20100114 Evaluation and Assessment of Probit Functions 1.2

8/12/2019 20100114 Evaluation and Assessment of Probit Functions 1.2

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Evaluation and assessment of probit functions

Date: January 14, 2010

Version: 1.2

Department: Centre for External Safety

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Introduction

This document describes the procedure for the evaluation and assessment of probit functions.

In the Netherlands, probit functions are used in the framework of the External Safety

(Establishments) Decree1, to calculate the mortality rate due to exposure to toxic substances at

a given exposure concentration and duration. In principle, only formally established probit

functions may be used in a quantitative risk assessment (QRA) performed under the Decree.

For a number of substances, probit functions have been formalized and implemented2. For

substances for which no probit function is available, a probit function may be derivedaccording to a specified methodology. A group of experts has been appointed to evaluate

newly derived probit functions, before they can be formalized.

Parties involved and responsibilities

Applicant Responsible for the notification of a substance and the compositionof the substance dossier. The applicant may be a governmental or

private party.

Expert panel Group of experts, responsible for evaluation and assessment of

substance dossiers, including probit functions. The members of the

expert panel are appointed by the Ministry of VROM.

Ministry of VROM The Netherlands Ministry of Housing, Spatial Planning andthe Environment; responsible for the appointment of expert

panel members, the formalization of probit functions, the

formalization of this procedure and the implementation of theestablished probit functions

DOEV Directeuren Overleg Externe Veiligheid. Consultative body of

national authorities involved with external safety; responsible forthe formal establishment of probit functions, the appointment of

expert panel members and the establishment of this procedure.

Technical secretariat Responsible for the administrative procedures on the establishmentof probit functions.

1Besluit van 27 mei 2004, houdende milieukwaliteitseisen voor externe veiligheid van inrichtingen

milieubeheer (Besluit externe veiligheid inrichtingen)2RIVM (2009) Reference Manual Bevi Risk Assessments, version 3.2.


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Procedure outline

There are two possible starting points for the procedure: a public and a private route. Thepublic route is intended for substances on a priority list, for which the establishment of a

probit function is considered of general interest. For these substances, the authorities willderive the probit function. The private route is intended for any other substance, for which

an applicant is interested in having a probit function established. An applicant may request tohave a substance of interest put on the priority list. If such a request is granted, the substance

will be handled through the public route; if not, the applicant itself should produce a

substance dossier and derive the probit function.

The stepwise procedure for the evaluation and assessment of probit functions is outlinedbelow. The consecutive steps are described in more detail hereafter. A time schedule is given

in the annex.

Public route (A) Private route (B)

A1. Placement of the substance on thepriority list

B1. Notification of a substance / request forplacement on the priority list

A2. Composition of the substance dossier B2. Submitting the substance dossier (ifsubstance is not put on the priority list)

Both routes

1. Completeness check of the substance dossier2. Placement on the agenda of the expert panel meeting3. Opportunity to comment on a proposed probit function4. Expert panel meeting5. Advice of the expert panel6. Formalization of the probit function7. Urgency procedure8. Review of established probit functions


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Procedure in detail

Public route

A1. Placement of the substance on the priority list

For certain substances, establishing a probit function can be considered of general interest.

For example, a substance may appear frequently in quantitative risk assessments, carried outin the framework of the External Safety (Establishments) Decree. For such substances of

general interest, the compilation of the substance dossier and the derivation of the probit

function is carried out by the authorities. Substances of general interest are placed on a

priority list. The priority list is formalized by the Ministry of VROM.If an applicant wishes a probit function be established for a substance, he may submit a

motivated request to the technical secretariat to have the substance put on the priority list (seeunder Private route/ B1).

A2. Composition of the substance dossier

For substances on the priority list, the substance dossier is compiled by (or on behalf of) the

National Institute of Public Health and the Environment (RIVM). The dossier should containall information on the substance relevant to the derivation of the draft probit function. A

technical support document should clarify all the steps leading to the derivation of the draft

probit function and should provide a rationale for the choices made.

Private route

B1. Notification of a substance

By notifying a substance, an applicant can express an interest in having a probit function

established for that substance. Notification may be done by any party with an interest in a

probit function for a certain substance.

The applicant submits a written notification to the technical secretariat.A private applicant may submit a motivated request to the technical secretariat to have the

substance put on the priority list (and thus have the probit function derived by the authorities).The Ministry of VROM decides whether or not a substance is placed on the priority list.

If the request is granted, the substance is placed on the priority list and will be handledthrough the public route. If the request is not granted, the applicant may decide to submit asubstance dossier through the private route (see under B2).


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B2. Submitting the substance dossier

The applicant submits a substance dossier for the notified substance. The substance dossiershould contain information on the identity of the applicant, the identity of the author of the

substance dossier, and the context of the application. The dossier should contain allinformation on the substance relevant to the derivation of the draft probit function. A

technical support document should clarify all the steps leading to the derivation of the draft

probit function and should provide a rationale for the choices made.When confidential data are used in the derivation of the probit function, the applicant may

label these data as such. The data will be treated confidentially and will not be made public,

with the exception of summary data.The substance dossier should be submitted in digital format (preferably in Portable DocumentFormat) to the technical secretariat.

Regarding the composition of the substance dossier, reference is made to Annex VI(Information requirements) of the REACH regulation

3.

Both routes

From here, the procedure is indentical for both the public and the private route.

1. Completeness check of the substance dossierThe substance dossier is checked for completeness by the technical secretariat. The results ofthe completeness check are reported in an evaluation document.For private dossiers, the technical secretariat informs the applicant on the completeness of

the substance dossier within 6 weeks after receipt of the dossier. If the dossier is judged to beincomplete, the applicant may decide to submit a revised substance dossier.

2. Placement on the agenda of the expert panel meetingIf a substance dossier is judged to be complete, the dossier is under discussion and the

probit function for that substance is assigned the status proposed. The substance is placedon the agenda of a meeting of the expert panel (in principle the next possible meeting, taking

into account the time schedule mentioned under 3). For private dossiers, the technicalsecretariat informs the applicant that the substance has been placed on the agenda.

3Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006

concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),

establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council

Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council

Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and

2000/21/EC


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Three months in advance of an expert panel meeting, the technical secretariat publishes the

agenda for the meeting, the technical support documents and, if applicable, the completenesscheck documents, on a designated website.

3. Opportunity to comment on a proposed probit functionAny party wishing to comment on a proposed probit function has the opportunity to do so, up

to 6 weeks before the meeting at which the probit function will be discussed.

Comments should be submitted to the technical secretariat.Any comments received are published on the website 4 weeks before the meeting at the latest.

4. Expert panel meetingSet-up of the meeting

The expert panel meets on a regular basis, approximately every 3 months.The expert panel consist of 5 members. The members of the panel are appointed by the

Ministry of VROM. For decision making, a minimum of 4 members should be present at themeeting (see underDecision making). A member unable to attend the meeting may provide

written input to the technical secretariat up to 24 hours before the meeting, including consentor rejection of a proposed probit function.

The technical secretariat takes minutes of the meetings.

Opportunity for oral clarification

A party that has provided comments is entitled to provide an oral clarification at the meeting,

before discussions start. A request thereto should be submitted to the technical secretariattogether with the comments document. The discussions and decision making of the expertpanel are not open to the public.

Discussion

Discussion of a substance by the expert panel focuses on two elements:

- assessment of the quality of the substance dossier;- discussion of the derivation of the probit function.

Any written input received from absent members is taken into account.

The expert panel starts the discussion by evaluating the quality of the substance dossier, usingthe completeness check document as a basis. If the quality of the substance dossier is

considered satisfactory, the panel proceeds to discuss the derivation of the probit function. Ifthe quality of the substance dossier is not considered satisfactory, the expert panel does not

discuss the derivation of the probit function. The expert panel provides (through the technicalsecretariat) a written explanation to the applicant, within 2 weeks after the meeting. Theapplicant may decide to submit a revised substance dossier (see under B2).

The discussion of the derivation of the probit function focuses on the steps that have led to theproposed probit function, including choices made and considerations. The method for

derivation of probit functions serves as a basis.

Decision making


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The decision making process of the expert panel is based on voting. Decisions are based on

majority rule. For a vote to be valid, at least 4 members of the panel should be present;members unable to attend the meeting may however provide written (dis)approval of a

proposed probit function, which will be valid for voting. When votes are equally divided,

voting is postponed to the next meeting.There are 3 possible outcomes of the decision making:

a. The probit function is accepted as such, and is assigned the status interim;b. The probit function is accepted with minor changes (to be noted by the expert panel

in its written advice; see under 5) and is assigned the status interim;c. The probit function is not accepted.

Members of the expert panel may themselves be involved in the compilation of substance

dossiers and the derivation of probit functions. For such dossiers, the members of the expertpanel will abstain from decision making.For private dossiers, the technical secretariat informs the applicant of the outcome within 2

weeks after the meeting. If the probit function for a substance is not accepted, the applicantmay decide to submit a revised substance dossier. The applicant may also decide to appeal,

through the Ministry of VROM, to the advice of the expert panel.

Documents that have been modified as a result of discussion by the expert panel, may be

discussed again in an expert panel meeting. However, documents that are expected to produceonly minor discussion (to be labeled as such by the technical secretariat), may be decided onby written voting.

5. Advice of the expert panel to the DOEVWithin 2 weeks after the meeting, the technical secretariat provides, on behalf of the expertpanel, a written advice for each substance discussed, explaining the panels decision on theproposed probit function. The technical secretariat informs the applicant and publishes the

relevant documents (i.e. the advice of the expert panel and, if applicable, the interim probitfunction and the technical support document) on the designated website.

6. Formalization of the probit functionFor a substance for which an interim probit function is available, a consequence analysis is

performed under the authority of RIVM.The Ministry of VROM decides whether or not a probit function will be formalized and

implemented, taking into account the results of the consequence analysis. The Ministry willnot question the scientific advice of the expert panel.

For harmonization purposes, any decision by the Ministry of VROM with regard to probitfunctions is discussed in the DOEV, a consultative body of representatives from departmentsinvolved with external safety, including the ministries of Transport, Public Works and Water

Management; Economic Affairs; Social Affairs and Employment; and Interior and KingdomRelations.

If a probit function is formalized, its status is raised from interim to established.Decisions on the formalization of probit functions are published on the designated website;


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the Reference Manual Bevi Risk Assessments and the External Safety Order are updated

accordingly.Interim probit functions that are not formalized by the Ministry may still be used in QRAs,

and RIVM will at all times advise to do so. This does not hold for revisions of already

formalized probit functions; if such a revision is not formalized, the existing probit functionremains valid.

7. Urgency procedureUnder certain circumstances, it may be desirable to have a probit function derived with

priority, e.g. when the probit function is urgently needed for a QRA. The Ministry of VROM

decides whether a given dossier (either a public or a private dossier) warrants theapplication of the urgency procedure. In this case, the substance is placed on top of thepriority list, and the substance dossier is discussed in the next possible meeting. Further, the

procedure as described above is followed.

8. Review of established probit functionsProbit functions that have been established will be subject to periodical review. RIVM willcarry out a survey of newly available relevant information for each substance for which a

probit function has been established. If this survey gives rise to revision of the probit function,the procedure described in this document will be followed.