FIFRA PDF

Chapter 13,“Pesticides” FIFRA ◼ Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) enacted in 1947 ◼ Pesticides distributed in interstate commerce must be registered with the USDA ◼ Some initial labeling requirements ◼ No real regulatory teeth ◼ Could...

Chapter 13,“Pesticides” FIFRA ◼ Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) enacted in 1947 ◼ Pesticides distributed in interstate commerce must be registered with the USDA ◼ Some initial labeling requirements ◼ No real regulatory teeth ◼ Could not refuse registration even for highly dangerous chemicals ◼ No control over off label use ◼ Only recourse was legal action for misbranding or adulteration FIFRA ◼ Misbranding ◼ If the label: ◼ Bears any false or misleading statement ◼ Does not bear the establishment or product registration number ◼ Does not prominently display any required word, statement, or other information ◼ Does not contain directions for use that are adequate to protect health and the environment ◼ Does not contain a warning or caution statement adequate to protect health and the environment; or does not contain the use classification FIFRA ◼ Adulteration https://www.law.cornell.edu/uscode/text/7/136 ◼ If its strength or purity differs from that stated on the label ◼ Any substance has been substituted in whole or part for the pesticide ◼ Any valuable constituent of the pesticide is not present DDT ◼ Used against polio: https://www.youtube.com/watch?v=yagO9jn gMWk ◼ The rise and fall of DDT: https://www.youtube.com/watch?v=MMSEnI VFBQ0 ◼ DDT and bald eagles: https://www.youtube.com/shorts/1HPWFhvyn BQ All-time low of 417 known nesting pairs in 1963 in the lower 48 states. In 2020 there were 71,400 nesting pairs FIFRA under EPA ◼ 1970 Nixon moved the USDA Pesticides division to EPA ◼ 1972 Federal Environmental Pesticide Control Act (FEPCA) overhauled FIFRA ◼ Everyone today still just calls it FIFRA ◼ DDT banned in 1972 Pesticide Registration ◼ Pesticide: Any substance intended for preventing, destroying, repelling, or mitigating any pest ◼ Exceptions: firearms, flyswatters, mousetraps ◼ Pests: Insects, rodents, worms, fungus, weeds, plants, virus, bacteria, micro-organisms, and other animal life ◼ Examples: Fungicides, herbicides, insecticides, insect repellent, week killer, disinfectants, swimming pool chemicals, antimicrobial soap https://www.epa.gov/ingredients-used-pesticide-products/types-pesticide-ingredients Pesticide Registration ◼ All pesticide products used in the US must be registered with EPA ◼ Separate registration required for different doses/concentrations, crop, insect, etc. ◼ Must show that the product warrants the proposed claim ◼ It performs the intended function without unreasonable adverse effects ◼ Proposed labeling complies with the requirements ◼ When used in accordance with widespread practice, it will not cause unreasonable adverse effects on the environment (like DDT) Adverse Effects Reporting ◼ Section 6(a)(2) of FIFRA requires that “if at any time after the registration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects on the environment of the pesticide, the registrant shall submit such information to the Administrator.” ◼ Similar to reporting required under Section 8(c) of the Toxic Substances Control Act (TSCA) ◼ This rule requires manufacturers and certain processors of chemical substances and mixtures to keep records of “significant adverse reactions” alleged to have been caused by such substances or mixtures. Pesticides and EPCRA ◼ Some pesticides (such as aldrin and toxaphene) are listed as toxic chemicals under Section 313 of EPCRA (are part of TCLP tests as well) ◼ This means that if covered facilities manufacture, process, or otherwise use these materials above threshold amounts, they must prepare a Toxic Release Inventory (TRI) report annually (under EPCRA) Antimicrobial Pesticides ◼ FIFRA defines an antimicrobial pesticide as a pesticide that is intended to “disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms” or a pesticide that is intended to “protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime” ◼ EPA: an “agent that kills microbial growth” Antimicrobial Pesticides ◼ Public Health Antimicrobial Pesticide Products: Products that bear a claim to control pest microorganisms that pose a threat to human health, including microorganisms infectious to man, and which meet one of the following claims: ◼ Control of specific organisms (either specific or a class) that are directly or indirectly pathogenic or infectious in humans and animals ◼ Microbial sterilant, disinfectant, virucide, sanitizer, or tuberculocidal for microorganisms that are infectious or pathogenic in humans and animals ◼ Fungicidal for use on fungi that are infectious or pathogenic to humans or animals ◼ Antimicrobial for use as a water purifier or microbial purification systems Antimicrobial Pesticides ◼ Non-Public Health Antimicrobial Pesticide Products: Products that target organisms in a scenario that would not normally lead to infection or disease in humans: ◼ Have a label claim for microorganisms of economic or aesthetic significance ◼ Algeaecides, slimicides, preservatives are examples Cleaning Products vs Antimicrobial Products ◼ Cleaning is the removal of visible organic and inorganic material, and can be accomplished with water, mechanical action, detergents, or enzymes ◼ Cleaning products are those that have no pesticidal claims and that merely clean or remove material (e.g., soil, dirt, dust, soap scum, etc.) from a surface, the water, or the air ◼ Thorough cleaning must occur prior to disinfection or sterilization, in order to remove organic and inorganic material that can interfere with the effectiveness of disinfection or sterilization processes Label Claims and Specific Use Conditions ◼ EPA must have sufficient data in the application paperwork to verify the claims made on the label ◼ This includes whether the antimicrobial is intended to work on one specific microbial agent, or a group of agents, and the appropriate application methodology for that particular product ◼ Labeling regulations specifically prevent special use claims for antimicrobials that do not have efficacy data to support those claims ◼ These claims, when used, include efficacy against designated test strains, as determined in the methodology provided by the EPA for testing antimicrobial activity ◼ Efficacy is represented as minimum of a 3-log10 reduction (i.e., ≥99.9% efficacy) over a certain contact time period ◼ Contact time is critical in understanding antimicrobial use Antimicrobial Use Selection ◼ Disinfectants and contact time: https://www.uvm.edu/safety/commonly-used-disinfectants-chart OSHA vs. FIFRA for Labeling ◼ 1910.1200 Does Not Require Labeling of: ◼ Chemicals subject to the labeling requirements of the Toxic Substances Control Act (EPA) ◼ Any food or drug, subject to the labeling requirements of the Federal Food, Drug, and Cosmetic Act (FDA) ◼ Any distilled spirits, wine, or malt beverage subject to the labeling requirements of the Federal Alcohol Administration Act (Bureau of Alcohol, Tobacco, Firearms and Explosives) ◼ Any consumer product subject to a consumer product safety standard or labeling requirement under the Consumer Product Safety Act (CPSC) ◼ Any pesticide as such term is defined in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) when subject to the labeling requirements of that Act and regulations issued by the EPA ◼ Agricultural or vegetable seed treated with pesticides and labeled in accordance with the Federal Seed Act and the regulations issued under that Act by the Department of Agriculture FIFRA Labeling vs OSHA Labeling ◼ EPA has not adopted the Globally Harmonized System (GHS) for pesticide/herbicide/insecticide/fungicide/ rodenticide product classification and labeling: ◼ Signal words – OSHA uses only danger and warning while EPA also uses caution ◼ Pictogram – EPA only uses skull and crossbones and flame; OSHA would use health hazard pictogram FIFRA Labeling vs OSHA Labeling ◼ EPA label only has to provide the hazard of the pesticide/herbicide, not the filler carrier, or “inert” material ◼ Often silica and flammable materials are used ◼ OSHA requires both labeling and SDSs while EPA regards SDSs for pesticides/herbicides to be labeling when they accompany the product ◼ What if the SDS doesn’t contain the FIFRA labeling information? FIFRA Labeling vs OSHA Labeling ◼ EPA has published a Pesticide Registration Notice (PRN 2012-1) to explain how to comply with both http://www.epa.gov/sites/production/files/2014-04/documents/pr2012-1.pdf ◼ “EPA recognizes that conflicts between: ◼ FIFRA labels and SDSs for the same chemicals, and ◼ FIFRA labels and the labels of other chemicals in the workplace, could mislead workers about hazards, in some instances perhaps creating the impression that pesticides are less hazardous when they are not. Confusion due to inconsistent labeling could result in increased risks to workers. The potential problem may be greatest in the pesticide manufacturing workplace, but workers and others also receive SDSs in other settings and may be confused about differing hazard information.” ◼ OSHA compliance https://www.osha.gov/laws- regs/standardinterpretations/1991-05-08 FIFRA Labeling vs OSHA Labeling ◼ “EPA believes that generally explaining why the FIFRA label and the SDS contain different hazard communication will prevent users from being misled by the inconsistencies. To provide an adequate explanation so the labeling is not misleading, EPA recommends registrants include in their SDSs the FIFRA label information and a brief explanation for any differences between that information and the SDS information. Section 15 of the SDS is an appropriate place to insert this information.” Pesticide Applicators ◼ Restricted Use Pesticides ◼ Pesticides too dangerous for general use but could be used safely by trained personnel ◼ Labeled for use “only under the direct supervision of a certified applicator” ◼ Applicators must meet minimum training and testing requirements ◼ Run at the state level, so different for each state ◼ Oklahoma: OK Dept. of Agriculture, Food & Forestry Consumer Protection Services Division https://ag.ok.gov/pesticides/ Agricultural Workers ◼ 40 CFR Part 170 Worker Protection Standard (not OSHA) ◼ Pesticide safety training ◼ Notification of pesticide applications ◼ Use of personal protective equipment ◼ Restricted entry intervals following pesticide application ◼ Decontamination supplies ◼ Emergency medical assistance https://enviro.blr.com/whitepapers/hazmat-and-chemicals/pesticide- manufacture-and-application/EPA-and-OSHA-on-Pesticide-Worker- Safety Pesticide Disposal ◼ If a pesticide product is listed in 40 CFR 261.31 or 261.33, or exhibits a hazardous waste characteristic, it becomes a hazardous waste when its holder decides to discard it ◼ List of pesticides that are hazardous waste: https://web.archive.org/web/20130606152552/https://psep.cce.cornell.edu/facts- slides-self/facts/pesthazard.aspx ◼ Rinsate should be disposed of (used) at the application site or reused as diluent for the next pesticide application ◼ If the pesticide is an unopened container of a commercial product, this could be coordinated for “reutilization” ◼ Some states coordinate this for agricultural and commercial users https://www.pa.gov/en/agencies/pda/plants-land-water/plant-industry/health- and-safety/environmental-programs/chemsweep.html ◼ For homeowners, use the Household Hazardous Waste system Food Quality Protection Act ◼ Delaney Clause: 1958 amendment to the Food, Drug, and Cosmetic Act that banned any cancer- causing food additive ◼ However, pesticide residues are considered food additives ◼ Detection limit of testing means that if you detect it, it can’t be used ◼ Pesticide residues are present in negligible levels in most meats, fruit, and vegetables, whether or not chemical are applied to them (p. 919) Food Quality Protection Act ◼ The Food Quality Protection Act (FQPA) 1996 replaced the Delaney Clause: ◼ Any pesticide residue on a food is considered unsafe unless EPA has set a tolerance level and the residue is below that level ◼ Tolerance level set through risk assessment https://www.epa.gov/laws-regulations/summary- food-quality-protection-act ◼ https://www.epa.gov/pesticide-science-and- assessing-pesticide-risks/assessing-human-health- risk-pesticides ◼ https://www.ecfr.gov/current/title-40/chapter- I/subchapter-E/part-180 (180.103) Food Quality Protection Act ◼ Factors that must be addressed before a tolerance can be established include: ◼ the aggregate non-occupational exposure from the pesticide (exposure through diet, from using pesticides in and around the home and from drinking water); ◼ the cumulative effects from pesticides that produce similar effect in the human body; ◼ whether there is increased susceptibility in infants and children, or other sensitive subpopulations, from exposure to the pesticide; and ◼ whether the pesticide produces an effect in humans similar to an effect produced by a naturally occurring estrogen or produces other endocrine-disruption effects. Pesticides and the Clean Water Act ◼ Under Section 301, pesticide manufacturers and formulators must apply for discharge permits if they release effluent into any body of water ◼ Runoff from agricultural application is considered a nonpoint source of pollution Integrated Pest Management ◼ Limits pesticide use to only needed applications ◼ Encourages biopesticides like Bacillus thuringiensis Homework ◼ Homework 7 ◼ Pesticide Labels: OSHA Outlines Differences between FIFRA and HazCom https://ehsdailyadvisor.blr.com/2019/02/pesticide-labels- osha-outlines-differences-between-fifra-and-hazcom/ ◼ EPA: http://www.epa.gov/sites/production/files/2014- 04/documents/pr2012-1.pdf