Emerging Issues: FDA Food Safety Foreign Suppliers & US Importers Rules Impact and Guidance in 2014 LIVE Webcast

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On July 26, 2013, the Food and Drug Administration (FDA) issued two proposed rules in accordance with Sections 301 and 307 of the FDA Food Safety Modernization Act (FSMA): (1) governing foreign …

On July 26, 2013, the Food and Drug Administration (FDA) issued two proposed rules in accordance with Sections 301 and 307 of the FDA Food Safety Modernization Act (FSMA): (1) governing foreign supplier verification and (2) governing third-party audits and certification.

The proposed rules represent a significant change in FDA’s approach and attempt to enhance FDA oversight of all imported human and animal food. Moreover, these rules require most importers to develop and implement a Foreign Supplier Verification Program (FSVP) for all food that they import. Lastly, imports that fail to comply with a FSVP may be subject to refusal of admission.

When finalized, the proposed rules will present a significant set of new compliance obligations for all food and beverage importers. Food companies and importers should have a complete understanding of FDA’s current thinking as reflected in this proposed rule to assess its potential impact on their businesses.

The Knowledge Group has assembled a panel of key thought leaders and practitioners to help you understand the complex issues related to the proposed rule and its impact on your firm and the broader market. The speakers will present their expert opinions in a two-hour LIVE Webcast.

To view the webcast go to this link: http://youtu.be/jrxi67UjiHw


To learn more about the webcast please visit our website: http://theknowledgegroup.org/

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  • 1. Speaker Firms and Organization: Keller and Heckman LLP Leslie T. Krasny Partner Hogan Lovells US LLP Maile Gradison Hermida Associate Thank you for logging into today’s event. Please note we are in standby mode. All Microphones will be muted until the event starts. We will be back with speaker instructions @ 11:55am. Any Questions? Please email: Info@knowledgecongress.org Group Registration Policy Please note ALL participants must be registered or they will not be able to access the event. If you have more than one person from your company attending, you must fill out the group registration form. We reserve the right to disconnect any unauthorized users from this event and to deny violators admission to future events. To obtain a group registration please send a note to info@knowledgecongress.org or call 646.202.9344. Presented By: May 16, 2014 1 Partner Firms:
  • 2. May 16, 2014 2 Follow us on Twitter, that’s @Know_Group to receive updates for this event as well as other news and pertinent info.  If you experience any technical difficulties during today’s WebEx session, please contact our Technical Support @ 866-779-3239.  You may ask a question at anytime throughout the presentation today via the chat window on the lower right hand side of your screen. Questions will be aggregated and addressed during the Q&A segment.  Please note, this call is being recorded for playback purposes.  If anyone was unable to log in to the online webcast and needs to download a copy of the PowerPoint presentation for today’s event, please send an email to: info@knowledgecongress.org. If you’re already logged in to the online webcast, we will post a link to download the files shortly.  If you are listening on a laptop, you may need to use headphones as some laptops speakers are not sufficiently amplified enough to hear the presentations. If you do not have headphones and cannot hear the webcast send an email to info@knowledgecongress.org and we will send you the dial in phone number.
  • 3. May 16, 2014 3  About an hour or so after the event, you'll be sent a survey via email asking you for your feedback on your experience with this event today - it's designed to take less than two minutes to complete, and it helps us to understand how to wisely invest your time in future events. Your feedback is greatly appreciated. If you are applying for continuing education credit, completions of the surveys are mandatory as per your state boards and bars. 6 secret words (3 for each credit hour) will be given throughout the presentation. We will ask you to fill these words into the survey as proof of your attendance. Please stay tuned for the secret word.  Speakers, I will be giving out the secret words at randomly selected times. I may have to break into your presentation briefly to read the secret word. Pardon the interruption.
  • 4. May 16, 2014 4 Welcome to the Knowledge Group Unlimited Subscription Programs. We have Two Options Available for You: FREE UNLIMITED: This program is free of charge with no further costs or obligations. It includes:  Unlimited access to over 15,000 pages of course material from all Knowledge Group Webcasts.  Subscribers to this program can download any slides, white papers, or supplemental material covered during all live webcasts.  50% discount for purchase of all Live webcasts and downloaded recordings. PAID UNLIMITED: Our most comprehensive and cost-effective plan, for a one-time fee:  Access to all LIVE Webcasts (Normally $199 to $349 for each event without a subscription). Including: Bring-a-Friend – Invite a client or associate outside your firm to attend for FREE. Sign up for as many webcasts as you wish.  Access to all of Recorded/Archived Events & Course Material includes 1,500+ hours of audio material (Normally $299 for each event without a subscription).  Free CLE/CPE/CE Processing (Normally $49 Per Course without a subscription).  Access to over 15,000 pages of course material from Knowledge Group Webcasts.  Ability to invite a guest of your choice to attend any live webcast Free of charge (Exclusive benefit only available for PAID UNLIMITED subscribers).  6 Month Subscription is $299 with No Additional Fees Other options are available.  Special Offer: Sign up today and add 2 of your colleagues to your plan for free Check the “Triple Play” box on the sign-up sheet contained in the link below. https://gkc.memberclicks.net/index.php?option=com_mc&view=mc&mcid=form_157964
  • 5. May 16, 2014 5 Knowledge Group UNLIMITED PAID Subscription Programs Pricing: Individual Subscription Fees: (2 Options) Semi-Annual: $299 one-time fee for a 6 month subscription with unlimited access to all webcasts, recordings, and materials. Annual: $499 one-time fee for a 12 month unlimited subscription with unlimited access to all webcasts, recordings, and materials. Group plans are available. See the registration form for details. Best ways to sign up: 1. Fill out the sign up form attached to the post conference survey email. 2. Sign up online by clicking the link contained in the post conference survey email. 3. Click the link below or the one we just posted in the chat window to the right. https://gkc.memberclicks.net/index.php?option=com_mc&view=mc&mcid=form_157964 Discounts: Enroll today and you will be eligible for the “Triple Play” program and 3% off if you pay by credit card. Also we will waive the $49 CLE/CPE processing fee for today’s conference. See the form attached to the post conference survey email for details. Questions: Send an email to: info@knowledgecongress.org with “Unlimited” in the subject.
  • 6. Partner Firms: May 16, 2014 6 Keller and Heckman counsels clients—from multinational corporations to start-up companies—on compliance with food and drug laws and regulations throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, dietary supplements, tobacco products, and cosmetics. Our attorneys advise clients on labeling and advertising issues, crisis management, compliance with U.S. bioterrorism laws and other laws and regulations affecting the global marketing of food and drug products, and product development and approval strategies. Keller and Heckman clients benefit from the in-depth expertise and extensive experience of our attorneys, many of whom have scientific and technical backgrounds. Our attorneys have worked for private industry; state, federal and international agencies; and consulting firms. And, with a staff of over twenty scientists, we are a leader in the use of interdisciplinary approaches to problem-solving. Players in the food and agriculture sectors address regulatory challenges at every stage of the production cycle, from farm to table. Food production, processing, labeling, distribution, and advertising present issues in which business and regulation intersect. Hogan Lovells helps clients anticipate, shape, and comply with regulations from numerous agencies at the national, state, and local levels. We also assess and implement strategies that ensure compliance while advancing business objectives. Our practice team includes lawyers with high-level experience in government and who have served in senior executive positions within the food industry, including as general counsel to food companies and trade associations. Our experience also extends into science and technology with several of our lawyers having academic degrees and professional backgrounds in these areas.
  • 7. Brief Speaker Bios: Leslie T. Krasny Leslie Krasny, Partner at Keller and Heckman in San Francisco, practices regulatory law, focusing on food/dietary supplements with respect to safety, labelling, advertising and substantiation. She represents food companies including growers, processors, distributors, foodservice and retailers, and serves as General Counsel to the Produce Marketing Association. Leslie is a member of the Board of Directors of the Food and Drug Law Institute, serves on its Food and Dietary Supplements Committee, and is on the Editorial Advisory Board of Food Processing Magazine. Prior to receiving her law degree, Leslie obtained a Masters in Cell and Molecular Biology and worked in pharmacology research at the University of California, San Francisco and at Stanford University, School of Medicine. Her scientific background is valuable in working with clients and with Keller and Heckman's scientific staff on legal matters involving technical complexity. May 16, 2014 7 ► For more information about the speakers, you can visit: http://theknowledgegroup.org/event_name/emerging-issues-fda-food-safety-foreign-suppliers-us-importers-rules-impact-and-guidance-in- 2014-live-webcast/ Maile Gradison Hermida Maile Gradison Hermida practices with Hogan Lovells in the area of food and agriculture law. She represents food companies, including manufacturers, distributors, retailers, and their trade associations. Her clients are regulated by the Food and Drug Administration, Department of Agriculture, Federal Trade Commission, and other health and safety regulatory agencies at both the federal and state levels. Maile advises clients on the development of label claims, website and promotional campaigns for products, as well as the various requirements applicable to the labeling of foods. She also provides assistance to trade associations and food companies with fashioning comments and developing strategies in response to agency rulemaking and other public policy issues. Her practice is increasingly focused on counseling companies and trade associations as to the implementation of the FDA Food Safety Modernization Act. Maile also assists clients with responses to Federal Trade Commission, Congressional, and state Attorney General investigations and counsels clients on the development, interpretation, and enforcement of laws and regulations governing food production, processing, and distribution.
  • 8. On July 26, 2013, the Food and Drug Administration (FDA) issued two proposed rules in accordance with Sections 301 and 307 of the FDA Food Safety Modernization Act (FSMA): (1) governing foreign supplier verification and (2) governing third-party audits and certification. The proposed rules represent a significant change in FDA’s approach and attempt to enhance FDA oversight of all imported human and animal food. Moreover, these rules require most importers to develop and implement a Foreign Supplier Verification Program (FSVP) for all food that they import. Lastly, imports that fail to comply with a FSVP may be subject to refusal of admission. When finalized, the proposed rules will present a significant set of new compliance obligations for all food and beverage importers. Food companies and importers should have a complete understanding of FDA’s current thinking as reflected in this proposed rule to assess its potential impact on their businesses. The Knowledge Group has assembled a panel of key thought leaders and practitioners to help you understand the complex issues related to the proposed rule and its impact on your firm and the broader market. The speakers will present their expert opinions in a two-hour LIVE Webcast. May 16, 2014 8
  • 9. Featured Speakers: May 16, 2014 9 Leslie T. Krasny Partner Keller and Heckman LLP Segment 1: Maile Gradison Hermida Associate Hogan Lovells US LLP Segment 2:
  • 10. Food Safety Modernization Act  Importers – required to establish foreign supplier verification program (FSVP)  Same level of public health protection as required under Hazard Analysis and Risk-Based Preventive Controls (HARPC) or Produce Safety Standards  Not adulterated or misbranded (allergen labeling)  Such other requirements as FDA deems necessary to show that imported food is as safe as food produced in U.S.  Importer definition  U.S. owner/consignee of food at time of entry, or  if none, U.S. agent/representative of foreign owner/ consignee  FDA must consider differences among importers and types of imported food, including level of risk May 16, 2014 10 Leslie T. Krasny Partner Keller and Heckman LLP Segment 1:
  • 11. Food Safety Modernization Act  Records must be maintained for at least 2 years, and be made available to FDA upon request  Exemptions -- seafood, juice, low-acid canned food facilities in compliance with HACCP; R&D; personal consumption  Prohibited act to import food if importer does not have FSVP in compliance with FSMA  FSMA -- verification activities may include:  Monitoring records for shipments  Lot-by-lot certification of compliance  Annual on-site inspections  Checking HARPC plan of foreign supplier  Periodically testing and sampling shipments May 16, 2014 11 Leslie T. Krasny Partner Keller and Heckman LLP Segment 1:
  • 12. Proposed FSVP Rule Who/what is covered?  Importer – same definition as statute  Foreign supplier – the establishment that manufactures or processes the food, raises the animals, or harvests the food that is exported to the U.S. without further manufacturing or processing by another establishment, except further activities of a de minimis nature, such as labeling  Food – “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” Section 201(f) of the FD&C Act. Pesticides are excluded. Definition includes food and feed ingredients and additives (including substances that migrate into food from packaging and other articles that contact food). May 16, 2014 12 Leslie T. Krasny Partner Keller and Heckman LLP Segment 1:
  • 13. Proposed FSVP Rule  Exemptions  Seafood/juice facilities in compliance with HACCP  Low-acid canned foods (micro hazards only)  Alcohol beverages (facilities w/ Dept. of Treasury approval)  R&D; personal consumption  Transshipment or import for further processing and export  Modified requirements  Very small importers and imported food from very small foreign suppliers (annual food sales <$500,000 )  Importers of food from countries with officially recognized or equivalent food safety systems  Importers of dietary supplements/components subject to current good manufacturing practices (CGMPs) May 16, 2014 13 Leslie T. Krasny Partner Keller and Heckman LLP Segment 1:
  • 14. Proposed FSVP Rule FSVP activities  Review and document compliance status (foods and foreign suppliers):  FDA Warning Letters  Import alerts  Requirement for certification under FSMA  FDA Form 483  Establishment Inspection Reports  Recall notices  Documents relating to injunctions and seizures May 16, 2014 14 Leslie T. Krasny Partner Keller and Heckman LLP Segment 1:
  • 15. Proposed FSVP Rule FSVP activities  Hazard analysis – reasonably likely to occur (RLTO)  Potential hazards – biological/chemical/physical/ radiological agent that is reasonably likely to cause illness or injury in absence of controls  Reasonably likely to occur – prudent importer would establish/verify controls: experience/illness data/scientific reports/other info provides basis to conclude reasonable possibility the hazard will occur in absence of controls  Hazard evaluation factors: o Ingredients o Foreign supplier’s establishment/equipment (condition/layout, etc.) o Transportation practices/storage and distribution o Harvesting/manufacturing/packing/packaging material o Intended or reasonably foreseeable use o Other relevant factors May 16, 2014 15 Leslie T. Krasny Partner Keller and Heckman LLP Segment 1:
  • 16. Proposed FSVP Rule FSVP activities  Verification and related activities  List of foreign suppliers  Hazards controlled by foreign supplier o Option 1: For high-risk hazards (reasonable probability of causing serious adverse health consequences or death to humans or animals (SAHCODHA)), importer must conduct onsite auditing. For non-SAHCODHA risks, importers must choose at least one verification activity. For hazards associated with raw agricultural commodities (RACs) subject to produce safety rule, onsite auditing is required. o Option 2: For all hazards, importers must choose at least one verification activity.  Hazards controlled by importer – document use of procedures that control the hazard  Hazards controlled by importer’s customer – obtain written assurance that specified procedures control the hazard May 16, 2014 16 Leslie T. Krasny Partner Keller and Heckman LLP Segment 1:
  • 17. Proposed FSVP Rule FSVP activities  Complaints, investigations and corrective actions  Review complaints  Investigate possible adulteration or misbranding  Take corrective actions if foods do not meet applicable U.S. food safety requirements  Revise if FSVP is inadequate May 16, 2014 17 Leslie T. Krasny Partner Keller and Heckman LLP Segment 1:
  • 18. Proposed FSVP Rule FSVP activities  Reassessment of FSVP  Reassess, at a minimum, within 3 years of establishing FSVP or last assessment  Reassess effectiveness if importer becomes aware of new information re potential hazards, such as: o Changes in raw materials or sources of raw materials o Product formulation o Processing methods o Distribution systems o Intended use May 16, 2014 18 Leslie T. Krasny Partner Keller and Heckman LLP Segment 1:
  • 19. Proposed FSVP Rule FSVP activities  Identification of importer at entry  If no U.S. owner/consignee, the foreign owner/consignee must designate a U.S. agent or representative  Importers must obtain a Dun & Bradstreet Data Universal Numbering System (DUNS®) number  Importer name and DUNS number must be provided electronically when filing for entry with Customs and Border Protection May 16, 2014 19 Leslie T. Krasny Partner Keller and Heckman LLP Segment 1:
  • 20. Proposed FSVP Rule FSVP activities  Records  Sign and date records re FSVP -- initial completion and any revisions  In English  Must be made available promptly to FDA on request  Maintain at importer’s place of business or reasonably accessible location (including electronic retrieval)  Retain for at least 2 years or, for records in use for a period of time (e.g., hazard analyses), until at least 2 years after the use is discontinued May 16, 2014 20 Leslie T. Krasny Partner Keller and Heckman LLP Segment 1:
  • 21. Proposed FSVP Rule  Qualified Individual  Must develop FSVP  Must perform or oversee most verification activities o Reviewing compliance status o Conducting hazard analysis o Performing foreign supplier verification activities o Reviewing complaints, conducting investigations, taking corrective actions o Reassessing FSVP and revising as appropriate  Must have the necessary education, training and experience to perform the required activities  Need not be an employee; may be a 3rd party auditor or an employee of a foreign government May 16, 2014 21 Leslie T. Krasny Partner Keller and Heckman LLP Segment 1:
  • 22. Comments to FDA on Proposed Rule  Key industry concerns  Final regulation should be flexible re verification (Option 2)  Existing industry verification activities, best practices, and standards (e.g., the Global Food Safety Initiative) should be recognized by FDA, as appropriate.  FDA should clarify how it will determine whether a country’s food safety system provides the “same level” of public health protection as FDA  Importers should not be required to maintain traceability records beyond “one step back” in the supply chain  Authorization to import should not be withdrawn for a technical infraction unrelated to food safety  Importers should not be required to maintain a list of foreign suppliers.  FDA should not be given remote access to records May 16, 2014 22 Leslie T. Krasny Partner Keller and Heckman LLP Segment 1:
  • 23. Comments to FDA on Proposed Rule  Key consumer interest concerns  FDA should require importers to verify “legal status” of a foreign supplier in its own country, including warning letters, regulatory violations, or other legal actions by that government for violating foreign food safety laws.  FDA should require importers to conduct their own verification activities for imported food substances that are marketed based on foreign supplier’s self-determined GRAS position.  For some high-risk hazards, product and environmental testing should be required in addition to onsite audits.  FDA should provide additional guidance re “hazard” and should interpret the term broadly to ensure that importers address all potential food safety risks presented by the imported food. May 16, 2014 23 Leslie T. Krasny Partner Keller and Heckman LLP Segment 1:
  • 24. Overview • FDA’s proposal would create a private auditing system for leveraging FDA inspection of foreign facilities under the Mandatory Import Certification (MIC) program or importers using the Voluntary Qualified Importer Program (VQIP) • FDA would recognize accreditation bodies • Accreditation bodies would accredit auditors/certification bodies • Auditors/certification bodies would audit and certify foreign facilities or foreign foods at least once a year May 16, 2014 24 Maile Gradison Hermida Associate Hogan Lovells US LLP Segment 2:
  • 25. Key Areas of Interest for Food Manufacturers Program comes with following “bells and whistles”: • Auditors would be required to report to FDA immediately any conditions identified during a food safety audit that present a “serious risk to public health” (broadly defined) • Regulatory audit reports would need to be sent to FDA routinely within 45 days of audit completion • Laboratory results taken during an accredited audit may be required to be automatically sent to FDA by accredited laboratories • Third-party audits must be unannounced Therefore, when these “bells and whistles” apply is very important. May 16, 2014 25 Maile Gradison Hermida Associate Hogan Lovells US LLP Segment 2:
  • 26. When Third-Party Certification Would be Required • Third-Party Certification would be required for: – MIC as determined by FDA • Foreign country’s regulatory system must be found to be “inadequate” • FDA has suggested such a determination will be infrequent – VQIP – (Narrow scope – specified in FSMA) • Same or similar requirements could affect: – FSVP/Domestic Supplier Verification – Consultative audits – (Potentially very broad scope) May 16, 2014 26 Maile Gradison Hermida Associate Hogan Lovells US LLP Segment 2:
  • 27. Key Terms • Accreditation Body: – The authority recognized by FDA to accredit/audit certification bodies. – Government or private organization • Auditor/certification body: – The body accredited to inspect foreign eligible entities. – Means the same as “third-party auditors” in FSMA – Used interchangeably in this presentation • Eligible Entity: – Foreign facility that elects to be audited – Facility has the same meaning as under Bioterrorism Act May 16, 2014 27 Maile Gradison Hermida Associate Hogan Lovells US LLP Segment 2:
  • 28. Key Terms • Food Safety Audit: – Regulatory Audit • Audit to determine whether eligible entity complies with FDA regulations • Used to determine whether food can be certified for import to U.S. – Consultative Audit • Audit to evaluate compliance with FDA requirements and industry standards • For internal purposes only – but would still trigger proposed reporting requirements of serious health risks and potentially of all sample testing results May 16, 2014 28 Maile Gradison Hermida Associate Hogan Lovells US LLP Segment 2:
  • 29. Accreditation Body: Proposed Requirements • Must be recognized by FDA • Authority to accredit certification bodies • Conduct annual assessment of accredited bodies • Must maintain records for 5 years • FDA recognition would last 5 years • FDA could revoke recognition for cause May 16, 2014 29 Maile Gradison Hermida Associate Hogan Lovells US LLP Segment 2:
  • 30. Auditor/Certification Body: Accreditation • Accredited by recognized accreditation body • Accreditation would last 4 years • FDA would retain authority to directly withdraw accreditation for cause May 16, 2014 30 Maile Gradison Hermida Associate Hogan Lovells US LLP Segment 2:
  • 31. Certification Process • Auditor/Certification body issues certification based on satisfactory regulatory audit • Certifications would last 12 months May 16, 2014 31 Maile Gradison Hermida Associate Hogan Lovells US LLP Segment 2:
  • 32. Food Safety Audits • In general – Records review and on-site inspection components • Inspection of facility, processes, and food products – On-site inspection conducted unannounced within a 30-day window identified by eligible entity – Records review can be pre-scheduled – Sampling • Environmental or product sampling as appropriate • Must use accredited lab for analyzing samples • FSMA requires accredited labs to report sample results to FDA in specified circumstances – Audits must be documented in audit reports May 16, 2014 32 Maile Gradison Hermida Associate Hogan Lovells US LLP Segment 2:
  • 33. Food Safety Audits • Regulatory Audits – To determine compliance with FDA regulations for purposes of certification – Copies of reports sent to certifier’s accreditation body – Audit report must be sent to FDA within 45 days – Serious findings (Class I or II) reported to FDA “immediately” – Certain lab tests to accredited labs and send to FDA – Audits unannounced May 16, 2014 33 Maile Gradison Hermida Associate Hogan Lovells US LLP Segment 2:
  • 34. Food Safety Audits (Recap) • Reporting Obligations for Certification Body – Regulatory Audits (MIC and VQIP): • Auditor must submit written audit report to FDA within 45 days • Auditor would be required to immediately report Class I or Class II recall risk-level conditions to FDA • All lab results would be reported to FDA by the accredited lab – Consultative audit reports would not be automatically filed with FDA, but: • Auditor would be required to immediately report Class I or Class II recall risk-level conditions to FDA • All lab results may be reported to FDA by the accredited lab • FDA would have access to consultative audit reports under its emergency records access authority under the Bioterrorism Act May 16, 2014 34 Maile Gradison Hermida Associate Hogan Lovells US LLP Segment 2:
  • 35. False Statements to Auditors • False statements to auditors could be prosecuted criminally – Not addressed in proposed rule, but FSMA section 303(b) provides that any false statement by a foreign entity under the scope of an audit by a accredited third-party auditor could be prosecuted criminally as if it were a false statement to FDA – Based on the proposed rule, this liability would seemingly apply to regulatory and consultative audits May 16, 2014 35 Maile Gradison Hermida Associate Hogan Lovells US LLP Segment 2:
  • 36. Potential Impact on Related Programs: FSVP • FSVP – FDA solicited comment on whether to require adherence to third-party audit rules whenever an accredited auditor is chosen to conduct the on-site FSVP audit – FDA has suggested it might make use of accredited auditors mandatory for FSVP third party audit purposes – Would significantly expand scope of accredited audits – Could make third-party certification a “surrogate” FDA inspection program NOTE: FDA has since stated that these “bells and whistles” will not be applicable to FSVP audits May 16, 2014 36 Maile Gradison Hermida Associate Hogan Lovells US LLP Segment 2:
  • 37. Potential Impact on Related Programs: Consultative Audits • Consultative Audits – The proposed rule would subject consultative audits to significant reporting requirements • Class I and II recall risk level conditions • Potentially all laboratory testing results – Consultative audits are often undertaken to help a company improve its operations – Could stifle use of consultative audits or FDA-approved auditors – Could result in split between accredited and non-accredited auditors Note: Significant issue for public comment to the FDA May 16, 2014 37 Maile Gradison Hermida Associate Hogan Lovells US LLP Segment 2:
  • 38. Scope of FDA Reporting Requirement • Statute says auditors must immediately report to the FDA any “serious risk to public health” • FDA says this is broader than “Class I” and also includes “Class II” –level risks • Counter argument is: – “serious risk” = Class I – “risk to public health” = RFR standard, which exempts products still under the control of the manufacturer because consumers are not at risk – i.e., no public health concern Therefore, industry argued for Class I/RFR standard May 16, 2014 38 Maile Gradison Hermida Associate Hogan Lovells US LLP Segment 2:
  • 39. Key Issues in Public Comments • FDA reporting requirements (“bells and whistles”) should only apply to statutory programs – MIC and VQIP – and not apply to voluntary use of third parties under FSVP • Immediate reporting under “serious risk to public health” should only apply to “Class I-level risks” as incorporated into RFR paradigm – i.e., no reporting if still under manufacturer control • Reporting to FDA should not apply to consultative audits, as not required by FSMA and would discourage use of FDA-approved auditors for those purposes May 16, 2014 39 Maile Gradison Hermida Associate Hogan Lovells US LLP Segment 2:
  • 40. Conclusions • FDA does need added control over imported food • The third-party accreditation rule should not have a direct impact on most food manufacturers (outside of those participating in VQIP)—if FDA sticks to the statute • The proposed rule suggested that FDA considered expanding beyond the statute for FSVP, but they seem to have backtracked during the comment period • Comments from the food industry reinforced this point May 16, 2014 40 Maile Gradison Hermida Associate Hogan Lovells US LLP Segment 2:
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  • 42. May 16, 2014 42 PRIVATE LABEL PROGRAM & INTERNAL TRAINING The Knowledge Group provides complete private label webcasts and in-house training solutions. Developing and executing webcasts can be a huge logistical nightmare. There are a lot of moving parts and devolving a program that is executed smoothly and cost effectively can prove to be a significant challenge for companies who do not produce events on a regular basis. Live events require a high level of proficiency in order to execute proficiently. Our producers will plan and develop your webcast for you and our webcast technicians will execute your live event with expert precision. We have produced over 1000 live webcasts. Put our vast expertise to work for you. Let us develop a professional webcast for your firm that will impress all your clients and internal stakeholders. Private Label Programs Include:  Complete Project Management  Topic Development  Recruitment of Speakers (Or you can use your own)  Marketing Material Design  PR Campaign  Marketing Campaign  Event Webpage Design  Slides: Design and Content Development  Speaker coordination: Arranging & Executing Calls, Coordinating Slides & Content  Attendee Registration  Complete LIVE Event Management for Speaker and Attendees including: o Technical Support o Event Moderator o Running the Live event (All Aspects) o Multiple Technical Back-ups & Redundancies to Ensure a Perfect Live Event o Webcast Recording (MP3 Audio & MP4 Video) o Post Webcast Performance Survey  CLE and CPE Processing Private Label Programs Start at just $999
  • 43. May 16, 2014 43 RESEARCH & BUSINESS PROCESS OUTSOURCING The Knowledge Group specializes in highly focused and intelligent market and topic research. Outsource your research projects and business processes to our team of experts. Normally we can run programs for less than 50% of what it would cost you to do it in-house. Here are some ideal uses for our services:  Market Research and Production o List Research (Prospects, Clients, Market Evaluation, Sales Lists, Surveys) o Design of Electronic Marketing Collateral o Executing Online Marketing Campaigns (Direct Email, PR Campaigns) o Website Design o Social Media  Analysis & Research o Research Companies & Produce Reports o Research for Cases o Specialized Research Projects  eSales (Electronic Inside Sales – Email and Online) o Sales Leads Development o eSales Campaigns  Inside Sales people will prospect for leased, contact them and coordinate with your sales team to follow up.  Our Inside eSales reps specialize in developing leads for big-ticket enterprise level products and services. o Electronic Database Building – Comprehensive service which includes development of sales leads, contacting clients, scoring leads, adding notes and transferring the entire data set to you for your internal sales reps.  eCustomer Service (Electronic Inside Sales – Email and Online) o Real-Time Customer Service for Your clients  Online Chat  Email o Follow-Up Customer Service  Responds to emails  Conducts Research  Replies Back to Your Customer Please note these are just a few ways our experts can help with your Business Process Outsourcing needs. If you have a project not specifically listed above please contact us to see if we can help.
  • 44. ► You may ask a question at anytime throughout the presentation today. Simply click on the question mark icon located on the floating tool bar on the bottom right side of your screen. Type your question in the box that appears and click send. ► Questions will be answered in the order they are received. Q&A: May 16, 2014 44 Leslie T. Krasny Partner Keller and Heckman LLP Segment 1: Maile Gradison Hermida Associate Hogan Lovells US LLP Segment 2:
  • 45. May 16, 2014 45 Welcome to the Knowledge Group Unlimited Subscription Programs. We have Two Options Available for You: FREE UNLIMITED: This program is free of charge with no further costs or obligations. It includes:  Unlimited access to over 15,000 pages of course material from all Knowledge Group Webcasts.  Subscribers to this program can download any slides, white papers, or supplemental material covered during all live webcasts.  50% discount for purchase of all Live webcasts and downloaded recordings. PAID UNLIMITED: Our most comprehensive and cost-effective plan, for a one-time fee:  Access to all LIVE Webcasts (Normally $199 to $349 for each event without a subscription). Including: Bring-a-Friend – Invite a client or associate outside your firm to attend for FREE. Sign up for as many webcasts as you wish.  Access to all of Recorded/Archived Events & Course Material includes 1,500+ hours of audio material (Normally $299 for each event without a subscription).  Free CLE/CPE/CE Processing3 (Normally $49 Per Course without a subscription).  Access to over 15,000 pages of course material from Knowledge Group Webcasts.  Ability to invite a guest of your choice to attend any live webcast Free of charge. (Exclusive benefit only available for PAID UNLIMITED subscribers.)  6 Month Subscription is $299 with No Additional Fees. Other options are available.  Special Offer: Sign up today and add 2 of your colleagues to your plan for free. Check the “Triple Play” box on the sign- up sheet contained in the link below. https://gkc.memberclicks.net/index.php?option=com_mc&view=mc&mcid=form_157964
  • 46. May 16, 2014 46 Knowledge Group UNLIMITED PAID Subscription Programs Pricing: Individual Subscription Fees: (2 Options) Semi-Annual: $299 one-time fee for a 6 month subscription with unlimited access to all webcasts, recordings, and materials. Annual: $499 one-time fee for a 12 month unlimited subscription with unlimited access to all webcasts, recordings, and materials. Group plans are available. See the registration form for details. Best ways to sign up: 1. Fill out the sign up form attached to the post conference survey email. 2. Sign up online by clicking the link contained in the post conference survey email. 3. Click the link below or the one we just posted in the chat window to the right. https://gkc.memberclicks.net/index.php?option=com_mc&view=mc&mcid=form_157964 Discounts: Enroll today and you will be eligible for the “Triple Play” program and 3% off if you pay by credit card. Also we will waive the $49 CLE/CPE processing fee for today’s conference. See the form attached to the post conference survey email for details. Questions: Send an email to: info@knowledgecongress.org with “Unlimited” in the subject.
  • 47. May 16, 2014 47 ABOUT THE KNOWLEDGE GROUP, LLC. The Knowledge Group, LLC is an organization that produces live webcasts which examine regulatory changes and their impacts across a variety of industries. “We bring together the world's leading authorities and industry participants through informative two-hour webcasts to study the impact of changing regulations.” If you would like to be informed of other upcoming events, please click here. Disclaimer: The Knowledge Group, LLC is producing this event for information purposes only. We do not intend to provide or offer business advice. The contents of this event are based upon the opinions of our speakers. The Knowledge Congress does not warrant their accuracy and completeness. The statements made by them are based on their independent opinions and does not necessarily reflect that of The Knowledge Congress' views. In no event shall The Knowledge Congress be liable to any person or business entity for any special, direct, indirect, punitive, incidental or consequential damages as a result of any information gathered from this webcast. Certain images and/or photos on this page are the copyrighted property of 123RF Limited, their Contributors or Licensed Partners and are being used with permission under license. These images and/or photos may not be copied or downloaded without permission from 123RF Limited