The notes are intended to address a potential problem common to both types of operation. Under the Environmental Protection Act 1990, HMIP has four months to authorise a process under IPC, and may take longer by agreement with the applicant.
This is at odds with the commercial imperatives of the two industries. Contract chemicals businesses need to respond quickly to customer demand if they are to compete with rivals elsewhere in Europe. And pharmaceutical manufacturers regularly carry out new process development or small-scale production for clinical trials in pilot plant. Having to apply for a full authorisation each time a process was changed would have caused serious difficulties for both sectors.
Some firms have been arguing that the way to avoid these difficulties in the case of pilot plants should be to declare them "de minimis" and exclude them from IPC altogether. This was rejected by HMIP, which says there is no provision in the 1990 Act for a "de minimis" approach.
Much of the subsequent argument was over how much latitude firms should be given under the new envelope authorisations. These will define the areas of process chemistry which may be carried out in a plant before a revised authorisation has to be sought, and companies have been pressing for this definition to be as broad as possible. However, HMIP's Director Dr David Slater says "there is no question of us giving anybody a blank cheque."
The approach taken by the two guidance notes is not identical, reflecting differences in the scale of operation, pollution potential and operators' capabilities between commercial and pilot production.
For full-scale plants, the authorisation envelope will generally be fairly narrowly defined. For example, according to the guidance, "it should not be automatically assumed that a company which carries out chlorinations using phosphorus pentachloride is competent to carry them out using chlorine or even thionyl chloride, whilst a company carrying out sulphonations may not have the necessary expertise to use oleum or liquid sulphur trioxide."
The thinking behind this approach is that it should be for companies to justify why their envelopes should be broadly defined by reference to their production facilities, pollution control equipment, expertise and standards of operator training and supervision. An application for an envelope authorisation, the guidance comments, should be "at least as detailed as one for a single product process." And according to Dr Slater, "the more competence that applicants can demonstrate, the wider their envelopes may be."
Companies have also been warned that they may need to apply for a number of authorisations if they operate multi-stage processes. "It may be possible" to write a single authorisation for such processes, the guidance notes, "but it seems more probable that multi-stage syntheses will be covered by several separate 'envelopes' each requiring separate authorisation."
Once the key step of defining the envelope boundaries has been completed, companies will need to prepare "process data sheets" for each product to be manufactured within the envelope. These will describe the process, the equipment and the proposed techniques for controlling releases to the environment. A production schedule will also be sought by HMIP.
If a company subsequently wishes to make a product which is not on this initial list, it can apply to have it included within the envelope by way of a "non-substantial variation." This is well short of a full application, and the guidance says that it should be possible for HMIP to respond within a few days. This is subject to the proviso that the process chemistry, equipment and releases involved are "similar" to those for products already included in the envelope.
On confidentiality, the guidance notes that the process data sheets are quite likely to contain sensitive information, but even if this is excluded from the public registers it must be available to inspectors in a separate document.
The guidance appears to have eased the anxieties of at least some chemical manufacturers. One observed that it is "a major step in the right direction, although we are still worrying a bit whether we will be able to define a sufficiently broad envelope to meet the needs of the average fine chemicals producer. The test will only come when HMIP tries to produce its first envelope authorisations."
A spokesman for another company commented that while the guidance took a generally reasonable line, it would be essential for the information in process data sheets to be kept confidential. "The pharmaceutical industry has lobbied very strongly on this," he said.
A different approach is taken to pilot plant authorisations. These may sometimes be covered by a normal authorisation for full-scale plant on the same site, but the guidance says that this will not be appropriate in some circumstances. Examples are small-scale production of drugs for clinical trials which never subsequently reach full-scale production, or piloting of process chemistry for products which are subsequently put out to contract manufacture.
A special pilot plant envelope authorisation has been developed for such cases. However, the guidance makes it clear that plants will qualify for this only if they are used solely for experimental purposes - although this may include the preparation of material for clinical trials or pre-launch samples.
The boundaries of the envelope will not be defined anywhere as narrowly as for full-scale plant. According to HMIP, this is because staff operating a pilot plant will often be professionally qualified, while the trials will probably be of short duration and involve modest quantities of material. Hence inspectors "may accept that a company is competent to operate a far wider range of processes on a pilot scale than would be the case for full-scale production."
In contrast to a normal envelope authorisation, companies will not have to specify in advance the products to be investigated in pilot plants. Instead, they will have to give HMIP at least seven days' prior notice of a new project. The notification may be phrased in general terms for reasons of confidentiality. Its purpose will be to alert inspectors to the need to make any inquiries before the pilot run commences.
Companies will be able to operate with their initial envelope authorisations unless a project is likely to result in release limits being exceeded or if they want to enter new areas of chemistry. In these cases they will have to apply for a "substantial variation," analagous to a full application.
Firms already operating pilot plants will not need to apply for an authorisation until the general deadline for authorising existing processes of the kind involved. However, if a new experimental programme involving a different area of chemistry or higher releases of pollutants than those carried out in the 12 months to 1 April 1991 is proposed, an immediate application for an authorisation covering all pilot investigations on the site will be expected.