UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 April 13, 2006 OFFICE OF PREVENTION PESTICIDES AND TOXIC SUBSTANCES Memorandum SUBJECT: Biological and Economic Analysis of Dichlorvos in Mushroom Houses FROM: Don Atwood, Entomologist Biological Analysis Branch TJ Wyatt, Economist Economic Analysis Branch Biological and Economic Analysis Division ( 7503C)

THRU: Arnet Jones, Chief Biological Analysis Branch Tim Kiely, Acting Chief Economic Analysis Branch Biological and Economic Analysis Division ( 7503C)

TO: Dayton Eckerson/ Eric Olson, Chemical Review Manager Reregistration Branch 1 Special Review and Reregistration Division ( 7508C)

PRP REVIEW DATE: March 31, 2006 SUMMARY The amount of dichlorvos used in mushroom houses is relatively low. While Sciarid flies are now generally controlled through exclusion, sanitation, and the use of IGR =

s to control the larval stage, Phorid fly control still depends on adulticides. There are few aduticides registered for use in mushroom houses. Dichlorvos and synthetic pyrethrins are the only 2 available insecticides to control phorid fly adults. As phorid resistance to synthetic pyrethroids has been demonstrated, dichlorvos is the only available alternative. Dichlorvos is currently used by 10% of growers in PA. Although only 5% of national mushroom production is currently treated, provides critical pest control for houses infested with phorid flies. If dichlorvos is not available for use in mushroom houses, it is assumed that those Eastern US farmers that have phorid fly problems that require the use of dichlorvos ( 10% of Eastern US farmers per year) could incur losses of as much as $ 1.6 million per farm, which represents a 30% decline in per farm revenues, due to losses in the quality and yield of the mushrooms harvested. If resistance to synthetic pyrethrin continues throughout the industry, dichlorvos use could expand to other areas.

I. SCOPE AND LIMITATIONS OF ASSESSMENT The scope of this assessment is at the national level but relies heavily on data from the 2 largest mushroom production states; Pennsylvania and California. This mitigation scenario is in response to the health risks identified by the Health Effects Division of the Office of Pesticide Programs for applicators in mushroom houses.

There are limits to this assessment. The primary limit is the lack of available data associated with mushroom production ( 1996 survey). In addition, this assessment is limited to Agaricus mushrooms and does not include specialty mushrooms ( shiitake, oyster, etc.). However, as a result of different production practices for specialty mushrooms, this assessment should be reflective of enclosed mushroom house production. This assessment ignores potential changes in production which could occur associated with dichlorvos availability. It is also assumed that producers will not shift to alternate crops.

II. MUSHROOM PRODUCTION Mushroom production can be broken down into 3 regions in the US: East ( CT, DE, FL, FA, MD, NY, PA and TN), Central ( IL, IN, IA, MI, MO, OH, OK, TX, and WI), West ( CA, CO, MT, ND, OR, UR, and WA) ( Table 1). Sales of the 2001 02 US mushroom crop was 851 million pounds with a sales value of $ 911 million, including both Agaricus and specialty mushroom. Agaricus mushrooms accounted for 98.4% of total mushroom production. US fresh market production was 83 percent of total sales volume with processed making up the remaining 17 percent. There were 262 commercial mushroom producers in the US in 2001 02, of which 129 were Agaricus mushroom growers. Yields averaged 5.73 pounds per square foot. Producers received an average return of $ 5.98 per square foot.

Pennsylvania accounted for 54.9% of the total volume of sales in 2001 02 followed by California with 15.3% of total volume of sales. Brown mushrooms, including Portabello and Crimini varieties, accounted for 923 million pounds or 11% of total Argaricus volume sold.

Substrate preparation, mushroom composting, is a process of recycling organic matter to create a physical and biological medium optimized for mushroom production that requires 4  6 weeks. The process normally involves a 2  3 week preconditioning period, a 2  3 week windrow period with periodic turnings, filling into beds or trays, and the last phase of composting that is a closely managed process which includes steam pasteurization at 140 ° F for 4 6 hr. The substrate is spawned ( seeded) and the spawn is allowed to grow through the compost for 2 wks. Spawn is a sterilized cereal grain, rye, millet, wheat, etc, that is thoroughly grown through with mushroom mycelium. Spawn is produced in an aseptic building by about a dozen highly specialized companies who sell their products to mushroom farmers.

When the substrate is colonized by the spawn, a top dressing, a casing that is made from sphagnum peat moss ( or similar material) and agricultural limestone, is applied to the surface of 3 the substrate. The casing is irrigated periodically and both temperature and carbon dioxide levels are managed during the 4 10 day period required for the spawn to reach the surface of the casing and form into small primordia of mushrooms called pins and buttons.

Table 1. Area, Sales, Price, and Value of Agaricus and Specialty US mushroom production in 2001 02 State Area in Production ( 1,000 sq ft) Total Fillings ( 1,000sq ft) Volume of Sales ( 1,000 lbs) Price per Pound* ($) Value of Sales ( 1,000 $)

East 23,682 96,756 557,417 0.9 503,410 Central 2,476 18,048 103,855 1.39 144,097 West 7,157 31,459 176,594 1.29 227,029 US 33,315 146,263 837,866 1.04 874,536 * Prices for mushrooms are the average prices producers receive at the point of first sale, commonly referred to as the average price as sold. For example, part of the fresh mushrooms are sold F. O. B. packed by growers, part are sold bulk to brokers or repackers, and some are sold retail at roadside stands, the mushroom average price as sold is a weighted average of the average price for each method of sale.

Mushrooms grow rhythmically, being ready for harvest every 5 to 7 days. Each wave of mushrooms is called a break or flush with farms keeping the crop for 3 breaks. Harvesting is currently done by hand. After 3 breaks have been harvested, the production room is steam pasteurized, cleaned out and prepared for another filling. Each production room is occupied by a crop for 10 to 12 weeks which means 4 5 crops can be grown in a room each year. The standard production room contains 8000 square feet of producing surface and it is called a >

double =; average production is 5.8 lbs square feet ( fresh weight) per crop cycle.

III. USE OF DICHLORVOS IN MUSHROOM HOUSES Data for dichlorovos use in mushroom houses is lacking. The registrant, American Vanguard ( AMVAC), indicated that dichlorvos marketed for mushroom house use only represented 0.31% of total dichlorvos sales in 1996. The registrant provided data indicates that only 424 lbs were sold for mushroom house pest control in 1996. Survey data from 1992, indicated that only 3 of 59 ( 5%) mushroom growers used dichlorvos. Of the 3 using dichlorvos, only 1 grower indicated that dichlorvos was a # 1 priority at that time. Phone conversations with the American Mushroom Institute ( AMI) in 2003 indicated dichlorvos sales in PA had grown to 10% of agaricus mushroom producers representing 5% of state production.

IV. TARGET PESTS IN MUSHROOM HOUSES Dichlorvos is used primarily to control adult Sciarid and Phorid flies in mushroom 4 production. The adult flies are attracted by the smell of the substrate used in mushroom production. Dichlorvos can be used early in the crop cycle or at the end of crop production. A. SCIARID FLY Sciarid flies are the major pest in mushroom production. The Sciarid fly larvae has caused major and minor crop losses intermittently at most mushroom farms. In addition, Sciarid flies serve as vectors for disease causing organisms, which reduce the yield further and also reduce the quality of harvested mushrooms, and create a significant nuisance to the pickers. Left unchecked, the Sciarid fly will damage a mushroom crop by limiting the yield of mushrooms by as much as 70%.

Female Sciarids invade production houses as the compost cools down after peak heating. The invasion continues during spawning. Once inside, females will land on compost near the point of entry and lay up to 150 eggs. Females can detect residues of Dimilin and avoid laying eggs on substrate with this pesticide. Larvae hatch from eggs in 4 6 days at regular compost temperatures and begin feeding immediately on mycelium and the compost itself. Larvae go through 4 molts. Twenty one days after egg hatch, larvae forms a non feeding pupae. The pupal stage generally lasts about 1 week.

Feeding of larvae in the first generation probably does little damage to the crop, except where Trichoderma green mold is prevalent. In these instances, even a small number of flies can signigicantly magnify the damage from this disease. Very high numbers of larvae feeding in the compost during spawn run can inhibit fruit body production by destroying the compost and the mycelium. Crop damage and loss of yield and quality may also result from the ability of sciaried flies to mechanically spread mushroom diseases. The feeding of the second generation larvae also can be extensive and result in yield loss through degradation of the compost and casing, and destruction of mycelium and fruit body primordia in the casing. Severe infestations may result in larvae tunneling up into the stip resulting in a condition referred to as A black stem @

which renders the mushrooms unmarketable. Left unchecked, the Sciarid fly can reduce the yield of mushrooms by as much as 70%.

B. PHORID FLY Phorid flies pose a threat to crop yields and crop quality mostly as vectors of mushroom pathogens, both fungi and bacteria. Adult phorids generally enter the production rooms and houses later in the crop cycle than Sciarids.

Phorids prefer warmer temperatures and drier conditions in the substrate. Females lay about 50 eggs in areas where there is fresh mycelia growth. Eggs 5 hatch in several days and larvae begin feeding. Larvae may develop through 3 4 instars to adults in only 15 days in warm compost ( 75 80 E F). During cropping with lower temperatures ( 60 70 E F) in the casing, development may extend up to 50 days. Larvae only feed for 1/ 3 of the development period with the remainder spen as non feeding pupae.

Because larvae feed selectively, they are not capable of causing the kind of damage that Sciarids do as larvae. Economic crop damage similar to that caused by Sciarids may not occur until Phorid numbers are 50 to 100 times greater. Nevertheless, Phorid control is necessary to maintain crop health as these flies are capable transmitters of fungal and bacterial diseases. Phorid flies cause >

fly speck =

on mushroom caps which reduces the quality of mushrooms to the cull grade. Adults can also be a significant irritant to picking crews and may need to be controlled to maintain efficiency.

V. ALTERNATIVE CONTROL A. INSECTICIDE ALTERNATIVES Insecticide alternatives for fly control in mushroom houses is dependent upon the presence or absence of a crop. When crops are present, only 2 insecticides are recommended for use. These are: azadirachtin ( insect growth regulator) and piperonyl butoxide + pyrethrins ( adulticide). Fly resistance to pyrethrins is common. In the absence of a production crop ( compost and casing only), 6 insecticides are available for fly control. These include the growth regulators diflubenzuron, methoprene, and cyromazine. Adulticides for use in the absence of a production crop include diazinon, malathion, and permethrin. However, diazinon application is limited to the walls and floors only and fly resistance to permethrin has been noted. Larval fly control using insect growth regulators in the substrate is the preferred control strategy. Outside perimeter and walls are also subject to periodic application of methylcarbamate and diazinon.

B. BIOLOGICAL CONTROL Mushroom flies are good targets for biological control. Some of the agents which can be used for mushroom fly control include nematodes, microorganisms, mites, fungi, and biologically derived chemicals. However, none of these biological control agents have proven as effective in field situations as in laboratory studies. Also, all biological control agents have not been successfully commercialized.

C. CULTURAL CONTROL Cultural measures are a key components in controlling flies in mushroom 6 houses. Composting material is steam pasteurized to eliminate most insects and nematodes from the substrate. Steam pasteurization takes place in a room where the substrate is layed out in beds or trays at a depth of 10 to 18 inches. Pasteurization requires 2 to 4 hr when the compost and air temperature is held to at least 140 ° F. The substrate containers are also steam pasteurized during this process. Outside air used to manage the compost temperatures is filtered to minimize ingress by adult flying insects and fungal spores. Fine screens over openings, caulked cracks in walls and ceilings and air filters reduce the insect threat. The threat to the substrate is further reduced by minimizing breeding and roosting sites of the flies by mowing the grass and eliminating still water.

D. SHORTENING CROP CYCLE Any technique that shortens the length of the crop cycle aids pest control by reducing the amount of time pathogenic organisms have to reproduce. The strategy is to complete the harvest and pasteurize the room before pest populations can damage the crop. The benefits are twofold: first, when pest organisms enter a growing room, they do not have sufficient time to reach economically injurious levels within that crop. Second, it reduces the amount of innoculum on the farm for new crops in other rooms. This applies to arthropod pests as well as fungal pathogens. There are many ways to reduce the time needed for the cropping cycle. Most important, run the growing rooms properly from the start. Low temperatures or mechanical problems in spawning or casing can delay the onset of picking and expose the room to excessive increases in pest populations. Phase II rooms must be brought into conditioning range without undo delay. Cooldown tospawning times should be kept to a minimum, and proper spawning rates must be used to ensure complete colonization in a minimal amount of time. During cropping, remaining mushrooms from each break should be stripped to help the next break come in more quickly. Growing techniques that shorten crop cycles also should be considered, such as adding CAC ing ( Compost At Casing) to the casing layer and reducing the number of breaks. Through spawning and supplementation are examples of methods used in the past to shorten crop cycles.

VI. BIOLOGICAL IMPORTANCE OF DICHLORVOS FOR MUSHROOM HOUSES Exclusion of adult mushroom flies from mushroom growing rooms and incorporation of an insect growth regulator into the mushroom substrate have been major factors in lowering crop losses caused by Sciarid flies. However, adulticides are still important tools to control Phorid flies in mushroom production. Dichlorvos is one of only two adulticides available to mushroom producers. Loss of dichlorvos would ensure increased reliance on pyrethrins with increased potential for insecticide resistance. BEAD concludes that although use of dichlorvos is low, dichlorvos has a niche use with high benefits for mushroom production due to the lack of 7 alternatives.

VII. ECONOMIC IMPORTANCE OF DICHLORVOS FOR MUSHROOM HOUSES As discussed previously, dichlorvos is critical for mushroom growers for the control of the phorid fly in the Eastern US mushroom producing areas. There is only one alternative to dichlorvos available, and resistance to this pesticide has developed in a number of cases. As a result, if dichlorvos is not available for use, it is assumed that mushroom growers that have a phorid fly problem which necessitates the use of dichlorvos ( an estimated 10% of Eastern US mushroom growers per year), will not achieve control of the phorid fly. If uncontrolled, phorid flies pose a threat to mushroom crop quality by causing specking on the surface of the mushrooms, and crop yield, as vectors of mushroom pathogens, both fungi and bacteria.

Adult phorid flies enter the production mushroom houses early in the crop cycle, and dichlorvos is applied at this time to achieve control of the flies and prevent damage to the mushrooms. On average, there are approximately 4 production ( crop) cycles per year, with 3 breaks ( harvests) per cycle in a typical mushroom house. If phorid flies are a problem on a farm, it is assumed that they will be a problem for 3 production cycles in that year  with less activity during the forth cycle. As a result it is expected that mushroom growers would apply dichlorvos 3 times per year, once per cycle when the phorid fly is a problem.

Since the use of dichlorvos is estimated to occur only in Pennsylvania ( the major mushroom producing state in the US), and not in other mushroom production regions of the US, we assume that the phorid fly is only a problem in the Eastern US, and, therefore, impacts are assumed only to occur in the Eastern US if dichlorvos is not available for use.

Based on USDA data, there are approximately 21 million square feet of mushroom production in Pennsylvania and 24 million square feet of mushroom production in the Eastern US. USDA data for 2001/ 2002 estimate that there are 88 mushroom growers in the Eastern US, which produce an estimated 558 million pounds of mushrooms, valued at $ 503 million ( at an average price of $ 0.90 per pound). Average production per farm is approximately 6 million pounds, and there is an average of 22 mushroom houses per farm.

A. IMPACTS FOR A TYPICAL INFESTED MUSHROOM HOUSE A typical mushroom house has 4 production cycles per year, with 3 breaks per cycle. If dichlorvos is not available for use, it is assumed that on those farms in the Eastern US where phorid fly is a significant problem, the mushroom houses will likely face both losses in mushroom quality and yield in each break of a cycle in which the phorid fly is active. Assuming that the phorid fly is active early in a production cycle, the following losses are expected per break if dichlorvos is not available for use: 8 1. In the first break phorid fly numbers are expected to be relatively low. However, an estimated 25% of the harvested mushrooms will face a loss in quality due to specking on the mushrooms caused by the flies.

2. By the second break, phorid fly populations are expected to increase substantially. As a result, it is estimated that as much as 70% of the harvested mushrooms will be lost due to the rapid spread and development of disease spread by the flies in the mushroom house. The remaining 30% of production would not be damaged.

3. In the third break, it is expected that as much as 100% of the harvested mushrooms will be lost due to the spread of the disease. It is likely that prior to this occurring ( soon after the second break), the grower would abandon the house and sanitize the house to rid it of the phorid fly, in preparation for the next harvest cycle.

Assuming 6 million pounds of production, 22 houses per farm, 4 cycles per year, and 3 breaks per cycle, there are an estimated 22,750 pounds of mushrooms produced per break in a cycle in an average mushroom house on the average mushroom farm in the Eastern US ( 6 million pounds/ 22 houses/ 4 cycles/ 3 breaks). At a price of $ 0.90 per pound of mushrooms, the value per break is $ 20,475. As a result of a phorid fly infestation in a house, based on the assumptions above, we would expect the following impact on production:

1. In the first break, as a result a 25% quality loss, 5,688 pounds of production would shift from the fresh market to the processed market, and receive the processed market price of $ 0.30. The remaining 17,062 pounds of production would receive the fresh market price of $ 0.90. The value of production would be $ 17,062. This represents a loss of $ 3,413 ( or 17%) from the per break value of production.

2. In the second break, as a result of a 70% loss in yield, 30% of production ( 6,825 pounds) would be harvested for sale in the fresh market. The value of production in this market would be $ 6,142, which represents a loss of $ 14,333 ( or 70%) from the per break value of production.

3. In the third break, a 100% yield loss is expected, so no revenue will be earned for this break in the cycle.

The total value of the cycle across all three breaks, with an uncontrolled phorid fly infestation would be $ 23,204, which is a decline of $ 38,221 ( or 62%) 9 from the average value of production for a cycle ($ 61,425). Assuming ( in the worst case) that if a house is infested with phorid fly in the first cycle, 2 of the remaining 3 cycles of a house would face a similar level of phorid fly infestation in a year, the value of production in that house would decline to $ 131,037. This represents a decline of $ 114,663 ( or 47%) from the value of production for a typical mushroom house ($ 245,700)

A. IMPACTS FOR A TYPICAL FARM A typical mushroom farm in the Eastern Region has an average of 22 mushroom houses. However, at any one time, only an average of 2/ 3 of the mushroom houses on the farm are in production. The other 1/ 3 of mushroom houses are in a non production phase. As a result, it is assumed that if a farm is infested with the phorid fly, a maximum of 14 houses could face mushroom damage from infestation. It is important to note that a mushroom farm may not have a phorid fly problem every year. In fact, only an estimated 10% of the farms in the Eastern US are expected to have a significant phorid fly problem from year to year, and it is not expected that the same farms would have a phorid fly problem every year, although it certainly could be the case.

In the absence of additional data, we assume that if a farm has a phorid fly problem that necessitates the use of dichlorvos, all 14 mushroom houses in production on the farm will face the losses estimated for a typical mushroom house if diclorvos is not available for use to control the phorid fly ( as discussed above). Assuming revenues of $ 131,037 for a mushroom house with uncontrolled phorid fly infestation, for the 14 houses on a farm, per farm revenues would fall to $ 3.8 million ( assuming the other 8 houses on an average farm suffer no adverse impacts to production from the phorid fly). This represents a 30% decline ( a loss of $ 1.6 million) in revenues from the typical per farm revenues ($ 5.4 million). 10 B. IMPACTS FOR EAST TOTAL ( PENNSYLVANIA AND OTHER EASTERN STATES)

In 2001/ 2002 there were an estimated 88 farms in the Eastern US ( 78 farms in Pennsylvania and 10 farms in the other Eastern US states). Total production in the Eastern US has averaged approximately 558 million pounds of mushrooms at a value of around $ 503 million ( at $ 0.90/ lb). Assuming that only 10 percent of these farms are treated with dichlorvos to control phorid fly in a typical year, an estimated 9 farms will be affected if dichlorvos is not available for use. These farms represents 54 million pounds of mushroom ( 6 million pounds per farm), at a value of $ 49 million in the absence of losses due to the phorid fly. Based on the per house and per farm assumptions presented above for instances where phorid fly is a problem and dichlorovos is not available for use, revenues on these 9 farms could fall to $ 34 million ( 9 farms x $ 3.8 million per farm), which represents a loss of $ 15 million across those 9 farms. As a result, total revenues in the Eastern US would fall to $ 488 million, which is a 3% loss in total revenues in the Eastern US.

C. SUMMARY AND FINDINGS If dichlorvos is not available for use in mushroom houses, it is assumed that those Eastern US farmers that have phorid fly problems that require the use of dichlorvos ( 10% of Eastern US farmers per year) losses of as much as $ 1.6 million per farm, which represents a 30% decline in per farm revenues, due to losses in the quality and yield of the mushrooms harvested. Assuming that only 10% of the farms ( 9 farms) in the Eastern US are expected to have phorid fly problems requiring the use of dichlorvos in an average year, losses for the Eastern US mushroom industry ( and for the entire US, assuming that only the Eastern US has phorid fly problems necessitating the use of dichlorvos) could be as high as $ 15 million or 3% of the total value of Eastern US mushroom production ( or 2% of the total value of US mushroom production) ( see Table 2). However, it should be noted that phorid resistance to permethrin may increase over time and increase the number of growers impacted above the level evaluated in this assessment. 11 Table 2. Estimated Impacts to Mushroom Growers Of Not Having Dichlorvos Available for Use To Control Phorid Flies Losses per House Losses per Farm Losses for the Eastern U. S.

$ 114,663 $ 3.8 million $ 15 million 47% decline in revenues per house 30% decline in revenues per farm 3% decline in Eastern US revenues and 2% decline in total US revenues Source: Agricultural Statistics Board, NASS, USDA, Mushrooms, August 2002.

I. REFERENCES 1. Mushrooms. August 2002. Agricultural Statistics Board, NASS, USDA 2. Crop Profile for Mushrooms in Pennsylvania. January 1999. USDA. http:// pestdata. ncsu. edu/ cropprofiles/ docs/ pamushrooms. html 3. Crop Profile for Mushrooms in California. October 1999. USDA. Http:// pestdata. ncsu. edu/ cropprofiles/ docs/ camushrooms. html 4. Pesticides for Agaricus Production. Penn State University. Http:// mushgrowinfo. cas. psu. edu/ pesticides_ for_ agaricus_ mushroom_ production. htm 5. Proprietary Survey Data  American Mushroom Institute. 1992. 6. Personal Communication. Phillip Coles. Giorgi Mushroom Company. 7. Personal Communication. Dr. David Beyer. Plant Pathology  Pennsylvania State University. 8. Personal Communication. Dr. Shelby Fleishcher. Entomology  Pennsylvania State University. 9. Personal Communication. Laura Phelps. American Mushroom Institute. 10. Pennsylvania Mushroom Integrated Pest Management Handbook. 2002. Pennsylvania State University. http:// paipm. cas. psu. edu/ pdf/ mushroomIPMhandbook. pdf 11. Personal Communication. Dr. Cliff Keil. Entomology  University of Maryland.


[Federal Register Volume 83, Number 192 (Wednesday, October 3, 2018)]
[Notices]
[Pages 49920-49921]
[FR Doc No: 2018-21498]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP18-548-000]

Notice of Application: Eastern Shore Natural Gas Company

    Take notice that on September 14, 2018, Eastern Shore Natural Gas
Company (Eastern Shore), 500 Energy Lane, Suite 200, Dover, Delaware,
19901, filed in Docket No. CP18-548-000 an application pursuant to
section 7(c) of the Natural Gas Act (NGA) and Part 157 of the
Commission's regulations for authorization to construct, own and
operate: (i) About 4.9 miles of 16-inch-diameter loop line and
appurtenant facilities in Kent County, Delaware; (ii) about 7.39 miles
of 8-inch-diameter mainline extension and appurtenant facilities in
Sussex County, Delaware; (iii) about 6.83 miles of 10-inch-diameter
mainline extension in Wicomico and Somerset Counties, Maryland; (iv)
upgrades to an existing pressure control facility, including 0.35 miles
of 10-inch-diameter mainline extension in Sussex County, Delaware; and
(v) delivery point measurement and regulating facilities in Sussex
County, Delaware and Somerset County, Maryland (Del-Mar Energy Pathway
Project). Eastern Shore states that the proposed facilities will result
in an increase of 11,800 dekatherms per day of additional firm
transportation service and 2,500 dekatherms per day of off-peak
transportation service, or 14,300 dekatherms per day total. Eastern
Shore estimates the cost of the Del-Mar Energy Pathway Project to be
$37,100,000, all as more fully set forth in the application which is on
file with the Commission and open to public inspection.
    The filing is available for review at the Commission in the Public
Reference Room or may be viewed on the Commission's website 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 protected] or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Any questions regarding this application should be directed to Mark
C. Parker, P.E., Engineering Manager, Eastern Shore Natural Gas
Company; 500 Energy Lane, Suite 200, Dover, DE, 19901 at 1 (844) 366-
3764, or by email at [email protected].
    Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9),
within 90 days of this Notice, the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 3 copies of filings made with the Commission and must provide a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list and will be
notified of any meetings associated with the Commission's environmental
review process. Environmental commentors will not be required to serve
copies of filed documents on all other parties. However, the non-party
commentors will not receive copies of all documents filed by other
parties or issued by the Commission and will not have the right to seek
court review of the Commission's final order.
    As of the February 27, 2018 date of the Commission's order in
Docket No. CP16-4-001, the Commission will apply its revised practice
concerning out-of-time motions to intervene in any new Natural Gas Act
section 3 or section 7 proceeding.\1\ Persons desiring to become a
party to a certificate proceeding are to intervene in a timely manner.
If seeking to intervene out-of-time, the movant is required to ``show
good cause why the time limitation should be waived,'' and should
provide justification by reference to factors set forth in Rule
214(d)(1) of the Commission's Rules and Regulations.\2\
---------------------------------------------------------------------------

    \1\ Tennessee Gas Pipeline Company, L.L.C., 162 FERC ]61,167 at
]50 (2018).
    \2\ 18 CFR 385.214(d)(1).
---------------------------------------------------------------------------

    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 3 copies of the protest or intervention to the
Federal Energy

Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    Comment Date: October 18, 2018.

    Dated: September 27, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-21498 Filed 10-2-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Notices]
[Pages 69665-69666]
[FR Doc No: 2013-27825]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2013-0001; FRL-9902-31]

SFIREG Full Committee; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Association of American Pesticide Control Officials
(AAPCO)/State FIFRA Issues Research and Evaluation Group (SFIREG), Full
Committee will hold a 2-day meeting, beginning on December 9, 2013 and
ending December 10, 2013. This notice announces the location and times
for the meeting and sets forth the tentative agenda topics.

DATES: The meeting will be held on Monday, December 9, 2013 from 8:30
a.m. to 5 p.m. and 8:30 a.m. to noon on Tuesday, December 10, 2013.
    To request accommodation of a disability, please contact the person
listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10
days prior to the meeting, to give EPA as much time as possible to
process your request.

ADDRESSES: The meeting will be held at EPA. One Potomac Yard (South
Bldg.)

2777 Crystal Dr., Arlington VA, 1st Floor, South Conference Room.

FOR FURTHER INFORMATION CONTACT: Ron Kendall, Field External Affairs
Division, Office of Pesticide Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. 7506P NW., Washington, DC 20460-0001;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>or Grier Stayton, SFIREG Executive
Secretary, P.O. Box 466, Milford DE 19963; telephone number (302) 422-
8152; fax<PHONE_NUMBER>; email address: Grier Stayton at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are
interested in pesticide regulation issues affecting States and any
discussion between EPA and SFIREG on FIFRA field implementation issues
related to human health, environmental exposure to pesticides, and
insight into EPA's decision-making process. You are invited and
encouraged to attend the meetings and participate as appropriate.
Potentially affected entities may include, but are not limited to:
Those persons who are or may be required to conduct testing of chemical
substances under the Federal Food, Drug and Cosmetics Act (FFDCA), or
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and
those who sell, distribute or use pesticides, as well as, any non-
government organization.
    If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket ID number EPA-HQ-
OPP-2013-0001 is available at http://www.regulations.gov, or at the
Office of Pesticide Programs Regulatory Public Docket Center (EPA/DC),
EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC
20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the OPP Docket is<PHONE_NUMBER>. Please review the visitor
instructions and additional information about the docket available at
http://www.epa.gov/dockets.

II. Tentative Agenda Topics

1. Issue Papers Status
2. Status of Non-Cropland Issue Resolution
3. Endangered Species Act Program Status
4. Soil Fumigation Risk Mitigation
5. Status of Pollinator Protection Issues Policy Development
6. Discussion of Herbicide Residues in Compost Activities
7. Cooperative Agreement Guidance/Grant Template
8. Project Officer Training
9. Rewrite of 24c Guidance
10. National Pesticide Information Center/State Lead Agency Information
Exchange/OPP Use of Data
11. Update on 25b Letter From EPA for States to Use
12. Program Performance Measures Development and Implementation
13. Tribal Pesticide Program Council (TPPC) Report/Tribal Pesticide
Policy Council/State Lead Agency Project Initiative
14. Regulator in Residence Activities

III. How can I request to participate in this meeting?

    This meeting is open for the public to attend. You may attend the
meeting without further notification.

List of Subjects

    Environmental protection.

    Dated: November 4, 2013.
Jay S. Ellenberger,
Acting Director, Field External Affairs Division, Office of Pesticide
Programs.
[FR Doc. 2013-27825 Filed 11-19-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 29 (Thursday, February 12, 2015)]
[Notices]
[Pages 7884-7886]
[FR Doc No: 2015-02916]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 31449; 812-14235]

AB Cap Fund, Inc., et al.; Notice of Application

February 6, 2015.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from section 15(a) of
the Act and rule 18f-2 under the Act, as well as from certain
disclosure requirements.

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

Summary of Application: Applicants request an order that would permit
them to enter into and materially amend subadvisory agreements without
shareholder approval and would grant relief from certain disclosure
requirements.

Applicants: AP Cap Fund, Inc. (the ``Corporation'') and
AllianceBernstein L.P. (``Adviser'' and together with the Corporation,
``Applicants'').

Filing Dates: The application was filed November 14, 2013, and amended
on March 31, 2014 and January 7, 2015.

Hearing or Notification of Hearing: An order granting the application
will be issued unless the Commission orders a hearing. Interested
persons may request a hearing by writing to the Commission's Secretary
and serving applicants with a copy of the request, personally or by
mail. Hearing requests should be received by the Commission by 5:30
p.m. on March 2, 2015 and should be accompanied by proof of service on
the applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Pursuant to rule 0-5 under the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, the reason
for the request, and the issues contested. Persons who wish to be
notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549-1090. Applicants: Emilie D. Wrapp,
Esq., AllianceBernstein L.P., 1345 Avenue of the Americas, New York, NY
10105.

FOR FURTHER INFORMATION CONTACT: Emerson S. Davis, Senior Counsel, at
(202) 551-6868, or Daniele Marchesani, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>.

Applicants' Representations

    1. The Corporation, a Maryland corporation, is registered under the
Act as an open-end management investment company that consists of
several series (``Series''), each with its own investment objectives,
policies and restrictions.\1\
---------------------------------------------------------------------------

    \1\ The Corporation's Series include the AB Multi-Manager
Alternative Strategies Fund series, the AB Multi-Manager Select
Retirement Allocation Fund series, the AB Multi-Manager Select 2010
Fund series, the AB Multi-Manager Select 2015 Fund series, the AB
Multi-Manager Select 2020 Fund series, the AB Multi-Manager Select
2025 Fund series, the AB Multi-Manager Select 2030 Fund series, the
AB Multi-Manager Select 2035 Fund series, the AB Multi-Manager
Select 2040 Fund series, the AB Multi-Manager Select 2045 Fund
series, the AB Multi-Manager Select 2050 Fund series, the AB Multi-
Manager Select 2055 Fund series and the AB Long/Short Multi-Manager
Fund (the ``Initial Funds''). Applicants request that the relief
sought herein apply to Applicants, as well as to any existing or
future Series of the Corporation and to any other existing or future
registered open-end investment company or series thereof that: (a)
Is advised by the Adviser (any such series or investment company,
including without limitation the Corporation, the Initial Funds and
any Series of the Corporation, a ``Fund''); (b) uses the manager of
managers structure described in this application (``Manager of
Managers Structure''); and (c) complies with the terms and
conditions of this application (the ``Subadvised Funds,'' and each a
``Subadvised Fund''). The only existing registered open-end
management investment company that currently intends to rely on the
requested order is named as an Applicant, and the Series that
currently intend to rely on the requested order are identified in
this application as Initial Funds. Any entity that relies on the
requested order will do so only in accordance with the terms and
conditions of this application. If the name of any Subadvised Fund
contains the name of a subadviser, the name of the Adviser that
serves as the primary adviser to that Subadvised Fund or a trademark
or trade name that is owned by or publicly used to identify that
Adviser will precede the name of the subadviser.
---------------------------------------------------------------------------

    2. AllianceBernstein L.P., a Delaware limited partnership, is and
any future Adviser (as defined below) will be registered as an
investment adviser under the Investment Advisers Act of 1940
(``Advisers Act''). AllianceBernstein L.P currently serves as the
investment adviser to the Initial Funds. An Adviser will serve as an
investment adviser to each Subadvised Fund pursuant to an investment
advisory agreement with the Corporation (each an ``Investment Advisory
Agreement''). Each Investment Advisory Agreement has been, or will be,
approved by the board of directors of the Corporation (the ``Board''),
including a majority of the directors who are not ``interested
persons,'' as defined in section 2(a)(19) of the Act, of the
Corporation or the Adviser (``Independent Directors'') and by the
shareholders of the relevant Subadvised Fund in the manner required by
sections 15(a) and 15(c) of the Act and rule 18f-2 under the Act.\2\
Applicants are not seeking any exemption from the provisions of the Act
with respect to the Advisory Agreement.
---------------------------------------------------------------------------

    \2\ The term ``Board'' also includes the board of trustees or
directors of an existing or future Subadvised Fund.
---------------------------------------------------------------------------

    3. Each Investment Advisory Agreement will permit the Adviser to
manage the investment and reinvestment of the assets of each Subadvised
Fund and to provide management services with respect to a Subadvised
Fund. For the investment management services it provides to a
Subadvised Fund, the Adviser will receive from that Subadvised Fund the
fee specified in its Investment Advisory Agreement, payable monthly at
an annual rate based on the average daily net assets of the Subadvised
Fund.
    4. The Investment Advisory Agreement will permit the Adviser to
enter into subadvisory agreements (``Subadvisory Agreements'') with
certain investment subadvisers (``Subadvisers''). Each Subadviser will
be an investment adviser as defined in section 2(a)(20) of the Act, and
either will be registered with the Commission as an investment adviser
under the Advisers Act or not subject to such registration. The Adviser
will evaluate, allocate assets to and oversee the Subadvisers, and make
recommendations about their hiring, termination and replacement to the
Board, at all times subject to the authority of the Board.
    5. For the services provided under each Subadvisory Agreement, it
is currently intended that the applicable Subadviser will receive from
the Adviser a fee based on a percentage of the Subadvised Fund's
average daily total or net assets or allocated portion thereof. Where
the Adviser is responsible for paying Subadvisory fees to the
Subadviser, the Adviser will compensate each Subadviser out of its
assets. Subadvised Funds may directly pay advisory fees to Subadvisers
in the future.
    6. Applicants request an order to permit the Adviser, subject to
Board approval, to select certain Subadvisers to manage all or a
portion of the assets of a Subadvised Fund pursuant to a Sub-Advisory
Agreement and materially amend Sub-Advisory Agreements without
obtaining shareholder approval. The requested relief will not extend to
any Subadviser that is an affiliated

person, as defined in section 2(a)(3) of the Act, of the Corporation, a
Subadvised Fund or the Adviser, other than by reason of serving as a
Subadviser to a Subadvised Fund (``Affiliated Subadviser'').
    7. Applicants also request an order exempting the Subadvised Funds
from certain disclosure provisions described below that may require the
Applicants to disclose fees paid to each Subadviser by the Adviser or a
Subadvised Fund. Applicants seek an order to permit each Subadvised
Fund to disclose (as a dollar amount and a percentage of a Subadvised
Fund's total or net assets) only: (a) The aggregate fees paid to the
Subadvised Fund's Adviser and any Affiliated Subadvisers; and (b) the
aggregate fees paid to Subadvisers other than Affiliated Subadvisers
(collectively, the ``Aggregate Fee Disclosure''). All other items
required by sections 6-07(2)(a), (b) and (c) of Regulation S-X will be
disclosed. A Subadvised Fund that employs an Affiliated Subadviser will
provide separate disclosure of any fees paid to the Affiliated
Subadviser.
    8. The Subadvised Funds will inform shareholders of the hiring of a
new Subadviser pursuant to the following procedures (``Modified Notice
and Access Procedures''): (a) Within 90 days after a new Subadviser is
hired for any Subadvised Fund, that Subadvised Fund will send its
shareholders either a Multi-manager Notice or a Multi-manager Notice
and Multi-manager Information Statement; \3\ and (b) the Subadvised
Fund will make the Multi-manager Information Statement available on the
Web site identified in the Multi-manager Notice no later than when the
Multi-manager Notice (or Multi-manager Notice and Multi-manager
Information Statement) is first sent to shareholders, and will maintain
it on that Web site for at least 90 days.
---------------------------------------------------------------------------

    \3\ A ``Multi-manager Notice'' will be modeled on a Notice of
Internet Availability as defined in rule 14a-16 under the Exchange
Act, and specifically will, among other things: (a) Summarize the
relevant information regarding the new Subadviser; (b) inform
shareholders that the Multi-manager Information Statement is
available on a Web site; (c) provide the Web site address; (d) state
the time period during which the Multi-manager Information Statement
will remain available on that Web site; (e) provide instructions for
accessing and printing the Multi-manager Information Statement; and
(f) instruct the shareholder that a paper or email copy of the
Multi-manager Information Statement may be obtained, without charge,
by contacting the Subadvised Funds. A ``Multi-manager Information
Statement'' will meet the requirements of Regulation 14C, Schedule
14C and Item 22 of Schedule 14A under the Exchange Act for an
information statement, except as modified by the requested order to
permit Aggregate Fee Disclosure. Multi-manager Information
Statements will be filed electronically with the Commission via the
EDGAR system.
---------------------------------------------------------------------------

Applicants' Legal Analysis

    1. Section 15(a) of the Act provides, in relevant part, that it is
unlawful for any person to act as an investment adviser to a registered
investment company except pursuant to a written contract that has been
approved by the vote of a majority of the company's outstanding voting
securities. Rule 18f-2 under the Act provides that each series or class
of stock in a series investment company affected by a matter must
approve that matter if the Act requires shareholder approval.
    2. Form N-1A is the registration statement used by open-end
investment companies. Item 19(a)(3) of Form N-1A requires disclosure of
the method and amount of the investment adviser's compensation.
    3. Rule 20a-1 under the Act requires proxies solicited with respect
to an investment company to comply with Schedule 14A under the
Securities Exchange Act of 1934 (``Exchange Act''). Items 22(c)(1)(ii),
22(c)(1)(iii), 22(c)(8) and 22(c)(9) of Schedule 14A, taken together,
require a proxy statement for a shareholder meeting at which the
advisory contract will be voted upon to include the ``rate of
compensation of the investment adviser,'' the ``aggregate amount of the
investment adviser's fees,'' a description of the ``terms of the
contract to be acted upon,'' and, if a change in the advisory fee is
proposed, the existing and proposed fees and the difference between the
two fees. Regulation S-X sets forth the requirements for financial
statements required to be included as part of a registered investment
company's registration statement and shareholder reports filed with the
Commission. Sections 6-07(2)(a), (b) and (c) of Regulation S-X require
a registered investment company to include in its financial statement
information about the investment advisory fees.
    4. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction or any class or classes of
persons, securities, or transactions from any provisions of the Act, or
from any rule thereunder, if such exemption is necessary or appropriate
in the public interest and consistent with the protection of investors
and the purposes fairly intended by the policy and provisions of the
Act. Applicants state that the requested relief meets this standard for
the reasons discussed below.
    5. Applicants assert that the shareholders expect the Adviser,
subject to the review and approval of the Board, to select one or more
Subadvisers who are well suited to achieve the Subadvised Fund's
investment objective. Applicants assert that, from the perspective of
the shareholder, the role of the Subadviser is substantially equivalent
to the role of the individual portfolio managers employed by an
investment adviser to a traditional investment company. Applicants
believe that without the requested relief, the Subadvised Funds may be
(i) precluded from promptly and timely hiring Subadvisers or materially
amending Subadvisory Agreements, or (ii) subject to delays and
additional expense of proxy solicitation when hiring Subadvisers or
materially amending Subadvisory Agreements considered appropriate by
the Adviser and the Board. Applicants note that the Investment Advisory
Agreement for each Subadvised Fund and subadvisory agreements with
Affiliated Subadvisers (if any) will continue to be subject to the
shareholder approval requirements of section 15(a) of the Act and rule
18f-2 under the Act.
    6. Applicants assert that the requested disclosure relief would
benefit shareholders of the Subadvised Funds because it would improve
the Adviser's ability to negotiate the fees paid to Subadvisers.
Applicants state that the Adviser may be able to negotiate rates that
are below a Subadvisers ``posted'' amounts, if the Adviser is not
required to disclose the Subadvisers' fees to the public. Applicants
submit that the requested relief will also encourage Subadvisers to
negotiate lower subadvisory fees with the Adviser if the lower fees are
not required to be made public.

Applicants' Conditions

    Applicants agree that any order granting the requested relief will
be subject to the following conditions:
    1. Before a Subadvised Fund may rely on the order requested herein,
the operation of the Subadvised Fund in the manner described in the
application will be approved by a majority of the Subadvised Fund's
outstanding voting securities as defined in the Act, or, in the case of
a Subadvised Fund whose public shareholders purchase shares on the
basis of a prospectus containing the disclosure contemplated by
condition 2 below, by the initial shareholder before such Subadvised
Fund's shares are offered to the public.
    2. The prospectus for each Subadvised Fund will disclose the
existence, substance, and effect of any order granted pursuant to the
application. In addition, each Subadvised Fund will hold itself out to

the public as employing the Manager of Managers Structure. The
prospectus will prominently disclose that the Adviser has the ultimate
responsibility, subject to oversight by the Board, to oversee the
Subadvisers and recommend their hiring, termination, and replacement.
    3. Subadvised Funds will inform shareholders of the hiring of a new
Subadviser within 90 days after the hiring of the new Subadviser
pursuant to the Modified Notice and Access Procedures.
    4. The Adviser will not enter into a Subadvisory Agreement with any
Affiliated Subadviser unless such agreement, including the compensation
to be paid thereunder, has been approved by the shareholders of the
applicable Subadvised Fund.
    5. At all times, at least a majority of the Board will be
Independent Directors, and the selection and nomination of new or
additional Independent Directors will be placed within the discretion
of the then-existing Independent Directors.
    6. Independent Legal Counsel, as defined in rule 0-1(a)(6) under
the Act, will be engaged to represent the Independent Directors. The
selection of such counsel will be within the discretion of the then-
existing Independent Directors.
    7. Whenever a subadviser change is proposed for a Subadvised Fund
with an Affiliated Subadviser, the Board, including a majority of the
Independent Directors, will make a separate finding, reflected in the
Board minutes, that the change is in the best interests of the
Subadvised Fund and its shareholders, and does not involve a conflict
of interest from which the Adviser or the Affiliated Subadviser derives
an inappropriate advantage.
    8. Whenever a subadviser is hired or terminated, the Adviser will
provide the Board with information showing the expected impact on the
profitability of the Adviser.
    9. The Adviser will provide the Board, no less frequently than
quarterly, with information about the profitability of the Adviser on a
per Subadvised Fund basis. The information will reflect the impact on
profitability of the hiring or termination of any subadviser during the
applicable quarter.
    10. The Adviser will provide general management services to each
Subadvised Fund, including overall supervisory responsibility for the
general management and investment of the Subadvised Fund's assets and,
subject to review and approval of the Board, will: (i) Set the
Subadvised Fund's overall investment strategies; (ii) evaluate, select,
and recommend Subadvisers to manage all or a portion of the Subadvised
Fund's assets; (iii) allocate and, when appropriate, reallocate the
Subadvised Fund's assets among Subadvisers; (iv) monitor and evaluate
the Subadvisers' performance; and (v) implement procedures reasonably
designed to ensure that Subadvisers comply with the Subadvised Fund's
investment objective, policies and restrictions.
    11. No Director or officer of a Subadvised Fund or director,
manager or officer of the Adviser will own directly or indirectly
(other than through a pooled investment vehicle that is not controlled
by such person) any interest in a Subadviser except for (i) ownership
of interests in the Adviser or any entity that controls, is controlled
by or is under common control with the Adviser; or (ii) ownership of
less than 1% of the outstanding securities of any class of equity or
debt of any publicly traded company that is either a Subadviser or an
entity that controls, is controlled by or is under common control with
a Subadviser.
    12. Each Subadvised Fund will disclose in its registration
statement the Aggregate Fee Disclosure.
    13. In the event the Commission adopts a rule under the Act
providing substantially similar relief to that in the order requested
in the application, the requested order will expire on the effective
date of that rule.
    14. Any new Subadvisory Agreement or any changes to an Investment
Advisory Agreement or to a Subadvisory Agreement that directly or
indirectly results in an increase in the aggregate advisory rate
charged to a Subadvised Fund will be required to be approved by the
shareholders of the Subadvised Fund.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Brent J. Fields,
Secretary.
[FR Doc. 2015-02916 Filed 2-11-15; 8:45 am]
BILLING CODE 8011-01-P


Occupational Handler and Postapplication Cancer Risk

There are no definitive data regarding the numbers of exposures per year
or numbers of years “worked” per lifetime of pesticide handlers or
of agricultural workers.  Therefore, HED calculated risk for handlers
and post-application workers assuming 10 and 30 days of exposure per
year over a 35-year “working” lifetime and a 70-year lifespan.  As
can be seen below in Tables 8.3.1 and 8.3.2, risks are not of concern
even for 30 days of exposure per year.

An estimate of cancer risk is calculated by multiplying the Q1* value by
a Lifetime Average Daily Dose (LADD).  The LADD is calculated using the
following convention:

(Average Daily Dose (mg ai/kg bw/day [dermal + inhalation]) * 10 day/yr
* 35 year

                                         70 year * 365 day/yr

The ADD is taken from Table 8.1 for occupational handlers and from the
post-application discussion in Section 8.2 for agricultural workers.  A
sample calculation for a mixer/loader using protective gloves is as
follows:

(0.000103 mg ai/kg bw/day dermal + 0.00027 mg ai/kg bw/day inhalation )
* 10 day/yr * 35 yr
                       				70 year * 365 day/yr

5.1 x 10-6 mg ai/kg bw/day.

Cancer risk is calculated by Q1* * LADD and in the example

1.49 x 10-2 mg ai/kg bw/day * 5.1 x 10-6 = 7.6 x 10-8.

See Table 8.3.1 and 8.3.2 below for a summary of cancer risks assuming
10 and 30 work days per year.

Table 8.3.1.  Handler and Post-Application Cancer Risks From Exposure to
Spirodiclofen Assuming 10 work days per year.

Lifetime Average Daily Dose

(mg ai/kg bw/day)	Q1*

(mg ai/kg bw/day)

	Mixer/loader Using Gloves

5.1 x 10-6

1.49 x 10-2

	7.6 x 10-8

Airblast Applicator Using Gloves

2.8 x 10-5

4.2 x 10-7

Airblast Applicator Not Using Gloves

3.6 x 10-5

5.4 x 10-7

Hops

Training vines

5.3 x 10-5

8.0 x 10-7

Table 8.3.2.  Handler and Post-Application Cancer Risks From Exposure to
Spirodiclofen Assuming 30 work days per year.

Lifetime Average Daily Dose

(mg ai/kg bw/day)	Q1*

(mg ai/kg bw/day)

	Mixer/loader Using Gloves

1.5 x 10-5

1.49 x 10-2

	2.0 x 10-7

Airblast Applicator Using Gloves

8.5 x 10-5

1.2 x 10-6

Airblast Applicator Not Using Gloves

1.2 x 10-4

1.5 x 10-6

Hops

Training vines

8.4 x 10-4

1.2 x 10-5

Since the estimated cancer risks are below 10-5 for all scenarios, HED
does not have a concern for the proposed use on hops.

REI

Spirodiclofen is classified in Acute Toxicity Category III for acute
oral and acute dermal toxicity and Acute Toxicity Category IV for acute
inhalation, primary eye irritation and primary skin irritation.  It is a
dermal sensitizer.  The interim Worker Protection Standard (WPS) REI of
12 hours is adequate to protect workers training hops vines after
treatment.  The proposed labels are in compliance with the WPS REI.

9.0  Data Needs and Label Requirements tc \l1 "10.0  Data Needs and
Label Requirements

Toxicology tc \l2 "10.1  Toxicology

The toxicological database for spirodiclofen is complete.  The HED HIARC
requested a 28-day inhalation toxicity study as a condition of
registration.  However, based on the low volatility and low inhalation
toxicity (Category IV) of spirodiclofen and inhalation MOEs of at least
1000 for the proposed handler uses, spirodiclofen qualifies for a waiver
of the 28-day inhalation toxicity study for the proposed uses (HED SOP
2002.01: Guidance: Waiver Criteria for Multiple-Exposure Inhalation
Toxicity Studies, 08/15/02).  The requirement for the 28-day inhalation
toxicity study is waived for this action only.  If in the future,
requests for new uses or formulations are submitted that may result in a
significant change in either the toxicity profile or exposure scenarios,
HED will reconsider this data requirement.

Attachments follow (2)

Attachment 1: Chemical Names and Structures of Spirodiclofen and its
Metabolites

Attachment 2: Toxicity Profile for Spirodiclofen

Attachment 1: Chemical Names and Structures of Spirodiclofen and its
Metabolites

Chemical Name	Structure

Spirodiclofen; BAJ2740

3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl
2,2-dimethylbutanoate

BAJ 2510

3-OH-enol

4-OH-enol

Attachment 2: Toxicity Profile for Spirodiclofen tc \l1 "Attachment 2:
Toxicology Data Requirements

Subchronic, Chronic and Other Toxicity Profile for Spirodiclofen

Guideline No./ Study Type/

MRID Nos.

Doses/Classification

Results

870.3100

Subchronic Oral

- Rat

45696715, 45696716 (1998,2003)

(0,100,500,2500,12500 ppm)

M:0,6.6,32.1,166.9,851.4 mg/kg/day

F:0,8.1,47.1 215.3995.8 mg/kg/day

Acceptable/guideline

For males, NOAEL = 32.1 mg/kg/day, LOAEL = 166.9 mg/kg/day based on
increased incidence and severity of small cytoplasmic vacuolation in the
cortex of adrenal glands, decreased cholesterol (week 5 and 13), and
decreased triglycerides (week 5).

For females, NOAEL= 8.1 mg/kg/day, LOAEL= 47.1 mg/kg/day based on
increased incidence of small cytoplasmic vacuolation in the cortex of
adrenal glands.

870.3100

Subchronic Oral

- Mouse

45696711,45696712,45696713(1997)

(0,100,1000,10,000 ppm)

M:0,15,164,1640 mg/kg/day

F: 0,30,234,2685 mg/kg/day

Acceptable/guideline

For males, NOAEL= 15 mg/kg/day, LOAEL= 164 mg/kg/day based on an
increased incidence of hypertrophic Leydig cells in the testes.

For females, NOAEL = 30 mg/kg/day, LOAEL= 234mg/kg/day based on an
increased incidence of cytoplasmic vacuolation of the adrenal cortex.

870.3150

Subchronic Oral

- Dog

45696803,45696804 (2000)

(0,200,630,2000 ppm)

0,7.7,26.6,84.7 mg/kg/day (M)

0,8.4,28.0,81.0 mg/kg/day(F)

Acceptable/guideline

For males, NOAEL= 7.7 mg/kg/day, LOAEL = 26.6 mg/kg/day based on
decreased body-weight gains, increased liver and adrenal weights,
decreased prostate weights, and histopathology findings in the adrenal
glands, testes, epididymis, thymus, and prostates.

For females, NOAEL (8.4 mg/kg/day. LOAEL=8.4 mg/kg/day based on
increased adrenal gland weight (two out of four animals) which coincided
with histopathology findings (cytoplasmic vacuoles in the Zona
fasciculata of the adrenal glands).

870.3200

28-Day dermal toxicity

- Rat

45696806 (1999)

0, 1000 mg/kg/day

Unacceptable/Guideline

The NOAEL=1000 mg/kg/day (HDT; highest dose tested); however, the
histopathology was not appropriately conducted as required by the
guideline. The study did not examine all of the tissues, especially the
possible target organs (i.e., uterus, prostate, etc).

870.3700a

Prenatal developmental

- Rat

45696906 (2000)

0,100,300,1000 mg/kg/day

Acceptable/Guideline

Maternal: NOAEL =1000 mg/kg/day (HDT)

Developmental:NOAEL= 300 mg/kg/day, LOAEL =1000 mg/kg/day based on an
increased incidence of slight dilatation of the renal pelvis.

870.3700b

Prenatal developmental

- Rabbit

45696714 (1998)

0,100,300,1000 mg/kg/day

Acceptable/guideline

Maternal: NOAEL = 100 mg/kg/day, LOAEL =300 mg/kg/day based on
body-weight loss and decreased food consumption.

Developmental: NOAEL =1000 mg/kg/day (HDT)

870.3800

Reproduction and fertility effects

- Rat

45696802,45696709 (2000)

(0,70,350,1750 ppm)

M: 0,5.2,26.2,134.8 mg/kg/day

F: 0,5.5,27.6,139.2 mg/kg/day

Acceptable/guideline

Parental/system:

For males: NOAEL= 5.2-6.4 mg/kg/day, LOAEL =26.2-30.2 mg/kg/day based on
decreased body weight in F0 males; decreased absolute and relative liver
weight in F0 males; decreased cholesterol and triglycerides in F1 males;
and increased severity of adrenal cortical vacuolation in F1 males. For
females, NOAEL= 5.5-7.0 mg/kg/day, LOAEL= 27.6-34.4 mg/kg/day based on
decreased unesterified fatty acids in F1 females, and increased severity
of adrenal cortical vacuolation in F0 and F1 females.

Reproductive:

For males: NOAEL= 26.2-30.2 mg/kg/day, LOAEL=134.8-177.6 mg/kg/day based
on delayed sexual maturation; decreased testicular spermatid and
epididymal sperm counts (oligospermia); and atrophy of the testes,
epididymides, prostate and seminal vesicles. For females: NOAEL=
27.6-34.4 mg/kg/day, LOAEL= 139.2-192.7 mg/kg/day based on increased
severity of ovarian luteal cell vacuolation/ degeneration.

Offspring:

NOAEL= 5.2-6.4 (M)/5.5-7.0 (F) mg/kg/day, LOAEL= 26.2-30.2 (M)/
27.6-34.4(F) mg/kg/day based on decreased body weight and weight gain in
F1 male and female pups.

870.4300

Chronic toxicity

-Rat

45696808,45696809 (2000)

(0,50,100,350,2500 ppm)

M: 0,2.0,4.1,14.7,110.1 mg/kg/day

F: 0,2.9,5.9,19.9,152.9 mg/kg/day

Acceptable/guideline

For males: NOAEL= 14.7 mg/kg/day, LOAEL= 110.1 mg/kg/day based on
decreased body weights, decreased body-weight gain, increased APh
levels, decreased cholesterol and triglyceride levels, increased
vacuolated jejunum enterocytes, and increased incidences of Leydig cell
hyperplasia.

For females: NOAEL= 19.9 mg/kg/day, LOAEL= 152.9 mg/kg/day based on
decreased body weights, decreased body-weight gain, increased APh
levels, increased TSH, uterus nodules, and increased vacuolated jejunum
enterocytes.

(testes Leydig cell adenoma in males, (uterine adenoma and/or
adenocarcinoma in females.

870.4100b

Chronic toxicity

- dog

45696810,45696811 (2001)

(0,20,50,150,500/600 ppm)

M: 0,0.56,1.38,4.33,16.1 mg/kg/day

F: 0,0.59,1.52,4.74,17.7 mg/kg/day

Acceptable/guideline

NOAEL= 1.38 (M)/1.52(F) mg/kg/day, LOAEL= 4.33(M)/4.74 (F) mg/kg/day
based on increased relative adrenal weights in both sexes, increased
relative testis weight in males and histopathology findings in the
adrenal gland of both sexes.

870.4200b

Carcinogenicity

- mouse

45696724 (2000)

(0,25,3500,7000 ppm)

M: 0,4.1,610,1216 mg/kg/day

F: 0,5.1,722,1495 mg/kg/day

Acceptable/guideline

NOAEL= 4.1(M)/5.1(F) mg/kg/day, LOAEL= 610 (M) mg/kg/day based on
increased absolute and relative liver and adrenal weights, decreased
absolute and relative kidney weight, enlarged adrenal gland, discolored
testis, adrenal gland vacuolization, interstitial cell degeneration of
the testes. For females, LOAEL= 722 mg/kg/day based on increased
absolute and relative adrenal weight, decreased absolute and relative
kidney weight, increased incidences of adrenal gland pigmentation, and
adrenal vacuolization.

(Hepatocellular adenoma and carcinoma.

870.5100

Gene mutation

Salmonella typhimurium

45696702

Acceptable/guideline

There was no evidence of increased revertant colonies above control in 5
Salmonella strains
(Tㅁ㌵ⰵ吠ㅁ㌵ⰷ吠ㅁ㌵ⰸ吠ㅁ〰䅔㠹
₱㥓愠⁴潣
据湥牴瑡潩獮甠⁰潴㔠〰‰枵瀯慬整ܮഇ㜸⸰㌵〰䤍
楶牴慍浭污慩敃汬䜠湥畍慴楴湯ഇ㔴㤶㘶㐱䄍捣
灥慴汢⽥畧摩汥湩ݥ

摧℔®	̀Ȥ␱愁Ȥ摧㯱	̀Ĥ␱愁Ĥ摧㯱

h

E

F

g

h

i

q

r

›

œ

¢

¥

º

È

É

Ì

Ï

Ñ

Þ

à

õ

þ

h

i

œ

º

Ë

Ì

÷

ž

Ÿ

ð

ñ

ø

ù

ú

ý

j

ᄀ脈栖⨤9ࡕ洁H渄H甄Ĉᄔ脈栖绝{䡭Ѐ䡮Ѐࡵḁ

j

  h°

h°

h°

h†

h†

@

gd†

h†

h†

h†

$

hþ

”ÿ@

	¬

”ÿ@

	¬

”ÿ@

	¬

”ÿ@

¬

”ÿ@

	¬

”ÿ@

	¬

@

@

hø

hø

hø

@

@

‰

gd†

@

@

@

 hÀc

à

á

õ

ö

F

Q

ý

þ

 hÀc

@

h†

@

h†

$

@

h/

h/

@

h

愀Ĥ摧眈Ï

愀Ĥ摧眈Ï

Î

Ï

*

+

K

L

Z

Ë

ä

å

愀Ĥ摧પ¡

@

@

\

\

\

\

\

\

\

\

\

\

\

\

摧પ¡ԀNegative, tested in Chinese Hamster lung fibroblast V79 cells
at concentrations up to 300 ug/mL -S9 and +S9. Cytotoxicity was observed
at (15 ug/mL -S9 and 80 ug/mL +S9.

870.5375

In vitro Mammalian Chromosome Aberration

45696615 (1996)

Acceptable/guideline

Negative, tested in Chinese hamster lung (V79) cells at concentrations
5-80 ug/mL or 0.75-12 ug/mL -S9 or 10-160 ug/mL +S9.

870.5395

In vivo Mouse Bone Morrow Micronucleus

45696701 (1996)

Acceptable/guideline

Negative, tested at a dose 800 mg/kg (MTD).  Clinical signs and
cytotoxicity were seen at 800 mg/kg.

870.6200

Acute Neurotoxicity

- Rat

45696725 (2000)

0,200,500,2000 mg/kg

Acceptable/guideline

NOAEL = 2000 mg/kg/day, no neurotoxicity observed.

870.6200

Subchronic neurotoxicity

- Rat

45696726 (2001)

(0,100,1000,12500 ppm)

M: 0,7.2,70.3,1088.8 mg/kg/day

F: 0,9.1,87.3,1306.5 mg/kg/day

Acceptable/guideline

NOAEL= 70.3(M)/87.3(F) mg/kg/day. LOAEL= 1088.8(M)/ 1306.5(F) mg/kg/day
based on decreased body weights, food consumption, and increased urine
staining in both sexes and decreased motor and locomotor activity (week
4) in females only.

870.6300

Developmental neurotoxicity

46324901 (2004)

(0, 70, 350 or 1500 ppm)

0/0, 6.5/14.0, 32.1/69.7 or 135.9/273.8 mg/kg/day (gestation/lactation)

The study classification is reserved for the guideline requirement
pending receipt of additional morphometric measurements for the low and
mid dose groups.

Maternal NOAEL = 135.9/273.8 mg/kg/day

LOAEL = Not established.

Offspring NOAEL = Not established

LOAEL = 6.5/14.0 mg/kg/day based on effects in memory phase of the water
maze test in PND 60 females.

870.6300

Developmental neurotoxicity	47166501 (2007)

(0, 70, 350 or 1500 ppm)

0/0, 5.4/13.0, 28.6/65.7 and 119.2/262.1 mg/kg/day (gestation/lactation)
Maternal NOAEL=119.2/262.1 mg/kg/day

LOAEL= Not established

Offspring NOAEL = 119.2/262.1 mg/kg/day

LOAEL= Not established

Page   PAGE  1  of   NUMPAGES  48


[Federal Register Volume 79, Number 181 (Thursday, September 18, 2014)]
[Proposed Rules]
[Pages 56027-56029]
[FR Doc No: 2014-22255]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. FDA-2014-N-1243]

Dental Devices; Reclassification of Salivary Stimulatory System,
To Be Renamed Electrical Salivary Stimulator System

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed Order.

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

SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify salivary stimulatory system, a class III device, into class
II (special controls), subject to premarket notification. FDA is also
identifying the proposed special controls that the Agency believes will
provide a reasonable assurance of safety and effectiveness of the
device. The Agency is proposing to rename the device ``electrical
salivary stimulatory system.''

DATES: Submit either electronic or written comments by December 17,
2014. Please see section IX of this document for the proposed effective
date of any final order that may publish based on this proposed order.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following way:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No.
FDA-2014-N-1243 for this rulemaking. All comments received may be
posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see section X of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Michael Ryan, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1615, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as
amended, 21 U.S.C. 301 et seq., establishes a comprehensive system for
the regulation of medical devices intended for human use. Section 513
of the FD&C Act (21 U.S.C. 360c) established three categories (classes)
of devices, reflecting the regulatory controls needed to provide
reasonable assurance of their safety and effectiveness. The three
categories of devices are class I (general controls), class II (special
controls), and class III (premarket approval).
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices) are
automatically classified by section 513(f)(1) of the FD&C Act into
class III without any FDA rulemaking process. Those devices remain in
class III and require premarket approval unless, and until, the device
is reclassified into class I or II, or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807).
    A postamendments device that has been initially classified in class
III under section 513(f)(1) of the FD&C Act may be reclassified into
class I or class II under section 513(f)(3) of the FD&C Act. Section
513(f)(3) provides that FDA acting by order can reclassify the device
into class I or class II on its own initiative, or in response to a
petition from the manufacturer or importer of the device. To change the
classification of the device, the proposed new class must have
sufficient regulatory controls to provide reasonable assurance of the
safety and effectiveness of the device for its intended use.
    Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent action where the reevaluation is made
in light of newly available regulatory authority (see Bell v. Goddard,
366 F.2d 177, 181 (7th Cir. 1966); Ethicon, Inc. v. FDA, 762 F. Supp.
382, 388-391 (D.D.C. 1991)), or in light of changes in ``medical
science'' (Upjohn v. Finch, 422 F.2d 944, 951 (6th Cir. 1970)). Whether
data before the Agency are old or new, the ``new information'' to
support reclassification under 513(f)(3) must be ``valid scientific
evidence'', as defined in section 513(a)(3) and 21 CFR 860.7(c)(2).
(See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985);
Contact Lens Mfrs. Assoc. v. FDA, 766 F.2d 592 (D.C. Cir.1985), cert.
denied, 474 U.S. 1062 (1986)).
    FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of regulation for devices. To be
considered in the reclassification process, the ``valid scientific
evidence'' upon which the Agency relies must be publicly available.
Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
premarket approval application (PMA) (see section 520(c) of the FD&C
Act (21 U.S.C. 360j(c)). Section 520(h)(4) of the FD&C Act provides
that FDA may use, for reclassification of a device, certain information
in a PMA 6 years after the application has been approved. This includes
information from clinical and preclinical tests or studies that
demonstrate the safety or effectiveness of the device but does not
include descriptions of methods of manufacture or product composition
and other trade secrets.
    Section 510(m) of the FD&C Act provides that a class II device may
be exempted from the 510(k) premarket notification requirements, if the
Agency determines that premarket notification is not necessary to
assure the safety and effectiveness of the device.

II. Regulatory History of the Device and the Device Description

    A salivary stimulatory system is a postamendments device classified
into class III under section 513(f)(1) of the FD&C Act. A salivary
stimulatory system is an intraoral device intended to stimulate a
relative increase in saliva production.

III. Proposed Reclassification and Summary of Reason for
Reclassification

    FDA is proposing to reclassify these devices from class III into
class II because sufficient information exists to establish special
controls that can provide a reasonable assurance of the

device's safety and effectiveness. FDA believes that these special
controls, together with general controls, will provide a reasonable
assurance of safety and effectiveness.
    In accordance with section 513(f)(3) of the FD&C Act and 21 CFR
part 860, subpart C, FDA is proposing to reclassify this postamendments
class III device into class II (special controls). FDA believes that
there is sufficient information available to FDA through FDA's
accumulated experience with these devices from review submissions,
knowledge of similar devices, peer-reviewed literature, and the
manufacturer's petition to demonstrate that the proposed special
controls can effectively mitigate the risks to health identified in the
next section.
    FDA is proposing to identify the salivary stimulatory system under
the new name of ``electrical salivary stimulator system'' to
distinguish it from other devices that stimulate saliva flow via non-
electrical means. Under this proposed order, if finalized, the
electrical salivary stimulatory system device will be a prescription
device restricted to patient use only upon the authorization of a
dental practitioner or physician licensed by law to administer or use
the device. (Proposed 21 CFR 872.5560(a); see 21 CFR 801.109
(Prescription devices.).) Prescription-use restrictions are a type of
general control defined in section 513(a)(1)(A)(i) of the FD&C Act. The
labeling of the device must bear all information required for the safe
and effective use of prescription devices as outlined in Sec.  801.109.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device FDA has determined
that premarket notification is necessary to provide reasonable
assurance of the safety and effectiveness of the device. Therefore,
this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit FDA a premarket notification prior to marketing the device.

IV. Risks to Health

    After considering the information available to FDA through review
submissions, the manufacturer's petition, peer-reviewed literature, and
knowledge of similar devices, FDA determined that the potential risks
to health associated with the use of electrical salivary stimulatory
systems are as follows:
     Hazards caused by electrical equipment--electrical
salivary stimulatory systems have the potential to cause electrical
shocks, thermal burns, and other hazards to a patient;
     hazards caused by electromagnetic interference and
electrostatic discharge--electrical salivary stimulatory systems have
the potential to cause electromagnetic interference or electrostatic
discharge that can negatively affect the performance of the system or
other electrical equipment in the vicinity of the system;
     damage to intraoral tissue or dentition--devices that
malfunction or are poorly designed may damage intraoral tissue such as
the gingiva or tongue or a patient's dentition; and
     adverse tissue reaction--devices with non-biocompatible
materials may cause intraoral tissue infection, inflammation,
irritation, or allergic reactions.

V. Summary of Data Upon Which the Reclassification Is Based

    FDA has considered and analyzed the following information: A search
of the Agency's Manufacturer and User Facility Device Experience
(MAUDE) database, which shows no adverse events for electrical salivary
stimulatory systems; data contained in PMAs approved 6 or more years
before the date of this proposal (reviewed under section 520(h)(4) of
the FD&C Act, also known as the 6-year rule); and a review of
transcutaneous electrical nerve stimulators, which are similar devices
technologically, and are currently regulated as class II devices.

VI. Proposed Special Controls

    FDA tentatively concludes that the following special controls,
together with general controls, are sufficient to mitigate the risks to
health described in section IV:
     The design characteristics of the device must ensure that
the geometry, material composition, and electrical output
characteristics are consistent with the intended use;
     any element of the device that contacts the patient must
be demonstrated to be biocompatible;
     appropriate analysis and/or testing must validate
electromagnetic compatibility (EMC) and electrical safety, including
the safety of any battery used in the device;
     software validation, verification, and hazard testing must
be performed; and
     documented clinical experience must demonstrate safe and
effective use for stimulating saliva production by addressing the risks
of damage to intraoral tissue or dentition and of ineffective treatment
and must capture any adverse events observed during clinical use.
    Table 1 demonstrates how these special controls will mitigate each
risk to health described in section IV.

Table 1--Risks to Health and Mitigation Measures for Electrical Salivary
                            Stimulator System
------------------------------------------------------------------------
       Identified risk to health               Mitigation measures
------------------------------------------------------------------------
Hazards caused by electrical equipment.  Design characteristics.
                                         EMC and electrical safety
                                          analysis and/or testing
                                          Software validation,
                                          verification, and hazard
                                          testing.
                                         Documented clinical experience.
Hazards caused by electromagnetic        Design characteristics.
 interference and electrostatic          EMC and electrical safety
 discharge.                               analysis and/or testing.
Damage to intraoral tissue or dentition  Design characteristics.
                                         Documented clinical experience.
Adverse tissue reaction................  Biocompatibility.
------------------------------------------------------------------------

VII. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VIII. Paperwork Reduction Act of 1995

    This proposed order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
part 807, subpart E have been approved under OMB control number 0910-
0120.

IX. Proposed Effective Date

    FDA proposes that any final order based on this proposal become
effective 30 days after the date of publication in the Federal
Register.

X. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

List of Subjects in 21 CFR Part 872

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321 et seq., as amended) and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR part 872 be
amended as follows:

PART 872--DENTAL DEVICES

0
1. The authority citation for 21 CFR part 872 continues to read as
follows:
    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Add Sec.  872.5560 to subpart F to read as follows:

Sec.  872.5560  Electrical salivary stimulatory system.

    (a) Identification. An electrical salivary stimulatory system is a
prescription intraoral device that is intended to electrically
stimulate a relative increase in saliva production.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The design characteristics of the device must ensure that the
geometry, material composition, and electrical output characteristics
are consistent with the intended use;
    (2) Any element of the device that contacts the patient must be
demonstrated to be biocompatible;
    (3) Appropriate analysis and/or testing must validate
electromagnetic compatibility and electrical safety, including the
safety of any battery used in the device;
    (4) Software validation, verification, and hazard testing must be
performed; and
    (5) Documented clinical experience must demonstrate safe and
effective use for stimulating saliva production by addressing the risks
of damage to intraoral tissue and of ineffective treatment and must
capture any adverse events observed during clinical use.

    Dated: September 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22255 Filed 9-17-14; 8:45 am]
BILLING CODE 4164-01-P