Articles not complying with paragraph 1 shall not be placed on the market.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

8.

Polybromobiphenyls; Polybrominatedbiphenyls (PBB)

CAS No 59536-65-1

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

1.

Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

2.

Articles not complying with paragraph 1 shall not be placed on the market.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

9.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(a)

Soap bark powder

                                                         (Quillaja saponaria) and its derivatives containing saponines

CAS No 68990-67-0

EC 273-620-4

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(b)

Powder of the roots of Helleborus viridis and Helleborus niger

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(c)

Powder of the roots of Veratrum album and Veratrum nigrum

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(d)

Benzidine and/or its derivatives

CAS No 92-87-5

EC No 202-199-1

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(e)

o-Nitrobenzaldehyde

CAS No 552-89-6

EC No 209-025-3

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(f)

Wood powder

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

1.

Shall not be used, in jokes and hoaxes or in mixtures or articles intended to be used as such, for instance as a constituent of sneezing powder and stink bombs.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

2.

Jokes and hoaxes, or mixtures or articles intended to be used as such, not complying with paragraph 1 shall not be placed on the market.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

3.

However, paragraphs 1 and 2 shall not apply to stink bombs containing not more than 1,5 ml of liquid.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

10.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(a)

Ammonium sulphide

CAS No 12135-76-1

EC No 235-223-4

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(b)

Ammonium hydrogen sulphide

CAS No 12124-99-1

EC No 235-184-3

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(c)

Ammonium polysulphide

CAS No 9080-17-5

EC No 232-989-1

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

1.

Shall not be used, in jokes and hoaxes or in mixtures or articles intended to be used as such, for instance as a constituent of sneezing powder and stink bombs.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

2.

Jokes and hoaxes, or mixtures or articles intended to be used as such, not complying with paragraph 1 shall not be placed on the market.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

3.

However, paragraphs 1 and 2 shall not apply to stink bombs containing not more than 1,5 ml of liquid.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

11.

Volatile esters of bromoacetic acids:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(a)

Methyl bromoacetate

CAS No 96-32-2

EC No 202-499-2

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(b)

Ethyl bromoacetate

CAS No 105-36-2

EC No 203-290-9

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(c)

Propyl bromoacetate

CAS No 35223-80-4

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(d)

Butyl bromoacetate

CAS No 18991-98-5

EC No 242-729-9

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

1.

Shall not be used, in jokes and hoaxes or in mixtures or articles intended to be used as such, for instance as a constituent of sneezing powder and stink bombs.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

2.

Jokes and hoaxes, or mixtures or articles intended to be used as such, not complying with paragraph 1 shall not be placed on the market.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

3.

However, paragraphs 1 and 2 shall not apply to stink bombs containing not more than 1,5 ml of liquid.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

12.

2-Naphthylamine

CAS No 91-59-8

EC No 202-080-4 and its salts

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

13.

Benzidine

CAS No 92-87-5

EC No 202-199-1 and its salts

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

14.

4-Nitrobiphenyl

CAS No 92-93-3

Einecs EC No 202-204-7

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

15.

4-Aminobiphenyl xenylamine

CAS No 92-67-1

Einecs EC No 202-177-1 and its salts

The following shall apply to entries 12 to 15:

Shall not be placed on the market, or used, as substances or in mixtures in concentrations greater than 0,1 % by weight.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

16.

Lead carbonates:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(a)

Neutral anhydrous carbonate (PbCO3)

CAS No 598-63-0

EC No 209-943-4

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(b)

Trilead-bis(carbonate)-dihydroxide 2Pb CO3-Pb(OH)2

CAS No 1319-46-6

EC No 215-290-6

Shall not be placed on the market, or used, as substances or in mixtures, where the substance or mixture is intended for use as paint.

However, Member States may, in accordance with the provisions of International Labour Organisation (ILO) Convention 13 on the use of white lead and sulphates of lead in paint, permit the use on their territory of the substance or mixture for the restoration and maintenance of works of art and historic buildings and their interiors.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

17.

Lead sulphates:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(a)

PbSO4

CAS No 7446-14-2

EC No 231-198-9

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(b)

Pbx SO4

CAS No 15739-80-7

EC No 239-831-0

Shall not be placed on the market, or used, as substances or in mixtures, where the substance or mixture is intended for use as paint.

However, Member States may, in accordance with the provisions of ILO Convention 13 on the use of white lead and sulphates of lead in paint, permit the use on their territory of the substance or mixture for the restoration and maintenance of works of art and historic buildings and their interiors.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

18.

Mercury compounds

Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is intended for use:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(a)

to prevent the fouling by micro-organisms, plants or animals of:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

the hulls of boats,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

cages, floats, nets and any other appliances or equipment used for fish or shellfish farming,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

any totally or partly submerged appliances or equipment;

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(b)

in the preservation of wood;

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(c)

in the impregnation of heavy-duty industrial textiles and yarn intended for their manufacture;

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(d)

in the treatment of industrial waters, irrespective of their use.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

18a.

Mercury

CAS No 7439-97-6

EC No 231-106-7

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

1.

Shall not be placed on the market:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(a)

in fever thermometers;

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(b)

in other measuring devices intended for sale to the general public (such as manometers, barometers, sphygmomanometers, thermometers other than fever thermometers).

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

2.

The restriction in paragraph 1 shall not apply to measuring devices that were in use in the Community before 3 April 2009. However Member States may restrict or prohibit the placing on the market of such measuring devices.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

3.

The restriction in paragraph 1(b) shall not apply to:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(a)

measuring devices more than 50 years old on 3 October 2007;

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(b)

barometers (except barometers within point (a)) until 3 October 2009.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

4.

By 3 October 2009 the Commission shall carry out a review of the availability of reliable safer alternatives that are technically and economically feasible for mercury containing sphygmomanometers and other measuring devices in healthcare and in other professional and industrial uses. On the basis of this review or as soon as new information on reliable safer alternatives for sphygmomanometers and other measuring devices containing mercury becomes available, the Commission shall, if appropriate, present a legislative proposal to extend the restrictions in paragraph 1 to sphygmomanometers and other measuring devices in healthcare and in other professional and industrial uses, so that mercury in measuring devices is phased out whenever technically and economically feasible.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

19.

Arsenic compounds

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

1.

Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is intended for use to prevent the fouling by micro-organisms, plants or animals of:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

the hulls of boats,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

cages, floats, nets and any other appliances or equipment used for fish or shellfish farming,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

any totally or partly submerged appliances or equipment.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

2.

Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is intended for use in the treatment of industrial waters, irrespective of their use.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

3.

Shall not be used in the preservation of wood. Furthermore, wood so treated shall not be placed on the market.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

4.

By way of derogation from paragraph 3:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(a)

Relating to the substances and mixtures for the preservation of wood: these may only be used in industrial installations using vacuum or pressure to impregnate wood if they are solutions of inorganic compounds of the copper, chromium, arsenic (CCA) type C and if they are authorised in accordance with Article 5(1) of Directive 98/8/EC. Wood so treated shall not be placed on the market before fixation of the preservative is completed.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(b)

Wood treated with CCA solution in accordance with point (a) may be placed on the market for professional and industrial use provided that the structural integrity of the wood is required for human or livestock safety and skin contact by the general public during its service life is unlikely:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

as structural timber in public and agricultural buildings, office buildings, and industrial premises,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

in bridges and bridgework,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

as constructional timber in freshwater areas and brackish waters, for example jetties and bridges,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

as noise barriers,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

in avalanche control,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

in highway safety fencing and barriers,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

as debarked round conifer livestock fence posts,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

in earth retaining structures,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

as electric power transmission and telecommunications poles,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

as underground railway sleepers.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(c)

Without prejudice to the application of other Community provisions on the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that all treated wood placed on the market is individually labelled “For professional and industrial installation and use only, contains arsenic”. In addition, all wood placed on the market in packs shall also bear a label stating “Wear gloves when handling this wood. Wear a dust mask and eye protection when cutting or otherwise crafting this wood. Waste from this wood shall be treated as hazardous by an authorised undertaking”.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(d)

Treated wood referred to under point (a) shall not be used:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

in residential or domestic constructions, whatever the purpose,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

in any application where there is a risk of repeated skin contact,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

in marine waters,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

for agricultural purposes other than for livestock fence posts and structural uses in accordance with point (b),

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

in any application where the treated wood may come into contact with intermediate or finished products intended for human and/or animal consumption.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

5.

Wood treated with arsenic compounds that was in use in the Community before 30 September 2007, or that was placed on the market in accordance with paragraph 4 may remain in place and continue to be used until it reaches the end of its service life.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

6.

Wood treated with CCA type C that was in use in the Community before 30 September 2007, or that was placed on the market in accordance with paragraph 4:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

may be used or reused subject to the conditions pertaining to its use listed under points 4(b), (c) and (d),

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

may be placed on the market subject to the conditions pertaining to its use listed under points 4(b), (c) and (d).

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

7.

Member States may allow wood treated with other types of CCA solutions that was in use in the Community before 30 September 2007:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

to be used or reused subject to the conditions pertaining to its use listed under points 4 (b), (c) and (d),

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

to be placed on the market subject to the conditions pertaining to its use listed under points 4(b), (c) and (d).

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

20.

Organostannic compounds

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

1.

Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is acting as biocide in free association paint.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

2.

Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture acts as biocide to prevent the fouling by micro-organisms, plants or animals of:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(a)

all craft irrespective of their length intended for use in marine, coastal, estuarine and inland waterways and lakes;

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(b)

cages, floats, nets and any other appliances or equipment used for fish or shellfish farming;

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(c)

any totally or partly submerged appliance or equipment.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

3.

Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is intended for use in the treatment of industrial waters.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

21.

Di-μ-oxo-di-n-butylstanniohydroxyborane/Dibutyltin hydrogen borate C8H19BO3Sn (DBB)

CAS No 75113-37-0

EC No 401-040-5

Shall not be placed on the market, or used, as a substance, or in mixtures in a concentration equal to, or greater than 0,1 % by weight.

However, the first paragraph shall not apply to this substance (DBB) or mixtures containing it if these are intended solely for conversion into articles, among which this substance will no longer feature in a concentration equal to or greater than 0,1 %.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

22.

Pentachlorophenol

CAS No 87-86-5

EC No 201-778-6 and its salts and esters

Shall not be placed on the market, or used,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

as a substance,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

as a constituent in other substances, or in mixtures, in a concentration equal to or greater than 0,1 % by weight.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

23.

Cadmium

CAS No 7440-43-9

EC No 231-152-8 and its compounds

For the purpose of this entry, the codes and chapters indicated in square brackets are the codes and chapters of the tariff and statistical nomenclature of Common Customs Tariff as established by Council Regulation (EEC) No 2658/87 (1).

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

1.

Shall not be used to give colour to articles manufactured from the following substances and mixtures:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(a)

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

polyvinyl chloride (PVC) [3904 10] [3904 21] [3904 22]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

polyurethane (PUR) [3909 50]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

low-density polyethylene (ld PE), with the exception of low-density polyethylene used for the production of coloured masterbatch [3901 10]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

cellulose acetate (CA) [3912 11] [3912 12]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

cellulose acetate butyrate (CAB) [3912 11] [3912 12]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

epoxy resins [3907 30]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

melamine — formaldehyde (MF) resins [3909 20]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

urea — formaldehyde (UF) resins [3909 10]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

unsaturated polyesters (UP) [3907 91]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

polyethylene terephthalate (PET) [3907 60]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

polybutylene terephthalate (PBT)

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

transparent/general-purpose polystyrene [3903 11] [3903 19]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

acrylonitrile methylmethacrylate (AMMA)

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

cross-linked polyethylene (VPE)

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

high-impact polystyrene

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

polypropylene (PP) [3902 10]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(b)

paints [3208] [3209]

However, if the paints have a high zinc content, their residual concentration of cadmium shall be as low as possible and shall in any event be less than 0,1 % by weight.

In any case, whatever their use or intended final purpose, articles or components of articles manufactured from the substances and mixtures listed above coloured with cadmium shall not be placed on the market if their cadmium content (expressed as Cd metal) is greater than 0,01 % by weight of the plastic material.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

2.

However, paragraph 1 shall not apply to articles to be coloured for safety reasons.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

3.

Shall not be used to stabilise the following mixtures or articles manufactured from polymers or copolymers of vinyl chloride:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

packaging materials (bags, containers, bottles, lids) [3923 29 10],

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

office or school supplies [3926 10],

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

fittings for furniture, coachwork or the like [3926 30],

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

articles of apparel and clothing accessories (including gloves) [3926 20],

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

floor and wall coverings [3918 10],

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

impregnated, coated, covered or laminated textile fabrics [5903 10],

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

imitation leather [4202],

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

gramophone records,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

tubes and pipes and their fittings [3917 23],

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

swing doors,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

vehicles for road transport (interior, exterior, underbody),

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

coating of steel sheet used in construction or in industry,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

insulation for electrical wiring.

In any case, whatever their use or intended final purpose, the placing on the market of the above mixtures, articles or components of articles manufactured from polymers or copolymers of vinyl chloride, stabilised by substances containing cadmium is prohibited, if their cadmium content (expressed as Cd metal) exceeds 0,01 % by weight of the polymer.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

4.

However, paragraph 3 shall not apply to mixtures and articles using cadmium-based stabilisers for safety reasons.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

5.

For the purpose of this entry, “cadmium plating” means any deposit or coating of metallic cadmium on a metallic surface.

Shall not be used for cadmium plating metallic articles or components of the articles used in the following sectors/applications:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(a)

equipment and machinery for:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

food production [8210] [8417 20] [8419 81] [8421 11] [8421 22] [8422] [8435] [8437] [8438] [8476 11]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

agriculture [8419 31] [8424 81] [8432] [8433] [8434] [8436]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

cooling and freezing [8418]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

printing and book-binding [8440] [8442] [8443]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(b)

equipment and machinery for the production of:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

household goods [7321] [8421 12] [8450] [8509] [8516]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

furniture [8465] [8466] [9401] [9402] [9403] [9404]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

sanitary ware [7324]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

central heating and air conditioning plant [7322] [8403] [8404] [8415]

In any case, whatever their use or intended final purpose, the placing on the market of cadmium-plated articles or components of such articles used in the sectors/applications listed in points (a) and (b) above and of articles manufactured in the sectors listed in point (b) above is prohibited.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

6.

The provisions referred to in paragraph 5 shall also be applicable to cadmium-plated articles or components of such articles when used in the sectors/applications listed in points (a) and (b) below and to articles manufactured in the sectors listed in (b) below:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(a)

equipment and machinery for the production of:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

paper and board [8419 32] [8439] [8441] textiles and clothing [8444] [8445] [8447] [8448] [8449] [8451] [8452]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(b)

equipment and machinery for the production of:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

industrial handling equipment and machinery [8425] [8426] [8427] [8428] [8429] [8430] [8431]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

road and agricultural vehicles [chapter 87]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

rolling stock [chapter 86]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

vessels [chapter 89]

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

7.

However, the restrictions in paragraphs 5 and 6 shall not apply to:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

articles and components of the articles used in the aeronautical, aerospace, mining, offshore and nuclear sectors whose applications require high safety standards and in safety devices in road and agricultural vehicles, rolling stock and vessels,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

electrical contacts in any sector of use, where that is necessary to ensure the reliability required of the apparatus on which they are installed.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

24.

Monomethyl — tetrachlorodiphenyl methane

Trade name: Ugilec 141

CAS No 76253-60-6

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

1.

Shall not be placed on the market, or used, as a substance or in mixtures.

Articles containing the substance shall not be placed on the market.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

2.

By way of derogation, paragraph 1 shall not apply:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(a)

in the case of plant and machinery already in service on 18 June 1994, until such plant and machinery is disposed of;

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(b)

in the case of the maintenance of plant and machinery already in service within a Member State on 18 June 1994.

For the purposes of point (a) Member States may, on grounds of human health protection and environmental protection, prohibit within their territory the use of such plant or machinery before it is disposed of.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

25.

Monomethyl-dichloro-diphenyl methane

Trade name: Ugilec 121

Ugilec 21

Shall not be placed on the market, or used, as a substance or in mixtures.

Articles containing the substance shall not be placed on the market.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

26.

Monomethyl-dibromo-diphenyl methane bromobenzylbromotoluene, mixture of isomers

Trade name: DBBT

CAS No 99688-47-8

Shall not be placed on the market, or used, as a substance or in mixtures.

Articles containing the substance shall not be placed on the market.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

27.

Nickel

CAS No 7440-02-0

EC No 231-111-4 and its compounds

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

1.

Shall not be used:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(a)

in any post assemblies which are inserted into pierced ears and other pierced parts of the human body unless the rate of nickel release from such post assemblies is less than 0,2 μg/cm2/week (migration limit);

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(b)

in articles intended to come into direct and prolonged contact with the skin such as:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

earrings,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

necklaces, bracelets and chains, anklets, finger rings,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

wrist-watch cases, watch straps and tighteners,

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

rivet buttons, tighteners, rivets, zippers and metal marks, when these are used in garments,

if the rate of nickel release from the parts of these articles coming into direct and prolonged contact with the skin is greater than 0,5 μg/cm2/week.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

(c)

in articles referred to in point (b) where these have a non-nickel coating unless such coating is sufficient to ensure that the rate of nickel release from those parts of such articles coming into direct and prolonged contact with the skin will not exceed 0,5 μg/cm2/week for a period of at least two years of normal use of the article.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

2.

Articles which are the subject of paragraph 1 shall not be placed on the market unless they conform to the requirements set out in that paragraph.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

3.

The standards adopted by the European Committee for Standardisation (CEN) shall be used as the test methods for demonstrating the conformity of articles to paragraphs 1 and 2.

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

28.

Substances which appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 classified as carcinogen category 1A or 1B (Table 3.1) or carcinogen category 1 or 2 (Table 3.2) and listed as follows:

<colgroup><col span="1" width="4%"><col span="1" width="96%"></colgroup>

—

Carcinogen category 1A (Table 3.1)/carcinogen category 1 (Table 3.2) listed in Appendix 1


[Federal Register Volume 84, Number 182 (Thursday, September 19, 2019)]
[Notices]
[Pages 49319-49320]
[FR Doc No: 2019-20281]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4456-DR; Docket ID FEMA-2019-0001]

Muscogee (Creek) Nation; Major Disaster and Related
Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the Muscogee (Creek) Nation (FEMA-4456-DR), dated August
7, 2019, and related determinations.

DATES: The declaration was issued August 7, 2019.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated August 7, 2019, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage to the lands associated with
the Muscogee (Creek) Nation resulting from severe storms, straight-
line winds, tornadoes, and flooding during the period of May 7 to
June 9, 2019, is of sufficient severity and magnitude to warrant a
major disaster declaration under the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''). Therefore, I declare that such a major disaster
exists for the Muscogee (Creek) Nation.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.

    You are authorized to provide Public Assistance and Hazard
Mitigation for the Muscogee (Creek) Nation. Consistent with the
requirement that Federal assistance be supplemental, any Federal
funds provided under the Stafford Act for Public Assistance and
Hazard Mitigation will be limited to 75 percent of the total
eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Benjamin D. Abbott, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.

The following areas have been designated as adversely affected by this
major disaster:

    The Muscogee (Creek) Nation for Public Assistance.
    The Muscogee (Creek) Nation is eligible to apply for assistance
under the Hazard Mitigation Grant Program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-20281 Filed 9-18-19; 8:45 am]
 BILLING CODE 9111-23-P


  SEQ CHAPTER \h \r 1 ENCLOSURE

United States’ Nomination Of The Aerosol Metered Dose Inhaler (MDI)

 As An Essential Use

Country:		United States of America

Contact Person:	Scott Monroe

Title:			Essential Use Program Manager

Address:  		U.S. Environmental Protection Agency

			Office of Air and Radiation (6205J)

1200 Pennsylvania Avenue, NW

Washington, DC  20460

Telephone:		1-202-343-9712

Fax:			1-202-343-2363

Email<EMAIL_ADDRESS>
I.	Summary of Nomination

A.	Please identify and describe in detail the proposed uses.  Please
indicate for what disease or treatment the proposed use is intended [(i)
pulmonary, e.g., asthma, or (ii) non-pulmonary conditions, e.g.,
cancer].

The proposed use is the Metered Dose Inhaler (MDI) for the treatment of
asthma and chronic obstructive pulmonary disease (COPD).  MDIs are
pocket-sized aerosol devices used to deliver (orally) precisely measured
doses of medicine directly to the lungs.

CFCs are used as propellants and suspension agents in MDIs (CFC-11, 12
and 114).  They are also used in the manufacture of MDI valves and in
cleaning MDI manufacturing equipment.

B.	Please indicate below each substance required for the proposed use
and the quantities requested of each substance in each year being
nominated.

Nominated Quantities for 2007

Ozone Depleting Substance	2007 Quantity (metric tonnes)

CFC-11, CFC-12, and CFC-114	1,493 metric tonnes [see also p. 15]

II.	Substantiation of Nomination

A.	Role in Society

	State whether the nomination is for the treatment of asthma and/or
COPD.  If not, explain why this use is necessary for health and/or
safety or critical for the functioning of society.

This nomination requests CFCs solely for use in MDIs for the treatment
of asthma and/or COPD.

Describe the nature of the disease(s)which the proposed use is intended
to treat, e.g., the nature and prevalence of the disease and the role of
MDIs (versus other forms of therapy) in treating the disease(s).

Nature of the Diseases

Asthma and chronic obstructive pulmonary diseases (COPD), such as
emphysema and chronic bronchitis, reduce the capacity for respiration.
In asthma and often in COPD, airways become inflamed and hyperreactive,
causing coughing and wheezing that disrupts breathing.  These diseases
can also cause swelling of the bronchi and produce mucus plugs that
further impede airflow.  In addition, nervous system stimulation can
contribute to further airway narrowing and worsening symptoms.  Finally,
in the case of emphysema and chronic bronchitis, this process gradually
destroys the surface area of the lung, reducing its capacity to exchange
oxygen and carbon dioxide.  Asthma and COPD greatly diminish the quality
of life for patients and their families, and in severe cases may cause
death.

Asthma

Asthma is a chronic and debilitating respiratory disease with sudden,
unpredictable, and potentially life-threatening effects.  The treatment
of asthma requires constant vigilance and the active involvement of
patients, families, physicians and other caregivers in a comprehensive
program to monitor, anticipate, and promptly respond to the onset of
asthmatic attacks.

Patients with asthma may be restricted from normal physical activity,
may be limited in their choice of work, afflicted by the side effects of
some medications, and subject to unpredictable and sudden asthma attacks
which disrupt their daily activities and may even threaten their lives.

	Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease produces inflammation, swelling,
and mucus in the human airway, and gradually destroys the surface area
of the lung.  COPD is progressive and generally irreversible, and
severely restricts the capacity for respiration.

Prevalence of the Diseases

The American Lung Association has issued a publication entitled “Lung
Disease Data 2000" which contains statistics concerning the prevalence,
mortality, and treatment of asthma and COPD in the United States.  The
report states that:

There are approximately 17 million asthma sufferers in the U.S.  Asthma
is now the sixth-ranking chronic condition and the leading serious
chronic illness in children. (p. 5).

“Asthma is unquestionably, and unaccountably, on the rise.”  Between
1982 and 1995, the prevalence rate (the rate per thousand persons) of
asthma rose from 34.8 to 56.8, a 63% increase.  The prevalence of
pediatric asthma rose from 40.1 to 74.9, a 72.3% increase. (p. 5)

There were 5,434 deaths from asthma recorded in 1997.  This represents
more than a two-fold increase since 1979. (p. 7)

Asthma attacks bring an estimated 1.9 million Americans to emergency
rooms each year and account for one in six of all pediatric emergency
room visits in the U.S. (p. 5)

Asthma costs the U.S. an estimated $11.3 billion in 1998.  This amount
includes direct health care expenses ($7.5 billion) and indirect costs
such as lost productivity ($3.8 billion). (p. 5)

In addition to those with asthma, more than 16 million Americans are
estimated to suffer from COPD, and it is the fourth-ranking cause of
death in the United States. (p. 22)

COPD was responsible for the death of over 103,000 Americans in 1997.
This is a new high in a steadily increasing toll (the 1980 figure was
just over 53,000). (p.22)

COPD costs the nation approximately $26.0 billion each year, which
includes both health care expenditures ($13.6 billion) and indirect
costs ($12.4 billion). (p. 22-23)

COPD is the third-ranking condition necessitating at-home care. ( p.23)

	Role of the MDI

There is international consensus that primary treatment of asthma and
COPD should be by the inhaled route.  This treatment is delivered
quickly and efficiently to the airways, which minimizes risk of adverse
reactions.  Therapy necessitates regular treatment, often with more than
one drug.  At this stage of the transition, MDIs remain the dominant
inhaled delivery system in most countries, for all categories of drugs.

2. 	Does the use include any MDI products approved after 31 December
2000 for the treatment of asthma and COPD?

	No.

B.	Description of Transition Status

1.  	Has a transition strategy been submitted to the UNEP Ozone
Secretariat (and where can it be accessed)?	Consistent with the request
of the Parties in Decision VIII/12, the United States has submitted to
the UNEP Ozone Secretariat its transition strategy in the form of
regulations developed by the U.S. Food and Drug Administration (USFDA).
These regulations describe the criteria that USFDA will use to determine
when it is appropriate to remove the essential use designation from
products that use ozone-depleting substances.  The final regulations
were published in the Federal Register on July 24, 2002.  The rule may
be accessed on the USFDA website at   HYPERLINK
http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm
http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm  by searching
for rules published on July 24, 2002.  The USFDA issued a proposal in
June 2004 setting out the process and considerations to remove the
essential use designation of CFC albuterol at a date certain in the
future.  USFDA plans to issue a final decision in Spring 2005 on a date
certain by which albuterol CFC-MDIs would be considered non-essential in
the United States.

2.	Describe progress in the transition to alternatives pursuant to the
national or regional transition strategy submitted to the Secretariat.

Substantial progress has been made in recent years to facilitate an
orderly transition to safe and effective CFC-free alternatives.
Following substantial investment in research and development by U.S.
firms, and completion of the required safety tests for new drug
products, USFDA has approved several new treatments for asthma and COPD
that do not rely on CFCs (see the table below).  Additional alternatives
are under review by USFDA.  Also, the U.S. Government has overseen the
consistent application of Decisions by the Parties regarding the
allocation of essential use allowances, by ensuring that amount granted
by the Parties are not used if they are not needed nationally.  In 2002
USFDA issued the final regulations that provide the framework for the
transition to CFC-free alternatives in the United States.  These
regulations describe the criteria for determining that a product using
ODSs is no longer medically essential.  The accelerating shift by U.S.
firms to CFC-free products, as well as the success of these products in
the U.S. market, are reflected in the 50% reduction in the 2007 U.S.
nomination as compared to the total approved by the Parties for 2004,
and the 20% reduction compared to the total approved for 2005.

3.  	Explain what substitutes and alternatives to the proposed use are
currently available.

Describe any new or existing forms of treatment available if not
previously submitted during essential use assessment.

Three CFC-free MDIs are now approved for marketing in the United States
(see next response), as are several dry powder inhalers (DPIs), and a
fourth CFC-free MDI has been approved for marketing.  Several additional
CFC-free products are either under review by USFDA or are under active
development by pharmaceutical companies.  Examples of areas of research
on new delivery systems are:

A soft mist inhaler that uses mechanical energy to direct two opposing
liquid jets to aerosolize on impaction.

A miniaturized, portable piezoelectric device that uses alternating
electric currents to generate a fine droplet mist from the surface of a
liquid.

An ultrasonic horn used to generate an aerosol cloud by capillary wave
action.

A device that aerosolizes a liquid by forcing it through a break-up
plate, mesh cap, or open-cell foam.

List the substitutes and alternatives to the proposed use that are
currently licensed and describe availability, including trends in the
availability and usage of alternative inhalation devices and the likely
impact of these trends on the need for CFCs for MDIs in the year for
which the nomination is made.

Below is a list of CFC-free products approved and available for the
treatment of asthma and COPD in the U.S:

Product		Drug Delivery System		Active Moiety			Product Approval Date

Proventil HFA		HFA MDI		Albuterol			15/08/96

Ventolin HFA		HFA MDI		Albuterol			19/04/01

Undetermined (IVAX)	HFA MDI		Albuterol			10/29/04

Q-Var 			HFA MDI		Beclomethasone			15/09/00

Advair Diskus		DPI			Fluticasone/salmeterol		24/08/01

Flovent Rotadisk		DPI			Fluticasone			07/11/97

Pulmicort Turbuhaler	DPI			Budesonide			24/06/97

Serevent Diskus		DPI			Salmeterol			19/09/97

Ventolin Nebules		Nebulizer		Albuterol			23/04/92

Ventolin Syrup		Oral			Albuterol			10/06/87

Ventolin Solution 	Nebulizer		Albuterol			16/01/87

for Inhalation

Ventolin Tablets		Oral			Albuterol			10/07/86

In part because of the presence of two HFA albuterol products on the
market (Ventolin and Proventil;), USFDA issued a proposed rule in June
2004 setting out the process and considerations to set a date certain to
withdraw albuterol as an essential use moiety.  It should be noted that
withdrawal of any essential use product is an important, deliberative
process that is contingent upon many factors, including the potential
health and economic impacts of transitioning patients from generic to
brand-name medications. We anticipate that the USFDA rulemaking process
will conclude in Spring 2005, and at that time the United States will
give due consideration to the ramifications of the outcome of that
process to our Essential Use Exemption nominations.

The HFA MDI product Q-Var, a CFC-free beclomethasone MDI, has taken over
a small portion of the inhaled corticosteroid market.  The total U.S.
production for beclomethasone in 1998 was about 6 million units, which
required about 200 tonnes of CFCs for production.  In future years, the
overall market for CFC-containing beclomethasone products may continue
to shrink as the non-CFC alternative gains acceptance and as other
asthma therapies become more important.

A dry-powder inhaler combination product of salmeterol and fluticasone
(tradename Advair) was approved by the FDA in 2000.  While Advair is not
a direct replacement product, it has achieved significant market
penetration since its approval and is expected to lead to reduced CFC
needs in future.

We are hopeful that the availability and use of alternatives will
obviate the need to use the entire volume of CFCs that the U.S. is
nominating.  However, there are many factors involved, particularly
supply chain issues for U.S. manufacturers in obtaining licenses and
supplies of newly produced CFCs.  Because of the difficulty in
predicting with precision a sufficient supply of CFCs to ensure patient
safety during the transition, we consider the nominated volume to be
appropriate.

In addition to the MDI and the DPI, three other forms of therapy exist
for the treatment of asthma and COPD:

orally administered drugs

injectable drugs

nebulizers

Orally administered and injectable drugs are prescribed for some
patients but rarely offer adequate relief by themselves.  As noted
above, there is “international consensus that primary treatment of
these diseases should be by the inhaled route.”  Nebulizers are
currently impractical replacements for MDIs due to issues of portability
and ease of use.  In its April 1999 report, the Technology and Economic
Assessment panel stated, “Novel oral compounds (leukotriene modifiers)
for the treatment of asthma have been introduced in some countries.
These may be of value to a certain number of those with asthma, but it
is unlikely that these will be a full substitute for current effective
inhaled preventive therapy” (p. 191).

4.  	Explain steps being taken to implement these substitutes and
alternatives

List and describe in detail the education efforts being undertaken to
accomplish the transition.

The U.S. Government, pharmaceutical companies, and other U.S.
stakeholders have undertaken a number of education efforts, including:

World Wide Web Sites

USEPA and USFDA have websites with information on the transition to
CFC-free metered dose inhalers.  They are located at
www.fda.gov/cder/mdi/ and
http://www.epa.gov/ozone/title6/phaseout/mdi/index.html.

The International Pharmaceutical Aerosol Consortium (IPAC), to which
several companies operating in the U.S. belong, also has a World Wide
Web site (  HYPERLINK www.ipacmdi.com. www.ipacmdi.com).   The purpose
of the web site is to provide patients and physicians with information
on the transition to CFC-free MDIs.  The web site showcases IPAC
brochures, newsletters, fact sheets, and publications that IPAC
distributes at medical conferences and symposia.

Brochure on the Transition

A group of parties – USEPA, USFDA, the US National Institutes of
Health, IPAC, the National Asthma Education and Prevention Program of
the National Heart, Lung, and Blood Institute – collaborated in the
publication of a brochure entitled “Your Metered-Dose Inhaler Will Be
Changing. . . Here are the Facts.”  This brochure explains the reasons
why the CFC MDI is being replaced, the effort being made to develop and
introduce the CFC-free MDI, the ways in which the CFC-free MDI may
differ from the CFC MDI, and a list of organizations from which patients
and physicians may receive further information.

Stakeholders

The U.S. Government maintains an ongoing dialogue on the MDI transition
with a range of stakeholder organizations (pharmaceutical companies,
public health organizations, and patient and provider advocacy
organizations).  USEPA and USFDA participate in meetings of the US
Stakeholders Group on the MDI Transition, which meets under the auspices
of the American Lung Association.

Educational Activities of Individual MDI Companies

The pharmaceutical industry promotes respiratory education in many ways.
 MDI companies often play a supporting role in the development of
respiratory symposia.  MDI pharmaceutical companies assist medical
professionals through in-service education programs, and by providing
reprints of articles and reports, as well as copies of educational aids
for distribution to patients.  Finally, MDI companies support
respiratory patient organizations through financial grants and the
distribution of educational aids.

Advertisements and other promotional materials are placed in medical
journals and circulated to prescribing physicians by pharmaceutical
companies to heighten medical professionals awareness of new respiratory
care products on the market, including MDIs and DPIs.

Role of Professional Associations

International professional associations such as the American Thoracic
Society (ATS), the American Academy of Allergy, Asthma, and Immunology
(AAAAI), and the European Respiratory Society (ERS) support medical
professionals active in the treatment of asthma and COPD.  These
associations publish medical journals, reports and newsletters and
organize medical congresses.  These activities are designed to inform
medical professionals about the management of asthma and COPD, and the
range of treatment options available for their patients.

Describe how MDI manufacturers or distributors differentiate the
packaging of non-CFC MDIs from CFC-driven MDIs and describe what
marketing strategies are being taken to assure that their non-CFC MDIs
are used, and describe the steps that companies applying for essential
use exemptions have taken to obtain approval for CFC-free alternatives
in their domestic and export markets.

MDI companies have and will continue to differentiate the packaging for
CFC-free MDIs from the packaging of CFC MDIs through the use of shapes,
sizes, colors, trademarks, logos, and other design features.  In
addition, leaflets have been and will be included in the packages
containing CFC-free MDIs which inform patients of the differences
between the CFC-free MDI and the CFC MDI.  These steps have been and
will continue to be taken in accordance with relevant regulations of the
U.S. FDA (for example, 21 Code of Federal Regulations (CFR) Part 201
(dealing with labeling requirements for drugs) and Part 314 (dealing
with approval of new drugs).  Also, all CFC MDIs sold in the U.S. carry
a USEPA notification that the contents of the MDI includes CFCs.

To encourage doctor and patient acceptance and use of CFC-free MDIs, MDI
companies in the U.S. will undertake national promotional campaigns that
include, among other things, meetings with and letters to health care
professionals, information booths at medical conferences,
advertisements, and distribution of educational materials introducing
these products into the market.  These steps will be taken in accordance
with relevant regulations of USFDA.

Numerous applications for approval of CFC-free asthma medications are
currently under review by USFDA.

Describe what steps have been taken to ensure that companies
manufacturing, distributing, or selling CFC MDIs and non-CFC
alternatives do not engage in false and misleading advertising targeted
at non-CFC alternatives or CFC MDIs.

The regulations of the USFDA prohibit advertisements which are false,
lacking in fair balance, or otherwise misleading (21 CFR 202(e)(5)).  An
advertisement shall be so deemed if, for example, it contains a
“representation or suggestion, not approved or permitted for use in
the labeling, that a drug is better, more effective, useful in a broader
range of conditions. . . than has been demonstrated by substantial
evidence or substantial clinical experience. . .” (21 CFR
202.1(e)(6)(i)).  The USFDA has a variety of means at its disposal to
enforce this requirement.  See generally sections 301, 502, and 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, and 355)
and 21 CFR Parts 202 and 314.U.S. Federal regulations may be accessed at
http://www.access.gpo.gov/su_docs/index.html.

Describe what steps have been taken to ensure that companies applying
for essential use exemptions participate in regulatory proceedings with
a view toward legitimate environmental, health and safety concerns.

FDA regulations governing participation in regulatory proceedings
generally prohibit any company, including any MDI company, from
advancing environmental, health and safety concerns that are
illegitimate, or from otherwise engaging in conduct that misleads or
obfuscates.  These regulations require, among other things, that:

“All submissions to the Dockets Management Branch [of the USFDA] are
representations that, to the best of the knowledge, information, and
belief of the person making the submission, the statements made in the
submission are true and accurate.  All submissions are subject to the
False Reports to the Government Act (18 U.S.C. 1001) under which a
willfully false statement is a criminal offense” [21 CFR §10.20(i)];

Any company filing a “citizen petition” with the USFDA must certify
that the petition “includes representative data and information known
to the petitioner which are unfavorable to the petition” [21 CFR
§10.30(b)]; and

Participants in a hearing at the USFDA must observe “judicial
standards of practice and ethics.” [21 CFR §12.90]

Explain why alternatives and substitutes are not sufficient or
appropriate to eliminate the proposed use.

MDIs possess numerous characteristics that, taken together, set them
apart from other inhalation delivery systems.  MDI propellants provide
the energy needed for drug delivery independent of any external power
source or extra inspiratory effort on the part of the patient.  In MDIs,
the delivered dose depends significantly on the metering valve and
formulation, not entirely on patient inspiration.  A patient who must
take multiple medications can operate a variety of MDIs using the same
technique.  MDIs provide very good protection from atmospheric humidity
and patient exhalation.  MDIs can be used for the inhalation of all of
the most commonly used respiratory 	medications and are widely available
for use with these medications.  They can be adapted to meet the needs
of special patient populations, including young children and infants.

Although three MDIs with an alternative (non-CFC) propellant are
available in the U.S., these products represent only a fraction of the
many drugs currently available in an MDI format.  Further, the market
penetration of the albuterol HFA MDI has been relatively low
(approximately 10% of all albuterol MDIs sold) due to the significant
cost differential between the HFA MDIs and generic CFC MDIs.Market
penetration for the beclomethasone HFA product may not make a large
impact of CFC use, since the overall market for beclomethasone has
shrunk in recent years.  While other CFC-free MDIs may be introduced in
the next few years, it is clear that CFC MDIs will still be vital for
the treatment of asthma and COPD in the U.S. for the foreseeable future.

Reports of the Aerosols Technical Options Committee

The 1993/94 UNEP Technical Options Report listed the reasons why the MDI
is a vital therapy option.  These reasons remain pertinent today:

	Nebulizers (1993/94 UNEP Technical Options Report, p. 49)

Most nebulizers "require a source of electricity or compressed gas, and
are very bulky and complicated to set up and use."

Currently available hand-held nebulizers are "inefficient."

Dose reproducibility in nebulizers "is not reliable."

Electric nebulizers require "10-20 minutes to deliver a dose."

	Oral Medication (1993/94 UNEP Technical Options Report, p. 50)

Oral medication usually produces "more side effects than inhaled
medication."

Some drugs which are effective by inhalation "are not absorbed as oral
therapy."

Treatment guidelines "have favoured a move from oral to inhaled route
for the treatment of respiratory diseases."

	Injectable Therapy (1993/94 Technical Options Report, p.50)

Injectable therapy “is not practical for general use in ambulatory
patients and is therefore reserved for the treatment of hospitalized
patients.”

	Dry Powder Inhalers (1993/94 UNEP Technical Options Reports, pp. 48-49)

DPIs are “difficult for patients with low inspiratory flow rates,
“e.g. small children, COPD patients, and asthmatics suffering from an
acute asthma attack.

DPIs require “special packaging for use in humid climates.”

Patient acceptance of DPIs “is not uniform.”

5. 	Assure that each company requesting essential use allocations has
fully complied with Decision VIII/10.1 to demonstrate ongoing research
and development of alternatives to CFC MDIs will all due diligence
and/or collaborate with other companies on such efforts.

All companies requesting essential use exemptions submitted information
to the U.S. government demonstrating their ongoing research and
development of alternatives to CFC MDIs.

6.  	Describe the steps to minimize emissions of CFCs during the
manufacture of essential use products.

	The waste minimization strategies employed in the manufacture of MDIs
include:

Use of a vapor return hose

Vapor return hoses minimize emissions during the transfer of CFCs from
tank trucks to on-site storage tanks.  These hoses ensure that CFC vapor
from the top of the storage tank flows back into the delivery vehicle
rather than being vented to the atmosphere.

Trucks and canisters dedicated to a single material

Delivery trucks and canisters are dedicated to a single type of
material.  Refilling of a truck or canister results in reduced emissions
through emission-controlled sampling and testing of the refilled truck
or canister for quality and purity of the CFC.  The need to vent and
clean multiple-use trucks and canisters is eliminated, thereby
decreasing associated emissions.

Installation of permanent, hard piping

Temporary, flexible hosing for CFC transfer is replaced with permanent,
hard piping.  The piping reduces CFC vapor emission because it does not
need to be drained, disconnected, or vented between runs.

Detection and prevention of pump failure

Electronic sensors and automatic valves are installed in order to close
off and isolate a pump in the event of pump failure.  Listening devices
are also installed to detect imminent pump failure.

Detection and prevention of leaks

Inspection and maintenance programs are employed to minimize the risk
of, and promptly detect and remedy, leaks in transfer networks.

Minimization of mixing vessel waste material

The blending of CFCs and pharmaceutical active ingredient(s) results in
an extremely small amount of CFC-containing waste material.  A process
has been developed to minimize this waste product.

Destruction or reclamation of CFC-containing waste material

CFC-containing waste material from blending and cleaning operations is
destroyed.  The possibility of reclaiming the CFCs in this waste
material is being explored.

Minimization of leaks during blending

Seals on blending vessels have been redesigned and improved to minimize
emissions during the formulation blending process.  Hermetically sealed
vessels are drained and cleaned without venting to the environment.
Programs are in place to check for leaks during the blending process.

Replacement of rubber elastomers in MDIs

New elastomers have been employed to reduce the number of rejected lots
and the leak rate of MDIs.

In-line stainless steel filters

CFC filters are used more efficiently and replaced less frequently,
thereby reducing the release of CFCs during each filter change.

Special gassing adapters

Gassing adapters specially designed for the MDI minimize the release of
propellant during the filling of each MDI canister.

Use of CFC-free solvents

CFC-free solvents are used for many elements of the cleaning process.

7. 	Provide details of the management of the stockpile and any surplus.

CFC stockpiles safeguard patient care by protecting against disruptions
and shortfalls in the production of new CFCs.  As an alternate source of
pharmaceutical propellants, these stockpiles ensure continuous
availability of essential MDIs in the event of off-specification
production, shipping and other logistical difficulties, catastrophic
loss, and unexpected delays in issuance of licenses for essential use
production.  CFC stockpiles also provide a margin of safety when the
need for essential CFC MDIs is greater than anticipated as a result of:
(i) larger than expected increases in CFC MDI market demand; (ii)
unforeseen delays in the approval of CFC-free MDIs; (iii) lower than
anticipated acceptance of alternatives to the MDI; and/or (iv)
manufacturing rationalization.

Due to the decrease in general demand for CFCs during the transition,
there is now only one facility, located in the Netherlands, still
supplying pharmaceutical grade CFC-11 and CFC-12 for the U.S. market.
At present U.S. MDI companies are wholly dependent upon pharmaceutical
grade CFC produced at this Dutch facility, which is scheduled to close
in 2005.  During 2005, there should be one or more other facilities in
the U.S. or Europe that can produce CFCs for use in MDIs.  Stockpiled
CFCs provide a small margin of safety should there be unexpected delays
or difficulties in new production.

The Montreal Protocol's Technology and Economic Assessment Panel (TEAP)
has recommended a 12-month level of reserves as reasonable to guard
against unforeseen events.  Decision XVI/12, taken by the Parties at
their Sixteenth Meeting in November 2004, instructed nominating
countries to “give due consideration to existing stocks, whether owned
or agreed to be acquired from a metered-dose inhaler manufacturer, of
banked or recycled controlled substances as described in paragraph 1(b)
of decision IV/25, with the objective of maintaining no more than one
year’s operational supply.”

The USEPA monitors reserves through information provided by companies
that receive essential use allowances.  In putting forward our 2007
essential use exemption nomination, the United States carefully reviewed
the size of company reserves, bearing in mind that information on
reserves at the end of 2003 or 2004 is not a reliable indicator of the
amounts that will be held, and their distribution at the beginning of
2007.  Bearing in mind this uncertainty, the United States has given due
consideration to the existence of stocks in accordance with Decision
XVI/12.  The United States also reviews the requests we receive from
companies for exemptions to ensure that the amount requested is
consistent with our view of the actual patient need in the marketplace.

USEPA regulations prohibit the sale of CFCs produced under the authority
of essential use allowances into any other market.  Companies that
produce or import CFCs with essential use allowances must either destroy
all stockpiled essential-use CFCs when the MDI transition ends using
approved technologies, or transfer the CFCs to other MDI companies as
provided by the Parties.

	Describe the steps being taken to provide a continuity of supply of
asthma and COPD treatment to importing non-Article 5(1) countries,
Article 5(1) countries and CEIT.  Also describe the steps being taken by
companies to assist their MDI manufacturing facilities in Parties
operating under Article 5(1) and CEIT in upgrading the technology and
capital equipment needed for manufacturing non-CFC asthma and COPD
treatments.

Although the U.S. exports only a small amount of CFC MDIs, many U.S.
pharmaceutical companies are multinational, and have introduced CFC-free
alternatives in many other countries.  As reformulation programs are
completed, and necessary regulatory approvals secured, CFC-free
alternatives will be introduced in both domestic and export markets.

III.	Substantiation of Volumes

1.	Please indicate below the actual or estimated quantities of
controlled substances used in years prior to the first year for which an
exemption is requested.

Metric Tonnes Used For MDIs

Ozone Depleting Substance	1993	1994	1995

CFC-11	646.25	351.42	742.85

CFC-12	1406.95	1606.94	1481.93

CFC-114	928.35	1086.25	1075.42

Total	2981.55	3044.61	3300.2

Data for years beyond 1995 are included the U.S. Reporting Accounting
Framework for Essential Uses.

The U.S. 2007 request of 1,493 metric tonnes includes a request for 932
metric tonnes for albuterol MDIs.  As noted above, there are currently
three HFA albuterol products approved for marketing in the United
States, although post-marketing data is only available for two of the
three.  USFDA issued a proposed rule in June 2004 setting out the
process and considerations to set a date certain to withdraw albuterol
as an essential use moiety.  It should be noted that withdrawal of any
essential use product is an important, deliberative domestic process
that is contingent upon many factors, including the potential health and
economic impacts of transitioning patients from generic to brand-name
medications. We anticipate that the USFDA rulemaking process will
conclude in Spring 2005, and at that time the United States will give
due consideration to the ramifications of the outcome of that process to
EUE nominations.

With regard to CFC MDIs other than albuterol MDIs, the United States
assumes that CFC-free alternatives will continue to increase their share
of the asthma/COPD market. However, the experience of all Parties has
demonstrated that the myriad of factors that play into a national
request, including unpredicted rationalization of production, makes it
very difficult to predict the precise level of CFCs needed over two
years in the future.  The USEPA has conferred with USFDA to ensure that
the U.S. nomination reflects a careful consideration of the various
factors that will affect volume requirements in the year 2006.  These
factors include:  (i) rate of increase in the diagnosis and treatment of
asthma and other respiratory diseases; (ii) the rate of increases in
prescriptions of CFC MDIs; (iii) the rate of approval, introduction, and
acceptance of CFC-free MDIs; and (iv) the rate of approval,
introduction, and acceptance of alternatives to the MDI.

The U.S. in the past has submitted essential use requests that were
conservative in order to ensure that the needs of patients in the U.S.
are met.  For example, the U.S. requested a total of 2,975 metric tonnes
of CFCs for the year 2004, but ultimately allocated only 2,078 metric
tonnes to companies due to reduced need reported by certain companies.
Since 2000, the U.S. has reduced the total amount of its nominated
exemptions by almost fifty percent. A conservative approach to essential
use nominations provides a valuable safety valve in the case of
unanticipated patient need, without incurring negative consequences for
the ozone layer.  The U.S. believes that it is critical to request
enough CFCs to meet potential patient needs in the face of uncertainty,
since underestimating the need could have significant public health
consequences.

	Estimate the proportion of the nominated quantity intended for use in
MDIs for export.  Assure that the Secretariat’s list of CFC MDI active
ingredients and/or category of products determined to be nonessential by
an importing Party has been consulted, and that none of the volumes
requested shall be used for items posted on that list.

We estimate that less than one percent of the total volume requested for
2007 will be used for production of CFC MDIs for export to other
industrialized countries.  These exports
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[Federal Register Volume 82, Number 107 (Tuesday, June 6, 2017)]
[Notices]
[Pages 26086-26089]
[FR Doc No: 2017-11697]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0180; FRL-9962-78]

FIFRA Scientific Advisory Panel; Notice of Public Meeting;
Request for Ad Hoc Expert Nominations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a 4-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review physiologically based pharmacokinetic modeling to
address pharmacokinetic differences between and within species.

DATES: The meeting will be held on October 24, 2017 to October 27,
2017, from approximately 9 a.m. to 5 p.m.
    Comments. Written comments should be submitted on or before
September 11, 2017. FIFRA SAP may not be able to fully consider written
comments submitted after September 11, 2017. Requests to make oral
comments should be submitted on or before September 25, 2017 by
contacting the Designated Federal Official (DFO) listed under FOR
FURTHER INFORMATION CONTACT. For additional instructions, see Unit I.C.
of the SUPPLEMENTARY INFORMATION.
    Nominations. Nominations of candidates to serve as ad hoc members
of FIFRA SAP for this meeting should be provided on or before July 21,
2017.
    Webcast. This meeting may be webcast. Please refer to the FIFRA SAP
Web site at https://www.epa.gov/sap for information on how to access
the webcast. Please note that the webcast is a supplementary public
process provided only for convenience. If difficulties arise resulting
in webcasting outages, the meeting will continue as planned.
    Special accommodations. For information on access or services for
individuals with disabilities, and to request accommodation of a
disability, please contact the DFO listed under FOR FURTHER INFORMATION
CONTACT at least 10 days prior to the meeting to allow EPA time to
process your request.

ADDRESSES: Meeting: The meeting will be held at the Environmental
Protection Agency, Conference Center, Lobby Level, One Potomac Yard
(South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202.
    Comments. Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2017-0180, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online

instructions for submitting comments. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
    Nominations, requests to present oral comments, and requests for
special accommodations. Submit nominations to serve as ad hoc members
of FIFRA SAP, requests for special accommodations, or requests to
present oral comments to the DFO listed under FOR FURTHER INFORMATION
CONTACT.

FOR FURTHER INFORMATION CONTACT: Dr. Marquea D. King, DFO, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001;
telephone number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may
be of interest to persons who are or may be required to conduct testing
of chemical substances under the Federal Food, Drug, and Cosmetic Act
(FFDCA) and FIFRA. Since other entities may also be interested, the
Agency has not attempted to describe all the specific entities that may
be affected by this action.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit CBI information to EPA through
regulations.gov or email. If your comments contain any information that
you consider to be CBI or otherwise protected, please contact the DFO
listed under FOR FURTHER INFORMATION CONTACT to obtain special
instructions before submitting your comments.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

C. How may I participate in this meeting?

    You may participate in this meeting by following the instructions
in this unit. To ensure proper receipt by EPA, it is imperative that
you identify docket ID number EPA-HQ-OPP-2017-0180 in the subject line
on the first page of your request.
    1. Written comments. Written comments should be submitted, using
the instructions in ADDRESSES and Unit I.B., on or before September 11,
2017, to provide FIFRA SAP the time necessary to consider and review
the written comments. FIFRA SAP may not be able to fully consider
written comments submitted after September 11, 2017.
    2. Oral comments. The Agency encourages each individual or group
wishing to make brief oral comments to FIFRA SAP to submit their
request to the DFO listed under FOR FURTHER INFORMATION CONTACT on or
before September 25, 2017, in order to be included on the meeting
agenda. Requests to present oral comments will be accepted until
September 25, 2017 and, to the extent that time permits, the Chair of
FIFRA SAP may permit the presentation of oral comments at the meeting
by interested persons who have not previously requested time. Oral
comments before FIFRA SAP are limited to approximately 5 minutes unless
arrangements have been made prior to September 25, 2017. The request
should identify the name of the individual making the presentation, the
organization (if any) the individual will represent, and any
requirements for audiovisual equipment. In addition, each speaker
should bring 15 copies of his or her oral remarks and presentation
slides (if required) for distribution to FIFRA SAP at the meeting by
the DFO.
    3. Seating at the meeting. Seating at the meeting will be open and
on a first-come basis.
    4. Request for nominations to serve as ad hoc expert members of
FIFRA SAP for this meeting. As part of a broader process for developing
a pool of candidates, both U.S. citizens and permanent residents who
can demonstrate that they are actively seeking U.S. citizenship will be
considered. For each meeting, FIFRA SAP staff routinely solicits the
stakeholder community for nominations of prospective candidates for
service as ad hoc members of FIFRA SAP. Any interested person or
organization may nominate qualified individuals to be considered as
prospective candidates for a specific meeting. Individuals nominated
for this meeting should have expertise in one or more of the following
areas: Physiologically-based pharmacokinetic (PBPK) modeling,
pharmacokinetics, pharmacodynamic (PD) modeling, in vitro to in vivo
extrapolation, human health risk assessment, neurotoxicity,
organophosphate pesticides, pyrethroids pesticides, N-methyl carbamate
pesticides, fungicides, acetylcholinesterase inhibition, and exposure
assessment. Nominees should be scientists who have sufficient
professional qualifications, including training and experience, to be
capable of providing expert comments on the scientific issues for this
meeting. Nominees should be identified by name, occupation, position,
address, email address, and telephone number. Nominations should be
provided to the DFO listed under FOR FURTHER INFORMATION CONTACT on or
before July 21, 2017. The Agency will consider all nominations of
prospective candidates for this meeting that are received on or before
that date. However, final selection of ad hoc members for this meeting
is a discretionary function of the Agency.
    The selection of scientists to serve on FIFRA SAP is based on the
function of the Panel and the expertise needed to address the Agency's
charge to the Panel. No interested scientists shall be ineligible to
serve by reason of their membership on any other advisory committee to
a Federal department or agency or their employment by a Federal
department or agency, except EPA. Other factors considered during the
selection process include availability of the potential Panel member to
fully participate in the Panel's review, absence of any conflicts of
interest or appearance of lack of impartiality, independence with
respect to the matters under review, and lack of bias. Although
financial conflicts of interest, the appearance of lack of
impartiality, lack of independence, and bias may result in
disqualification, the absence of such concerns does not assure that a
candidate will be selected to serve on FIFRA SAP. Numerous qualified
candidates are identified for each Panel. Therefore, selection
decisions involve carefully weighing a number of factors including the
candidates' areas of expertise and professional qualifications and
achieving an overall balance of different scientific perspectives on
the Panel. In order to have the collective breadth of experience needed
to address the Agency's peer review charge for this meeting, the Agency
anticipates selecting approximately 13 ad hoc scientists.

    FIFRA SAP members are subject to the provisions of 5 CFR part
2634--Executive Branch Financial Disclosure, Qualified Trusts, and
Certificates of Divestiture, as supplemented by EPA in 5 CFR part 6401.
In anticipation of this requirement, prospective candidates for service
on FIFRA SAP will be asked to submit confidential financial information
which shall fully disclose, among other financial interests, the
candidate's employment, stocks, and bonds, and where applicable,
sources of research support. EPA will evaluate the candidate's
financial disclosure form to assess whether there are financial
conflicts of interest, appearance of a lack of impartiality, or any
prior involvement with the development of the documents under
consideration (including previous scientific peer review) before the
candidate is considered further for service on FIFRA SAP. Those who are
selected from the pool of prospective candidates will be asked to
attend the public meetings and to participate in the discussion of key
issues and assumptions at these meetings. In addition, they will be
asked to review and to help finalize the meeting minutes and the final
meeting report. The list of FIFRA SAP members participating at this
meeting will be posted on the FIFRA SAP Web site at https://www.epa.gov/sap or may be obtained from the OPP Docket at http://www.regulations.gov.

II. Background

A. Purpose of FIFRA SAP

    FIFRA SAP serves as the primary scientific peer review mechanism of
EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) and is
structured to provide scientific advice, information and
recommendations to the EPA Administrator on pesticides and pesticide-
related issues as to the impact of regulatory actions on health and the
environment. FIFRA SAP is a Federal advisory committee established in
1975 under FIFRA that operates in accordance with requirements of the
Federal Advisory Committee Act (5 U.S.C. Appendix). FIFRA SAP is
composed of a permanent panel consisting of seven members who are
appointed by the EPA Administrator from nominees provided by the
National Institutes of Health and the National Science Foundation. The
FIFRA SAP is assisted in their reviews by ad hoc participation from the
Science Review Board (SRB). As a scientific peer review mechanism,
FIFRA SAP provides comments, evaluations, and recommendations to
improve the effectiveness and quality of analyses made by Agency
scientists.

B. Public Meeting

    The 2009 National Research Council's report ``Science and
Decisions'' recommends that the EPA use the best, most current science
to support or revise the default assumptions in risk assessment. In
addition, the 2013 Institute of Medicine's report on ``Environmental
Decisions in the Face of Uncertainty'' further recommends that
replacing default uncertainty factors with data-derived extrapolation
factors (DDEFs) that delineate the differences between species would
reduce uncertainty in risk assessment. Such inter- and intra-species
extrapolation factors can be derived using a PBPK modeling approach to
organize mechanistic data on properties that determine the absorption,
distribution, metabolism, and excretion (ADME) of chemicals that enter
the body. In the 2006 document on ``Approaches for the Application of
Physiologically Based Pharmacokinetic (PBPK) Models and Supporting Data
in Risk Assessment'', the Agency recognizes that PBPK model analysis is
a scientifically sound approach that allows for estimating the internal
dose of a chemical or its metabolite at a target site, and can act as a
means to evaluate and describe the uncertainty in a risk assessment.
    PBPK models incorporate the relevant physiology, chemistry,
biochemistry that determines the ADME processes, and thus, they are
useful for predicting internal dosimetry related to a certain chemical
within and outside the testing conditions (e.g., species, dose ranges).
PBPK models have been used to assist high-to-low dose, route-to-route,
aggregation of exposure from multiple routes, and inter-species
extrapolations that are necessary for estimating human health risks
based on the results of animal toxicity studies. The physiological
structure of PBPK models also allows for examining the effects of
changing physiology, such as aging, early life-stage, or pregnancy. The
temporal change in the dose metric simulated by a PBPK model can also
be linked to a PD model to predict quantitative changes in biological
effects, such as acetylcholinesterase (AChE) inhibition.
    Several registrants, including the Council for the Advancement of
Pyrethroid Human Health Risk Assessment (CAPHRA), Tessenderlo Kerley
Inc. (TKI), FMC/Cheminova, and Syngenta, are developing PBPK (or PBPK-
PD) models for the chemicals: Acibenzolar, carbaryl, deltamethrin,
dimethoate, malathion, and permethrin. All six models will include
life-stage physiological changes from birth to adulthood, so that dose
metrics can be predicted at any age. These life-stage models, however,
will not include gestation and lactational phases, therefore; it is not
expected that these models will have the capability to predict dose
metrics in pregnant women or fetuses or breastfeeding exposures. These
models are intended as a means to estimating inter- and intra-species
data derived extrapolation factors and/or human points of departure
(PoD) for various exposure scenarios (e.g., routes of exposure). For
dimethoate, malathion, and carbaryl, the PBPK models will be coupled
with PD models to predict AChE inhibition in red blood cells (RBCs) and
other tissues (e.g., brain).
    The purpose of the October 2017 SAP will be to review five PBPK or
PBPK-PD models (carbaryl, deltamethrin, dimethoate, malathion, and
permethrin) for the purposes of model structures, mathematical
representations, parameter estimations, computer implementations,
variability and uncertainty analysis, and model predictive
capabilities, as well as the appropriateness of their applications in
human health risk assessments. The details for each model, including
their inputs, parameters and associated distributions, and the model
code, written in software program acslX or R, will be provided for five
(not including acibenzolar) chemicals as part of the background
materials for the meeting. The agency will solicit comments from the
SAP members on the evaluation of these PBPK (or PBPK-PD) models
regarding their capability to predict appropriate internal dose metrics
in humans. In addition, the SAP members will be asked to evaluate the
appropriateness of using these models for intended risk assessment
purposes, such as deriving chemical-specific DDEFs to replace default
uncertainty factors, or estimating human PoDs for various exposure
scenarios (e.g., dietary, drinking water, and worker exposures).
Finally, the SAP members will be asked to comment on the potential for
using these models as a basis for extrapolation to other chemicals
within the same chemical class.
    For the sixth PBPK model (acibenzolar), developed in Simcyp,
details including inputs, parameters and associated distributions, will
be provided as background materials. The SAP members, however, will not
be asked to review the Simcyp model code. Instead, the agency will
solicit comments from the SAP members as a consultation on this model
as primarily

a proof-of-concept study, highlighting newer in vitro and in silico
based approaches. This model is not anticipated to be used in a risk
assessment by the Agency.

C. FIFRA SAP Documents and Meeting Minutes

    EPA's background paper, charge/questions to FIFRA SAP, and related
supporting materials will be available on or before August 11, 2017. In
addition, a list of candidates under consideration as prospective ad
hoc panelists for this meeting will be available for public comment by
mid to late August (see link for listing of nominees to appear in mid
to late August at https://www.epa.gov/sap). Comments should be provided
to the DFO listed under FOR FURTHER INFORMATION CONTACT on or before
the deadline listed on the Web site given above. Your comments will be
placed in the public docket by the DFO. You may obtain electronic
copies of most meeting documents, including FIFRA SAP composition
(i.e., members and ad hoc members for this meeting) and the meeting
agenda, at http://www.regulations.gov and the FIFRA SAP Web site at
https://www.epa.gov/sap.
    FIFRA SAP will prepare meeting minutes summarizing its
recommendations to the Agency approximately 90 days after the meeting.
The meeting minutes and final report will be posted on the FIFRA SAP
Web site or may be obtained from the OPP Docket at http://www.regulations.gov.

    Authority: 7 U.S.C. 136 et. seq.; 21 U.S.C. 301 et seq.

    Dated: May 25, 2017.
Stanley Barone Jr.,
Director, Office of Science Coordination and Policy.
[FR Doc. 2017-11697 Filed 6-5-17; 8:45 am]
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