[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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[Docket No. FDA-2015-N-2881]

Standards-Based Approach to Analytical Performance Evaluation of
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    Dated: December 3, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-30937 Filed 12-8-15; 8:45 am]
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[Federal Register Volume 74, Number 124 (Tuesday, June 30, 2009)]
[Notices]
[Pages 31271-31272]
[FR Doc No: E9-15450]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the Record Communications; Public Notice

June 24, 2009.
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             Docket No.                 date     Presenter or  requester
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1. P-2210-169.......................   6-19-09  Allan Creamer.\1\
2. P-2210-169.......................   6-11-09  Jeffrey Browning.\2\
3. P-13283-000......................   6-11-09  Hon. David Vitter.
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\1\ Record of telephone communication.
\2\ E-mail correspondence re: exchange of information with Virginia DCR.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-15450 Filed 6-29-09; 8:45 am]
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DEPARTMENT OF ENERGY

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[Docket No. RP06-336-002]

Pine Needle LNG Company, LLC; Notice of Tariff Filing

December 28, 2006.
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Magalie R. Salas,
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 [FR Doc. E6-22683 Filed 1-5-07; 8:45 am]

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SMIG  Effects of Clearcutting on Stream Temperature ( article: September 2002)

Estimating Cumulative Effects of Clearcutting on Stream Temperatures by John M. Bartholow U. S. Geological Survey Fort Collins Science Center 2150 Centre Avenue, Bldg C Fort Collins, CO 80526 8118 Internet: john_ bartholow@ usgs. gov Phone: ( 970) 226 9319 $ nbsp; FAX: ( 970) 226 9230 Editor's note: This paper was published in the journal Rivers. This version is based on the final draft provided to the journal; as such, minor discrepancies between this and the final manuscript may be present.

This version of the paper has all of the figures and tables converted to thumbnails with links to the larger images. A version with most of the figures and tables inline is also available; the download time will be longer, but the inline figures may be more convenient for viewing and printing.

In order to make this article easier to print out, a version without the navigation tools on the left hand side is available through the pageprint script.

Citation: Bartholow, J. M., 2000, Estimating cumulative effects of clearcutting on stream temperatures, Rivers, 7( 4), 284 297.

Contents Abstract http:// smig. usgs. gov/ SMIG/ features_ 0902/ clearcut. html ( 1 of 23) [ 9/ 30/ 2003 10: 11: 49 AM] SMIG  Effects of Clearcutting on Stream Temperature ( article: September 2002)

Introduction Methods The Model Conceptual Model Relating Cumulative Clearcut Effects To Stream Temperatures Literature Review Model Implementation Results Discussion Acknowledgements References Abstract The Stream Segment Temperature Model was used to estimate cumulative effects of large scale timber harvest on stream temperature. Literature values were used to create parameters for the model for two hypothetical situations, one forested and the other extensively clearcut. Results compared favorably with field studies of extensive forest canopy removal. The model provided insight into the cumulative effects of clearcutting. Change in stream shading was, as expected, the most influential factor governing increases in maximum daily water temperature, accounting for 40% of the total increase. Altered stream width was found to be more influential than changes to air temperature. Although the net effect from clearcutting was a 4oC warming, increased wind and reduced humidity tended to cool the stream. Temperature increases due to clearcutting persisted 10 km downstream into an unimpacted forest segment of the hypothetical stream, but those increases were moderated by cooler equilibrium conditions downstream. The model revealed that it is a complex set of factors, not single factors such as shade or air temperature, that governs stream temperature dynamics.

Introduction The effects of manipulating forest shade on stream temperature have been the focus of much debate. One school of thought indicates that solar radiation is critical in controlling stream temperature ( Beschta et al., 1988; Beschta, 1991; Beschta, 1997), such that riparian vegetation, and even large woody debris, is to be thoroughly protected during timber harvest. Another perspective maintains that ambient air temperature, or a warm environment in general, is the factor http:// smig. usgs. gov/ SMIG/ features_ 0902/ clearcut. html ( 2 of 23) [ 9/ 30/ 2003 10: 11: 49 AM] SMIG  Effects of Clearcutting on Stream Temperature ( article: September 2002)

largely governing stream heating ( Sullivan et al., 1990; Larson and Larson, 1996; Zwieniecki and Newton, 1999). In addition, some authors ( Beschta and Taylor, 1988; Beschta et al., 1988) have argued that any stream heating due to timber practices is carried downstream, while others ( Burton and Likens, 1973; Sullivan et al., 1990; Zwieniecki and Newton, 1999) have argued that regardless of the site specific effects of clearcutting or other disturbances, streams return to their thermal " signature" once the stream enters its downstream " recovery zone" and the elements of heat flux to and from the water return to " normal". Although both sides of the debate concede certain points, none have made a comprehensive attempt to address the full suite of factors involved in stream heating resulting from large scale timber harvest.

" Comprehensive" can of course mean many things. Models have been developed to accurately predict stream shading or its effect on water temperature ( Quigley, 1981; Theurer et al., 1982; Knapp and Williamson, 1984; Reid and Ferguson, 1992; Rutherford et al., 1997). Yet streamside vegetation contributes to several ecosystem functions, not just stream shading. Bank stability, woody debris accumulation, seedling survival, understory desiccation rates, tree disease rates, changes in leaf morphology, snowmelt rate, summer flows, stream roughness, and fish, invertebrate, and algal biomass are all potentially influenced by the nature and extent of riparian vegetation ( Tucker and Emmingham, 1977; Beschta, 1991; Schmid et al., 1991; Li et al., 1994). Physical models have been applied to predict stream temperature as a function of shading ( e. g., Brown, 1970), but few prior applications have explored the cumulative effects of vegetative removal on the streamside ecosystem. " Cumulative" in this sense implies not simply direct effects, but also second order consequences, namely meteorologic and hydrologic changes to the system in question.

The objective of this paper is to quantify the cumulative effects that large scale clearcutting may have on stream temperatures and determine the relative contribution of various physical changes to that effect. The approach used was to 1. develop a conceptual model of the multiple effects of clearcutting with some qualitative hypotheses concerning the nature of expected changes; 2. perform a literature review to determine realistic parameters for such a model in a hypothetical stream setting; 3. implement and test the model; 4. quantify the degree to which incremental physical changes cumulatively influence stream temperatures; and 5. verify that the results are in general agreement with previous empirical data.

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Methods The Model The Stream Network Temperature Model ( SNTEMP; Theurer et al., 1984) has been used to predict longitudinal stream temperatures caused by alterations in flow regimes, dam release temperature, or the channel, including stream canopy manipulation. This model is a component of the Instream Flow Incremental Methodology ( IFIM; Stalnaker et al., 1995) and is a first principles model based on well studied physical phenomena. Supplied with high quality input data, the SNTEMP model has been shown to simulate mean daily stream temperatures with a high degree of accuracy, typically < 0.5oC, with little or no calibration ( Bartholow, 1991). Close agreement between measured and simulated stream temperatures, in turn, supports using this and similar models in an exploratory mode ( e. g., What if we changed the canopy cover by a certain percentage?). The model has been used infrequently to address multiple perturbations, and there is no published information to indicate its application to assess the cumulative effects of major land use changes on stream temperature.

The Stream Network Temperature Model is a mechanistic, steady state onedimensional heat transport model that predicts daily mean and maximum water temperatures. It also predicts both mean and maximum equilibrium temperatures, the theoretical values approached if all model inputs remained the same for a long time. Net heat flux is calculated as the sum of heat from long wave atmospheric radiation, direct short wave solar radiation, convection, conduction, evaporation, streamside shading, streambed fluid friction, and the water's back radiation. The model requires that the hydrologic network be divided into homogeneous stream segments, each described by flow, length, top width, slope, channel roughness ( Manning's n) or travel time, and shading characteristics. Meteorological data used in the model are air temperature, relative humidity, wind speed, percent possible sun ( inverse of cloud cover), and ground level solar radiation. The model calculates within segment streamflow accretions by mass balance, but groundwater accretion temperatures are necessary inputs. For a complete list of data requirements, see Theurer et al. ( 1984) and Bartholow ( 1989). The model's analytic components have been validated ( Theurer and Voos, 1982; Theurer, 1985; Mattax and Quigley, 1989; Bartholow, 1991), and its performance has compared favorably with other water temperature models ranging from simple to more complex ( Sullivan et al., 1990; Tu, unpublished report; Tu et al., 1992).

Like any model, SNTEMP has strengths and weaknesses ( Theurer et al., 1984; Bartholow, 1989). It http:// smig. usgs. gov/ SMIG/ features_ 0902/ clearcut. html ( 4 of 23) [ 9/ 30/ 2003 10: 11: 49 AM] SMIG  Effects of Clearcutting on Stream Temperature ( article: September 2002)

1. may be applied to a stream network of any order using time steps ranging from one day to one month; 2. predicts solar radiation as a function of latitude, time of year and prevailing meteorology; 3. predicts shading from riparian and topographic elements; 4. corrects air temperature, relative humidity, and atmospheric pressure for elevation within the watershed; 5. uses regression aids to fill and/ or smooth missing observed water temperature measurements at boundary conditions; and 6. provides statistical goodness of fit tools to help judge the model's power of estimation.

An important aspect of the model's design was to produce reasonable predictions with readily available input data. The model also has limitations. It is not applicable for rapidly varying flows such as hydropeaking. Also, maximum temperature predictions are not as accurate as mean temperature predictions ( Sullivan et al., 1990) without additional calibration. In particular, the model has no " memory" of upstream conditions that may influence downstream maximum temperatures ( Bartholow, 1989). The model assumes that maximum temperatures may be derived by heating a parcel of water from solar noon to sunset. Depending on the travel time, that parcel may have originated above the segment being modeled, and therefore may have traveled through radically different conditions. This " memory" problem is minimized when segments are long ( generally greater than 10 km) such that the downstream segment conditions dominate all heat flux.

The Stream Network Temperature Model has been used in a variety of applications. It was verified by Theurer et al. ( 1982, 1985) using data from two vastly different case studies to ensure model applicability: the relatively large upper Colorado River basin and the much smaller Tucannon River in Washington State. Since initial development, the model has been used widely, especially to assess biological flow requirements in bypass reaches below hydropower facilities ( Lifton et al., 1985, 1987; Voos et al., 1987). In addition, SNTEMP has been used in a broad range of climates, from the cold water of Alaska ( Meyer et al., unpublished paper) to the warmer waters of Nebraska ( Dinan, unpublished paper). The model has also been applied in less conventional situations, such as evaluating standards for streamside timber removal ( Sullivan et al., 1990), revegetation requirements to increase shading and channel restoration ( Bartholow, 1991, 1993), and channel manipulation to increase salmon rearing habitat by removing vegetated berms ( Zedonis, 1994). The use of SNTEMP in conjunction with fish population models to supply temperatures for egg incubation, juvenile growth, and mortality is a recent trend ( Bartholow et al.,

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1993).

Another model, the Stream Segment Temperature model ( SSTEMP; U. S. Geological Survey, 2000) was developed as a subset of SNTEMP, applicable only for single stream reaches and single time steps. This model uses the same numerical methods as SNTEMP, but was designed for Microsoft WindowsTM and is relatively easy to use in an exploratory mode. Both models have proven popular since their release, with documentation and limited technical support currently available from the U. S. Geological Survey ( 2000). For modeling single segments, or very simple networks, SSTEMP is interchangeable with SNTEMP and was used for this effort.

Conceptual Model Relating Cumulative Clearcut Effects To Stream Temperatures Clearcutting is a timber harvest practice in which all trees are removed from a designated area, with the possible exception of snags protected for wildlife benefits ( Brown, 1970). Clearcut areas may range from small parcels up to much larger areas covering small watersheds. Although clearcutting techniques have been under increased scrutiny in recent years, especially in fragile ecosystems, the method remains in use through large areas of the United States and Canada ( Young, 2000). This is particularly true in the Pacific Northwest, with annual clearcuts totaling more than 4,000 hectares in California alone, although with ever more stringent Best Management Practices ( BMPs) to safeguard the natural environment ( Russ Henly, California Dept. of Forestry and Fire Protection, personal communication). Perhaps the single most widely used protective measure is to leave uncut buffer strips along riparian zones. Gross effects of clearcutting have been extensively cataloged ( Anderson, 1973; Beschta et al., 1988). Here I will focus on effects directly related to stream temperature, namely meteorology, hydrology, and stream geometry. Since such effects would be expected to be a function of the geographic extent and time of year, and since most biological effects are related to high temperatures, I chose to focus on the warm summer period and larger scale disturbances. Therefore, I have ignored effects of vegetative loss on winter temperatures ( Hartman et al., 1984) and winter diel fluctuations ( Martin et al., 1986).

Conceptually, there are many effects of landscape scale vegetative removal on local meteorology and hydrology. Tree removal can be expected to have effects on local microclimates. Air temperature may be increased or decreased depending on the time of day. Wind resistance would undoubtedly decline, leading to an increase in wind speeds near the stream and increased evaporative cooling. Relative humidity likely would be reduced given a decrease in local http:// smig. usgs. gov/ SMIG/ features_ 0902/ clearcut. html ( 6 of 23) [ 9/ 30/ 2003 10: 11: 49 AM] SMIG  Effects of Clearcutting on Stream Temperature ( article: September 2002)

vegetative transpiration coupled with increased airflow and surficial evaporation. Uninterrupted solar radiation might be expected to warm the ground, which in turn could warm interflow accretion temperatures to the stream. On a watershed scale, removal of vegetation might increase the surface reflectivity ( i. e., how much of the incoming solar radiation is reflected back into the atmosphere). Further, it is conceivable that there would be an increase in airborne dust since the ability of foliage to capture and filter dust would be reduced. Increased dust could affect the amount of solar radiation reaching ground level.

Changes in microclimates and vegetative transpiration may result in hydrologic alterations. Overall water yield in the form of accretions to the stream may increase. Further, the timing of stormwater runoff is likely to shift with the watershed becoming more " flashy." In addition, with few exceptions, clearcutting usually involves extensive haul road construction. Best Management Practices have significantly reduced environmental degradation due to road construction. However, some unavoidable sedimentation effects remain, potentially affecting stream width and stream roughness in addition to water quality. Channel geometry changes may affect stream depth and travel time. Aggredation may affect the stream gradient and, potentially, stream width and length. Increased sedimentation may also influence the insulation of streamflow from ground temperatures and reduce the rate of exchange between surface waters and the hyporheic zone ( Ronan et al., 1998). The following section reviews the literature available for each of the above possibilities.

Literature Review From the above conceptual model, it is relatively easy to connect the many environmental effects of clearcutting to mechanisms known to influence water temperature. It is difficult to draw a clear boundary around the relative magnitude of effects without doing some " ground truthing" with values reported in the literature. A brief survey has been summarized in Table 1. The review was not meant to be exhaustive, but rather representative of what one may find in this rather broad field. Often, values were not found in the text, but were estimated from figures provided by the authors; these are flagged as estimates. No values were was found for some elements of the conceptual model.

Table 1. Documented changes to the environment of small streams and watersheds associated with extensive forest clearing. Changes are representative of hot summer days and indicate the mean daily effect unless otherwise indicated.

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Estimates ( E) were derived from figures provided by authors.

Air Temperature. Edgerton and McConnell ( 1976) showed that removing all or a portion of the tree canopy resulted in cooler terrestrial air temperatures at night and warmer temperatures during the day, enough to influence thermal cover sought by elk ( Cervus canadensis) on their eastern Oregon summer range. Increases in maximum air temperature varied from 5 to 7oC for the hottest days ( estimate). However, the mean daily air temperature did not appear to have changed substantially since the maximum temperatures were offset by almost equal changes to the minima. Similar temperatures have been commonly reported ( Childs and Flint, 1987; Fowler et al., 1987), even with extensive clearcuts ( Holtby, 1988). In an evaluation of buffer strip width, Brosofske et al. ( 1997) found that air temperatures immediately adjacent to the ground increased 4.5oC during the day and about 0.5oC at night ( estimate). Fowler and Anderson ( 1987) measured a 0.9oC air temperature increase in clearcut areas, but temperatures were also 3oC higher in the adjacent forest. Chen et al. ( 1993) found similar ( 2.1oC) increases. All measurements reported here were made over land instead of water, but in aggregate support about a 2oC increase in ambient mean daily air temperature resulting from extensive clearcutting.

Relative Humidity. Brosofske et al. ( 1997) examined changes in relative humidity within 17 to 72 m buffer strips. The focus of their study was to document changes along the gradient from forested to clearcut areas, so they did not explicitly report pre to post harvest changes at the stream. However, there appeared to be a reduction in relative humidity at the stream of 7% during the day and 6% at night ( estimate). Relative humidity at stream sites increased exponentially with buffer width. Similarly, a study by Chen et al. ( 1993) showed a decrease of about 11% in mean daily relative humidity on clear days at the edges of clearcuts.

Groundwater Inflows. Stednick ( 1996) comprehensively reviewed studies of timber harvest effects on water yield. Although he did not provide a summary of changes to either peak or base flows, his work suggested that changes in water yield become measurable after about 20% of the catchment area is harvested. Harr et al. ( 1982) found an increased water yield in two small central Oregon watersheds cut to varying degrees. Although increased yield was substantial ( 20 40 cm), neither the size nor timing of peak flows changed significantly. Instead, the number of low flow days during the summer, including drought years, decreased, perhaps due to reduced evapotranspiration. Unfortunately, the authors noted that " Variation in volume of flow during low flow periods precluded any meaningful analyses of low flow volumes." Burton ( 1997) reported that the mean annual daily discharge increased by 66% on a large ( 2145 hectare) watershed in http:// smig. usgs. gov/ SMIG/ features_ 0902/ clearcut. html ( 8 of 23) [ 9/ 30/ 2003 10: 11: 49 AM] SMIG  Effects of Clearcutting on Stream Temperature ( article: September 2002)

northern Utah due to a 25% clearcut, but the increase was in peak flows, not base flows. Jones and Grant ( 1996) report similar results. Fowler et al. ( 1987) found no significant increases in annual water yield for three small watersheds in northeastern Oregon. Although overall water yield may increase with logging, the literature reviewed does not appear to support any significant change to low summer base flows.

Ground Temperature. The SSTEMP model uses ground temperature as one element in calculating conductive heat flux. Ground temperature may also be used as a surrogate for accretion temperatures if no other source of information is available. Brosofske et al. ( 1997) showed substantial changes in soil temperature immediately outside 17 to 72 m wide buffer strips. Increases averaged about 4oC during the day and 3.5oC during the night ( estimate). Although at stream soil temperatures seemed unchanged, the overall effect of increased soil temperature appeared to exert a strong influence on stream temperature, more so than buffer strip width, air temperature, or wind speed. Similarly, Hewlett and Fortson ( 1982) suggested that elevated ground temperature might have explained a large portion of increases in stream temperature in a low gradient piedmont stream. Childs and Flint ( 1987) measured large differences in ground temperature between clearcut and shelterwood cut sites in southwestern Oregon. Maximum temperatures differed by as much as 17oC at 20 mm deep and by about 5oC at 320 mm ( estimate from figure). Fowler and Anderson ( 1987) found that 250 mm ground temperatures averaged 2.4oC cooler in forested conditions, while Chen et al. ( 1993) found a 4.4oC increase in soil temperatures at a depth of 100 mm. On balance, it appears that one could reasonably expect a small increase in ground temperature that would influence interflow temperatures adjacent to the stream.

Wind Speed. Brosofske et al. ( 1997) reported almost no change in wind speed at stream locations within buffer strips adjacent to clearcuts. Speeds quickly approached upland conditions toward the edges of the buffers, with an indication that wind actually increased substantially at distances of about 15 m from the edge of the strip, and then declined farther upslope to preharvest conditions. Chen et al. ( 1993) documented increases in both peak and steady winds in clearcut areas; increments ranged from 0.7 to 1.2 m/ s ( estimated).

Solar Radiation. Estimates of ground level solar radiation may be used as a supplemental input to SSTEMP. Radiation input determines what reaches the ground in the absence of any shading from topography or vegetation. Literature values on measured solar radiation, however, can help estimate the shading effects of forest cover. Brosofske et al. ( 1997) examined changes in mean daily solar radiation within buffer strips. Post harvest radiation increased approximately 200% at the stream ( estimate) even with " leave" trees, increasing http:// smig. usgs. gov/ SMIG/ features_ 0902/ clearcut. html ( 9 of 23) [ 9/ 30/ 2003 10: 11: 49 AM] SMIG  Effects of Clearcutting on Stream Temperature ( article: September 2002)

to full sun values beyond the edge of the strips. The total amount of radiation at the stream decreased exponentially with buffer width.

Ground Reflectivity. Theurer's ( 1984) temperature model uses an estimate of ground reflectivity to calculate the amount of ground level short wave solar radiation reflected back to the atmosphere. This uncommonly measured value was estimated by Holbo and Childs ( 1987) in their model of net radiation balance on clearcut areas in southwestern Oregon. Although there was variability among sites, they estimated a small ( 6%) decrease in total reflectivity comparing shelterwood to slashburned clearcut sites. This is in contrast with generally accepted values for the albedo of surface cover that suggests about a 5% increase in reflectivity on conversion from coniferous vegetation to open meadow land ( Halverson and Smith, 1979).

Stream Width. Dose and Roper ( 1994) found a moderate positive correlation between timber harvest activity ( cut area, road density, and large woody debris) and low flow wetted stream widths within a 1400 km2 watershed in southwestern Oregon. Although some of the streams did not appear to have changed from 30 year old historical surveys, the median increase was 145% of the prelogging width while the top 10% of sites increased by 223% or more. Much of the increase was attributed to lack of recovery from a peak flow event 20 years prior to post harvest measurements. Heede ( 1991) measured changes in channel crosssectional area for streams in the White Mountains of Arizona. He found stream width increases averaging 10% in the logged watershed compared to + 2.5% in the unlogged portion. He estimated that all of the streams were in a disequilibrium condition prior to harvest.

In my review of the literature, I found no useful information on changes in airborne dust, stream slopes, or stream length due to timber harvest. Theurer et al. ( 1984) however reported a 3% decrease in a 100 km portion of the Tucannon River after extensive land use alterations, including " straightening" due to flooding of the degraded system. Stream slopes may respond on much longer time scales and site specific airborne dust may be infrequently investigated.

Model Implementation Values in Table 1 were subjectively synthesized to create parameters for an SSTEMP model of a hypothetical small stream. Latitude and elevation were assumed similar to the Pacific Northwest watersheds used to develop Table 1. The simulation was run for early August to represent a hot, low flow day, and was arbitrarily assigned a length of 10 km, a slope of 3%, and a discharge of 0.425 m3/ s ( 15 cfs). Solar radiation was internally calculated by the model for http:// smig. usgs. gov/ SMIG/ features_ 0902/ clearcut. html ( 10 of 23) [ 9/ 30/ 2003 10: 11: 49 AM] SMIG  Effects of Clearcutting on Stream Temperature ( article: September 2002)

that time of year, latitude ( 46.25oN) and other meteorological values. The change in solar radiation for the clearcut simulation ( Table 1) is attributable to altered ground reflectivity. I assumed that riparian buffer strips ( about 50% stream surface shading) would be maintained by current regulatory BMPs, but I also assumed that there would still be a 5% change in direct riparian shading per Brosofske et al. ( 1997). Inflow temperature was assumed to represent a cold, spring fed stream ( 9oC). The model was run for a forested ( baseline) case and for a watershed wide clearcut case, recording the differences in predicted maximum daily water temperature for each single variable change, and for the set as a whole. The contribution that each parameter had singly on the total change in maximum temperature was calculated as a simple proportion. Model derived temperatures were recorded to the nearest hundredth degree, not because it is possible to measure with this resolution in the field, but because it is instructive in comparing magnitudes and because it facilitates more accurate conversion to the Fahrenheit scale if desired.

Results Model results for the individual forested and clearcut simulations are given in Table 2 and Figure 1. Overall, clearcutting increased mean daily temperatures by 2.4oC and maximum temperatures by 3.6oC over the 10 km reach. Stream shading was the most sensitive variable, accounting for 1.48oC of the increase in maximum daily water temperature, although stream width was a close second, accounting for 1.35oC. Air temperature was the next most sensitive single variable, adding 0.61oC to the maximum. Three variables ( relative humidity, wind speed, and ground reflectivity) resulted in reductions in the maximum daily stream temperature. There was a small synergistic effect (+ 0.13oC) attributable to all variables combined.

Table 2. Mean daily input values used to simulate hypothetical forested and clearcut stream temperatures, and resulting change in maximum temperature for each attribute singly, and collectively, as predicted by SSTEMP simulations. Collective change to mean daily and maximum daily water temperature is also given. No change is indicated by "".

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Figure 1. Percent of total thermal gain attributable to single variables from basinwide clearcutting a small, hypothetical stream. The last item, synergistic, is that additional gain resulting from all variables combined. Estimates were computed based on simulations using the SSTEMP model.

To explore the downstream consequences of upstream changes, SSTEMP was used to project outflow temperatures from the hypothetical study area another 10 km downstream through an unimpacted watershed with attributes exactly the same as for the forested condition listed in Table 2, but with mean inflow water temperatures increasing as predicted from 13.24oC to 15.66oC. As shown in Table 3, the forested to forested pair predicted a mean outflow temperature of 15.78oC and a maximum of 20.38oC. The clearcut to forested linkage predicts a mean outflow temperature of 17.18oC with a maximum of 21.52oC. As expected, equilibrium temperatures were identical in all forested simulations because the governing hydrologic, meteorologic, and stream geometry conditions were identical.

Table 3. Comparison of simulated outflow temperatures ( oC) for upstream " treatment" and downstream " recovery zone" simulations based on SSTEMP projections. Outflow temperatures for the upstream segment became inflow temperatures for the downstream segment. Note that equilibrium temperatures are the same for all forested conditions.

Discussion Quantifying the multiple effects of clearcutting has been enlightening. The model has shown that it is a complex set of factors, not simply a single factor, that governs stream temperature increases due to large scale timber harvest. Of foremost importance, even slight alterations to stream shading during harvest ( intended to emulate adherence to strict BMPs) may result in increases to maximum daily water temperature. Air temperature did not appear to be as important in governing the increase in maximum daily water temperature as direct solar radiation. Although air temperature was influential, the more subtle second order effect of stream widening was even more important. Not all harvesthttp smig. usgs. gov/ SMIG/ features_ 0902/ clearcut. html ( 12 of 23) [ 9/ 30/ 2003 10: 11: 49 AM] SMIG  Effects of Clearcutting on Stream Temperature ( article: September 2002)

related effects generated in stream warming; increased wind speed and reduced humidity resulted in stream cooling. The 2.4oC increase in mean upstream temperature due to timber harvest persisted 10 km downstream into an unimpacted forest segment of the hypothetical stream, but those increases translated to only a 1.4oC increase in mean temperature 10 km farther downstream because they were moderated by cooler equilibrium conditions. Thus the downstream equilibrium temperature tends to " recover" temperature increases ( sensu Zwieniecki and Newton, 1999), but cannot fully mitigate those increases. The model did not suggest a " strong influence" of ground temperatures on stream temperature as suggested by Hewlett and Fortson ( 1982) and Brosofske et al. ( 1997), but this is the subject of ongoing research ( Johnson and Jones, in press). The results did, however, confirm both the importance of riparian shade ( Beschta, 1997), in contrast to the views of Larson and Larson ( 1996), and confirmed the hypothesis of a stream's " thermal signature" ( Zwieniecki and Newton, 1999).

A more thorough investigation may be warranted for two reasons. First, attributes in downstream areas would not be expected to remain the same as upstream. Air temperatures would warm with decreased elevation ( Theurer et al., 1984) and exposure would increase given " natural" changes to stream width in the longitudinal direction ( Leopold et al., 1964). Second, the temperature model has no memory of upstream conditions. Therefore it cannot " remember" that incoming maximum water temperatures may be elevated from their expected value. Nevertheless, the conservative assumptions used here argue both for persistence of effects and eventual convergence on " signature" temperatures for this moderately sized stream. Smaller streams, or those even more thoroughly shaded and having an equilibrium temperature cooler than inflowing waters, might be expected to recover more quickly ( Zwieniecki and Newton, 1999). From a land management perspective, however, what may be most relevant is whether factors other than water temperature, most notably stream width, are impacted downstream. If the width were increased in a forested downstream setting due to upstream land use changes, cooling attributable to relative humidity and wind speed may no longer partially offset upstream temperature increases.

Few models have been used in an attempt to understand cumulative effects related to stream temperatures. Brown ( 1970) pioneered work in this area showing how to calculate maximum changes in stream temperature from different degrees of clearcut. However, Brown's model relied almost exclusively on estimates of changes in surface area exposed to the sun and did not address cumulative effects as examined here. To get at cumulative effects, I have fabricated a stream meant to be representative of a system in the Pacific Northwest. Obviously, the simulation results would be different if I had made different assumptions, particularly on the scale of effects, as river heat budgets are highly variable in both time and space ( Webb and Zhang, 1997). But do the http:// smig. usgs. gov/ SMIG/ features_ 0902/ clearcut. html ( 13 of 23) [ 9/ 30/ 2003 10: 11: 49 AM] SMIG  Effects of Clearcutting on Stream Temperature ( article: September 2002)

results compare favorably with observations made from actual cases? There are many examples in the literature that can be used to assess the realism of model predictions. Some examples, however, do not reflect recent timber harvest BMPs; therefore direct comparisons should be tempered with caution.

Beschta and Taylor ( 1988) documented changes in the 325 km2 Salmon Creek watershed in western Oregon that accompanied removal of forest cover over a 29 year period. They calculated that average daily maximum stream temperatures increased 6oC at the watershed's mouth for the ten warmest days of each year, even although air temperatures appeared to decline over the same period. They noted that it was difficult to draw a tight cause and effect chain from timber harvest to stream temperature given natural hydrologic events in combination with changes in harvest activity and management practices. Levno and Rothacher ( 1967) reported a 2.2oC increase in weekly maximum temperatures after 100% logging of one small 61 hectare watershed in Oregon. Another similar watershed was only 25% cut, but suffered from extensive scour in a 1964 flood. This watershed showed mean monthly water temperature increases of 3.9o to 6.7oC from April through August following the flood. Brown and Krygier ( 1970) reported an average monthly maximum temperature increase of about 8oC after clearcutting a small Oregon watershed. They attributed changes to increased solar radiation reaching the stream. Amaranthus et al. ( 1989) described maximum water temperature increases ranging from 3.3o to 19oC in adjacent southern Oregon watersheds burned to varying degrees. Increases were negatively correlated with summer streamflow and remaining streamside shading, even if shading was composed largely of dead vegetation. Kopperdahl et al. ( 1971) reported maximum water temperature increases of 3.3 to 9.4oC in small watersheds cut and " roaded" to varying degrees in the fog belt of northern California, an area where air temperatures and solar radiation are generally moderate. However, much of the temperature increase may have been due to bulldozers " working" the streams. The report also summarized other studies documenting temperature changes in nearby watersheds of 11oC and 13.8oC. Feller ( 1981) recorded maximum temperature changes of 3.6 to 5.7oC in two coastal British Columbia watersheds paired with untouched areas, with effects lasting seven years or longer depending on the treatment. Holtby ( 1988) examined the effects of extensive ( 41%) clearcuts on Carnation Creek in British Columbia. Although he found no significant logging effect on air temperatures, every month exhibited an increase in mean monthly water temperature, ranging from 0.71oC in December to 3.25oC in August.

In an extensive study, Barton et al. ( 1985) examined the influence of the size ( width and length) of buffer strips on maximum stream temperature in southern Ontario. They found a strong positive correlation between the percent of http:// smig. usgs. gov/ SMIG/ features_ 0902/ clearcut. html ( 14 of 23) [ 9/ 30/ 2003 10: 11: 49 AM] SMIG  Effects of Clearcutting on Stream Temperature ( article: September 2002)

watershed forested and maximum water temperatures. Unvegetated watersheds averaged 5oC warmer than those with 100% forest coverage. Swift and Messer ( 1971) related maximum water temperature to a variety of timber harvest treatments in southern Appalachians hardwood forests. Generally, maximum water temperatures increased about 4oC, but extreme clearing was accompanied by changes of up to 7oC. Hewlett and Forston ( 1982) documented maximum stream temperature increases of 11oC with buffers in a clearcut loblolly pine stream in the southeast United States. Rishel et al. ( 1982) found average monthly maximum temperature increases of 4.4oC in the northeast after extensive clearcuts followed by herbicide treatment, although some instantaneous temperature increases approached 10oC.

To summarize, the literature from a variety of geographic locations suggests that increases to mean temperatures of 3 6oC, and to maximum temperatures of 3 8oC, have been common. Therefore, the SSTEMP model predictions for this hypothetical stream are reasonable, perhaps even low. They may be low because some reports were made prior to effective riparian management. I believe the model predictions are valuable, however, not because they may approximate the cumulative effect per se, but because they illustrate the relative magnitude of change caused by the physical variables that govern water temperature. In particular, altered stream width, when it occurs, may account for a significant proportion of increases to maximum temperature. Therefore, BMPs devoted to mitigating increases in stream width could be expected to have a relatively large influence on stream temperatures.

Has the strict definition of " cumulative effects" been met by this analysis? I fear that the answer is no. Concentration on the physical dimension ignores the far more complex biological arena ( Johnson and Jones, in press). Could thermal increases be a barrier to up or downstream migration of salmonids, growth rates or stress ( Lynch et al., 1984)? Would benthic food production be adversely affected in altered habitats ( Duncan et al., 1989)? This analysis alone cannot answer those questions. However, first principles models like SNTEMP and SSTEMP are good integration tools that can capture many important first order linkages between land use changes and stream temperature ( e. g., shading). They can also be used hypothetically to explore second order cumulative effects, although they can never be conclusive. In this mode, such models are useful in five broad categories of application:

1. Understanding: What are the important physical processes?; 2. Communication: How does one visualize and communicate cumulative effects to diverse audiences?; 3. Sensitivity analysis: Which variables most warrant accurate measurement http:// smig. usgs. gov/ SMIG/ features_ 0902/ clearcut. html ( 15 of 23) [ 9/ 30/ 2003 10: 11: 49 AM] SMIG  Effects of Clearcutting on Stream Temperature ( article: September 2002)

at a site?; 4. Incremental quantification: How much change in water temperature might one expect given single or cumulative changes in input variables (" whatif analysis)?; and 5. Coherence of monitoring results: Does it all make sense?

It is encouraging that stringent timber management BMPs that limit the size and contiguity of clearcut parcels may be reducing the cumulative effects of harvest on stream temperatures. However, strict BMPs do not appear to be widespread ( Young, 2000). Model applications such as the one presented here may be useful in continuing to address these and similar problems such as the cumulative effects of agricultural development or urbanization.

Acknowledgements This paper grew out of an informal presentation that I gave at the Stream Temperature Monitoring and Assessment workshop sponsored by the Forest Science Project at Humboldt State University, January 1998, in Sacramento, California. I am indebted to Zack Bowen, Blair Hanna, Bob Milhous, Kent Smith, and Paul Zedonis for providing many constructive comments on earlier drafts. Additional comments from Bob Beschta, Sherri Johnson, and three anonymous reviewers significantly improved the final manuscript.

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Stewart Rounds, SMIG coordinator < sarounds@ usgs. gov> U. S. Geological Survey http:// smig. usgs. gov/ SMIG/ features_ 0902/ clearcut. html Last modified Wednesday  Oct 2, 2002 at 10: 19: 50 PDT Privacy Statement · Disclaimer · FOIA · Accessibility http:// smig. usgs. gov/ SMIG/ features_ 0902/ clearcut. html ( 23 of 23) [ 9/ 30/ 2003 10: 11: 50 AM]


[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35659-35662]
[FR Doc No: 2018-16069]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2775]

Food Safety Modernization Act Domestic and Foreign Facility
Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal
Year 2019

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
fiscal year (FY) 2019 fee rates for certain domestic and foreign
facility reinspections, failures to comply with a recall order, and
importer reinspections that are authorized by the Federal Food, Drug,
and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety
Modernization Act (FSMA). These fees are effective on October 1, 2018,
and will remain in effect through September 30, 2019.

FOR FURTHER INFORMATION CONTACT: Jason Lewis, Office of Management,
Office of Regulatory Affairs, Food and Drug Administration, 12420
Parklawn Dr., Rm. 2406, Rockville, MD 20857,

301-796-5957, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 107 of FSMA (Pub. L. 111-353) added section 743 to the FD&C
Act (21 U.S.C. 379j-31) to provide FDA with the authority to assess and
collect fees from, in part: (1) The responsible party for each domestic
facility and the U.S. agent for each foreign facility subject to a
reinspection, to cover reinspection-related costs; (2) the responsible
party for a domestic facility and an importer who does not comply with
a recall order, to cover food \1\ recall activities associated with
such order; and (3) each importer subject to a reinspection to cover
reinspection-related costs (section 743(a)(1)(A), (B), and (D) of the
FD&C Act). Section 743 of the FD&C Act directs FDA to establish fees
for each of these activities based on an estimate of 100 percent of the
costs of each activity for each year (section 743(b)(2)(A)(i), (ii),
and (iv)), and these fees must be made available solely to pay for the
costs of each activity for which the fee was incurred (section
743(b)(3)). These fees are effective on October 1, 2018, and will
remain in effect through September 30, 2019. Section 743(b)(2)(B)(iii)
of the FD&C Act directs FDA to develop a proposed set of guidelines in
consideration of the burden of fee amounts on small businesses. As a
first step in developing these guidelines, FDA invited public comment
on the potential impact of the fees authorized by section 743 of the
FD&C Act on small businesses (76 FR 45818, August 1, 2011). The comment
period for this request ended November 30, 2011. As stated in FDA's
September 2011 ``Guidance for Industry: Implementation of the Fee
Provisions of Section 107 of the FDA Food Safety Modernization Act,''
(http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodDefense/ucm274176.htm),
because FDA recognizes that for small businesses the full cost recovery
of FDA reinspection or recall oversight could impose severe economic
hardship, FDA intends to consider reducing certain fees for those
firms. FDA does not intend to issue invoices for reinspection or recall
order fees until FDA publishes a guidance document outlining the
process through which firms may request a reduction in fees.
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    \1\ The term ``food'' for purposes of this document has the same
meaning as such term in section 201(f) of the FD&C Act (21 U.S.C.
321(f)).
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    In addition, as stated in the September 2011 Guidance, FDA is in
the process of considering various issues associated with the
assessment and collection of importer reinspection fees. The fee rates
set forth in this notice will be used to determine any importer
reinspection fees assessed in FY 2019.

II. Estimating the Average Cost of a Supported Direct FDA Work Hour for
FY 2019

    FDA is required to estimate 100 percent of its costs for each
activity to establish fee rates for FY 2019. In each year, the costs of
salary (or personnel compensation) and benefits for FDA employees
account for between 50 and 60 percent of the funds available to, and
used by, FDA. Almost all of the remaining funds (operating funds)
available to FDA are used to support FDA employees for paying rent,
travel, utility, information technology (IT), and other operating
costs.

A. Estimating the Full Cost per Direct Work Hour in FY 2019

    Full-time equivalent (FTE) reflects the total number of regular
straight-time hours--not including overtime or holiday hours--worked by
employees, divided by the number of compensable hours applicable to
each fiscal year. Annual leave, sick leave, compensatory time off, and
other approved leave categories are considered ``hours worked'' for
purposes of defining FTE employment.
    In general, the starting point for estimating the full cost per
direct work hour is to estimate the cost of an FTE or paid staff year.
Calculating an Agency-wide total cost per FTE requires three primary
cost elements: Payroll, non-payroll, and rent.
    We have used an average of past year cost elements to predict the
FY 2019 cost. The FY 2019 FDA-wide average cost for payroll (salaries
and benefits) is $157,731; non-payroll--including equipment, supplies,
IT, general and administrative overhead--is $91,008; and rent,
including cost allocation analysis and adjustments for other rent and
rent-related costs, is $24,400 per paid staff year, excluding travel
costs.
    Summing the average cost of an FTE for payroll, non-payroll, and
rent, brings the FY 2019 average fully supported cost to $273,139 per
FTE, excluding travel costs. FDA will use this base unit fee in
determining the hourly fee rate for reinspection and recall order fees
for FY 2019 prior to including domestic or foreign travel costs as
applicable for the activity.
    To calculate an hourly rate, FDA must divide the FY 2019 average
fully supported cost of $273,139 per FTE by the average number of
supported direct FDA work hours in FY 2017--the last FY for which data
are available. See table 1.

Table 1--Supported Direct FDA Work Hours in a Paid Staff Year in FY 2017
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Total number of hours in a paid staff year...................      2,080
Less:
10 paid holidays.............................................        -80
20 days of annual leave......................................       -160
10 days of sick leave........................................        -80
12.5 days of training........................................       -100
26.5 days of general administration..........................       -184
26.5 days of travel..........................................       -212
2 hours of meetings per week.................................       -104
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Net Supported Direct FDA Work Hours Available for Assignments      1,160
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    Dividing the average fully supported FTE cost in FY 2019 ($273,139)
by the total number of supported direct work hours available for
assignment in FY 2017 (1,160) results in an average fully supported
cost of $235 (rounded to the nearest dollar), excluding inspection
travel costs, per supported direct work hour in FY 2019.

B. Adjusting FY 2017 Travel Costs for Inflation To Estimate FY 2019
Travel Costs

    To adjust the hourly rate for FY 2019, FDA must estimate the cost
of inflation in each year for FY 2018 and FY 2019. FDA uses the method
prescribed for estimating inflationary costs under the Prescription
Drug User Fee Act (PDUFA) provisions of the FD&C Act (section 736(c)(1)
(21 U.S.C. 379h(c)(1)), the statutory method for inflation adjustment
in the FD&C Act that FDA has used consistently. FDA previously
determined the FY 2018 inflation rate to be 1.6868 percent; this rate
was published in the FY 2018 PDUFA user fee rates notice in the Federal
Register (September 14, 2017, 82 FR 43244). Utilizing the method set
forth in section 736(c)(1) of the FD&C Act, FDA has calculated an
inflation rate of 1.6868 percent for 2018 and 1.7708 percent for 2019,
and FDA intends to use these inflation rates to make inflation
adjustments for FY 2019 for several of its user fee programs; the
derivation of this rate will be published in the Federal Register in
the FY 2019 notice for the PDUFA user fee rates.
    The average fully supported cost per supported direct FDA work
hour, excluding travel costs of $235 already takes into account
inflation as the calculation above is based on FY 2019

predicted costs. FDA will use this base unit fee in determining the
hourly fee rate for reinspection and recall order fees for FY 2019
prior to including domestic or foreign travel costs as applicable for
the activity. In FY 2017, FDA's Office of Regulatory Affairs (ORA)
spent a total of $5,846,091 for domestic regulatory inspection travel
costs and General Services Administration Vehicle costs related to
FDA's Center for Food Safety and Applied Nutrition (CFSAN) and Center
for Veterinary Medicine (CVM) field activities programs. The total ORA
domestic travel costs spent is then divided by the 10,289 CFSAN and CVM
domestic inspections, which averages a total of $568 per inspection.
These inspections average 34.05 hours per inspection. Dividing $568 per
inspection by 34.05 hours per inspection results in a total and an
additional cost of $17 (rounded to the nearest dollar) per hour spent
for domestic inspection travel costs in FY 2017. To adjust for the $17
per hour additional domestic cost inflation increases for FY 2018 and
FY 2019, FDA must multiply the FY 2018 PDUFA inflation rate adjustor
(1.016868) times the FY 2019 PDUFA inflation rate adjustor (1.017708)
times the $17 additional domestic cost, which results in an estimated
cost of $18 (rounded to the nearest dollar) per paid hour in addition
to $235 for a total of $253 per paid hour ($235 plus $18) for each
direct hour of work requiring domestic inspection travel. FDA will use
these rates in charging fees in FY 2019 when domestic travel is
required.
    In FY 2017, ORA spent a total of $2,566,050 on 480 foreign
inspection trips related to FDA's CFSAN and CVM field activities
programs, which averaged a total of $5,346 per foreign inspection trip.
These trips averaged 3 weeks (or 120 paid hours) per trip. Dividing
$5,346 per trip by 120 hours per trip results in a total and an
additional cost of $45 (rounded to the nearest dollar) per paid hour
spent for foreign inspection travel costs in FY 2017. To adjust $45 for
inflationary increases in FY 2018 and FY 2019, FDA must multiply it by
the same inflation factors mentioned previously in this document
(1.016868 and 1.107708), which results in an estimated cost of $47
(rounded to the nearest dollar) per paid hour in addition to $235 for a
total of $282 per paid hour ($235 plus $47) for each direct hour of
work requiring foreign inspection travel. FDA will use these rates in
charging fees in FY 2019 when foreign travel is required.

                 Table 2--FSMA Fee Schedule for FY 2019
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                                                           Fee rates for
                      Fee category                            FY 2019
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Hourly rate if domestic travel is required..............            $253
Hourly rate if foreign travel is required...............             282
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III. Fees for Reinspections of Domestic or Foreign Facilities Under
Section 743(a)(1)(A)

A. What will cause this fee to be assessed?

    The fee will be assessed for a reinspection conducted under section
704 of the FD&C Act (21 U.S.C. 374) to determine whether corrective
actions have been implemented and are effective and compliance has been
achieved to the Secretary of Health and Human Services' (the Secretary)
(and, by delegation, FDA's) satisfaction at a facility that
manufactures, processes, packs, or holds food for consumption
necessitated as a result of a previous inspection (also conducted under
section 704) of this facility, which had a final classification of
Official Action Indicated (OAI) conducted by or on behalf of FDA, when
FDA determined the non-compliance was materially related to food safety
requirements of the FD&C Act. FDA considers such non-compliance to
include non-compliance with a statutory or regulatory requirement under
section 402 of the FD&C Act (21 U.S.C. 342) and section 403(w) of the
FD&C Act (21 U.S.C. 343(w)). However, FDA does not consider non-
compliance that is materially related to a food safety requirement to
include circumstances where the non-compliance is of a technical nature
and not food safety related (e.g., failure to comply with a food
standard or incorrect font size on a food label). Determining when non-
compliance, other than under sections 402 and 403(w) of the FD&C Act,
is materially related to a food safety requirement of the FD&C Act may
depend on the facts of a particular situation. FDA intends to issue
guidance to provide additional information about the circumstances
under which FDA would consider non-compliance to be materially related
to a food safety requirement of the FD&C Act.
    Under section 743(a)(1)(A) of the FD&C Act, FDA is directed to
assess and collect fees from ``the responsible party for each domestic
facility (as defined in section 415(b) (21 U.S.C. 350d(b))) and the
United States agent for each foreign facility subject to a
reinspection'' to cover reinspection-related costs.
    Section 743(a)(2)(A)(i) of the FD&C Act defines the term
``reinspection'' with respect to domestic facilities as ``1 or more
inspections conducted under section 704 subsequent to an inspection
conducted under such provision which identified non-compliance
materially related to a food safety requirement of th[e] Act,
specifically to determine whether compliance has been achieved to the
Secretary's satisfaction.''
    The FD&C Act does not contain a definition of ``reinspection''
specific to foreign facilities. In order to give meaning to the
language in section 743(a)(1)(A) of the FD&C Act to collect fees from
the U.S. agent of a foreign facility subject to a reinspection, the
Agency is using the following definition of ``reinspection'' for
purposes of assessing and collecting fees under section 743(a)(1)(A),
with respect to a foreign facility, ``1 or more inspections conducted
by officers or employees duly designated by the Secretary subsequent to
such an inspection which identified non-compliance materially related
to a food safety requirement of the FD&C Act, specifically to determine
whether compliance has been achieved to the Secretary's (and, by
delegation, FDA's) satisfaction.''
    This definition allows FDA to fulfill the mandate to assess and
collect fees from the U.S. agent of a foreign facility in the event
that an inspection reveals non-compliance materially related to a food
safety requirement of the FD&C Act, causing one or more subsequent
inspections to determine whether compliance has been achieved to the
Secretary's (and, by delegation, FDA's) satisfaction. By requiring the
initial inspection to be conducted by officers or employees duly
designated by the Secretary, the definition ensures that a foreign
facility would be subject to fees only in the event that FDA, or an
entity designated to act on its behalf, has made the requisite
identification at an initial inspection of non-compliance materially
related to a food safety requirement of the FD&C Act. The definition of
``reinspection-related costs'' in section 743(a)(2)(B) of the FD&C Act
relates to both a domestic facility reinspection and a foreign facility
reinspection, as described in section 743(a)(1)(A).

B. Who will be responsible for paying this fee?

    The FD&C Act states that this fee is to be paid by the responsible
party for each domestic facility (as defined in section 415(b) of the
FD&C Act) and by the U.S. agent for each foreign facility (section
743(a)(1)(A) of the FD&C Act). This is

the party to whom FDA will send the invoice for any fees that are
assessed under this section.

C. How much will this fee be?

    The fee is based on the number of direct hours spent on such
reinspections, including time spent conducting the physical
surveillance and/or compliance reinspection at the facility, or
whatever components of such an inspection are deemed necessary, making
preparations and arrangements for the reinspection, traveling to and
from the facility, preparing any reports, analyzing any samples or
examining any labels if required, and performing other activities as
part of the OAI reinspection until the facility is again determined to
be in compliance. The direct hours spent on each such reinspection will
be billed at the appropriate hourly rate shown in table 2 of this
document.

IV. Fees for Non-Compliance With a Recall Order Under Section
743(a)(1)(B)

A. What will cause this fee to be assessed?

    The fee will be assessed for not complying with a recall order
under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C
Act (21 U.S.C. 350a(f)) to cover food recall activities associated with
such order performed by the Secretary (and by delegation, FDA) (section
743(a)(1)(B) of the FD&C Act). Non-compliance may include the
following: (1) Not initiating a recall as ordered by FDA; (2) not
conducting the recall in the manner specified by FDA in the recall
order; or (3) not providing FDA with requested information regarding
the recall, as ordered by FDA.

B. Who will be responsible for paying this fee?

    Section 743(a)(1)(B) of the FD&C Act states that the fee is to be
paid by the responsible party for a domestic facility (as defined in
section 415(b) of the FD&C Act) and an importer who does not comply
with a recall order under section 423 or under section 412(f) of the
FD&C Act. In other words, the party paying the fee would be the party
that received the recall order.

C. How much will this fee be?

    The fee is based on the number of direct hours spent on taking
action in response to the firm's failure to comply with a recall order.
Types of activities could include conducting recall audit checks,
reviewing periodic status reports, analyzing the status reports and the
results of the audit checks, conducting inspections, traveling to and
from locations, and monitoring product disposition. The direct hours
spent on each such recall will be billed at the appropriate hourly rate
shown in table 2 of this document.

V. How must the fees be paid?

    An invoice will be sent to the responsible party for paying the fee
after FDA completes the work on which the invoice is based. Payment
must be made within 90 days of the invoice date in U.S. currency by
check, bank draft, or U.S. postal money order payable to the order of
the Food and Drug Administration. Detailed payment information will be
included with the invoice when it is issued.

VI. What are the consequences of not paying these fees?

    Under section 743(e)(2) of the FD&C Act, any fee that is not paid
within 30 days after it is due shall be treated as a claim of the U.S.
Government subject to provisions of subchapter II of chapter 37 of
title 31, United States Code.

    Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16069 Filed 7-26-18; 8:45 am]
BILLING CODE 4164-01-P