification, and Produce Safety

Transcription

1 FSMA Final Rules: Foreign Supplier Verification, Accredited Third Party Certification, and Produce Safety Webinar for the American Frozen Food Institute Elizabeth Barr Fawell, Counsel Maile Gradison Hermida, Senior Associate November 23, 2015

2 Agenda Foreign Supplier Verification Program (FSVP) Accredited Third Party Certification Produce Safety 2

3 Disclaimer Every company should conduct its own detailed review of the final rule This presentation provides an overview and uses shorthand, so it should not be relied on as a substitute for reading the final rule, obtaining legal advice, or as a summary of all regulatory requirements 3

4 Foreign Supplier Verification Program 4

5 Overview 21 CFR Part 1, Subpart L ( et seq.) FSVP applies to importers Will particularly affect: Food companies importing finished food products produced by a facility located outside the U.S. Retailers Food import businesses (e.g., brokers) FSVP is less consequential for facilities subject to the preventive controls regulations 5

6 Interplay with Preventive Controls Importers are deemed in compliance with FSVP if they are a receiving facility under PC and: Implement PCs for the hazards in the food; Implement a supply chain program under PC; or Are not required to implement a PC because: (1) the food could not be consumed without applying a control, or (2) they rely on someone later in the supply chain to control the hazard and have appropriate documentation Must identify the FSVP importer at entry 6

7 Scope FSVP applies to all food imported into the U.S. unless specifically exempted Includes: Food packaging Food-grade chemicals (if reasonably expected to be directed to a food use) Intra-company shipments RACs exempt from the produce safety rule Live animals intended for consumption 7

8 Importer The importer is the U.S. owner or consignee of an article of food that is being offered for import into the United States The U.S. owner or consignee is the person in the United States who, at the time of U.S. entry, either owns the food, has purchased the food, or has agreed in writing to purchase the food If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer This can be a different U.S. agent than designated for facility registration purposes 8

9 Identification of the Importer For each line entry of food, provide: Name address Unique facility identifier recognized as acceptable by FDA FDA plans to require use of Dun & Bradstreet Data Universal Numbering System (DUNS) numbers Importers will be able to request the use of different identification numbers, but this may require manual review of entry submissions 9

10 Basic Requirements 1. Identify hazards requiring a control for each imported food If no hazards require a control, you do not have to evaluate suppliers or conduct verification activities unless you are importing fruits or vegetables covered by the produce rule 2. If the hazard is controlled subsequently in the supply chain, obtain written assurance 3. Evaluate the risk posed by a food, using the results of the hazard analysis and evaluating the foreign supplier s performance You must consider specified factors, including the supplier s performance, food safety history, and compliance with FDA food safety regulations Supplier/food risk matrix alone is not adequate, must be individualized 10

11 Basic Requirements, continued 4. Conduct (and document) verification activities Annual audits required for SAHCODHA suppliers, unless you can support another approach 5. Conduct corrective actions No requirement to review consumer complaints 6. Identify yourself as the importer at entry 7. Document everything and retain records 8. Reevaluate hazards and reassess the program When you become aware of new information or at least every 3 years 11

12 Use of Approved Suppliers Importers must establish and follow written procedures to ensure they import foods only from approved foreign suppliers Use of these procedures must be documented Unapproved foreign suppliers can be used on a temporary basis (e.g., weather-related crisis; supplier equipment breakdown) if the foods are subject to adequate verification activities before import 12

13 Reliance on Third-Parties Importers can leverage work by third-parties by reviewing and assessing (and documenting the review and assessment of) their: Hazard analysis Evaluation (or reevaluation) of a foreign supplier s performance and the risk posed by a food Supplier approval procedures Determination of appropriate foreign supplier verification activities Performance of supplier verification activities No requirement to maintain documentation of supplier verification activities performed by other entities, but you must be able to obtain the documentation and make it available to FDA upon request 13

14 Audits If the food is subject to FDA food safety regulations, the audit must consider such regulations and include a review of the supplier s food safety plan and its implementation for the hazard being controlled Audits conducted solely to meet FSVP requirements can be conducted by an audit agent of a certification body accredited through the FDA process without being subject to the requirements in that regulation Certain inspections can substitute for audits 14

15 Role of GFSI Audits To the extent that the results of GFSI, GAP, or any other audit schemes appropriately verify that the foreign supplier produces the food consistent with FDA food safety standards, importers may use audits conducted under those schemes to meet the requirements of the FSVP regulation. We understand that... many of the widely used food safety auditing schemes are considering whether and how to revise their practices in light of the requirements of FDA regulations, including our new FSMA regulations. We further understand that the updating of schemes is a lengthy process that often involves engagement with experts and other stakeholders. Therefore, we believe it is premature to reach any definitive conclusions as to whether importers can rely on the results of audits conducted under any existing auditing schemes to verify compliance with the safety requirements of this rule. Over time, we expect that scheme owners and benchmarking organizations will develop tools to assess their schemes against FDA requirements to demonstrate the levels of health protection their schemes provide. Until such time, if an importer choses to use a GFSI, GAP, or other similar audit, the importer might need to supplement that audit to meet the requirements of or otherwise determine that the audit meets the requirements of this section. 15

16 Training/Qualifications FSVP must be developed by a qualified individual Activities must be performed by a qualified individual Qualified Individual : A person who has the education, training, or experience (or a combination thereof) necessary to perform an activity required under this subpart.... Each qualified individual only needs to be qualified to perform the FSVP activities they are engaging in they don t need to be qualified to perform all FSVP activities Audits must be conducted by a qualified auditor 16

17 Recordkeeping EVERYTHING MUST BE DOCUMENTED! Records must be retained for at least 2 years after they are created or their use is discontinued All records concerning the FSVP must be signed and dated Can be electronic and exempt from Part 11 Can be stored offsite, so long as they are accessible within 24 hours Can be kept in a foreign language, so long as an English translation is provided to FDA upon request 17

18 FDA s Records Access All required records must be made available to FDA, upon request, for inspection and copying If requested in writing by FDA, you must send records to the agency electronically (or through another prompt means) rather than making the records available for review at your place of business 18

19 FOIA Records are subject to public disclosure under the Freedom of Information Act (FOIA), but note that there are FOIA exemptions for trade secrets and confidential commercial information FDA acknowledges that many FSVP records will be exempt from public disclosure (e.g., evaluations of foreign supplier performance; results of onsite audits) 19

20 Exemptions Suppliers covered by seafood or juice HACCP Raw materials or ingredients for use in a food under seafood or juice HACCP Food imported for research or evaluation Food imported for personal consumption Alcoholic beverages Food that is transshipped or imported for processing and export U.S. food returned (i.e., exported U.S. food returned without further processing) Meat, poultry, and eggs subject to USDA jurisdiction 20

21 Hazard Analysis for Raw Fruits and Vegetables If imported produce is covered by the produce safety rule: You always are required to engage in supplier verification because there is a presumption of biological hazards associated with fruits and vegetables covered by the produce rule You do not have to determine whether there are any biological hazards requiring a control because of this presumption You are required to determine whether there are any other types of hazards (e.g., chemical hazards) requiring control 21

22 Downstream Controls With the exception of fruits/vegetables covered by the produce rule, you do not have to evaluate your supplier or engage in verification activities if: The type of food cannot be consumed without application of an appropriate control (e.g. cocoa beans, coffee beans, grains) When a hazard is controlled by another entity later in the distribution chain (e.g., your customer; your customer s customer) Disclose that food is for further processing (e.g., not processed to control Salmonella ) Annually obtain written assurance that the hazard will be controlled by your customer (including an identification of the procedures) or that your customer will disclose the hazard and only sell the food to another entity that agrees in writing to control the hazard or obtain a similar written assurance Customer = commercial customer, not a consumer 22

23 Low-Acid Canned Foods For imports of low-acid canned foods produced under 21 CFR Part 113, verify and document that the food was produced in accordance with Part 113 No FSVP is required for microbiological hazards for raw materials or ingredients imported for use in LACF under Part 113 Must have an FSVP for all matters not controlled by LACF regs (i.e., nonmicrobiological hazards) 23

24 Dietary Supplements The requirements for dietary supplements vary according to a number of factors, including whether the import is a finished product or an ingredient/component 24

25 Very Small Importers and Certain Small Foreign Suppliers Modified FSVP requirements apply for very small importers and imports of food from certain small suppliers (e.g., written assurances rather than verification activities) Very small importer = $1 million in sales for human food and $2.5 million in sales for animal food Certain small foreign suppliers: Qualified Facilities Farms exempt from the produce safety rule due to their small size Shell egg producers with fewer than 3,000 laying hens 25

26 Comparability/Equivalence Many of the standard FSVP requirements do not apply to food from foreign suppliers in countries whose food safety systems FDA has officially recognized as comparable or determined to be equivalent to that of the U.S. Importers must document certain conditions are met New Zealand currently is the only country determined to meet these criteria Canada may be designated soon 26

27 Compliance Dates Importers need to comply by the latest of the following dates: months after publication of the final rule (May 2017); 2. For importation of food from a supplier subject to PC or the produce rule, 6 months after the foreign supplier is required to comply with the relevant regulations; or 3. For an importer that also is subject to the supply-chain program provisions in the PC rule, the date the importer (as a receiving facility) is required to comply with the supply-chain program provisions of the PC regulation 27

28 Enforcement FSVP inspections will not occur at entry Inspections will be records-based and occur at where FSVP records are kept (e.g., importers offices) The results of FSVP inspections will be incorporated into the PREDICT system to better target food imports based on risk Failure to comply with FSVP can result in refusal of admission of imported food 28

29 FSVP Guidance FDA is developing several guidance documents General guidance on FSVP How to obtain the necessary experience to be a qualified auditor Working with the FSPCA to establish training and technical assistance programs FSPCA training includes a module on the FSVP rule for processors who import foods and a full FSVP course for non-processor importers FDA s Technical Assistance Network is now operational 29

30 Accredited Third Party Certification 30

31 Overview Establishes a system for FDA to recognize accreditation bodies that in turn accredit third-party certification bodies Third party certification bodies perform food safety audits and issue certifications for foreign food facilities and the foods they produce Certification used for: VQIP Mandatory Import Certification 31

32 Overview Continued Regulatory framework sets out requirements for accreditation bodies seeking recognition by the FDA, as well as requirements for third-party certification bodies seeking accreditation Legal authority, competency, capacity, conflict-of-interest safeguards, quality assurance, and record procedures Also sets out requirements for conducting audits, developing audit reports, providing those to FDA, and notifying FDA of certain conditions 32

33 Key Terms and Definitions Food Safety Audit: Includes both regulatory audits and consultative audits Regulatory Audit: An audit to determine whether an entity complies with FDA food safety requirements and the results of which are used determine whether a certification can be issued Consultative Audit: An audit to determine whether an entity complies with FDA food safety requirements and industry standards, the results of which are for internal purposes, and which is conducted in preparation for a regulatory audit 33

34 Food Safety Audits- Scope Food safety audits do not include: Audits conducted by certification bodies not accredited under FDA s program Audits conducted to determine compliance with industry standards Audits that are announced Audits conducted solely for Preventive Controls supplier verification purposes or FSVP Accredited third party certification bodies can offer food safety audits and other services outside the scope of the rule 34

35 Importance of Scope Because of certain notification and reporting requirements associated with audits conducted under the rule, it is important to understand which audits are covered When working with accredited third party certification bodies, be sure to clearly identify what type of audit you are requesting (i.e., is it a food safety audit ) Particularly important for foreign facilities requesting consultative audits 35

36 Requirements for Conducting Audits Must be unannounced (within a 30 day scheduling window) Records review component can be scheduled, but must be before onsite visit When deficiencies requiring corrective actions are identified, the auditor can verify corrective actions were implemented, but cannot provide on the CA When testing is conducted, must be performed by a lab accredited to ISO/IEC 17205:2005 or equivalent FDA and accreditation bodies must be allowed to observe a food safety audit 36

37 Notification and Reporting Requirement Certification body/auditor must immediately notify FDA if it discovers a condition that could cause or contribute to a serious risk to public health This is broader that hazards that could cause serious adverse health consequences or death to humans or animals (SAHCODHA) and includes No exception for circumstances where the food has not left the control of the entity Certification bodies should take into consideration factors such as whether the condition concerns pre-production materials or finished product, and relation to product intended for the U.S. Must notify entity and accreditation body, too 37

38 Audit Report Contents Consultative audit reports must include Certain entity identification information, including: FDA establishment identifier FDA registration number (where applicable) Unique facility identifier, if designated by FDA Any deficiencies that may affect whether the entity is in compliance with FDA requirements that require corrective actions, the corrective action plan, and date on which they were completed Do not need to include deficiencies solely associated with compliance with industry standards 38

39 Audit Report Contents Continued Regulatory audit reports must include: Entity identification information Any deficiencies that present a reasonable probability of that a food: Will cause serious adverse health consequences or death May cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote The corrective action plan for each deficiency (unless implemented immediately and verified onsite) Whether any testing is performed by the facility Whether the entity has made any significant changes in the past two years to its facility, processes, or foods 39

40 Submission of Audit Reports Regulatory audit reports must be submitted, electronically, and in English to FDA and the accreditation body Even if no certification is issued Consultative audit reports do not need to be submitted to FDA Must be maintained and are available to FDA under the Bioterrorism Act records access standard 40

41 Certifications Cannot be issued until accredited third party certification body verifies that corrective actions in response to deficiencies were implemented Corrective actions in response to serious risk deficiencies (those that triggered notification to FDA) must be verified onsite Must be submitted to FDA in English electronically 12 month term FDA can refuse to accept if deemed to be not valid or reliable 41

42 Records Certification bodies must maintain records for 4 years Must be maintained electronically Must maintain records of audit reports and related documents (notes, corrective actions, lab reports) Must be available for review and copying at place of business or reasonably accessible location Must be submitted electronically within 10 days if requested Subject to standard FOIA disclosures, exemptions 42

43 Websites Accredited certification bodies must maintain on their website a list of entities to which it has issued certifications, including: Duration and scope of certification Date entity paid certification body FDA will have a website registry of: Recognized accreditation bodies And those denied or had recognition revoked Accredited third party certification bodies And those denied or had accreditation withdrawn Generally FDA will not post audit reports 43

44 Produce Safety 44

45 Overview The rule establishes, for the first time, sciencebased minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption Agricultural water Biological soil amendments Worker hygiene Employee training Buildings, tools, and equipment Domesticated and wild animals Sprouts 45

46 Overview continued Focus is on microbiological hazards because those pose a risk of serious adverse health consequences or death Chemical and physical hazards continue to be addressed through the statutory prohibition on adulteration Applies to both domestic and foreign produce Primarily applies to farms, but may also apply to packing houses or other operations that engage in harvesting, packing or holding covered produce 46

47 Impact on Manufacturers and Processors Whether a farm/produce is covered affects supplier verification activities If supplier must comply with the produce rule, should understand basic requirements to verify compliance with those requirements If supplier is exempt from the produce rule, manufacturer will engage in different verification activities If produce is exempt from coverage because you will commercially process it, you will have certain obligations under this rule 47

48 What Foods are Covered? Produce: any fruit or vegetable (including mixes of intact fruits and vegetables) and includes mushrooms, sprouts (irrespective of seed source), peanuts, tree nuts, and herbs, but does not include food grains That is a raw agricultural commodity 48

49 What Foods Are Not Covered? Produce rarely consumed raw (see next slide) Produce that is for personal or on-farm consumption Farms that have an average annual value of produce sold during the previous three-year period of $25,000 or less Produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance, with certain conditions Qualified farms are subject to modified rules 49

50 Produce Rarely Consumed Raw asparagus; black beans, great Northern beans, kidney beans, lima beans, navy beans, and pinto beans; garden beets (roots and tops) and sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts This is an exhaustive list and is different than in the proposed rule 50

51 Modified Requirements for Qualified Farms Qualified farms: Must have food sales averaging less than $500,000 per year during the previous three years; and The farm s food sales to consumers and/or local retailers and restaurants must exceed sales to all others combined during the previous three years Modified requirements: Disclose the name and the complete business address of the farm where the produce was grown either on the label of the produce or at the point of purchase. Establish and keep certain documentation 51

52 Produce that Receives Commercial Processing Produce that receives commercial processing that adequately reduces microorganisms of public health significance is exempt, provided certain conditions are met Examples of commercial processing include processes that comply with LACF requirements, acidified food processes, juice HACCP, treating with a validated process to eliminate sporeforming microorganisms (such as processing to produce tomato paste or shelf-stable tomatoes), and processing such as refining, distilling, or otherwise manufacturing/processing produce into products such as sugar, oil, spirits, wine, beer 52

53 Are Frozen Fruits and Vegetables Exempt? It depends Blanching and/or freezing processes may qualify [as commercial processing that adequately reduces the presence of pathogens] if they are validated to ensure that the specific procedures followed adequately reduce pathogens in the food 53

54 Commercial Processing Exemption Continued Farm must disclose in documents accompanying the produce that it is not processed to adequately reduce the presence of microorganisms of public health significance Farm must obtain annual written assurance from the customer that performs the commercial processing that it has established and is following procedures identified in the written assurance that adequately reduce the presence of microorganisms of public health significance 54

55 Commercial Processing Exemption Continued If the farm s s customer is not the processor, then it must obtain documentation from the customer that some other party in the distribution chain will process the produce and It will make the requisite disclosure in documentation accompanying the produce It will only sell to an entity that agrees in writing either To follow procedures (identified in a written assurance) that adequately reduce the presence of microorganisms of public health significance OR obtain a similar written assurance from its customer Farm must keep documentation of its disclosures and annual written assurances 55

56 Requirements for Processors Commercial processors must: Provide annual written assurances identifying the procedures they have established and will implement to adequately reduce microorganisms of public health significance Document compliance with those procedures This applies to any entity that agrees to provide the written assurance, even if exempt from compliance with the Preventive Controls rule (e.g., processors in compliance with juice HACCP) 56

57 Small and Very Small Businesses Very small business: average annual monetary value of produce sold during the previous 3-year period is no more than $250,000 Small business: average annual monetary value of produce sold during the previous 3-year period is more than $250,000, but no more than $500,000 57

58 General Compliance Dates Most produce safety requirements (excluding sprouts): Large business: 2 years Small business: 3 years Very small business: 4 years Add an extra two years for compliance with certain agricultural water requirements 58

59 All Compliance Dates 59

60 Worker Training Provisions Establish qualification and annual training requirements for all personnel who handle (contact) covered produce or food-contact surfaces and their supervisors Importance of health and hygiene Produce safety standards Special training requirements for workers engaged in harvesting Recognizing produce that cannot be harvested Inspecting harvesting containers and equipment Require documentation of required training and corrective actions 60

61 Health and Hygiene Provisions Establish hygienic practices and other measures needed to prevent persons, including visitors, from contaminating produce with microorganisms of public health significance No communicable diseases Personal cleanliness Avoiding contact with animals Hand washing Maintaining gloves in an intact and sanitary condition No eating, chewing gum, using tobacco products 61

62 Agricultural Water Provisions Safe and adequate sanitary quality of water Inspection of water system under farm s control Water treatment, if a farm chooses to treat water Tiered approach to water testing based on source Lower frequency for untreated ground water High frequency for untreated surface water Specific microbial criteria for water used for certain purposes Direct contact vs. growing Corrective measures Records requirements 62

63 Biological Soil Amendment Provisions Standards for treated (stabilized compost) and untreated (raw manure) Restrictions on application method depending on treatment status Application-to-harvest interval for certain untreated BSAs of animal origin is [reserved] FDA currently working on risk assessment Use of human waste for growing covered produce is prohibited except in compliance with EPA regulations for such uses Untreated BSA of animal origin cannot contact covered produce during application Requirements for treatment of biological soil amendments of animal origin with scientifically valid, controlled, biological, physical and/or chemical processes that satisfy certain specific microbial standards Require certain records, including documentation from suppliers 63

64 Domesticated and Wild Animals If there is a reasonable probability that grazing animals, working animals, or animal intrusion will contaminate covered produce, then the farm must take measures to assess as needed relevant areas during growing If significant evidence of potential contamination is found Evaluate whether covered produce can be harvested Take measures reasonably necessary throughout the growing season to ensure covered produce that is reasonably likely to be contaminated will not be harvested (e.g., identify contaminated areas with flags) 64

65 Growing, Harvesting, Packing and Holding Establishes requirements to keep covered produce separate from excluded produce and to adequately clean and sanitize food contact surfaces that contact excluded produce before using them for covered produce Prohibits harvesting produce that is likely to be contaminated, including that visibly contaminated with animal excreta Visual assessment of the growing area required Prohibits distribution of dropped produce Food packaging materials must be appropriate for use 65

66 Equipment, Tools, and Buildings Provisions Requirements include: Equipment/tools: designed and constructed to allow adequate cleaning and maintenance. Food contact surfaces of equipment and tools must be inspected, maintained, cleaned, and sanitized as necessary. Buildings: size, design and construction must facilitate maintenance and sanitary operations. Toilet and hand-washing facilities must be adequate, and readily accessible during covered activities. Require certain records related to the date and method of cleaning or sanitizing equipment and corrective actions 66

67 Sprout Provisions Establish measures that must be taken related to seeds or beans for sprouting Establish measures that must be taken for the growing, harvesting, packing, and holding of sprouts Require testing the growing environment for Listeria species or Listeria monocytogenes and testing each production batch of spent sprout irrigation water or sprouts for E. coli O157:H7, Salmonella species and, under certain conditions, other pathogens, and taking appropriate follow-up actions Require certain records, including documentation of treatment of seeds or beans for sprouting, a written environmental monitoring plan and sampling plan, test results, certain test methods used, and corrective actions 67

68 More to Come! Under the court order, FDA is required to submit the remaining final rules to the Federal Register for publication by the following dates: March 31, 2016: Sanitary Food Transportation May 31, 2016: Food Defense 68

69 Conclusion FSMA implementation is in full swing If you have not already done so, it s time to prepare Convene a multi-functional team Educate them on the final rules Conduct a thorough gap assessment Get help from legal counsel Train for and implement good recordkeeping practices Self-audit before FDA starts inspections 69

70 Questions? 70

71 Elizabeth Barr Fawell, Counsel (202) Maile Gradison Hermida, Senior Associate (202) Hogan Lovells has offices in: Alicante Amsterdam Baltimore Beijing Brussels Budapest* Caracas Colorado Springs Denver Dubai Dusseldorf Frankfurt Hamburg Hanoi Ho Chi Minh City Hong Kong Houston Jakarta* Jeddah* Johannesburg London Los Angeles Luxembourg Madrid Mexico City Miami Milan Monterrey Moscow Munich New York Northern Virginia Paris Philadelphia Rio de Janeiro Riyadh* Rome San Francisco São Paulo Shanghai Silicon Valley Singapore Tokyo Ulaanbaatar Warsaw Washington DC Zagreb* "Hogan Lovells" or the "firm" is an international legal practice that includes Hogan Lovells International LLP, Hogan Lovells US LLP and their affiliated businesses. The word "partner" is used to describe a partner or member of Hogan Lovells International LLP, Hogan Lovells US LLP or any of their affiliated entities or any employee or consultant with equivalent standing. Certain individuals, who are designated as partners, but who are not members of Hogan Lovells International LLP, do not hold qualifications equivalent to members. For more information about Hogan Lovells, the partners and their qualifications, see. Where case studies are included, results achieved do not guarantee similar outcomes for other clients. Attorney Advertising. Hogan Lovells All rights reserved. *Associated offices

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