Food Defense Plans

By Barbara J. Masters, D.V.M.

One of the goals of the Food Safety and Inspection Service’s Strategic Plan is to “ensure that facilities implement safeguards and systems to protect food from contamination by people who might try to intentionally and maliciously harm consumers.”  The Agency has a FY 2015 target of 90% of all establishments having a functional food defense plan. Since 2006, annual surveys have been conducted to measure progress.  The largest establishments currently exceed the goal (97% have a functional plan) while the very small establishments are not yet at the target.

The Food Safety Modernization Act (FSMA) requires the Food and Drug Administration (FDA) to implement measures to protect the food supply from intentional contamination.  A proposed rule to address hazards resulting from intentional contamination was issued on December 24, 2013.

Both FSIS and FDA have taken substantial measures to assist the food industry in the development of food defense plans.  The FSIS webpage includes a tool that an establishment can download to select the specific elements appropriate for their facility.  FDA maintains an on-line food defense plan builder free to all users.  Once a plan is documented, the establishment must implement the plan.  Steps to implementing a food defense plan include:

  • Testing the plan (e.g., check locked doors, take unannounced walks around the perimeter), and
  • Reviewing and maintaining the plan (review and update as needed).

Food defense plans should be tailored to the facility.  Small establishments do not need to make the plan overly burdensome.  For example, a plant that only employs family members would not need background checks on employees as a critical element.  However, this establishment could document the use of door locks and outdoor lighting at key locations in the facility.

Areas to be considered in a food defense plan are: outside security, inside security, personnel security measures and incident response security measures.

When I go visit any establishment, I am always asked to show my identification.  I am always escorted during the visit, and I see emergency plans posted at every facility.  These are all elements of a food defense program.  If these elements for secure food are already in place, it is logical that they could easily be documented and verified by the establishment.

I encourage those plants that are not currently maintaining a functional food defense plan to review the FSIS and FDA websites.  I challenge them to consider that they very likely already have all the elements in place for a food defense plan – the plan just needs to be documented.  By documenting the plan – the establishment is taking the necessary steps to ensure all team members are aware of the program and are taking steps to consistently implement it.

If by maintaining a functional food defense plan we can contribute to a safer and more secure food supply, then I am certain we are all in favor of meeting this objective.

FDA Provides Another Guidance Concerning FDA’s Use of Foreign Study Data

By Mason Weeda

FDA’s Center for Devices and Radiological Health (“CDRH”) and Center Biologics Evaluation and Research (“CBER”) recently published a new draft guidance entitled “Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States [(“OUS”)] (“Draft Guidance”) (available here). With this Draft Guidance, FDA aims to minimize the possibility for additional or duplicative U.S. studies, to harmonize global clinical trial standards, and to promote public health and innovation.

The Draft Guidance adds to a myriad of policies, statutory and regulatory provisions, and proposed rules on OUS studies, including:

  • FDCA § 569B (or 21 U.S.C. § 360bbb-8) which requires FDA to accept data from clinical investigations conducted OUS, in deciding whether to approve or clear a device. Pursuant to §569B, if FDA finds that such data are inadequate under applicable standards to support clearance or approval of the device, then FDA must provide the sponsor with written notice of the finding and FDA’s rationale.
  • 21 C.F.R. § 814.15 which provides that OUS clinical study data submitted in support of a Premarket Approval Application (“PMA”) and conducted under an Investigational Device Exemption (“IDE”) shall comply with Part 812. If an OUS study in support of a PMA is not conducted under an IDE, FDA will accept studies which have been conducted outside the United States and begun after November 18, 1986, “if the data are valid and the investigator has conducted the studies in conformance with the ‘Declaration of Helsinki’ or the laws and regulations of the country in which the research is conducted, whichever accords greater protection to the human subjects.” If relying on a study that started before November 19, 1986, FDA must be satisfied that “the data are scientifically valid and that the rights, safety, and welfare of human subjects have not been violated.” A PMA based solely on foreign clinical data and otherwise meeting the criteria for approval under this part may be approved if the foreign data are: “applicable to the U.S. population and U.S. medical practice;” “have been performed by clinical investigators of recognized competence;” and “considered valid without the need for an on-site inspection by FDA or… FDA can validate the data through an on-site inspection or other appropriate means.”
  • Proposed Rulemaking. Over two years ago, FDA published a proposed rule on “Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices.” The proposed rule, when finalized, would require that foreign clinical studies in support of PMAs, IDEs, HDEs and 510(k)s be conducted in accordance with good clinical practice (“GCP”).
  • 2001 Guidance. In March 2001, FDA issued guidance on acceptance of foreign clinical studies titled “Guidance for Industry-Acceptance of Foreign Clinical Studies”, which describes the acceptance of foreign clinical studies in support of an application for marketing approval of human drugs, medical devices and biological products. This guidance merely clarifies that FDA incorporated the 1989 Declaration of Helsinki in its regulation governing investigational drug trials conducted in foreign countries and that it was not amending the regulation to incorporate the 2000 amendments to the Declaration.

The Draft Guidance elaborates on FDA’s regulation and provides some insight on what FDA may focus on when evaluating the adequacy of an OUS study. Not surprisingly, FDA makes it clear that sponsors should seek input from FDA prior to initiating an OUS device study to ensure that it will generate adequate and valid scientific data. The Draft Guidance essentially provides three primary considerations related to relying on OUS clinical data:

  • Differences in study populations. To the extent a device has disparate safety effects in different demographic groups, differences in the race, ethnicity, age, gender and sex of a foreign population can affect the applicability of the study to the intended U.S. population. Reporting on the representation of such groups in the device submission allows appropriate sub-group analyses. The foreign population and the intended U.S. patient populations may also differ in the prevalence of clinical factors that can affect risks of an intervention as well as clinical response.
  • Differences in clinical conditions. Differences in OUS clinical conditions versus those in the U.S. can affect the relevance of the data to the intended U.S. population. OUS countries may have different standards of care, clinical facilities, or levels of clinical skill which can cause OUS data to not be generalized to U.S. clinical practice and which can impact the data’s usefulness in supporting the safety and/or effectiveness of the device.
  • Differences in regulatory requirements. When studies conducted OUS are initiated to satisfy the requirements of foreign countries, the studies may not be designed to address the questions necessary to satisfy FDA requirements.

The Draft Guidance provides a number of useful examples that demonstrate the application of the above considerations. Although the proposed rulemaking on “Acceptance of Data from Clinical Studies for Medical Devices” is not yet final, the Draft Guidance concludes by highlighting the importance of GCP. It states that “showing compliance with GCP is one way sponsors of device applications may be able to show that their OUS data comply with applicable FDA requirements.” FDA’s requirements for IDE studies address GCPs through applicable regulations, such as 21 C.F.R. Part 50, 54, 56 and 812. The Draft Guidance also provides that FDA considers the following two standards to be GCP principles that articulate ethical and policy standards for OUS clinical trials:

  • ICH E6, “Good Clinical Practice: Consolidated Guidance,” and
  • ISO 14155 “Clinical Investigation Of Medical Devices For Human Subjects – [GCP]”

FDA is requesting comments on the Draft Guidance before it begins work on the final guidance. The Agency will be accepting comments until July 21, 2015.

Warning Letters Update

By Mason Weeda

This past week FDA made a number of Warning Letters available on its website, with issues ranging from Juice HACCP to cGMPs for finished pharmaceuticals. A Warning Letter is informal and advisory, with the aim to achieve voluntary compliance and to establish prior notice. It communicates the agency’s position on a matter, but it does not commit FDA to taking enforcement action. Basically, you should read Warning Letters relevant to your industry because they can provide you with examples of what not to do. Here’s a quick run-down of Warning Letters published this week that we thought merited a closer look:

  • FDA issued a March 31, 2015 Warning Letter to Hospira S.p.A. for alleged violations of current good manufacturing practice regulations (cGMP) for finished pharmaceuticals at a manufacturing plant in Italy. The Warning Letter provides that Hospira failed to:
    • establish procedures to prevent microbiological contamination of sterile drug products and include validation of sterilization processes;
    • thoroughly investigate any unexplained discrepancy or failure of any batch;
    • exercise appropriate controls over computer or related systems so that only authorized personnel institute changes in master production/controls records; and
    • ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards.

The Warning Letter details Hospira’s failure to evaluate certain airflow studies, and its improper rejection of various vials during the manufacturing process without explanation. Ultimately, FDA stated that Hospira’s response to its inspectional observations lacked adequate corrective action.

  • FDA issued March 27, 2015 Warning Letters respectively to Avanti Health Care and Kings Pharmacy regarding deficiencies in their practices for producing sterile drug products. Both firms compound drugs and registered with FDA as outsourcing facilities and, therefore, were required to, among other things, comply with the Compounding Quality Act and cGMP requirements. Though Avanti was cited for six (6) cGMP violations and Kings was cited for three (3), the letters are very similar in many respects. During the inspections of both facilities, respectively, FDA observed that, among many violations, drug products were prepared under insanitary conditions, where operators failed to use proper aseptic technique in designated areas. Both firms also failed to include mandatory labeling for compounded products (i.e., “this is a compounded drug” and “not for resale”). These letters demonstrate FDA’s ongoing effort to more closely regulate and inspect outsourcing facilities. Avanti registered as an outsourcing facility on April 21, 2014, and FDA began its inspection only two (2) months later on June 23; Kings Pharmacy registered on December 23, 2013, and was inspected just three (3) months later.
  • FDA issued a March 25, 2015 Warning Letter to Skin Authority, LLC for making promotional claims on its website that indicate that its products, though labeled as cosmetics, were, in fact, promoted as drugs. The Warning Letter lists examples of drug claims for serums, scrubs and creams made on the website, including, for example, “help inhibit cellular breakdown,” “foster skin growth,” “help counteract infection,” “improve anti-inflammatory response,” and “increase cell growth.” The products were not generally recognized as safe and effective for the uses listed on the website, were not subject to any FDA-approved New Drug Application, and, therefore, were “new drugs” that required FDA approval prior to marketing.

The information that the agency communicates in a Warning Letter can be invaluable as it provides important, cautionary lessons for regulated industry and provides a view into the agency’s current thinking. You can keep tabs on Warning Letters by checking our blog periodically or by looking on FDA’s Warning Letters webpage.

Food Facility Registration Rules To Be Updated by FDA

by Michael J. O’Flaherty

FDA has published a proposed rule that would amend and update its regulatory requirements governing registration of food facilities.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which essentially directed FDA to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply, added section 415 to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Among other actions taken to implement the Bioterrorism Act, pursuant to section 415 the agency established regulations requiring that food facilities register with FDA. These regulations became effective on December 12, 2003.

The FDA Food Safety Modernization Act (FSMA) of 2011 amended section 415 of the FD&C Act to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the U.S. submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. As amended, section 415 also requires food facilities to renew their registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances. FDA has issued a number of guidance documents to assist the industry in complying with the food facility registration requirements. See generally Guidance for FDA Staff: Compliance Policy Guide Sec. 100.250 Food Facility Registration – Human and Animal Food (June 2014); Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Sixth Edition) (rev. Nov. 18, 2014); Guidance for Industry: What You Need to Know About Registration of Food Facilities; Small Entity Compliance Guide (rev. Dec. 17, 2014); and Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (rev. May 18, 2014)..

Under FDA’s present regulations, certain food facilities, including retail food establishments, are exempted from the requirement to register. The proposed rule would amend the regulatory definition of a “retail food establishment” in a way that would expand the number of establishments that are subject to the exemption. A retail food establishment is currently defined as an establishment that sells food products directly to consumers as its primary function. An establishment’s primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers. The proposed rule would clarify that, in determining the primary function of an establishment, the sale of food directly to consumers from an on-farm establishment includes sales by the establishment at such direct sales platforms as roadside stands, farmers’ markets, and Community Supported Agriculture (CSA) programs. Based on currently available data, FDA estimates that there are approximately 71,000 farms that only sell food products directly to consumers in ways that include farmers markets, roadside stands, and CSA programs. [Note: Inasmuch as the amended definition would exempt additional establishments from the requirement to register, these establishments also would not be subject to the requirements of the FSMA preventive controls rulemakings, which apply to facilities that are required to register.] See generally Questions and Answers for Farmers on FSMA Proposed Rule for Food Facility Registration (rev. Apr. 8, 2015).

For food facilities that are not exempt from registration, the proposed rule would add new provisions to the current regulations to codify certain requirements of FSMA that were self-implementing and effective upon enactment of FSMA. Those requirements are:

  • Registrations for domestic facilities must contain the email address of the contact person of the facility, and registrations for foreign facilities must contain the email address of the U.S. agent for the facility.
  • Food facilities that are required to register with FDA must renew their registrations every two years, between October 1 and December 31 of each even-numbered year.
  • All food facility registrations must contain an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.

In addition, the proposed rule would add certain new requirements, including:

  • All food facility registrations would be required to be submitted to FDA electronically; however, this requirement would not take effect before January 4, 2016.
  • Registrations would be required to contain the type of activity conducted at the facility for each food product category.
  • The proposed rule would provide for measures to verify certain information submitted in registrations.
  • The proposed rule would identify additional circumstances under which FDA will cancel registrations (i.e., FDA independently verifies that the facility is not required to register; information about the facility’s address was not updated in a timely manner; the registration was submitted by a person not authorized to submit it).

Public comments on FDA’s proposed rule may be submitted electronically or by regular mail until June 8, 2015.

FDA DRAFT Guidance: “Ensuring Safety of Animal Feed Maintained and Fed On-Farm”

By Jolyda O. Swaim

In earlier blogs, I have mentioned having horses and other animals while growing up on a small farm.  Even now, to my husband’s dismay, I have never outgrown being “horse crazy.”  But during all this time, I never remember being concerned about the animal feed I have purchased or used.  I do qualify this statement in that I knew certain things could not be fed to horses and that you better know where your sawdust was coming from to ensure it did not include black walnut.  But as to the commercial feed I purchased – I never gave it a thought.

Recently, the FDA issued a draft guidance entitled “Ensuring Safety of Animal Feed Maintained and Fed On-Farm.”  Comments on the draft are due by June 3, 2015.

This guidance is intended to help animal producers – those who feed animals, including horses – in developing and implementing on-farm practices to ensure animal feed is maintained and fed in a safe manner.  It provides good information for not only those feeding animals commercially, but for those who have one or two animals in the backyard they are raising for personal use.

In general, the guidance encourages people feeding animals to consider and apply the following principals:

  1. Know what feed contaminants may be present in your animals’ feed and the measures known to prevent such contaminants from becoming unacceptable feed risks;
  2. Obtain feed from safe and reliable sources;
  3. Recognize unexpected changes in the feed at your farm (e.g., changes in color, smell, texture, or appearance);
  4. Know where in your production system unacceptable feed risks may occur;
  5. Monitor animal feed products for contaminants during receiving, holding, and handling; and
  6. Be aware that other actions, such as limiting access to the premises to authorized personnel, following feed labeling directions, proper personnel training, and sampling and testing of feed, can help ensure feed safety.

The definition of “feed contaminants” are “any biological, chemical, physical, or radiological agent that if present in feed has the potential to cause illness or injury to animals or humans.”  Appendix A to the draft guidance lists examples to be considered.  When a contaminant rises to the level that is “reasonably likely to cause illness or injury in animals or humans,” this is considered an “unacceptable feed risk.”  Appendix A also lists examples of these.

The guidance provides a number of sources for review that identify feed contaminants that can be associated with particular types of farms and feed activities.  These include:

The guidance also has recommendations for safe feeding practices that farms should consider adopting such as knowing the requirements for animal feed in your state, and  taking steps to prevent or significantly minimize the occurrence of feed contaminants in feed (e.g., pest control measures, regular and adequate cleaning of animal feeding areas and equipment, good storage practices) among others.  Information is even provided regarding your pastures and bedding – think my comment on sawdust!

Many considerations relate to how you store feed, such as the need to ensure use of oldest first, and that the correct feed is used for each animal.  The guidance also has recommendations for farms with intensive animal feeding operations.  Other information includes safe use of pesticides, fertilizers, and other agricultural chemicals, personnel training and sampling and analyzing feed.

Finally, FDA provides information on steps to take if you have a concern about feed safety.  These include:

  1. Take immediate measures to ensure the product is not fed to animals;
  2. Review the FDA website about reporting problems to the agency;
  3. Promptly consult a veterinarian if feed may cause or has caused a negative effect on animal health; and
  4. If you suspect there could be a negative effect on human health from ingestion of food products derived from animals that ate contaminated feed, promptly contact local and state health departments.

The guidance provides thoughtful advice on what should be considered when feeding animals on small or large farms and should be reviewed by anyone with a few animals to many animals.

Tip

At minimum, after you dump that bag of feed into your grain bin, cut off the label with the lot number and maintain it in a plastic bag!  Always keep the current feed’s label(s) in the plastic bag.  This way, if something does go wrong, you have the information on what you last fed your animal/s.  This goes for whatever type of animal you are feeding, including your dogs and cats.  With this information, you won’t be trying to figure out whether or not what you have in that storage container is part of the most recently-announced recall!

Regulatory Round-Up Newsletter, Spring 2015

On behalf of the Agriculture practice group at OFW Law, here is a copy of our Spring newsletter.  We hope you find it useful.  To receive this periodic newsletter by e-mail, please contact Carrie Morgan at cmorgan@ofwlaw.com.

Tonight: Global Child Nutrition Foundation Honors USDA Secretary Vilsack

By Peter B. Matz

Secretary Vilsack

Please join the Global Child Nutrition Foundation (GCNF) and its partners in honoring Secretary Vilsack for his remarkable achievements in child nutrition. GCNF’s Annual Gala has become a signature Washington event, bringing together executives from industry as well as high-level officials from both government and NGO’s.  It will take place tonight, from 5:30-7:30 PM, at the Ronald Reagan Building and International Trade Center in Washington, DC.  Details below.

The Gala raises funds for GCNF’s efforts to end child hunger by helping developing countries establish sustainable school feeding programs. At this moment, over 350 million hungry children live in extreme poverty throughout the world. School feeding programs nourish children, provide an incentive for children to go to school, and help lift children, their families and their communities out of poverty.

Global Child Nutrition Foundation’s Annual Gala Reception Honoring

U.S. Department of Agriculture Secretary Tom Vilsack

Thursday, April 16 2015

5:30pm-7:30pm

The Ronald Reagan Building and International Trade Center

1300 Pennsylvania Avenue Northwest, Washington, DC 20004

More information at www.gcnf.org

Secretary Tom Vilsack

Throughout his long and distinguished career in public service, Secretary Vilsack has demonstrated his commitment to the nutritional well-being of children at home and abroad. As Governor of Iowa, Vilsack created the Iowa Food Policy Council to advance local food systems, enhance family farm profitability, and combat hunger and malnutrition.  At USDA, Secretary Vilsack is a key Cabinet leader on global food security and served as one of the primary architects of President Obama’s Feed the Future Initiative launched in 2009. Under his leadership, USDA has contributed to improved global food security by focusing on capacity building to improve markets information, food safety systems, basic and applied research and innovations in agricultural productivity.

In 2013, Secretary Vilsack led U.S. efforts on the Global Open Data for Agriculture and Nutrition, which seeks to support global efforts to make agricultural and nutritionally relevant data available, accessible, and usable for unrestricted use worldwide in order to improve consumer health and expand economic opportunities for farmers. Building on those efforts, in 2014, Secretary Vilsack led the launch of U.S. participation in the Global Alliance for Climate-Smart Agriculture, a global effort to share knowledge and practices to address climate change and its impact on agriculture and chart a new path forward towards greater global food security.

Secretary Vilsack continues to be a strong voice for improving the nutritional quality of domestic child nutrition programs and has focused USDA’s McGovern-Dole School Feeding Program on meeting rigorous nutrition and literacy goals. Child nutrition programs in the United States have become global models of excellence under Secretary Vilsack’s leadership and commitment.