BOARD MEETING DATE: February 12, 1999 AGENDA NO. 30
PROPOSAL:
Amend Rule 1401 – New Source Review of Toxic Air Contaminants
SYNOPSIS:
At the January 8, 1999 public hearing, hydrochloric acid and sodium hydroxide were added to Rule 1401; and 41 additional compounds for which the state Office of Environmental Health Hazard Assessment recently finalized risk values were also added. In order to provide adequate public notice, the public hearing was continued to February 12, 1999 to consider proposed changes to some of the effective dates in Table I. The Board also delayed until its February meeting consideration of adding nickel and nickel compounds, pending a peer review meeting of the Toxicology Excellence for Risk Assessment report on the carcinogenicity of soluble nickel.
COMMITTEE: Stationary Source, January 22, 1999, Reviewed
RECOMMENDED ACTION:
- Adopt the attached resolution;
- Certify the Addendum to the Final Environmental Assessment (certified at the July 10, 1998 Board meeting) for Rule 1401 – New Source Review of Toxic Air Contaminants; and
- Amend Rule 1401 – New Source Review of Toxic Air Contaminants, as proposed, in accordance with the attached Resolution.
Barry R. Wallerstein, D.Env.
Executive Officer
Background
In July 1998 and January 1999, the South Coast Air Quality Management District (AQMD) Governing Board (Board) made significant progress in implementing Environmental Justice Initiative #10 by adopting revisions to Rule 1401 - New Source Review of Toxic Air Contaminants. Approximately 140 compounds and a requirement to consider non-cancer impacts have been added to the rule.
In July 1998, the Board postponed consideration of adding nickel and nickel compounds to the January 1999 meeting to address an industry request for time to finish a literature review on soluble nickel by Toxicology Excellence for Risk Assessment (TERA). At the January meeting, the Board further continued the meeting to February 12, 1999, when industry representatives requested an additional one-month delay to allow time for a peer review of the TERA report. The table below summarizes the key testimony received at the January meeting related to this issue. A more detailed summary is contained in the minutes of the January Board meeting.
Organization |
Comments |
Metal Finishers Association of Southern California (several speakers) |
Delay one month, pending TERA review study. |
Office of Environmental Health Hazard Assessment (OEHHA) |
Nickel compounds, including soluble nickel, are potentially carcinogenic. Respectfully disagree with draft TERA findings. |
Environmental Groups (2 speakers) |
There is sufficient evidence to add nickel compounds to the rule. |
UC Irvine professor |
Recommended addition of nickel compounds to Rule 1401. |
USC lung physician and professor |
Recommended addition of nickel compounds to Rule 1401. |
The public hearing was also continued to February 12, 1999 to consider changes to the effective dates for using the noncancer risk values for toxic air contaminants in Rule 1401, Table I. In order to obtain additional public comment on those changes, staff conducted a public consultation meeting on January 14, 1999, which was attended by approximately 50 people. No significant comments were received and the proposal to delay effective dates was generally accepted.
Relevant excerpts from the January 8, 1999 Board package and the July 10, 1998 Socioeconomic Report, previously provided to the Board and the public, are attached as further documentation of staff's analysis.
Nickel and Nickel Compounds
TERA Review Meeting
A senior AQMD manager and the AQMD’s Health Effects Officer attended the TERA peer review on January 13 and 14, 1999 as observers. After 2 days of technical discussions, several changes were made to the draft report. The first involves the classification of soluble nickel. A 1986 EPA classification scheme was used which allows only three choices for classifying a carcinogen: likely; cannot be determined; or unlikely. In order to support a determination of ‘likely,’ information on dose-response and a suggested mechanism are required. Dose response is the relationship between the amount of chemical exposure and resulting health effects (including cancer). Mechanism relates to understanding how the chemical enters cells and causes damage to genetic material. The draft TERA report stated that soluble nickel is "unlikely to be carcinogenic at low concentrations, but may be carcinogenic at high concentrations." The reviewers recommended that the classification be revised to "the carcinogenicity of inhaled soluble nickel cannot be determined" because of insufficient information on dose-response, and lack of agreement on the mechanism. The table below summarizes the changes in the TERA report as a result of the peer review:
Draft Report |
Peer Review |
Soluble nickel is unlikely to be carcinogenic at low concentrations, but may be at high concentrations. |
The carcinogenicity of soluble nickel cannot be determined because of insufficient information on dose-response and lack of agreement on the mechanism. |
There is an unequivocal difference between soluble and insoluble nickel. |
The carcinogenicity of soluble and insoluble nickel cannot be compared. |
Soluble nickel may enhance the carcinogenicity of other nickel compounds. |
Majority concurred. |
Other Information
In addition to reviewing the draft TERA report and attending the peer review meeting, staff has been working with experts and reviewing much of the technical information relative to this issue. This information includes the draft TERA report and its review process, epidemiology studies, animal studies, literature reviews on nickel carcinogenicity and information from other agencies (see Table following Board letter for a list of information reviewed).
There are many organizations throughout the world that classify soluble nickel as a possible or known human carcinogen. These include:
EPA has not evaluated soluble nickel. The Occupational Safety & Health Administration (OSHA) and the American Conference of Governmental Industrial Hygienists (ACGIH) list soluble nickel as ‘cannot be classified,’ which is similar to the TERA report.
OEHHA extensively considered the carcinogenicity of nickel and nickel compounds in a 1991 risk assessment document on nickel compounds. Their recommendation was based largely on human studies. After reviewing the draft TERA report, they continue to recommend that nickel compounds be considered potentially carcinogenic and be included in Rule 1401.
OEHHA states that health effects of nickel on humans include respiratory tract irritation, sensitization and asthma, and lung and nasal cancer. Because nickel ions are genotoxic, all forms (soluble and insoluble) may cause cancer, including strong evidence of cancer from inhaled compounds based on occupational studies involving workers exposed to soluble and insoluble forms. Based on human studies, the ICNCM (1990) concluded that more than one form of nickel compounds, including soluble nickel, causes lung and nasal cancers. These findings were confirmed in studies conducted in 1996 (Andersen et al.) and follow-up studies to that of ICNCM in 1998 (Antilla et al.).
OEHHA reviewed the draft TERA report and concluded that the evidence does not refute their earlier findings that all nickel compounds should be considered potentially carcinogenic. The weight of evidence regarding soluble nickel as a carcinogen is strongly supported by human epidemiology data, whereas animal data relied upon by TERA is limited. OEHHA states that "the weight of evidence continues to support identification of nickel and nickel compounds, including soluble nickel, as being potentially carcinogenic to humans."
The Scientific Review Panel
The state Scientific Review Panel reviews and approves OEHHA recommendations. The Scientific Review Panel is established by the state legislature and includes nine members serving three-year staggered terms. Appointments to the Scientific Review Panel are made by the California Secretary of Environmental Protection (five members), the Senate Committee on Rules (two members), and the Speaker of the Assembly (two members). The appointments include scientists in the fields of toxicology, pathology, oncology, epidemiology, atmospheric science, biostatistics, or other relevant scientific experience. The appointments also include a physician or scientist specializing in occupational medicine and a biochemist or molecular biologist.
Summary
Staff recommends adding nickel compounds to Rule 1401 because of the strong weight of evidence that nickel compounds are related to human cancer. This is based on extensive assessment by staff of numerous scientific literature including the draft TERA report and peer review, epidemiology and animal studies, information from OEHHA and other agencies, and literature reviews relevant to this topic. Risks from individual tanks can range from under 1 to over 50 in a million. There are over 500 plating facilities, each with two to dozens of existing tanks. Approximately 50 new tanks are added each year. There are commercially available emission controls for the reduction of nickel emissions. Costs would be approximately $17,000 to $115,000 (for very large tanks). These estimates are derived from manufacturers information which was verified by a contract that was jointly implemented by AQMD and the MFASC. This effort evaluated actual purchase, installation, maintenance and operating costs at a typical small, medium, and large facility. The plating industry has been successful in developing emission reduction techniques for reducing chromium emissions from plating. Development of similar mist suppression systems or equipment redesign may reduce control costs in the future. Nickel and nickel compounds also have pending chronic and acute values, which will be effective upon Scientific Review Panel approval.
Industry intends to submit the final TERA report to OEHHA and request reconsideration of the carcinogenicity of soluble nickel. While OEHHA is unlikely to change its opinion, even if it did, it may take years to change risk values for nickel and nickel compounds. If OEHHA revises the factor for nickel, nickel compounds or any other toxic air contaminants (TAC), staff will bring the revised factor back to the Board according to the requirements set forth in Rule 1401, paragraph (e)(2).
At the January Board meeting, the Board also included a directive to staff to place a moratorium on deeming complete any permit applications with associated nickel and nickel compound emissions received between January 8 and February 12, 1999, consistent with all rules and laws. If nickel and nickel compounds are added to Rule 1401 in February, the cancer risk requirements would apply to those applications deemed complete on or after the adoption date.
Changes to Effective Dates
Staff also recommends a change in the effective date for some compounds in Rule 1401 Table I. A commitment had been made by staff during rule development that the rule would regulate compounds based on final approved risk values. Staff has become aware that risk values for compounds with acute and chronic effects (with the exception of perchloroethylene and acetaldehyde), although utilized for AB2588 health risk assessments, have not yet received official final approval by the Scientific Review Panel. For these compounds, the risk values were published several years ago and have been incorporated within CAPCOA guidelines. In keeping with its commitment, staff proposes to clarify Table I to define the effective date for chemicals with chronic and acute effects based on the Scientific Review Panel final approval. This change does not affect any carcinogenic risk values. Only 2 of these chemicals (acrolein - a combustion product, and ethylene glycol monobutyl ether – used in some water-based coatings) are associated with equipment that would possibly require control equipment to meet the risk limits in Rule 1401.
AQMP & Legal Mandates
Rule 1401 is a program that is in part mandated by state and federal requirements. The proposed changes to Rule 1401 are consistent with CARB guidelines for toxic new source review.
CEQA & Socioeconomic Impact
AQMD staff has reviewed the proposed amendments to Rule 1401 pursuant to state CEQA Guidelines Section 15002 (k)(2). An Addendum to the June 1998 Final Environmental Assessment (SEA) (certified at the July 1998 Governing Board meeting) has been prepared. The Addendum to the Final EA concludes that the proposed modifications to Rule 1401 would not create any new significant adverse impacts than those previously analyzed in the previously certified EA or make substantially worse any existing significant adverse impacts generated by the original project. The proposed modification did not change the environmental analysis or conclusions in the previously certified Final EA. Pursuant to CEQA Guidelines Section 15164(c), an addendum need not be circulated for public review. Copies of the Final EA are available at the AQMD public information center by calling (909) 396-3600.
A final socioeconomic assessment was included as part of the July 10, 1998 staff report. Impacts from adding compounds related to metal plating are expected to be lower than estimates in the July 1998 amendment package, because some nickel tanks may not require controls. The July 1998 report estimated that a range of 10 to 52 jobs per year would be foregone from the two main industries that use nickel plating, fabricated metal and electronic equipment. Control equipment is estimated at $17,000 - $115,000 per tank, depending on size. Based on the July 1998 report, the estimated annual average cost to the metal plating industry, as a whole is $608,000 to $3.4 million.
Implementation Plan
Existing AQMD resources will be used to implement the rule. The guidance document will be updated for use in analyzing all permit applications for new, modified or relocated equipment emitting the affected compounds. Engineering staff will be trained on the changes to the risk values.
Attachment A: Summary of Proposal
Attachment B: Key Issues and Responses
Attachment C: Rule Development Process
Attachment D: Key Contacts List
Attachment E: Resolution
Proposed Rule Language
Excerpts from July 10, 1998 and January 8, 1999 Board Packages
Addendum to the June 1998 Final Environmental Assessment
June 1998 Final Environmental Assessment (certified at the July 1998 Governing Board
meeting) (Copies of this document are provided for AQMD Board Members only –
others may obtain a copy by calling the Public Information Center at (909) 396-3600).
Summary of Studies and Sources of Literature Evaluated
/ / /