## Proposed Registration of Furfural on Golf Courses (Greens and Tees)

and Sod Farms for the Control of Root Infesting Plant Parasitic Nematodes and Certain Fungal Diseases

May 21, 2010

U.S. Environmental Protection Agency Office of Pesticide Programs Registration Division2 of 23 Proposed Registration of Furfural Use on Golf Courses (Greens and Tees) and Sod Farms for the Control of Parasitic Nematodes and Certain Fungal Diseases

REGULATORY PROPOSAL

The U.S. Environmental Protection Agency, he reon referred to as EPA or the Agency, is proposing to register uses of the active ingredient, furfural, formul ated as a flowable concentrate end-use product (Multiguard® Protect) for soil treatment of golf courses (greens and tees) and sod farms, under the Federal Insecticide, Fungici de, and Rodenticide Act (FIFRA), as amended. Based on the high volatility of furfural in the en vironment after an application, and the potential for high inhalation exposure concerns, the Agency determined it was appropriate to assess and require mitigation measures consistent with the process for soil fumigants. There are no registered food uses for furfural.

I. INTRODUCTION

Furfural is currently registered for use on or namentals in enclosed greenhouses to control root-infesting plant paras itic nematodes and certain fungal diseases, including Phythium, Phytophthora, Fusarium, and Rhizoctonia . It is a colorless, oily liq uid with an almond-like odor.

Furfural’s mode of action is reported to destroy the nemat ode cuticle, causing it to die by dehydration. Furfural has a vapor pressure of 2.6 mm Hg, which is considered to be highly

volatile relative to t ypical pesticides.

Furfural is a naturally-occ urring compound that is ubiquitous in the environment, with greater concentrations found in various agricultural plant matter byproducts, such as corn cobs, oat husks and bran, sawdust, and sugar cane bagasse . Furfural is currently used as a flavoring ingredient, as well as in indus trial applications, including use as a solvent in petrochemical refining, and to produce solid resins such as fi berglass. Furfural is considered Generally Recognized as Safe by the Flavor and Extract Ma nufacturers’ Association, regarding its use as a flavoring agent; dietary intake of natural sources of furfural are sign ificantly higher than exposure sources from use as a flavoring agent.

Given the unique fumigant-like properties (i .e., high volatility potentia l after application), the Agency determined that it is most appropriate to assess and regulate furfural on the basis that

furfural’s behavior in the environm ent is similar to that of the soil fumigants. Therefore, similar mitigation measures are necessary to reduce risk s from acute inhalation exposure to handlers, other workers, and bystanders. The Agency has re quired fumigant labels to instruct users to

establish buffer zones for certain time durations around treated areas to reduce acute inhalation exposures. The buffer zone is a distance around th e perimeter of the treatment area, measured from the edge of the treatment block, where entr y into the treated area and its buffer zone is prohibited for the duration that the buffer zone is in place. A buffer zone is necessary for furfural because its exposure profile is similar to that of soil fumigants. Establishing buffer zones in order to reduce acute exposures are al so protective of potential systemic effects. Therefore, the Agency is proposing the a ddition of labeling language to include the

establishment of buffer zones ar ound the treated areas, and environmental hazard statements to reduce the potential for off-s ite movement of furfural.3 of 23 II. HUMAN HEALTH RISK ASSESSMENT

EPA evaluated the potential human health risk for exposures to furfural-treated golf course turf and sod farms. The following in formation is a summary of the human health exposure and risk assessment for the proposed golf course and sod farm uses of furfural. For additional information, refer to the Agency’s document Furfural. Human Health Risk Assessment for Use on Golf Course Tees (Tees and Greens) and Sod Farms , dated February 18,

2010.

Given the high application rate of furfural and the potential for tr ansport resi dues into drinking water sources, the Agency also c onducted acute and chronic exposure dietary assessment (drinking water only) to determine if dietary exposures would pose any concern. For acute and chronic assessments, risk is expresse d as a percentage of a maximum dose (i.e., the

dose which EPA has concluded will result in unreasonable adverse he alth effects).

The Agency uses the term Margin of Exposure (MOE) to refer to the risk associated with the exposure estimate. The MOE is defined as: the dose, typically the No Observed Adverse Effects Level (NOAEL), divided by the estimated amount of human exposure. For example, an

MOE of 100 means that the estimated level of human exposure is 100 times lower than the highest tested dose that produced no adverse effects in the releva nt toxicology study. The greater the MOE, the lower potential for ri sk to humans from exposures.

Based on the proposed use patterns, inhala tion exposure to furfural is possible for workers who handle and apply furfural, as well as individuals living or working nearby an application site because of the higher volatility potential of furfural. To calculate potential inhalation exposure, the air concentration was estimated using modeling estimates (from the Probabilistic Exposure and Risk model for Fumiga nts (PERFUM)) based on fi eld volatility data. Human-equivalent concentrations (HEC) from the available i nhalation study were calculated using the reference concentration methodologies , which incorporates some pharmacokinetic differences for interspecies extrapolation. These HECs were then used to calculate margins of exposure (MOE).

Dermal exposures were estimated based on a dislodgeable foliar residue study and standard assumptions, and then compared to th e No Observed Adverse Effect Level (NOAEL) from a dermal study. Post-app lication dermal exposure may o ccur for individuals who enter areas in a golf course after furfural has been applied. Occupational post-application dermal exposures can also occur for those who harvest or otherwise handle treated sod.

A. Toxicological End Points

Acute Dietary Exposure : The acute reference dose (aRfD) of 0.01 mg/kg/day is derived from the NOAEL of 10 mg/kg/day base d on clinical signs of toxicity at the maternal LOAEL of 50 mg/kg/day in the rat developmental toxicity study. In this study, dams exhibited clini cal signs one hour post dosi ng and during subsequent dialing examinations. In the 28-day derm al toxicity study conducted on rabbits, there were indications of potential neurotoxicity, but was not considered severe. Without4 of 23 neurotoxicity studies to bette r characterize the neurotoxicit y potential of furfural, the Agency applied an additional 10X database uncertainty factor to account for this uncertainty. A 1,000-fold uncertainty factor was applied to estimating acute dietary risk based on 10X inter-species extrapolat ion, 10X intra-species variability, and an additional 10X safety factor due to the limited oral database.

Chronic Dietary Exposure : The chronic reference dos e (cRfD) of 0.01 mg/kg/day is derived from the 2-year carcinogenicity st udy in the rat, based on liver pathological

observations observed at the LOAEL of 30 mg/kg/day. A 3,000-fold uncertainty factor (10X inter-species extrapolation, 10X intra- species variability, 30X due to the

lack of NOAEL and limited oral database ) was applied.

Short- and Intermediate-Term Dermal Exposure. A rat dermal toxicity study was used to select the dose and endpoint for asse ssing risk due to short- and intermediateterm dermal exposures. For this stud y, the NOAEL of 250 mg/ kg/day is based on adverse clinical signs, an increase in mo tor activity, and increased mortality at the LOAEL of 500 mg/kg/day. The MOE for short- and intermediate-term dermal exposure to furfural is 100 for occ upational exposure ( 10X inter-species extrapolation, 10X intra-sp ecies variability) and 1,000 fo r non-occupational exposure (additional 10X due to the lack of reproduc tion study to evaluate susceptibility in children). Long-term exposure is not e xpected from the proposed use pattern.

Acute, Short-, and Intermediate-term Inhalation Bystander (Nonoccupational) Exposure . To calculate the potential acute inhalation bystander exposure after a furfural application, the Agency estimated an HEC of 0.33 mg/m 3 as the concentration of concern, based on the inci dence of nasal irritation effects in the repeat inhalation toxicity study. To calculate the shor t- and intermediate-term inhalation bystander exposure after a furfur al application, the Ag ency estimated an HEC of 0.24 mg/m 3 . The Agency also applied an uncertainty factor of 30, which is based on 3X for inter-species extrapolation (reduced from 10X because EPA’s RfC methodology incorporates some pharmacokinetic differences between rats and humans), and 10X for intra-spec ies variability). The uncertainty factor is applied to

the HEC to define the air con centration of concern (COC).

Buffer zones were estimated for six mete orological regions for several field sizes ranging from a half-acre to 80 acres to refl ect exposures from applications to golfcourses to the larger sod farm acreages. Because it is possible for a bystander to be near the treated field at anytime, the HEC was adjusted to account for potential exposure that can occur over a 24-hour period. For all inhalation exposure scenarios, the target MOE is 30. Long-term exposure is not expected from the proposed use

pattern.

Acute, Short- and Intermediate-term Inhalation Occupational Exposure . To calculate the potential in halation occupational exposur e for acute, short-, and intermediate-term durations, the Agency estimated an HEC of 0.99 mg/m 3 , based on

the incidence of nasal irritati on effects in the repeat inha lation toxicity study. The5 of 23 HEC was adjusted to account for potential e xposure that could occur during an 8-hour workday duration.

Similar to the bystander assessment, postappl ication inhalation exposure to furfural can occur for workers, e.g., if harvesting sod from a recently-treated area, or nearby a furfural application. Because the results of the bystander assessment are considered protective of occupational postapplicati on inhalation exposure, bystander buffer zones were used to represent occupational buffer zones. For all inhalation exposure scenarios, the target MOE is 30. Long-te rm exposure is not expected from the proposed use pattern.

Cancer . The Agency has not classified the human carcinogenic potential of furfural

at this time. Available information incl udes carcinogenicity st udies conducted by the National Toxicity Program (NTP). Based on the tumor responses in these studies,

NTP characterized the results as clear evidence of carcinogenic activity in male mice,

some evidence in female mice and male rats and no evidence in female rats. The classification of furfural’s human carcinogeni city potential may be considered by the Agency if additional uses result in higher exposure. Therefore, a cancer risk

assessment was not conducted at this time.

B. Dietary Exposure

The current proposed use pattern is for turf a pplications only, and the use of furfural is considered a non-food use. However, because of the high application rate of furfural, and the large amounts of water used during and after a pplication, there is the potential for furfural residues to move into drinking water sources. Th erefore to be health protective, the Agency conducted a dietary assessment (acute a nd chronic exposures) for drinking water.

Furfural residues in drinking water were esti mated to be significant lower than natural background sources, which were estimated to be approximately 0.3 mg/kg/day; the highest furfural concentrations found in cocoa or coffee can be as high as 255 mg/kg. The maximum acute dietary exposure (water onl y) from the proposed use of furfural was estimated to be 0.059 mg/kg/day. In the chronic di etary exposure analysis, the most highly exposed population subgroup is All Infants (<1 year old) which ut ilizes <1% of the cRfD . The general U.S. population utilizes <1% of the cRfD. Therefore, dietary exposure to furfural residues in drinking water does not pose a risk of concern to the Agency.

C. Occupational Exposure

Handler Exposure and Risk. For all handler exposure scenarios, which include mixers, loaders, and applicators, dermal risks are not of concern, provid ed that handlers use baseline personal protective equipment (long -sleeved shirt, long pants, s hoes, and socks) and gloves are worn; dermal MOEs range from 100 to 1,200. Inhala tion risk was identified for applicators that apply furfural to large acreag es (80 acres was assessed) wi th an open cab groundboom and for mixer/loader exposures during groundboom applica tion or chemigation, resulting in MOEs from 22 to 46. However, with the addition of a resp irator (with an organic-vapor-removing cartridge6 of 23 or other respirator with a canis ter approved for pesticides); in halation MOEs range from 220 to

360.

The registrant indicated that applications ma de to sod farms will likely be less than 80 acres per application, given the limitation of the additional irrigation water needed after a furfural treatment. Furthermore, that sod farm s will likely not treat more than 20 acres per day,

which would translate to MOEs of 144 based on the addition of gloves with baseline personal protective equipment (PPE). Therefore, provide d that the directions for use on the proposed label stating that furfural app lications totaling no greater than 18 acres can be made per 24-hour period, then no respirator is neede d. If the registrant chooses to re tain use to include directions for applications using groundboom equipment made to more than 18 acres per day, the applicator must wear an appropriate organic-vapor-removing respirator. With these mitigation reflected on the label, occupational handler exposures do not pose a risk of concern to the Agency.

Applications made to golf course greens and tees, which do not fall under the Worker Protection Standard purview, can also be sour ces of dermal and/or inhalation exposures. However, applications made to turf on golf courses will be significantly smaller treatment areas, where a treated area is no greater than one acr e, presuming a contiguous green and tee. For example, if one acre is treated using an ope n cab groundboom, the result ing inhalation MOE for applicators is 2,880 with out a respirator.

Postapplication Occupational Inhalation Exposure and Risk . The occupational postapplication inhalation assessment yielded results that were almost identical to those for bystanders. Because the results of the bysta nder assessment are considered protective of occupational postapplication inhala tion exposure, bystander buffer z ones were used to represent occupational buffer zones. Refer to Tables 1 and 2 for the specific MOEs and buffer zones for the respective treatment acreages.

Even with the available volatility studies th at reflect an irrigation event after a furfural application, there is stil l a significant amount of flux that can off-gas from the soil surfaces where a person may experience high inhalati on exposures. In the inhalation modeling assessment, the furfural flux values in the fi rst 8-hour averaging pe riod of the PERFUM run captured all of the predicted con centrations that were above th e COC. In other words, the majority of the furfural emissions decreased afte r the first eight hours to below levels that would pose risks of concern. Therefore, to reduce inhalation exposures to bystanders and workers around treated golf course areas, EPA is requiri ng that a buffer zone commensurate to the treatment size be established and in place for a minimum of eight (8) hours. No person under any circumstance is permitted to enter the treatm ent area or the buffer zone before the 8-hour duration has passed.

Postapplication Dermal Exposure and Risk . The results of the occupational postapplication dermal exposure and risk asse ssment for golf course maintenance and sod harvesting indicate that the dermal MOEs range from 7,000 to 14,000, which are greater than the target MOE of 100 on the day of application, and th erefore, are not of co ncern. These MOEs are

based on estimated residues that workers can be exposed to, assuming reentry into the treated area 12 hours after treatment. Although furfur al would trigger a 24-hour REI based on the7 of 23 Toxicity Category II for primary eye irritation study, the DFR study indicates that residues

decline to levels below detectable limits within 8 hours of applic ation. Therefore, to minimize potential dermal exposures and fo r consistency with the standard WPS restricted entry durations, a 12-hour restricted entry interval is appropriate for the sod farm use. For workers that would need to conduct early entry activ ities in the treated area, access is prohibited until after the 8- hour buffer zone duration has elapsed, provi ded that the appropriate PPE is worn.

D. Residential (Bystander) Exposure

Bystander inhalation exposure was assesse d for individuals living or working nearby application sites. Post application dermal exposure was assessed for golfers that may use the golf

course after furfural treatments. When dete rmining the potential fo r dermal exposure, the Agency considers foliar residues, leaf-to-skin residue transfer, a nd the exposure duration to that pesticide. To calculate potential inhalation e xposure, air concentrations were estimated using modeling estimates from PERFUM and HECs cal culated using the reference concentration methodologies were then used to calculate the MOEs.

Bystander exposure to furfural emissions pr imarily depends on the following factors - the

rate of furfural vola tilization, the field condi tions that may impact its volatility, and the dispersion of the emitted furfural relative to the location of the exposed individual. Risk from furfural exposures was estimated based on a concentration of con cern (COC), where the exposure is of concern if the COC is exceeded. The Agency used the PERFUM to evaluate the potential inhalation risks, which incorporates act ual weather data and residue flux distributions. PERFUM establishes a grid of contoured plot lin es representing calculated air concentrations at each receptor location for each day. With thes e estimated emission concentrations at, for example, the 95 th percentile, the Agency can estimate exceedances of the COC based on either: 1) the buffer zone at which there will not be an exceedance for 95% of the days; or 2) based on the whole field distribution, where the 95 th percentile maximum field buffer distance is that distance below which air concentrations will not exceed COCs along the 95 th % of total combined buffer zone perimeters.

Dermal Exposure . Although a specific turf transf erable residue (TTR) study was not submitted, the Agency used the available dislodgeable foliar residues (DFR) study on ornamentals to estimate potential turf residue values, which genera lly results in residues higher than levels seen in a TTR study. Even assuming that individuals can enter treated areas on a golf course as early as 12 hours after a furfural application at the hi ghest use rate, the resulting MOE is 190,000. Therefore, these dermal exposures are not of concern, including both adults and children that may be exposed to furfural re sidues on treated areas in golf courses.

Inhalation Exposure . The target MOE of 30 for bystander inhalation exposure is

achieved at the 75 th percentile based on a 0.5 acre tr eated field, and between the 70 th -75 th
percentile based on a treated 0.5 or 1 acre field, resulting in approximately between a 15 to 30 feet buffer zone, respectively. Tables 1 and 2 are summaries of the MOEs relative to the buffer zone distance (in meters), the buffer zone distance at which percentage there is no exceedance of the COC, and the meteorological region repres enting the potential flux, based on the maximum application rate.8 of 23 Table 1. MOEs at Varied Distances from a 0.5 Acre Treated Field 1

Distance Meteorological Region Percentile 5 m 10 m 20 m

75 18 41 --

90 7 8 11 Ventura 3pm 2

95 6 6 8

50 -- -- --

75 165 -- --

90 5 6 9 Ventura 7am 2

95 `3 3 4

50 -- -- --

75 -- -- --

90 4 4 6 Ventura 7pm 2

95 3 3 3

50 -- -- --

75 28 83 --

90 7 7 9 Bakersfield

95 5 5 7

50 -- -- --

75 17 41 --

90 4 5 7 Bradenton

95 3 4 5

50 -- -- --

75 41 165 --

90 9 10 13 Flint

95 7 7 9

50 -- -- --

75 28 83 --

90 7 7 10

95 5 5 7 Tallahassee

99 3 3 4

50 -- -- --

75 41 165 --

90 6 7 10 Yakima

95 4 4 6

1 Based on 24-hour average whole field air concentrations estimated from the Georgia 3E flux profile, with an application rate of 69.5 lbs ai/A. MOE = bystander HEC (i.e., = 0.33 mg/m 3 ) / air concentration at given distance. The LOC is MOE < 30.

2 GA3E flux subplot study was started at 3:00 pm; additional PERFUM runs, using hypothetical morning and evening start times, were conducted to evaluate the effects of more stable atmospheric conditions (7:00 AM and 7:00 PM) and warmer air temperatures (7:00 PM). -- indicates concentration estimate is zero for this percentile at this distance.

Table 2. MOEs at Varied Distances from an 1 Acre Treated Field 1

Distance Meteorological Region Percentile 5 m 7 m 10 m

Ventura 3pm 2 50 -- -- --9 of 23 Distance

70 41 83 165

75 10 13 18

90 5 6 6

95 5 5 5

50 -- -- --

70 -- -- --

75 41 83 165

90 3 4 4 Ventura 7am 2

95 2 2 2

50 -- -- --

70 -- -- --

75 -- -- --

90 3 3 3 Ventura 7pm 2

95 2 2 2

50 -- -- --

70 165 165 --

75 13 15 21

90 5 5 5 Bakersfield

95 3 4 4

50 -- -- --

70 33 55 165

75 9 11 17

90 3 3 4 Bradenton

95 3 3 3

50 -- -- --

70 83 165 --

75 21 24 41

90 7 7 7 Flint

95 5 5 5

50 -- -- --

70 41 55 165

75 14 18 28

90 5 5 5 Tallahassee

95 3 4 4

50 -- -- --

70 83 165 --

75 18 24 41

90 4 4 5 Yakima

95 3 3 3

1 Based on 24-hour average whole field air concentrations estimated from the Georgia 3E flux profile, with an application rate of 69.5 lbs ai/A. MOE = bystander HEC (i.e., = 0.33 mg/m 3 ) / air concentration at given distance. The LOC is MOE < 30.

2 GA3E flux subplot study was started at 3:00 pm; additional PERFUM runs, using hypothetical morning and evening start times, were conducted to evaluate the effects of more stable atmospheric conditions (7:00 AM and 7:00 PM) and warmer air temperatures (7:00 PM).10 of 23 -- indicates concentration estimate is zero for this percentile at this distance.

Even with the available volatility studies th at reflect an irrigation event after a furfural application, there is stil l a significant amount of flux that can off-gas from the soil surfaces where a person may experience high inhalati on exposures. In the inhalation modeling assessment, the furfural flux values in the fi rst 8-hour averaging pe riod of the PERFUM run captured all of the predicted con centrations that were above th e COC. In other words, the majority of the furfural emissions decreased afte r the first eight hours to below levels that would pose risks of concern. Therefore, to reduce inhalation exposures to bystanders and workers around treated golf course areas, EPA is requiri ng that a buffer zone commensurate to the treatment size be established and in place for a mini mum of eight (8) hours. The buffer zone is a distance around the perimeter of the treatment area, measured from the edge of the treatment block, where entry into the treated area and its bu ffer zone is prohibited for the duration that the buffer zone is in place. With the establishmen t of the buffer zone for the eight hour duration, the Agency believes that this would allow sufficien t time for residues to significantly decline to below COCs, and be protective of any risk from potential inhalation a nd dermal exposures.

E. Aggregate Exposure

Based on the current and proposed furfural applications, there is no common effect observed in the toxicity studies selected to assess oral, dermal and inhalation exposure expected to co-occur that would warrant conducting an ag gregate assessment. Therefore, an aggregate

risk assessment was not conducted.

III. ECOLOGICAL EXPOSURE AND RISK

EPA evaluated the potential ecological fate and risk for exposures to nontarget organisms from furfural-treated golf course turf and s od farms. Although the eco logical risk assessment also reflects applications made to outdoor-grown ornamentals, the registra nt has since requested to delete this proposed us e from the draft label, and thus will not be further considered as part of this registration action. The following informati on is a summary of the ecological exposure and risk assessment for the proposed golf course and sod farm uses of furfural. For additional information, refer to the Agency’s document Furfural. Environmental Fate and Ecological Risk Assessment of Proposed Uses on Turf and Ornamentals , dated April 5, 2010.

A. Environmental Fate

Furfural is a heterocyclic aromatic aldehyde th at is expected to be relatively short-lived (aerobic soil half-life ≤ 1 day), and highly mobile in the environment due to its very high solubility in water and low soil affinity. Biotic processes and volatilization are e xpected to be the major routes of dissipation. Furfural has a relatively high vapor pressure and moderately high Henry’s Law constant, which indicate that there is a high pot ential of volatility; however, furfural’s volatility from a wa ter surface is reduced when diluted with water. With the high potential for solubility in water, furfural is expected to reach surface water through runoff and/or spray drift. The Agency will require new aerobic and anaerobic metabolism studies, since the submitted studies provided limited information to describe the fate of furfural and, more importantly, of its degradates in the environment.11 of 23 Persistence and Transformation . Furfural is stable in hydrolysis, but biodegrades in both, aerobic and anaerobic environments at ob served rates from approximately one hour to <3 days, and via aqueous photolysis (half-life of approxima tely 6.5 days). Furfural is expected to have a low bioaccumulation potential with dissi pation following the various primary routes of degradation in both aerobic and anaerobic envi ronments, and transfor mation. The two major degradates are furfuryl alcohol, which is pres umed to have similar toxicity to furfural per se because they both contain the furan ring, and 2-furo ic acid, which is presumed to have equal to or less toxicity than th at of the parent.

In one of the available furfural aerobi c soil metabolism studies, conducted on a sandy loam soil, 2-furoic acid was the primary degradate detected in the soil extracts, with the highest recovery level at 31.9% of the applied amount at 8 through 24 hours post-treatment, and was last detected at 30.7% two days afte r application. Furfuryl alcohol wa s detected at a maximum level of 14.7% at four hours post-treatment and was not detected at any subsequent sampling interval.

Transport and Mobility . Available batch equilibrium data indicate that furfural residues, namely 2-furoic acid, are moderately mobile to mobile in a study us ing sterilized soils. The pH level of the soil may affect the ionizatio n potential of 2-furoic acid, where more acidic soils (lower pH) would likely produce higher concentrations of 2-furoic acid, with lower mobility; in the ionized form, higher mobility is expected at higher pH s. It appears that 2-furoic acid has the potential to cont aminate groundwater due to its mobility observed in available laboratory and field studies. Another factor th at would impact mobility is the high irrigation levels typically used on establ ished turf and golf courses.

An available laboratory volatility study on furfural indicated that there was rapid

metabolism of furfural in the viable soils that prevents very substantial volatilization, whereas the degree of volatilization was greater in sterile soil. Another volatility study, conducted in the field, measured the rate of vola tilization, or flux, when furfural was applied in California and Georgia soils to bare ground/seeded turf plots, and to establishe d turf plots. All plots were irrigated before and after application. In genera l, the field volatilizati on study indicated that the majority of the flux occurred with in the two hours after application, especially in the established plots over the bare ground plots. The amount of furfural loss from the fields to the air varied widely in California, accounting for approximate ly between 5 and 55.5% of the applied amount in California, and varied to a lesser extent in Georgia accounti ng for 0.9 to 4.4% of the applied

furfural.

Bioaccumulation . Bioaccumulation is not expected fo r furfural and its degrades since the octanol-water partition coefficient is low (K OW <1,000). The K OW values ranged from 1.9 to 4.4. Since the rate of transformation is rapid in the environment, furfural is not expected to biomagnify.

Atmospheric Effects . Given furfural’s physical and ch emical properties and its behavior in the environment, ground-level oz one creation is possible in air sh eds where furfural is used in high volumes. However, given the use pattern and the requirement to irrigate the treated area within 15 minutes after applicati on, the Agency believes that furfural emissions are likely to12 of 23 minimally, or not contribute to any process rela ted to stratospheric oz one depletion or global warming potential.

B. Ecological Risk

The Agency’s ecological risk assessment compares toxicity e ndpoints from ecological toxicity data to estimated environmental con centrations (EEC) based on environmental fate characteristics, soil and water chemistry, and pesticide use data. To evaluate the potential risks to nontarget organisms from the use of furfural, the Agency calculates a Risk Quotient (RQ),

which is the ratio of the EEC to the most sensit ive toxicity endpoint valu es, such as the median lethal dose (LD 50 ) or the median leth al concentration (LC 50 ).

RQ values are compared to the Agency’s levels of concern (LOC), which indicate whether a pesticide, when used as labeled, has th e potential to cause adverse effects on nontarget organisms. When the RQ exceeds the LOC for a particular category, the Agency presumes a potential risk of concern to that category. Table 3 describes the Agency’s LOCs and its respective risk presumptions. Thes e RQ values may be further refi ned by characterization of the risk in the assessment. Use, toxicity, fate a nd exposure are considered when characterizing the risk, as well as the levels of certainty and uncertainty in the assessment.

Table 3. Agency’s LOCs and Risk Presumptions

Agency’s LOCs and Risk Presumptions LOC

Terrestrial Animals LOC Aquatic Animals LOC Plants (Terrestrial, Semi-aquatic, and Aquatic)

Acute Risk ≥ 0.5 ≥ 0.5 ≥ 1

Chronic Risk ≥ 1 ≥ 1 N/A
N/A = not applicable

The calculated RQs represent a screening-leve l assessment. Screening-level assessments are based on conservative assumptions. For ex ample, in screening-level assessments the maximum labeled application ra te, the maximum number of a pplications, and the shortest treatment interval between applications are always used.

Aquatic Animals and Plants

The highest acute RQ for fres hwater fish is 0.12, which is below the acute LOC of 0.5. All other assessed exposures were below the Agency’s LOCs, which include the following scenarios: chronic RQs for freshwater fish; acut e and chronic RQs for freshwater invertebrates; acute RQs for estuarine/marine fish; acute RQs for estuarine/marine invertebrates; and, acute risk to aquatic plants. Currently, there are no data to assess chronic risk for marine/estuarine fish and

invertebrates.

Terrestrial Animals and Plants

Avian Oral (acute and chronic). Based on available acute oral data, acute risks are expected to birds from consumption of treat ed food items in and near treated areas. Additionally, no avian inhalation, avian dietary, or avian reproduction studies are available;13 of 23 therefore, the Agency presumes the potential fo r risk from these routes of exposure in the

absence of data. The acute risk LOC is exceeded for all assessed bird sizes and food items, with the highest acute RQ of 310 for the smallest size bird assessed.

Avian Inhalation Exposure . In addition to the risk to birds from consumption of furfural-contaminated food items, the Agency believes that there is a potential for inhalation exposure and risk due to the volatil ity of furfural in the environment. Acute inhalation data was not available to quantify potential inhalation exposures to birds, and the Agency believes that extrapolation of mammalian da ta to estimate avian exposures would likely underestimate exposures. However, a relative sensitivity ratio can be extrapolated to the inhalation route to estimate avian acute inhalation toxicity using ava ilable mammalian and avian acute oral toxicity

data and the mammalian acute inhalation data. The avian inhalation RQ of 0.28 slightly exceeds the Agency’s acute LOC based on the upper bou nd estimated air concentrations from the PERFUM model for an applic ation to a 100 acre treated fi eld, adjusting the estimated concentrations to correct for the time gap in the air monitoring data, and adjusting for the potential for stagnant meteorological conditions based on application timing.

Mammalian Oral (acute and chronic). Based on available ma mmal acute oral data, acute risks are expected to occur at all modele d size classes of mammals. The Agency assessed chronic exposure risks to mammal s using developmental toxicity data. The acute risk LOC is

exceeded for almost all assessed mammal sizes a nd food items, with the hi ghest acute RQ of 68 for the smallest size mammal assessed. For chronic exposures, RQs were exceeded for all size classes and food items, with the highest RQ of 723 for the smallest mammal size assessed.

Mammalian Inhalation Exposure . In addition to the risk to mammals from consumption of furfural-contaminated food items, there is a potential fo r inhalation exposure and risk due to the volatility of furf ural in the environment. Using available measured data from available field volatility studies to estimate maxi mum air concentrations compared to available

mammalian acute inhalation effect s data, estimated RQs (highest of 0.02) were less than the Agency’s LOC. However, the Agency believes that use of the PERF UM modeling provide an upper-bound estimated air concentration and risks estimates to nontarget animals. Estimated concentrations were corrected for the time gap in the air monitoring data, and adjusting for the potential for stagnant meteorol ogical conditions based on applicat ion timing. Using the EEC at 5 meters from the edge of the treated area of a 100- acre treated field, this re sulted in an estimated RQ of 0.12 for inhalation exposur e to mammals, which is belo w the Agency’s acute species

LOC of 0.5.

Plants (monocot and dicot) . Terrestrial modeling of the turf application using TerrPlant indicates that the RQ of 1.32 slig htly exceeds the acute risk LOC for listed dicots in semi-aquatic

habitats. All other modeled scen arios for monocots and dicots in dry and semi-aquatic areas are below the Agency’s LOC.

Terrestrial Invertebrates . The Agency does not currently calculate terrestrial invertebrate RQs for most assessments. Furf ural is considered practically non-toxic to honeybees based on available data.14 of 23 IV. REGISTRATION DECISION

The registrant, AgriGuard, submitted applica tions proposing the addition of turf and sod farm uses for the end-use product Multiguard ® Protect (EPA Reg. No. 75753-1) on October 11, 2007. The requested application use is for the co ntrol of nematodes and certain soil-born fungal diseases, including Phythium, Phytophthora, Fusarium, and Rhizoctonia , on golf course tees, greens, and practice greens, as well as turf/s od farms. As required by FIFRA, the Agency published a Notice of Receipt for these first us e applications on Oct ober 26, 2009 and received no comments during the public comment period.

A. Human Health Assessment

The human health risk assessment concluded that the databases are adequate for dietary, occupational, and non-occupational (bystander) exposures to support a conditional registration for these proposed uses and application rates for the furfural end-us e product Multiguard ® Protect, provided that the labeling changes listed below are incorporated onto the label, and the receipt of the required studies. Since the applicat ion for the registration of these furfural uses was received by the Agency, EPA also included a dditional guideline requirements for toxicity testing, for which sufficient time has not elapse d to generate data. To confirm the EPA’s assumptions made in the respective risk asse ssments, the following studies are required as conditions of the registration for the proposed fu rfural uses. The list includes summaries of the assumptions made in the absence of data.

Human Health Data Requirements

1. Acute and Subchronic Neurotoxicity Studies . In the available developmental toxicity study conducted on the rat, dams e xhibited clinical sign s one hour post dosing and during subsequent dialing examinations . In the 28-day dermal toxicity study conducted on rabbits, there were indications of potential neurotoxicity, but was not considered severe. Without neurotoxicity stud ies to better character ize the neurotoxicity potential of furfural, the Agency applied an additional 10X database uncertainty factor to account for this uncertainty. To confirm that the adequacy of the uncertainty factor and

to characterize the effects seen in the two studies, EPA is requiri ng these neurotoxicity

studies.

2. Multigeneration Reproduction Study . Part of the revise d CFR Part 158 guidelines includes the submission of a two-genera tion reproduction rat study. There was no quantitative or qualitative suscepti bility seen in either the rat or rabbit developmental oral studies. However, there is no multigenerati on reproductive toxicity study available to evaluate the potential for postnatal toxicity fr om furfural exposure; therefore, the Agency applied an additional 10X database uncertainty factor to account for this uncertainty. To confirm that there is no potential for postnatal toxicity from furfur al exposure, EPA is requiring a multigeneration reproduction study.

3. Immunotoxicity Study . The toxicological database for furfural for the major routes of concern, namely oral and inhalation, is lim ited. However, the most sensitive toxicity15 of 23 endpoints have been identified for the current dietary and inhalation risk assessments. As part of the revised CFR Part 158 data requireme nts, this study is now required to confirm

that there are no immunotoxic ity effects that would be of concern to the Agency.

4. Metabolism Study . Currently, there are no pharm acokinetic or furfural-specific metabolism studies and the metabolic pathwa y has not been determined. However, available open literature studies in humans and animals indica te that furfural is readily absorbed and excreted in the urine. The pr imary degradates, 2-furoic acid and furfuryl alcohol, are expected to be of e qual or less toxicity than that of the parent. As part of the revised CFR Part 158 data requirements and be cause there is no available information to describe the potential impacts from exposure to the metabolites of furfural, this study is now required to confirm that exposure to any furfural metabolites would not cause any effects of concern to the Agency.

4. Acute Inhalation Study . The high potential for the volat ilization of furfural indicates that individuals may be inadvertently expos ed through ambient air. Data for other volatile chemicals, e.g., fumigants, indicate th at acute inhalation e xposures to bystanders and workers typically present the greatest risk concern. In the case of furfural, the risk assessment identifies the potential for inhala tion exposures of concern in the bystander scenarios, i.e., golf course workers and indi viduals who play on gol f courses, or live nearby golf courses. EPA assumes that expos ure can occur at any and all times after application (i.e., 24 hours/7 days). In the tw o available repeat-inh alation studies, both studies identified a port-of-entry effect of nasal irritation, th e most sensitive effect than any systemic endpoints via this exposure ro ute. However, the repeat inhalation study does not provide information that would show the potential for acute effects, e.g., nasal irritation; therefore, in the ab sence of an acute inhalation study, the Agency presumes that nasal irritation could result from a single exposur e. In the absence of an acute inhalation study, the Agency relied on the available subchron ic inhalation toxicity study to calculate

the HEC.

The combination of using this more -conservative endpoint with the highest (acute) exposure typically results in hi gher estimates. The bystander inhalation assessments represent upper-bound estimates wi th the assumption that a treatment area (contiguous tee and green) falling between 0.5 to 1 acre. Additionally, the point of departure used for the bystander inhalati on assessments was based on nasal irritation effects seen in the repeat inhalation toxicity study, whic h is protective of any other potential effects, e.g., systemic effects. Finally, furfural rapidly dissipates in the environment, as seen in available fiel d volatility studies where flux levels are significantly reduced within one hour of application.

Irrigation is essential to manage furfur al emissions from the soil surface. Even with the available volatility studies that re flect an irrigation event after a furfural application, there is still a significant amount of flux that can off-gas from the soil surfaces where a person may experience high in halation exposures. To reduce inhalation exposures to bystanders and wo rkers around treated golf course areas, EPA is requiring

that a buffer zone commensurate to the trea tment size be established and in place for16 of 23 eight hours. The buffer zone is a distance around the perimeter of the treatment area, measured from the edge of the treatment bl ock, where entry into the treated area and its buffer zone is prohibited for the durati on that the buffer zone is in place.

Given the environmental characteristics of furfural, the conservative approach to assess potential bystander inha lation exposures, and applying any uncertainty factors to address any database deficiencies, the Agency believes that there is sufficient information to support a safety finding to proceed registering the propos ed uses, provided that the mitigation measures are adopted (e.g., buffer zones) and proposed labeling changes are incorporated onto the draft labe l. To confirm the Agency’s assumptions used in assessing inhalation exposure, and because inhalation exposure is a primary exposure route of concern, an acute inhalation toxi city study as well as additional field volatility studies are required as part of the c onditions of registration.

5. Confirmatory Turf Transferrable Residue Study . To confirm the Agency’s assumptions made in using the DFR study, a turf transferrabl e residue study is required as one of the conditions for registration of these proposed uses.

Buffer Zones

Buffer zones were estimated using the output s from the PERFUM modeling, based on the various percentiles of th e whole field distributions, and predic ted MOEs for various distances. The buffer zones were determined approximately based on an MOE of 20, which was achieved

around the 75 th percentile. EPA used a weight of evidence approach to set the buffers which

included consideration of the hazar d profile of furfural, the conser vative assumptions made in the risk assessments, the use profile and application of furfural, and comprehensive analysis of results from PERFUM modeling. Agency’s goal for risk management was to achieve buffer distances where associated risks may occur, and developed buffer zone dist ances that are scaled based on the application block size. It should be noted that the distances in the tables below are not model outputs, although as described above the model outputs were used to inform the

selection of buffer zone distances . With these buffers listed in Table 4, the Agency believes that these are representative of potential inhalation exposures and are protective of human health.

Table 4. Buffer Zones for Furfural Use on Golf Courses (Tees and Greens) and Sod Farms
Area Treated (acres) at Maximum Application Rate of 69.5 lbs ai/A Buffer Zone Distance

in Feet

0.5 15

1 30

5 150

10 250

20 360

40 55017 of 23 B. Ecological Fate and Effects Assessment

The ecological fate and effects review conclude d that the database is adequate to conduct a limited screening-level assessment with the available data. Based on the available ecological studies and information on furfural, the Agency determined that the available information are sufficient to support a conditional registration for these proposed uses and application rates for the furfural end-use product Mu ltiguard ® Protect, provided that the labeling changes are incorporated onto the label, and the receipt of the required studies. The following is a summary of the assumptions made in the absence of data , as well as the consideration of the proposed

furfural uses and its known char acteristics in the environment.

Ecological Data Requirements

1. Nontarget Aquatic Organisms. There are some signifi cant uncertainties in the aquatic exposure assessment, given the lim ited information in available aerobic soil metabolism studies, and the amount of furfural that would move below the soil surface after an irrigation event. To account for these data deficiencies, conservative assumptions were made where possible to estimate potential e xposure and risk to nontarget aquatic organisms, which were s lightly exceeded only for acute exposure to freshwater fish and dicots in semi-aquatic environments. The Agen cy believes that this screening-level asse ssment is reflective of upper- bound estimates, where the actual

amount of available furfural that could move to waterbodies and other semi-aquatic areas will likely be lower. In the absence of cer tain toxicity data on aquatic organisms, the Agency assumes that there are potential e xposure risks to nontarget animals, and will require additional environmental hazard stat ements on the label. To reduce the number

of uncertainties identified in the risk assessm ent due to limited or no data, and the risk assumptions made in conducting the assessments, the following studies will be required as part of conditions for regi stration: fish acute toxicity (rainbow trout and fathead minnow), estuarine/marine acute toxicity (s hrimp), aquatic invertebrate life cycle (estuarine/marine), early life-stage fish (e stuarine/marine), and a fish life cycle study (freshwater).

2. Nontarget Terrestrial Animals. There are some uncertainties in the terrestrial oral exposure assessments, given the limited amount of information on remaining furfural residues after an irrigation even t, and environmental factors th at would impact flux rates. To account for these data deficiencies, c onservative assumptions were made where possible by assuming exposure at upper- bound EECs, exposures are based on 100 acretreated fields, and that the bird or mammal is in or adjacent to the treated area

commensurate with the furfur al application rate.

These assumptions likely overestimate e xposure, where models do not consider the actual habitat requirements of any partic ular terrestrial species , but assumed that the animals occupy, exclusively and permanentl y, the treatment area being assessed. The assumptions made in the ecological assessment conservatively addre ssed different routes of exposure that can be affected by varyi ng environmental conditions. Factors include the significance of the additional irrigation after a furfural app lication, the timing of18 of 23 application, and the rapid dissi pation of furfural in the e nvironment, all of which can significantly reduce the amount of residues remaining on the surface of food items. In order to be efficacious, the treated area must be irrigated soon after application (product label says to irrigate the treated area within 15 minutes of application) in order for the

furfural to move into the root zone of the soil and come into contact with the target pests, i.e., nematodes. This movement of furfural into the soil zone reduces the availability of

furfural residues on the surface of food items that could otherwise be available to foraging animals. EPA is proposing to requ ire a terrestrial fiel d dissipation study to measure the washoff from the grass to addre ss this uncertainty. Therefore, the Agency

believes that there is a lower likelihood of significant furfural residues remaining on

treated areas that could advers ely affect nontarget terrestrial animals. To refine the screening-level assessment and confirm the assumptions made in the ecological assessment, the Agency is requiring the follo wing studies: avian acu te inhalation, avian acute oral toxicity (passeri ne/songbird species), avian sub acute dietary toxicity, avian reproduction toxicity study, and a ma mmalian reproduction toxicity study.

C. Required Labeling Changes

Based on the Agency’s findings and proposed mitigation measured needed to be protective of human health and exposures to nonta rget organisms, the following changes must be made to the proposed draft label, as listed belo w. The most recent stamped and approved label (EPA Reg. No. 75753-1), dated December 5, 2007, is accessible online through the Pesticide Product Label System at http://oaspub.epa.gov/pestlabl/ppls.home

.

1. This pesticide is subject to the soil Fumi gant Management Plans, Good Agricultural Practices requirements, and placard/posti ng requirements, as determined by the Agency, to be consistent with the mitigati on measures outlined for the soil fumigants. Refer to the Agency’s webpage on the Implementation of Risk Mitigation Measures for Soil Fumigant Pesticides: http://www.epa.gov/opp00001/reregistration/soil_fumigants/

.

2. For the proposed sod farm use, add labe ling statements that prohibit entry by any person (including workers and bystanders) into the treated area and its buffer zone for a minimum duration of eight (8 ) hours after application for both occupational (subject to the WPS) and nonoccupational uses (e.g., golf courses).

3. For the proposed sod farm use, add labe ling statements for groundboom applications made to areas totaling 18 acres or grea ter in the same 24-hour period, all handlers (including mixers, loaders, and applicators) must wear a respirat or with an organicvapor-removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH approval prefix TC-23C), or a respirator with a canister approved for pesticides (MSHA/NIOSH approval prefix TC-14G).

4. Add labeling statements in the Directions fo r Use sections, as well as in the general use directions throughout the label for each use site: “The fumiga nt-like properties of19 of 23 this pesticide can pose severe risks from inhalation exposure if present in the

treatment area or buffer zone dur ing and after an application.”

5. Add labeling statements to requir e irrigation after application.

6. Add labeling statements to require buffer zones commensurate to the treatment area,

as listed in Table 4 above.

7. Reinstate all labeling statements, incl uding placards, posting, and notificationlanguage from the most recent Agency-stamped and approved label for the currentlyregistered greenhouse ornamental use.

8. The Environmental Hazard statement in the draft label must be amended to read as

follows:

“This pesticide is toxic to birds. Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark. Do not apply when weather conditions favor drift from treated areas. Drift and runoff from treated areas may be hazardous to aquatic organisms in water adjacent to treated areas. Do not contaminate water when dispos ing of equipment washwaters or rinsate.

Furfural has certain properties and char acteristics associated with chemicals detected in groundwater. Furfural residues may leach into ground water if used in areas where soils are permeable, particular ly where the water table is shallow. Furfural may also impact surface water quality due to runoff of rain water. This is especially true for poorly draining soils a nd soils with shallow ground water. This chemical is classified as having high pot ential for reaching surface water via runoff several days after application. Leaching and run off of these chemicals will be reduced by avoiding applications when heavy rainfall is forecasted to occur within 48

hours.”

8. The following language must be added in the Directions for Use section:

“ Air Stagnation and Temperature Inversions

Prior to application, the National Weather Se rvice weather forecast for the day of the application and the 8-hour period followi ng the application must be checked to

determine if unfavorable weather conditions exist or are predic ted (see Identifying Unfavorable Weather Conditions section) and whether applica tion should proceed.

Do not apply if an air stagna tion advisory is in effect.

Do not apply if there are light wind conditions observed (under 2 mph) or if the wind speed is forecast to remain be low 5 mph during the application.

Do not apply if still or stagnant wind condi tions are forecast to persist for more than20 of 23 18 consecutive hours after the start of the application.

Detailed local forecasts for weather conditions, wind speed, and air stagnation advisories may be obtained on-line at: http://www.nws.noaa.gov , on weather radio, or by contacting your local National W eather Service Forecasting Office.

Identifying Unfavorable Weather Conditions

Unfavorable weather conditions block upwar d movement of air, which results in trapping vapors near the ground. The resu lting air mass can move off-site in unpredictable directions. These conditions typi cally exist prior to sunset and continue past sunrise and persist as late as noon time. Unfavorable co nditions are common on nights with limited cloud cover and light to no wind and their presence can be indicated by ground fog or smog and can also be identified by smoke from a ground source that flattens out below a ceiling laye r and moves laterally in a concentrated cloud. Measurement of wind speed can be determined by taking measurements every minute for a ten-minute period. The wind sp eed is the average of the one-minute measurements over this ten-minute period.”

D. Rationale to Not Impose a Restricted Use Pesticide Classification

Currently registered soil fumigants have been classified as Restricted Use Pesticides (RUP) based on their toxicity pr ofiles, which meet specific triggers that warrant this classification. Additionally, the complex nature in typical fumigation applications is such that requires significant training and expertise by certified applicators better ensures that these fumigants are properly and safely applied. The majority of soil fumigants requires specialized application equipment that inject s the fumigant into the soil, or other means of moving the chemical below the soils surface, then followed by a sealing of the soil either by compacting the soil layer, tarping the treated area, or applying sufficient wate r to create a water seal.

While furfural is fumigant-like in many resp ects, unlike typical fumigants, furfural is applied in a dilute aqueous solution. Additiona lly, furfural can be applied using conventional ground sprayer and hand-held spraye r application equipment and methods. On the basis that furfural applications can be made following conventional management practices, the regulatory point of departure is based on the most sensitive endpoint, and the overall lower toxicity profile

of furfural relative to some of the soil fumigants, the Agency believes that it is not appropriate to impose a RUP classification for furfural at this time.

E. Benefits

The registrant, AgriGuard, submitted documentation stating that the proposed furfural uses would meet the criteria in determining that registration of these uses is in the public’s interest. Furfural was originally proposed to be an alternative chemical to methyl bromide, and a potential alternative to certain te lone uses in golf courses. EPA does not believe this is a direct alternative to methyl bromide, the Agency believ es that the proposed uses of furfural meet a unique use niche for which there are few alternatives.21 of 23 Although, furfural does not appear to target the broad spectrum of pests as does methyl bromide and other soil fumigants, furfural would serve as one of two existing pesticides (telone, also known as Curfew®, being the other) register ed for use on establishe d turf to kill plant parasitic nematodes. One of the major benefits of furfural is th e lower phytotoxicity potential in turf applications, reducing or po ssibly eliminating the temporary turf damage from telone, or requiring a complete turf renovation of the affected area. Specific to the golf course use, EPA believes that even with the 8-hour duration that buffer zones must be in place, golf course managers are still afforded the flexibility to ap ply furfural safely while avoiding the need to prohibit access to the golf course beyond operational hours. Furthermore, there are some geological/ geographical restricti ons where telone cannot be app lied, i.e., Karst-type soils. Finally, the proposed furfural applications can be made using standard ground application equipment, versus the specialized equipment requi red for telone applications (i.e., soil injected

and rolled over the surface to create a crust seal to contain the gas).

F. Section 3(c)(7)(B) Finding

Section 3(c)(7)(B) of FIFRA authorizes the Ag ency to issue a conditi onal registration for the proposed additional uses in the absence of certain required data or data that may be insufficient to grant an unconditi onal registration, if the Agency determines the following: 1) the applicant has submitted satisfactory data to suppor t the proposed uses; and, 2) that the proposed uses would not significantly in crease the risk of any unreas onable adverse effect on the

environment.

In reference to the first determination above, the Agency believes that while certain Part 158 data has not been submitted, the applicant ha s submitted satisfactory data to support the proposed uses. For the Part 158 data that has not been submitted, insufficient time has elapsed for the generation of the data since those data requirements were imposed. The Agency proposes to require these data as part of the conditions of registration. Th is determination is based on the fact that the applications for registration were received for approximately three months prior to the effective date (December 2007) of the ne w data requirements. For the other data requirements, the Agency is requiring the submi ssion of these studies to confirm the assumptions and address any database uncertain ty factors applied in the respective risk assessments. Even with these outstanding data requirements, EP A believes that there is sufficient available information to support the conditional registration of these proposed uses, and that the most sensitive endpoints have been identified for human exposure a nd are likely protective of systemic effects.

In reference to the second determination a bove, the Agency does not believe that the use of furfural during the period of conditional registration wi ll significantly increase the risk of any unreasonable adverse human health or ecological e ffects. This determination is based on the finding in the Agency’s conservative human health risk assessment that dietary, occupational, and bystander exposure to furfural would not ex ceed the Agency’s level of risk concern, and thereby, cause unreasonable adverse human health effects. The combination of using this moreconservative endpoint with the hi ghest (acute) exposure typically results in very conservative estimates. The bystander inhalation assessments represent upper-bound estimates, higher than22 of 23 those that could occur in typical scenarios. Additionally, the point of departure used for the bystander inhalation assessments was based on nasal irritation effects seen in the study, which is protective of any other potential effects, e.g., systemic effects. Finally, the implementation of the

buffer zones for at least an 8-hour duration would be sufficient to ensure that the furfural flux rates have dropped to below the COCs, and subsequently, below the Agency’s LOC.

The ecological risk assessment indicated that there is potential for avian and mammalian oral exposure risks from furfural residues on food items. As indica ted above, however, the highly conservative ecological assessment assumes exposure at upper-bound EECs and that the bird or mammal is solely feeding in or adjacent to the treated area. If nontarget animals were to be exposed to furfural via dietary exposure, the actual residues on or in the food items are expected to be significantly lo wer, given the characteristics of furfural biodegradation and volatilization in the environment. Also, as noted above, the very slight exceedances for freshwater fish acute RQs are not of regulator y concern based on the current screening-level

assessment.

G. Agency’s Proposed Decision

The Agency believes that with the revised la beling as described above, 1) the applicant has submitted satisfactory data to support use of furfural on golf course greens, tees, practice greens, and turf/sod farms and, 2) that the proposed uses would not significantly increase the risk of any unreasonable adverse effect on the environm ent. Therefore, the Agency proposes to grant this conditional registration, provi ded that the labeling changes are incorporated onto the label. The Agency proposes that submission of the following data, of a quality acceptable to the Agency and in accordance with a schedule that will be specified in the registration notice, be a condition of registration:

1. Acute and Subchronic Ne urotoxicity Studies.

2. Multigeneration Reproduction Study.

3. Immunotoxicity Study.

4. Metabolism Study.

5. Turf Transferrable Residues Study.

6. Acute Inhalation Study.

7. Avian acute inhalation.

8. Avian acute oral toxicity, conducted on passerine/songbird species.

9. Avian subacute dietary toxicity.

10. Avian reproduction.23 of 23 11. Fish acute toxicity – rain bow trout and fathead minnow.

12. Estuarine/marine acute toxicity – shrimp.

13. Aquatic invertebrate life cycle (estuarine/marine).

14. Early life-stage fish (estuarine/marine).

15. Fish life cycle (freshwater).

16. Mammal reproduction. In lieu of an ecologi cal-specific study, the Agency will accept an acceptable multigeneration reproduction study in order to assess the potential mammalian reproductive effects from exposure to furfural.

17. Terrestrial Field Dissipation Study and Field Volatility Study

18. Aerobic Soil Metabolism Study

19. Anaerobic Soil Metabolism Study

20. Environmental Chemistry Methods and Inde pendent Laboratory Validations for Soil, Water, and Air (parent only) for furfural pa rent and its degradat es, 2-furioc acid, and furfuryl alcohol