Data Driven Decision Making by Dr. Doom

By Barbara J. Masters, D.V.M.

When asked to visit an establishment to assess compliance, my first step is always to ask for data.  Establishment food safety data, laboratory results, regulatory data, audits…. What story is being told?  Is there a trend in the making?  Upward trend?  Downward trend?

It is important for establishments that are regulated by the Food Safety and Inspection Service (FSIS) to recognize that the Public Health Information System (PHIS) provides a tool for the Inspection Personnel to understand what (using data) is happening on a day to day basis at our facilities:

  • Lab data
  • HACCP compliance/non compliance
  • Sanitation compliance/non compliance.

In the past, FSIS relied on managers to generate “alerts” or flag data trends in the PHIS.  However, there is now enough data in PHIS that the system will “send” alerts to inspection program personnel when the data suggest a trend is developing at an establishment that warrants further review.

For example, the Agency focuses on data related to public health NRs for HACCP and sanitation non-compliances.  The Agency has indicated that for 2015, the “cut point” for public health NRs in processing establishments will be 6.55% and in combination (or pure slaughter) establishments, it will be 9.37%.  Establishments that experience higher noncompliance rates than these can expect that the inspection personnel will receive “alerts” within PHIS indicating the need for additional verification.

FSIS also is using the PHIS data to schedule Food Safety Assessments and Hazard Analysis Verification tasks.

As FSIS supervisors are “looking into the system” and gaining a better understanding of what is happening at establishments based on our data, are we doing the same?

  • Are we reviewing our own data?
  • Do we track trends and take actions based on the findings?
  • Have we signed up for PHIS-industry access?
    • A report for public health NRs will be available beginning November 16th.
  • Do we know where we are relative to the FSIS “cut points” for public health NRs?
    • What is our HACCP compliance rate?
    • SSOP compliance rate?
      • If we have had failures, have they been for a specific area, e.g., failing to maintain records?
      • Do we have similar findings in our own data?

I encourage you not only to maintain the necessary records, but to review them and use the data to improve your processes.  The only thing worse than having information and not using it, is having the regulatory agency use it “for” you.

About “Dr. Doom”

Mixed in with the attorneys at OFW Law is the former USDA Food Safety Inspection Service’s (FSIS) Administrator, Dr. Barbara Masters.  Dr. Masters is a veterinarian who spent eighteen years with FSIS – the final three years as Acting Administrator and Administrator.  During her rise to the Administrator’s position, Dr. Masters served as the Deputy Assistant Administrator for Office of Field Operations.  While in these key leadership positions at FSIS, Dr. Masters’ primary focus was on the implementation of science-based policies for the protection of public health.  Dr. Masters issued the initial Federal Register Notices for a systematic approach to humane treatment of livestock and poultry.

Dr. Masters was involved in the drafting of the training of inspection personnel on the Hazard analysis and critical control points (HACCP) and Sanitation Standard Operating Procedures (SSOP) regulations.  She was the lead of the FSIS HACCP Hotline.  In addition, Dr. Masters provided technical review for establishment’s hazard analysis, HACCP plans and supporting documentation.  She started her career at FSIS as a public health veterinarian that had responsibilities for ante-mortem inspection, sanitation inspection and all post-mortem inspection responsibilities.  She has a good understanding of what happens at the in-plant location, because she has spent many of long days working there.

John Block Reports: Dietary Guidelines for Americans 2015 Edition – Losing It’s Way on Caffeine (Part 1)

This week, OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block

There are a variety of disturbing questions surrounding the Dietary Guidelines for Americans now being drafted for release in 2015. The questions relate to whether the Dietary Guidelines Advisory Committee should focus its review and recommendations on scientific advances in nutrition and diet, or should they venture into policy and political issues? One topic that the Advisory Committee has been discussing is what they have called “high dose caffeine” products.

USDA and HHS have jointly published the Dietary Guidelines for Americans every five years since 1980. In 1990, Congress mandated the Guidelines concluding that they “shall contain nutritional and dietary information and guidelines for the general public.” Congress went on to say that the Guidelines “shall be based on the preponderance of scientific and medical knowledge…current at the time of the report.”

Despite these clear instructions and limitations, the 2015 Dietary Guidelines Advisory Committee is looking to expand its scope and recommendations by addressing caffeine consumption. As a part of that conversation, the Committee has arbitrarily categorized energy drinks – and only energy drinks – as ‘high dose caffeine products’ despite the fact that many commercial coffee products contain the same – and often more – caffeine than most energy drinks. Further, neither the Advisory Committee nor FDA have established an acceptable, daily intake limit for caffeine.

When we consider the fact that caffeine has been safely consumed for hundreds of years and that 90 percent of caffeine in the American diet continues to come from coffee, tea, and caffeinated soft drinks like colas, the creation of the undefined category “high dose” caffeine products is even more puzzling. Energy drinks contribute only 2 percent of total dietary caffeine intake. The leading brands are labeled with total caffeine content and contain approximately the same amount of caffeine as home brewed coffee. The Advisory Committee, working with FDA, should consider all caffeinated products equally. The fact is, the caffeine in energy drinks is not different from the caffeine in coffee or tea. A more sensible approach would be for ALL products, including coffee and colas, to disclose their caffeine content as well as establishing a recommended dietary intake limit for daily caffeine consumption. Demonizing energy drinks under the guise of safe caffeine consumption is not an appropriate function for the Advisory Committee.

The Dietary Guidelines should be a practical and achievable set of recommendations based on balance, variety, and moderation. The process should not become a political circus where certain interest groups seek to impose their agenda without the sound scientific basis required by Congress.

How to Legally Import and Market Foods and Beverages in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP

October 29, 2014, 1:00 p.m. EST

During this webinar, attendees will learn about the regulatory requirements necessary to successfully and legally import and market foods and beverages in the U.S. and Canada. Topics for each country will include, among others:

  • A general understanding of the regulatory framework for foods and beverages, including the distinction between foods and natural health products in Canada
  • Agencies responsible for regulating foods and beverages
  • Requirements for food and beverage imports
  • A general introduction to labeling and promotional requirements and restrictions
  • Enforcement and food safety compliance including an overview of the status of the U.S. Food Safety and Modernization Act and the Safe Food for Canadians Act, and managing a food recall.

The webinar will be approximately 40 minutes long with a Q and A session at the end. There is no cost to attend this webinar, but space is limited.

To register for the webinar, please go to http://www.cvent.com/d/14qf66.

About the presenters:

Bob Hahn is a principal at Olsson Frank Weeda Terman Matz PC in Washington, DC. He advises companies and trade associations on compliance with the Federal Food, Drug, and Cosmetic Act and Food and Drug Administration (FDA) regulatory requirements for foods and beverages, including product formulation, food safety, food defense, food labeling and advertising, import/export of food, and handling of inspections, recalls, and enforcement actions. Bob’s clients include all levels of the food production and distribution chain, including manufacturers, processors, packers, distributors, and retailers, as well as industry trade associations. He regularly speaks and writes on FDA food regulatory matters.

Sara Zborovski is a partner in Davis LLP’s Toronto office and is head of the firm’s Food and Beverage Group. Sara assists companies in navigating the regulatory landscape imposed by the Food and Drugs Act and its related regulations. She advocates before all branches of Health Canada on behalf of, among others, the food and beverage industry. Sara works with clients to get products from idea to market, providing strategic advice on approval and marketing strategies. She also works with clients in matters relating to product safety, including Health Canada inspections and enforcement, crisis management and product recalls. Sara is a regular contributor to a number of food and beverage industry publications and conferences and is an active blogger on food safety and other regulatory matters (www.thefoodlawyer.ca).

Ask Not for Whom the Bell Tolls, it Tolls for Your LDT (Part 1)

By Evan P. Phelps

On October 3 of this year, the Food and Drug Administration (FDA) published draft guidance documents that, when finalized, will mark a “game changer” for clinical laboratories. Specifically, these guidances call for the active regulation of a subset of in vitro diagnostic devices known as Laboratory Developed Tests (LDTs) and the firms that produce them. As a result, clinical laboratories that have developed and use their own clinical diagnostic tests in-house will find themselves regulated by FDA as medical device manufacturers and their LDTs as medical devices. This is the first of a multipart series of posts that will sketch out FDA’s plans for the regulation of LDTs and what they will require of clinical laboratories in the future.

The draft guidance documents may be found here: Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Oversight of Laboratory Developed Tests (LDTs); and here Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs).

Traditionally, most LDTs have not been actively regulated by FDA although FDA has repeatedly asserted its authority to do so. With the lack of such regulatory oversight, there has been the opportunity for much innovation in the field. However, in view of such innovation and the related growth in complexity of tests, the agency has come to believe that their active regulation and involvement in the field is now necessary to protect the public health.

The agency intends to apply varying levels of regulatory controls to LDTs based on the risk associated with the tests. In the guidances, the agency outlines various risk-based categories of LDTs and the regulatory controls it will apply to each group.

In the series of postings that are to follow, we will provide an overview of these various groups and the regulatory controls that the agency will impose upon them. In this posting, we begin by describing the notification and adverse event reporting requirements.

Notification and adverse event reporting will be required of all but a select few LDTs. Those that will not be required to comply with these, or any other planned LDT requirements are those laboratories that produce LDTs used exclusively for law enforcement purposes (forensic use) and those used in CLIA-certified, high-complexity histocompatibility laboratories for transplantation. FDA indicated that it intends not to impose any requirements on the limited number of LDTs that fall into these categories. Instead, the agency indicates that it will continue to exercise enforcement discretion for these tests. All remaining laboratories producing LDTs for clinical use that do not fall into either of these categories will be required, at a bare minimum, to comply with the notification and adverse event reporting requirements.

NOTIFICATION

Laboratories that produce LDTs that are for clinical use will be required to notify FDA that they are producing LDTs and provide additional information regarding each of their tests to the agency. This option is being offered as an alternative to compliance with FDA’s Establishment Registration and Device Listing requirements found in 21 C.F.R. Part 807 that otherwise apply to medical device manufacturers. Notification will be required prior to the introduction of a new LDT for clinical use by the laboratory and when the laboratory significantly modifies one of its existing LDTs. Once the final version of the guidance document has been published, these labs must, within six months, provide information on its existing LDTs to FDA and continue to comply with these requirements for new and significantly modified existing LDTs on an ongoing basis. Laboratories have the option to opt out of the notification requirement. However, those that do will be required to comply with the Establishment Registration and Device Listing requirements applicable to other device manufacturers. Among other things, this process requires payment of a registration fee which, for the Fiscal Year 2015, will be $3,646.

MEDICAL DEVICE REPORTING

In addition, FDA will require these laboratories to comply with its Medical Device Reporting (MDR) regulation (21 C.F.R. Part 803) beginning six months after the date the final guidance is published by FDA. The MDR regulation requires manufacturers (laboratories in this case) to submit reports to FDA whenever they become aware of information that reasonably suggests that a device they market (use) may have caused or contributed to a death or serious injury or has malfunctioned in a way that would be likely to cause or contribute to a death or serious injury should the malfunction recur in the future. What the guidances do not reveal are the underlying requirements that are necessary to establish a compliant MDR reporting system nor does the guidance shed any light on the historical fact that that many established medical device companies have had difficulties in establishing and maintaining compliant MDR reporting systems leading to enforcement actions being directed against them by FDA.

Among other things, establishing a compliant MDR reporting system requires manufacturers to develop, maintain, and implement written procedures that provide for the timely and effective identification, communication, and evaluation of events that may be MDR reportable. These procedures must also provide for a standardized review procedure for determining when an event meets the criteria for reporting as an MDR and, in the case that it does, the procedures must also ensure the “timely” transmission of any MDR report to the agency. Moreover, such procedures also include documentation and recordkeeping requirements for information that was evaluated to determine if an event was reportable as well as the reports themselves and other information submitted to FDA. One should note that the regulation requires that such records be available for inspection by FDA upon request. See 21 C.F.R. § 803.17.

There are even requirements for the information that must appear in and be maintained in a firm’s MDR event files. Among other things, these files are required to contain all information in your possession (or references thereto) related to the adverse event, including all documentation of the company’s decision making processes used to determine if an event was or was not reportable as an MDR. In addition, there are FDA requirements that affect where these files must be maintained and how long they must be retained and kept accessible by FDA. See 21 C.F.R. § 803.18.

CONCLUSION

Unquestionably, these minimum requirements that will apply to virtually all LDTs intended for clinical use will create significant regulatory challenges that will be novel to the laboratories that produce them. Fortunately for the affected laboratories, there are a few organizations that possess the regulatory expertise to assist them in meeting these challenges if one knows where to look.

In the second part of these series of postings, we will give an overview of the additional levels of regulatory oversight in the works, on whom they will be imposed, and when FDA plans to do so.

FDA To Hold Public Meeting on FSMA Supplemental Proposed Rules

By Robert A. Hahn

The Food and Drug Administration (FDA) has announced a public meeting to be held on November 13, 2014 to discuss its four supplemental proposed rules under the Food Safety Modernization Act (FSMA). On September 29, FDA published supplemental proposed rules for four of its “foundational” FSMA rulemakings:

  • Produce Safety
  • Preventive Controls for Human Food
  • Preventive Controls for Animal Food
  • Foreign Supplier Verification Programs

See our October 10th blog post on the supplemental proposed rules here.

Given the significant changes being proposed, a public meeting seems appropriate.  FDA officials have stated the agency may also schedule some listening sessions around the country during the comment period, which ends December 15, 2014, but these have not been announced yet.

The stated purpose of the meeting is to inform the public of the proposed changes and the rulemaking process, to respond to questions about the supplemental proposed rules, and to hear oral comments.  The public meeting is to discuss the supplemental proposed rules only.

The meeting will be held at the Food and Drug Administration’s Wiley Building, 5100 Paint Branch Parkway, College Park, MD 20740 on November 13, 2014 from 8:30 am to 5:00 pm. Early registration is recommended because of limited seating. The meeting also will be webcast live for those unable to attend in person.  Information about how to register to attend in person or via webcast, how to request a time slot to make an oral presentation, and other details can be found here.  Requests to make oral presentations must be submitted by October 27th.

A transcript of the meeting will become part of the administrative records in the four rulemakings.  The transcript and a video recording of the meeting will be made available on FDA’s FSMA website and at http://www.regulations.gov.

Settlement Agreement Reached on GRAS Notification Program Final Rule

By Mark L. Itzkoff

On October 20, 2014, FDA and the consumer group called the Center for Food Safety (CFS) filed a consent decree in the U.S. District Court for the District of Columbia that requires FDA to promulgate a final rule regarding the GRAS Notification (GRASN) Program by August 31, 2016.  The decree resolves a lawsuit by CFS filed last February seeking to invalidate FDA’s GRAS Notification Program.  (See our report on the lawsuit here.)

In the lawsuit, CFS noted that FDA has operated the GRASN Program for over 15 years under the provisions of a proposed rule published in 1997.  CFS asked the court to vacate the proposed rule and reinstate the GRAS Affirmation Petition process that had been used prior to the proposed rule.  FDA and CFS have now agreed to settle the lawsuit.  Under the provisions of the consent decree, FDA is required to submit for publication a final rule on “Substances Generally Recognized to be Safe” by August 31, 2016.  In addition, FDA agrees to commit the necessary resources to meet the deadline.  The decree also provides a process for extending the deadline if the agency is unable to issue the final rule “despite [its] best efforts.”

The consent decree appears to be a significant victory for the current GRASN Program.  The agency had previously announced its intent to finalize the proposed rule in 2015, so the deadline imposed by the decree will only reinforce FDA’s current schedule.  Further, the decree does not require any changes to the current GRASN Program and would not invalidate the current program even if FDA fails to meet the new deadline.  In other words, FDA will continue to operate the program as it has since 1998 and will issue a final rule on the program as it already intended to do.  We will be following FDA’s progress on the final rule and will report new developments in this blog.

FDA Tweaks Its Four Foundational FSMA Proposed Rules 1

By Robert Hahn

FDA has published supplemental proposed rules for the four “foundational” rules that will implement the Food Safety Modernization Act (FSMA).  Those four rules are:

  1. Produce Safety;
  2. Preventive Controls for Human Food;
  3. Preventive Controls for Animal Food; and
  4. Foreign Supplier Verification Programs (FSVP).

Comments on the supplemental proposed rules are due December 15, 2014.

The “Supplementals” respond to many of the strongest criticisms of the proposed rules, including:

  • Criticism that the proposed rule on Preventive Controls for Human Food would cause many farms to have to comply with both that rule and the Produce Safety rule;
  • Criticism of the agricultural water standards in the Produce Safety rule as unrealistic and not scientifically based;
  • Criticism that it would be unfair to require product testing, environmental monitoring, and supplier verification in the final rules on Preventive Controls for Human Food and Preventive Controls for Animal Food without first offering specific regulatory language for public comment; and
  • Criticism that FDA access to audit reports required in the Preventive Controls for Human Food and FSVP rules would discourage free communication between third-party auditors and audited facility personnel.

FDA officials are claiming that the Supplementals would increase the flexibility of the proposed rules and reduce the burden of compliance.  While that is true for the most part, the Supplementals would also increase the burden on industry in some respects.  Some examples of that increased burden include:

  • The aforementioned addition of product testing, environmental monitoring, and supplier verification (and new recordkeeping requirements associated with those new measures) in the two preventive controls rules;
  • The added requirement that importers perform a broad risk evaluation (and associated recordkeeping) in the FSVP rule; and
  • The added requirement that the hazard analysis performed by facilities under the preventive controls rules and by importers under the FSVP rule consider the potential for economically motivated adulteration.

Another concern is the use of somewhat vague or subjective standards that will require further elucidation in guidance and inevitably leave much discretion to FDA field inspectors.  Examples of this include:

  • The two preventive controls rules would require product testing as a verification measure, when appropriate, based on the facility, the food, and the nature of the preventive control.
  • The preventive controls rules and the FSVP rule would permit use of supplier verification activities other than annual onsite audits for hazards that present a threat of serious adverse health consequences or death to humans or animals (SAHCODHA) if the facility or importer documents its determination that such other verification activities are adequate to ensure safety. Under what circumstances would such a determination be reasonable?
  • Under the preventive controls rules and the FSVP rule, facilities and importers would be required to consider economically motivated adulteration in their hazard analyses when that type of adulteration is reasonably foreseeable. Although FDA offers some discussion of when economically motivated adulteration should be considered reasonably foreseeable, there are certainly to be many instances where this is likely to be a close call.

Below we provide what we hope is a handy summary of the major changes to the four proposed rules that would be made by the Supplementals.

Produce Safety

  • Changes the scope of farms subject to the Produce Safety Rule:
    • The definition of “farm” would be expanded to include farms that engage in certain additional activities (g., packing raw agricultural commodities (RACs) grown on other farms not under the same ownership, drying/dehydrating RACs to create a distinct commodity where such drying is akin to harvesting).
    • Farms and farm mixed-type facilities with average annual sales of produce (not all food) of $25,000 or less during the previous 3-year period would be exempt.
  • Revises the water quality standard and water testing frequency:
    • Quantitative microbial quality standards consistent with the Environmental Protection Agency’s (EPA) 2012 recreational water quality criteria (RWQC) would be adopted.
    • Farms would be able to meet the new standards by alternative means (g., allowing a sufficient time interval between last irrigation and harvesting to allow for microbial die-off using a specified die-off rate, allowing a sufficient time interval between last irrigation and end of storage to allow for microbial die-off).
    • Different frequencies for water testing would be established based on the source and use of the water.
  • Revises the interval between application of biological soil amendments and harvesting:
    • The proposed 9-month interval for untreated manure would be withdrawn, to be replaced by a to-be-decided interval after FDA conducts additional research and a risk assessment.
    • The proposed 45-day interval for composted manure has been eliminated as unnecessary.
    • FDA states that it does not intend to object, for the time being, to farmers that comply with the intervals specified for organic crops in the National Organic Program regulations.
  • Clarifies that the Produce Safety Rule does not require farms to engage in “taking” of threatened or endangered species, destroy wild animal habitat, or clear borders around outdoor growing areas or drainages.
  • Establishes withdrawal and reinstatement procedures for the exemption for “qualified facilities.”

Preventive Controls for Human Food

  • Expands exemptions from preventive controls:
    • The definition of “farm” would be expanded to encompass farms that engage in certain additional activities (consistent with the Produce Safety Rule change discussed above).
    • The exemption for facilities solely engaged in the storage of RACs, other than fruits and vegetables, for further distribution or processing would be expanded to encompass storage facilities that engage in activities incidental to the storage of food (g., fumigation, blending lots of the same RAC, grading).
    • The exemption for facilities solely engaged in the storage of packaged foods that are not exposed to the environment would be expanded to include storage facilities that also engage in activities incidental to the storage of food (g., affixing tracking labels, breaking down pallets, assembling variety packs).
    • “Very small business” would be defined to mean businesses with annual sales of human food of less than $1 million.
  • Expands exclusions from current good manufacturing practice (CGMP) to include:
    • Farms (using the expanded definition of “farm” discussed above);
    • Activities of farm mixed-type facilities that fall within the definition of “farm”:
    • Holding or transportation of RACs;
    • Hulling, shelling, and drying of nuts (but not roasting, which constitutes “manufacturing/processing”); and
    • Fishing vessels that are not required to register with FDA.
  • Expands the hazard analysis requirement:
    • A covered facility’s hazard analysis would be required to consider the risk of economically motivated adulteration where there is a past history of such adulteration involving that food.
    • A covered facility’s hazard analysis would be required to consider environmental pathogens where a ready-to-eat (RTE) food is exposed to the environment prior to packaging and the packaged food does not receive a treatment that would significantly minimize the environmental pathogen.
  • Adds supplier controls as a new preventive control:
    • Receiving facilities would be required to implement supplier control programs for raw materials and ingredients for which they have identified a significant hazard that is controlled before the raw materials or ingredients reach the receiving facility.
    • “Receiving facility” would be defined as a facility subject to preventive controls that manufactures/processes raw materials or ingredients. Therefore, facilities that only pack or hold food (g., warehouses) would not be required to have supplier controls.
    • Supplier controls would not be required if the hazard is controlled by: (a) the receiving facility; or (b) the receiving facility’s customer (provided the receiving facility annually obtains from the customer written assurance that the customer follows procedures to control the hazard).
    • To verify their suppliers, receiving facilities may choose from four options: (a) onsite audits of suppliers; (b) sampling/testing of raw materials and ingredients; (c) review of suppliers’ food safety records; and/or (d) other appropriate verification activities.
      • However, if there is a reasonable probability that the hazard in a raw material or ingredient would cause serious adverse health consequences or death to humans, the receiving facility must conduct annual onsite audits of the supplier, unless it can document that other verification activities or less frequent audits provide adequate assurance that the hazard is controlled.
      • Alternative verification requirements would apply to “qualified facilities” and farms that are not subject to the Produce Safety Rule.
    • In lieu of onsite audits of a supplier, a receiving facility may rely on inspections by FDA or a foreign food safety authority of a country whose food safety system FDA has officially recognized as comparable or equivalent to the U.S.
    • The receiving facility would be required to take action to address supplier nonconformance, but FDA would not mandate any particular action.
  • Adds requirement to conduct product testing and environmental monitoring, under certain circumstances, to verify the implementation and effectiveness of a facility’s preventive controls:
    • Product testing would be required where a covered facility determines it is appropriate based on the facility, the food, and the nature of the preventive controls (which product testing would be used to verify).
    • Environmental monitoring would be required where an environmental pathogen is identified as a significant hazard in a RTE food that is exposed to the environment prior to packaging and does not receive a treatment that would significantly minimize the pathogen after packaging.
  • Adds new recordkeeping requirements, but clarifies that existing records may be used to satisfy all recordkeeping requirements.
  • Clarifies that human food facilities that ship byproducts for use in animal food are not subject to the Preventive Controls for Animal Food Rule, unless they engage in processing of the byproducts for use in animal food (g., drying, heat treatment).
  • Establishes procedures for withdrawal and reinstatement of exemption for “qualified facilities.”

Preventive Controls for Animal Food

Note: Some of these changes (e.g., requirements for product testing and environmental monitoring, supplier controls, and addressing economically motivated adulteration) are being proposed explicitly to garner public comments and will not necessarily be included in the rules when finalized.

  • Expands exemptions from preventive controls:
    • The definition of “farm” would be expanded to encompass farms that engage in certain additional activities (consistent with the Produce Safety Rule change discussed above).
    • The exemption for facilities solely engaged in the storage of RACs, other than fruits and vegetables, for further distribution or processing would be expanded to encompass storage facilities that engage in activities incidental to the storage of food (g., fumigation, blending lots of the same RAC, grading).
    • The exemption for facilities solely engaged in the storage of packaged foods that are not exposed to the environment would be expanded to include storage facilities that also engage in activities incidental to the storage of food (g., affixing tracking labels, breaking down pallets, assembling variety packs).
    • “Very small business” would be defined to mean businesses with annual sales of animal food of less than $2.5 million.
    • Human food facilities that provide byproducts used in animal food would be exempt, unless they further process such byproducts.
  • Adds requirement that a facility’s hazard analysis to consider the potential for economically motivated adulteration.
  • Adds supplier controls as a new preventive control:
    • Receiving facilities would be required to implement supplier control programs for raw materials and ingredients for which they have identified a significant hazard that is controlled before the raw materials or ingredients reach the receiving facility.
    • “Receiving facility” would be defined as a facility subject to preventive controls that manufactures/processes raw materials or ingredients. Therefore, facilities that only pack or hold food (g., warehouses) would not be required to have supplier controls.
    • Supplier controls would not be required if the hazard is controlled by: (a) the receiving facility; or (b) the receiving facility’s customer (provided the receiving facility annually obtains from the customer written assurance that the customer follows procedures to control the hazard).
    • To verify their suppliers, receiving facilities may choose from four options: (a) onsite audits of suppliers; (b) sampling/testing of raw materials and ingredients; (c) review of suppliers’ food safety records; and/or (d) other appropriate verification activities.
      • However, if there is a reasonable probability that the hazard in a raw material or ingredient would cause serious adverse health consequences or death to animals, the receiving facility must conduct annual onsite audits of the supplier, unless it can document that other verification activities or less frequent audits provide adequate assurance that the hazard is controlled.
      • Alternative verification requirements would apply to “qualified facilities” and farms that are not subject to the Produce Safety Rule.
    • In lieu of onsite audits of a supplier, a receiving facility may rely on inspections by FDA or a foreign food safety authority of a country whose food safety system FDA has officially recognized as comparable or equivalent to the U.S.
    • A receiving facility would be required to take action to address a supplier’s nonconformance, but FDA would not mandate any particular action.
  • Adds requirement to conduct product testing and environmental monitoring, under certain circumstances, to verify the implementation and effectiveness of a facility’s preventive controls:
    • Product testing would be required where a covered facility determines it is appropriate based on the facility, the animal food, and the nature of the preventive controls.
    • Environmental monitoring would be required where an environmental pathogen is identified as a significant hazard in a RTE animal food (g., dog and cat kibble) that is exposed to the environment prior to packaging and does not receive a treatment that would significantly minimize the pathogen after packaging.
  • Makes changes to proposed animal food CGMP:
    • The requirement that ill employees be excluded from working in animal food facilities would be deleted.
    • The requirement that raw material and ingredients must be free of microorganisms harmful to human or animal health, or be treated to eliminate them, would be deleted.
    • Facilities that hold animal food would be required to store them in a manner that prevents contamination from garbage or trash, and shipping containers and bulk vehicles used to distribute animal food would be required to be inspected prior to use.
  • FDA is also requesting comment regarding whether feed mills associated with fully vertically-integrated animal farming operations should be subject to CGMP and preventive controls. FDA is considering whether to subject fully vertically-integrated farming operations to the same regulatory requirements as vertically-integrated operations that provide feed to contract farmers.

Foreign Supplier Verification Programs

  • Expands the hazard analysis requirement, adding a new “risk evaluation”:
    • The requirement that importers conduct a compliance status review of each foreign supplier and imported food would be deleted, but that requirement would be folded into the new risk evaluation.
    • A new risk evaluation requirement would be added. The risk evaluation would be required to evaluate the hazard analysis, which entity is controlling identified hazards, the foreign supplier’s food safety procedures and practices, applicable FDA food safety regulations and the foreign supplier’s compliance with those regulations, the foreign supplier’s food safety performance history, and other appropriate factors (g., storage and transportation practices, recent changes in the management of the foreign supplier).
    • The importer’s hazard analysis would be required to consider the risk of economically motivated adulteration where there is a past history of such adulteration in that type of food from that country.
    • The importer’s hazard analysis would be required to consider environmental pathogens where an environmental pathogen is a significant hazard in a RTE food that is exposed to the environment prior to packaging and does not receive a treatment that would significantly minimize the pathogen after packaging.
  • Modifies the verification activities that importers must perform:
    • Importers generally would be able to choose from four options: (a) onsite audits of foreign suppliers; (b) sampling/testing of imported foods; (c) review of foreign suppliers’ food safety records; and/or (d) other appropriate verification activities.
      • However, if there is a reasonable probability that the hazard in an imported food would cause SAHCODHA, the importer must conduct annual onsite audits of the foreign supplier, unless it can document that other verification activities or less frequent audits provide adequate assurance that the hazard is controlled.
      • Alternative verification requirements would apply when the foreign supplier is a farm that is not subject to the Produce Safety Rule.
    • In lieu of onsite audits of a supplier, a receiving facility may rely on inspections by FDA or a foreign food safety authority of a country whose food safety system FDA has officially recognized as comparable or equivalent to the U.S.
    • Verification activities would not be required if: (a) preventive controls by the importer (under the Preventive Controls for Human Food Rule) are adequate to significantly minimize or prevent all significant hazards in the imported food; or (b) preventive controls by the importer’s customer (under the Preventive Controls for Human Food Rule) are adequate to significantly minimize or prevent all significant hazards in the imported food, and the importer annually obtains from its customer written assurance that it follows procedures to control such hazards.
    • A new requirement that the importer establish and follow written procedures to ensure that it imports food only from approved foreign suppliers would be added. However, importers would be permitted to import food from unapproved foreign suppliers when necessary on a temporary basis, provided the importer conducts adequate verification activities (g., sampling and testing individual shipments) before using or distributing such food.
    • The requirement that importers maintain a list of all of their foreign suppliers would be deleted.
  • Defines “very small importer” and “very small foreign supplier” to mean an importer or foreign supplier with less than $1 million in annual sales of human food. Modified requirements apply to very small importers and imports from very small foreign suppliers.
  • Clarifies that importers that are also facilities subject to one of the preventive controls rules, and that are in compliance with the supplier control requirements of the applicable preventive controls rule, are deemed to be in compliance with FSVP Rule, except that they must still identify the importer at time of entry.

How to Legally Import and Market Pharmaceuticals in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP

October 15, 2014, 1:00 p.m. EST

During this webinar, the second of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfully and legally import and market pharmaceuticals in the U.S. and Canada. Topics will include, among others:

  • Requirements for drug importation into the U.S. and Canada
  • Pharmaceutical market approval pathways in both countries
  • Pharmaceutical manufacturing controls in both countries
  • Pricing of brand and generic pharmaceuticals in Canada
  • Labeling and promotional requirements and restrictions for drugs in the U.S. and Canada
  • Post-market requirements in both countries including recordkeeping and adverse event reporting in the U.S.
  • Inspections and enforcement

The webinar will be approximately 40 minutes long with a Q and A session at the end. There is no cost to attend this webinar, but space is limited.

To register for the webinar, please visit www.cvent.com/d/14qf66.

To view or share this information as a PDF, please click here.

About the presenters:

Tish Pahl is a principal at the Washington, D.C.-based firm OFW Law where she has been practicing as a member of the firm’s Pharmaceutical Practice Group for nearly 20 years. In this capacity, she has counseled clients on the lawful marketing of their drugs, cosmetics, and dietary supplements under the Federal Food, Drug, and Cosmetic Act.  She has particular expertise in health care communications, advertising, labeling, and commercial distribution of products regulated by the U.S. Food and Drug Administration (FDA).  Tish frequently provides strategic advice to healthcare entrepreneurs and inventors on pathways into the U.S. market.  She has been a frequent speaker on numerous topics, including drug regulation, advertising and labeling compliance.

Sara Zborovski is a partner in Davis LLP’s Toronto office and is a member of firm’s Life Sciences and Intellectual Property Groups. Sara assists companies in navigating the regulatory landscape imposed by the Food and Drugs Act and its related regulations. She advocates before all branches of Health Canada on behalf of the pharmaceutical and biotech industries. Sara works with clients to get products from idea to market, providing advice on approval and marketing strategies and intellectual property issues. Sara has particular experience navigating Canada’s Patented Medicines (Notice of Compliance) Regulations (the equivalent of Hatch-Waxman litigation in the U.S.) and with the Federal Court review of regulatory decisions.  She also works with clients in matters relating to product safety, including Health Canada inspections and enforcement, crisis management and product recalls.

Consumers are Misled About Organic Safety

By John R. Block, as published in the Des Moines Register

Every day millions of shoppers are paying out as much as 50 or 100 percent more to buy organic foods for themselves and their families. I have friends who make these choices because they have no reason to question claims on labels, in advertising and on social media that organic foods are safer, healthier and more nutritious.

One thing they will not read on any label is a new finding from Academics Review, a group of scientists dedicated to testing popular claims against peer-reviewed science.

The scientists’ conclusion based on U.S. Food and Drug Administration (FDA) reported recall information: Organic foods are four to eight times more likely to be recalled than conventional foods for safety issues like bacterial contamination. Nor will consumers see anywhere a reference to the body of peer-reviewed research finding that organic foods are no more nutritious than foods produced by conventional agriculture.

Why are consumers so misinformed? This is not an unimportant problem. It’s dangerous. The very people most likely to seek out organic food for its purported safety — the elderly, pregnant women, parents of young children and people with compromised immune systems — are most at risk from organic’s higher risk of contaminants, including deadly e-coli.

As Academics Review founder Bruce Chassy, a professor of food microbiology at the University of Illinois, recently reported to a professional trade association, not only is the federal government failing to require that the organic food industry state these risks to consumers. It also allows organic companies to make unfounded safety claims that, if they were made by any other industry, would attract the ire of federal regulators.

Lacking such scrutiny, the organic industry appears to have adopted “black marketing” against conventionally grown foods as its core strategy. The Natural Marketing Institute admitted as much when it reported that “the safety message is a clear driver” of organic sales. A marketing executive for a major organic company was little blunter: “You can, and perhaps should, lead with fear as an industry.”

The industry does, in fact, lead with fear. The websites, social media, product packaging, marketing materials and annual reports of organic food companies are full of fear-based advertising against conventional farming. Even more hysterical claims about conventional foods are pushed in food scare campaigns run by NGOs funded by the organic foods industry, as well as by allied natural food and health companies.

In the midst of such claims, where do consumers turn for reliable information? They trust federal regulators to give them the straight scoop based on science. Yet even here, the federal government is passively complicit in allowing unscientific claims to mislead consumers. Exhibit A in federal complicity is the U.S. Department of Agriculture (USDA) certified Organic label.

USDA’s research shows that more than 70 percent of consumers are likely to believe a food is safer, more nutritious or of higher quality if it bears the organic label. In fact, all the label signifies is that a given food has been grown, handled and processed without many of the modern techniques of conventional agriculture.

The label does not even mean that a certain food was grown without pesticides. Organic foods are routinely produced with certain kinds of “organic” pesticides. Meanwhile, organic recalls due to bacterial contamination are ballooning along with the expanding market for organic food.

In short, the federal government is strict about science, labeling and claims for all industries except one. The marketers of organic food are allowed to make scientifically false and misleading claims about the safety and wholesomeness of conventional food, while their products are increasingly likely to be recalled for safety reasons.

Federal agencies have a statutory responsibility to crack down on untruthful and misleading claims in food marketing. They also have a responsibility to warn consumers about real dangers.

The findings by Academics Review raise a number of questions federal regulators should have to answer.

– Will the USDA, FDA and Federal Trade Commission enforce existing rules against misleading advertising when marketers misuse the organic label to vilify competitors?

– Will regulators regard the sponsored attacks on conventional agriculture as advertising, subject to standards of truth?

– Will the Centers for Disease Control and the Food and Drug Administration investigate what is behind the frighteningly high recall record of organic food?

– And will the government perform more research on the safety of organic foods?

This is no longer a matter of who wins at the checkout counter. For many vulnerable people, it is a matter of safety. They just don’t know it yet.

JOHN R. BLOCK was U.S. secretary of agriculture from 1981 to 1986. The lifelong farmer now is senior policy adviser to the law firm of Olsson Frank Weeda Terman Matz PC in Washington, D.C. Contact: jblock@ofwlaw.com.

What to Do After I Filed My Comment on FDA’s Proposed “Nutrition Facts” Labeling Regulations

Don’t sit back and wait: Be proactive!

By Bruce Silverglade

The comment period for FDA’s proposed regulations revising the “Nutrition Facts” label has closed.  The comment period has also closed for FDA’s proposed rule that would lead to more than 30 new serving sizes for foods.  This is a big deal because the nutrient content information that appears on the “Nutrition Facts” label must be listed for customarily consumed amounts determined by FDA.  So, new serving sizes will effectively dictate the amount of each nutrient for particular foods that will appear on the label.  Similarly, the Agency has proposed to redefine what a single serving package is, and to require that calories, fat, sodium, sugars and other nutrient amounts be listed for the entire package on the assumption that it will be consumed on a single eating occasion.  In brief, larger serving sizes mean labels will list larger amounts of nutrients that some consumers may wish to avoid.

Hundreds of companies and trade associations have filed comments with the Agency; some believe that filing is the end of the public participation process.  Nothing could be further from the truth. Filing a comment with FDA is the first, not the last, step in participating in the development of a final regulation.

The comments that have been filed are being analyzed by Agency staffers and summaries will be given to senior FDA policy makers in the Commissioner’s office.  Under the Administrative Procedure Act, FDA is required to review and respond to the comments and provide a “reasoned explanation,” in a preamble to any final regulation, explaining why the Agency agrees or disagrees with the views that have been expressed.

That may sum up the textbook description of the rulemaking process but, in reality, numerous other factors will influence FDA’s final regulations.  Concerned stakeholders should consider the following additional actions:

  • Review the comment record:  The comments already submitted to FDA on key provisions of the proposed regulations can provide a treasure trove of information.  By reviewing the comment record, interested parties can discern who may share their viewpoint, who is opposing, and why.  In some cases, stakeholders may be surprised at what they find.
  • Meet with FDA officials:  Agency officials will sometimes agree to meet and sometimes will not.  But the importance of face-to-face discussions with Agency decision makers cannot be overemphasized.  As in any business development situation, meeting personally with those in charge can be infinitely more valuable than communicating in writing.  Unlike business situations, FDA officials will place a short memorandum on the public record indicating that a meeting took place, but that legal requirement should not deter stakeholders from making efforts to reach out to the Agency.
  • Contact the White House Office of Information and Regulatory Affairs (OIRA):  OIRA is a department within the White House Office of Management and Budget.  OIRA plays a major role in reviewing regulations proposed by FDA and other agencies by conducting rigorous economic and public policy analyses before permitting proposed regulations to be finalized.  Contrary to conventional wisdom, OIRA has assumed a particularly strong role under the Obama Administration.  OIRA officials may agree to meet with stakeholders.  Meetings may be difficult to obtain, but should remain a key objective of concerned parties because OIRA, not FDA, may make the final determination about what the Agency’s rules actually require.
  • Urge OIRA to require FDA to follow proper procedures: OIRA signed off on a portion of FDA’s proposal requiring “added sugar” content to be disclosed on the “Nutrition Facts” label (total “sugars” are already required to be disclosed), but inexplicably failed to approve a research study the Agency wanted to conduct to determine how consumers would react to the new disclosure before the proposed regulation was published in the Federal Register.  OIRA finally approved the research planned by the Agency after the proposed rule was published, but clearly FDA should not proceed any further with its proposed rulemaking until the results are in, put out for public comment, and analyzed.  Despite the delay, OIRA retains authority to compel FDA to follow that sensible approach.
  • Meet with key Members of Congress: To maximize the chances of seeing final FDA regulations that comport with the recommendations in a company’s written comment, stakeholders should meet with key Members of Congress (or their senior staffers) to inform Hill offices about the issues at stake, the tentative position of the FDA, and your company’s concerns.  It is particularly effective to request meetings with Members of the House and Senate Committees that have jurisdiction over FDA’s annual appropriations, as well as leading Members from Congressional committees that have FDA oversight responsibilities. These Members of Congress have a particular interest in seeing that the Agency is on the right course and making decisions on the basis of sound public policy.  Ultimately, concerned parties may request that Members of Congress write the FDA, hold oversight hearings, or consider restrictions in FDA’s annual appropriations bill that require the Agency to act in a particular manner.

These advocacy measures are well known within the Washington Beltway, but are often overlooked by stakeholders who believe there is little they can do to affect FDA policy once a written comment is submitted.  Parties wishing to maximize their chances of achieving changes in FDA’s proposed rules before they are finalized should consider availing themselves of these additional steps that can, and almost certainly will, affect the final regulatory requirements they will have to comply with in the not so distant future.