OFCCP Reduces Veteran Hiring Benchmark

OFCCPOn June 16th, Office of Federal Contract Compliance Programs, OFCCP, announced that, effective March 4, 2016, the annual hiring benchmark for veterans pursuant to Vietnam Era Veterans’ Readjustment Assistance Act, VEVRAA,regulation is 6.9%.  This is a slight decrease from last year’s 7.0% benchmark.

As part of the release OFCCP clarified that

“Contractors who adopted the previous year’s national benchmark of 7 percent after March 4, 2016, but prior to this announcement may keep their benchmark at 7 percent.”

The agency noted that going forward the effective date for the annual benchmark will match the date the Bureau of Labor Statistics publishes the data from which OFCCP calculates the benchmark.  This usually takes place in March every year.

Jackson Lewis P.C. © 2016

Supreme Court: False Claims Act & Materiality Requirement

False claims act Supreme courtThe U.S. Supreme Court has rendered a unanimous decision in the hotly-awaited False Claims Act case of Universal Health Services v. United States ex rel. Escobar.  This case squarely presented the issue of whether liability may be based on the so-called “implied false certification” theory.  Universal Health Service’s (“UHS) problem originated when it was discovered that its contractor’s employees who were providing mental health services and medication were not actually licensed to do so. The relator and government alleged that UHS had filed false claims for payment because they did not disclose this fact and thus had impliedly certified that it was in compliance with all laws, regulations, etc.  The District Court granted UHS’s motion to dismiss because no regulation that was violated was a material condition of payment. The United States Court of Appeals for the First Circuit reversed, holding that every submission of a claim implicitly represents regulatory compliance and that the regulations themselves provided conclusive evidence that compliance was a material condition of payment because the regulations expressly required facilities to adequately supervise staff as a condition of payment.

The Supreme Court vacated and remanded the matter in a manner that represents a compromise view of implied false certification.

The Court recognized the vitality of the implied false certification theory but also held that the First Circuit erred in adopting the government’s expansive view that any statutory, regulatory, or contractual violation is material so long as the defendant knows that the Government would be entitled to refuse payment were it aware of the violation.

Instead, the Court held that the claims at issue may be actionable because they do more than merely demand payment; they fall squarely within the rule that representations that state the truth only so far as it goes, while omitting critical qualifying information, can be actionable misrepresentations.   Here, UHS and its contractor, both in fact and through the billing codes it used, represented that it had provided specific types of treatment by credentialed personnel.  These were misrepresentations and liability did not turn upon whether those requirements were expressly designated as conditions of payment.

The Court next turned to the False Claims Act’s materiality requirement, and stated that statutory, regulatory, and contractual requirements are not automatically material even if they are labeled conditions of payment. Nor is the restriction supported by the Act’s scienter requirement. A defendant can have “actual knowledge” that a condition is material even if the Government does not expressly call it a condition of payment. What matters is not the label that the Government attaches to a requirement, but whether the defendant knowingly violated a requirement that the defendant knows is material to the Government’s payment decision.

The FCA’s materiality requirement is demanding. An undisclosed fact is material if, for instance, “[n]o one can say with reason that the plaintiff would have signed this contract if informed of the likelihood” of the undisclosed fact.   When evaluating the FCA’s materiality requirement, the Government’s decision to expressly identify a provision as a condition of payment is relevant, but not automatically dispositive. A misrepresentation cannot be deemed material merely because the Government designates compliance with a particular requirement as a condition of payment. Nor is the Government’s option to decline to pay if it knew of the defendant’s noncompliance sufficient for a finding of materiality. Materiality also cannot be found where noncompliance is minor or insubstantial.

Moreover, if the Government pays a particular claim in full despite its actual knowledge that certain requirements were violated, that is very strong evidence that those requirements are not material. The FCA thus does not support the Government’s and First Circuit’s expansive view that any statutory, regulatory, or contractual violation is material so long as the defendant knows that the Government would be entitled to refuse payment were it aware of the violation.

The materiality requirement, stringently interpreted, and the fact that the First Circuit’s expansive view was rejected suggest that the game is far from over and that there still are viable defenses, facts allowing, to cases premised upon the implied false certification theory.

©2016 Epstein Becker & Green, P.C. All rights reserved.

Informed Consent and Health Information Security Essential: New American Medical Association Guidelines for Telemedicine

american medical associationOn June 13, 2016, the American Medical Association (AMA) approved new ethical guidelines pertaining to the appropriate use of audio-video technologies to connect with and treat patients remotely. Through these guidelines, the AMA advocates for greater use of telemedicine by physicians while concomitantly encouraging such providers to inform patients regarding the limitations of any technology, including explaining the capabilities and limitations of such services and documenting the same. Further, the new AMA guidance emphasizes the need for appropriate protocols to prevent unauthorized access and to protect the security and integrity of patient information obtained through telemedicine or disseminated to subsequent health care providers following a telemedicine encounter.

The new ethical guidelines will be codified in Opinion E-5.025, “Physician Advisory or Referral Services by Telecommunication,” and Opinion E-5.027, “Use of Health-Related Online Sites.” Through these guidelines, physicians who provide telemedicine services to patients remotely should:

(a) Inform prospective patients about the limitations of the telemedicine relationship and services.

(b) Advise prospective patients regarding the potential need for follow-up care as indicated.

(c) Encourage patients who have existing primary care providers to inform such physicians about the patient’s receipt of telemedicine consultations and services, even if subsequent in-person care is not immediately needed.

(d) Be proficient in the use of relevant technologies.

(e) Recognize the limitations of such technologies and take appropriately steps to overcome or address any such limitations.

(f) Prudently perform appropriate diagnostic evaluations or prescribe medications by:

  • Establishing the patient’s identity;
  • Confirming that the telemedicine services are appropriate for that patient’s individual situation and medical needs;
  • Evaluating the indication, appropriateness and safety of any prescriptive medication in accordance with best practices and state prescriptive formularies; and
  • Sufficiently documenting the clinical evaluation and prescription and a medical record.

(g) Obtain an appropriately documented informed consent regarding the distinctive features of telemedicine in addition to information regarding the specific medical issues and treatment options.

(h) Take appropriate steps to preserve continuity of care, including giving consideration to the preservation of information and accessibility of such information for subsequent providers.

In addition to disseminating the above guidelines – violation of which could expose a physician to professional licensure sanction by state licensing boards – the AMA is encouraging physicians to collectively advocate for the access of telehealth and telemedicine services for all patients who could benefit from receiving care electronically. The AMA is similarly advocating for professional organizations and institutions to monitor telehealth and telemedicine developments to identify and proactively address both positive and negative outcomes to bring about further improvement in such technologies.

In light of the AMA’s advocacy of telehealth and telemedicine, such support could lead to relaxed restrictions on physician’s use of such technology to treat patients remotely and encourage greater levels of reimbursement by Medicare, Medicaid and private insurers for such treatment. Nonetheless, physicians should recognize that their fundamental duties to ensure patient safety and quality of care are not lessened when providing services via telehealth and telemedicine. Moreover, physicians should also be cognizant that the AMA guidelines do not supersede or displace state laws pertaining to telehealth and telemedicine; rather, the guidelines complement such regulations.

© 2016 Dinsmore & Shohl LLP. All rights reserved.

Los Angeles Employers Must Pay Higher Minimum Wages And Provide Expanded Paid Sick Leave

higher minimum wagesOn July 1, 2016, employers who have more than 25 employees performing some work in the City of Los Angeles (the “City”) will need to provide higher minimum wages and six paid sick days per year. Employers with fewer workers in the City will need to expand sick leave benefits by July 1, 2016, but they will not be subject to minimum wage hikes until the same day next year.

Earlier this month, the City Council passed the Los Angeles Minimum Wage Ordinance (Ordinance No. 184320) (the “City Ordinance”) requiring employers to pay a higher minimum wage and provide more sick leave benefits than state law. A summary of the City Ordinance is below, but employers with questions regarding compliance should contact their employment counsel.

Minimum Wage Increases

The City Ordinance raises the minimum wage as follows:

26 Employees
Or More 

25 Employees 

Or Less

July 1, 2016

$10.50

$10.00

July 1, 2017

$12.00

$10.50

July 1, 2018

$13.25

$12.00

July 1, 2019

$14.25

$13.25

July 1, 2020

$15.00

$14.25

July 1, 2021

$15.00

$15.00

On July 1, 2022, and every following year, the minimum wage will increase based on the Consumer Price Index for Urban Wage Earners and Clerical Workers for the City’s metropolitan area. Beginning in 2022, the City’s Office of Wage Standards of the Bureau of Contract Administration will publish additional minimum wage increases on February 1 of each year, with the increases taking effect on July 1 of each year.

Notably, this new law defines “Employee” as a person who: (1) “in a particular week performs at least two hours of work within the geographic boundaries of the City for an Employer”; and (2) qualifies as an employee entitled to receive the state-mandated minimum wage. The average number of Employees, as defined above, for the previous calendar year will be used to determine the size of an employer. Any new employer must count the total number of Employees, as defined above, during its first pay period.

The City Ordinance requires increases to the minimum wage sooner than the anticipated raises in California’s state-wide minimum wage, which will be set for employers with more than 25 employees to $10.50 on January 1, 2017, with gradual increases to ultimately $15.00 per hour on January 1, 2022. For smaller employers (25 employees or less) the gradual increases in state-wide minimum wage (much like the City Ordinance) will be delayed one year. Employers with exempt employees, however, should note that local minimum wage hikes (such as the City Ordinance) do not affect the minimum salary requirements to qualify for various wage and hour exemptions under state law. For example, the executive, administrative and professional exemptions—which permit employers to pay certain qualifying employees a salary instead of hourly wages with overtime—require a minimum monthly salary equivalent of at least twice the state-wide minimum wage.

The law also contains special provisions for nonprofit and transitional employers as well as for employers with employees who are 14 to 17 years old.

Expansion of Paid Sick Leave

The ordinance also provides six paid sick days (instead of the state-mandated three days) to Employees who, on or after July 1, 2016, work in the City for the same employer for 30 days or more within a year from his or her employment start date. The main requirements include:

  • Paid sick leave must accrue on the first day of employment, or July 1, 2016, whichever is later;

  • An Employee may use paid sick leave beginning on the 90th day of employment, or July 1, 2016, whichever is later;

  • An Employee may take up to 48 hours (i.e., six work days) of sick leave for themselves, a family member, or “any individual related by blood or affinity whose close association with the employee is the equivalent of a family relationship” in each year of employment, calendar year, or 12 month period;

  • Employers must provide paid sick leave either by: (1) granting the entire 48 hours to an Employee at the beginning of each year of employment, calendar year, or 12-month period; or (2) using an accrual rate of one hour of paid sick leave for every 30 hours worked;

  • If an employer has a paid leave or paid time off policy (or provides payment for compensated time off) that is at least 48 hours, no additional time is required;

  • Accrued unused paid sick leave must carry over to the next year, but employers may implement a cap of at least 72 hours;

  • An employer may require an Employee to provide reasonable documentation of the reason for sick leave (though employers still must be cautious of state medical privacy laws);

  • Like state law, accrued unused paid sick leave is not payable upon termination of employment; and

  • If the Employee separates from employment and then is rehired within one year, then the employer must reinstate the Employee’s previously accrued and unused paid sick leave.

A separate but related ordinance (the Los Angeles Office of Wage Standards Ordinance, Ordinance No. 184319) passed by the City provides for restitution and additional penalties for failure to comply with the above standards, and it also requires every Employer to post the notice published each year by the Office of Wage Standards. The notice must be in English, Spanish, Chinese (Cantonese and Mandarin), Hindi, Vietnamese, Tagalog, Korean, Japanese, Thai, Armenian, Russian and Farsi, and any other language spoken by at least five percent of the Employees at the workplace. This notice can be found online at: http://wagesla.lacity.org/.

Microsoft Acquiring LinkedIn as Move into Enterprise Social Media

Linkedin MicrosoftMicrosoft has announced that it is buying LinkedIn for $26.2 billion, one of the largest tech acquisitions in history, and that it intends to use the business social media giant to put Microsoft at the center of our work lives.

Currently, LinkedIn has 433 million members in 200 countries. Microsoft has 1.28 billion Office users worldwide. Microsoft CEO Satya Nadella said in an interview with Bloomberg:

“This is about the coming together of the leading professional cloud and the leading professional network. This is the logical next step to take. We believe we can accelerate that by making LinkedIn the social fabric for all of Office.”

Nadella said that Microsoft’s vision is to place your LinkedIn profile at the center of your online work life, connecting it with Windows, Outlook, Skype, PowerPoint and other Microsoft products.

For example, Cortana (Microsoft’s digital assistant) could provide users with information on other participants in an upcoming meeting by pulling data from LinkedIn profiles. Members working on a project could pull up LinkedIn articles concerning their project or use LinkedIn profiles to search for an “expert” to help with the project.

Microsoft also sees LinkedIn playing a major role in developing a new customer relationship management (CRM) tool for sales organizations. LinkedIn analytics could be integrated with Microsoft’s Dynamics tool, which competes with Salesforce.com, to assist companies with managing their customers.

Here’s a CNBC interview with Nadella and LinkedIn CEO Jeff Weiner explaining the opportunities.

© The Rainmaker Institute, All Rights Reserved

“KIND” of Nutritious—FDA Permits “Healthy” Label and Agrees to Rethink Its Definition of “Healthy” Foods

kind bar healthyThe Food and Drug Administration has kindly permitted Kind LLC to use the term “healthy” on its snack bars again, but with the caveat that the term must only be used in text clearly presented as part of Kind’s corporate philosophy, and not as a claim about the products’ nutrient content.

In March 2015, the FDA issued a warning letter to Kind, concerning four of Kind’s snack bars which the FDA said were misbranded as “healthy.” According to the FDA, the Kind snack bars at issue, which contain fruits and nuts among other things, contain more fat and saturated fat than the FDA’s definition of “healthy” allows.  Moreover, the FDA said, the product labels claimed the bars were rich in antioxidants, had no trans fats, and were good sources of fiber without including certain necessary disclosures. The FDA says that after receiving this warning, Kind took corrective actions, including removing and amending certain nutritional content claims on its packaging and labeling. Kind then returned to the FDA to confirm that it was not barred from using the phrase “healthy and tasty” in text “clearly presented as its corporate philosophy, where it isn’t represented as a nutrient content claim, and does not appear on the same display panel as nutrient content claims or nutrition information.”  The FDA agreed not only to this proposal, but also to reconsider how the agency defines “healthy” more generally in response to a citizen petition initiated by Kind in December 2015.

Kind’s citizen petition points out that the FDA’s definition of “healthy” is over 20 years old and excludes foods such as nuts, avocados, olives, and salmon, while embracing fat-free chocolate pudding and some sugary cereals. According to Kind, these outdated food labeling regulations focus on specific nutrient levels of proteins and fats rather than on the nutritional value of the whole foods. Kind therefore asked the FDA to update its existing food labeling requirements to be consistent with the 2010 Dietary Guidelines for Americans and the Scientific Report of the 2015 Dietary Guidelines Advisory Committee, and to amend the definition of “healthy” to emphasize the importance of overall nutrition quality of foods in their whole form rather than specific nutrient levels.  The FDA evidently did not think Kind’s arguments were entirely nutty and, in response, has indicated that it will soon be reexamining how it defines “healthy” food in light of evolving nutrition research, and will be seeking public comment on this issue.

For now, companies may be able to market their food products as part of a “healthy” corporate philosophy in the same manner that the FDA has sanctioned for Kind. But watch this space for more developments as the FDA rethinks what it means to eat healthy.

© 2016 Proskauer Rose LLP.

Supreme Court Stryker/Halo Decision Makes it Easier for Courts to Award Enhanced Damages In Patent Infringement Cases

The recent Supreme Court decisions in the Stryker and Halo cases just made it easier for courts to award enhanced damages in patent infringement cases, discarding Seagate’s “objective recklessness” test.

The Seagate Test

In 2007, the Federal Circuit announced a test for enhanced damages whereby a plaintiff seeking enhanced damages had to show that the infringement of his patent was “willful.”  In re Seagate Technology, LLC,  497 F. 3d, 1360, 1371.  The Federal Circuit set forth a two-part test to establish such willfulness: First, “a patentee must show by clear and convincing evidence that the infringer acted despite an objectively high likelihood that its actions constituted infringement of a valid patent,” without regard to “[t]he state of mind of the accused infringer.” Id., at 1371. This objectively defined risk is to be“determined by the record developed in the infringement proceedings.” Ibid. “Objective recklessness will not be found” at this first step if the accused infringer, during the infringement proceedings, “raised a ‘substantial question’ as to the validity or noninfringement of the patent.” That bar applied even if the defendant was unaware of the arguable defense when he acted.Supreme Court Patent infringement

Second, after establishing objective recklessness, a patentee had to show by clear and convincing evidence the risk of infringement “was either known or so obvious that it should have been known to the accused infringer.”Seagate, 497 F. 3d, at 1371. Only when both steps were satisfied could the district court proceed to consider whether to exercise its discretion to award enhanced damages. Ibid. 

Stryker / Halo Decisions Restore Courts’ Discretion to Award Enhanced Damages

The Supreme Court’s recent decision in the Stryker and Halo cases discarded the Seagate test and restored courts’ discretion to award enhanced damages.  The Court held “[t]he Seagate test is not consistent with §284.”  The relevant language of § 284 contains “no explicit limit or condition on when enhanced damages are appropriate, and this Court has emphasized that the “word ‘may’ clearly connotes discretion.”  So the Court found no explicit requirement for Seagate’s “objective recklessness” test.

The Court also found Seagate unnecessarily required a finding of “objective recklessness” even when wrongdoing was demonstrated by the facts of a case.  The Court also disagreed with Seagate’s requirement of a “clear and convincing evidence” standard for showing recklessness, and held that the proper standard for enhanced damages was a “preponderance of the evidence” — the same standard as for patent infringement determinations.

The Court explained that its decision did not contradict § 298, that failure to present advice to the court may not be used to prove willful infringement:

Section 298 provides that “[t]he failure of an infringer to obtain the advice of counsel” or “the failure of the infringer to present such adviceto the court or jury, may not be used to prove that the accused infringer willfully infringed.” 35 U.S.C. § 298. Respondents contend that the reference to willfulness reflects an endorsement of Seagate’s willfulness test. But willfulness has always been a part of patent law, before and after Seagate. Section 298 does not show that Congress ratifiedSeagate’s particular conception of willfulness. Rather, it simply addressed the fallout from the Federal Circuit’s opinion in Underwater Devices Inc. v. Morrison-Knudsen Co., 717 F. 2d 1380 (1983), which had imposed an “affirmative duty” to obtain advice of counsel prior to initiating any possible infringing activity, id., at 1389–1390. See, e.g., H. R. Rep. No. 112–98, pt. 1, p. 53 (2011).

Consequently, nine years after Seagate, the Supreme Court has made it easier for courts to make a determination of enhanced damages.  Time will tell if this decision will spur additional patent opinion practice, such as prior to the 2007 Seagate decision.

ARTICLE BY Timothy Bianchi of Schwegman, Lundberg & Woessner, P.A.
© 2016 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.

July 2016 Visa Bulletin Released

july 2016 visa bulletinProjections include EB-1 Cutoff Date for China and India, Slow EB-2 and EB-3 Movement, EB-4 Backlogs for Latin America to ease, and EB-5 China to advance slightly.

 

This week, the Department of State (DOS) has released the July 2016 Visa Bulletin. We are three months from the end of the fiscal year and the dwindling visa numbers remaining are likely to bring about tepid advancement in many employment-based categories before October. This Bulletin brings several particular items of note relating to the anticipated movement of final action dates:

  • For the first time in recent collective memory, the State Department is predicting that EB-1 (which is usually “Current”) will have a cutoff date “no later than September” for China and India, but becoming current again in October 2016. Worldwide is expected to remain Current through all relevant times.

  • In the EB-2 category, a date for Worldwide chargeability is likely to be “imposed by September” with a return to “current” in October. The State Department predicts that there will be no forward movement for China EB-2, and India EB-2 will only move one week beyond India EB-3.

  • Limited movement is predicted in EB-3, with the exceptions of India reaching early 2005 and Philippines reaching late 2009 or early 2010.

  • Mexico, El Salvador, Guatemala, Honduras, and Mexico face an EB-4 priority date of Jan. 1, 2010. Although this 6.5 year backlog may appear daunting, the State Department does caution the following:

Readers should be aware that the establishment of the Employment Fourth preference Final Action date of January 1, 2010 does not mean that applicants are now subject to a wait in excess of six years. That Final Action Date is intended only to stop any further use of numbers by applicants from those countries under the FY-2016 annual limit, not to indicate how long it will be before applicants will be eligible for final action.”

In October, Mexico EB-4 is projected to become current. El Salvador, Guatemala, and Honduras are anticipated to have a 2015 cutoff date.

  • In the EB-5 realm, China has not advanced from June 2016. The “best case” scenario is a March 1, 2014, cutoff date by September.

For those seeking to adjust status, The United States Citizenship and Immigration Service (USCIS) website indicates that the Application Final Action Dates chart must be used for filing Form I-485.

The July 2016 Final Action Dates for Employment-Based Applications are as follows:

July 2016 visa bulletin 1

Likewise, the July 2016 Dates for Filing are:

Jule 2016 visa bulletin 2

©2016 Greenberg Traurig, LLP. All rights reserved.

Lawmakers Continue Focus on TSA Wait Times, While House Spending Panel Approves TSA Funding for FY 2017; Government Officials React to Deadliest Shooting in US History, Worst Terror Attack Since 9/11

TSA wait linesLawmakers Continue Focus on TSA Wait Times, While House Spending Panel Approves TSA Funding for FY 2017

The House Appropriations Committee approved it draft FY 2017 homeland security appropriations measure on Thursday, June 9, including $7.6 billion for the Transportation Security Administration (TSA), $163 million more than in FY 2016 and $21.8 million greater than the Obama Administration’s FY 2017 budget request.  The House Appropriations Committee has yet to approve a request from the U.S. Department of Homeland Security (DHS) for an additional $28 million to help keep airport security lines under control during the ongoing summer travel season.  The Senate Appropriations Committee, which has already approved of its FY 2017 homeland security spending measure increasing funds for TSA, has also signed off on the reallocated funds, the second such request from DHS this year.

On June 7, the House of Representatives approved legislation, the Checkpoint Optimization and Efficiency Act of 2016 (H.R. 5338), aimed at shortening TSA wait times.  The measure would direct both the TSA Administrator and the Government Accountability Office (GAO) to review TSA’s staffing allocation model.  The Act also requires the TSA Administrator to take a number of actions related to the agency’s staffing and resource allocation.  Across the Capitol, TSA Administrator Peter Neffenger testified before a Senate Homeland Security and Governmental Affairs Committee hearing last week, where lawmakers encouraged the agency to increase access to PreCheck, an expedited security screening program.

This Week’s Hearings:

  • Tuesday, June 14: The House Homeland Security Committee Subcommittee on Border and Maritime Security will hold a hearing titled “Overstaying Their Welcome: National Security Risks Posed by Visa Overstays.”

  • Wednesday, June 15: The Senate Homeland Security Committee will hold a hearing titled “America’s Insatiable Demand for Drugs: Examining Alternative Approaches.”

  • Thursday, June 16: The Senate Judiciary Committee will hold a meeting to consider pending legislation and nominations.

Executive Branch Activity

Government Officials React to Deadliest Shooting in US History, Worst Terror Attack Since 9/11

President Barack Obama, senior Administration officials, and lawmakers reacted to the shooting at a crowded Orlando nightclub filled with members of the lesbian, gay, bisexual and transgender community.  As of Sunday night, the shooting, which ended with police storming the club after a three-hour stand-off, had left 50 dead and at least 53 injured.  Reports indicated the alleged shooter had pledged allegiance to ISIS, making it the United States’ worst terror attack since September 11, 2001, and the deadliest mass shooting in the country’s history.

President Obama delivered remarks from the White House early in the day, confirming he had met with his homeland security and national security advisors and assuring Americans that he has “directed that the full resources of the federal government be made available for this investigation.”  Congressman Mike McCaul (R-TX), Chairman of the House Homeland Security Committee, offered thoughts and prayers for the victims and thanked local law enforcement for their efforts responding to the attack, calling it “a sobering reminder that radical Islamists are targeting our country and our way of life.” Senator Ron Johnson (R-WI), Chairman of the Senate Homeland Security and Governmental Affairs Committee, echoed his House colleague, confirming that his committee “will work to support the federal role in investigating this terror attack and protecting against further threats.”  Secretary of Homeland Security Jeh Johnson stated that senior agency officials “are dedicated to investigating this tragedy, along with the FBI and our state and local partners, and supporting the Orlando community in the tragedy’s aftermath.”  Secretary Johnson canceled planned travel to Beijing in light of the attack.

© Copyright 2016 Squire Patton Boggs (US) LLP

Food Packaging: FSANZ Reports on Nanotechnology in Food Packaging Find No Health Risks

food packagingA review of scientific literature on exposure to nanoscale silicon dioxide, titanium dioxide, and silver in food, including from sources of food packaging, did not find any significant health risks, according to the results of a study which was recently commissioned by Food Standards Australia New Zealand (FSANZ).  The results of the study were published in two reports: Nanotechnologies in Food Packaging: an Exploratory Appraisal of Safety and Regulation and Potential Health Risks Associated with Nanotechnologies in Existing Food Additives.

The report on nanotechnologies in food packaging noted that current applications of nanomaterials in food packaging include:

  • Enhancement of barrier properties through the incorporation of nano-fillers (e.g., nano-clay)

  • “Active” food packaging, with controlled release of active substances such as antimicrobials to improve the shelf-life of food (e.g., nanosilver)

  • Improvement of physical characteristics to make the packaging more tensile, durable, or thermally stable (e.g., nano-titanium dioxide, titanium nitride)

The food packaging report states that no evidence was found in the literature review to indicate that nano-clay is likely to cause adverse effects on health when used in food packaging.  Further, the majority of migration studies on nanosilver have shown levels of migration of ionic silver into foods and food simulants below thresholds set by well-established scientific and regulatory bodies, such as the European Food Safety Authority’s (EFSA) specific migration limit (SML) of 0.05 mg Ag/kg food. Overall, the data reviewed for most of the studied nanomaterials in food packaging indicate that migration of intact nanoparticles from food packaging into food simulants is negligible, implying consumer exposure to these materials is likely to be low. The authors conclude that this suggests “there is low potential for safety issues related to the ‘nano-ness’ of the materials incorporated into food packaging.”

The report points out that the majority of the existing patents for nanomaterials originate in the United States.  No patents for nanomaterials in food packaging were identified in Australia and New Zealand, implying that domestically-sourced nanomaterials may not presently be used in food packaging applications in Australia or New Zealand; however, the report suggests that food and packaging materials incorporating imported nanomaterials may be used in Australia and New Zealand.

While neither report identified any health concerns from any of the nanotechnologies described, FSANZ did note that nanotechnology is a rapidly evolving field, and that the conclusions set forth in the reports may need to be revisited as the sophistication and application of nanotechnologies to food and food packaging continues to advance.

© 2016 Keller and Heckman LLP