Summary Tables Describing the Status of Activities to Implement the Recommendations of the Risk Assessment Advisory Committee
The Risk Assessment Advisory Committee (RAAC) was convened following the passage of SB 1082 into law in 1993. The RAAC, comprised of 34 distinguished scientists from across the nation, undertook an intensive, year-long review of the methods, policies and practices used by the California Environmental Protection Agency (Cal/EPA) to assess the risks posed by chemicals in the environment. The RAAC issued its final report of findings and recommendations in October 1996.
In December 1996, Governor Pete Wilson issued Executive Order W-137-96 which required all state agencies which "assess the toxicity of, exposure to, or risk of chemicals in the environment to human health" to evaluate the RAAC report and develop plans to implement the recommendations contained therein. Cal/EPA and other state agencies encompassed by the Executive Order developed and submitted implementation plans to OEHHA, the lead agency for this activity, by June 30, 1997, the deadline specified in the Executive Order. Thus, the summary tables attached to this memorandum provide a status report following 1 year of implementation activity since the completion of the implementation plans.
Table 1. Air Resources Board, Cal/EPA
Implementation Activities for Addressing the Recommendations of the Risk Assessment Advisory Committee
| Activity Description | Performance Measures | Status |
|---|---|---|
| Peer Review | ||
| Continue peer review practices as established for the Assembly Bill (AB) 1807 Air Toxics Program. | Identification of Diesel Exhaust as a Toxic Air Contaminant:
--Public comment periods --Scientific Review Panel (SRP) --SRP Expert Workshop --45 day public comment period prior to public hearing. Update of the Toxic Air Contaminant List to reflect substances prioritized for entry into the Identification process. |
Ongoing. The public outreach efforts for the identification of diesel exhaust has consisted of: three public comment periods, three public workshops, three SRP meetings, and one special SRP meeting with invited scientists. Currently in 45 day comment period prior to July 30, 1998, hearing.
Ongoing. Local air pollution control districts, the Office of Environmental Health Hazard Assessment, and Department of Pesticide Regulation have participated. The Scientific Review Panel has discussed the updated list at two meetings. 1 public comment period completed, 1 comment period planned for summer 1998. |
| TAC and Indoor Exposure Research Projects | The Research Screening Committee (RSC) reviews proposed research projects and Final Reports. The RSC consists of nine external scientists appointed by the Board to review all ARB extramural research projects. They review to assure that needed research is completed using appropriate scientific methods and practices.
External peer review is obtained on some projects as needed. |
Ongoing. |
| Work with other Cal/EPA Boards, Departments, and Offices in developing a flexible standard operating procedure for scientific peer review. | ARB worked with other Boards, Departments, and Offices to develop a standard operating procedure for scientific peer review in response to SB 1320. | Completed. |
| Continue to peer review the
AB 2588 Air Toxics "Hot Spots" Integrated Software through the California Air Pollution Control Officers Association’s (CAPCOA) Toxics Committee. |
The "Hot Spots" Integrated Software will assist industry, the local air pollution districts (districts), and the public with the requirements of the AB 2588 Air Toxics "Hot Spots" Program. This software will link:
1) the emission inventory (both toxics and criteria pollutants); 2) prioritization of facilities; 3) air dispersion modeling; and 4) multipathway health risk assessment, including the new OEHHA risk assessment guidelines. The initial software features were developed through a 34 member work group including industry, districts, OEHHA, and ARB. |
Ongoing, anticipated availability middle 1999. |
| Interface Between Risk Assessment and Risk Management | ||
| Continue to get early input from local, state and federal agencies, public, and stakeholders on new projects under the AB 1807 Air Toxics Identification Program. | Update of the Toxic Air Contaminant List to reflect substances prioritized for entry into the Identification process. | Ongoing. A staff report will be released Summer 1998 explaining the process of the update and future plans.
As a result of our prioritization work, 10 substances are nominated for the development of health numbers and exposure assessment. |
| Participate on CAPCOA Toxics Committee. | The ARB participates in meetings of the CAPCOA Toxics Committee which includes staffs from many districts, OEHHA, and ARB. This committee discusses risk assessment and risk management issues, develops guidance documents, and provides a forum to establish consistency for implementation of California’s air toxics program. | Ongoing. |
| AB 1807 Air Toxics Control Program. | Once the Board identifies a substance as a TAC, the ARB begins the control phase of the State’s TAC program. In this phase, an assessment is conducted to determine the need for, and degree of, controls for the substance. Public outreach is an integral element in the development of a control plan and control measures. The ARB works with districts and holds numerous public workshops and individual meetings with stakeholders. | Ongoing. |
| SB 1731 Risk Reduction Audits and Plans. | Under SB 1731, facilities determined by the districts to pose a significant potential risk to the public are required to conduct a risk reduction audit of their facility, develop a risk reduction plan, and implement the plan to reduce its risk below the significant risk level.
SB 1731 directs the ARB to assist smaller businesses in these efforts. Six source-specific risk reduction audit and plan guidelines and a general guidance document have been developed. The source categories covered by the specific guidelines are: aerospace, autobody refinishing, chrome plating, degreasing, dry cleaners, and gasoline service stations. |
Ongoing, expected completion 1999.
--gasoline service station document under management review. --drycleaning document ongoing. --all other documents completed. |
| Review and comment on District Toxic New Source Review Rules. | The ARB reviews and comments on district toxics new source review (T-NSR) rules. The ARB compares the T-NSR rule to the methods in the ARB’s Risk Management Guidelines for New and Modified Sources (Guidelines), applicable Best Available Control Technology Guidelines, existing T-NSR rules in other comparable districts, and federal toxic new source review (section 112(g)) requirements. The Guidelines were approved in July 1993 and are based on the CAPCOA Air Toxics "Hot Spots" Program Risk Assessment Guidelines (January 1992). | Ongoing. |
| Continue to get early input from local, state and federal agencies, public, and stakeholders on new projects under the AB 1807 Air Toxics Identification Program. | Diesel Exhaust Risk Management Working Group: Diesel exhaust is currently being evaluated under the AB 1807 Toxic Air Contaminant Identification Program. At the
July 30, 1998, hearing, the Air Resources Board will consider a proposal to identify diesel exhaust as a toxic air contaminant (TAC). |
Should diesel exhaust be identified as a TAC, it will enter the risk management phase of the program. During this phase, a Diesel Exhaust Risk Management Working Group will be formed to help identify potential control measures to reduce the public’s exposure to diesel exhaust. |
| Incorporate, when approved, the Cal/EPA Risk Characterization Policy into risk assessments being developed by the Risk Assessment Advisory Work Group (RACWG). | RACWG, formed by OEHHA, is developing the draft Cal/EPA Risk Characterization Policy. The ARB is a member of this workgroup. This draft policy is intended to provide a framework to better assess the information in a risk assessment and is modeled after the U.S. EPA’s Policy for Risk Characterization; however, it allows flexibility to different Boards, Departments, and Offices within Cal/EPA to adapt the policy to the needs of their programs. The ARB will work to implement this policy into risk assessments performed by the ARB and the districts. | Completed. |
| Develop risk management guidelines for inorganic lead in cooperation with OEHHA. | The ARB will use available models to develop risk management guidelines which will relate air lead levels to blood lead levels. These models will assist risk managers in making estimates of health impacts due to lead emissions and will help districts with setting risk levels under AB 2588 and SB 1731 and in the permitting of
lead-emitting sources. The lead risk management guidelines are needed because the techniques previously used to assess non-cancer risk are not suitable for evaluating the non-cancer effects of lead. |
Following a public workshop in June 1997, ARB staff formed a workgroup of interested parties which has met five times. The workgroup has reviewed two drafts of the guidelines in November 1997 and February 1998. The next meeting is scheduled for
July 17, 1998. Estimated completion fourth quarter, 1998. |
| Evaluate the need to update the Risk Management Guidelines for New and Modified Sources. | The Board approved the Risk Management Guidelines for New and Modified Sources (Guidelines) in
July 1993. They were developed through a series of workshops and meetings with representatives from the districts, environmental groups, trade associations, industry, and governmental agencies. The Guidelines were developed to assist districts in making permitting decisions and designing toxic new source review programs. Once OEHHA adopts the new risk assessment guidance, the ARB will reevaluate the Guidelines after the release of OEHHA’s guidance to determine if changes are needed. |
Estimated evaluation post 1998. |
| Incorporate OEHHA Risk Assessment Guidelines into the "Hot Spots" Emission Inventory Criteria and Guidelines Report. | The AB 2588 Air Toxics "Hot Spots" Program currently uses the CAPCOA Risk Assessment Guidelines as the risk assessment procedures for determining emission reporting requirements. Once OEHHA has adopted their Risk Assessment Guidelines, the ARB will amend the Emission Inventory Criteria and Guidelines Report through a public regulatory process to incorporate the approved OEHHA Risk Assessment Guidelines as the designated risk assessment procedures. The public regulatory process includes public review and comment on the new procedures, public meetings and workshops with the general public, industry and environmental stakeholders, and the districts, followed by formal Board adoption at a public hearing. | Future activity, middle 1999. |
| Exposure Assessment | ||
| Fund projects to refine and validate the California Population Indoor Exposure Model. | The California Population Indoor Exposure Model was recently developed to provide a tool for estimating Californians' indoor air exposures to selected TAC’s. Results of simple model evaluation and verification tasks have been promising, but the model has not yet been validated. Various model refinements such as updating some of the model inputs also need to be conducted. | Ongoing, estimated completion 2003. A request for proposals to update and refine the model was approved by the Research Screening Committee. The RFP will be released in fall 1998. |
| Examine ways to apportion human exposures to TAC sources. | Exposure source apportionment is best done through tracer studies, sample component analysis, and similar approaches in combination with personal exposure monitoring. Data from questionnaires and activity pattern studies, usually accompanied by selected indoor and outdoor measurements, provide alternate, although less robust, methods. The utility of these and other exposure source apportionment methods are being examined. | Ongoing. |
| Continue to fund research to refine assumptions for fate and transport such as the current research efforts designed to study ozone and particulate matter in the San Joaquin Valley and South Coast Air Basins. | The California Regional PM10 Air Quality Study, a multi-year research project, is expected to provide comprehensive information about the origin and the effects of potential controls for the San Joaquin Valley's airborne particles. The study objectives are to: 1) provide an improved understanding of emissions, PM10 and PM2.5 composition, and dynamic atmospheric processes;
2) develop methods to identify the most efficient and cost-effective emission control strategies to achieve the PM10/PM2.5 standards. The general understanding of fate and transport of ozone and PM10, and new models, can lend themselves to improving the assessment of fate and transport of TAC’s. The 1997 Southern California Ozone Study (SCOS97-NARSTO) focused on how ozone moves from one area to another in Southern California. The study monitored the entire southern portion of the state, from Bakersfield to the northern fringe of Mexico and from the Pacific Ocean to the Arizona-Nevada border. Groups participating in the study include ARB, the SCAQMD, the U.S. EPA, the U.S. Navy, the U.S. Marine Corps, several industry groups, and four other Southern California air quality districts. |
Ongoing, monitoring phase complete. Data management and analysis began in March 1998. |
| Provide uncertainty and variability measures in exposure estimates. | The ARB has recently incorporated the use of the California Population Indoor Exposure Model into the TAC exposure assessment process, and now provides a calculated standard deviation with each mean exposure value provided to OEHHA for calculation of risk. Further work is needed to provide calculated measures of uncertainty and variability in future exposure estimates. | Ongoing, included in the RFP to update and revise the model. |
| Participate in OEHHA RACWG and the OEHHA Ecotoxicology Interagency Work Group. | The ARB participates on two OEHHA working groups with other Cal/EPA Boards, Departments, and Offices. These working groups provide an open interagency forum for the discussion of risk assessment and risk management methods and practices, and the development of both human and ecological guidelines or materials pertaining to risk assessment. | Ongoing. |
| Coordinate with Department of Toxic Substances Control (DTSC) on risk assessments which evaluate air impacts of hazardous waste sites. | Under a MOU, the ARB provides technical assistance to DTSC on the exposure assessment portion of risk assessments. This assistance consists of reviewing and evaluating potential air impacts of hazardous waste treatment, storage, and disposal facilities, as well as site cleanups. | Ongoing. |
| Continue to update stationary source test methods to provide more accurate and precise emissions for risk assessment and emissions inventory. | The ARB will work with U.S. EPA to harmonize source test methods. | Ongoing. To harmonize source test methods, the ARB will consider approving the revisions to 20 existing test methods at its August 1998 meeting. If approved, the U.S. EPA will consider these revised 20 test methods as equivalent to federal test methods and can be used to meet federal requirements. |
| Assess the advantages, disadvantages, feasibility, and cost implications to develop an integrated indoor and outdoor exposure model. | Currently, outdoor population-weighted concentrations of TACs are estimated using models that incorporate ambient air quality data, meteorological data, emissions data, and population census data. The results are then input into the California Population Indoor Exposure Model to develop statewide and regional estimates of Californians' indoor and total air exposures to TACs. The ARB staff plans to examine whether the indoor and outdoor models can be easily integrated or whether a new model would need to be developed, and the pros, cons, and cost implications of pursuing an integrated model. | Future activity, estimated target date to begin assessment 1999. |
| Seek co-funds to expand personal exposure and source apportionment, indoor air chemistry, and pollutant delivery research efforts. | Such studies are expensive, and only a few have been conducted in California. U.S. EPA funded the major portion of all but one of the studies. Co-funding will need to be obtained in order to pursue personal exposure research and exposure source apportionment research. | Ongoing. |
| Pursue co-funds for research on improved ways to estimate and present uncertainty and variability in exposure estimates. | The assumptions and complexity of modeling increase the difficulty of improving uncertainty and variability estimates. Funding is needed to support the review and statistical assessment of characterizing uncertainty and variability in the current exposure assessment process. | Future activity. |
| Consistency With U.S. EPA | ||
| Follow U.S. EPA Exposure Assessment Guidelines provided in the Federal Register dated
May 29, 1992, and adhere to their definitions; utilize the U.S. EPA, Scientific Advisory Board (SAB), and National Academy of Sciences (NAS) guidance for estimating human exposure. |
The most recent SAB and NAS guidance documents for estimating exposure were incorporated into
U.S. EPA's 1992 Exposure Assessment Guidelines. California should use these guidelines to promote harmonization with federal approaches to exposure assessment and assure that California assessments are based on current science and methods. |
Ongoing. |
| Continue to work closely with
U.S. EPA to integrate California data into U.S. EPA’s Exposure Factors Handbook. |
A revised version of U.S. EPA's Exposure Factors Handbook that includes the ARB's activity pattern data and pulmonary ventilation study data will be released soon. The ARB staff will work with the U.S. EPA staff to assure integration of new information when the handbook is revised again in five years. | Ongoing, released in late 1997 (dated August 1997). Revisions to be completed every 5 years. |
| Integrate federal toxic new source review requirements into California program. | Section 112(g) requires the districts to certify with U.S. EPA that they have a rule in place no later than
June 29, 1999. |
Ongoing, expected completion June 1999. The ARB and CAPCOA released guidance
May 1998. ARB is working with districts to ensure that requirements for 112(g) are met. |
| Participate in U.S. EPA’s Residual Risk Working Group. | Section 112(f) of the federal Clean Air Act requires the U.S. EPA to report to Congress on the residual risk to public health from sources subject to standards developed under section 112(d). The ARB is participating in U.S. EPA’s Residual Risk Working Group to integrate the federal residual risk program with existing California air toxics control programs. The ARB’s involvement with U.S. EPA will help to reduce unnecessary additional regulatory burdens on California businesses. | Ongoing, expected completion 2000. The U.S. EPA released a draft report to Congress for public comment in April 1998. ARB provided comments in July. Once the report is released, the U.S. EPA will begin development of their final program. |
| Participate in development activities for U.S. EPA’s Urban Area Source Program. | Section 112(k) of the federal Clean Air Act establishes a national program intended to achieve a substantial reduction of the emissions of hazardous air pollutants (HAPs) from area sources. The U.S. EPA must prepare a national strategy which identifies not less than 30 HAPs in the largest urban areas and identify the source categories of those emissions. | Ongoing, expected completion 2000. The ARB is actively participating in efforts to develop a national strategy and is participating in a work group consisting of the U.S EPA, and state and local air agencies. In addition, we have provided information on monitoring data and emissions inventory, and are addressing risk from existing air toxics programs such as AB 2588 and SB 1731. |
| Coordinate with U.S. EPA on future health and exposure assessments under the AB 1807 Air Toxics Program. | Identification of Diesel Exhaust as a Toxic Air Contaminant. | Ongoing dialog with U.S. EPA on health effects of diesel exhaust. |
| Continuing Education | ||
| Staff attendance at meetings, seminars, scientific meetings, and training courses. | The ARB management encourages and supports the attendance of the ARB staff at seminars, scientific meetings, and training courses. This will allow the ARB staff to be kept abreast of state-of-the-art techniques related to risk assessment and risk management. | Ongoing. |
| Continue to develop informational material for the public. | The ARB has a public information office and an on-going public outreach policy. Periodically, the ARB develops air toxics related materials including brochures, pamphlets, or advisory papers. These materials are designed to keep the public informed of ARB’s programs. | Ongoing. For asbestos, ARB assisted in the development of an asbestos "white paper", developed six fact sheets with information of interest to the public, participated in a public forum, and is currently conducting asbestos air monitoring in California. |
| Continue to publish indoor air quality guidelines that tell the public how they can reduce their exposures to pollutants. | The ARB's Research Division has published two indoor air quality guidelines, one on formaldehyde and the other on indoor combustion pollutants. The guidelines provide the public information about possible indoor sources of those pollutants, their potential health effects, and methods to prevent or reduce their indoor exposures. Additional guidelines on indoor chlorinated hydrocarbons, particles and dust, and ozone are under development. | Ongoing, currently working on three air quality guidelines. Also, have begun to update the indoor formaldehyde guideline. |
| Establish AB 2588 "Hot Spots" Page on the World Wide Web (Web) to access emission estimation information, and to provide tools necessary to complete accurate air toxics emission inventories and risk assessments. | The ARB has established an AB 2588 Air Toxics "Hot Spots" Program home page on the Web. This allows easy access to information including the Program overview, Emission Inventory Guidelines Report, the Fee Regulation, emission estimation information and computer software tools, and connections to other governmental agencies. | Ongoing, initial phase complete, continual updates. |
| Periodically reassess staff’s training needs. | The ARB will periodically reassess training needs to assure that technical staff is aware of the latest science, skills, and technology. | Future activity. |
| Update the AB 2588 "Hot Spots" Web Page to provide additional "Hot Spots" Program information, especially in the area of risk assessment (late 1998). | The ARB will update the
AB 2588 "Hot Spots" Program Web Pages with new tools and information. The updated Web pages will allow access to the new OEHHA Risk Assessment Guidelines when approved, the completed "Hot Spots" Integrated Software, Prioritization Guidelines, Industry-wide Risk Assessment Guidelines, and Risk Reduction Guidelines. |
Ongoing. Web page set up, information added as developed. |
| Databases | ||
| Develop ways of providing monitoring data to public and government agencies through the Internet and compact discs. | Toxics air quality data monitored since 1990 are available through the ARB’s Web site and on compact disc. The monitoring data on compact disc contains the Voyager Data Analysis Software. This software program allows the TAC monitoring data collected by the ARB to be readily accessible for analysis by the public and other interested parties. | Ongoing, completed first version of the CD 12/97. Distributed 650 CDs. Next update to include 1997 data due winter 1998. |
| Continue to provide final reports from research contracts through the National Technical Information System (NTIS). | Final reports from all research funded through the ARB's research programs are available to the public from NTIS. | Ongoing, internet link completed. |
| Update OEHHA database. | Work with OEHHA to restructure their AB 2588 Risk Assessment database to enable data sharing and comparisons with ARB’s AB 2588 databases. | Expected completion date February 1999. |
| Add the Toxics Air Monitoring Database to the U.S. EPA Aerometric Information Retrieval System (AIRS). | Starting in January 1996, all TAC data collected from the ARB’s TAC monitoring network are submitted to the AIRS database. | Ongoing. |
| Update the AB 2588 Air Toxics Emission Data System (ATEDS) with more current and accurate data. | The AB 2588 Air Toxics "Hot Spots" Program requires high priority facilities to update their air toxics emission inventories every four years. The ARB is responsible for maintaining the statewide air toxics emission inventory and making it available to the public. | Ongoing. |
| Distribute the California Air Toxics Emission Factor (CATEF) database to enable more accurate estimation of air toxics emissions. | In 1996, the ARB began distributing the CATEF database of air toxics emission factors for use in estimating emissions for the AB 2588 Air Toxics "Hot Spots" Program. CATEF includes facility air toxics source test data developed for the "Hot Spots" Program using ARB approved source test methods. The CATEF database is available to districts, the U.S. EPA, consultants and other interested parties. CATEF enables facilities to accurately estimate their air toxics emissions and avoid the high cost of source testing. | Ongoing. |
| Update the CATEF database with new emission factors. | Due to the success and interest in the development of CATEF, the ARB will soon begin a new research contract to collect more air toxics source test data and develop additional emission factors. Based on comments received from CATEF users, the contractor will also develop more user-friendly software. | Ongoing, update late 1999. |
| Merge the AB 2588 air toxics emissions data from ATEDS with the ARB’s criteria pollutant emissions database from CEIDARS. | The ARB will continue to merge its criteria pollutant emission inventory with its air toxics emission inventory. This is a multi-year effort and requires working closely with districts to ensure the data are accurate and consistent. The end result will allow all air pollutant information for a facility to be located in a single database. | Ongoing, late 1999. |
Table 2. California Energy Commission
Implementation Activities for Addressing the Recommendations of the Risk Assessment Advisory Committee
| Activity Description | Performance Measures | Status |
|---|---|---|
| Consistency and Harmonization | ||
| Assure Consistency with risk assessment approach and policies of the U.S. EPA. | Review the Commission's risk assessment methods to ensure concordance with those of Cal EPA and U.S. EPA. | Completed. |
| Participate in activities of the Cal/EPA Risk Assessment Coordination Work Group (RACWG). | Attend RACWG meetings. Participate in review of risk harmonization documents, e.g., as tabled under OEHHA performance measures. | Ongoing. |
| Peer Review | ||
| Develop a formalized program for peer review. | The Commission staff does not develop its own risk assessment methods. It relies instead on methods developed by Cal EPA or the U.S. EPA and therefore has no formalized programs for the peer review of its health analyses. | The Commission does not intend to develop a peer review program. |
| Interface Between Risk Assessment and Risk Management | ||
| Seek early input by risk managers and other stake holders and encourage public participation in the process of developing risk assessments. | Maintain a program allowing for public workshops to discuss the project-specific risk assessments conducted by the Commission staff. | Completed. |
| Establish a process for bringing together risk assessment and risk management personnel to better translate risk assessment methods, policies and results. | Maintain a program to facilitate management, stakeholder, and public input into the risk assessment process. | Completed. |
| Develop approaches to risk assessments that balance the level of effort and resources, with the relative importance of potential impacts. | Evaluate the complexity of risk assessments conducted by staff in connection with projects certified by the Commission. | Completed. |
| Organization and Resources | ||
| Evaluate the various scientific disciplines required to ensure that adequate resources are available within the agency. | Assess the adequacy of risk assessments conducted by the Commission staff with regard to projects permitted by the Commission. | Completed. |
| Use of Best Science | ||
| Encourage continuing education and participation of staff in professional organizations involved in risk assessments. | Review the Commission's Continuing Education Program to ensure adequate funding for staff activities related to risk assessments and underlying scientific principles. | Completed. |
| Improve the characterization of uncertainty and variability in risk assessments. | Maintain a program that allows for public workshops to discuss the limitations of the risk assessment process. | Completed. |
Table 3. Department of Health Services
Implementation Activities for Addressing the Recommendations of the Risk Assessment Advisory Committe
| Activity Description | Performance Measures | Status |
|---|---|---|
| Consistency and Harmonization | ||
| Participate in activities of the Cal/EPA Risk Assessment Coordination Work Group (RACWG). | Attend RACWG meetings. Participate in review of risk harmonization documents, e.g., as tabled under OEHHA performance measures. | Ongoing. |
| Coordinate with OEHHA/Cal/EPA in environmental fate-and-transport modeling. | Coordinate efforts on multiple issues, including emergency response (RAPID), statewide fish issues, and mercury in farm produce. | As needed. |
| Interface Between Risk Assessment and Risk Management | ||
| Serve as "risk manager" for OEHHA risk assessments. | OEHHA risk assessments, e.g., risk assessments related to the establishment of maximum contaminant levels (MCLs) in drinking water. | Ongoing. |
| Coordinate with OEHHA, Cal/EPA in incorporating risk assessment into risk management.
|
Coordination of response to exposure incidents, e.g., the reopening of commercial oyster beds in Humbolt Bay following an oil spill.
Coordination of environmental assessment activities in the Lompoc area by the Lompoc Interagency Workgroup. Coordination of environmental assessment activities along the U.S.-Mexican border. |
As needed.
Ongoing. |
| Exposure Assessment | ||
| Perform receptor-based exposure assessment (Exposure recommendation #2 of the RAAC). | Exposure assessment examples: measurement of dioxins in chicken eggs;
measurement of PCBs in fish at a state hazardous waste site. |
Pending.
Completed. |
Table 4. Department of Pesticide Regulation, Cal/EPA
Implementation Activities for Addressing the
Recommendations of the Risk Assessment Advisory Committee
| Activity Description | Performance Measures | Status |
|---|---|---|
| Harmonization and Consistency |
|
|
|
Utilize the Department of Pesticide Regulation (DPR) - U.S. Environmental Protection Agency (EPA) harmonization process to reduce duplication of effort. |
Expand the harmonization process to include areas in addition to toxicology and exposure study review and human health risk assessment.
Increase the exchange of reviews and sharing of work products and workload to avoid duplication of effort. |
Discussion of harmonization process limited due to resource requirements of FQPA.
In FY 96/97, 77 reviews were exchanged with U.S.EPA. In FY 97/98, 75 reviews have been provided to U.S. EPA. Reviews include acute, subchronic, and chronic studies. In several cases, U.S. EPA has used DPR study reviews to expedite its review process and reduce its registration backlog. In 1997, DPR, U.S. EPA, and Health Canada shared the review of the active ingredient cyprodinil. Similar work sharing is underway for other active ingredients. |
|
Work cooperatively with the U.S. EPA in implementing the Food Quality Protection Act (FQPA). DPR participation, with U.S. EPA, on national and international harmonization work groups DPR participation, with U.S. EPA, on national and international harmonization work groups (continued) |
Director served on FQPA Food Safety Advisory Committee. Chief Deputy Director serves on U.S.EPA/USDA Tolerance Assessment Committee, attends meetings of U.S. EPA Pesticide Program Dialog Committee.
Scientific staff have served on U.S. EPA Common Mechanism of Action and Aggregate Exposure steering committees. DPR has provided technical comments to FIFRA SAP regarding generic issues (application of additional 10x safety factor, assessing cholinesterase inhibition) and chemical specific assessments. DPR provides technical input to EPA on the revision of their guidelines. |
|
|
|
Scientific staff member serves on exposure harmonization subcommittee of NAFTA Technical Working Group on Pesticides. Director serves on U.N. Environmental Programme - Methyl Bromide technical Options Committee. Scientific staff provide comments, through U.S. EPA on proposed O.E.C.D. guidelines. Chief Deputy represents DPR on NAFTA Technical Working Group. |
|
| Continued participation within Cal/EPA to achieve consistency of risk assessment methods. | Continued participation in the Risk Assessment Coordination Work Group.
Continued participation in the Environmental Fate and Transport Work Group. Develop an agreement between OEHHA and DPR defining organizational roles and responsibilities. |
Ongoing.
Ongoing.
Under discussion at directorate level. |
|
Peer Review |
|
|
|
Cal/EPA development of Agency-wide peer review policy. |
Participate in the development of a consistent Cal/EPA peer review policy. | Unified California Environmental Protection Agency Policy and Guiding Principles for External Scientific Peer Review- completed, March 13 1998. |
|
Develop a consistent DPR institutional peer review process. |
Identify the types of DPR documents that are appropriate for internal or external peer review.
Identify different levels and types of review that are currently used by DPR. Adopt a departmental peer review policy consistent with the general peer review policy of Cal/EPA. |
Initiated. Completion expected by 10/98.
Initiated. Completion expected by 10/98.
Will follow above two steps. First draft of DPR policy by end of 1998. First draft will reflect current practices. Subsequent drafts will follow and will contain modifications to the policy to adequately address the need for peer review. |
| Best Use of Scientific Information and Development of Guidelines |
|
|
|
Implement a program to encourage and support staff training and professional development. |
Develop a DPR policy that facilitates participation of staff in continuing education and scientific societies, based on institutional needs and Individual Development Plans.
Encourage and support staff participation in state and national scientific forums and publication of scientific papers on work related topics. |
Action item on DPR Strategic Plan. Each Branch assigned task of developing a training plan that identifies and addresses the technical needs of the staff. Implementation depends on resources.
Working draft of publication policy has been developed. |
| Document the procedures and assumptions used for scientific analyses. | Update scientific guidance documents. Include a documentation of the procedures as well as an identification of the default options and assumptions.
Develop a procedure to regularly examine and update the risk assessment process and guidance documents. |
Update of Worker Health and Safety guidance document on conduct of exposure assessments has been initiated. Completion expected in FY 98/99.
A continuous evaluation of the risk assessment process occurs on an on-going basis. There are currently regular, as well as informal, meetings between scientists from Medical Toxicology and Worker Health and Safety to discuss risk assessment and exposure assessment practices. |
|
Institute a process to ensure that the data collected and generated by DPR are in usable formats and are used in departmental analyses. |
Catalog the data bases that are collected and maintained by DPR.
Implement a program to ensure that the data bases are in formats that are amenable to use in the appropriate programs. Implement procedures to ensure that the appropriate data bases are fully utilized in departmental scientific analyses. |
A Quality Team has been formed to address the use of data bases.
The data bases at DPR have been cataloged. A standard has been adopted for the format of all data bases collected by DPR. A Quality Team formed with the specific charge of ensuring that all appropriate data are fully utilized in Departmental scientific analyses. Completion expected in FY 98/99. |
| Institute a process to facilitate the incorporation of new scientific knowledge and technology. | Institute a seminar series for external scientists to present advances in science and technology.
Establish an interdisciplinary technical team to develop recommendations for the incorporation of new technological developments into the appropriate DPR procedures. |
While resources have not yet permitted the establishment of a formal seminar series, 3 - 4 seminars are presented by outside scientists each year.
Rather than establishing a single standing interdisciplinary team, it has been more effective to establish ad hoc interdisciplinary teams on specific topics, such as emerging biotechnology. |
| Interface Between Risk Assessment and Risk Management |
|
|
| Institute a process to ensure that the risk assessments meet the needs of the DPR risk managers. | Implement meetings between the risk managers and risk assessors to document the risk management needs.
Develop a process to ensure early consultation with risk managers in a risk assessment.
Finalize the process for external stakeholder scientific input into a risk assessment. Improve Department’s responsiveness to public concerns about pesticide application and potential impacts, through a public outreach program. |
On a quarterly basis, Assistant Directors and Branches meet to discuss generic risk assessment and risk management issues.
The Director, the Assistant Director, and Branches meet to discuss the risk assessment and risk management issues related to a specific chemical. The Assistant Directors receive weekly updates from Branches on risk assessment and risk management issues. Process for external stakeholder scientific input completed and in place. Quality Team formed 5/98 with charge to address responsiveness to public concerns. |
| Organization and Resources |
|
|
| Optimize the operational efficiency and consistency of the risk assessment process. | Evaluate the risk assessment process and identify appropriate methods of increasing the efficiency of the process, while still maintaining scientific quality.
Evaluate the DPR resource requirements with regards to risk assessment. |
Department has made commitment to Legislature, as part of budget hearings, to complete 35 pesticide health evaluations by the end of FY 98/99.
Medical Toxicology Branch has developed and adopted a formal process for the selection of toxicology endpoints. This process will streamline the hazard identification and dose-response portions of the risk assessment. Risk assessment resource requirements will be evaluated on an ongoing basis. |
| Continual Improvement |
|
|
| Consider additional RAAC recommendations. | Update the implementation plan on a yearly basis to incorporate additional recommendations. | Implementation plan will be updated as part of the update of Department’s strategic Plan. |
Table 5. Department of Toxic Substances Control, Cal/EPA
Implementation Activities for Addressing the Recommendations of the Risk Assessment Advisory Committee
| Activity Description | Performance Measures | Status | |
|---|---|---|---|
| Consistency and Harmonization | |||
| Implement Executive Order W-137-96 of the Governor and assist the Secretary of Environmental Protection to harmonize and improve the scientific basis of chemical risk assessment practices in the state of California. | DTSC and US EPA risk assessment guidance is applied across all facilities and sites. | Continuing policy position and practice that only DTSC and US EPA risk, environmental fate and transport, and exposure guidance and approach are to be followed at all hazardous waste sites and facilities by all responsible parties. | |
| Participation in the Cal/EPA Risk Assessment Coordination Work Group (RACWG) to promote consistency in risk assessment practice within Cal/EPA. | Facilitate an assessment of environmental fate and transport capability and expertise in the Cal/EPA. Participate in the Cal/EPA OEHHA Exposure Assessment and Stochastic Analysis Work Group. Provide parameter values for exposure scenarios and associated probability distributions. |
Completed. Consensus was reached that insufficient expertise exists within the Cal/EPA to predict fate and transport in the hydro- and geosphere. Completed. Stochastic Exposure Assessment Guidelines were completed by OEHHA. The guidelines are being finalized for SRP review by OEHHA. |
|
| Harmonize hazardous waste site and facilities risk assessment activities with US EPA offices in Washington DC and Region IX. | Integration of a full multimedia risk assessment approach into the process of calculating preliminary remediation goals (PRGs). Provide model calculations (input parameter varied) of site-specific preliminary remediation goals (PRGs) using the DTSC Cal/TOX approach. Provide toxicological, fate and transport and exposure parameter values and probability distributions. |
Ongoing. Routine use of Cal/TOX to develop initial PRGs continues. Completed. Provided fully integrated probabilistic multimedia calculations for PRGs to the joint US EPA Region IX and Cal/EPA workgroup. Completed. Developed and provided input parameters and associated probability distributions to the joint US EPA Region IX and Cal/EPA workgroup. |
|
| Best Use of Scientific Information and Development of Guidelines | |||
| Encourage and support scientific staff training and professional development. | Use of the "Individual Development Plan" process to encourage and facilitate participation of scientific staff in (1) continuing education and scientific societies and (2) state and national scientific forums. Promote the use of the "Individual Development Plan" process to encourage and facilitate scientific staff efforts to publish scientific papers in peer reviewed journals and maintain professional certifications. |
Ongoing. Planning and management tool to promote balanced scientific expertise within budget constraints. Staff participated in national meetings, symposia, and conferences on risk assessment and environmental protection. Ongoing. Planning and management tool to promote balanced scientific expertise within budget constraints. 4 staff completed training and certification process in industrial hygiene. 7 of 8 IH staff are now fully certified. |
|
| Document the procedures and assumptions used in the conduct of the stochastic multi-media, multi-pathway risk assessment using the best available science. | Develop guidance manual on the theory, background, and operation of the multi-media risk assessment program, Cal/TOX, to document behavior of Cal/TOX. Examine and update the structure, process and data embedded in Cal/TOX. Continue "sensitivity runs" on various input parameters to study behavior of Cal/TOX. Development of initial "abstracted" air dispersion models for the offsite fate and transport of chemicals in the air and integration into Cal/TOX. Development of initial "abstracted" groundwater transport and dispersion models for prediction of the offsite fate and transport of chemicals in unsaturated and saturated groundwater compartments and integration into Cal/TOX. Expansion of the toxicological and chemical properties database within Cal/TOX.
|
Completed document under the DTSC Regulatory Structure Update Program for the National Academy of Sciences.
Completed document under the Regulatory Structure Update DTSC Program for the National Academy of Sciences.
|
|
| Peer Review and Peer Involvement | |||
| Develop a formalized program of peer review. | Supervisor peer review of staff analysis of site and facility risk assessments submitted by responsible parties and permit applicants, respectively. HERD peer review of OEHHA analysis of site and facility risk assessments (whereby OEHHA has been designated lead under the interagency agreement) submitted by responsible parties and permit applicants, respectively. Random audit OEHHA peer review for HERD analysis of site and facility risk assessments submitted by responsible parties and permit applicants, respectively. The level of peer review will be commensurate with the document being reviewed. Develop a set of Standard Operating Procedures for peer review of Cal/TOX, that is in concert with the peer review policy of Cal/EPA. Establish external scientific peer review mechanism for major scientific proposals and approaches. |
On-going.
|
|
| Interface Between Risk Assessment and Risk Management | |||
| Continue coordinated interaction between HERD scientists and DTSC Program risk managers and external stakeholders. | Meet with DTSC Program risk managers by attendance of monthly Division and Branch Level Meetings on HWCA, DSMOA, and RP-lead sites and projects to ensure (1) early consideration of the risk assessment process, resources, and limitations within the risk management process, (2) that the resources devoted to the risk assessment are commensurate with the significance of the risk management decision that is needed and (3) the risk assessment product is fully considered in the final risk management decision. Training of DTSC Program risk managers on the fundamental concepts, process and outputs of risk assessment by HERD scientist at monthly DTSC Division and Branch Level Meetings on HWCA, DSMOA, and RP-lead sites and projects. Scientific support of DTSC’s Site Mitigation’s Program’s "Site Mitigation Update" in the development of acceptable risk ranges, risk-based remediation goals, and risk-based tiered approach to site-mitigation and cleanup. Scientific support of DTSC’s Office of Pollution Prevention and Technology Development "Tiered Certification Program" in the consideration of potential risks posed by a technology during routine operation, off-spec operation, catastrophic process failure, or transportation related accidents. |
On-going.
On-going.
On-going.
On-going. |
|
| Communicate with and educate stakeholders on environmental and public health issues associated with hazardous waste sites and facilities. | Provide informational materials and presentations on environmental and human health risk assessment to stakeholders involved in specific hazardous waste sites and facilities. |
On-going. Continued operation and maintenance of HERD World Wide Web site. |
|
Table 6. Department of Transportation (CalTrans)
Implementation Activities for Addressing the Recommendations of the Risk Assessment Advisory Committee
|
Activity Description |
Performance Measures |
Status |
|---|---|---|
|
Training |
|
|
|
Continuous education is needed to be certain that expert personnel keep abreast of new developments. With rapid change, one’s university education is inadequate to sustain a career without frequent updating. Mechanisms such as two-way temporary staff exchange program, forums, and training should be encouraged. |
Office of Environmental Engineering (OEE) Implement training program outlined in Statewide Storm Waste Management Plan (SWMP), including personnel training, informational exchanges with construction contractors, and public education and participation.
Send Staff members to workshops, meetings and conferences as well as having internal seminars. |
This year 950 people received training on how storm water management practices will be incorporated into the design process. Of the 950 people, 84 were from other agencies. This year Caltrans has issued 10 Construction Pollution Prevention Bulletins and four Maintenance Storm Water Pollution Prevention Bulletins aimed at identifying key practices, possible problems, and recommended solutions. Continue to use private consulting firms and university staff in house for their expertise. Risk Based Corrective Action Training held for hazardous waste management staff. Headquarters staff sent to Cal/EPA sponsored Workshop on Risk and Decision Making. |
|
Data Management |
|
|
|
Institute measures for quality control of data in databases and data being added to the databases. For example, the quality of data relies, in part, on the sampling strategy employed. Additionally, improve the accessibility of data to all interested parties. |
OEE Implement storm water Sampling Analysis and Collection Plan, which provides a comprehensive, step-by-step description of the process to be used by every District. Create a database and make data available via the Internet. |
The Sampling Analysis and Collection Plan has been implemented and is reviewed on an annual basis. Data availability via the internet is under development. |
| OHWM
Evaluate the recommendations made for lead sampling program for their usability. |
Developed guidance to Districts and consultants on sampling and analysis of lead data. |
|
| Peer Review | ||
| Develop a formalized policy for internal and external peer review of program activities.
|
OEE
Continue to have project designs and outcomes reviewed by staff of private consulting firms, universities, and regulatory agencies. OHWM Continue to use regulatory agencies and objective private consulting firms in the review process. |
Continuing.
Continuing. |
| Receptor Based Exposure Assessments | ||
| Receptor-based exposure assessment is a powerful tool that could help to prioritize efforts to reduce exposures and protect public health. Cal/EPA should acknowledge the uncertainty that results from the reliance on scenario based exposure assessments. | OEE
Evaluate the necessity for further research efforts regarding receptor locations for the carbon monoxide program. OHWM Not Applicable. |
Ongoing: UC Davis has prepared receptor-based assessments and commented on CO NAAQS Reassessment currently underway. Need to partner with Cal/EPA to develop consensus. Ultimately, additional study may be needed with Federal EPA participation. |
| Exposure/Fate and Transport Models | ||
| A well run modeling exercise provides our best view into the future. More effort is needed to validate models with real experimental data. In assessing transport and dispersion models, the quality and characteristics of input data to the models, such as emissions data and dispersion parameters, should be considered in addition to the validity of the models themselves. | OEE
Conduct additional research projects to evaluate the validity of air models and their input parameters needed.
OHWM Evaluate the applicability of models to site specific conditions as needed. |
Continuing: •UC Davis conducting field studies •MOU (Caltrans/ARB) to improve emission models.
Continuing. |
Table 7. Office of Environmental Health Hazard Assessment, Cal/EPA
Implementation Activities for Addressing the Recommendations of the Risk Assessment Advisory Committee
| Activity Description | Performance Measures | Status |
|---|---|---|
| Consistency and Harmonization | ||
| Implement the Governor’s Executive Order W-137-96 and assist the Secretary of Environmental Protection to harmonize and improve the scientific basis of chemical risk assessment practices in the state of California. | Facilitate agencies and departments in preparing their workplans in order to address recommendations of the Risk Assessment Advisory Committee.
Prepare a progress report to the Secretary of Cal/EPA on the implementation of Executive Order W-137-96. Set up a mechanism by which the RAAC core members provide continuity and advice on Agency progress to implement the RAAC recommendations. |
Completed. Implementation plans were submitted to OEHHA by 6/30/97, the deadline of the Executive Order.
|
| Convene and coordinate activities of the Cal/EPA Risk Assessment Coordination Work Group (RACWG) to promote consistency in risk assessment practice within Cal/EPA. Form a subcommittee to address issues in fate and transport modeling. (Recommendation 3) | Reduce inconsistencies within Cal/EPA by building consensus on cancer and non-cancer risk assessments, emphasizing chemicals of greatest concern.
Release lists of cancer potency factors and toxicity values that are to be used by all programs of Cal/EPA.
Adapt the US EPA Guidance for Risk Characterization for use by all Cal/EPA Boards, Departments and Offices. |
Compilation of non-cancer values into a database has begun.
A list of consensus cancer potency factors was developed and posted on the OEHHA homepage. It will be updated periodically. Completed. The RACWG developed and adopted guidelines for characterizing chemical-specific and site-specific risk assessments. The guidelines were reviewed and approved by the DBOs of Cal/EPA. |
| Harmonize risk assessment activities with US EPA offices in Washington DC and Region IX. (Recommendation 1) | Sign and implement a Memorandum of Understanding (MOU) with US EPA National Center for Environmental Assessment for collaboration on risk assessment activities.
Develop a screening level risk assessment method applicable across Cal/EPA programs, US EPA Region IX, RCRA and Superfund. Harmonize potency estimates by adopting the I-TEF approach for assessing health risks associated with chlorinated dioxins and dibenzofurans across all programs of Cal/EPA. |
The MOU was signed in late 1996. Collaborative work activity with US EPA has been initiated. Public Health Goal documents were sent to US EPA for review.
Planned future activity as additional resources become available.
|
| Best Use of Scientific Information | ||
| Develop and coordinate technical support on guidance documents, policy documents, and white papers.
Provide a forum for the identification, evaluation, and promotion of new or existing knowledge which can improve the scientific basis for risk assessment. (Recommendation 4) |
Finalize Stochastic Exposure Assessment Guidelines. Release new guidelines for the "Air Toxics Hot Spots" program.
Develop a unified multi-media, multi-pathway exposure assessment method that is acceptable to all Cal/EPA programs. Prepare a briefing book for the Secretary of Cal/EPA on identifying future emerging environmental challenges. Prepare white papers on scientific issues, e.g., criteria for generally accepted scientific principles and experimental protocols for toxicity tests.
Issue a report that summarizes the pilot study results and recommendations of an inter-departmental work group on the evaluation of the draft US EPA Guidelines for Carcinogen Risk Assessment. Prepare supplemental guidance documents to be used together with the draft US EPA Guidelines for Carcinogen Risk Assessment. |
Completed the peer review and public comment phase of development, the guidelines are being finalized for SRP review.
A 2-day public workshop has been scheduled on June 25-26, 1998. Organized public workshops on safety assessment for essential elements and a survey of fish consumption rates. Finalized and are implementing a plan for development of ecological risk assessment guidelines for chemical exposures. Three draft risk assessments using the proposed methods and a summary report on the draft guidelines are near completion.
|
| Improve environmental contaminant data management. | Through the RACWG fate and transport subcommittee, conduct a feasibility study for improving data management practices of Cal/EPA (determine scope of work, resources needed, and timelines). | Planned future activity, as additional resources become available. |
| Serve as designated science advisor to the Office of the Secretary on environmental and risk assessment issues. (Recommendations 2 and 9) | Provide advice and counsel to the Secretary, utilizing the expertise of the OEHHA staff, the current Science Advisory Board members and ad hoc panels of independent scientists with specialized expertise, as needed, on environmental and risk assessment issues.Provide advice and counsel to the Secretary (and to other BDOs), utilizing the current Science Advisory Board, RAAC core members and ad hoc panels of independent scientists with specialized expertise, on scientific, environmental and risk assessment issues. | On-going. Provide information upon request (e.g. MTBE, Proposition 65 listing, methyl mercury, Emerging Environmental Challenges). |
| Continue staff training and professional development activities. (Recommendation 6) | Attend and make contributions to professional society and scientific meetings/forums.
Actively participate in state and national coordinating and harmonization committee meetings, on risk assessment issues. |
On-going. Presented scientific papers and participated in professional meetings, e.g., SOT, SETAC, SRA, US EPA SAB, GETA, and others.
Participated in national meetings, symposia, and conferences on risk assessment and environmental protection (e.g., US EPA acute toxicity committee, endocrine disrupters screening tests committee). |
| Continue ongoing efforts in methods development.
e.g., physiologically-based pharmacokinetics, stochastic methods, benchmark dose, and molecular mechanisms of carcinogenesis (including receptor mechanisms). (Recommendation 4) |
Publish scientific papers in peer reviewed journals.
Collaborate with University of California and other institutes of higher learning to organize seminars on new techniques or approaches in human health risk assessment, e.g., benchmark dose for cancer and non-cancer endpoints.
|
On-going.
New approaches and methods, such as benchmark dose methods, pharmacokinetic-physiologic models are routinely applied, as appropriate. |
| Peer Review and Peer Involvement | ||
| Convene and provide technical and logistical support to the core members of the RAAC to advise Cal/EPA on implementation of the RAAC recommendations. | Hold 1-2 public meetings, coordinate the preparation of briefing materials. | A public workshop has been scheduled in the fall of 1998 for the RAAC members to review and give Cal/EPA advice on the implementation of the RAAC recommendations. |
| Assist Boards, Departments and Offices in developing and implementing scientific peer review processes. (Recommendation 5) | Provide general guidelines and consultation on scientific peer review, processes and procedures. | On-going. |
| Enhance and expand ongoing peer review and public outreach activities. (Recommendation 5) | Develop Standard Operating Procedures for scientific peer review. | In response to SB1320, OEHHA participated in an agency-wide team to develop Cal/EPA guidelines for scientific peer review. OEHHA has identified a need for additional resources to conduct adequate peer review. |
| Interface Between Risk Assessment and Risk Management | ||
| Seek early input into the risk assessment process from risk managers and from external stakeholders. (Recommendation 7)
Cal/EPA should establish a process to bring together risk assessment and risk management personnel to better translate emerging methods in risk assessment into risk management policy. (Recommendation 8) |
Hold public workshops and meetings with risk managers and interested parties.
Develop procedures for public input.
Work with risk assessors and risk managers on guidelines development. |
Public workshops were convened for many programs (e.g., Proposition 65 program: authoritative bodies, prioritization process, delisting of chemicals, essential elements, and hazard identification documents; PHG program: MTBE; TAC program: diesel exhaust).
Meetings were held with attorney general’s office and/or interested parties on authoritative bodies, styrene, diesel exhaust, methylmercury, MTBE, and diethylhexylphthalate. OEHHA works with responsible party and regulatory agency to develop protocols for site-specific risk assessments. Member of risk management group for lead exposures. Formal procedures for a variety of Proposition 65 activities have been developed and posed on the OEHHA homepage (e.g., prioritization, authoritative bodies, delisting). Collaborate with local air district authorities and external stakeholders in developing Stochastic Guidelines. |
| Establish a process to bring together risk assessment and risk management personnel to better translate emerging methods in risk assessment into risk management policy. (Recommendation 8) | Work with risk assessors and risk managers on guidelines development. | Collaborated with local air district authorities and external stakeholders in developing Stochastic Guidelines and lead risk management guidelines. |
| Communicate with stakeholders by means of seminars, and articles in the popular and business press, and computer networks on issues related to environmental protection and public health. | Provide educational materials and presentations on human health risk assessment to staff of other Boards and Departments of Cal/EPA, legislators, local governments, and the public.
Develop and write a layman’s guide to risk assessment. Develop a layman’s guide to the Proposition 65 program.
Post updates on the department’s activities on the OEHHA world wide web site. |
On-going. Provided training on the "Hot Spots" program to local air pollution control districts. Developed fact sheets on departmental activities and environmental issues. Various talks delievered to civic groups, air districts and regional societies. Gave a course on risk assessment to IWMB.
Completed. Draft document in internal review process. Completed. Proposition 65 guide developed and published in the California Regulatory Notice Register. Fact sheets and notices about OEHHA activities, environmental issues, and scientific evaluations are placed on the OEHHA homepage. |
| Organize training courses for risk assessors and risk managers on risk assessment and risk communication. | In collaboration with US EPA Region IX, in provide training courses to state and local government staff in Risk and Decision Making and Risk Communication and Public Involvement. | Future activity. |
| Consider an approach in conducting chemical risk assessments that balances the level of effort and resources with the importance of the risk assessment. (Recommendation 11) | Utilize tiered approach to risk assessment and program processes, examples:
|
New Stochastic guidelines follow a tiered approach for exposure assessment.
Prop 65 prioritization process has increased levels of review and detail as an agent moves through the listing process. NSRL’s are being derived and revised according to a tiered procedure in regulation.New NSRL’s which are akin to "screening levels" are being derived based on perceived need of the risk manager. |
| Dose-response Assessment | ||
| Dose-Response Assessment
ECal/EPA should explore alternative ways, other than using large uncertainty factors, to bridge gaps in toxicity data. |
Examine and utilized the benchmark dose / margin of exposure (MOE) approach. Evaluate procedures in the 1996 US EPA Proposed Guidelines on Carcinogen Risk Assessment. Benchmark dose / margin of exposure (MOE) approach examined as part of pilot project to evaluate the US EPA draft carcinogen guidelines and in PHG risk assessments. Employ PBPK modeling in assessments where data warrants this approach.
Human data utilized preferentially to animal data, if appropriate. |
On-going.
Benchmark dose/MOE approached used in recent PHG assessments. Three draft risk assessments and a summary report evaluating the US EPA draft guidelines are near completion. Completed. Three draft risk assessments and a summary report evaluating the draft guidelines is near completion. Benchmark dose/MOE approached used in recent PHG assessments. PBPK modeling utilized in several assessments including MTBE, trichloroethylene, arsenic, and perchloroethylene. On-going. Human data used as the basis of the PHGs for fluoride and lead. |
| DCal/EPA should develop guidelines on the appropriate use of uncertainty factors, and provide guidance on how severity of effect should be taken into account in setting these factors. | Develop guidelines on the use of uncertainty factors, which takes into account severity of the adverse effect. | Completed. Criteria developed and utilized. Acute and chronic (air) Reference Exposure Levels (REL) issued by OEHHA linked magnitude of UF with severity of effect. |
| Exposure Assessment | ||
| EXPOSURE ASSESSMENT
TCal/EPA should take steps to integrate fate and transport modeling efforts with human exposure assessment. |
Form Fate and Transport Subcommittee of the RACWG. Fate and transport Subcommittee formed as subcommittee of the RACWG. Stochastic exposure assessment guidelines. |
Completed.
Group formed and a survey of the modeling capabilities of BDOs of Cal/EPA was conducted. A survey on the modeling capabilities of BODs of Cal/EPA was conducted.
On-going. Simple "Hot Spots" fate and transport model is integrated with the human exposure assessment described in the stochastic guidelines. |
| PCal/EPA should put more emphasis on receptor-based exposure assessment when it is appropriate and cost-effective. | Utilize receptor-based approach when appropriate and cost effective.
Develop accurate means of estimating toxicant exposure via fish consumption.Current approach when appropriate and cost effective |
On-going. Receptor-based approach utilized for assessment Proposition 65 evaluations.
Completed. Developed and implemented an agreement with US EPA to collect fish samples in California and analyze for chemical contaminants.Receptor-based approach utilized for assessment of methyl mercury toxicity. Developed and implemented an agreement with US EPA to collect fish samples in California and analyze for chemical contaminants. |
| Risk Characterization | ||
| RISK CHARACTERIZATION
ICal/EPA should improve the characterization of uncertainty and variability in its risk assessments and in the communication of this information to risk managers and the public. |
Develop policy and guidelines on risk characterization.Policy and guidelines on Risk Characterization was developed by the RACWG and stressed the communication of variability and uncertainty.
Develop stochastic guidelines for ‘Hot Spots’ program to provide information on variability in human activities and intake factors.Stochastic guidelines (‘Hot Spots’ program) provides information on variability in human activities and intake factors. |
Completed.
Guidelines developed by RACWG stressing the communication of variability and uncertainty. Policy was reviewed and approved by Cal/EPA Boards, Departments, and Offices.Guidelines developed by RACWG and reviewed and approved by Cal/EPA BDOs
Guidelines completed the peer review and public comment phase of development, and are being finalized for SRP review.Completed the peer review and public comment phase of development, being finalized for SRP review. |
| Take steps to make tThe extent and depth of OEHHA’s Cal/EPA risk analyses should be responsive to the needs of the decision-maker and to the decisions they are intended to support. | Utilize tiered approach to risk assessment and program processes, examples:
|
New Stochastic guidelines follow a tiered approach and provide more detailed information to the risk manager on variability and uncertainty.
Prop 65 prioritization process has increased levels of review and detail as an agent moves through the listing process. NSRL’s are being derived and revised according to a tiered procedure in regulationNew NSRL’s which are akin to "screening levels" are being derived based on perceived need of the risk manager. |
| Data Management | ||
| DATA MANAGEMENT
RCal/EPA should review present data collection/data management efforts and initiate measures to minimize overlap and to improve accessibility and quality of data. |
Develop an ecological toxicology relational database for use in ecological risk assessment.
Improve the availability of the RACWG list of consensus potency values for use in California regulatory programs. |
AThe database was jointly developed with UC Davis; it is contained in Visual FoxPro that is keyword searchable and contains life history and chemical-specific information on 65 California species. Status: in pre-beta test version, eventually to be placed on the OEHHA homepage.
Cancer potency list was recently updated and will be posted on the OEHHA homepage soon. |
Table 8. State Water Resources Control Board, Cal/EPA
Implementation Activities for Addressing the Recommendations of the Risk Assessment Advisory Committee
|
Activity Description |
Performance Measures |
Status |
|---|---|---|
| Consistency and Harmonization | ||
| Establish internal Cal/EPA working group to insure agency-wide consistency and harmonization. | Participate in Cal/EPA RAAC work group.
Participate in Cal/EPA Risk Assessment Coordination Work Group (RACWG). Participate in Cal/EPA RACWG Environmental Fate and Transport Subcommittee. |
Completed (folded into RACWQ).
Ongoing.
Ongoing. On hold pending additional resources. |
| Initiate steps to assure consistency/cooperation with US EPA and other federal counterparts. | Participate in US EPA and Cal/EPA Risk Harmonization Work Group.
Participate in US EPA’s Biological Technical Advisory Group. Policy meeting with US EPA to use US EPA standards for ambient and health risk criteria (ISWP/EBEP). |
On hold pending additional resources.
|
| Best Use of Scientific Information and Development of Guidelines | ||
| Review data collection/ management for overlap, institute quality control measures, and improve accessibility of present data. | Develop proposal for Comprehensive Water Quality Data Management for collection, validation, and dissemination.
Continue the SWRCB Information Management Team efforts to improve data accessibility. |
Ongoing.
Ongoing. |
| Clearly state the scientific and policy basis for each default option. | Participate in Cal/EPA development of guidance for communicating the basis for "science based" policy decisions. | Ongoing |
| Peer Review and Peer Involvement | ||
| Formalize peer review program. | Participate in the peer review process established by Cal/EPA through a MOU with the University of California (SB 1320). | Completed (Draft Policy on Peer Review being implemented). |
| Interface between Risk Assessment and Risk Management | ||
| Seek early input from risk managers, external stakeholders and general public during the risk assessment process. | Continue external stakeholder involvement through existing and ad-hoc committees (e.g., surface water NPS/ISWP/EBEP/BPTCP, and disposal to land - Chapter 15 stakeholders groups). | Ongoing. |
| Better translation of emerging risk assessment methods into risk management policy. | Identify SWRCB program areas that would benefit from this translation (e.g., underground tanks policy and ambient water quality objective program). | Ongoing. |
| Organization and Resources | ||
| Balance level of effort and resources with the importance of the risk assessment. | Incorporate economic/technical feasibility in ground water assessment.
Continue using a tiered approach for characterizing nature and extent of groundwater pollution. |
Ongoing.
|
| Evaluate adequacy of resources for various scientific disciplines required for risk assessment. | Prepare (as appropriate) BCPs for in-house expertise in contaminant fate and transport, environmental chemistry, and modeling. | Ongoing. |
| Formalize staff participation in continuing education programs/ national and international scientific organizations. | Continue existing Strategic Plan's training program, encourage staff participation in scientific organizations (e.g., SETAC). | Ongoing. |