        DEPARTMENT OF TRANSPORTATION
        National Highway Traffic Safety Administration
        49 CFR Part 571
        [Docket No. NHTSA-2016-0021]
        Federal Motor Vehicle Safety Standards; Occupant Crash Protection

          AGENCY:
          National Highway Traffic Safety Administration (NHTSA), DOT.

          ACTION:
          Denial of petition for rulemaking.

          SUMMARY:
          This document denies a rulemaking petition submitted by Mr. James E. Hofferberth on April 1, 2013. His petition includes two requests: (1) To regulate the performance of supplementary automotive restraint systems that are marketed specifically for pregnant women; and (2) to require prominent warning labels in all vehicles with the intent of informing pregnant women that “seat belts could injure or kill their unborn child,” specifically by crushing the unborn baby in a frontal crash. NHTSA is denying the petition to regulate the performance of these systems because the agency does not have sufficient information at this time to state whether there is an additional net safety benefit/disbenefit to be derived from their use or whether one type of device is superior to another. NHTSA is denying the petition for labeling because this would provide advice that, if followed, would threaten the safety of both the mother and the unborn child in a crash.

          FOR FURTHER INFORMATION CONTACT:

            For Non-Legal Issues: Mr. Louis Molino, Office of Crashworthiness Standards, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590, Telephone: (202) 366-1740, Facsimile: (202) 493-2990.

            For Legal Issues: Mr. John D. Piazza, Office of Chief Counsel, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590, Telephone: (202) 366-2992, Facsimile: (202) 366-3820.

        SUPPLEMENTARY INFORMATION:
        Table of Contents

          I. Background
          A. Past Petition for Rulemaking
          B. Agency Position: Pregnant Women Should Wear Their Seat Belts
          C. Pregnant Women in Motor Vehicle Crashes
          1. Past Studies
          2. Available Field Data

          (a) Data Sources
          (b) NASS CDS Data
          (c) NHTSA Case Studies
          II. Current Petition
          III. NHTSA's Consideration of the Petition
          A. General Principles
          B. Analysis of the Petition
          IV. Future Plans
          V. Conclusion

        I. Background
        In a letter dated April 1, 2013, Mr. James E. Hofferberth petitioned NHTSA to regulate the performance of supplementary automotive restraint systems for pregnant women and to also require prominent warning labels in all vehicles with the intent of informing pregnant women that “seat belts could injure or kill their unborn child.” This is the petitioner's second request for rulemaking regarding the safety of seat belts for pregnant women.
        A. Past Petition for Rulemaking

        In 2005, NHTSA received a petition for rulemaking from this same petitioner, Mr. James E. Hofferberth, requesting that the agency initiate rulemaking to require an advisory placard warning occupants that seat belts should not be worn by pregnant women. On March 23, 2006, NHTSA published a Federal Register notice (71 FR 14675) denying that petition because the requested warning label would provide advice that, if followed, would threaten the safety of both the mother and the unborn child in a crash.
        B. Agency Position: Pregnant Women Should Wear Their Seat Belts
        NHTSA recommends that pregnant women wear their seat belts, as does the American College of Obstetricians and Gynecologists (ACOG).1
           NHTSA publishes a flyer 2
           developed in conjunction with ACOG and the National Healthy Babies Coalition that addresses this topic. The flyer describes the proper way for a pregnant woman to position her seat and to wear both the shoulder and lap belt portion of her seat belt, and it also explains that pregnant women should wear their seat belts even in vehicles equipped with air bags.

            1 American College of Obstetricians and Gynecologists. “Car Safety for You and Your Baby, Frequently Asked Questions: FAQ018, Pregnancy,” August 2011, http://www.acog.org/~/media/For%20Patients/faq018.pdf?dmc=1&ts=20130603T1624145840.

            2 NHTSA, The Pregnant Woman's Guide to Buckling Up, Your Top 5 Seat Belt Questions Answered, March 2010, http://www.trafficsafetymarketing.gov/newtsm/tk-bua/PregnantWomenSeatBeltFlyer.pdf.

        The safety benefits to pregnant women from wearing seat belts are supported by a research study,3
           which concluded that “[p]roper restraint use, with and without air bag deployment, generally leads to acceptable fetal outcomes in lower severity crashes, while it does not affect fetal outcome in high-severity crashes.” The study concluded that “compared to properly restrained pregnant occupants, improperly restrained occupants have a higher risk of adverse fetal outcome in lower severity crashes.” It is also recommended that all pregnant women seek medical attention after a car crash regardless of the severity of maternal injury. NHTSA and other experts agree that the best way to protect an unborn child is to protect the mother.4

            3 Klinich, K. D., Schneidier, L. W., Moore, J. L., Pearlman, M. D., entitled “Investigations of Crashes Involving Pregnant Occupants,” dated 1999. This work was supported by General Motors Corporation, pursuant to an agreement with the U.S. Department of Transportation.

            4 Duma, S., Moorcroft, D., Stitzel, J., Duma, G., entitled “A Computational Model of the Pregnant Occupant: Effects of Restraint Usage and Occupant Position in Fetal Injury Risk,” published June 2005 in the Proceedings of the 19th International Technical Conference on the Enhanced Safety of Vehicles.

        C. Pregnant Women in Motor Vehicle Crashes
        The agency conducted an extensive review in its analysis of the petition. This included a review of technical literature, including a study by the University of Michigan Transportation Research Institute (UMTRI), as well as the papers cited by the petitioner. The agency also conducted a full review of the NHTSA field data repositories for evidence of supplementary automotive restraints causing harm to pregnant women in motor vehicle crashes (MVCs). The agency's findings are provided in the following sections of this notice, and they reaffirm the position stated in the 2006 denial notice.
        1. Past Studies
        NHTSA has sponsored research studying and demonstrating the effectiveness of properly adjusted restraint systems for pregnant women from as early as 1971,5
           when seat belts composed of both a lap and shoulder portion were not as prevalent as they are today. Other research, independent of NHTSA, has also been conducted, and both biomedical research and restraint technologies have advanced over time. For example, a 1998 paper written by researchers at UMTRI explains that the unborn baby is protected by amniotic fluid, which isolates the unborn baby by acting as a shock absorber.6
           This amniotic fluid is what naturally resists the forces from the lap portion of a seat belt, and it prevents the belt from penetrating through the unborn baby's body. Mr. Hofferberth's petition claims that the belt penetrates through the unborn baby's body.

            5 King, A. I., Crosby, W. M., Stout, L. C., Eppinger, R. H., entitled “Effects of Lap Belt and Three-Point Restraints on Pregnant Baboons Subjected to Deceleration,” published in 1971 in the 15th Stapp Crash Conference Proceedings and the Society of Automotive Engineers as paper #710850.

            6 Klinich, K. D., Schneidier, L. W., Moore, J. L., Pearlman, M. D., entitled “Injuries to Pregnant Occupants in Automotive Crashes,” published October 1998 in the 42nd Annual Proceedings of the Association for the Advancement of Automotive Medicine.

        More recently, a 2008 paper written by these same researchers at UMTRI 7

           summarized a study in which in-depth investigations of MVCs involving pregnant women were conducted, with a focus on determining how restraint conditions and specific crash characteristics had affected the outcome of the unborn baby. Studies conducted up to this point generally did not include complete and accurate information about crash severity and restraint use, or they emphasized crashes with adverse outcomes for the unborn babies in order to illustrate unusual and/or severe injuries. By including crashes with both positive and adverse outcomes for the unborn baby and also studying both belted and unbelted pregnant women, this study provided medical practitioners and safety engineers more of a comprehensive, quantitative analysis for giving advice to pregnant women and improving the design of vehicle restraints.

            7 Klinich, K. D., Flannagan, C. A., Rupp, J. D., et al, entitled, “Fetal outcome in motor-vehicle crashes: effects of crash characteristics and maternal restraint,” published April 2008 in the American Journal of Obstetrics & Gynecology.

        The 57 investigated cases all involved women of at least 20 weeks gestation who were involved in a motor vehicle crash that was not a rollover and who agreed to participate. Natural spontaneous pregnancy loss before 20 weeks of gestation being not uncommon, which made association of fetal loss so early in pregnancy with an MVC questionable, and the difficulty in determining injury causation to occupants during a rollover event 8
           resulted in cases with these two factors being excluded. Case subject interviews and examinations of physical evidence were used to determine seat belt use, and estimated change in velocity (delta-V) from a crash reconstruction program was used to determine crash severity. The outcome of the unborn baby was studied for a period of one month after the crash took place, and these outcomes were classified as either good, minor complications, major complications, or fetal loss. Injuries to the mothers were classified using the Injury Severity Score (ISS), excluding injuries to the placenta or uterus, and these scores were used to classify the mothers' injuries as either nonexistent, minor, moderate, or major. Maternal death was also tracked, regardless of the mother's ISS. Restraints were classified as either proper (3-point belt or 3-point belt plus air bag) or improper (unrestrained, air bag only, and shoulder belt only with air bag, and shoulder belt only without air bag).9

            8 Excluding rollover events may have created a slight bias in the database. The paper states that “. . . rollovers account for only 2 percent of all crashes annually in the United States. The effect of this exclusion is therefore expected to have minimal impact on the study findings.”

            9 None of the maternal occupants in the cases studied wore only a lap belt.

        The database created by this study became the largest collection of MVCs involving pregnant women including detailed quantitative information about both the crash event and the outcome for the unborn baby, with a focus on crashes with both positive and negative fetal outcomes. The seat belt usage rate in the database was reported as 72 percent,10
           and the study results showed a positive effect on fetal outcome from the mother's proper use of a seat belt during a crash. The statistical risk curves from this study's data analysis “indicate[d] that an 84 percent reduction in risk of adverse fetal outcome is obtained by properly wearing a seatbelt. On the basis of this relative risk and an overall belt use rate of 80 percent, unbelted pregnant women sustain an estimated 62 percent of all fetal losses in motor vehicle crashes . . . Crash severity is the factor most strongly associated with fetal outcome . . . Claims that restraints cause adverse fetal outcomes cannot be substantiated without reliable information on crash severity . . . [M]aternal injury is predictive of fetal outcome, and proper restraint use reduces maternal injury severity.”

            10 This statistic was reported in the 2008 Klinich paper, referring to the 2005 NHTSA report, DOT HS 810 623, Traffic Safety Facts 2005. A more specific comparison would be the seat belt use rate for women of likely childbearing age.

        2. Available Field Data
        (a) Data Sources
        To analyze the claims in the petition, the agency studied crashes involving pregnant women in the applicable NHTSA data repositories: Artemis,11
           the Fatality Analysis Reporting System (FARS),12
           the National Automotive Sampling System (NASS) Crashworthiness Data System (CDS),13
           and the Special Crash Investigations (SCI) program.14
           Artemis does not currently contain any entries related to complaints or reported injuries resulting from the use of supplemental restraint devices. Although FARS does capture information about fetal demise, its fetal demise data-capturing capabilities are limited because it utilizes the American National Standards Institute (ANSI) definition 15
           of a person as “any living human . . . [A] fetus is considered to be part of a pregnant woman rather than a separate individual.” 16
           Hence, FARS only captures information about fetal demise if someone else involved in the crash also expired. NASS CDS and SCI cases were also consulted for the following analysis. Though the sample of pregnant women in NASS CDS is relatively small, it is an appropriate and applicable source of data to explore the crash risks for this cohort because it is from a nationally representative sample.17
           SCI cases are intended to provide an engineering perspective on anecdotal data, examining special crash circumstances or outcomes. As discussed below, an examination of NASS CDS and SCI data reaffirmed NHTSA's current position that pregnant women should wear a seat belt.

            11 Artemis is the agency's repository of motor vehicle and motor vehicle equipment defects. It contains consumer complaints and manufacturer early warning and reporting information, recalls, and safety defect investigations.

            12 FARS is a census of fatal motor vehicle crashes from 1975 to the present from the fifty States, the District of Columbia, and Puerto Rico. To qualify as a FARS case, the death of either a non-motorist or a motorist must occur within 30 days of the crash and the vehicle must be traveling on a trafficway customarily open to the public.

            13 NASS CDS is a database containing a probability sample of all police reported crashes in the U.S. Cases are chosen from all police reported crashes involving a harmful event (property damage and/or personal injury) resulting from a crash and involving at least one towed passenger car, light truck, or van in transport on a trafficway.

            14 SCI cases are selective, highly detailed and in-depth crash investigations using data from police and insurance reports as well as medical records, site and vehicle inspections, and interviews.

            15 DOT HS 811 694, 2011 Fatality Analysis Reporting System (FARS) and National Automotive Sampling System (NASS) General Estimates System (GES) Coding and Validation Manual, Page 5, Section 103.1, published 2012.

            16 Section 2.1.1 of standard ANSI D16.1-2007, the Manual on Classification of Motor Vehicle Traffic Accidents, Seventh Edition, prepared by the D16 Committee on Classification of Motor Vehicle Traffic Accidents under the direction of the Association of Transportation Safety Information Professionals of the National Safety Council Highway Traffic Safety Section and approved on August 2, 2007 by the American National Standards Institute, Inc. Board of Standards Review.

            17 In 2009, NASS CDS started collecting only partial occupant assessment records and no occupant injury records for vehicles more than 10 model years old. Information about occupant seat belt usage, a woman's pregnancy and the status of a fetus comes solely from a police report for these vehicles more than 10 model years old, and typically police reports subscribe to Section 2.1.1 of standard ANSI D16.1-2007 in regards to the fetus being considered an occupant.

        (b) NASS CDS Data
        NASS CDS started tracking fetal demise in 2006. The sampling is designed in such a way that it is possible to use the data to compute estimates representative of the entire country through application of a multiplier (case weight) to each NASS CDS case.18
           During this six-year time period there was a weighted estimate of 18,859,898 occupants of passenger vehicles involved in crashes qualifying as NASS CDS cases across the United States. Of these occupants, 0.6 percent [112,341/18,859,898] were pregnant women. The maternal fatality rate for this data set was 0.22 percent [245/112,341]. Where seat belt use was known, 85.0 percent of the pregnant women were reportedly wearing a seat belt and 15.0 percent were not.19
           Of the pregnant women reported to be wearing a seat belt, 99.7 percent [87,065/87,365] did not suffer a uterine or placental injury.

            18 DOT HS 811 675, National Automotive Sampling System—Crashworthiness Data System 2011 Analytical User's Manual, Page 6, Section 3, “The Sampling System and Sample Design,” published October 2012.

            19 The seat belt wearing status of 8.5 percent [9,533/112,341] of the pregnant females was reported as unknown. It should also be noted that those coded as wearing a seat belt were not necessarily wearing the seat belt correctly.

        The weighted estimate of 112,341 pregnant women was derived from 439 unweighted cases. Twenty-four of these 439 cases were coded as involving the death of an unborn child. However, the agency believes that four of these cases were miscoded with respect to fetal demise.20
           In addition, one of the twenty-four cases involved a crash for which a NASS investigator inspection of the vehicle was not permitted due to a pending legal case.21
           These five cases were excluded from the data set used for the analysis, and the 19 remaining cases correspond to a weighted estimate of 2,460 pregnant women who lost their unborn baby following a crash. The weighted data show that 2.2 percent of pregnant women lost an unborn child after being involved in a crash during this 6 year period, and 99.9 percent [87,251/87,365] of those known to be wearing a seat belt did not lose an unborn child due to a seat belt-caused uterine or placental injury.

            20 Cases 2007-43-199, 2008-43-24, 2009-43-188, and 2010-78-43 were flagged in the database as involving fetal demise, but they were excluded because examination of the case files provided convincing evidence that these were likely miscoded.

            21 Because both vehicle occupants perished in the crash, occupant interviews could not be conducted.

        Due to the small number of cases involving pregnant women who lost an unborn child after a crash and variation in the NASS CDS case weight factors applied to small numbers,22
           the following statistics associated with the data are provided for illustration only. The known belt use rate 23
           for the fetal demise data set was 85.1 percent [2,094/2,460], which is nearly identical to the known belt use rate for the data set of 112,341 pregnant women previously described. The maternal fatality rate was 9.1 percent [223/2,460]. This is more than forty times the maternal fatality rate for the data set of all pregnant women (0.22 percent). The rate of placental injury in this data set was 42.4 percent [155/366] for the unbelted pregnant women, but only 5.4 percent [114/2,094] for the belted. Placental injuries sustained by the unbelted women were caused by contact with either the steering wheel or the ground after ejection from the vehicle. The maternal fatality rate for the unbelted occupants with fetal demise was 30.3 percent [111/366] but only 5.3 percent [112/2,094] for the belted occupants. For belted occupants, 94.6 percent [1,980/2,094] of the pregnant women who lost an unborn child did not suffer a uterine or placental injury from the seat belt.24
           In other words, 94.6 percent of the time when a pregnant woman was wearing her seat belt and her unborn baby died in an MVC, the seat belt did not injure her uterus or placenta. Moreover, NASS CDS, a nationally representative sample, contains few cases of fetal demise, illustrating the rarity of this event.

            22 The weight factor for the remaining 19 cases ranges from 8.35 to 594.

            23 Though all of these women did wear a seat belt, not all of them wore their seat belts correctly with the lap belt portion snug and low, across the hips.

            24 Injuries to the mother not caused by a seat belt tended to be from contact to other interior vehicle parts or from other sources such as the striking vehicle. In some cases injury causation could not be determined, and these cases were not included in calculating this value.

        (c) NHTSA Case Studies
        In order to be consistent with previous research in studying the deaths of unborn babies in frontal crashes, NHTSA aligned the NASS CDS data with that of the 2008 UMTRI study. This eliminated 18 of the 19 cases from the 2006-2011 NASS CDS dataset involving the death of an unborn child: Eight cases 25
           because they involved pregnant women in their first trimester, four cases 26
           because they involved a rollover or other multi-event crash scenario, and six cases 27
           because their principal direction of force (PDOF) did not indicate a frontal collision.28
           This left one case that was consistent with the UMTRI study's criteria. In addition, the agency included one case from the multi-event crash group in which the first event was a frontal impact and the second event was relatively minor. These cases are discussed below. This exercise demonstrated both the rarity of fetal demise in a vehicle crash as well as the complex nature of injury causation for a pregnant woman, further supporting the agency's position that pregnant women should wear a seat belt.

            25 NASS CDS cases 2006-47-56, 2006-75-212, 2007-41-1, 2007-48-128, 2007-72-119, 2008-11-21, 2008-75-5, and 2008-75-20.

            26 NASS CDS cases 2006-12-69, 2008-09-26, 2009-74-143, and 2011-13-152.

            27 NASS CDS cases 2006-73-35, 2006-73-106, 2007-76-25, 2008-75-84, 2010-48-127, and 2011-49-15.

            28 In addition to keeping an occupant inside of the vehicle during a rollover or side impact, a seat belt also holds an occupant into the seat during an event which would send an unrestrained occupant forward toward the steering wheel and windshield. It is during these forward motions that the seat belt becomes a potential source of injury to an unborn child, and these forward occupant motions are caused by frontal collisions where the vehicle's PDOF is pushing the car backwards. For this assessment a case was determined to be a frontal collision if the PDOF for the pregnant woman's vehicle was within ±45° of normal to the vehicle's frontal plane.

        Case 2006-78-71
        The one NASS CDS case that matched the 2008 UMTRI study criteria was case 2006-78-71. In this case, two vehicles were involved in a head-on collision. The 32 year old driver of the second vehicle, a 1993 Mazda 626 equipped with air bags, was 9 months pregnant and not wearing a seat belt. She was 150 cm tall and weighed 64 kg, with a Body Mass Index (BMI) 29
           of 28.4. Crash reconstruction estimated the Delta-V to be 34 km/h longitudinally, and the NASS CDS investigator noted that there was no steering wheel rim/spoke deformation. The driver air bag did not deploy in this crash. The driver's most severe injury was an AIS 5 30
           complex uterus laceration, judged to have certainly 31
           been caused by direct contact with the steering wheel. She also had an AIS 2 minor mesentery laceration and an AIS 1 abrasion to her right hip, both also certain to have been caused by direct contact with the steering wheel. She was discharged from the hospital after 12 days, and medical records confirmed the death of the unborn baby.

            29 Centers for Disease Control and Prevention (CDC). Healthy Weight—it's not a diet, it's a lifestyle!. September 13, 2011. http://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/.

            30 An AIS 5 is the highest survivable AIS score, with an AIS 6 indicating that a particular injury was unsurvivable.

            31 NASS CDS investigators must assign a confidence level to all injury sources. The choices for these levels in descending order of investigator confidence are “Certain,” “Probable,” “Possible,” and “Unknown.”

        Case 2008-09-26
        This multi-event case from NASS CDS was also the focus of a NHTSA SCI investigation due to the concern that placental abruption was possibly caused by the seat belt. In this case, the vehicle containing the 40 year old pregnant woman, a 2006 Mercedes Benz E350, collided with a 2005 Ford Explorer Sport Trac attempting to make a left-hand turn. Crash reconstruction estimated the pregnant woman's vehicle to have a longitudinal Delta-V of 37 km/h. The Mercedes struck the Ford forward of its center of gravity, causing the Ford to quickly rotate and strike the Mercedes in a side-slap impact. The pregnant woman was seated in the first row passenger seat and was wearing her seat belt, though it is unknown whether the seat belt was worn correctly. She was 165 cm tall and weighed 91 kg at the time of the crash, corresponding to a BMI of 33.4, placing her in the obese category.

        The pregnant woman had 11 injuries with AIS scores ranging from 1 to 3. The most critical six were determined to have possibly resulted from contact with the driver and the center console during the side-slap, the most severe being an AIS 3 cerebrum subarachnoid hemorrhage. These injuries did not occur in the uterine area, and they were not directly related to the death of the unborn child. Injury number 7 of 11 was an AIS 3 lower placental abruption,32
           possibly caused by the belt webbing/buckle. The only other injury to the pregnant woman's uterine area was an abdominal skin contusion with the precise location unknown, possibly caused by the belt webbing/buckle.

            32 The emergency personnel response time could not be determined for this case, though upon arrival at the scene, it was noted that the pregnant woman complained of head, chest, and abdominal pain with vaginal bleeding. She was transported by ground ambulance to a trauma center 10 miles away, where an ultrasound was immediately conducted, and a reduced fetal heartbeat was noted. The pregnant woman then had an emergency caesarian section, about 120 minutes post-crash, and a live 24.2 oz female baby was delivered in critical condition and transported to the Neonatal Intensive Care Unit (NICU). The baby died about 26 hours post-delivery due to premature birth as a consequence of the placental abruption.

        While the crash was assigned to NHTSA's SCI team, the SCI investigators were not able to conduct interviews or inspect the vehicle until approximately 6 months after the crash. Though it was certain that the pregnant woman had been wearing her seat belt, investigators were not able to conclusively determine whether or not she had been wearing it correctly.
        II. Current Petition
        Mr. Hofferberth petitions for two rulemakings. First, he requests that the agency initiate a rulemaking for Supplementary Automotive Restraint Systems for Pregnant Women. Second, the petitioner requests that the agency initiate rulemaking to require the warning of pregnant women that the seat belts could injure or kill their unborn children.33
           The petition includes a proposed performance specification and validation test procedure for supplementary restraint systems for pregnant women, including labelling, fit, position retention, strength, and stiffness requirements, as well as a design for a test platform. The petition also includes an unpublished report, “Prevention of Fetal Injury in Motor Vehicle Crashes,” written by the petitioner.34
           The petitioner makes a number of factual assertions and arguments regarding his belief that the lap belt presents a significant hazard for the unborn child of a pregnant woman.

            33 As explained above, and discussed in more detail below, this is contrary to NHTSA's considered view and the available evidence which establishes that pregnant women should wear their seat belts.

            34 In this report, the petitioner also states, as a “Recommendation,” that NHTSA should update its recommended usage of the lap and shoulder belt by pregnant women to reflect the petitioner's views, as well as research the petitioner cites as supporting his views. Although this request is not a petition for rulemaking, the agency's decision on the petition for a warning label rulemaking is responsive to this suggestion. The petitioner also recommends that NHTSA initiate rulemaking requiring pregnant motor vehicle occupants to use a supplemental restraint system. NHTSA does not have statutory authority for such a rulemaking.

        The petitioner, in both his letter and the attached report, states his beliefs that unborn babies are in danger of being crushed by the lap belt portion of a seat belt during a frontal collision and that seat belts are not appropriate for use by pregnant women. He cites research that he asserts shows that the lap belt portion of the restraint system has been implicated in causing specific trauma to the placenta and unborn child in relatively minor vehicular accidents. He also cites other research that he argues shows a high rate of fetal and placental injury and asserts that research shows that the fetus of a pregnant woman is approximately five times more likely to receive serious injury than a 0-1 year old child using a supplementary infant or child restraint riding in the same car.
        The petitioner also states that there are many supplementary restraint products on the market for pregnant women, which are not all equally effective and in some cases dangerous. The petitioner presents depictions and makes assertions regarding the effectiveness of several of these restraints, including a restraint which he patented.
        III. NHTSA's Consideration of the Petition
        A. General Principles
        Motor vehicle safety standards must be practicable, meet the need for motor vehicle safety, and be stated in objective terms. 49 U.S.C. 30111(a). Petitions for rulemaking are governed by 49 CFR part 552. Pursuant to Part 552, the agency conducts a technical review of the petition, which may consist of an analysis of the material submitted, together with information already in possession of the agency. In deciding whether to grant or deny a petition, the agency considers this technical review as well as appropriate factors, which may include, among others, allocation of agency resources and agency priorities.
        B. Analysis of the Petition
        The agency's technical review of the petition had several main parts. First, the agency reviewed the petition and the sources it cited before conducting a comprehensive literature review, which included material from the early 1970s through the present. Additionally, the agency, as described above, conducted an updated review of crash data available from the NHTSA field databases, including NASS CDS. The agency considered all of the information contained in the petition, and for the reasons stated below, the agency is denying the petition.

        The first part of Mr. Hofferberth's petition asks that NHTSA regulate the performance of supplementary automotive restraint systems for pregnant women. In assessing this aspect of the petition, NHTSA first attempted to quantify the safety problem, i.e., whether there is an unreasonable risk of death or injury to pregnant women or to unborn children in a belted condition when exposed to a crash that would lead NHTSA to propose a performance requirement for supplemental restraint devices. The agency could not establish this through the technical review of the submitted petition materials.
        For example, the petitioner asserts that unborn babies are in danger of being crushed by the lap belt portion of a seat belt during a frontal collision and that seat belts are not appropriate for use by pregnant women. However, the comprehensive UMTRI study showed that a pregnant woman's proper use of a seat belt has a positive effect on fetal outcome in a crash: “an 84 percent reduction in risk of adverse fetal outcome is obtained by properly wearing a seatbelt. On the basis of this relative risk and an overall belt use rate of 80 percent, unbelted pregnant occupants sustain an estimated 62 percent of all fetal losses in motor vehicle crashes.” In addition, the amniotic fluid is capable of resisting the forces from the lap portion of a seat belt, and can aid in preventing the belt from penetrating through the unborn baby's body.
        Similarly, the petitioner asserts that the lap belt portion of the restraint system causes fetal trauma in relatively minor crashes. However, as discussed above, a study 35
           found that “[p]roper restraint use, with and without air bag deployment, generally leads to acceptable fetal outcomes in lower severity crashes,” and went on to conclude that “compared to properly restrained pregnant occupants, improperly restrained occupants have a higher risk of adverse fetal outcome in lower severity crashes.”

            35 Klinich, K. D., Schneidier, L. W., Moore, J. L., Pearlman, M. D., entitled “Investigations of Crashes Involving Pregnant Occupants,” dated 1999. This work was supported by General Motors Corporation, pursuant to an agreement with the U.S. Department of Transportation.

        Additionally, the agency performed an updated review of crash data available from the NHTSA field databases, including NASS CDS. Although the petitioner asserts that unborn babies are in danger of being crushed by the lap belt portion of a seat belt and cites research that he argues shows a high rate of fetal and placental injury, the agency found that a low percentage (2.22 percent) of pregnant women lost their child after being exposed to a crash. The detailed review of all fetal demise cases indicated that all but one fell into the exclusion criteria used by UMTRI in their field data analysis. This one case was of an unbelted woman who sustained an AIS 5 complex uterus laceration caused by direct contact with the steering wheel.36
           Additional information regarding the analysis of NHTSA data for placental injury to belted pregnant women and the correlation of fetal mortality with higher crash severity, illustrating the beneficial effects of seat belt use by pregnant women, is provided above in section I.C.2. Accordingly, at this time the analysis of the field data does not indicate a safety need to propose a standard for supplemental restraints for pregnant women.

            36 Case 2008-09-26 did involve a pregnant woman who experienced a placental abruption, but investigators were not able to determine whether the occupant had been wearing the belt correctly.

        With regard to establishing performance requirements for supplemental restraints, NHTSA does not have sufficient information at this time to state whether there is any additional net safety benefit/disbenefit to be derived from their use or whether one type of device is superior to another. The agency notes that these devices are considered motor vehicle equipment, and manufacturers of these devices are subject to the recall and remedy requirements of the Motor Vehicle Safety Act (49 U.S.C. 30118-30120). To date NHTSA has not seen evidence of these devices causing harm to pregnant women. Artemis, the agency's central repository of data on motor vehicles and motor vehicle equipment defects, does not currently contain entries related to complaints or reported injuries resulting from the use of such devices.
        Given the observed correlation between maternal and fetal outcome, the agency believes that improvements in crashworthiness, particularly advancements in occupant restraint systems, will serve to protect pregnant women and their unborn children. NHTSA continues to work towards these improvements through research efforts in the areas of advanced restraints and improvements to the Federal motor vehicle safety standards. The petitioner did not provide any data or testing to support the benefits of supplemental devices or the merits of the proposed test procedure to discriminate between good and bad performance to serve as a basis for such a performance requirement.

        The second request in the petition asks that the agency warn pregnant women of the risk from the seat belt through a prominent warning label required in every vehicle. As noted in the Federal Register notice denying Mr. Hofferberth's 2005 petition to initiate rulemaking on a similar advisory placard (71 FR 14675), the agency disagrees with the claim that seat belts are hazardous to unborn babies. The agency position regarding the benefits of seat belts for both the mother and the unborn child has not changed since the publication of the 2006 denial notice and is supported, as discussed above, by the agency's review of the technical literature and field data.
        As noted above, the agency conducted an extensive literature review and reviewed all sources cited by the petitioner. It is the agency's view that this literature shows that the most effective way to protect the unborn baby is to protect the pregnant woman. Technical studies were discussed in the preceding sections of this notice of decision. Additionally, the agency is not aware of any serious injuries to pregnant women caused by seat belts in non-impact situations, and the aforementioned 2008 Klinich paper showed that “[c]laims that restraints cause adverse fetal outcomes cannot be substantiated without reliable information on crash severity.”
        The agency's field data analysis shows, among other things, that seat belt-caused uterine or placental injuries during crashes are extremely rare (0.1 percent of cases) and that seat belt use dramatically reduces the risk of dying in a crash for both pregnant women and unborn children. Additional information regarding the agency's field data analysis is provided above in section I.C.2.
        Accordingly, for the reasons stated above, the petition is denied.
        IV. Future Plans
        A study showed that despite NHTSA recommending specific seat belt best practices for pregnant women, approximately one quarter of the pregnant women being studied did not follow the recommendation, and nearly two thirds of them had not received the information.37
           When asked about the effects of seat belts on their unborn babies during a motor vehicle collision, 34.0 percent of these same pregnant women were not sure, and another 10.7 percent believed that the seat belts would actually cause harm.38
           A study supported by the Federal Highway Administration reported that “[e]ducational level is a factor predicting seatbelt use. Among women with less than a high school education, 41 percent did not employ seatbelt restraints as compared with 18.8 percent who were high school graduates . . . [P]regnant women of lower educational level and socioeconomic status are at particular risk for failing to correctly employ seatbelts during pregnancy.” 39

            37 McGwin Jr., G., Willey, P., Ware, A., et al., entitled, “A Focused Educational Intervention Can Promote the Proper Application of Seat Belts during Pregnancy,” published May 2004 in The Journal of Trauma Injury, Infection, and Critical Care.

            38 McGwin, Jr., G., Russell, S., Rux, R., et al., entitled, “Knowledge, Beliefs, and Practices Concerning Seat Belt Use During Pregnancy,” published March 2004 in The Journal of Trauma Injury, Infection, and Critical Care.

            39 Taylor, A. J., McGwin Jr., G., Sharp, C. E., et al., entitled, “Seatbelt Use During Pregnancy: A Comparison of Women in Two Prenatal Care Settings,” published June 2005 in the Maternal and Child Health Journal, Vol. 9, No. 2.

        Another recent study supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, of the National Institutes of Health, reported that even though most pregnant women wear seat belts, those who do are not necessarily wearing them correctly. Additionally, this report states that despite ACOG's recommendation that all pregnant women receive prenatal seat belt counseling, not all women receive it. It also suggests that increased educational efforts emphasizing not only the use of seat belts but also their proper placement would be appropriate.40

            40 Vladutiu, C. J., Weiss, H. B., entitled, “Motor Vehicle Safety During Pregnancy,” published October 2011 in the American Journal of Lifestyle Medicine, Vol. 6, No. 3.

        The agency believes that it is very important to convey the importance of proper seat belt use to pregnant women. As indicated by the aforementioned studies, a large percentage of pregnant women are not following the current recommendations; therefore, NHTSA has decided to increase outreach efforts in this area. NHTSA currently posts the agency's official brochure, If You are Pregnant: Seat Belt Recommendations for Drivers and Passengers, on all official Web sites. It is a popular download from TrafficSafetyMarketing.gov,41

           the Web site for all NHTSA partners to find official publicity material. To increase the dissemination of this brochure, the agency plans to add it to the social networking outreach rotation of messages distributed through outlets such as Facebook and Twitter, and its content has been more prominently featured on Parents Central.42
           Proper seat belt use and seat positioning for pregnant women will also be the focus of an upcoming Safety in Numbers feature on the NHTSA Web site.

            41 http://www.trafficsafetymarketing.gov/CAMPAIGNS/Seat+Belts/Buckle+Up+America/Thanksgiving+Weekend/Pregnant+Women's+Guide+To+Buckling+Up.

            42 http://www.safercar.gov/parents/SeatBelts/Pregnancy-Seat-Belt-Safety.htm.

        V. Conclusion
        After carefully considering the safety need for the requested rulemaking and supporting information and in accordance with 49 CFR part 552, NHTSA hereby denies Mr. James E. Hofferberth's April 1, 2013 petition to regulate the performance of supplementary automotive restraint systems that are marketed specifically for pregnant women and to require prominent warning labels in all vehicles with the intent of informing pregnant women that “seat belts could injure or kill their unborn child.” Research and real-world data show the substantial benefits of seat belt use for both pregnant women and unborn children, and the agency recommends that all pregnant women wear properly adjusted seat belts.
        The agency takes the safety of pregnant women very seriously and has already begun to increase awareness and educational efforts related to the proper use of seat belts while continuing to monitor the data trends surrounding this issue.
        In accordance with 49 CFR part 552, this concludes the agency's review of the petition.

          Authority:
           49 U.S.C. 322, 30111, 30115, 30117, and 30162; delegation of authority at 49 CFR 1.95.

          Issued in Washington, DC, on: March 31, 2016 under authority delegated in 49 CFR 1.95.
          Raymond R. Posten,
          Associate Administrator for Rulemaking.

      [FR Doc. 2016-07827 Filed 4-5-16; 8:45 am]
       BILLING CODE 4910-59-P


        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 223
        [Docket No. 100813359-1195-01]
        RIN 0648-AY96
        Endangered and Threatened Species; Proposed Protective Regulations for the Gulf of Maine Distinct Population Segment of Atlantic Sturgeon

          AGENCY:
          National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

          ACTION:
          Proposed rule; request for comments; notice of availability of an environmental assessment.

          SUMMARY:
          This proposed rule proposes to extend the Endangered Species Act (ESA) section 9(a)(1)(A) through 9(a)(1)(G) prohibitions to all activities impacting the Gulf of Maine (GOM) Distinct Population Segment (DPS) of Atlantic sturgeon throughout its range except for two types of activities, scientific research and rescue/salvage activities, when those activities occur within the riverine range of the GOM DPS. The ESA section 9 prohibitions are comprehensive and pertain to any person subject to the jurisdiction of the United States. Specifically, section 9 of the ESA prohibits the import, export, taking, possession, sale or offering for sale in interstate or foreign commerce, delivery, receiving of, carrying, transportation, or shipping in interstate or foreign commerce any such species, or violation of any regulation pertaining to such species. On October 6, 2010, we, the National Marine Fisheries Service (NMFS), proposed to list the DPS of Atlantic sturgeon in the GOM as threatened under the ESA. When a species is listed as “threatened” under the ESA, we are required to issue protective regulations under section 4(d) of the ESA. Such protective regulations are ones deemed “necessary and advisable for the conservation of the species” and may include any act prohibited for endangered species under section 9(a)(1) of the ESA. The prohibitions and exceptions proposed in this rule are deemed necessary and advisable for the conservation of this species. We expect that the result of extending such prohibitions will be to protect the GOM DPS of Atlantic sturgeon from direct forms of take, such as physical injury or killing, and from indirect forms of take, such as harm that results from habitat degradation while still allowing scientific research as well as salvage of dead fish and rescue of injured fish by experienced personnel. These actions will help preserve and recover the GOM DPS of Atlantic sturgeon by addressing the negative effects from stressors impeding recovery of the DPS.

          DATES:
          Comments on this proposal must be received by August 9, 2011.

          ADDRESSES:
          You may submit comments, identified by the RIN No. 0648-AY96, by any of the following methods:
          • Federal eRulemaking Portal: http//www.regulations.gov. Follow the instructions for submitting comments.
          • Fax: To the attention of Lynn Lankshear at (978) 281-9394.
          • Mail or hand-delivery: Submit written comments to the Assistant Regional Administrator, Protected Resources Division, NMFS, Northeast Region, 55 Great Republic Drive, Gloucester, MA 01930.

            Instructions: All comments received are a part of the public record and will generally be posted to http://www.regulations.gov without change. All Personal Identifying Information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information.
          We will accept anonymous comments (enter “n/a” in the required fields if you wish to remain anonymous). Attachments to electronic comments will be accepted in Microsoft Word, Excel, WordPerfect, or Adobe PDF file formats only.

          The proposed rule and other reference materials regarding this determination are available electronically at http://www.nero.noaa.gov/prot_res/atlsturgeon/under the section titled “What's New” or by submitting a request to the Assistant Regional Administrator, Protected Resources Division, NMFS, Northeast Region, 55 Great Republic Dive, Gloucester, MA 01930.

          FOR FURTHER INFORMATION CONTACT:
          Lynn Lankshear, NMFS, Northeast Region (978) 282-8473, Kimberly Damon-Randall, NMFS, Northeast Region (978) 282-8485 or Lisa Manning, NMFS, Office of Protected Resources (301) 713-1401.

        SUPPLEMENTARY INFORMATION:
        Background
        As described in the Federal Register notices published October 6, 2010 (75 FR 61872 and 75 FR 61904), NMFS determined that there are five Atlantic sturgeon DPSs within the United States. Along with the GOM DPS, there are also the New York Bight (NYB), Chesapeake Bay (CB), Carolina, and South Atlantic DPSs. NMFS has determined that listing all of the U.S. Atlantic sturgeon DPSs except the GOM DPS as endangered is warranted.

        The prohibitions listed under section 9(a)(1) of the ESA automatically apply when a species is listed as endangered but not when listed as threatened. Section 9 of the ESA prohibits any person subject to the jurisdiction of the United States from: (a) Importing any such species into, or exporting any such species from the U.S.; (b) taking any such species within the U.S. or the U.S. territorial sea; (c) taking any such species upon the high seas; (d) possessing, selling, delivering, carrying, transporting, or shipping, by any means whatsoever, any such species that was illegally taken; (e) delivering, receiving, carrying, transporting, or shipping in interstate or foreign commerce, by any means whatsoever and in the course of commercial activity, any such species; (f) selling or offering for sale in interstate or foreign commerce any such species; or (g) violating any regulation pertaining to such species or to any threatened species of fish or wildlife. The ESA defines “take” as to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or attempt to engage in any such conduct (16 U.S.C. 1532(19)). The term “harm” is defined in the regulations as any act which kills or injures fish or wildlife. Such an act may include significant habitat modification or degradation that results in death or injury of wildlife by significantly impairing essential behavioral patterns, including breeding, spawning, rearing, migrating, feeding, or sheltering (50 CFR 222.102). The term “harm” is used in this proposed rule as defined in the regulations.
        In the case of a species listed as threatened, section 4(d) of the ESA requires the Secretary of Commerce (Secretary) to issue such regulations as deemed necessary and advisable to provide for the conservation of the species. The Secretary may by regulation prohibit with respect to any threatened species any act prohibited under section 9(a)(1). Whether section 9(a)(1) prohibitions are necessary and advisable for a threatened species is largely dependent on the biological status of the species and the potential impacts of various activities on the species. The proposed rule (75 FR 61872) and Atlantic Sturgeon Status Review (Atlantic Sturgeon Status Review Team (ASSRT), 2007) provided extensive information on the status of the GOM DPS and impacts to Atlantic sturgeon belonging to the GOM DPS. The information is summarized here.
        Genetics data and tagging information support the conclusion that the GOM DPS includes all anadromous Atlantic sturgeon whose freshwater range occurs in the watersheds from the Maine/Canadian border southward to include all associated watersheds draining into the Gulf of Maine as far south as Chatham, MA. Within this range, Atlantic sturgeon have been documented from the Penobscot, Kennebec, Androscoggin, Sheepscot, Saco, Piscataqua, and Merrimack rivers. The marine range, including coastal bays and estuaries, of Atlantic sturgeon belonging to the GOM DPS extends from the Bay of Fundy, Canada to the St. Johns River, FL and overlaps throughout with the marine range of Atlantic sturgeon that originate from the other four U.S. DPSs that are proposed to be listed as endangered.
        Because Atlantic sturgeon use both riverine waters and the marine environment, they are affected by a multitude of activities. Coast-wide commercial over-harvesting throughout the 19th century and most of the 20th century caused a precipitous decline in Atlantic sturgeon abundance for all of the U.S. Atlantic sturgeon DPSs. A coast-wide moratorium on harvesting Atlantic sturgeon was implemented in 1998 pursuant to Amendment 1 of the Atlantic States Marine Fisheries Commission's (ASMFC) Interstate Fishery Management Plan for Atlantic sturgeon (ASMFC, 1998). Retention of Atlantic sturgeon from the U.S. Exclusive Economic Zone (EEZ) was prohibited by NMFS in 1999 (64 FR 9449; February 26, 1999). However, despite these prohibitions on directed fishing for and retention of incidentally caught Atlantic sturgeon, other anthropogenic activities continue to take Atlantic sturgeon. These include incidental bycatch in commercial fisheries, vessel strikes, activities affecting water quality, and habitat disturbances such as dredging. Bycatch, water quality and dredging are primary stressors for the GOM DPS of Atlantic sturgeon (ASSRT, 2007). As described in the proposed rule (75 FR 61872), new analyses suggest that the level of bycatch mortality is not sustainable for the GOM DPS in the long-term (ASMFC, 2007). With respect to habitat, the water quality for coastal waters north of Cape Cod is generally fair to good (EPA, 2008), and the majority of historical Atlantic sturgeon spawning habitat is accessible in all but the Merrimack River of the GOM DPS (ASSRT, 2007). Nevertheless, it is difficult to verify whether Atlantic sturgeon spawning habitat in the GOM DPS is fully functional. In addition, NMFS has not implemented any bycatch reduction measures specifically for Atlantic sturgeon, and existing bycatch reduction measures are inadequate for reducing bycatch of Atlantic sturgeon in federally regulated fisheries. NMFS does not have the authority or discretion to require action to reduce the effects of in-water projects (e.g., dredging) specifically for Atlantic sturgeon and there are no specific regulations requiring action(s) to reduce effects of in-water projects to Atlantic sturgeon. NMFS has limited authority and discretion by which to regulate vessel activities in areas where Atlantic sturgeon occur.
        Comprehensive information on current abundance for the GOM DPS of Atlantic sturgeon does not exist (ASSRT, 2007). However, surveys have provided qualitative information on Atlantic sturgeon abundance for the GOM DPS, including river-specific information on abundance, trends, evidence of spawning, and/or documentation of multiple year-classes. For example, new evidence of Atlantic sturgeon year-round presence in the Saco River, where they have not been observed for many years, suggests that the numbers of Atlantic sturgeon in the GOM DPS may be increasing. Additionally, the catch-per-unit effort (CPUE) of subadult Atlantic sturgeon during gill net surveys in the Kennebec River increased considerably from 1977-2000 (1977 B 1981 CPUE = 0.30 versus 1998 B 2000 CPUE = 7.43) while the CPUE of adult Atlantic sturgeon showed a slight increase over the same time period (1977-1981 CPUE = 0.12 versus 1998-2000 CPUE = 0.21) (Squiers, 2004).
        The Kennebec River is currently the only known spawning river for the GOM DPS. Spawning likely occurs in the Penobscot River, and Atlantic sturgeon that use other historical spawning rivers may represent additional spawning groups (ASSRT, 2007). However, there is, as yet, no evidence that Atlantic sturgeon of the GOM DPS spawn in any river other than the Kennebec River (ASSRT, 2007).

        Protecting the GOM DPS of Atlantic sturgeon from direct forms of take, such as physical injury or killing, whether incidental or intentional, will help preserve and recover the DPS's remaining subpopulations. Protecting the GOM DPS of Atlantic sturgeon from indirect forms of take, such as harm that results from habitat degradation, will likewise help preserve the DPS's subpopulations and also decrease synergistic, negative effects from other stressors impeding recovery of the DPS. We therefore propose to extend the ESA section 9(a)(1)(A) through 9(a)(1)(G) prohibitions to all activities impacting the GOM DPS throughout its range except for two types of activities, scientific research and rescue/salvage activities, when those activities occur within the riverine range of the GOM DPS. Specifically, we propose to exempt from the section 9(a)(1)(B) take prohibitions: (a) Scientific research of Atlantic sturgeon belonging to the GOM DPS when conducted in the manner specified in this proposed rule; and, (b) salvaging dead and aiding/resuscitating live Atlantic sturgeon belonging to the GOM DPS by NMFS personnel or their designated agents as specified in this proposed rule. NMFS is proposing to exempt these activities from the ESA section 9 take prohibitions only when these activities occur within the riverine range of the GOM DPS to ensure that only Atlantic sturgeon belonging to the GOM DPS are taken. We have determined that exempting these activities as specified is necessary and advisable for the conservation of this DPS.
        Identification of Activities That Would Constitute a Violation of Section 9 of the ESA
        On July 1, 1994 (59 FR 34272), NMFS and the U.S. Fish and Wildlife Service (collectively, the “Services”) published a policy committing us to identify, to the maximum extent practicable at the time a species is listed, those activities that would or would not constitute a violation of section 9 of the ESA. The intent of this policy is to increase public awareness of the effect of a listing on proposed and ongoing activities within the species range.
        Based upon available information, we believe that the activities that may take Atlantic sturgeon belonging to the GOM DPS include, but are not limited to: (1) Commercial and recreational fisheries; (2) scientific research and monitoring of Atlantic sturgeon, (3) emergency rescue/salvage of Atlantic sturgeon; (4) scientific research and monitoring directed at other species; (5) habitat altering activities affecting passage of adult sturgeon to and from spawning areas and availability of habitat for egg, larval or juvenile stages; (6) entrainment and impingement of all life stages of GOM DPS sturgeon during the operation of water diversions, dredging projects, and power plants; (7) activities impacting water quality for all life stages of GOM DPS sturgeon such as discharge, dumping, or applications of toxic chemicals, pollutants, or pesticides into waters or areas that contain GOM DPS sturgeon; (8) vessel strikes; and, (9) introduction or release of non-native species that are likely to alter the habitats of, or to compete for space or food, with GOM DPS sturgeon.

        This list is not exhaustive. It is intended to provide examples of the types of activities that are most likely to result in take of GOM DPS Atlantic sturgeon and a violation of this proposed rule (unless within the specific exemptions proposed by this rule). Whether a take results from a particular activity is dependent upon the facts and circumstances of each incident. The fact that an activity may fall within one of these categories does not mean that the specific activity will cause a take. Due to such factors as location and scope, specific actions may not result in direct or indirect adverse effects on the species. Further, an activity not listed here may in fact result in a take. Questions regarding whether specific activities would constitute a take prohibited by this rule, and general inquiries regarding prohibitions and permits, should be directed to NMFS—Northeast Regional Office (see ADDRESSES).
        Activities Affecting the GOM DPS That Do Not Violate Section 9 Including Exemptions
        Section 9(a)(1)(A), 10(a)(1)(A), and 10(a)(1)(B) of the ESA provide the authority to grant exemptions to the section 9 prohibitions. Section 10(a)(1)(A) scientific research and enhancement permits may authorize exemptions to any of the section 9 prohibitions and may be issued to Federal and non-Federal entities conducting research or conservation activities that involve directed (i.e., intentional) take of listed species. Section 10(a)(1)(B) take permits may be issued to non-Federal entities performing activities that may incidentally take listed species in the course of an otherwise legal activity. These section 10 permits are mechanisms for providing exemptions to the section 9(a)(1)(B) prohibitions should the GOM DPS become listed, and impacts on the GOM DPS from actions in compliance with such permits would not constitute violations of this proposed rule.
        Likewise, should the GOM DPS become listed, federally funded or approved activities that incidentally take Atlantic sturgeon belonging to the GOM DPS would not constitute violations of this proposed rule when the activities are conducted in accordance with an incidental take statement issued through a biological opinion provided by NMFS pursuant to section 7 of the ESA. Section 7 of the ESA requires all Federal agencies to consult with NMFS if actions they fund, authorize, or carry out may affect any ESA-listed species under NMFS jurisdiction. Section 7 authorizes NMFS to issue an incidental take statement with a biological opinion if NMFS has determined that the activity may adversely affect, but will not jeopardize, the continued existence of the listed species. Therefore, if this rule and the proposed rule to list the GOM DPS are finalized, incidental take of GOM DPS Atlantic sturgeon resulting from federally funded, authorized, or implemented activities would not violate the section 9(a)(1)(B) or 9(a)(1)(C) take prohibitions, provided the activities are conducted in accordance with an incidental take statement and all reasonable and prudent measures and terms and conditions to minimize the effects of the taking on the listed species.
        As described above, we have determined that in certain circumstances, extending the ESA section 9(a)(1)(B) take prohibitions to the GOM DPS of Atlantic sturgeon is not necessary and advisable. We are proposing two exemptions to these prohibitions for activities that provide for the conservation of the GOM DPS: (1) Scientific research conducted on GOM DPS Atlantic sturgeon within the riverine portion of its range and in accordance with accepted NMFS protocol(s); and, (2) salvage of dead and recovery of live stranded or injured GOM DPS Atlantic sturgeon found within the riverine range of the GOM DPS. These exemptions are described in more detail rule in later sections (see “Exemption for Scientific Research” and “Salvage and Recovery” below).
        The prohibitions of section 9(a)(1)(B) apply to all other activities that do not meet the specific exemptions for scientific research, salvage and recovery as described in this proposed rule. All other prohibitions of sections 9(a)(1)(A) and 9(a)(1)(C) through 9(a)(1)(G) would apply to the GOM DPS unless authorized under a section 10 permit or through consultation under section 7 as previously described.
        In determining that it is not necessary and advisable to apply ESA section 9 take prohibitions on the certain activities described here, we recognize that new information may require a reevaluation of that conclusion at any time. For any of the exemptions from the prohibitions described in this proposed rule, we will periodically evaluate the activity's effect on the conservation of the GOM DPS of Atlantic sturgeon. We will impose take prohibitions on the activities previously exempted through rulemaking if we determine that it is necessary and advisable for the conservation of the species.
        Exemption for Scientific Research

        Adult and subadult Atlantic sturgeon that originate from different rivers mix in the marine environment (Stein et al., 2004; USFWS, 2004), and are visually indistinguishable from each other regardless of the river or DPS of origin. However, mixing is not known to occur within the riverine environment. Atlantic sturgeon use the riverine environment for spawning and are intolerant of saline environments from the egg stage through the first year of life (Van Eenennaam et al., 1996; Niklitschek, 2001). Thus, the spawning adults must enter the riverine environment to spawn. Genetic analyses and other information support that Atlantic sturgeon originating from the Kennebec River are part of a discrete population segment (ASSRT, 2007). This means that straying of Atlantic sturgeon from other Atlantic sturgeon DPSs into riverine waters of the GOM DPS of Atlantic sturgeon does not typically occur and is unlikely to occur. Therefore, Atlantic sturgeon that occur in riverine waters of the GOM DPS are considered GOM DPS Atlantic sturgeon.

        To ensure that the proposed exemption would result in the taking of only GOM DPS Atlantic sturgeon, we are proposing that the scientific research exemption to the section 9(a)(1)(B) take prohibitions apply only to Atlantic sturgeon found within the riverine range of the GOM DPS (Table 1). Within-river boundaries for the proposed exemptions were selected using reported salinity data, threshold salinities of less than 20 ppt (highest reported value for bottom salinity was used, when available), and identification of easily recognizable landmarks, such as a bridge, located at or upstream of the location where the referenced salinity measurement was taken. For example, for the Kennebec River (and Androscoggin, which flows into the Kennebec above the salinity-based cutoff point), the location where salinity is unlikely to exceed 20 ppt was determined using Mayer et al. (1996), who reported a maximum salinity of 19.38 at 15 m depth in September 1994 at a sampling station approximately 5 km downstream of the U.S. Route 1 bridge crossing in Bath, ME. In order to clearly demarcate the area in which the proposed exemptions would apply, the U.S. Route 1 Bridge in Bath, ME is proposed as the exemption boundary. The exemption to the section 9(a)(1) prohibitions for scientific research would apply upstream of this boundary; whereas downstream, the exemption would not apply. Exemption boundaries for other river systems within the range of the GOM DPS were determined using similar methodology. Latitude and longitude are also provided for points on either side of each river. The straight line between the two points can be used to help identify the exemption boundary.

          Table 1—Exemption Boundary for Each Named River. The Exemptions Apply to Waters Upstream of the Exemption Boundary. Latitude and Longitude Are Provided for a Single Point on Either Side of Each River To Help Identify the Exemption Boundary. The Reported Salinities and the Data Sources Used To Identify Exempted Waters Are Indicated.

            River
            Exemption boundary
            Right and left bank points
            Salinity (ppt) and source

            Merrimack
            U.S. Rt. 1 Bridge Newburyport, MA
            42.813848N, 70.874524W42.817869N, 70.870277W

            20.74; EPA NCA.

            Piscataqua
            Leigh's Mill Pond South Berwick, ME
            43.218014N, 70.813416W43.217966N, 70.811286W

            17.9; EPA NCA.

            Saco
            Main St. Bridge Biddeford, ME (2 spans)
            43.492736N, 70.449813W43.493564N, 70.448071W
              43.495848N, 70.447886W
              43.496733N, 70.446901W

            20; Gupta et al., 1994.

            Kennebec
            U.S. Rt. 1 Bridge Bath, ME
            43.911797N, 69.813828W43.911835N, 69.802635W

            19.38; Mayer et al., 1996.

            Androscoggin
            U.S. Rt. 1 Bridge Bath, ME
            43.911797N, 69.813828W43.911835N, 69.802635W

            19.38; Mayer et al., 1996.

            Sheepscot
            Sheepscot Rd Bridge Newcastle, ME
            44.05154N, 69.613313W44.049814N, 69.609584W

            19.38; Mayer et al., 1996.

            Penobscot
            Cove Brook Winterport, ME
            44.693549N, 68.849642W44.696325N, 68.831188W

            0-26.71; Goulette, 2004.

            1 Source Goulette (2004, unpub. data) reported a maximum bottom salinity of 26.7 ppt during low flows at Bald Hill Cove in Winterport, ME. However, because this value was significantly higher than the next highest reported bottom salinity (17 ppt) and was measured during very low flow conditions, NMFS considered it to be an outlier.

        Many important aspects of Atlantic sturgeon life history are still unknown (Murawski and Pacheco, 1977; Van den Avyle, 1983; Smith and Dingley, 1984; Smith and Clugston, 1997; Bain, 1997; Bemis and Kynard, 1997; Kynard and Horgan, 2002; ASSRT 2007). Scientific research (including monitoring) is vital for improving our understanding of the status and risks facing Atlantic sturgeon, and providing critical information for assessing the effectiveness of current and future management practices. Research activities aid in the conservation of listed species by furthering our understanding of the species' life history and biological requirements. We recognize, however, that many scientific research activities involve take and may pose some level of risk to individuals or to the species. Therefore, it is necessary for research activities to be carried out in a manner that minimizes the adverse impacts of the activities on individuals and the species while obtaining crucial information that will benefit the species.

        Properly planned and implemented research and assessment are critical to minimizing the risks and maximizing the conservation benefit of the research. Guidelines developed by sturgeon researchers in cooperation with NMFS for Atlantic and other sturgeon species have helped facilitate standardization of research protocols while minimizing risk to the species as a result of handling and sampling. In 2000, Moser et al. developed guidelines for shortnose and Atlantic sturgeons that described the most acceptable methods (i.e., minimizing stress and mortality) at that time for short-term holding, identification and measurement, tagging, tissue sampling, gastric lavage, and collection. In 2007, NMFS provided funding to the ASMFC to co-host a workshop in order to identify necessary activities, techniques and methodologies for updating Moser et al. (2000), which was intended to be a `living document' to be revised as new or refined techniques were developed. As a result of this workshop, a subgroup of sturgeon researchers was formed to write a comprehensive document, subject to peer review, describing research protocols and techniques specifically for Atlantic sturgeon. The resulting document, titled “Atlantic Sturgeon Research Techniques” (Damon-Randall et al., 2010), is intended as a guide that describes the purpose and application of common Atlantic sturgeon research techniques. A second document, titled “A Protocol for Use of Shortnose, Atlantic, Gulf, and Green Sturgeons” (Kahn and Mohead, 2010), was also developed by NMFS to provide a comprehensive review of safe, standardized research practices for the multiple sturgeon species under NMFS's jurisdiction. This document was intended as a guide to assist researchers in applying for appropriate research permits and includes safe handling and sampling protocols in cases where Atlantic sturgeon co-occur with other ESA-listed fishes (e.g. shortnose sturgeon). As described in more detail below, any research activities exempted under this proposed rule would first be required to undergo review by NMFS to ensure consistency with recommended protocols.

        Technologies and methods for research that do not require capture of individual sturgeon are becoming more widely available (e.g., side-scan sonar, Didson, in-water detection technology). These technologies have been shown to be effective at providing needed information on, among other things, Atlantic sturgeon habitat use and abundance, while eliminating the likelihood of injury or mortality to the sturgeon that can result from capture and handling. Technological advances are also making it possible to use non-invasive methods (e.g., ultrasound) in place of invasive methods (e.g., laparoscopy) for sturgeon research, thus reducing the risk of harm to the sturgeon even when capture and handling is necessary. Damon-Randall et al. (2010) includes a recommendation on using passive techniques such as sonar, video, and a combination of both whenever possible. These non-invasive techniques have not been shown to negatively affect Atlantic sturgeon behavior (i.e., do not cause harm), may increase the likelihood of successfully obtaining data, reduce the effort needed to achieve the research objectives, and reduce the potential for gear loss (e.g., nets used for capturing sturgeon).
        As described above, the collection of needed scientific information provides a conservation benefit to ESA-listed species. The permitting process (see 50 CFR parts 222, 223 and 224) is intended to ensure that, in the course of conducting bona-fide research, work is conducted in a manner that minimizes harm (including injury and death) to the species and individual animals. However, research of the GOM DPS that is already in progress may potentially be impeded if researchers are required to suspend work and obtain a section 10(a)(1)(A) permit, given that permit processing times can take 90 days or more, and that NMFS cannot process and finalize a permit request until publication of a final rule listing the GOM DPS under the ESA. Delay or interruption of research could negatively affect the ability to maintain time-series data and acquisition of information necessary for the survival and recovery of the species. Therefore, we conclude that it is not necessary and advisable to impose the ESA-take prohibitions on research that results in take, but not harm, of Atlantic sturgeon belonging to the GOM DPS under certain specified conditions.
        To comply with the research exemption proposed in this rule, researcher(s) would be required to submit a notice to NMFS's Northeast Regional Administrator (RA) at least 60 days prior to the commencement of such research, providing: (a) A statement describing the purpose of the research; (b) a detailed description of the study design, including all techniques and methodologies for sampling, and the data to be collected; (c) a list of the researchers performing the proposed research activities, including information demonstrating the level of experience for each of the technologies/methods to be used and the institution to which each is affiliated; (d) an estimate of the total take anticipated from such research by life stage; and, (e) the time period and specific location(s) of the research. To ensure that Atlantic sturgeon belonging to the GOM DPS, Atlantic sturgeon belonging to other DPSs, or any other ESA-listed species are not harmed as a result of this exemption to the 9(a)(1)(B) take prohibitions, and to monitor and enforce the use of this exemption, research activities: (a) Must be conducted in accordance with NMFS-approved methods for Atlantic sturgeon or use technologies that do not require capture or handling of Atlantic sturgeon; (b) must be directed at Atlantic sturgeon of the GOM DPS and not be incidental to research of another species; (c) must be conducted within the riverine range of the GOM DPS as specified in this rule; (d) must be intended as involving only non-lethal take; (e) must not take Atlantic sturgeon for artificial spawning or enhancement activities; (f) must comply with all other laws, including state permits, if applicable; and, (g) must be conducted by researchers with documented experience conducting the proposed methodologies/techniques on Atlantic sturgeon or another sturgeon species. Once the RA receives information for scientific research as described above, the RA will review the information and respond to the researcher(s) with a letter acknowledging that the research meets the exemption to the take prohibitions applied to Atlantic sturgeon GOM DPS, or a letter informing the researcher(s) that the exemption does not apply to the proposed research. The RA's letter is not a permit, and the letter does not provide authorization to conduct the research. Rather, the letter is intended as an acknowledgement that the specified research is or is not consistent with the exemption to the take prohibitions for scientific research provided in this rule. In order to give researchers enough time to submit a letter to the RA, we propose that ESA section 9 take prohibitions not apply to the scientific research that would otherwise fall under the exemption until two months after publication of a final section 4(d) rule.
        The researcher(s) must provide a report of the research results to the RA no later than 60 days following completion or termination of the research activity, including the total take (by life stage) and the method of take (e.g., harassment, capture, handling, etc.). For multi-year studies, researchers must provide an annual report to the RA summarizing the results to date, including the number of Atlantic sturgeon takes (by life stage) and the method of take (e.g., harassment, capture, handling, etc.). The research must be immediately suspended and the RA notified if any aspect of the research results in or is believed to have resulted in take causing harm (i.e., injury or death) to any Atlantic sturgeon belonging to the GOM DPS, or take (with or without causing harm) of any other ESA-listed species for which the researcher does not have an incidental take permit issued in accordance with Section 10(a)(1)(B).
        Salvage and Recovery
        To ensure that only Atlantic sturgeon listed as threatened would be affected, this proposed exemption would apply only to Atlantic sturgeon found within the riverine range of the GOM DPS (Table 1) given the overlap in distribution of all five U.S. DPSs within marine waters.

        Atlantic sturgeon carcasses and live, stranded sturgeon can provide pertinent life history data and information on activities affecting the GOM DPS. Collection of samples, as appropriate, from carcasses and live stranded or injured sturgeon can also help reduce the need for the intentional capture of Atlantic sturgeon for scientific research. Therefore, salvage of dead Atlantic sturgeon and recovery of live, stranded Atlantic sturgeon belonging to the GOM DPS affords a conservation benefit to the species by providing valuable data without putting the DPS at further risk.
        In order to obtain the most information, carcasses must be collected and transported as quickly as possible to an appropriate facility. Similarly, prompt attention to a live, stranded or injured sturgeon will increase its chances of survival. NMFS does not have sufficient personnel throughout the riverine range of the GOM DPS to respond promptly to all Atlantic sturgeon salvage and recovery events. NMFS does, however, work cooperatively with the U.S. Fish and Wildlife Service (FWS) and state wildlife agencies for salvage and recovery events involving other protected species including shortnose sturgeon, sea turtles and marine mammals. Some exemptions to the ESA take prohibitions for salvage or to aid a sick or injured animal already exist for some of these species. Therefore, we propose a similar exemption from the take prohibitions of section 9(a)(1)(B) for any agent or employee of NMFS, FWS, or any other Federal land or water management agency, or any agent or employee of a state agency responsible for fish and wildlife who is designated by his or her agency for such purposes, when acting in the course of his or her official duties to take Atlantic sturgeon belonging to the GOM DPS without a permit if such taking is necessary to salvage a dead specimen, which may be useful for scientific study; dispose of a dead specimen; or aid a sick, injured, or stranded specimen. Whenever possible, live specimens must be returned to their aquatic environment as soon as possible. This exception to the take prohibitions would only apply if the action is reported to the NMFS Northeast Regional Administrator within 30 days of occurrence of the event.
        References Cited

        A complete list of the references used in this proposed rule is available upon request (see ADDRESSES).
        Classification
        National Environmental Policy Act (NEPA)

        Whenever a species is listed as threatened, the ESA requires that we issue such regulations as we deem necessary and advisable to provide for its conservation. Accordingly, the promulgation of ESA section 4(d) protective regulations is subject to the requirements of NEPA, and we have prepared a draft Environmental Assessment (EA) analyzing the proposed 4(d) regulations and alternatives. We are seeking comment on the draft EA, which is available on the Federal eRulemaking Portal Web site (http://www.regulations.gov) or upon request (see DATES and ADDRESSES, above).
        Executive Order (E.O.) 12866
        This proposed rule has been determined to be not significant for the purposes of E.O. 12866.
        Regulatory Flexibility Act
        The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The factual basis for this determination is as follows.
        The proposed action would establish protective regulations for the Gulf of Maine Distinct Population Segment (GOM DPS) of Atlantic sturgeon. NMFS has proposed to list the GOM DPS of Atlantic sturgeon as threatened, and to list four other Atlantic sturgeon DPSs as endangered (75 FR 61872 and 75 FR 61904; October 6, 2010). All five DPSs share the same marine range, but each DPS has a unique riverine range.
        The prohibitions under section 9(a)(1) of the ESA apply automatically when a species is listed as endangered but not when a species is listed as threatened. In the case of threatened species, section 4(d) of the ESA leaves it to the Secretary's discretion whether and to what extent to extend the section 9 prohibitions of the ESA and directs the agency to issue regulations it considers necessary and advisable for the conservation of the species. Protecting the GOM DPS of Atlantic sturgeon from direct forms of take (including harass, harm, pursue, hunt, shoot, wound, kill, trap, or collect; or to attempt any of these) and indirect forms of take, such as harm that results from habitat degradation, will help preserve and recover the DPS. However, applying the section 9(a)(1) prohibitions to all forms of take for GOM DPS Atlantic sturgeon could impede necessary scientific research given the lengthy processing time to acquire a section 10(a)(1)(A) scientific research permit. Scientific research activities aid in the conservation of listed species by furthering our understanding of the species' life history and biological requirements. Collection of samples, as appropriate, from carcasses and live stranded or injured sturgeon can also help reduce the need for the intentional capture of Atlantic sturgeon for scientific research. Therefore, we propose to extend the ESA section 9(a)(1)(A) through 9(a)(1)(G) prohibitions to all activities impacting the GOM DPS throughout its range except for: (1) Scientific research conducted on GOM DPS Atlantic sturgeon within the riverine portion of its range and in accordance with accepted NMFS protocol(s); and, (2) salvage of dead and recovery of live stranded or injured GOM DPS Atlantic sturgeon found within the riverine range of the GOM DPS.
        Within the marine range of the GOM DPS of Atlantic sturgeon, the section 9(a)(1) prohibitions proposed by this action are the same as the prohibitions that will automatically apply to the same area upon listing of any of the other four DPSs as endangered. Therefore, the entities affected by this action are those which conduct the activities exempted from the section 9 prohibitions for GOM DPS Atlantic sturgeon. These are Federal and state agencies, research institutions and universities which conduct scientific research, salvage, and recovery activities for Atlantic sturgeon within the river range of the GOM DPS. The only impact to these entities would be that scientific research, salvage of dead and recovery of live injured GOM DPS Atlantic sturgeon in the river portion of its range could take place without a section 10(a)(1)(A) permit. This action would not impose any additional economic impacts on these affected entities.
        As a result, an initial regulatory flexibility analysis is not required and has not been prepared.
        Paperwork Reduction Act (PRA)

        Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number. This proposed rule contains collection-of-information requirements subject to the Paperwork Reduction Act (PRA) and which have been submitted to OMB for review and approval. Public reporting burden per response for this collection of information is estimated to average: (1) 40 hours to prepare reports on research of GOM DPS Atlantic sturgeon; and (2) 5 hours to prepare reports on emergency rescue, salvage or disposal of GOM DPS Atlantic sturgeon. These estimates include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. We invite comments regarding these burden estimates, or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see ADDRESSES) and to OMB at the Office of Information and Regulatory Affairs, Office of Management and Budget, Washington DC 20503 (Attention: NOAA Desk Officer).
        Information Quality Act
        The Information Quality Act directed the Office of Management and Budget to issue government wide guidelines that “provide policy and procedural guidance to federal agencies for ensuring and maximizing the quality, objectivity, utility, and integrity of information (including statistical information) disseminated by federal agencies.” Under the NOAA guidelines, this action is considered a Natural Resource Plan. It is a composite of several types of information from a variety of sources. Compliance of this document with NOAA guidelines is evaluated below.
        • Utility: The information disseminated is intended to describe a management action and the impacts of that action. The information is intended to be useful to state and Federal agencies, non-governmental organizations, industry groups and other interested parties so they can understand the management action, its effects, and its justification.
        • Integrity: No confidential data were used in the analysis of the impacts associated with this document. All information considered in this document and used to analyze the proposed action, is considered public information.
        • Objectivity: The NOAA Information Quality Guidelines standards for Natural Resource Plans state that plans be presented in an accurate, clear, complete, and unbiased manner. NMFS strives to draft and present proposed management measures in a clear and easily understandable manner with detailed descriptions that explain the decision making process and the implications of management measures on natural resources and the public. This document was reviewed by a variety of biologists, policy analysts, and NOAA attorneys.
        E.O. 13132—Federalism
        In keeping with the intent of the Administration and Congress to provide continuing and meaningful dialogue on issues of mutual state and Federal interest, this proposed rule will be given to the relevant state agencies in each state in which Atlantic sturgeon belonging to the GOM DPS occurs as well as the ASMFC, and they will be invited to comment. We intend to continue engaging in informal and formal contacts with the States and ASMFC, and other affected local or regional entities, giving careful consideration to all written and oral comments received.
        E.O. 12898—Environmental Justice
        E.O. 12898 requires that Federal actions address environmental justice in decision-making process. In particular, the environmental effects of the actions should not have a disproportionate effect on minority and low-income communities. The proposed protective regulations are not expected to have a disproportionately high effect on minority populations or low-income populations.
        Coastal Zone Management Act (16 U.S.C. 1451 et seq.)
        Section 307(c)(1) of the Federal Coastal Zone Management Act of 1972 requires that all Federal activities that affect any land or water use or natural resource of the coastal zone be consistent with approved state coastal zone management programs to the maximum extent practicable. NMFS has determined that this action is consistent to the maximum extent practicable with the enforceable policies of approved Coastal Zone Management Programs of each of the states within the range of the GOM DPS. Letters documenting NMFS's determination, along with the proposed rule, have been sent to the coastal zone management program offices in each affected state. A list of the specific state contacts and a copy of the letters are available upon request.

          List of Subjects in 50 CFR Part 223
          Endangered and threatened species, Exports, Imports, Transportation.

          Dated: June 6, 2011.
          John Oliver,
          Deputy Assistant Administrator for Operations, National Marine Fisheries Service.

        For the reasons set out in the preamble, 50 CFR part 223 is proposed to be amended as follows:

          PART 223—THREATENED MARINE AND ANADROMOUS SPECIES
          1. The authority citation for part 223 continues to read as follows:

            Authority:

            16 U.S.C. 1531-1543; subpart B, § 223.201-202 also issued under 16 U.S.C. 1361 et seq.; 16 U.S.C. 5503(d) for § 223.206(d)(9).

          2. In subpart B, add § 223.211 to read as follows:

            § 223.211
            Atlantic sturgeon.
            (a) Prohibitions. The prohibitions of sections 9(a)(1)(A) through 9(a)(1)(G) of the ESA (16 U.S.C. 1538) relating to endangered species apply to the threatened Gulf of Maine Distinct Population Segment (GOM DPS) of Atlantic sturgeon listed in § 223.102(c)(30).
            (b) Exemptions. Exemptions to the take prohibitions described in section 9(a)(1)(B) of the ESA (16 U.S.C. 1538(a)(1)(B)) applied in paragraph (a) of this section to the threatened GOM DPS listed in § 223.102(c)(30) are described in paragraphs (b)(1) and (2) of this section.
            (1) Scientific research exemption. The prohibitions of paragraph (a) of this section relating to the threatened GOM DPS listed in § 223.102(c)(30) do not apply to ongoing or future scientific research if:
            (i) The scientific research is conducted in accordance with NMFS-approved methods for Atlantic sturgeon or uses technologies that do not require capture or handling of Atlantic sturgeon;
            (ii) The research is directed at Atlantic sturgeon of the GOM DPS and is not incidental to research of another species;
            (iii) The research is conducted upstream of the U.S. Route 1 Bridge at Newburyport, MA on the Merrimack River, upstream of Leigh's Mill Pond, South Berwick, ME on the Piscataqua River, upstream of the Main Street Bridge, Biddeford, ME on the Saco River, upstream of the U.S. Route 1 Bridge at Bath, ME on the Kennebec River, upstream of the Sheepscot Road Bridge at Newcastle, ME on the Sheepscot River, or upstream of Cove Brook at Winterport, ME on the Penobscot River (i.e., within the riverine range of the GOM DPS);
            (iv) The research is conducted in compliance with all other laws, including state permits, if applicable;
            (v) The research is conducted by researchers with documented experience conducting the proposed methodologies/techniques on Atlantic sturgeon or another sturgeon species;
            (vi) Researchers make every effort to ensure that take is non-lethal;
            (vii) Take does not involve artificial spawning or enhancement activities;

            (viii) The researcher provides the following to the NMFS Northeast Regional Administrator at least 60 days prior to the commencement of such research (or, for ongoing research, within 60 days of issuance of a final rule): a description of the study objectives and justification; a summary of the study design and methodology; a list of the researchers who will perform the study, including information demonstrating prior experience with Atlantic sturgeon or another sturgeon species for each of the technologies/methods to be used; the institution to which each participating researcher is affiliated; an estimate of the total take (by life stage) anticipated from the study; and the time period and location of the research;
            (ix) Reports that include the total take (by life stage) and the method of taking (e.g., harassment, capture, handling) are provided to the NMFS Northeast Regional Administrator no later than 60 days following completion or termination of the research activity, or annually for multi-year studies; and
            (x) The researcher(s) immediately suspend field studies and report to the NMFS Northeast Regional Administrator if any aspect of the research results in or is believed to have resulted in take causing injury or mortality of any Atlantic sturgeon belonging to the GOM DPS, or take (with or without causing injury or mortality) of any other ESA-listed species for which the researcher does not have an incidental take permit issued in accordance with section 10(a)(1)(B) of the ESA.
            (2) Salvage and Recovery Exemption. The prohibitions of paragraph (a) of this section relating to the threatened GOM DPS of Atlantic sturgeon listed in § 223.102(c)(30) do not apply to Atlantic sturgeon salvage and rescue activities performed by persons described in paragraph (b)(2)(i) of this section, that include disposing of dead fish, salvaging dead Atlantic sturgeon for use in scientific studies or aiding sick, injured, or stranded Atlantic sturgeon, if:
            (i) The activity is conducted by an employee of NMFS, the U.S. Fish and Wildlife Service, any other Federal land or water management agency, or any agent or employee of a state agency responsible for fish and wildlife who is designated by his or her agency for such purposes, when acting in the course of his or her official duties;
            (ii) The activity is conducted in compliance with all other laws, including state permits, if applicable;
            (iii) The activity is conducted upstream of the U.S. Route 1 Bridge at Newburyport, MA on the Merrimack River, upstream of Leigh's Mill Pond, South Berwick, ME on the Piscataqua River, upstream of the Main Street Bridge, Biddeford, ME on the Saco River, upstream of the U.S. Route 1 Bridge at Bath, ME on the Kennebec River, upstream of the Sheepscot Road Bridge at Newcastle, ME on the Sheepscot River, or upstream of Cove Brook at Winterport, ME on the Penobscot River (i.e., within the riverine range of the GOM DPS);
            (iv) Live specimens are returned to their natural environment as soon as the sturgeon is no longer in danger (i.e., sick or injured); and
            (v) The Northeast Regional Administrator is notified within 30 days after such an event whether the activity was a salvage or recovery, the individual(s) who salvaged or recovered the sturgeon, his or her agency affiliation, and the disposition of the specimen.

      [FR Doc. 2011-14454 Filed 6-9-11; 8:45 am]
      BILLING CODE 3510-22-P