1 MEMORANDUM DATE: 04/ 10/ 2006 SUBJECT: Ortho Phenylphenol, and its Sodium and Potassium Salts. Dietary Exposure Assessments for the Reregistration Eligibility Decision PC Codes: 064103, 064104, 064108 REVIEWER: Robert Quick, Chemist Risk Assessment & Science Support Branch Antimicrobials Division ( 7510C)

THROUGH: Norm Cook, Chief Risk Assessment & Science Support Branch Antimicrobials Division ( 7510C)

TO: Rebecca Miller, Chemical Review Manager Regulatory Management Branch II Antimicrobials Division ( 7510C) 2 I. Introduction Ortho phenylphenol( OPP) and its potassium and sodium salts are antimicrobials that can be used as disinfectants or sanitizers on counter tops, tables, refrigerators; on animal premises;

as a preservative in papermaking; as a preservative in adhesives and on mushroom premises.

There are other registered uses for these chemicals that include but are not limited to odor elimination in rooms, beauty parlors and medical premises. There are registered products that contain OPP or its potassium and sodium salts as active ingredients that may result in dietary exposure.

These uses of antimicrobial chemicals on food or feed contact surfaces, agricultural commodities, in animal premises and poultry premises including hatcheries and application to food grade eggs, in papermaking, in mushroom houses, in hydroponic growing of commodities, in plastics and polymers and in adhesives may result in pesticide residues in human food. These uses are indirect food uses. The Agency must determine the risk to human health that may occur from exposure to these chemicals.

Residue Information Review of the Agency's residue chemistry database does not show any residue data for ortho phenylphenol on food or on any food commodities as a result of antimicrobial use.

Note: Agricultural uses for ortho phenylphenol on raw agricultural commodities are being reviewed by the Health Effects Division. The U. S. D. A. Pesticide Data ( PDP) program provides some residue data for mushrooms, presumably from an antimicrobial use. No other residue chemistry data and analyses are available for inclusion in this antimicrobial dietary exposure chapter. 3 II. Dietary Exposure and Risks to Ortho Phenylphenol as an Indirect Food Additive REFRIGERATORS, COUNTER TOPS, SINKS AND STOVES REFRIGERATORS, COUNTER TOPS, SINKS AND STOVES are use sites on registered labels. These surfaces that have been treated with the ortho phenylphenol products may bear small residues of the ortho phenylphenol products after rinsing with potable water; i. e., rinsing with potable water may not remove all residues deposited on the treated surfaces from the proposed uses. Note: Historically the EPA and the Food & Drug Administration have taken the position that rinsing treated surfaces with potable water removes all residues. The Agency recognizes that rinsing treated surfaces with potable water does not remove all residues from treated surfaces and also recognizes that not all users do rinse treated surfaces. More recent information shows that while a portion of the residue is rinsed from treated surfaces by a potable water rinse, some residue deposits will remain. Residues from treated surfaces can migrate to food coming into contact with the treated and rinsed surfaces and can be ingested by humans.

The maximum rate for ortho phenylphenol in sanitizer end use solutions that is permitted in the 40 CFR 180.940 is 400 ppm. The maximum concentration in an end use solution in a product registered as a disinfectant is 4200 ppm; e. g. Reg.# 1270 237 is a ready to use disinfectant product containing 0.216% OPP ( 2160 ppm of OPP) and Reg.# 777 27 a ready to use disinfectant product containing 0.42% OPP ( 4200 ppm OPP). Calculation: %

A. I. in formulation x 10,000). The reason for this is probably because it was assumed when cleaning and disinfectant products were registered for application to food contact surfaces,

rinsing treated surfaces or washing treated surfaces with soap and water would remove residues and that there would not be a transfer of residues to food that contacts treated surfaces.

In the absence of residue data for residues of ortho phenylphenol on treated food contact surfaces,

the Agency can calculate residue levels that may occur in food from the application rates on food contact surfaces. 4 To estimate the Estimated Daily Intake ( EDI), the Agency has used the following model calculation. This model is taken from FDA Guidelines.

1. The maximum ingredient percentage for ortho phenylphenol in a ready to use product registered for use on drain boards, cabinets, counters, refrigerators and stoves is 0.42%

( EPA Reg. 777 27).

The concentration of ortho phenylphenol in the one product is 4200 ppm( 0.42% x 10,000)

EDI from Equation 1 = 4200 µ g/ 1000 mg( ppm) x 0.10 mg/ cm2 x 2000 cm2 / kg BW = 840 µ g a. i./ BW Assuming that an average adult consumes 3000 gm of food per day,

840 µ g a. i./ 3000 gm food = 0.28 µ g a. i./ gm ( ppm) of food 840 µ g a. i./ 70 kg BW = 12 µ g ortho phenylphenol/ kg/ day for male adult 840 µ g a. i./ 60 kg BW = 14 µ g ortho phenylphenol/ kg/ day for female adult 840 µ g a. i./ 15 kg BW = 56 µ g ortho phenylphenol/ kg/ day for child 2. The maximum application rate for ortho phenylphenol in food handling establishments from the various labeled products that are diluted with water prior to use is 0.5 fl oz/ gallon for a product containing 10.5% a. i.( EPA Reg.# 70627 6)

Calculation:

0.5 oz of product/ gal of water 5 0.5 oz product/ 128 fl oz of water = 0.39% solution of product in water ortho phenylphenol in formulation is 10.5%

0.105 x 0.0039 x 1,000,000 = 410 ppm of ortho phenylphenol in treatment water EDI from Equation 1 = 410 µ g/ 1000 mg( ppm) x 0.10 mg/ cm2 x 2000 cm2 / kg BW = 82 µ g a. i./ BW Assuming that an average person consumes 3000 gm of food per day,

82 µ g a. i./ 3000 gm food = 0.027 µ g a. i./ gm ( ppm) of food 82 µ g a. i./ 70 kg BW = 1.2 µ g ortho phenylphenol/ kg/ day for male adult 82 µ g a. i./ 60 kg BW = 1.4 µ g ortho phenylphenol/ kg/ day for female adult 82 µ g a. i./ 15 kg BW = 5.5 µ g ortho phenylphenol/ kg/ day for a child * The 10% transfer rate for residues is taken from the Agency Residential SOPs. The use of the 10% transfer rate instead of the use of a 100% transfer rate that is used in the FDA Sanitizer Solution Guidelines requires the submission of confirmatory data to establish the reliability of the use of the 10% transfer rate.

Dishwashing Liquid Use Ortho phenylphenol is registered as a preservative in a dishwashing liquid. The use is to formulate a dishwashing liquid containing 0.01 0.08 lbs of the antimicrobial formulation containing sodium ortho phenylphenate to 100 lbs of dishwashing liquid. The antimicrobial formulation contains 25.3% active ingredient ( EPA Reg.# 464 656)( equivalent to 22.4% ortho phenylphenol). A dishwashing liquid could be used on dishes, glassware, utensils pots and pans, counter tops, 6 stoves. This would be equivalent to exposing the human dietary intake to at least 4,000 cm2 per day of treated surface The Agency does not have a model for estimating residues in food resulting from a dishwashing use. We are using a model that appears on the internet as http:// www. scienceinthebox. com/ en

UK/ safety/ imgestionfromsurface en. html. This model uses a dishware surface area of 5400 cm2/ day.

The equation cited is:

Oral exposure from residue on dishware = ( amount of liquid product used in wash cycle) x ( amt.

of a. i. in a formulation) x ( rinse water in contact with dishware surface) x ( portion of product in final rinse cycle) x dishware surface area per day)]/ ( mean body weight for consumers) =

gm/ kg/ day In the case of this ortho phenylphenol preservative added to the dishwashing product, the calculation would use a figure of 0.018% a. i. in the product formulation.

Calculation for Dishwashing Use:

0.08 lb a. i. 0.224(% of ortho phenylphenol in the formulation/ 100 lb of dishwashing product) x 100 = 0.018% ortho phenylphenol in the dishwashing product Then:

( 105 gm ( amount of liquid product used in wash cycle) x 0.018% ( amt. of a. i. in a formulation) x 0.0023 gm/ cm2 ( rinse water in contact with dishware surface) x 0.39% ( portion of product in final rinse cycle) x 5400 cm2/ day dishware surface area per day)]/ BW ( mean body weight for consumers) = 0.0000915 gm a. i./ BW/ day or 91.5 µ g/ BW/ day 91.5 µ g/ a. i. per day/ 3000 gm food per day = 0.0305 µ g a. i/ gm of food or 0.0305 ppm 7 91.5 µ g a. i./ 70 kg BW = 1.3 µ g ortho phenylphenol/ kg/ day for male adult 91.5 µ g a. i./ 60 kg BW = 1.5 µ g ortho phenylphenol/ kg/ day for female adult 91.5 µ g a. i./ 15 kg BW = 6.1 µ g ortho phenylphenol/ kg/ day for a child The registered uses for counter tops and food preparation surfaces provides a higher dietary exposure for ortho phenylphenol than the dishwashing use and the two uses could be additive.

Mushroom Houses Use Potassium ortho phenylphenate and ortho phenylphenol formulations can be used in mushroom houses. Mushrooms are a food crop ( See 40 CFR 158, App. A, 1. Agricultural crops). The label use is for the purpose of cleaning and sanitizing non food contact surfaces between crops in mushrooms. Surfaces that are treated include tanks, air conditioners, air ducts, fans and breezeways, compost wharf, concreted surfaces, inside and outside walls of mushroom houses,

lofts, floors, spawning machines, tampers, casing rings, storage sheds and track alleys before spawning. Application is made only to surfaces that do not come into contact with the crop.

There is a restriction against application to the crop, compost or casings. Some labels do not require rinsing treated or washing treated surfaces with water before use. Other labels specify that treated surfaces are to be rinsed with potable water before they contact the crop, compost or casing.

The USDA Pesticide Data Program ( PDP) provides residue monitoring data for pesticide chemicals of interest on various agricultural commodities. The monitoring data for years 2001,

2002 and 2003 were made available to the Antimicrobials Division. The monitoring data for these years reports OPP residues in mushrooms. There are no EPA pesticide tolerances for residues of OPP in mushrooms ( 40 CFR 180.129) and there are no crop groupings for mushrooms in the 40 CFR 180.41 under which mushrooms could be included. Mushrooms are specifically excluded from crop groupings under that Regulation. 8 The PDP residue monitoring data reports residues ranging of up to 0.75 ppm OPP in/ on mushrooms over the 2001 2003 timeframe. The 2001 data showed OPP residues in 63 of 184 samples analyzed. Residues in mushrooms had declined to reports of OPP in 35 of 552 samples in 2003 but the highest OPP residue reported that year was 0.75 ppm. ( Health Effects Division notes that the likely cause of these residues involved disinfection and sanitization in the mushroom houses).

It is likely that the occurrence of OPP residues in mushrooms grown in mushroom houses that have been disinfected with OPP is because the mushroom houses have not been adequately cleaned after the disinfection process. The cleaning of mushroom houses after OPP disinfection involves rinsing with water. The interiors of mushroom houses are constructed of wood and it is difficult to totally eliminate OPP residues from the treated wood with a washing process. The OPP is likely absorbed into the wood and then slowly released into the mushroom compost and is available for uptake by the mushrooms grown in the treated house.

The establishment of a tolerance for indirect residues of OPP in mushrooms under a 40 CFR 180.129 subsection should be considered.

General Agricultural Premise Use Agricultural premise uses involve the application of a pesticide chemical to the hard surface interior surfaces of the interior of barns and poultry houses. These uses involve application to the physical structure of the premises ( including floors and walls) and also include, but not limited to,

watering troughs, feed troughs, animal halters, ropes and forks. ( See 40 CFR 158, App. A, 5. Pets and Domestic Animals animals and their man made premises which includes dairy and meat animals; and 40CFR 158. A, 4. Processed and manufactured products, and food or feed containers or dispensers.)

The ortho phenylphenol labels also include either a potable water rinse or a soap/ detergent scrubbing following a ten minute wait after application. Historically a scrubbing or a potable rinse after pesticidal application has been considered a non food use. This was because it was assumed 9 that the wash or scrub or rinse was assumed to eliminate all residues from the treated surfaces.

However with the advent of improved and more sensitive analytical methods, it has been found that small residues would be expected to remain after scrubbing or rinsing. This would be especially true of treated wood surfaces. Wood is porous and residues would likely be absorbed into the treated surfaces. This would also be true to a lesser extent on concrete surfaces. Metal surfaces would not be porous and rinsing well or scrubbing would likely remove most or all pesticide residues. Livestock feed and watering troughs would be filled with feed and water and would be expected to absorb some of the remaining residue from the treated surfaces.

Consumption by livestock of feed and water bearing pesticide residues may result in pesticide residues in animal tissues, milk, poultry tissues and eggs. This would necessitate the establishment of pesticide animal commodity tolerances under the Food, Drug & Cosmetic Act. Tolerances for these commodities would be inserted into the EPA Title 40 CFR 180 along with other pesticide tolerances.

Note: The establishment of tolerances for animal commodities also occurs in those cases in which an agricultural pesticide is used in livestock premises. In those cases, there are generally other pesticidal uses from either animal feed or dermal treatment uses for the agricultural chemical that result in higher pesticide residues in animal commodities that necessitate the establishment of livestock commodity tolerances. The need for livestock tolerance commodity tolerances for those pesticide uses in agricultural premises is encompassed by other animal feed or dermal treatment uses that result in animal commodity tolerances.

In addition to animals consuming feed and water from treated troughs, livestock would also ingest residues from chewing on treated wood in livestock structures.

Livestock would also likely inhale residues from the air in treated farm structures and would also be exposed dermally to residues in treated farm structures through rubbing themselves on the treated surfaces. These residues could also appear as secondary residues in animal tissues and milk and in poultry tissues and eggs. 10 There are no residue data for livestock and poultry reflecting the application of ortho phenylphenol or its potassium and sodium salts to agricultural premises.

The labels do not bear any restrictions for the farm premises uses that would prohibit treatment of wood feed and water troughs, racks and other feeding and watering devices. Residues would likely be absorbed into the wood surfaces of farm premises and would not be completely removed by soap/ detergent scrubbing and potable water rinses. Wood is a likely construction material that would be used in construction of farm premise equipment, especially on smaller farms.

These residues would be ingested in the human diet. The label uses for agricultural premises would not be a non food use.

Confirmatory data are needed to show whether residues would be absorbed into treated surfaces,

especially wood surfaces, of feeding devices and not be removed by scrubbing with soap and rinsing with water. If the antimicrobial residues are absorbed into the wood, these residues would be available for livestock ingestion. This finding could entail the need to generate data for large animals including livestock and poultry metabolism studies, analytical methods for livestock and poultry tissues and residue data for livestock and poultry.

Poultry Hatcheries Use Poultry hatcheries are not used in the production of eggs for food grade eggs for human consumption. Hatchery eggs are used for the production of chicks.

Sanitizer chemicals could penetrate the egg shell and become a residue in the developing chick.

Any residues that did penetrate the egg shell and occur in the chick would not be expected to be detectable in birds that are ready for consumption because of growth dilution in the growing birds.

The use of ortho phenylphenol products in poultry hatcheries appears to be a non food use. 11 Poultry Laying Facilities Use A registered use exists for application in a poultry laying operation ( e. g., EPA Reg.# 11725 7).

The use is not an egg sanitizer use. Residues could remain on treated layer facilities after treatment and rinsing with potable water or after scrubbing with soap and water. As a result, trace residues could occur on egg shells that contact treated and rinsed surfaces. However these would be minimal and would not likely penetrate the egg shell. Measurable residues would not be expected to occur in the egg content from this type of use.

Greenhouse and Hydroponic Uses Food commodities can be grown in greenhouses ( See 40 CFR 158, App. A, 1. Agricultural crops,

includes commercial greenhouses for greenhouse food crops) and on hydroponic farms. The food commodities can be grown in a growing media or hydroponically in water.

There is a label restriction against application to crop, soil or growing media in which a crop grows or will be grown. There is also a label instruction that requires a potable water rinse before treated surfaces contact the crop or the substrate in which the crop is or will be grown.

A potable water rinse for treated surfaces will likely remove a part, but not all of the residues from treated surfaces. The growing structures could be made of wood, plastic, concrete or metal.

The greatest potential for residues adhering to treated surfaces would be expected to be from the use of wood structures. Wood is porous and residues would likely be absorbed into the treated surfaces. This would also be true to a lesser extent on concrete surfaces. Metal surfaces would not be porous and rinsing well or scrubbing would likely remove most or all pesticide residues.

Confirmatory data are needed to show whether ortho phenylphenol residues would be absorbed into treated surfaces, especially wood surfaces, of feeding devices and not be removed by scrubbing with soap and rinsing with water. If the antimicrobial residues are absorbed into the growing structures these residues would be available for plant uptake with residues occurring in the food plants. 12 Polymers and Plastics Use There is a registered use for ortho phenylphenol in polymers and plastics: 0.1 0.5% by weight of material to be protected ( e. g., EPA Reg.# 464 126).

This formulation can be formulated into polymers and plastics which could have contact with both food and water. The use of label restrictions to preclude food contact with impregnated plastics and polymers would not be practical because the end use of treated plastics would be difficult to control. This is an indirect food use. The antimicrobial chemical can migrate out of the polymer/ plastic into food and water and be ingested by humans. The use of ortho phenylphenol under 21 CFR 177.1632 for articles with repeated contact with food is for the ortho phenylphenol to be included at 0.01% of base polymer.

There are, to our knowledge, no migration studies for ortho phenylphenol from plastics and polymers. If the registrant( s) has submitted migration data to the FDA, the Agency should receive a copy of the study so that those data can be included in our risk assessment.

Otherwise, a migration study should be generated for OPP and submitted to the Agency.

Wood and Wood Product Use There is a registered use for ortho phenylphenol on, Apallets, fruit and vegetable pallets: 1 3% by wt of solution@, ( e. g., EPA Reg.# 464 126). The definition of a pallet is: Aa portable platform for handling, storing, or moving materials and <EMAIL_ADDRESS>The registrant( s) should clarify whether this use includes packing crates for fruits and vegetables and whether the use will permit contact between treated wood and fruits and vegetables. Note: Dow Chemical believes that the residues of ortho phenylphenol on mushrooms may be attributed to the use of ortho phenylphenol on treated wood used in the construction of containers that were used to ship mushrooms.

There is also a registered use for ortho phenylphenol as a temporary sapstain control for fresh cut lumber and other lumber in fruit and vegetable containers at a rate of 5.7 17.0%( e. g., EPA Reg.# 13 39967 11). It is unclear what the dosage applies to. This appears to be a use for ortho phenylphenol intended for use in wood for fruit and vegetable crates. This use has the potential for transfer of residues to the agricultural produce packed in the containers. Residue data are needed to show the residual level of residue that could transfer from the treated wood crate to fruits and vegetables in contact with the treated wood.

Paper Slurry Uses The Food & Drug Administration establishes the 21 CFR Regulations and or the FDA Notifications for food contact paper uses for antimicrobial chemicals. There are no paper uses listed for slimicide use in the 21 CFR 176.300 or in the FDA Notifications for Food Contact Substances. Sodium o phenylphenate is cleared for use in paper coatings in 21 CFR 176.170( b)( 2) and 21 CFR 176.180( b)( 1). There is also a use for ortho phenylphenol as a defoamer in the 21 CFR 176.200.

It is unclear to us from the labels whether o phenylphenol is intended for use as a slimicide.

The use purpose on some labels is to protect from deterioration during manufacture, storage and service life. The ortho phenylphenol registrants should clarify the label uses for paper auxiliaries and paper slurries. In the absence of other information, we are assuming that this is a slimicide use. If use is intended as a paper slimicide or as a paper coating, clearance from the FDA must be sought.

The maximum label use rate proposed on the labels with a paper slurry use ( presumably a slimicide use) is 0.6% of the product ( 0.12% active ingredient). It is unclear from the label whether this concentration is for the paper slurry or for the end paper product. We will consider that the use rate is for the paper slurry at the wet end of the papermaking process. ( Note: 0.12%

is 1200 ppm). The registrant( s) must clarify the use pattern.

Paper Slimicide Use RASSB calculations based on FDA modeling for the slimicide use: 14 If RASSB uses the FDA model to calculate residue levels in paper and in food, the following assumptions would be used:

$ The maximum label use rate proposed on the labels with a paper slurry use is 0.6% of the product ( 0.12% active ingredient). It is unclear from the label whether this concentration is for the paper slurry or for the end paper product. We will consider that the use rate is for the paper slurry at the wet end of the papermaking process. ( Note: 0.12% is 1200 ppm).

$ Prior to entering the driers, the pulp slurry is 33% pulp and 67% water.

$ The standard basis weight for paper is that the paper weighs 50 mg/ in2.

$ Finished paper ( after paper making) contains approximately 92% pulp and 8% water.

$ Food mass to surface area of treated paper is 10 gm food/ in2.

$ There is 100% migration of the ortho phenylphenol residue from the treated paper into food. The consumption factor is 10% ( from the FDA guidance document for indirect food additives.

Many of the above assumptions are from the FDA document entitled, Recommendations For Chemistry Data For Indirect Food Additive Petitions.

The proposed use is for application of otho phenylphenol to be added to the paper slurry at a rate of 0.12% of the slurry.

Then the concentration of active ingredient ( a. i.) in the pulp prior to entering the driers is:

( Application rate) x ( water/ pulp ratio)

( 1200 µ g a. i./ gm of pulp slurry) ( 0.67 gm water/ 0.33 gm pulp) = 2436 µ g ortho phenylphenol/ gm 15 pulp Then, the dietary concentration is:

( µ g of a. i./ gm of pulp) ( gm of pulp/ gm of paper) ( basis weight of paper) ( food mass to surface area)

( 2436 µ g a. i / gm pulp) ( 0.92 gm pulp/ gm of paper) ( 0.05 gm/ in. 2) ( 1 in. 2/ 10 gm food) =

11.2 µ g of ortho phenylphenol/ gm. food.

Using a Consumption Factor of 0.1( from the FDA Recommendations for Chemistry Data For Indirect Food Additive Petitions) for uncoated paper, the concentration of ortho phenylphenol in the daily diet is then;

11.2 µ g. a. i./ gm. of food x 0.1 = 1.12 µ g of ortho phenylphenol/ gm.( 1.12 ppm) of food.

Assuming 3 kg of food in the daily diet for an adult and 1500 gm for a child, then:

1.12 µ g of ortho phenylphenol/ gm of food x 3000 gm = 3360 µ g ortho phenylphenol/ adult/ day 1.12 µ g of ortho phenylphenol/ gm of food x 1500 gm = 1680 µ g ortho phenylphenol/ child/ day 3360 µ g a. i./ 70 kg BW = 48 µ g ortho phenylphenol/ kg/ day for male adult 3360 µ g a. i./ 60 kg BW = 56 µ g ortho phenylphenol/ kg/ day for female adult 1680 µ g a. i./ 15 kg BW = 112 µ g ortho phenylphenol/ kg/ day for a child We understand that industry residue data are available to show the migration level of OPP from OPP treated paper to food. These data will be submitted to the Agency to support registration. 16 Paper Coating Preservative Use RASSB calculations based on FDA modeling for a coating use:

The maximum label use rate proposed on the labels with a paper auxiliary use is1.7% of the product ( 0.34% active ingredient). We are assuming that the coating use and that the slimicide use are additive.

The coating use for Reg# 464 78, Dowicide A, contains 71.7% sodium ortho phenylphenate and the suggested concentration of product in the coating is 0.1 1.0% or 0.717% active ingredient in the coating ( equivalent to 0.63% orthophenylphenol). ( EPA Reg.# 464 78)

$ The preservative is added to paper coating formulations at a maximum application rate of 6300 ppm $ The paper coating is approximately 10% by weight of paper $ The standard basis weight for paper is that the paper weighs 50 mg/ in2 $ Food mass to surface area of treated paper is 10 gm food/ in2.

$ There is 100% migration of the ortho phenylphenol residue from the treated paper into food. The consumption factor is 10% ( from the FDA guidance document for indirect food additives.

Then, the dietary concentration is:

Calculations:

Application rate x % of paper that is coating x basis weight of paper x food mass to surface area x % migration ( 6300 µ g a. i./ g of coating) ( 0.1 gm coating/ gm of paper) ( 0.05 gm/ in2) ( 1 in2/ 10 gm of food = 3.15 17 µ g a. i./ gm of food Using a Consumption Factor of 0.1 ( from the FDA guidance document for indirect food additives.

3.15 µ g. a. i./ gm. of food x 0.1 = 0.315 µ g of ortho phenylphenol/ gm of food Assuming 3 kg of food in the daily diet, then:

0.32 µ g of ortho phenylphenol/ gm of food x 3000 gm = 960 µ g ortho phenylphenol/ adult/ day 0.32 µ g of ortho phenylphenol/ gm of food x 1500 gm = 480 µ g ortho phenylphenol/ child/ day 960 µ g a. i./ 70 kg BW = 13.7 µ g ortho phenylphenol/ kg/ day for male adult 960 µ g a. i./ 60 kg BW = 16.0 µ g ortho phenylphenol/ kg/ day for female adult 480 µ g a. i./ 15 kg BW = 32 µ g ortho phenylphenol/ kg/ day for a child Adhesives Use Ortho phenylphenol is cleared for use by the Food & Drug Administration as an adhesive component ( 21 CFR 175.105). The Food & Drug Administration provides a calculated dietary estimate for residues resulting from use of an adhesive in food packaging material at 7 ppb. ( April 2002.: Guidance for Industry Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances: Chemistry Recommendations. Final Guidance). 18 Table 1. Cumulative Estimated Dietary Intake/ Daily Dietary Dose and % cPADs for Ortho Phenylphenol Use Dietary Conc.

( ppb) Estimated Daily Intake ( µ g/ person/ day) Daily Dietary Dose ( mg/ kg bw/ day) % cPAD Countertop Disinfectant 280 840 ( adult)

420( child) 0.012( adult)

0.056( child) 3.08 14.4 Dishwashing Disinfectant 91.5 274( adult)

137.5( child) 0.004( adult)

0.0092( child) 1.03 2.36 Paper Slimicide Use 1120 3360( adult)

1680( child) 0.048( adult)

0.017( child) 12.3 4.36 Paper Coating Preservative 3200 960( adult)

480( child) 0.014( adult)

0.032( child) 3.59 8.21 Paper Adhesive Preservative 7 21( adult)

10.5( child) 0.0003( adult)

0.0007( child) 0.08 0.18 Cumulative 4978 5455( adult)

2728( child) 0.078( adult)

0.11( child) 20.1 29.5 19 4.4 DIETARY EXPOSURE ASSESSMENT FOR CONVENTIONAL ( AGRICULTURAL) PESTICIDES This part of the non cancer dietary risk assessment was carried out by OPPs Health Effects Division ( David Hrdy, Barcode: D319639). It was conducted using the Dietary Exposure Evaluation Model ( DEEM FDIC J ), Version 2.03 as well as Lifeline Model Version 3.0 which uses food consumption data from the USDAs Continuing Surveys of Food Intake by Individuals ( CSFII) from 1994 1996 and 1998. This assessment is Tier 1, conservative ( assumes 100% crop treatment) and uses the deterministic approach. As input parameters for modeling analyses,

residue levels tolerances were used as point estimates.

The chronic analyses were below the Agencys level of concern for the general US Population ( 7.1% of cPAD) and all other population subgroups ( the most highly exposed being children 1 2 years old with a 24.6% of the cPAD).

Table 2. ( attachment from Dave Hrdys document) summarizes the Dietary Exposure for OPP/ SOPP/ KOPP based on DEEM FCID J and Lifeline Model results.

==================================================== Table 2. Total exposure by population subgroup  Total Exposure  Population mg/ kg Percent of Subgroup body wt/ day Rfd    U. S. Population ( total) 0.027769 7.1% U. S. Population ( spring season) 0.027756 7.1% U. S. Population ( summer season) 0.025804 6.6% U. S. Population ( autumn season) 0.027836 7.1% U. S. Population ( winter season) 0.029815 7.6%

Northeast region 0.036468 9.4% Midwest region 0.025900 6.6% Southern region 0.023917 6.1% Western region 0.028107 7.2% 20 Hispanics 0.036660 9.4% Non hispanic whites 0.025299 6.5% Non hispanic blacks 0.031023 8.0% Non hisp/ non white/ non black 0.037770 9.7%

All infants (< 1 year) 0.037606 9.6% Nursing infants 0.020614 5.3% Non nursing infants 0.044057 11.3% Children 1 6 yrs 0.077565 19.9% Children 7 12 yrs 0.041654 10.7%

Females 13 19 ( not preg or nursing) 0.026256 6.7% Females 20+ ( not preg or nursing) 0.019846 5.1% Females 13 50 yrs 0.022823 5.9% Females 13+ ( preg/ not nursing) 0.025276 6.5% Females 13+ ( nursing) 0.025877 6.6%

Males 13 19 yrs 0.028211 7.2% Males 20+ yrs 0.018416 4.7% Seniors 55+ 0.020089 5.2%

Children 1 2 yrs 0.096127 24.6% Children 3 5 yrs 0.072170 18.5% Children 6 12 yrs 0.043942 11.3% Youth 13 19 yrs 0.027479 7.0% Adults 20 49 yrs 0.018780 4.8% Adults 50+ yrs 0.019974 5.1% Females 13 49 yrs 0.020530 5.3%

III. Discussion of Uncertainties The Agency has determined that a 10% migration factor ( MF in equation 1) will be used. The Agency will ask for confirmatory data to support the 10% migration factor.

REFERENCES 21 EPA, 1997. AExposure Factors Handbook, Volume III: Activity Factors.@ EPA/ 600/ P 95/ 002Fc August 1997.

EPA, 1999. AAvailable Information on Assessing Exposure from Pesticides, A User= s Guide.@

http:// www. epa. gov/ fedrgstr/ EPA PEST/ 2000/ July/ Day 12/ 6061. pdf. Last accessed June 9, 2003.

FDA, 2003a. Guidance For Industry: Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances: Chemistry Recommendations. Final Guidance.

April, 2003. http:// www. cfsan. fda. gov/~ dms/ opa2pmnc. html. Last accessed June 9, 2003.

FDA, 2003b. ASanitizing Solutions: Chemistry Guidelines for Food Additive Petitions.@

January, 1993. http:// www. cfsan. fda. gov/~ dms/ opa cg3a. html. Last accessed June 9, 2003.


[Federal Register: August 17, 2006 (Volume 71, Number 159)]
[Notices]
[Page 47532-47534]
[DOCID:fr17au06-85]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. NRTL1-88]

MET Laboratories, Inc., Application for Expansion of Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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SUMMARY: This notice announces the application of MET Laboratories,
Inc., for expansion of its recognition to use additional test
standards, and presents the Agency's preliminary finding to grant this
request for expansion. This preliminary finding does not constitute an
interim or temporary approval of this application.

DATES: You must submit information or comments, or any request for
extension of the time to comment, by the following dates:
     Hard copy: postmarked or sent by September 1, 2006.
     Electronic transmission or facsimile: sent by September 1,
2006.

ADDRESSES: You may submit information or comments to this notice--
identified by docket number NRTL1-88--by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the instructions for submitting comments.
     OSHA Web site: http://ecomments.osha.gov. Follow the

instructions for submitting comments on OSHA's Web page.
     Fax: If your written comments are 10 pages or fewer, you
may fax them to the OSHA Docket Office at<PHONE_NUMBER>.
     Regular mail, express delivery, hand delivery and courier
service: Submit three copies to the OSHA Docket Office, Docket No.
NRTL1-88, U.S. Department of Labor, 200 Constitution Avenue, NW., Room
N-2625, Washington, DC 20210; telephone<PHONE_NUMBER>. (OSHA's TTY
number is<PHONE_NUMBER>). OSHA Docket Office

hours of operation are 8:15 a.m. to 4:45 p.m., EST.
    Instructions: All comments received will be posted without change
to http://dockets.osha.gov, including any personal information

provided. OSHA cautions you about submitting personal information such
as social security numbers and birth dates.
    Docket: For access to the docket to read background documents or
comments received, go to http://dockets.osha.gov. Contact the OSHA

Docket Office for information about materials not available through the
OSHA Web page and for assistance in using the Web page to locate docket
submissions.
    Extension of Comment Period: Submit requests for extensions
concerning this notice to the Office of Technical Programs and
Coordination Activities, NRTL Program, Occupational Safety and Health
Administration, U.S. Department of Labor, 200 Constitution Avenue, NW.,
Room N-3655, Washington, DC 20210. Or, fax to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Office of Technical Programs and
Coordination Activities, NRTL Program, Occupational Safety and Health
Administration, U.S. Department of Labor, 200 Constitution Avenue, NW.,
Room N-3655, Washington, DC 20210, or phone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Notice of Application

    The Occupational Safety and Health Administration (OSHA) hereby
gives notice that MET Laboratories, Inc. (MET) has applied for
expansion of its current recognition as a Nationally Recognized Testing
Laboratory (NRTL). MET's expansion request covers the use of additional
test standards. OSHA's current scope of recognition for MET may be
found in the following informational Web page: http://www.osha.gov/dts/otpca/nrtl/met.html
.

    OSHA recognition of an NRTL signifies that the organization has met
the legal requirements in Sec.  1910.7 of Title 29, Code of Federal
Regulations (29 CFR 1910.7). Recognition is an acknowledgment that the
organization can perform independent safety testing and certification
of the specific products covered within its scope of recognition and is
not a delegation or grant of government authority. As a result of
recognition, employers may use products ``properly certified'' \1\ by
the NRTL to meet OSHA standards that require testing and certification.
---------------------------------------------------------------------------

    \1\ Properly certified means, in part, that the product is
labeled or marked with the NRTL's ``registered'' certification mark
(i.e., the mark the NRTL uses for its NRTL work) and that the
product certification falls within the scope of recognition of the
NRTL.
---------------------------------------------------------------------------

    The Agency processes applications by an NRTL for initial
recognition or for expansion or renewal of this recognition following
requirements in Appendix A to 29 CFR 1910.7. This appendix requires
that the Agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides its preliminary finding and, in the second
notice, the Agency provides its final decision on the application.
These notices set forth the NRTL's scope of recognition or
modifications of that scope. We maintain an informational Web page for
each NRTL, which details its scope of recognition. These pages can be
accessed from our Web site at http://www.osha-slc.gov/dts/otpca/nrtl/index.html
.

    The most recent notice published by OSHA specifically related to
MET's recognition granted an expansion of its NRTL scope, which became
effective on December 5, 2005 (70 FR 72470).
    The current address of the MET facility already recognized by OSHA
is: MET Laboratories, Inc., 914 West Patapsco Avenue, Baltimore, MD
21230.

General Background on the Application

    MET has submitted an application, dated August 23, 2005 (see
Exhibit 39-1) to expand its recognition to include 10 additional test
standards. MET later amended its application through a follow-up
request to add 10 more test standards (see Exhibit 39-2). The NRTL
Program staff has determined that each of these 20 standards is an
``appropriate test standard'' within the meaning of 29 CFR 1910.7(c).
However, one standard is already included in MET's scope. Therefore,
OSHA would approve 19 test standards for the expansion.
    MET seeks recognition for testing and certification of products for
demonstration of conformance to the following test standards:

UL 82 Electric Gardening Appliances
UL 234 Low Voltage Lighting Fixtures for Use in Recreational Vehicles
UL 298 Portable Electric Hand Lamps
UL 588 Seasonal and Holiday Decorative Products
UL 867 Electrostatic Air Cleaners
UL 917 Clock-Operated Switches
UL 987 Stationary and Fixed Electric Tools
UL 1081 Swimming Pool Pumps, Filters, and Chlorinators
UL1090 Electric Snow Movers
UL 1363 Relocatable Power Taps
UL 1447 Electric Lawn Mowers
UL 1448 Electrical Hedge Trimmers
UL 1450 Motor-Operated Air Compressors, Vacuum Pumps, and Painting
Equipment
UL 1559 Insect-Control Equipment--Electrocution Type
UL 1563 Electric Spas, Equipment Assemblies, and Associated Equipment
UL 1662 Electric Chain Saws
UL 1776 High-Pressure Cleaning Machines
UL 1994 Luminous Egress Path Marking Systems
UL 2089 Vehicle Battery Adapters

    OSHA's scope of recognition of MET, or any NRTL, for a particular
test standard is limited to equipment or materials (i.e., products) for
which OSHA requires third-party testing and certification before use in
the workplace. Consequently, if a test standard also covers any
product(s) for which OSHA does not require such testing and
certification, an NRTL's scope of recognition does not include that
product(s).
    Many UL test standards are approved as American National Standards
by the American National Standards Institute (ANSI). However, for
convenience, we use the designation of the standards developing
organization for the standard as opposed to the ANSI designation. Under
our policy, any NRTL recognized for an ANSI-approved test standard may
use either the latest proprietary version of the test standard or the
latest ANSI version of that standard. You may contact ANSI to find out
whether or not a test standard is currently ANSI-approved.

Preliminary Finding on the Application

    MET has submitted an acceptable request for expansion of its
recognition as an NRTL. In connection with this request, OSHA did not
perform an on-site review of MET's NRTL testing facilities. However,
NRTL Program assessment staff reviewed information pertinent to the
request and recommended that MET's recognition be expanded to include
the additional test standards listed above (see Exhibit 39-3). Our
review of the application file, the assessor's recommendation, and
other pertinent documents indicate that MET can meet the requirements,
as prescribed by 29 CFR 1910.7, for expansion of its scope to include
the additional test standards listed above. This preliminary finding
does not constitute an interim or temporary approval of the
application.
    OSHA welcomes public comments, in sufficient detail, as to whether
MET has met the requirements of 29 CFR 1910.7 for expansion of its
recognition as a Nationally Recognized Testing

Laboratory. Your comments should consist of pertinent written documents
and exhibits. Should you need more time to comment, you must request it
in writing, including reasons for the request. OSHA must receive your
written request for extension at the address provided above no later
than the last date for comments. OSHA will limit any extension to 30
days, unless the requester justifies a longer period. We may deny a
request for extension if it is not adequately justified. You may obtain
or review copies of MET's requests, the on-site review report, other
pertinent documents, and all submitted comments, as received, by
contacting the Docket Office, Room N-2625, Occupational Safety and
Health Administration, U.S. Department of Labor, at the above address.
Docket No. NRTL1-88 contains all materials in the record concerning
MET's application.
    The NRTL Program staff will review all timely comments and, after
resolution of issues raised by these comments, will recommend whether
to grant MET's expansion request. The Assistant Secretary will make the
final decision on granting the expansion and, in making this decision,
may undertake other proceedings that are prescribed in Appendix A to 29
CFR Section 1910.7. OSHA will publish a public notice of this final
decision in the Federal Register.

    Signed at Washington, DC this 9th day of August, 2006.
Edwin G. Foulke, Jr.,
Assistant Secretary.
 [FR Doc. E6-13549 Filed 8-16-06; 8:45 am]

BILLING CODE 4510-26-P


[Federal Register Volume 88, Number 236 (Monday, December 11, 2023)]
[Rules and Regulations]
[Pages 85833-85836]
[FR Doc No: 2023-27111]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-1816; Project Identifier MCAI-2021-01460-R;
Amendment 39-22599; AD 2023-22-15]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters Deutschland GmbH
(AHD) Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Airbus Helicopters Deutschland GmbH (AHD) Model MBB-BK 117 D-3
helicopters. This AD was prompted by recalculations of the inspection
intervals for certain parts. This AD requires revising the
airworthiness limitations section (ALS) of the existing helicopter
maintenance manual or instructions for continued airworthiness for your
helicopter and the existing approved maintenance or inspection program
for your helicopter, as applicable, to reduce the inspection interval
of certain parts, as specified in a European Union Aviation Safety
Agency (EASA) AD, which is incorporated by reference. The FAA is
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective January 16, 2024.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of January 16,
2024.

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-1816; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this final rule, the EASA AD, any comments received,
and other information. The address for Docket Operations is U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590.
    Material Incorporated by Reference:
     For EASA material that is incorporated by reference in
this final rule, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne,
Germany; telephone +49 221 8999 000; email [email protected]; internet
easa.europa.eu. You may find the EASA material on the EASA website at
ad.easa.europa.eu.
     You may view this material at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available at
regulations.gov under Docket No. FAA-2023-1816.
    Other Related Service Information: For Airbus Helicopters service
information identified in this final rule, contact Airbus Helicopters,
2701 North Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-
0000 or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at airbus.com/en/products-services/helicopters/hcare-services/airbusworld. You may also
view this service information at the FAA contact information under
Material Incorporated by Reference above.

FOR FURTHER INFORMATION CONTACT: Dan McCully, Aviation Safety Engineer,
FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone (303)
342-1080; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0290, dated December 23, 2021;
corrected December 23, 2021 (EASA AD 2021-0290), to correct an unsafe
condition for all serial-numbered Airbus Helicopters Deutschland GmbH
Model MBB-BK117 D-3 and D-3m helicopters.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to Airbus Helicopters
Deutschland GmbH (AHD) Model MBB-BK 117 D-3 helicopters. The NPRM
published in the Federal Register on September 7, 2023 (88 FR 61485).
The NPRM was prompted by recalculations of the inspection intervals for
certain parts. The NPRM proposed to require accomplishing the actions
specified in EASA AD 2021-0290, as incorporated by reference, except
for any differences identified as exceptions in the regulatory text of
this AD and except as discussed under ``Differences Between this AD and
the EASA AD. The FAA is issuing this AD to address the unsafe condition
on these products.
    You may examine the EASA AD in the AD docket at regulations.gov
under Docket No. FAA-2023-1816.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the costs.

Conclusion

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA reviewed the relevant
data and determined that air safety requires adopting this AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these helicopters.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0290 requires replacing components before exceeding
their life limits and accomplishing maintenance tasks within thresholds
and intervals specified in the applicable ALS. Depending on the results
of the maintenance tasks, EASA AD 2021-0290 requires accomplishing
corrective action(s) or contacting AHD [Airbus Helicopters Deutschland
GmbH] for approved instructions and accomplishing those instructions.
EASA AD 2021-0290 also requires revising the Aircraft Maintenance
Programme (AMP) by incorporating the limitations, tasks, and associated
thresholds and intervals described in the specified ALS as applicable
to helicopter model and configuration. Revising the AMP constitutes
terminating action for the requirements to replace components before
exceeding their life limits and accomplish maintenance tasks within
thresholds and intervals specified in the applicable ALS as required by
EASA AD 2021-0290.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Other Related Service Information

    The FAA reviewed Airbus Helicopters Alert Service Bulletin ASB MBB-
BK117 D-3-04A-001, Revision 0, dated December 22, 2021. This service
information specifies checking the total accumulated flight hours since
new for bolt part number (P/N) D671M7501201, bolt P/N D671M7501211, and
mast bolt P/N D620M0501203, and accomplishing the airworthiness
inspection within the reduced airworthiness inspection interval of 400
flight hours.
    The FAA also reviewed Airbus MBB-BK117 D-3 Chapter 04, ALS,
Revision 1, dated December 14, 2021. This service information specifies
airworthiness limitations, tasks, and associated thresholds and
intervals for various parts. Revision 1 of this service information
specifies various updates for certain components.

Differences Between This AD and the EASA AD

    EASA AD 2021-0290 applies to Model MBB-BK117 D-3m helicopters,
whereas this AD does not because that model is not FAA type-
certificated.
    EASA AD 2021-0290 requires replacing certain components before
exceeding applicable life limits, accomplishing certain maintenance
tasks within thresholds and intervals as

specified in the ALS, as defined within, and depending on the results,
accomplishing corrective action within the compliance time specified in
that ALS. EASA AD 2021-0290 also requires revising the approved AMP to
incorporate the limitations, tasks, and associated thresholds and
intervals described in that ALS within 12 months after its effective
date. Whereas, this AD requires revising existing documents and
programs within 30 days to incorporate the limitations, tasks, and
associated thresholds and intervals described in that ALS, and
clarifies that if an incorporated limitation or threshold therein is
reached before 30 days after the effective date of this final rule, you
still have up to 30 days after the effective date of this final rule to
accomplish the corresponding task.

Costs of Compliance

    The FAA estimates that this AD affects 29 helicopters of U.S.
Registry. Labor rates are estimated at $85 per work-hour. Based on
these numbers, the FAA estimates the following costs to comply with
this AD.
    Revising the ALS of the existing helicopter maintenance manual or
instructions for continued airworthiness for your helicopter and the
existing approved maintenance or inspection program for your
helicopter, as applicable, will take about 2 work-hours for an
estimated cost of $170 per helicopter and $4,930 for the U.S. fleet.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2023-22-15: Airbus Helicopters Deutschland GmbH (AHD): Amendment 39-
22599; Docket No. FAA-2023-1816; Project Identifier MCAI-2021-01460-
R.

(a) Effective Date

    This airworthiness directive (AD) is effective January 16, 2024.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Helicopters Deutschland GmbH (AHD)
Model MBB-BK 117 D-3 helicopters, certificated in any category.

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 6710, Main Rotor
Control.

(e) Unsafe Condition

    This AD was prompted by recalculations of the inspection
intervals for certain parts. The FAA is issuing this AD to reduce
the inspection intervals for certain parts. The unsafe condition, if
not addressed, could result in failure of a part and loss of control
of the helicopter.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2021-0290, dated December 23, 2021; corrected December 23, 2021
(EASA AD 2021-0290).

(h) Exceptions to EASA AD 2021-0290

    (1) Where EASA AD 2021-0290 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) This AD does not adopt the requirements specified in
paragraphs (1), (2), (4), and (5) of EASA AD 2021-0290.
    (3) Where paragraph (3) of EASA AD 2021-0290 specifies revising
``the approved AMP'' within 12 months after its effective date, this
AD requires revising the airworthiness limitations section of your
existing helicopter maintenance manual or instructions for continued
airworthiness and your existing approved maintenance or inspection
program, as applicable, within 30 days after the effective date of
this AD.
    (4) The initial compliance time for doing the tasks specified in
paragraph (3) of EASA AD 2021-0290 is on or before the applicable
``limitations'' and ``associated thresholds'' as incorporated by the
requirements of paragraph (3) of EASA AD 2021-0290, or within 30
days after the effective date of this AD, whichever occurs later.
    (5) This AD does not adopt the ``Remarks'' section of EASA AD
2021-0290.

(i) Provisions for Alternative Actions and Intervals

    After the airworthiness limitations section of the existing
helicopter maintenance manual or instructions for continued
airworthiness; and the existing approved maintenance or inspection
program, as applicable, has been revised as required by paragraph
(g) of this AD, no alternative actions (e.g., inspections) and
associated thresholds and intervals, including life limits, are
allowed unless they are approved as specified in the provisions of
the ``Ref. Publications'' section of EASA AD 2021-0290.

(j) Special Flight Permit

    Special flight permits are prohibited.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (l) of
this AD. Information may be emailed to: [email protected].

    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(l) Related Information

    For more information about this AD, contact Dan McCully,
Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; phone<PHONE_NUMBER>; email
[email protected].

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2021-0290,
dated December 23, 2021; corrected December 23, 2021 (EASA AD 2021-
0290).
    (ii) [Reserved]
    (3) For EASA AD 2021-0290, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; internet easa.europa.eu. You may find the EASA
material on the EASA website at ad.easa.europa.eu.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this material at the National Archives and
Records Administration (NARA). For information on the availability
of this material at NARA, email: [email protected], or go to:
www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on November 30, 2023.
Victor Wicklund,
Deputy Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-27111 Filed 12-8-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 242 (Tuesday, December 17, 2013)]
[Rules and Regulations]
[Page 76195]
[FR Doc No: 2013-29856]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

Federal Register / Vol. 78, No. 242 / Tuesday, December 17, 2013 /
Rules and Regulations

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[USCG-2013-0982]

Drawbridge Operation Regulations; Hackensack River, New Jersey

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulations governing the operation of the
Port Authority Trans-Hudson Corporation (PATH), National Railroad
Passenger Corporation (AMTRAK) and New Jersey Transit Rail Operation
(NJTRO) Railroad Bridges. This deviation allows the PATH Bridge, mile
3.0; Amtrak's Portal Bridge, mile 5.0; and NJTRO's Upper Hack and HX
Bridges, miles 6.9 and 7.7, respectively, all across the Hackensack
River, NJ to remain closed during the Super Bowl XLVIII weekend to
facilitate the movement of more than 150,000 visitors, guests and area
residents to various public events and activities in New York and New
Jersey.

DATES: This deviation is effective from 10 a.m. Saturday, February 1,
through 1 a.m. Monday, February 3, 2014.

ADDRESSES: The docket for this deviation, [USCG-2013-0982] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140, on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Joe Arca, Project Officer, First
Coast Guard District<EMAIL_ADDRESS>or<PHONE_NUMBER>. If you
have questions on viewing the docket, call Barbara Hairston, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the closed position the PATH Bridge, mile
3.0, has a vertical clearance of 40 feet at mean high water, and 45
feet at mean low water; AMTRAK Portal Bridge, mile 5.0, has a vertical
clearance of 28 feet at mean high water, and 23 feet at mean low water;
NJTRO Upper Hack Bridge, mile 6.9, has a vertical clearance of 8 feet
at mean high water, and 13 feet at mean low water; NJTRO HX Bridge,
mile 7.7, has a vertical clearance of 8 feet at mean high water and 13
feet at mean low water. The existing drawbridge operating regulations
for these bridges are found at 33 CFR 117.723.
    The bridge owners requested that the bridges not open for marine
traffic from 10:00 a.m. Saturday, February 1 through 1:00 a.m. Monday,
February 3, 2014, to facilitate the expected movement of more than
150,000 visitors, guests and area residents to various public events
and activities in the New York and New Jersey area during the Super
Bowl XLVIII weekend.
    Hackensack River is transited primarily by commercial navigation.
Bridge owners reported that there were no requests for bridge openings
for any of the bridges for the past three years. Vessels that can pass
under the closed draws may do so at all times.
    Under this temporary deviation the PATH, Portal, Upper Hack and HX
bridges may remain closed for marine traffic from 10:00 a.m. on
Saturday, February 1 through 1:00 a.m. on Monday, February 3, 2014.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
deviation period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: December 2, 2013.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. 2013-29856 Filed 12-16-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 82 (Tuesday, April 29, 2014)]
[Notices]
[Page 24032]
[FR Doc No: 2014-09679]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72008; File No. SR-CBOE-2014-017]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Designation of a Longer Period for Commission
Action on a Proposed Rule Change, as Modified by Amendment 1 Thereto,
to Amend Its Rules Related to Complex Orders

April 23, 2014.
    On February 19, 2014, Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to amend its rules relating to
complex orders. On March 3, 2014, the Exchange filed Amendment No. 1 to
the proposed rule change. The proposed rule change, as modified by
Amendment No. 1 thereto, was published for comment in the Federal
Register on March 10, 2014.\3\ The Commission received no comments on
the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 71648 (March 5,
2014), 79 FR 13359.
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    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day for this filing is April 24, 2014. The Commission is extending
this 45-day time period.
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    \4\ 15 U.S.C. 78s(b)(2).
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    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider this proposed rule change. The proposed
rule change, if approved, would require any complex order with three or
more legs to participate in the Exchange's complex order auction prior
to entering the Exchange's complex order book.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\5\ designates June 6, 2014, as the date by which the Commission
should either approve or disapprove, or institute proceedings to
determine whether to disapprove, the proposed rule change (File No. SR-
CBOE-2014-017).
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    \5\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
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    \6\ 17 CFR 200.30-3(a)(31).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-09679 Filed 4-28-14; 8:45 am]
BILLING CODE 8011-01-P