1 Notice of Filing Interregional Research Protect # 4 ( IR 4)

3E4173, 5E4570, 9E5054, and 9E5061 EPA has received pesticide petitions 3E4173, 5E4570, 9E5054, and 9E5061 from IR 4, 681 Highway 1 South, North Brunswick, NJ 08902 3390 proposing, pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR part 180.176 by establishing tolerances for residues of mancozeb in or on the raw agricultural commodities sugar apple, cherimoya, atemoya, custard apple, and sweetsop at 3 ppm ( 9E5061); mango, star apple ( caimito), canistel, mamey sapote, sapodilla, and white sapote at 15 ppm ( 5E4570); ginseng at 2 ppm ( 9E5054); and the cucurbit vegetable group at 4 ppm ( 3E4173). EPA has determined that the petitions contain data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petitions. Additional data may be needed before EPA rules on the petitions.

A. Residue Chemistry 1. Plant metabolism. The plant metabolism of mancozeb is understood. Plant metabolism has been evaluated in five diverse crops, including potato, soybean, sugar beet, tomato, and wheat. These studies demonstrate that mancozeb is extensively metabolized to natural products ( proteins, carbohydrates, lipids, lignins, etc.) with minor amounts of degradation products including ethylenethiourea ( ETU), ethyleneurea, ethylene bisisocyanate sulfide, and ethylenediamine.

2. Analytical method. Residues of mancozeb are determined by decomposing the residue with a strong acid to release carbon disulfide ( CS 2 ). The CS 2 can be measured by gas chromatography or by absorbance of a colored copper dithiocarbamate complex formed by sweeping the CS 2 through a trap and into a reaction tube containing a solution of copper acetate and an amine. Adequate methodology for enforcement is available in the Pesticide Analytical Manual ( PAM II, Method II).

3. Magnitude of Residues. The residues of mancozeb will not exceed 3 ppm in or on sugar apple, cherimoya, atemoya, custard apple, and sweetsop; 15 ppm in or on mango, star apple ( caimito), canistel, mamey sapote, sapodilla, and white sapote; 2 ppm in or on ginseng; or 4 ppm in or on the cucurbit crop group.

B. Toxicological Profile 2 1. Acute toxicity. Mancozeb is not acutely toxic, with Category IV toxicity for the oral, dermal, and inhalation routes. Mancozeb is not a skin irritant ( Category IV) and it is not a skin sensitizer. Mancozeb is classified as Category III for eye irritation.

2. Genotoxicity. Mancozeb was negative ( non mutagenic) in an Ames assay with and without activation. It was negative in a hypoxanthine guanine phosphoribosyl transferase ( HGPRT) gene mutation assay using Chinese hamster ovary ( CHO) cells when tested with and without activation. It was negative in the mouse host mediated assay. Mancozeb was negative in the in vivo bone marrow cytogenetic study and mouse micronucleus assay. Mancozeb did not induce unscheduled DNA synthesis ( UDS) or repair, it was negative in the in vitro transformation ( 10T1/ 2 cell) and in vitro transformation/ promotion ( 10T1/ 2 cell) studies. In the sister chromatid exchange ( SCE) assay with CHO cells, mancozeb was positive without activation and negative with activation. A weight of the evidence evaluation demonstrates that mancozeb is not genotoxic in mammalian systems.

3. Reproductive and developmental toxicity.  i. Developmental toxicity in the rat. In the developmental study in rats, the maternal ( systemic) no observed adverse effect level ( NOAEL) was 32 mg/ kg/ day, with a maternal lowest observed effect level ( LOAEL) of 128 mg/ kg/ day based on decreased food consumption, body weight, and body weight gains. The developmental NOAEL was 128 mg/ kg/ day and the developmental LOAEL was 512 mg/ kg/ day based on gross developmental effects, central nervous and skeletal effects, cryptorchidism, abortions, increased resorptions and decreased fetal weight. These effects occurred only at doses that produced significant maternal toxicity, including mortality, and are not considered relevant for human risk assessment. _ There were no developmental effects at doses below those which were maternally toxic, so mancozeb was not uniquely toxic to the conceptus.

ii. Developmental toxicity in the rabbit. In the developmental study in rabbits, the maternal ( systemic) NOAEL was 30 mg/ kg/ day and the maternal LOAEL was 80 mg/ kg/ day based on reduced feed intake, weight loss, mortality, and clinical signs. The developmental NOAEL was greater than 80 mg/ kg/ day because no effects were seen without severe maternal toxicity. Mancozeb was not developmentally toxic in this study.

iii. Reproductive toxicity. In the 2 generation reproduction study in rats, the maternal ( systemic) NOAEL was 6.95/ 7.47 mg/ kg/ day males/ females and the parental LOAEL was 68.90/ 79.37 mg/ kg/ day males/ females based on body weight decrements, increased relative thyroid weights, and increased incidence of thyroid follicular cell hyperplasia. The reproductive NOAEL is greater than or equal to 69.90/ 79.37 mg/ kg/ day males/ females ( the highest dose tested). There were no adverse reproductive or offspring effects. Mancozeb does not show reproductive toxicity. In conclusion, mancozeb is not a reproductive toxicant and developmental effects occurred only at doses that were 3 maternally toxic and the effects are secondary to excessive maternal toxicity. 4. Subchronic toxicity.   i. Rat 90 day feeding study. A subchronic feeding study in rats conducted for 13 weeks had a NOAEL of 9.24/ 14.98 mg/ kg/ day in females/ males and a LOAEL of 17.82/ 57.34 mg/ kg/ day in females/ males based on decreased serum thyroxine. In males, the LOAEL was 57.34 mg/ kg/ day based on decreased body weights, changes in thyroid hormones, changes in liver enzymes, increased absolute and relative thyroid weights and increased relative liver weights in the males.

ii. Mouse 90 day feeding study. A 90 day subchronic study resulted in a NOAEL of 18.13/ 21.68 mg/ kg/ day in males/ females and a LOAEL of 166.9/ 233.8 mg/ kg/ day in males/ females based on microscopic lesions of thyroid follicular cell hypertrophy or hyperplasia in females and decreased liver MFO enzyme activity in males.

iii. Dog 90 day feeding study. A subchronic feeding study in dogs conducted for three months had a NOAEL of 2.98/ 3.35 mg/ kg/ day in males/ females and a LOAEL of 28.62/ 28.91 mg/ kg/ day in males/ females based on dehydration, decreased body weights and food consumption, anemia, thymic cortical lymphoid depletion, elevated cholesterol and prostate hypogenesis.

iv. Rat 28 day dermal study. No toxicity, including no changes in thyroid hormones, was seen at the limit dose of 1000 mg/ kg/ day. The NOAEL is greater than 1000 mg/ kg/ day.

v. Rat 90 day neuropathology study. A subchronic feeding study in rats conducted for three months had a NOAEL of 8.2 mg/ kg/ 10.5 mg/ kg in males/ females based on decreased body weight, body weight gain and food consumption in females and neurohistopathological changes in both sexes at 49.7/ 63.3 mg/ kg in males/ females.

5. Chronic toxicity.  i. Rat. A 24 month chronic/ carcinogenicity study in male and female rats was conducted at 20, 60, 125, or 750 ppm of mancozeb. The NOAEL was 125 ppm ( 4.83/ 6.72 mg/ kg/ day in males/ females) with a LOAEL of 750 ppm ( 30.9/ 40.2 mg/ kg/ day in males/ females) based on changes in thyroid hormone levels, microscopic thyroid changes ( follicular cell hypertrophy and hyperplasia, adenomas and carcinomas), changes in thyroid weights and bilateral retinopathy.

ii. Mouse. A 78 week chronic/ oncogenicity study was conducted in male and female mice dosed at 0, 30, 100, or 1000 ppm. The NOAEL was 100 ppm ( 13/ 18 mg/ kg/ day in males/ females) based on minor decreased body weight and body weight gain and changes in hormone levels at the LOAEL of 1000 ppm ( 131/ 180 mg/ kg/ day in males/ females). There was no evidence of carcinogenicity.

iii. Dog. A 1 year feeding study in dogs resulted in a NOAEL of 50 ppm ( 1.75 mg/ kg/ day) for males and 200 ppm ( 7.02 mg/ kg/ day) for females. The LOAEL was 200 4 ppm ( 7.26 mg/ kg/ day) in males based on decreased body weight gain and 800 ppm ( 29.24 mg/ kg/ day) in females based on anemia.

iv. Carcinogenicity. Mancozeb is classified as a Group B2 carcinogen based on the metabolite ETU. ETU has a Q* of 0.06 ( mg/ kg/ day) 1 based on mouse liver tumors and a ¾ scaling factor.

6. Animal metabolism. The absorption, distribution, excretion, and metabolism of mancozeb in rats, goats, and hens were investigated. Following oral administration, mancozeb was rapidly and essentially completely excreted. The bulk of the residue is incorporated into natural products.

7. Metabolite toxicity. The mancozeb metabolite of toxicological concern is ethylenethiourea ( ETU). ETU is classified as a B2 carcinogen with a Q* of 0.06 ( mg/ kg/ day) 1 based on mouse liver tumors and ¾ scaling factor. The non cancer chronic toxicity of ETU is based on a NOAEL of 0.18 mg/ kg/ day in a chronic dog study. Using a 1000X safety factor ( 100X based on inter and intra species uncertainty and 10X database uncertainty factor), the cPAD is 0.0002 mg/ kg/ day. The acute endpoint is based on a rat developmental study with a NOAEL of 5 mg/ kg/ day, resulting in an aPAD of 0.005 mg/ kg/ day with a 1000X safety factor. The ETU developmental effects are species specific. ETU is not developmentally toxic in rabbits, guinea pigs or cats and has equivocal effects in mice and hamsters.

8. Endocrine disruption. The endocrine system includes the reproductive hormones estrogen and androgens as well as the thyroid hormone system. Mancozeb and ETU are not known to interfere with reproductive hormones and mancozeb and ETU do not have reproductive toxicity. While thyroid effects were seen in testing in rodents, it is well known and accepted that rats are more sensitive to thyroid effects than humans. Mancozeb and ETU are not expected to show thyroid effects at the levels of human or environmental exposure. Additionally, the chronic risk assessments are based on thyroid effects and the % cPAD is substantially below the level of concern.

C. Aggregate Exposure 1. Dietary exposure.  i. Food. Dietary exposure assessments for mancozeb and ETU from mancozeb were conducted using the Dietary Exposure Evaluation Model ( DEEM) software with the Food Commodity Intake Database ( DEEM FCID   , Version 1.3), which incorporates consumption data from USDA's Continuing Survey of Food Intakes by Individuals ( CSFII), 1994 1996 and 1998. The acute and chronic dietary ( food) risk analyses utilized anticipated residue values from a market basket survey for EBDCs and ETU and field trial data when market basket survey data were not available. For the crops described in these petitions, papaya field trial data with mancozeb applied at the maximum papaya label rate were used as a surrogate for mango, star apple ( caimito), 5 canistel, mamey sapote, sapodilla, and white sapote. Maximum rate sugar apple field trial data were used for sugar apple, cherimoya, atemoya, custard apple, and sweetsop. Field trial data were used for ginseng. Cucumber, squash, and melon field trial data were used to support the cucurbit crop group, with the exception that cucumber market basket survey data were used for cucumbers. The exposure and risk assessments described in this Notice of Filing include all crops currently on the mancozeb labels plus the above mentioned crops in the four petitions. Residues were adjusted for processing factors, cooking factors, and percent of crop treated. However, a default of 100% crop treated was assumed for the crops in the four petitions that are the subject of this Notice. For the purposes of this Notice of Filing, exposures calculated by EPA have been used to describe the acute and chronic risk assessments. Numerous refinements can be made with actual percent of crop treated data for some crops and corrections to anticipated residue calculations. These adjustments will lead to considerable reduction of the acute and chronic exposures. The adjustments have been taken into account for the theoretical cancer risk assessments.

a. Acute dietary exposure. There is no acute toxicology endpoint for mancozeb because mancozeb is not developmentally toxic. The exposure from ETU derived from mancozeb at the 99.9th percentile is 0.000898 mg/ kg/ day, or 18% of the aPAD of 0.005 mg/ kg/ day. Mancozeb is a member of the ethylenebisdithiocarbamate ( EBDC) group of fungicides. The EBDC group also includes maneb and metiram. The ETUdietary exposure from all sources ( including mancozeb, maneb, and metiram) is 0.0026 mg/ kg/ day, or 52% aPAD. The % aPAD will be lower when corrections to EPA's calculations are taken into account.

b. Chronic dietary exposure. The chronic reference dose for mancozeb is based on a NOAEL of 4.83 mg/ kg/ day and an uncertainty factor of 100, resulting in a cPAD of 0.05 mg/ kg/ day. The cPAD for ETU is 0.0002 mg/ kg/ day based on a NOAEL of 0.18 mg/ kg/ day and an uncertainty factor of 1000, which includes an extra 10X database uncertainty factor. The mancozeb chronic ( non cancer) dietary exposure to the general U. S. population is 0.000053 mg/ kg/ day, or < 1% cPAD; and is 0.000175 mg/ kg/ day, or < 1% cPAD for children 1 2 years old, which are the most highly exposed population subgroup. For ETU derived from mancozeb, the exposures are 0.000022 or 0.000065 mg/ kg/ day, resulting in 11% cPAD for the general U. S. population or 33% cPAD for children 1 2 years old, respectively. The ETU exposure from all sources is 0.000034 mg/ kg/ day or 17% cPAD for the general U. S. population and 0.000104 mg/ kg/ day, or 52% cPAD for children 1 2 years old.

c. Cancer dietary exposure. The cancer dietary exposure is based on ETU, with a Q* of 0.06 ( mg/ kg/ day) 1. The ETU exposure comes from three sources: directly measured ETU, metabolic ETU from 7.5% conversion of an EBDC to ETU in vivo, and processing ETU, due to formation of some ETU when an EBDC is heated. The relevant 6 population is the general U. S. population. The theoretical cancer risk for ETU derived from mancozeb is 6.5 X 10 7. The theoretical cancer risk estimate of ETU from all sources is 1.2 X 10 6.

ii. Drinking water. The drinking water risk is based only on ETU because mancozeb is very short lived in soil and water and is not expected to reach drinking water for human consumption from either surface water or ground sources. Monitoring data for ETU from a targeted surface water and ground water study are available for risk assessment. Samples were collected from rural wells and community water systems in areas of high usage of EBDC fungicides. In the study, none of the samples from surface water monitoring sites had residues that were above the limit of quantitation of 0.1 ppb. For surface water, the estimated drinking water concentrations ( EDWC's) for acute exposure range from 0.1 ppb from the monitoring study to 25.2 ppb based on PRZM EXAMS modeling. PRZM EXAMS modeling was based on application of maneb to peppers in Florida at the maximum label rate of 6 applications of 2.4 lb a. i./ acre, an ETU aerobic soil half life of about 3 days, aquatic aerobic metabolism half life assumed to be 6 days ( double the soil half life), and an aerobic aquatic metabolism half life of 149 days. The modeling prediction can be refined by incorporating the average actual application rate instead of the maximum label application rate. When the actual application rate of 1.18 lb a. i./ acre is used for the modeling, the highest one in ten year acute surface water EDWC is 7.6 ppb rather than 25.2 ppb. The surface water estimates will be considerably reduced by incorporating the refined EDWC. The chronic surface water EDWC is calculated conservatively at the limit of quantitation of 0.1 ppb based on the monitoring data.

A ground water EDWC for all durations ( acute and chronic) of 0.21 ppb is based on a result from the targeted monitoring study in Florida. The 0.21 ppb is the highest concentration in an untreated sample at a community water system intake source. The 0.21 ppb is a conservative value for risk assessment because ETU was not detected in any of the treated community drinking water in any of the 84 sites in the monitoring survey. The concentration for human consumption is actually < 0.1 ppb based on the analysis of the treated water samples.

Potential exposure to ETU from both ground and surface water is below the drinking water level of concern ( DWLOC) for acute risk when combined with exposure through food. For mancozeb uses, the acute DWLOC for ETU from mancozeb is 123 ug/ L. EPA's calculated upper bound ETU estimates of 25.2 ppb modeled for surface water and 0.21 ppb in the ground water monitoring study are significantly less than the DWLOC. Using actual application rates of 1.18 lb a. i./ acre, the acute EDWC of 7.6 ppb is even lower than the DWLOC.

With a surface water EDWC of 0.1 ppb, the surface water chronic risk has a % cPAD of 1.1% for the U. S. population and 1.6% for children 1 2 years. The theoretical 7 surface water cancer risk is 1.27 X 10 7. With an EDWC of 0.21 ppb to calculate the chronic and cancer risks for ground water, the % cPAD is 2.2% for the U. S. population and 3.3% for children 1 2 years old and the theoretical ground water cancer risk is 2.66 X 10 7. The aggregate food and surface water exposure for ETU from mancozeb yields an ETU DWLOC of 123 ppb, and the modeled EDWC of 25.2 ppb is below the level of concern. The acute food and surface water aggregate risk for ETU from all sources is 86% of the aPAD. The acute risks will be lower with incorporation of 7.6 ppb surface water EDWC based on actual use patterns. For aggregate risk of food and water from surface water and ground water sources, EPA calculated chronic risks for ETU from mancozeb of 12% and 13% cPAD, respectively, and 34% and 36%, respectively, for children 1 2 years old. When Mancozeb Task Force corrections are incorporated, the aggregate food and cancer risk for mancozeb derived ETU in food and water is 9 X 10 7 and 1.0 X 10 6 from surface water and ground water sources, respectively. The results of the acute, chronic, and cancer risk assessments demonstrate that exposure to ETU from mancozeb and other EBDC sources would not result in unacceptable levels of aggregate human health risk.

2. Non dietary exposure.  i. Residential uses. Mancozeb is used on sod farms and by home gardeners. The sod MOE is greater than the target ETU MOE of 1000 for exposure to infants and children when there is a 3 day pre harvest restriction for mancozeb applications to sod. This value is very conservative because it does not take into account all of the watering that occurs on sod after it is transplanted to ensure that the sod knits to the ground, and does not take into account the fact that children are not likely to be on transplanted sod before it is established. EPA calculated risks to home gardeners applying mancozeb to vegetable gardens and ornamentals, using the maximum application rate of 2.4 lb a. i./ acre for all crops. For handlers, short term margins of exposure ( MOEs) are significantly higher than the target MOEs of 100 and 1000 for mancozeb and ETU, respectively. Mancozeb MOEs range from 890,000 to 3,000,000 and ETU MOEs range from 110,000 to 620,000. The ETU cancer risks range from 2 X 10 8 to 4 X 10 9. The highest adult cancer post application risk is 5.3 X 10 7 for homeowners harvesting sweet corn. This risk is highly conservative because the risk assessment was conducted at double the label rate for sweet corn and there is minimal use of mancozeb on home garden sweet corn.

ii. Recreational uses. Mancozeb is used on golf courses and athletic fields. Using 100% of the golf courses treated, the MOE to adult golfers is 6,600 and the theoretical cancer risk is 2.0 X 10 7. However, only 1.6% of the golf courses are treated with mancozeb, and with this refinement the theoretical cancer risk is 3.2 X 10 9. EPA calculated an athlete MOE of 450, however this calculation does not account for the clothing worn by athletes. The cancer risk to athletes was calculated to be 6.0 X 10 7 with 100% of the athletic fields treated. However, the mancozeb use on athletic fields is so low 8 that its usage is not even reported. Using a conservative estimate of 1% of the athletic fields treated, the theoretical athletic cancer risk is 6 X 10 9.

The aggregate risk for ETU from mancozeb ranges from 6.8 X 10 7 to a maximum of 1.3 X 10 6, even with the double application rate on home garden sweet corn. The aggregate risk from all sources of ETU ranges from 1.4 X 10 6 to 2.0 X 10 6.

D. Cumulative Effects. Mancozeb is a member of the EBDC class of fungicides, all of which have ETU as a common metabolite. During a previous Special Review of the EBDCs ( mancozeb, maneb, and metiram), the Agency considered the three active ingredients to be related due to the common metabolite ETU. For the purposes of this Notice, both the ETU derived from mancozeb and ETU from all EBDCs have been considered.

E. Safety Determination.

1. U. S. population. EPA has assigned an uncertainty factor of 100 for mancozeb and 1000 for ETU for toxicology endpoints with threshold effects. The 100 fold safety factor includes intraspecies and interspecies variations. For ETU, an extra 10X uncertainty factor was added to account for database uncertainties. EPA determined that no additional Special FQPA safety factors are required. The uncertainty factors have been applied to the acute and chronic threshold risk assessments. For the acute risk assessment, the subpopulation of concern is females 13 49. EPA determined that the aggregate ( food and drinking water) acute risk to ETU from all sources is 86% of the aPAD and the DWLOC for ETU derived from mancozeb is 123, exceeding the surface water EDWC of 25.2 ppb, which can be refined to 7.6 ppb for future risk assessments. Because the acute aggregate risks are less than 100% of the aPAD they are below the level of concern. An acute endpoint for mancozeb is not appropriate because mancozeb is not developmentally toxic. The chronic risks for mancozeb in food are < 1% for the U. S. population. The aggregate food and water risk for ETU derived from mancozeb is 12% cPAD for surface water and 13% for ground water. EPA calculated aggregate food and water risks for ETU from all sources of 18% for surface water and 19% for ground water. These risks are less than 100% of the cPAD and are therefore below the level of concern. The acute and chronic risks include conservative assumptions and will be reduced with incorporation of adjustments and corrections provided by the registrants.

Aggregate mancozeb MOEs for residential handlers ( chronic food plus residential) range from 140,000 to 160,000. The ETU short term aggregate risk for residential handlers applying mancozeb is below EPA's level of concern, with aggregate MOE's ranging from 75,000 to 161,000 ( food, water, and residential exposure). Aggregate MOEs from all sources of ETU for chronic food and drinking water and golfing or gardening exposures range from 4,500 to 62,000. These MOEs are higher than the target 9 of 100 and are not of concern.

Theoretical cancer aggregate risks were calculated for food and water, food/ water/ golfing, food/ water/ home garden handler, food/ water/ home garden post application, and food/ water/ athletic exposures, with either surface water or ground water. The aggregate theoretical cancer risk for ETU derived from mancozeb ranges from 6.8 X 10 7 to a maximum of 1.3 X 10 6. The theoretical risk from ETU from all sources ranges from 1.4 X 10 6 to 2.0 X 10 6. These risks are not statistically different from 1 X 10 6 and are thus below the level of concern.

2. Infants and children. EPA evaluated the potential for increased susceptibility of infants and children from exposure to mancozeb. Acceptable developmental and reproduction studies demonstrated that there was no indication of increased susceptibility to fetuses or offspring in the developmental and reproduction studies. Based on the lack of evidence of pre and/ or postnatal susceptibility resulting from exposure to mancozeb and considering the lack of residual uncertainties, the Special FQPA Safety Factor was removed ( reduced to 1X). The Agency also determined that there was no need for a database uncertainty factor for mancozeb. EPA also evaluated the potential for increased susceptibility of infants and children from exposure to ETU. While ETU had developmental effects in rats, the effects are well characterized and there is a clear dose response relationship with a well established NOAEL based on numerous studies in rats. The developmental NOAEL with the lowest endpoint was selected for the acute reference dose. Additionally, the thyroid effects from ETU were selected for deriving the chronic reference dose. Therefore, EPA concluded that there were no residual uncertainties with regard to pre and/ or postnatal toxicity and that the Special FQPA Safety Factor could be removed ( reduced to 1X). EPA concluded that a 10X database uncertainty factor was required for ETU, so the total ETU safety factor is 1000X.

For chronic risk, the most highly exposed population is children 1 2 years old. The % cPAD for mancozeb is < 1% and the % cPAD for ETU is 33%. The % cPAD for ETU from all sources is 52%. These numbers are less than 100% and are therefore below the level of concern. The risk to infants and children from transplanted sod was also evaluated. With a three day pre harvest restriction interval, the target MOE of 1000 is met. This number is highly conservative because it does not account for the extensive watering of sod after transplant or the length of time that occurs prior to sod exposure to enable the sod to get established.

F. International Tolerances. Of the crops in this petition, Codex tolerances have been established for cucumber ( 2 ppm carbon disulfide equivalents, or 4 ppm mancozeb), mango ( 2 ppm carbon disulfide equivalents, or 4 ppm mancozeb), summer squash ( 1 ppm carbon disulfide, or 2 ppm mancozeb), and winter squash ( 0.1 ppm carbon disulfide, or 0.2 ppm mancozeb). Numerous additional Codex tolerances are established for other 10 commodities. Because the use patterns in the United States are different than those used to establish many of the Codex tolerances, it is not necessary to harmonize the tolerances with Codex.


[Federal Register Volume 80, Number 250 (Wednesday, December 30, 2015)]
[Notices]
[Pages 81534-81536]
[FR Doc No: 2015-32833]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM15-14-000]

Revised Critical Infrastructure Protection Reliability Standards;
Supplemental Notice of Agenda and Discussion Topics for Staff Technical
Conference

    This notice establishes the agenda and topics for discussion at the
technical conference to be held on January 28, 2016, to discuss issues
related to supply chain risk management. The technical conference will
start at 10:00 a.m. and end at approximately 4:30 p.m. (Eastern Time)
in the Commission Meeting Room at the Commission's Headquarters, 888
First Street NE., Washington, DC. The technical conference will be led
by Commission staff, and FERC Commissioners may be in attendance. All
interested parties are invited to attend, and registration is not
required.
    The topics and related questions to be discussed during this
conference are provided as an attachment to this Notice. The purpose of
the technical conference is to facilitate a structured dialogue on
supply chain risk management issues identified by the Commission in the
Revised Critical Infrastructure Protection Standards Notice of Proposed
Rulemaking (NOPR) issued in this proceeding and raised in public
comments to the NOPR. Prepared remarks will be presented by invited
panelists.
    This event will be webcast and transcribed. The free webcast allows
listening only. Anyone with Internet access who desires to listen to
this event can do so by navigating to the ``FERC Calendar'' at
www.ferc.gov, and locating the technical conference in the Calendar of
Events. Opening the technical conference in the Calendar of Events will
reveal a link to its webcast. The Capitol Connection provides technical
support for the webcast and offers the option of listening to the
meeting via phone-bridge for a fee. If you have any questions, visit
www.CapitolConnection.org or call<PHONE_NUMBER>. The webcast will be
available on the Calendar of Events at www.ferc.gov for three months
after the conference. Transcripts of the conference will be immediately
available for a fee from Ace-Federal Reporters, Inc.<PHONE_NUMBER>).
    FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to<EMAIL_ADDRESS>or call toll free (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a fax to<PHONE_NUMBER>
with the requested accommodations.
    There is no fee for attendance. However, members of the public are
encouraged to preregister online at: https://www.ferc.gov/whats-new/registration/01-28-16-form.asp.
    For more information about the technical conference, please
contact: Sarah McKinley, Office of External Affairs,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
    Dated: December 23, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.

[GRAPHIC] [TIFF OMITTED] TN30DE15.000

Critical Infrastructure Protection Supply Chain Risk Management RM15-
14-000 January 28, 2016

Agenda

Welcome and Opening Remarks by Commission Staff

9:30-9:45 a.m.

Introduction

    In a July 16, 2015 Notice of Proposed Rulemaking (NOPR) in the
above-captioned docket, the Commission proposed to direct the North
American Electric Reliability Corporation (NERC) to develop new or
modified Critical Infrastructure Protection (CIP) Reliability Standards
to provide security controls relating to supply chain risk management
for industrial control system hardware, software, and services. The
Commission sought and received comments on this proposal, including:
(1) The NOPR proposal to direct that NERC develop a Reliability
Standard to address supply chain risk management; (2) the anticipated
features of, and requirements that should be included in, such a
standard; and (3) a reasonable timeframe for development of a standard.
The purpose of this conference is to clarify issues, share information,
and determine the proper response to address security control and
supply chain risk management concerns.

Staff Presentation: Supply Chain Efforts by Certain Other Federal
Agencies

9:45 a.m.-10:05 a.m.

Break

10:05 p.m.-10:15 p.m.

Panel 1: Need for a New or Modified Reliability Standard

10:15 a.m.-11:45 a.m.

    The Commission staff seeks information about the need for a new or
modified Reliability Standard to manage supply chain risks for
industrial control system hardware, software, and computing and
networking services associated with bulk electric system operations.
Panelists are encouraged to address:
     Identify challenges faced in managing supply chain risk.
     Describe how the current CIP Standards provide supply
chain risk management controls.
     Describe how the current CIP Standards incentivize or
inhibit the introduction of more secure technology.
     Identify possible other approaches that the Commission can
take to mitigate supply chain risks.
Panelists
1. Nadya Bartol, Vice President, Industry Affairs and Cybersecurity
Strategist, UTC
2. Jon Boyens, Project Manager, Information Communication Technology
(ICT) Supply Chain Risk Management, National Institute of Standards &
Technology (NIST)
3. John Galloway, Director, Cyber Security, ISO New England
4. John Goode, Chief Information Officer/Senior Vice President,
Midcontinent Independent System Operator (MISO)
5. Barry Lawson, Associate Director, Power Delivery & Reliability,
National Rural Electric Cooperative Association (NRECA)
6. Helen Nalley, Compliance Director, Southern Company
7. Jacob Olcott, Vice President of Business Development, Bitsight Tech
8. Marcus Sachs, Senior Vice President and Chief Security Officer,
North American Electric Reliability Corporation (NERC)

Lunch

11:45 a.m.-1:00 p.m.

Panel 2: Scope and Implementation of a New or Modified Standard

1:00 p.m.-2:30 p.m.

    The Commission staff seeks information about the scope and
implementation of a new or modified Standard to manage supply chain
risks for industrial control system hardware, software, and computing
and networking services associated with bulk electric system
operations. Panelists are encouraged to address:
     Identify types of assets that could be better protected
with a new or modified Standard.
     Identify supply chain processes that could be better
protected by a Standard.
     Identify controls or modifications that could be included
in the Standard.
     Identify existing mandatory or voluntary standards or
security guidelines that could form the basis of the Standard.
     Address how the verification of supply chain risk
mitigation could be measured, benchmarked and/or audited.
     Present and justify a reasonable timeframe for development
and implementation of a Standard.
     Discuss whether a Standard could be a catalyst for
technical innovation and market competition.
Panelists
1. Mike Ahmadi, Global Director--Critical Systems Security, Synopsys
2. Jonathan Appelbaum, Director, NERC Compliance, The United
Illuminating Company
3. Brent Castegnetto, Manager, Cyber Security Audits & Investigations,
WECC
4. Art Conklin, Ph.D., Associate Professor and Director of the Center
for Information Security Research and Education, University of Houston
5. Edna Conway, Chief Security Officer, Value Chain Security, Cisco
6. Bryan Owen, Principal Cyber Security Manager, OSIsoft
7. Albert Ruocco, Vice President and Chief Technology Officer, American
Electric Power (AEP)
8. Doug Thomas, Vice President and Chief Information Officer, Ontario
Independent Electricity System Operation (IESO)

Break

2:30 p.m.-2:45 p.m.

Panel 3: Current Supply Chain Risk Management Practices and
Collaborative Efforts

2:45 p.m.-4:15 p.m.

    The Commission staff seeks information about existing supply chain
risk management efforts for information and communications technology
and industrial control system hardware, software, and services in other
critical infrastructure sectors and the government. Panelists are
encouraged to address:
     Generally describe how registered entities and other
organizations currently manage supply chain issues.
     Identify standards or guidelines that are used to
establish supply chain risk management practices. Specifically, discuss
experience under those standards or guidelines.
     Identify organizational roles involved in the development
and implementation of supply chain risk management practices.
     Generally describe approaches for identifying, evaluating,
mitigating, and monitoring supply chain risk.
     Generally discuss how supply chain risk is addressed in
the contracting process with vendors and suppliers.

     Generally describe the capabilities that registered
entities currently have to inspect third party information security
practices.
     Generally describe the capabilities that registered
entities currently have to negotiate for additional security in their
hardware, software, and service contracts. Describe how this may vary
based on the potential vendor or supplier and the type of service to be
provided.
     Generally describe how vendors and suppliers are managing
risk in their supply chain.
Panelists
1. Douglas Bauder, Vice President, Operational Services, and Chief
Procurement Officer, Southern California Edison
2. Andrew Bochman, Senior Cyber & Energy Security Strategist, INL/DOE
3. Dennis Gammel, Director, Security Technology, Schweitzer Engineering
4. Andrew Ginter, Vice President, Industrial Security, Waterfall
Security Solutions
5. Steve Griffith, Industry Director, National Electrical Manufacturers
Association (NEMA)
6. Maria Jenks, Vice President, Supply Chain, Kansas City Power & Light
(KCP&L)
7. Robert McClanahan, Vice President/Chief Information Officer,
Arkansas Electric Cooperative Corporation (AECC)
8. Thomas O'Brien, Chief Information Officer, PJM Interconnection, LLC

4:15 p.m.-4:30 p.m. Closing Remarks

[FR Doc. 2015-32833 Filed 12-29-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 214 (Tuesday, November 5, 2013)]
[Notices]
[Page 66374]
[FR Doc No: 2013-26395]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2013-0029; OMB No. 1660-0005]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

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 December 5, 2013.

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, 1800 South Bell Street, Arlington, VA
20598-3005, facsimile number<PHONE_NUMBER>, or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Collection of Information

    Title: National Flood Insurance Program Claims Forms.
    Type of information collection: Revision of a currently approved
information collection.
    Form Titles and Numbers: FEMA Form 086-0-6; Worksheet-Content-
Personal Property; 086-0-7; Worksheet--Building; 086-0-8; Worksheet--
Building (Continued); 086-0-9; Proof of Loss; 086-0-10; Increased Cost
of Compliance Proof of Loss; 086-0-11; Notice of Loss; 086-0-12;
Statement as to Full Cost of Repair or Replacement under the
Replacement Cost Coverage, Subject to Terms and Conditions of this
Policy; 086-0-13; National Flood Insurance Program Preliminary Report;
086-0-14; National Flood Insurance Program Final Report; 086-0-15;
National Flood Insurance Program Narrative Report; 086-0-16; Cause of
Loss and Subrogation Report; 086-0-17; Manufactured (Mobile) Home/
Travel Trailer Worksheet; 086-0-18; Manufactured (Mobile) Home/Travel
Trailer Worksheet (Continued); 086-0-19; Increased Cost of Compliance
(ICC) Adjusters Report; 086-0-20; Adjuster Preliminary Damage
Assessment; 086-0-21; Adjuster Certification Application; NFIP Claims
Appeals Process.
    Abstract: The National Flood Insurance Program (NFIP) appeal
process establishes a formal mechanism to allow NFIP policyholders to
appeal the decisions of any insurance agent, adjuster, insurance
company, or any Federal Emergency Management Agency (FEMA) employee or
contractor, in cases or unsatisfactory decisions on claims, proof of
loss, and loss estimates.
    Affected Public: Individuals or households; Farms; and Businesses
or other for profit.
    Estimated Number of Respondents: 97,242.
    Estimated Total Annual Burden Hours: 73,815.
    Estimated Cost: There are no recordkeeping, capital, start-up or
maintenance costs associated with this information collection.

    Dated: October 29, 2013.
Charlene D. Myrthil,
Director, Records Management Division, Mission Support Bureau, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2013-26395 Filed 11-4-13; 8:45 am]
BILLING CODE 9110-11-P