Tag: regulation

FWS Proposes New Conservation Measures in Advance of Potential Monarch Butterfly Listing

The Monarch Butterfly is a species of concern, but not currently “listed” as a threatened or endangered species under the Endangered Species Act. In advance of the potential, and some would say likely, listing of the Monarch Butterfly, the U.S. Fish and Wildlife Service (“FWS”) has published for public comment a program it hopes will attract landowners and developers in the butterfly’s anticipated habitat who wish to avoid future regulatory concerns related to the eventual listing of the butterfly. The program is available for public comments until June 14, 2019. More information on the program can be found here.

If accepted, non-federal landowners can voluntarily agree to undertake land management activities to support the conservation of the butterfly in exchange for assurances that no additional conservation measures or land, water, or resource use restrictions will be imposed under the Endangered Species Act. Benefits of this voluntary program include incidental take authorization should the butterfly become a listed species and positive public relations.

Examples of the proposed conservation measures include:

  1. Establishing and using native seed mixes containing a diversity of wildflowers including milk weed,

  2. Minimizing use of grazing in monarch habitat during peak breeding and migration periods,

  3. Removing woody plants in densely covered shrub areas and invasive plant species to promote grassland habitats,

  4. Sustaining idle lands with suitable habitat, and

  5. Using conservation mowing to enhance floral resources and habitat.

Please note the agreement includes activities supporting the operations of existing rights of ways and associated lands but not the construction of new pipelines.

 

© Steptoe & Johnson PLLC. All Rights Reserved.
This post was written by Laura M. Goldfarb of Steptoe & Johnson PLLC.
Read more Environmental news on our environmental type of law page.

CBD Risk Management

Advising companies on CBD (cannabidiol) risk management is made challenging by the rapid pace of developments and frequent confusion caused by often false or misleading online information. This article attempts to provide a concise analysis of critical CBD legal and risk management issues.

Do Not Conflate “Legality” under the 2018 Farm Bill with U.S. Food and Drug Laws

The 2018 Farm Bill, which was signed in to law in December 2018, exempts hemp and hemp-derived products, including hemp-derived CBD, from the Controlled Substances Act (CSA). In the lead-up to passage of the Farm Bill, there was widespread confusion in the public as to the extent of the “legality” of hemp-derived CBD, with many commentators and even some legal experts conflating legality under the CSA with legality under the Food Drug and Cosmetics Act (FDCA) and state food and drug laws. This confusion prompted former FDA Commissioner Scott Gottlieb to issue a public statement clarifying that Congress had explicitly preserved the FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the FDCA, regardless of whether they are derived from cannabis or hemp. 

Identify How the CBD Product Will Be Defined under the FDCA

A product containing a cannabinoid could be considered a drug, food, food additive, dietary supplement or cosmetic depending on how the product is marketed and sold. How aggressively these products are policed by FDA and state agencies depends on the nature of the product and how it is defined under the FDCA and state law.

CBD as “Food” or “Dietary Supplement”

FDA’s position since at least 2015 is that certain cannabinoids, including CBD, are impermissible additives that adulterate food and dietary supplements for both humans and animals. Under the FDCA’s drug exclusion rule, once a substance that was never previously in the food supply is (1) an active ingredient of an approved drug product or (2) an active ingredient of a product in clinical trials that have been made public, a food or supplement containing that substance cannot be shipped in interstate commerce. FDA has cited Epidiolex® as an example of a clinical investigation regarding CBD that has been made public. Epidiolex was approved by FDA in June 2018 for treatment of childhood seizures associated with two rare forms of epilepsy. FDA has therefore concluded that CBD products are in fact drugs and require FDA approval under the FDCA. The new drug-approval process is exorbitantly expensive; in 2016, the Journal of Health Economics estimated the average cost per approved drug at well over $1 billion.

CBD as a “Cosmetic”

Cosmetics are generally less heavily regulated by FDA than food or drugs, and until recently the agency has remained silent on the use of CBD in cosmetic products. On April 2, 2019, FDA provided much-needed insight, stating that although certain cosmetic ingredients are prohibited or restricted by regulation, “currently that is not the case for any cannabis or cannabis-derived ingredients.” However, FDA warned that no ingredient − including cannabis-derived ingredients – can be used in a cosmetic if “it causes the product to be adulterated or misbranded.” A cosmetic may be considered adulterated “if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling.” FDA cautions that a product may be considered both a cosmetic and a drug, even if it affects the appearance, if it is “intended to affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease.”

Several large national retailers, including CVS, Walgreens and Rite-Aid, recently announced they will begin selling CBD-infused cosmetics in certain stores.

FDA Currently Uses “Enforcement Discretion”

Other than issuing letters to companies that sell CBD-infused oils and food products warning them to refrain from making impermissible health claims, FDA has to date taken no other visible enforcement action in that regard. Former FDA Commissioner Scott Gottlieb recently testified before a Senate appropriations subcommittee that “we are using enforcement discretion right now,” and that “I will take enforcement action against CBD products that are on the market if manufacturers are making what I consider over the line claims.” This would certainly include the egregious health claims at issue in the recent warning letters, such as that CBD can cure cancer or prevent Alzheimer’s disease. Gottlieb nevertheless acknowledged that FDA has not taken action against numerous products on the market given its enforcement priorities and limited resources. He cautioned, however, that FDA’s lack of enforcement is “not an invitation for people to continue marketing these products.”

State Enforcement of CBD

Authorities in several states have stepped up enforcement actions, including unannounced inspections and CBD product embargos ordered by authorities in California, New York, Texas and other states. Several states and cities, including California, Maine, North Carolina, Ohio and New York City, have banned CBD-infused food products under state and local laws.

Notwithstanding this state-led crackdown, certain states are working to provide greater legal access to CBD products under state law. Lawmakers in California and Texas, for example, are working on bipartisan legislation to allow sales of CBD products in those states, notwithstanding FDA’s prohibition.

CBD’s Pathway to Legality

As a result of significant pressure by industry groups and members of Congress, FDA has signaled a willingness to consider a potential easing of restrictions on CBD. On April 2, 2019, FDA issued a press release that announced new steps for advancing the potential regulatory pathways for CBD products. The press release explains that FDA primarily is concerned that permitting widespread commercial availability of CBD products negatively impacts research that may otherwise be performed to support regulatory approval through FDA’s drug review process. Similarly, FDA does not want to incentivize patients to forgo appropriate medical treatment by substituting unapproved products for FDA-approved medicines. Also of concern is the potential for liver injury and cumulative exposure to CBD if accessed by consumers across a range of products.

Notwithstanding the intense pressure on FDA to fast-track the CBD approval process, without congressional action that exempts CBD from FDA’s regular rulemaking process, it is likely that the approval process for use of CBD in foods or supplements will take years. In Gottlieb’s recent Senate testimony, he explained that “we don’t have a clear route to allow [CBD] to be lawfully marketed short of promulgating new regulations.” He noted, however, that there is precedent for Congress to issue legislation in the context of a single ingredient, similar to prior legislation for human growth hormone. Gottlieb also has appeared to embrace the idea of legislation that classifies CBD according to defined concentration levels, whereby CBD would be classified as a dietary supplement up to a defined concentration threshold, above which it would be considered a pharmaceutical drug. This is similar to the way fish oil has been regulated.

A public hearing scheduled to take place on May 31, 2019, will cover a range of CBD-related topics, including (1) health and safety, (2) manufacturing and product quality and (3) marketing/labeling/sales. FDA is encouraging public comments and participation at the hearing.

Acting FDA Commissioner Ned Sharpless is now leading the agency. Some have expressed concern over how Sharpless will approach CBD because he is a former cancer drug researcher who has less experience with the dietary supplement and food regulation side of FDA’s mandate. According to a recent interview with former associate FDA Commissioner Peter Pitts, Sharpless is expected to manage the process already in place with respect to CBD for the time being.  How much attention Sharpless will give to CBD issues in the future “depends on the priorities and the new commissioner’s stomach for battle.”

CBD Risk Management … in the Meantime

Until the legal pathway for CBD is clear, companies that market most CBD products must tread carefully. Some, such as the large national retailers that recently announced the sale of CBD products, are focused on safer cosmetic products. Others choose to market and sell CBD-infused foods and supplements based on a higher appetite for risk and a “safety in numbers” assessment in the face of no visible FDA enforcement.

No matter how a company chooses to participate in the CBD industry, it must be counseled on FDA regulatory risk based on the product type in addition to the risks of marketing and selling CBD products on a state-by-state basis. Because the legality of CBD products varies widely by state and is changing so rapidly, providing accurate counsel can be a challenge. In addition, CBD product labels must be carefully reviewed for compliance under both federal and state law. Some states have specific and onerous labeling requirements for CBD products.

Although many companies tend to downplay the risk and potential financial severity of regulatory enforcement by federal or state agencies when it comes to CBD, they ignore at their own peril the risk presented by potential civil tort exposure. CBD products may be considered adulterated, contaminated or mislabeled under federal and state law. This may give rise to financially ruinous lawsuits, including consumer class actions or competitor suits that allege false advertising or unfair competition under state consumer protection statutes. It is essential for every CBD company to have a solid grasp of both the CBD regulatory risks and the unfair competition laws to fairly compete in the new CBD marketplace, and to avoid unwittingly being named as a defendant in an expensive and potentially company-ending lawsuit.

To this end, it also is important for any company that markets and sells CBD products to conduct an insurance coverage review with an attorney and broker that understand the nuances of the CBD insurance market. With passage of the 2018 Farm Bill, insurance coverage for hemp-derived products, including CBD, is expanding rapidly. Problematic endorsements and exclusions remain, however, with respect to limitations on coverage as a result of regulatory penalties, product seizures, resulting business interruption and tort damages premised on violations of law.

Most importantly, CBD risk management requires constant education and vigilance to stay abreast of an area of the law changing more rapidly than any other in recent history.

 

© 2019 Wilson Elser
This post was written by Ian A. Stewart of Wilson Elser. 
Read more on marijuana and CBD policy on the National Law Review’s Biotech page.

PFAS — What’s all the Fuss?

Recently, per- and polyfluoroalkyl substances (PFAS) have been the subject of much publicity, major ongoing litigation over alleged personal injury and property damage, and statutory and regulatory action. In Massachusetts and New Hampshire, contamination incidents, lawsuits, and concerns over drinking water impacts have led to proposals for adoption of extremely low (parts per trillion) drinking water guidelines or enforceable standards. Nationally, although there are drinking water “advisories,” the U.S. Environmental Protection Agency (EPA) is considering whether to start rulemaking to identify PFAS as “hazardous substances” under the federal Superfund law, and whether to adopt enforceable maximum contaminant levels as national drinking water standards.

What’s all the fuss? Although manufacturers stopped making two of the most well-known PFAS (PFOA and PFOS) over a decade ago, PFAS are a category of substances that includes hundreds of compounds, and a number of them appear to have toxic effects. PFAS had – and continue to have – a variety of uses in a multitude of products, and therefore have been manufactured or used (and sometimes released) at a large number of facilities. Commercial products have included, among others, cookware, food packaging, personal care products, and stain resistant chemicals for apparel and carpets. Industrial and commercial uses included photo imaging, metal plating, semiconductor coatings, firefighting aqueous film-forming foam, car wash solutions, and rubber and plastics. As a result, PFAS are present in the environment, and have been detected in certain drinking water systems. Further, PFAS are still being manufactured and used, but discharge of PFAS in air and water typically have not been regulated. PFAS also are highly mobile and highly persistent in the environment, and, therefore, will be present for scores of years.

Although the toxicological risks for many PFAS have not yet been determined with confidence, PFOA and PFOS have been tested fairly extensively. Manufacturers point out that not all PFAS have the same chemical structures and toxicity. Nevertheless, the Conservation Law Foundation and other environmental advocates are petitioning for regulation of the entire class.

Because PFAS haven’t yet fallen under most federal regulatory schemes, many states have been “filling the gap” with guidance and regulatory action. In Maine, PFAS are already the subject of guidance and regulations by the Maine Department of Environmental Protection (DEP). The most recent DEP Remedial Action Guidelines (RAGs, 2018) for PFOA, PFOS, and PFBS issued by Maine include:

  • Soil RAGs as low as 0.0095 ppm
  • Groundwater residential use RAG as low as 0.40 ppb
  • Fish tissue guidelines for recreational anglers as low as 0.052 ppm

And under DEP Chapter 418, Screening Levels for Beneficial Use have been set for certain PFAS as low as 0.0025 ppm.

It is clear there will be more regulation and legislation at federal and state levels. Further, litigation has commenced in a number of states (including Maine) for perceived or real damages from PFAS contamination under negligence and other tort theories.

What to do? Depending on where you sit, here are a few actions to consider.

  • If you are unsure whether you use PFAS, a limited review of safety data sheets may identify PFAS chemicals.
  • Determine if you stored, used, or currently use PFAS, and consider the potential toxicity of the specific compounds and potential impact of potential regulations.
  • If you stored or used PFAS in the past, consider whether there were potential releases or residuals that could pose health risks or liability risks.
  • If you are considering purchasing a business or real property, consider whether PFAS may have been used or released on site, and the potential risk and liability issues. Note that because PFAS are not federal “hazardous substances” they are not within the scope of the standard Phase I Environmental Site Assessment.
  • If you generate or ship wastes that may contain PFAS, consider voluntary testing and the possibility that testing may soon be requested or required.
  • If you use groundwater as drinking water or for production use, consider whether PFAS may be present from historic or recent uses.
  • Keep posted on national and state regulatory and legislative developments.
©2019 Pierce Atwood LLP. All rights reserved.
This post was written by Kenneth F. Gray and Thomas R. Doyle of Pierce Atwood LLP.

Lapse in Government Funding Continues to Affect FDA, USDA

As previously covered on this blog, without either a fiscal year 2019 appropriation or a Continuing Resolution, a partial government shutdown, which began on December 22, 2018, has continued to impact both the U.S. Department of Agriculture and the U.S. Food and Drug Administration. As of the time of this blog’s publication, the government has been partially shut down for over 20 days.

Most recently, in a Twitter thread, FDA Commissioner Scott Gottlieb noted that the agency stopped a limited number of domestic food inspections because of the shutdown, but the agency is, “taking steps to expand the scope of food safety surveillance inspections we’re doing during the shutdown to make sure we continue inspecting high risk food facilities.” Several commodities are deemed “high risk” and include: seafood, soft cheeses, fresh fruits and vegetables, spices, shell eggs, infant formula and medical foods. Gottlieb noted that the mechanism to expand the domestic inspections will be in place beginning the week of January 14.

As for the USDA, Senator Debbie Stabenow submitted a letter to the Secretary of Agriculture on January 9 requesting information on the impact that the shutdown is having on the agency, including the delay in implementing the recently-passed Farm Bill. As of the time of this publication, the Secretary has yet to respond. USDA put out a press release at the end of 2018 regarding activities that would be affected by the shutdown, but the department has not updated it since that time.

 

© 2019 Keller and Heckman LLP.
This post was contributed by Food and Drug Law at Keller and Heckman.
For more legal news on the Food and Drug Administration check out the National Law Review’s Biotech Food and Drug Type of law page.

Department of Education Unveils Proposed Title IX Regulations

On Friday, November 16, 2018, the Department of Education (DOE) released proposed Title IX regulations dictating the process by which colleges and universities must handle allegations of sexual misconduct.

Institutions of higher education have been in limbo since September 2017 when the DOE rescinded Obama-era guidance that called for hard-hitting enforcement of Title IX and issued interim guidance as a placeholder until they could engage in the formal rulemaking process. Today’s proposed regulations, if enacted, will take the place of the DOE’s September 2017 interim guidance.  According to the DOE, the new regulations would substantially decrease the number of investigations into complaints of sexual misconduct and save institutions millions over the next decade.

Many of the new regulations deviate significantly from prior guidance. The most significant changes increase the discretion given to universities in crafting procedures for adjudicating Title IX claims within their institutions.  The proposed guidance allows universities to choose the applicable evidentiary standard (either “preponderance of the evidence” or “clear and convincing evidence”) in determining responsibility, as long as it is consistent with the standard used in other student disciplinary matters.  The new regulations also permit the use of informal resolution processes to resolve sexual misconduct allegations if the parties agree.

Other notable provisions of the proposed regulations include the following:

  • The definition of “sexual harassment” has been more narrowly defined as “unwelcome conduct on the basis of sex that is so severe, pervasive and objectively offensive that it denies a person access to the school’s education program or activity.”
  • For purposes of administrative enforcement, universities would be held to a “deliberately indifferent” standard. In other words, to avoid liability, a university with “actual knowledge” of sexual harassment need only respond in a manner that is not “deliberately indifferent.” An institution would be found deliberately indifferent “only if its response to sexual harassment is clearly unreasonable in light of the known circumstances.”
  • “Actual knowledge” is defined in the proposed regulations as notice of sexual harassment or allegations of sexual harassment provided to an official of the institution “who has the authority to institute corrective measures on behalf of the [institution].” In contrast to prior guidance, this definition excludes most professors, administrators, and staff.
  • Under the proposed regulations, universities would no longer be allowed to investigate allegations of sexual harassment that occurred off-campus.
  • The proposed regulations would require universities to provide written notice to a respondent upon receipt of a complaint, which would include a statement that the responding party is presumed to be not responsible for the alleged conduct and that a determination of responsibility will be made at the end of the grievance process.
  • Live fact-finding hearings would be mandatory for universities under the new regulations. Investigators would also be precluded from serving as factfinders.  This would eliminate the use of the single investigator model currently used by many universities.
  • Universities must permit cross-examination of any party or witness by the opposing party’s advisor, but not by the party him/herself.  If a party or witness refuses to submit to cross-examination, that person’s testimony could not be relied on by the fact-finder. The party’s choice of advisor could not be limited by the institution of higher education.
  • Religious institutions of higher education would no longer be required to seek assurances of exemption from Title IX regulations in advance of a DOE investigation. Under the new regulations, a religious institution of higher education could invoke an exemption to Title IX’s requirements at any time during the investigation.

The new regulations address other topics such as constitutional issues and the intersection between Title IX and Title VII of the Civil Rights Act. They also clarify that, just as an institution’s treatment of a complaining party may constitute discrimination based on sex, an institution’s treatment of the responding party may also constitute discrimination based on sex. Institutions of higher education must continue to comply with all applicable state laws regarding sexual misconduct and sexual misconduct investigations.

Now that the proposed regulations have been published, the public has sixty days to submit comments before the regulations go into effect. The final regulations, however, are likely to closely mirror what has been proposed today, and colleges and universities should act immediately to carefully review their sexual misconduct policies and practices for compliance.

 

Jackson Lewis P.C. © 2018
This post was written by Susan D. Friedfel, Monica H. Khetarpal Marla N. Presley Crystal L. Tyler and Hobart J. Webster.

Army Corps of Engineers Issues Draft Guidance on Section 408 Permission Requests, Solicits Comments

On January 23,  2018, the United States Army Corps of Engineers (Corps) issued Draft Engineering Circular (EC) 1165-2-220, Policy and Procedural Guidance for Processing Requests to Alter U.S. Army Corps of Engineers Civil Works Projects Pursuant to 33 U.S.C. § 408 (Draft EC).  Comments on the draft circular are due March 7th, but there are reports that the comment deadline may be extended to April 6th.

The Draft EC,  once finalized, will replace existing guidance on the permission process required by Section 14 of the Rivers and Harbors Act of 1899, as amended and codified in 33 U.S.C. § 408 (Section 408).  The Draft EC consolidates existing guidance on Section 408 permissions and makes numerous changes to the existing guidance, including revising the test for when a Section 408 permission will be required, announcing general terms and standards that will be applied to all Section 408 permissions, and prescribing new timeframes for the Section 408 review process.  The comment period provides an opportunity for entities that need Section 408 permissions to address specific concerns with the Section 408 process and to advise the Corps on how to better streamline the Section 408 process.

Background

Section 408 requires that any proposed occupation or use of an existing Corps civil works project be authorized by the Secretary of the Army.  Examples of civil works projects include levees, dams, sea walls, bulkheads, jetties, dikes, wharfs, piers, and wetland restoration projects funded by or built by the Corps.  The Corps may grant such permission if it determines the alteration proposed will not be “injurious to the public interest” and “will not impair the usefulness” of the civil works project.  Under Corps policy, a Section 408 permission will not be issued before decisions on Clean Water Act Section 404 permits and Rivers and Harbors Act Section 10 permits are made.

Section 408 review may be required in a wide variety of situations.  For example, a Section 408 permission was required for the Dakota Access Pipeline, a crude oil pipeline, to cross 2.83 miles of federal flowage easements and approximately 0.21 miles of federally-owned property.  In addition, Section 408 review may be required where the Corps’ only connection to the project is funding, such as a wetland restoration project.

Section 408 permissions have become a significant issue in recent years because they have the potential to significantly delay projects.  The Corps has limited capacity to review Section 408 permission requests because such requests are not handled by the Corps’ regulatory program.  In the event that a Section 408 permission is required, the Corps may not have the staff resources to review the request unless the applicant pays for such a review.  Under the authority of Section 214 of the Water Resources and Development Act (WRDA) of 2000, the Corps may accept funds from non-Federal public entities to expedite the review and evaluation of a Section 408 request.  Under the 2016 WRDA, funding privileges were extended to certain private entities.  It should be noted that the recent Presidential “infrastructure legislative outline” that was released on January 12, 2018 along with the President’s budget would allow any non-federal entity to pay for expedited review and evaluation of a Section 408 request.

The Corps previously issued EC 1165-2-216 in 2014 on Section 408 permissions and since that time has issued a number of interim memoranda to improve the Section 408 permission process.  The Draft EC, once finalized, will replace EC 1165-2-216 as well as all interim memoranda, and will be effective for two years.

Proposed Changes to Section 408 Permission Process

Key changes proposed under the Draft EC include the following:

Program Governance Changes.  The Draft EC updates the Section 408 program governance.  It commits the Corps to conduct an internal audit of its decisions to examine whether Section 408 is being implemented consistently.  It provides for the creation of a database, which will be partially available to the public, as a tool for requestors to be informed about the status of their requests.

Section 408 Applicability Changes.  The Draft EC clarifies the geographical limitations on the applicability of the Section 408 permission process.  The Section 408 process applies to the lands and real property interests identified and acquired for a Corps project.  The Draft EC clarifies that, within navigable waters, the Section 408 process applies to alterations proposed to submerged lands and waters occupied or used by a Corps project.  The Draft EC process may be applied to alterations proposed in the vicinity of a Corps project that occur on or in submerged lands and waters that are subject to the navigation servitude.

The Draft EC clarifies how emergency situations should be addressed under Section 408.  Emergency alterations performed on a Corps project pursuant to Public Law (PL) 84-99 do not require a Section 408 permission, but urgent alterations that do not fit within the definition of emergency under PL 84-99 may require a Section 408 permission.  PL 84-99 authorizes the Corps to undertake activities, including disaster preparedness, “advance measures” to prevent or reduce flood damage from imminent threat of unusual flooding, emergency operations, rehabilitation of flood control works threatened or destroyed by flood, protection or repair of federally authorized shore protective works threatened or damaged by coastal storm, and provisions of emergency water due to drought or contaminated source.  The Draft EC indicates that when an alteration cannot be performed pursuant to PL 84-99, Corps districts can reprioritize and expedite reviews as appropriate given the urgency required for each specific situation.

The Draft EC identifies certain activities that will not require a Section 408 permission.  As under the existing guidance, non-federal sponsor activities that are included in an operation and maintenance (O&M) manual for the project do not require Section 408 permission.  The Draft EC also provides that a Section 408 permission is not required if a non-federal sponsor is performing activities on a Corps project that restores such project to the physical dimensions and design of the constructed project.  Although a Section 408 permission will not be required, the project sponsor may still need to coordinate with the Corps.  In addition, under the Draft EC, a Section 408 permission is not required for geotechnical explorations that comply with the Corps’ drilling requirements.

The Draft EC recognizes that the requirements of Section 408 may be fulfilled by another process.  For example, where a project requires a real estate outgrant—an authorization of the use of real property managed by the Corps—or a Rivers and Harbors Act of 1899 Section 10 permit that covers the same scope and jurisdiction as a Section 408 permission, a separate Section 408 permission is not required.  What is not addressed in the Draft EC is whether a Section 408 permission will be required to conduct O&M on a non-Corps project for which a Section 10 was previously issued.

Procedural Changes.  The Draft EC identifies new procedures for seeking a Section 408 permission.  Under the existing guidance, there are two options for review under Section 408—a single-phase review and a categorical review.  In a single-phase review, all information for a Section 408 permission is submitted at the same time.  In a categorical review, the Corps performs an analysis of impacts and environmental compliance in advance for a common category of activities.  When a Section 408 permission request meets the criteria of the categorical permission, the Section 408 permission may be granted under a simplified validation process.  To add flexibility, particularly for projects that involve multiple stages of engineering or construction, the new guidance allows for a multi-phased review.  The Draft EC also removes the requirement that plans and specifications be, at a minimum, 60% complete to initiate the Section 408 review process.

The Draft EC incorporates new timelines for a Section 408 review that are provided in the 2016 WRDA.  When a Corps district receives a Section 408 request, the district must respond within 30 days, informing the requestor that the submission was complete or specifying what additional information is required.  The Draft EC does not speak to the Corps’ failure to respond within 30 days.  If a completeness determination is made, the Corps district has 90 days to render a decision.  If the district cannot meet the 90 day timeline, it can provide an estimated date of a final decision.  If that estimate extends beyond 120 days, the Corps must provide congressional reporting.

Click here for a side-by-side chart comparing the Draft EC to the legislative provision on Section 408 developed by our firm’s Corps Reform Working Group and the legislative provisions on Section 408 that are contained in the President’s “infrastructure legislative outline”.

 

© 2018 Van Ness Feldman LLP
This post was written by Jenna R. Mandell-Rice and Brent Carson of Van Ness Feldman LLP.

A short United States Department of Justice memorandum with big legal consequences

On Jan. 25, 2018, the United States Department of Justice (U.S. DOJ) issued a memorandum limiting the use of federal agency guidance documents in civil enforcement actions that could have far reaching consequences in the private sector. See here.

Under the directives contained in this memorandum, U.S. DOJ attorneys are instructed not to use noncompliance with federal agency guidance documents that have not gone through formal rule-making under the Administrative Procedures Act as evidence of violations of applicable law in federal civil enforcement actions. In particular, the U.S. DOJ instructs its attorneys that they may not use a private party’s noncompliance with an agency guidance document for presumptively or conclusively establishing that a party violated an applicable statute or rule that an agency has delegated authority to implement. The memorandum continues by saying “[t]hat a party fails to comply with agency guidance expanding upon statutory or regulatory requirements does not mean that the party violated those underlying legal requirements; agency guidance documents cannot create any additional legal obligations.”

In the past, federal agency guidance policy has been used by agencies as well as the U.S. Department of Justice as evidence of whether a regulated party has complied with federal statutes. For example, this use of guidance policies for enforcement decision has been regularly used by numerous federal agencies, such as the EPA, OSHA, SEC, Labor, the Treasury, FTC and many other federal agencies, in referring matters to the U.S. DOJ for enforcement of the federal statutes and regulations that these agencies have delegated authority to administer.

The U.S. DOJ memorandum will provide creative lawyers with new ammunition for negotiation with federal agencies when those agencies use noncompliance with their guidance as evidence of violations of laws that carry significant civil penalties for such actions. In addition, these same creative lawyers in the private sector will use the memorandum as evidence that a federal agency should not use guidance documents as evidence for important agency decision making such as permit decision making or related important agency decisions that have important consequences for the regulated community.

 

Copyright © 2018 Godfrey & Kahn S.C.
This post was written by Arthur J. Harrington of Godfrey & Kahn S.C.
Read more of the National Law Review’s  Coverage of Government Regulations.

Illinois Employers Face A Recent Rash of Class Action Lawsuits Filed Under State Biometric Information Privacy Law

Illinois enacted its Biometric Information Privacy Act (“BIPA”) in 2008 to regulate, among other things, employer collection and use of employee biometric information.  Biometrics is defined as the measurement and analysis of physical and behavioral characteristics.  This analysis produces biometric identifiers that include things like fingerprints, iris or face scans, and voiceprints, all of which can be used in a variety of ways, including for security, timekeeping, and employer wellness programs.

Illinois is not the only state with a biometrics privacy law on its books, however, its version is considered the nation’s most stringent.  BIPA requires a business that collects and uses biometric data to protect the data in the same manner it protects other sensitive or confidential information; to establish data retention and destruction procedures, including temporal limitations of three years; to publish policies outlining its biometric data collection and use procedures; and to obtain prior, informed consent from any individuals from whom it plans to obtain and use biometric data.   The statute also requires  businesses to notify employees in the event of a data breach.

Protection of biometric data is viewed as critical because, unlike passwords comprised of letters, numbers, or typographical characters, biometric data is unique and cannot be replaced or updated in the event of a breach.  Technology now allows biometric data to be captured surreptitiously, such as recording a voice over the phone, or face mapping individuals in a crowd or through photographs, increasing the risk for its theft or unauthorized or at least, unknown, use.  In fact, these more furtive methods of collecting and using biometric data is what led to the filing of five BIPA class action lawsuits in 2015 – four against Facebook, and one against online photo website Shutterfly – that alleged these companies used facial recognition software to analyze online posts, but did not comply with BIPA’s consent or other procedural requirements.  These first lawsuits brought attention to the private right of action authorized under BIPA, which provides that any “aggrieved” person may sue and recover $1,000 for each negligent violation and $5,000 for each intentional or reckless violation, or, in both circumstances, actual damages if greater than the statutory damages.  Prevailing parties may also recover their attorneys’ fees and costs.

The plaintiffs’ employment bar recently has gotten seriously into the BIPA class action game; since August 2017, approximately 30 lawsuits have been filed in Cook County, Illinois (where Chicago is), alone.  These putative class actions have been filed against employers in many industries including gas stations, restaurants, and retail, and typically involve the employer’s use of fingerprint operated time clocks.  The cases allege that the defendant employers failed to obtain proper informed consent or fail to maintain and inform employees about policies on the company’s use, storage, and destruction of biometric data.  Many of these lawsuits also allege the employer companies have improperly shared employee biometric data with third-party time clock vendors, and some even name the vendor as a defendant.

In addition to the obvious cost of class action litigation, these suits present additional legal challenges because many aspects of BIPA remain untested.  For example, the statutory term “aggrieved” person leaves open the question whether a plaintiff must be able to prove actual harm in order to recover.  The U.S. District Court for the Northern District of Illinois and U.S. District Court for the Southern District of New York both have dismissed BIPA suits for lack of standing where the plaintiffs did not allege actual harm.  The latter case, Santana v. Take-Two Interactive Software, is currently before the United States Court of Appeals for the Second Circuit, which heard oral argument in October 2017, but has not yet issued its ruling.   Other aspects of BIPA also remain in flux – such as whether facial recognition through photography is biometric data, as defined under the statute, and what forms of consent are compliant.  On the other side, defendants are challenging the constitutionality of the damages provisions, arguing that their potentially disproportionate nature to any actual harm violates due process.  As these issues are flushed out under BIPA, they are certain to affect other states who have already enacted, or may seek to enact, laws regarding use of biometric data.

This post was written by Daniel B. Pasternak of Squire Patton Boggs (US) LLP., © Copyright 2017
For more Labor & Employment legal analysis go to The National Law Review 

FDA Issues Final Regulations Easing the Path for Direct-to-Consumer Genetic Testing

New regulations issued on November 7, 2017 by FDA will make it easier for companies to offer certain types of genetic tests directly-to-consumers, without a health-care provider intermediary.

The first regulation finalizes a new medical device classification for “autosomal recessive carrier screening gene mutation detection systems.”  This regulation essentially codifies classification already established by FDA in response to a request by 23andMe, and  enables other laboratories to offer their DTC tests according to the criteria specified in the classification regulation.  These tests may be offered without the need for FDA premarket review.

Similarly, the second regulation finalizes a new medical device classification for  DTC “genetic health risk assessment” (GHR)  (i.e., predictive) tests.  The classification specifies the conditions under which these tests may be marketed, and includes the requirement for a 510(k) premarket notification to FDA. However, in a Federal Register Notice, also issued yesterday, FDA proposes to exempt GHR tests from the 510(k) premarket submission requirement after a lab has successfully obtained FDA clearance of its first GHR assay.  Comments to this proposed exemption are being accepted by FDA until January 8. 

This post was written by Gail H. Javitt of Epstein Becker & Green, P.C. All rights reserved., ©2017
For more Health Care legal analysis, go to The National Law Review