FDA Denies Citizen Petition’s Request to Ban Marketing of Non-Absorbable Surgical Mesh Products for Transvaginal Repair of Pelvic Organ Prolapse

Covington BUrling Law Firm

 

On July 14, 2014, FDA publicly posted its response denying Public Citizen’s August 2011 citizen petition concerning the marketing of non-absorbable surgical mesh products for transvaginal repair of pelvic organ prolapse (POP).  In its response, FDA took the position that a ban or recall of POP devices is not warranted at this time.

As background, in August 2011, Public Citizen filed a citizen petition asserting that POP devices “offer no clinically significant benefits in comparison to surgical repairs for POP performed without placement of surgical mesh” and “have high rates of serious complications.”  Public Citizen requested that the agency take the following actions: (1) ban the marketing of all available non-absorbable surgical mesh products for transvaginal repair of POP; (2) order all manufacturers to recall these products; and (3) classify all new non-absorbable surgical mesh products for transvaginal repair of POP as class III devices and approve the products only under a premarket approval application (PMA).

In its response, dated May 1, 2014, FDA denied the citizen petition.  While the agency rejected Public Citizen’s call for a ban or recall of POP devices, FDA noted that it shares some of the concerns outlined in the citizen petition and is taking actions to address these concerns.  In addition, the agency also determined that “a citizen petition is not the appropriate mechanism for requesting a reclassification of a device.”

FDA explained that in September 2011, the agency convened an advisory committee meeting of the Obstetrics and Gynecology Devices Panel to discuss the safety and efficacy of transvaginal surgical mesh products used for repair of POP.  The Panel determined that “a favorable benefit-risk profile” for these devices “had not been well-established” and that the devices should be reclassified from class II to class III.  The Panel also recommended that manufacturers conduct postmarket studies of currently marketed surgical mesh products for transvaginal repair of POP.  As of May 2014, FDA had issued 126 postmarket surveillance orders to 33 manufacturers of these devices.

FDA explained that it has evaluated information from the Panel’s recommendations and the published scientific literature and has tentatively determined that the device should be reclassified as a class III device.  On May 1, 2014, FDA published a proposed order in the Federal Register to reclassify surgical mesh for transvaginal repair of POP from class II to class III.  On the same day, FDA published another proposed order in the Federal Register to require the filing of a PMA following the reclassification of the device to class III.  Thus, although FDA did not grant Public Citizen’s third request, the agency “initiated the process that could ultimately result” in reclassification of the device and the requirement to submit a PMA for these devices.

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Kentucky Supreme Court Approves Plugging Holes with Others' Piggy Banks using Budget Drafting

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Budget drafting is one of the most challenging, yet essential, functions of state governments. Unlike the federal government, which has the ability to run large deficits and print its own currency, almost every state – Kentucky included – has a statutory or Constitutional framework requiring a balanced budget. Every two years, the Commonwealth’s budget drafters utilize familiar methods to balance the ledger: debt restructuring, adjusting tax rates and spending levels, infusing federal funds and taxing new revenue sources. Another option, less understood by the public but increasingly utilized by Kentucky policy makers, is “sweeping” restricted funds. This controversial task has just been made easier thanks to a recent decision by the Kentucky Supreme Court. In a 5-2 opinion, the practice of sweeping regulatory accounts was declared lawful, meaning that lawmakers may continue to transfer fees and fines collected by state regulatory agencies to the General Fund without violating the Kentucky Constitution. The legality of sweeping funds that are generated by a statutory tax (rather than fines and fees) was not directly addressed by the Court, leaving open the possibility that the sweeping of such funds may yet be deemed unconstitutional.

As background, state regulatory agencies have the power to police certain occupations and activities in order to protect the health, welfare, and safety of the public. The cost of administering such regulation is borne by those in that occupation, who pay state-imposed fees and/or fines. Regulatory fees can only be levied to compensate an agency for issuing a license and playing a supervisory role over the profession; they cannot be used to generate state general fund revenue.The statutes that govern state agencies contain anti-lapse provisions that allow monies collected in one fiscal year to remain in the agency’s account for the next year. Further, Section 180 of the Kentucky Constitution provides that taxes must be levied with a specific, distinct purpose and cannot be devoted to any other purpose after collected.

Although the practice is not new, the genesis of this case was the passage of the 2008-2010 biennial budget in 2008. Pursuant to an Executive Order by Governor Beshear that year, and in response to a General Fund budget shortfall of hundreds of millions of dollars, anti-lapse provisions were suspended, and funds in certain agency accounts were transferred to the General Fund. Subsequently, two separate set of appellants brought suit, arguing that regulatory fees may only be used by the collecting agency for regulatory purposes, and that their transfer to the General Fund for general revenue purposes, in effect, converts them to taxes, in violation of the Kentucky Constitution.

The two cases made their way through the trial court and Court of Appeals and were then certified for discretionary review at the Kentucky Supreme Court. Because they presented similar issues, the Court consolidated their review and issued a single opinion.

At issue before the Supreme Court wasthe transfer of $700,000 from the Department of Charitable Gaming (“DCG”) and the transfer of $10 million from various funds created within the Department of Housing, Buildings and Construction (“DHBC”). DCG and DHBC both rely upon licensing, permit and inspection fees and fines (for example, for building code violations or illegal gaming) to carry out their regulatory responsibilities.

According to the Court, “it is not unlawful for the General Assembly to provide in a budget bill for the suspension of anti-lapse provisions in agency enabling statutes and for the transfer to the General Fund of surpluses incidentally existing in agency accounts.” The only requirement is that the fees collected bear a “reasonable relation” to the regulatory expense so that a revenue-raising intent does not appear. In addition, though the funds come solely from private sources, the agencies’ supervisory actions (e.g., building codes and gaming regulations) benefit the public at large; thus, they are considered public funds and subject to budget-bill transfer.

The dissent, authored by Judge Venters and joined by Judge Scott, disagrees with the majority that the amounts transferred from the agencies were genuinely “surplus.” There is a clear distinction, as the dissent sees it, between a true surplus left over when a project is complete (such as the construction of a court house or the building of a road) versus the cases at hand where the money could have been used to pay for ongoing regulatory functions. Transferring funds, Venters wrote, results in higher fees on future participants, along with less agency service and protection.

While neither DCG nor DHBC generated funds through statutory taxation, some state agencies do, and these agencies are having substantial portions of their account balances transferred as well. For example, $9 million was swept from the Tourism Marketing Fund in order to balance the 2014-2016 budget. This fund is generated by a 1% tax on hotel rooms in Kentucky, which was passed overwhelmingly by the General Assembly in a 2005 omnibus tax bill. The Supreme Court only gives passing reference, in a footnote, to the important distinction between taxes and regulatory fees in this decision, but does little more to address the constitutionality of sweeping revenues generated through taxes, which is a clear violation of Section 180.[1] The 2014-16 budget calls for agency transfers totaling about $300 million.

Although the practice of transferring funds was commonplace long before this court ruling, it did not take long for policymakers to cite it as justification for subsequent sweeps. Kentucky’s biennial budget bills often include a “General Fund Budget Reduction Plan” which authorizes the governor to cut the budget at the margins in the event of a shortfall, without calling the legislature back to redraft and pass another budget. A one-percent reduction in estimated revenue left a $90.9 million hole that needed to be filled before closing the books on the 2014 fiscal year. Less than one month after the ruling, Governor Beshear transferred almost $50 million from a range of agency funds, including the Board of Nursing, another transfer from Housing, Buildings and Construction, various environmental protection funds, among dozens of others. “The use of fund transfers is a valuable tool in how we manage and balance the overall budget of the Commonwealth, and one that keeps us from making deeper cuts to state agencies,” Governor Beshear said. “The recent ruling by the Kentucky Supreme Court again affirms the constitutionality of this practice, thus ensuring much needed flexibility for the executive and legislative branches.”

For now, it appears that all branches of state government are content with addressing budget shortfalls with money from agency pockets. The Supreme Court was clear that the transfer of regulatory fees does not constitute a hidden tax, but because they remained silent on the issue of the constitutionality of sweeping funds accrued from an express tax, further litigation or legislation may be required before agencies can stop the raid of taxes from their funds.


[1] See Footnote 6, “In a broad sense, perhaps, any monetary exaction by a governmental entity could be thought a tax, but a ‘tax’ in the strict sense of monies levied to meet the general expenses of government has been distinguished in a variety of contexts from more particularized exactions, such as fines, user fees – tolls, for example – infrastructure assessments, or regulatory fees, such as those at issue here…[T]he classic ‘tax’ is ‘imposed by a legislature upon many, or all, citizens. It raises money, contributed to a general fund, and spent for the benefit of the entire community…[T]he classic ‘regulatory fee’ is imposed by an agency upon those subject to its regulation…[I]t may serve regulatory purposes directly by, for example, deliberately discouraging particular conduct by making it more expensive…[O]r, it may serve such purposes indirectly by, for example, raising money placed in a special fund to help defray the agency’s regulation-related expenses.'” (citing San-Juan Cellular Tel. Co. v. Pub. Serv. Comm’s of Puerto Rico, 967 F.2d 683, 685 (1st Cir. 1992)(citations omitted).

New Transportation Investment Center Boosts P3 (Public-Private Partnerships) Projects: “P3 or Not P3?” That is the Question. Obama Says: “P3.”

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President Obama last week formally embraced the expansion of Public-Private Partnerships (P3s) as a means to fill the gap in public sector transportation financing. Infrastructure developers and project sponsors should look to a planned September 9 summit on infrastructure investment hosted by the U.S. Treasury Department to learn more about how they may gain access to/benefit from expanded resources for P3s.

In an announcement culminating after a series of events aimed at cajoling Congress into addressing the looming deficit in the Highway Trust Fund, the President established the “Build America Transportation Investment Center,” a new office in the U.S. Department of Transportation (DOT) focused on encouraging P3s. Citing the potential for domestic and foreign investment in American infrastructure, the President moved to create this resource center within DOT to assist states and local governments find ways to expand the use of innovative financing to build needed projects.

For many years, the Office of Innovative Program Delivery Finance was housed within theFederal Highway Administration (FHWA). This latest move will centralize P3 resources at DOT for highway, transit and other crucial projects, particularly those considered to be of regional and national significance and “those that cross state boundaries,” according to the White House statement.

If those sorts of projects are truly the focus of this initiative, perhaps there could be new life (or added momentum) for long-planned, but delayed projects like the Columbia River Crossing in Washington State/Oregon or the New International Trade Crossing between Detroit and Windsor, Ontario or even a variety of high-speed rail proposals that fell victim to budgetary politics during President Obama’s first term.

The President’s announcement offers the promise of additional access to existing DOT credit programs, including the highly successful Transportation Infrastructure Finance and Innovation Act (TIFIA) program. According to government estimates, each dollar of TIFIA loans leverages an additional $10 in private loans, guarantees, and lines of credit. The new Investment Center will also offer technical assistance to states that wish to expand private infrastructure investment and the 20 states that have not yet entered the P3 market at all. The Center may offer case studies of successful projects, examples of deal structures, and analytical toolkits.

The White House also announced that the Treasury Department will host a summit on infrastructure investment in the U.S. on September 9, 2014 for state and local officials to meet with their federal counterparts.

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Illinois Bans Employment Application Questions About Criminal Convictions

Vedder Price Law Firm

On July 21, 2014, Illinois Governor Pat Quinn signed into law the Job Opportunities for Qualified Applicants Act (HB 5701), which generally prohibits private-sector employers from inquiring about an applicant’s criminal history on a job application. When this law goes into effect on January 1, 2015, Illinois will join Hawaii, Massachusetts, Minnesota and Rhode Island as the fifth state to enact a “ban the box” law applicable to private-sector employers. A number of municipalities, including Philadelphia and San Francisco, have passed similar laws prohibiting the use of check-this-box questions on employment applications inquiring about an applicant’s criminal history.

The new Illinois law applies to private-sector employers with 15 or more employees and to employment agencies. The law prohibits covered employers from asking about an applicant’s criminal record or criminal history until after the employer has deemed the applicant qualified for the position and scheduled an interview. If hiring decisions are made without an interview, then the employer may not inquire about an applicant’s criminal record or history until it has made a conditional offer of employment to the applicant.

These restrictions do not apply to positions (a) for which federal or state law prohibits the employment of individuals who have been convicted of certain crimes or (b) for which individuals are licensed under the Emergency Medical Services Systems Act. In addition, a more limited exception applies to positions requiring a fidelity bond.

Employers with Illinois operations should plan to review the employment application forms they use and make necessary changes this fall in advance of the law’s effective date of January 1, 2015. For most covered employers, this will involve postponing until later in the hiring process the time at which questions are asked about prior criminal convictions.

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New York Proposes First State Bitcoin Regulations

Proskauer Law firm

One might have thought the biggest news in the digital currency world lately was Dell announcing that it was now accepting bitcoin. However, after a series of highly-publicized hearings in January, New York State rolled out its proposed regulations surrounding bitcoin and virtual currency – the first state in the nation to propose licensing requirements for virtual currency businesses.

 

The July 23rd New York State Register includes a Notice of Proposed Rule Making from the New York State Department of Financial Services (the “NYSDFS”) regarding the regulation of virtual currency (“Regulation of the Conduct of Virtual Currency Businesses,” No. DFS-29-14-00015-P). The proposed rule calls for the creation of the “bitlicense” which the NYSDFS has hinted at in the past. The state agency goals are two-fold: to protect New York consumers and users and ensure the safety and soundness of New York licensed providers of virtual currency products and services. Virtual currency is still a nascent industry that is generally unregulated outside of federal anti-money laundering regulations, and while anti-establishment bitcoin pioneers may revel in the “wild west” atmosphere of the digital currency, the NYSDFS feels that their proposed regulations will protect consumers from undue risk, encourage prudent practices for those engaged in virtual currency business activity and foster the growth of the New York financial sector.

 

The Notice, which refers to the full text of the proposed rule originally made available by NYSDFS on July 17th, marks the beginning of a 45-day window for public comment on the proposed rule. Interestingly, the NYSDFS concurrently released a copy of the proposed regulations on the social news site Reddit to elicit debate (note, Ben Lawsky, Superintendent of Financial Services at the NYSDFS, participated in a Reddit AMA (“Ask Me Anything”) session in February as the agency was developing the rules).

 

The proposed rule appears to be drafted to carefully exclude merchants and bitcoin miners from the scope of the licensing requirement, but include exchanges, digital wallet services, merchant service providers and others in the virtual currency ecosystem. It imposes many of the same types of requirements that we already have in the area of money transmission and clearing house services, including capital requirements, anti-money laundering safeguards, and “know your customer” type issues. It also includes requirements with respect to business continuity and cyber security issues.

 

This alert will outline some of the major elements of the “bitlicense” regulations.

 

Who’s Covered?

 

Under the proposed regulations, “Virtual Currency Business Activity” means any one of the following activities involving New York or a New York resident:

 

(1) receiving Virtual Currency for transmission or transmitting the same;

(2) securing, storing, holding, or maintaining custody or control of Virtual Currency on behalf of others;

(3) buying and selling Virtual Currency as a customer business;

(4) performing retail conversion services, including the conversion or exchange of Fiat Currency or other value into Virtual Currency, the conversion or exchange of Virtual Currency into Fiat Currency or other value, or the conversion or exchange of one form of Virtual Currency into another form of Virtual Currency; or

(5) controlling, administering, or issuing a Virtual Currency.

 

Such “virtual currency businesses” would have to obtain a license from the agency before engaging in any such business activity, though persons chartered under the New York Banking Law to conduct exchange services and are approved by the NYSDFS to engage in virtual currency business activity would be exempt. As previously mentioned, the proposed rules seemingly excludes consumers who buy goods and services with digital currency, merchants who accept digital currency and bitcoin miners from the scope of the licensing requirement, but explicitly include digital currency exchanges, digital wallet apps and services, merchant service providers, virtual currency issuers,  and other similarly situated businesses.  Specially, the agency is not seeking to regulate virtual currency used solely on online gaming platforms or digital units used exclusively for customer affinity or rewards program, but cannot be converted into fiat currency.

 

Other Important Requirements

 

  • Application Details:  Applicants would have to submit financial, insurance and banking particulars; organization charts and background reports for the principal officers and stockholders (along with fingerprints for officers, principals and employees); and an explanation of the methods used to calculate the value of virtual currency in fiat currency, among other things. Upon filing of an application, the agency will investigate the financial condition and responsibility of the applicant before issuing the bitlicense, and may revoke the license on sufficient grounds. Moreover, if the licensee wants to make a “material change” to an existing product or service, it would need the NYSDFS’s prior approval; similar approval would be required in the event of any changes of control or mergers and acquisitions.
  • Compliance: Applicants would have to comply with all federal and state laws and regulations, appoint a compliance officer to monitor activity within the business, and maintain written compliance policies relating to anti-fraud, anti-money laundering, cybersecurity, and privacy and data security. In addition, virtual currency businesses would have to submit quarterly financial statements and audited annual financial statements to the NYSDFS.
  • Capital Requirements: The proposed regulations do not outline specific capital requirements. Rather, the text suggests that licensee shall maintain levels of capital as the NYSDFS determines is sufficient to ensure financial stability, taking into account basic financial barometers. The proposed regulations also would require licensees to only invest earnings in high-quality investments with maturities of up to one year, such as certificates of deposit regulated under U.S. law, money market funds, state or municipal bonds, or U.S. Gov’t securities.
  • Anti-Money Laundering: Each licensee would be expected to enforce an anti-money laundering program with adequate internal controls and training, as well as a written policy reviewed and approved by the licensee’s board. Under the regulations, virtual currency records would have to include records containing the identity and physical addresses of the parties involved, the amount of the transaction, the method of payment, the date(s) on which the transaction was initiated and completed, a description of the transaction, and special reports of any aggregate daily transactions that exceed $10,000 or otherwise involve suspicious activity. Covered businesses would also have to conduct adequate due diligence on new customers, with enhanced scrutiny for foreign entities. Such regulations are presumably similar to the March 2013 Financial Crimes Enforcement Network (“FinCEN”) Guidance (FIN-2013-G001), which clarified that federal anti-money laundering regulations covering  “money services businesses” also applied to virtual currency exchanges.
  • Examinations: Each licensee would have to permit the NYSDFS to examine the licensee’s accounting and operations at least once every two years to determine financial stability, business soundness and compliance.
  • Cybersecurity: Under the bitlicense regulations, each licensee would have to establish an effective cybersecurity program for their electronic systems and maintain a written cybersecurity policy that covers data and network security, data governance, access controls, business continuity and disaster recovery, customer privacy, vendor management, and incident response, among others. Licensees would also have to appoint a Chief Information Security Officer responsible for implementing the cybersecurity program and also submit an annual report assessing the cybersecurity program.
  • Protection of Customer Assets: The regulations would require each licensee to maintain a bond or trust account for the benefit of its customers in an amount acceptable to the NYSDFS, and hold virtual currency of the same type and amount the licensee is storing for a customer. The licensee would be prohibited from selling or encumbering virtual currency assets stored on behalf of a customer.
  • Consumer Protection: The proposed regulations require certain disclosures before a consumer may enter into a transaction, including disclosure of the material risks associated with digital currency (e.g., digital currency is not legal tender, transactions are generally irreversible, values may fluctuate, and cyberattacks are a real concern), the general terms and conditions of conducting business with the licensee, and a detailed receipt following the completion of any transaction.

 

Looking Ahead

 

All entities involved in or planning on being involved in virtual currency-related businesses should study this proposed rule carefully. There is still an opportunity to voice concerns and have the final rule reflect any issues that the NYSDFS views as important (for example, some commentators have suggested that the regulations should contain exemptions for smaller digital currency start-ups that handle small transactions, while the Bitcoin Foundation suggests that the comment period should be open for a longer period of time to allow the industry to digest the proposal). It is likely that whatever is enacted in New York will be used as a model in other states that wish to enact a similar virtual currency licensing structure. Moreover, the regulations, as they stand today, require that any entity engaged in a “virtual currency business activity” would have to apply for a license within 45 days of the effective date of the regulations or risk being deemed to be conducting an unlicensed virtual currency business, further suggesting the importance in getting up to speed with the emerging digital currency regulatory environment in New York. It remains to be seen how onerous the final regulations and compliance obligations will be to both established digital currency service providers and start-ups alike.

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EEOC Expands Reach of Pregnancy Discrimination Act

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On July 14, 2014 the Equal Employment Opportunity Commission (“EEOC”) issued its first “enforcement guidance” on the Pregnancy Discrimination Act (“PDA”) since 1983.  One of the more significant aspects of the Guidance is the EEOC’s view of an employer’s duty to accommodate pregnant workers under the Americans with Disabilities Act (ADA).

The EEOC now takes the position that employers must accommodate a pregnant employee’s work restrictions to the same extent it accommodates non-pregnant employees with similar restrictions.

This means, in the EEOC’s view, that employers who offer light duty work to individuals injured on the job must also offer light duty work to pregnant employees with work restrictions, regardless of the fact that the light duty policy only applies, by its terms, to those employees who have restrictions stemming from a work related injury.

The EEOC’s Enforcement Guidance is quite extensive.  The entire Guidance document can be found here.

The EEOC also issued a “Questions & Answers” document, found here.

As if that wasn’t enough summer reading, the EEOC also issued a “Fact Sheet” that summarizes the PDA’s requirements here.

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Update on USCIS Processing Time for I-526, I-829 and I-924 Petitions

Greenberg Traurig Law firm

On July 17, 2014, USCIS released updated processing times for EB-5 related petitions. The following chart provides the average processing times for cases being adjudicated by the Immigrant Investor Program Office (IPO), as May 31, 2014:

Form Processing Timeframe
as of May 31, 2014

I-526, Immigrant Petition by Alien Entrepreneur

13.2 months

I-829, Petition by Entrepreneur to Remove Conditions

7.9 months
I-924, Application for Regional Center 5.4 months

USCIS reminds I-526 applicants that case status can be checked online at www.uscis.gov or through an email to USCIS.ImmigrantInvestorProgram@uscis.dhs.gov.

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Executive Order Extends Workplace Anti-Discrimination Protections to LGBT Workers of Federal Contractors

Jackson Lewis Law firm

Though it took longer than expected, President Barack Obama has signed an Executive Order extending protections against workplace discrimination to members of the lesbian, gay, bisexual, and transgender (“LGBT”) community. Signed July 21, 2014, the Executive Order prohibits discrimination by federal contractors on the basis of sexual orientation or gender identity, adding to the list of protected categories. It does not contain any exemptions for religiously affiliated federal contractors, as some had hoped. Religiously affiliated federal contractors still may favor individuals of a particular religion when making employment decisions.

The President directed the Secretary of Labor to prepare regulations within 90 days (by October 19, 2014) implementing the new requirements as they relate to federal contractors under Executive Order 11246, which requires covered government contractors and subcontractors to undertake affirmative action to ensure that equal employment opportunity is afforded in all aspects of their employment processes. Executive Order 11246 is enforced by the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP).

The Executive Order will apply to federal contracts entered into on or after the effective date of the forthcoming regulations. OFCCP likely will be charged with enforcement authority.

We recommend that employers who will be impacted by this Executive Order review their equal employment opportunity and harassment policies for compliance with the Executive Order. For example, employers who are government contractors should add both sexual orientation and gender identity as protected categories under these policies and ensure that mechanisms are put in place to ensure that discrimination is not tolerated against LGBT employees.

We will provide additional information and insights into the proposed regulations when they are available.

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Commerce Department Rulings Spur Oil Export Battle

Covington BUrling Law Firm

As reported in our blog post of last week, the Commerce Department Bureau of Industry and Security (“BIS”) recently determined in two private classifications that lease condensate — a type of stabilized and distilled light crude oil — is not subject to the United States’ broad ban on crude oil exports.  BIS has for years defined “crude oil” in its regulations as “a mixture of hydrocarbons that existed in liquid phase in underground reservoirs and remains liquid at atmospheric pressure after passing through surface separating facilities and which has not been processed through a crude oil distillation tower.”   Although the regulations state that this definition includes lease condensate, BIS appears to have determined that lease condensate that has been distilled is a refined petroleum product that is not subject to the broad ban on crude oil exports from the United States.

While BIS claims that there has been “no change in policy on crude oil exports,” the recent determinations have spurred the debate over whether the U.S. should change its position on crude oil exports.  In particular, Senators Robert Menendez (D-NJ) and Edward Markey (D-Mass.) — who have been vocal opponents of lifting the ban on crude oil exports — wrote a letter to Commerce Secretary Priztker alleging that BIS may have impermissibly approved the exports of lease condensate and demanding copies of the two determinations and information on the legal rationale for approving such exports by July 14, 2014.  Senators Markey and Menendez argue that allowing exports of crude oil would increase reliance on foreign oil and cause domestic gas prices to rise.  However, with U.S. crude oil production surging as a result of the advancements in hydrofracking technology, Senators Lisa Murkowski and Mary Landrieu have championed the effort to reconsider the ban on crude oil exports, which has been in place since the Arab oil embargo and global energy supply shortages of the 1970s.  In particular, Senator Murkowski has issued a report calling for a “renovation” of U.S. energy export policy, which includes an April 2014 white paper in advocating for condensate exports.

While some view BIS’ approval of condensate exports as a step towards a greater liberalization in crude oil export policy, financial analysts such as Morgan Stanley are not bullish on any significant changes occurring before this years’ mid-term elections.  Moreover, recent reports indicate that the White House may not have been aware that BIS was planning to issue such determinations, and therefore this may not represent a conscious effort on the part of the Obama Administration to change crude oil export policy.  Indeed, Secretary Pritzker has confirmed publicly that the rulings were not a change in policy.  However, the Secretary also said that “it’s a mistake to think there isn’t serious conversation going on within the administration about what we should do,” and that the issue of energy exports overall should be “examined holistically from an economic, strategic, and diplomatic standpoint.”  These statements suggest that the Administration is not backing down from the condensate rulings, and is considering the broader policy issues involved in allowing exports of other oil products.

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SEC Settles Charges Against Hedge Fund Adviser for Conducting Prohibited Transactions and Retaliating Against Whistleblower

Vedder Price Law Firm

On June 16, 2014, the SEC settled charges against a hedge fund advisory firm,Paradigm Capital Management, Inc., for engaging in principal transactions with an affiliated broker-dealer without providing effective disclosure to, or obtaining effective consent from, a hedge fund client. The SEC also settled charges against the firm’s owner, Candace Weir, for causing the improper principal transactions.

According to the SEC’s order, Paradigm’s former head trader made a whistleblower submission to the SEC that revealed the principal transactions between Paradigm and the affiliated broker-dealer. The SEC found that, after learning that its head trader had reported potential violations to the SEC, Paradigm engaged in a series of retaliatory actions that ultimately resulted in the head trader’s resignation. This is the first time the SEC has filed a case under its new authority to bring anti-retaliation enforcement actions. According to the SEC, Ms. Weir conducted transactions between Paradigm and an affiliated broker-dealer while trading on behalf of a hedge fund client. The SEC’s order also found that Paradigm failed to provide effective written disclosure to the hedge fund and did not obtain its consent as required prior to the completion of each principal transaction. The SEC’s order stated that Paradigm attempted to satisfy the written disclosure and consent requirements by establishing a conflicts committee to review and approve each of the principal transactions on behalf of the hedge fund. The SEC’s order found that the conflicts committee itself, however, was conflicted, because its two members, Paradigm’s chief financial officer and chief compliance officer, each reported to Ms. Weir and Paradigm’s CFO also served as CFO of the affiliated broker-dealer. The SEC also found that Paradigm’s Form ADV was materially misleading for failing to disclose its CFO’s conflict as a member of the conflicts committee.

The SEC’s order found that Paradigm violated, among other things, Sections 206(3) and 207 of the Advisers Act. The SEC’s order also found that Ms. Weir caused Paradigm’s violations of Section 206(3) of the Advisers Act. Paradigm and Ms. Weir agreed to jointly and severally pay disgorgement of $1.7 million for distribution to current and former investors in the hedge fund, and pay prejudgment interest of $181,771 and a penalty of $300,000. Paradigm also agreed to retain an independent compliance consultant.

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