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Focus on Regulation

DOJ and FTC Clarify Antitrust Implications of Cybersecurity Information Sharing

On April 10, 2014, the Department of Justice (“DOJ”) and Federal Trade Commission (“FTC”) issued a joint policy statement on the antitrust implications of sharing cybersecurity information to help facilitate the flow of cyberintelligence throughout the private sector. The statement addresses the long-standing concern that sharing cyberintelligence may violate antitrust law under certain circumstances and explains the analytical framework for such arrangements to make it clear that legitimate cyberintelligence exchanges will not raise antitrust issues.

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New FCC Task Force Gearing Up to Encourage Broadband-Enabled Healthcare Solutions

Last week the Federal Communications Commission (“FCC”) announced that its latest broadband focused healthcare project—the CONNECT2HEALTHFCC Task Force—was preparing to hold its first meetings to seek “broad and meaningful input” from stakeholders.  What remains to be seen is how this latest approach to solving the problem of improving consumer access to medical care through technology will fit into the agency’s already full roster of health-related initiatives. Continue Reading

Update on Developments Regarding the U.S. and EU Ukraine Related Sanctions

On Friday, 11 April 2014, the U.S. Treasury Department’s Office of Foreign Assets Control (OFAC) designated an additional seven individuals in Ukraine as being subject to U.S. sanctions. The following persons were designated: Aleksei Mikhailovich Chaliy, Mikhail Grigorevich Malyshev, Valery Kirillovich Medvedev, Rustam Ilmirovich Temirgaliev, Sergey Pavlovich Tsekov, Yuriy Gennadievych Zherebtsov, and Pyotr Anatoliyovych Zima. These individuals were already targeted by EU sanctions, illustrating an increasing overlap between EU and U.S. lists of designated persons.

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NEW EUROPEAN UNION CLINICAL TRIALS REGULATION ADOPTED ON 14 APRIL 2014

On 14 April 2014, a new Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (hereafter “Clinical Trials Regulation”) was adopted following a vote by the Council of the European Union (hereafter “Council”).  The Council voted in favour of the text adopted by the European Parliament on 2 April 2014.

The new Clinical Trials Regulation, which will replace the existing Clinical Trials Directive, introduces a complete overhaul of the existing regulation of clinical trials for medicinal products in the European Union (hereafter “EU”).  As a regulation, it will be directly binding in all EU Member States without the need for any national implementing legislation. Moreover, for harmonisation purposes this New Clinical Trials Regulation is expected to serve as a model for the on-going work by the European Parliament and the Council regarding the revisions of the EU medical devices regulatory framework.

The Clinical Trials Regulation is expected to enter into force six months following the full functionality of a new EU Database and single online EU Portal (hereafter “EU Portal”) created under the new Regulation.  However, the Regulation states that, in any event, it will enter into force no later than two years following its publication in the Official Journal of the European Union.

An outline of some of the most noteworthy changes concerning the conduct of clinical trials in the EU is provided below.

Coordinated authorization procedure

Under the existing Clinical Trials Directive, a clinical trial is approved by a competent national authority and an Ethics Committee in each EU Member State where the sponsor intended to conduct the clinical trial.  This authorization procedure is conducted in parallel in all relevant EU Member States.

The new Clinical Trials Regulation replaces these parallel national procedures with a coordinated procedure initiated through an EU Portal managed by the European Medicines Agency (hereafter “EMA”) in cooperation with the European Commission and the EU Member States.  All the competent authorities of the EU Member States involved in the assessment of the application for the authorisation of a clinical trial will be subject to strict deadlines for review.  This will include a provision for automatic authorisation of the clinical trial if the concerned EU Member States do not notify the Sponsor of their decision within the specific deadlines.

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U.S. Tax Reform Update: House Ways and Means Chairman Tax Reform Discussion Draft – Proposals That Impact Colleges and Universities

The building blocks for what could eventually form the base of U.S. tax reform include dramatic proposals that will impact universities and colleges. The 979-page “Tax Reform Act of 2014” discussion draft introduced by House Ways and Means Chairman Dave Camp (R-MI)in March 2014 is a comprehensive reform package that would reduce U.S. corporate and individual rates, reform U.S. international tax rules, and significantly alter the existing landscape of industry tax preferences.

As we noted in an earlier alert it is important to pay attention to these proposals as they will become possible offsets in any future tax bill, including a tax extenders bill.

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Secretary of the Interior’s Report on Landscape-Scale Mitigation Policy

Secretary of the Interior Sally Jewell has released a Departmental report—including multiple “Near Term Policy Deliverables”—which responds to Secretarial Order No. 3330 (October 31, 2013).  In her Order, the Secretary challenged the Department and its constituent agencies, acting through its Energy and Climate Change Task Force, to “develop a coordinated Department-wide strategy to strengthen mitigation practices”.

The Secretary’s Report, released on April 10, is more an aspirational policy framework than a definitive statement of new direction for mitigation practice across the Department’s several resource management agencies, including the U.S. Fish and Wildlife Service, the Bureau of Land Management, and the National Park Service.  Acknowledging that “the application and effectiveness of the mitigation hierarchy (i.e., avoid, minimize and mitigate) to date has been uneven and difficult to evaluate”, the Report seeks “(t)o address these challenges and improve mitigation practices while accommodating both infrastructure development and the conservation needs of America’s rapidly changing landscapes”.

Considerable attention is paid, appropriately, to innovative mitigation strategies which have emerged as the result of leadership outside the Federal establishment, where states, stakeholder groups and the private sector have contributed to the development of important new tools.  The Report identifies many of these, such as the Western Governors’ Association Crucial Habitat Assessment Tool (CHAT), in a section titled “Signs of Progress”.  Some stakeholders will object to the inclusion of the Range Wide Conservation Plan for the lesser prairie chicken as “proof of concept”, since this five-state collaboration with the private sector, based on CHAT, was largely ignored by the Department in its decision to list the bird as “threatened” under the Endangered Species Act.

The Report also includes a discussion of compensatory mitigation, including mitigation banking and in-lieu fee mitigation, which are being employed increasingly to account for the environmental impacts of infrastructure projects in sensitive areas.  Perhaps because of its focus on public lands and resources, the Report does not account for recent growth in private sector mitigation initiatives, or the utility of markets for ecosystem services to meet mitigation objectives.

The Report is mostly useful as a guide to future actions by which now-diverse agency programs will be brought into conformity with the Secretary’s objectives, including a new Department Manual Mitigation Chapter (Q3, 2014) and long-awaited revisions of Fish and Wildlife Service (Q4) and BLM (Q3) mitigation policies.

Sanctions and Export Control Alert

The Department of Commerce’s move was announced on 25 March 2014 on the website of the Bureau of Industry and Security (BIS), which administers the export licensing process for items on the Export Administration Regulations (EAR) Commerce Control List. The notice reads, “Since March 1, 2014, BIS has placed a hold on the issuance of licenses that would authorize the export or re-export of items to Russia. BIS will continue this practice until further notice.” No further details were provided in the notice, but a BIS official has confirmed that the policy applies to new license applications only; existing licenses remain valid and use of license exceptions is not impacted at this time. The official indicated that BIS anticipates issuing further guidance within a week, likely in the form of a website notice or an update to BIS’ FAQs. If necessary, a change to the EAR will be made.

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Read more on Ukraine and Russia Sanction Developments

FERC initiates rulemaking to align natural gas pipeline scheduling and RTO and ISO generation dispatch times and enhance flexibility of pipeline services

On 20 March 2014, the Federal Energy Regulatory Commission (Commission) issued a proposed rulemaking and two related orders designed to better align scheduling of gas flows with dispatch of electric generation and to improve flexibility associated with transportation of natural gas. The Commission’s actions come at an interesting time. As winter comes to a close, electricity customers in New England are experiencing a significant increase in electricity prices — increases that were not expected when ISO-New England met with the Commission last fall. The Commission’s orders appear to respond to conditions in New England, without specifically addressing whether these conditions are due in part to extreme-cold, pipeline constraints, disincentives to obtaining firm transportation capacity, or some combination of these and other factors.

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Supreme Court strikes down aggregate political contribution limits

Today the Supreme Court, in McCutcheon v. FEC, issued a ruling striking down the aggregate limits on individual campaign contributions under the Federal Election Campaign Act. By a 5-4 decision, the court found the restrictions to be a violation of First Amendment rights. Prior to today’s decision, individuals could contribute up to US$48,600.00 to all political candidates and US$74,600.00 to all political action committees and parties over a two-year election cycle period. Also, individuals were limited to a total of US$123,200.00 per election cycle to all candidates, political action committees, and party committees. The Supreme Court’s decision today strikes these limitations.

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EPA and Army Corps of Engineers issue proposed Clean Water Act jurisdiction rule

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On 25 March 2014, the U.S. Environmental Protection Agency (EPA) and the U.S. Army Corps of Engineers (Corps) released a joint proposed rule defining the jurisdictional reach of the Clean Water Act (CWA). The agencies also simultaneously issued an immediately effective interpretive rule to exempt a list of discrete agricultural conservation practices from CWA regulation under 33 U.S.C. § 1344(f)(1)(A). Federal regulatory authority under the CWA is limited to “navigable waters,” defined as “waters of the United States, including the territorial seas.” The proposed rule, if finalized, will offer a long-awaited update to the regulatory definition of jurisdictional “waters of the United States” — in particular, addressing when discharges of dredged and fill material will constitute discharges to such waters requiring a permit issued by the Corps. However, as described further below, it seems unlikely that a final rule modeled on this proposal would bring the clarity for regulated entities promised by the government.

The scope of CWA jurisdiction has been in some disarray since the Supreme Court’s 2006 decision in Rapanos v. United States. At that point, the relevant CWA regulations specified that “waters of the United States” categorically included tributaries to navigable waters and wetlands adjacent to tributaries, without providing a definition of “tributary” or a detailed explanation of the term “adjacent,” and without addressing the status of waters that are not direct tributaries to navigable waters. See 33 C.F.R. § 328.3; 40 C.F.R. § 122.2. This incomplete regulatory definition left the jurisdictional status of any non-navigable water and many wetlands uncertain. In Rapanos, a plurality of four justices endorsed a narrow reading of “waters of the United States” as including only “relatively permanent, standing or flowing bodies of water,” as opposed to “channels containing merely intermittent or ephemeral flow,” based on the plain meaning of the word “waters.” Meanwhile, Justice Kennedy, writing in concurrence, subscribed to a broader but less definitive interpretation of “waters of the United States,” centering on whether the water or wetland in question has a “significant nexus” to a traditional navigable water in that it “significantly affect[s] the chemical, physical, and biological integrity” of that downstream water, either alone or in combination with similarly situated waters.  Subsequent enforcement of the CWA has rested on a case-by-case analysis of whether the water in question satisfies either of these two tests.

The centerpiece of this proposed rule is a new definition of “waters of the United States” as categorically including two types of waters — (1) tributaries to traditional navigable waters, and (2) wetlands and waters adjacent to such tributaries and navigable waters — through a regulatory determination that would replace the existing case-specific jurisdictional determination process. A final rule in line with this proposal can be expected to facilitate more expansive administrative and judicial enforcement of the CWA (including citizen suits under 33 U.S.C. § 1365(a)(1)).

In general, this proposal would codify an extremely broad definition of “waters of the United States,” but without necessarily shedding light on where the line between jurisdictional waters and non-jurisdictional waters and other landscape features lies. For example, the term “tributary” would, according to the proposed rule, include any area with a bed, banks, and ordinary high water mark, regardless of how often water can be found there — a definition that is both difficult to square with the plain meaning of “waters” as outlined by the plurality in Rapanos and potentially impossible to apply in practice for a landowner or potential purchaser of property who may lack the extensive historical knowledge necessary to know whether any area of the property has on occasion contained water and should therefore be examined for the relevant physical features. Although the proposal ostensibly excludes “gullies, rills, and non-wetland swales” from this definition, EPA and the Corps have solicited comment on how to differentiate those features from jurisdictional tributaries, highlighting the difficulty of drawing any clear line between the two categories.

A similar issue arises with respect to “other waters” not categorically designated as jurisdictional. EPA and the Corps propose to assert jurisdiction over “other waters” based on a case-by-case determination of whether a water or wetland in that category has a “significant nexus” to a jurisdictional water, which under the proposed regulation means that, “either alone or in combination with other similarly situated waters in the region,” it “significantly affects the chemical, physical, or biological integrity of a [jurisdictional] water” in a way that is “more than speculative or insubstantial.” Among other ambiguous aspects of this analysis, which waters should be considered “similarly situated” is open to interpretation; it is a question that EPA has flagged for comment, but the proposed rule currently offers only the vague explanation that “similarly situated” waters are those that “perform similar functions and are located sufficiently close together or sufficiently close to a ‘water of the United States’ so that they can be evaluated as a single landscape unit.” If such ambiguities persist in the final regulation, the government would receive considerable deference in determining whether “other waters” are jurisdictional as long as its approach is not “plainly erroneous or inconsistent with the regulation,” Auer v. Robbins — potentially opening the door to EPA enforcement even where a regulated party has made a reasonable attempt to comply with unclear regulations. Even where an entity is able to discern the contours of the required analysis, conducting the equivalent of a watershed study to determine whether a given water or wetland is jurisdictional could be difficult, costly, and time consuming, yet — with no guidance as to how to determine whether the effects of the aggregated waters is “more than speculative or insubstantial” — ultimately inconclusive as to its jurisdictional status.

All told, this proposal offers the government an important tool to facilitate its CWA enforcement efforts, but its benefits to the regulated community are less evident. There are a number of aspects of the proposed rule that will require significant development if the resulting regulations are not to create effectively unbounded regulatory authority for EPA and the Corps. The government is accepting comment on the proposal for 90 days following the date of publication in the Federal Register.