ECOLOGICAL HAZARD AND ENVIRONMENTAL RISK ASSESSMENT Poly( hexamethlenebiguanide) hydrochloride ( PHMB)

CASE 3122 PC CODE 111801 November 18, 2005 Kathryn V. Montague, M. S. Antimicrobials Division Office of Pesticide Programs U. S. Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC 20460 Table of Contents 1. Ecological Toxicity Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 a. Toxicity to Terrestrial Animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 1. Birds, Acute and Subacute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2. Mammals, Acute and Chronic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 b. Toxicity to Aquatic Animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1. Freshwater Fish, Acute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 2. Freshwater Invertebrates, Acute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 3. Estuarine and Marine Organisms, Acute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 4. Aquatic Organisms, Chronic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 c. Toxicity to Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 2. Risk Assessment and Risk Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 a. Environmental Fate Assessment Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 b. Environmental Exposure Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 c. Environmental Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 d. Listed Species Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 3. References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 1 Ecological Effects Hazard and Environmental Risk Assessment Poly( hexamethlenebiguanide) hydrochloride ( PHMB)

PHMB is used as a microbiocide in swimming pools/ spas, secondary oil recovery ( label prevents marine/ estuarine use), industrial processing applications, eating establishments, hospitals, metalworking fluids, and textiles.

1. Ecological Toxicity Data The toxicity endpoints presented below are based on the results of PHMB toxicity studies submitted to EPA to meet the Agency's ecological effects data requirements for the uses of PHMB. Additional information was located in EPA/ ORD's ECOTOX database, which provides summary endpoints from the open scientific literature as well as studies submitted to the Agency. PHMB technical is a 20% aqueous solution; thus, submitted testing was all conducted with 20% active ingredient ( ai). Some earlier reviews erroneously reported these studies as being conducted for the end use product of PHMB, and not the technical grade of the active ingredient ( TGAI). This has been corrected where necessary to ensure that data requirements are not listed as outstanding for the TGAI. Endpoint values in the tables below are provided for the 20% solution, as well for 100% active ingredient. Toxicity classifications are similarly reported for both the 20% solution and pure ai where necessary.

a. Toxicity to Terrestrial Animals ( 1) Birds, Acute and Subacute In order to establish the toxicity of PHMB to avian species, the Agency required an acute oral toxicity study using the TGAI. The preferred test species is either mallard duck ( a waterfowl) or bobwhite quail ( an upland game bird). The results of one toxicity study are provided in the following table ( Table 1).

Table 1. Acute Oral Toxicity of PHMB to Birds Species % Active Ingredient ( ai) Endpoint ( mg/ kg) Toxicity Category ( TGAI) Satisfies Guidelines/ Comments Reference Mallard ( Anas platyrhynchos) 20 LD50 > 2510 (> 502 mg ai/ kg) NOEL = 2510 ( 502 mg ai/ kg) Slightly toxic Yes ° core study ° 14 day test duration Fink and Beavers, 1979/ Burt, 1990 ( MRID# 27491/ 93191001) 2 The results indicate that pure PHMB is moderately toxic to avian species on an acute oral basis. The 20% technical solution is practically non toxic to birds on an acute oral basis. The study is acceptable and fulfills guideline requirements ( 71 1/ OPPTS 850.2100).

A subacute dietary study using the TGAI may be required on a case by case basis depending on the results of lower tier ecological studies and pertinent environmental fate characteristics in order to establish the toxicity of a chemical to avian species. This testing was not required for PHMB. However, two studies were available in the OPP database. Results of these studies are provided in Table 2.

Table 2. Subacute Dietary Toxicity of PHMB to Birds Species % Active Ingredient ( ai) Endpoint ( ppm) Toxicity Category Satisfies Guidelines/ Comments Reference Bobwhite quail ( Colinus virginianus) 20 LC50 > 5620 (> 1124 ppm ai) NOEC 5620 ppm ( 1124 ppm ai) Practically nontoxic ( TGAI)

Slightly toxic ( 100% ai) Core study Beavers and Fink, 1979/ Burt, M. E. 1990. ( MRID# 41382/ 93191002)

Mallard duck ( Anas platyrhynchos) 20 LC50 > 5620 (> 1124 ppm ai) NOEC 5620 ( 1124 ppm ai) Practically nontoxic ( TGAI)

Slightly toxic ( 100% ai) Core study Beavers and Fink, 1979/ Burt, M. E. 1990. ( MRID# 41382/ 93191002)

The results indicate that pure PHMB is slightly toxic to avian species on a subacute dietary basis. PHMB technical ( 20% active ingredient) is practically non toxic to birds on a dietary basis. The studies are acceptable and fulfill guideline requirements ( 71 2/ OPPTS 850.2200).

( 2) Mammals, Acute and Chronic Toxicity Wild mammal testing was not required by the Agency. In most cases, rat toxicity values obtained from studies conducted to support data requirements for human health risk assessments substitute for wild mammal testing. These toxicity values are reported below ( Table 3). Further information on the mammalian toxicology of PHMB may be found in the Toxicology Disciplinary Chapter of this RED document. 3 Table 3. Acute Toxicity of PHMB to Mammals ( excerpted from Toxicology Chapter)

Species Test Type LD50 ( mg/ kg) NOEL ( mg/ kg/ day) LOEL ( mg/ kg/ day) Reference ( MRID)

Rat Acute oral 2747   00030330 Rat Acute dermal LD50 > 5.0   00065124 Rat 90 day oral No mortality at levels up to 5000 ppm   MRID 00053460 Dog 90 day oral The NOAEL for this 90 day dog feeding study appears to be 5500 ppm ( low dose). The high dose treatment caused a lower total weight gain in female dogs and slight hemosiderons in 2 out of 4 male dogs. MRID 00053461 Rabbit Developmental Maternal NOAEL = 20, based on increased mortality, reduced food consumption, and clinical toxicity Maternal LOAEL 40 42865901 Rat Developmental Based on the increased incidence of ribs in fetus, the Developmental Toxicity NOAEL is 50 mg/ kg/ day. Maternal Toxicity LOAEL is 50 mg/ kg/ day, based on reduced body weight and reduced food consumption.

Developmental LOAEL is 100 mg/ kg/ day CTL/ P/ 1262, 1976 cited in Report # 003810, 1978. Section C 11 Mammalian acute oral and dermal toxicity from PHMB is low. However, it is a dermal and eye irritant. Longer term ( subchronic) studies showed no systemic effects but also indicated dermal irritation. There was no quantitative or qualitative evidence of increased susceptibility of developmental effects following in utero exposure in the rat or rabbit. Maternal toxicity was reported at lower dose levels than the developmental toxicity in rats. In rabbits, developmental effects were observed at the same dose level as the maternal effects. 4 b. Toxicity to Aquatic Animals ( 1) Freshwater Fish, Acute In order to establish the acute toxicity of PHMB to freshwater fish, the Agency required a freshwater fish toxicity study using the TGAI. Data are generally required on only one species for indoor use antimicrobial pesticides. The preferred test species are rainbow trout ( a coldwater fish) or bluegill sunfish ( a warmwater fish). Results of studies are presented in Table 4.

Table 4. Acute Toxicity of PHMB to Freshwater Fish Species % Active Ingredient ( ai) Endpoints ( ppm) Toxicity Category Satisfies Guidelines/ Comments Reference Rainbow Trout ( Oncorhynchus mykiss) 20 96 hr. LC50 = 13.5 ( 2.7 ppm ai) Moderately toxic ( TGAI & 100% ai) Supplemental study ( core for formulated product) ° flow through system ° 96 hr test duration Hill et al., 1975 ACC# 234289 MRID# 77928 Bluegill sunfish ( Lepomis macrochirus) 20 96 hr. LC50 = 0.62 ( 0.46  0.83) ( 0.124 ppm ai) Highly toxic ( TGAI & 100% ai) Supplemental study ( core for formulated product) Buccafusco and Sleight, 1977 ACC# 234289 MRID# 77929 Bluegill sunfish ( Lepomis macrochirus) 20 96 hr. LC50 = 0.91 ( 0.182 ppm ai) Highly toxic ( TGAI & 100% ai) Supplemental Sousa, J. V. 1981 Rainbow Trout ( Oncorhynchus mykiss) 20 96 hr. LC50 = 0.02545 ppm ai ( 0.017  0.033) NOEC = 0.0098 ppm ai Very highly toxic ( TGAI & 100% ai) Core study Penwell and Roberts, 1995 MRID# 43949001 The results indicate that PHMB, as well as the technical solution, is moderately toxic to very highly acutely toxic to freshwater fish. The guideline requirements for a freshwater fish acute study have been fulfilled.

( 2) Freshwater Invertebrates, Acute The Agency required a freshwater aquatic invertebrate toxicity study using the TGAI to establish the acute toxicity of PHMB to freshwater invertebrates. The preferred test species is Daphnia magna. Results of the study are provided in the following table ( Table 5). 5 Table 5. Acute Toxicity of PHMB to Freshwater Invertebrates Species % Active Ingredient ( ai) Endpoints ( ppm) Toxicity Category Satisfies Guidelines/ Comments Reference Waterflea ( Daphnia magna) 20 48 hr. EC50 = 0.18( 0.12  0.30) ( 0.036 ppm ai) NOEC = 0.7 ( 0.14 ppm ai) Highly toxic ( TGAI)

Very highly toxic ( 100% ai) ° Core formulated product study LeBlanc and Sleight, 1977 ACC# 234289 The results of this study indicate that PHMB is highly to very highly toxic to freshwater invertebrates. The guideline requirement has been fulfilled ( 850.1010/ 72 2).

( 3) Estuarine and Marine Organisms, Acute Acute toxicity testing with estuarine and marine organisms using the TGAI is required when the end use product is intended for direct application to the marine/ estuarine environment or effluent containing the active ingredient is expected to reach this environment. Although PHMB is used for oil recovery applications, the labeling prohibits the use of the product over or near marine and/ or estuarine oil fields. Therefore, marine/ estuarine acute toxicity testing was waived for PHMB. A search of the ECOTOX database provided several endpoints for the marine polychaete, Platynereis dumerilii, summarized in the table below:

Table 6. Acute Toxicity of PHMB to Marine/ Estuarine Invertebrates Species % Active Ingredient ( ai) Endpoints ( ppm) Toxicity Category Reference Polychaete ( Platynereis dumerilii) Not reported 24 h LC50 = 13.4 ( 10.0  18.0) 48 hr. LC50 = 10.9 ( 8.43  14.5) 48 hr NOEC ( mort.) = 5.6 Slightly toxic Hutchinson et al., 1995 The results of this study indicate that PHMB is slightly toxic to the marine polychaete.

( 4) Aquatic Organisms, Chronic Chronic toxicity testing ( Fish early life stage, 850.1300/ 72 4a and aquatic invertebrate life cycle, 850.1400/ 72 4b) was originally required for PHMB due to its hydrolytic stability and the potential for continuous exposure from oil recovery applications. Chronic fish and invertebrate testing for microbiocides were waived by OPP, however ( 1992 memorandum from OPP/ EFED to 6 OPP/ SRRD), and deferred to the Office of Water under their NPDES program permitting regulations. Therefore, no chronic testing was submitted for PHMB, and no comparable endpoints were found in the ECOTOX database.

c. Toxicity to Plants Plant toxicity testing is not required for PHMB. No phytotoxicity data were found in the ECOTOX database.

2. Risk Assessment and Characterization Risk assessment integrates the results of the exposure and ecotoxicity data to evaluate the likelihood of adverse ecological effects. One method of integrating the results of exposure and ecotoxicity data is called the quotient method. For this method, risk quotients ( RQs) are calculated by dividing exposure estimates by ecotoxicity values, both acute and chronic:

RQ = EXPOSURE/ TOXICITY RQs are then compared to OPP's levels of concern ( LOCs). These LOCs are criteria used by OPP to indicate potential risk to nontarget organisms and the need to consider regulatory action. The criteria indicate that a pesticide used as directed has the potential to cause adverse effects on nontarget organisms. LOCs currently address the following risk presumption categories: ( 1) acute high  potential for acute risk is high, and regulatory action may be warranted in addition to restricted use classification; ( 2) acute restricted use  the potential for acute risk is high, but this may be mitigated through restricted use classification; ( 3) acute endangered species  the potential for acute risk to endangered species is high, and regulatory action may be warranted; and ( 4) chronic risk  the potential for chronic risk is high, and regulatory action may be warranted. Currently, AD does not perform assessments for chronic risk to plants, acute or chronic risks to nontarget insects, or chronic risk from granular/ bait formulations to mammalian or avian species.

The ecotoxicity test values ( i. e., measurement endpoints) used in the acute and chronic risk quotients are derived from the results of required studies. Examples of ecotoxicity values derived from the results of short term laboratory studies that assess acute effects are: ( 1) LC 50 ( fish and birds) ( 2) LD 50 ( birds and mammals) ( 3) EC 50 ( aquatic plants and aquatic invertebrates) and ( 4) EC 25 ( terrestrial plants). Examples of toxicity test effect levels derived from the results of long term laboratory studies that assess chronic effects are: ( 1) LOEC ( birds, fish, and aquatic invertebrates) ( 2) NOEC ( birds, fish and aquatic invertebrates) and ( 3) MATC ( Maximum Allowable Toxic Concentration) ( fish and aquatic invertebrates). For birds and mammals, the NOEC value is used as the ecotoxicity test value in assessing chronic effects. Other values may be used when justified. Generally, the MATC ( defined as the geometric mean of the NOEC and LOEC) is used as the ecotoxicity test value in assessing chronic effects to fish and aquatic invertebrates. However, the NOEC is used if the measurement endpoint is production of offspring or survival. 7 Risk presumptions, along with the corresponding RQs and LOCs are tabulated below.

Risk Presumptions for Terrestrial Animals Risk Presumption RQ LOC Birds and Wild Mammals Acute High Risk EEC1/ LC50 or LD50/ sqft2 or LD50/ day3 0.5 Acute Restricted Use EEC/ LC50 or LD50/ sqft or LD50/ day ( or LD50 < 50 mg/ kg) 0.2 Acute Endangered Species EEC/ LC50 or LD50/ sqft or LD50/ day 0.1 Chronic Risk EEC/ NOEC 1 1 abbreviation for Estimated Environmental Concentration ( ppm) on avian/ mammalian food items 2 mg/ ft2 3 mg of toxicant consumed/ day LD50 * wt. of bird LD50 * wt. of bird Risk Presumptions for Aquatic Animals Risk Presumption RQ LOC Acute High Risk EEC1/ LC50 or EC50 0.5 Acute Restricted Use EEC/ LC50 or EC50 0.1 Acute Endangered Species EEC/ LC50 or EC50 0.05 Chronic Risk EEC/ MATC or NOEC 1 1 EEC = ( ppm or ppb) in water Risk Presumptions for Plants Risk Presumption RQ LOC Terrestrial and Semi Aquatic Plants Acute High Risk EEC1/ EC25 1 Acute Endangered Species EEC/ EC05 or NOEC 1 Aquatic Plants Acute High Risk EEC2/ EC50 1 Acute Endangered Species EEC/ EC05 or NOEC 1 1 EEC = lbs ai/ A 2 EEC = ( ppb/ ppm) in water 8 a. Environmental Fate Assessment Summary ( excerpted from the Environmental Fate Science Chapter, of this RED document)

PHMB is hydrolytically stable ( half life > 30 days). The environmental fate science chapter states that no other environmental fate data were submitted or evaluated for this RED.

b. Environmental Exposure Assessment Environmental exposure modeling was not conducted for PHMB. The only use likely to result in significant outdoor exposure is the oil recovery use. However, there is a label statement prohibiting use over or near marine/ estuarine ( e. g., offshore) oil fields.

c. Environmental Risk Assessment The uses of PHMB considered in this RED make it unlikely that any appreciable exposure to terrestrial or aquatic organisms would occur. The high toxicity of PHMB to freshwater organisms is of concern in the event of a spill or misuse of the product. Product labeling indicates that the chemical is toxic to fish. Facilities using PHMB for indoor industrial applications are required to have NPDES permits before discharging effluents into receiving waters.

d. Listed Species Considerations Section 7 of the Endangered Species Act, 16 U. S. C. Section 1536( a)( 2), requires all federal agencies to consult with the National Marine Fisheries Service ( NMFS) for marine and anadromous listed species, or the United States Fish and Wildlife Services ( FWS) for listed wildlife and freshwater organisms, if they are proposing an " action" that may affect listed species or their designated habitat. Each federal agency is required under the Act to insure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. To jeopardize the continued existence of a listed species means " to engage in an action that reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species." 50 C. F. R. § 402.02.

To facilitate compliance with the requirements of the Endangered Species Act subsection ( a)( 2) the Environmental Protection Agency, Office of Pesticide Programs has established procedures to evaluate whether a proposed registration action may directly or indirectly reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of any listed species ( U. S. EPA 2004). After the Agency's screening level risk assessment is performed, if any of the Agency's Listed Species LOC Criteria are exceeded for either direct or indirect effects, a determination is made to identify if any listed or candidate species may co occur in the area of the proposed pesticide use. If determined that listed or candidate species may be present in the proposed use areas, further biological assessment is 9 undertaken. The extent to which listed species may be at risk then determines the need for the development of a more comprehensive consultation package as required by the Endangered Species Act.

For certain use categories, the Agency assumes there will be minimal environmental exposure, and only a minimal toxicity data set is required ( Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs U. S. Environmental Protection Agency  Endangered and Threatened Species Effects Determinations, 1/ 23/ 04, Appendix A, Section IIB, pg. 81). Chemicals in these categories therefore do not undergo a full screening level risk assessment, and are considered to fall under a " no effect" determination. Due to the low likelihood of exposure and low toxicity of PHMB, the Agency expects no effects to listed species or critical habitat and therefore makes a " No Effect" determination for this chemical. 10 REFERENCES Beavers, J. B., and R. Fink. 1979. Acute Oral LD50 for Mallard Duck, Final Reports. Wildlife International, Ltd., for ICI Americas, Inc. Unpublished data, EPA MRID# 27491/ 93191001.

Beavers, J. B and R. Fink. 1979. Eight day Dietary LC50 Mallard Duck Final Report. Wildlife International. Ltd., for ICI Americas. Unpublished data, EPA MRID# 41382/ 93191002.

Beavers, J. B., and R. Fink 1979. Eight day Dietary LC50 Bobwhite Quail Final Report. Wildlife International, Ltd., for ICI Americas, Inc. Unpublished data, MRID# 41382/ 93191002.

Buccafusco, R. J., and B. H. Sleight. 1977. Acute Toxicity of Vantocil 1B, mix No. 1857, to Bluegill ( Lepomis macrochirus) and the Waterflea ( Daphnia magna). EG& G Bionomics, Aquatic Toxicology Laboratory, Report # C 23. Unpublished Data, EPA Accession Number 234289/ MRID# 77929.

Hill, R. W., B. G. Maddock, and B. Hart. 1975. Determination of the Acute Toxicity to Rainbow Trout of Vantocil 1B in Freshwater. Brixham Laboratory, ICI Ltd., BL/ B/ 1631. Unpublished data, EPA Accession number 234289/ MRID# 77928.

Hutchinson, T. H., A. N. Jha, and D. R. Dixon. 1996. The Polychaete Platynereis dumerilii ( Audouin and Milne Edwards0: A New Species for Assessing the Hazardous Potential of Chemicals in the Marine Environment. Ecotoxicol. Environ. Saf. 31( 3): 271 281 LeBlanc , G. A. and B. H. Sleight. 1977. Acute Toxicity of Vantocil 1B, mix No. 1857, to Bluegill ( Lepomis macrochirus) and the Waterflea ( Daphnia magna). EG& G Bionomics, Aquatic Toxicology Laboratory, Report # C 23.. Unpublished Data, EPA Accession Number 234289/ MRID# 77929.

Penwell, A. J., and G. C. Roberts. 1995. PHMB: Acute toxicity to rainbow trout Oncorhynchus mykiss. Brixham Environmental Laboratory for Zeneca, Ltd. Unpublished data., EPA MRID# 43949001.

Sousa, J. V. 1981. Acute Toxicity of Vantocil P to Bluegill. EG& G Biomonics for ICI Americas, Inc., Report # BW 81 3 847. Unpublished data.


[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12564-12565]
[FR Doc No: 2016-05247]

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DEPARTMENT OF TRANSPORTATION

GPS Adjacent Band Compatibility Assessment Testing

AGENCY: Office of the Assistant Secretary for Research and Technology,
Department of Transportation.

ACTION: Notice; Request for voluntary participation.

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SUMMARY: The Department of Transportation, through the Office of the
Assistant Secretary for Research and Technology (OST-R), will begin
testing Global Positioning System/Global Navigation Satellite System
(``GPS/GNSS'') receivers this April pursuant to the DOT Adjacent Band
Compatibility Study (``the Study'') test plan published with this
notice. Device testing will take place at the U.S. Army Research
Laboratory at the White Sands Missile Range (WSMR) facility in New
Mexico.
    The Study provides for testing categories of receivers that include
aviation (non-certified), cellular, general location/navigation, high
precision, timing, networks, and space-based receivers. DOT seeks to
include a broad range of devices used in rail, aviation, motor vehicle,
maritime, and space transportation safety systems, among a number of
other applications of GPS/GNSS. The goal of the Study is to evaluate
the adjacent radio frequency band power levels that can be tolerated by
GPS/GNSS receivers, and advance the Department's understanding of the
extent to which such power levels impact devices used for
transportation safety purposes, among other GPS/GNSS applications.
    The Study will involve testing of receivers provided by government
agencies. In addition, to maximize diversity in the devices tested and
breadth of relevant data collected for analysis in the Study, the
Department requests voluntary participation in this Study by any
interested GPS/GNSS device manufacturers or other parties whose
products incorporate GPS/GNSS devices. Such participation could involve
provision of GPS/GNSS receivers to DOT for use in testing, provision of
data on receiver design to facilitate data collection pursuant to the
test plan, and/or on-site commitment and support from manufacturers and
other entities providing GPS/GNSS receivers for testing. DOT expects
that any onsite commitment and support would take approximately one
work week.

FOR FURTHER INFORMATION CONTACT: Any GPS device manufacturer interested
in providing such assistance for the adjacent band study should contact

Stephen Mackey at the DOT/OST-R Volpe National Transportation Systems
Center at<EMAIL_ADDRESS>or<PHONE_NUMBER> by March 18, 2016.

SUPPLEMENTARY INFORMATION: The final Study test plan published with
this notice reflects input the Department obtained from broad public
outreach over the past year that included four public meetings with
stakeholders on September 18 and December 4, 2014, and March 12 and
October 2, 2015, public issuance of a draft test plan on September 9,
2015 (see 80 FR 54368), and comments received regarding the test plan.
    In addition, recognizing that providing support for the Study may
involve sharing information with the Department that GPS/GNSS
manufacturers may consider to be confidential business information or
otherwise protected from disclosure to the public under the Freedom of
Information Act, the Department on November 20, 2015 circulated for
review by GPS/GNSS manufacturers and other stakeholders a draft Non-
Disclosure Agreement (``NDA'') that manufacturers could enter into with
the Department. With this notice the Department also is publishing a
revised NDA that takes into account comments submitted by stakeholders.
Under this NDA, information the Department receives from GPS/GNSS
manufacturers for use in the Study may be shared with other federal
agencies and will be protected from unauthorized disclosure or use in
accordance with applicable confidentiality laws, such as the Trade
Secrets Act, 18 U.S.C. 1905, and may be exempt from disclosure to the
public, to the extent permitted by the Freedom of Information Act.
    The documents referenced in this Notice and further background can
be viewed at: http://www.gps.gov/spectrum/ABC/.
    Privacy Act: Anyone can search the electronic form of comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review a
Privacy Act system of records notice regarding our public dockets in
the January 17, 2008 issue of the Federal Register (73 FR 3316).

    Issued in Washington, DC, on March 3, 2016.
Gregory D. Winfree,
Assistant Secretary for Research and Technology.
[FR Doc. 2016-05247 Filed 3-8-16; 8:45 am]
 BILLING CODE 4910-9X-P