Changes to Chapter 62-780, F.A.C., Contaminated Site Cleanup Criteria, to provide clarification on applicability of Referenced Guidelines, provide a list of references for toxicity and exposure information, clarify requirements for probabilistic ...

 

DEPARTMENT OF ENVIRONMENTAL PROTECTION

RULE NOS.:RULE TITLES:

62-780.100Referenced Guidelines

62-780.600Site Assessment

62-780.650Risk Assessment

62-780.680No Further Action and No Further Action with Controls

PURPOSE AND EFFECT: Changes to Chapter 62-780, F.A.C., Contaminated Site Cleanup Criteria, to provide clarification on applicability of Referenced Guidelines, provide a list of references for toxicity and exposure information, clarify requirements for probabilistic risk assessments and to provide criteria for risk-based closure without institutional controls.

SUMMARY: The proposed changes to Chapter 62-780, F.A.C., clarify specific rules pertaining to derivation of alternative cleanup target levels and the use of probabilistic risk assessments.

The first proposed revision to rule 62-780.650, F.A.C., is the addition of a list of sources of information that can be used as references for the latest science with regard to toxicity or exposure factors. This expanded list of references will enable the use of the most current information in calculating alternative cleanup target levels and in making risk management decisions.

A second proposed revision to rule 62-780.650, F.A.C., provides clarification to an existing rule provision regarding the use of probabilistic risk assessments (PRAs). The proposed language clearly identifies the appropriate components of a PRA and the level and detail of supporting information.

A third proposed revision is to rule 62-780.680, F.A.C., to provide for risk-based site closure without institutional or engineering controls upon demonstration that such controls are not necessary based upon scientific studies or reports relating to a contaminant’s toxicity or carcinogenicity or based upon non-site-specific exposure factors. Previously, the rule required institutional controls in all cases where contamination above the default cleanup target levels was being left on site. This revised provision provides regulatory relief from that requirement.

A fourth, technical amendment to rule 62-780.100 clarifies that the Referenced Guidelines in the Chapter are for informational purposes only and are not enforceable. One of the referenced guidelines, the Institutional Controls Procedures Guidance, has been updated.

OTHER RULES INCORPORATING THIS RULE: 62-730.210, 62-730.225, 62-701.510, 62-777.150, 62-777.170, 62-780.150, 62-780.200, 62-780.210, 62-780.220, 62-780.450, 62-780.500, 62-780.550, 62-780.560, 62-780.610, 62-780.690, 62-780.700, 62-780.750 and 62-780.900, F.A.C.

EFFECT ON THOSE OTHER RULES: The amendments to 62-780.100, .600, .650 and .680, F.A.C., will not have any effect on those rules cited above.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The proposed rules provide greater flexibility and options for the regulated community and do not increase costs or regulatory burdens. Therefore, no SERC is required and the requirement for legislative ratification is not triggered.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 376.303, 376.30701, 376.3071, 376.3078(4), 376.81, 403.061, 403.0877 FS.

LAW IMPLEMENTED: 376.30701, 376.3071, 376.3078(4), 376.81, 403.021, 403.061, 403.062, 403.0877 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW (IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):

DATE AND TIME: Tuesday, October 8, 2013, 9:00a.m. until conclusion, but no later than 5:00 p.m.

PLACE: Department of Environmental Protection, 2600 Blair Stone Rd, Room 609, Tallahassee, FL or VIA Webinar: https://www2.gotomeeting.com/register/531345978

Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 5 days before the workshop/meeting by contacting: Brian Dougherty at [phone] or [e-mail]. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Brian Dougherty at [phone] or [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

62-780.100 Referenced Guidelines.

Specific references to the guidelines listed below are made within this chapter. The guidelines are not standards as defined in Section 403.803, F.S. Use of these guidelines is not mandatory and not enforceable; the guidelines are included for informational purposes only.

(1) through (6) No change.

(7) Institutional Controls Procedures Guidance, Division of Waste Management, Florida Department of Environmental Protection, dated September 2013 June 2012.

(8) through (9) No change.

Rulemaking Authority 376.303, 376.3071, 376.30701, 376.3078(4), 376.81 FS. Law Implemented 376.3071, 376.30701, 376.3078(4), 376.81 FS. History–New 4-17-05, Amended 6-12-13,_________.

 

Editorial Note: Portions of this rule were copied from 62-770.140; 62-782.100; and 62-785.100.

 

62-780.600 Site Assessment.

(1) through (4) No change.

(5) The site assessment shall include tasks that are necessary to achieve objectives described in subsection 62-780.600(3), F.A.C., and include the following, as applicable:

(a) through (b) No change.

(c) Sampling of soil from the unsaturated zone for the following criteria, as applicable:

1. No change.

2. Measurement of appropriate soil properties such as texture, pH, moisture content, dry bulk density, organic carbon content, and infiltration rate using the test methods specified in Chapter 62-777, F.A.C., Table III, if such properties are chosen for the development of alternative soil CTLs in accordance with the technical report referenced in subsection 62-780.100(2), F.A.C. If soil properties are chosen to be used, mMeasurements shall be made on soil from within the contaminated area when feasible. If measurement from within the contaminated area is not feasibleOtherwise, measurements may be made on soil from an alternative location that has equivalent soil properties or the PRSR may propose the use of other applicable and relevant data on soil properties;

3. through 5. No change.

(d) through (u) No change.

(6) through (7) No change.

(8) The Site Assessment Report shall:

(a) No change.

(b) Summarize conclusions regarding site assessment objectives outlined in subsection 62-780.600(3), F.A.C., and include one of the following:

1. through 2. No change.

3. A recommendation to prepare a Risk Assessment or a Risk Assessment Work Plan shall be included if the PRSR chooses to justify alternative CTLs using risk assessment studies demonstrating that human health, public safety, and the environment are protected to at least the same degree provided by sections 376.30701, 376.3071, 376.3078, or 376.81, F.S., as applicable the CTLs referenced in this chapter. The work plan shall include a schedule for completion of a Risk Assessment and documentation adequate to support the request to do one or more of the task elements of subsection 62-780.650(1), F.A.C., and shall specify the parameters or exposure assumptions that will be used to develop the alternative CTLs pursuant to Rule 62-780.650, F.A.C.; or

4. No change.

(9) through (10) No change.

Rulemaking Authority 376.303, 376.3071, 376.30701, 376.3078(4), 376.81, 403.0877 FS. Law Implemented 376.3071, 376.30701, 376.3078(4), 376.81, 403.0877 FS. History–New 4-17-05, Amended 6-12-13,_________.

 

Editorial Note: Portions of this rule were copied from 62-770.600, Formerly 17-70.008 and Formerly 17-770.600; 62-782.600; and 62-785.600.

 

62-780.650 Risk Assessment.

(1) During the risk assessment process, the PRSR is encouraged to have discussions with the Department at various decision points to establish applicable exposure factors, relevant receptors, and risk management options based on the current and projected land use(s) at the site. If a risk assessment is performed, the following risk assessment task elements shall be performed, as appropriate:

(a) An exposure assessment that identifies pathways and routes by which human and environmental receptors may be exposed to contaminants and determines levels of contaminants to which human and environmental receptors may be exposed. The exposure assessment shall:

1. Identify actual and potential exposure pathways and routes;

2. Identify actual and potential human and environmental receptors for each exposure pathway, and sensitive sub-populations;

3. Determine expected concentrations of contaminants to which actual and potential human and environmental receptors may be exposed, with the most recent sampling of representative monitoring wells having occurred no more than 270 days prior to Risk Assessment Report submittal;

4. Determine exposure factors (e.g., exposure duration, exposure and frequency, body weight and ingestion rate) based on:

a. Ssite-specific characteristics, including consideration of current and plausible projected land uses. Institutional and engineering controls may be proposed in order to ensure that exposure factors do not change; or and

b. Non-site-specific exposure factors contained in the most current U.S. Environmental Protection Agency Exposure Factors Handbook or other information on exposure factors applicable to a Florida exposure scenario.

5. Estimate the contaminant doses received by relevant receptors.

(b) A toxicity assessment that determines human health and environmental criteria for contaminants found at the site.

1. The criteria, taking into consideration acute and chronic health effects associated with short-term and long-term exposure, shall be applicable to exposure pathways and routes identified in the exposure assessment, including, as appropriate:

a.1. Potable water exposure from ingestion, dermal contact, and inhalation of vapors and mists;

b.2. Non-potable water exposure from dermal contact, inhalation of vapors and mists, ingestion of food crops irrigated with such water, lawn watering, and other related exposures, and exposures to pets and livestock from ingestion;

c.3. Soil exposure from ingestion, dermal contact, inhalation, and ingestion by humans or animals of food crops grown in contaminated soil; and

d.4. Non-potable surface water exposure from ingestion, dermal contact, and inhalation of vapors and mists. Adverse effects on freshwater or marine biota (including any bio-accumulative effects in the food chain) and on humans (for example, through incidental ingestion and dermal contact while using the resource for recreational purposes or fish consumption) shall be considered.

2. Input assumptions different from those used to develop default CTLs may be used to propose alternative CTLs. The appropriate equations from Chapter 62-777, F.A.C., must be used in calculating the alternative CTLs. Toxicity values for quantifying human health risks and for developing alternative CTLs may be taken from the following tiers of information sources, in order of precedence.

a. Tier 1, in order of precedence:

(I) Integrated Risk Information System (IRIS), or

(II) The Provisional Peer Reviewed Toxicity Values (PPRTV) derived by EPA's Superfund Technical Support Center for the USEPA Superfund program.

b. Tier 2. If a toxicity value is available from more than one source in this tier, the value based upon the most recent review of the toxicological literature and accompanying dose-response analysis should be selected:

(I) Agency for Toxic Substances and Disease Registry Minimal Risk Levels (MRLs),

(II) Upper intake limits developed by the National Academy of Sciences,

(III) Health Effects Assessment Summary Tables,

(IV)Human Health Benchmarks for Pesticides and other toxicity values in technical documents available from the USEPA Office of Pesticide Programs, or

(V) Office of Water, Drinking Water Regulations and Health Advisory Levels.

c. Tier 3. If a toxicity value is available from more than one source in this tier, the value based upon the most recent review of the toxicological literature and accompanying dose-response analysis should be selected:

(I) The California Environmental Protection Agency Office of Environmental Health Hazard Assessment's Chronic Reference Exposure Levels and Cancer Potency Values,

(II) World Health Organization Tolerable Daily Intake values,

(III) International Toxicity Estimates for Risk Assessment,

(IV) Withdrawn IRIS Values, or

(V) Values from sources other than Tiers 1 or 2 that are either selected by FDEP or proposed by a PRSR and accepted by FDEP.

(c) A risk characterization that utilizes the results of the exposure assessment, the toxicity assessment, and any other relevant public health and epidemiological assessments, to characterize cumulative risks to the affected population(s) and the environment from contaminants found at the site. Based on the concentrations of contaminants found at the site, the characterization shall include:

1. Risks to human health and safety from exposure to the contamination;

2. Risks from the contamination to non-human species and ecosystems; and

3. Derivation of apportioned alternative CTLs, as applicable. [Refer to Appendix C of the technical report referenced in subsection 62-780.100(2), F.A.C., for guidance on the derivation of alternative CTLs for TRPHs based on a sub-classification methodology; and to Chapter 62-777, F.A.C., Table III for methods that may to be used in determining soil properties for the derivation of alternative CTLs based on site-specific soil characteristics, if soil properties are used to derive alternative CTLs.] In developing alternative CTLs, when scientific data are available the potential for additive, synergistic, or antagonistic interactions among contaminants and the potential for exposure to contaminants via multiple pathways shall be considered based on target organ(s) affected, mechanism(s) of toxicity, and empirical observations from clinical and laboratory studies. The default assumptions shall be that non-carcinogenic chemicals affecting the same target organ(s)/systems have additive effects and that carcinogenic risk, regardless of target organ, is additive. However, non-default target organ(s)/system(s) or effects may be justified through a detailed toxicological analysis of the contaminants present at a specific site.

(d) A justification for apportioned alternative CTLs, as applicable, for groundwater or soil. The justification for the alternative CTLs shall be based upon the site-specific data, modeling results, risk assessment studies, risk reduction techniques or a combination thereof characteristics affecting the site. In establishing the alternative CTLs for groundwater or soil, the following factors shall be used, as applicable: calculations using a lifetime excess cancer risk level of 1.0E-6 and a hazard index of 1, and (for groundwater only) nuisance, organoleptic, and aesthetic considerations. However, the Department shall not require site rehabilitation to achieve a CTL for an individual contaminant that is more stringent than the site-specific background concentration for that contaminant or the best achievable detection limit for that contaminant. The justification shall be based on:

1. State-wide, as applicable, or The site-specific characteristics pertinent to which affect the site, including:

a. The present and projected uses of the affected aquifer(s) and adjacent surface water, with particular consideration of the probability that the contamination is substantially affecting, or will migrate to and substantially affect, a known public or private source of potable water;

b. The technical feasibility of achieving the soil or water quality criteria based on a review of available technology; and

c. Site soil characteristics; and

2. The results of the exposure assessment, toxicity assessment, and risk characterization pursuant to paragraphs 62-780.650(1)(a), 62-780.650(1)(b), and 62-780.650(1)(c), F.A.C.

(2) Fate and transport models for contaminants may be employed, pursuant to Rule 62-780.610, F.A.C., to document that human health and environmental risks are acceptable, and to document that potential risks associated with from the establishment of alternative CTLs are acceptable. If a fate and transport model for contaminants is used, the model shall be validated during subsequent monitoring to justify a No Further Action Proposal, or during natural attenuation monitoring or active remediation monitoring, and adjusted as appropriate using empirical data as the data are obtained.

(3) Probabilistic Risk Assessments may be employed to document that human health and environmental risks are acceptable, and to document that potential risks associated with the establishment of alternative CTLs are acceptable provided:

(a) The equations in Chapter 62-777 Figures (1)-(10), as applicable, shall be used as the basis for calculation of cumulative risks and for the calculation of the alternative CTL.

(b) The selection of the alternative CTL shall be the value representing the 90th percentile of the final exposure or risk distribution produced by the model (equivalent to the 10th percentile of the CTL distribution); and

(c) The following information regarding the Probabilistic Risk Assessment model is submitted to and approved by the Department pursuant to subsection 62-780.610(2), F.A.C.:

1. All information required by paragraph 62-780.610(2)(b), F.A.C.;

2. The type of simulation used;

3. Whether the simulation used is an open-source model or a proprietary model;

4. The source(s) for the distribution(s) used in the model;

5. Any information describing the applicability or limitations of the distribution(s) used in the model;

6. Any assumptions made regarding the shapes of distribution(s) used in the model and the basis for these assumptions; and

7. Any default model parameter values that were replaced with other values for the purposes of the Probabilistic Risk Assessment and the rationale for such replacement, specifically including any change made to the algorithms for sampling from the distributions. The PRSR may submit the information listed in paragraph 62-780.650(3)(c), F.A.C., above for review and approval in advance of the submittal of the model results; and

8. A discussion of the uncertainties associated with the models and inputs used in the probabilistic risk assessment, including contributions from:

a. The nature and sources of exposure and toxicity information;

b. The shape of input distributions and limits, and choice of point value inputs, if any, used in the analysis; and

c. The selection of specific models used in the analysis.

(4)(3) Within the time frames specified in Table A, located at the end of Rule 62-780.900, F.A.C., or the CAD, the PRSR shall submit to the Department for review an electronic or paper copy of the Risk Assessment Report.

(5)(4) The Risk Assessment Report shall contain a description of the task elements undertaken, summarize the conclusions obtained, include the tables required pursuant to subparagraph 62-780.600(8)(a)27., F.A.C., updated as applicable, include a scaled site map for each contaminated medium, that illustrates the degree and extent of contamination (and, for groundwater, the flow direction), and include one of the following:

(a) A No Further Action Proposal without institutional controls or without institutional and engineering controls shall be included if the site meets the applicable No Further Action criteria of subsection 62-780.680(1), F.A.C., or a No Further Action Proposal with institutional controls or both institutional and engineering controls may be included if the site meets the applicable No Further Action criteria of subsection 62-780.680(2) or (3), F.A.C.,; or a No Further Action Proposal with or without institutional controls or both institutional and engineering controls may be included if the site meets the applicable No Further Action criteria of subsection 62-780.680(3), F.A.C.

(b) A Natural Attenuation Monitoring Plan may be included if the site meets the Natural Attenuation Monitoring criteria of Rule 62-780.690, F.A.C.; or

(c) A recommendation to prepare a Remedial Action Plan pursuant to Rule 62-780.700, F.A.C., shall be included, unless a recommendation pursuant to paragraph 62-780.650(4)(a) or 62-780.650(4)(b), F.A.C., is included.

(6)(5) The Department shall:

(a) Provide the PRSR with written approval of the Risk Assessment Report and:

1. If the No Further Action Proposal is approved, with a Site Rehabilitation Completion Order as referenced in subsection 62-780.680(7), F.A.C.;

2. If the Natural Attenuation Monitoring Plan is approved, with a Natural Attenuation Monitoring Plan Approval as referenced in paragraph 62-780.690(5)(a), F.A.C.; or

3. If the recommendation to prepare a Remedial Action Plan is approved, with a written notification that the Remedial Action Plan shall be prepared pursuant to Rule 62-780.700, F.A.C.; or

(b) Notify the PRSR in writing, stating:

1. The reason(s) why the Risk Assessment Report does not contain information adequate to support the proposed alternative CTLs; or

2. The reason(s) why the proposal, plan, or recommendation submitted pursuant to subsection 62-780.650(3), F.A.C., is not supported by the applicable criteria.

(7)(6) If the Risk Assessment Report is incomplete in any respect, or is insufficient to satisfy the objectives set forth in subsection 62-780.650(5) 62-780.650(4), F.A.C., the Department shall inform the PRSR pursuant to paragraph 62-780.650(6)(b) 62-780.650(5)(b), F.A.C., of the basis for a rejection or determination of insufficiency, including the technical and scientific basis for any such rejection.and Tthe PRSR shall submit to the Department for review an electronic or paper copy of a Risk Assessment Report Addendum that addresses the deficiencies within 60 days after receipt of the notice.

Rulemaking Authority 376.303, 376.3071, 376.30701, 376.3078(4), 376.81, 403.061 FS. Law Implemented 376.3071, 376.30701, 376.3078(4), 376.81, 403.021, 403.061, 403.062 FS. History–New 4-17-05, Amended 6-12-13;___________.

 

Editorial Note: Portions of this rule were copied from 62-770.650; 62-782.650; and 62-785.650.

 

62-780.680 No Further Action and No Further Action with Controls.

(1) through (2) No change.

(3) Risk Management Options Level III – A No Further Action with institutional controls, if needed, and, if appropriate, engineering controls shall apply if the controls are protective of human health, public safety, and the environment and are agreed to by the current real property owner(s) of all properties subject to the institutional or engineering controls. Alternative CTLs that are based on limitations to land use must be used in conjunction with institutional controls to ensure that the limited land use upon which the exposure duration and frequency assumptions were based remains in effect in perpetuity until the PRSR submits information to the Department that supports removal or modification of the institutional controls. The PRSR may also use scientific studies or reports to support a No Further Action Proposal without institutional controls under this subsection. Proposals may be based on information about a contaminant’s toxicity or carcinogenicity, provided such information is consistent with the requirements of subparagraph 62-780.650(1)(b)2., F.A.C. Proposals for no further action without controls may also be based on information about non-site-specific exposure factors, provided such information is consistent with the requirements of sub-subparagraph 62-780.650(1)(a)4.b. Fate and transport models, as defined in Rule 62-780.610, F.A.C., supported by a minimum of one year of monitoring data, may be utilized to justify the No Further Action Proposal. It shall be demonstrated to the Department that the following conditions are met for those contaminants that do not meet Risk Management Options Level I or Level II criteria of subsection 62-780.680(1) or 62-780.680(2), F.A.C.:

(a) through (c) No change.

(4) through (5) No change.

(6) If the No Further Action Proposal is incomplete in any respect, or is insufficient to satisfy the objectives of subsection 62-780.680(1), 62-780.680(2), or 62-780.680(3), F.A.C., the Department shall inform the PRSR pursuant to paragraph 62-780.680(5)(b), F.A.C., of the basis for a rejection or determination of insufficiency, including the technical and scientific basis for any such rejection.and Tthe PRSR shall submit to the Department for review an electronic or paper copy of a revised No Further Action Proposal that addresses the deficiencies within 30 days after receipt of the notice. If the deficiencies are not timely corrected, or cannot be corrected, the PRSR shall submit to the Department for review, as appropriate, an electronic or paper copy of a Natural Attenuation Monitoring Plan pursuant to Rule 62-780.690, F.A.C., or an electronic or paper copy of a Remedial Action Plan pursuant to Rule 62-780.700, F.A.C., within 60 days after receipt of the notice.

(7) through (9) No change.

Rulemaking Authority 376.303, 376.3071, 376.30701, 376.3078(4), 376.81, 403.061, 403.0877 FS. Law Implemented 376.3071, 376.30701, 376.3078(4), 376.81, 403.0877 FS. History–New 4-17-05, Amended 6-12-13,__________.

 

Editorial Note: Portions of this rule were copied from 62-770.680; 62-782.680; and 62-785.680.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Jorge R. Caspary, Director, Division of Waste Management

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Herschel T. Vinyard Jr., Secretary, Department of Environmental Protection

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 30, 2013

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 28, 2011