Preventing Drug Abuse: Low Participation by Pharmacies and Other Entities as Voluntary Collectors of Unused Prescription Drugs

In 2015, 3.8 million Americans reported misusing prescription drugs within the last month, and deaths from prescription opioids have more than quadrupled since 1999. About half of the people who reported misusing prescription drugs in 2015 received them from a friend or relative.

One way to help prevent this kind of diversion and potential misuse is by providing secure and convenient ways to dispose of unused, unneeded, or expired prescription medications. The Secure and Responsible Drug Disposal Act of 2010 authorizes pharmacies and other entities already authorized by DEA to handle controlled substances to also collect unused prescription drugs for disposal. In 2014, DEA finalized regulations for the implementation of the Act, establishing a voluntary process for eligible entities to become authorized collectors of unused prescription drugs using disposal bins.

GAO was asked to review participation among authorized collectors that maintain disposal bins. In this report GAO describes (1) participation rates among entities eligible to collect unused prescription drugs and (2) factors that affect participation. GAO analyzed the most currently available DEA data from April 2017 on entities eligible to participate and those participating as authorized collectors. GAO also conducted interviews with DEA officials and a nongeneralizable sample of 11 stakeholder organizations selected to illustrate different types of authorized collectors and long-term care facilities. GAO is not making any recommendations. DEA provided technical comments, which GAO incorporated as appropriate.

GAO found that about 3 percent of pharmacies and other entities eligible to collect unused prescription drugs for disposal have volunteered to do so. The Drug Enforcement Administration (DEA) authorizes these entities to dispose of unused drugs to help reduce their potential misuse. Analysis of DEA data shows that as of April 2017, 2,233 of the 89,550 (2.49 percent) eligible entities—that is, certain entities already authorized by DEA to handle controlled substances—had registered with DEA to use disposal bins to collect unused prescription drugs. Most—about 81 percent—of the authorized collectors were pharmacies, followed by hospitals or clinics. GAO also found that participation rates varied by state, though in 44 states less than 5 percent of the state's pharmacies and other eligible entities had registered to become authorized collectors.

Stakeholders cited several factors that may explain why relatively few pharmacies and other eligible entities have registered with DEA as authorized collectors of unused drugs. Most notably, stakeholders representing authorized collectors told GAO that because participation is voluntary, the cost associated with maintaining a disposal bin—which includes purchasing and installing the bin according to DEA requirements and paying for the destruction of its contents—is an important factor to weigh against potential benefits. DEA noted that availability of disposal by law enforcement agencies also contributes to low participation.

The misuse of prescription drugs is widespread and contributes to  overdoses and deaths. Federal data show that in 2015, 3.8 million  Americans reported misusing prescription drugs within a 1-month period  and that prescription drug misuse was the second most common type of  illicit drug use, after marijuana use. The misuse of prescription drugs has  also contributed to the nation’s opioid epidemic and the overdoses  associated with it, as 91 people in the United States die each day, on  average, from an opioid overdose, including overdoses involving  prescription opioids and heroin. Furthermore, the number of deaths  resulting from prescription opioids has more than quadrupled since 1999.

About half of the people who reported misusing prescription drugs in 2015  received them from a friend or relative. One way to help prevent this type  of diversion of prescription drugs from their intended users and the  resulting potential for abuse is by providing secure and convenient  disposal mechanisms for unused, unneeded, or expired prescription  medications. Under the Secure and Responsible Drug Disposal Act of  2010 (“Disposal Act”), the Drug Enforcement Administration (DEA) may  authorize eligible retail pharmacies and other entities—which are certain  entities already authorized by the DEA to handle controlled substances— to also collect unused prescription drugs from the public. In September  2014, DEA finalized regulations for the implementation of the Disposal  Act, providing pharmacies and other eligible entities the option to register  with DEA to become authorized collectors of unused controlled  prescription drugs using collection receptacles, which are bins used to  collect drugs meant for disposal. The regulation establishes  requirements participating entities must meet, such as installing the  disposal bin securely to a permanent structure and making the bin  inaccessible to the public when an employee is not present.

You requested that we review DEA’s requirements for authorized  collectors of prescription drugs and participation rates. In this report, we  describe  1.  participation rates of eligible pharmacies and other entities as DEA- authorized collectors of unused prescription drugs, and  2.  factors that affect voluntary participation as authorized collectors of  unused prescription drugs.

To describe the rates of eligible pharmacies and other entities that  participate as DEA-authorized collectors of unused prescription drugs  using disposal bins, we analyzed DEA data as of April 20, 2017, the most  current data available at the time of our analysis. We determined the  number and percentage of eligible entities participating as authorized  collectors nationwide, by state, and by type of entity. We also determined the number of eligible and participating authorized collectors in rural and  urban areas, using DEA’s data and Rural-Urban Commuting Area codes.  Finally, we analyzed DEA’s data and data from the U.S. Census Bureau’s  American Community Survey 5-year population estimates for 2011  through 2015 to estimate the number of individuals and the percentage of  the U.S. population living within varying distances of a DEA authorized  collector’s disposal bin. For all data used in these analyses, we  interviewed knowledgeable officials and reviewed related documentation  and, based on these steps, determined that the data were sufficiently  reliable for our purposes. Our review is limited to DEA-authorized  collectors that use disposal bins to collect unused prescription drugs from  the public. Other methods of drug disposal by eligible entities and all  methods of disposal by law enforcement agencies, which do not require  DEA authorization to dispose of controlled substances, are outside the  scope of our work.

To describe the factors that affect voluntary participation as authorized  collectors of prescription drugs, we interviewed DEA officials. In addition,  we conducted interviews with 11 stakeholder organizations—8 selected  because they represent different types of authorized collectors, such as  pharmacies and reverse distributors, and 3 selected because they  represent long-term care facilities. Our findings cannot be generalized  beyond the stakeholder organizations we interviewed.

We conducted this performance audit from November 2016 to October  2017 in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our findings and conclusions based on our audit objectives. We believe  that the evidence obtained provides a reasonable basis for our findings  and conclusions based on our audit objectives.

The DEA, within the Department of Justice, is responsible for ensuring  the availability of controlled substances for legitimate uses while  preventing their diversion through its administration and enforcement of  the Controlled Substances Act and its implementing regulations. Under  the Controlled Substances Act, all persons or entities that manufacture,  distribute, or dispense controlled substances are required to register with  DEA, unless specifically exempted. DEA regulates these entities to limit  diversion and prevent abuse. For example, DEA regulates  pharmaceutical companies that manufacture controlled substances,  health care providers who prescribe them to patients, and pharmacies  that dispense them.

In October 2010, the Disposal Act amended the Controlled Substances  Act to allow the public to deliver unused controlled substances to an entity  authorized by DEA to dispose of the substances. DEA was given  responsibility for promulgating the implementing regulations, and the  Disposal Act stipulated that the regulations should prevent diversion of  controlled substances while also taking into consideration public health  and safety, ease and cost of implementation, and participation by various  communities. In addition to disposal bins, DEA’s regulations describe two  other options for the public to transfer controlled substances for the  purpose of disposal: mail-back programs and take-back events. Law  enforcement agencies may use all three methods of drug disposal without  the need for authorization by DEA. The Disposal Act stipulates that the  regulations cannot require an entity to participate in or establish any of  the disposal options.

Requirements for Authorized Collectors of Unused Prescription Drugs

To participate as authorized collectors of unused prescription drugs,  eligible entities—retail pharmacies, hospitals/clinics with an on-site  pharmacy, narcotic treatment programs, reverse distributors, distributors,  and drug manufacturers that are already authorized by DEA to handle  controlled substances—must modify their DEA registration. According to  DEA officials, such modification is free and simple to do. Eligible retail  pharmacies or hospitals/clinics that become authorized collectors are able  to install and maintain disposal bins in long-term care facilities in addition  to their own location. DEA’s website contains a public search feature to  identify authorized collectors located near a specific zip code or  address.

Authorized collectors must install, manage, and maintain the disposal  bins following DEA regulations. For example, under DEA’s regulations for  maintaining the disposal bins,  the disposal bin must be securely fastened to a permanent structure,  securely locked, substantially constructed with a permanent outer  container and removable inner liner, and have a small opening that  allows contents to be added but not removed;  the bin must also prominently display a sign indicating which types of  substances are acceptable; users must dispose the unused prescriptions into the collection  receptacle themselves without handing them to staff at the  pharmacy;  the disposal bin must typically be located in an area where an  employee is present and near where controlled substances are  stored, and the bin must be made inaccessible to the public when an  employee is not present;  the inner liner of the disposal bin must meet certain requirements,  including being waterproof, tamper-evident, tear-resistant, opaque,  and having the size and identification number clearly labeled; and  the installation and removal of inner liners must be performed under  the supervision of at least two employees of the authorized collector.

DEA regulations also require that all controlled substances collected in  the disposal bin’s inner liners must be destroyed in compliance with  applicable federal, state, and local laws and rendered non-retrievable.  According to DEA regulations, non-retrievable means that the physical  and chemical conditions of the controlled substance must be permanently  altered, thereby rendering the controlled substance unavailable and  unusable for all practical purposes. Authorized collectors are permitted to  destroy the inner liner on their premises if they have the capacity to do so.  If not, the inner liners can be transported to a separate location to be  destroyed. Typically, in this case, an authorized collector contracts with a  reverse distributor to periodically remove, transport, and destroy the inner  liners. DEA regulations require that two reverse distributor employees  transport the inner liners directly to the disposal location without any  unnecessary stops or stops of an extended duration. Authorized  collectors must document certain information, including inner liner  identification numbers and the dates that each liner is installed, removed,  and transferred for destruction. The authorized collectors must maintain  these records for 2 years. Figure 1 summarizes the steps involved in the  collection of unused prescription drugs.

About 3 Percent of Eligible Pharmacies and Other Entities Voluntarily Participate as DEA-Authorized Collectors of Unused Prescription Drugs

About 3 percent of pharmacies and other eligible entities have voluntarily  chosen to become DEA-authorized collectors of unused prescription  drugs, according to DEA data. As of April 2017, 2,233 of the 89,550 (2.49  percent) of eligible entities—which are already authorized by DEA to  handle controlled substances—had registered to use disposal bins to  collect unused prescription drugs. Most of the authorized collectors— about 81 percent—were pharmacies, followed by hospitals or clinics.  (See table 1). Narcotic treatment programs, reverse distributors, and  distributors made up approximately 1 percent of the authorized collectors.

We also found that participation rates varied by state, though in most  states relatively few of the eligible entities had registered with DEA to  become authorized collectors of unused prescription drugs. In 44 states,  less than 5 percent of the eligible entities had registered. (See figure 2  and appendix I for more information on the participation rates of  authorized collectors in each state). As of April 2017, Connecticut,  Missouri, and Maine had the lowest participation rates, with 0.11, 0.22,  and 0.70 percent, respectively. In contrast, North Dakota had the  highest participation rate, with 32.0 percent of its pharmacies and other  eligible entities registered to be authorized collectors. The state with next  highest participation rate was Alaska, with 8.96 percent. In North Dakota,  the state’s Board of Pharmacy provides funding for authorized collectors  to purchase and maintain the disposal bins. According to a board official,  the board decided to fund these activities to increase participation rates  and plans to continue its funding indefinitely using revenue generated  from prescription drug licensing fees it collects.

In addition, our analysis shows that about 82 percent of all authorized  collectors were located in urban areas as of April 2017. However, when  comparing the entities registered to be authorized collectors with the total  number of eligible entities, we found that a larger percentage of the  eligible entities in rural areas became authorized collectors compared  with those in urban areas (see table 2).

The data we obtained on the number of eligible and participating  authorized collectors and their locations are the only available DEA data  on the use of disposal bins to collect unused prescription drugs.  According to DEA officials, the agency does not collect any other  information on the use of disposal bins, such as the extent to which the  bins are used, or the amount and types of prescription drugs deposited  into the bins. For example, to minimize the risk of diversion, DEA  regulations do not allow authorized collectors to open and inspect the  inner liners of the disposal bins, so information on their contents cannot  be collected. According to DEA officials, the agency is not responsible  for collecting information on the amount and types of prescription drugs  destroyed through the disposal bins. DEA officials told us that the agency  views its responsibility solely as giving pharmacies and other eligible  entities the opportunity to become authorized collectors.

Though we do not have information on the extent to which individuals use  DEA’s prescription drug disposal bins, we were able to estimate that as of  April 2017, about half of the country’s population lived less than 5 miles  away from a pharmacy or other DEA-authorized entity offering a  prescription disposal bin. In 21 states, at least 50 percent of the state’s  population lived within 5 miles of a prescription disposal bin. (See   figure 3).

While close to half of the nation’s population lived less than 5 miles from a  disposal bin as of April 2017, the availability of nearby disposal bins  varied significantly for people depending on whether they lived in an  urban or a rural area. Specifically, about 52 percent of the population in  urban areas lived less than 5 miles away from a disposal bin, compared  to about 13 percent of the population in rural areas. Furthermore, about  44 percent of the population in rural areas lived even further away—more  than 30 miles away from a disposal bin. An exception to this is North  Dakota, where about 86 percent of its urban population and about 64  percent of its rural population lived within 5 miles of a disposal bin.

Stakeholders Cited Cost and Other Factors as Affecting Decision to Become DEA-Authorized Collectors of Unused Prescription Drugs

According to officials from the 11 stakeholder organizations we  interviewed—which represent authorized collectors and long-term care  facilities—several factors may explain why relatively few pharmacies and  other eligible entities have chosen to become authorized collectors of  unused prescription drugs. These factors include the associated costs of  participating, uncertainty over proper implementation, and participation in  other, similar efforts for disposing of unused prescription drugs.

Costs: Stakeholders said that the costs associated with purchasing,  installing, and managing the disposal bins is a factor that explains the  relatively low rate of participation. One stakeholder told us that many  eligible entities may decide that the benefit of participating does not  outweigh the costs associated with doing so. Specifically, stakeholders  told us that the major costs associated with participating include  the one-time cost of purchasing and installing a disposal bin;  the ongoing costs to train personnel to manage the bins; and  the cost of contracting with a reverse distributor to periodically dispose  of the bin’s inner liner and contents.

Stakeholders gave varying examples of the specific costs associated with  these investments. For example, one stakeholder estimated the yearly  costs of maintaining a disposal bin ranged from $500 to $600 per  location; another stakeholder said that the cost is thousands of dollars per  location per year, but did not provide a specific estimate. These  stakeholders added that costs can increase if the disposal bins fill more  quickly and need to be emptied more often than expected.

For their part, officials from the reverse distributor stakeholders we  interviewed cited incinerating hazardous waste, the availability of  incinerators, and the cost of personnel as factors that increase the cost of  their services for authorized collectors. One reverse distributor  stakeholder told us that there are not many incinerators available,  requiring them to travel long distances to incinerate collected waste. The  other reverse distributor stakeholder added that DEA’s requirement that a  second employee be present during the transportation and disposal  increases the cost of their services.

While some stakeholders speculated that costs are a reason for low  participation, a few stakeholders told us that the benefits are worth the  costs. In fact, two stakeholders we spoke with told us that the benefit to  the communities was so important that they decided to provide funding to  retail pharmacies, alleviating an individual pharmacy’s concern about the  cost of installing and maintaining the disposal bins. We found that as of  April 2017, over a quarter of the 2,233 authorized collectors using  disposal bins received external funding to pay for the costs associated  with installing and maintaining the disposal bins. In addition, stakeholders  told us that some localities have enacted laws known as extended  producer responsibility ordinances, which require that pharmaceutical  manufacturers pay for certain costs associated with drug disposal. When  asked about the costs associated with operating disposal bins, DEA  officials told us that addressing cost issues with eligible participants falls  outside of their responsibilities.

Uncertainty: Stakeholders also told us that uncertainty regarding how to  comply with aspects of DEA’s regulations for prescription drug disposal  bins affected their decisions to participate. One stakeholder added that  many eligible entities decide not to participate because uncertainties over  participation requirements could result in inadvertent non-compliance with  DEA’s regulations.

As an example of their uncertainty over some of the requirements  governing the disposal bins, officials from both of the reverse distributor  stakeholders we interviewed cited DEA’s non-retrievable standard for  destruction of the inner liners of the bins. DEA requires that the method of  destruction be sufficient to render all controlled substances non- retrievable, meaning that the physical and chemical conditions of the  controlled substances must be permanently altered and unusable in order  to prevent diversion for illicit purposes. Both reverse distributor  stakeholders told us that they are uncertain about whether certain  disposal methods meet this standard, and they said that the agency has  not provided further guidance on how reverse distributors can meet this  requirement. DEA officials told us that the agency responds to questions  about whether a specific method of destruction meets the non-retrievable  standard by telling the registrant to test the remnants after destruction, to  see if any components of the controlled substance are still present. In its  summary of the regulations implementing the Disposal Act, DEA stated  that in order to allow for the development of various methods of  destruction, the agency did not require a specific method of destruction as  long as the desired result is achieved. However, DEA officials stated  that to their knowledge, incineration is the only method known to meet the  non-retrievable standard to date, but the officials hoped other methods  will be developed in the future.

When asked about the guidance they provide to authorized collectors of  unused prescription drugs or those eligible to become authorized  collectors, DEA officials told us that they post frequently-asked questions  on their website, routinely answer questions from participants and others,  and give training presentations at conferences that include information on  the disposal bins. In our prior work, we found problems with DEA’s  communication and guidance to stakeholders. In 2015, we recommended  that DEA identify and implement cost-effective means for communicating  regularly with pharmacies and other entities authorized to handle  controlled substances. DEA agreed with the recommendation, and  officials told us that, starting in August 2017, these entities can subscribe  to DEA’s website to receive notifications when it is updated with new  guidance.

Stakeholders also noted that some DEA requirements related to disposal  bins may conflict with other state and federal requirements governing the  transportation and disposal of hazardous waste, which includes some  controlled substances. For example, the two reverse distributor  stakeholders told us that some incinerator permits issued by states  require that hazardous waste be examined before incineration; however,  DEA requirements do not allow the contents of the liners to be examined,  even at the time of incineration. To address the incinerator permit  requirements, one reverse distributor told us that they use the  Environmental Protection Agency’s hazardous waste household  exemption, which treats the liners as household waste and thereby allows  incinerator facilities to destroy the liners without examining the contents or  violating their state permit. In addition, some stakeholders raised  concerns that DEA’s regulations may conflict with other federal  regulations. For instance, one stakeholder noted that they recently  learned that transporting the disposal bin’s inner liners could violate  Department of Transportation regulations. DEA officials told us that they  were aware of this, explaining that the conflict was between DEA’s  requirement that controlled substances be transported in liners and the  Department of Transportation’s requirement that this type of waste be  transported in sturdy containers. According to DEA officials, this conflict  has been resolved by the Department of Transportation allowing reverse  distributors to place the liners inside sturdy containers kept on trucks.

Participation in or Availability of Similar Efforts: Stakeholders said  that some pharmacies and other eligible entities were already  participating in other, similar efforts that allow for the safe disposal of  controlled substances, and therefore they did not want to invest additional  resources into participating as authorized collectors using disposal bins.  For example, the Centers for Medicare & Medicaid Services has an  established process that long-term care facilities use to dispose of their  unused controlled substances. As a result, all of the long-term care  stakeholders told us that long-term care facilities may choose not to  partner with pharmacies interested in placing disposal bins within their  facilities because it adds significant cost and effort without any additional  benefit. Furthermore, pharmacy stakeholders noted that because of the  availability of other prescription drug collection efforts in their  communities, they did not think that maintaining a disposal bin at their  locations was needed. For example, two of the stakeholders explained  that local law enforcement precincts already had a similar type of disposal  bin in place to collect unused prescription drugs. DEA officials told us  that they were aware of other options for the public and entities such as  long-term care facilities that are not registered as authorized collectors to  dispose of controlled substances. The officials also indicated that the  availability of disposal options at law enforcement agencies contributes to  the low participation rates among pharmacies as authorized collectors of  unused prescription drugs.

We provided a draft of this report to the Department of Justice for  comment. DEA, part of the Department of Justice, provided technical  comments, which we incorporated as appropriate.

As agreed with your offices, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date. At that time, we will send copies to the Attorney General of  the United States and the Administrator of DEA. In addition, the report will  be available at no charge on the GAO website at http://www.gao.gov.

If you or your staff have any questions about this report, please contact  me at (202) 512-7114 or draperd@gao.gov. Contact points for our Offices  of Congressional Relations and Public Affairs may be found on the last  page of this report. GAO staff who made key contributions to this report  are listed in appendix II.

Appendix I: Entities Eligible to Register with DEA to Become Authorized Collectors and Participating Collectors, by State, April 2017

Appendix II: GAO Contact and Staff Acknowledgments

In addition to the contact name above, Elizabeth H. Curda (Director), Will  Simerl (Assistant Director), Kathryn Richter (Analyst-In-Charge), Nick  Bartine, Giselle Hicks, Jessica Lin, and Emily Wilson made key  contributions to this report. Also contributing were Muriel Brown and  Krister Friday.

In 2015, 3.8 million Americans reported misusing prescriptions in the prior month, and deaths from prescription opioids have quadrupled since 1999. Most people get these drugs from friends or relatives, so providing secure and convenient ways for people to dispose of their unused drugs could help.

A 2010 federal law authorized pharmacies and other entities to voluntarily maintain a prescription drug disposal bin for the public. We found that 3% of entities eligible to collect drugs in this way volunteered to do so. Stakeholders reported that this is partly due to the cost of purchasing a bin and paying for the destruction of collected drugs.


DNA Evidence: Preliminary Observations on DOJ's DNA Capacity Enhancement and Backlog Reduction Grant Program

Many state and local crime labs have backlogs of requests for DNA analysis of crime scene evidence, as reported by grantees participating in DOJ's CEBR grant program. These backlogs can include sexual assault kits. Since 2011, DOJ's Office of Justice Programs—the primary grant-making arm of DOJ—has awarded nearly $500 million to states and local jurisdictions through the CEBR grant program to help reduce DNA evidence awaiting analysis at crime labs. There have been concerns that these backlogs of unanalyzed evidence have enabled serial offenders to reoffend or have delayed justice.

This statement is based on preliminary observations and analyses from GAO's ongoing review of (1) the level of crime scene DNA evidence backlogs among CEBR grantees and the factors that contribute to such backlogs; (2) the extent to which DOJ has clearly defined goals for CEBR; and (3) the extent to which OJP has controls for CEBR related to federal conflicts of interest and lobbying requirements. To develop these preliminary findings, GAO reviewed CEBR grantee data from 2011-2016 (the latest data available) and studies relevant to the DNA backlog, visited selected labs, and interviewed DOJ officials, among others.

GAO's preliminary analysis found that, among the Department of Justice's (DOJ) DNA Capacity Enhancement and Backlog Reduction Program (CEBR) grantees (state and local entities with forensic crime labs), the reported aggregated backlog of crime scene DNA analysis requests has increased by 77 percent from 2011-2016. The growth in this reported aggregate backlog is the result of labs receiving more requests than they were able to complete, although they were receiving and completing more requests, as shown in the figure below.

GAO's preliminary analysis also found that the National Institute of Justice (NIJ)—the component within DOJ's Office of Justice Programs (OJP) that is responsible for administering CEBR grants—has not defined CEBR program-wide goals in clear, specific, and measurable terms. Additionally, GAO's ongoing work identified statements in NIJ and CEBR program documentation that communicated program-wide goals, but the documentation did not consistently identify the same goals or cite the same number of goals. GAO continues to evaluate CEBR program goals and is in the process of evaluating related CEBR performance measures as part of its ongoing work.

GAO's preliminary analysis found that OJP has some controls to implement federal requirements associated with conflicts of interest and lobbying that apply to both OJP CEBR grant administrators as well as recipients of CEBR grant funding, but OJP has not fully established all appropriate controls related to lobbying.

GAO is not making recommendations in this testimony but will consider them, as appropriate, as it finalizes its work.

Thank you for the opportunity to discuss preliminary observations from  our ongoing work on backlogs of DNA evidence. In the criminal justice  context, DNA analysis may be used to develop investigative leads, link an  offender or victim to a crime scene, or confirm or disprove an account of a  crime. Many state and local crime labs have backlogs of requests for  DNA analysis of crime scene evidence, as reported by grantees  participating in the Department of Justice’s (DOJ) DNA Capacity  Enhancement and Backlog Reduction grant program (CEBR). These  backlogs can include sexual assault kits (SAKs). There have been  concerns that these backlogs of unanalyzed evidence have enabled serial  offenders to reoffend or have delayed justice. In addition, questions have  been raised about potential improper connections among those who profit  from DNA testing and those who advocate for CEBR funding, such as  private companies providing financial assistance to CEBR funding  advocates.

Since 2011, DOJ has awarded nearly $500 million to states and local  jurisdictions through CEBR to help reduce DNA evidence awaiting  analysis at crime labs. CEBR funds can be used to process DNA  evidence collected from crime scenes or offenders.

My statement today is based on preliminary observations and analyses  from our ongoing review for Senator Grassley of DNA evidence backlogs  and the CEBR grant program. Specifically, I will address the following  topics: (1) the level of crime scene DNA evidence backlogs among CEBR  grantees and the factors that contribute to such backlogs; (2) the extent  to which DOJ has clearly defined goals for CEBR; and (3) the extent to  which DOJ’s Office of Justice Programs (OJP)—the primary grant-making  arm of DOJ—has controls for CEBR related to federal conflicts of interest  and lobbying requirements.

As part of our ongoing work, we reviewed CEBR grantee data and studies  relevant to the DNA backlog, we visited selected labs, and we interviewed  DOJ officials, among others. To assess the backlog of DNA evidence  among CEBR grantees, we collected yearly baseline performance data  from CEBR grantees from 2011 through 2016. We selected 2011 to  coincide with the year in which two grant programs were combined into  what is now known as the CEBR grant program, and 2016 was the latest  year for which grantee data were available. To assess the extent to which  DOJ-compiled CEBR baseline data are reliable, we completed a number  of data reliability steps, including discussing data entry issues with  grantees and running logic tests on the data. Despite some limitations  found with regards to validating and reporting requirements, after  completing these steps, we determined that CEBR data were sufficiently  reliable for the purposes of illustrating year-over-year aggregate trends  among CEBR grantees.

Additionally, to identify factors that contribute to backlogs of unanalyzed  DNA evidence at laboratories, we reviewed relevant studies and  discussed factors with DNA evidence stakeholders, including DOJ  officials, CEBR grantees, forensic crime laboratory directors, and relevant  academics and practitioners. We summarized information from these  sources to identify common factors, and we included illustrative examples  of the types of factors we have identified to date in our statement. To  assess the extent to which DOJ has clearly defined goals for CEBR, we  are reviewing OJP CEBR documentation, including the most recent  CEBR grant solicitation and CEBR program performance reports. We  also discussed program goals with OJP officials. Finally, to assess the  extent to which OJP has controls associated with federal conflicts of  interest and lobbying requirements, we identified federal statutes and  regulations governing conflicts of interest and lobbying. We are reviewing  OJP documentation and statements from OJP officials to determine the  extent to which OJP has controls in place consistent with those  requirements.

This work is being conducted in accordance with generally accepted  government auditing standards. Those standards require that we plan  and perform the audit to obtain sufficient, appropriate evidence to provide  a reasonable basis for our findings and conclusions based on our audit  objectives. We believe that the evidence obtained provides a reasonable  basis for our findings and conclusions based on our audit objectives.

Analysis of DNA evidence from crime scenes can help law enforcement  link offenders or victims to crime scenes. After crimes occur, law  enforcement submits physical evidence from crime scenes, victims, and  suspects (hereafter referred to as “crime scene evidence”) to labs for  analysis. Labs then perform “DNA analysis,” which, as used in this  statement, refers to (1) biology screening (locating, screening, identifying,  and characterizing blood and other biological stains and substances);  and/or (2) DNA testing (identifying and comparing DNA profiles in  biological samples). In order to compare the victim’s or offender’s DNA  profile to the recovered crime scene DNA, the lab will need to have  known biological samples available. Thus, samples are generally  collected from victims and may also be collected from others—such as  suspects, crime scene personnel, first responders, and consensual  sexual partners (in cases of sexual assault).

Matching DNA Profiles in the FBI’s Combined DNA Index System

Matching DNA profiles from unknown potential offenders to existing DNA  profiles can help law enforcement develop investigative leads. If a case  has no suspects to compare the DNA evidence to, the DNA profile of the  unknown potential offender can be entered in the Federal Bureau of  Investigation’s (FBI) Combined DNA Index System (CODIS), where it can  be compared to existing DNA profiles at the local, state, or national level.  Labs can then compare unknown potential offender profiles to other  profiles already in CODIS, including:  1.  Profiles generated from evidence taken from other crime scenes and  connected to other unknown potential offenders.  2.  Profiles generated from samples taken from known convicted  offenders, arrestees, and others as required by law (hereafter  “offender samples”). According to DOJ, the federal government, all 50  states, the District of Columbia, and Puerto Rico have laws requiring  the collection of DNA samples from individuals convicted of certain  crimes; in addition, the federal government, over half of the states,  and the District of Columbia have laws authorizing the collection of  DNA from individuals arrested for certain crimes.

When an unknown potential offender’s profile matches another profile  within CODIS, a “hit” or investigative lead may be developed and shared  with law enforcement, as shown in figure 1 below.

Only federal, state, or local government labs that meet the FBI’s Quality  Assurance Standards can participate in CODIS. As of January 1, 2018  there were 201 labs that participated in CODIS in the U.S. Of these, 143  performed just forensic casework DNA analysis, 4 performed just offender  sample DNA analysis, and 54 performed both. According to the FBI, as of  May 2018, the national level of CODIS contained over 16 million profiles  generated from offender samples and over 850,000 profiles generated  from crime scene evidence. Also, the FBI reported that as of May 2018,  CODIS had produced over 422,000 hits that aided more than 406,000  investigations.

DOJ’s Capacity Enhancement and Backlog Reduction Grant Program

The CEBR grant program is administered by the National Institute of  Justice (NIJ), a component within OJP. NIJ, the research arm of DOJ, is  responsible for evaluating programs and policies that respond to crime,  and providing and administering awards for DNA analysis and forensic  activities, among other criminal justice activities. The CEBR grant  program is funded by an appropriation “for a DNA analysis and capacity  enhancement program and for other local, State, and Federal forensic  activities.” The broad appropriations language enables NIJ to allocate  funding for a variety of forensic programs at funding levels established by  the agency; however, congressional reports accompanying the  appropriation have directed that OJP make funding for DNA analysis and  capacity enhancement a priority. CEBR awards can be used to enhance  capacity and reduce backlogs at government labs that analyze crime  scene DNA evidence and/or process offender DNA samples. NIJ defines  a “backlogged” request for analysis of crime scene evidence as a request  that has not been completed within 30 days of receipt in the laboratory.

CEBR is a formula grant program that dates back to 2004. Grant  awards are made non-competitively to states and units of local  government based on a formula set by DOJ that allocates certain  amounts to each state. This formula takes into account each state’s  population and associated crime, and guarantees a minimum amount for  eligible applicants from each state. CEBR has broad participation from  states and local jurisdictions. For instance, in 2017 OJP awarded $61  million in CEBR grants to 131 grantees in 49 states, the District of  Columbia, and Puerto Rico.

Preliminary Analysis of CEBR Data Show that the Backlog of Requests for Crime Scene DNA Analysis Is Increasing and Stakeholders Attribute This to Various Factors

Our preliminary analysis of CEBR grant program data show that the  backlog of requests for crime scene DNA analysis has increased by 77  percent from 2011 through 2016, and that demand for such DNA analysis  has outpaced laboratory capacity. In our review, we identified numerous  factors that have contributed to an increased demand for DNA analysis  beyond laboratories’ capacities, including scientific advancements in DNA  analysis technology and state laws requiring testing of certain DNA  evidence.

Preliminary Analysis of CEBR Data Show an Increasing Backlog for Crime Scene DNA Analysis at Laboratories among CEBR Grantees, though Backlogs Vary Among Individual Labs

We found that, among CEBR grantees, the reported aggregated backlog  of requests for crime scene DNA analysis has increased by 77 percent  from 2011 through 2016. As part of the grant application process, NIJ  requires applicants for CEBR grants to provide data from all labs in their  jurisdiction, even if certain labs will not be using CEBR funds. NIJ does  this to assist in understanding nationwide trends in DNA analysis  backlogs. The reported growth in the aggregate backlog among CEBR  grantees is the result of labs receiving more requests than they were able  to complete over time, as shown in the figure below.

Although reported aggregate trends show an increase in the backlog  among CEBR grantees, the data also reveal that this increase is not  uniform across all labs. For example, among the 118 grantees for which  we had data from 2011 through 2016, 30 grantees (25 percent) reported  an overall decrease in the backlog. In addition, data from CEBR grantees  show differences in the average time it takes to process requests  (turnaround time) among grantees. Stakeholders also stated, and NIJ has  reported, that labs generally have shorter average turnaround times for  requests associated with violent crimes than for requests associated with  non-violent crimes—because labs generally prioritize requests associated  with violent crimes. For our ongoing review, we continue to analyze  CEBR data and data from other sources pertaining to this issue.

Various Factors, Such as Scientific Advancements, Have Increased Demand for DNA Analysis Beyond Laboratories’ Capacities

Based on a review of a selection of studies and discussions with DNA  evidence stakeholders, we identified the following factors that are  reported to have contributed to an increased demand for crime scene  DNA analysis beyond laboratories’ capacities. As a result, these factors  are believed to have helped contribute to increased backlogs:  Recent scientific advancements have increased the quality of  DNA analysis by allowing lab analysts to obtain DNA profiles from  smaller amounts of biological evidence. This has increased the  amount of evidence that is eligible to be analyzed and, as a result,  has increased the demand for DNA testing.

One DNA evidence stakeholder was able to produce preliminary  data demonstrating that, as a general trend, labs that decreased  their turnaround time saw corresponding increases in requests  from law enforcement. Other DNA stakeholders, including NIJ,  made similar observations.

Increased awareness among law enforcement and the public  Increased awareness among law enforcement officers of the value  of DNA analysis in solving current and older cases has led to law  enforcement agencies submitting more DNA evidence to labs for  analysis. Further, NIJ and other stakeholder officials we  interviewed stated that the volume of DNA profiles in CODIS has  increased significantly over recent years. This, in turn, increased  the usefulness of DNA evidence in testing suspect DNA profiles  against a well-populated database of existing offenders. This  usefulness has increased awareness among law enforcement  personnel of CODIS, which contributes to increased demand for  DNA analysis, thereby contributing to the backlog. Additionally,  when deciding whether to submit DNA evidence for analysis, law  enforcement and prosecutors may consider jurors’ expectations  that DNA analysis is presented.

Recent legislation requiring Sexual Assault Kit (SAK) analysis  State legislation requiring SAK analysis has caused an increase in  demand for DNA analysis. As of July 2018, we identified at least  25 states that have enacted laws requiring law enforcement to  submit for testing SAKs that come into law enforcement  possession. Eleven of these states also required the submission  for testing of previously untested SAKs. Twenty-one of these laws  were passed in 2014 or later.

In addition to the factors that have contributed to increased demand,  resource challenges and constraints on lab capacity are reported to have  helped contribute to crime scene evidence backlogs. State and local labs  generally receive appropriations from state or local governments and are  subject to local funding priorities. Federal grants can help, but even  combined federal and jurisdictional funding may not increase lab capacity  enough to keep up with increases in demand. Additionally, these labs  report facing lengthy hiring and training processes for forensic analysts,  and often lose staff to private or federal labs which may offer higher pay,  further limiting lab capacity for completing analysis.

Preliminary Results Show that DOJ Has Not Clearly Defined and Documented CEBR Grant Program Goals

DOJ’s NIJ has not defined CEBR program-wide goals in clear, specific,  and measurable terms. We identified statements in NIJ and CEBR  program documentation that communicated program-wide goals, but the  documentation did not consistently identify the same goals or cite the  same number of goals. For example, a stated goal of improving the  quality of DNA testing was included in only 2 of 4 NIJ documents we  reviewed. In addition, NIJ officials verbally clarified that the CEBR  program has two goals, (1) to increase laboratory capacity for DNA  analysis, and (2) to reduce backlogs of DNA evidence awaiting analysis.  These differences can be seen across goal statements outlined in various  NIJ sources as shown in table 1 below.

NIJ officials acknowledged that they do not have documentation that  further defines the goals of the program in clear, specific, and measurable  terms. These goals are specified as increasing laboratory capacity for  DNA analysis and reducing backlogs of DNA evidence awaiting analysis.  Officials provided an explanation as to what the goals mean. Specifically,  officials stated that:  Increasing lab capacity refers to increasing samples analyzed,  reducing processing times, and increasing the number of DNA profiles  uploaded into CODIS—all while either maintaining or increasing the  quality of DNA analysis at labs.

Reducing backlogs refers to reducing the number of backlogged  requests awaiting analysis by more than the number of requests that  become backlogged during the same timeframe. Officials stated that  although they believe the goal of reducing the crime scene evidence  backlog is unachievable in the foreseeable future, they have kept it as  a program goal because each year it is included in the appropriation  language that supports the program.

However, these clarifications and definitions are not available in CEBR  documentation, which is an indication that NIJ may not be using clear,  specific, and measurable goals to guide program development or assess  progress.

We continue to evaluate CEBR program goals and we are in the process  of evaluating related CEBR performance measures as part of our ongoing  work.

Preliminary Analysis Shows that OJP Has Established Controls for Conflicts of Interest Related to CEBR Grants, but Has Not Fully Established Controls Related to Lobbying

Our preliminary results show that OJP has controls to implement federal  requirements associated with conflicts of interest and some controls  related to lobbying that apply to both OJP CEBR grant administrators as  well as recipients of grant funding; however, OJP has not fully established  all appropriate controls related to lobbying.

We found that OJP has established controls to implement federal conflicts  of interest requirements that apply to OJP employees administering  CEBR grants and CEBR grantees. For example, federal law prohibits  government employees from participating personally and substantially in  particular government matters, such as the administration of federal  grants, which could affect their financial interests. We found that OJP  has established an agency-wide ethics program and uses tools such as  the DOJ Ethics Handbook and annual financial disclosure reports, among  others, to help employees and their supervisors to determine whether  they have potential conflicts of interest. See table 2 below for a list of the  federal conflicts of interest requirements we identified, as well as our  preliminary assessment of related OJP controls to ensure that the  requirements are met.

OJP Has Some Controls for Lobbying as They Apply to Recipients of CEBR Grant Funds, but Has Not Fully Established All Appropriate Controls

We found that OJP has established some controls related to lobbying but  has not fully established controls needed to meet applicable  requirements. Specifically, federal law sets forth several requirements  related to lobbying “certification” and “disclosure.” Lobbying certification  refers to agreeing not to use appropriated funds to lobby, and lobbying  disclosure refers to disclosing lobbying activities with respect to the  covered federal action paid for with nonappropriated funds. Federal  regulation requires recipients of all federal awards over $100,000 to file  certification documents and disclosure forms (if applicable) with the next  tier above, and to forward those same forms from the tier below if they  issue subawards for $100,000 or more. In the case of CEBR grants,  tiers include OJP, grantees, subgrantees, contractors under grantees and  subgrantees, and subcontractors. Subawards include subgrants,  contracts under grants or subgrants, and subcontracts.

We found that OJP had established controls to obtain lobbying  certification documents and disclosure forms from grantees, but had not  fully established controls to ensure grantees obtain these documents from  tiers below them, see table 3 below.

OJP has established mechanisms to ensure it obtains lobbying  certification documents and disclosure forms from grantees. Specifically,  according to OJP, it requires that grant applicants electronically agree to  the certification document during the application process; if applicants do  not agree to it, they cannot move on in the process. OJP also requires  that applicants submit the lobbying disclosure form as part of the grant  application process. Upon submission, a grant manager reviews the form  for completeness and content and checks a box in an application review  checklist.

However, OJP has only partially established a mechanism to ensure that,  for subawards over $100,000 (1) CEBR grantees obtain certification  documents and disclosure forms, as applicable, from tiers below them,  and (2) disclosure forms are forwarded from tier to tier until received by  OJP. Specifically, OJP requires grant applicants to agree to the  certification document set forth in regulation. This certification  document, in turn, lists certification and disclosure requirements, and  states that, “The undersigned shall require that the language of this  certification be included in the award documents for all subawards at all  tiers (including subgrants, contracts under grants and cooperative  agreements, and subcontracts) and that all subrecipients shall certify and  disclose accordingly.” However, the certification document does not state  in clear terms what the specific requirements of the regulation are or how  they are to be carried out.

OJP attorneys responsible for overseeing their implementation were not  aware of specific requirements in the regulation. For example, they were  not aware that disclosure forms were required to be forwarded from tier to  tier until received by OJP. Additionally, 3 of 4 CEBR grantees we spoke  with were not aware of one or more of these requirements.

Lastly, we found that OJP does not provide guidance to grantees to  ensure they understand the requirements nor does OJP follow-up with  grantees to ensure they are implementing them. The statute requires that  federal agencies “take such actions as are necessary to ensure that the   are vigorously implemented and enforced in   agency.” As part of our ongoing work, we will continue to monitor and  assess OJP’s compliance with statute and regulations related to grantee,  subgrantee, and contractor lobbying disclosure requirements and make  recommendations, as appropriate.

Chairman Grassley, Ranking Member Feinstein, and Members of the  Committee, this concludes my prepared statement. I would be pleased to  respond to any questions that you may have at this time.

If you or your staff members have any questions about this testimony,  please contact Gretta L. Goodwin, Director, Homeland Security and  Justice at (202) 512-8777 or GoodwinG@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on  the last page of this report. Key contributors to this testimony included  Dawn Locke (Assistant Director), Adrian Pavia (Analyst-in-Charge),  Stephanie Heiken, Jeff Jensen, Chuck Bausell, Daniel Bibeault, Pamela  Davidson, Eric Hauswirth, Benjamin Licht, Samuel Portnow, Christine  San, Rebecca Shea, Janet Temko-Blinder, and Khristi Wilkins.

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Many state and local crime labs across the country have backlogs of requests for DNA analysis of crime scene evidence.

Since 2011, the Department of Justice has awarded nearly $500 million to states and localities through a grant program to help reduce DNA evidence backlogs.

This testimony covers preliminary observations and analyses from our ongoing review of the program. For example, we found that backlogs are growing as several factors increase demand for DNA analysis. Also, labs may not have the resources to keep up with demand.