FDA/ONC/FCC Health IT Report Signals Possible Deregulation of Certain Software Medical Devices

By Neil F. O’Flaherty

Has the U.S. Food and Drug Administration (FDA) opened the door to deregulation of certain software medical devices?  Its recently issued Health IT Report seems to indicate so, and FDA is seeking comments on the report.  Now is the time to weigh in on what FDA ultimately should do.

Federal law enacted by Congress in 2012 mandated that the FDA, in collaboration with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC), develop and post on their websites “a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.” The report was issued on April 3, 2014, which was somewhat after the statutory deadline.

The proposed strategy and recommendations identify three categories of health IT functionality: 1) administrative health IT functions, 2) health management health IT functions, and 3) medical device health IT functions.  According to the report, each health IT functionality category presents different public health risk levels, driving different corresponding risk controls and measures.  For instance, the proposed strategy and recommendations for the health management health IT framework focuses on four priority areas: 1) promote the use of quality management principles; 2) identify, develop and adopt standards and best practices; 3) leverage conformity assessment tools; and 4) create an environment of learning and continued improvement.  In addition to implementing actions to address these four priorities, the report proposes to establish a public-private Health IT Safety Center.  The proposed framework favors this approach for these types of products as opposed to a formal regulatory/legal framework.

According to the report, certain lower risk clinical decision support (CDS) products can fall under the category of health management health IT functionality, even though they meet the statutory definition of a medical “device.” FDA does not intend to focus its regulatory oversight on such products under the proposed strategy and recommendations.

The report gives the following examples of CDS product functionalities that fall within this catagory: evidence-based clinician order sets tailored for a particular condition, disease, or clinician preference; drug-drug interactions and drug-allergy contraindication alerts to avert adverse drug events; most drug dosing calculations; drug formulary guidelines; reminders for preventative care (e.g., mammography, colonoscopy, immunizations, etc.); facilitation of access to treatment guidelines and other reference materials that could provide information relevant to particular patients; calculation of prediction rules and severity of illness assessments (e.g., APACHE score, AHRO Pneumonia Severity Index, Charlson Index); duplicate testing alerts; and suggestions for possible diagnoses based on patient-specific information retrieved from a patient’s electronic health record.  Traditionally, products with some of these functions have been actively regulated by FDA as medical devices.

Elaborating on CDS products, the report states that they provide health care providers and patients with knowledge and patient-specific information, intelligently filtered or presented at appropriate times, to enhance health care.  According to the report, because the risks of CDS are generally low compared to the potential benefits, FDA does not intend to focus its oversight on most CDS products.  Instead, FDA intends to focus its oversight on a limited set of CDS products that pose higher risks to patients.  The report gives the following examples of higher risk CDS functionalities: computer-aided detection/diagnostic software; remote display or notification of real-time alarms (physiological, technical, advisory) from bedside monitors; radiation treatment planning; robotic surgical planning and control; and electrocardiography analytical software.

The Health IT Report only puts forth a proposal.  It does not necessarily represent where the FDA regulatory framework ultimately will end up. For interested parties with a stake in how various health management health IT products are (or are not) ultimately regulated, now is the time to act and to start influencing the process and decision-making.  With ONC and FCC, FDA is holding a public workshop on the proposed strategy and recommendations May 13-15, 2014, at the National Institute of Standards and Technology in Gaithersburg, Maryland.  FDA has also asked that comments on the proposed strategy and recommendations be submitted by July 7, 2014.

Steps to Prevent Allergen Recalls, Part Two – Another Practice Tip from Ms. Gloom

By Jolyda O. Swaim

In Part One, we discussed using transparencies on the receiving dock as an easy way for personnel to quickly ascertain whether or not the incoming ingredient (at least its ingredient statement) was the same as your specification.  See our earlier blog posting.  In this post, we want to discuss some of the steps a facility may take to ensure that allergens are controlled through product formulation and batching, and finished product labeling.

Formulation and Batching Process

A key in ensuring that your product does not contain an undeclared allergen is to make sure that the “batch sheet” being used at the batching station is correct.  With today’s technology, many companies use computer systems that only permit the most recently-approved batch sheet to be the one available.  There are, however, many facilities still using a hard-copy that was printed off by the Supervisor or designated personnel.  Unfortunately, many times these “hard-copies” find their way into lockers or files where they are “available” the next time that product is run – or three months from now after a formulation change was made.

Many recalls have been the result of an old formulation print-off being used with a new finished product label.  Usually this occurs because someone accidentally used an obsolete batch sheet they had tucked away in a file or in their locker.

Facilities need to ensure that no one maintains copies of batch sheets where one can be inadvertently used.

Personnel should be notified that copies are not to be maintained and all of those “batch sheet hiding places” should be checked for obsolete copies.  Anyone who has spent time dealing with this will know where these places are.  These have included the normal locations – batch employee’s locker – to the not-so-normal – above the suspended ceiling over the batching station.  Make it a point to have a procedure to issue batch sheets as needed and make this easy for those authorized employees needing the batch sheets.  If it is difficult for the employees to get the batch sheet, they will find ways to make it easier – which usually involves making an “unauthorized copy.”

All batch sheets should contain a revision date or formula version number.  When schedules are printed, this information on the formula version should be included.  All responsible personnel should be trained to check that the batch sheet is the correct version listed on the schedule.  This should be a mandated step required to be completed before any actual ingredient batching begins.

Another procedure that will assist in ensuring the proper formulation is used is to have two different employees responsible for staging and batching.  For example, the employee responsible for staging the necessary ingredients uses a batch sheet issued to him and marks this off to ensure the proper ingredients have been staged.  The batching employee then checks off ingredients on his batch sheet.  This provides two (hopefully independent) checks that a batch is being properly formulated and will match its finished product ingredient statement.

Finished Product Labeling

Another reason for undeclared allergens is the use of the wrong finished product label.  While many facilities have this as a CCP, it is still easy to miss a change in an ingredient statement.  I was gloomy when I had an entire shift of beef hotdogs produced using the packaging for a combination beef and pork formula on one of four production lines.  The printing on the beef hot dogs was all in red while the combination product was printed in green.  The QA technician checked the film on all four lines every hour and marked that it was correct on each line – even though the film was green, the product name was wrong, and the formula was different on one line.  Moreover, the two employees on that line packing the hotdog packages into the cases also “looked” at the film.  Remember, people sometimes see what they expect to see, not what is actually there.

One way to prevent a very gloomy day is to train personnel to read the label information out loud during packaging checks.  When you read out loud, you will be concentrating on what you are actually looking at – not what you “expect” to be there.  If the technician had read the product name on the hotdogs out loud, he would have not said the word “beef” on the line in question.  Chances are that the mistake would have been identified at the first check.  This also holds true for ingredient statements or any information that must be reviewed routinely.  Read it out loud to increase your chances of ensuring it is actually correct.

Finally, verification checks should also be done at some frequency to ensure that the batch sheets in use have the latest version number or revision date, and that these also agree with the finished product labeling.  Have a program in place to control formulation changes so that everyone is aware when they will occur.  Control your finished product labeling:  if you receive in “new” film with an updated ingredient statement, literally keep it under “lock and key.”  Do not keep it in regular inventory as there is a good chance it will get used by accident.  Likewise, if you do not use all “old” labeling up before you change your formulation, lock up the remaining inventory.  An employee will need a partial roll of labels and grab that which is the easiest to get.  Make it difficult to grab the “wrong” labels by keeping these (“old” or “new”) out of reach.

About “Ms. Gloom”

In the attorney ranks at OFW Law, there is only one who would raise a hand if all were asked if they had any “hands-on” experience in the operation of a Townsend “Frank-O-Matic” hotdog maker, producing bean sprouts for use in egg rolls or in managing a food facility sanitation crew.  In fact, there are probably no attorneys out there who could raise their hands except Jolyda Swaim.

Prior to law school and OFW Law, Ms. Swaim spent years in the food industry, beginning as a microbiologist and Quality Assurance technician.  In these years, she had direct charge of quality assurance, production, sanitation and consumer affair departments at various companies producing products from pickles, sauerkraut and barbeque sauce, to various meat and poultry products, to frozen entrees, egg rolls and pizza to spices and spice blends.  Her last position at Sara Lee as Director of Food Safety had her auditing its facilities in the United States and Mexico to ensure facilities producing ready-to-eat products were following best practices in sanitation and product handling.

FDA Regulation of Ackee Fruit Products

By Michael J. O’Flaherty

Ackee fruit is harvested from the ackee tree (Blighia sapida), which is native to West Africa, but is also found in Central and South America, many Caribbean countries, and southern Florida.  Ackee is an evergreen tree that grows about 10 meters tall, with a short trunk and a dense crown.  Its fruit is pear-shaped.  When it ripens, it splits open to reveal three large, shiny black seeds, surrounded by soft flesh, the edible arilli.  The fruit is rich in essential fatty acids, vitamin A, zinc, and protein.

Canned, frozen, and other ackee products are marketed in the United States, largely to people from Caribbean cultures.  Most of the ackee products in the United States are imported from tropical countries, such as Jamaica, Belize, and Haiti; however, in recent years, there has been interest by a domestic processor(s) to market ackee products in interstate commerce.

The ackee fruit’s seeds and arilli naturally contain the toxin hypoglycin A (a/k/a simply hypoglycin), which drops to negligible levels in the edible portion of the fruit when it is fully ripe.  Hypoglycin may pose a health risk in concentrations above 100 parts per million (ppm), according to an FDA risk assessment.  The presence of hypoglycin in a finished ackee product at levels above 100 ppm can be attributed to improper processing of the product.

FDA Import Alert 21-11 authorizes the agency’s District Offices to detain, without physical examination, all ackee products offered for import, except for those from firms that are identified on a “Green List” included in the Import Alert.  The firms on the Green List have demonstrated to FDA that they have food safety controls in place to ensure that only properly ripened ackees, without seeds or rind, are included in finished products.

FDA also has published a final Compliance Policy Guide (CPG) that provides guidance for FDA staff on the agency’s enforcement criteria for canned ackee, frozen ackee, and other ackee products that contain hypoglycin.  The CPG (section 550.050) recommends seizure or import refusal of canned, frozen, and other ackee products that contain greater than 100 ppm of hypoglycin.  Beginning today, persons wishing to comment on the final CPG may submit electronic or written comments to FDA.

NRDC Issues Report Critical of GRAS Self-Determinations and CSPI Joins in Criticism

By Mark L. Itzkoff

On April 7, 2014, the Natural Resources Defense Council (NRDC) issued its latest report on GRAS self-determinations, entitled Generally Recognized as Secret: Chemicals Added to Food in the United States.  We previously reported on NRDC’s and the Pew Charitable Trust’s prior criticism of the GRAS provision here and here.  The new article reports on a study of GRAS ingredients that NRDC concluded were marketed in the U.S. based on GRAS self-determinations that were either never submitted to FDA or were the subject of GRAS Notifications to FDA that subsequently were withdrawn.  NRDC claims to have identified “275 chemicals from 56 companies that appear to be marketed for use in food based on undisclosed GRAS safety determinations.”  The report categorizes the GRAS exemption as “the loophole that has swallowed the law.”  NRDC concludes that “[t]he system is broken and plagued with conflicts of interest,” that a food ingredient cannot be GRAS “if its identity, chemical composition and safety determination are not publicly disclosed,” and that a legislative change to GRAS authorizations is necessary.

In a coordinated effort, the Center for Science in the Public Interest (CSPI) issued an alert to its members, alleging that GRAS self- determinations are a “frightening problem” and asking their supporters to join its “campaign to strengthen FDA’s role on food safety and let them know how shocked and disappointed you are that they have fallen down on the job and put you at risk.”

As an initial matter, we note that there is nothing improper with a company making a GRAS determination and marketing its product based on that determination.  See FDA, Proposed Rule, Substances Generally Recognized as Safe, 62 Fed Reg 18938, 41 (April 17, 1997) (“a manufacturer may market a substance that the manufacturer determines is GRAS without informing the agency …”).  Under Section 201(s) of the Federal Food, Drug and Cosmetic Act (FFDCA), 21 USC 321(s), an ingredient that is generally recognized as safe is not a “food additive” and is not subject to the food additive pre-market review requirements.

The NRDC article overlooks several facts that render their conclusions questionable.  Specifically:

  • The identities of GRAS  food ingredients are not unknown;
  • A GRAS determination must be based on “the same quantity and quality of scientific evidence as is required to obtain approval of a food additive regulation for the ingredient,” 21 CFR 170.30(b); and
  • Foods containing ingredients based on improper GRAS determinations are “adulterated” and subject to FDA enforcement actions.

Several times in the report NRDC claims that the chemical identity of some GRAS ingredients are not “publicly disclosed.”  [NRDC suggests that the acronym GRAS should stand for “Generally Recognized as Secret.]  However, FDA regulations require that all ingredients in a processed food (except for processing aids and other incidental additives) be listed on the label in the ingredient declaration.  21 CFR 101.4(a)(1).  Since the GRAS ingredients will be listed on the label, they are not secret.  Further, since a GRAS determination must be based on published data, 21 CFR 170.30(b), the public is able to review the safety data and make their own determinations as to the safety of the ingredient.

NRDC also implies that substances deemed to be GRAS are less safe than substances cleared through a food additive petition or GRAS Notification.  However, as noted above, FDA regulations require the same evidence for GRAS determinations that are required for food additive petitions.  In addition, FDA requires that this information be published, usually in a peer-reviewed journal, before the GRAS determination is made.  Thus, the data used to support a GRAS determination has undergone an independent evaluation and been found to be suitable for publication before a proper GRAS determination is made.

In the article, NRDC contends that FDA needs more authority to regulate GRAS ingredients.  However, the article never discusses FDA’s current authority and how FDA has acted in the past to control the use of ingredients that may not be GRAS.  Under the FFDCA, a food ingredient that is neither GRAS nor used in accordance with an applicable regulation is an unapproved food additive and is deemed to be unsafe under FFDCA §409(a)(2), 21 USC §348(a)(2).  Any food that contains an unsafe food additive is considered to be adulterated under FFDCA §402(a)(2)(c)(i),  21 USC §342(a)(2)(c)(i) and may not be introduced into interstate commerce.  FFDCA §301(a), 21 USC §331(a).

Over the past few years, FDA has issued Warning Letters to companies it believes are marketing food containing ingredients that are not GRAS.  For example, FDA issued letters to 30 companies on November 13, 2009, asking them to provide data supporting their determinations that caffeine is GRAS for use in alcoholic beverages.  The agency followed up with Warning Letters to 4 companies supplying caffeinated alcoholic beverages on November 17, 2010, questioning the GRAS status of caffeine as an ingredient in their products (see here and here).   FDA’s actions in this matter were highly effective and all of the caffeinated alcoholic beverages have now been removed from the marketplace.  In situations where a food poses a more immediate public health concern, FDA has authority to seize adulterated foods, FFDCA §304(a), 21 USC §334(a).

In coordination with the NRDC article, CSPI issued an alert alleging that GRAS self determinations are a “frightening problem.” The alert included an “infographic” that it claims exposes “the spaghetti-tangle of FDA’s failure to ensure the safety of food additives.”  CSPI asked their supporters to share its material through social media.  The infographic suggests that suppliers can ignore FDA questions regarding GRAS determinations and use the product in food without adequate safety data.  This ignores the fact that, as explained above, FDA has significant authority to prevent such use.

The CSPI infographic also fails to address the primary reason many companies choose to pursue a GRAS self-determination rather than submit a food additive petition or GRAS Notification.  Under the FFDCA, FDA is required to respond to a food additive petition within 180 days.  FFDCA §409(c)(2), 21 USC §348(c)(2).  However, in practice, the review period for most food additive petitions is 3 years or more.  For many companies, the delay incurred by the food additive petition process is unfeasible.

Neither NRDC nor CSPI make a persuasive argument that reform of the GRAS process is needed to protect consumer safety.  Without a clear and significant threat to public health, it appears unlikely that Congress will enact the changes to the FFDCA that would be needed to significantly restrict the ability of companies to make GRAS determinations.

How to Decide When to Challenge GIPSA Enforcement Actions Under the Packers and Stockyards Act

By Brett T. Schwemer

Each year, the USDA’s Grain Inspection, Packers and Stockyards Administration (GIPSA) initiates over one-hundred enforcement actions against packers, dealers, market agencies, live poultry dealers and other regulated entities for alleged violations of the Packers and Stockyards (P&S) Act.  These actions are taken for alleged unfair and deceptive trade practices, or anticompetitive behavior, such as collusion between dealers and packers, or agreements between dealers to alternate bids or refrain from competing on livestock at auctions. GIPSA also brings enforcement actions for other violations of the P&S Act and implementing regulations, such as failure to make full payment promptly, failure to provide a seller of livestock or poultry details of the purchase contract, and failure to register with USDA as a dealer or market agency.

Most of GIPSA’s enforcement actions take the form of “Notices of Violations” or offers of “Stipulation Agreements.”  A Notice of Violation alleges a minor infraction of the P&S Act and simply requests corrective measures.  An offer for Stipulation Agreement alleges minor infractions of the P&S Act, seeks a small civil penalty, and can be resolved informally without the need for an administrative proceeding.

However, enforcement actions can also take the form of “formal administrative proceedings.” Here, the agency files a Complaint before an Administrative Law Judge (ALJ) requesting that the ALJ impose a substantial civil penalty and an Order requiring the regulated entity to cease and desist from engaging in the alleged unlawful activity (i.e., “Cease and Desist Order”).   In the case of dealers and market agencies, the agency might also request that the ALJ issue an Order suspending the dealer or market agency’s P&S registration, without which they can buy and sell livestock.

Faced with an offer of Stipulation Agreement or an administrative Complaint, regulated entities must decide whether to settle the matter by paying a civil penalty and, in the case of Complaints, agreeing to a Cease and Desist Order and possibly a suspension of registration, or challenge the action by requesting an administrative hearing before the ALJ.  This is a difficult decision, and one in which it is necessary that both the regulated entity and its attorney understand the administrative process for challenging GIPSA enforcement actions.

The administrative process for challenging GIPSA enforcement actions is not exactly stacked in the favor of regulated entities (otherwise known as “respondents”).   First, although the respondent is entitled to a hearing before an ALJ, it is important to understand that the ALJ is a USDA employee.  A review of ALJ decisions shows that the ALJ more often than not rules in favor of the agency.   If the ALJ rules in favor of the agency and assesses a civil penalty and a Cease and Desist Order, the respondent can appeal the ALJ’s decision to another USDA employee, the Judicial Officer (JO).  Only after losing at this stage can the respondent appeal the agency’s decision to the United States Court of Appeals in the circuit where the respondent resides.   The Court of Appeals will review the JO’s decision under a deferential standard, reviewing the JO’s conclusions of law de novo, but affirming the JO’s finding of fact if, upon review of the record, they are supported by substantial evidence.

Second, although the respondent has an opportunity to introduce witness testimony and evidence at the hearing before the ALJ and cross-examine GIPSA’s witnesses, respondents have limited opportunities for discovery prior to the Hearing.  Discovery is generally limited to the ALJ ordering the agency and respondent to exchange proposed exhibits and a witness list, which includes a short description of the witnesses’ testimony.  Although GIPSA regulations also allow respondents to request that the ALJ order the issuance of subpoenas or allow depositions, these requests are not granted very often.

This does not mean that the above hurdles make it impossible for Respondents to have success at the ALJ or JO stages of the administrative process.  For example, in one matter in which we represented the respondent, the ALJ found that our client violated the P&S Act but denied GIPSA’s request to impose a civil penalty of more than $1,000,000 (and issued no civil penalty) because the ALJ determined that our client’s action was unintentional, and GIPSA did not put our client on notice that its conduct would have violated the P&S Act.  Notwithstanding, the above hurdles should be considered when contemplating whether or not to challenge a GIPSA enforcement action.

Respondents should also consider the following additional factors:

  • What is the likelihood of success at each level of the administrative process and at the Court of Appeals?
  • What will be the legal costs involved in challenging the enforcement action at each step of the process?
  • How much would the civil penalty be if the case was settled compared to how much it would be if the case went to a hearing and the respondent loses? How does the projected civil penalty compare to the estimated legal costs?
  • If a Cease and Desist Order is issued, how onerous would it be to comply with the Order (violations of a Cease and Desist Order can be prosecuted as a criminal offense)?
  • In the case of dealers and market agencies, is GIPSA seeking to suspend registrations, without which they can conduct business? If so, how long would the registrations be suspended?
  • How would sellers or buyers of the regulated entity respond if the regulated entity agreed to settle a GIPSA enforcement action or was found by the ALJ, JO or Court of Appeals to have violated the P&S Act (GIPSA will issue press releases announcing impositions of civil penalties and Cease and Desist Orders)?

Only the regulated entity can make the decision whether it is worthwhile to contest a GIPSA enforcement action or to settle it.  However, to fully consider the factors above and make a sound business decision, the entity would be well advised to seek advice from someone who fully understands the administrative process, P&S precedent in similar enforcement proceedings, and the GIPSA employees who are involved in the administrative process.  Making a decision to fight cases that have an unlikely chance of success results in the business paying far more money in legal costs than the civil penalty ultimately imposed.  Making a decision simply to accept the GIPSA complaint has downsides as well – payment of an excessive penalty or agreeing to a unsupportable cease and desist can have an adverse effect on your business.

FDA Issues Guidance on Labeling of Honey

By Robert A. Hahn

The Food and Drug Administration (FDA) has issued a draft guidance document on labeling of honey and honey products.

According to FDA, “honey” is the common or usual name for “a thick, sweet, syrupy substance that bees make as food from the nectar of flowers and store in honeycombs.”  The floral source of honey may be included on the label (e.g., “orange blossom honey,” “clover honey”), provided that (1) the particular plant or blossom is the chief floral source of the honey; and (2) the producer, manufacturer, processor, packer, or distributor can show that the designated plant or blossom is the chief floral source.  See also Compliance Policy Guide Section 515.300 (Honey – Source Declaration).  Honey, when sold as such, is a single-ingredient food and does not need to bear an ingredients declaration.

Only products made exclusively of honey may be called “honey.”  A product consisting of honey and another sweetener must bear a common or usual name that accurately describes the product (e.g., “blend of honey and sugar” if honey is the predominant ingredient, or “blend of sugar and honey” if sugar is the predominant ingredient) and include an ingredients declaration listing its ingredients in descending order of predominance by weight.  Similarly, a product consisting of honey and another ingredient, such as a flavoring, must bear an appropriate common or usual name (e.g., “raspberry flavored honey”) and an ingredients declaration that lists the other ingredient(s).

There have been some reports in recent years claiming that much of the honey on the market is not real honey (see, e.g., Andrew Schneider, Tests Show Most Store Honey Isn’t Honey, foodsafetynews.com, Nov. 7, 2011).

The draft guidance discusses FDA’s enforcement authority and notes that passing off diluted products as honey may result in both misbranding and adulteration (i.e., economic adulteration) charges. FDA also has several import alerts relevant to imported honey, including an import alert for honey adulterated with corn or cane sugar (Import Alert 36-01) and an import alert recommending detention without physical examination for honey that appears to contain unsafe drug residues (e.g., chloramphenicol, fluoroquinolones) (Import Alert 36-04).

The draft guidance notes that FDA received a petition from the American Beekeeping Federation in 2006 requesting the agency to establish a standard of identity for “honey” based on the Codex Alimentarius Commission’s standard for honey, but FDA concluded that a standard of identity was unnecessary and denied the petition.  FDA believes the integrity of honey can be protected under existing laws.

A few states have enacted their own standards of identity for honey that impose additional restrictions beyond those in FDA’s draft guidance.  For example, Utah’s standard of identity for honey provides that it may “not be heated or processed to such an extent that its essential character is changed or its quality is impaired.”  Utah Administrative Code Sec. R70-520-4.  In the absence of a federal standard of identity, there is no federal preemption of such state laws.

FDA Final Rule and Guidance on Emergency Records Access

By Robert A. Hahn

The Food and Drug Administration (FDA) has issued a final rule expanding its emergency records access authority, as provided by the Food Safety Modernization Act (FSMA).  Establishment, Maintenance, and Availability of Records: Amendments to Record Availability Requirements; 79 Fed. Reg. 18799 (April 4, 2014).  The final rule adopts, without change, an interim final rule issued in February 2012.

The final rule expands FDA’s records access authority in emergency situations, i.e., when the agency has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.  In such situations, FDA may inspect and copy records relating to the suspect article of food that are held by any person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such food.

Under this final rule, FDA’s records access authority is expanded to include records relating to the suspect article of food and “any other article of food that [FDA] reasonably believes is likely to be affected in a similar manner.”  Specifically, FDA may inspect and copy records of domestic and foreign person that manufacture, process, pack, transport, distribute, receive, hold, or import food (excluding farms and restaurants) if either:

(a) FDA has a reasonable belief that an article of food, and any other food that FDA reasonably believes is likely to be affected in a similar manner, is adulterated and presents a threat of serious adverse health consequences or death to humans or animals; or

(b) FDA believes there is a reasonable probability that use of or exposure to an article of food, or any other food that FDA reasonably believes to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals.

FDA has also issued two final guidance documents explaining how it will exercise this new authority: Guidance for Industry: FDA Records Access Authority Under Section 414 and 704 of the Federal Food, Drug, and Cosmetic Act and Guidance for Industry: What You Need to Know About Establishment, Maintenance, and Availability of Records; Small Entity Compliance Guide.

FDA must invoke this emergency records access authority by providing a special written notice, Form FDA 482c (Notice of Inspection – Request for Records), to the owner, operator, or agent in charge of the facility.  FDA’s internal procedures for exercising this authority can be found in § 10-4 of the agency’s Regulatory Procedures Manual.

FDA is most likely to invoke this authority in the following situations:

  • Foodborne illness outbreaks;
  • Epidemiologic evidence implicating a particular food as a cause of illness;
  • Product recalls;
  • Reports to FDA’s Reportable Food Registry;
  • Adverse event reports (e.g., for dietary supplements);
  • Consumer complaints; or
  • Other situations in which a specific food presents a threat of serious adverse health consequences.

A determination that another article of food is likely to be affected in a similar manner to the suspect article of food will be made by FDA on a case-by-case basis.  FDA offers the following examples of situations in which another article of food may be affected in a similar manner to the suspect article of food:

  • Both articles of food prepared and packed on the same processing line;
  • Both articles of food processed in shared-use equipment;
  • Both articles of food prepared, packed, or held under similar conditions; or
  • Both articles of food implicated by epidemiologic evidence as potential sources of foodborne illness.

Under this authority, FDA may inspect and copy: (a) records of immediate previous sources and immediate subsequent recipients of the foods in question (“one up-one down records”); and (b) any records related to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of the foods in question that are needed by FDA to determine whether the food presents a threat of serious adverse health consequences.  Examples of the latter include: manufacturing records, raw material receipt records, product inventory records, product distribution records, testing records, recall records, customer distribution lists, complaint and adverse event records, and Reportable Food Registry records.

FDA may not access the following records:

  • Financial data;
  • Pricing data;
  • Personnel data;
  • Research data;
  • Sales data (other than shipment data regarding sales);
  • Recipes;
  • Records from farms;
  • Records from restaurants; or
  • Records relating to food under the exclusive jurisdiction of the U.S. Department of Agriculture.

The final rule is effective immediately upon publication.  In fact, it makes no change, since the interim final rule has been in effect since March 1, 2012.

HHS Releases HIPAA Security Rule Risk Assessment Tool

By Jonathan M. Weinrieb

The Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR), Office of the National Coordinator for Health Information Technology (ONC), and Office of the General Counsel (OGC), have released their Security Risk Assessment (SRA) tool.  The SRA tool is designed to assist Covered Entities and their Business Associates (BA) ensure compliance with the HIPAA Security Rule’s requirements that they establish administrative, physical, and technical safeguards for electronic protected health information (ePHI).  A thorough risk assessment should reveal areas where an organization’s ePHI may be at risk and head off breaches or other security incidents.

This SRA tool is geared toward small- to medium-sized Covered Entity health care providers but serves as a useful guide for all Covered Entities and BAs regulated by the HIPAA Security Rule.  The tool serves as a local repository for security-related information and does not send data outside of a Covered Entity or BA but provides a report that an entity can share with its security auditors.

You can download the tool here; view training/tutorial videos here; access the use guide here; and review OCR’s press release here.  The SRA Tool is a self-contained application that can be run on various environments including Windows Operating Systems for desktop and laptop computers and Apple’s iOS (for iPad only).

Regulated industry should be careful to distinguish this broader Risk “Assessment” – often referred to by HHS as a Risk “Analysis” – from the four-factor Risk Assessment required in order to determine whether an impermissible use or disclosure of PHI constitutes a breach under HHS’s January 2013 omnibus rulemaking (previously a “risk of harm” analysis under the 2009 Interim Final Rule).

Steps to Prevent Allergen Recalls – A Practice Tip from Ms. Gloom

By Jolyda O. Swaim

Anyone who is remotely involved in the food arena knows that the number one reason for a recall of meat and poultry regulated under USDA’s Food Safety and Inspection Service (FSIS) or all other types of food regulated under the Food and Drug Administration (FDA) is an undeclared allergen.  In fact, a quick review of recalls in Canada shows that undeclared allergens probably result in most of their recalls as well.

So what is happening in food facilities that result in all of these products being manufactured or labeled improperly?  What can be done to control the process and prevent the risk to the consumers who depend on the product label to provide the correct ingredient statement – besides all of the regulatory oversight that will occur at the facility once you have a recall?  There are several procedures that facilities can implement to ensure products are not only produced, but also labeled, correctly.

Many facilities say that they control allergens by having a critical control point (CCP) at packaging to ensure that the finished product is correctly labeled.  For example, someone checks that a hotdog package or package of hotdog buns has the right label on it as part of a CCP at packaging.  The “right” label is determined because the schedule indicates that beef hotdgs were being made or white buns were to be packaged.  The problem with this approach is that while someone can determine that beef hotdogs were made or that a regular white bun was used and the label reflects this fact, the person visually checking the product and label won’t know whether someone used the wrong spice blend in the product.  The person would not know that soy oil was added to the bun instead of a different type of oil because the manufacturer changed sources of oil without notifying the establishment.  While it is important to ensure that the correct label is going on at the end of the line, the real work starts at receiving!

Receiving Ingredients

Anyone who has reviewed ingredient statements for products with numerous ingredients knows how difficult it is to compare two statements which are the virtually the same – except one is missing an ingredient or two, or the statements have the same ingredients but not in the same order of predominance.  Now, try to do this while efficiently unloading 22 pallets of various ingredients from a trailer as is the procedure at many facilities.  Even when there are several personnel involved in the receiving process, this becomes a difficult task.

In reviewing the lessons learned through recalls, many recalls resulted from the ingredient supplier changing the formula of, for example, a spice blend or a complex sauce and neglecting to notify all of their customers beforehand – or the notification occurred but did not reach the receiving dock. This should always be a concern when trying to compare the incoming ingredient label with the ingredient statement in your spec book while keeping up with the unloading of materials.

A tip to prevent a gloomy day: if you receive multi-component ingredients, you can make it easy for your employees at receiving to quickly identify whether or not the incoming item has the same ingredient statement as that approved – and which is used on the respective finished product label: use transparencies.


If you are old enough, you may remember that before we had computers and Power Point presentations, we had transparencies.  These were clear plastic sheets we could run through the copier and print our presentations or pictures on to, which we then displayed onto a screen with an overhead projector.  These clear plastic sheets can still be run though the copier and printed with “life size” copies of your suppliers’ ingredients statements.

Get an actual ingredient label from all of your incoming ingredients which you have verified as correct.  Take each of these and make a “transparency.”  Provide these to your incoming receiving personnel.  These transparencies can then be used by these personnel to quickly place over the respective incoming ingredients statement to determine whether or not there has been a change.  If the label on the transparency perfectly “matches up,” then there has been no change and product is good to receive.  If it does not match up, something has changed and the receiver can take appropriate next steps.

The use of transparencies will greatly speed up the process of ensuring ingredients received are correct with much greater accuracy than trying to actually compare two statements side-by-side.  Transparencies will not “catch” an issue where the supplier formulated a product incorrectly; they will, however, prevent those issues where the formulation and label were changed and the facility was not made aware of the change – an issue which has accounted for numerous allergen recalls.

My next blog will address some steps to take to try to ensure you are formulating, batching, and labeling your products correctly.

About “Ms. Gloom”

In the attorney ranks at OFW Law, there is only one who would raise a hand if all were asked if they had any “hands-on” experience in the operation of a Townsend “Frank-O-Matic” hotdog maker, producing bean sprouts for use in egg rolls or in managing a food facility sanitation crew.  In fact, there are probably no attorneys out there who could raise their hands except Jolyda Swaim.

Prior to law school and OFW Law, Ms. Swaim spent years in the food industry, beginning as a microbiologist and Quality Assurance technician.  In these years, she had direct charge of quality assurance, production, sanitation and consumer affair departments at various companies producing products from pickles, sauerkraut and barbeque sauce, to various meat and poultry products, to frozen entrees, egg rolls and pizza to spices and spice blends.  Her last position at Sara Lee as Director of Food Safety had her auditing its facilities in the United States and Mexico to ensure facilities producing ready-to-eat products were following best practices in sanitation and product handling.

Global Food Security

By Marshall L. Matz, as published in Agri-Pulse

Agriculture is a business, a very big business.  Whether you look at net farm income, agriculture exports or the number of people employed in the farm and food value chain, agriculture is big business by any criteria.

As the Old Testament tells us, however, agriculture is more than just a business. Agriculture is special. Agriculture provides the basic sustenance for all of us and we have an obligation to help the hungry.

It is, therefore, very troubling that according to the Food and Agriculture Organization (FAO) there are still 842 million people, or one in eight, who are suffering from chronic hunger or food insecurity. FAO defines food insecurity as not getting enough food to conduct an active life. This is a lower number than the 868 million reported a few years ago and the number of undernourished has fallen by 17 percent since 1990-92.

The United Nations World Food Program (WFP) is the largest humanitarian agency fighting hunger worldwide, providing food to more than 97 million people in 80 countries last year. WFP crosses some of the toughest terrain on the planet to get food to hungry people. On any given day, WFP operates an average of 50 aircrafts, 30 ships and 5,000 trucks. With its own fleet of airplanes, ships and logistics staff, the WFP staff frequently risk their lives to reach those with the highest risk of starvation.

WFP also provides school meals to more than 24 million children each year. School meals help to improve children’s nutrition, ability to learn and life chances. School feeding also gives poor families an incentive to send children to school, especially girls.

School lunch program in Kibera, Kenya

School lunch program in Kibera, Kenya

Food insecurity, compared to “hunger” is a more complex condition. According to the FAO, its dimensions are a series of indicators including food availability, access, utilization and stability. Asia has the largest number of hungry people (over 500 million) but Sub-Saharan Africa has the highest prevalence (24.8 percent of population). Three-quarters of all hungry people live in rural areas, mainly in the villages of Asia and Africa. Overwhelmingly dependent on agriculture for their food, these populations have no alternative source of income or employment.

FAO calculates that around half of the world’s hungry people are from smallholder farming communities, surviving off marginal lands prone to natural disasters like drought or flood. Another 20 percent belong to landless families dependent on farming and about 10 percent live in communities whose livelihoods depend on herding, fishing or forest resources.

The remaining 20 percent live in shanty towns on the periphery of the biggest cities in developing countries. The numbers of poor and hungry city dwellers are rising rapidly along with the world’s total urban population.

This brings us full circle. In order to dramatically decrease food insecurity, we need to help smallholder farmers boost production.

“Half of those who are food insecure are smallholder farmers.”

–Rick Leach, President, WFP-USA

Howard Buffett hit the nail on the head when he said, “Small-scale farmers play a crucial role in fighting global hunger and poverty, both for their own families and for the regions in which they live.” For that reason, the effort to help smallholder farmers is fast becoming the focus of attention in the fight to eliminate food insecurity:

  • Feed the Future, the U.S. Government’s global hunger and food security initiative, supports country-driven approaches to address the root causes of hunger and poverty. Through this Presidential initiative, the United States is helping countries transform their own agricultural sectors to grow enough food to sustainably feed their people.
  • In 2012, the G-8 (now G-7) committed to working with our African and other international partners to launch a New Alliance for Food Security and Nutrition in order to accelerate the flow of private capital to African agriculture, take to scale new technologies and other innovations that can increase sustainable agricultural productivity, and reduce the risk borne by vulnerable economies and communities.
  • The African Union’s Comprehensive Africa Agriculture Development Programme (CAADP) program is urging all African governments to invest at least 10 percent of their national budgets in agriculture.
  • The Bill and Melinda Gates Foundation‘s agricultural development strategy is “premised on a hypothesis that it is possible for smallholder farmers to double and in some cases even triple their yields in the next 20 years while preserving the land. Increased productivity growth will contribute to overarching goals of hunger and poverty reduction.”
  • The Alliance for a Green Revolution in Africa is focused on assisting smallholder farmers across Africa.

According to the Office of Food Security at the State Department, we need to increase global food production by 70 percent before 2050. Women make up the majority of the agricultural workforce in many areas of the world. Yet today, for every investment we make in producing food, we fail to get the best results because MANY women lack the access they need to land, seeds, water, credit and markets.

The 2013 Millennium Development Goals Report says that the target of halving the percentage of people suffering from hunger and food insecurity is within reach. That is correct; with concerted action by national governments, international partners and the private sector focused on smallholder women farmers, the hunger target can be achieved.

The bottom line is that assisting smallholder farmers boost production is the key to both reducing food insecurity and at the same time improving economic development and political stability.  Africa, in particular, is on the cusp of dramatic change as it has over half of the world’s underutilized agricultural land.  We can do this!

Marshall Matz specializes in agriculture and global food security at OFW Law in Washington, D.C. He serves on the Board of Directors of the World Food Program—USA and the Congressional Hunger Center.  Before entering private practice, Marshall was General Counsel to the Senate Select Committee on Nutrition and Counsel to the Senate Committee on Agriculture. mmatz@ofwlaw.com