Current through Register Vol. 54, No. 44, November 2, 2024
Section 16.32 - Threshold level toxic effects(a) A threshold effect is defined as an adverse impact that occurs in the exposed individual only after a physiological reserve is depleted. For these effects there exists a dose below which no adverse response will occur. Threshold toxic effects include most systemic effects and developmental toxicity, including teratogenicity. Developmental toxicity includes all adverse effects in developing offspring resulting from prenatal exposure to a causative agent.(b) Control of threshold toxics is based upon animal testing or epidemiological studies that report no- or lowest-observed adverse effect levels of the substance (NOAEL or LOAEL). In evaluating a particular toxic, toxicologists weigh the merits of all the tests, and choose, in their best professional judgment, the safe level. By applying standard margins of safety to the NOAEL, extrapolations from the laboratory animals to humans (factor of 10), for sensitive subpopulations (10), and from short-term to chronic studies (10) can be taken into account. An additional factor of 10 is used if only a LOAEL is available. Modifying factors (1-10), which account for deficiencies in the toxicity studies, are also considered in determining an acceptable exposure level. The current term for this acceptable level is reference dose (RfD); it was previously called the acceptable daily intake (ADI). Adverse effect levels may be calculated using Benchmark Dose (BMD) Modeling. The purpose of the BMD is to derive a point of departure for calculating a risk value, such as a reference dose or a reference concentration. In the customary approach, the point of departure is the NOAEL or the LOAEL. The BMD values are calculated by dividing a point of departure by the uncertainty factors. This most sensitive effect is also called the critical effect, and it is used as the point of departure in establishing a toxicity benchmark. The RfD, can be calculated using a LOAEL, a NOAEL or BMD. It is adjusted for protection of an average (80 Kg) person. It is then divided by expected exposure conditions to result in an applicable criterion. Exposure conditions by means of water include 2.4 liters per day of drinking water and consumption of 22.0 grams of fish per day. The bioaccumulation of toxics in edible portions of fish is accounted for by use of bioaccumulation factors (BAF). The BAF is the ratio in liters per kilogram that accounts for the chemical accumulation in aquatic organisms from all potential exposure routes, including water, food and sediment.(c) The Department will establish criteria for threshold toxics in accordance with the following guidelines: (1) If the EPA has developed criteria, the Department will evaluate and accept the criteria when it is determined that they are adequate to protect the designated water uses.(2) If the EPA criteria have been evaluated, and have been determined to be inadequate to protect designated uses, or when no criteria have been developed for a substance identified or expected in a discharge, the Department will develop criteria following EPA's standard toxicological procedures outlined in the Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health (EPA-822-B-00-004, October 2000), as amended and updated.(3) If no data are available to characterize the human health hazard of a chemical, no criterion will be developed. A criterion to protect the next most sensitive use will be used. A threshold criterion will be developed at a future date if information becomes available.(d) The sources the Department uses to obtain relevant risk assessment values for protection for threshold level toxic effects to human health are as follows: (1) Verified reference doses, listed in the EPA agency-wide supported data system known as IRIS (Integrated Risk Information System) and other EPA approved data sources.(2) Maximum Contaminant Level Goals.(3) The EPA's CWA § 304(a) health criteria listed under the National Toxics Rule in 40 CFR 131.36 (57 FR 80848, December 22, 1992) (relating to toxics criteria for those States not complying with Clean Water Act section 303(c)(2)(B)), as amended and updated and other final criteria published by the EPA and the Great Lakes Initiative Clearinghouse.(4) Teratology and other data that have been peer-reviewed may provide information for criteria development.The provisions of this §16.32 adopted March 10, 1989, effective 3/11/1989, 19 Pa.B. 1059; amended April 9, 1993, effective 4/10/1993, 23 Pa.B. 1727; amended December 26, 1997, effective 12/27/1997, 27 Pa.B. 6817; amended November 17, 2000, effective 11/18/2000, 30 Pa.B. 6111; amended May 15, 2009, effective 5/16/2009, 39 Pa.B. 2523; amended July 10, 2020, effective 7/11/2020, 50 Pa.B. 3485.Amended by Pennsylvania Bulletin, Vol 53, No. 40. October 7, 2023, effective 10/7/2023 This section cited in 25 Pa. Code § 16.33 (relating to nonthreshold effects (cancer)); and 25 Pa. Code § 16.61 (relating to special provisions for the Great Lakes System).