DEPARTMENT OF ENVIRONMENTAL PROTECTION
RULE NOS.:RULE TITLES:
62-780.100Referenced Guidelines
62-780.600Site Assessment
62-780.650Risk Assessment
NOTICE OF CHANGE
Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 39, No. 179, September 13, 2013 issue of the Florida Administrative Register.
62-780.100 Referenced Guidelines and Information Sources.
Specific references to the guidelines and information sources listed below are made within this chapter. The guidelines and information sources are not standards as defined in Section 403.803, F.S. Use of these guidelines and information sources is not mandatory and not enforceable; the guidelines and information sources 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 November September 2013.
(8) through (9) No change.
(10) USEPA Integrated Risk Information System (IRIS) database.
(11) Provisional Peer Reviewed Toxicity Values (PPRTV) derived by the USEPA’s Superfund Technical Support Center for the USEPA Superfund program.
(12) Agency for Toxic Substances and Disease Registry Minimal Risk Levels (MRLs).
(13) Tolerable Upper Intake Levels issued by the Institute of Medicine, National Academy of Sciences.
(14) USEPA Health Effects Assessment Summary Tables (HEAST).
(15) Human Health Benchmarks for Pesticides and other toxicity values in technical documents available from the USEPA Office of Pesticide Programs.
(16) USEPA Office of Water, Drinking Water Regulations and Health Advisory Levels.
(17) California Environmental Protection Agency Office of Environmental Health Hazard Assessment's Chronic Reference Exposure Levels and Cancer Potency Values.
(18) World Health Organization Tolerable Daily Intake values.
(19) International Toxicity Estimates for Risk.
(20) Values listed as “Withdrawn” in the IRIS database.
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, measurements shall be made on soil from within the contaminated area when feasible. If measurement from within the contaminated area is not feasible, measurements may be made on soil from an alternative location that has the same soil type using the U.S. Department of Agriculture, Natural Resource Conservation Service soil survey maps or the Unified Soil Classification System, 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 (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) If the PRSR elects to perform a risk assessment, then dDuring 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 applicable 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 frequency, body weight and ingestion rate) based on:
a. Site-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
b. Non-site-specific exposure factors contained in the most current U.S. Environmental Protection Agency USEPA Exposure Factors Handbook (2011 Edition), hereby adopted and incorporated by reference, (http://www.flrules.org/Gateway/reference.asp?No=Ref-03403), 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 applicable appropriate:
(b)1.a. through d. No change.
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 information sources listed in Section 62-780.100, F.A.C.,tiers of information sources, in order of preference precedence.
a. Tier 1, in order of preference precedence:
(I) USEPA Integrated Risk Information System (IRIS) database, 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) Tolerable Upper Intake Levels issued Upper intake limits developed by the Institute of Medicine, National Academy of Sciences,
(III) USEPA Health Effects Assessment Summary Tables (HEAST),
(IV) Human Health Benchmarks for Pesticides and other toxicity values in technical documents available from the USEPA Office of Pesticide Programs, or
(V) USEPA 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) Values listed as “Withdrawn” in the IRIS database 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 that meet statutory requirements.
(c) through (d) No change.
(2) through (6) No change.
(7) If a the Risk Assessment Report or Risk Assessment Report Addendum is incomplete in any respect, or is insufficient to satisfy the objectives set forth in subsection 62-780.650(5), F.A.C., the Department shall inform the PRSR pursuant to paragraph 62-780.650(6)(b), F.A.C., of the basis for a rejection or determination of insufficiency, including the technical and scientific basis for any such rejection. The 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.
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