FDA and EPA Seek Comment on Revising Fish Consumption Advice

by Elisabeth Ulmer

The Food and Drug Administration (“FDA”) and the Environmental Protection Agency (“EPA”) jointly seek comment on the substance and structure of their updated advice regarding the safety of eating fish.  This draft update will include “both advice and supplemental questions and answers for those who want to understand the advice in greater detail.”

In 2004, the FDA and EPA released a document named, “What You Need to Know About Mercury in Fish and Shellfish,” to assist the public in reaping the health benefits of eating fish, while reducing mercury exposure.  Fish (which includes both fish and shellfish) contain protein, omega-3 fatty acids, and many micronutrients, and are low in saturated fat, but they also contain methylmercury, a form of mercury that can harm the central nervous system and the developing brain of fetuses.

The FDA and EPA now propose to update this 2004 advice in order to align it with the Dietary Guidelines for Americans 2010.”  The FDA drafted its assessment in 2009 and recently modified it after receiving comments and advice from peer reviewers, the public, and federal agencies, including the EPA.  Although these recommendations are directed toward a target audience of women who are pregnant, may become pregnant, or are breastfeeding, this information is intended for the public at large as well.

The updated advice from FDA and EPA includes the following four recommendations for the target audience.  First, these women should consume at least 8 and up to 12 ounces (2 or 3 servings) per week “of a variety of fish lower in mercury within their calorie needs.”  Second, they should avoid tilefish from the Gulf of Mexico, shark, swordfish, and king mackerel because these four fish contain the highest mercury concentrations.  Third, they should eat no more than 6 ounces of white (albacore) tuna per week.

Fourth, as the 2004 FDA guidelines advised, those who eat local fish caught by family and friends should follow “locally posted fish advisories regarding safe catch.”  Although the amount of mercury in local waters is unknown, the levels tend to be higher in local fish than in commercially available fish.  In the absence of such advisories, consumers of locally caught fish should eat no more than 6 ounces per week and refrain from consuming any other fish in the same week.  In addition, given the continued development of their nervous systems, the FDA and EPA recommend that children eat less fish than adult women.

Furthermore, the FDA and EPA wish to solicit comments regarding ways to change the substance and structure of their updated advice in order to make the recommendations “both understandable and influential.”  The agencies also invite comment regarding whether to add orange roughy and marlin to the list of fish that both young children and the target audience of women who are pregnant, may become pregnant, or are breastfeeding should avoid.  These two fish contain less mercury than the aforementioned four fish that the target audience should avoid, but orange roughy and marlin contain more mercury than “nearly all other commercial fish” and “can be unusually low in omega-3 fatty acids.”  Thus, their benefits do not outweigh the costs.

Finally, the FDA and EPA seek public comment on the following:

1. Whether the final updated advice should track the Dietary Guidelines for Americans 2010 more or less closely than the draft of that updated advice now does.

2. Any new science that has become available since the Dietary Guidelines for Americans 2010 were issued that would be relevant to the updated advice.

3. Information upon which to base advice on young children's fish consumption. There have been a number of studies that have examined the effects of both postnatal exposure to mercury as well as postnatal fish consumption by young children, but this research has not been as extensive as the research on prenatal exposures and maternal fish consumption.

4. As stated previously, suggestions for improving the clarity and utility of the advice.

5. How to integrate advice from local advisories for those who consume fish from local streams, rivers, and lakes.

In addition to inviting comments, the FDA and EPA will hold a public meeting, in which the FDA Advisory Committee on Risk Communication will offer its thoughts on the updated advice.  The agencies will also publish information in the Federal Register about other public meetings that they plan to host around the country.

The comment period will close 30 days after the transcripts of the aforementioned meetings are published. The closure date will be published in a Federal Register notice.  Interested parties are invited to submit comments by any of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov 
• Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852

The FDA will share with EPA all of the comments that it receives.

Supreme Court Teleconference Series: King v. Burwell

The Section's Supreme Court Teleconference Series continues March 5, 2015 from 3:30 - 4:30 p.m. EST with a discussion on King v. Burwell, a challenge to the Administration's policy on the availability of subsidies through the federal health insurance exchange under the Affordable Care Act.  On March 4, the Supreme Court will hear oral arguments for the case, which has attracted a significant amount of media attention because of its political and health policy implications.   The issues before the Justices turn largely on questions of statutory interpretation and agency discretion, perhaps informed by notions of federalism and the separation of powers. 

The Section's teleforum will discuss the Justices' questions, the parties' arguments, and their likely ramifications.  Confirmed panelists include Josh Blackman, assistant professor at the South Texas College of Law, and Simon Lazarus, senior counsel at the Constitutional Accountability Center.  Adam White of the Manhattan Institute and Boyden Gray & Associates will moderate the discussion. 

RSVP by Wednesday, March 4, 2015 with your name and e-mail address to angela.petro@americanbar.org. 

USPTO Seeks Public Input on Proposed Patent Quality Changes

by Shannon Allen

The United States Patent and Trademark Office (“USPTO”) seeks input from the public to provide guidance regarding enhancing patent quality.  The USPTO is making efforts to improve patent operations and procedures to provide the best work products, to enhance customer experience, and to improve existing quality metrics.  Thus, the USPTO is introducing a comprehensive and enhanced quality initiative.  This initiative starts with an invitation for public input on USPTO’s proposals and continues with a two-day “Quality Summit” with the public to discuss the proposals.  Through this interactive and long-term partnership with the public, the USPTO strives to ensure the issuance of the best quality patents and provide the best customer service possible.

A robust patent system cultivates the innovation that drives economic growth and the creation of employment opportunities.  The promotion of that kind of innovation requires that issued patents fully comply with . . . statutory requirements and, . . . that the patent examination process advance quickly, transparently, and accurately. High quality patents promote certainty and clarity of rights, and that sparks necessary innovation.  To this end, the USPTO is launching a new, wide-ranging initiative to enhance the quality of patents issued.  The purpose of the USPTO’s proposals is to stimulate the public's thinking on the larger topic of patent quality, and to focus the discussion at the Quality Summit to a limited number of concrete proposals.

The USPTO begins this enhanced patent quality initiative, by focusing on three aspects of patent quality, called the “patent quality pillars.”  In addition, the USPTO has developed six proposals for enhanced patent quality within these pillars:

• Pillar One: Excellence in work products, in the form of issued patents and Office actions. Focuses on the quality of work products provided at every stage of the patent process, including both quality of issued patents and quality of all work products during the filing, examination, and issuance process.  USPTO Proposals - 1) Applicant Requests for Prosecution Review of Selected Applications; 2) Automated Pre-Examination Search; and 3) Clarity of the Record 
• Pillar Two: Excellence in measuring patent quality, including appropriate quality metrics.  Focuses on measurement of quality to evaluate work products and customer interactions. USPTO Proposal - Review of and Improvements to Quality Metrics 
• Pillar Three: Excellence in customer service. Focuses on quality customer experience, including treating customers promptly, fairly, consistently, and professionally at all stages of the examination process.  USPTO Proposal – 1) Review of Current Compact Prosecution Model and the Effect on Quality and 2) In-Person Interview Capability with All Examiners

The USPTO seeks to improve general aspects of quality, to issue higher quality patents, and invites feedback regarding the following questions.

1. Are there aspects of enhanced quality other than the three “pillars” previously described that should guide the USPTO's enhanced quality initiative? 
2. Are there any new or necessary changes to existing procedures that the USPTO should consider to improve the efficiency and effectiveness of the examination process? 
3. What should be included at the time of application filing in order to enhance patent quality?

The USPTO welcomes additional public input that may lead to the issuance of higher quality patents.  In addition to written comments, interested parties are invited to attend the two-day Quality Summit on March 25 and 26, 2015 in the Madison Building, USPTO Headquarters, in Alexandria, Virginia.  The following information should be included with written comments: (1) the name and affiliation of the individual responding; and (2) an indication of whether comments offered represent views of the respondent's organization or are the respondent's personal views.  Written comments must be received on or before May 6, 2015 and may be submitted by one of the following methods:

• Electronic mail message to: [preferred] WorldClassPatentQuality@uspto.gov. 
• Postal mail addressed to: Mail Stop Comments—Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, Virginia 22313-1450, marked to the attention of Michael Cygan, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Deputy Commissioner for Patent Examination Policy.

Despite Flurry of New Rulemakings, DOL Continues Retrospective Review

by Lynn White

On February 3, 2015, the U.S. Department of Labor (DOL) issued a Request for Information (RFI) on “how the Department can increase the effectiveness of its significant regulations while minimizing the burden on regulated entities.”  The RFI is a continuation of the agency’s efforts to comply with President Obama’s Executive Order 13563, which requires agencies to review existing regulations to determine whether they “may be made more effective or less burdensome.”  DOL published an RFI on March 21, 2011 requesting information to help the agency develop the Preliminary Plan for Retrospective Analysis of Existing Rules it published on May 20, 2011.  After gathering additional public input, the agency published its Plan for Retrospective Analysis of Existing Rules in August 2011. 

DOL seeks comments from the regulated community, academia and public on how it can “prepare workers for better jobs, improve workplace safety and health, promote fair and high-quality work environments, and secure a wide range of benefits for employees and those who are seeking work, all in ways that are more effective and least burdensome.”  The agency is specifically requesting information on the following:

• What regulations should be considered for review or modification? 
• What reporting requirements and information collections can be streamlined? 
• What regulatory reforms may require short-term cost increases, while providing long term savings? 
• How should the Department capture information about changes in firm and market behavior in response to a regulation? 
• What should the agency review to determine estimated costs and benefits of existing regulations? 
• What information would help better assess the long-term impact of regulatory reforms on important protections?

Stakeholders have until February 25, 2015 to submit comments. 

The RFI comes at a time when several programs in DOL have embarked on unprecedented regulatory agendas.  The agency’s Fall 2014 Regulatory Agenda has dozens of rules listed that are in the proposed or final rule stage.  The DOL Office of Federal Contract Compliance Programs (OFCCP), which enforces equal employment opportunity requirements for federal contractors, alone has five rulemakings listed, including a proposal to revise the program’s sex discrimination guidelines that is currently open for public comment.  OFCCP also recently finalized three rulemakings, two that drastically changed federal contractor affirmative action and nondiscrimination requirements for veterans and individuals with disabilities and another prohibiting discrimination based on sexual orientation or gender identity. 

Needless to say, while DOL’s efforts to conduct a retrospective review of existing rules are admirable, many stakeholders are still trying to determine the impact of the flood of new regulations and proposals.  At a minimum, DOL should extend the comment period to allow the public to meaningfully consider the questions the agency presented and provide adequate feedback. 

Meet William Haeberle, Section Law Student Division Representative

1.  Where do you attend law school and what led you to law school?

I am a second year student at Case Western Reserve University School of Law in Cleveland, OH and hold a Master’s in Applied Medical Ethics from Arizona State University. I became interested in law while researching issues in public health ethics. While doing this research, I confronted the massive overlay of laws and regulations that affect public health and discovered I was more interested in studying the macro aspects of public health regulation than I was in pursuing the original research question.

2.  What experiences with administrative or regulatory law have you had?

Unfortunately, I have had very little experience with administrative law beyond research in public health. I am however, currently working with the City of East Cleveland, through a CWRU course, to develop legislation for the regulation of flavored non-cigarette tobacco products. Additionally, I am hoping to work with one of the plethora of public health agencies this summer and gain insight and experience into the regulatory/policy side of this field.

3.  How did you become interested in studying or pursuing a career in administrative law?

While pursuing my Master’s I learned two major points that led me administrative law. First, that good philosophy doesn’t necessarily make good policy; and second, that the law’s impact is very much determined by administrative/regulatory bodies.  

4.  Based on your experiences thus far, what do you perceive to be challenges facing administrative law practitioners?

I believe one of the greatest challenges facing administrative lawyers is a lack of resources necessary for agencies to take on the panoply of important tasks they’ve been assigned. While administrative agencies’ responsibilities continue to grow, their budgets are being cut. This lack of resources is especially troubling in the health care field, where even delays in services can severely impact the agencies’ mission.

For law students or new attorneys considering a career in administrative law, what do you think would be a good way of familiarizing themselves with the field?

Administrative law is everywhere’ as a practitioner you can’t avoid it. I personally believe Admin Law should be a required course. Though, this could be personal zeal speaking. Interested students should remember that administrative agencies work at every level of government, from local communities to the national level. Students and new practitioners should look for these opportunities and also the opportunity to clerk for administrative law judges.

5.  From a law student’s perspective, how would you characterize the dialogue between academics, students, and practitioners in the area of administrative law?

I think the Administrative Law Section does a wonderful job facilitating dialogue. The Section offers law students free admission into the Section and free attendance at many Section events. Because of geographical limitations of holding events, one can’t be everywhere at once, so the ability to communicate through events is somewhat limited. However, the Section also holds teleconferences and webinars to promote further dialogue.

6.  As the Law Student Division representative to the Administrative Law & Regulatory Practice Section, what were your goals for the year? What do you think could be done in future years to foster interest in administrative law or joining the Section? What have you enjoyed most and found to be most challenging in your role?

The Administrative Law Section’s motto is “Admin Law, everyone does it.” I think the truth of this motto should be the basis for outreach to law students. No matter what area of law one intends to practice there’s likely an administrative agency the attorney will have to deal with. I’m hoping to help put together some sort of programming that is easily accessible to law students – perhaps a webinar – and that introduces the vast array of administrative bodies and their effect on the practice of law. I think that such an outreach program would help increase interest in the field to the many law students who don’t realize the impact administrative law has on their future practice.

As for difficulties in my role, I think the most difficult challenge has come from the geographic divide. The Section and many of its leaders are in D.C. and I’m sitting in Cleveland, which is a seven-hour drive away. I think this difficulty is similar to the difficulties the Section has with outreach generally. However, I think the Section does a great job with communication and inclusiveness.

7.  Outside of the law, what are your favorite activities or hobbies?

I have been a rock climber for the past seven years. Due to the general lack of climbing in the Cleveland/Ohio area and the time necessary to focus on law studies, I built a climbing wall in my apartment. On a few warmer weekends, I travel to climb.