[Federal Register: February 12, 2008 (Volume 73, Number 29)]
[Notices]
[Page 8040]
[DOCID:fr12fe08-22]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP08-67-000]

Tennessee Gas Pipeline Company; Notice of Request Under Blanket
Authorization

February 6, 2008.
    Take notice that on February 1, 2008, Tennessee Gas Pipeline
Company (Tennessee), 1001 Louisiana, Houston, Texas 77002, filed in
Docket No. CP08-67-000, a prior notice request pursuant to sections
157.205 and 157.212 of the Federal Energy Regulatory Commission's
regulations under the Natural Gas Act for authorization to construct,
own, and operate an interconnection with Golden Pass Pipeline LLC
(Golden Pass), located in Calcasieu Parish, Louisiana, all as more
fully set forth in the application, which is on file with the
Commission and open to public inspection. The filing may also be viewed
on the Web at http://www.ferc.gov using the ``eLibrary'' link. Enter

the docket number excluding the last three digits in the docket number
field to access the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,

(202) 502-8659.
    Specifically, Tennessee proposes to establish a new interconnection
with Golden Pass on Tennessee's pipeline designated as Line 800-1 at an
existing side valve in Calcasieu Parish, Louisiana. Tennessee proposes
to install a twenty-four inch flanged tee, as well as appurtenances
constructed pursuant to section 2.55(a), including a ball valve, check
valve, electronic gas measurement, chromatograph with sensing elements,
communications for SCADA, and an 8 x 10 building. Tennessee estimates
the cost of the interconnection facilities to be $387,000, for which
Tennessee will be fully reimbursed by Golden Pass. Tennessee states
that the interconnection will allow Golden Pass to deliver and
Tennessee to receive up to 600 MMcf/day.
    Any questions regarding the application should be directed to Jay
V. Allen, Senior Counsel, Tennessee Gas Pipeline Company, 1001
Louisiana, Houston, Texas 77002, call<PHONE_NUMBER> or fax (713) 420-
1601, or Debbie Kalisek, Analyst, Certificates & Regulatory Compliance,
call<PHONE_NUMBER> or fax<PHONE_NUMBER>.
    Any person or the Commission's Staff may, within 60 days after the
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and, pursuant to section 157.205 of
the Commission's Regulations under the Natural Gas Act (NGA) (18 CFR
157.205) a protest to the request. If no protest is filed within the
time allowed therefor, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request shall be treated as
an application for authorization pursuant to section 7 of the NGA.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-2529 Filed 2-11-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 108 (Thursday, June 5, 2014)]
[Notices]
[Page 32566]
[FR Doc No: 2014-13090]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2014-0012; OMB No. 1660-0004]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; Application for Participation in the National
Flood Insurance Program (NFIP)

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use.

DATES: Comments must be submitted on or before July 7, 2014.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Records Management Division, 500 C Street SW., Washington, DC 20472-
3100, facsimile number<PHONE_NUMBER>, or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Collection of Information

    Title: Application for Participation in the National Flood
Insurance Program (NFIP).
    Type of information collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0004.
    Form Titles and Numbers: FEMA Form 086-0-30, Application for
Participation in the National Flood Insurance Program.
    Abstract: The National Flood Insurance Program (NFIP) provides
flood insurance to the communities that apply for participation and
make a commitment to adopt and enforce land use control measures that
are established to reduce risk to people and property in flood-prone
areas. The application form and supporting documentation will enable
FEMA to continue to rapidly process new community applications and to
thereby more quickly provide flood insurance protection to the
residents in these communities.
    This collection has been updated to account for the burden hours
associated with the communities' floodplain development permitting
process. To qualify for the NFIP, a participating community must adopt
certain minimum standards in accordance with FEMA's regulations at 44
CFR 60.3, 60.4, and 60.5. In order to verify whether communities
maintain such standards, the NFIP requires participating communities to
retain documentation on development taking place in the flood hazard
areas within the community. 44 CFR 59.22. Such information will be made
available to FEMA upon request. This information assists FEMA in
evaluating the effectiveness of a community's floodplain management
program and, through that, the community's continuing eligibility to
participate in the program. In the past, the NFIP application did not
account for burden hours associated with this collection of
information.
    The Application for Participation in the NFIP and the Community
Development Permit Process are separate actions documented under the
same collection.
    Affected Public: State, local or Tribal Government.
    Estimated Number of Respondents: 20,344.
    Estimated Total Annual Burden Hours: 221,121 hours.
    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $9,382,164.30. There are no annual costs to respondents
operations and maintenance costs for technical services. There is no
annual start-up or capital costs. The cost to the Federal Government is
$74,788.

    Dated: May 28, 2014.
Charlene D. Myrthil,
Director, Records Management Division, Mission Support Bureau, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2014-13090 Filed 6-4-14; 8:45 am]
BILLING CODE 9110-12-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES February 28, 2002 MEMORANDUM SUBJECT: Asulam. HED Human Health Assessment for the Tolerance Reassessment Eligibility Decision ( TRED). Chemical No. 106901/ 02. No MRID #. DP Barcode No. D276505.

FROM: José J. Morales, Chemist/ Risk Assessor John Liccione, Toxicologist Barry O Keef, Residential Exposure Reregistration Branch 3 Health Effects Division ( 7509C)

THRU: Catherine Eiden, Branch Senior Scientist Reregistration Branch 3 Health Effects Division ( 7509C)

TO: Demson Fuller, Chemical Review Manager Special Review and Reregistration Division ( 7508C)

This memorandum and attachments are the Health Effects Division's Tolerance Reassessment Eligibility Decision Document ( TRED) for asulam, taking into consideration requirements of the 1996 Food Quality Protection Act ( FQPA). This assessment only discusses the human health risk assessment required for reassessment of tolerances and does not include an occupational risk assessment required for reregistration of products. Cumulative risk assessment considering risks from other pesticides which may have a common mechanism of toxicity is also not addressed in this document.

Attachments: Hazard Identification Review Committee ( HIARC) report ( J. Liccione, 12/ 6/ 01) FQPA Committee Report ( C. Christensen, 2/ 5/ 02) Toxicology Chapter ( J. Liccione, 12/ 12/ 01) Chemistry Chapter ( J. Morales, 12/ 6/ 01) Dietary Exposure Analysis ( J. Morales, 12/ 18/ 01) Drinking Water Assessment to Support the TRED for Asulam ( N. Birchfield, 1/ 8/ 02) ASULAM HED s HUMAN HEALTH RISK ASSESSMENT 1.0 Executive Summary The Health Effects Division ( HED) has conducted a human health risk assessment for asulam for the purpose of making a Tolerance Reassessment Eligibility Decision. HED evaluated the toxicology, residue chemistry, and residential databases for asulam and determined that the data are adequate to support a Tolerance Reassessment Eligibility Decision ( TRED).

Use Profile Asulam ( methyl sulfanilylcarbamate) is a selective, postemergent systemic, carbamate herbicide whose chemical structure and biological properties differ considerably from those of carbamate insecticides. It is structurally related to chlorpropham and phenmedipham. It has no registered residential uses. Therefore, potential residential exposures are not anticipated as a result of applications of asulam. Use sites include sugarcane ( the only registered food use), Christmas tree plantings, turf ( for sod only), ornamentals ( junipers & yews only), and non crop land ( e. g., rights of way, fence rows, etc.). Sugarcane represents 95 percent of asulam utilization; therefore, the remaining five percent is utilized on the other use sites.

Hazard Profile The toxicity database for asulam included asulam technical ( 98  100% ai) and the sodium salt of asulam ( 88% ai). The acute toxicity of asulam is low. The acute oral LD50 for asulam in rats exceeded 5000 mg/ kg. The acute inhalation LC50 was greater than 5 mg/ L in rats. The acute dermal LD50 for asulam in rabbits exceeded 4000 mg/ kg. Application of technical asulam to rabbit eyes produced mild chemosis, irritation, and redness which cleared by day seven post treatment. Asulam was not an irritant in a primary skin irritation study in rabbits. It did not cause dermal sensitization in guinea pigs.

Subchronic and chronic toxicity studies demonstrate that the thyroid gland is a target organ for asulam in the rat and dog. Thyroid findings, consisting of hyperplastic changes in thyroid follicular cells in male rats reported in a two year combined chronic/ oncogenicity feeding study were observed at the lowest observed adverse effect level ( LOAEL) of 180 mg/ kg/ day; the no observed adverse effect level ( NOAEL) was 36 mg/ kg/ day. The chronic RfD for asulam is derived from the NOAEL of 36 mg/ kg/ day, based on thyroid follicular hyperplasia at 180 and 953 mg/ kg/ day. An uncertainty factor of 100 was applied to the NOAEL for interspecies extrapolation and intraspecies variability. Thyroid weights were not monitored in the study.

Other toxicological effects included adrenal medullary hyperplastic alterations in male rats, and decreased body weight gains in male and female rats. In a six month dog study, increased thyroid weights ( elevated absolute weights in females at 300 mg/ kg/ day and elevated absolute and relative weights in males and females at 1500 mg/ kg/ day) were reported. Similar findings were noted in a three month gavage study in the dog. Asulam is classified as Group C, possible human carcinogen, based on thyroid and adrenal tumors in the rat study. The Cancer Peer Review Committee determined that a low dose linear extrapolation risk model was not appropriate for asulam ( memorandum dated 2/ 17/ 88). The 12/ 06/ 01 HIARC document, has concluded that the submission and review of a new mouse study did not impact the current classification of asulam as a Group C, possible human carcinogen or the CARC conclusion that a cancer risk assessment is not required.

A two generation reproduction study in the rat study provided evidence for a quantitative increased susceptibility of the rat fetus to asulam exposure relative to adults. Additionally, the HIARC determined that a comparative thyroid rat assay in adults and offspring be conducted. In the rat reproductive toxiciity study, significantly fewer mean live births per litter were observed at 250 mg/ kg/ day and 1250 mg/ kg/ day in the first generation. A dose response relationship was evident. The LOAEL for offspring effects was 250 mg/ kg/ day. No effects on mean live births per litter were observed at 50 mg/ kg/ day, the NOAEL for offspring toxicity. The LOAEL for parental systemic toxicity is 1250 mg/ kg/ day and was based on decreased body weights ( F0 males, F1 females) and organ weight effects ( increased absolute and relative thyroid weights in F1 males and F2 males and females; increased absolute and relative liver weights in F1 females; and increased ovarian weights in F1 females at 31 days old, but not at terminal necropsy). The NOAEL for parental systemic toxicity is 250 mg/ kg/ day.

Asulam has been evaluated for potential developmental effects in the rat and the rabbit. There was no indication of treatment related effects on developmental parameters ( at dose levels up to 750 mg/ kg/ day) in a developmental toxicity study in the rabbit. In the developmental study in the rat, a slight to moderate increase in preimplantation loss was observed at the high dose level ( 1,500 mg/ kg/ day). Decreased maternal body weight gain was noted at 1,500 mg/ kg/ day, but not at 1,000 mg/ kg/ day. In a developmental toxicity study in the rabbit, decreased maternal body weight gain was observed at a LOAEL of 750 mg/ kg/ day; the NOAEL is 300 mg/ kg/ day.

Asulam was tested in several genetic toxicology studies, which included assessments of gene mutation, chromosomal aberrations, and cell transformation. All assays were negative.

FQPA Safety Factor Based upon the developmental studies reviewed, there does not appear to be any quantitative or qualitative evidence of increased susceptibility of rat or rabbit fetuses following in utero exposure to asulam. However, there was evidence of quantitative susceptibility for offspring ( significantly fewer mean live births) in a two generation reproduction study in the rat. Although neurotoxicity studies were not performed, there was no indication of neurotoxicity in the submitted studies or in the published literature. A developmental neurotoxicity study was not required by HIARC, however a comparative thyroid rat assay in adults and offspring is being required. The FQPA Safety Factor Committee ( 12/ 10/ 01) determined that for asulam, the 10 fold safety factor for the protection of infants and children should be retained because:

1) There was evidence of quantitative susceptibility in a two generation reproduction study in the rat; and, 2) HIARC recommended the requirement for a comparative thyroid rat assay in adults and offspring and this is considered a data gap for asulam.

3 Toxic Endpoints Selected for Risk Assessment The HED Hazard Identification Assessment Review Committee ( HIARC) met on 11/ 13/ 01 to select endpoints for human health risk assessments and to reevaluate increased susceptibility of offspring and fetuses to asulam exposures. The quality of the toxicity studies for asulam provided reasonable confidence in the toxicity endpoints and doses selected for risk assessment. All doses for risk assessment purposes were assessed along with the uncertainty factors of 10X for interspecies extrapolation and 10X for intraspecies variability.

No acute dietary toxicity endpoint was identified because no adverse effect attributable to a single dose of asulam was observed. A chronic Reference Dose ( cRfD) of 0.36 mg/ kg/ day was established based on the NOAEL of 36 mg/ kg/ day, and a 100X uncertainty factor for interspecies extrapolation, and intraspecies variability. An additional safety factor of 10X was applied to the cRfD to account for quantitative increased susceptibility in offspring/ fetuses resulting in a chronic Population Adjusted Dose ( cPAD) of 0.036 mg/ kg/ day. A chronic dietary risk assessment was conducted to estimate risks from average exposures to asulam in foods.

Short, intermediate, and long term dermal and inhalation endpoints were selected because there are occupational exposures. Although dermal and inhalation toxicity studies were available, these studies did not include an examination of the thyroid gland, the target organ for asulam. Therefore, oral endpoints were selected for dermal and inhalation endpoints. Because the risk assessments conducted for this document are intended to support a TRED, no occupational exposure and risk assessments were conducted.

No endpoints for short, or intermediate term incidental ingestion were selected. Although dermal and inhalation endpoints were selected, dermal and inhalation risk assessments for residential exposures were not conducted because there are no registered residential uses of asulam. Although asulam is classified as a C carcinogen, it has not been quantified as per the CARC ( memo dated 2/ 17/ 88). Therefore, a quantitative exposure and risk assessment for cancer has not been conducted.

Chronic Dietary Risk Assessment The risk estimates for chronic dietary exposures to asulam analyses reflect a refined exposure assessment. Anticipated residues ( ARs) and percent crop treated information were incorporated in the analysis. ARs were calculated using field trial data. There are no monitoring data ( USDA PDP) available for asulam.

Chronic dietary risk is estimated by using average consumption and residue values. A risk estimate that is less than 100% of the chronic Population Adjusted Dose ( cPAD) does not exceed HED s level of concern. The cPAD ( 0.036 mg/ kg/ day) is the RfD ( 0.36 mg/ kg/ day) divided by the FQPA safety factor ( 10x for asulam).

Chronic dietary risks estimated using a cPAD of 0.036 mg/ kg/ day are below the Agency s level of concern (< 100% cPAD) for all population subgroups. The chronic dietary risk estimate for children 1 6 years ( the highest exposed population subgroup) is 1% of the cPAD. All other population subgroups have chronic dietary risk estimates that are < 1% of the cPAD.

4 Drinking Water Risk Assessment The Environmental Fate and Effects Division ( EFED) provided a drinking water assessment using simulation models to estimate the potential concentration of asulam and its degradates, sulfanilamide and sulfanilic acid, in surface water. Sulfanilamide is a major soil and water degradate of asulam ( Reregsitration Eligibility Decision ( RED) September 1995). EFED used the FIRST reservoir model to calculate estimated environmental concentrations ( EECs) in surface water. A prospective groundwater study was used to estimate the groundwater EEC for residues of asulam and the sulfanilamide degradate. Since no data are available on degradates, FIRST modeling assumed immediate conversion upon application to very persistent and mobile degradates.

With respect to the exposure in surface water, conservative Tier I ( FIRST) modeling indicated that EECs in surface water are not likely to exceed an average concentration of 6.6 ppb for asulam, and an average concentration of 272 ppb for asulam plus the degradates ( sulfanilamide and sulfanilic acid) for use in chronic exposure assessments. Residues of asulam and sulfanilamide in ground water are not likely to exceed a maximum of 154 ppb, and an average of 43 ppb. These EECs represent upper bound concentrations for asulam residues in surface water and groundwater as can be seen by a comparison with monitoring data provided in the synopsis below.

In a separate water monitoring study, asulam was detected in public drinking water sources from ground and surface water. At the request of EPA, Rhone Poulenc conducted a drinking water monitoring study in areas of high asulam use in Florida and Louisiana. The surface water study was designed to sample raw surface water in up to 15 community water systems in Florida and 4 systems in Louisiana. Samples were collected monthly for one year and analyzed for asulam and the metabolite sulfanilamide at a detection limit of 1 ppb. In addition to surface water collection, the study collected samples from potable wells in Florida and Louisiana that were located within 1,000 feet of an asulam treated area.

Seven of the ten surface water community systems sampled contained traces (< 1 ppb) of asulam residues during May through June. Four of the community systems were located in Louisiana and three were in Florida.

A total of 28 drinking water wells were sampled in Florida. Because of poor water quality in this area of Florida, many of the wells reportedly use some type of treatment system prior to use. Three wells contained quantifiable asulam residues up to 1.92 ppb. Ten other wells contained detectable traces (< 1 ppb). Reportedly, the depth of the well and distance to treated area did not have any statistically significant effects on the concentrations observed. No residues were detected in 12 wells sampled in the " sandier" areas of Hendry County. Rhone Poulenc reported that there was less intensive use of asulam in this area. No residues were detected in ground water samples in Louisiana.

Occupational Risk Assessment Because this assessment is a TRED, occupational handler and post application scenarios will not be assessed.

Residential Risk Assessment 5 Potential residential exposures are not anticipated as a result of applications of asulam. All end use product labels contain the following statements:   FOR AGRICULTURAL OR COMMERCIAL USE ONLY  and   NOT FOR USE BY HOMEOWNERS . Use sites include sugarcane, Christmas tree plantings, turf ( for sod only), ornamentals ( junipers & yews only), and non cropland ( e. g. rights of way, fence rows, etc.). Sugarcane represents 95 percent of asulam utilization; so therefore, the remaining five percent is utilized on the other use sites. Based on the registrants total estimate of 235,000 245,000 gallons of asulam sold and used annually in the US, the amount used annual on use sites other than sugarcane is approximately 12,000 gallons. Of these use sites, no residential exposures would be anticipated from the Christmas tree plantings and non cropland sites. The use on turf is restricted to sod farms, and the application to the sod is made four to five months prior to the sod being pulled up and subsequently sold. Therefore, no residential exposures would be anticipated from the turf/ sod use. The registrant stated that use of asulam on ornamentals is very limited, since its cost is high. Use of asulam on ornamentals in a residential setting would not be expected. In summation, residential exposures are considered unlikely.

Aggregate Risk Assessment In examining aggregate exposure, HED takes into account the available and reliable information concerning exposures from pesticide residues in food and other exposures including drinking water and non occupational exposures, e. g., exposure to pesticides used in and around the home ( residential). Risk assessments for aggregate exposure consider both short, intermediate and long term ( chronic) exposure scenarios considering the toxic effects which would likely be associated with each exposure duration. There are no residential uses of asulam. Therefore, the considerations for aggregate exposure are those from food and water. Since modeling was done to estimate concentrations in drinking water, Drinking Water Levels of Comparison ( DWLOCs) were calculated. A DWLOC is a theoretical upper concentration limit for a pesticide in drinking water based on how much of the PAD remains once exposures in food and in the home have been estimated and subtracted. For asulam, only chronic DWLOCs were calculated since an acute endpoint was not selected. HED compares DWLOCs to surface water and groundwater EECs. If the EECs for residues of asulam in surface water and groundwater are less than the DWLOCs for residues of asulam, HED has no concern for aggregate exposures to asulam residues in food and drinking water.

Upon comparison of the chronic DWLOCs ( 1,254 ppb for males; 1,075 ppb for females; 355 ppb for children) with the EECs for residues of asulam in surface and groundwater, all EECs are less than the chronic DWLOCs for all populations. Consequently, HED has no concerns for chronic exposures to combined residues of asulam in food and drinking water, regardless of the drinking water source ( surface water or groundwater).

Table 1. Chronic DWLOCs Compared to Surface Water and Groundwater EECs Population Subgroups DWLOCs ( ppb) Surface Water EEC ( ppb) ( average concentration) Groundwater EEC ( ppb) ( maximum/ average concentration)

Adult males 1254 6.6 ( asulam)/ 272 ( asulam + degradates) 154 ( maximum)/ 43 ( average)

Adult females 1075 6.6 ( asulam)/ 272 ( asulam + degradates) 154 ( maximum)/ 43 ( average)

6 Children ( 1 to 6 years old) 335 6.6 ( asulam)/ 272 ( asulam + degradates) 154 ( maximum)/ 43 ( average)

2.0 Physical/ Chemical Properties Characterization Asulam ( methyl sulfanilylcarbamate) is an herbicide used for weed control on sugarcane. Asulam is formulated into and applied as the asulam sodium salt.

H2 N OH NO S CH3 OO Asulam Empirical Formula:

Molecular Weight:

CAS Registry No.:

Shaughnessy No.: H2 N O Na+ NO S CH3 OO Asulam, sodium salt C8 H10 N2 O4 S ( asulam) C8 H9 N2 NaO4 S ( asulam sodium salt) 230.2 ( asulam) 252.2 ( asulam sodium salt) 3337 71 1 ( asulam) 2302 17 2 ( asulam sodium salt) 106901 ( asulam) 106902 ( asulam sodium salt)

Asulam is a colorless crystalline solid with a melting point of 143 145 EC. Asulam sodium salt is a buff colored powder with a melting point of 212 215 EC. Asulam is soluble at approximately 0.5% in water, and moderately soluble in chlorinated hydrocarbons, petroleum oils, and hydroxylic solvents. Asulam sodium salt is soluble at > 100 g/ 100 mL in water at pHs 5, 6.5, and 9.

3.0 Hazard Characterization 3.1 Hazard Profile Toxicology data are used by HED to assess the potential hazards to humans. The data are derived from a variety of acute, subchronic, and chronic toxicity tests; developmental/ reproductive tests; and tests to assess mutagenicity and pesticide metabolism. The database for asulam is adequate to support this TRED 7 Acute toxicity values and toxicity categories for asulam are summarized in Table 2. The data indicate that asulam has low acute oral ( category IV), dermal ( category III), and inhalation ( category IV) toxicity. Asulam is category III with respect to ocular irritation. It is not a dermal sensitizer. A primary dermal irritation study shows that asulam is category III.

Study Type Table 2. Acute Toxicity of Asulam MRID No.: Result 81 1. Acute Oral Toxicity  rat. Rhone Poulenc Ag Co., Study No.: 51 260, November 7, 1988 409605 01 LD50 > 5000 mg/ kg. Toxicity Category IV Classification: Guideline 81 2. Acute Dermal Toxicity  rabbit. Rhone Poulenc Ag Co., Study No.: 51 260, November 8, 1988 409605 01 LD50 > 4000 mg/ kg. Toxicity Category III Classification: Guideline 81 3. Acute Inhalation Toxicity  rat. Rhone Poulenc Ag Co., Study No.: 51 583, November 7, 1988 409605 02 413616 01 LC50 > 5 mg/ L Toxicity Category IV Classification: Minmum 81 4. Primary Ocular Irritation  rabbit. Rhone Poulenc Ag Co., Study No.: R. Tox. 57, June 1981 00098534 Some chemosis, redness, and irritation were noted, but eyes were clear by day 7. Toxicity Category III Classification: Minimum 81 5. Primary Dermal Irritation  rabbit. Rhone Poulenc Ag Co., Study No.: RES 2853, March 1977 00098535 No dermal irritation was observed. Toxicity Category III Classification: Minimum 81 6. Dermal Sensitization  guinea pig. Rhone Poulenc Ag Co., Study No.: RES 2853, March 1977 00098535 No evidence of sensitization in the Guinea Pig. Classification: Minimum.

No subchronic oral toxicity studies in the rodent per se were identified in the data base for asulam. However, the chronic oral studies in the rodent provided frequent monitoring of clinical signs and interim measurements of body weights, food consumption, hematology, clinical chemistry and urinalysis, and the results provided insight into potential subchronic effects.

In a subchronic oral ( 90 day) study, dogs displayed increased thyroid weights. Although the study was classified as   unacceptable guideline , it was supported by the findings of the 6 month oral dog study. The results of the two studies were similar ( i. e., the LOAEL and NOAEL based on increased thyroid weights).

A one month inhalation toxicity study and 21 day dermal toxicity study were available; however, neither study included assessment of thyroid weights and pathology. The data base for 8 subchronic toxicity is considered complete for oral and dermal studies. A 28 day subchronic inhalation study is required, one that includes examination of thyroid weights and thyroid pathology.

The 21/ 28 day dermal toxicity study in the rat showed that no apparent treatment related systemic effects were observed when body weight, food consumption, clinical pathology, organ weights, ophthalmology, urinalysis, and histopathology were examined. Also, local skin irritation, which was slight and transient, was observed in a small number of treated females.

There are no 90 day inhalation toxicity studies available on asulam. However, a one month inhalation toxicity study ( MRID # 00098537) in the rat was available. This study is limited because of the lack of thyroid weight measurements and pathological examination of the thyroid.

Developmental studies in rats and rabbits, designed to identify possible adverse effects on the developing organism which may result from the in  utero exposure to the pesticide were also conducted. The data base for prenatal developmental toxicity is considered complete. The prenatal developmental toxicity study in the rat showed that there were no treatment related effects on other maternal parameters including mortality, clinical signs, and food consumption. A slight to moderate increase ( not statistically significant) in preimplantation loss was observed in the mid and high dose groups ( compared to controls). The slight increase in postimplantation loss at the high dose ( 1500 mg/ kg/ day) was not statistically significantly different from control values, and was not of any apparent biological significance.

In the prenatal developmental toxicity study in rabbits, the high dose selected was 1,500 mg/ kg/ day. However, severe maternal toxicity ( greater than 20% weight loss, mortality, and signs of starvation) occurred after administration of the 1,500 mg/ kg/ day dose level. All animals in this group died or were sacrificed for humane reasons. A new group was added to the study using a lower dose of 750 mg/ kg/ day. Mean maternal body weight gain was markedly reduced ( 35% but not statistically significant) in the 750 mg/ kg/ day group than in controls during the dosing period. In addition, mean maternal body weight gains were markedly reduced during days 5 9, 5 13, and 5 17. During the postdosing period, mean body weights of rabbits treated with 750 mg/ kg/ day were comparable to those of controls, and rabbits displayed some improvement in body weight gain. Rabbits given 750 mg/ kg/ day exhibited a non statistically significant decrease in food consumption at several intervals during dosing. There were no apparent treatment related effects on mortality or clinical signs.

The data base for reproductive toxicity is considered complete. No additional studies are required at this time. Systemic effects observed at the high dose ( 25,000 ppm) included decreased body weights in F0 males and F1 females, increased absolute and/ or relative thyroid weights in F1 males and F2 males and females, increased absolute and relative liver weights in F1 females, and increased ovarian weights in F1 females ( at age 31 but not at terminal necropsy). The LOAEL for systemic toxicity is 25,000 ppm ( 1250 mg/ kg/ day) based on decreased body weights ( F0 males, F1 females) and organ weight effects ( increased absolute and relative thyroid weights F1 males and F2 males and females, increased absolute and relative liver weights in F1 females, and increased ovarian weights in F1 females at 31 days old but not at terminal necropsy).

9 The data base for chronic toxicity is considered complete. No additional studies are required at this time. In the six month chronic toxicity study in the dog, there was no apparent relationship between test material administration and mortality. Treatment related findings included reductions in body weight gains and food consumption in the high dose males and females; increased frequency of emesis and diarrhea in the high dose males and females; increased absolute thyroid weights in the mid and high dose females and in the high dose males; increased relative ( to body weight) thyroid weights in the high dose males and females; decreased absolute testes and lung weights in the high dose males; decreased relative testes weights in the high dose males; and increased relative kidney weights in the high dose males. No histopathological effects of toxicological significance were observed. There were no apparent effects on prothrombin time, kaolin partial thromboplastin time or platelet counts in males. Platelet counts were slightly decreased in treated females; however, the decreases were not dose related at most intervals and control values appeared to be slightly elevated. Platelet count in the high dose females was significantly lower at the 26 week interval only. Plasma and brain cholinesterase activities were not affected by treatment in either sex.

The carcinogenicity data base for asulam is considered complete. There is one acceptable combined chronic toxicity/ oncogenicity dietary study in the rat, and one acceptable oncogenicity dietary study in the mouse. In a two year combined chronic feeding/ carcinogenicity study in the rat, there was a statistically significant increase in thyroid gland C cell carcinomas in both the low and mid dose males. There was also a statistically significant increase in adrenal medullary pheochromocytomas at the high dose in males. With the exception of a non dose related enlargement of the pituitary gland in female rats, no unusual toxicological findings occurred in the animals sacrificed at 78 weeks.

In the two year carcinogenicity toxicity study in the mouse, increased mortality was observed in the high dose females; however, the number of high dose females was adequate to assess the carcinogenic potential of asulam. There was no treatment related effect on food consumption. Hematologic findings in the high dose males and females consisted of increased leukocyte counts, decreased erythrocyte counts, and decreased hematocrit levels. Organ weight changes included decreased brain weight in the high dose females, and increased spleen weight in the high dose males. There was an increased incidence of brown granular pigment deposits in the livers of males of all treatment groups and high dose females. Increased incidences of brown granular pigment deposits were also noted in the spleens of the high dose rats of both sexes. The brown granular pigment deposit was not identified, and is therefore of uncertain toxicological significance. There was no increase in the incidence of any tumors.

With the exception of the dominant lethal mutation assay in mice, all other mutagenicity assays were found to be acceptable. These studies satistfy the pre 1991 guideline requirements for mutagenicity studies; no further testing is required at this time. The data indicate that there is no mutagenicity/ genetic toxicity concern.

No acute, subchronic, or developmental neurotoxicity studies have been conducted. However, there is no evidence of neurotoxicity in the available acute, subchronic, chronic, and oncogenicity studies. In the March 31, 1998 HIARC meeting, the HIARC concluded:   The data and information provided by the Registrant demonstrate that Asulam, being a carbamate herbicide 10 rather than a carbamate insecticide, has chemical structure and biological properties considerably different from those of the insecticides. Several studies were cited to illustrate the lack of cholinesterase inhibition and the absence of clinical signs suggestive of neurotoxicity. Based on these factors, the Agency waived the requirements for acute, subchronic, and developmental neurotoxicity studies ( memorandum, L. Taylor to C. Peterson, dated January 29, 1992.

The data base for metabolism is considered to be complete. No additional studies are required at this time. The urinary route is the predominant route of elimination in the rat.

Table 3. Toxicology Profile for Asulam Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.3100 90 Day oral toxicity in rodents See combined chronic feeding and carcinogenicity study. See combined chronic feeding and carcinogenicity study.

870.3150 90 Day oral toxicity in nonrodents 00056414 ( 1968)/ Unacceptable/ Guideline/ 0, 5, 50 or 500 mg/ kg/ day. LOAEL = 500 mg/ kg/ day, based on increased absolute and relative thyroid weights in male and female dogs.

NOAEL = 50 g/ kg/ day 870.3200 21 Day dermal toxicity in rabbits 41076901 ( 1989) Acceptable/ Guideline/ 0 or 1000 mg/ kg/ day. NOAEL = 1000 g/ kg/ day 870.3250 90 Day dermal toxicity No study. No study.

870.3465 90 Day inhalation toxicity No study. No study 870.3700a Prenatal developmental in rodents 00098538/( 1981)/ Accept able/ guideline/ 0, 500, 1,000, or 1,500 mg/ kg/ day Maternal l LOAEL = 1,500 mg/ kg/ day based on body weight gain decrement. aternal Maternal NOAEL = 1,000 mg/ kg/ day.

Developmental LOAEL = 1,500 mg/ kg/ day based on slight to moderate increase in preimplantation loss. Developmental NOAEL = 1,000 mg/ kg/ day.

870.3700b Prenatal developmental in rabbits 00098539/ 1981/ Acceptable/ Guideline/ 0, 60, 300, or 750 mg/ kg/ day Maternal LOAEL = 750 mg/ kg/ day based on decreased body weight during the dosing period.

Maternal NOAEL = 300 mg/ kg/ day.

Developmental NOAEL = 750 mg/ kg/ day. m m The m 11 Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.3800 Reproduction and fertility effects 00098540/ 1981/ Acceptable/ 0, 50, 250 or 1250 mg/ kg/ day. Parental/ Systemic LOAEL = 1250 g/ kg/ day ( HDT) based on decreased body weights ( F0 males, F1 females) and organ weight effects ( increased absolute and relative thyroid weights in F1 males and F2 males and females, increased absolute and relative liver weights in F1 females, and increased ovarian weights in F1 females at 31 days old but not at terminal necropsy).

Parental/ Systemic NOAEL = 250 mg/ kg/ day.

Reproductive/ Offspring LOAEL = 250 mg/ kg/ day based on decreased mean live births per litter.

Reproductive/ Offspring NOAEL = 50 mg/ kg/ day.

870.4100a Chronic toxicity rodents See combined chronic feeding and carcinogenicity study. See combined chronic feeding and carcinogenicity study.

870.4100b Chronic toxicity dogs 00098536/ 1979/ Acceptable/ Nonguideline/ 0, 60, 300, or 1,500 mg/ kg/ day. LOAEL = g/ kg/ day, based on significant ( p < 0.05) increases in absolute thyroid weights in females. Absolute and relative thyroid weights were elevated at the high dose ( 1500 mg/ kg/ day) in both males and females. roid weights in the mid and high dose females appeared dose related.

NOAEL = 60 mg/ kg/ day.

870.4200 Combined Chronic Feeding and Carcinogenicity rats 00098543/ 1981/ Acceptabl e Guideline/ 0, 36, 180 and 953 mg/ kg/ day in males and 0, 47, 243 and 1,280 mg/ kg/ day in females. LOAEL = 180 mg/ kg/ day, based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells of males.

NOAEL = 36 mg/ kg/ day. Under the conditions of this study, there was evidence of an increase in tumor incidence in males when compared to controls. Therefore, asulam is a potential oncogen in this study. m 300 m The increased absolute thy 12 Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.4300 Carcinogenicity mice 42338201/ 1982/ Acceptable/ Guideline/ 0, 74, 730 and 8,040 mg/ kg/ day in males and 0, 95, 938 and 10,353 mg/ kg/ day in females LOAEL = 8,040 mg/ kg/ day in males, and 10,353 mg/ kg/ day in females, based on increased spleen weight and decreased body weight gain in males, and decreased brain weight and survival in females.

NOAEL = 730 mg/ kg/ day in males and 938 mg/ kg/ day in females.

Under the conditions of this study, there was no evidence of carcinogenicity of asulam.

870.4300 Carcinogenicity mice 00081183/ 1978/ Unacceptable/ Guideline/ 0, 225, and 750 mg/ kg/ day. LOAEL = 225 mg/ kg/ day, based on enlargement of the spleen in females, decreased absolute and relative thyroid weights in females, intestinal calcification in males and females, and a dose related increase in the incidence of mild skin/ subcutis hyperkeratosis in males.

NOAEL was not achieved.

Under the conditions of this study, there was no definitive evidence of carcinogenicity of asulam.

One Month Inhalation study in the rat 00098537/ 1977/ Accept able Nonguideline/ nose only exposure at concentrations of 0, 1.6, 3.9, or 15.3 mg/ L for 4 hours per day, 5 days per week, for 4 weeks. NOAEL = 15.3 mg/ L ( HDT).

Oral Range Finding in mice 42110002/ 1989/ Accept able Nonguideline/ 0, 512, 1,673, 5,103, and 9,022 mg/ kg/ day for males, and 0, 675, 2,263, 6,835, and 10,828 mg/ kg/ day for females LOAEL = 9,022 mg/ kg/ day based on decreased body weight and body weight gain in males.

NOAEL is 5,103 mg/ kg/ day.

Gene Mutation 870. A table presenting the mutagenicity data base is already included under section 4.7.

870.6200a Acute neurotoxicity screening battery No study. No study 13 Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.6200b Subchronic neurotoxicity screening battery No study. No study.

870.6300 Developmental neurotoxicity Not required.

870.7485 Metabolism and pharmaco kinetics 41345601 ( 1989) Metabolism studies in the rat demonstrate that asulam was rapidly eliminated, primarily in the urine, following administration of a single oral or intravenous dose, or after repeated intravenous doses for 14 days. No unusual localization of asulam occurred in tissues. Unchanged parent compound was identified as the major excretory product, with acetylasulam and acetylsulphanilamide as minor metabolites.

870.7600 Dermal absorpt ion No Study. No Study.

14 Table 4. Mutagenicity/ Genotoxicity Studies for Asulam Study Results Bacterial mutagenicity ( Ames test)  Salmonella typhimurium. Litton Bionetics, Inc., Study No.: E 9177, 1983. MRID No.: 40415302 Not mutagenic with and without metabolic activation at doses up to 2000 Fg/ plate. Classification: Acceptable Guideline Dominant lethal  Mouse  Hess & Clark ( Div. of Rhodia), Study No.: SEH 75, 1975 MRID No.: 00082250 No evidence of induction of dominant lethal effect at dietary concentrations of 1500 or 5000 ppm. Classification: Unacceptable because purity information on the test material was not provided.

In vitro cell transformation assay in C3H/ 10T1/ 2 cells. Mason Research Institute. Study No.: 596 249 8, October 1979. MRID No.: 00098542 No evidence of induction of morphological transformation at dose levels of 256, 512, 1024, or 2048 Fg/ mL for 18 hours exposure. Cytotoxicity was apparent at 2048 Fg/ mL. Classification: Acceptable ( Nonguideline).

In vitro cytogenetics in human lymphocytes. Litton Bionetics, Inc. Study No.: 20990, March 1984. MRID No.: 40415301 Cabinet d Etudes et de Recherches en Tox. Study No.: 658, May 10, 1982. MRID No.: 00144051 No evidence of induction of a clastogenic response at doses of 125 2500 Fg/ mL ( absence of metabolic activation) or 250 2500 Fg/ mL. Classification: Acceptable.

3.2 FQPA Considerations The FQPA Safety Factor Committee evaluated the available hazard and exposure data for asulam on December 10th , 2001 and made the recommendation for the FQPA safety factor to be used in human health risk assessments ( as required by Food Quality Protection Act of August 3, 1996). The committee concluded that the FQPA safety factor be retained ( 10x) in assessing the risk posed by this chemical.

The Committee recommended that the FQPA safety factor be retained ( 10x) for the following reasons:

  There was evidence of quantitative susceptibility in a two generation reproduction study in the rat; and,   HIARC recommended the requirement for a comparative thyroid rat assay in adults and offspring and this is considered a data gap for asulam.

The safety factor is required for all population subgroups when assessing chronic dietary exposure since the evidence for increase susceptibility was seen in the two generation study, and the results from the comparative thyroid study, may provide an endpoint for chronic risk assessment.

15 3.3 Dose Response Assessment On November 13, 2001, the Health Effects Division ( HED) Hazard Identification Assessment Review Committee ( HIARC) reviewed the recommendations of the toxicology reviewer for asulam with regard to the acute and chronic Reference Doses ( RfDs) and the toxicological endpoint selection for use as appropriate in occupational/ residential exposure risks assessments. This is the first re evaluation after a 1995 RED.

Acute RfD: No appropriate toxicological endpoint clearly attributable to a single exposure was identified including the oral developmental toxicity studies in rats and rabbits.

Chronic RfD: NOAEL of 36 mg/ kg/ day based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells observed in male rats at 180 mg/ kg/ day. An uncertainty factor of 100 was applied to this endpoint. This endpoint is of the appropriate route and duration of exposure and applies to the population of concern ( general population, including infants and children).

Classification of Carcinogenic Potential: On November 12, 1987, the Carcinogenicity Peer Review Committee met to discuss and evaluate the weight of the evidence on asulam with particular reference to its carcinogenic potential ( Peer Review of Asulam  memo date 2/ 17/ 88). The Committee concluded that the available data for asulam provided limited evidence for the carcinogenicity of the chemical in rats, and asulam was classified as a Category C Carcinogen. The Committee recommended that the 18 month carcinogenicity mouse study ( MRID 00081183; unacceptable guideline) be repeated and agreed to reevaluate the classification when a new mouse study on asulam was submitted and reviewed.

A new mouse study ( MRID # 423382 01; discussed previously) was submitted by the registrant and reviewed. The committee considered the new mouse study to be acceptable. The dose levels tested in the mouse study were considered to be adequate for carcinogenicity testing. The high dose tested was higher than the limit dose level as specified under Subpart F of the Pesticide Assessment Guideline for carcinogenicity testing in mice. The treatment did not alter the spontaneous tumor profile for this strain of mouse. The Committee concluded that the new mouse study did not impact the current classification of asulam as a   Group C,  possible human carcinogen, not requiring a quantitative risk assessment.

Short Term ( 1 Day  1 Month) Incidental Oral Exposure: Since there are no residential uses, toxic endpoints were not selected.

Intermediate Term ( 1 6 Months) Incidental Oral Exposure: Since there are no residential uses, toxic endpoints were not selected.

Dermal Absorption Factor: 100%. There are no dermal absorption studies with asulam. Comparison of the developmental oral rabbit study to the dermal rabbit study is not appropriate. The dermal rabbit study did not include examination of the thyroid, the target organ.

16 Short Term Dermal ( 1 Day  1 Month) Exposure: For this exposure scenario, the two generation reproduction study in the rat ( MRID# 00098540) is selected for risk assessment because the decreased mean live births per litter occurred during days 0  30, which is the appropriate duration of exposure for this risk assessment. It is also protective of offspring/ reproductive effects, and possibly protective of thyroid effects. A dermal absorption study was not available. A dermal absorption factor of 100% will be used for route to route extrapolation.

Intermediate Term Dermal ( 1 6 Months) Exposure: For this exposure scenario, the two generation reproduction study in the rat ( MRID# 00098540) is selected for risk assessment because the decreased mean live births per litter occurred during days 0  30, which is the appropriate duration of exposure for this risk assessment. It is also protective of offspring/ reproductive effects, and possibly protective of thyroid effects. A dermal absorption study was not available. A dermal absorption factor of 100% will be used for route to route extrapolation.

Long Term Dermal ( Longer than 6 Months) Exposure: A long term dermal toxicity study was not available. In addition, there was no dermal absorption study. The combined chronic toxicity/ carcinogenicity oral study in the rat is of the appropriate duration of exposure. An inhalation absorption factor of 100% will be used for route to route extrapolation.

Short term Inhalation ( 1 Day  1 Month) Exposure: For this exposure scenario, the two generation reproduction study in the rat ( MRID# 00098540) is selected for risk assessment because the decreased mean live births per litter occurred during days 0  30, which is the appropriate duration of exposure for this risk assessment. It is also protective of offspring/ reproductive effects, and possibly protective of thyroid effects. An inhalation absorption study was not available. An inhalation absorption factor of 100% will be used for route to route extrapolation.

Intermediate term Inhalation ( 1 6 Months) Exposure: For this exposure scenario, the two generation reproduction study in the rat ( MRID# 00098540) is selected for risk assessment because the decreased mean live births per litter occurred during days 0  30, which is the appropriate duration of exposure for this risk assessment. It is also protective of offspring/ reproductive effects, and possibly protective of thyroid effects. An inhalation absorption study was not available. An inhalation absorption factor of 100% will be used for route to route extrapolation.

Long term Inhalation ( Longer than 6 Months) Exposure: A long term inhalation toxicity study was not available. In addition, there was no inhalation absorption study. The combined chronic toxicity/ carcinogenicity oral study in the rat is of the appropriate duration of exposure. An inhalation absorption factor of 100% will be used for route to route extrapolation.

Margins of Exposure for Occupational/ Residential Risk Assessments: A margin of exposure ( MOE) of 100 is adequate for dermal/ inhalation occupational exposure risk assessment. The acceptable MOEs for non occupational and dietary exposures will be determined by the FQPA SF Committee.

Recommendation for Aggregate Exposure Risk Assessments: There are no residential uses for asulam. The chronic aggregate risk assessment is therefore limited to food and water.

17 The specific doses and endpoints are summarized as follows:

Table 5. Summary of Toxicity Endpoints and Doses for Risk Assessment EXPOSURE SCENARIO DOSE ( mg/ kg/ day) ENDPOINT STUDY Acute Dietary An appropriate endpoint attributable to a single dose was not identified.

Acute RfD = not established Chronic Dietary NOAEL = 36 mg/ kg/ day UF = 100 FQPA Safety Factor = 10 The LOAEL was 180 mg/ kg/ day based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells of males. Combined Chronic Toxicity/ Oncog enicity in the rat Chronic RfD = 0.36 mg/ kg/ day Chronic PAD = 0.036 mg/ kg/ day Incidental Oral, Short Term A toxicity endpoint was not selected because there are no residential uses.

Incidental Oral, Intermediate Term A toxicity endpoint was not selected because there are no residential uses.

Dermal, Short Term Oral NOAELa = 50 mg/ kg/ day The LOAEL was 250 mg/ kg/ day based on significant decreases in mean live births per litter. Two Generation Reproduction Study in the rat Dermal, Intermediate Term Oral NOAELa = 50 mg/ kg/ day The LOAEL was 250 mg/ kg/ day based on significant decreases in mean live births per litter. Two Generation Reproduction Study in the rat Dermal, Long Term Oral NOAELa = 36 mg/ kg/ day The LOAEL was 180 mg/ kg/ day based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells of males. Combined Chronic Toxicity/ Oncog enicity in the rat Inhalation, Short Term Oral NOAELb = 50 mg/ kg/ day The LOAEL was 250 mg/ kg/ day based on significant decreases in mean live births per litter. Two Generation Reproduction Study in the rat Inhalation, Intermediate Term Oral NOAELb = 50 mg/ kg/ day The LOAEL was 250 mg/ kg/ day based on significant decreases in mean live births per litter. Two Generation Reproduction Study in the rat Inhalation, Long Term Oral NOAELb = 36 mg/ kg/ day The LOAEL was 180 mg/ kg/ day based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells of males. Combined Chronic Toxicity/ Oncog enicity in the rat aApply 100% dermal absorption factor for route to route extrapolation. bAssume 100% inhalation absorption factor for route to route extrapolation.

3.4 Endocrine Disruption 18 EPA is required by FQPA, to develop a screening program to determine whether certain substances ( including all pesticide active and other ingredients) " may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee ( EDSTAC), EPA determined that there was scientific bases for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC s recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program ( EDSP).

When the appropriate screening and/ or testing protocols being considered under the Agency s EDSP have been developed, asulam may be subjected to additional screening and/ or testing to better characterize effects related to endocrine disruption.

4.0 Exposure Assessment and Characterization 4.1 Summary of Registered Uses Asulam ( methyl 4 sulfanilylcarbamate) is a postemergent systemic carbamate herbicide marketed under the trade name ASULOX ® Herbicide by Aventis CropScience. ASULOX ® contains the sodium salt of asulam and is registered for use on sugarcane as a 3.34 lb/ gal soluble concentrate/ liquid ( SC/ L) formulation. This formulation may be applied postemergence as a band or broadcast application using ground or aerial equipment or as a spot treatment. Apart from its food use on sugarcane, asulam is used on christmas tree plantations, ornamentals, turf ( sod farms only) and non cropland uses.

Asulam is primarily used in agriculture with key markets in Florida and Louisiana. Sugarcane is the major use site for asulam ( 95% of the market). The asulam use rate, for sugarcane, ranges from 2.5 to 3.34 lbs a. i./ A and can applied up to two times per year. For all other uses, it can be applied only once. The average rate of 2.5 lbs ai/ acre is the typical labeled use rate for Sugarcane.

Apart from its use on sugarcane, asulam is used on Christmas tree plantations, ornamentals, turf ( Sod Farms Only) and non cropland uses ( boundary fences, fencerows, hedgerows, lumberyards, storage areas and industrial plant sites, and warehouse lots). For Christmas trees and ornamentals, the label use rate is 3.34 lbs a. i./ A and can be applied once per year as a postemergent treatment. For turf, the label use rate is about 2 lbs. a. i./ A and can be applied once per year. For non cropland uses, the label use rate ranges between 2.9 lbs a. i./ A to 3.34 lbs a. i./ A and can be applied once per year.

4.2 Dietary Exposure/ Risk Pathway 19 4.2.1 Residue Profile A tolerance is established for negligible residues of asulam per se in/ on sugarcane at 0.1 ppm [ 40 CFR § 180.360]. HED has recommended that the tolerance expression be revised to include all metabolites containing the sulfanilamide moiety. An adequate enforcement method is available for the determination of combined residues of asulam and all metabolites containing the sulfanilamide moiety in/ on sugarcane.

The qualitative nature of the residue in plants is adequately understood based on sugarcane metabolism studies. The terminal residues of concern are free and conjugated asulam, sulfanilamide, N4  acetylasulam, and N4  acetylsulfanilamide determined as a common moiety.

The qualitative nature of the residue in animals is adequately understood based on acceptable poultry and ruminant metabolism studies. The terminal residues of concern are free and conjugated asulam, sulfanilamide, N4  acetylasulam, and N4  acetylsulfanilamide determined as a common moiety.

4.2.2 Acute Dietary An acute dietary risk assessment was not performed since there was no acute endpoint identified by HIARC.

4.2.3 Chronic Dietary The asulam chronic dietary exposure assessment was conducted using the Dietary Exposure Evaluation Model ( DEEM   ) software Version 7.73, which incorporates consumption data from USDA s Continuing Surveys of Food Intake by Individuals ( CSFII), 1989 1992. The 1989 92 data are based on the reported consumption of more than 10,000 individuals over three consecutive days, and therefore represent more than 30,000 unique   person days  of data. Foods   as consumed  ( e. g., apple pie) are linked to raw agricultural commodities and their food forms ( e. g., apples cooked/ canned or wheat flour) by recipe translation files internal to the DEEM software. Consumption data are averaged for the entire US population and within population subgroups for chronic exposure assessment, but are retained as individual consumption events for acute exposure assessment.

Anticipated residues were calculated using field trial data. No monitoring data exist for asulam. In addition, estimates of percent crop treated (% CT) generated by BEAD were used to refine the assessment. This refined Tier 2/ 3 chronic dietary risk assessment was conducted for all supported ( i. e., currently registered and proposed) asulam food uses.

For chronic exposure and risk assessment, an estimate of the residue level in each food or food form ( e. g., orange or orange juice) on the commodity residue list is multiplied by the average daily consumption estimate for that food/ food form. The resulting residue consumption estimate for each food/ food form is summed with the residue consumption estimates for all other food/ food forms on the commodity residue list to arrive at the total estimated exposure. Exposure estimates 20 are expressed in mg/ kg body weight/ day and as a percent of the cPAD. This procedure is performed for each population subgroup.

HED notes that there is a degree of uncertainty in extrapolating exposures for certain population subgroups from the general U. S. population which may not be sufficiently represented in the consumption surveys, ( e. g., nursing and non nursing infants or Hispanic females). Therefore, risks estimated for these population subgroups were included in representative populations having sufficient numbers of survey respondents ( e. g., all infants or females, 13 50 years).

Exposures > 100% of the cPAD exceed HED s level of concern. That is, estimated exposures above this level are of concern, while estimated exposures at or below this level are not of concern. The DEEM analyses estimate the dietary exposure of the U. S. population and 26 population subgroups. The results reported in Table 6 are for the U. S. Population ( total), all infants (< 1 year old), children 1 6, children 7 12, females 13 50, males 13 19, males 20+, and seniors 55+ years of age. The results for the other population subgroups are not reported in Table 6. This is because the numbers of respondents in the other subgroups were not sufficient, and thus the exposure estimates for these subgroups contained higher levels of uncertainty. However, the respondents in these subgroups were also part of larger subgroups which are listed in Table 6. For example, nursing and non nursing infants are included in all infants. The subgroups which are broken down by region, season, and ethnicity are also not included. This assessment concludes that for all commodities, the chronic risk estimates are below the Agency s level of concern (< 100% cPAD) for the general U. S. population (< 1% of the cPAD) and all population subgroups. The chronic dietary exposure estimate for children 1 6 years [ highest exposed population subgroup] is 1% of the cPAD.

Table 6. Results of Chronic Dietary Exposure Analysis Population Subgroup cPAD ( mg/ kg/ day) Exposure ( mg/ kg/ day) % cPAD U. S. Population ( total) 0.036 0.000157 < 1%

All Infants (< 1 year) 0.036 0.000300 < 1%

Children 1 6 years 0.036 0.000449 1%

Children 7 12 years 0.036 0.000275 < 1%

Females 13 50 years 0.036 0.000107 < 1%

Males 13 19 years 0.036 0.000185 < 1%

Males 20+ years 0.036 0.000105 < 1%

Seniors 55+ years 0.036 0.000087 < 1%

4.2.4 Cancer Dietary A cancer dietary risk assessment is not required for asulam.

4.3 Water Exposure/ Risk Pathway 21 The Environmental Fate and Effects Division ( EFED) provided a drinking water assessment using simulation models to estimate the potential concentration of asulam and its degradates, sulfanilamide and sulfanilic acid, in surface water. Sulfanilamide is a major soil and water degradate of asulam ( Reregsitration Eligibility Decision ( RED) September 1995). EFED used the FIRST reservoir model to calculate estimated environmental concentrations ( EECs) in surface water. A prospective groundwater study was used to estimate the groundwater EEC for residues of asulam and the sulfanilamide degradate. Since no data are available on degradates, FIRST modeling assumed immediate conversion upon application to very persistent and mobile degradates.

With respect to the exposure in surface water, conservative Tier I ( FIRST) modeling indicated that EECs in surface water are not likely to exceed an average concentration of 6.6 ppb for asulam, and an average concentration of 272 ppb for asulam plus the degradates ( sulfanilamide and sulfanilic acid) for use in chronic exposure assessments. Residues of asulam and sulfanilamide in ground water are not likely to exceed a maximum of 154 ppb, and an average of 43 ppb. These EECs represent upper bound concentrations for asulam residues in surface water and groundwater as can be seen by a comparison with monitoring data provided in the synopsis below.

In a separate water monitoring study, asulam was detected in public drinking water sources from ground and surface water. At the request of EPA, Rhone Poulenc conducted a drinking water monitoring study in areas of high asulam use in Florida and Louisiana. The surface water study was designed to sample raw surface water in up to 15 community water systems in Florida and 4 systems in Louisiana. Samples were collected monthly for one year and analyzed for asulam and the metabolite sulfanilamide at a detection limit of 1 ppb. In addition to surface water collection, the study collected samples from potable wells in Florida and Louisiana that were located within 1,000 feet of an asulam treated area.

Seven of the ten surface water community systems sampled contained traces (< 1 ppb) of asulam residues during May through June. Four of the community systems were located in Louisiana and three were in Florida.

A total of 28 drinking water wells were sampled in Florida. Because of poor water quality in this area of Florida, many of the wells reportedly use some type of treatment system prior to use. Three wells contained quantifiable asulam residues up to 1.92 ppb. Ten other wells contained detectable traces (< 1 ppb). Reportedly, the depth of the well and distance to treated area did not have any statistically significant effects on the concentrations observed. No residues were detected in 12 wells sampled in the " sandier" areas of Hendry County. Rhone Poulenc reported that there was less intensive use of asulam in this area. No residues were detected in ground water samples in Louisiana.

4.4 Residential and Occupational Exposure/ Risk Pathway Because this assessment is for a TRED, occupational handler and post application scenarios will not be assessed.

22 Potential residential exposures are not anticipated as a result of applications of asulam. All end use product labels contain the following statements:   FOR AGRICULTURAL OR COMMERCIAL USE ONLY  and   NOT FOR USE BY HOMEOWNERS . Use sites include sugarcane, Christmas tree plantings, turf ( for sod only), ornamentals ( junipers & yews only), and non cropland ( e. g. rights of way, fence rows, etc.). Sugarcane represents 95 percent of asulam utilization; so therefore, the remaining five percent is utilized on the other use sites. Based on the registrants total estimate of 235 245,000 gallons of asulam sold and used annually in the US, the amount used annual on use sites other than sugarcane is approximately 12,000 gallons. Of these use sites, no residential exposures would be anticipated from the Christmas tree plantings and non cropland sites. The use on turf is restricted to sod farms, and the application to the sod is made four to five months prior to the sod being pulled up and subsequently sold. Therefore, no residential exposures would be anticipated from the turf/ sod use. The registrant stated that use of asulam on ornamentals is very limited, since its cost is high. Use of asulam on ornamentals in a residential setting would not be expected. In summation, residential exposures are considered unlikely.

Spray drift is always a potential source of exposure to the public or near spraying operations. This is particularly the case with aerial application, but, to a lesser extent, could also be a potential source of exposure from groundboom application methods. The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and State Lead Agencies for pesticide regulation and other parties to develop the best spray drift management practices. The Agency is now requiring interim mitigation measures for aerial applications that must be placed on product labels/ labeling. The Agency has completed its evaluation of the new data base submitted by the Spray Drift Task Force, a membership of U. S. pesticide registrants, and is developing a policy on how to appropriately apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard airblast and ground hydraulic methods. After the policy is in place, the Agency may impose further refinements in spray drift management practices to reduce off target and risks associated with aerial as well as other application types where appropriate.

5.0 Aggregate Risk Assessments and Risk Characterizations Because an acute toxicity endpoint was not identified by HIARC, an acute aggregate risk assessment is not required.

In examining aggregate exposure, HED takes into account the available and reliable information concerning exposures from pesticide residues in food and other exposures including drinking water and non occupational exposures, e. g., exposure to pesticides used in and around the home ( residential). Risk assessments for aggregate exposure consider both short, intermediate and long term ( chronic) exposure scenarios considering the toxic effects which would likely be associated with each exposure duration. There are no residential uses of asulam. Therefore, the considerations for aggregate exposure are those from food and water. Since conservative modeling was done to estimate concentrations in drinking water, Drinking Water Levels of Comparison ( DWLOCs) were calculated. A DWLOC is a theoretical upper concentration limit for a pesticide in drinking water based on how much of the PAD remains once exposures in food and in the home have been estimated and subtracted. For asulam, only chronic DWLOCs were calculated since an acute endpoint was not selected. HED compares DWLOCs to surface water and groundwater EECs.

23 If the EECs for residues of asulam in surface water and groundwater are less than the DWLOCs for residues of asulam, HED has no concern for aggregate exposures to asulam residues in food and drinking water.

Upon comparison of the chronic DWLOCs ( 1,254 ppb for males; 1,075 ppb for females; 355 ppb for children) with the EECs for residues of asulam in surface and groundwater, all EECs are less than the chronic DWLOCs for all populations. Consequently, HED has no concerns for chronic exposures to combined residues of asulam in food and drinking water, regardless of the drinking water source ( surface water or groundwater).

Table 7. Chronic DWLOCs Compared to Surface Water and Groundwater EECs Population Subgroups DWLOCs ( ppb) Surface Water EEC ( ppb) ( average concentration) Groundwater EEC ( ppb) ( maximum/ average concentration)

Adult males 1254 6.6 ( asulam)/ 272 ( asulam + degradates) 154 ( maximum)/ 43 ( average)

Adult females 1075 6.6 ( asulam)/ 272 ( asulam + degradates) 154 ( maximum)/ 43 ( average)

Children ( 1 to 6 years old) 335 6.6 ( asulam)/ 272 ( asulam + degradates) 154 ( maximum)/ 43 ( average)

6.0 Cumulative The Food Quality Protection Act ( 1996) stipulates that when determining the safety of a pesticide chemical, EPA shall base its assessment of the risk posed by the chemical on, among other things, available information concerning the cumulative effects to human health that may result from dietary, residential, or other non occupational exposure to other substances that have a common mechanism of toxicity. The reason for consideration of other substances is due to the possibility that low level exposures to multiple chemical substances that cause a common toxic effect by a common mechanism could lead to the same adverse health effect as would a higher level of exposure to any of the other substances individually. A person exposed to a pesticide at a level that is considered safe may in fact experience harm if that person is also exposed to other substances that cause a common toxic effect by a mechanism common with that of the subject pesticide, even if the individual exposure levels to the other substances are also considered safe.

Although asulam had been included in the list of potential carbamates for cumulative risk assessment of carbamates as a group, it will not be included in the carbamate cumulative assessment. The available data indicate that asulam is a carbamate herbicide that has chemical structure and biological properties that are considerably different from those of the carbamate insecticides. For instance, several studies on asulam ( e. g., chronic oral dog, combined chronic toxicity/ oncogenicity dietary rat) demonstrate the lack of cholinesterase inhibition and absence of clinical signs suggestive 24 of neurotoxicity. Acute studies reveal a low toxicity for asulam ( e. g., no deaths and clinical signs of nonspecific origin). There are no specific mechanism of toxicity studies on asulam.

Before undertaking any cumulative risk assessment, HED will follow procedures for identifying chemicals that have a common mechanism of toxicity as set forth in the   Guidance for Identifying Pesticide Chemicals and Other Substances that Have a Common Mechanism of Toxicity  ( 64 FR 5795 5796, February 5, 1999).

25 7.0 Tolerance Reassessment Recommendations 7.1 Tolerance Reassessment Recommendation Table 8 summarizes the tolerance reassessment for asulam.

Commodity Table 8. Tolerance Reassessment Summary Current Tolerance ( ppm) Tolerance Reassessment ( ppm) Comment Tolerance listed under 40 CFR § 180.360 Sugarcane, cane 0.1 1.0 Tolerances to be Established Under 40 CFR § 180.360 Sugarcane, molasses   30 Milk   0.05 Cattle, meat Cattle, fat Goat, meat Goat, fat Hog, meat Hog, fat Horse, meat Horse, fat Sheep, meat Sheep, fat   0.05 Cattle, meat byproducts Goat, meat byproducts Hog, meat byproducts Horse, meat byproducts Sheep, meat byproducts   0.2 8.0 Data Needs/ Label Requirements 8.1Toxicology   Comparative thyroid rat assay in adult and offspring.   21 day Dermal Study in Rats with examination of thyroid weight and pathology.   28 day Inhalation Study in Rats with examination of thyroid weight and pathology.

8.2 Product and Residue Chemistry 26   Because hydroquinone/ quinone remains a chemical of toxicological concern, if the registrant proposes new uses for this chemical, new plant metabolism studies m ust be performed ( relevant to the proposed new uses), aimed specifically at determining the presence and concentration of radiolabeled hydroquinone/ quinone. The registrant should also determine the naturally occurring background levels of hydroquinone/ quinone and arbutin in sugarcane. The Metabolism Committee will reconsider its position if new metabolism studies show that quinone/ hydroquinone/ arbutin comprises a significant portion of the radiolabeled residue.

  HED has recommended that the registrant request label amendments specifying a maximum of two asulam applications per year to sugarcane at a maximum single application rate of 3.34 lbs. a. i./ A, a PHI of 100 days for Louisiana, a PHI of 140 days for the remainder of the US mainland, and a PHI of 400 days for Hawaii. If the regsitrant requests the recommended label changes, no further sugarcane field trial data are required for asulam at this time. If the registrant does not propose the recommended label changes, existing labels must be supported by new field trials.

  The following product chemistry data guidelines remain unfulfilled for the technical asulam sodium salt: GLN 830.6317 ( Storage Stability) and 830.6320 ( Corrosion Characteristics).

  Tolerance Reassessment 1. The existing tolerance of 0.1 ppm for asulam residues on sugar cane established in 40 CFR § 180.360 has been reassessed. HED recommends the tolerance be raised to 1.0 ppm;

2. HED recommends a tolerance of 30 ppm for asulam residues in molasses from sugar cane be established in 40 CFR § 180.360;

3. HED recommends a tolerance of 0.05 ppm for asulam residues in milk, and meat and fat from cattle, goats, hogs, horses, and sheep be established in 40 CFR § 180.360;

4. HED recommends a tolerance of 0.2 ppm for asulam residues in meat byproducts from cattle, goats, hogs, horses, and sheep be established in 40 CFR § 180.360;

5. Because there are no poultry feed items associated with asulam's use, tolerances on poultry tissues and eggs are not warranted.

27


[Federal Register Volume 78, Number 220 (Thursday, November 14, 2013)]
[Notices]
[Pages 68501-68502]
[FR Doc No: 2013-27235]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

International Standards on the Transport of Dangerous Goods

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. PHMSA-2013-0237, Notice No. 13-17]

Preparations for the 44th Session of the United Nations Sub-
Committee of Experts on the Transport of Dangerous Goods (UNSCOE
TDG) and the 26th Session of the UN Sub-Committee of Experts on the
Globally Harmonized System of Classification and Labelling of
Chemicals (UNSCEGHS)

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
Department of Transportation and the Occupational Safety and Health
Administration (OSHA), Department of Labor.

ACTION: Notice of public meeting.

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SUMMARY: This notice is to advise interested persons that PHMSA and
OSHA will conduct a joint public meeting in preparation for United
Nations meetings being held in Geneva, Switzerland. PHMSA is hosting
the morning portion of the meeting to discuss proposals in preparation
for the 44th session of the United Nations Sub-Committee of Experts on
the Transport of Dangerous Goods (UNSCOE TDG) to be held November 25 to
December 4, 2013, in Geneva. During this meeting, PHMSA is also
soliciting comments relative to potential new work items which may be
considered for inclusion in its international agenda. OSHA is hosting
the afternoon portion of the meeting to discuss proposals in
preparation for the 26th session of the United Nations Sub-Committee of
Experts on the Globally Harmonized System of Classification and
Labelling of Chemicals (UNSCEGHS) to be held December 4 to 6, 2013, in
Geneva. OSHA, along with the U.S. Interagency GHS (Globally Harmonized
System of Classification and Labelling of

Chemicals) Coordinating Group, plans to consider the comments and
information gathered at this public meeting when developing the U.S.
Government positions for the UNSCEGHS meeting.

DATES: The meeting will be held on Tuesday, November 19, 2013. The
PHMSA Session will be from 9:00 a.m. to 12:00 noon; while the OSHA
Session will be from 1:30 p.m. to 4:30 p.m.

ADDRESSES: The meeting will be held at the DOT Headquarters, West
Building, Conference Room 7, 1200 New Jersey Avenue SE., Washington, DC
20590.
    Registration: It is requested that attendees pre-register for this
meeting by completing the form at http://www.phmsa.dot.gov/hazmat/regs/international. Attendees may pre-register for the morning PHMSA
session, the afternoon OSHA session, or both sessions of the meeting.
Failure to pre-register may delay your access to the building.
Participants attending in person are encouraged to arrive early to
allow time for security checks necessary to obtain access to the
building.
    Conference call-in and ``live meeting'' capability will be provided
for this meeting. Specific information on call-in and live meeting
access will be posted when available at http://www.phmsa.dot.gov/hazmat/regs/international and at http://www.osha.gov/dsg/hazcom/.

FOR FURTHER INFORMATION CONTACT: Vincent Babich or Kevin Leary, Office
of Hazardous Materials Safety, International Standards, Department of
Transportation, Washington, DC 20590; telephone<PHONE_NUMBER>. You may
also contact Maureen Ruskin, Office of Chemical Hazards-Metals, OSHA
Directorate of Standards and Guidance, OSHA, U.S. Department of Labor,
Room N-3178, 200 Constitution Avenue NW., Washington, DC 20210;
telephone:<PHONE_NUMBER>.
    Copies of this Federal Register notice can be obtained as follows:
Electronic copies are available at http://www.regulations.gov. This
Federal Register notice, as well as other relevant information, is
available also on the OSHA Web page at http://www.osha.gov.

SUPPLEMENTARY INFORMATION:

I. PHMSA Public Meeting (November 19, 2013; 9:00 a.m.-12:00 Noon)

    The primary purpose of this meeting will be to prepare for the 44th
session of the UNSCOE TDG. The 44th session of the UNSCOE TDG is the
second of four meetings scheduled for the 2013-2014 biennium. The
UNSCOE will consider proposals for the 19th Revised Edition of the
United Nations Recommendations on the Transport of Dangerous Goods
Model Regulations which will be implemented within relevant domestic,
regional, and international regulations from January 1, 2017. Copies of
working documents, informal documents, and the meeting agenda may be
obtained from the United Nations Transport Division's Web site at
http://www.unece.org/trans/main/dgdb/dgsubc3/c3age.html.
    General topics on the agenda for the UNSCOE TDG meeting include:

 Listing, classification and packing
 Electric storage systems
 Transport of gases
 Miscellaneous proposals of amendments to the Model Regulations
 Electronic data interchange for documentation purposes
 Cooperation with the International Atomic Energy Agency (IAEA)
 Global harmonization of transport of dangerous goods
regulations
 Globally Harmonized System of Classification and Labeling of
Chemicals (GHS)

Following the 44th session of the UNSCOE TDG, a copy of the Sub-
Committee's report will be available at the United Nations Transport
Division's Web site at http://www.unece.org/trans/main/dgdb/dgsubc3/c3rep.html. PHMSA's site at http://www.phmsa.dot.gov/hazmat/regs/international provides additional information regarding the UNSCOE TDG
and related matters.

II. OSHA Public Meeting (November 19, 2013; 1:30 p.m.-4:30 p.m.)

    OSHA is hosting an open informal public meeting of the U.S.
Interagency GHS Coordinating Group to provide interested groups and
individuals with an update on GHS-related issues and an opportunity to
express their views orally and in writing for consideration in
developing U.S. Government positions for the upcoming UNSCEGHS meeting.
Interested stakeholders may also provide input on issues related to
OSHA's activities in the U.S.-Canada Regulatory Cooperation Council
(RCC) at the meeting. The public is invited to attend and is requested
to pre-register for the meeting by following the instructions provided
in the Registration section of this notice. General topics on the
agenda include:

 Review of Working papers
 Working Group updates
 Regulatory Cooperation Council (RCC) Update

Information on the work of the UNSCEGHS including meeting agendas,
reports, and documents from previous sessions, can be found on the
United Nations Economic Commission for Europe (UNECE) Transport
Division Web site located at the following web address: http://www.unece.org/trans/welcome.html. The UNSCEGHS bases its decisions on
Working Papers. The Working Papers for the 26th session of the UNSCEGHS
are located at http://www.unece.org/trans/main/dgdb/dgsubc4/c42013.html.
    Informal Papers submitted to the UNSCEGHS provide information for
the subcommittee and are used either as a mechanism to provide
information to the subcommittee or as the basis for future Working
Papers. Informal Papers for the 26th session of the UNSCEGHS are
located at http://www.unece.org/trans/main/dgdb/dgsubc4/c4inf26.html.

III. Authority and Signature

    Magdy El-Sibaie, Associate Administrator for Hazardous Materials
Safety directed the preparation of this notice.

    Signed at Washington, DC, on November 7, 2013.
Magdy El-Sibaie,
Associate Administrator for Hazardous Materials Safety.

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, authorized the preparation of this
notice under the authority granted by the Secretary of Labor's Order
No. 1-2012 (77 FR 3912, Jan. 25, 2012).

    Signed at Washington, DC, on October 29, 2013.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2013-27235 Filed 11-13-13; 8:45 am]
BILLING CODE 4910-60- 4510-26-P


[Federal Register Volume 77, Number 10 (Tuesday, January 17, 2012)]
[Notices]
[Page 2289]
[FR Doc No: 2012-702]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project Nos. 12924-002 and 14077-000]

FFP Project 33, LLC and Northland Power Mississippi River LLC;
Notice Announcing Preliminary Permit Drawing

    The Commission has received two preliminary permit applications
deemed filed on February 1, 2011, at 8:30 a.m.,\1\ for proposed
projects to be located on the Mississippi River, in Warren County,
Mississippi, and Tensas and Madison Parishes, Louisiana. The
applications were filed by FFP Project 33, LLC for Project No. 12924-
002, and Northland Power Mississippi River LLC for Project No. 14077-
000.
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    \1\ Under the Commission's Rules of Practice and Procedure, any
document received after regular business hours is considered filed
at 8:30 a.m. on the next regular business day. 18 CFR 385.2001(a)(2)
(2011).
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    On January 17, 2012, at 9 a.m. (eastern time), the Secretary of the
Commission, or her designee, will conduct a random drawing to determine
the filing priority of the applicants identified in this notice. The
Commission will select among competing permit applications as provided
in section 4.37 of its regulations.\2\ The priority established by this
drawing will be used to determine which applicant, among those with
identical filing times, will be considered to have the first-filed
application.
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    \2\ 18 CFR 4.37 (2011).
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    The drawing is open to the public and will be held in room 2C, the
Commission Meeting Room, located at 888 First St. NE., Washington, DC
20426. A subsequent notice will be issued by the Secretary announcing
the results of the drawing.

    Dated: January 10, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-702 Filed 1-13-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 156 (Tuesday, August 13, 2013)]
[Notices]
[Page 49308]
[FR Doc No: 2013-19511]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69829A; File No. SR-PHLX-2013-65]

Self-Regulatory Organizations; Notice of Filing of Proposed Rule
Change Relating To Which Complex Orders Can Initiate a Complex Order
Live Auction; Correction

June 21, 2013.
AGENCY: Securities and Exchange Commission.

ACTION: Notice; correction.

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SUMMARY: The Securities and Exchange Commission published a document in
the Federal Register of June 27, 2013 concerning a Notice of Filing of
Proposed Rule Change Relating to Which Complex Orders Can Initiate a
Complex Order Live Auction. The document was dated incorrectly.

FOR FURTHER INFORMATION CONTACT: Charles Sommers, Division of Trading
and Markets, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549,<PHONE_NUMBER>.

Correction

    In the Federal Register of June 27, 2013, in FR Doc. 2013-15370, on
page 38750, in the 27th line of the third column, the date is corrected
to read as noted above.

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-19511 Filed 8-12-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 192 (Wednesday, October 3, 2018)]
[Notices]
[Pages 49921-49922]
[FR Doc No: 2018-21556]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-RCRA-2015-0836; FRL-9984-87--Region 3]

Proposed Information Collection Request; Comment Request;
Collection of Information on Anaerobic Digestion Facilities Processing
Wasted Food To Support EPA's Sustainable Food Management Programs

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``Collection of Information on
Anaerobic Digestion Facilities Processing Wasted Food to support EPA's
Sustainable Food Management Programs'' (EPA ICR No. 2533.02, OMB
Control No. 2050-0217) to the Office of Management and Budget (OMB) for
review and approval in accordance with the Paperwork Reduction Act.
Before doing so, EPA is soliciting public comments on specific aspects
of the proposed information collection as described below. This is a
request for approval of a renewal of an existing ICR. An Agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.

DATES: Comments must be submitted on or before December 3, 2018.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-RCRA-
2015-0836 online using www.regulations.gov or by mail to: EPA Docket
Center, Environmental Protection Agency, Mail Code 228221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Melissa Pennington, U.S. Environmental
Protection Agency, Region 3, Mail Code 3LC33, 1650 Arch Street,
Philadelphia, PA 19103; telephone number:<PHONE_NUMBER>; fax number:
215-814-3114; email address: [email protected].

SUPPLEMENTARY INFORMATION:
    Supporting documents which explain in detail the information that
the EPA will be collecting are available in the public docket for this
ICR. The docket can be viewed online at www.regulations.gov or in
person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution
Ave. NW, Washington, DC. The telephone number for the Docket Center is
202-566-1744. For additional information about EPA's public docket,
visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: EPA's Sustainable Food Management (SFM) Program promotes
the sustainable management of food which is a systematic approach that
seeks to reduce wasted food and its associated impacts over its' entire
lifecycle. The lifecycle of food includes use of natural resources,
manufacturing, sales, and consumption and ends with decisions on
recovery or final disposal.

Diversion of food waste from landfills is a critical component of this
effort. In order to effectively divert food waste from landfills,
sufficient capacity to process the diverted materials is required.
Knowledge of organics recycling capacity is needed to facilitate food
waste diversion and anaerobic digestion facilities provide a
significant amount of the needed capacity.
    EPA's food recovery hierarchy prioritizes potential actions to
prevent and divert wasted food. According to the hierarchy, processing
wasted food via anaerobic digestion is a more desirable option than
landfilling or incineration because it creates more benefits for the
environment, society and the economy. Anaerobic digestion of food waste
and other organic materials generates renewable energy, reduces methane
emissions to the atmosphere, and provides opportunities to improve soil
health through the production of soil amendments. The SFM program
supports these efforts by educating state and local governments and
communities about the benefits of wasted food diversion. The SFM
program also builds partnerships with state agencies and other
strategic partners interested in developing organics recycling capacity
and provides tools to assist organizations in developing anaerobic
digestion (AD) projects.
    The nationwide collection of data about AD facilities processing
food waste began in 2017 with a survey of all known AD facilities under
the initial Information Collection Request (ICR No. 2533.01). EPA
published the first annual report of findings based on this data in
July 2018. This information collection consists of a request to renew
ICR No. 2533.02 in order to continue to monitor growth and evaluate
trends in the capacity for processing of food waste and the amount of
food waste being processed via AD in the United States.
    Data will be collected using electronic surveys that will be
distributed to respondents by email and will be available on EPA's AD
website.
    Form numbers: EPA Form 6700-03, EPA Form 6700-04, EPA Form 6700-05.
    Respondents/affected entities: Project Developers, Project Owners
or Plant Operators, and Livestock Farmers.
    Respondent's obligation to respond: Voluntary.
    Estimated number of respondents: 382 (total).
    Frequency of response: Annually.
    Total estimated burden: 254 hours (per year). Burden is defined at
5 CFR 1320.03(b).
    Total estimated cost: $7,594 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in estimates: The overall burden has slightly decreased
from the original ICR. For this renewal, some questions have been
revised for clarity, numerous questions have been eliminated and a
series of questions have been streamlined. The time to complete the
survey will decrease for operating years 2017, 2018, 2019 and 2020 for
Respondents that previously provided data.

    Dated: September 24, 2018.
John A. Armstead,
Director, Land and Chemicals Division, EPA Region III.
[FR Doc. 2018-21556 Filed 10-2-18; 8:45 am]
 BILLING CODE 6560-50-P