Guidance documents

G. Russwurm and J. W. Childers, FTIR Open Path Monitoring, Guidance Document, EPA Contract 68-D5-0049, ManTech Environmental Technology Inc., Research Park, N.C., 1996. 

The ECPI approach has been adopted by the European Commission in their "Technical Guidance Document on the Risk Assessment of Notified New Substances" as the model for assessment of environmental exposure from additives in plastics. It is important to note, however, that due to the effect of ultraviolet degradation and microbial attack, a significant proportion of the emissions from flexible PVC consists of plasticizer degradation products. In these instances, therefore, the level of plasticizers appearing in the environment will be significantly less than indicated by the plasticizer loss data. 

Additionally, the EPA pubhshes a newsletter entitled Pollution Prevention News that contains information including EPA news, technologies, program updates, and case studies. The EPA s Risk Reduction Engineering Laboratoiy and the Center for Environmental Research Information has pubhshed several guidance documents, developed in cooperation with the California Department of Health Services. The manuals supplement generic waste reduction information presented in the EPA s Waste Minimization Opportunity Assessment Manual (Ref. 9). 

A copy of Form R is included in this booklet. Remove this form and photocopy as many copies of it as you need. Additional copies of ERA Form R and related guidance documents may be obtained from ... 

Technical Guidance Document in Support of the Commission Directive 93/67/EEC on Risk. Assessment for New Notified Substances and the Commission Regulation (EC) 1488/94 on Risk Assessment for Existing Substances, European Commission, 1996. 

Directs national efforts to meet air quality goals, particularly for smog, air toxics, carbon monoxide, lead, particulate matter (soot and dust), sulfur dioxide, and nitrogen dioxide. The office is responsible for more than half of the guidance documents, regulations, and regulatory activities required by the Clean Air Act Amendments of1990. 

These common requirements were then used to develop management standards, guidance documents, and new or revised procedures and work instructions for integrated ESH activities. In some cases, the integration went beyond ESH boundaries and also included engineering, maintenance, and technology centers. 

In April 1982, a data workshop was held to evaluate, discuss, and critique data in order to establish a consensus generic data set for the USNRC-RES National Reliability Evaluation Program (NREP). The data set contains component failure rates and probability estimates for loss of coolant accidents, transients, loss of offsite power events, and human errors that could be applied consistently across the nuclear power industry as screening values for initial identification of dominant accident sequences in PRAs. This data set was used in the development of guidance documents for the performance of PRAs. 

In March of 1998, the FDA announced a draft guidance document for Industry for the manufacturing, process, or holding of APIs [64]. We shall apply our interpreta-... 

The guidance document requires calculation of actual yields and percentages of expected yields. The yield should be recorded at the conclusion of each phase of manufacturing of an API. The expected yield and ranges are established during process validation or from a pilot-scale production run [66]. 

In addition to the legal texts, you will also encounter guidance documents issued by the agencies involved in application and enforcement of legislation and other interested parties. 

The IC H focuses on developing harmonised guidance documents under four topic headings ... 

A five-step process is used to develop new guidance documents (see Figure 2.12). The process is initiated by presenting a concept paper to the Steering Committee. 

European Medicines Agency non-harmonised guidance documents http //www.emea.europa.eu/htms/human/humanguidelines/nondinical.htm. 

A harmonised guidance document on GCP has been developed by the ICH (ICH E6). The core principles of GCP, as agreed in the guidance document, are outlined in Table 5.2. 

The ICH have issued guidelines on how to organise the data in the modules. These guidance documents, which are shown in Table 6.3, deal primarily with how the information should be organised, whereas advice on how to generate the data is provided in the quality, safety and efficacy guidelines that were discussed in the previous chapters. We shall now look at the stmcture of the modules in a little more detail, starting with the basic data modules. 

The CFR references are provided for most items in order to indicate what type of information should be submitted in each section. For further information, the applicant may consult the guidance documents that are available from the Agency. 

Site-specific modeiiing used the Technical Guidance Document (CEC, 2003) generic modelling used the BUSES model. 

Technical Guidance Document (CEC, 2003) calculations lead to significantly higher results than those derived using BUSES. This is mainly due to the assumption that local air emissions will enter the wastewater stream — which is not applied to the BUSES calculations. 

By comparison with the measured data presented above, it can be seen that the local PECs are generally below, or in the order of, the maximum values measured in the aquatic environment. By way of exception, the values reported for methyltins, and in particular dimeth-yltin dichloride, from stabilizer production using the Technical Guidance Document (CEC, 2003) equations are significantly higher than the maximum measured values reported in the environment. 

CEC (2003) Technical guidance document on risk assessment in support of Commission Directive 93/67/EEC on risk assessment for new notified substances and Commission Regulation (EC) No 1488/94 on risk assessment for existing... 

Hill, I.R., Matthiessen, R, and Heimbach, F. (Eds.) (1993). Guidance Document on Sediment Toxicity Tests and Bioassays for Ereshwater and Marine Environments. SETAC Europe Workshop on Sediment Toxicity Assessment. Renesse, the Netherlands, November 8-10, 1993. 

Another important aspect for discussion is the impact of regulations, spe-cihcally the regulation on electronic document management and electronic signatures, 21 CFR Part 11, published by the Food and Drug Administration (FDA) for the hrst time in 1997 [1] (also see Chapter 26, which covers 21 CFR Part 11 in detail). Since that time the draft rules of Part 11 have been withdrawn and reissued along with various guidance documents [2-3], Some of the key points of Part 11 are as follows ... 

FDA. Draft Guidance for Industry on Part 11, Electronic Records Electronic Signatures—Scope and Application Availability of Draft Guidance and Withdrawal of Draft Part 11 Guidance Documents and a Compliance Policy Guide, Fed Regr 68 (37), 8775-6 (25 Eebruary 1997). 

Commission Directive 96/46/EC of 16 July 1996, amending Annex II to the Directive 91/414/EEC, is the basis for the assessment of residue analytical methods for crops, food, feed, and environmental samples." Provisions of this Directive cover methods required for post-registration control and monitoring purposes but not data generation methods. Because it is necessary to provide applicants as precisely as possible with details on the required information, the guidance document S ANCO/825/00 rev. 6 dated 20 June 2000 (formerly 8064/VI/97 rev. 4, dated 5 December 1998)" was elaborated by the Commission Services in cooperation with the Member States. 

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