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The National Law Forum - Page 516 of 753 - Legal Updates. Legislative Analysis. Litigation News.

EPA Issues Changes to Due Diligence Requirements for All Appropriate Inquiries (AAI) Under Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA)

RCA Logo

2005 ASTM No Longer Accepted Effective Oct. 6, 2015

On October 6, 2014, EPA issued a final rule mandating the use of the 2013 standard, ASTM E1527-13, for conducting Phase I Environmental Site Assessments for satisfaction of All Appropriate Inquiries (“AAI”) under CERCLA. [Click here for a copy of EPA’s preamble to the final rule, published in the federal register today].

In December 2013, EPA adopted a new AAI rule allowing use of the updated 2013 standard and continuing to allow use of the 2005 standard, ASTM E1527-05. The reference to both standards was widely criticized as a source of confusion in due diligence requirements. Prospective owners/operators were strongly encouraged to use the 2013 standard; however, they had flexibility to decide whether to use the 2013 or 2005 standard for each particular site.

Today’s revised AAI rule removes the reference to the 2005 standard, thus allowing use of only the 2013 standard for entities performing AAI. The new rule does not modify the 2013 standard; it merely mandates the use of it for AAI.

Notably, the new rule will not become effective until October 6, 2015, giving prospective property owners/operators and consultants one year to complete site assessments that are currently being performed consistent with the 2005 standard. Though EPA’s expectation is that entities will no longer use the 2005 standard and transition to the 2013 standard, the EPA’s rule allows use of the 2005 standard for property acquired prior to the effective date of October 6, 2015.

The primary differences between the 2013 and 2005 standards are:

  1. The 2013 standard requires evaluation of the potential for the release of subsurface vapor contamination (vapor migration), and more clearly identifies vapor migration as a recognized environmental condition. The 2005 standard did not explicitly require an analysis of vapor migration
  2. The 2013 standard clarifies existing and adds new definitions, which as a result, revises the potential scope of assessment. For example, the term “Controlled Recognized Environmental Condition” was added to the standard to include past releases that have been addressed but allow contamination to remain in place.
  3. The 2013 standard requires a more extensive review of agency files and historical site documents.

Overall, the 2013 standard is considered more comprehensive and thorough based on today’s realities and is touted by EPA in its final rule preamble as “the consensus-based, good customary business standard.”

Copyright © 2014 Ryley Carlock & Applewhite. A Professional Association. All Rights Reserved.
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“The Good Wife” Defends Genetically Modified Organisms (GMOs)

Schwegman Lundberg Woessner

Last Sunday’s episode of “The Good Wife” featured a Christian mediation between a farmer (Robert Joy) sued by a Pioneer-like company, represented by the actor Richard Thomas, for saving GMO corn seed for replanting. The facts were a mash-up of J.E.M. Ag Supply v. Pioneer Hi-Bred., 534 U.S. 124 (2001), and Monsanto Canada v. Schmeiser, 1 S.C.R. 902 (2004). In the former case, JEM was selling Pioneer’s hybrid seed that had been “saved” by farmers from a previous crop of the seed, in violation of the shrink wrap-type license on the original Pioneer seed they had purchased at JEM. In Monsanto-Canada, a farmer saved and replanted glyphosate-resistant canola seed from a field he claimed was contaminated by “GMO” pollen from neighboring fields.

In J.E.M. Ag Supply, the only defense mounted by J.E.M. was that utility patents should not be issued on plants and, fortunately, the Supreme Court disagreed, in a decision that includes both plants made by conventional breeding techniques and transgenic modifications. In Monsanto Canada, the farmer was found to have infringed Pioneer’s patents.

In the “Good Wife” episode, the farmer was accused of saving seed in violation of the agribusiness’ patents. He argued that his field had been contaminated by “seed” blown from neighboring GMO fields, but Florick Agos presented an expert witness who “testified” that such blow-over would only “contaminate” about 6% of a non-GMO crop per year. The farmer and the agribusinessman were friends and after the farmer admitted he had replanted the transgenic canola, they settled the dispute with the farmer agreeing to pay some small amount of damages, as I recall.

The major issue for patent attorneys working in the ag biotech area (and for agribusiness itself) is the public perception –despite decisions upholding the patentability of plants in the U.S. or of the transgene or the transformed plant cell in Canada—that it is wrong to patent living organisms. At the end of the “Good Wife” mediation scene, one of the parties – the preacher? – exclaims that he is shocked that plants can be patented. J.E.M. was one of the last Supreme Court decisions that expanded the scope of patent rights. The Canadian Supreme Court was divided in ruling for Monsanto. As succinctly summarized by the majority:

“Inventions in the field of agriculture may give rise to concerns not raised in other fields—moral concerns about whether it is right to manipulate genes in order to obtain better weed control or higher yields. It is open to Parliament to consider these concerns and amend the Patent Action should it find them persuasive.”

© 2014 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.
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Help the NLR get a $150K grant from Chase! Please vote!

National Law Review Mission Main Street Small Business Grant Sponsored by Chase

The National Law Review is applying for a grant from Chase’s Mission Main Street program. Chase is committed to helping a small business like ours. They are awarding $3 Million to help small businesses, like the National Law Review, make it big!

We are committed to providing quality compiles timely, well-researched articles submitted to us from law reveiws, law journals, law firm newsletters, bar associations and original thought leadership.  The dynamic landscape of healthcare reform, data privacy and human resources compliance, is frustrating and time consuming for business professionals. The National Law Review streamlines news updates and research, by curating vetted experts who provide timely insight and solutions – no login needed.

We have done all these incredible things with a very small team. Imagine the great things we can do with help from a Mission Main Street Grant. Please cast your vote for us! Thank you so much for supporting the National Law Review and all small businesses!

Reclassification of Hydrocodone Takes Effect This Week

McBrayer NEW logo 1-10-13

The U.S. Drug Enforcement Administration (“DEA”) published a Final Rule on August 22, 2014, which elevates hydrocodone-combination products (“HCPs”) to a Schedule II category of drugs under the Controlled Substances Act. That rule becomes effective this week – on October 6, 2014. While some hydrocodone products are already listed as Schedule II, some combination products (such as Vicodin, Norco, and Tussionex) were previously listed on the less-restrictive Schedule III. In determining whether rescheduling was necessary, the DEA considered multiple factors including the potential for abuse, likelihood of dependence, and the threat to public health posed by the drug.

How does the new rule affect prescribers?

According to DEA, HCPs prescriptions issued prior to October 6, 2014 and authorized to be filled or refilled may be dispensed if such dispensing occurs before April 8, 2015. In some cases, pharmacy dispensing software products may not be able to process existing refills starting on October 6, or pharmacies may simply choose not to dispense refills after the effective date.

Pursuant to the Final Rule, HCPs prescriptions written on or after October 6, may not be refilled. No refills are allowed by any practitioner for Schedule II controlled substances and Schedule II prescriptions may only be given for maximum of a 30-day supply. Commentators to the proposed rule worried that rescheduling would result in more trips to the doctor to receive appropriate pain control. In response to these concerns, the DEA noted in the Final Rule that prescribers may issue multiple prescriptions authorizing patients to receive up to a 90-day supply, provided certain regulatory requirements (established in 21 CFR 1306.12) are met.

Prescription Bottle of Pills Spilled on Table

In addition, in Kentucky, Schedule II controlled substance prescriptions may not be faxed or called in to a pharmacy except as provided for in 902 KAR 55:095. Schedule II controlled substance prescriptions that are electronically prescribed must use a system that has been audited for compliance with the regulations specified in 21 CFR 1311. Further, Schedule II controlled substance prescriptions are valid for 60 days from the date written and controlled substance prescriptions must be signed and dated on the date issued by the prescriber.

Kentucky prescribers should be aware that restrictions on prescribing existing Schedule II pure hydrocodone products remain under current Kentucky statutes and regulations because these products were not rescheduled to Schedule II.

Midlevel providers who operate under collaborative agreements or are limited in their ability to prescribe certain Schedules of medications may be particularly affected by the Final Rule. In Kentucky, KRS 314.011, Section 8 (a) limits APRN prescribing of Schedule II controlled substances to a 72 hour supply with no refills, except certified psychiatric-mental health nurses are permitted to prescribe up to a 30-day supply of a Schedule II psychostimulant with no refills. KRS 314.011, Section 8 (b) limits APRN prescribing of Schedule III controlled substances to a 30-day supply with no refills. Because KRS 314.011, Section 8 (b) was in effect March 19, 2013, all APRNs will continue to be permitted to prescribe a 30-day supply of Schedule II hydrocodone combination products if allowed under their DEA license.

Even if the Final Rule does not specifically affect a prescriber’s abilities, prescribers should be prepared to work with pharmacies in order to minimize dispensing disruptions after the effective date. They should also identify and inform patients who are currently receiving HCPs about the rescheduling and, if necessary, discuss alternative pain management options. And, as prescribers well know, any new regulatory framework also brings with it the expectation of greater scrutiny and oversight in the future from regulatory authorities and law enforcement agencies.

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Register for the ABA's 9th Annual GPSolo National Solo and Small Firm Conference, October 23-25, San Antonio

The National Law Review is pleased to present you with information about the American Bar Association’s 9th Annual GPSolo National Solo and Small Firm Conference.

 

ABA 9th GPsolo Oct2014

Book your travel now for the 2014 GPSolo 9th Annual National Solo & Small Firm Conference (NSSFC). This year’s theme is “Building a Texas-Sized Practice on a Lone Star Budget.” Traditionally, the NSSFC attracts more than 200 solos and small firm practitioners from across the country and abroad. However, this year’s meeting in Texas is going supersize as we expect to draw record numbers. Come join the excitement and learn to build or expand your practice without spending a fortune.

Some exciting highlights of the meeting include:

–        Off-the-charts networking opportunities such as meet-and-greets with legal service plan providers and potential new business referrals

–        Rainmaking Forum; U.S. Supreme Court Swearing-In Ceremony (register now to take part); Naturalization Ceremony for new U.S. citizens; and an accreditation course for practice before the U.S. Department of Veterans Affairs (which, like Social Security representation, can result in a fee award). All these programs are new this year.

–        Opportunity to choose up to ten hours of CLE from more than 25 hours of offerings. This is not your everyday CLE. We will have several GPSolo book authors presenting on chapters from their recent publications, including the outstanding Run Your Firm Like a Business by Frank T. Lockwood, the timely Lawyer’s Guide to Financial Planning by Cynthia Sharp, and the ever-important Debt Collector’s Handbook by David J. Cook.

–        Sessions presented by the ABA Commission on Immigration for both immigration and non-immigration practitioners, including a mock trial demonstration with an immigration judge showing you the ins and outs of practicing before the immigration courts.

–        Difference Makers Awards Luncheon, where we celebrate the accomplishments of our honorees.

–        Training for pro bono representation with Kids in Need of Defense (KIND) to assist unaccompanied children who currently represent themselves in immigration court proceedings.

–        The opportunity to help educate high school students about being aware of debt through our Financial Literacy Outreach public service program.

Improving Medicare Post-Acute Care Transformation (IMPACT) Act to be Signed into Law

Drinker Biddle Law Firm

The Improving Medicare Post-Acute Care Transformation Act of 2014, known as the IMPACT Act, passed the House on September 16th. It was introduced in the House by Ways and Means Chairman Dave Camp (R-MI) and in the Senate by Finance Committee Chairman Ron Wyden (D-OR) on June 26, 2014. The Senate voted to approve the legislation on Thursday, September 18, meaning it will now be sent to President Obama for his signature.

The IMPACT Act establishes requirements for post-acute care (PAC) providers to report and share standardized assessment data, including patient assessments, quality measures, and information about resource use. The bill gives various facilities between two and just over four years to implement processes that allow them to report different kinds of data. The legislation also directs the Medicare Payment Advisory Commission (MedPAC) to evaluate payment systems that consider individual characteristics rather than just the type of facility at which a patient is treated. The new data to be reported will help illustrate facility performance and could help determine if a payment system that takes patient outcomes into account is preferable.

Additionally, the bill directs the Secretary of Health and Human Services (HHS) to conduct two studies using additional data to determine what effect, if any, socioeconomic and other factors have on quality and resource use measures.  To learn more, read the District Policy Group bill summary, written by Legislative Assistant Sarah Williams here.

Read a summary from the Library of Congress here.

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Join the ABA and LMA on Wednesday! Women, Minorities, Business & the Law: Using Diversity Initiatives and Affinity Groups

Register Today!

Event Date: Wednesday, October 8, 2014
Time: 11:30 am, networking; 12:00 pm, panel discussion
Location: The American Bar Association, 21st Floor, 321 N. Clark St., Chicago, IL 60654

Recent reports illustrate that women and minorities are still struggling to reach equity partner status at their firms and are not being asked to join key client engagement teams. Furthermore, many firms continue to struggle to attract and retain women and diverse attorneys. Why should legal marketers and business developers care about these issues? Why should they coordinate with the legal diversity personnel within their firms and how can they better coach and support their women and minority attorneys? Our panel draws on several unique perspectives to address these and other challenges and discuss answers.

Program attendees will learn:

  • How women lawyers, LGBT lawyers, and lawyers of color can leverage their affinity group memberships to advance their careers and develop a pipeline of business and referrals
  • How to utilize sponsorships of various affinity groups and diversity initiatives as business development and marketing tools
  • How companies and legal departments are driving greater legal diversity and inclusiveness and how legal marketers can support their firm’s legal diversity personnel in attracting, retaining, and promoting diverse attorneys

 

Moderator:

  • Jonathan Becks, Marketing and Business Development Manager, Horwood Marcus & Berk Chtd.

 

Panelists:

  • Cynthia Photos Abbott, Chief Litigation Counsel, Motorola Mobility LLC
  • Jeanette Hait Blanco, Senior Product/Regulatory Counsel, PayPal, Inc.
  • Hon. Patricia Brown Holmes (Ret.), Partner, Schiff Hardin LLP
  • Mario A. Sullivan, Principal, Johnson and Sullivan Ltd.

This program is ideal for legal marketers, attorneys, and legal diversity personnel who are interested in understanding and benefitting from the intersection of diversity and business development. Members of the LMA and co-sponsoring organizations receive a discounted registration rate. Due to building security rules, all guests must be pre-registered to attend the event. Space is limited, so register today!

Help the NLR get a $150K grant from Chase! Please vote!

National Law Review Mission Main Street Small Business Grant Sponsored by Chase

The National Law Review is applying for a grant from Chase’s Mission Main Street program. Chase is committed to helping a small business like ours. They are awarding $3 Million to help small businesses, like the National Law Review, make it big!

We are committed to providing quality compiles timely, well-researched articles submitted to us from law reveiws, law journals, law firm newsletters, bar associations and original thought leadership.  The dynamic landscape of healthcare reform, data privacy and human resources compliance, is frustrating and time consuming for business professionals. The National Law Review streamlines news updates and research, by curating vetted experts who provide timely insight and solutions – no login needed.

We have done all these incredible things with a very small team. Imagine the great things we can do with help from a Mission Main Street Grant. Please cast your vote for us! Thank you so much for supporting the National Law Review and all small businesses!

Recent Changes to the Law of Private Construction Contracts – Your Government is Here to Help You Again – Massachusetts

As part of the end-of-session rush at the Massachusetts General Court this summer, significant changes were made to Massachusetts law governing private construction contracts at the urging of general contractor and subcontractor industry groups. Members of the development and lending community were largely taken unaware as the bill moved forward, and unsuccessfully attempted in the later stages of the process to modify or defeat the legislation. Consequently, developers, lenders, contractors, sub-contractors, design professionals and attorneys need to be aware of substantial changes (and many unanswered questions) created by the new statute in the areas of withholding and release of retainage, defining substantial completion, and preparation of punchlists.

Key highlights of Chapter 276 of the Acts of 2014, to be codified at M.G.L. c. 149, sec. 29F:

  • Applicability: All contracts on projects on which the prime contract (a) is entered into after November 6, 2014, and (b) has a contract price of $3 million or more, except projects of 1 to 4 dwelling units.

  • Withholding of Retainage:  Caps retainage to be withheld from progress payments at 5% (long-standing practice has been to retain 10% of each progress payment, with reduced (or no) withholding of further retainage after the project achieves some level (typically 50%) of completion).

  • New Definition of “substantial completion”: “The stage in the progress of the project when the work… is sufficiently complete in accordance with the contract for construction so that the project owner may occupy or utilize the work for its intended use…”  Parties may divide a project into phases and apply the statutory scheme applicable to “substantial completion” separately to each designated project phase.

Process for determining substantial completion:

  • Within 14 days after achieving substantial completion, the prime contractor submits a notice of substantial completion to the owner (form provided in the statute) with contractor’s determination of the date of substantial completion.

  • Within 14 days after receiving this notice, the owner must accept or reject it and return it to the contractor.  If the owner does neither, the notice is deemed accepted and the date of substantial completion determined by the contractor is binding.

  • If the owner rejects the notice, it must notify the prime contractor within this 14-day period, including the “factual and contractual basis for the rejection”, which must be certified as made in good faith.  The dispute is then governed by the contractual dispute resolution provisions, which the contractor must commence within 7 days of its receipt of the owner’s rejection notice.

Punchlist:

  • Within 14 days after the date of substantial completion is established (either through the notice process described above or the applicable dispute resolution proceeding), the owner must submit to the prime contractor a list (certified as made in good faith) of (a) all defective or incomplete work and (b) all outstanding deliverables required under the prime contract.

  • Within 7 days after the prime contractor’s receipt of that list, it must submit a similar list (certified as made in good faith) of all defective or incomplete work and outstanding required deliverables to each sub from whom it is withholding retainage.

Release of Retainage:

  • Applications for release of retainage can be submitted starting 60 days after the date of substantial completion (unless the contract provides for earlier submission), and each application must be accompanied by a list (certified as made in good faith) identifying the defective or incomplete work and deliverables on that party’s punchlist which have been completed, repaired and delivered.

  • Contract must permit applications for release of retainage at least monthly.

  • Retainage (other than that withheld in accordance with the new statute) must be released within 30 days of submission of the application for release, with an additional 7 days added for each tier of subcontractor.

Withholding Release of Retainage:

  • Only the following amounts can be withheld from retainage in response to an application for its release:

    • For incomplete, incorrect or missing deliverables, either (a) the value of the deliverables as mutually agreed to by the contracting parties, or (b) if no value has been agreed to, the reasonable value of the deliverables (not to exceed 2.5% of the total adjusted contract price of the party seeking release of retainage);

    • 150% of the reasonable cost to complete or correct incomplete or defective work; and

    • Reasonable value of any claims, costs, expenses and, where permitted under the contract of the party seeking release of retainage, attorneys’ fees.

  • No retainage can be withheld unless the withholding party provides to the party seeking the retainage, before the date payment is due, a notice (certified as made in good faith) (i) identifying the defective or incomplete work and the incomplete, incorrect or missing deliverables, (ii) the “factual and contractual basis” for any claims, and (iii) the value attributable to each item of incomplete or defective work, deliverable, and claim.

  • Multiple sequential applications for release of retainage are permitted as work is completed or corrected/deliverables are delivered/claims are resolved.

  • Unless the owner has declared the prime contractor in default under its contract, the owner cannot withhold retainage owed by the contractor to a subcontractor except for withholding based on a default by that sub.

  • Rejection of an application for release of retainage is subject to contractual dispute resolution procedures.  Contract provisions requiring a party to wait more than 30 days after rejection of an application for release of retainage before being permitted to commence dispute resolution procedures are void and unenforceable.

Additional Provisions:

  • All communications provided for in the new statute may be made electronically.

  • Section 29F(l) provides that any provision in a contract “which purports to waive, limit or subvert this section or redefine or expand the conditions for achievement of substantial completion for payment of retainage, shall be void and unenforceable.”

The new statute creates major areas of uncertainty for all parties on private construction projects, including:

  • How far an owner can go in adding requirements for deliverables, issuance of permanent C of Os, completion of commissioning, etc. as conditions to achieving “substantial completion”, in light of the new statutory definition of that term and the limitations imposed by Section 29F(l);

  • How an owner can mobilize its design professionals, its lender’s construction inspector, and its own construction team to respond to the prime contractor’s notice of substantial completion in the detailed manner required by the statute within the very short (but required) 14-day period;

  • How disputes over whether substantial completion has been achieved can be resolved through contractual dispute resolution procedures without jeopardizing project delivery deadlines;

  • What constitutes the “factual and contractual basis” required for various actions by the owner; and

  • How lenders will respond to the mandatory reduction in retainage to 5% (some are already saying that they will require an additional 5% in equity from the owner to make up the 10% retainage traditionally withheld by owners).

Although the consequences (intended or otherwise) of this new statute for the real estate lending, development and construction industries in Massachusetts remain to be seen over the coming months and years, they are likely to include:

  • Owners requiring retainage to be withheld on components of the contract price that previously may not have been subject to retainage (e.g., contractor’s fee, general conditions); exercising much greater control over a contractor’s use of contingency funds; requiring bonds from prime contractors and subs more regularly; and policing variations from the project schedule and/or the contract documents more strictly earlier in the project; and

  • Owners being much more selective in the choice of prime contractors and subs, tending towards repeat relationships, leading to greater consolidation within the industry and raising the barriers to entry by new companies.

There is already discussion underway about efforts to amend, limit or repeal this statute, so this will be something to watch for in 2015.

© 2014 SHERIN AND LODGEN LLP
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Join the ABA Wednesday! Women, Minorities, Business & the Law: Using Diversity Initiatives and Affinity Groups to Build & Win Business

Register Today!

Event Date: Wednesday, October 8, 2014
Time: 11:30 am, networking; 12:00 pm, panel discussion
Location: The American Bar Association, 21st Floor, 321 N. Clark St., Chicago, IL 60654

Recent reports illustrate that women and minorities are still struggling to reach equity partner status at their firms and are not being asked to join key client engagement teams. Furthermore, many firms continue to struggle to attract and retain women and diverse attorneys. Why should legal marketers and business developers care about these issues? Why should they coordinate with the legal diversity personnel within their firms and how can they better coach and support their women and minority attorneys? Our panel draws on several unique perspectives to address these and other challenges and discuss answers.

Program attendees will learn:

  • How women lawyers, LGBT lawyers, and lawyers of color can leverage their affinity group memberships to advance their careers and develop a pipeline of business and referrals
  • How to utilize sponsorships of various affinity groups and diversity initiatives as business development and marketing tools
  • How companies and legal departments are driving greater legal diversity and inclusiveness and how legal marketers can support their firm’s legal diversity personnel in attracting, retaining, and promoting diverse attorneys

 

Moderator:

  • Jonathan Becks, Marketing and Business Development Manager, Horwood Marcus & Berk Chtd.

 

Panelists:

  • Cynthia Photos Abbott, Chief Litigation Counsel, Motorola Mobility LLC
  • Jeanette Hait Blanco, Senior Product/Regulatory Counsel, PayPal, Inc.
  • Hon. Patricia Brown Holmes (Ret.), Partner, Schiff Hardin LLP
  • Mario A. Sullivan, Principal, Johnson and Sullivan Ltd.

This program is ideal for legal marketers, attorneys, and legal diversity personnel who are interested in understanding and benefitting from the intersection of diversity and business development. Members of the LMA and co-sponsoring organizations receive a discounted registration rate. Due to building security rules, all guests must be pre-registered to attend the event. Space is limited, so register today!