    [Senate Hearing 112-324]
    [From the U.S. Government Publishing Office]

                                                            S. Hrg. 112-324

                         CONCUSSIONS AND THE MARKETING
                              OF SPORTS EQUIPMENT

    =======================================================================

                                    HEARING

                                   before the

                             COMMITTEE ON COMMERCE,
                          SCIENCE, AND TRANSPORTATION
                              UNITED STATES SENATE

                          ONE HUNDRED TWELFTH CONGRESS

                                 FIRST SESSION

                                   __________

                                OCTOBER 19, 2011

                                   __________

        Printed for the use of the Committee on Commerce, Science, and
                                 Transportation

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           SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION

                          ONE HUNDRED TWELFTH CONGRESS

                                 FIRST SESSION

                JOHN D. ROCKEFELLER IV, West Virginia, Chairman
    DANIEL K. INOUYE, Hawaii             KAY BAILEY HUTCHISON, Texas,
    JOHN F. KERRY, Massachusetts             Ranking
    BARBARA BOXER, California            OLYMPIA J. SNOWE, Maine
    BILL NELSON, Florida                 JIM DeMINT, South Carolina
    MARIA CANTWELL, Washington           JOHN THUNE, South Dakota
    FRANK R. LAUTENBERG, New Jersey      ROGER F. WICKER, Mississippi
    MARK PRYOR, Arkansas                 JOHNNY ISAKSON, Georgia
    CLAIRE McCASKILL, Missouri           ROY BLUNT, Missouri
    AMY KLOBUCHAR, Minnesota             JOHN BOOZMAN, Arkansas
    TOM UDALL, New Mexico                PATRICK J. TOOMEY, Pennsylvania
    MARK WARNER, Virginia                MARCO RUBIO, Florida
    MARK BEGICH, Alaska                  KELLY AYOTTE, New Hampshire
                                         DEAN HELLER, Nevada
                        Ellen L. Doneski, Staff Director
                       James Reid, Deputy Staff Director
                       Bruce H. Andrews, General Counsel
                    Todd Bertoson, Republican Staff Director
               Jarrod Thompson, Republican Deputy Staff Director
       Rebecca Seidel, Republican General Counsel and Chief Investigator

                                C O N T E N T S

                                  ----------
                                                                       Page
    Hearing held on October 19, 2011.................................     1
    Statement of Senator Rockefeller.................................     1
    Statement of Senator Boozman.....................................     3
    Statement of Senator Udall.......................................     4
        Prepared statement...........................................     5
    Statement of Senator Klobuchar...................................    61
    Statement of Senator Pryor.......................................    63
    Statement of Senator Thune.......................................    68

                                   Witnesses

    Alexis Ball, Albuquerque, New Mexico.............................    22
        Prepared statement...........................................    24
    Steven Threet, Tempe, Arizona....................................    26
        Prepared statement...........................................    28
    Jeffrey S. Kutcher, MD, Associate Professor, University of
      Michigan, Department of Neurology; Director, Michigan
      NeuroSport; Chair, Sports Neurology Section, American Academy
      of Neurology...................................................    29
        Prepared statement...........................................    31
    Ann C. McKee, MD, Professor of Neurology and Pathology, Boston
      University School of Medicine; Director, VISN-1 Neuropathology
      Laboratory for the New England Veterans Affairs Medical
      Centers; Director, Brain Banks for the Boston University
      Alzheimer's Disease Center, Framingham Heart Study, and
      Centenarian Study; Co-Director, Center for the Study of
      Traumatic Encephalopathy.......................................    34
        Prepared statement...........................................    37
    Mike Oliver, Executive Director and Legal Counsel, The National
      Operating Committee on Standards for Athletic Equipment
      (NOCSAE).......................................................    46
        Prepared statement...........................................    48

                                    Appendix

    Hon. Frank R. Lautenberg, U.S. Senator from New Jersey, prepared
      statement......................................................    79
    Hon. Mark Warner, U.S. Senator from Virginia, prepared statement.    79
    Sporting Goods Manufacturers Association (SGMA), prepared
      statement......................................................    80
    Scott Hallenbeck, Executive Director, USA Football, prepared
      statement......................................................    84
    Stanley Herring, MD, Clinical Professor Departments of
      Rehabilitation Medicine, Orthopedics and Sports Medicine, and
      Neurological Surgery University of Washington; Co-Medical
      Director Seattle Sports Concussion Program; Team Physician
      Seattle Seahawks and Seattle Mariners; and Member, National
      Football League's Head, Neck and Spine Committee, prepared
      statement......................................................    93
    Letter dated October 29, 2011 to Hon. Jay Rockefeller from Ralph
      & Joy Conradt..................................................    95
    Response to written question submitted by Hon. Frank R.
      Lautenberg to Alexis Ball......................................    96
    Response to written question submitted to Steven Threet by:
        Hon. Frank R. Lautenberg.....................................    96
        Hon. John Thune..............................................    96
    Response to written questions submitted to Jeffrey Kutcher, MD
      by:
        Hon. Frank R. Lautenberg.....................................    97
        Hon. Tom Udall...............................................    98
        Hon. John Boozman............................................    99
    Response to written questions submitted to Ann C. McKee, MD by:
        Hon. Frank R. Lautenberg.....................................   100
        Hon. John Boozman............................................   100
    Response to written questions submitted to Mike Oliver by:
        Hon. Frank R. Lautenberg.....................................   101
        Hon. Tom Udall...............................................   102
        Hon. John Thune..............................................   119

                         CONCUSSIONS AND THE MARKETING
                              OF SPORTS EQUIPMENT

                                  ----------

                          WEDNESDAY, OCTOBER 19, 2011

                                           U.S. Senate,
            Committee on Commerce, Science, and Transportation,
                                                        Washington, DC.
        The Committee met, pursuant to notice, at 2:34 p.m., in
    room SR-253, Russell Senate Office Building, Hon. John D.
    Rockefeller IV, Chairman of the Committee, presiding.

           OPENING STATEMENT OF HON. JOHN D. ROCKEFELLER IV,
                    U.S. SENATOR FROM WEST VIRGINIA

        The Chairman. This hearing will come to order, and it is
    going to be an absolutely wonderful hearing.
        There are actually 14 Senators in front of you. You just
    can't see all of them. It is something that we are working on
    with NASA. We become invisible at proper moments.
        I am very proud that you are here, and I am very proud of
    our two Senators over here. This one, although you would never
    know looking at him, is a football player and--or was, I guess
    I should say. Yes.
        Senator Boozman. Two stadiums ago.
        The Chairman. There you go. So I am going to make an
    opening statement, and then I wish each of them would. We try
    to keep it brief because we want to have plenty of time for you
    to talk and for us to question.
        I am so grateful for all of you being here, all of you.
    This is a massive subject. The story which I may tell about my
    son reveals that parents can't always be as effective as they
    would like to be. I haven't decided whether to do that or not,
    whether it is an invasion of his privacy. But you can advise me
    when you give your testimony.
        So, anyway, every afternoon at the end of the school day,
    millions of our children head to playing fields, gymnasiums, or
    hockey rinks to participate in team sports. I should have said
    soccer fields, too. Playing sports doesn't just make our kids
    stronger and healthier. It also teaches them important values.
    They learn about hard work, about leadership, about living with
    pain and going through it, about working together for a common
    goal.
        The camaraderie that comes out of sports units is wonderful
    to see. It is real, and it lasts forever. Most of our young
    athletes will not end up playing sports at the collegiate or
    professional level, but we hope they will all carry the
    positive lessons they have learned on the playing fields with
    them throughout life, and they will.
        So our hearing today is about the head injuries that tens
    of thousands of these athletes sustain every year while playing
    the sports they love. Many of us are reluctant to talk about
    the risks involved in playing sports because we know what a
    positive role that sports play in our communities.
        On the other hand, the last thing we can do here is not
    talk about this problem of concussions and gear and all the
    rest of it. I mean, America has to have this conversation, and
    there will be many, many hearings on it, I know.
        In fact, more of our children should be playing sports, not
    fewer. Too many kids are spending their afternoons in front of
    computer or televisions screens, instead of on the sports
    field. And that is said every day by everybody who is involved
    in healthcare. I am going to give you a couple of pathetic
    figures.
        According to the latest data compiled by the Centers for
    Disease Control, only 17 percent of American high school
    students get an hour of daily physical activity, which is our
    current health guidelines. They say that, that you need to have
    that to stay healthy--only 17 percent. One-third of our
    children are now overweight or obese, which makes it more
    likely that they will suffer from chronic health conditions,
    such as heart disease or diabetes, things which will plague
    them for the rest of their lives as, indeed, what we will be
    talking about today could do to some.
        But the risks involved in playing sports are also very,
    very real. And by now, we have all heard about the National
    Football League players who are struggling with serious mental
    and physical health problems because they sustained repeated
    mild traumatic brain injuries, which is what concussions are
    called, I guess, medically, during their playing years. And it
    is very, very sad.
        I mean, I have seen a number of these players, people that
    I had worshipped growing up, in wheelchairs. Who was the guy
    that played--he was a cornerback for the Raiders? The greatest
    interceptor of all time, Woody--come on, give me----
        No. No. Doesn't matter. Doesn't matter.
        [Laughter.]
        The Chairman. But I mean, it was awful. I was at an event
    with him, and he was seated in a wheelchair, and he couldn't
    even pull his head up. And I leaned down and whispered in his
    ear. I think I kissed him, too. I am not sure. But it was
    having seen from this to that and who knows, especially this
    was 8 years ago. Nobody was talking about it.
        We now understand, however, that this is not an injury only
    NFL players can suffer. According to research conducted at the
    Nationwide Children's Hospital in Columbus, Ohio, more than
    70,000 high school football players sustain concussions every
    single year.
        And it is not just a football problem. One of our witnesses
    today, Alexis Ball, will talk about the concussions she
    suffered while playing soccer in high school and college.
    According to Nationwide Children's Hospital, more than 10,000
    high school girl soccer players sustain concussions each year.
        So what we are going to do is we are going to hear from Ms.
    Ball and our other witnesses today, who I should name. Dr.
    Jeffrey Kutcher. Jeffrey, you are not in my opening script. So
    I have to do this, and you forgive me. Associate Professor,
    Department of Neurology, University of Michigan; Director,
    Michigan NeuroSport. And Dr. Ann McKee, Professor of Neurology
    and Pathology at Boston University and Director of
    Neuropathology Core, BU Alzheimer's Disease Center. I guess
    that is Boston University's. And Mr. Mike Oliver, who is
    Executive Director of the National Operating Committee on
    Standards for Athletic Equipment.
        We welcome all of you, and I will just close right there
    and ask if the Chairman of the Subcommittee would wish to say
    something because he has been just terrific on this subject and
    also the Ranking Member.
        Go ahead.

                    STATEMENT OF HON. JOHN BOOZMAN,
                       U.S. SENATOR FROM ARKANSAS

        Senator Boozman. Well, thank you, Mr. Chairman, again for
    us holding this very important hearing this afternoon.
        As a former player, it is certainly something that I am
    interested in. But also there are so many moms and dads and
    coaches and players all across the country that also are very
    interested and probably should be more interested than what
    they realize. And I think that is the great thing about having
    this hearing is to try and get that information out and really
    discuss a potential very serious problem. Not a potential very
    serious problem, a very serious problem, period.
        Sports play a vital role in development of young men and
    women. They help build youth social relationships and learn to
    work as a team while keeping them physically active and healthy
    and having fun. According to the National High School Sports-
    Related Injury Surveillance Study, participation in high school
    sports has almost doubled in the last 30 years.
        This is fantastic news, and I think it is important for us
    to highlight the benefits of playing sports. However,
    participation in athletics does carry with it significant risk
    of injury. Just last week, there was news of a tragic death of
    a 16-year-old high school football player who died after
    sustaining a head injury during a game.
        It is important that everyone--coaches, parents,
    physicians, and the athletes themselves--understand those risks
    and be able to identify injuries when they occur. Concussions
    especially have the potential for severe injury, and multiple
    concussions can cause significant repercussions later in life,
    as we are going to hear about today.
        Especially with many recent media reports of high-profile
    incidents in the NFL, we often associate football with
    concussions. As I am well aware and as Mr. Threet will mention
    in his testimony, concussions are a risk with playing football,
    but players in many sports run the risk of sustaining
    concussion, as we will hear from Ms. Ball in her story about
    playing soccer.
        It is imperative for coaches and parents involved in all
    sports to be aware of the dangers associated with concussions,
    know how to recognize the signs and symptoms and what to do if
    a player suffers a concussion. I look forward to hearing from
    Dr. Kutcher and Dr. McKee about the research to further the
    knowledge that we have about concussions, but many questions
    remain as to the causes and effects of concussions. I am very
    interested in hearing from the experts on what is known and
    where we can go from here.
        As we will also discuss, there is a wide variety of
    athletic equipment on the market that claim to use concussion-
    reducing or concussion-preventing technology. Parents want to
    keep their children protected, but navigating the many products
    and claims in the marketplace, especially online, can be
    overwhelming. It can be easy to read that something offers the
    best maximum security protection and assume that their child
    will be safe from injury. That is simply not true.
        Some products may offer better protection than others, but
    we need to explore what resources exist to help parents and
    coaches know what level of safety a product will actually
    provide. I also do not know how the average parent or coach can
    be confident that the equipment they purchase genuinely offers
    a greater safety benefit or if its advertisement contains
    misleading or deceptive claims. I hope our witnesses today will
    be able to help me answer this question.
        Along with knowing the safety benefits and limitations of
    sports equipment, parents and coaches need to educate
    themselves on what to look for in the event that an athlete has
    a potential concussion. There are a number of different
    materials available for this purpose. Perhaps the most well-
    known education effort is the ``Heads Up'' initiative, led by
    the CDC in partnership with dozens of professional
    organizations and individuals.
        Individual associations, like USA Football, also have their
    own education campaigns for coaches, how to teach proper
    execution of plays and tackles so athletes are in as little
    danger as possible. However, education campaigns must be
    effective in order to effect change. I am interested to learn
    if there is data that shows whether these efforts are reaching
    a wide enough audience and promoting awareness sufficiently.
        Mr. Chairman, I know today's hearing will draw attention to
    this important safety issue. Parents, coaches, and athletes
    must have the resources available to them to understand the
    severity of concussions and how to react when one occurs. As I
    said earlier, the benefits from participating in sports are
    many, and I hope that the potential for injury does not prevent
    anyone from playing.
        Mr. Chairman, again, I thank you for calling this very
    important hearing and look forward to hearing from our
    witnesses. I ask unanimous consent that a statement from the
    Sporting Goods Manufacturers Association and USA Football be in
    the record.
        The Chairman. It is so done.
        [The statement can be found in the Appendix.]
        Senator Boozman. And with that, I yield back.
        The Chairman. I thank the Senator and call upon Senator
    Udall, who has been huge in putting together all of this.

                     STATEMENT OF HON. TOM UDALL,
                      U.S. SENATOR FROM NEW MEXICO

        Senator Udall. Thank you, Chairman Rockefeller, and thank
    you for that nice comment.
        And I very much appreciate you holding this hearing today.
    I would like to say a few words and ask that my full statement
    be put in the record. And Mr. Chairman, I greatly appreciate
    your efforts to promote brain research and, as Chairman of this
    Subcommittee, your close attention to consumer protection
    issues.
        Concussions used to be dismissed as simply ``dings'' or
    ``bell-ringers.'' We know now that a concussion is a form of
    traumatic brain injury that should be taken seriously.
    According to a recent Centers for Disease Control report,
    emergency room visits for sports and recreation-related
    traumatic brain injuries increased by 60 percent among children
    and adolescents over the last decade.
        The CDC attributes this rise to greater concussion
    awareness, which is a good thing. Now that athletes, coaches,
    and parents have a better understanding of concussions, some
    sports equipment makers appear to be taking advantage. There
    are a number of so-called ``anti-concussion'' and ``concussion-
    reducing'' devices on the market.
        While we should encourage any innovation to protect young
    athletes, we need to make sure that advertisers play by the
    rules. Expert witnesses today can shed some light on ``anti-
    concussion'' claims used by some sports equipment
    manufacturers.
        Although we now know more about the dangers of concussions,
    we shouldn't forget how important sports and physical activity
    is for children. The CDC estimates that only 18 percent of
    American high school students participate in at least 1 hour of
    physical activity a day. That is the amount recommended by the
    Department of Health and Human Services.
        Among high school students in New Mexico, only 23 percent
    are getting it. This could lead to negative health consequences
    that last a lifetime. So we need to encourage kids to play
    sports, to exercise, and to be more physically active. Injury
    is always a risk, but the benefits far outweigh the dangers.
    And as we learn more about the dangers of concussions for young
    athletes, we can take steps to make sure that they are played
    more safely.
        I want to thank all the witnesses for being here and
    testifying today. I especially want to recognize Ms. Alexis
    Ball, who traveled from Albuquerque to share her experience
    with sports concussions.
        In reviewing Dr. McKee's testimony, I find it especially
    poignant that she discusses Dave Duerson, a former NFL player
    who tragically took his own life earlier this year. In 2007, he
    testified before this committee. According to news reports,
    Duerson informed his family that he wanted his brain to be
    studied. He hoped people could learn more about the effect of
    brain trauma so kids could play football more safely in the
    future.
        In keeping with this sentiment, I hope that this hearing
    today will advance the goal of making sports safer for our
    children.
        With that, Chairman Rockefeller, thank you very much, and
    thanks for being here and the Ranking Member for being here.
    Appreciate it.
        The Chairman. That is a pretty powerful statement.
        Senator Udall. Thank you.
        [The prepared statement of Senator Udall follows:]

     Prepared Statement of the Hon. Tom Udall, U.S. Senator from New Mexico
        Concussions used to be dismissed as simply ``dings'' or ``bell
    ringers.'' Today we know that a concussion is a form of traumatic brain
    injury that should be taken seriously. For young people between 15 and
    24 years old, playing sports is the second-leading cause of traumatic
    brain injury--second only to motor vehicle crashes.
        According to a recent Centers for Disease Control and Prevention
    (CDC) report, Nonfatal Traumatic Brain Injuries Related to Sports and
    Recreation Activities Among Persons Aged >19 Years--United States,
    2001-2009, emergency room visits for sports and recreation-related
    traumatic brain injuries increased by 60 percent among children and
    adolescents over the last decade. The CDC attributes this rise to
    greater concussion awareness, which is actually a good thing.
        Now that athletes, coaches, and parents have a better understanding
    of concussions, some sports equipment makers appear to be taking
    advantage of their new concerns about safety. There are a number of so-
    called ``anti-concussion'' and ``concussion reducing'' devices on the
    market--from helmets and headbands to mouth guards, and even dietary
    supplements. While we should encourage any innovation to protect young
    athletes, we need to make sure that advertisers play by the rules.
    Claims they make about the safety of their equipment should be truthful
    and not misleading. Expert witnesses today can shed light on some of
    these concussions-related claims, and I look forward to hearing their
    testimony.
        Earlier this year, I asked the Federal Trade Commission (FTC) to
    investigate some of the safety claims used to sell football helmets.
    Given the seriousness of concussion risk and the potential for real
    injury to children, the FTC should have the ability to impose civil
    penalties, at the agency's discretion, for any violation of the FTC Act
    that involves the use of false injury prevention claims to sell
    children's sports gear.
        I also introduced legislation. This bill, the Children's Sports
    Athletic Equipment Safety Act, would allow the FTC to impose civil
    penalties for using false injury prevention claims to sell any kind of
    children's sports equipment. Again, under my bill the use of this
    enforcement power would be at the agency's discretion. It would also
    require improvements to the current voluntary safety standard for
    football helmets. I am pleased to be working on this important
    legislation in a bipartisan manner with Representatives Bill Pascrell
    and Todd Russell Platts, the Co-Chairs of the Congressional Brain
    Injury Task Force. I also want to thank fellow Commerce Committee
    member Sen. Lautenberg for his support and co-sponsorship of the
    legislation.
        I believe it is important to share with my Commerce committee
    colleagues some of the potentially misleading advertising that is used
    to market so-called ``anti-concussion'' and ``concussion reducing''
    sports gear for children's use.
        My January 4, 2011 letter to FTC Chairman Jon Leibowitz cited
    several troubling advertisements for youth football helmets in
    particular. For example, one troubling claim comes from Riddell, the
    leading helmet-maker in the country. Riddell continues to use a
    concussion reduction claim that appears to be deceptive, misleading,
    and unsubstantiated.
        The CEO of Riddell, Dan Arment, told the House Committee on the
    Judiciary at a January 4, 2010 hearing on ``Legal Issues Relating to
    Football Head Injuries'' that:

            ``We have independent, peer-reviewed, published research in the
            medical journal Neurosurgery, February of 2006, showing that
            the Revolution [helmet] reduces the risks of concussions by 31
            percent when compared to traditional helmets. . . . Today, over
            one million high school, college, and professional players have
            made the switch from traditional helmets to the Revolution
            family of helmets.'' (See also ``House Judiciary Committee
            hearing--Dan Arment opening statement.'' Video recording.
            Available at http://www.youtube.com/watch?feature
            =player_embedded&v=v1gmwk2nqi4 accessed Oct. 19, 2011)

        Riddell bases this claim on a single study of high school football
    players using brand new Riddell Revolution helmets compared with
    players wearing used and reconditioned helmets of unknown condition.
    Scientists who commented on the article cautioned against drawing broad
    conclusions from a single study that compared the performance of new
    helmets with used headgear of unknown condition and that examined just
    136 high school players who experienced concussions.
        Nevertheless, Riddell launched a media campaign featuring the claim
    from the 2006 study that, according to its ``Riddell Revolution UPMC
    Media Campaign Highlights'' video news release, created ``over 60
    million media impressions, nearly 150 television placements, over 100
    newspaper clips, over 250 on-line placements, [and] 6 live sports radio
    interviews.'' (See http://www.riddell.com/pressreleases_upmc
    study/, accessed Jan. 6, 2011.)
        Several helmet and sports safety experts have criticized Riddell's
    use of this concussion prevention claim to sell Revolution type
    helmets. In his 2007 book, Head Games: Football's Concussion Crisis
    from the NFL to Youth Leagues, Chris Nowinski notes that:

            ``As it is well established that rotational forces have a major
            role in football concussions, and that football helmets do
            little to reduce those forces, we could skip the discussion of
            the benefits of the newest football helmets, the Riddell
            `Revolution' and the Schutt `DNA.' If they make any difference
            it all, it would be minor. But. . .. both these companies are
            spending a lot of money to get you to buy these newer and more
            expensive helmets. You deserve to know what's really going
            on.''

        In his book, Nowinski also quotes Dr. Robert Cantu, a board member
    of the National Operating Committee on Standards for Athletic Equipment
    (NOCSAE), who told him that:

            ``The theory behind the [Riddell] `Revolution' is that if you
            build a helmet that's a little bit bigger, especially in the
            temple area, and padded more thickly, then you'll reduce force
            more than you would if you had thinner padding and not so big
            an outer shell. That theory is good for blows that go right to
            the temple, but that's it.''

        NOCSAE's technical director, Dave Halstead, told the New York Times
    in an October 27, 2007 story titled ``Studies for Competing Design
    Called Into Question'' that ``. . . the [Riddell] Revolution is a good
    helmet. . . . But I have problems with that particular [2006
    Neurosurgery] study. The helmet is not shown to do what they say it
    does.'' In another October 21, 2010 New York Times article titled ``As
    Injuries Rise, Scant Oversight of Helmet Safety,'' Halstead bluntly
    told reporter Alan Schwarz that ``. . . I don't believe that 31 percent
    [reduction in concussion risk claim] for a Yankee minute.'' These
    public statements from one author of the 2006 study and other helmet
    safety experts call into question whether there is competent and
    reliable scientific evidence to substantiate Riddell's marketing claim.
        Moreover, Riddell advertisements cited in my letter to the FTC do
    not disclose that the company provided a grant to underwrite the 2006
    Neurosurgery study. Nor do they disclose that Riddell's vice president
    of research and development, Thad Ide, was one of the study authors. An
    official Neurosurgery commenter highlighted the authors' conflicts of
    interest and stated that the study's conclusions ``should be
    interpreted accordingly.'' Nevertheless, this claim has been
    extensively used in Riddell marketing of high school and youth helmets.
        Here is just one example taken from the website of Riddell's parent
    company, Easton Bell, that does not disclose Riddell's role in funding
    and writing the 2006 study:

            ``An extensive long-term study by the University of Pittsburgh
            Medical Center was published in the February 2006 issue of
            Neurosurgery. The results were impressive: Players wearing the
            Riddell Revolution football helmet were 31 percent less likely
            to suffer a concussion than athletes who wore traditional or
            standard football helmets. For athletes who had never suffered
            a previous concussion, wearing the Riddell Revolution
            decreased their relative risk of concussion by 41 percent. . .
            .* * NEUROSURGERY, FEBRUARY 2006, VOL. 58, NO. 2'' (See http://
            www.eastonbellsports.com/brands/riddell, accessed Oct. 19,
            2011).

        The same Easton Bell webpage includes an image of a Riddell
    Revolution Speed helmet with the claim that ``[r]esearch shows a 31
    percent reduction in the risk of concussion in players wearing Riddell
    Revolution helmets when compared to traditionally designed helmets.*
    *NEUROSURGERY, FEBRUARY 2006, VOL. 58, NO. 2.'' (See image at end of
    statement.)
        Riddell also uses its reduced risk of concussion claim to sell
    youth helmets that were not actually tested in the 2006 study of high
    school football players. For example, Riddell's online store advertises
    the Riddell Revolution Youth football helmet with the claim that
    research shows a 31 percent reduction in the risk of concussion when
    wearing the Riddell Revolution helmet compared to traditional helmets.
    This webpage does not disclose that the youth helmet was not actually
    included in the published study:

            Based on the same technology that made the varsity Riddell
            Revolution helmet possible--we offer in a Youth version--the
            Riddell Revolution Youth. . . . After an extensive long-term
            study by the University of Pittsburgh Medical Center was
            published in the February 2006 issue of Neurosurgery. The
            results were impressive: research shows a 31 percent reduction
            in the risk of concussion in players wearing a Riddell
            Revolution football helmet when compared to traditional
            helmets.* * NEUROSURGERY, FEBRUARY 2006, VOL. 58, NO. 2'' (See
            https://shop.riddell.com/riddell/app/displayApp/
            %28cpgsize=20&layout=
            7.0-
            7_2_3_75_12_13_67_77_6_4_5&carea=0000000002&cpgnum=1%29/.do?rf=y
            , viewed Oct. 17, 2011)

        Since concussion risk may differ depending on the age group and
    skill level of players, the results of a single study of high school
    football players may not be valid for younger children, especially if
    they wear a different helmet not used in the study. That the youth
    helmet was not actually tested in the 2006 Neurosurgery study may be a
    significant omission in such marketing claims used by Riddell and other
    retailers to sell Revolution youth helmets.
        As the official helmet of the National Football League (NFL),
    Riddell also highlights the use of its products ``by the pros'' when
    marketing helmets for high school and younger players. I am concerned
    by some of the product testimonial claims from one NFL head athletic
    trainer, Tim Bream of the Chicago Bears, who states in a Riddell
    Revolution Video News release titled ``Riddell Revolution UPMC Media
    Campaign Highlights:''

            ``We've had some players who have had ongoing problems with
            head injury, and we made the switch to the new protective
            headwear when it came out, at its inception. And these players
            have had no problems since then, or no repeated concussions.''

        Bream does not name the players who ``had ongoing problems with
    head injury'' before switching to Riddell Revolution helmets. However,
    the NFL Injury Report website and news articles discussing head
    injuries suffered by Chicago Bears players during the 2010 football
    season seem to contradict the claim that wearing the Riddell Revolution
    helmet prevents all repeated concussions. Three Chicago Bears players
    who are listed as having head injuries during the 2010 season seem to
    be wearing Riddell Revolution helmets in press photos. Even if this
    Riddell Revolution testimonial claim of ``no repeated concussions''
    were true at the time the video was made, one can question whether
    those who buy the Riddell Revolution helmet for youth or high school
    players would see similar results of ``no repeated concussions.''
        Riddell uses additional endorsements from this athletic trainer in
    a January 9, 2006 press release titled Research Shows Riddell
    Revolution Football Helmet Provides Better Protection Against
    Concussions (available at: http://www.riddell.com/wp-content/uploads/
    2006_UPMC_Press_Release_web3.pdf, accessed Oct. 19, 2011) and a 2006
    Riddell brochure titled Revolution Helmet Research Findings (available
    at: http://www.lohud.com/assets/pdf/BH1661391028.PDF, accessed Oct. 19,
    2011). In the brochure, Bream states that the ``new data [from the 2006
    Neurosurgery study] helps our players make an informed choice when
    deciding which helmet is best for them.''
        Coaches and athletic equipment managers for youth and high school
    teams with players who have suffered concussions might also be
    particularly susceptible to such injury prevention claims. The Orlando
    Sentinel newspaper's Varsity Sports blog reported on October 17 that
    one high school football coach and athletic trainer issued a
    fundraising appeal to buy 60 new Riddell helmets that are ``the most-
    up-to-date . . . concerning concussion reduction technology'' since he
    is concerned about team athletes with multiple concussions. He told the
    Varsity Sports blog that:

            ``In the last three years, we have had eight concussions on the
            football team. . . . What brought us to this point is we have a
            player who has had a second concussion and of course there is
            [former South Sumter linebacker] Your highness Morgan [a
            junior] at Florida Atlantic University but he can't play
            because he has had three concussions in the last two years.
            We're afraid we are putting our kids at risk. There are recent
            studies that have shown multiple concussions can lead to a
            lifetime of medical problems. It's twice the price of the
            helmets we are wearing now and it's a lot of money to ask a
            small community to raise but truly, I'm not sure how you cannot
            afford to get these helmets.'' (Available at http://
            blogs.orlandosentinel.com/sports_highschool_varsity/2011/10/17/
            south-sumter-raising-money-for-new-helmets/, accessed Oct. 19,
            2011.)

        New Riddell helmets may be very good products. It may also be
    advisable for this team to replace its old helmets with new headgear.
    Yet there are still real dangers to overstating the ability of
    children's sports equipment to prevent brain injury, particularly to
    coaches and parents of young athletes who have already suffered
    multiple concussions.
        Unfortunately, misleading ``anti-concussion'' claims appear in
    advertisements for more than just football helmets. There are other
    troubling examples of children's sports equipment sold with concussion
    prevention claims. Although there is evidence that wearing properly
    fitted mouth guards reduces the risk of dental injuries, Dr. William
    Meehan, director of the Sports Concussion Clinic at Children's Hospital
    Boston, writes in his 2011 book Kids, Sports, and Concussion: A Guide
    for Coaches and Parents that any ``effects of [custom mandibular
    orthotics] and other mouth guards on concussions remains unknown.''
        Such uncertainty about the ability of mouth guards to prevent
    concussions does not keep some companies from using concussion
    reduction claims to market mouth guards for youth and high school
    athletes. The product packaging for the Brain Pad Lo Pro+ junior mouth
    guard, which is sold for athletes aged eleven years and under,
    prominently states that it ``Reduces the Risk of CONCUSSIONS!'' and
    ``Creates this: BRAIN SAFETY SPACE!'' On its Brain Pad Blog, the
    company highlights in a banner image the claim ``BioMechanically Tested
    and Proven to Reduce Concussions Risk by 40 percent!'' (see: http://
    blog.brainpads.com/, accessed Oct. 19, 2011).
        In Brain Pad's online video advertisement titled Head Trainer
    announces ``Zero concussions with Brain Pad mouth guards!'', a head
    athletic trainer ``at one of the top 5 private [high] schools in the
    country'' who is ``responsible for the well-being of 800 student
    athletes at the school'' states that:

            ``We've been using the Brain Pad since 1995. In all those
            years, whenever I go out on the field, especially if somebody
            has a potential of a concussion, I always check to see what
            type of mouth guard they're wearing. And I have never, ever
            seen anybody wearing the Brain Pad and having a concussion. . .
            . Since 1995, my experience with this mouth guard preventing
            concussions has been absolutely awesome.'' (see http://
            www.youtube.com/user/brainpads#p/u/3/mtg1EF
            6LdVQ, accessed Oct. 17, 2011.)

        Similar to the Riddell Revolution helmet video described above,
    this testimonial claim of no concussions among student athletes wearing
    the Brain Pad mouth guard seems to imply that those who purchase the
    product will have similar results. This could lead to young athletes
    putting themselves at greater risk of head injury if they believe that
    they will never suffer a concussion while wearing the Brain Pad mouth
    guard.
        Another company makes the ``Tap Out Youth Mouthguard'' for ages 5
    to 11 years. The back of the product packaging states that the mouth
    guard has a ``Concussion Defense System backed by a $30,000 Dental
    Warranty.'' Although this Tap Out mouth guard claim is not as prominent
    as the previously cited claims for the Brain Pad mouth guard, it is not
    clear how the product's ``Concussion Defense System'' actually protects
    children from sports-related head injury.
        There are also sporting goods companies that sell protective
    headbands for soccer players with potentially misleading concussion
    prevention claims. Dr. Meehan notes in Kids, Sports, and Concussion: A
    Guide for Coaches and Parents that although many headbands advertise
    the ability to reduce the risk of concussion, there is little medical
    evidence to support this assertion.
        The website for ForceField FF headband describes concussions as a
    problem in soccer and notes that their headband ``can come between you
    and a head injury'' (see image at end of statement). The company
    website states that:

            ``Research on concussions in soccer has shown that soccer
            players have concussion rates similar to football and ice
            hockey. . . . The ForceField FF Headband will reduce the risk
            of head injury when exposed to any type of external force.''
            (See http://www.forcefieldheadbands.com/sportrelated.html
            accessed Oct. 17, 2011)

        Another webpage indicates that the result of wearing the ForceField
    headband is a ``[s]ignificant reduction of the risk of head injuries
    when exposed to all types of impacts'' (available at: http://
    www.forcefieldheadbands.com/rationale.html, accessed Oct. 17, 2011).
    The company also markets this headband specifically for use by young
    children (see: http://www.forcefieldheadbands.com/children.html,
    accessed Oct. 17, 2011).
        Full90 Sports sells other ``performance headguards'' to protect
    against concussion in soccer. The company's online store claims the F90
    Performance Headguard's ``ForceBloc foam reduces impact force by up to
    50 percent, meaning fewer concussions overall and a reduction of
    severity of injury.'' The company further states that an unnamed
    ``recent study'' found that ``college players not wearing a Full90
    Performance Headguard were 2.65 times more likely to receive a
    concussion than players that did.'' (See http://www.full90.com/
    products/protect/club/ accessed Oct. 19, 2011).
        Full 90 Sports' website also includes a product testimonial from a
    pro soccer player supported by a photo apparently taken moments after
    he collided with another player. Wearing Full90 headgear, the player
    looks at his opponent who, not wearing any headgear, appears injured on
    the ground. The quote accompanying the image is as follows:

            ``We don't know exactly how much [the headgear] reduced the
            force of [the impact] but I just thank God . . . I was wearing
            that thing because I might not be here talking to you had I not
            worn it. (available at http://www.full90.com/players/pro/
            accessed Oct. 19, 2011. See also image enclosed at end of
            statement.)

        Although this photo and testimonial statement may accurately convey
    the player's honest belief in the protective properties of Full90
    headgear, it is questionable whether there is a reasonable basis to
    claim that such soccer headgear actually reduces the likelihood and
    severity of brain injury to any degree.
        Such concussion prevention claims used in advertising for a variety
    of children's sports equipment are very concerning. Paying for a
    product that does not work as effectively as advertised is bad enough.
    It is far worse when a product sold for children's use might actually
    increase the risk of brain injury due to a false sense of security.
    Enacting the Children's Sports Athletic Equipment Safety Act would
    discourage companies from misleading coaches, parents, and young
    athletes.
        Unfortunately, one even finds similar, potentially misleading
    concussion claims in marketing for dietary supplements for children's
    use. Newport Nutritionals sells Sports Brain Guard, a ``[d]aily tri-
    delivery bioactive protection program'' that ``help[s] protect your
    brain from concussion injury'' (see http://www.sports
    brainguard.com/ accessed Oct. 19, 2011; See also image at end of
    statement). Elsewhere on the website, Sports Brain Guard claims to
    ``maximize the brain's ability to heal and reduce inflammation.'' While
    this claim may be true, it is not clear that there is enough scientific
    evidence to date to substantiate that this dietary supplement actually
    protects the brain from concussion.
        Moreover, the net impression of the product's advertising may
    improperly convey the message that athletes who are concussed or
    recovering from the lingering effects of concussion can safely ``stay
    in the game'' by taking Sports Brain Guard supplements. This ``stay in
    the game'' advertising slogan, which is used throughout the product's
    website, contrasts with the concussion safety and awareness efforts
    promoted by the CDC and various sports leagues. In fact, the CDC
    recommends that concussed athletes never return to sports activities
    ``the day of the injury and until a health care professional,
    experienced in evaluating for concussion, says they are symptom-free
    and it's OK to return to play'' (see http://www.cdc.gov/concussion/
    what_to_do.html, accessed Oct. 19, 2011).
        Yet, despite all this, elsewhere on the site, Newport Nutritionals
    also prominently announced on the product's homepage that Sports Brain
    Guard is ``Recommended by Dr. Joseph Maroon--Expert in head Injury
    treatment, Heindl Scholar in Neuroscience, [and] Team Neurosurgeon for
    the Pittsburg Steelers'' (See Sports Brain Guard website from Feb 10,
    2011. Internet Archive Wayback Machine. Available at http://
    web.archive.org/web/20110210114509/http://sportsbrainguard.com/,
    accessed Oct. 19, 2011). In a separate webpage highlighting his expert
    endorsement, Maroon states:

            ``Over the past 30 years, as a practicing neurosurgeon, I have
            treated thousands of athletes with sports related concussions--
            players from the NFL, NHL, NBA, NCAA and all the way down to
            kids playing youth sports. . . . I have personally recommended
            [this] product, Sports Brain Guard, to athletes at all levels
            following concussions.'' (See http://www.sportsbrainguard.com/
            maroonmsg.
            aspx, accessed Oct. 19, 2011 and see also image at end of
            statement)

        This kind of testimonial in support of the product from a doctor
    who has worked in the field of sports concussion is very concerning. It
    is seems to be intended to provided a level of consumer confidence in
    the efficacy of Sports Brain Guard supplements that does not appear to
    be justified by scientific data.
        Also of great concern, the product website homepage includes a
    ``Notice to Parents'' about children and concussion risk that seems to
    indicate that this product is sold for use by young athletes (See
    http://www.sportsbrainguard.com/, accessed Oct. 19, 2011; see also
    image at end of statement). Given the intent seems to be to sell for
    use by young athletes, it is even more important that the product
    advertising claims are accurate and supported by scientific evidence.
        There are undoubtedly more examples of ``anti-concussion'' and
    ``concussion reducing'' products marketed for children's use. The
    examples cited above, however, demonstrate that this is already a
    problem that could become even worse as awareness of sports concussion
    increases. As we continue to look for the best ways to tackle the
    problem of sports concussion, we should work to take false advertising
    out of the game. I hope that responsible sporting goods manufacturers
    and sports leagues--which are already working to improve concussion
    awareness among athletes, coaches and parents--will also join in this
    important effort.
        In conclusion, I want to emphasize the very positive role of sports
    for individuals and our society. Although we now know more about the
    dangers of concussion, we must not forget how important physical
    activity and sports are for children. The CDC estimates that only 18
    percent of American high school students participate in at least one
    hour of physical activity a day. That is the amount recommended by the
    Department of Health and Human Services. Among high school students in
    New Mexico, only 23 percent are getting the recommended amount of
    physical activity. This could lead to negative health consequences that
    last a lifetime.
        We know that physically-active youth have lower rates of body fat,
    better cardio-respiratory fitness, stronger muscles and bones. They
    also have less anxiety, stress, and depression. As highlighted in HSS's
    Physical Activities Guidelines for Americans, the bottom line is that
    the health benefits of physical activity far outweigh the risks of
    adverse events for almost everyone.
        So we need to encourage kids to play sports, to exercise, and to be
    more physically active. As we learn more about the dangers of
    concussions for young athletes, we can take steps to make sure sports
    are played more safely.
        Enclosures:
        1. Image from Easton Bell website, available at http://
    www.eastonbellsports.com/brands/riddell, accessed Oct. 19, 2011.
        2. Image and testimonial statement from ``Riddell Revolution UPMC
    Media Campaign Highlights'' video news release available at: http://
    www.riddell.com/press
    releases_upmcstudy/, accessed Jan. 6, 2011.
        3. Image of product packaging (top front) for Brain Pad Lo Pro+
    junior mouth guard.
        4. Image of product packaging (back) for Brain Pad Lo Pro+ junior
    mouth guard.
        5. Image from ForceField FF Headbands website, available at http://
    www.force
    fieldheadbands.com, accessed Oct. 19, 2011.
        6. Image from ForceField FF Headbands website, available at http://
    www.force
    fieldheadbands.com/children.html, accessed Oct. 19, 2011.
        7. Image and testimonial statement from Full90 Sports website,
    available at http://www.full90.com/players/pro/, accessed 10-19-11.
        8. Image from Sports Brain Guard website, available at http://
    www.sports
    brainguard.com/purchase.aspx, accessed Oct. 19, 2011.
        9. Image of Sports Brain Guard website, ``Stay in the Game with
    Sports Brain Guard.'' available at http://www.sportsbrainguard.com/
    maroonmsg.aspx, accessed Oct. 19, 2011.
        10. Image of Sports Brain Guard website and text excerpt, ``Stay in
    the Game with Sports Brain Guard.'' available at http://
    www.sportsbrainguard.com/maroon
    msg.aspx, accessed Oct. 19, 2011.
                                     ______

                                   Enclosures

                                    ------

        The Chairman. Ms. Alexis Ball, I would like to call on you
    first.

           STATEMENT OF ALEXIS BALL, ALBUQUERQUE, NEW MEXICO

        Ms. Ball. Chairman Rockefeller and members of the
    Committee, I want to thank you for inviting me here today.
        My name is Alexis Ball, and I am a senior at the University
    of New Mexico. Concussions have greatly altered my life, and I
    appreciate the opportunity to take an advocacy role on
    concussion awareness.
        I have played soccer since I was 4, and I have always been
    the high-achieving student athlete. In high school, I was New
    Mexico's Gatorade Player of the Year and our valedictorian. By
    my junior year in college, I was an academic all-American,
    captain of my team, and had received first team all-conference
    honors.
        However, for as many awards as I have accumulated, I have
    accrued about as many concussions. I was medically disqualified
    from playing collegiate athletics in December 2009. This
    decision came after a season of struggle, following two
    concussions I sustained in the beginning of the season.
        The Chairman. Ms. Ball, what you are saying is so important
    and so moving and powerful that I want you to slow down just a
    tiny bit so we don't miss a syllable.
        Ms. Ball. I am sorry.
        The Chairman. OK?
        Ms. Ball. During preseason, I was offered the opportunity
    to shadow a doctor in the ER. A man came in with a knee
    laceration, which I was not prepared to see. I fainted and hit
    my head. It was clear I had a concussion, due to the dizziness,
    vomiting, and seizures that followed.
        My coaches were not pleased when I called them the
    following morning, informing them of the concussion. In
    accordance with the team doctor's requirements, I sat out for a
    week. After that week, I met with him again. He asked me the
    normal concussion questions. Do you have a headache? Are you
    dizzy? Can you remember these three words?
        I was still experiencing headaches and bouts of dizziness
    at the time, but it was the week of our first game and I wanted
    to play. Thus, I supplied the necessary answers to get cleared.
    I played for about 2 weeks with minimal issues. However, in our
    third game, I took a header on the top of my head.
        I was not able to stand up and needed assistance to leave
    the field. I had sustained another concussion. I sat out for
    about a week and returned to play. However, the weeks following
    this concussion were horrible. I was playing terribly and
    simply was not myself.
        I was no longer able to sleep at night. I would fall asleep
    around 3 o'clock in the morning after lying restlessly in my
    bed since 10 p.m. the night before. I could not pay attention
    in any of my classes.
        However, the most disturbing change was the twist in my
    personality. I no longer enjoyed partaking in anything. I would
    go to practice and feel void of emotions, or I would begin
    crying randomly in the middle of practice. I would also sit in
    my room and stare into space, not comfortable in my own body. I
    did not know who I was anymore.
        I thought that Alexis, the high-achieving student athlete,
    was permanently gone. My mom was seriously concerned about my
    well-being and forced me to go see my doctor. I told him about
    all my struggles, and he, too, was rather concerned.
        In an effort to see what was happening, I took a neuropsych
    test. The test revealed that my visual memory was impacted. I
    now fall in the 20th percentile of all people for visual
    recall, and my doctor also explained that I was experiencing
    prolonged symptoms from the combination of the two concussions
    I had sustained months prior.
        I was shocked. My doctor and I also talked about the status
    of my future in soccer. We talked about implications for my
    future if I were to sustain another concussion. I had already
    accumulated 10 concussions in about 8 years, most of which
    while wearing protective headgear.
        The doctor concluded that for the safety of my future, I
    should hang up my cleats. This was a crushing blow, yet one
    that needed to be done. Ultimately, I had to separate my head
    from my heart.
        Concussions are a very serious insult to your brain. People
    frequently claim an athlete ``just sustained a concussion,''
    like it is no big deal. Too often, coaches, athletes, and
    parents dismiss the severity of concussions because it is not a
    visible injury. If an athlete tears their ACL or sprains their
    ankle, it is apparent externally that they are injured. This is
    not the case with concussions.
        A doctor or coach often cannot see the physical
    manifestations of the concussion. Moreover, many of the
    symptoms of post-concussion syndrome are not usually associated
    with the initial blow. I had no idea that my insomnia or the
    sadness I had felt could be correlated to an injury that I had
    sustained in the months prior, which is something I really want
    to emphasize today.
        Athletes must be aware that if they sustain a concussion,
    symptoms can last longer than a few days, or weeks, for that
    matter. They can last a lifetime.
        Another issue athletes need to be aware of is the limited
    efficacy of headgear or helmets. I wore protective headgear
    since my second concussion in high school, per the
    recommendation of my trainers. It was supposed to be a
    preventive measure against concussions, and clearly, this did
    not hold true. I sustained about eight concussions since
    wearing that. It is essential for athletes and coaches to know
    that athletes are not free from concussions because they have
    protective headgear.
        Furthermore, I believe it is important to note that the
    mentality to return to play as quickly as possible is very
    prevalent in the world of athletics. There is a lot of pressure
    on athletes to just deal with their injuries, or they will be
    in jeopardy of losing their starting position or playing time.
        This cultures an environment in which it is really easy to
    lie about your symptoms, especially when it comes to
    concussions. I knew the answers needed to return to play. No
    one could prove whether I had a headache or not, so I was apt
    to lie. In retrospect, this was a very poor decision, but I did
    not understand the severity of concussions at the time.
        I continued to play much longer than I probably should
    have, due to the high number of concussions I had throughout my
    career. And I most certainly returned to play too quickly.
    People have only one brain for life. I will never regain the
    visual memory I once had. I will also not be able to regain the
    respect I lost while I struggled through my final season of
    soccer.
        I hope from my story you have learned that concussions and
    brain injury are not a minor injury. In order to prevent more
    stories like mine, concussion awareness needs to be more
    prevalent among coaches and athletes in our society. I believe
    that most coaches and athletes do not truly understand the
    long-term ramifications of concussions. And people also need to
    understand that wearing protective gear does not stop
    concussions from occurring.
        Therefore, I want to thank you again for inviting me here
    today in a step to further public education about this
    invisible injury.
        [The prepared statement of Ms. Ball follows:]

           Prepared Statement of Alexis Ball, Albuquerque, New Mexico
        Chairman Rockefeller, Ranking Member Hutchison, and members of the
    Committee, I want to thank you for inviting me here today. My name is
    Alexis Ball, and I am a senior at the University of New Mexico.
    Concussions have greatly altered my life. I appreciate the opportunity
    to take an advocacy role in concussion awareness.
        I have played soccer since I was four and have always been a high
    achieving student athlete. Throughout my career, I earned numerous
    academic and athletic awards. In high school, I was New Mexico Gatorade
    Player of the Year and our valedictorian. By my junior year in college,
    I was an Academic All American, captain of my team, and had received
    First Team All Conference honors. My coaches often spoke of my
    potential to lead our team to a place that it has never been. However,
    for as many awards as I have accumulated, I have accrued about as many
    concussions. I sustained approximately five concussions prior to
    college and five concussions throughout college while wearing
    ``protective'' headgear. In fact, it was a concussion that terminated
    my collegiate career a year early.
        I was medically disqualified from playing collegiate athletics in
    December 2009. This decision came after a season of struggle following
    two concussions I sustained in the beginning of the season. During pre-
    season, I was offered the opportunity to shadow an ER doctor. I
    excitedly took the opportunity because I want to be a doctor. A man
    came in with a knee laceration that I was not prepared to see, and I
    fainted and hit my head. It was clear I had a concussion due to the
    dizziness, vomiting, and seizures that followed.
        My coaches were not so pleased when I called them the following
    morning informing them of the concussion. I had already sustained three
    concussions at UNM, and no one wanted me to add any more to the list.
    In accordance with the team doctor's requirements, I sat out for a
    week. However, my rest time still forced me to be watching practices in
    the blistering hot temperatures of August in New Mexico. I met with the
    sports medicine doctor a week after the concussion in order to be
    cleared to play. The doctor asked me the normal concussion questions,
    such as ``do you have a headache right now?'' Or ``can you remember
    these three words?'' I had heard these questions all too many times
    before. I was still experiencing headaches and bouts of dizziness at
    this time, but it was the week of our first game and my coaches wanted
    me to play. Thus, I supplied the necessary answers to get cleared.
        I played for about two weeks without many issues. I did not play
    well, but I was there. In about our third game, I took a header off the
    top of my head (an area of my head which was not covered by my head
    gear). I was not able to stand up and needed assistance to leave the
    field. I had sustained another concussion. I sat out for a week again
    and then returned to play.
        However, the weeks following this concussion were horrible. Not
    only had I lost my starting position, but I seemed incapable of getting
    it back. I was playing terribly and simply was not myself. Many other
    things had changed as well. I no longer was able to sleep at night. I
    would fall asleep around 3 o'clock in the morning after lying
    restlessly in my bed since 10 o'clock at night. I could not pay
    attention in any of my classes. However, the most disturbing change was
    the twist in my personality. I no longer enjoyed partaking in anything.
    I would go home and sit in my room and stare into space, not
    comfortable in my own body. I did not know who I was anymore. I would
    either go to practice and feel void of all emotion or begin crying
    uncontrollably randomly in the middle of it. I was lost. My teammates
    initially asked if I was ok, and I would shrug my shoulders, replying
    weakly, ``yes I'm fine.''
        As the weeks progressed and my playing continued to deteriorate, I
    felt my teammates distancing themselves from me. About two months into
    the season, I had a meeting with my fellow captains. They informed me
    that they had lost respect for me and felt that I was selfish by acting
    so introverted at practices. I was in disarray, and these comments only
    worsened my fragile emotional state. Only my best friend and my parents
    remained by my side. I didn't know who to be anymore. I thought that
    Alexis, the high achieving student athlete, was permanently gone.
        My mom was seriously concerned about my well-being. She e-mailed a
    doctor that she knew with her concerns and urged me to consult with
    him. I was very resistant to this idea because I felt that not sleeping
    and having some gloomy days were such silly reasons to see the doctor.
    I finally went and talked to him. I told him all about my struggles,
    and he was rather concerned. In an effort to see what was happening, I
    took a neuropsychology test. The test revealed that my visual memory
    was impacted. I now fell in the 20th percentile of all people for
    visual recall. My doctor informed me that I was experiencing prolonged
    symptoms from the combination of the two concussions I sustained months
    prior. I was shocked.
        My doctor and I talked about the status of my future in soccer. We
    discussed the numerous concussions I have had throughout my soccer
    career. I had accumulated 10 concussions in about 8 years. We also
    talked about the implications for my future if I were to sustain
    another one. The doctor concluded that for the safety of my future, I
    should hang up my cleats. It was a crushing blow, yet one that needed
    to be done. Ultimately I had to separate my head from my heart.
        Concussions are a very serious insult to your brain. People
    frequently claim an athlete just sustained a concussion, like it is no
    big deal. Too often coaches, athletes, and parents dismiss the severity
    of concussions because it is not a visible injury. If an athlete tears
    their ACL or sprains their ankle, it is apparent externally that they
    are injured. This is not the case with concussions. A doctor or coach
    often cannot see the physical manifestations of a concussion. Moreover,
    many of the symptoms of post-concussion syndrome are not easily
    associated with the initial blow. I had no idea that my insomnia or the
    sadness I had felt could be correlated to an injury that I had
    sustained months prior. That is one message that I want to emphasize
    today. Athletes who have had concussions must be aware that symptoms
    can last longer than a few days or weeks. They can last for months and
    in some cases for life.
        Another issue athletes need to be aware of is the limited efficacy
    of head gear or helmets. I wore protective head gear since my second
    concussion in high school per the recommendation of my trainer. It was
    supposed to be a preventative measure against concussions. Clearly this
    gear did not prevent me from sustaining further concussions. It is
    essential for coaches and athletes to know that athletes are not free
    from concussions because they have protective head gear.
        Furthermore, I believe it is also important to note that the
    mentality to return to play as quickly as possible is very prevalent in
    the world of high school and collegiate athletics. There is a lot of
    pressure on athletes to just deal with their injuries or they will be
    in jeopardy of losing their starting position or playing time. This
    cultures an environment in which it is really easy to lie about your
    symptoms, especially when it comes to concussions. I knew the test
    questions and the answers needed to return to play. No one could prove
    whether I had a headache or not, so I was apt to lie. In retrospect,
    this was a very poor decision, but I did not understand the severity of
    concussions at the time. I also believe that most coaches and athletes
    do not truly understand the long term ramifications of concussions. I
    continued to play much longer than I probably should have due to the
    high number of concussions I had throughout my entire career. I most
    certainly returned to play too quickly. People only have one brain for
    life. It is not something that can be repaired via surgery like most
    other injuries. I will never regain the visual memory I once had. I
    also will not be able regain the respect I lost while I struggled
    through my final season of soccer.
        Concussions adversely impacted my life. I hope from my story you
    have learned that concussions and brain injury are not a minor injury.
    In order to prevent more stories like mine, concussion awareness needs
    to be more prevalent among coaches and athletes in our society. People
    need to understand that wearing protective gear does not stop
    concussions from occurring. Therefore, I want to thank you again for
    inviting me here today in a step to further public education about this
    invisible injury.

        The Chairman. Thank you. You did extremely well.
        Mr. Steven Threet, who is a student at Arizona State
    University, was a quarterback and is still there. A starting
    quarterback, but you are still associated----
        Mr. Threet. Yes, sir.
        The Chairman. Working with the team?
        Mr. Threet. Yes, I am coaching with the team. Yes. Yes,
    sir.
        The Chairman. OK. We welcome you.

               STATEMENT OF STEVEN THREET, TEMPE, ARIZONA

        Mr. Threet. Thank you, Chairman Rockefeller and the other
    Committee members, for inviting me.
        It is a great honor to be speaking here on a topic that has
    changed my life, and I am happy to help raise awareness about
    such a critical issue in both male and female sports. Dealing
    with concussions can be a very difficult process for the
    injured player and their family. So it is exciting for me to
    see such a prestigious and capable group of individuals who are
    willing to learn more in an effort to help better educate and
    protect all athletes.
        Throughout my playing career, I faced a multitude of
    injuries. However, none caused more confusion, both literally
    and figuratively, at the time they occurred than concussions.
    Each of the four documented concussions that I experienced were
    unique in the way in which they occurred.
        I sustained concussions from hits directly to my head by
    another player, from my head hitting the ground, and also as a
    result of consecutive impacts on separate plays. While my
    symptoms were often similar--they ranged from slight dizziness
    and blurred vision to extreme light sensitivity and constant
    headache--the severity of my symptoms had no recognizable
    pattern.
        In two of the cases, I returned to play 1 week after the
    injury I sustained. In one instance, it only took me 2 weeks to
    recover. However, my final concussion I suffered on November
    26, 2010, and the resulting symptoms were the reason that I
    decided to end my football playing career.
        During my playing days, brain injury was never a major
    concern to me. After my first concussion, which happened on the
    last play of a high school game senior season, I was able to
    start the next game. It was not until my symptoms became
    serious that my attitude about the injury changed.
        At the time when I decided to retire, I saw my decision
    simply as the right one to make. However, in the aftermath, it
    has become apparent to me that my decision can also be seen as
    an example of how dangerous brain injury is.
        I want to make it clear that my goal in speaking is not to
    deter athletes from competing. I only wish that they
    acknowledge the seriousness of brain injury and respect the
    process that comes with the recovery.
        In all sports, a certain aggressive mentality is required
    to be successful. The passion and intensity a football player
    relies on is an example of this, and it is what I think makes
    the game beautiful. As a former quarterback at premier college
    football programs, I know the importance of and took pride in
    being physically and mentally tough, outworking my opponent and
    leaving it all on the field, and playing through injury.
        However, athletes must understand that a mild brain injury
    is not a mild shoulder separation. It is not an injury to be
    played through. They must understand that playing through a
    brain injury is not a sign of toughness, but it is a sign that
    says athletes are still uninformed on the topic.
        Statistics have recently revealed that about 40 percent of
    athletes who have sustained a concussion returned to play too
    early and that up to 50 percent of concussions go unnoticed.
    This makes me believe that the only focus should be to create
    an open dialogue between athletes, coaches, doctors, and
    families that address the seriousness of brain injuries in
    athletics and the need for a full recovery before we return to
    play.
        I know it is possible to decrease those statistics, and I
    also know progress on this issue is already being made, and
    many states have passed legislation dealing with concussion
    protocols. Unfortunately, there is no brain brace. There is no
    concussion-proof helmet or magic pill for immediate recovery.
    However, I believe there is a misunderstanding about concussion
    prevention and treatment within the athlete cohort, as well as
    the general public.
        For example, a football helmet is often thought of as a
    brain protector when, in reality, it is designed to protect the
    bone structure of the individual and not the brain. If the
    helmet could guarantee concussion prevention, I would still be
    playing football.
        Once again, I would like to thank you for the opportunity,
    but more importantly, thank you for taking the time to learn
    and show your support for this issue today. And I look forward
    to the future progress that I know can and will be made on the
    topic.
        Thank you.
        [The prepared statement of Mr. Threet follows:]

                      Prepared Statement of Steven Threet

        First I would like to thank Chairman Rockefeller and the other
    committee members for inviting me. It is a great honor to be here
    speaking on a topic that has changed my life and I am happy to help
    raise awareness about such a critical issue in both male and female
    sports. Dealing with concussions can be a very difficult process for
    the injured person and their family; so it is exciting for me to see
    such a prestigious and capable group of individuals who are willing to
    learn more in an effort to better educate and protect all athletes.
        Throughout my playing career I faced a multitude of injuries.
    However, none caused more confusion both literally and figuratively at
    the time that they occurred than concussions. Each of the four
    documented concussions that I experienced were unique in the way in
    which they occurred. I have sustained concussions from hits directly to
    my head by another player, from my head hitting the ground, and also as
    a result of consecutive impacts on separate plays. While my symptoms
    were often similar, they ranged from slight dizziness and blurred
    vision to extreme light sensitivity and a constant headache. The
    severity of my symptoms had no recognizable pattern. In two of the
    cases I was cleared and played without problem one week after I
    sustained a concussion. In one instance I returned to play two weeks
    after the injury. However the most severe symptoms were a result from
    my last concussion, which I suffered on November 26, 2010. Those
    symptoms ultimately led to my decision to end my football playing
    career.
        During my playing days, brain injury was never a major a concern to
    me. After my first concussion, which happened on the last play of a
    high school game my senior year, I was able to start the next game. It
    was not until my symptoms became serious that my attitude about the
    injury changed. At the time when I decided to retire, I saw my decision
    simply as the right one to make. However, in the aftermath it has
    become apparent to me that my decision can also be seen as an example
    of how dangerous brain injuries can be. I want to make it clear that my
    goal in speaking is not to deter athletes from competing. I only wish
    that they acknowledge the seriousness of a brain injury and respect the
    process that comes with recovery.
        In all sports a certain aggressive mentality is required to be
    successful. The passion and intensity football players rely on is an
    example of this; and what makes the game beautiful. As a former
    quarterback at premier college football programs I know the importance
    of and took pride in being physically and mentally tough, out working
    my opponent, leaving it all on the field, and playing through injury.
    However, athletes must understand that a mild brain injury is not a
    shoulder separation. It is not an injury to be played through. They
    must understand that playing through a brain injury is NOT a sign of
    toughness, but it is a sign that says athletes are still uninformed.
        Statistics recently revealed that about 40 percent of athletes who
    have sustained a concussion return to play too early and that 50
    percent of concussions go unnoticed. This makes me believe that the
    only focus should be to create an open dialogue between athletes,
    coaches, doctors, and families that addresses the seriousness of brain
    injuries in athletics and the need for a full recovery before returning
    to play. I know it is possible to decrease those statistics. I also
    know progress on this issue is already being made and many states have
    already passed legislation dealing with concussion protocols.
        Unfortunately, there is no brain brace, concussion proof helmet, or
    magic pill for immediate recovery. However I believe THERE IS a
    misunderstanding about concussion prevention and treatment within the
    athlete cohort as well as the general public. For example, a football
    helmet is often thought of as a brain protector. However, it is
    designed to protect the bone structure of the head, not the brain
    itself. If a helmet could guarantee protection from concussions, I
    would still be playing football.
        Once again thank you for this opportunity but more importantly
    thank you for taking the time to learn and show your support for this
    issue here today. I look forward to the future progress that I know can
    and will be made.

        The Chairman. Thank you very, very much.
        And you talk about an elite program. You are exactly right.
    You are exactly right.
        Dr. Kutcher, bring us some Michigan and NeuroSport wisdom.

                  STATEMENT OF JEFFREY S. KUTCHER, MD,

              ASSOCIATE PROFESSOR, UNIVERSITY OF MICHIGAN,

              DEPARTMENT OF NEUROLOGY; DIRECTOR, MICHIGAN

              NEUROSPORT; CHAIR, SPORTS NEUROLOGY SECTION,

                     AMERICAN ACADEMY OF NEUROLOGY

        Dr. Kutcher. I will do my best, sir.
        Chairman Rockefeller, members of the Committee, and
    distinguished guests, it is my distinct honor to join you
    today. I am extremely grateful to be given the opportunity to
    provide my testimony.
        My name is Jeffrey Kutcher. I am a sports neurologist and
    team physician at the University of Michigan. Since 2005, I
    have been the director of Michigan NeuroSport, University of
    Michigan's comprehensive academic sports neurology program.
        Our program provides clinical care for athletes of all ages
    and abilities, conducts clinical and basic science research on
    sports concussion, provides education to athletes, parents,
    coaches, administrators, and healthcare providers. In my
    clinical practice, I care for athletes at the time of injury,
    through the return-to-play process, over the course of their
    seasons, their careers, and after they retire.
        Since 2009, I have also been the Chair of the Sports
    Neurology Section of the American Academy of Neurology. The
    American Academy of Neurology is dedicated to the neurological
    care of athletes at all levels and is a leading voice in the
    arena of sports concussion.
        I am currently co-leading the academy's effort to produce
    an evidence-based clinical practice guideline on sports
    concussion, an effort that includes the critical review and
    grading of every academic paper ever published on sports
    concussion.
        Also pertinent to this topic, I have recently been named
    the director of the National Basketball Association's
    concussion program, and I also consult for the National Hockey
    League Players Association.
        Clearly, the issue of sports concussion has been gaining
    significant public and Government interest over the past
    several years. A majority of this interest has been focused on
    those athletes already in the spotlight, the ones who play our
    professional contact sports.
        While these athletes are experiencing the greatest doses of
    head impact over their lifetimes, they represent only a small
    fraction of the population at risk of being injured, which is
    why I am encouraged that today's hearing is focusing on the
    protective equipment being used by all athletes, regardless of
    level of play, age, or gender.
        It is a common misconception that concussion is a problem
    seen only in males. As Ms. Ball has demonstrated, concussions
    occur in females as well, with some data suggesting that
    concussion incidence is actually higher in females when
    compared to males playing similar sports.
        Concussion is an injury that occurs at every age, at every
    level of play. Up to 3.8 million concussions are estimated to
    occur in the United States each year from sports and
    recreational activities, and the majority of those occur in our
    youth.
        There is great uncertainty and great concern regarding the
    notion of possible long-term effects from concussion,
    especially on the pediatric population, which may be at even
    greater risk given the ongoing development of the pediatric
    brain.
        So what is a concussion? I will spend a moment just
    describing that in my own words. It is an injury to the brain
    that occurs when the brain moves fast enough or suddenly enough
    to disrupt the normal electrical function of its component
    cells.
        Given that the brain is floating in fluid inside of the
    skull and that the head can act as a pendulum when the body is
    struck, movements of the brain significant enough to cause
    concussion can occur with or without a direct blow to the head.
    As long as the skull and thus the brain inside of it is
    accelerated or decelerated with enough force, the normal
    processes of the brain may be compromised.
        The resulting concussion can take on many different forms,
    but typically includes transient disorientation, slowed
    thinking, memory difficulties, or other signs of brain
    dysfunction. Symptoms such as headache, nausea, and sensitivity
    to light are also quite common.
        Concussions cannot be diagnosed by any test. That is
    extremely important to remember. It is a diagnosis that can
    only be made after a careful clinical evaluation performed by a
    healthcare professional, and preferably one with training and
    experience caring for brain injuries.
        It is important to realize that concussion is not the only
    brain injury that can occur from head trauma. Emergent
    injuries, such as bleeding in or around the brain or skull
    fracture, can occur anytime an athlete or an object is moving
    quickly in the field of play.
        On the other side of the spectrum, there is emerging
    evidence--brought forth by Dr. McKee, for example with some of
    her excellent work--that forces from multiple impacts that may
    not even produce concussion may be having potentially negative
    long-term health effects on athlete's brains.
        Helmets have an extremely important role to play in head
    injury prevention. Without them, the potential for serious
    injury would make many of our sports and recreational
    activities unacceptably risky. In this way, helmets are
    extremely effective pieces of equipment.
        With the introduction of hard-shell helmets, for example,
    skull fractures from playing football have essentially been
    eliminated. What helmets do not do well is significantly slow
    down the contents of the skull when the head is struck or moved
    suddenly.
        Since concussions occur not as a result of the forces
    experienced by the skull, but by those experienced by the
    brain, it is extremely unlikely that any helmet can be designed
    that will prevent concussions to the same significant degree
    that they have been shown to prevent skull fractures.
        Currently, there are no convincing data in the published
    medical literature that show any particular helmet being better
    than any other at preventing sports concussion. Such data is
    hard to collect, grant you, for two main reasons.
        First, given the many variables that exist in the athletic
    population and the varied exposure to impacts, it is extremely
    difficult to perform a randomized, controlled clinical trial on
    similar populations of athletes. Second, given that concussion
    is a clinical diagnosis with no available reference standard or
    diagnostic test, any study of concussion is significantly
    limited by the ambiguity of the very clinical outcome that is
    being studied.
        For these same reasons, there are no published data
    supporting the idea that other types of protective equipment,
    such as mouth guards or soccer headbands, prevent concussion.
    Moreover, in sports such as soccer, where protective headgear
    is the exception rather than the rule, I have seen the use of
    headgear result in athletes altering their playing style in the
    wrong direction as their newfound sense of protection
    encourages more physically aggressive play.
        Every week, I am asked in my clinic by patients, parents,
    and coaches about the claims they hear and what equipment they
    should buy to prevent concussions. The simple truth is that no
    current helmet, mouth guard, headband, or other piece of
    equipment can significantly prevent concussions from occurring.
    They occur as the result of the nature of our sports.
        Concussion prevention is much more about teaching proper
    technique, playing by the rules, and limiting the overall dose
    of impacts. The potential harm that I see caused by products
    that claim to prevent concussion when they do not is far more
    than simply the financial harm of paying more for something
    that isn't likely to work as claimed. It is the harm that comes
    from having a false sense of security, from not understanding
    how the injury occurs, and what can actually be done to prevent
    it.
        The public deserves to know that equipment has a
    significant, but inherently limited ability to prevent
    concussion. There is still a tremendous amount yet to be
    learned about the nature of concussions and their possible
    effects on brain health. In the interim, I am deeply encouraged
    by today's hearing and honored to be included in the efforts of
    the Committee as we work together for the safety of our
    athletes.
        Thank you.
        [The prepared statement of Dr. Kutcher follows:]

      Prepared Statement of Jeffrey S. Kutcher, MD, Associate Professor,
      University of Michigan, Department of Neurology; Director, Michigan
       NeuroSport; Chair, Sports Neurology Section, American Academy of
                                   Neurology

        Chairman Rockefeller, members of the Committee, and distinguished
    guests, it is my distinct honor to join you today and I am extremely
    grateful to be given this opportunity to provide my testimony.
        My name is Jeffrey Kutcher. I am a sports neurologist and team
    physician at the University of Michigan. Since 2005, I have been the
    Director of Michigan NeuroSport, the University of Michigan's
    comprehensive academic program in sports neurology. The NeuroSport
    program provides clinical care for athletes of all ages and abilities,
    conducts clinical and basic science research on sports concussion and
    other issues in sports neurology, and provides education to athletes,
    parents, coaches, administrators, and health care providers. My
    experience allows me to speak directly to the complete spectrum of
    athletes that experience sports-related brain injuries. I care for
    athletes at the time of their injury, over the course of their season,
    their career, into their retirement, and beyond.
        Since 2009, I have also been the Chair of the Sports Neurology
    Section of the American Academy of Neurology. The American Academy of
    Neurology, the world's largest professional association of
    neurologists, is dedicated to the neurological care of athletes at all
    levels by optimizing clinical practice, research, and education, and is
    a leading voice in the arena of sports concussion. I am currently co-
    leading the American Academy of Neurology's effort to produce a
    meaningful, evidence-based, clinical practice guideline on sports
    concussion, an effort that includes the critical review and grading of
    every academic paper published on sports concussion. Also pertinent to
    this topic, I am the Director of the National Basketball Association's
    Concussion Program and a consultant to the National Hockey League
    Players' Association.

    The Scope of the Problem
        Clearly, the issue of sports concussion has been gaining
    significant public and government interest over the past few years.
    Fueled by increasing awareness of possible long-term effects from head
    injuries, the majority of the media coverage has focused on those
    athletes already in the spotlight, the ones who play our professional
    contact sports. While these athletes are experiencing the greatest
    doses of head impact over their lifetimes, they represent only a very
    small fraction of the population at risk of being injured. That is why
    I am encouraged that today's hearing is focusing on the protective
    equipment being used by all athletes, regardless of level of play, age,
    or gender.
        It is a common misconception that concussion is a problem seen only
    in males. Concussions occur in females as well, with some data
    suggesting that concussion incidence is higher in females when compared
    to males playing similar sports. Concussion is an injury that occurs at
    every age and at every level of play. Up to 3.8 million concussions are
    estimated to occur in the United States each year from sports and
    recreational activities, and the majority of these occur in our youth.
    There is great uncertainty, and with it significant concern, regarding
    the notion of possible long-term effects from concussion, especially on
    the pediatric population, which may be at even greater risk given the
    ongoing development of the pediatric brain.

    What is Concussion?
        Simply put, concussion is an injury to the brain. It occurs when
    the brain moves fast enough, and suddenly enough, to disrupt the normal
    electrical function of its' component cells. Given that the brain is
    floating in fluid inside of the skull, and that the head can act as a
    pendulum when the body is struck, movements of the brain significant
    enough to cause concussion can occur with or without a direct blow to
    the head. As long as the skull, and thus the brain inside of it, is
    accelerated or decelerated with enough force, the normal processes of
    the brain may be compromised. The resulting concussion can take on many
    different forms, but typically includes transient disorientation,
    slowed thinking, memory difficulties, or other signs of brain
    dysfunction. Symptoms, such as headache, nausea, and sensitivity to
    light are also quite common. I should also note that a loss of
    consciousness is relatively rare in concussion, occurring in less than
    10 percent of cases. Concussion cannot be diagnosed by any one test. It
    is a diagnosis that can only be made by a careful clinical evaluation
    performed by a health care professional, and preferably one with
    training and experience caring for brain injuries.
        It is important to realize that concussion, as defined above, is
    not the only brain injury that can occur from head trauma. More acutely
    serious or emergent injuries, such as bleeding in or around the brain
    or a skull fracture, can occur anytime an athlete or an object is
    moving quickly in the field of play. On the other side of the spectrum,
    there is emerging evidence that forces from multiple impacts that are
    not significant enough to result in a concussion may have potentially
    negative effects on long-term brain health.

    Equipment Limitations
        Helmets have an extremely important role to play in head injury
    prevention. Without them, the potential for bone fracture or
    intracranial injury would make many of our sports and recreational
    activities unacceptably risky. In this way, helmets are extremely
    effective pieces of equipment. With the introduction of hard-shell
    helmets, for example, skull fractures and resulting deaths from playing
    football have essentially been eliminated. What helmets do not do well
    is significantly slow down the contents of the skull when the head is
    struck or moves suddenly. Since concussions occur not as a result of
    the forces experienced by the skull, but by those experienced by the
    brain, it is extremely unlikely that any helmet can be designed that
    will prevent concussions to the same significant degree that they have
    been shown to prevent skull fractures.
        Currently, there is no data in the published medical literature
    that shows any particular helmet being better than any other at
    preventing sports concussions. Such data is hard to collect for two
    main reasons: First, given the many variables that exist in the
    athletic population and the varied exposure to impacts, it is extremely
    difficult to perform a randomized, controlled, clinical trial on
    similar populations of athletes. Second, given that concussion is a
    clinical diagnosis, with no available reference standard or diagnostic
    test, any study of concussion is significantly limited by the ambiguity
    of the very clinical outcome that is being studied.
        For these same reasons, there are no published data supporting the
    idea that other types of protective equipment, such as mouthguards or
    soccer headbands, prevent concussion. Moreover, in sports such as
    soccer, where protective headgear is the exception rather than the
    rule, I have seen the use of headgear result in athletes altering their
    playing style in the wrong direction, as their newfound sense of
    protection encourages more physically aggressive play.
        While clinical data that speaks to concussion prevention is hard to
    generate, there are many extremely well performed laboratory studies
    that provide excellent data on the amount of force a helmet allows to
    get through to a model brain in a mechanical head. This does not mean
    that these data can be used to construct an estimate of concussion
    risk. Concussions do not occur at a particular force threshold. They
    occur across a wide range of forces and are dependent on the complex
    and variable physiological nature of each individual's brain.

    The Potential Harm of Misinformation
        With the increased public awareness of an injury that occurs
    frequently in children and may produce significant negative long-term
    health outcomes, it is not surprising that the marketplace for products
    designed to prevent concussions is a busy one. Every week I am asked by
    patients, parents, and coaches about the claims they hear and what
    equipment they should buy to prevent concussions. I wish there was such
    a product on the market. The simple truth is that no current helmet,
    mouthguard, headband, or other piece of equipment can significantly
    prevent concussions from occurring. They occur as the result of the
    nature of sports. Concussion prevention is much more about teaching
    proper technique, playing by the rules, and limiting the overall dose
    of impacts. Preventing bad outcomes and long-term damage, meanwhile, is
    clearly about recognizing the injury when it occurs, removing that
    athlete from participation, and allowing for appropriate recovery
    before they return.
        The potential harm that I see being caused by products that claim
    to prevent concussion when they do not is far more than simply the
    financial harm of paying more for something that isn't likely to work
    as claimed. It is the harm that comes from having a false sense of
    security, from not understanding how the injury occurs and what can
    actually be done to prevent it. This issue is a growing public concern,
    and rightly so. The public deserves to know that equipment has a
    significant, but inherently limited, ability to prevent concussions.
    For the health of all athletes, we must see that each player, parent,
    and coach becomes educated on concussion, including the use of proper
    technique, the need for reporting the injury, and the importance of
    allowing for a full recovery before returning.
        There is still a tremendous amount yet to be learned about the
    nature of concussions and their possible effects on brain health. In
    the interim, I am deeply encouraged by today's hearing and honored to
    be included in the efforts of the Committee as we work together for the
    safety of our athletes.

        The Chairman. Thank you very much, Doctor.
        And can we go on now to Dr. McKee?

              STATEMENT OF ANN C. McKEE, MD, PROFESSOR OF

           NEUROLOGY AND PATHOLOGY, BOSTON UNIVERSITY SCHOOL

              OF MEDICINE; DIRECTOR, VISN-1 NEUROPATHOLOGY

            LABORATORY FOR THE NEW ENGLAND VETERANS AFFAIRS

               MEDICAL CENTERS; DIRECTOR, BRAIN BANKS FOR

           THE BOSTON UNIVERSITY ALZHEIMER'S DISEASE CENTER,

             FRAMINGHAM HEART STUDY, AND CENTENARIAN STUDY;

     CO-DIRECTOR, CENTER FOR THE STUDY OF TRAUMATIC ENCEPHALOPATHY

        Dr. McKee. Chairman Rockefeller and members of the
    Committee, thank you for the invitation to testify today on
    sports concussions and their consequences.
        My name is Dr. Ann McKee. I am a Professor of Neurology and
    Pathology at Boston University's School of Medicine, and I
    direct the neuropathology laboratory for the New England
    Veterans Affairs Medical Center at the Boston VA.
        I am also Co-Director for the Center for the Study of
    Traumatic Encephalopathy. My testimony today reflects my
    professional opinion. I am not speaking officially on behalf of
    the Department of Veterans Affairs.
        Mild traumatic brain injury, or concussion, is a temporary
    state of neurologic dysfunction resulting from forces on the
    brain--acceleration, deceleration, lateral and rotational
    forces. Subconcussion is caused by these same type of forces,
    but the forces are milder, and no symptoms are produced.
        In all of these conditions, concussion or subconcussion,
    the brain looks normal after the injury, and there is no
    detectable damage on routine neuroimaging, such as CT scan or
    MRI, which is why these injuries are sometimes considered
    invisible. However, the acceleration, deceleration, rotational
    forces cause the brain to move rapidly within the skull, and
    the brain, which is firm, but gelatinous, is stretched and
    deformed by these forces. And as the brain as a whole is
    deformed, there is also stretch and strain of the individual
    nerve cells and support cells within the brain.
        The brain abnormalities associated with concussion and
    subconcussion occur at the microscopic, cellular, molecular,
    and metabolic levels. If an athlete returns to play before the
    symptoms resolve, the athlete risks developing post-concussive
    syndrome and second impact syndrome, or SIS, a rare, but often
    fatal condition.
        In addition, repetitive mild concussive injury can trigger
    a progressive deterioration of the brain called ``chronic
    traumatic encephalopathy.'' Chronic traumatic encephalopathy is
    a progressive neurodegeneration that evolves slowly over
    decades and usually does not become apparent until many years
    after the player has retired from the sport.
        CTE is triggered by repetitive concussive injuries
    superimposed on a brain that has not healed from a previous
    injury. This is why concussion awareness is so critical and why
    proper diagnosis and management of concussion, allowing the
    brain to completely rest and recover after an injury, is so
    important in youth sports.
        The Chairman. Perhaps even more so on the part of very
    relatively young children whose brains are still growing?
        Dr. McKee. Absolutely.
        The Chairman. They are still playing football, other
    things.
        Dr. McKee. Right. The youth or immature brain is more
    susceptible to concussive injuries than the mature adult brain.
    Children and young adults recover more slowly from a
    concussion. Youth athletes are also more at risk for concussion
    due to their disproportionally large head size compared to body
    size and the weakness of their neck musculature.
        Furthermore, young athletes are uniquely susceptible to
    second impact syndrome, which has only been reported in
    athletes under the age of 24 and most often under the age of
    18. Second impact syndrome occurs when a young athlete sustains
    an initial head injury, then suffers a second head injury
    before the symptoms associated with the first impact have
    cleared.
        Typically, the athlete returns to play too early and
    receives a second blow to the head, which may be remarkably
    minor. The affected athlete may appear stunned at first, but in
    the next few seconds to minutes, the athlete collapses to the
    ground, semi-comatose, and the outcome is often fatal or
    associated with severe and permanent disability.
        Since 2008, as Director of the Center for the Study of
    Traumatic Encephalopathy Brain Bank, I have diagnosed chronic
    traumatic encephalopathy in the brains of 58 athletes and other
    individuals, which is more than double the history of the
    world's experience with this condition. I have diagnosed CTE in
    40 football players, and that includes professional football
    players, college football players, as well as high school
    football players, 5 hockey players, and 15 military veterans.
        Chronic traumatic encephalopathy causes changes in behavior
    and personality. In particular, individuals with CTE become
    more irritable, angry, or aggressive. They develop mood
    changes, such as depression, and sometimes become suicidal, and
    develop drug and alcohol abuse. As the disease progresses, they
    develop short-term memory loss, which leads to increasing
    cognitive impairment and ultimately dementia and, in some
    cases, parkinsonism.
        Pathologically, CTE is caused by a buildup of a protein
    called tau. It forms neurofibrillary tangles within the brain.
    Under normal circumstances, this abnormal tau protein is found
    in only limited quantities, but in CTE, there is a striking
    buildup of this protein, even at young ages.
        For example, advanced chronic traumatic encephalopathy was
    found in the brain of Dave Duerson, a former defensive back for
    the Chicago Bears. Dave Duerson began playing football at age 8
    and experienced more than 10 concussions in his 11-year NFL
    career. After retiring from the NFL, he was very successful and
    had a loving family and four children.
        At the age of 46, he experienced financial difficulties and
    the dissolution of his marriage. He became hot-tempered,
    physically and verbally abusive. He developed memory lapses,
    mood swings, and piercing headaches. And on February 17, 2011,
    he killed himself inside his Florida apartment. He left
    instructions to donate his brain to my laboratory, and my
    examination showed that he was suffering from moderately severe
    CTE, even though he was only 50 years old.
        Another example is Owen Thomas, a defensive end for the
    University of Pennsylvania who played football since age 9. One
    day in the spring of 2010, he called his parents and told them
    he was stressed by school and having trouble with several of
    his courses. And 2 days later, he hanged himself in his off-
    campus apartment.
        When I looked at Owen's brain, I saw unmistakable changes
    of early CTE. In fact, if you compare the brain of Owen Thomas
    to the brain of Dave Duerson, there was remarkably similar,
    although milder pathology, suggesting that if Owen Thomas had
    lived another 30 years, his CTE would have progressed to the
    advanced stage demonstrated by Dave Duerson.
        I have recently had the opportunity to study the brain of a
    17-year-old high school football player. He suffered a
    concussion 3 weeks before the day of his death and had recently
    been cleared to return to play. During the game, he intercepted
    a pass, was tackled, and hit the ground. As he walked to the
    bench, he complained of a severe headache, then collapsed to
    the ground, unconscious. He died the following day.
        Neuropathologic examination showed a thin subdural
    hemorrhage consistent with SIS and very early changes of CTE.
    He is the youngest player ever diagnosed with changes of CTE.
        I have now examined the brains of 58 individuals with CTE,
    and I have found early CTE in college and high school players,
    including players as young as 17 and 18. We know that CTE is a
    neurodegeneration associated with repeated concussive injury
    that usually occurs in an individual's teens and 20s.
        We know that once CTE is triggered, the neurodegeneration
    progresses slowly over decades to involve widespread
    degeneration of many brain structures. We know that the
    symptoms of CTE are subtle and begin in mid life with
    personality and behavioral changes, including irritability,
    short fuse, depression, suicidal ideations, impulsivity, and
    memory loss. We know there is a slow deterioration that
    progresses to dementia and parkinsonism.
        However, there are many things that we do not understand
    about CTE. We do not understand or we do not know the exact
    incidence and prevalence of this disorder, even though we now
    clearly understand that this disease exists, and it is
    surprisingly common.
        What factors determine who will develop CTE? How many
    concussions, how many subconcussive injuries, how close
    together the injuries, how severe, and at what age? All of
    these are aspects of the disease that are unknown at this time.
        Importantly, we do not know how to diagnose this disease in
    living individuals, how to stop its progression, or how to
    reverse its course. But we can make important changes to
    prevent this disease from developing in young athletes, and
    those changes include understanding what a concussion is,
    recognition of concussion when it occurs, and proper medical
    management of concussion after it happens.
        We can also teach our young athletes to play smart and keep
    their head out of the game as much as possible. Rule changes to
    protect athletes from dangerous styles of play, rule
    enforcement, and player and coach education will go a long way
    toward reducing the frequency of concussion and subconcussion.
        With these changes in the way that sports are played,
    continued education, increased scientific interest and research
    into the mechanisms of CTE pathogenesis, and the development of
    diagnostic tools and therapeutic strategies to interrupt this
    disease progression, we can make enormous improvements to
    protect the mental health of millions of young athletes and
    military service members for many years to come.
        Thank you.
        [The prepared statement of Dr. McKee follows. In addition
    to her written testimony, Dr. McKee submitted three articles:]

        Brandon E. Gavett, PhD, Robert A. Stern, PhD, and Ann C. McKee, MD,
    ``Chronic Traumatic Encephalopathy: A Potential Late Effect of Sport-
    Related Concussive and Subconcussive Head Trauma,'' Clinical Sports
    Medicine 30 (2011) 179-188
        Daniel H. Daneshvar, MA, Christine M. Baugh, AB, Christopher J.
    Nowinski, BA, Ann C. McKee, MD, Robert A. Stern, PhD, Robert C. Cantu,
    MD ``Helmets and Mouth Guards: The Role of Personal Equipment in
    Preventing Sport-Related Concussions,'' Clinical Sports Medicine 30
    (2011) 145-163
        Ann C. McKee, MD, Robert C. Cantu, MD, Christopher J. Nowinski, AB,
    E. Tessa Hedley-Whyte, MD, Brandon E. Gavett, PhD, Andrew E. Budson,
    MD, Veronica E. Santini, MD, Hyo-Soon Lee, MD, Caroline A. Kubilus, and
    Robert A. Stern, PhD, ``Chronic Traumatic Encephalopathy in Athletes:
    Progressive Tauopathy After Repetitive Head Injury,'' Journal of
    Neuropathology and Experimental Neurology Vol. 68, No. 7, July 2009,
    pp. 709-735
                                     ______

      Prepared Statement of Ann C. McKee, MD, Professor of Neurology and
       Pathology, Boston University School of Medicine; Director, VISN-1
        Neuropathology Laboratory for the New England Veterans Affairs
       Medical Centers; Director, Brain Banks for the Boston University
      Alzheimer's Disease Center, Framingham Heart Study, and Centenarian
      Study; Co-Director, Center for the Study of Traumatic Encephalopathy
        Mr. Chairman and Members of the Committee:

        Thank you for the invitation to testify today on sports concussions
    and their consequences. My name is Dr. Ann McKee. I am a Professor of
    Neurology and Pathology at Boston University School of Medicine and I
    am the Director of the Neuropathology Laboratory for the New England
    Veterans Affairs Medical Centers at the Boston VA Medical Center. I
    also direct the Brain Banks for the Boston University Alzheimer's
    Disease Center, the Framingham Heart Study, and the Centenarian Study,
    and I am a co-director for the Center for the Study of Traumatic
    Encephalopathy at Boston University. My testimony today reflects my
    professional opinion; I am not speaking officially on behalf of the
    Department of Veterans Affairs.
        I received my medical degree in 1979, and I am board certified in
    both Neurology and Neuropathology. I have broad experience in
    neuropathology of neurological disease and have written extensively on
    the neuropathology of many neurodegenerative diseases, including
    Alzheimer's disease, Parkinson's disease, Frontotemporal Dementia and
    Traumatic Brain Injury. For the past 25 years, I have been studying the
    brains of individuals after death and correlating the pathological
    findings to the patient's clinical symptoms during life. For the past 9
    years I have been specifically analyzing the effects of repetitive mild
    traumatic brain injury or repetitive concussion on the brain.
        A traumatic brain injury (TBI) is caused by a blow, a jolt to the
    head or a penetrating head injury that disrupts the function of the
    brain. A TBI may range from mild--with a brief change in mental
    status--to severe, with an extended period of unconsciousness or
    amnesia after injury. Eighty percent of all TBI is mild, approximately
    10% is moderate, and approximately 10% is severe. What we are primarily
    concerned with today is repetitive mild TBI (mTBI) or concussion; the
    terms concussion and mild TBI are interchangeable. Mild TBI and
    concussion are temporary states of neurological dysfunction resulting
    from acceleration, deceleration, lateral and rotational forces on the
    brain. Subconcussion is caused by the same acceleration-deceleration-
    rotational forces but the forces are milder and no symptoms are
    produced. In all these conditions, the brain appears macroscopically
    normal after the injury and there is no detectable damage on routine
    neuroimaging, including CT scan or MRI, which is why concussion and
    subconcussive injury are sometimes considered ``invisible'' brain
    injuries. However, these acceleration deceleration-rotational forces
    cause the brain to move rapidly within the skull and the brain, which
    is firm, but gelatinous, is stretched and deformed by these forces. As
    the brain as a whole is deformed, there is also stretch and strain of
    the individual nerve cells and supporting cells within the brain. The
    brain abnormalities associated with concussion and subconcussion occur
    at the microscopic, cellular, molecular and metabolic levels. There is
    mild, but widespread injury to axons, the long, slender projections of
    a nerve cell that conduct electrical impulses away from the nerve cell
    and contact other nerve cells. The nerve cell and axonal injury most
    often completely resolve with rest. Indeed, most individuals recover
    completely from a single mTBI or concussion within weeks to months, but
    in some individuals (fewer than 10%), post-concussive symptoms can last
    for months to years, especially in situations where an athlete is not
    properly treated after a concussion. If an athlete returns to play
    before symptoms resolve, the athlete also risks a rare but sometimes
    fatal event known as second impact syndrome (SIS). In addition,
    repetitive concussion or repetitive subconcussion can trigger a
    progressive deterioration of the brain called Chronic Traumatic
    Encephalopathy (CTE) (McKee 2009, McKee 2010, Gavett 2010, Daneshvar
    2011, Gavett 2011).
        CTE is a progressive neurodegeneration triggered by repetitive
    concussion and subconcussion that evolves slowly over decades and
    usually does not become apparent until many years later. Although the
    exact relationship between concussion, subconcussion and CTE is not
    entirely clear, most likely repetitive concussive and subconcussive
    injury superimposed on unresolved nerve cell and axonal injury
    initiates a series of metabolic, ionic, membrane, and cytoskeletal
    disturbances that triggers the pathological cascade that leads to CTE.
    This is the reason why concussion awareness is so critical and why
    proper diagnosis and management of concussion, allowing the brain to
    completely rest and recover after an injury, is so important in youth
    sports and all other activities that result in mTBI.
        There is also evidence that the youth or immature brain may be more
    susceptible to concussive injuries than the mature adult brain. The
    brain continues to develop and mature, laying down myelinated fiber
    tracts, until the mid-twenties. Children and young adults recover more
    slowly from a concussion than adults. Youth athletes are also more at
    risk for concussion due to their disproportionately large head size
    compared to body size and the weakness of their neck musculature.
    Further evidence of the enhanced susceptibility of young athletes to
    mTBI is second-impact syndrome (SIS), an entity that has only been
    reported in athletes 24 years and younger, and the vast majority of the
    SIS cases in the literature have involved athletes under the age of 18.
        SIS occurs when a young athlete sustains an initial head injury and
    then suffers a second head injury before the symptoms associated with
    the first impact have cleared (Cantu and Gean 2010). Typically, the
    athlete suffers post-concussion symptoms after the first head injury,
    which may include headache; dizziness; visual, motor, or sensory
    changes; confusion and memory problems. Before these symptoms resolve,
    which may take days or weeks, the athlete returns to competition and
    receives a second blow to the head. The second blow may be remarkably
    minor. The affected athlete may appear stunned, usually does not
    experience loss of consciousness but in the next few seconds to several
    minutes, the athlete, who is conscious yet stunned, precipitously
    collapses to the ground, semicomatose. The outcome is often fatal or
    associated with severe permanent disability. The pathophysiology of the
    SIS is generally believed to be caused by a loss of autoregulation of
    the cerebrovasculature. This dysautoregulation leads to precipitous
    brain swelling, high intracranial pressure, brain herniation and often,
    death. The adolescent or youth brain does not autoregulate well and is
    more susceptible to poor outcomes following mTBI (Chaiwat 2009).
        In 2008, we created the Center for the Study of Traumatic
    Encephalopathy (CSTE) with the goal of studying the long-term effects
    of sports-related mTBI and CTE. We initiated a brain donation registry,
    a clinical registry of amateur and professional athletes, and the CSTE
    Brain Bank at the Bedford VA. The purpose of the VA CSTE Brain Bank is
    to study the effects of repetitive mTBI (repetitive concussion and
    subconcussion) by neuropathologically examining brains donated by
    deceased athletes and other individuals with a history of repetitive
    mTBI.
        CTE was first reported in 1928 by Harrison Martland, a New Jersey
    pathologist and medical examiner, who described the clinical spectrum
    of abnormalities found in ``nearly one half of the fighters who have
    stayed in the game long enough'' (McKee 2009, Gavett 2011). Boxers
    exhibiting cognitive, behavioral, or motor abnormalities were well
    known within the community and were referred to by various terms, such
    as ``punch drunk,'' ``goofy,'' and ``slug-nutty'', and later by the
    more formal term ``dementia pugilistica.'' By the 1970s, a sufficient
    number of boxers with dementia pugilistica had been studied
    pathologically to support the conclusion that this distinct
    neurodegeneration was a consequence of repeated mTBI and was not
    restricted to boxers, and the term ``chronic traumatic encephalopathy''
    or CTE, became most widely used. Over the last few decades, clinical
    and neuropathologic evidence of CTE has emerged in association with
    various sports, including American football, professional wrestling,
    professional hockey, and soccer, as well as other activities associated
    with repetitive mild head trauma, such as physical abuse, epileptic
    seizures, head banging and military service. Although the incidence and
    prevalence of CTE is currently unclear, it most likely varies by sport,
    position, duration of exposure, and age at the time of initial or
    subsequent head trauma, and additional variables, such as genetic
    predisposition.
        In 2009, I reviewed the world's literature on neuropathologically-
    verified CTE and found 51 cases of CTE including 3 cases of our own
    from BU and the Bedford VA (McKee 2009). Over the past 3\1/2\ years,
    the brains and spinal cords of 97 athletes and military veterans who
    experienced mTBI or concussion have been donated to the VA CSTE Brain
    Bank. We have found CTE in 58 individuals, more than doubling the
    history of the world's experience combined. We have neuropathologically
    diagnosed CTE in 40 football players, at all levels of play,
    professional, college and high school, 5 hockey players, and 15
    military veterans and are currently preparing a manuscript for
    submission describing our experience.
        The onset of CTE is often in midlife, usually after athletes have
    retired from their sport. The early manifestations of CTE affect
    behavior and personality; in particular, individuals with
    neuropathologically documented CTE have been described as being more
    irritable, angry, or aggressive or as having a shorter fuse. There are
    mood changes, usually of depression, and increased suicidality, drug
    and alcohol abuse, and paranoia may be present. These changes are
    usually followed by short-term memory loss and executive dysfunction.
    Later in the disease, increasing cognitive impairment, movement
    disorders (e.g., parkinsonism), and speech disorders may emerge.
        Macroscopic pathological changes found in CTE include an anterior
    cavum septum pellucidum and posterior septal fenestrations. These
    changes are likely caused by the force of the head impact being
    transmitted through the fluid ventricular system, thereby affecting the
    integrity of the intervening tissue. Enlargement of the lateral and
    third ventricles is also commonly seen in CTE with the third ventricle
    disproportionately widened. In advanced cases, there is also atrophy of
    the frontal and temporal cortices and medial temporal lobe, thinning of
    the hypothalamic floor, shrinkage of the mammillary bodies, pallor of
    the substantia nigra, and hippocampal sclerosis.
        Microscopically, CTE is characterized by an abundance of
    neurofibrillary tangles (NFTs), neuropil threads, and glial tangles
    within the brain, composed of hyperphosphorylated tau protein. CTE is
    distinguished from other neurodegenerations associated with build up of
    tau protein, such as Alzheimer's disease, by several unique features.
    First, the distribution of tau pathology in CTE is strikingly
    perivascular and most dense at the depths of cortical sulci, especially
    in early stages of the disease. The tau pathology in CTE is also
    extremely irregular and superficial, largely confined to foci in the
    frontal, temporal, and insular cortices. With increasing severity the
    tau pathology spreads to involve the limbic cortices, subcortical
    nuclei and brainstem.
        Recently, in addition to severe tau neurofibrillary pathology, we
    have found that there is a widespread TDP-43 proteinopathy in more than
    80% of their cases of CTE. Ten percent of athletes with CTE and a
    florid TDP-43 proteinopathy also develop a motor neuron disease similar
    to Amyotrophic Lateral Sclerosis (McKee 2010). The deposition of both
    tau and TDP-43 as aggregated phosphorylated proteins associated with
    neurodegeneration in CTE suggests that repetitive mTBI or repetitive
    axonal injury provokes the pathologic accumulation of both proteins.
    Case studies

    Cognitively normal individuals
        Under normal circumstances, phosphorylated 1au protein, is found
    only in very limited quantities in the brains of cognitively normal
    people. I have examined over 70 brains of cognitively intact
    individuals ranging in age from 18-103 years using the identical
    techniques that I use in studying the athlete brains. Basically, unless
    the individual is in the preclinical stages of a neurodegenerative
    disease, there is very little ``normal'' build up of phosphorylated tau
    protein in the brain and then only in restricted regions of individuals
    aged 70 years or older (Figure 1).

        Figure 1. Coronal sections of brain from a 65-year-old cognitively
    normal individual without a history of mild TBI compared to the changes
    found in a 66-year-old former NFL player with CTE. The brain sections
    have been immunostained for phosphorylated tau protein, which appears
    as a dark brown color when the slides are viewed with the naked eye.
    The normal brain does not contain any appreciable amounts of
    phosphorylated tau protein, however there are substantial deposits of
    tau protein in many regions of the brain in the individual with CTE.

    Case 1. Former professional boxer
        In January of 2003, as part of my work with the Boston University
    Alzheimer's Disease Center and the Bedford VA, I examined the brain of
    a man who died at the age of 72 after 15 years of severe dementia
    requiring institutionalization. The man had been a world champion boxer
    and had been clinically diagnosed with Alzheimer's disease beginning at
    the age of 58. However, when I looked at his brain on postmortem
    examination, I found that there was absolutely no evidence of
    Alzheimer's disease; there was no evidence of beta amyloid, a protein
    that accumulates in the brain in people with Alzheimer's disease and is
    thought by many to be the cause of Alzheimer's disease. Instead, the
    brain of this world champion boxer showed a massive build-up of
    phosphorylated tau protein as NFTs and glial tangles throughout his
    brain. The neurofibrillary and glial tangles were distributed in a
    unique pattern that is diagnostic of CTE; this pattern not found in any
    other neurodegenerative condition. When viewed microscopically it was
    clear that many individual nerve cells of the boxer contained NFTs, in
    fact they were found in nearly every nerve cell and there were almost
    no normal appearing cells. In CTE, tau protein builds up in individual
    nerve cells and prevents them from making normal connections with other
    nerve cells, eventually killing the cells. In this man's brain, there
    were massive numbers of NFTs and glial tangles, so many in fact that
    you could see the abnormalities on the glass slides without the use of
    a microscope (Figure 2). This individual, a former professional boxer,
    had been clinically diagnosed with Alzheimer's disease during life, but
    the disease that actually caused his tragic 15 year decline in
    intellect and eventual hospitalization for severe dementia was CTE, a
    disorder that would have been entirely prevented if he hadn't suffered
    repeated head injury in his younger years as a boxer.

        Figure 2. Left panel, top and bottom: coronal section of brain from
    a normal control showing the absence phosphorylated tau protein (dark
    brown). The bottom section is a microscopic view of a normal brain
    showing intact nerve cells and support cells. Middle panel, John
    Grimsley, showing marked deposition of tau protein in the amygdala and
    temporal cortex (top) and nerve cells filled with abnormal tau protein
    (bottom). The sections on the right are from a 72 year old professional
    boxer who died with advanced CTE. The top section shows dense
    deposition of abnormal tau protein in the amygdala and the bottom
    section shows a microscopic view of the dense accumulation of tau in
    nerve cells and support cells.

    Case 2. John Grimsley, former linebacker Houston Oilers
        John Grimsley, a former linebacker for the Houston Oilers died of
    an accidental gunshot wound while cleaning his gun at the age of 45.
    According to his wife, he was concussed 3 times during his college
    football years, and at least 8 times during his NFL career, however,
    only one ``cerebral concussion'' was medically confirmed. He was never
    formally diagnosed with post concussion syndrome and never sought
    medical attention for residual cognitive and behavioral difficulties.
    There was no history of ever losing consciousness for more than a few
    seconds and he never required being carried off the field or
    hospitalization. He never took any performance enhancing drugs or used
    illicit drugs. He was a nonsmoker and there was no known family history
    of dementia. According to his wife and close friends, he began showing
    changes in his behavior and cognitive decline at age 40. He developed
    difficulties in short-term memory, attention, concentration,
    organization, planning, problem solving, judgment, and the ability to
    juggle more than one task at a time. For example, he would ask the same
    questions repeatedly over the course of the day and he would ask to
    rent a movie that he had already seen. He had difficulty assembling his
    tax records, shopping alone, and understanding television. His symptoms
    gradually progressed and became quite severe by the end of his life. He
    also developed a ``shorter and shorter fuse'' and would become angry
    and verbally aggressive over seemingly trivial issues. When I first
    looked at his brain, it showed the exact same pattern of changes that I
    had found in the brains of boxers with CTE. There were large numbers of
    tau containing neurofibrillary tangles throughout all parts of the
    brain and there was absolutely no evidence of beta amyloid protein or
    Alzheimer's disease. The brain of this 45 year old husband and father,
    at the prime of his life, showed profound neurofibrillary degeneration,
    changes of CTE that were identical in nature to the changes I found in
    the brains of the boxers, but were now found in a football linebacker
    some 30 years younger. In John Grimsley's brain, there were striking
    changes in regions of the brain controlling personality and behavior,
    such as the frontal lobes, profound changes in the areas controlling
    impulsivity and rage behavior such as the amygdala, and severe changes
    in anatomic structures that are responsible for memory, such as the
    hippocampus, mammillary bodies and thalamus. In Figure 2, the brain of
    John Grimsley is seen in the middle; in the top middle panel, you can
    see severe tau deposition in the frontal lobe and microscopically; in
    the bottom middle panel, you can see numerous nerve cells containing
    tau and NFTs. In a normal 45 year old, absolutely none of these changes
    would be found. Indeed these changes would not be found in a normal 65
    year old, 85 year old or 100 year old.

    Case 3. Louis Creekmur, former offensive lineman Detroit Lions
        Louis Creekmur was a former offensive lineman for the Detroit Lions
    and eight-time Pro Bowler. Louis Creekmur played ten seasons for the
    Lions and was famous for suffering at least 13 broken noses and 16
    concussions. Beginning at the age of 58, he began to show increasing
    cognitive and behavioral difficulties including memory loss, problems
    with attention and organization, and outbursts of anger and aggression.
    He died from complications of dementia at the age of 82. The brain of
    Mr. Creekmur showed advanced GTE including marked shrinkage of medial
    temporal lobe structures that control memory, shrinkage of the frontal
    and temporal lobes, and marked dilation of the spinal fluid cavities
    that line the brain's interior. There was widespread and severe tau
    deposition as NFTs throughout the frontal and temporal lobes, amygdala,
    hippocampus, thalamus and brainstem in the unique pattern that is only
    found in GTE. In Mr. Creekmur's case, the abnormalities were extremely
    severe. There was absolutely no evidence of beta amyloid, Alzheimer's
    disease or any other neurodegenerative disorder, and the findings again
    indicated that if Mr. Creekmur had not sustained repetitive head trauma
    during the play of football, he would be alive and well and enjoying
    his family and grandchildren today.

        Figure 3. Coronal sections of the brain of Louis Creekmur stained
    for phosphorylated tau protein show dense abnormalities throughout the
    brain. Bottom row: microscopic views of abnormal tau deposits. There
    was extensive nerve cell loss and advanced neurodegenerative changes
    throughout the brain.

    Case 4. Dave Duerson, former defensive back Chicago Bears
        Dave Duerson began playing football at age 8 and played a total of
    24 total seasons as a safety in college and as a defensive back in the
    NFL He experienced more than 10 concussions in his 11-year NFL career,
    several with loss of consciousness, although he was never admitted to
    hospital. After retiring from the NFL, he was very successful in the
    food supply industry (Duerson Foods), active in NFL Players Association
    and Benefits Board; he had a loving family with three sons and a
    daughter and was considered in generally good health. In 2007, he began
    to experience business and financial difficulties that culminated in
    the loss of his business and the dissolution of his marriage. He was
    known to be smart, charming, kind and gentle but he became
    progressively more hot-tempered, physically and verbally abusive. He
    began to experience memory lapses; mood swings, piercing headaches on
    the left side of his head, difficulty spelling simple words, and
    blurred eyesight. On February 17, 2011, Duerson killed himself inside
    his Florida apartment at age 50. He left a note that carried a request:
    ``Please, see that my brain is given to the NFL's brain bank'' (The VA
    CSTE brain bank). The request was accompanied by an unusual method of
    suicide; he shot himself in the heart. At autopsy, his brain showed
    extensive changes of moderately advanced CTE, without evidence of any
    other disorder including Alzheimer's disease (Figure 4).

        Figure 4. Coronal sections of the brain of Dave Duerson stained for
    phosphorylated tau protein show dense abnormalities throughout the
    brain. Bottom row: microscopic views of abnormal tau deposits showing
    extensive abnormalities of tau in nerve cells and support cells.
    Case 5. Owen Thomas. defensive end University of Pennsylvania
        Owen Thomas was a University of Pennsylvania defensive end who
    loved football and had played football since age 9. He was considered
    to be the life of the team and was unanimously voted team captain.
    There was no history of documented or undocumented concussion,
    depression or psychiatric difficulties, and no evidence of substance
    abuse. One day in the spring of 2010, he called his parents and told
    them he was stressed by school and having trouble with several of his
    subjects, two days later he hanged himself in his off campus apartment.
    Neuropathological examination of Owen's brain showed the unmistakable
    changes of early CTE with focal collections of NFTs in multiple areas
    of his frontal cortex and evidence of spread of the NFTs to adjacent
    cortical regions (Figure 6). Comparison of the brain of Owen Thomas to
    the brain of Dave Duerson shows remarkable similar pathology and
    suggests that if Owen Thomas had lived another 30 years, his CTE would
    have progressed to the moderately severe stage demonstrated by Dave
    Duerson.

        Figure 5. Coronal sections of the brain of Owen Thomas stained for
    phosphorylated tau protein show dense abnormalities throughout the
    brain. Bottom row: microscopic views of abnormal tau deposits. There
    was extensive nerve cell loss and advanced neurodegenerative changes
    throughout the brain.

    Case 6. 18-year-old high school football player
        I also have had the opportunity to examine the brain of a high
    school football player who died at the age of 18. He had played
    football and other sports for 4 years and suffered several concussions.
    The brain of an 18 year old should be pristine; there should be no
    abnormalities whatsoever. But in the brain of this young man, there
    were several areas of damage in the frontal lobe that you could see
    even looking at the slides with your naked eye (Figure 6, top row). In
    those areas, there were hundreds of degenerating nerve cells containing
    tau NFTs and disordered nerve cell processes indicative of early CTE.

        Figure 6. Brain sections from an 18 year old high school football
    and rugby player showing areas of damage in the frontal lobe (top row,
    red boxes), and microscopic views of views of phosphorylated tau
    containing NFTs in nerve cells and their processes in lower row.

    Case 7. 17-year-old high school football player. death from Second
            Impact Syndrome (SIS)
        A 17-year-old high school football player suffered a concussion 3
    weeks before the day of his death and was cleared to return to play 2
    days earlier. During the game, the running back and linebacker
    intercepted a pass and hit the ground. Nothing seemed exceptional about
    the tackle; it was considered a routine play. Yet as he walked to the
    bench, he complained of a severe headache and then collapsed to the
    ground unconscious. He died the following day. Neuropathological
    examination showed a thin subdural hemorrhage entirely consistent with
    Second-Impact Syndrome (SIS) and very early changes of CTE. He is the
    youngest player ever known to have changes of CTE on neuropathological
    examination.

    Summary
        I have now examined the brains of 58 individuals with
    neuropathologically verified CTE--including 40 professional and amateur
    football players, 5 hockey players and 15 military veterans.Ihave found
    changes of early CTE in several college and high school football
    players, including early changes in players as young as 17 and 18
    years. We know that CTE is a tauopathy and TDP-43 proteinopathy
    associated with repeated mTBI that most commonly occurs early in life,
    usually an individual's teens and early twenties. We know that once CTE
    is triggered, the neurodegeneration progresses slowly over decades to
    involve widespread degeneration of many brain structures. We know that
    the symptoms of CTE are often insidious and begin in mid-life with
    prominent early personality and behavioral changes, including
    irritability, short fuse, depression, suicidal ideations, impulsivity,
    and memory loss. We know there is a slow deterioration that may
    progress to include dementia, parkinsonism, gait and speech disorders.
    However, there remain many things that we do not understand about CTE.
    An autopsy case series will never establish incidence and prevalence of
    this disorder, even though we now clearly understand that CTE exists--
    and that it is surprisingly common. What factors determine who will
    develop CTE--how many concussions or how many subconcussive injuries,
    how close together the injuries are, how severe, and at what age--all
    of these are aspects of this disease that are unknown at this time.
    Most importantly, we do not know how to diagnose this disease in living
    individuals, how to stop its progression or how to reverse its course
    at the present time. But we can make important changes to prevent this
    disease from developing in young athletes, and those changes include
    understanding what a concussion is, recognition of concussion when it
    occurs, and proper medical management of concussion after it happens.
    We can also teach our young athletes to play smart and to keep their
    head out of the game as much as possible. Rule changes to protect
    athletes from dangerous styles of play, rule enforcement and player and
    coach education will go a long way towards reducing the frequency of
    concussion. With these changes in the way sports are played, continued
    education, increased scientific research into the mechanisms of CTE
    pathogenesis, and the development of diagnostic tools and therapeutic
    strategies to interrupt disease progression, we can make an enormous
    improvements to protect the mental health of millions of young athletes
    and military service members for many years to come.

    References
        1. McKee AC, Cantu RC, Nowinski CJ, Hedley-Whyte ET, Gavett BE,
    Budson AE, Santini VE, Lee H-Y, Kubilus CA. Stern RA. Chronic Traumatic
    Encephalopathy in Athletes: Progressive Tauopathy following Repetitive
    Head Injury. J Neuropath Exp Neurol, 2009 68(7): 709-735.
        2. McKee A, Gavett B, Stern R, Nowinski C, Cantu R, Kowall N, Perl
    D, Hedley-Whyte E, Price B, Sullivan C, Morin P, Lee H-S, Kubilus C,
    Daneshvar D, Wulff M, Budson A. TDP-43 Proteinopathy and Motor Neuron
    Disease in Chronic Traumatic Encephalopathy, Journal Neuropathol Exp
    Neurol, 2010, 69: 918-929.
        Authors' reply: McKee AC, Budson AE, Gavett BE, Stern RA, Daneshvar
    D, Nowinski CJ, Cantu RC, Kowall NW, Perl DP, Hedley-Whyte ET. J
    Neuropathol Exp Neural. 2011 Jan; 70(1): 98-100.
        3. Gavett, B, Stern R, Cantu R, Nowinski C, McKee A. Mild traumatic
    brain injury: A risk factor for neurodegeneration, Alzheimer's Research
    and Therapy, 2010, Jun 25; 2(3): 18.
        4. Gavett B, Stern R. McKee A. Chronic Traumatic Encephalopathy: A
    Potential Late Effect of Sport Related Concussive and Subconcussive
    Head Trauma. Clinics in Sports Medicine, 2011 Jan; 30(1):179-88, xi.
        5. Daneshvar D, Nowinski C, McKee A, Stern R, Cantu R. Helmets and
    Mouth guards: The Role of Personal Equipment in Preventing Sports
    Related Concussions. Clinics in Sports Medicine, 2011 Jan; 30(1): 145-
    63, X.
        6. Cantu RC, Gean AD. Second-Impact Syndrome and a Small Subdural
    Hematoma: An Uncommon Catastrophic Result of Repetitive Head Injury
    with a Characteristic Imaging Appearance. J Neurotrauma 2010 27:1557-
    1564.
        7. Chaiwat 0, Sharma D, Udomphorn Y, Armstead WM, Vavilala MS.
    Cerebral hemodynamic predictors of poor 6-month Glasgow Outcome Score
    in severe pediatric traumatic brain injury. J Neurotrauma 2009 26(5):
    657-63.

        The Chairman. That was excellent.
        And so, we then finish with Mr. Mike Oliver. Let me repeat,
    Executive Director of the National Operating Committee on
    Standards for Athletic Equipment. And having read my
    preparation for this hearing, I am still a little bit confused
    about what you all do and what you don't do.
        Mr. Oliver. I think I can cover that.
        The Chairman. OK.

    STATEMENT OF MIKE OLIVER, EXECUTIVE DIRECTOR AND LEGAL COUNSEL,
      THE NATIONAL OPERATING COMMITTEE ON STANDARDS FOR ATHLETIC
                           EQUIPMENT (NOCSAE)

        Mr. Oliver. Thank you, Mr. Chairman, Ranking Member
    Boozman, and members of the Committee.
        I appreciate the invitation to come here today and provide
    some testimony and answer questions of the Committee on a topic
    that is extremely important to me personally, as well as to the
    organization I represent.
        My name is Mike Oliver. Since 1995, I have served as the
    Executive Director and General Counsel for NOCSAE. NOCSAE is
    the National Operating Committee on Standards for Athletic
    Equipment. We are a nonprofit corporation which develops and
    publishes standards for athletic equipment, including helmets,
    faceguards, safety balls, and even soccer shin guards.
        We operate as a board of 18 directors representing a wide
    variety of national sports, sports medicine, and other
    interested organizations. Each organization, by definition
    through our bylaws, selects one or two of its members to sit as
    a director on the board. And in addition to the 18 voting
    directors, NOCSAE has 2 nonvoting positions, representing the
    national sports governing bodies of the NCAA and the National
    High School Federation, the NFHS.
        There is no single controlling interest or interest group
    on the NOCSAE Board, and a balance of interests and
    nondominance is inherent in the operational structure and
    function that is provided through our bylaws. NOCSAE is not a
    trade organization. There is no membership category. Funding
    for the operations and research that we undertake is received
    through licensing fees that we charge to manufacturers who want
    to certify equipment to our standards and to use our
    trademarked and registered logos, properties, and phrases.
        Although NOCSAE is not a certifying body--we do not certify
    equipment independently of the manufacturers--we do engage in
    market surveillance of certified equipment, and we monitor
    product performance through mandatory third-party laboratory
    validation testing as required by our standards, as well as
    direct product testing through an A2LA accredited testing
    laboratory with whom we contract to provide technical support
    and services.
        Decisions regarding changes to standards or the creation
    and adoption of new standards are driven exclusively by science
    and motivated by the desire of all board members to protect
    athletes, not by issues of manufacturer liability, profit,
    market share, or any other interests.
        The mission of NOCSAE since its inception in 1968, is to
    commission research and establish standards for athletic
    equipment where feasible and to encourage the dissemination of
    research findings on athletic equipment and sports injuries. In
    fulfilling that mission, NOCSAE has funded more than $6 million
    in research grants since the first grant was issued in 1994,
    and that number includes more than $5 million dedicated to
    concussion-related research.
        To be certified as meeting our standards, helmets, whether
    they are football helmets or batter's helmets, must score less
    than 1,200 severity index units on each of 16 impacts conducted
    at 12 miles per hour, including 2 high-temperature impacts and
    impacts on 2 randomly selected locations. In addition to those,
    there are four impacts at lower speeds, which have lower
    threshold requirements.
        Although the standard for helmets that NOCSAE publishes are
    not concussion specific, the NOCSAE standard does directly
    address linear forces that are involved in most concussive
    events, and a helmet that passes the NOCSAE standard does
    provide some level of protection against those concussions
    caused primarily by induced linear accelerations to the brain.
    We do not promote helmets as being concussion preventive or
    anti-concussion because there is no way to accurately measure
    the extent of protection provided.
        What the NOCSAE standard does not yet address and cannot
    yet address, and is a subject that is not addressed by any
    other helmet standard in the world, is how to establish and
    incorporate a threshold for rotational accelerations of the
    head that result from impact forces not directed through the
    center of gravity of the head. These rotational accelerations
    are directly involved in causing a significant number of
    concussions, and these types of accelerations can occur even
    without a blow to the head.
        There is no protective equipment standard available today
    from any source that specifically addresses concussion
    prevention, and the development of a concussion-specific
    standard for any protective equipment requires substantial
    scientific support that compliance with the standard would, in
    fact, further eliminate or reduce the severity of concussions
    without increasing the risk of injury in other areas.
        While helmets certified to the NOCSAE standards play a very
    important role in protecting athletes on the field of play,
    certainly helmets are not the only solution to providing better
    protection against concussion. Prevention, diagnosis,
    treatment, and management decisions about when athletes should
    return to play are equally important and, in fact, in some
    circumstances may be more immediately effective in reducing the
    number of concussions.
        Education programs that have been referenced earlier today
    address these issues and are underway for coaches, and in fact,
    NOCSAE has entered into a partnership, as mentioned earlier,
    with the CDCP to create a specific Heads Up to Parents program
    as an educational resource to promote this education among
    those who are certainly motivated to provide the best level of
    protection and education to their children.
        NOCSAE recognizes that concussions are complex events, both
    biomechanically and physiologically. And scientists are working
    hard to understand these issues so that improvements might be
    made in protection, prevention, and treatment.
        We are one of the primary funding sources for this
    research, and we are hopeful that answers will be found that
    will permit an amendment to our standards that will effectively
    and specifically address concussions. Any device, including
    helmets, promoted as being able to prevent, diagnose, or cure a
    concussion must be supported by scientific data and peer-
    reviewed research. The same is true with regard to standards
    for athletic equipment.
        We fund concussion research with the intent to advance the
    science so that changes can be made to standards that will
    reduce concussions without increasing risk in other areas, and
    we have taken specific steps to be ready to do that when the
    answers are found. But without solid scientific support for a
    concussion-specific change to an existing helmet standard, any
    changes made to address concussions becomes nothing more than a
    hopeful experiment, turning players into involuntary test
    subjects. And that is something that we will not do.
        I look forward to the Committee's questions and the
    discussion today on a topic that we consider to be extremely
    important.
        Thank you.
        [The prepared statement of Mr. Oliver follows:]

        Prepared Statement of Mike Oliver, Executive Director and Legal
      Counsel, The National Operating Committee on Standards for Athletic
                               Equipment (NOCSAE)

        Parents, athletes, and coaches, are becoming more aware and
    informed regarding concussion prevention, diagnosis, treatment, and the
    importance of following recognized return-to-play criteria. This
    increased awareness and public discussion is vitally important to
    advancing athlete safety, but it also creates a demand for quick
    solutions. Unfortunately, there are quick solutions offered for sale
    which have neither scientific nor medical support, and which carry the
    potential for creating a false sense of security and reliance on a
    level of protection that does not exist.
        The neurobiology and biomechanics of sports concussions present
    complex and rapidly evolving areas of expertise both as to cause and
    prevention. Through its grant research funding program, NOCSAE has been
    one of the international leaders in helping to advance the scientific
    and medical knowledge relating to concussions. Despite the dedication
    of more than $5,000,000 in research grants since 1994, directed
    specifically towards the issue of understanding and preventing sports
    concussions and to developing protective equipment performance
    standards that could eliminate concussions or reduce their frequency
    and severity, scientific support for such standard does not yet exist.
        NOCSAE, the National Operating Committee on Standards for Athletic
    Equipment, is an independent and nonprofit standard-setting body with
    the primary mission to enhance athlete safety through scientific
    research, education, and where feasible, the creation of performance
    standards for protective equipment. NOCSAE efforts include the
    development of helmet performance and test standards for football,
    baseball and softball, ice hockey, and lacrosse, as well as faceguards
    and face protectors used in connection with these helmets. NOCSAE
    bylaws provide that the Board is comprised of representatives selected
    by national organizations representing a broad base of interested
    parties and expertise. Broken into three general categories, NOCSAE
    directors representing end-user or direct athlete involvement include
    two new members from the National Athletic Trainers Association (NATA),
    the Athletic Equipment Managers Association (AEMA), and the American
    Football Coaches Association (AFCA). NOCSAE directors representing
    sports medicine and related scientific research include representatives
    from the American College of Sports Medicine (ACSM), the American
    College Health Association (ACHA), American Orthopedic Society for
    Sports Medicine (AOSSM), the American Academy of Pediatrics (AAP), and
    the American Medical Society for Sports Medicine (AMSSM). NOCSAE
    directors representing product and manufacturing interests are selected
    by the Sporting Goods Manufacturers Association (SGMA) and the National
    Athletic Equipment Reconditioners Association (NAERA). In order to
    maintain balance between the interests represented and to preclude
    dominance or control by any group or interest, some organizations have
    one seat, while others have two. Currently there are 18 voting
    directors, five of which represent manufacturing and retail interests,
    7 represent the athlete and end user interests, and 6 representing
    medical and scientific interests. NOCSAE also has two non-voting
    directors, one representing the National Federation of State High
    School Associations (NFHS) and one representing the National Collegiate
    Athletic Association (NCAA).
        In support of its mission, the NOCSAE board utilizes a Scientific
    Advisory Committee consisting of independent leading experts in the
    areas of neurology, neurosurgery, orthopedics, biomechanics, and
    epidemiology. This committee meets as needed, and provides support,
    guidance, and advice in the areas of standards development as well as
    identifying areas for directed or targeted research.
        NOCSAE also maintains an ongoing independent contract with an A2LA
    accredited and ISO 17025 certified testing laboratory, and a contract
    with Fred Mueller PhD who, as the Director of Research, oversees and
    administers the NOCSAE research grant application and funding program.

    History of NOCSAE
        NOCSAE was created in 1968 through the combined efforts of the
    NCAA, the American College Health Association, the NFHS, and the
    Sporting Goods Manufacturers Association to develop a football helmet
    standard that would be effective in reducing or eliminating fatalities
    from head injuries such as skull fractures and subdural bleeding that
    were occurring in organized football.
        The standard which resulted from the efforts of the original NOCSAE
    directors and scientists mandated that football helmets meet a specific
    injury threshold criteria, commonly referred to as the Gadd Severity
    Index, Severity Index, or simply SI. The SI threshold in the NOCSAE
    standard works by limiting the magnitude of linear head accelerations
    that result when the helmet is hit. The first NOCSAE football helmet
    standard was originally published in 1973 and new helmets began to
    appear on the market certified to this new standard shortly afterwards.
    Eventually a requirement of compliance with the NOCSAE standard was
    incorporated into the rules of play by the NCAA and the NFHS in 1978
    and 1980 respectively, and within a few years, helmets certified to the
    NOCSAE standards became required in all rules of play for governing
    bodies controlling football, even extending to the United States
    Military through the Department of Defense-Education Activity (DoDEA).
        To be certified as meeting the NOCSAE standard, helmets must score
    less than 1200 SI on each of 16 impacts at 12 mph including two at high
    temperatures and two randomly selected locations, plus 4 additional
    impacts at two different lower speeds which have lower SI threshold
    requirements. Although not concussion specific, the NOCSAE standard
    directly addresses linear forces that are involved in most concussive
    events, and a helmet that passes the NOCSAE standard does provide some
    protection against those concussions caused by induced linear
    accelerations.
        What the NOCSAE standard cannot yet address, and which is not
    addressed by any other helmet standard in the world, is how to
    establish and incorporate a threshold for rotational accelerations of
    the head that result from impact forces that are not directed through
    the center of gravity of the head. These rotational accelerations are
    directly involved in causing a significant number of concussions, and
    these types of accelerations can occur even without a blow to the head.
    Even less is known scientifically about concussion threshold values
    when the blow to the head results in a combination of linear and
    rotational accelerations occurring at different points in the same
    impact and with different magnitudes.
        There is no helmet standard available today from any source that
    specifically addresses concussion prevention, and the development of a
    concussion specific standard for any protective equipment requires
    substantial scientific support that compliance with such a standard
    will in fact further eliminate or reduce the severity of concussions
    without increasing the risk of injury and other areas.

    Protecting Against Concussions
        While helmets certified to NOCSAE standards play an incredibly
    important role in protecting athletes in the field of play, improved
    protective equipment is not the only solution to providing better
    protection against concussion. Prevention, diagnosis, treatment, and
    management decisions about when athletes should return to play are
    equally important, and prevention can be enhanced by enforcing the
    rules of play in a particular sport.

       Teaching and enforcing proper tackling techniques, which
            include not using the head as a weapon or primary contact
            point. These types of changes can make an immediate and likely
            measurable impact on the number and severity of concussions.

       Teaching athletes and active children at all ages that the
            signs and symptoms of a potential concussion should not be
            ignored, and should be followed up with an evaluation by
            someone properly trained and skilled in evaluating concussions.

       Adopting and enforcing return to play criteria that will
            prevent an athlete from returning to play until a complete and
            objective evaluation is completed.

       Helping parents, coaches, and players understand that
            although helmets provide a substantial level of protection, no
            helmet can prevent all head injuries, including concussions.

        The Centers for Disease Control (CDC) estimates approximately 1.6
    to 3.8 million sports-and recreation-related concussions occur each
    year in the United States, and children and teens are at highest risk.
    Parents, coaches and trainers must exercise caution in deciding when
    athletes can and should return to play. The Center for Injury Research
    and Policy at Nationwide Children's Hospital, funded in part by grants
    from NOCSAE, found that in 2008, more than 40 percent of high school
    athletes were allowed prematurely to return to play after suffering
    concussions. And, of those players, 16 percent of concussed football
    players were actually allowed to return to play in the same game after
    losing consciousness.

    NOCSAE ongoing efforts to address concussions
        As stated earlier, there are currently no helmet standards
    published in the world which contain performance thresholds specific to
    concussions. Helmet standards which limit linear accelerations do
    provide a level of protection for those concussions where linear
    acceleration may be the primary cause, but a concussion specific helmet
    standard to be effective must incorporate not only limitations to
    linear accelerations, but also reflect and incorporate an understanding
    of injury thresholds associated with rotational accelerations and
    strong scientific support for the concussion injury thresholds
    utilized. For many years, NOCSAE has dedicated its resources to
    answering those questions NOCSAE's first concussion research grant
    award of $49,000 was given in 1996 to Dr. Kevin Guskiewicz at the
    University of North Carolina to study the ``Effect of Mild Head Injury
    on Cognition and Postural Stability'' in evaluating potential
    concussion diagnostic modalities. In the past 10 months, NOCSAE has
    funded specific targeted concussion research grants totaling $2,319,000
    to scientists and biomechanical researchers at Dartmouth Medical
    School, Dartmouth Department of Engineering, Wayne State University
    School of Engineering, Ottawa University Bioengineering Laboratory, and
    the Southern Impact Research Center. From that first concussion grant
    in 1996 through today's date, NOCSAE has dedicated over $5,000,000 to
    the study of sports related concussions to advance medicine and science
    in that area to the point that concussion specific changes to the
    NOCSAE standards can be adopted. These concussion specific grants are
    in addition to other NOCSAE funded research in the areas of sports
    medicine and science, including research that eventually identified the
    biomechanics and physiology of which may be preventable through the use
    of an appropriately tested chest protector that meets an impact
    standard currently being developed by NOCSAE.
        As early as 2002 and 2003, NOCSAE was becoming aware through its
    sponsored research and from the research of others that any performance
    standard that might effectively address injury thresholds from
    rotational accelerations would require a new testing methodology in
    addition to the drop test which is utilized by all existing helmet
    performance standards. To that end, NOCSAE advanced funding for the
    fabrication of five prototype horizontal ram impactor devices,
    sometimes referred to as a linear impactor. This impactor is designed
    in such a way as to permit a testing apparatus to induce rotational
    accelerations into a helmet and headform in unlimited magnitudes,
    direction, and orientation, which no existing helmet impact drop tests
    are able to accomplish. NOCSAE decided in 2004 that the validation of
    such a testing component was necessary so that there would be no delay
    in incorporating rotational acceleration thresholds and testing in the
    NOCSAE standards once those thresholds were identified. A proposed
    revision to the NOCSAE standard incorporating this new testing protocol
    was published in 2004, and work has continued to this day in validating
    and refining the linear at five different laboratory locations around
    the country.

    Public Education programs
        In addition to regular public speaking engagements, daily
    interaction with the public to telephone calls and e-mails, and
    providing and disseminating research and educational information
    through the Internet, NOCSAE has entered into a partnership with the
    CDC National Center for Injury Prevention and Control to develop and
    disseminate a concussion awareness and educational campaign called
    ``Heads up to Parents.'' This national campaign utilizes multiple
    informational outlets, including social media, to present parents and
    athletes with concussion information, building on the CDC's already-
    successful ``Heads Up'' initiative, featuring free tools that provide
    important information on preventing, recognizing and responding to a
    concussion. Materials can be found on the CDC's website, www.cdc.gov/
    concussion/sports/. These tools are an invaluable resource for parents
    as their athletes take the field, and NOCSAE is proud to be a partner
    with the CDC Foundation to provide financial and substantive support
    for the program.

    Changes to the NOCSAE helmet standards
        The NOCSAE helmet standard, unique among all existing helmet
    standards for the use of a biofidelic headform, the use of a pass fail
    criteria which incorporates both impact force and time duration (SI),
    and the requirement of low-speed and high-speed certification impacts,
    has undergone significant and substantial revisions and improvements
    since it was first adopted and published in 1973.

       In 1992, NOCSAE undertook a multi-factor revision to its
            testing protocol, which included implementation of a
            scientifically proven calibration method of the NOCSAE headform
            using a specially designed impact surface, added a requirement
            that headform calibration be performed rigid, and the air craft
            cable guide wires were replaced with smoother music wire. This
            decreased friction in the drop system and increased stability
            of the carriage assembly throughout the drop impact. The test
            impact pad was hardened from a 36 Shore A hardness natural
            rubber surface to a 43 Shore A hardness urethane to produce a
            more consistent impact surface. These changes resulted in
            significantly higher impact velocities and increased impact
            energies to the helmet, a more demanding test than in the
            previous standard. The increased impact energies now required
            in the testing were so significant that the impacts began to
            break expensive head forms and attachment assemblies, which
            required a redesign of those components.

       In 1996, NOCSAE amended its helmet standards by toughening
            pass fail criteria for helmets. The original SI value of 1500
            was reduced to 1200, making it is 20 percent more demanding,
            and bringing the pass fail threshold in line with Federal Motor
            Vehicle Safety Standards.

       In 1999 an anthropometrically correct size medium testing
            headform was introduced along with other design changes to
            allow the headforms to withstand the new impact energies that
            resulted from the changes in 1992 and 1996.

       In 2003, a proprietary data acquisition system and
            standardization of data collection was developed by NOCSAE and
            implemented with all licensees, requiring that the pretest and
            posttest system checks be performed correctly or all helmet
            test data performed between these system checks becomes
            invalid. A temperature sensor incorporated in the software
            automatically invalidates all test data generated when the
            temperature of the test lab is outside the specified range.
            Additionally, the results of all impact certification tests are
            stored in encrypted files and available to NOCSAE by direct
            download or electronic exchange.

       In 2011, the football helmet standard was revised to add low
            level pass/fail thresholds for drop impacts at 7 miles per hour
            This low speed impact threshold is in addition to the 1200 SI
            pass/fail for drops of 12 mph.

    NOCSAE enforcement of its standards
        The NOCSAE name, and the various sport specific logos, phrases, and
    designs that are incorporated into the NOCSAE standards are registered
    and trademarked properties, and NOCSAE controls the use of those
    properties through a license agreement. Any manufacturer which intends
    to certify equipment to the NOCSAE standards must first sign a license
    agreement to do so. This agreement obligates the manufacturer to not
    only comply with the specific requirements of the standards, but also
    requires that each licensee provide certification testing data, quality
    assurance and quality control program documentation, and annual reports
    from third party independent testing laboratories certified compliant
    with ISO 17025 requirements proving compliance with the NOCSAE
    standards for every piece of equipment certified by that licensee in
    the previous 12 months. In exchange for permitting the manufacturer to
    use the intellectual property of NOCSAE, a license fee is also charged.
    This license fee is non-negotiable, and is assessed on a per unit
    basis. The fees per unit are extremely small, but generate the revenue
    used by NOCSAE to fund the scientific research grant program which
    supports the content of standards.
        The license agreement also obligates each licensee to obtain prior
    approval of proposed advertising which uses the NOCSAE name or
    references NOCSAE as part of its advertising.
        Although NOCSAE is not a certifying body, we do engage in market
    surveillance of certified equipment, and we independently investigate
    certified equipment performance through mandatory annual third party
    laboratory validation testing, and direct product testing through our
    own contracted and A2LA accredited testing laboratory.

    Recertification of reconditioned equipment
        In addition to the standards that apply to the certification of new
    athletic equipment, NOCSAE has also published standards that permit
    previously certified equipment to be recertified as part of a formal
    reconditioning process. NOCSAE standards for the recertification of
    previously certified athletic equipment provide schools, clubs,
    universities, and even professional teams with a way to economically
    maintain the performance and integrity of their certified helmets, and
    provide NOCSAE with the opportunity to reevaluate helmet performance
    even after they have been in use for one or more seasons. The
    recertification standards require that reconditioners test a
    statistically significant number of helmets submitted for
    reconditioning and recertification. These helmets must be tested first
    in the condition they are in ``as received from the field'' before any
    repair or reconditioning is undertaken. Following completion of the
    reconditioning process which includes a thorough and complete
    inspection of every individual helmet for cracks and defects, and the
    replacement of worn or damaged padding and fitting components, these
    same randomly selected helmets are retested utilizing a proprietary
    data acquisition software program developed for NOCSAE by engineers at
    the University of Tennessee. The test results of the nearly 50,000
    helmets from both pre-and post reconditioning tests are collected and
    evaluated every year.

    Conclusion
        Concussions are complex events both biomechanically and
    physiologically, and scientists are working hard to understand these
    issues so that improvements can be made in protection, prevention, and
    treatment. Any device or supplement promoted as being able to prevent,
    diagnose, or cure a concussion must be supported by scientific data and
    peer reviewed research. The same is true with regard to standards for
    protective equipment. Without solid scientific support for a concussion
    specific change to an existing helmet standard, any changes made to
    address concussions becomes nothing more than a hopeful experiment,
    turning players into involuntary test subjects.

        The Chairman. Thank you for that excellent testimony.
        We have been joined by Senator Klobuchar from Minnesota,
    where they are having quarterback difficulties.
        [Laughter.]
        Senator Klobuchar. We do have a team, however.
        The Chairman. Yes, you do. That is true.
        Senator Klobuchar. Thank you.
        The Chairman. I am from West Virginia. I deserve that.
        What is interesting--that is good, Amy.
        [Laughter.]
        The Chairman. I have spent a lot--my mother spent I think
    about 12 years dying from Alzheimer's. Actually, you couldn't
    really be sure. But die she did. My wife's father died from
    Alzheimer's. There are so many--there are 5 million people that
    have Alzheimer's in this country.
        And one of the stunning things about Alzheimer's, which,
    incidentally, if you are working in that traumatic brain injury
    area, you can do that while you are working on Alzheimer's
    because there is a lot of sort of common threads in there. The
    stunning thing is the New York Times came out with an article 6
    or 8 months ago basically saying that the last 30 years of
    research at the great institutes of research in this country
    had produced absolutely no progress whatsoever on finding out
    the cure for Alzheimer's.
        Not for preventing and not for slowing it down, not even
    yet for testing to find out whether you have it, although that
    may be on the way. But that doesn't cure it, which is what we
    want. That is a stunning figure.
        Now comes along the injuries that are sustained by
    concussions, made more poignant by the fact that they come so
    early in life and can have such terrible consequences that you,
    Mr. Threet, and you, Ms. Ball, decided not to do what you had
    spent your whole life preparing to do. It is not necessarily
    typical. I mean, it was a very mature, wise decision to make.
        So I just want to kind of throw this at all of you. You
    could develop a 50-pound helmet and all it would do is more
    securely, I think--unless I am wrong--it would just more
    securely make sure that your head doesn't get split open. But
    it wouldn't do one thing for the movement of the brain, to stop
    the movement of the brain.
        Which then, if you say that emphatically enough, it raises
    the question of what can you do medically? You can analyze. We
    do that with Alzheimer's. People--you have a registry of
    Alzheimer's brains. People leave their brains to be studied
    just like you have had, and you learn from that, from the
    synapses and all those kinds of things, the tangles. You can
    tell.
        But that doesn't do them any good. And so, I want to raise
    two questions. One is to the medical side of this. Do you think
    I am wrong? I mean, do you think that this is just because it
    is a relatively early discovery?
        To be quite honest, I didn't know at all that somebody who
    played soccer could get this until I watched that movie about
    the winning when we beat China back in 19--whatever it was, in
    1980. And that incredible, powerful back that the Chinese all
    stayed away from because she just flattened them, she had
    chronic fatigue syndrome. She didn't have a brain concussion of
    any sort.
        And you see soccer a lot now. All of us watch soccer a lot
    more, and you see people using their heads and you don't notice
    whether bands are on there or not. But just the amazingness of
    the ignorance of the American people about this problem, even
    though we now know much more than we did know about it.
        I want to know just right off the bat how hopeful you all
    are realistically about being able to find a solution to this
    so that the brain is not thrown off of its axis, you know,
    electric stimulus and all the rest of it. Can this happen?
        Dr. McKee. Well, I personally am very hopeful. We didn't
    know about this disease 5 years ago in any real way, and what
    we have learned in the last 5 years has been extraordinary. We
    have just made enormous gains in understanding how it affects
    the disease, what the disease looks like, how it progresses
    through the nervous system.
        And now we understand this disease exists. We can try to
    model it in experimental systems and come up with those
    therapies that might help us treat living patients.
        And I actually think that this disease may ultimately be a
    window or provide insight into the diseases like Alzheimer's
    disease. Alzheimer's disease is characterized by a buildup of
    this protein tau as well, and maybe by understanding how this
    disease starts and how it progresses, we may actually have
    insight into Alzheimer's disease and how it starts.
        One of the most difficult things about Alzheimer's disease
    is we don't have any idea. It starts silently. Maybe in a
    person's 50s. We can never identify it precisely, how it
    exactly starts. But this is a disease we know has a time
    course, and we know what to expect, and it develops over time.
    And I think it is going to give us an enormous opportunity for
    intervention.
        The other thing about Alzheimer's disease is most of those
    therapies----
        The Chairman. Do you mean a prevention of the disease
    because of helmets or other----
        Dr. McKee. No. I think understanding the actual pathologic
    process and intervening there, intervening maybe at the start
    of the disease where it is triggered or preventing it from
    progressing through the nervous system. There appears to be a
    transmissibility through the nervous system that it develops in
    one nerve cell, and then it causes the disease to be propagated
    in another nerve cell.
        If we could interrupt that progression, we could make an
    enormous difference in this disease, and that may be applicable
    to Alzheimer's as well. One of the issues with Alzheimer's is
    we were focused on the beta amyloid protein, and that has
    really come up pretty--we haven't come up with much. But we
    haven't focused on tau that much, and maybe that is the
    cellular element we really need to start paying attention to.
        The Chairman. Can I ask one of you two athletes, is it the
    prevention of something that you now know you already have from
    becoming worse that interests you the most? Well, the answer
    has to be yes. Or is it the absolutely vast amount of change in
    the way everybody in this country thinks about the playing of
    sports, the carrying out of sports, the responsibility that
    people have?
        I mean, there are a lot of coaches in rural states that are
    also math teachers. That probably isn't very good for either
    coaching or math. But that is the way that works. People don't
    know.
        So if you are talking about not letting it happen in the
    first place, that means you have got to tell the person to keep
    their head up. Well, try telling that to an NFL player who has
    just been chop-blocked by somebody, and he has a chance to get
    back at them. You know, human behavior is very hard. Human
    behavior under stress is very hard to control.
        And so, I don't know what the chances are or if we have
    enough time, or maybe if the shock of what people are learning
    or if we do more of this that coaches and parents--and parents
    are often a lot less helpful than they think they can be in
    this. Have a lot less influence on their kids because kids just
    want to go ahead and do it. ``I am 17. Don't tell me I can't do
    this again.'' So, I mean, you do it after you know you have it,
    and try to prevent it from happening?
        Mr. Threet. I would say yes. I mean, obviously, I believe
    awareness would be the biggest issue. If you could just
    increase the knowledge base for the general public and for the
    athletes, I feel like recovery would--that athletes would do a
    lot better with recovery. They would take time to allow their
    brains to recover.
        I don't think brain injury is viewed as a serious issue
    throughout athletes. It wasn't for me until I had a concussion
    that changed what I was able to do in school on a daily basis.
        The Chairman. In your locker room--I am way over time. I
    apologize. In your locker rooms, both of you, is there any
    discussion about all of this among the athletes themselves?
        Ms. Ball. Concussions are talked about kind of lightly
    still, at least when I went through playing. It is a lot of
    people, even if you have got your concussion one day and then
    you are resting, players are like, ``Well, I don't see them
    hurt. Why are they sitting out?''
        And I think that mentality needs to change is you see that
    your fellow athlete got a concussion. You need to give them the
    respect to let them rest, and that just comes from the culture
    that we have right now about the ignorance about concussions.
        The Chairman. I will bet our doctors, do our doctors get
    any good training on this in their medical?
        Dr. Kutcher. I would have to say not as good as I would
    like.
        The Chairman. It is like geriatrics, right? They study it.
        Dr. Kutcher. Essentially.
        The Chairman. They go into it for a while, find they can
    make more money elsewhere, and they depart?
        Dr. Kutcher. Pretty much. I mean, that wraps it up. I would
    like to make a comment on your original question, if I could,
    about am I optimistic or not? And the answer is yes. I am
    optimistic.
        But your story about Alzheimer's and the lack of
    improvement and understanding for treatments is very applicable
    to this situation, but it is also not unique to brain pathology
    in general. Think about stroke, multiple sclerosis. We don't
    have cures for these things either, and decades and decades and
    billions of dollars. So the bottom line is the brain is
    complicated.
        I do want to make a quick comment that I think we are
    talking about more than one thing here, at least two or three
    as far as diagnoses go. CTE, on the one hand, a degenerative
    neurological process that most likely is coming from repetitive
    blows to the head, and concussion are two different things. And
    I don't think for a moment that these folks here are a risk--a
    high risk of developing CTE, the neurodegenerative disease
    itself.
        I think we are at a stage now where we are just starting to
    understand the scope of the problem. As Dr. McKee mentioned, we
    don't know the prevalence of this. We are finding the tau more
    and more often in brains of athletes who have had impacts, and
    military personnel as well. But how does the tau relate to the
    neurological disease? We don't know that.
        There are people that she has found tau in that had no
    neurological problem at all. So I don't want to over alarm
    these folks over here that because they have had concussions
    that they are going to have CTE later in life.
        The Chairman. I am way over my time. I apologize to my
    colleagues.
        Senator Boozman?
        Senator Boozman. I am glad you mentioned that because I was
    going to ask Dr. McKee. She mentioned the 17-year-old that had
    one reported concussion then passed away. Were there other
    reported concussions prior to that?
        Dr. McKee. No. I don't have--I don't have any other
    reported concussions.
        Senator Boozman. So we really don't know if he played
    through----
        Dr. McKee. Right.
        Senator Boozman.--concussion or just the repeated blows of
    being in whatever position he was in. It really is a real
    problem. I think you all testified so well, Ms. Ball and Mr.
    Threet, the problem is to play athletics at the level that you
    played at, you are in pain every day that you go out there.
        Sometimes they are not significant injuries, but there are
    broken fingers--a fingernail that was pulled off, or something.
    I mean, these nagging things that can be very, very painful and
    athletes are taught you have got to play through that or you
    don't get to the level that you all were able to play through.
    So it is very difficult.
        To follow up, you really didn't feel like then that head
    injuries, the concussion aspect, really was talked about very
    much in your career?
        Mr. Threet. Yes, for me, it wasn't a serious topic until my
    last concussion I had playing quarterback. I had to be out on
    the field, whether it was shoulder separation, ankle sprain,
    whatever it was. You know, shoot it up. I am ready to go. And
    that is not the case with brain injury.
        You can't--like I said, you can't just take something to
    get rid of the pain and then deal with it later and let it
    recover at a later time.
        Senator Boozman. And sometimes not really being in horrible
    pain----
        Mr. Threet. Right.
        Senator Boozman.--compared to some of these other injuries
    that aren't that significant.
        Mr. Threet. Right. Exactly.
        Senator Boozman. Do you agree with that, Ms. Ball? You
    didn't get much education in that regard?
        Ms. Ball. I agree completely. I think now concussions are
    something that is being taught in youth sports, but when I was
    growing up, playing both high school and college, it was just a
    concussion. That is all it was.
        Senator Boozman. Dr. McKee, working with the VA, I have
    been on the VA Committee in the House and now in the Senate,
    and we really spend a lot of money trying to figure out the IED
    component of this, which is similar or the same. Do we have a
    test now that we can identify if somebody has gotten a pretty
    good blow? Is there an easy test to determine?
        Dr. McKee. No. We need lots of research to determine that.
    And that is something we don't have. We don't have a way of
    identifying definitively a concussion, other than a series of
    neuropsychometric tests, balance tests, all sorts of things. So
    we don't have an easy way of detecting it or monitoring it.
        And that is definitely a very important issue that the VA
    is addressing, as well as the Department of Defense. That is a
    crucial issue.
        Senator Boozman. You two are board certified and well
    trained, and I suppose that with your licensure, you have to
    achieve so many hours of continuing education to continue your
    certification. What I am wondering in the course of this, we
    hadn't really talked too much about the education aspect of
    people that are wanting, Mr. Threet, you are wanting to get
    into--you are coaching a little bit now, and perhaps maybe you
    are going to pursue that.
        Were you a PE major?
        Mr. Threet. No, sir. No, sir. I am coaching as my playing
    career ended.
        Senator Boozman. What I am concerned about, and maybe we
    can visit with somebody at some point, is when you are taking
    the course ``Coaching Football,'' or ``Coaching Basketball,''
    if they are talking about this and the importance of education.
        Dr. Kutcher. I can speak to that. At the NCAA level, they
    have made essentially a policy that all athletes and coaches
    need to receive concussion education annually. You see
    conferences like the Big 10 and the Mid American Conference
    that I work with having that policy as well.
        When they started their careers, we didn't do that. At the
    University of Michigan now, every year, all of our athletes get
    a lecture from me or one of my delegates on concussion. So do
    the coaches. So things are improving.
        There is a long way to go, especially as we go down the
    levels to high school and junior high school and the Pop Warner
    leagues. We have a lot more work to do, but there is sort of a
    push in that direction to make people need to get education
    before they participate either as a player or a coach.
        Senator Boozman. No, I think that is excellent. And I do
    think that those are the little things that really are going to
    make a difference.
        And then, again, encouraging our teaching institutions to
    include that in the curriculum. And then, also in the State
    sanctions, as they do their continuing education, to make this
    something that is talked about every year would be very, very
    helpful.
        The other thing I would like to touch on very briefly, and
    you all can comment, Dr. Kutcher, Dr. McKee--and Mr. Oliver, I
    know that you are probably going to talk much more about this.
    But the idea about being able to certify a helmet as something
    that won't prevent concussions.
        The Chairman mentioned about a 50-pound helmet.
    Theoretically, as you reinforce the helmet and make it heavier,
    if you could do that, then it is more of a weapon. So you
    actually create another problem in doing that.
        But can you just comment briefly about that.
        Mr. Oliver. Certainly. Senator Boozman, I appreciate that
    comment because I think it is very apropos of the difficulties
    that we face in trying to come up with a standard to address a
    specific issue like concussions.
        To a certain extent, the mass of a helmet is protective.
    The more the mass, the more energy it takes to move the helmet
    and move the head. In theory, the ideal helmet weighs, has an
    infinite mass at the point it is struck and then goes back to
    zero mass afterwards, which is clearly impossible to do.
        But there are limits to what you can do with a helmet as
    far as mass. You get to a certain point, that extra weight
    becomes a risk in other areas, and you increase the risk of
    neck injuries. You increase the risk of other injuries by doing
    that. So there is a tradeoff in that regard.
        I do think there is progress that can be made once science
    gets to the point where they can identify those specific forces
    or combinations of forces and the resultant forces that are
    likely responsible for some of these concussive issues. The
    thing that is probably most restrictive is the fact that right
    now you can't study a living human brain at that level, at the
    molecular level or at the axonal level, while it is being
    subjected to blows to the outside to see how they respond.
        There are ways to collect data in the field to show how
    much the forces are and how much the head is seeing, and we
    just started a very large research project with Dartmouth
    University, Dartmouth School of Engineering, and Wayne State
    University to look at the use of diffusion tensor imaging,
    MRIs, which can look at actually the nerve fibers following an
    injury, to follow a football player from a concussive event.
        We know the forces. We can do the DTI imaging and then take
    that information and put it into a finite, what is called a
    finite element analysis program that Wayne State is creating
    that would then, hopefully, let us model what happens to the
    brain when it is struck in certain circumstances and with that
    model be able to start coming up with concepts about how to
    address those forces, how to attenuate certain kinds of forces
    better than they are being done right now.
        With the goal, and I am very hopeful that we will get there
    at some point, to be able to come up with a standard that we
    can confidently say if a helmet meets this standard, which
    would include these issues, then you can have a comfort level
    that it will provide against, provide protection against
    concussions.
        Now, not all concussions and it certainly would never be
    said to prevent a particular amount, but it would be designed
    to meet those specific issues that we know cause concussions.
    But having the science behind that is absolutely preliminary,
    and you can't move forward without it.
        Senator Boozman. Thank you, Mr. Chairman.
        The Chairman. Thank you, Senator.
        Senator Udall?
        Senator Udall. Thank you, Mr. Chairman.
        Dr. Kutcher, your testimony states, and I think you said
    this also orally here, there is no data in the published
    medical literature that shows any particular helmet being
    better than any other at preventing sports concussions.
        Last year, however, the CEO of Riddell testified before a
    different Congressional committee that Riddell has
    ``independent, peer-reviewed, published research in the medical
    journal Neurosurgery, February 2006, showing that
    Revolution''--that is the name of their helmet--``reduces the
    risk of concussions by 31 percent when compared to traditional
    helmets.''
        One of the authors of the 2006 study told the New York
    Times earlier this year that he disagreed with Riddell's
    marketing the 31 percent figure without acknowledging its
    limitations. Yet Riddell has extensively used this concussion
    safety claim in its marketing, and here is just one example
    with this poster that is behind me.
        [An image of the poster follows:]

        This is an example taken today from the website of
    Riddell's parent company, and I think you can read that.
        The Chairman. I can't read it.
        Senator Udall. Do you think this single 2006 study provides
    a reasonable basis for Riddell to claim that the research shows
    that Revolution helmets reduce the risk of concussion by 31
    percent compared to the traditional helmets?
        Dr. Kutcher. No, I do not. I am aware of this study, and
    what I said was that there is no significant data to make that
    claim in the literature. I know there is data. That study is in
    the literature.
        There are mainly two problems with that study. First is the
    quality of the study itself, how it was set up in trying to
    look at two different populations, one wearing a certain
    helmet, one wearing another kind of helmet. You want those
    populations to be as equal as possible, other than which helmet
    they are wearing. And that was not very well done in that
    study, to the point where I would not really consider the study
    design to be acceptable scientific protocol.
        The second main critique is that the 31 percent figure is a
    relative percent change. So the two populations, the one that
    had the old helmet had a 7.6 percent concussion rate over the
    study period. The new helmet had a 5.3 percent rate. The change
    was 2.6 percent. The absolute percent change. That is a
    relative percent change.
        But when you put the 31 percent figure in front of people
    like that, they are going to think that there are 31 percent
    less concussions. Well, actually, it is 2.6 percent and that
    amount, given the study limitations, would more than account
    for sort of that noise in the data.
        Senator Udall. And you can see why a parent who would be
    concerned about concussions with all the awareness, increasing
    awareness that is out there would see something like this and
    see 31 percent and think, ``I am going to get a really
    protective helmet for my child.'' And really, what we are
    talking about is something that is very, very misleading.
        Dr. Kutcher. Well, I can see that, and I do see that every
    week in my clinic. I see patients coming in with their parents
    saying they want to buy the new helmet. This is the concussion
    helmet. What do you think about it? That is a very real
    conversation I have all the time.
        Senator Udall. And they are asking you that question over
    and over again?
        Dr. Kutcher. Correct.
        Senator Udall. And typically, what do you tell them? And
    then, do you know what they do afterwards?
        Dr. Kutcher. So my advice is the most important thing is to
    have a new helmet if you can get one. In other words, try to
    avoid the reconditioning situation where you don't know whether
    the helmet is still up to standards provided by NOCSAE.
        But fit is really important. Make sure the helmet is fit
    correctly. And then, after that, I say look at the different
    manufacturers, and if money is not an option, buy the highest
    one on the line because what is lost in this conversation is
    you can't have a concussion without force, right? But force is
    not the only thing going on here, right?
        So if I took 100 athletes or 100 people and gave them the
    same blow to the head I am going to get 100 different
    responses. So to say that concussion is the issue is ignoring
    the fact that it is forces acting on a brain that is very
    individualized and very dynamic.
        So, at the end of the day, if I am going to pick between a
    helmet that gets the least amount of force through versus one
    that gets a little more force through, I am going to pick the
    one that gets the least amount of force through. I think that
    is a fair thing to say. But to say that it is going to prevent
    concussion is not understanding the whole complexity of the
    issue.
        Senator Udall. Thank you very much.
        Thank you, Mr. Chairman.
        The Chairman. Thank you, Senator.
        Senator Klobuchar.

                   STATEMENT OF HON. AMY KLOBUCHAR,
                      U.S. SENATOR FROM MINNESOTA

        Senator Klobuchar. Thank you very much, Mr. Chairman.
        And again, I heard about this really for the first time.
    You had heard stories in my State, but at the Alzheimer's
    dinner, this big dinner they have in Minnesota. And an athlete
    actually came and spoke about the research, and I just walked
    away from that sort of blown away at some of the facts and
    things that are out there and the need for more education.
        And I then held an Alzheimer's forum this summer, and one
    of the things that I learned was that just this early diagnosis
    of Alzheimer's and the same thing what I learned was that a lot
    of the players are donating their brains, I understand, that
    get dementia to research. But how the early diagnosis of
    Alzheimer's and also of this any advancement of problems due to
    a concussion could really help us not just help the patient,
    but potentially develop a cure.
        Because the Mayo Clinic is the one that diagnosed Pat
    Summit, the most winningness high school basketball coach in
    history--college. Thank you, Mr. Pryor. And the Mayo Clinic was
    able to do that because they have these advanced ways to now
    recognize early diagnosis.
        And I finally realized that that is part of finding a cure
    because you can't practice different kinds of solutions and
    medications and things without knowing early on. If you wait
    too long, when someone is too advanced, you can't actually tell
    whether things are working or not. And do you want to comment
    on that, Dr. McKee?
        Dr. McKee. Well, absolutely. You have to have some sort of
    test that can monitor the course of the disease in order to be
    able to tell in a living patient if it is being effective. So
    the first thing we have to do is develop diagnostic markers,
    biomarkers of both concussion and these other phenomenon.
        So, concussion, post-concussive syndrome, and CTE, they are
    all quite different. But we definitely need the diagnostic
    marker so that we can monitor living patients. And in that way,
    once we develop therapies in the lab in experimental models and
    we get to the point where we are testing them in living people,
    we can actually see if they are working. Without that, we can't
    tell if they are working or not.
        Senator Klobuchar. And Dr. Kutcher, the Academy of
    Neurology headquarters based in Minnesota, we are proud of the
    work of the Neurology Association in our state, and could you
    talk about the work that is being done to develop meaningful,
    evidence-based clinical practice guidelines? I know that is
    happening.
        Dr. Kutcher. Sure.
        Senator Klobuchar. So that we are able to get guidelines
    for athletes, and if there is any scientific data available on
    that?
        Dr. Kutcher. Well, right now, if you look in the
    literature, you will see maybe a dozen or more consensus
    statements. Groups get together and come up with what the
    experts think should be the best way to approach concussion
    diagnosis and management. But to date, there has not been an
    effort that has looked at the totality of the literature in a
    critical way, looking at the quality of the data, sorting
    through the papers, and coming up with what do we have that is
    evidence based in this issue. So that is what our effort is.
        We started this 2\1/2\ years ago. It is a committee of 12
    people--5 neurologists, 7 non-neurologists. The other seven
    folks are from other medical specialties--sports medicine,
    physiatry, neurosurgery, neuropsychology. And the goal here was
    to really create a sense of where we are and where we need to
    go.
        Now there are some of our management practices that have
    some evidence, but I will tell you that most of them don't. And
    so, the goal here, and we are hoping to be published in the
    spring of 2012, is to really set forth what are the steps we
    need to take to get the data to have a good sense that we are
    doing something that is evidence based.
        Senator Klobuchar. Very good. Ms. Ball, Mr. Threet, thank
    you so much for being here today.
        I know that organizations like the Brain Injury
    Association, NFL, Athletic Trainers Association, Centers for
    Disease Control are working to increase awareness, educate the
    public. As students who had this happen, what do you think the
    best ways are to get the information out there to your fellow
    students and players?
        Mr. Threet. Well, I believe there is a lot of progress
    being made already through information, educational seminars
    that we have at the schools. I know in Arizona, I was part of
    Bill 1521 that implemented protocol for high school athletes
    that they have to attend a class, their parents have to attend
    a class, their coaches have to.
        I think just a requirement to understand what the brain is
    doing when it is injured and how serious that it is.
        Senator Klobuchar. And we did that in our state this year,
    too.
        Mr. Threet. Exactly, yes.
        Senator Klobuchar. And I would hope that is happening.
        Mr. Threet. And it is spreading, and I think it will only
    increase, to gain significance.
        Senator Klobuchar. Ms. Ball?
        Ms. Ball. I agree with preventive measures needs to start,
    we are doing high school. But if we can even start younger,
    youth sports that are like I know within soccer, there is club
    soccer, which is very prevalent among youth. And within New
    Mexico, different clubs are taking initiatives to teach the
    coaches about concussions, and I think that needs to be spread
    out to the teams and to the parents as well.
        Because once people are aware of what a concussion is and
    how serious it can be, I think that is when we finally take
    that next step forward.
        Senator Klobuchar. One last question. After you had your
    concussions and you decided not to keep playing, did you feel
    any pressure to keep playing from your peers, from other
    parents, from----
        Mr. Threet. I personally didn't. All my doctors, coaches,
    family, fellow players were very supportive of my decision to
    stop playing.
        Ms. Ball. Yes. I think people respect your decision to
    stop. Obviously, they want you to keep playing because they
    miss you playing with them. But overall, people have been very
    supportive.
        Senator Klobuchar. Very good. Thank you very much for being
    here.
        The Chairman. Thank you, Senator Klobuchar.
        Senator Pryor?

                     STATEMENT OF HON. MARK PRYOR,
                       U.S. SENATOR FROM ARKANSAS

        Senator Pryor. Thank you, Mr. Chairman.
        And thank you for having this hearing. It is a very
    important issue that touches this country all over the map and
    also in many different sports.
        Let me start with you, if I may, Mr. Oliver, I would just
    like a little context on the legal framework here in terms of
    are there state laws on helmets in sports? Do athletic
    conferences--like high school athletic conferences and
    associations--do they have rules about this and standards?
        And also, the NCAA and the NFL, when it comes to football,
    do they have standards? What is the legal framework here?
        Mr. Oliver. Well, the legal framework is actually fairly
    simple. The standards that we publish, for example, for
    football helmets, and that is the best example because it
    probably applies across the board to other sports. We publish
    the standards that are performance standards that indicate what
    helmets are supposed to do to meet the standard, and it is a
    multifactored standard.
        Then an organization, for example, like the NCAA will
    incorporate into their rules of play a requirement that helmets
    that are worn by those athletes meet our standard.
        Senator Pryor. In terms of the helmet itself?
        Mr. Oliver. In terms of the helmet itself. You cannot wear
    a helmet for play in the NCAA unless it has been certified as
    being--as meeting our standard.
        Senator Pryor. And then they may also change their rules in
    terms of, like, hitting the quarterback or----
        Mr. Oliver. Absolutely.
        Senator Pryor.--head-to-head contact, that type of thing?
        Mr. Oliver. Absolutely. The rules of play then control, if
    you will, how the helmets are used. But certainly, things like
    spearing or butting or ramming an opponent using your helmet as
    a weapon are also prohibited by the rules of play.
        The same process applies to high schools through the
    National High School Federation, although because it is a
    federation, it doesn't control directly each of the state
    associations. But they participate voluntarily.
        There are some states, for example, California, has a law
    that requires at the high school level that athletic equipment,
    including helmets, be cleaned or sanitized on an annual basis.
    That has been interpreted to mean that the helmets included in
    football play must be also reconditioned. And if they are
    reconditioned, then they are going to get recertified, which
    means you are going to be subject to recertification testing
    and evaluation.
        Senator Pryor. Which means new pads, no cracks----
        Mr. Oliver. Exactly. And it means they have to be subject
    to a fairly rigorous sample testing program. They are tested
    before they are reconditioned and tested again after they are
    reconditioned.
        But that is the only state to my knowledge that actually
    imposes that requirement by law.
        Senator Pryor. But on the high school level generally, is
    it voluntary?
        Mr. Oliver. For the reconditioning?
        Senator Pryor. Yes.
        Mr. Oliver. It is voluntary. There is no requirement that
    helmets be reconditioned or recertified on any frequent basis
    at the high school level.
        Senator Pryor. And how long--in your organization's view,
    how long--again, let us stay with the football helmet--how long
    is it good for? Is it good for one season before it needs to be
    reconditioned or----
        Mr. Oliver. That is really going to depend upon how hard
    the helmet is used and what kinds of use and abuse it has been
    subjected to. We strongly recommend any time I am contacted
    that helmets be subject to reconditioning and recertification
    every year, simply because there is no way to tell in advance
    whether a particular helmet needs it or doesn't.
        And we know from the reconditioning data because we get
    this data back from them every year that about 90 percent of
    the helmets that they recondition and recertify have been in
    the previous year. So a large percentage of them are done on an
    annual basis.
        What is not happening, which is something we are trying to
    address, both through the CPSE as well as individual work, is
    those football organizations at the youth level that aren't
    subject to state control or NCAA control, where very little is
    known about the nature of the population of those helmets. If
    they don't voluntarily submit those helmets to a
    recertification program or replace them on their own, there
    really is no umbrella organization that is in charge of most of
    those players in those clubs. And that is an area that does
    need to be addressed.
        Senator Pryor. One last thing, Mr. Oliver, what is the
    general life expectancy of a football helmet?
        Mr. Oliver. You know, it depends on the manufacturer.
    Riddell has for years put what is basically a 10-year life on
    their helmet. They have said that after 10 years, no warrantees
    apply. They don't allow helmets that are older than 10 years to
    be reconditioned or recertified, and that has been their policy
    for a long time.
        Schutt, one of the other major manufacturers, has said as
    long as the helmet is properly cared for and it has been
    properly reconditioned, which means parts replaced, padding
    replaced, shells inspected, at the end of 10 years, the only
    part of that helmet that is 10 years old is probably going to
    be the shell.
        And you can't replace the shell in the reconditioning
    process. If it is cracked or damaged, the helmet is done. So it
    really just depends on the helmet and the company as far as how
    long it is going to last and how well it is cared for.
        Senator Pryor. Dr. Kutcher, if I may ask one more question?
    Dr. Kutcher, what is the--and you maybe covered this earlier,
    and I am sorry I was late coming to the hearing--but what is
    the sort of age scale we are looking at for concussions in
    sports? I mean, I assume you have some at very early ages, but
    is there--do they get more common and more severe as you get
    older, as the players get bigger, stronger, faster? Is that how
    that works, or tell me what the statistics say.
        Dr. Kutcher. So the range goes down to the youngest athlete
    you could imagine, whenever they start playing organized
    sports. So 7, 8, 9 years old, I see kids with concussions that
    young.
        As they mature and get faster and stronger, you will see
    larger impacts and more injuries. I think as they go up, junior
    high, high school, you are going to see greater numbers of
    concussions. And actually, there is some data that shows that
    basically every level you go up from organized youth to high
    school, to college, to pros, the incidence will go up. And you
    can imagine why. Because the play is a little faster. Athletes
    are a little stronger.
        The other idea, though, is that the younger kids may have
    longer injuries. They may have more complex injuries, maybe
    more difficult to get them back as quick. So that sort of adds
    a different wrinkle to it.
        Senator Pryor. Mr. Chairman, if I can ask just one more
    question? Again, maybe you covered this earlier. But when I
    think of concussions and sports, I think of football, but I may
    be totally wrong on that. Is that the most common, and sort of
    what is the list of the most risky sports for concussion?
        Dr. Kutcher. I would say football is at the top of the
    list.
        Senator Pryor. It is way ahead of everybody else or----
        Dr. Kutcher. So, first, it is tough to get good data that
    compares sport to sport because you have to study it in the
    same population. There are some pretty good studies that have
    looked at in the high school population. For example, in
    Fairfax County, Virginia, researchers did some great work there
    looking at the different sports.
        And football had about a double the incidence of the next
    highest sport, which I believe was lacrosse. But women's soccer
    was right there. And then, after that, it was men's soccer,
    wrestling, basketball, softball, going down the list. Ice
    hockey wasn't in that study, but I would put ice hockey
    probably a little bit lower than football, maybe 20 percent
    lower than that in general.
        Senator Pryor. Thank you, Mr. Chairman.
        The Chairman. Thank you.
        We can start another round. Incidentally, every time the
    bell rings, what you have to understand is that is telling you
    precisely that there is nothing happening on the floor of the--
    --
        [Laughter.]
        The Chairman. It is only when it keeps ringing that we have
    to go vote.
        Ms. Ball, we are talking about soccer. And Mr. Threet, just
    like Tony Romo, you were slammed down to the ground. I mean,
    that is part of the deal, right? It is not just that you hit a
    helmet, but you slam the guy down. So his head has to hit the
    ground, which is often hard.
        There are so many ways in football to see how a revenge
    hit, just a mean player who is famous for that and loves it and
    gets endorsements because of it, commercial endorsements.
    Soccer is extremely brutal, exhausting, on a huge field where
    there is usually, what, one, two, three, or four goals scored,
    and that is it.
        So in thinking about it myself, and I have watched a lot of
    it basically because of that 1980 triumph, it is heading the
    ball. Or because I don't think that you probably are slammed
    down to the ground or tripped up, a lot of tripping up,
    deliberate tripping up. Does that mean the head hits? I don't
    know.
        But what are some of the ways, if it was ranked number
    three by Dr. Kutcher, what are some of the ways that
    concussions come about in soccer other than heading the ball?
    And if it is heading the ball, is it heading the ball from any
    part of your head?
        Ms. Ball. Concussions come about in a lot of different ways
    while playing soccer. Heading the ball tends to be relatively
    safe if you use your forehead. The concussions come when you
    take the ball off the top of your head, most likely from a punt
    because of the ball is moving at much greater speeds, or when a
    ball gets shot and you happen to be in the way, you will take
    it on the side of your head. That is how concussions can also
    occur.
        For me, the most common way of sustaining a concussion was
    actually I hit my head to the ground. It was the type of player
    I was. I would get my legs knocked out from underneath me, and
    I would hit my head on the ground. And when you watch soccer,
    you are watching where the ball is at.
        So that play might happen, and you just don't even see that
    that player goes down and hits their head. And so, that is why
    I think oftentimes those thoughts are bypassed is because you
    are not aware because you are following the ball, where that is
    going.
        And then another risky area is where you are going in
    confrontations against the goalie. The goalie is either going
    to get--I have seen goalies get their heads kicked, and I have
    also seen players going up against the goalie getting kneed in
    the head.
        And so, there are a lot of different circumstances that you
    can get a concussion.
        The Chairman. Like in hockey?
        Ms. Ball. Right.
        The Chairman. Yes. There is so much work to be done by so
    many. I think of--I am a sports fan. You know, you watch
    college and professional football, and there is almost an
    instinct to look, Mr. Threet, for the player who plays dirty.
    And then, if he does, you turn your wrath on Roger Goodell and
    the NFL for not having him ejected from the game. Referees have
    that responsibility. They can fine him or push him back 15
    yards. They should be ejected from the game.
        How do you influence--I mean, young men who play football
    are in it to win. They don't have long careers.
        Mr. Threet. Right.
        The Chairman. If you are a running back or if you are a
    quarterback, what is your career?
        Mr. Threet. Running back has the shortest, yes.
        The Chairman. Yes. So that adds sort of a desperation to
    succeed. How do you get at that stuff? I mean, somebody comes
    in and gives you a lecture, all the athletes are gathered in a
    big locker room, somebody gives them a lecture on concussions.
    I will bet half the people aren't listening because they
    haven't had them.
        Mr. Threet. Yes, and I think it is very difficult,
    especially in football, from the defensive side of the game,
    violence is probably the biggest, the biggest characteristic
    you need to be successful on defense. You have to be able to be
    violent, and that is----
        The Chairman. And known to be violent?
        Mr. Threet. Right. Yes, and that is part of--yes, exactly.
        The Chairman. You have to show your violence, right? You
    have to prove it?
        Mr. Threet. Right. Right. And that is part of the football
    game. And so, as far as that sport is considered, I feel like
    it is more of the understanding about brain injury and
    understanding of the recovery process, as opposed to, yes, you
    know, they are changing the game, getting rid of head-to-head
    contact and that aspect. But I think more of it is the recovery
    when it happens because there is always going to be big hits in
    football.
        The Chairman. And a lot of those big hits----
        Mr. Threet. And a lot of them are legal, too. But it is not
    just like the doctors have said. Exactly.
        The Chairman. Yes, a lot of them--if another, a third
    person involved clobbers the second or the first.
        Mr. Threet. Exactly. And it is blows to the body just as
    well as it is blows to the head, as Dr. Kutcher noted also. So
    I think it is----
        The Chairman. Oh, I mean, if you get clobbered in the chest
    or something, that can concuss you?
        Dr. Kutcher. Absolutely.
        The Chairman. I am sorry. I missed that.
        Dr. Kutcher. Yes. Anytime your head moves fast enough and
    the brain inside is moving fast enough. So you get a whiplash
    type of thing.
        The Chairman. What will do that?
        Dr. Kutcher. What is that?
        The Chairman. What kind of hit will do that?
        Dr. Kutcher. Hit to the body, hit from the side, anything
    that transmits enough force to stop your movement.
        The Chairman. So that means that quarterback and tight ends
    ought to be very, very large?
        Dr. Kutcher. Right. Steve gets sacked, gets hit in the
    chest and the body hard enough, his head whips back. He doesn't
    have to hit anything else, and that could do it.
        Mr. Oliver. Chairman Rockefeller, a perfect example of
    that, last year we all heard about DeSean Jackson's concussion
    playing in the game between the Atlanta Falcons and the
    Philadelphia Eagles, and I don't recall whether there was a
    fine or a penalty for that hit. But if you watch that hit in
    slow motion, and it is available I think even on the Internet,
    you will see that there was no head-to-head contact between the
    tackling player and DeSean Jackson.
        He was hit here in the shoulder. But it snapped his head
    violently forward and then violently backward as he is going
    down, and that is, I think, exactly the kind of mechanics that
    you are talking about. You have these concussions where you
    don't have a blow to the head, but the head itself is moving
    through so many different planes of motion so rapidly that the
    brain sort of doesn't have time to catch up to itself and sort
    of gets folded over and compressed.
        The Chairman. I am over my time once again. I thank
    everyone.
        I am going to have to leave. I have to go to a
    cybersecurity hearing. That is a different kind of threat, and
    Senator Udall is going to take over the hearing.
        But the Ranking Member? Oh, Senator Thune? He could have
    been a tight end.
        [Laughter.]
        The Chairman. Please?

                     STATEMENT OF HON. JOHN THUNE,
                     U.S. SENATOR FROM SOUTH DAKOTA

        Senator Thune. I am up?
        The Chairman. You are up.
        Senator Thune. Oh, OK. Thank you.
        Well, I appreciate that very much. Thanks for holding the
    hearing, and I thank our panelists for sharing your thoughts
    with us. And I kind of want to follow up on some of the line of
    questioning that was started earlier, but this is--you know,
    you are seeing participation at an all-time high in terms of
    kids, young people across the country participating in sports
    and an incredible number of sports-related injuries among
    youth.
        And sometimes they are head injuries, a lot of other
    injuries as well. And I think when most people think of
    concussions, as was mentioned, we think about football. I think
    there are lots of other sports where we are seeing that.
        We have got a lot of younger people participating in
    football, for example, and I know my--I have got an 11-year-old
    nephew who got a concussion. He is out for a month. And it was
    a hit where he went back and hit his head on the ground.
        But it just seems like we have got, with young people out
    there, more and more injury occurring at an earlier and earlier
    age. And my question relates to whether that is something that
    we should be concerned about? I mean, are we starting kids too
    early in sports like football, where they are experiencing
    concussions at higher rates than they have in the past?
        I mean, what is your perspective on the rise in the number
    of concussions? And I guess--are some of these kids developed
    enough, capable enough of taking the kind of shots that they
    are taking and the kind of hits that they are taking at that
    age and the types of injuries that they are sustaining at an
    earlier and earlier age?
        Dr. Kutcher. I will start. I think concussions--the issue
    with concussions being up, we are seeing more of them. I think
    it really has three main causes. The biggest one is awareness.
    I think that would explain the vast majority of the increased
    numbers that we see over the past really 5 to 6 years.
        The second one would be kids being faster and stronger at
    earlier ages and playing perhaps more violently, but also our
    games have changed, too. If you look at how football has
    evolved, for example. I had one of our ex-coaches, old-time
    coach, lecture me on how people have been blocking over the
    years and tackling over the years, and now we see a lot more
    hitting and a lot less tackling.
        When actually if you think about the point in football on
    the defensive side is to stop the ball, you do a much better
    job if you have got somebody up, bring him to the ground,
    rather than trying to launch yourself and cause this big,
    violent hit. And so, for those three reasons, I think the
    numbers are up.
        As far as concussions in the younger ages, I think there is
    always a sense for me that we have to keep track of the dose of
    hits that the kids are taking. I think the younger ages, yes,
    you want to be more careful. And do we want to postpone when
    you can hit in hockey, postpone when people can start wearing
    pads and playing tackle football?
        I think that is a very good idea, but it is more
    complicated than that because at some point, kids have to learn
    how to hit and how to be hit and how to avoid the big forces,
    and that can only come with practice. So it is a pretty
    complicated question there.
        Senator Thune. Well, I think that, you know, I look at the
    advances in equipment--just my dad played football back in the
    late 1930s. He was a senior in high school in 1937. I remember
    at that time, they had leather helmets, and he was 130 pounds.
    He played middle linebacker, and he was hitting a lot of guys
    coming across. And I know he got knocked out, got knocked cold
    in one game. And I think at that time, they treated everything
    with whiskey.
        But when I played in the 1970s, the helmets had gotten a
    lot better, and I look at the athletes today, and the equipment
    has improved a lot. I mean, the amount of padding in there,
    protective gear that athletes are able to wear. And so, we have
    made great advancements.
        But as you have said, these athletes are bigger, stronger,
    faster, and the contact, the hits that I watch just every
    Sunday watching the NFL, there are some real contact being made
    there. And so, you wonder if the type of equipment that we have
    is adequate to that.
        And that, specifically, might be more to football, but I am
    interested in knowing, too, in some of these other sports like
    soccer or rugby, water polo, that haven't traditionally
    required a great deal of safety gear, is there additional
    equipment available that could lessen injuries and concussions
    in those types of sports? Anybody on the panel who would care
    to answer that?
        Mr. Oliver. Well, I mean, I can address that in general.
    Whatever you can do to reduce the severity of concussions or
    the frequency or perhaps even eliminate some concussions in one
    sport would be the same in the other. I mean, you are talking
    about the same brain responses, the same input forces, the same
    accelerations.
        And if you can determine how that can be done from a
    biomechanical standpoint and a biophysical standpoint in
    football, you can probably figure out how to do that in other
    sports. So I think the key is first finding those answers that
    would let you to address it in a particular sport, and then you
    can extend those by reference to other sports, if you can get
    to that point.
        Senator Thune. Anybody else want to add to that, soccer
    player, no?
        OK. I see my time has expired, Mr. Chairman. So thank you.
        Senator Udall [presiding]. Thank you, Senator Thune.
        And Senator Boozman, you want to----
        Senator Boozman. Just very quickly.
        Senator Udall. Yes, you have some things that----
        Senator Boozman. It seems that 99.9 percent of the injuries
    that are suffered are not due to current equipment failure. You
    guys, when you were hurt, your pads were there. Something
    didn't break and sustain. Now I don't know about through the
    little leagues, but in the stuff that is being tested, most of
    that is working pretty well.
        I don't worry so much about the big hits that we see where
    somebody is actually having to be helped off the field because
    we all know something is wrong. I worry more about the injury
    where you tackle somebody, and as you tackle them, he knees you
    in the face and smacks you pretty good. And you are able to get
    up.
        We are conditioned or you guys were conditioned, we were
    all conditioned to play through injury, and you go ahead and
    stay out there. The way I would like to close, as we have a lot
    of moms and dads and coaches and players watching this is with
    any messages that you can send out to the parents, how they can
    be better prepared to deal with this if it does come up? And
    chances are, it probably will.
        Mr. Threet. Yes. Well, I mean, I think from the athletes'
    standpoint, just increasing their ability to be honest with
    coaches and parents and athletic trainers and understanding for
    themselves when something doesn't feel right. Light-headedness,
    dizziness, any of the symptoms. If the symptoms are known and
    they start feeling those, then it needs to be required that
    they make that known because it can happen on any hit.
        I have had ones that happened on not severe hits, and the
    Riddell helmet is 30 percent less.
        Ms. Ball. I think it is important not only to address your
    symptoms when you have them, but even once you finish having
    the symptoms is give yourself the little bit of extra time
    because that can prevent you from maybe not having to end your
    career is if you give yourself those few extra days of leeway,
    then you can prevent the long-term injury.
        Dr. Kutcher. I will add to that. I think the recognition of
    the injury issue is huge, and athletes hide their injuries. I
    know that. I see that every day. But acutely concussed people
    also don't know they are concussed often. They are not aware of
    it.
        And what that means is that falls on the responsibility of
    everybody else around--their teammates, the coaches, parents,
    whoever--to look after them. And when a kid says, ``Oh, I am
    fine. I am straight. I can go,'' you have to question that a
    little bit. So recognizing the injury, and I am actually
    starting to see teammates coming to me and saying, ``Hey, I
    think he is not right. Go check him out.''
        And as Steve said, once it has been recognized, you have to
    report that to the medical staff, to whoever, and have that
    patient or that athlete removed from participation and then
    allow them to recover fully before they get back to play. So,
    actually, it is four Rs. It is recognition, reporting,
    removing, and recovering.
        Senator Boozman. Very good. Dr. McKee?
        Dr. McKee. I guess what I would say is that I don't see
    this--I think I would say that I don't see this problem going
    away with equipment. I think equipment is going to improve this
    issue, but it is not going to solve this issue.
        And we really have to address the way sports are played,
    the nature, the style of play, the amount of hitting that we
    allow, the amount of contact we allow in the play of the sport.
    And that is what is going to make a tremendous difference, I
    think, down the road. But I don't see, even a perfect helmet,
    there is always going to be those acceleration, deceleration
    sort of whiplash forces that we can't control.
        Senator Boozman. Mr. Oliver?
        Mr. Oliver. I think I would simply echo the panel's
    comments. There are a number of interventions that need to be
    enforced and encouraged. And depending on the circumstances,
    one may be more important than another. But overall, you can't
    avoid any of them. And to the extent that you shouldn't just
    rely on better diagnosis and return to play criteria, you also
    can't rely on just having good equipment. You have to do all of
    those things.
        You have to change the attitudes of the players and the
    parents about reporting those symptoms. Take that stigma away
    from this need to be macho or strong or invincible.
        One of the things that I have seen, and it has been
    effective, is changing behavior based upon some of the data
    that has been collected at the collegiate level through the
    helmet instrumentation. They have noticed the ability to
    identify players who have more hits on the top or the crown of
    their helmet than other players, which shouldn't be happening
    because there is an association with an increased likelihood of
    concussion there.
        We see schools, I know University of North Carolina
    specifically, with Dr. Guskiewicz, identifying those players
    and going in and engaging in behavioral modification so that
    they are taking that act out of the game.
        If you start that at the very beginning with youth players
    and teach those coaches and teach those players that you don't
    hit with the top of your head, you don't hit with your head at
    all. The helmet is there to protect you in case you get hit,
    and you can't avoid it. You change all those things, I think
    you make significant reductions in the number of concussions
    and the severity.
        And you certainly can reduce the chance of having these
    catastrophic consequences of returning to play too soon or
    having multiple concussions that aren't properly treated that
    let you heal. So all of them are important, and I don't think
    you can ignore one or treat one as more important than the
    other.
        Senator Boozman. Thank you, Mr. Chairman.
        Senator Udall. Thank you, Senator Boozman.
        I wanted to return just a little bit to some of the
    misleading claims on equipment. I know there has been a lot of
    discussion about equipment, and Dr. McKee, talk a little bit
    about anti-concussion mouth guards. Have you seen ads such as
    this one for a mouth guard that is sold for use by kids 11
    years and under?
        And you can see the poster here in the background. This
    mouth guard was purchased last month. The product packaging
    states this mouth guard reduces the risk of concussions, and it
    creates brain safety space. Given your firsthand knowledge of
    the dangers of repetitive brain trauma, are you troubled by
    this type of marketing for youth sports equipment? Do you think
    young athletes who have already had a concussion might be
    particularly susceptible to advertising claims for so-called
    anti-concussion devices?
        [An image of the poster follows:]

        Dr. McKee. Well, I believe there is no clear evidence that
    any mouth guard or chin guard reduces either the rate or the
    severity of concussions. So I would have great objection to
    this claim.
        The only thing that I am aware that mouth guards and chin
    guards do is they reduce oral and facial, dental, dental
    injuries. But the nature of concussion would not be improved by
    the use of a mouth guard.
        Senator Udall. I know you weren't able to see the one I was
    holding up, and I think it has been produced down there just in
    case you see anything else on it you wanted to comment on.
        Dr. Kutcher. I agree on that.
        Senator Udall. Yes, please?
        Dr. Kutcher. I don't know what ``brain safety space''
    really means. That term--that is little alarming, really.
        Senator Udall. Well, there is a diagram on it.
        Dr. Kutcher. Yes, I see it.
        Senator Udall. You can see it. There is a diagram, and it
    shows a space, and it says ``creates brain''--I believe
    specifically it says, ``creates''--what is the term it uses?
    ``Creates brain safety space.''
        Dr. Kutcher. Again, the idea from some of the work that has
    been done with accelerometers and helmets of football players
    and seeing at what forces they end up having clinically
    diagnosed concussions, those concussions are occurring over a
    wide range of forces.
        There are 15-g hits that do it. There are 115-g hits that
    don't, right? And so, if you are taking amount of force that is
    115 and you are reducing it to 110 or so--I don't want to get
    the numbers wrong--because of a mouth guard, you might be
    reducing the forces a little bit if the hit is coming from this
    way, but concussions are occurring on a spectrum of forces that
    that won't address.
        Senator Udall. I know Ms. Ball mentioned headbands in
    soccer, and I want to ask, Dr. Kutcher, you about this one. You
    discuss in your testimony the potential harm from creating a
    false sense of security when companies falsely claim that
    products prevent concussions.
        This is not just about helmets, and it is not just about
    football. Here is another example. This is a protective
    headband sold to soccer players and other athletes. Here is an
    image taken from this company's website that says, ``This can
    come between you and a head injury.''

        Does this type of advertising for a protective headband
    trouble you? Is there a danger that a young athlete might put
    himself or herself at greater risk of injury if they believe
    that this headband will come between them and a head injury?
        Dr. Kutcher. I do believe there is a problem there. This
    type of advertising is a little more vague because it just
    mentions head injury and not concussion. So you could make an
    argument that perhaps there is a mechanism there to prevent
    some superficial lacerations and bruising and that kind of a
    thing. But for concussion, I don't believe that--well, there is
    no data that supports that they decrease the risk of
    concussion.
        I have seen in my own practice, as I testified, athletes
    who have become more aggressive and have actually injured
    themselves and others because they have the headband on. They
    go up and they head the ball more. They get involved in head-
    to-head hits more when they would not have done that without
    the equipment before.
        Mr. Oliver. Senator?
        Senator Udall. Yes, please, go ahead.
        Mr. Oliver. What I was going to say is there is another
    risk here. We have seen this both with helmets as well as
    devices like headbands that a player who has sustained a
    concussion now sees this or the parent sees this as the answer.
    My kid has had a concussion. He is just now getting over it.
    But if I put this on, everything is fine.
        And so, not only a false sense of security from being
    protected from the first concussion, but being protected
    because I just had one, and this will give me this extra layer.
    And it is incredibly dangerous.
        Senator Udall. Did either of you as athletes experience any
    of this that we are talking about here in terms of the headband
    being protective or--yes, Ms. Ball?
        Ms. Ball. I wore headgear that is not this brand, but
    similar after I got my second concussion as a preventive
    measure. And I will say that I did adjust my play, whether I
    had my headgear on or off.
        And I didn't really think about it critically, whether it
    would be actually doing anything for me. If I had my headgear
    on, I would head the ball more aggressively. I would play
    differently because I thought for some reason, I would like be
    secure from getting another concussion. And if I didn't have my
    headgear on, I played much differently.
        Senator Udall. Mr. Threet?
        Mr. Threet. For me, I used a variety of different football
    helmets. I would always get a new one after a concussion. I
    would alternate brands, styles. Yes, so I would try different
    things, but they all--I guess the risk is still there.
        Dr. Kutcher. And that is really common, by the way, to
    college football or football in general. You get a concussion,
    go on to the next brand because, obviously, that brand is not
    the right one for you.
        Right? That is----
        Mr. Threet. Yes. I mean, that is the equipment managers
    would say that, well, maybe just try a different style and be
    better next time.
        Senator Udall. Let me return to the Riddell helmet
    testimonial claim, the one on no repeated concussions. In a
    July 23, 2010, memorandum to head coaches, head athletic
    trainers, and club equipment managers, NFL Commissioner Roger
    Goodell wrote, and this is a quote, ``It is important to
    remember that no helmet can prevent concussions or reduce the
    risk of concussion to any specified degree.''
        Yet one NFL head athletic trainer has made several product
    endorsements for the Riddell Revolution football helmet. And a
    Riddell video news release, titled ``Riddell Revolution UPMC
    Media Campaign,'' highlights Tim Bream of the Chicago Bears,
    states that, ``We have had some players who have had ongoing
    problems with head injury, and we made the switch to the new
    protective headgear when it came out at its inception, and
    these players have had no problems since then or no repeated
    concussions.''
        Dr. Kutcher, do you expect a youth or high school football
    team to have no repeated concussions after switching from
    traditional helmet designs to Riddell Revolution helmets?
        Dr. Kutcher. No, I don't.
        Senator Udall. Pretty straightforward in your opinion.
        Dr. Kutcher. Yes.
        Senator Udall. Dr. McKee, I don't know if you have any
    thoughts?
        Dr. McKee. I think this is beyond my level of expertise. It
    is not my area.
        Senator Udall. And Mr. Oliver, I want to ask about the
    maximum life span of football helmets. I think you talked about
    that a little bit in relation to Senator Pryor questioning you.
    The National Athletic Equipment Reconditioners Association
    announced that starting next year, it will no longer
    recondition helmets that are 10 years or older.
        NAERA executive director stated that he would not want his
    son wearing a helmet that old. NOCSAE's technical director Dave
    Halstead told the New York Times that he, and this is his
    quote, ``would never let his kid wear a helmet that is more
    than 10 years old.''
        Well, Ralph Conradt's 17-year-old son Max was unknowingly
    wearing a 20-year-old football helmet when he suffered a brain
    injury. Ralph wrote to me. It was after some of this came out.
    ``How is it possible that our son was issued a helmet 3 years
    older than he was?'' Why does the NOCSAE standard not set a
    maximum life span or number of years before a helmet should no
    longer be used?
        Mr. Oliver. There are a number of reasons why we don't, and
    the first reason is you have to tell me what the helmet is you
    are looking at. If it is a 10-year-old helmet that has never
    been used or has been used two seasons, should that helmet be
    replaced simply because it has reached a birth date of 10
    years?
        There is no data that suggests that that helmet, because it
    has reached an age of 10 years, is more or less protective than
    any other helmets that are of a similar age. The other thing
    has to do with whether or not you are using a 10-year life or a
    12-year life or an 8-year life because there has been a change
    in technology.
        If 10 years ago or 9 years there was a radical change in
    the technology of helmets such that older helmets don't provide
    the same measurable level of protection, then it would make
    sense to have that life span cutoff. We have always relied on
    the manufacturers to specify if there is a safe life on their
    helmets.
        And one of the reasons we do that is because we, by intent,
    maintain our standards as design neutral. Part of the design
    neutral process is to not impose upon a manufacturer an
    obligation to use a particular kind of material or a particular
    shape of the shell or a particular design to allow innovation
    and progress in those areas.
        If a helmet company makes a helmet and they say this helmet
    is good for 15 years as long as it is regularly reconditioned
    and recertified, then they must have data to support that, and
    it is their helmet, their design. What we do know, and we know
    this from reconditioning testing data, that helmets that are
    properly cared for--they are properly reconditioned. Their
    padding is replaced when it starts to wear. They are inspected
    for cracks, and they are properly cared for.
        When they are retested after being used in the field and
    after being reconditioned, those test numbers look very much
    like they did when that helmet was brand new. No way for us as
    an association or as an organization that sets the standards to
    say from our tests that a helmet that is now 8 years old or 10
    years old that scores essentially the same as it did when it
    was new should be replaced and force schools, for example, to
    replace maybe a third or half of their helmets, when maybe the
    helmets don't need to be replaced.
        And the other question that you have to ask yourself is,
    right now, there are Revolution helmets on the market that are
    approaching 8 years old. And I am not endorsing any particular
    helmet. But there has been a great cry, if you will, to move
    from older style helmets to newer style helmets.
        If there is a helmet on the market today or being used
    today that is 8 years old and it is a new technology helmet,
    and it has been properly cared for, padding replaced, and
    retested on an annual basis, what is it that happens at 10
    years that makes that helmet suddenly need to be thrown away if
    it was safe at 9 years or safe at 8 years? And we don't have
    the data to suggest that.
        I think the position, the decision that NAERA made with
    regard to 10-year helmets was a policy decision they made that
    they just weren't going to do that for helmets older than 10
    years. And I know they see some helmets that are 15 and 20
    years old.
        Senator Udall. Does NOCSAE require the helmets have a
    clearly visible date of manufacture and a date of last
    reconditioning label?
        Mr. Oliver. We do. We require both of those things.
        Senator Udall. And do you know how many high school or
    younger football players are wearing helmets that are 10 years
    or more in age?
        Mr. Oliver. We don't know specifically. What we know is
    from the data for helmets that come back in for reconditioning
    because we get that test data back at the end of each season.
    And we know that sample, and this is a ballpark figure. But
    approximately 89 to 92 percent of those helmets are less than
    10 years of age.
        Again, it is going to vary year to year, but that is the
    best we can come up with.
        Senator Udall. And do those helmets 10 years and older
    still meet NOCSAE current helmet standards?
        Mr. Oliver. They will if they have been through the proper
    program and have been properly reconditioned and had the
    padding replaced. They will. If they don't, they get failed,
    and they won't make it through the reconditioning process.
        Senator Udall. Yes. There is--I am shifting the issue a
    little bit here to supplements, and I think both of our
    physicians realize there has been a lot of evidence recently on
    supplements. And this has kind of surprised me.
        There is a company selling supplements which claims that
    they ``protect against concussions.'' It is called Sports Brain
    Guard. What are your thoughts on these claims about supplements
    and concussions?
        [The information referred to follows:]

        And I am going to send one of these down to you, but it is
    a dietary supplement that is called Brain Guard. Do you have
    any thoughts on that?
        Dr. Kutcher. I do. What are the components of Brain Guard?
    Is that the DHA, one of the DHA products, I imagine? Much like
    the other discussions we have had, there is no data that this
    type of thing will help prevent concussion at all really.
        And I just kind of go back to a conversation we had earlier
    in the hearing about the amount of time and money that has gone
    into neuroprotective agents for things like stroke. I mean,
    decades and decades and billions of dollars, and we haven't
    found anything for a mechanism that we know much more about,
    cell death and stroke. We know that. We know how that works at
    the molecular level a lot more than concussion anyway.
        And yet we don't have any answer there. So I don't see any
    data that would support the use of this, nor would I expect
    that we would be able to find any.
        Senator Udall. Let me just briefly just say in closing,
    first of all, thank you to the entire panel. I think your
    testimony has been very, very helpful, and I think parents and
    families out there are increasingly wanting to hear more about
    this, and I think the way you have engaged this today helps
    them a lot.
        I think this issue of awareness, I think all of you have
    talked about raising the awareness level, and we need more
    education, and we need to start younger. And those are very,
    very important points.
        And then the second, which you can see that I am passionate
    about, is this whole idea about misleading claims when it comes
    to equipment. It just seems to me that there is so much work
    that we need to do there to educate people. And people need to
    realize the old statement that is always used, ``Buyer
    beware.'' I mean, you need to check out when you have one of
    these products, whether it is supplements or whether it is a
    mouth guard or a headband, you really need to look a little
    deeper than the advertising there.
        So let me thank you again, and the hearing is adjourned.
        [Whereupon, at 4:39 p.m., the hearing was adjourned.]
                                A P P E N D I X

                Prepared Statement of Hon. Frank R. Lautenberg,
                          U.S. Senator from New Jersey

        No parent should ever have to fear for their child's life when they
    play sports. Minor injuries are always a risk, but no young athlete
    should ever walk off the field with life-threatening brain trauma. All
    it takes is one serious injury to keep a young person on life's
    sidelines forever.
        In 2009 alone, almost 250,000 people aged 19 and younger ended up
    in an emergency room with traumatic brain injuries they suffered while
    playing sports. These injuries affect girls and boys alike. Girls
    soccer and boys football are the sports where most concussions occur
    among high school students.
        This is a problem in college sports, too. In my state, Eric
    LeGrand--a Rutgers University football player--was paralyzed from the
    neck down during a game a year ago. Mr. LeGrand is improving, but his
    story reminds us we have a lot of work to do to make sports safer for
    all athletes.
        I am working with Senator Tom Udall to strengthen safety standards
    for helmets. Parents are increasingly aware of the danger of
    concussions, and they deserve safe helmets that will protect their
    children from injury. Our bill will also make it a crime for helmet
    makers to make false or misleading claims about safety benefits.
        Parents need the straight truth about helmets--not exaggerated
    claims that lull them into a false sense of security. I look forward to
    working with my colleagues to pass this bill and help parents, schools
    and helmet makers work together to protect our children.
        I thank the Chairman for holding this important hearing.
                                     ______

                    Prepared Statement of Hon. Mark Warner,
                           U.S. Senator from Virginia

        Thank you, Chairman Rockefeller, for calling this hearing. I'd also
    like to thank my colleague, Senator Tom Udall, who has been a leader in
    highlighting this important issue for our country's student and
    professional athletes. Understanding the dangerous nature of
    concussions, better educating parents, coaches, trainers, and the
    athletes themselves on the symptoms and the precautions to avoid
    concussions, is critically important. Ensuring that all parties have
    the best, scientifically accurate information also is an important step
    in both the education and precaution of all of those involved.
        I am fortunate to represent Virginia Polytechnic Institute and
    State University, Virginia Tech, located in Blacksburg, VA, which is
    home to both the four-time ACC championship team and a group of
    researchers who are doing groundbreaking research into understanding
    how different helmet construction can impact the severity of the impact
    of concussions. Led by Steven Rowson and Stefan Duma, Virginia Tech and
    Wake Forest researchers have developed a five-star rating system to
    better evaluate helmet performance for football players. Similar to the
    current star-rating systems for cars, the National Impact Database will
    provide better clarity on the construction of helmets and how that may
    impact exposure and risk of concussion. The database's first analysis
    of 10 adult helmets was published in May of this year, and it was first
    time researchers have provided the public with a bioengineering impact
    data study with comparative test results. The rating system was funded
    in part by the National Institutes of Health and the Department of
    Transportation, and this research is independent of helmet
    manufacturers.
        This research indicates that current helmet performance is not
    directly related to cost. The database can now help consumers make
    better informed decisions based on independent data that compares the
    biomechanical performance of these helmets. I hope the star-ratings may
    also help push manufacturers to come up with better designs. The
    researchers do note, and I believe appropriately, that no helmet can
    provide full protection against concussions. There is considerable
    chance involved in head injuries in football and other sports, and what
    advanced-design helmets can do is lower the risk. However, transparency
    and information certainly can help consumers, players, coaches and
    trainers make better-informed decisions.
        I understand there have been concerns that some manufacturers have
    inappropriately marketed sports equipment, including helmets, by
    overstating the protections they provide. I share that concern, and I
    believe we must educate players, parents, coaches and trainers on the
    dangers of concussion and other injuries regardless of the equipment
    used. I look forward to working with the members of this Committee to
    ensure that there is minimal confusion in the marketplace over what it
    is that sports equipment can do. Helmets and other sports equipment
    provide one layer of protection, and it certainly does not eliminate
    the need for more awareness and public education about ways we might
    prevent and better manage concussions during sports activity.
        I do, however, continue to strongly support continued research,
    based on sound science that helps us to help better understand how we
    can keep our young people safer while competing in sports activity.
    This includes--but it certainly is not limited to--the groundbreaking
    research on concussions that is currently going on at Virginia Tech.
        I thank the Committee for holding a hearing on this important topic
    and stand ready to work with the Committee on possible solutions as we
    move forward. Thank you.
                                     ______

     Prepared Statement of Sporting Goods Manufacturers Association (SGMA)

        The Sporting Goods Manufacturers Association (SGMA) appreciates
    this opportunity to submit a statement for the record of this important
    hearing. We regret not being able to be represented in person but could
    not accommodate the hearing schedule due to a long-planned Board of
    Directors meeting in Chicago.
        SGMA is the national trade association of sports footwear, apparel,
    equipment and accessories manufacturers, distributors and marketers.
    Our membership consists of hundreds of brands which produce and sell
    sports products in the United States and around the world. SGMA
    believes sports and physical activity enhance people's lives. Our
    industry's products make sports, fitness, recreation and exercise
    accessible, enjoyable, fulfilling and healthy for millions of Americans
    every day. Our member companies are proud of the role they play in
    supporting healthy, active lifestyles for all.
        The primary business for many SGMA member companies focuses on
    designing, building, selling and maintaining protective sports
    equipment. We all recognize that participation in sports activities
    carries some risk of injury. While our products are designed to reduce
    that risk, no protective equipment can completely eliminate the risk.
    No helmet, regardless of design, material construction or technology
    can prevent all concussions or for that matter, all injury. With that
    realization, our companies strive through research, innovation,
    testing, refinement and consumer education to deliver products with
    improved protective qualities and properties, thereby enhancing the
    sport experience for the participant.
        From its very inception, SGMA has been a leader in bringing the
    industry together to face challenges around reducing risk of injury.
    When SGMA was founded in 1906, national concern over football related
    injuries dominated the sports landscape. SGMA's original member
    companies banded together and joined forces with the newly formed
    National Collegiate Athletic Association (NCAA) to change the way
    football was played. Among the major rule changes implemented at that
    time were the prohibition of the Flying Wedge blocking technique and
    re-design of additionally protective football pants, rule changes that
    brought virtually immediate reduction in football injuries. The
    complementary nature of problem identification, rules modification,
    product innovation and culture change is a recurring theme in
    successful action to reduce sports injury, and one that bears
    thoughtful analysis as we address the urgent need to comprehensively
    address concussions in sport. Our experience tells us reducing sports
    injury requires a multi-disciplinary approach that engages the views
    and expertise of athletes, parents, coaches, trainers, sports league
    administrators, medical professionals, rules makers, standards setting
    bodies, scientific investigators, product developers and marketers, and
    the media.
        In 1931, the industry adopted 11 Trade Practice Rules, '' to
    provide new standards of competition, and . . . to abandon all that is
    unfair to the public and to one another.'' One of those Trade Practice
    Rules was ``to work closely with various governing bodies to assure
    standardization of equipment specifications.'' This statement
    foreshadowed the need for an independent, science-based standards-
    setting organization, a subject we will revisit later in this testimony
    when discussing the National Operating Committee for Standards in
    Athletic Equipment (NOCSAE).
        That same year, legendary Notre Dame Football coach Knute Rockne
    said of the SGMA membership: ``I want to compliment the sporting goods
    manufacturers on the fine protective measures they have given football.
    Despite the much larger number of football players, there are fewer
    injuries now than in the past. The biggest factor in reducing the
    number of injuries has been the added protection which has been built
    into football equipment. Your industry is a fine asset to college
    athletics. You are making equipment right.''
        A few years later in 1934, SGMA founded its educational and
    instructional arm known as The Athletic Institute, which evolved for a
    time into a world leader in the production of educational books, films,
    and videos. One of the goals of The Athletic Institute was ``to develop
    educational/training aids for athletes and coaches.'' For many years,
    SGMA and The Athletic Institute produced and distributed more sports
    instructional materials than virtually anyone in the United States.
    While SGMA is no longer in the training video business, we do believe
    tremendous progress in reducing risk of sports injury is attainable by
    utilizing new media capabilities to teach coaches, players and parents
    about proper technique. USA Football, the national governing body for
    youth football, has created an impressive on-line program that provides
    specific guidance on teaching age and size appropriate blocking and
    tackling technique. Pop Warner also has an excellent coaching education
    program. These are the basic cornerstones of reducing risk of injury.
    Matched with the NFL's concerted effort to reduce and ban head to head
    contact, sustainable cultural change is happening across the football
    community.
        The sports products industry absolutely has a role to play here. It
    starts with product design and innovation. Helmet technology is
    steadily improving. Our companies invest heavily in research and
    development exploring new materials, design, construction, and
    durability. They explore performance and protective qualities at
    extreme temperatures and repeated use, direct impacts and glancing
    blows, linear and rotational forces. Currently, a tremendous effort is
    being directed at managing energy from low impacts, reflecting the
    possibility that concussions may be generated from lower energy forces
    than have traditionally been the focus of helmet design.
        Football helmet manufacturers study videotapes of actual impacts to
    analyze and develop responses to concussive impacts. New technologies
    are being developed and implemented that measure in real time the
    nature and severity of impacts players receive on the field. There are
    several schools that currently employ this technology in their helmets,
    with immediate data being transmitted to sideline computers for trained
    professionals to monitor.
        These innovations are not limited to football. Technology transfers
    amongst lacrosse, baseball and hockey head protection are raising
    quality of protective products in these sports as well.
        The marketplace is vibrant. Two manufacturing brands have entered
    the football helmet business in recent years. Both have created
    excitement and awareness for their product, giving consumers additional
    choices of head protection.
        A reflection of the product improvements generated by the overall
    football helmet industry may be found in a recently published paper
    from Virginia Tech University's Dr. Stefan Duma. While SGMA is not in a
    position to speak to Dr. Duma's ranking of different helmet models, Dr.
    Duma's broad conclusion merits mention. Dr. Duma stated, ``The results
    clearly show that the newer technologies across all manufacturers are
    significantly better at reducing the risk of concussions compared to
    older models.''
        In addition to creating innovative products, the sports equipment
    industry can help leverage our connection to players and parents to
    communicate critically important pieces of information. One area the
    football helmet industry is exploring today centers on the appropriate
    fitting of a football helmet. Regardless of brand or model, one of the
    most important factors in the effectiveness of a football helmet is
    that it is correctly fitted to the player's head. Correct fitting is
    fundamental to ensuring the protective properties of a helmet are
    maintained. All football helmets are designed to fit snugly, they
    should never come off in normal course of play. Yet, on any given
    Saturday or Sunday in the fall, television images of helmets flying off
    players heads are far too common. Our industry is exploring ways to
    work together in educating coaches, league administrators, parents,
    equipment managers--anyone responsible for providing helmets to
    players--on how to ensure the helmet is properly fitted.
        Further to the point of education, the football helmet industry is
    in early stages of discussing if there is a way to improve warnings--
    messages to consumers as to what the product can do, and perhaps as
    important, what the product cannot do. Of course, all sports protective
    products currently carry warnings. The industry, in consultation with
    many partners and interested parties, is exploring whether standardized
    language, graphics and placement would improve the clarity of the
    message to the consumer.
        Recognizing so much that can and should be done to address
    concussions, it's important also to note some of the significant and
    specific challenges we face in developing a successful integrated
    approach to reducing incidence of concussions in sport. Most vexing is
    that scientific consensus of what is a concussion and what causes
    concussions is evolving. Clearly, the medical and scientific community
    has gained a better understanding of the symptoms, proper precautions,
    cumulative impact and long term effect of concussions. The ``Return to
    Play'' protocols being enacted around the country are a great response
    certain to improve player health. These new understandings have led to
    new helmet technology and innovation, but the direct effects of low
    force impacts and their causal relation to concussive events remain
    unclear. Influences such as ambient temperature and hydration levels of
    players may be important, along with ``g'' forces and direction of
    impact. Simply put, more research is needed. Products innovations will
    continue based on available data, but helmet manufacturers need more
    conclusive data.
        The issue of a special performance standard for youth football
    helmets arises here. At one level, it may be intuitive that a specific
    standard for youth helmets is required. However, many in the scientific
    and helmet research community have raised concerns that creating a new
    standard without understanding the risks of unintended consequences is
    bad policy. Again, lack of scientific consensus raises a red flag for
    some. SGMA members welcome the call for additional dedicated research
    on this specific question, as soon as possible.
        The National Operating Committee on Standards for Athletic
    Equipment (NOCSAE) is the primary standards-setting body for sports
    equipment in the United States. Product performance standards are
    created and managed by NOCSAE, along with test protocols to ensure
    product integrity. The 20-member Board of Directors oversees NOCSAE
    operations. SGMA sits on the Board, along with representatives of the
    American College Health Association, American College of Sports
    Medicine, American Orthopedic Society for Sports Medicine, American
    Football Coaches Association, and the American Medical Society for
    Sports Medicine, amongst others. The organization is independent and
    science-based. NOCSAE ensures the sports products industry is regulated
    and monitored. SGMA believes NOCSAE has been effective in establishing,
    promulgating and enacting strong voluntary standards, with demonstrable
    results.
        Since the advent of the NOCSAE football helmet standard,
    catastrophic head injuries in the sport have declined by 85.5 percent.
    It is important to note this reduction was accomplished during a period
    when the number of athletes playing football more than tripled and the
    size, strength and speed of the players increased exponentially. It's
    penetration of the football helmet market, for example, is total. SGMA
    believes that virtually no helmet sold in the U.S. marketplace fails to
    meet the NOCSAE Standard.
        The chart below highlights the impact the NOCSAE standard has had
    on catastrophic football injuries since it was introduced.

        NOCSAE Football Helmet Standard published 1973. Reconditioner's
    Standard Revised to NOCSAE standard, 1977.
        Source: Football Fatalities and Catastrophic Injuries 1931--2008.
    Dr. Fredrick Mueller and Dr. Robert Cantu, Carolina Academic Press.

        The NOCSAE football helmet standard has been modified more than 20
    times since it was created in 1973. The NOCSAE Scientific Advisory
    Committee consists of many of the country's leading researchers on
    helmet protection and neuroscience. They have a primary responsibility
    for recommending changes to the standard. Unfortunately, the science of
    preventing concussions is limited. The science of severity of
    concussions is constantly changing. The industry believes NOCSAE has
    brought together the best thinking on the prevention of sport
    concussions in the NOCSAE Scientific Advisory Committee to formulate
    leading edge approaches to concussion management. NOCSAE has made, and
    continues to make, substantial grants to these and other researchers to
    do concussion-related research. SGMA and its members support this use
    of NOCSAE funds.
        Though we have focused much of this statement on football-related
    matters, it is important to note that concussions are not limited to
    football, and a variety of protective products are being created to
    offer protection across many sports. Mouthguards have evolved from a
    simple piece of plastic to a more malleable product intended to better
    absorb the shock from a blow to the chin, knee braces are more common
    now due to lighter and stronger materials, eyewear is required in field
    hockey and girls' lacrosse and the use of face-masks for fielders in
    fast-pitch softball has increased. The growing use of these products is
    evidence of the sports equipment's industry's commitment to reducing
    injuries in sports. Although participating in sports comes with the
    inherent risk of potential injury, equipment manufacturers and
    governing bodies work hard to reduce injuries through innovations in
    protective equipment and rules changes to better protect players.
        In closing, the industry is aware of the need to work aggressively
    to address concussions in sports. We also know, until there is more
    definitive medical science, there is a limit in what a helmet can do to
    eliminate concussions in sports. Until there is a consensus in
    concussion science, the helmet industry is taking a multidisciplinary
    approach working with trainers to insure equipment is fit correctly,
    sport governing bodies to create rules for protecting players from
    unnecessary helmet to helmet contact and working with coaches to adopt
    proper sport play techniques changing the current football culture to
    understand the seriousness of the concussion issue. Through NOCSAE, the
    industry is working with the Center for Disease Control providing
    educational materials to consumers, helping them understand and
    evaluate the concussion risk in sports.
        Thank you.
                                     ______

                    Prepared Statement of Scott Hallenbeck,
                        Executive Director, USA Football
        Chairman Rockefeller and Members of the Committee:

        My name is Scott Hallenbeck. I am the executive director of USA
    Football, the sport's national governing body in the United States.
        Approximately 3.0 million American children age 6-14 and 415,000
    adult volunteers power youth tackle football, making it one of our
    country's most popular youth sports. USA Football is an independent
    non-profit organization with members residing in all 50 states and the
    District of Columbia. Our members are youth football coaches, players,
    league commissioners and football game officials. Within our spectrum
    of responsibility is to lead and serve the youth football community. We
    do this in several ways, including giving information in the area of
    health and safety through our work with the Centers for Disease Control
    and Prevention (CDC) and other experts.
        USA Football was endowed by the National Football League (NFL) and
    the NFL Players Association (NFLPA) in 2002 through the NFL Youth
    Football Fund. The NFL Youth Football Fund is a non-profit foundation
    created by the NFL and NFLPA in 1998. I have served as USA Football's
    executive director since 2005.
        Twenty-six (26) youth sports organizations, including USA Football,
    began working with the CDC since 2007 to educate the youth sports
    community on concussion awareness and management. Fortunately, this
    number of youth sports organizations has increased in recent years.
    Player health and safety, including concussion education and
    management, is a point of emphasis for USA Football.
        USA Football's CDC-approved concussion awareness work has garnered
    national media attention. This underscores the public's thirst for
    additional knowledge and education on this topic.
    Summary of USA Football's CDC-Approved Concussion Awareness
            Information
        USA Football's coaching education curriculum, football training
    events, and resources provide youth football players, parents, coaches,
    league commissioners, and game officials with a strong knowledge base
    of football's fundamentals. Although no physical activity is injury-
    proof, coaches who understand how to properly teach blocking and
    tackling within the rules will foster a positive football experience
    and will likely lessen the chance of injury.
        The following summarizes how USA Football, with CDC-approved
    practices, educates the youth football community on how to recognize a
    concussion and how to respond if one occurs. This information is
    promoted on our website--www.usafootball.com--and is available without
    cost.
        USA Football's online tackle and flag coaching courses were
    bolstered in April 2010 with 35 minutes of video addressing concussion
    (11 minutes), heat and hydration (13 minutes), proper helmet fitting (7
    minutes) and proper shoulder pad fitting (4 minutes). USA Football
    earned national publicity for these courses promoting player safety
    (Associated Press, 4/28/10). All videos may be viewed at
    usafootball.com at no cost at usafootball.com/health-safety/videos-and-
    downloads.
        Each of the tackle football coaching course's 15 chapters are
    followed by a quiz to strengthen comprehension. A coach's progress
    within the course can be tracked by a league's commissioner. A coach
    must correctly answer at least 80 percent of the questions in a chapter
    quiz in order to advance to the next chapter.
        More than 75,000 youth football coaches have been educated by USA
    Football in our organization's history. Of these 75,000 coaches, more
    than 43,000 have been trained by USA Football in the past 18 months,
    illustrating the increasing value that youth leagues place in our
    educational resources. USA Football does not operate youth leagues nor
    does it have the ability to mandate youth coaches to complete its
    coaching courses. Leagues independently decide to employ USA Football's
    courses and resources on a value-based proposition.

        USA Football's online coaching course, successfully completed by
    more than 61,000 youth football coaches, teaches how to properly coach
    football fundamentals.

        Following each USA Football coaching course chapter, coaches are
    quizzed on what they learned. A cumulative score of at least 80 percent
    on each chapter quiz is needed to advance through the course.

        Youth sports leagues--not only those pertaining to football--are
    encouraged to adopt USA Football's CDC-approved concussion awareness
    and management policy (below). USA Football recommends that every youth
    sports league employs a policy such as this:
    Prevention and Preparation for Coaches (Primary Source: CDC)
        (1) Educate athletes and parents about concussion

            (a) Talk with athletes and parents about preventative measures,
            symptoms, and proper action to take relative to concussions.

            (b) Emphasize the dangers of playing through a concussion.

        (2) Insist that safety comes first

            (a) Teach athletes safe playing techniques and good
            sportsmanship

            (b) Review the ``Concussion Fact Sheet for Players'' found at
            usafootball.com with players and their parents

        (3) Teach athletes and parents that it is not safe to play with a
    concussion

            (a) Explain that it is not ``courageous'' nor does it show
            strength to play with a concussion

        (4) Prevent long-term problems

            (a) ``When in doubt, sit them out.'' Keep athletes with known
            or suspected concussion off the field until an appropriate
            health care professional clears them to return. Returning to
            play must be a medical decision.
    Signs & Symptoms of Concussion (Primary Source: CDC)

    Observations made by Coaching Staff      Symptoms reported by Athlete

     Appears dazed or stunned     Headache or ``pressure''
                                          in the head
     Is confused about            Nausea or vomiting
     assignment or position
     Forgets plays                Balance problems or
                                          dizziness
     Unsure of game, score, or    Double or blurry vision
     opponent
     Loses consciousness (even    Sensitivity to light or
     briefly)                             noise
     Shows behavior or            Feeling sluggish, hazy,
     personality changes                  foggy, or groggy
     Can't recall events prior    Concentration or memory
     or after the hit or fall             problems

    What a Coach Should Do When a Concussion is Suspected (Primary Source:
            CDC)
        (1) Remove the athlete from play

            (a) Look for signs and symptoms of concussion if an athlete
            experienced a bump or blow to the head

            (b) ``When in doubt, sit them out''--athletes with signs or
            symptoms of concussion must not return to play

        (2) Ensure that the athlete is evaluated immediately by an
    appropriate health care professional

            (a) Do not try to judge the severity of the injury yourself

            (b) Coaches recording the following can help a health care
            professional in assessing the athlete:

                    (i) Cause of the injury and the force of the hit or
                    blow to the head

                    (ii) Any loss of consciousness and if so, for how long

                    (iii) Any memory loss or seizures immediately following
                    the injury

                    (iv) Number of previous concussions (if any)

        (3) Inform the athlete's parents/guardians of the possible
    concussion and give them the concussion fact sheet for parents found on
    usafootball.com

            (a) Ensure at parents know the athlete must be seen by an
            appropriate healthcare professional

            (b) Provide formal documentation of the injury and notify the
            league commissioner

        (4) Allow the athlete to return to play only after an appropriate
    healthcare professional clears his or her return

            (a) A repeat concussion that occurs before the brain recovers
            from the first can slow recovery or increase the likelihood of
            having long-term problems
    USA Football Educational Resources & Initiatives
        The following outlines USA Football's educational resources and
    initiatives, including information distribution channels.
    Education
     USA Football Events: Knowing the game's fundamentals and how
        to teach them fosters a positive football experience

       AUSA Football Coaching Schools: youth coaches are
            instructed how to teach the sport's fundamentals properly

       USA Football Player Academies: youth players (aged 7-14)
            are taught proper football fundamentals

       Football State Leadership Forums: commissioners learn
            best practices, including insight on concussion

         USA Football stresses that athletes who have or are
                suspected to have suffered a concussion must not return to
                play until an appropriate healthcare professional clears
                them to do so.

     USA Football's Online Coaching Education Program for Youth
        Tackle and Flag Football

       Concussion awareness and management information is part
            of USA Football's basic online coaching courses for both tackle
            and flag football

         USA Football's concussion-related course content is
                created by its Football & Wellness Committee, the CDC, and
                the National Athletic Trainers' Association (NATA)

         USA Football's Football & Wellness Committee is composed
                of experts in several areas, including concussion,
                hydration, and nutrition

     National Federation of State High School Associations (NFHS)
        ``Fundamentals of Coaching Football'' Course

       Produced by USA Football, this course teaches proper
            coaching fundamentals to America's high school football coaches

       High school head football coaches in Arkansas and
            Massachusetts are mandated by the high school athletic
            associations in those states in order to successfully complete
            the NFHS's three-part online coaching curriculum; USA
            Football's coaching course accounts for one of these three
            parts.
    Rules
     USA Football Youth Football Rulebook

       USA Football's Youth Football Rulebook, made available
            to all youth football leagues in the United States, is written
            with assistance from the National Association of Sports
            Officials (NASO) and the NFHS to establish important youth
            football standards

       Work done by USA Football's Rules Committee in Nov. 2010
            enlarged the scope of illegal contact made to a player's helmet
            to increase player safety. The rule change earned coverage from
            The Associated Press (Nov. 10, 2010).
    Research
     Youth Football Participation and Safety Surveillance Studies

       USA Football continues youth football's most accurate
            participation study monitoring players, coaches, and teams

       USA Football will invest to execute a study to learn
            more about youth football injury rates and how they are
            affected by varying standards of play (Age & Weight, Age and
            Grade-based)

         Data collection will begin during the 2012 football season
    USA Football Equipment Grant Program
        USA Football, through financial support provided by the NFL Youth
    Football Fund, has awarded more than $4 million in football equipment
    based on merit and need to youth and high school programs across the
    United States since 2006. More than 700 youth and high school football
    programs in 44 states were assisted through USA Football grants awarded
    in 2011 alone.
        USA Football equipment grants make youth and high school football
    safer and compliments programs' existing fundraising endeavors for new
    equipment. Selected youth leagues choose one of 14 equipment packages,
    each valued at $1,000. Selected high school programs also choose one of
    14 packages, each valued at $1,500.
        Dozens of football program leaders have expressed appreciation for
    equipment grants awarded by USA Football:
        ``This is going to enable a lot more kids to play. This grant keeps
    kids on the field. It'll definitely help us and we are so very
    grateful.''
            --Cassandra Jetter-Ivey, Newark (N.J.) North Ward Scorpions
            Youth Football Program
        ``We appreciate USA Football's help. This allows a sense of relief
    that we're keeping our children safe from injury by placing them in new
    and sturdier helmets. Since we are supporting children who are
    predominately underprivileged, this assistance is especially valuable
    as it keeps our registration fees as low as possible.''
            --DeAndrea Singleton, Westbury Redskins; Houston, Texas
        ``The equipment grant we were awarded from USA Football will
    provide equipment and uniforms to young athletes in low-income, inner-
    city neighborhoods. Most of the youths are between the ages of 5-12
    years and the majority of them are financially disadvantaged. USA
    Football helps us make a difference in the lives of our kids and we
    appreciate their non-profit office's support.''
            --Steve Billingslea, Middle Tennessee Bulldogs; Nashville,
            Tenn.
    USA Football's Football and Wellness Committee
        USA Football has assembled a Football and Wellness Committee to
    further promote best practices for America's youth football community.
    The committee, composed of 26 experts spanning football coaching,
    player health, and other areas, share insight with youth football
    coaches, game officials, league commissioners, youth players, and
    parents to lead the game's development and foster a positive football
    experience for youth and amateur players. The committee's expertise
    will be shared with USA Football members through www.usafootball.com,
    our quarterly USA Football Magazine, and our football training events,
    which are conducted in more than two dozen states.
        This committee roster represents a variety of organizations
    including the American Red Cross, the Andrews Institute, the National
    Center for Sport Safety, and several medical centers from across the
    United States. USA Football's Football & Wellness Committee Members:

            Name                  Expertise                Organization

    Tom Bainter          Football expert, running    Bothell (Wash.) High
                          backs                       School
    Tom Bass             Football advisor            USA Football
    Marcus Boyles        Football expert, receivers  Wayne County (Miss.)
                                                      High School
    Jody Brylinsky       Coaching performance        Western Michigan
                                                      University
    Ron Courson          Sports medicine             University of Georgia
    Ted Crites           First aid, CPR/AED, injury  American Red Cross
                          prevention
    Jeremy Gold          Football expert, defensive  Chicago Morgan Park
                          line                        High School
    Dr. Ann Grandjean    Medical and nutrition       University of Nebraska
                          education                   Medical Center
    Dr. Brad Hatfield    Kinesiology                 University of Maryland
    Dr. Stan Herring     Concussion awareness and    University of
                          management                  Washington
    Kirk Heidelberg      Football expert, offensive  Rockford (Ill.)
                          line                        Christian High School
    Kent Johnston        Football expert, physical   Cleveland Browns
                          skills
    Dr. David Joyner     Medical expert, orthopedic  Penn State University
                          physician
    Chuck Kyle           Coaching performance        Cleveland St. Ignatius
                                                      High School
    Dr. John Lehtinen    Family medicine             Peninsula Medical
                                                      Center
    Dr. Larry Lemak      Sports Medicine             Lemak Sports Medicine
    George Maczuga       Equipment                   Riddell
    Chris Merritt        Football expert, defensive  Miami Christopher
                          backs & sp. teams           Columbus High School
    Dr. Joel             Neurology                   Duke University Medical
     Morgenlander                                     Center
    Dr. Lonnie Paulos    Orthopedics                 The Andrews Institute
    Mike Price           Insurance                   Essix Insurance
    Dr. JohnEric Smith   Hydration                   Gatorade Sports Science
                                                      Institute
    Steve Specht         Football expert,            Cincinnati St. Xavier
                          linebackers                 High School
    Gary Swenson         Football expert,            West Des Moines (Iowa)
                          quarterbacks                Valley High School
    Kim Schwabenbauer    Nutrition                   Corporate dietitian,
                                                      Super Bakery
    Dr. Dave Yukelson    Sport psychology            Penn State University

    Player Progression Development Model
        America's youth football community is learning how to coach and
    play the sport in a way never done before.
        Developed throughout 2010 and 2011, USA Football introduced a
    Player Progression Development Model (PPDM) earlier this year. Youth
    football coaches in 15 states completed USA Football's age-appropriate
    teaching and learning approach to the game prior to the start of the
    2011 football season.
        USA Football's PPDM develops youth football players by having them
    learn the game, increase their skills and build confidence at age-
    appropriate levels. It directs youth coaches how to teach the game in a
    progression based on a player's age and physical abilities as well as
    the player's mental, emotional and social maturity.
        Player age segments within USA Football's Player Progression
    Development Model:

     Under-6 (flag      Under-10        Under-14
     football)                  (tackle)                (tackle)
     Under-8 (tackle)   Under-12
                                (tackle)

        USA Football's Player Progression Development Model is woven into
    all USA Football programming--more than 80 football developments events
    for coaches, players and commissioners and its online educational and
    skill-strengthening resources for coaches and players.
        USA Football created its Player Progression Development Model
    (PPDM) under the direction of the following experts:

                        Name                          Area of Expertise

    Tom Bainter, Bothell (Wash.) H.S. Football   Running Backs
     Coach
    Jeremy Gold, Chicago Morgan Park H.S.        Defensive Line
     Football Coach
    Kirk Heidelberg, Rockford (Ill.) Christian   Offensive Line
     H.S. Athletic Director
    Kent Johnston, Cleveland Browns Strength     Physical Abilities
     and Conditioning Coach
    Chuck Kyle, Cleveland St. Ignatius H.S.      Principles of Coaching
     Football Coach
    Larry Lauer, Ph.D., Michigan State           Exercise & Sport Science,
     University                                   Sport Psychology
    Chris Merritt, Miami Christopher Columbus    Defensive Backs and Special
     H.S. Football Coach                          Teams
    Anne Pankhurst, Independent Consultant       Physical Abilities, Growth
                                                  and Maturation
    Cathy Sellers, United States Olympic         Principles of Coaching
     Committee
    Steve Specht, Cincinnati St. Xavier H.S.     Linebackers
     Football Coach
    Gary Swenson, West Des Moines (Iowa) Valley  Quarterbacks
     H.S. Football Coach
    Dave Yukelson, Ph.D., Penn State University  Sport Psychology

        ``A structured player development model is good--and needed--for
    football, particularly youth football,'' said Cleveland St. Ignatius
    head football coach Chuck Kyle, a 10-time Ohio state champion coach and
    member of the Ohio High School Football Coaches Association Hall of
    Fame. ``This is a game of innovation, rooted in fundamentals,'' Kyle
    adds. ``USA Football's Player Progression Development Model is an
    extraordinary example of how these two dynamics work together and form
    the foundation of an exceptional team sport of the mind, body and
    spirit.''
    USA Football Tackle Advisory Committee
        Head football coaches with NFL, collegiate, high school and youth
    experience as well as a leading sport psychologist were selected for
    USA Football's Tackle Advisory Committee in June 2011, the first
    committee of its kind to benefit America's youth football community.
        The group of experts helps youth coaches teach tackling
    fundamentals and strengthen player safety on a national level through
    USA Football resources.
        The five-member committee has assisted in developing a tackle
    progression model--a step-by-step process for youth coaches to teach
    tackling fundamentals in proper order. The tackle progression and its
    drills were created by USA Football. USA Football's tackle progression
    model further strengthens player safety and identifies ways to build
    confidence in youth players by appropriately introducing them to
    contact.
        USA Football's Tackle Advisory Committee Members:

        Name                  Position                    Organization

    Pat           Head Football Coach              Northwestern University
     Fitzgerald
    Merril Hoge   Youth Football Coach and NFL     ESPN (NFL Alumnus)
                   Analyst
    Chris         Head Football Coach              Miami Christopher
     Merritt                                        Columbus High School
    Jim Mora      Youth Football Coach and Former  Atlanta Falcons and
                   NFL Head Coach                   Seattle Seahawks
    David         Sport Psychologist               Penn State University
     Yukelson

        A series of 12 instructional videos within USA Football's Tackle
    Progression Model divides tackling into five fundamentals--breakdown
    position, buzz, hit position, rip and shoot--providing drills to teach
    each step, beginning in a non-contact environment and progressing to
    player-to-player contact. The instruction is designed to improve
    tackling skills, increase safety and limit helmet-to-helmet contact,
    lessening the chance for injury, including concussion.
        Within the model, a USA Football-produced Level of Contact video
    directs youth coaches on how they may incrementally introduce their
    players to contact to build their confidence and help them learn the
    game's fundamentals. Drills can be run at varying speeds, starting slow
    when they are first introduced and accelerated as players master skills
    and techniques. The video introduces contact in the following ways:

    ------------------------------------------------------------------------
            Level of Contact                        Definition
    ------------------------------------------------------------------------
    Air                              Players run a drill unopposed without
                                      contact.
    ------------------------------------------------------------------------
    Bags                             Drill is run against a bag or another
                                      soft-contact surface.
    ------------------------------------------------------------------------
    Wrap                             Drill is run between two players until
                                      the moment of contact; one player is
                                      pre-determined the ``winner'' by the
                                      coach. Contact remains above the waist
                                      and players stay on their feet.
    ------------------------------------------------------------------------
    Thud                             Drill is run between two players until
                                      the moment of contact; no pre-
                                      determined ``winner.'' Contact remains
                                      above the waist, players stay on their
                                      feet and a quick whistle ends the
                                      drill.
    ------------------------------------------------------------------------
    Live-Action                      Drill is run in game-like conditions
                                      and is the only time that players are
                                      taken to the ground.
    ------------------------------------------------------------------------

        ``Directing youth football teams to incrementally incorporate
    contact into their practices lessens the amount of incidental contact
    that players receive through their helmets,'' said Dr. Stanley Herring
    of USA Football's Football and Wellness Committee and the NFL's Head,
    Neck and Spine Committee. ``This is a strong step forward for player
    safety in youth football that any youth sport should consider
    emulating.''
    Concussion-Related Education
        USA Football works with the CDC to promote concussion-related
    education materials for its members and the entire youth football
    community at www.usafootball.com. In addition to the CDC, USA Football
    is advised by Dr. Stanley Herring on concussion awareness and
    management. Dr. Herring is a member of USA Football's Football &
    Wellness committee and is a board-certified physical medicine and
    rehabilitation specialist who has been in practice for more than 27
    years. Dr. Herring also is a clinical professor in the departments of
    Rehabilitation Medicine, Orthopaedics & Sports Medicine, and
    Neurological Surgery at the University of Washington.
        Dr. Herring is USA Football's internal advisor on concussion
    awareness material for our coaching course, which was shared with the
    CDC for review prior to being made available to the youth football
    community. USA Football informs coaches of the CDC-approved message
    that athletes who are even suspected of having suffered a concussion
    must not return to play until an appropriate health care professional
    clears them to return. Returning to play must be a medical decision.
        In September 2010, USA Football introduced a national campaign
    called ``Put Pride Aside for Player Safety'' to emphasize concussion
    awareness in youth sports, particularly football.
        ``Put Pride Aside for Player Safety'' is the only national youth
    sports initiative promoting concussion education and management uniting
    a sport's national governing body (USA Football), collegiate athletic
    conferences (Atlantic Coast Conference, Mid-American Conference, The
    Patriot League) and a professional sports league (NFL).
        Through television, radio and website media placements, ``Put Pride
    Aside for Player Safety'' continues USA Football's commitment toward
    youth sport concussion education and management. ``Put Pride Aside for
    Player Safety'' challenges and instructs coaches, parents and youth
    players to make the right decision when a concussion is suspected,
    which is to remove an athlete from play the day of the injury and not
    allow him or her to return until a medical professional deems the
    athlete symptom-free and gives clearance for a return to play.
        Key components of USA Football's ``Put Pride Aside for Player
    Safety'' campaign:

       Television PSA airing on NFL team, ACC, Mid-American
            Conference and Patriot League programming as well as on
            usafootball.com

       Radio PSA airing on NFL team-owned inventory

       Player safety videos (12) covering proper equipment fitting,
            tackling techniques and concussion management on websites of
            NFL teams, the ACC, the MAC, the Patriot League and
            usafootball.com

       Banner ads on websites of NFL teams, the ACC, the MAC, the
            Patriot League, and usafootball.com
    Legislation
        USA Football has joined other sports and medical organizations
    across the country in testifying in person or via letters of support
    for state legislation to foster greater awareness and management of
    concussion.
        Many of these state laws, most of which have been passed since
    August 2010, require:

       Information handouts to parents and players on the signs and
            symptoms of concussion; returned and signed by parents and
            youth athletes acknowledging the risk of concussion and head
            injuries prior to practice or competition.

       Removal of a youth athlete who is suspected of or sustains a
            concussion or head injury from play--``When in doubt, sit them
            out.''

       Written clearance prior to returning to play from a licensed
            health care provider knowledgeable in the diagnosis and
            management of concussion for a youth athlete who has been
            removed from play.

       Compliance from private, non-profit youth sports
            associations with the policies adopted in that state.

        Such laws cannot prevent an initial concussion from happening on a
    football or soccer field, a basketball court, a baseball diamond, or a
    hockey rink, but they can help prevent damaging repeated concussions
    from happening in all of these places.
        USA Football is committed to concussion awareness and management
    and would encourage other sports' national governing bodies to join us.
        Concussion is not relegated to football--or even boys' athletics.
    According to a study titled, ``Concussions Among United States High
    School and Collegiate Athletes'' in the Journal of Athletic Training in
    2007, concussion rates per 1,000 athlete exposures were as follows (an
    ``athlete exposure'' is one practice or one game):

       Football: 0.47

       Girls Soccer: 0.36

       Boys Soccer: 0.22

       Girls Basketball: 0.21

       Boys Basketball: 0.07

        These numbers underscore the need for all sports to recognize the
    seriousness of concussions and the need for further education among our
    coaches, league administrators, game officials, athletes, and parents.
    More Education Needed
        Concussion awareness, even within the medical community, is
    limited. The CDC has even created a concussion fact sheet for
    physicians in addition to the general public. This drives the point
    that consistent nomenclature and the coordinated cooperation of all
    youth sports stakeholders is necessary to continue this positive change
    that we are experiencing in youth sports relative to concussion.
                                     ______

                                    Appendix

        Created by the CDC for USA Football, this information was placed on
    a clipboard sticker and distributed at more than 35 full-day USA
    Football Coaching Schools in 25 states in 2010. This image can be
    downloaded at no cost at usafootball.com.

        The above four-page Concussion Education brochure with content from
    the CDC was distributed at single-day USA Football Coaching Schools in
    2011.
                                     ______

         Prepared Statement of Stanley Herring, MD, Clinical Professor
        Departments of Rehabilitation Medicine, Orthopedics and Sports
         Medicine, and Neurological Surgery University of Washington;
     Co-Medical Director Seattle Sports Concussion Program; Team Physician
     Seattle Seahawks and Seattle Mariners; and Member, National Football
                    League's Head, Neck and Spine Committee
    Chairman Rockefeller, Ranking Member Hutchison, and members of the
    Committee:

        My name is Dr. Stan Herring. I am the Co-Medical Director of the
    Seattle Sports Concussion Program and a Clinical Professor at the
    University of Washington. In addition, I serve as a Team Physician for
    the Seattle Seahawks and the Seattle Mariners. I submit this statement
    to you today as a Member of the National Football League's Head, Neck
    and Spine Committee and the Chairman of the Subcommittee on Education
    and Advocacy.
        Mr. Chairman, thank you for calling this hearing to bring greater
    awareness to the important topic of concussion in sports. As a medical
    advisor to the NFL, I believe that the NFL values its leadership role
    on the issue of concussions, not only for professional football
    players, but for all sports at all levels. I appreciate the opportunity
    to submit a statement summarizing some of the NFL's work on this
    important matter.
        As a physician who has worked on the sidelines of Seattle Seahawks
    games for many years, I know there is nothing more important to the NFL
    than the health of its players. Effective safety equipment is one
    important component in protecting the health of athletes. Among the
    many equipment related initiatives pursued by the League was a recent
    study into the effectiveness of the helmets worn by NFL players. The
    results of this study were shared not only with the players, but also
    the equipment manufacturers and made available to the public. The more
    information people have about equipment safety, especially as it
    relates to head injuries, the safer sports will be.
        Additionally, last December the NFL hosted a symposium in New York
    to discuss the performance of safety equipment, including helmets.
    Invited stakeholders included helmet and accelerometer manufacturers,
    the Department of Defense, the National Operating Committee on
    Standards for Athletic Equipment, the NFL Players Association, and
    researchers, among others. The daylong meeting allowed the most
    informed and knowledgeable individuals working on helmet safety to
    share ideas and learn from each other's work. All of those invited
    shared the same goal--making the game as safe as possible for those who
    play it.
        There currently are no products on the market that can make an
    athlete concussion-proof. Equipment technology will continue to evolve
    over time. The NFL is encouraging the pace of this change. In the
    meanwhile, we cannot look to equipment to replace the critical role of
    medical evaluation and treatment.
        We need not wait for the development of new technology to protect
    children from the dangers of concussions. Greater awareness and
    education can protect athletes of all ages, in all sports. The NFL
    promotes broader education about concussion in all levels of sport.
    Through collaboration with the CDC, educational posters now hang in NFL
    training rooms. I was personally involved in developing a similar
    poster to be used by youth athletes and made available through the CDC.
    Additionally, with support from the NFL, I have been involved in
    developing educational materials for coaches and clinicians so they can
    be better informed in treating athletes who have suffered a concussion.
    All of these materials are available, for free, on the CDC's website at
    www.cdc.gov/concussion.
        The NFL invests in research, and our medical committee works to
    examine the latest developments in technology. In the NFL's most recent
    collective bargaining agreement with the NFL Players Association, there
    is an agreement to dedicate $100 million over the next ten years to
    medical research, the majority of which will go toward brain injury
    research.
        Youth athletes who have suffered a concussion will routinely
    recover and return to play eventually if properly treated. For this
    reason, it is important that appropriate protocol is followed when
    children suffer concussions. One way to ensure that parents, coaches
    and others involved in youth sports are aware of the best possible way
    to treat concussions is through the adoption of laws with
    internationally accepted guidelines for how to treat youth concussions.
    A year ago, the NFL announced a campaign to advocate for the passage of
    youth concussion laws across the country. The laws all contain at least
    these three key principles:

            1. Student athletes and a parent or guardian must sign an
            education sheet that provides them with information about the
            signs and symptoms of concussion;

            2. Any youth athlete who appears to have suffered a concussion
            in any sport is removed from play or practice at that time; and

            3. That athlete must be cleared by a licensed healthcare
            provider trained in the diagnosis and management of concussions
            before returning to play or practice.

        Laws containing these provisions have been enacted in thirty
    states, as well as the District of Columbia. Twenty-two have become law
    in the last year alone. The NFL has pledged to continue its advocacy
    until every state has adopted a way to protect youth athletes.
        The importance of these laws is personal for me. In October 2006,
    Zackery Lystedt was a 13-year-old star football player who suffered an
    undiagnosed concussion with a few minutes left in the first half. An
    injury time-out was called. After resting during halftime, Zackery
    returned to play in the second half while still having symptoms from
    his injury. He sustained further head blows during the second half of
    the game, and at the end of the game collapsed in his father's arms. He
    lapsed into a coma suffering from life-threatening injuries. Zackery
    survived, but continues to face a long road of rehabilitation. In the
    meanwhile, a coalition in Washington State began work on a law designed
    to prevent the next child and the next family from suffering the way
    Zackery and his family did. The adoption of the Zackery Lystedt law in
    Washington is already making a difference in our state. Thanks to the
    fine work of advocates across the country to promote this law, many
    more kids will play sports safer.
        I am proud that the NFL is a leader to the benefit of athletes at
    all levels of sport. As more is learned about concussions, I believe
    that the NFL will continue to make the necessary changes to best
    protect its players and to lead and serve as a model for all sports.
        Thank you again for this opportunity today.
                                     ______

                                            Ralph & Joy Conradt
                                             Bend, OR, October 29, 2011
    Chairman Jay Rockefeller,
    Senate Committee on Commerce, Science, and Transportation,
    Washington, DC.

                                     Re: Football helmet safety

    Dear Senator Rockefeller,

        Having viewed the October 19th Senate Hearing, I have a number of
    comments regarding the statements made by equipment-industry-
    representative Oliver. First though it is ironic that the 10/19/11
    hearing occurred on the ten-year anniversary of my son Max's
    catastrophic brain injury while wearing a twenty year-old football
    helmet.
        1. At the time of Max's injury, we had no reason to question the
    reconditioning process. We just assumed all helmets were tested every
    year and reconditioning consisted of more than deodorizing, painting
    and checking for cracks. Mr. Oliver stated that an old helmet, properly
    reconditioned, offers the same protection as a state-of-the-art helmet.
    Our experience is that this is not the case. Max's helmet was drop-
    tested at the NOCSAE lab and failed over 50 percent of the standards of
    the year 2000. Oliver says a helmet should not necessarily have an
    established shelf life since it may sit unused for several seasons.
    Clearly Mr. Oliver clearly has never owned a product made of
    polycarbonate, commonly known as plastic. If he did he would recall
    that while exposed to air, polycarbonate becomes brittle and no longer
    effectively absorbs shock.
        2. Oliver further stated an older helmet would meet current
    standards if `new parts were installed'. This position is ridiculous,
    as the primary component of a helmet is the shell. Since helmet shape
    has changed over the years the older shells will not accommodate new
    padding, bladders, head-sizers etc. Only parts made exactly to fit the
    old technology will work. Thus, even in the best-case scenario, such a
    helmet could only meet old standards, not recent standards.
        3. It troubles to me that children are allowed to play with these
    older products once newer standards are established. Why then have new
    standards? A reporter asked Max's principal, Von Taylor of Waldport
    High School in Oregon, how Max, the quarterback of his team and
    arguably the most valuable player, be assigned a 20-year-old helmet??
    Taylor replied that Max's was not the only helmet of that vintage.
        This sort of justification explains why young players continue to
    suffer life-altering injuries and death--the most recent death just a
    week ago in New York. In 2008 I attended a coaches' conference where a
    coach questioned why he should be so concerned about examining and
    fitting helmets and sitting out players that felt a little dizzy when
    in fifteen years he had never had a player suffer a major injury. I was
    happy to explain to him that Max's coach tearfully expressed similar
    sentiments to me in the ICU while we stood over my son's comatose body.
        4. Max assured me that in his junior year he was using a ``new''
    helmet. Had I known that in his senior year he would be issued a 20-
    year-old helmet, which was three years older than he was, I would not
    have let him step onto the field. Max and I used to race our track car.
    It was mandatory, in that sport, that helmets be replaced every ten
    years, even if they were never worn in an accident. Helmets that had
    been dropped or which showed signs of minor impact also required
    replacement.
        5. Oliver stated that a helmet's age could be readily determined
    from a stamp in the shell. There are three problems with that
    statement. (A) Most schools do not allow players to take helmets home
    for parents' inspection; (B) the date stamp is usually disguised in a
    code and (C) the code is usually obscured by padding, which only
    coaches may remove.
        6. Coaches have only recently begun to take the issue of head
    protection seriously. Les Totten is CEO of SportsSoft, a company that
    offers teams a product to track all the conditioning and parts
    replacement for equipment. Les stated to me on-camera that he has never
    been in a school's equipment room and not found a helmet that was
    clearly ineffective by date of manufacture or reconditioning.
        Lastly, shortly after my 3.95 GPA son slipped into a four-month
    coma I was contacted by Riddell representative Mark Elmblade. He was
    concerned that one of his helmets might have been worn by Max. I
    assured him that it was a Bike helmet made by Schutt. Elmblade was
    relieved, but said he had recently visited Waldport coach Donald
    Kordosky. During their conversation Elmblade picked up one of the
    helmets in Waldport's stock and exclaimed ``These are a brain injury
    waiting to happen!'' Kordosky justified the use of out-dated helmets
    because he had no budget to replace them. Parents were not notified of
    this dangerous situation and had I known of the dire budgetary
    situation I would have gladly bought new helmets for the starting
    players.
        Lincoln County School District saved a few dollars and my son paid
    with his life. He will never work, never again join me in car racing.
    He will not provide me with grandchildren or contribute to our society
    with his once-exceptional brain power.
        Had Max's antiquated helmet been relegated to the trash heap there
    is every reason to believe that I would still have a whole son.
    Hopefully in your next Hearing, Mr. Oliver will be asked to respond to
    the issues raised here.
        Lastly as a filmmaker I have on tape almost every game Max played
    in. This footage became a major source of visuals for my film ``What
    Happened, Dad?''
                                            Ralph & Joy Conradt
                                     ______

     Response to Written Question Submitted by Hon. Frank R. Lautenberg to
                                  Alexis Ball

        Question. Parents normally associate concussions with football, but
    the CDC reports that soccer has the second highest incidence and rate
    of concussions. Do you believe that parents and coaches are aware of
    the concussion risks related to sports like soccer?
        Answer. I do not think that parents/athletes tend to associate
    concussions with sports like soccer. Much of the attention generated
    about concussions in sports is centered on football and thus I believe
    that other sports get overlooked. With the high number of young kids
    playing sports like soccer, it is essential to educate coaches,
    parents, and athletes about frequency of concussions occurring in
    sports other than football such as soccer.
                                     ______

     Response to Written Question Submitted by Hon. Frank R. Lautenberg to
                                 Steven Threet

        Question. Do you have advice for young athletes who may have
    suffered a concussion?
        Answer. My advice for young athletes who believe they have suffered
    a brain injury is to report it. It is better to speak to a trainer or a
    doctor and have them be able to rule out the possibility that a brain
    injury has occurred rather than the worst-case scenario where an
    athlete would stay quiet because they don't think their injury is
    significant enough to be reported and subsequently return to play
    before their brain is ready. This reporting process is significant
    because the brain is at a much greater risk for serious or permanent
    injury as a result of a second impact, known as Second Impact Syndrome.
                                     ______

         Response to Written Question Submitted by Hon. John Thune to
                                 Steven Threet

    Improper Tackling Technique and Concussions
        Question 1. I'm aware that NFL and college football teams today
    have significantly reduced the amount of time devoted during practice
    to proper tackling and other football fundamentals. I recognize that
    coaches are limiting some of the physical contact during practice to
    prevent injuries. However, my concern is that less time devoted to
    teaching proper tackling technique may be contributing to an increase
    in concussions during games. Specifically, players these days seem to
    lead with their head rather than wrapping a player up with one's arms
    and body, and keeping their head up. Do you see any connection, at all
    levels of football, to improper tackling technique and an increase in
    concussions?
        Answer. I do believe that there is a connection between tackling
    technique and concussion. I believe that this is an issue being
    addressed by the NFL as well as in the college game. There has been a
    concentrated effort to lower the strike zone and to enforce it with
    penalties and in the NFL with fines as well. There is difficultly in
    this area because the speed of the game. Often times it appears that a
    player will tackle with proper technique but then the offensive player
    will make a last second adjustment in his body position in anticipation
    of the impact and subsequently bring their head lower and back into the
    striking zone for the defensive player.

        Question 2. Do you think this improper tackling technique is caused
    by less time being devoted to teaching good technique in practice?
        Answer. I believe that as players get older less time is spent
    teaching proper technique. At elite levels of the game coaches either
    assume it is known or do not feel they can spend the time focusing on
    technique. I think this is because there are such strict rules by the
    NCAA about the time that coaches can spend with their players. The off-
    season would be a great time for position players to teach their
    players but contact between coach and player in this way is currently
    not allowed. Because of time constraints the emphasis of practice is
    learning the defensive scheme in the spring and the preseason and
    preparing for the opponents during the season.

        Question 3. As part of the campaign to highlight concussion
    awareness, how much emphasis is being placed on educating coaches and
    players about using proper tackling technique to reduce concussions?
        Answer. I believe that there is some emphasis being placed on how
    proper technique can help reduce the frequency of brain injury. However
    the greatest emphasis on the awareness front is getting athletes to
    appreciate the seriousness of brain injury. I believe that as more
    people begin to recognize the problem, it will be possible to switch
    the focus of the awareness effort to include partial-solutions like a
    greater emphasis on tackling technique.
                                     ______

    Response to Written Questions Submitted by Hon. Frank R. Lautenberg to
                              Jeffrey Kutcher, MD

        Question 1. Concussions and other traumatic brain injuries pose a
    serious and increasing risk for our youth. In 2009, emergency rooms
    treated an estimated 248,418 sports and recreation-related concussions
    and other brain injuries among children and adolescents. These injuries
    have increased by 60 percent over the last decade even though school
    sports participation has fallen. What more can be done to prevent these
    injuries? How can we ensure that kids who experience concussions don't
    suffer long-term consequences?
        Answer. The increase in emergency room visits for sport and
    recreation related brain injury is very likely multi-factorial. First,
    although school sports participation may be trending down, the overall
    exposure to activities with an inherent risk of brain injury is more
    difficult to quantify. It may be, for example, that overall exposure is
    up, once we factor in those activities that are not school organized.
    Second, increased awareness of head injury has almost certainly led to
    a higher percentage of head injuries presenting to an emergency room.
    Thus, the 60 percent increase in ER visits over the last decade may not
    necessarily represent an increase in the absolute number of injuries.
        That being said, there is no question that a serious problem exists
    and injury prevention is key. A significant number of injuries could be
    prevented through proper education and awareness campaigns that address
    known high-risk activities. These efforts should stress the use of
    well-fitted and certified equipment, proper technique, and adherence to
    the rules of whatever sport or activity is being considered. As is the
    nature of the concussion issue, what we don't know puts a limit on our
    ability to make a difference. To truly prevent concussion, we need to
    understand much more about the injury itself, how a traumatic force
    acts to insight the injury, how the brain responds to the injury, and
    what additional factors may influence the clinical outcome.
        Currently, we do not know enough about concussion or traumatic
    brain injury to ensure that any individual can be free of long-term
    consequences. The simple answer is that long-term problems likely come
    from a combination of intrinsic (genetic) and extrinsic (environmental)
    factors, including the total lifetime dose of biomechanical forces.
    Thus, the only way to truly ensure that long-term problems do not
    develop is to avoid exposure to biomechanical forces completely. This
    is clearly not a realistic goal. Given what we know, I stress the need
    to let every concussion heal prior to returning to a contact risk
    environment. I also suggest that the overall exposure to contact risk
    be considered. For example, I advise my patients who play a contact
    sport to avoid other contact sports, giving their brains time to
    recover in the off-season. Finally, I believe that it is critical for
    any contact sport participant to undergo periodic neurological
    evaluation and screening for any signs of brain dysfunction that might
    be related to head trauma.

        Question 2. Rates of concussion and other brain injury have
    dramatically risen over the last decade as have sales of equipment that
    is supposed to protect our kids from these injuries. Are these products
    really protective?
        Answer. Equipment plays a critical role in injury prevention. The
    very nature of contact sports, such as football and ice hockey, is
    determined, in no small part, by the presence of protective equipment
    such as helmets. To this end, equipment being an integral part of the
    game means that it is both preventive and causative. Obviously, any
    football player who for some reason participates without a helmet is at
    a significantly higher risk of injury. The protective nature of helmets
    is limited, however. They are very good at preventing bone fracture and
    superficial injury, but are not very good at preventing concussion.
    Concussion can occur from direct blows to the head or as the result of
    a blow to the body causing a whiplash event. No helmet could ever
    prevent the latter. The amount of biomechanical force that is absorbed
    by helmets, in my opinion, is not enough to expect that they could ever
    significantly alter concussion risk. With that in mind, I tell my
    patients to make sure all of their equipment is properly fitted and
    certified. I also advise them that while newer generation helmets might
    not be able to greatly reduce concussion risk, they may lower the
    absolute amount of force that their brain will experience.
                                     ______

         Response to Written Questions Submitted by Hon. Tom Udall to
                              Jeffrey Kutcher, MD

        Question 1. Helmet requirements for high school football. The
    National Federation of State High School Associations (NFHS) sets
    football playing rules and equipment guidelines that are adopted by
    many state athletic associations. The 2010 NFHS Football Rules book
    requires players to wear a football ``helmet and face mask which met
    the NOCSAE test standard at the times of manufacture'' (see page 17).
    However, these NFHS rules allow a football helmet that is no longer in
    compliance with NOCSAE standards to be worn by a high school player as
    long as the helmet met NOCSAE standards when it was originally made.
    NFHS also does not require that an older helmet be reconditioned and
    recertified to NOCSAE standards. Should high school football players
    wear helmets that meet current NOCSAE requirements when they are
    actually being worn--and not just on the day their helmets were
    manufactured?
        Answer. Absolutely. I believe it is critical that high school
    football players wear helmets that meet current NOCSAE standards while
    they are in use. Every reasonable effort should be made to ensure that
    this is the case. Allowing helmets to be worn that no longer meet
    standards defeats the purpose of having standards in the first place.

        Question 2. NOCSAE drop test and helmet quality. My understanding
    is that the NOCSAE safety standard for football helmets is primarily a
    drop test method that requires helmets to score less than a 1200
    severity index (SI) level. Is there a difference in the level of
    protection offered by a helmet that tests at a 1199 SI level and a
    helmet that tests at a 300 SI level?
        Answer. Theoretically, yes. The difficulty resides in trying to
    quantify the level of protection that any helmet offers. When speaking
    about injuries that are easy to document objectively, such as skull
    fractures or bleeding events inside the skull, one can make a
    reasonable estimate of risk. When speaking about concussion, however,
    as well as possible long-term effects of brain trauma such as chronic
    traumatic encephalopathy, it is much more difficult, if not impossible,
    to quantify the risk in a way that's precise enough to allow for
    comparisons between helmet types. First, we need to advance the science
    of concussion to a point that we have a consistent and well-defined
    clinical outcome to study, and one with an objective confirmatory test.
    Then, helmet types could be studied to see how they differ in
    preventing these outcomes. As it stands now, our estimates of risk, and
    therefore the amount of protection that any helmet can provide, is
    little more than guesswork.
        That being said, it certainly makes sense from a neuropathological
    perspective that brains would rather experience less force than more,
    especially over the course of a lifetime. For that reason, it would
    seem to be an axiom that a helmet with an SI level of 300 would be
    preferable to one with an SI of 1199. Although we cannot expect this
    difference to significantly mitigate the risk of experiencing a
    clinical concussion, it is more plausible that it could account for
    some amount of decreased risk of developing long-term neurological
    effects. If this effect does exist, however, it likely represents a
    very small proportion of the overall risk, and, therefore, we should
    not expect advancing helmet technology alone to solve the problem.

        Question 3. Concussions tests. Dr. Kutcher, we hear more and more
    in the media about ``concussion tests'' used to diagnose athletes and
    determine if they are fit to return to play. Yet we also hear reports
    that some athletes may intentionally fail or ``sandbag'' their baseline
    neuro-cognitive tests in order to reduce the chance of being removed
    from play following a concussion later in the season. How effective are
    computerized neuro-cognitive tests in diagnosing concussed athletes and
    determining when it is safe for them to return to playing sports?
        Answer. Computerized neuro-cognitive tests cannot diagnose
    concussion. Actually, there is no test currently available that can do
    so. Concussion is a diagnosis that is made clinically. Computerized
    neuro-cognitive tests provide information on brain function that an
    experienced physician can use, together with other pieces of
    information, to help make the diagnosis of concussion and help
    determine when the injury is over. I am very concerned with the degree
    to which computerized neuro-cognitive tests are being used
    inappropriately in our country. The problem stems from the fact that an
    abnormal result on these tests is not specific for concussion. An
    athlete who is in pain for any reason, or one who is sleep deprived,
    distracted, or unmotivated can produce abnormal results, whether they
    are concussed or not.
        Furthermore, having a result on one of these tests that falls
    within a population-based norm does not mean that the person in
    question is not concussed. The best use of these tests comes when there
    is a pre-injury baseline result for comparison. The trick is that
    producing a baseline neuro-cognitive study truly representative of that
    individual's ability is more difficult than it sounds. Environmental
    and motivational factors frequently act to set a ``false baseline''
    that is then used for comparison later.
        Computerized neuro-cognitive testing is, potentially, a very useful
    concept. Used incorrectly, however, it can be misleading at best and
    dangerous at worst. I strongly encourage any clinician who uses this
    modality in their practice to understand the strengths and weaknesses
    of the individual tests and to use them as extensions of their physical
    examination, and never as a diagnostic test. In the end, diagnosing
    concussion and making a return to play decision not only involves
    clinical decision-making, but is very much a medical decision that
    should only be made by a physician.
                                     ______

        Response to Written Question Submitted by Hon. John Boozman to
                              Jeffrey Kutcher, MD

    Concussion Education
        Question. Are educational campaigns, such as the CDC's Heads Up
    campaign, effectively reaching parents and coaches across the country?
    Do you feel they are reducing the number of concussions that occur and/
    or changing the way people react when someone sustains one? Should
    anything be done to make these education campaigns more effective?
        Answer. The publicly available concussion education programs, such
    as the CDC's Heads Up campaign, are helping, but only to a degree. They
    are part of the larger changing landscape of increased concussion
    awareness and, as such, do have some impact on moving the issue
    forward. I do not believe they are significantly reducing the number of
    concussions, nor do I see a significant change in how concussed
    athletes are being treated. We can, and certainly should, do better.
    There are four main reasons that I see for this overall lack of
    effectiveness:
        First, I have found that the value of any educational resource
    depends on how specifically the material is designed for a particular
    audience. Most available concussion resources take a generic approach
    that appeals to the public at large. Granted, this may be a result of
    the need to produce materials that cover a wide audience with limited
    resources. Concussion education, however, needs to address every
    stakeholder in the issue. We need programs that are designed for each
    population specifically, speaking to their concerns, using their
    language, and engaging them in the learning process. We need to have
    programs that are created for athletes of different age groups, coaches
    of all levels of sport, parents, administrators, officials, and medical
    staff.
        Second, most concussion education materials I have seen are fairly
    average in quality. They provide superficial content in a non-
    stimulating way. Successful education programs use creative
    instructional design and an interactive format that motivates and
    challenges the learner.
        Third, there is a significant issue with lack of quality control
    and consistency between programs. In some cases, information is
    outdated, incorrect, or contradictory. Much of this may be due to the
    fact that our understanding of concussion is evolving quickly. I'm
    afraid, however, that in an age when anybody can produce an educational
    tool using electronic media, that many programs are designed for the
    purpose of marketing a product or service. The public is thirsty for
    knowledge and deserves information that is accurate, current, and not
    driven by ulterior motives.
        Finally, while having these materials available to those who are
    actively seeking knowledge is a wonderful start, I believe the majority
    of athletes, parents, and coaches would not seek these programs out
    voluntarily. Whenever possible, we need to make concussion education a
    mandatory activity prior to playing, coaching, or consenting for a
    child to participate in contact sports.
                                     ______

    Response to Written Questions Submitted by Hon. Frank R. Lautenberg to
                                Ann C. McKee, MD

        Question 1. Concussions and other traumatic brain injuries pose a
    serious and increasing risk for our youth. In 2009, emergency rooms
    treated an estimated 248,418 sports and recreation-related concussions
    and other brain injuries among children and adolescents. These injuries
    have increased by 60 percent over the last decade even though school
    sports participation has fallen. What more can be done to prevent these
    injuries? How can we ensure that kids who experience concussions don't
    suffer long term consequences?
        Answer. The primary way to reduce the number of concussions
    suffered by children and adolescents is to raise awareness and educate
    the public--coaches, parents, medical doctors, psychologists and kids--
    about what a concussion is, what kind of activities increase the risk
    of concussion, and how to properly manage a concussion after it occurs.
    A concussion properly recognized and medically managed is the best
    protection against the long-term consequences. Ensuring that the child
    or adolescent rests sufficiently (including cognitive rest) after a
    concussion and not allowing the resumption of play of the sport or
    other activities until fully recovered is the best way to reduce
    complications down the road. Other prevention measures include wearing
    proper protective gear when bicycling, skiing, skateboarding, etc and
    avoiding activities that are associated with repetitive brain trauma,
    e.g., leading with your head or tacking with your head in football and
    other sports.

        Question 2. Rates of concussion and other brain injury have
    dramatically risen over the last decade as have sales of equipment that
    is supposed to protect our kids from these injuries. Are these products
    really protective?
        Answer. There is no product marketed today that prevents
    concussion, including helmets, although helmets make sports safer by
    reducing catastrophic injuries. Reducing the incidence of sports-
    related concussion will require changing the way many of our popular
    sports, including football, soccer and hockey, are played.
                                     ______

        Response to Written Questions Submitted by Hon. John Boozman to
                                Ann C. McKee, MD

    Risks in Concussions/Death
        Question 1. Last month, a 16-year-old high school football player
    died from a head injury after collapsing during a game. I understand
    the possibility of further injury due to multiple concussions, yet
    according to the news report, there was no evidence of any pre-existing
    injury or condition that would have contributed to his death. How can a
    seemingly healthy 16-year-old with no previous head injury history die
    after what appeared to be an ordinary football play?
        Answer. While I'm not certain I know what specific case you are
    referring to, it sounds as though it may be a case of second impact
    syndrome or SIS. SIS occurs when a young athlete sustains an initial
    head injury and then suffers a second head injury before the symptoms
    associated with the first impact have cleared. There are many times
    when the athlete does not report the initial injury--he may not realize
    that he had a concussion, he may be minimizing the symptoms or his
    desire to return to the playing field may cloud his judgment. Before
    the first injury completely resolves, which may take days or weeks, the
    athlete returns to competition and receives a second blow to the head--
    which may be remarkably minor--as in an ordinary football play. Yet the
    second impact produces sudden brain swelling, high intracranial
    pressure, and results in death or severe neurological disability. The
    pathophysiology of the SIS is believed to be dyregulation of the
    cerebrovasculature, which young brains are more susceptible to. SIS
    occurs only in young athletes and has never been reported in an athlete
    over the age of 24 years.
        Another possible cause of sudden collapse and death on the football
    field is bleeding into the brain, such as a subdural or an epidural
    hemorrhage. Although these are very rare events and would not be
    expected to occur after an ordinary football play.

        Question 2. Are injuries such as this one preventable?
        Answer. Not playing while recovering from a concussion, even a
    seemingly minor concussion, is the best prevention against this injury.

        2Question 3. How does an injury like this differ from a concussion?
        Answer. A concussion is a temporary state of neurological
    dysfunction accompanied by microscopic evidence of multifocal axonal
    injury and disordered cerebral metabolism. SIS occurs when there is a
    second concussive impact on a brain that has not fully recovered from
    the first one. The second injury produces sudden brain swelling that
    leads to brain herniation and death or severe neurological injury.
                                     ______

    Response to Written Questions Submitted by Hon. Frank R. Lautenberg to
                                  Mike Oliver

        Question 1. Why has NOCSAE not substantially updated helmet
    standards in nearly 40 years?
        Answer. This is a common and persistent misconception or
    misunderstanding. NOCSAE helmet standards including football helmet
    standards have been updated, revised, expanded, and strengthened
    regularly over the past 40 years. Changes to the NOCSAE standard over
    time have included revisions and modifications to the pass fail
    criteria, and at other times the revisions, although appearing to be
    small simple changes in test methodology and procedures, in fact proved
    to be substantial and demanding changes that forced helmets to become
    more robust, more protective, and more durable.
        As a result of improvements and updates to the NOCSAE football
    helmet standard and advances in materials technology and engineering
    and design innovation, the average pass fail test scores for new
    helmets has dropped from 600 SI in 1998 to just under 500 SI in 2010.
    Although there is no way to quantify what this reduction means in terms
    of injury protection and prevention, it is evidence of improvement. It
    also must be kept in mind that even though the pass fail threshold is
    1200 SI which threshold is based on the science behind the Gadd
    Severity Index (``SI''), in order to meet the Quality Assurance and
    Quality Control requirements of the NOCSAE standards, helmets must
    average 500-600 SI in certification testing.
        Football helmets certified to the NOCSAE standard and used in high
    school and collegiate play are involved in over 600,000,000 practice
    and game impacts during the course of a single football season, and
    sometimes they must perform across two and three seasons of continuous
    use before they are submitted for reconditioning and recertification.
    Tests performed on these helmets before they are reconditioned
    establishes that, unless padding has been removed or altered, these
    helmets will have test results that are nearly the same as when the
    helmet was new. Under the circumstances, changes to a standard which
    already provides an extremely high level of protection and performance
    can only be undertaken and adopted when there is solid and consensus
    scientific support for those changes. NOCSAE is one of the leading
    research funding sources for the advancement of that kind of scientific
    knowledge, in the hope that additional revisions and updates can be
    made to the standards to further enhance protection and performance.
        Some examples of changes and updates to the NOCSAE standard are
    listed below.

       1990--A random location impact requirement was added to the
            six predetermined impact locations contained in the standard.
            As a result of this change, helmets would not be required to be
            tested in locations in as many as 58 different locations not
            previously evaluated. This simple change prevented a helmet
            from being designed to meet the standard only at designated
            impact locations, and ensured that football helmets would meet
            the standard which struck at any location on the helmet shell
            and within defined limits of the edges of the shell.

       1992--Implementation of a scientifically proven calibration
            method of the NOCSAE headform using the three inch MEP is
            introduced. Required calibration performed before testing,
            produced increased repeatability between laboratories. This
            change was mandatory for all NOCSAE licensees. The NOCSAE
            carriage assembly was made more rigid and the air craft cable
            guide wires were replaced with smoother music wire. This
            decreased friction in the drop system and increased stability
            of the carriage assembly throughout the drop impact. A tapered
            bolt for locating the different impact sites was introduced.
            The test MEP was hardened from a 36 Shore A hardness natural
            rubber surface to a 43 Shore A hardness urethane to produce a
            more consistent impact surface. These changes resulted in
            significantly higher impact velocities and increased impact
            energies to the helmet, a more demanding test than in the
            previous standard. The impact energies and the velocities were
            increased to the point that sophisticated testing headforms
            were being broken and had to be redesigned and replaced at a
            cost of $350,000.

       1996--The pass/fail threshold was toughened by 20 percent,
            by changing the pass/fail threshold value from 1500 SI to 1200
            SI. The SI value of 1200 corresponds almost directly with the
            Federal Motor Vehicle Safety Standard head injury criteria
            (HIC) value of 1000.

       1999--The new anthropometrically correct size medium
            headform was introduced. This change produced a more robust
            head model to prevent the excessive breaking of headforms that
            had resulted from the earlier changes made to the drop system
            that increased drop velocities and energies. This change
            created a head model that is less likely to break under normal
            use and resulted in a more demanding helmet test particularly
            for impact sites located along the rear portion of the
            headform. After extensive tests were carried out on the new
            medium head model, the size small and large headforms were
            introduced in 2002.

       In 1994, NOCSAE introduced a proprietary data acquisition
            and analysis computer and software program and mandated its
            implementation by all licensed helmet recertification entities.
            This system has been refined multiple times over the
            intervening years, and in 2003, the entire system was replaced
            with a second-generation data acquisition system. One of the
            strengths of this test and data acquisition system is to
            prevent invalid helmet test results from being recorded.

        In the last five years, NOCSAE has clarified the zero defect or
    zero AQL quality assurance requirements of the standards, has added a
    third low-level impact requirement with a separate lower pass fail
    threshold, and has required that helmet impact velocities during the
    test be directly measured with a light activated velocity gate instead
    of utilizing mathematical calculations based upon acceleration of
    gravity.
        As a result of the revisions, modifications, and updates made by
    NOCSAE to its standards, football helmets certified to the NOCSAE
    standard outperform helmets certified to any other standard, whether in
    energy management, head coverage, durability, weight, low-energy and
    high energy impact performance.

        Question 2. Given the misleading claims by many manufacturers based
    on little or no scientific evidence, why has NOCSAE not developed
    marketing guidelines for products that meet its standards?
        Answer. NOCSAE is a standards development organization. The scope
    of our authority is limited to matters regarding compliance with the
    NOCSAE standards by licensed manufacturers and reconditioners who
    certified products to the NOCSAE standards. NOCSAE does exercise
    control over advertising content with regard to the appropriate and
    proper use of all registered and trademarked names, marks, and
    properties used in connection with certification to the NOCSAE
    standards. Unless the licensee improperly and impermissibly uses those
    registered properties as part of the objectionable content in
    advertising, NOCSAE has no authority to address or provide guidelines
    beyond that scope. The license agreement NOCSAE has with each
    manufacturer or reconditioner covers a licensee obligations with regard
    to certification and compliance with the standards is a unique and
    powerful control over the integrity and validity of the NOCSAE
    standards, but it cannot provide a legal basis for the regulation of
    advertising content unrelated to the proper use of registered and
    trademarked properties in compliance with the NOCSAE standards.
                                     ______

         Response to Written Questions Submitted by Hon. Tom Udall to
                                  Mike Oliver

        Question 1. NOCSAE's standard development process. Mr. Oliver, many
    standards development organizations follow a code of good practice
    embodied in the American National Standards Institute's Essential
    Requirements: Due process requirements for American National Standards.
        These ANSI Essential Requirements include provisions for balance,
    openness and lack of dominance by any single interest category,
    individual or organization. Despite your description of NOCSAE's
    membership and mission, your organization falls short of the ANSI
    Essential Requirements for standards development in several important
    respects. Will NOCSAE commit to becoming fully compliant with the ANSI
    Essential Requirements for standards development? If so, by what date?
        Answer. NOCSAE voted in June 2011, to seek accreditation as an ANSI
    Standards Developer, and is in the process of preparing an application
    for that purpose. It is anticipated that such accreditation will be
    straightforward, given the fact that existing NOCSAE procedures and
    board membership already comply with the essential due process
    requirements contained in the ANSI procedures.
        Being an ANSI Accredited Standards Developer signifies that
    standards are developed using a fair, open process that ensures a level
    playing field and will meet the needs of materially affected interests,
    and NOCSAE written policies and by-laws address those core concepts and
    values.
        According to published ANSI 2010 Essential Due Process provisions,
    the hallmarks of the ANSI due process are openness, consensus by a
    balance of materially-affected interests, consideration of views and
    objections, lack of dominance by any affected interest, transparency of
    the process, and provisions to provide fundamental fairness. The NOCSAE
    By-Laws define the membership of the board of directors to create a
    balanced and diverse consensus body representing materially affected
    interests from a variety of national organizations which represent
    those diverse interests on a broad national scale. These interest
    categories include medical, consumer/athlete end-user, scientific, and
    manufacturing interests. Membership number limits each category
    precludes any single interest group from having a controlling vote or
    veto. This defined membership structure of the NOCSAE board also
    satisfies the ANSI definition of a consensus body.
        Additionally, ANSI requirements for specific written procedures to
    be followed in adopting and publishing standards that provide for
    public notice and comment periods, periodic review and reaffirmation,
    and the use of standardized nomenclature have been a part of the NOCSAE
    procedures for many years.
        The application for ANSI accreditation will be submitted before
    January 30, 2012, but it cannot be known when the application will be
    approved by ANSI.

        Question 2a. NOCSAE's market surveillance. Mr. Oliver, you state in
    your testimony that NOCSAE performs market surveillance. This seems to
    contradict what is written in the NOCSAE drop impact test method used
    for football helmets, which clearly states that:
        ``NOCSAE publishes standards but does not conduct surveillance to
    assure compliance to standards. It is the sole responsibility of firms
    that manufacture or recertify protective products to certify that all
    requirements of these standards are met, including ongoing
    statistically relevant QC protocols.'' Can you explain this discrepancy
    between your statement and what is written in the NOCSAE standard?
        Answer. The reference in the standards that NOCSAE ``. . . does not
    conduct surveillance to assure compliance to standards'' refers to
    market surveillance that is typically performed by certifying bodies,
    such as CE Notified Bodies in Europe, and certifying bodies in the
    United States such as Underwriters Laboratories and the Snell
    Foundation as part of their product certification duties. NOCSAE is not
    a certifying body and so does not conduct formal market surveillance as
    part of the standards development process, and the referenced paragraph
    is intended to make that fact clear to consumers, manufacturers, and
    licensees.
        The purpose of a market surveillance program utilized by certifying
    bodies is to protect the integrity of the certification mark, to
    prevent counterfeit and non-conforming products from reaching the
    consumer market, and as a check on the manufacturer who is placing the
    certifying body's mark on the product. ``Market surveillance'' as
    commonly used in this context involves the certifying body
    supplementing its own product certification testing on limited samples
    provided by a manufacturer with tests on a sample of unused certified
    products purchased in the market after the certified product has been
    distributed by the original manufacturer.
        But many of the policies and duties imposed by the NOCSAE standards
    and the license agreement between a manufacturer and NOCSAE involve
    activities that would fit the definition of market surveillance, and
    which accomplish the same goals as with a certifying body, although on
    a much more demanding and far reaching scope than any traditional
    market surveillance program maintained by a certifying body.
        Formal and traditional market surveillance programs test only new
    products purchased at retail to verify the accuracy of the
    certification mark, but no surveillance program tests used products as
    part of that process. The NOCSAE recertification standards involve
    testing and evaluating previously certified equipment for as long as
    the equipment is being used and submitted for recertification. To make
    an analogy, the NOCSAE product surveillance program would be the
    equivalent of Underwriters Laboratories going into homes and re-testing
    toasters that have been in use for years, and verifying that the
    toasters still comply with the original UL mark.
        Testing used helmets for the purpose of recertification is also an
    affirmation and validation of the integrity of the new helmet
    certification. If the helmet meets the standard after it has been used
    for several seasons, it is a given that it met the standard when it was
    newly certified. That fact alone obviates the need to purchase new,
    unused helmets at retail in order to verify the accuracy of the
    original certification.
        Each year, NOCSAE licensed recertifiers re-test tens of thousands
    of randomly selected helmets of varying brand, model, age and condition
    based on time elapsed since last reconditioned. This recertification
    process is regulated by NOCSAE standard, and controlled by proprietary
    testing and data acquisition software developed by and for NOCSAE. The
    re-testing process is randomized sample based, and involves testing a
    helmet both in the exact condition it was in when it last came off a
    player's head, without any repair or modification, and then testing the
    very same helmet again after it has completed the reconditioning
    process. For each helmet tested, the program collects 28 separate data
    points, including brand, model, model year, size, test headform model
    and size, test laboratory temperature, date and time of testing, the
    name of the test technician and the laboratory name and location, and
    the performance test scores for 8 separate impacts across 4 different
    impact locations.
        In the 2009-2010 reconditioning season, there were 50,508 different
    football helmets tested representing over 50 different models spanning
    more than 10 model years. Additionally there were 880 lacrosse helmets
    tested, and over 1,500 batters helmets tested.
        The NOCSAE data acquisition computer and software used by each
    recertification facility forces an internal and external system
    function and calibration check before and after each batch of helmet
    testing. If the pre-test calibration check test fails, the system
    prohibits testing until the calibration failure is resolved. If the
    system and calibration check test fails after a batch of helmets is
    tested, the test results for those helmets is voided and dumped into a
    special file, and all the helmets tested in that batch must be re-
    tested. If the pre-and post-test calibration and system checks pass,
    the helmet test results are stored in an encrypted file which is
    accessible only by the NOCSAE Technical Director for review and
    analysis.
        This dataset provides market and product surveillance information
    for certified helmets new and old, as well as information on team and
    school reconditioning frequency across the country, and on the quality
    controls of each licensed recertifier. From this data an extremely
    detailed historical record of the performance over time of helmet
    models by year, age, and years since last reconditioned has been
    developed. As an example, in the 2009-2010 dataset, the before and
    after performance of several models can be compared over 15 model years
    to determine whether there is a decline in the performance of the
    helmet, and to what extent the reconditioning process has restored or
    even improved the helmet's original performance levels. There is no
    other market surveillance program in the world for personal protective
    equipment that comes close to evaluating the continuing validity of the
    equipment certification.
        A combined dataset that includes testing done from 2005 through
    2011 contains 7,728,000 separate data points on 276,000 individual
    helmets, and includes 2,208,000 helmet impact performance data points.
        This product surveillance process is supplemented by a mandate that
    each certification and recertification facility participate in round-
    robin system equipment calibration programs directed by an A2LA
    accredited laboratory at least once a year, and more often if
    indicated.
        As with many international product certification programs, the
    NOCSAE standards mandate that licensees submit certified products for
    testing and validation annually to a third party testing laboratory
    certified to ISO 17025 standards, and that new products or models must
    be submitted for third party laboratory validation in advance of
    distribution. In order to receive a license agreement an applicant must
    first submit a report from an appropriately accredited third party
    laboratory confirming that the products they intend to certify to the
    NOCSAE standard actually meet the standard. Those validation tests and
    reports are a check on the accuracy and validity of the original
    certification of that product consistent with the goals and intent of a
    formal market surveillance program. NOCSAE follows almost the identical
    third-party laboratory validation protocol requirements mandated by the
    CPSC for bicycle helmets certified to the CPSC standard.
        Additionally, if NOCSAE is made aware of a potential invalid or
    incorrect certification, NOCSAE does engage in a focused investigation
    in the form of direct helmet purchase at retail, and testing to
    determine whether the manufacturer's certification is void or valid. We
    will also demand the production of all certification testing data and
    results, including all QA and QC that the licensee uses to support its
    certification of helmets, both as an independent check on the
    certification process, and as part of an investigation as to a specific
    product.
        NOCSAE does not conduct formal market surveillance as part of a
    product certification program, but the requirements in the NOCSAE
    equipment performance standards result in a product surveillance and
    validation function which far exceeds traditional certifying body
    market surveillance programs both in scope and performance demands as
    it validates and verifies helmet standard compliance certification for
    new and used helmets.

        Question 2b. Did NOCSAE ``market surveillance'' efforts, if any,
    discover problems related to compliance with NOCSAE standards at any
    helmet manufacturer or reconditioner? My understanding is that NOCSAE
    did not learn of problems at a New Jersey reconditioning company, for
    example, until after they were exposed by a Federal criminal probe.
        Answer. The only reconditioner that was the subject of a Federal
    investigation was Circle System in Easton, Pennsylvania, and that
    investigation did not involve failed helmets or a failure to properly
    test helmets. The breach in that case was the fraudulent underreporting
    of the number of helmets recertified. There was never a finding by the
    FBI or NOCSAE, following its own separate investigation, that the
    recertified helmets from Circle System failed the recertification
    tests, or that the helmets were poorly reconditioned. From what little
    has been revealed by the investigators and in the press, the owners of
    Circle System apparently defrauded their insurance company and NOCSAE
    by intentionally underreporting the total number of helmets
    recertified, thereby saving significant premium expenses and license
    fees, while at the same time double billing school districts and
    customers.
        Market surveillance testing would not have discovered this type of
    fraud. Reconditioned helmets are not sold at retail, and the helmets
    reconditioned and recertified by Circle System had been reconditioned
    several times before the fraud was discovered, and there was no data to
    support any conclusion that he helmets had been improperly
    reconditioned or incorrectly recertified.
        Although no incidents of product failures have been discovered,
    NOCSAE has discovered several situations which required a licensee to
    revise and supplement its QA and QC programs, and provide supplemental
    testing of larger samples to meet those requirements.

        Question 3. No NOCSAE requirement for maximum helmet lifespan. Mr.
    Oliver, you stated during the hearing that NOCSAE relies on
    manufacturers regarding the recommended lifespan of football helmets.
    However, NOCSAE's own technical director, Dave Halstead, told The New
    York Times he ``would never let [his] kid wear a helmet that is more
    than 10 years old.'' Another NOCSAE expert, Dr. Robert Cantu, wrote in
    review comments for the 2006 Neurosurgery study of Riddell Revolution
    football helmets that:

            ``As Vice President of the National Operating Committee on
            Standards for Athletic Equipment (NOCSAE), the organization
            that makes the certification standards for football helmets and
            other athletic equipment, I am aware . . . that new helmets
            test to a higher severity index level than older helmets. New
            helmets out of the box before receiving the thousands of hits
            that they will incur on ensuing seasons often test
            significantly below the 1200 severity index that they must
            pass. Then, with each year's passage of time, their abilities
            to attenuate acceleration forces decline.''

        Dr. Cantu is also quoted in the book Head Games: Football's
    Concussion Crisis from the NFL to Youth Leagues (page 109) as follows:
    ``The brand new helmets that come right off the shelf are about 800
    [SI], way better than the letter of the rule. Over the course of a
    season, or seasons, they get worse. . . .''
        Given that NOCSAE's own experts believe newer helmets are safer
    than older ones, will NOCSAE commit to revising its football helmet
    standards to include a maximum lifespan for football helmets?
        Answer. Questions regarding the proper life span of a helmet,
    sometimes referred to as the useful safe life, involve considerations
    unique to each manufacturer such as design function, product liability
    exposure, proper care and treatment, and materials performance
    characteristics that are outside the authority and function of an
    independent standards setting body such as NOCSAE. Helmet performance
    standards developed by NOCSAE are intentionally design neutral so that
    engineers and designers are not restricted in their approach to helmet
    function and design. That freedom has resulted in the development of at
    least three unique engineered approaches to protecting the heads of
    athletes that involve different materials, different mechanical
    properties, and even different physics principles. Because of these
    differences, life span issues that might be relevant to one type of
    system may not be relevant to the others. Because a standard, by
    definition, must apply equally to all products within its scope, any
    provision that imposes a limit on how long a helmet can be used will be
    an arbitrary decision which can unduly harm one brand while giving an
    advantage to another. The creation of a maximum life for a helmet
    through a standard also creates a risk that players and parents will
    assume that a helmet is safe and needs no attention as long as it is
    still within the defined ``useful safe life.'' Notwithstanding these
    concerns, what NOCSAE can do, and what it does, is continuously
    evaluate the performance of helmets over time to see if there are data
    that might indicate the need to further investigate this issue.
        I am personally familiar with each individual quoted, and based
    that and the actual helmet performance test data that NOCSAE has
    collected over the past 15 years, I am confident that Dr. Cantu and Mr.
    Halstead were referring to older helmets that have not been properly
    and regularly reconditioned when they were commenting on helmets of a
    particular age. Recertification test data covering hundreds of
    thousands of helmets document a helmet's performance over time and
    under various reconditioning frequencies, and the data does not support
    a conclusion that a helmet's age, standing alone, is related to that
    helmet's performance abilities. There is very little, if any, decline
    in the performance of a football helmet over the course of a season,
    absent significant abuse or intentional alteration of the padding
    system. Football helmets are designed to handle repeated impacts in
    quick succession over thousands of impacts. Current literature
    involving the in vivo collection of football helmet impacts over more
    than 7 seasons by researchers at upper division colleges and at the
    high school level has shown that a player's helmet will likely be hit
    more than a thousand times per season. In 2009-2010, new 2009 helmet
    models tested after just a single football season and before any
    reconditioning, averaged in the 500 to 600 SI range on the impact
    location which is most likely to have the highest SI values. That value
    is almost identical to the average SI values scores as new unused
    helmets, and in many cases that number is actually lower than when the
    helmet model was tested for certification as a new helmet.
        For a 10 year old helmet that has been properly reconditioned and
    has had the padding system replaced with new padding that meets or
    exceeds the original padding performance levels, the only 10 year old
    part of that helmet is the shell, and unless the shell is cracked,
    which would prevent its recertification, that helmet should perform as
    good if not better, than when it was new. And the recertification
    testing data shows that such is true.
        Tragically, catastrophic and even fatal head injuries have occurred
    to players wearing brand new helmets, which speaks more to the fact
    that there are some serious and even fatal head injuries which cannot
    be prevented by any helmet. The rapid and usually fatal brain swelling
    and auto-regulatory dysfunction that is seen in second-impact syndrome,
    which seems consistent with facts describing the injury to Max Conradt,
    can occur from very slight hits to the head and even without head
    contact through whiplash type accelerations of the head if that player
    has been returned to play too soon following a concussion. In those
    cases, the injury risk likely is unrelated to the age or performance of
    the helmet being worn.

        Question 4. Helmet requirements for high school football. The
    National Federation of State High School Associations (NFHS) sets
    football playing rules and equipment guidelines that are adopted by
    many state athletic associations. The 2010 NFHS Football Rules book
    requires players to wear a football helmet and face mask that ``met the
    NOCSAE test standard at the times of manufacture'' (see page 17).
    However, NFHS rules allow a football helmet that is no longer in
    compliance with NOCSAE standards to be worn by high school player as
    long as the helmet met NOCSAE standards when it was originally made.
    NFHS also does not require that an older helmet be reconditioned and
    recertified to NOCSAE standards. Should high school football equipment
    rules require that any helmet used by a player meet current NOCSAE
    requirements when it is actually being worn--and not just on the day it
    was manufactured?
        Answer. As with any equipment or product certified as compliant
    with a standard at the time the new product was manufactured, once
    placed in use, the continued validity of that certification is
    dependent not only upon proper use and care, but also on the designed
    durability of all component parts, and the margin between the
    standard's pass-fail threshold requirements and the actual helmet test
    performance when certified. From years of post-use recertification
    testing of all brands and models and ages of helmets, 99.86 percent of
    the helmets tested from the field after one or more seasons of use and
    before reconditioning will perform far below the threshold and still
    meet the standard by a significant margin. This extremely high
    percentage includes all helmet models, all ages, and all conditions,
    and it includes helmets which may have had altered or damaged padding,
    since the BEFORE reconditioning test of these randomly selected helmets
    does not permit repair before the helmet is tested. When tested after
    reconditioning, the percentage that passes is 99.95 percent, and the
    0.05 percent that doesn't pass is not returned to the school or club.
    So the persistence of the validity of a helmet's certification to the
    NOCSAE standard over time and use is extremely high when helmets are
    regularly reconditioned. That means that it is extremely rare for a
    helmet to be used by a player that doesn't meet the standard, even
    after significant use over several seasons.
        An important reason for such extremely high certification validity
    persistence is the Quality Control and Quality Assurance levels that
    are imposed upon NOCSAE licensees who certify their equipment to NOCSAE
    standards. In order to reach the zero defect or 0 AQL levels, the
    average passing SI value for every new helmet impact location must be
    substantially below the pass-fail threshold of 1200 SI. For all new
    2010 adult and varsity helmets in size medium certified to the NOCSAE
    standard, the average certification SI value was 497 on the front
    location, which historically has the highest SI values. This same
    general margin has existed for many years.
        With the levels of Quality Assurance and Quality Control mandated
    by the NOCSAE standard, all organizations, including high schools,
    should have the highest level of confidence that the helmets meet the
    NOCSAE standard.

        Question 5. Football helmet reconditioning. The NOCSAE website FAQ
    page states that ``There is nothing in the NOCSAE standard that
    requires any helmet to be recertified on any regular basis.'' Ralph
    Conradt states that his son Max was injured while wearing a twenty year
    old helmet that, when tested after Max's injury, was found to not meet
    NOCSAE's safety standards. Given that some high school football players
    could be wearing unsafe helmets that are twenty years old and that no
    longer meet NOCSAE standards, will NOCSAE commit to updating its
    football helmet standards to require reconditioning on a regular basis?
        Answer. How frequently a particular helmet should be reconditioned
    and recertified is dependent upon many uncontrollable variables,
    including the level and intensity of usage and condition at the end of
    a season. The reconditioning and recertification process is a
    significant budget item for most high schools, and a standard
    arbitrarily mandates annual reconditioning where the data does not
    support the conclusion that annual recertification is necessary at
    every school or with every helmet simply adds additional budget and
    expense burdens to school districts already facing severe pressures.
    NOCSAE is committed to exploring options in this regard, and currently
    strongly recommends reconditioning and recertification every year. When
    a school or club cannot afford annual recertification of all their
    helmets, NOCSAE strongly recommends the adoption of a two-year or
    three-year cycle of regular reconditioning and recertification such
    that each year one third to one half of the helmets in the program are
    submitted for reconditioning and recertification, and the remainder are
    evaluated pursuant to a written inspection and assessment program to
    identify helmets with obvious damage, missing pads or components, or
    other signs that indicate the need for reconditioning and
    recertification, even if that helmet is not scheduled for
    reconditioning.
        Data available to NOCSAE from the recertification test datasets
    establishes that, with the exception of helmets which are missing pads
    or which have been altered or may have broken shells, there is no
    statistically difference in the average SI values of helmets submitted
    every year for reconditioning/recertification and those submitted every
    other year, or even every three years. As a general rule, the primary
    benefit of annual reconditioning and recertification is that it inserts
    an experienced third party into the helmet inspection and assessment
    process, and increases the likelihood that hidden problems or
    unrecognized damage will be discovered and addressed, and it probably
    would limit the swapping of pads and padding systems among different
    helmet brands and models.

    Max Conradt
        When the helmet used by Max Conradt was made and certified to the
    NOCSAE standard in 1983, the pass/fail threshold in the standard was
    1500 SI. Helmets can only be recertified to the standard applicable to
    the original certification. The testing data presented to the court in
    the Conradt case by an accredited laboratory acceptable to the court
    and to each side, established that the helmet in question, when tested
    to the NOCSAE standard after Max Conradt was injured passed all impact
    test locations below the 1500 SI threshold, and even passed all impact
    location tests to the 1200 SI threshold, with one location exception,
    and that location was not a location where it was suspected that Max
    had been hit. The Conradt helmet was manufactured in 1983, just 3 years
    after the NFHS made compliance with the NOCSAE standard mandatory for
    high school play. As recently as 2009-2010, of the 48,000 randomly
    selected helmet sample set tested for recertification, there were 28
    helmets in the sample set made before 1991, and all tested below the
    1200 threshold BEFORE (meaning as they were in use and on the field)
    reconditioning on every test impact location, even though the
    applicable threshold for those helmets was 1500.
        The type of severe and life changing head injury sustained by Max
    Conradt, although very rare, has no specific association with the age
    or SI values of a particular football helmet. Almost identical non-
    fatal and fatal injuries have occurred to players wearing brand new
    2009 and 2010 helmet models, and some epidemiological data suggest that
    the rate of occurrence of these types of injuries has remained
    relatively steady over time, unaffected by improvements in helmet
    technology, SI values or helmet age.
        Certainly the best level of protection any helmet can provide is a
    function of proper maintenance, regular reconditioning and
    recertification, and following warnings and instructions. No standard
    can guarantee an outcome or even a performance level, but compliance
    with the NOCSAE standard will provide the player, coach and parent with
    the highest level of protection available today, and as much assurance
    as is possible that the helmet will continue to meet that standard as
    long as it is properly maintained.

        Question 6. Football helmets in use at high school and younger
    level. USA Football estimates that there are 3 million youth football
    players. In addition, there are an estimated 1.4 million high school
    football players. Of this group of about 4.4 million football players,
    how many are wearing:

            (1) new helmets

            (2) helmets manufactured or reconditioned in the last year

            (3) helmets manufactured or reconditioned in the last two years

            (4) helmets that have not been reconditioned in more than two
            years

            (5) helmets older than two years that have never been
            reconditioned?

        Answer. It is impossible to know the answers with definite
    certainty because many of those players are outside the control and
    supervision of any national governing body. We do know that on average
    there are approximately 800,000 new helmets sold each year, and
    approximately 52 percent of those are categorized as ``youth models''
    which could include models intended for use at the middle school level.
    We also know that there are youth players who must wear adult or
    varsity helmets because the youth models are too small for them.

            (1) new helmets: approximately 800,000 are wearing new helmets

            (2) helmets manufactured or reconditioned in the last year: 2.5
            million

            (3) helmets manufactured or reconditioned in the last two
            years: 3 million

            (4) helmets that have not been reconditioned in more than two
            years: it is impossible to know this number exactly. We know
            that each year there are approximately 250,000 helmets sent for
            reconditioning and recertification that have not been
            reconditioned for more than 2 years, but we currently have no
            way to know whether that number is statistically representative
            of the helmets in the field.

            (5) helmets older than two years that have never been
            reconditioned: unless the helmets are sent for reconditioning,
            there is no way to answer to this question.

        Question 7. NOCSAE drop test and helmet quality. My understanding
    is that the NOCSAE safety standard for football helmets is primarily a
    drop test method that requires helmets to score less than a 1200
    severity index (SI) level. Is there a difference in the level of
    protection offered by a helmet that tests at an 1199 SI level and a
    helmet that tests at a 300 SI level?
        Answer. The answer depends on which type of injury is being
    analyzed. The 1200 SI threshold is premised upon a risk analysis curve,
    very much the same as HIC values used in Federal Motor Vehicle Safety
    Standards. The HIC and SI plotted curves are logarithmic and as the
    values pass downward through 1200 the curve flattens such that
    measurable differences between 1200, 1100, 1000, and on down become
    very small. As to those injuries for which the 1200 SI threshold is
    intended to address, no quantitative or qualitative comparisons can be
    made between SI values of 300 and 1100 as to which will prevent more
    injuries. Certainly lower (all other helmet attributes like mass and
    shape being the same) would be better in general, but there is no
    linear relationship or scale than can state with any confidence how
    much more protective a lower value is over a higher value. This is
    particularly true with regard to the kinds of engineering and design
    changes that might be necessary to obtain lower values, and whether the
    impact being tested is a high energy impact or a low energy impact.
        An SI score of 1200 is essentially equivalent to a HIC score of
    1000, which represents the ``safe'' limit of human injury tolerance,
    above which the risk of a fatal or catastrophic head injury is clear,
    and the probability of that type of injury rapidly increases with
    higher SI values. But because of the logarithmic characteristic of the
    scale, the converse is not true as the values decrease below 1200. The
    1200 SI threshold is like a doorway, once you are through it you can go
    further into the room, but outside is still outside. An SI value lower
    than 1200 represents some reduction in risk, although very minor
    (negligible), but going higher represents a near exponential increase
    in risk. The importance and validity of HIC or SI as weighted impulse
    criteria is frequently debated but the criterion remains extensively
    used because no better formulations or thresholds have demonstrated
    reduced injury risk. For example, in the USA, Europe and elsewhere,
    government mandated performance requirements for automotive seatbelts,
    airbags and other safety devices are specified in terms of a `not to
    exceed' HIC score, with no specified benefits for being under that
    limit by any percentage.

        Question 8. Clearly visible labels. Mr. Oliver, you stated during
    the hearing that NOCSAE does require clearly visible ``date of
    manufacture'' and ``date of last reconditioning'' labels for football
    helmets. However, the primary NOCSAE technical standard for football
    helmets, NOCSAE DOC (ND) 001-08m10, in section 9.4, states that helmets
    must have:

            ``A permanent and legible label or mark that denotes the month
            and year of manufacture that can be easily read without
            removing any permanent component. If this mark or label
            requires a `code' to determine month and year, such code shall
            be made available upon request.''

        This contrasts with the standard's requirements that other labels
    are ``not obscured in any manner.''

       Will NOCSAE commit to revising its standard to include a
            requirement for clearly visible date of manufacture and date of
            last reconditioning labels that are not obscured in any manner?

       Will NOCSAE commit to revising its standard to require that
            the date of manufacture and date of last reconditioning be
            easily read and understood by players, coaches and parents? In
            other words, will NOCSAE require that such labels are not
            written in ``code'' which can only be interpreted by the
            manufacturer or reconditioner
        Answer. New Helmets. NOCSAE is committed to evaluating the existing
    standard requirements for the placement and visibility of a
    manufacturing and recertification date for helmets certified or
    recertified to the NOCSAE standard. The NOCSAE standards incorporate
    the considerations contained in ANSI Z535.4, and NOCSAE is committed to
    continued compliance for all helmet labeling and warning requirements.
    We are currently exploring several options for improvement, and we are
    committed to that process as we always are in maintaining NOCSAE
    standards. Deciding whether and how a specific piece of information is
    located and identified on the helmet also involves human factors
    consideration as to whether such information may dilute the effect of,
    or divert visual attention from, other specific hazard warnings and
    signal words already on the external portions of the helmet.
        ANSI warning label requirements distinguish between warning labels
    that address hazards and those which convey information that may be
    related to hazards and indicate matters such as location and
    visibility. The age of the helmet shell, which is all the manufactured
    date will reliably indicate for a used helmet, is not related to any
    identified hazard or risk of injury, nor is it a piece of information
    reasonably necessary to be accessed under emergent circumstances. There
    is also no common agreement or understanding with regard to whether the
    more important date for a consumer or user is the date the helmet was
    first used and not the date the shell was made. A helmet with a
    manufactured date of 2009 may not first be used by a player until the
    fall of 2011. Is the manufactured date for that helmet more
    representative of its quality and ability to perform than a helmet with
    a manufactured date of 2010, but which has been used for part of the
    2009-2010 season and all of the 2010-2011 season?
        To complicate matters more, there are helmets which may have their
    component parts manufactured on different dates and not actually
    assembled for a year or more. Which date is the one which should be
    provided to the consumer in those cases? If the shell was manufactured
    in 2009, the various protective energy attenuating system components
    manufactured in 2008, 2009, and 2010, and final assembly of that helmet
    did not occur until 2012, which of those dates is provides material and
    useful information for the consumer to know with regard to the ability
    of that helmet to perform? The issue of a manufactured date is not a
    simple one, and NOCSAE is committed to investigate and address the
    matter to determine if there's a better or more functional way to
    present the model year information.

    Reconditioned Helmets
        NOCSAE recertification standards have required for many years that
    the reconditioning and recertification date be plainly visible and
    placed on the helmet. The recertification date and the identity of the
    entity that performed the reconditioning and recertification are
    required. All licensed recertifying companies follow the same format
    and actually use the same company to print the labels for each season.
    If the manufacturer's original certification logo is no longer visible
    on the outside of the helmet, then a recertification label must be
    placed on the outside. An example of the outside information mandated
    by the NOCSAE standard is:

        Every recertified helmet must also have a label on the inside,
    underneath the padding, which includes a statement verifying
    recertification and indicating the year and name of the company which
    performed the recertification. Placement of this information on the
    inside of the helmet shell and underneath removable padding makes it
    easily accessible, while also protecting the label and information from
    damage and removal during usage. As with the manufacturing date of a
    helmet or helmet shell, the recertification date and identity of the
    recertifying entity is not information that would need to be accessed
    quickly under emergency circumstances, but should be easily accessible
    without having to remove permanent component parts.

        Question 9. NOCSAE licensing agreement and advertisements with
    NOCSAE seal. Mr. Oliver, your written testimony states that NOCSAE's
    licensing agreement with helmet makers ``obligates each licensee to
    obtain prior approval of proposed advertising which uses the NOCSAE
    name or references NOCSAE as part of its advertising.''
        A Riddell brochure titled ``Revolution Helmet Research Findings''
    (available at: http://www.lohud.com/assets/pdf/BH1661391028.PDF,
    accessed Oct. 19, 2011) references NOCSAE in three separate places and
    includes the NOCSAE seal in two places. This advertisement prominently
    features Riddell's claim that research shows a ``31 percent reduction
    of the relative risk of sustaining a concussion when wearing a
    Revolution vs. a traditional helmet.''

       Did Riddell obtain approval from NOCSAE to use the NOCSAE
            seal and name in this brochure?

       If so, why did NOCSAE approve the use of its seal and name
            in an advertisement featuring a concussion reduction claim that
            NOCSAE technical director Dave Halstead and NOCSAE board member
            Dr. Robert Cantu have publicly criticized?

        Answer. The authority of NOCSAE under the license agreement to
    review licensee advertising is limited to ensuring compliance with
    permitted uses of the name, phrases and certification marks which are
    trademarked and registered properties of NOCSAE. The license agreement
    does not provide NOCSAE with a blanket right or duty to review and
    approve all advertising content, nor to impose its own opinions as to
    the accuracy of claims that do not involve actual or potential misuse
    of the registered and trademarked properties. The NOCSAE seal, mark and
    name were properly used in the referenced advertising, and were not a
    part of or suggested as support for the other claims in the
    advertising. NOCSAE does not endorse recommend or indicate the use of
    any particular helmet, other than to state that the helmet meet the
    standard.
        NOCSAE board members and independent contractors, such as Mr.
    Halstead, are free to comment on matters of interest to them, including
    the references described in this question.

        Question 10. Independent Testing and Certification. Mr. Oliver,
    your testimony states that ``NOCSAE also maintains an ongoing
    independent contract with an A2LA accredited and ISO 17025 certified
    testing laboratory.''

       Is this testing laboratory also accredited to ISO Guide 65,
            ``General Requirements for Bodies Operating Product
            Certification Systems''?

       Does NOCSAE's testing laboratory have any commercial ties to
            helmet manufacturers or reconditioners that could potentially
            create a conflict of interest when certifying helmets to NOCSAE
            standards? If so, please clearly describe any such potential
            conflict of interest.

        Answer. It should be kept in mind that neither NOCSAE nor the
    laboratory in question certifies products or equipment to the NOCSAE
    standards. ISO Guide 65 pertains only to entities which actually
    certify products or equipment. Certification of compliance with NOCSAE
    standards is done by the manufacturer pursuant to a license agreement,
    and annual proof of compliance with the standards through third-party
    laboratory validation testing. The procedure tracks very closely to the
    self-certification made by manufacturers under the CPSC rules for
    bicycle helmets, except that the authority of NOCSAE over the
    manufacturer is based on the license agreement, not Federal laws and
    regulations.
        The laboratory with which NOCSAE contracts for technical advice and
    testing is the Southern Impact Research Center, (``SIRC''). SIRC is
    A2LA accredited and certified as compliant with ISO 17025 standards for
    independent testing laboratories to perform testing to all NOCSAE
    standards, and is also an approved and accredited testing laboratory
    under the CPSC Bicycle helmet standard, and is directly approved by the
    CPSC for independent testing under 16 CFR Part 1203 and Part 1501. SIRC
    is also A2LA accredited to perform testing under FMVSS 218 VESC-8, Sec
    8 for motorcycle helmets eye protection and many other helmets. The lab
    is under contract with the military for independent testing of military
    related items.
        SIRC is not certified under ISO Guide 65, at least for NOCSAE
    purposes, as they do not perform product certification to the NOCSAE
    standards, but SIRC is involved with product certifications with the
    Safety Equipment Institute which is a Guide 65 entity.
        The only commercial relationships which SIRC has with manufacturers
    who may also be NOCSAE licensees would be on a job by job basis where a
    licensee may contract with SIRC laboratory to conduct validation
    testing, or to submit products for evaluative testing. All board
    members and contractors are required to submit conflict of interest
    disclosure statements.

        Question 11. NOCSAE not keeping football helmet standard up to
    date. Mr. Oliver, several NOCSAE members have publicly criticized your
    organization for not doing enough when it comes to keeping helmet
    standards up to date. In an October 20, 2010 New York Times article,
    reporter Alan Schwarz quotes Dr. Robert Cantu as saying that NOCSAE has
    been ``asleep at the switch'' and that Cantu has been ``calling for a
    new standard to be written for football helmets for years, and NOCSAE
    has been sitting on their duffs.''
        The New York Times article further notes that: ``Dr. Cantu. . .said
    that the board has become as concerned about legal liability as about
    child safety. If [NOCSAE] were to supplement its helmet standard in an
    attempt to address concussions, it could open itself to lawsuits
    brought by players saying that their helmet did not prevent the injury.
    . . .''
        Dr. Blaine Hoshizaki, from the University of Ottawa, told the The
    New York Times that he lobbied NOCSAE to strengthen its standard five
    or six years ago but he says, ``It was like punching a balloon; they,
    yes, understand, and then do nothing.'' In the article, he goes on to
    say of NOCSAE: ``They say they don't know what the thresholds are; OK,
    but I can tell you that less angular acceleration is better than more .
    . . To suggest we have no idea so we'll do nothing is not an excuse to
    me. This has become a serious impediment to making a safer football
    environment.''

       Given this level of criticism from NOCSAE's own experts, why
            should coaches and parents of young football players rely on
            NOCSAE to maintain up-to-date voluntary safety standards for
            football helmets?

       What steps will NOCSAE take to update and maintain its
            helmet standards given new medical understanding of concussion
            risk and the latest state of the art in helmet technology?

        Answer. I have attached copies of the written responses from each
    gentleman addressing The New York Times assertions with regard to
    NOCSAE. I cannot explain why the quotes in the article differ markedly
    from what the quoted speakers have said in response, nor can I explain
    why the article contains assertions that differ from the documented and
    uncontested facts
        The quotes from The New York Times do not accurately reflect the
    comments and opinions of those who were quoted. In a letter he prepared
    and sent to Mr. Schwarz, (attached as Appendix A) Dr. Cantu took issue
    with the quotes attributed to him:

            ``Since 2000, NOCSAE has provided approximately $2.4 million to
            fund research grants looking at all aspects of concussion in
            sports, including validation of the new linear impactor. In
            January 2010, by motion I fully supported, NOCSAE created a
            special ad hoc committee to examine any other possible avenues
            to more rapidly advance science and research in the area of
            concussion. The NOCSAE Multi-Disciplinary Expert Task Force
            which met on October 23 on Cape Cod was one of those avenues
            identified by the ad hoc committee. This meeting was being
            planned and developed long before your investigation and is a
            process which NOCSAE has followed in the past.

            These activities are not those of a group that is ``asleep at
            the switch'' or that has been ``sitting on its duff,'' quotes
            you attributed to me. Every NOCSAE Board member is frustrated
            that there is yet no answer as to how concussions might be more
            effectively addressed in our helmet standards, but the
            frustration is not with NOCSAE, it is that despite our own
            internal efforts and substantial research funding to outside
            experts, science has yet to find an answer that we can
            incorporate into our helmet standards to specifically improve
            concussion protection.''

        As general counsel I can state with certainty that no decision
    regarding new standards or changes to existing standards was based or
    premised upon potential legal liability that might arise because of the
    differences between helmets certified under older standards and ones
    certified to the newer standards. Such a decision was in fact made when
    the first NOCSAE football helmet standard was published in 1973. That
    new standard rendered almost 80 percent of existing helmets non-
    compliant. And the same decision was made when the pass/fail threshold
    was revised from 1500 SI to 1200 SI.
        To the extent any legal liability might exist at all, it would
    arise from acting arbitrarily in adopting or revising a standard
    without the valid scientific data necessary to support a conclusion
    that the change would be effective, and that it would not create an
    increased risk of other injuries. NOCSAE has a responsibility to the
    public and to players and parents to premise its standards on science
    and valid data, and it will not abandon that responsibility to cater to
    the pressures and demands of non-scientists. In order for the public to
    have the confidence that the NOCSAE standard has meaning and validity,
    it must be premised upon sound and consensus scientific data.
        Regarding the quotes attributed to Dr. Hoshizaki, I asked him for
    clarification following the printing of the article in question. The
    quotes attributed to him were personally puzzling because I knew he had
    never contacted me to discuss any of the issues identified in the
    article. I also knew that he had not attended any board meetings since
    I became Executive Director in 1995, and I was unable to find any
    correspondence or other e-mail contacts from him on those subjects. Dr.
    Hoshizaki was kind enough to respond in writing (attached as Appendix B
    to these responses), and he explained to me:

            ``As for the comments recorded in The New York Times article
            they were the author's interpretation of what I felt is a
            disconnect between NOCSAE and the broader scientific community.
            My previous discussions with David Hallstead [sic] revolved
            around understanding the process for the [sic] making decisions
            regarding the development of the NOCSAE test standards and
            resulting implications.''

        Dr. Hoshizaki is certainly a well-respected scientist and
    biomechanical engineer, and has published some excellent work regarding
    helmet performance and biomechanics of head injury. It appears that he
    was frustrated with his understanding of the NOCSAE process, and
    perhaps his interactions with Mr. Halstead on other standards related
    issues with other organizations. Mr. Halstead and Dr. Hoshizaki have
    worked together on many non-NOCSAE activities and are in fact at this
    time working together on a research project in this very area. There
    was never any lobbying effort by Dr. Hoshizaki as the reporter
    described, and the board meeting minutes do not contain any references
    to such attempts. Any such requests by Dr. Hoshizaki would certainly
    have been seriously considered and discussed, simply because of his
    reputation. In fact, the NOCSAE board had contacted Dr. Hoshizaki in
    the year prior to the printing of The New York Times article to request
    that he serve on a NOCSAE sponsored Concussion Task Force expert panel
    that was convened in October 2010 to help NOCSAE map out a plan for
    focusing research efforts to better address concussions through helmet
    standards.
        As for his quote regarding the injury threshold levels, all that
    can be said is that almost every peer reviewed article that has
    considered this question in the last 10 years has reached a different
    conclusion. The consensus scientific opinion on this issue is clearly
    expressed by Dr. Kevin Guskiewicz in a 2011 article describing the
    elusive injury threshold for concussions and mTBI:

            ``What is the relationship between clinical outcome measures
            from our earlier work and biomechanical factors? The literature
            has not adequately addressed this question. We hypothesize that
            within the spectrum of concussion or mTBI, the biomechanical
            threshold for sustaining the injury is not only elusive, but
            impact severity (measured in acceleration/deceleration) may be
            clinically irrelevant.'' Guskiewicz, K. M. and J. P. Mihalik
            (2011). ``Biomechanics of sport concussion: quest for the
            elusive injury threshold.'' Exerc Sport Sci Rev 39(1): 4-11.

        The Task Force Committee, with significant input from Dr. Hoshizaki
    and Dr. Guskiewicz, agreed there was no present threshold which could
    be incorporated into a helmet standard that could effectively reduce
    the frequency and or severity of concussions. The Task Force committee
    identified specific research and work that would be necessary to reach
    a point where revisions could be made to the NOCSAE standards that
    could effectively address concussion issues. Dr. Hoshizaki is currently
    doing some of that very work at the present time under a focused
    research grant from NOCSAE.
        There is no helmet standard in the world which more effectively or
    aggressively addresses head injuries than does the NOCSAE standard.
    Apart from the Federal government, there is no other organization that
    has invested more research dollars over the past 10 years to address
    concussion protection through helmet performance standards than has
    NOCSAE. As explained by Dr. Cantu and his written response to the
    inaccurate quotes in The New York Times article, these are the actions
    of a group that is leading the way for the development of helmet
    standards to address concussions effectively, not an entity sitting on
    the sidelines waiting on someone else to do the work.
        To the extent there is a ``new medical understanding of concussion
    risk and the latest state of the art in helmet technology'' referenced
    in the question, such advances exist in very large part due to the
    financial support from NOCSAE research grants, and the NOCSAE board,
    staff, and its Scientific Advisory Committee are intimately familiar
    with such developments, but this ``new understanding'' has not answered
    the specific questions necessary to support a change to the NOCSAE
    standards to address concussions.
        You ask ``. . .why should coaches and parents of young football
    players rely on NOCSAE to maintain up-to-date voluntary safety
    standards for football helmets?''
        In comparative testing performed on almost every type of protective
    helmet, whether sports, or otherwise, football helmets certified to the
    NOCSAE standard consistently and markedly outperform every helmet in
    all impact categories, whether in protecting from low-level impacts,
    high velocity impacts, head coverage, or durability. There is no other
    helmet standard in the world which demands the same level of quality
    control and quality assurance in the manufacturing and production
    process as that which is mandated by the NOCSAE standards. And although
    millions of research dollars have been and are being invested by NOCSAE
    to improve the standards and reduce the frequency and severity of all
    head injuries including concussions, football helmets certified to the
    NOCSAE standard perform at the highest levels. Helmet testing data,
    including the testing of bare head forms without helmets, show that a
    helmet certified to the NOCSAE standard will reduce the resultant head
    accelerations in large and small impacts by almost 70 percent. Between
    high school and collegiate football players, there are more than
    600,000,000 helmet impacts during the course of a single season which
    result in head accelerations exceeding 15 g's after the helmet has done
    its work. It is arguable, that without a helmet certified to the NOCSAE
    standard, each of those blows to the head would have been hard enough
    to result in a concussion or worse.
        NOCSAE is committed to improving helmet performance standards to
    effectively address concussions, and when there is reliable consensus
    scientific support for a specific change to accomplish that goal,
    NOCSAE will undoubtedly be the first to incorporate those changes.
    Until then, coaches and parents can count on NOCSAE not to experiment
    with their children's safety by making changes to the standard simply
    on the hope that a scientifically unsupported change might work.
                                     ______

                    Appendix A--Letter from Dr. Robert Cantu

                                     ______

                  Appendix B--Letter from Dr. Blaine Hoshizaki

                                     ______

         Response to Written Questions Submitted by Hon. John Thune to
                                  Mike Oliver

        Question 1. Improper Tackling Technique and Concussions. I'm aware
    that NFL and college football teams today have significantly reduced
    the amount of time devoted during practice to proper tackling and other
    football fundamentals. I recognize that coaches are limiting some of
    the physical contact during practice to prevent injuries. However, my
    concern is that less time devoted to teaching proper tackling technique
    may be contributing to an increase in concussions during games.
    Specifically, players these days seem to lead with their head rather
    than wrapping a player up with one's arms and body, and keeping their
    head up. Do you see any connection, at all levels of football, to
    improper tackling technique and an increase in concussions?
        Answer. In the course of a football game players will receive high
    energy hits to the head that are unavoidable and unintentional, and it
    is not likely those kinds of hits can be eliminated from the game of
    football. But the use of tackling techniques in which the player
    initiates contact with the head or targets the head of the other
    offensive player are dangerous, unnecessary, and avoidable. Not only do
    they increase the risk of sustaining a concussion or causing a
    concussion in the opposing player, or both, those techniques also place
    the tackling player at an increased risk of spinal cord injury and even
    death.
        Debate exists among experts in concussion epidemiology whether
    there is really an increase in the number of concussions, or whether
    the increase in diagnosis is a function of greater awareness and
    attention to the importance of addressing concussions. I think most
    believe that the actual rate is essentially unchanged, but recognition
    and diagnosis is much greater. But even if the rate is not higher today
    than it has been historically, the number of concussions can be
    significantly reduced simply by eliminating the intentional use of the
    head to initiate contact, and the vast majority of those events happen
    through poor tackling techniques.
        Sometimes those incorrect techniques are taught, but in many cases
    they develop from a lack of teaching and player correction at early
    ages. Dr. Kevin Guskiewicz at the University of North Carolina has been
    monitoring the players on the football team at UNC through the use of
    an in-helmet impact monitoring and telemetry system that records the
    magnitude and location of every impact to a player's helmet in
    practices and games. One of the information gleaned from this data is
    that they are able to identify those players who record far more
    impacts to the top of the helmet than other players on the team. Dr.
    Guskiewicz and his staff are able to meet with these players and
    undertake behavior modification to try and eliminate those avoidable
    hits to the top of the head. Clearly the issue of leading with the head
    is very important in the efforts to reduce the frequency and severity
    of concussions, even with elite athletes at the collegiate level.

        Question 2. Do you think this improper tackling technique is caused
    by less time being devoted to teaching good technique in practice?
        Answer. As players mature and develop, it is natural for most
    coaches to focus more on the subtle aspects and complicated skills of
    the game, and spend less time on the fundamentals. If players don't
    develop the reaction and muscle memory to effectively ``see what you
    hit'' when tackling and blocking as youth players, it is unlikely they
    will suddenly develop those skills in high school, and even less likely
    in college. The time to spend the time is when players have not yet
    developed the bad habits.

        Question 3. As part of the campaign to highlight concussion
    awareness, how much emphasis is being placed on educating coaches and
    players about using proper tackling technique to reduce concussions?
        Answer. The emphasis on concussion prevention and recognition is
    extensive and growing monthly.
        NOCSAE in partnership with the CDCP is creating a parent targeted
    concussion awareness and prevention program called ``Heads Up to
    Parents'' which designed and created to reach all parents of football
    players and provide access to an extensive online resource to address
    all aspects of concussion prevention, including proper tackling and
    blocking techniques.
        There are coaching education programs at all levels which provide
    the necessary instruction and teaching tools to help coaches instruct
    their players. The American Football Coaches Association provides such
    training and educational programs for high school through collegiate
    levels, and has teamed with the National Athletic Trainers Association
    to make education and training videos that address head and neck injury
    prevention, which can be accessed at http://www.afca.com/article/
    article.php?id=968. The National Federation of State High School
    Associations (``NFHS'') provides online coaching education and
    certification in the areas of concussion prevention as well. For youth
    football, USA Football in partnership with the NFL provides a wealth of
    coaching and player education programs in person and online that
    address concussion prevention through proper playing and tackling
    techniques. These resources can be accessed at http://
    www.usafootball.com/health-safety/prevention-preparation.