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) Decree
1
, 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 implemented
2
. For
substances for which no probit function is available, a probit function may be derived
according 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 composition
of 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 and
the Environment; responsible for the appointment of expert
panel members, the formalization of probit functions, the
formalization of this procedure and the implementation of the
established probit functions

DOEV Directeuren Overleg Externe Veiligheid. Consultative body of
national authorities involved with external safety; responsible for
the 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 establishment
of probit functions.


1
Besluit van 27 mei 2004, houdende milieukwaliteitseisen voor externe veiligheid van inrichtingen
milieubeheer (Besluit externe veiligheid inrichtingen)
2
RIVM (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. The
public 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 will
derive 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 to
have 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 outlined
below. 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 the
priority list

B1. Notification of a substance / request for
placement on the priority list
A2. Composition of the substance dossier B2. Submitting the substance dossier (if
substance is not put on the priority list)


Both routes


1. Completeness check of the substance dossier

2. Placement on the agenda of the expert panel meeting

3. Opportunity to comment on a proposed probit function

4. Expert panel meeting

5. Advice of the expert panel

6. Formalization of the probit function

7. Urgency procedure

8. 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 out
in 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 (see
under 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 contain
all 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 handled
through the public route. If the request is not granted, the applicant may decide to submit a
substance 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 dossier
should 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 all
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.
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 Document
Format) 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 dossier

The substance dossier is checked for completeness by the technical secretariat. The results of
the 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 be
incomplete, the applicant may decide to submit a revised substance dossier.
2. Placement on the agenda of the expert panel meeting

If 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 placed
on 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 technical
secretariat informs the applicant that the substance has been placed on the agenda.

3
Regulation (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 completeness
check documents, on a designated website.
3. Opportunity to comment on a proposed probit function

Any 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 meeting

Set-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 the
meeting (see under Decision making). A member unable to attend the meeting may provide
written input to the technical secretariat up to 24 hours before the meeting, including consent
or 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 secretariat
together with the comments document. The discussions and decision making of the expert
panel 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, using
the 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. If
the 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 technical
secretariat) a written explanation to the applicant, within 2 weeks after the meeting. The
applicant 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 the
proposed 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 expert
panel 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 applicant
may 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 produce
only minor discussion (to be labeled as such by the technical secretariat), may be decided on
by written voting.
5. Advice of the expert panel to the DOEV

Within 2 weeks after the meeting, the technical secretariat provides, on behalf of the expert
panel, a written advice for each substance discussed, explaining the panels decision on the
proposed 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 probit
function and the technical support document) on the designated website.
6. Formalization of the probit function

For 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 will
not question the scientific advice of the expert panel.
For harmonization purposes, any decision by the Ministry of VROM with regard to probit
functions is discussed in the DOEV, a consultative body of representatives from departments
involved with external safety, including the ministries of Transport, Public Works and Water
Management; Economic Affairs; Social Affairs and Employment; and Interior and Kingdom
Relations.
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 function
remains valid.
7. Urgency procedure

Under 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 the
application of the urgency procedure. In this case, the substance is placed on top of the
priority 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 functions

Probit functions that have been established will be subject to periodical review. RIVM will
carry 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.