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Exposure 		Modeling Public Meeting (EMPM) Information and Products

Minutes of the October 26, 2005 Exposure Modeling Public Meeting

Minutes of the October 26, 2005 Exposure Modeling Public Meeting

Office of Pesticide Programs (OPP) Conference Room 1126

1801 S. Bell St. - Crystal Mall 2

Arlington, VA  22202

On this Page

Attendees

Welcome and Introductions

Brief Updates

Major Presentations

Wrap up

Attendees

Name	Association

Marietta Echeverria			OPP/EFED

Ron Parker 				OPP/EFED

Betsy Behl				OPP/EFED

Mark Corbin				OPP/EFED

Dirk Young				OPP/EFED

Mohamed Ruhman			OPP/EFED

Nelson Thurman 			OPP/EFED

Lucy Shanaman				OPP/EFED

Norm Birchfield			OPP/EFED

Faruque Kahn				OPP/EFED

Cheryl Sutton				OPP/EFED

Keara Moore				OPP/EFED

Subijoy Dutta				OPP/EFED

Holly Galavotti				OPP/EFED

Lisa Eisenhauer				OPP/EFED

Kathy Carr				Monsanto

Russell Jones 				Bayer CropScience

Nasser Assaff				Valent

Paul Hendley 				Syngenta

Scott Jackson 				BASF

Wenlin Chen				Syngenta

Greg Leyes				ISKB

Mark Cheplick 				Waterborne Environmental

Amy Ritter				Waterborne Environmental

Chris Holmes				Waterborne Environmental

Cathleen Hapeman			USDA/ARS

Qingli Ma				Environment and Turf Services

LaJan Barnes				Environment and Turf Services

T. S. Ramanaryananan			Bayer CropScience

Aldos Barefoot				Dupont

Bruce H Stanley			Dupont

Michelle M Thomson			Dupont

Adrian Wadley				Stone Environmental

Cecil Dharmasri			Syngenta

R. Srinivasan				Texas A&M University

Tom Nolan				USGS

Jim Ascough				USDA

Jane Tang				Bayer

Kris Garber				Syracuse Research Corporation

Tim Negley				Syracuse Research Corporation

John Troiano				CDPR

Ann Pitchford				EPA/ORD

Elise McCoy				FMC

Kevin Armbrust				Mississippi State University

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Welcome and Introductions

The Exposure Modeling Work Group hosts quarterly meetings that are open to the public and provide a forum for cooperative exchange of facts and technical information on technical issues related to pesticide exposure modeling between EFED and stakeholders with similar technical expertise.  Marietta Echeverria (OPP/EFED) chaired the meeting in the capacity of co-chair of the EFED Water Quality Tech Team (WQTT).

This meeting includes presentations which focused on incorporation of geospatial tools and data in pesticide risk assessments.  All FIFRA EMWG agendas, minutes and presentations and be found at:

 http://www.epa.gov/oppefed1/models/water/emwg_top.htm

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Brief Updates

PRZM 3.12.2 Evaluation

Jim Hetrick reported that the QA/QC report for PRZM 3.12.2 is complete and has gone through management review.  Currently, they are addressing comments and providing clarification on issues such as irrigation and volatilization.  The report should be finished soon and will be made available at that time.

EFED's Modeling Scenarios

Mark Corbin reported on EFED's effort to respond to public comments on PRZM surface water runoff modeling scenarios. There has been a delay because EFED is using contractor support to update the scenarios and is now working out the contract for the new fiscal year.  The revised scenarios are expected to be ready by the end of the year.  The new version of PRZM, the new shell, and the updated scenarios will all be implemented at the same time.

Spray Drift Update

Al Barefoot of CLA presented a comparison of measured field data with values predicted by the 2004 beta version of the AGDISP ground model.  AGDISP ground uses many of the same inputs and tools as the aerial model.  Unlike AGDRIFT, it is predictive rather than empirical.  Two sets of field data were considered:  data from a 1993 study by the Spray Drift Task Force and data provided by Tom Wolf.  The comparison showed that AGDISP generally over predicted deposition values, more so for the SDTF data than for Wolf's data.  Possible explanations for the difference are that AGDISP may handle the coarse sprays used by Wolf better than fine sprays emphasized by the SDTF, that the different nozzles used in Wolf's study may be represented better by the model, or that AGDISP may perform better at locations closer to the edge of the field.  AGDISP also predicted higher deposition than AGDRIFT.

Top of page

Major Presentations

All of the following presentations will be posted on the EMWG website.

Applying Traditional Variance Component Methods For Quantifying and Predicting End-Points Under Spatial Variability (Bruce H. Stanley, Dupont Crop Protection)

Dr. Bruce Stanley of Dupont Crop Protection (Dupont) gave the first presentation at the October 2005 Exposure Modeling Working Group (EMWG) titled "Applying Traditional Variance Component Methods For Quantifying and Predicting End-Points Under Spatial Variability".  Dr. Stanley's talk focused on the utilization of spatial variability to understand uncertainty and variation over a distance in the field of geostatistics. The importance of variograms and correlograms in predictions over geographic space was emphasized.  Geographic areas are almost always broken into discrete units with a clear boundary, such as a ditch, compacted road or stable geopolitical boundary.  Therefore, traditional statistical methods such as variance component analysis lend themselves readily to the summarization and prediction in the presence of spatial variation.

Dr Stanley discussed the importance of including covariates where there are known trends over space.  In addition, he noted that logical weights can be used to account for differing sizes and covariance's can be included for correlated adjacent areas.  Because of the discrete nature of the geographic units, these traditional variance component estimates can be tabled and "rolled-up" when the predictions are needed over a broader geographic area.  Further, because of the discrete geographic nature of the terrain, continuous model-based methods, such as many of the tools in geostatistics may give poor fits (i.e., predictions) due to inappropriate model specification.  The talk explored how traditional statistical methods can be applied to summarize data and make predictions in light of spatial variability.  The discussion and questions after the presentation focused on how to distinguish between variability and uncertainty and the importance of temporal changes in the analysis of variance.

GIS Tool for Associating Estuarine/Marine Habitat with Agricultural Pesticide Uses (Kris Garber and Tim Negley, Syracuse Research Corporation)

Kris Garber of Syracuse Research Corporation (SRC) presented a new GIS tool, called Crop Mapping and Assessment Program (CMAP) 1.0 (beta version) for associating estuarine/marine habitat with agricultural pesticide applications. This tool was developed due to the need to define when pesticide uses should result in the assessment of risks to estuarine/marine habitats.  CMAP 1.0 includes two main sources of spatial data: NOAA National Estuary Inventory which defines the natural boundaries of the estuarine and costal drainage areas and the USDA/NASS Census of Agriculture 1997 and 2002 crop harvest data which quantifies crop yields on a county level. Using a MS Access database, the tool determines the intersection of the fraction of the area of a county that is within an estuarine/marine area and the crops harvested in each county. The output includes a U.S. (continental states) map and a calculated percent crop harvested in the estuarine/marine habitat.  CMAP could eventually be used by risk assessors to determine if applications of a pesticide to crops would potentially overlap with estuarine/marine areas, indicating a need to assess risks of a pesticide of concern to these habitats.  SRC is interested in distributing the tool to those participating in beta testing.

National Geo-spatial Data Policy (Kevin Kirby, EPA/OEI)

Kevin Kirby of the Office of Environmental Information of the US Environmental Protection Agency presented an overview of EPA's new, integrated approach to geospatial policy, architecture, and investment.  The new National Geospatial Data Policy addresses the entire data life cycle from planning through collecting, processing, storing, access, maintenance and retirement.  It moves away from the previous policy's impractical and unnecessary 25-meter accuracy definition and, instead, allows for multiple accuracy tiers in order to support the varying program-specific geospatial data priorities; for example, Superfund needs may range from sub meter to 5-meter accuracy while environmental assessments of national scope may only need 1000-meter accuracy.  Default accuracy is 150 meters.  The new Geospatial Data Policy was released in August 2005, and is currently in its comment period with the expectation that it will be finalized by December 2005.  EPA is coordinating at the standards level with other federal agencies through the Federal Geographic Data Committee (FGDC) and with Europe and other countries through the International Organization for Standardization technical committee for geographical information/geomatics (ISO/TC 211).  Key stakeholder involvement in implementation of this Geospatial Policy will be essential.  Contact Kevin Kirby<EMAIL_ADDRESS>for a copy of the Policy.

The MARIA Spatial Water Quality Modeling Framework (James Ascough, USDA-ARS-NPA)

The major products of the research facility in Ft. Collins include the Root Zone Water Quality Model (RZWQMP), Management of Agricultural Resources through Integrated Assessment and GIS (MARIA), Integrated Farm and Ranch Management (iFARM), Special Landscape Agricultural Model (SLAM), and the Object Modeling Systems (OMS).

The MARIA is a water quality tool that has been developed to predict space-time planning scenarios across spatially variable agricultural landscapes. The tool runs under the ArcGIS 9 environment, and consists of a multi-functional system for agricultural production and water quality simulation modeling; and spatial data storage, analysis, and display.  The major features of MARIA include the following:

Offers a spatial framework for integrating a complex, agricultural system 	water quality model (modified USDA-ARS RZWQM)

Provides interaction between simulated land areas via overland runoff and 	run on

Provides increased interface sophistication necessary for distributed 	hydrologic modeling

Works in a spatially distributive mode.

Predicts space-time planning scenarios across spatially variable 	agricultural landscapes.

Significant progress in component model - soil erosion component, transport, 	and nutrient cycling

Uses Tiger 2003 and other available data

Works in a ArcGIS 9 environment and presently calls for a manually drawn 	vector in the GIS MAP

Has a file builder wizard for guidance in creating input files

MARIA is applied to predict crop yield, nitrate (N) concentration, drainage volume, and nitrate loading.  Predicted results showed improved model performance considering spatially variable soil properties and overland flow generation within study plots in northeastern Iowa as compared to point-based model, such as RGWQM. Some of the assumptions used by the model include homogeneous soils with no flow routing.  Future work involves developing a Java-based object modeling framework which would allow code reuse and sharing.  Enhancing the Object Modeling System (OMS) for building new models for Field, Farm, and Watershed Scales is also in their agenda. For further information see

www.ars.usda.gov/npa/ftcollins/gpsr

Utility of USGS Water Use Data on Drinking Water Exposure Assessment (T. S. Ramanarayanan, Bayer CropScience)

TS Ramanarayanan of Bayer Crop Science discussed the USGS' water use information program and related it to EFED's selection of sites for surface water scenarios.  Every five years, the USGS gathers source level data about water use nationwide.  Mr. Ramanarayanan presented maps displaying the distribution of drinking water from surface and groundwater sources, each of which provides about half of the country's drinking water.  The sites for EFED's surface water scenarios are chosen based on vulnerability, rather than water use.  A map overlaying the location of the standard scenarios with the surface water use distribution demonstrated that some scenarios are located in areas that are not significant sources of drinking water, including several Florida, Mississippi, Georgia, and Minnesota scenarios.  A more detailed analysis of Florida drinking water sources was presented indicating that less than 9% of the Florida population depends on surface water.  It was recommended that for drinking water assessments, surface water use distribution should be taken into account in selecting scenario locations.  Audience comments pointed out that the goal of EFED's assessments is to be protective even for small populations.

Framework for Spatially Explicit Risk Assessments (Nelson Thurman and Mark Corbin, EPA/OPP)

Nelson Thurman and Mark Corbin presented EFED's progress in making risk assessments increasingly spatially-explicit.  The presentation focused on the definition of "spatially-explicit" as it applies to risk assessments, fitting the use of spatially-explicit data and processes in the context of the Agency's guidelines for conducting Risk Assessments, and examples of works in progress which illustrate the use of spatially-explicit data and processes.  As defined at the 2003 Society for Risk Analysis workshop, spatially-explicit risk assessments consider the relative spatial distributions of the stressor (pesticide) and the receptor (non-target organism).  Assumptions of "equal and random" access of receptor to the stressor are broken down and explicit consideration is given to the heterogeneous distributions of receptors and contaminants.  In the context of the Agency's guidelines for conducting Risk Assessments, spatially-explicit data and approaches can be incorporated into the Problem Formulation phase which includes the development of the conceptual model, as well as the Analysis of Exposure and Effects and Risk Characterization phases of the Risk Assessment process.  In particular, while considering a screening approach to risk assessments if estimated exposure exceeds a level of concern it may be appropriate to consider the distribution in the stressor and receptor range in order to delineate the extent of the area to where the exceedance is likely to be limited.

Nelson and Mark presented examples of spatially-explicit risk assessments currently underway in the division including the Pacific Northwest salmonid endangered species assessments and the N-methyl carbamate cumulative assessment.  For endangered species assessments, spatial data and analyses are being used to define the potential "Action Area".  In order to define the action area, the product label identifying potential use sites and Ag census crop location data are used to define the extent of the potential stressor range while delineated evolutionarily significant units (ESUs) and occupied stream segments are used to define the receptor range.  The intersection of the stressor and receptor ranges is the resultant action area.  For the N-methyl carbamate cumulative assessment, spatially-explicit pesticide use data, site vulnerability, and location of drinking water intakes are being used to identify scenarios of likely high-end exposure.   Monitoring data in Florida illustrated that detections of N-methyl carbamates in groundwater followed distinct spatial trends.  Specifically, detections were correlated to citrus use sites along the central ridge which is characterized by high potential for leaching soils.  These types of spatial analyses help identify characteristics that may indicate high exposure potential in other areas of the country that may not have robust monitoring data.

PLUS: Geospatial Leaching Assessment Tool (Mark Cheplick, Waterborne Environmental)

Mark Cheplick gave this presentation (Scott Jackson and Paul Hendley are coauthors).  PLUS (PRZM-3 Leaching US) is a tool to geographically rank sites in the US for leaching potential for a pesticide of interest.  PLUS was presented as a possible Tier II national leaching assessment tool.

Cheplick noted that PLUS has the following benefits:

Provides soil vulnerability rankings with regards to leaching of a specific 	pesticide.

Provides a spatial aspect to leaching vulnerability assessment.

Allows for a probabilistic aspect to ground water exposure assessment.

PLUS allows selection of state, MLRA, soils, crops, and realistic weather scenarios (including irrigation water inputs, as appropriate).    With PLUS one can also quickly run PRZM for the pesticide of interest, as a benchmark for comparison, the FIFRA Exposure Model Validation Task Force (FEMVTF) prospective groundwater scenarios (based on some older Prospective Ground-Water Monitoring studies conducted for submission to EPA or other similarly detailed field-scale studies of pesticide fate).  The benchmark FEMVTF sites can be run either with their own-site specific weather or with weather from a site representative of the geographic region of interest for the pesticide being evaluated.  Specifics of how PRZM is calibrated to the field results at the FEMVTF sites were not discussed in this particular presentation.

User inputs for PLUS are fairly simple, the shell preselecting most of the inputs for the models.  For example:

Pesticide Specific properties.

adsorption value (Koc/Kd)

Half-life values by depth in the vadose zone (up to 12 feet?) and for 		ground water.

Application rate and type.

PLUS couples a ground-water dilution model (ADAM) to PRZM.  Inputs include:

Aquifer properties

Screen length - depth of dilution zone in the aquifer

Hydraulic conductivity

Head gradient

Porosity

Bulk Density in the aquifer material

Organic carbon content - for water and the bearing material

Aquifer Mix - how much mixing is there between old residue and new flush of 	mass?

The PLUS output automatically includes daily pesticide concentrations, mean annual shallow ground water concentrations, and 36-year mean concentrations by site (soil series).

PLUS has many embedded simplifying assumptions which enable automated modeling of a large number of sites.  Among these are assuming a standard sandy soil type below a specified depth, the same standard depth to ground water at all sites (i.e., 12 feet), selecting a standard set of aquifer characteristics for all sites run, and similar behavior of the pesticide at all sites (adsorption coefficients and half-lives are not varied by site). The only input variables that change by geographic location are topsoil characteristics and weather / irrigation.   Consequently, PLUS does not technically provide geographically specific estimates of the extent of pesticide leaching to ground water.  However, the authors propose that PLUS output does provide a useful generalized ranking of sites for pesticide leaching.

National Hydrography Dataset (NHDplus) (Cindy McKay, Horizon Systems Corporation)

Cindy McKay of Horizon Systems Corporation (HSC) presented NHD-Plus, a "reach file on steroids" developed in partnership between EPA OW, HSC, USGS WRD, and RTI Intl. that had EMWG members waving their credit cards.  NHD-Plus is the 1:100K National Hydrography Dataset (NHD) with enhanced analysis, navigation, and display functionality, including elevation-based catchments, catchment characteristics, flow direction grids, flow accumulation grids, flow line min/max elevations and slopes, cumulative drainage area characteristics, and flow volume and velocity estimates for every flow line in a stream network.  This analysis tool will integrate with nearly any landscape dataset and is designed for compatibility with a variety of analysis and modeling software.  Cindy gave some examples to demonstrate the power of NHD-Plus, such as adding dynamic definition to watersheds, overcoming quad density artifacts, and defining drainage areas with catchments, which leads to simple calculation and display of drainage area characteristics.  HUC-2 data are currently built in for the Pacific Northwest region and are coming soon for other regions of the U.S.  NHD-Plus will be available in a few months on the EPA OW website and the Reach Address Database.  Cindy has an initial distribution available from HSC upon request at

<a href="mailto:LDM<EMAIL_ADDRESS>.

National Pyrethroid Aquatic Exposure Analysis; Estimation of Drift and Erosion Potential at the Watershed Level (Christopher Holmes, Waterborne Environmental)

This presentation described a national aquatic exposure analysis undertaken to characterize watersheds across the conterminous US for relative risk to pyrethroid exposure via spray drift and erosion. Results were generated for each of approximately 62,000 watersheds (USGS Enhanced River Reach File dataset (ERF1_V2)) to create a nationwide distribution ranking potential aquatic exposure via spray drift and erosion.  Spatial proximity of agriculture to surface water was used as an indicator of potential exposure from agricultural spray drift. Surface water data from the National Hydrography Dataset (NHD) was combined with the National Land Cover Dataset (NLCD) to determine the spatial location of agricultural land proximate to surface water. These data were linked with 2002 Census of Agriculture to assess the likely occurrence of specific crops within marginal areas. Watersheds were also ranked based on potential edge of field pyrethroid transport via erosion. Pesticide Root Zone Model (PRZM) runs were made for each combination of soil, weather and crop, resulting in several hundred thousand simulations. The individual results were weighted (based upon area of occurrence) and then combined to provide an overall potential pyrethroid edge of field erosive loss per watershed. The relative sensitivity of pyrethroid exposure to both spray drift and erosion entry potential was examined. The linked EPA PRZM-EXAMS models were used to estimate the relative contribution of drift and runoff to pyrethroid sediment loads across representative crop-regions. Over 40,000 simulations were run for various pyrethroid/crop/drift/weather /soil/organic matter/slope length (LS) factor combinations under local weather conditions. Results of the proximity and erosion analyses, combined with estimated relative drift and erosion vulnerability, will be used to develop an optimum strategy for more detailed regional and crop-specific analyses of potential pyrethroid exposures in US water bodies.

Top of page

Wrap up

Continuing Actions

EFED continues to addressing PRZM Volatization routine and PRZM Temperature routines in the established QA/QC process.

Next EMWG Meeting to focus on model version control and quality assurance processes in exposure models

New Actions

Action:  CLA to share detailed output from the review shown in Al Barefoot's presentation

Action: Consider incorporating a detailed review of the AgDISP ground model at future EMWG meeting.

Action:  Next meeting will be January 24th in room 1126 EPA offices, Washington DC

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DEPARTMENT OF ENERGY

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[Docket No. ES06-29-000]

NorthWestern Corporation; Notice of Filing

March 14, 2006.
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 [FR Doc. E6-4039 Filed 3-20-06; 8:45 am]

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[Federal Register Volume 80, Number 24 (Thursday, February 5, 2015)]
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[Pages 6448-6452]
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2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number in the ``SEARCH'' box and click ``SEARCH.''
Click on Open Docket Folder on the line associated with this
rulemaking. You may also visit the Docket Management Facility in Room
W12-140 on the ground floor of the Department of Transportation West
Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

3. 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 notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one, using one of the methods specified under ADDRESSES.
Requests for a public meeting must be received on or before March 9,
2015. Please explain why you believe a public meeting would be
beneficial. If we determine that one would aid this rulemaking, we will
hold one at a time and place announced by a later notice in the Federal
Register.

B. Regulatory History and Information

    On a routine basis, the Coast Guard previously established similar
temporary moving security zones around escorted vessels as temporary
final rules for the Lower Mississippi River. Those temporary final
rules are accessible as explained above under ADDRESSES, [Docket Number
USCG-2013-0994, 79 FR 7587, Feb. 10, 2014

and Docket Number USCG-2011-1063, 77 FR 30402, May 23, 2012]. There is
a difference in the size of the moving security zones previously
established. Docket USCG-2013-0994 established a 100 yard zone and
Docket USCG-2011-1063 established a 300 yard zone. Based on the quality
of communication and additional time allowed to grant permission to
deviate from the rules, the Coast Guard will utilize the 300 yard zone
for this interim rule. Through this interim rule, effective January 31,
2015 through July 1, 2015, the Coast Guard will enforce temporary
moving security zones around vessels being escorted by one or more
Coast Guard or other Federal, State, or local law enforcement assets on
the navigable waters of the Lower Mississippi River between river miles
90.0 to 106.0 Above Head of Passes (AHP), New Orleans, LA. Once in
effect, the specific enforcement dates and times for a temporary moving
security zone around an escorted vessel will be noticed through
broadcast notices to mariners.
    The Coast Guard is issuing this interim rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule. Minimal notice regarding vessel escort
operations is customary for security purposes. Based on risk
evaluations completed, and information gathered after evaluating the
security needs for escorted vessels during a period of high activity on
and around the waterway, the Coast Guard determined that moving
security zones are required. These moving security zones are needed to
protect life and property, surrounding and including escorted vessels
and their personnel from destruction, loss, or injury from sabotage or
other subversive acts, accidents, or other causes of a similar nature
during vessel escort operations. The NPRM process would be contrary to
public interest by delaying the effective date or foregoing the
necessary protections required for persons and property, surrounding
and including escorted vessels and their personnel. Immediate action
for each vessel escort and security zone is necessary to provide both
waterway and waterside security and protection for life and property,
surrounding and including escorted vessels and their personnel on the
Lower Mississippi River.
    For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard
finds that good cause exists for making this rule effective less than
30 days after publication in the Federal Register. Providing a full 30
day notice would be contrary to the public interest because immediate
action is needed to provide both waterway and waterside security and
protection during vessel escort operations.

C. Basis and Purpose

    The legal basis and authorities for this rule are found in 33
U.S.C. 1231, 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33
CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Public Law 107-295, 116 Stat.
2064; and Department of Homeland Security Delegation No. 0170.1, which
collectively authorize the Coast Guard to establish and define
regulatory security zones.
    The purpose of this rule is to provide enhanced protections related
to escorted vessels transiting through the Lower Mississippi River
between river miles 90.0 to 106.0 AHP during times of increased
activity on and around the waterway. During these times, certain
vessels, including high capacity passenger vessels, vessels carrying
certain dangerous cargoes as defined in 33 CFR part 60, tank vessels
constructed to carry oil or hazardous materials in bulk, and vessels
carrying liquefied hazardous gas as defined in 33 CFR part 127 have
been deemed by the Captain of the Port (COTP) New Orleans to require
escort protection.
    As an additional protective measure for all those transiting the
waterway during a vessel's escort, the Coast Guard will establish
temporary moving security zones restricting navigation in portions of
the Lower Mississippi River between river miles 90.0 to 106.0 AHP to
provide both waterway and waterside security and protection. These
security zones are necessary to protect life and property, surrounding
and including escorted vessels and their personnel from destruction,
loss or injury from sabotage or other subversive acts, accidents or
other causes of a similar nature. This interim rule enables the COTP
New Orleans to provide effective port security. This interim rule is
also intended to minimize confusion and reduce administrative burdens
related to implementing multiple individual temporary rulemakings for
each security zone related to an escorted vessel.

D. Discussion of the Interim Rule

    The Coast Guard is establishing this interim rule under which the
COTP New Orleans will enforce temporary moving security zones related
to escorted vessels. Each security zone will extend 300 yards in all
directions from the escorted vessel as it transits the Lower
Mississippi River between river miles 90.0 to 106.0 AHP. Persons and
vessels are prohibited from entering, remaining in or transiting
through the security zone surrounding escorted vessels, unless
authorized by the Coast Guard COTP New Orleans or a COTP designated
representative. A vessel may request permission from the COTP New
Orleans or the on-scene Coast Guard or enforcement agency asset to
deviate from the requirements of this rule. Deviations from this rule
may be requested from the COTP New Orleans through the on-scene Coast
Guard or enforcement agency asset, via VHF Ch. 16 or 67. If permitted
to enter the security zone or deviate from this rule, a vessel must
proceed at the minimum safe speed possible for safe navigation and must
comply with all orders issued by the COTP New Orleans or the on-scene
asset. Vessels permitted to deviate from this rule and transit through
the security zone shall maintain a distance of at least 50 yards from
the escorted vessel.
    An escorted vessel is a vessel, other than a large U.S. naval
vessel as defined in 33 CFR 165.2015, that is accompanied by one or
more Coast Guard assets or other Federal, State or local law
enforcement agency assets, clearly identifiable by flashing lights,
vessel markings, or with agency insignia as listed below: Coast Guard
surface or air asset displaying the Coast Guard insignia; Federal,
State and/or local law enforcement asset displaying the applicable
agency markings and/or equipment associated with the agency.
    In addition to the presence of these law enforcement assets for
escorted vessels, the COTP New Orleans or a designated representative
will inform the public through a broadcast notice to mariners that a
temporary moving security zone is in effect around the escorted vessel.
The broadcast notice to mariners of each temporary moving security zone
concerning escorted vessels will inform the public of the enforcement
period, size of the zone, and the navigable waters that will be
affected. The broadcast notice will normally be issued at approximately
30-minute intervals while the temporary moving security zone
restrictions remain in effect.

    This rule is effective on January 31, 2015 through July 1, 2015.

E. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. It is not
``significant'' under the regulatory policies and procedures of the
Department of Homeland Security (DHS). Due to the duration of each
individual temporary moving security zone that may be enforced under
this interim rule and location, the impacts on routine navigation are
expected to be minimal.
    This rule is not a significant regulatory action because each
individual temporary moving security zone enforced under this interim
rule will be in effect for short periods of time and notifications to
the marine community will be made through broadcast notices to
mariners. Deviation from this rule may be requested and will be
considered on a case-by-case basis by the COTP New Orleans or the on-
scene Coast Guard or enforcement agency asset. Approved deviations will
allow other vessels transiting the area to transit through the security
zone, maintaining a distance of at least 50 yards from the escorted
vessel. Additionally, the security zones are located within the New
Orleans Harbor Vessel Service Area where vessels are required to check
in when entering the area or departing berth. This check in requirement
can assist in early review and granting of permission to deviate from
this rule. Therefore, the impacts on routine navigation are expected to
be minimal.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule will affect the following entities, some of which
may be small entities: The owners or operators of vessels, intending to
transit in the vicinity of escorted vessels between river miles 90.0
and 106.0 AHP of the Lower Mississippi River. This rule will not have
significant impact on a substantial number of small entities because
the zones will be of limited sizes, encompassing the escorted vessel,
of short durations and notifications to the marine community will be
made through broadcast notices to mariners. In some cases, the security
zones will leave ample space for vessels to navigate around them. If
not, and security conditions permit, the COTP will attempt to provide
flexibility for individual vessels to transit through the zones as
needed. Deviation from this rule may be requested and will be
considered on a case-by-case basis by the COTP or the on-scene Coast
Guard or enforcement agency asset. Approved deviations will allow other
vessels transiting the area to transit through the security zone,
maintaining a distance of at least 50 yards from the escorted vessel.
Additionally, the security zones are located within the New Orleans
Harbor Vessel Service Area where vessels are required to check in when
entering the area or departing berth. This check-in requirement can
assist in early review and granting of permission to deviate from the
rule.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section, above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves temporary moving security zones that
prohibits persons and vessels from entering, remaining in or transiting
through the security zone surrounding escorted vessels as they transit
within the navigable waters of the Lower Mississippi between river
miles 90.0 to 106.0 AHP, unless authorized by the Coast Guard COTP or a
COTP designated representative. This rule is categorically excluded
from further review under paragraph (34)(g) of Figure 2-1 or the
Commandant Instruction. An environmental analysis checklist supporting
this determination and a Categorical Exclusion Determination are
available in the docket where indicated under ADDRESSES. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.843 to read as follows:

Sec.  165.843  Moving Security Zone; Escorted Vessels; Lower
Mississippi River; New Orleans, LA.

    (a) Definitions. The following definitions apply to this section:
    COTP means Captain of the Port New Orleans, LA.
    Designated representatives means Coast Guard Patrol Commanders
including Coast Guard coxswains, petty officers and other officers
operating Coast Guard vessels, and Federal, State, and local officers
designated by or assisting the COTP, in the enforcement of the security
zone.
    Escorted vessel means a vessel, other than a large U.S. naval
vessel as defined in 33 CFR 165.2015, that is accompanied by one or
more Coast Guard assets or other Federal, State or local law
enforcement agency assets clearly identifiable by flashing lights,
vessel markings, or with agency insignia as follows: Coast Guard
surface or air asset displaying the Coast Guard insignia. State and/or
local law enforcement asset displaying the applicable agency markings
and/or equipment associated with the agency.
    Minimum safe speed for navigation means the speed at which a vessel
proceeds when it is fully off plane, completely settled in the water
and not creating excessive wake or surge. Due to the different speeds
at which vessels of different sizes and configurations may travel while
in compliance with this definition, no specific speed is assigned to
minimum safe speed for navigation. In no instance should minimum safe
speed be interpreted as a speed less than that required for a
particular vessel to maintain steerageway. A vessel is not proceeding
at minimum safe speed if it is:
    (i) On a plane;
    (ii) In the process of coming up onto or coming off a plane;
    (iii) Creating an excessive wake or surge.
    (b) Effective date. This rule is effective in the CFR on February
5, 2015, and effective with actual notice for purposes of enforcement
on January 31, 2015, through July 15, 2015.
    (c) Regulated area. All navigable waters, as defined in 33 CFR
2.36, on the Lower Mississippi River between river miles 90.0 to 106.0
Above Head of Passes (AHP), New Orleans, Louisiana.
    (d) Security zone. A temporary moving security zone, extending 300
yards in all directions of an escorted vessel, will be established
around each escorted vessel within the regulated area described in
paragraph (b) of this section. The security zone will not extend beyond
the boundary of the regulated area in this section.
    (e) Notice of security zone. The COTP will inform the public of the
existence or status of any temporary moving security zones around
escorted vessels in the regulated area by broadcast notices to
mariners. The broadcast notice to mariners will inform the public of
the enforcement period, size of the zone, and the navigable waters that
will be affected, and will normally be issued at approximately 30-
minute intervals while the moving security zone remains in effect.
Escorted vessels will be identified by the presence of Coast Guard
assets or other Federal, State or local law enforcement agency assets
clearly identified by flashing lights, vessel markings, or agency
insignia.
    (f) Regulations. (1) In accordance with the general regulations in
Sec.  165.33, No person or vessel may enter or remain in a security
zone without the permission of the Captain of the Port. Section 165.33
also contains other general requirements.
    (2) Vessels may request permission from the Captain of the Port New
Orleans through the on-scene Coast Guard or other agency asset to enter
the security zone described in paragraph (c) of this section.
    (i) If permission to enter and transit through the security zone is
granted, the vessel shall operate at the minimum speed necessary to
maintain a safe course, unless required to maintain speed by the
Navigation Rules, and must proceed as directed by the COTP or a
designated representative. When within the security zone, no vessel or
person is allowed within 50 yards of the escorted vessel unless
authorized by the Coast Guard.
    (ii) [Reserved]

    (g) Contact information. The COTP New Orleans may be reached via
phone at<PHONE_NUMBER>. Any on-scene Coast Guard or designated
representative assets may be reached via VHF-FM channel 16 or 67.

    Dated: January 9, 2015.
P.C. Schifflin,
Captain, U.S. Coast Guard, Captain of the Port New Orleans.
[FR Doc. 2015-02322 Filed 2-4-15; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 147 (Wednesday, August 2, 2023)]
[Notices]
[Pages 50876-50879]
[FR Doc No: 2023-16434]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2780]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Premarket Notification for a New Dietary Ingredient

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on the procedure by which a manufacturer or
distributor of a new dietary ingredient or of a dietary supplement
containing a new dietary ingredient is to submit to FDA information
upon which it has based its conclusion that a dietary supplement
containing the new dietary ingredient will reasonably be expected to be
safe.

DATES: Either electronic or written comments on the collection of
information must be submitted by October 2, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 2, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-N-2780 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Premarket Notification for a New

Dietary Ingredient.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Premarket Notification for a New Dietary Ingredient--21 CFR 190.6

OMB Control Number 0910-0330--Revision

    This information collection supports Agency regulation, guidance,
and associated Form FDA 3880. Under section 413(a)(2) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350b(a)(2)), the
manufacturer or distributor of a new dietary ingredient (NDI) or a
dietary supplement that contains the NDI, must submit an NDI
notification (NDIN) to FDA (as delegate for the Secretary of Health and
Human Services) at least 75 days before introducing the product into
interstate commerce, unless the NDI and any other dietary ingredients
in the dietary supplement ``have been present in the food supply as an
article used for food in a form in which the food has not been
chemically altered'' (21 U.S.C. 350b(a)(1)).
    The notification must contain the information, including any
citation to published articles, which provides the basis on which the
manufacturer or distributor of the NDI or dietary supplement (the
notifier) has concluded that the dietary supplement containing the NDI
will reasonably be expected to be safe (21 U.S.C. 350b(a)(2)). If the
required premarket notification is not submitted to FDA, section 413(a)
of the FD&C Act provides that the dietary supplement containing the NDI
is deemed to be adulterated under section 402(f) of the FD&C Act (21
U.S.C. 342(f)). Even if the notification is submitted as required, the
dietary supplement containing the NDI is adulterated under section
402(f) unless there is a history of use or other evidence of safety
establishing that the NDI, when used under the conditions recommended
or suggested in the labeling of the dietary supplement, will reasonably
be expected to be safe.
    Section 190.6 (21 CFR 190.6) specifies the information a notifier
must include in its NDIN and establishes the administrative procedures
for these notifications. Section 190.6(a) requires each manufacturer or
distributor of an NDI, or of a dietary supplement containing an NDI, to
submit to the Center for Food Safety and Applied Nutrition's (CFSAN's)
Office of Dietary Supplement Programs (ODSP) notification of the basis
for their conclusion that said supplement or ingredient will reasonably
be expected to be safe. Section 190.6(b) requires that the notification
include the following: (1) the complete name and address of the
manufacturer or distributor, (2) the name of the NDI, (3) a description
of the dietary supplement(s) that contain the NDI, including the level
of the new dietary ingredient in the dietary supplement and the dietary
supplement's conditions of use, (4) the history of use or other
evidence of safety establishing that the dietary ingredient will
reasonably be expected to be safe when used under the conditions
recommended or suggested in the labeling of the dietary supplement, and
(5) the signature of a responsible person designated by the
manufacturer or distributor.
    These NDIN requirements are designed to enable us to monitor the
introduction into the marketplace of NDIs and dietary supplements that
contain NDIs in order to protect consumers from ingredients and
products whose safety is unknown. We use the information collected in
the NDINs to evaluate more efficiently the safety of NDIs in dietary
supplements and to support regulatory action against ingredients and
products that are potentially unsafe.
    FDA developed guidance to further assist industry with NDINs. In
the Federal Register of July 5, 2011 (76 FR

39111), we announced the availability of a draft guidance for industry
entitled ``Dietary Supplements: New Dietary Ingredient Notifications
and Related Issues'' (the 2011 draft guidance). We gave interested
parties an opportunity to submit comments on the substance of the
guidance by October 3, 2011. In the Federal Register of September 9,
2011 (76 FR 55927), we extended the comment period to December 2, 2011.
We received numerous comments on the 2011 draft guidance. Based on
those comments and our meetings with industry and other stakeholders,
we revised the 2011 draft guidance. In the Federal Register of August
12, 2016 (81 FR 53486), we announced the availability of a revised
draft guidance for industry with the same title (the 2016 revised draft
guidance) that supersedes the 2011 draft guidance (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-new-dietary-ingredient-notifications-and-related-issues). We gave interested parties another opportunity to
submit comments on the substance of the guidance by October 11, 2016.
In the Federal Register of October 4, 2016 (81 FR 68434), we extended
the comment period to December 12, 2016. It is with this notice that we
solicit comments on the information collection in the guidance.
    The 2016 revised draft guidance, when finalized, is intended to
provide instruction and further assist industry in deciding when a
premarket safety notification for a dietary supplement containing an
NDI is necessary and in preparing an NDIN. The draft guidance discusses
in question-and-answer format FDA's views on what qualifies as an NDI,
when an NDIN is required, the types of data and information that
manufacturers and distributors should consider when they evaluate the
safety of a dietary supplement containing an NDI, and what should be
included in an NDIN as well as other topics. We intend to divide the
2016 revised draft guidance into discrete sections for ease of use,
consistent with stakeholder requests (including from industry)
submitted in the form of comments to the docket for the draft guidance,
and issue a series of several guidances. These guidances will reflect,
among other things, public comments submitted to the docket in response
to the 2011 draft guidance and the 2016 revised draft guidance.
Sections of the 2016 revised draft guidance that FDA is prioritizing to
issue at this time address administrative procedures, identity, safety,
and master files. Per our standard process, FDA will announce guidance
documents we plan to issue within a calendar year via our FDA Foods
Program Guidance Agenda, available at: https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/foods-program-guidance-under-development. The following
sections discuss the various topics related to NDINs, all of which were
previously referenced or discussed in the 2016 revised draft guidance.
1. Administrative Procedures
    The recommendations found in section V, NDI Notification Procedures
and Timeframes, of the 2016 revised draft guidance and certain
recommendations in section IV.C., Other Questions About When an NDI
Notification Is Necessary, provide instruction for certain ways
manufacturers and distributors can reduce the number of NDINs they must
file and provide some clarification with regard to when data and
information from a previous NDIN may be used in a notification. We
recommend that certain information should be provided in list form for
ease of reference and to help ensure completeness.
    Certain recommendations found in the 2016 revised draft guidance,
section IV.C., Determining Whether a New Dietary Ingredient (NDI)
Notification Is Required; Other Questions About When an NDI
Notification Is Necessary, discusses information that should be
included if referring to non-public information from a previous
notification. Such information to include with a notification could
involve written authorization to reference information from another
firm. The option to reference certain information from a previous
notification should reduce notifiers' burden for preparing and
submitting identity, manufacturing, and safety information.
    We encourage manufacturers or distributors of NDIs to submit their
NDINs electronically via the CFSAN Online Submission Module (COSM).
Although we encourage electronic submission, notifiers also have the
option of submitting a paper NDIN for us to review. The recommendations
found in the 2016 revised draft guidance, section V, Recommended
Template for Organizing an NDI Notification, recommends that
information in a paper NDIN should be organized in a specific manner,
and that some information should be provided in list form, for ease of
reference and to ensure completeness. Doing so will help notifiers
provide a complete, well-organized NDIN, which should facilitate an
efficient and timely FDA review.
    These sections of the 2016 revised draft guidance provide
instruction and help dietary supplement manufacturers and distributors
understand what to expect when submitting an NDIN and enhance
industry's ability to submit a complete notification that FDA can
efficiently review.
2. Identity Information About the NDI and the Dietary Supplement
    Certain recommendations found in the 2016 revised draft guidance,
section VI.A., What to Include in an NDI Notification; Identity
Information About the NDI and the Dietary Supplement, provide
instruction and discuss information that is important in describing the
identity of an NDI and the dietary supplement containing the NDI. We
will recommend that certain information should be provided in table
form for ease of reference and to help ensure completeness.
3. History of Use or Other Evidence of Safety
    Certain recommendations in the 2016 revised draft guidance,
sections VI.B., History of Use or Other Evidence of Safety, and VI.C,
Summary of the Basis for Your Conclusion of Safety, as well as table 3,
the Safety Testing Recommendations Matrix, provide instruction and
discuss information that is important in describing the basis for which
a dietary supplement containing the NDI will reasonably be expected to
be safe. While the FD&C Act does not specify the type or amount of
information that must be included in an NDIN, the notification should
include a dietary supplement safety narrative containing the objective
evaluation of the history of use or other evidence of safety cited in
the notification, along with an explanation of how the evidence of
safety provides a basis to conclude that the dietary supplement
containing the NDI, when used under the conditions described in the
NDIN, will reasonably be expected to be safe. Once finalized, the
recommendations will instruct and help dietary supplement manufacturers
and distributors understand what to consider when evaluating the safety
of a dietary supplement containing an NDI and what should be included
in an NDIN in this regard.
4. Electronic Submission
    We developed an electronic portal that respondents may use to
electronically submit their notifications to ODSP via COSM. COSM
assists respondents filing regulatory

submissions and is specifically designed to aid users wishing to file
submissions with CFSAN. COSM allows safety and other information to be
uploaded and submitted online via Form FDA 3880. This form provides a
standard format to describe the history of use or other evidence of
safety on which the manufacturer or distributor bases its conclusion
that the NDI is reasonably expected to be safe under the conditions of
use recommended or suggested in the labeling of the dietary supplement,
as well as a description of the ingredient and other information. Firms
that prefer to submit a paper notification in a format of their own
choosing have the option to do so; however, Form FDA 3880 prompts a
notifier to input the elements of an NDIN in a standard format that we
will be able to review efficiently. Form FDA 3880 may be accessed at
https://www.fda.gov/food/new-dietary-ingredients-ndi-notification-process/how-submit-notifications-new-dietary-ingredient.
    Description of Respondents: The respondents to this collection of
information are certain manufacturers and distributors in the dietary
supplement industry.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
    Activity; type of respondent; citation        Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDIN submission; Sec.   190.6................              55               1              55  20.......................................           1,100
List Form and Template; Administrative                      1               1               1  1........................................               1
 Procedures; Section V.
Written Authority; Master Files; Section                   10               1              10  0.4 (24 minutes).........................               4
 IV.C.1 and 4.
Table Form; Identity Specifications; Section               55               1              55  1........................................              55
 VI.A.
Manufacturing Process Information; Identity                55               1              55  5........................................             275
 Information; Section VI.B and C.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................           1,435
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimate is based on our experience with information
collections related to past NDIN submissions. The estimated burden also
reflects an industry average, although burden associated with
individual submissions may vary depending on the complexity of the
notification. Due to a program change we are revising this information
collection request to include recommendations found in the 2016 revised
draft guidance. Therefore, we have increased our total burden hour
estimate by 335. However, the number of respondents remains the same.
    We estimate that 55 respondents each submits 1 NDIN annually. We
estimate that extracting and summarizing the relevant information from
what exists in the company's files and presenting it in a format that
meets the requirements of Sec.  190.6 will take approximately 20 hours
of work per notification. We believe that the burden of the premarket
notification requirement is reasonable because we are requesting only
safety and identity information that the manufacturer or distributor
should already have developed to satisfy itself that a dietary
supplement containing the NDI is in compliance with the FD&C Act. If
the required premarket notification is not submitted to FDA, section
413(a) of the FD&C Act provides that the dietary supplement containing
the NDI is deemed to be adulterated under section 402(f) of the FD&C
Act. Even if the notification is submitted as required, the dietary
supplement containing the NDI is adulterated under section 402(f) of
the FD&C Act unless there is a history of use or other evidence of
safety establishing that the NDI, when used under the conditions
recommended or suggested in the labeling of the dietary supplement,
will reasonably be expected to be safe. This requirement is separate
from and additional to the requirement to submit a premarket
notification for the NDI.
    FDA's regulation on NDINs, Sec.  190.6(a), requires the
manufacturer or distributor of the NDI or dietary supplement containing
the NDI to submit to FDA the information that forms the basis for its
conclusion that the NDI, or dietary supplement containing the NDI, will
reasonably be expected to be safe. Thus, Sec.  190.6 only requires the
manufacturer or distributor to extract and summarize information that
should have already been developed to meet the safety requirement in
section 413(a)(2) of the FD&C Act.
    We estimate that 95 percent of respondents submit electronically,
leaving about 3 who submit their NDIN in paper format (5% x 55 = 2.75,
rounded up to 3). However, we have seen a trend of decreased paper
submissions over the past 2 years and expect usage to remain low. Thus,
we estimate only one NDIN will be submitted in paper format. We
estimate that information in this NDIN regarding the table of contents,
names of contacts, and reference lists will be provided in list form.
Because the underlying information should be already readily available,
we estimate that it will take about 60 minutes to prepare the
information in list form, which would create a burden of 1 hour (1 x 1
hour).
    We estimate that 10 notifiers will each reference information once
from a previous notification and will provide written authorization to
do so. We estimate that it will take about 24 minutes to prepare a
written authorization. We calculate that the burden for this activity
will be 4 hours annually (10 notifiers x 1 authorization x 0.4 hour).
    We estimate that 55 notifiers each will provide identity
specifications in table form with their NDIN submissions. Because the
underlining information should be already readily available, we
estimate that it will take about 1 hour to prepare the information in
table form, which would create a burden of 55 hours (55 tables x 1
hour).
    We estimate that 55 notifiers each will provide information about
the manufacturing process with their NDIN submissions. We estimate that
it will take about 5 hours to prepare this information, which would
create a burden of 275 hours (55 manufacturing process x 5 hours).

    Dated: July 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16434 Filed 8-1-23; 8:45 am]
BILLING CODE 4164-01-P


OMB# XXXX XXXX Expiration Date: __/__/____

1 Date _______________

Name of Person Responding _______________________________ Title ______________________

Name of School ____________________________________________________________________

Address ___________________________________________________________________________

City ___________________________________ State _________ Zip Code ____________________

County __________________________ School District ____________________________________

Phone _________________ Fax __________________ E mail _______________________________

School Type: Public ___________ Grade Levels: Elementary_______________

Private __________ Middle/ Jr. High__________

Sr. High________________

Other __________________

No. of Students __________________ No. of Faculty and Staff _____________________________

School Size ( sq. ft.) ____________ No. of Buildings ________ Age of School ( yrs)_______________

HVAC Type: Central Air Handling System ( each unit serves multiple rooms)__________________

Unit Ventilators ( each unit serves a single room) _____________________________

Other ______________________________________________________________ U. S. Environmental Protection Agency's ( EPA) IAQ Practices in Schools Survey 1. What IAQ Management Program are you using in your school? ( check one)

( a) EPA's Indoor Air Quality Tools for Schools ( b) Other _____________________________ ( c) None ( go to question 7)

2. How long has your school had an IAQ management plan? ( check one)

less than 1 year

1 2 years

2 4 years

more than 5 years Questions 3 7 ask you to rate certain characteristics of your school's IAQ program on a scale of 0 to 5 as follows:

0 = none, not at all 3 = moderate, adequate 1 = not much, poor 4 = a lot, good 2 = somewhat, fair 5 = very much, excellent 2 Rating Scale 0 = none, not at all 2 = somewhat, fair 4 = a lot, good 1 = not much, poor 3 = moderate, adequate 5 = very much, excellent 0 1 2 3 4 5 3. Please rate the quality and effectiveness of your school's IAQ management plan ( rate each item)

A person is designated as IAQ coordinator/ manager and has authority to carry out the IAQ management plan The building and HVAC system receive regular maintenance to insure that all systems are consistently functioning as designed IAQ is a priority consideration for repairs and upgrades of the school building and HVAC system The HVAC system consistently provides adequate control of temperature, humidity and outdoor air ventilation to all occupied spaces Art classes, industrial art classes, and science laboratories choose products and/ or incorporate specific methods, e. g., exhaust ventilation, to minimize exposures of all students and staff to pollutants produced from these activities Housekeeping ( custodial) services maintain clean conditions in all areas Administrative and custodial staff are trained to read and follow directions for all cleaning products and methods to minimize exposure of staff and students An IAQ walkthrough inspection along with periodic check ups are used to monitor IAQ conditions and practices in the school( s)

4. Pest control in the school( s) is accomplished using the following ( rate each item)

Traps are used to monitor pest populations Threshold targets are established for pest populations Traps are used to kill and control pests Hygienic conditions are strictly maintained to prevent infestations Leaks, spills, condensation, and other moisture sources are strictly controlled Pesticides are applied on a regular basis Rating Scale 0 = none, not at all 2 = somewhat, fair 4 = a lot, good 1 = not much, poor 3 = moderate, adequate 5 = very much, excellent 0 1 2 3 4 5 3 5. School personnel actively participate in the IAQ program ( rate participation by each group)

Teachers Administrative staff Custodial staff Food service staff Health Officers/ School Nurses Facilities and Maintenance staff Other ( specify)

6. Please rate the extent to which the following have been barriers to implementing IAQ practices in your school( s)

Potential liability Costs Lack of resources Lack of knowledge Competing priorities School administration School Board 7. In your opinion, has your IAQ program led to any of the following? ( check all that apply)

Lower Absenteeism Better Test Scores Increased Productivity Fewer Asthma Episodes Improved Work Place Satisfaction Fewer Visits to the Health Officer/ School Nurse 8. The outdoor air ventilation rate in your school( s) is set at ( check one)

No particular setting ( cfm = cubic feet per minute)

less than 5 cfm per occupant 4 5 to 10 cfm per occupant 11 to 14 cfm per occupant 15 or more cfm per occupant STOP HERE IF YOU ARE NOT USING IAQ TOOLS FOR SCHOOLS!

9. If you are using EPA's IAQ Tools for Schools, the following IAQ checklists have been distributed ( check all that apply)

Teachers Administrative Staff Health Officers/ School Nurses Ventilation Renovation and Repairs Building Maintenance Food Services Waste Management Walkthrough 10. If you are using EPA's IAQ Tools for Schools, approximately what % of the following IAQ checklists have been completed and returned? ( rate each item) 0 25% 26 50% 51 75% 75 100%

Teachers Administrative Staff Health Officers/ School Nurses Ventilation Renovations and Repairs Building Maintenance Food Services Waste Management Walkthrough Burden means the total time, effort, or financial resources expended by persons to generate , maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. 5