(a) General. Subpart B of this part and § 158.2201 describe how to use the table in paragraph (d) of this section to determine the applicator exposure data requirements for antimicrobial pesticide products. Notes that apply to an individual test including specific conditions, qualifications, or exceptions are listed in paragraph (e) of this section.
(1) The Agency may accept surrogate exposure data estimations and/or modeling estimations from other sources to satisfy exposure data requirements. The surrogate data must meet the basic quality assurance, quality control, good laboratory practice, and other scientific requirements set by EPA. To be acceptable, the Agency must find that the surrogate exposure data estimations have adequate information to address the applicable exposure data requirements and contain adequate monitoring events of acceptable quality. The data must reflect the specific use prescribed on the label and the activity of concern, including formulation type, application methods and rates, type of activity, and other pertinent information.
(2) Occupational uses include not only handlers, mixers, loaders, and applicators, but also commercial applications to residential sites. Residential uses are limited to non-occupational, i.e., non-professional, antimicrobial applications. Both occupational and residential applicator data may be required for the same product.
(b) Criteria for testing. Applicator exposure data described in the table to paragraph (d) of this section are required based on toxicity and exposure criteria. Data are required if at least one of the toxicity criteria in paragraph (b)(1) of this section, and at least one of the exposure criteria in paragraph (b)(2) of this section are met.
(1) Toxicity criteria. (i) Evidence of potentially significant adverse effects have been observed in any applicable toxicity studies.
(ii) Scientifically sound epidemiological or poisoning incident data with a clear cause-effect relationship indicating that adverse health effects may have resulted from exposure to the pesticide.
(2) Exposure criteria. (i) Dermal exposure may occur during product use.
(ii) Respiratory exposure may occur during product use.
(c) Key. R = Required; CR = Conditionally required; TEP = Typical end-use product.
(d) Antimicrobial applicator exposure data requirements table. The following table shows the data requirements for applicator exposure. The test notes appear in paragraph (e) of this section.
Table—Antimicrobial Applicator Exposure Data Requirements
| Guideline No.
| Data requirements
| Use sites
| Test
substance
| Test note No.
|
|---|
| Occupational
| Residential
|
|---|
| 875.1100 | Dermal exposure | R | R | TEP | 1, 2, 3, 4
|
| 875.1200
| | | | | |
| 875.1300 | Inhalation exposure | R | R | TEP | 1, 2, 3, 4
|
| 875.1400
| | | | | |
| 875.1500 | Biological monitoring | CR | CR | TEP | 1, 2, 3
|
| 875.1600 | Data reporting and calculations | R | R | TEP | 5
|
| 875.1700 | Product use information | R | R | TEP | |
(e) Test notes. The following test notes apply to the data requirements in the table to paragraph (d) of this section:
1. Prior to initiation of the study, protocols involving intentional exposure of human subjects must be submitted for review by EPA and then the Human Studies Review Board (HSRB) according to 40 CFR 26.1125. Examples of proposed human study research can be found in various reviews provided by the Human Studies Review Board (http://www.epa.gov/osa/hsrb/index.htm).
2. Biological monitoring data may be submitted in addition to, or in lieu of, dermal and inhalation passive dosimetry exposure data, provided the human pharmacokinetics of the pesticide or metabolite/analog compounds (i.e., whichever method is selected as an indicator of body burden or internal dose) allow for the back calculation to the total internal dose.
3. For products with both indoor and outdoor uses, and similar conditions of use, data are generally required for the indoor applications only. However, data for outdoor uses are required if the Agency expects outdoor uses to result in greater exposure than indoor uses (e.g., higher use rates and application frequency, or longer exposure duration, or application methods/equipment create potential for increased dermal or inhalation exposure in outdoor versus indoor use sites). In certain cases, when a pesticide may be used both indoors and outdoors under dissimilar conditions of use, the Agency may require submission of applicator exposure data for both use patterns.
4. EPA will consider waiving this data requirement for antimicrobials applied via closed loading systems if the antimicrobial has a low vapor pressure.
5. Data reporting and calculations are required only if handler exposure data are required.