Sep. 23, 2024
Chemicals
The global potassium formate market is projected to attain a valuation of US$ 746.13 million in and is expected to reach US$ million by , expanding at a CAGR of 4.7% during the forecast period.
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Superior functional properties and sustainability of potassium permeate liquids are driving their applications in the oil & gas industry as an alternative to conventional drilling fluids. In addition to this, stringent regulations implemented to encourage carbon emission control worldwide are expected to continue pushing sales over the assessment period.
The demand for eco-friendly products growing in various sectors. This has in turn encouraged manufacturers to launch innovative potassium formate solutions. These factors are expected to continue boosting sales in the market over the assessment period.
FMI presents a half-yearly comparison, analytical research, and key market developments for the potassium formate industry. Further, the market has been significantly impacted by global industrialization, the rise of value-added manufacturing, as well as certain macroeconomic factors, including chemical industry growth, an increase in investment in specialty chemicals, etc.
The market's development prospects vary significantly depending on how vibrant the local manufacturing sector is, with China, India, and the Association of Southeast Asian Nations witnessing substantial growth prospects.
According to FMI analysis, the variation between the BPS values observed in the potassium formate market in H1, - Outlook over H1, projected reflects the addition of 10 units. While a comparison to H1, , the market is expected to increase by 40 bps in H1 - .
The exploration of new and innovative, significantly expanding applications for potassium formate as a heat transfer liquid is one of the key factors pushing the demand graph upward. Further, numerous demographic and legal changes in the use of de-icing solutions in many nations are also playing a vital role in promoting the demand for potassium formate.
The frigid climate in the area makes Europe a significant consumer of de-icing solutions. Also, sales are rising across the region as a result of tighter regulations in countries that mandate the use of de-icing solutions to normalize transportation.
Report Attributes Details Expected Market Value () US$ 746.13 million Anticipated Forecast Value () US$ million Projected Growth Rate ( to ) CAGR 4.7%Don't pay for what you don't need
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The market of potassium formate was worth US$ 628.6 million in and it reached a valuation of US$ 716.4 million in while capturing a CAGR of 3.3% during the forecast period.
Companies operating in the oil & gas industry are striving to achieve cost reduction, enhanced quality, and increase productivity in operations. Besides this, the growing need for safety, efficacy, and agility of drilling fluids is spurring demand for smooth fluids with high chemical strength. All these factors are expected to drive sales of potassium formate solutions over the assessment period.
Increasing sales of potassium formate for de-icing at airports worldwide is expected to continue augmenting the growth of the market over the forecast period. Moreover, product innovations by manufacturers are diversifying potassium formate uses across various industries. For instance,
The high quality and eco-friendliness of formic acid, along with the wide acceptance of potassium formate as an alternative to conventional and hazardous chemical-based salts is anticipated to augment the growth of the market, opines Future Market Insights (FMI).
The demand for potassium formate is projected to rise with a CAGR of 4.7% during the forecast period.
Potassium formate finds applications as a heat-transfer liquid in various products. Owing to the growing emphasis on sustainability, demand for eco-friendly alternatives is on the rise, which is pushing sales of the product in heating and cooling applications.
The product offers functional properties, cost-effectiveness, and premium quality, which makes it a viable alternative to be used in refrigerated systems instead of calcium chloride and other brine solutions.
Potassium formate is easily biodegradable and has minimal impact on the environment as compared to conventionally used salts for drilling fluid applications, de-icing, and heating transfer liquids in cold chain storage equipment.
The product is less corrosive than other salts that are used in de-icing airports. Stringent regulations about the usage of harmful chemicals for de-icing across North America and Europe are the primary factors driving applications of potassium formate.
Driven by high demand, manufacturers operating in the market are investing in research and development to diversify the applications of potassium formate solutions. This is expected to continue augmenting the growth of the market in the forthcoming years.
Nikhil KaitwadePrincipal Consultant
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Potassium Formate Solutions are Increasingly Preferred for Heat-Transfer Applications
The United States of America is expected to dominate North America&#;s potassium formate market owing to the growing demand for sustainable alternatives in heating and cooling applications. As per FMI, sales in North America&#;s market are slated to account for 34.4% of the total market share in . The demand for potassium formate in the region is expected to rise with a CAGR of 4.6% during the forecast period.
Growing demand for packaged and frozen foods is propelling demand for effective cold chain storage solutions across the country. Further, due to stringent regulations regarding carbon emissions and sustainability, potassium formate liquid is being used as a feasible solution in heating and cooling applications.
The high demand for non-toxic and non-hazardous materials in refrigerated systems, along with surging applications of potassium formate for de-icing airports in the United States is expected to continue driving sales in the forthcoming years.
Surging Demand in De-icing Applications to Drive Sales of Potassium Formate Liquid
Stringent regulations implemented in the aerospace industry are mandating the usage of environment-friendly solutions for de-icing applications at airports in the United Kingdom, which in turn is driving sales. Europe&#;s potassium formate market is projected to account for 24.3% of the total market share in . Further, the region is expected to witness potassium formate sales with a CAGR of 4.3% during the forecast period.
Potassium formate is gradually replacing urea and potassium acetate for de-icing of runways in the United Kingdom Apart from airports, municipal and commercial sectors are also utilizing potassium formate solutions as de-icing agents for roads during winters.
The non-toxic nature of potassium formate liquids is expected to further propel its applications in the aerospace industry, along with roadways and pathways across suburbs and cities. Backed by the aforementioned factors, sales in the United Kingdom are expected to continue gaining momentum over the forecast period.
Surging Applications of Potassium Formate Solutions in the Oil & Gas Industry Expected to Fuel Sales
Growing applications of potassium formulation as a drilling fluid in the oil & gas industry in China has positioned the country as a significant pocket in East Asia. Driven by this, the East Asia potassium formate market is projected to account for 20.8% of the total market share in , finds FMI. Further, the market in this region is anticipated to expand with a significant CAGR of 4.9% during the forecast period.
China is home to one of the large oil & gas sectors worldwide, along with the Middle East. Potassium carbonate is being adopted as a drilling fluid owing to stringent regulations regarding the usage of hazardous chemicals in drilling and mining applications, which in turn is driving sales in China&#;s market.
Potassium Formate Liquid is Increasingly Used in Drilling and Heat-Transfer Applications
In terms of form, sales of potassium formate brine are expected to remain high during the assessment period. Also, the demand from this segment is expected to rise with a CAGR of 5.2% during the forecast period. Growth can be attributed to increasing applications in drilling applications, particularly in high-temperature (HPHT) oil wells.
Potassium formate-based fluids are environment-friendly and biodegradable. They also improve polymer stability when used as drilling and completion fluids. Besides this, they are being used as de-icers for airports and municipal roadways, which is projected to continue driving the potassium formate market over the assessment period.
Demand for Potassium Formate Solution as Drilling Fluids to Remain High
Based on application, sales of potassium formate in the oil & gas sectors as drilling liquids are expected to continue gaining traction over the forecast period. The demand for potassium formate as drilling fluids is expected to rise with a CAGR of 5.8% during the forecast period. As per FMI, demand in North America, Europe, China, and the Middle East is expected to surge owing to the presence of a well-established oil & gas industry in the region.
Manufacturers are investing in product development to achieve high efficiency, performance, and quality in liquid formulations. This is expected to continue pushing sales of potassium formate liquids in the oil & gas industry over the assessment period.
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Start-ups are crucial in identifying growth prospects and fostering industry growth, thanks to their ability to efficiently convert inputs into outputs and adapt to volatile market conditions. Within the potassium formate market, numerous start-ups are actively involved in manufacturing and offering related services.
The market for potassium formate is characterized by extreme competition, as key industry players are making significant investments to improve their manufacturing capabilities.
The key industry players operating in the market are BASF SE, Evonik Industries, Honeywell International Inc, Cabot Corporation, Addcon GmbH, Dynalene Inc., Perstorp Holding AB, GELEST, INC, Tomiyama Pure Chemical Industries, Ltd., ICL, TETRA Technologies, Inc.
Recent Developments in the Potassium Formate Market
The market is expected to flourish at a CAGR of 4.7%.
The market is expected to reach US$ 746.13 million in .
China is expected to register a 4.9% CAGR until .
North America is expected to hold a 34.4% share in .
BASF SE, Evonik Industries, and Cabot Corporation are the leading market players.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP--, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. , Constitution Ave., NW, Washington, DC -. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The number for the Public Reading Room is (202) 566-, and the number for the OPP Docket is (703) 305-. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/&#;dockets .
This regulation is effective December 4, . Objections and requests for hearings must be received on or before February 4, , and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ).
This regulation establishes an exemption from the requirement of a tolerance for residues of calcium formate (CAS Reg. No. 544-17-2) when used as an inert ingredient (carrier) in pesticide formulations applied to growing crops only. ADAMA Agan, Ltd. c/o Makhteshim Agan of North America, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of calcium formate.
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/&#;cgi-bin/&#;text-idx?&#;&&#;c=&#;ecfr&&#;tpl=&#;/&#;ecfrbrowse/&#;Title40/&#;40tab_&#;02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/&#;ocspp and select &#;Test Methods and Guidelines.&#;
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-- in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before February 4, . Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP--, by one of the following methods:
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/&#;dockets.
In the Federal Register of April 11, (83 FR ) (FRL--57), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-) by ADAMA Agan, Ltd. c/o Makhteshim Agan of North America, Inc., Highwoods Blvd., Suite 100, Raleigh, NC . The petition requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of calcium formate (CAS Reg. No. 544-17-2) when used as an inert ingredient (carrier) in pesticide formulations applied to growing crops only. That document referenced a summary of the petition prepared by ADAMA Agan, LTD, the petitioner, which is available in the docket, http://www.regulations.gov.
This is based on the Agency's risk assessment which can be found at http://www.regulations.gov in document: Calcium Formate; Human Health Risk Assessment in docket ID number EPA-HQ-OPP--. No comments were received in response to the notice published by EPA.
Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and ( print page ) diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term &#;inert&#; is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.
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Featured content:Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is &#;safe.&#; Section 408(b)(2)(A)(ii) of FFDCA defines &#;safe&#; to mean that &#;there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.&#; This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to &#;ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .&#;
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for calcium formate including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with calcium formate follows.
EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
The toxicity database on calcium formate is somewhat limited. Consequently, studies on appropriate surrogates were used to supplement the database on calcium formate. Formic acid, sodium formate, potassium formate and ammonium formate were selected as appropriate surrogates since they are either the acid form of calcium formate or other salts of formic acid.
Calcium formate is not expected to be acutely toxic based on acute toxicity data. There are no subchronic or chronic studies on calcium formate, although there are studies on potassium formate. These studies show effects based on reduced body weight gain. A two-year study with potassium formate indicates the compound is not carcinogenic to Wistar rats.
In mutagenicity studies with calcium formate, sodium formate and methyl formate, results of the test were negative for all chemicals. The weight-of-evidence suggests that calcium is not expected to be mutagenic.
There are no available developmental toxicity studies on calcium formate; however, both a rat and rabbit developmental toxicity study have been conducted on sodium formate. In the rat study, the maternal and developmental no-observed-adverse-effect-level (NOAEL) was considered the highest dose tested at 945 milligram/kilogram/day (mg/kg/day). In the rabbit study, the maternal and developmental toxicity NOAEL was also the highest dose tested at 1,000 mg/kg/day. A five-generation rat reproductive toxicity study on calcium formate has been conducted with a NOAEL of >200 mg/kg/day (only dose tested). In a three-generation reproduction study in rats via drinking water, no treatment related effects were observed in the parental animals and off springs at doses up to 200 mg/kg/day.
No studies were submitted for immunotoxicity. However, the toxicity studies available did not show any signs of immunotoxicity up to limit doses. Therefore, immunotoxicity is not of concern.
There are no available studies for neurotoxicity. However, the functional observation battery performed in the 90-day oral toxicity study did not show any signs of neurotoxicity up to limit doses. Therefore, neurotoxicity is not of concern.
A metabolism study is available in the toxicity database. Calcium formate breaks down into calcium and formate ions. Calcium ions are ubiquitous in the natural environment and can be considered as having little toxicity or hazard. Formate ions are readily converted to carbon dioxide in the environment by biodegradation or photooxidation.
Specific information on the studies received and the nature of the adverse effects caused by calcium formate as well as the NOAEL and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document Calcium Formate Risk Assessment at page 7 in docket ID number EPA-HQ-OPP--.
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level&#;generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)&#;and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a ( print page ) complete description of the risk assessment process, see http://www.epa.gov/&#;pesticides/&#;factsheets/&#;riskassess.htm.
No toxicological endpoints of concern were identified for calcium formate based on available toxicity studies on surrogate chemicals. Formic acid, sodium formate, potassium formate and ammonium formate were selected as appropriate surrogates since they are either the acid form of calcium formate or other salts of formic acid. Most of the available studies on these substances were not conducted up to the limit dose. The highest dose of 200 mg/kg/day in a lifelong study in rats via drinking water did not produce any systemic toxicity (IUCLID, Calcium formate, ). Therefore, a conservative risk assessment was conducted using a NOAEL of 200 mg/kg/day for chronic dietary and short- and intermediate-term dermal exposure risk estimates. An uncertainty/safety factor of 100X (10X for interspecies variability and 10X for interspecies extrapolation) was used. The Food Quality Protection Act (FQPA) factor of 10X was reduced to 1X, therefore, the chronic Reference Dose (cRfD) of 2 mg/kg/day is equal to the chronic Population Adjusted Dose (cPAD). A 100% dermal absorption factor is assumed for converting oral to dermal equivalent doses in the absence of dermal toxicity or dermal absorption studies.
For short and intermediate term inhalation exposure, the route specific study was used. The NOAEL of 0.62 mg/l (32 parts per million (ppm)) was observed in a 90-day inhalation toxicity study in rats (IUCLID, Formic acid, ). The uncertainty factor is 100X (10X for interspecies variability and IOX for interspecies extrapolation). The FQPA factor of 10 X was reduced to 1X.
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to calcium formate, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from calcium formate in food as follows:
Because no endpoint was identified for acute exposure, an acute exposure assessment was not conducted.
In conducting the chronic dietary exposure assessment using the Dietary Exposure Evaluation Model DEEM-FCIDTM , EPA used food consumption information from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, what we eat in America, (NHANES/WWEIA). This dietary survey was conducted from -98. As to residue levels in food, no residue data were submitted. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high-use insecticides, herbicides, and fungicides. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled &#;Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.&#; (D, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP--.
In the dietary exposure assessment, the Agency assumed that the residue level of the inert ingredient would be no higher than the highest tolerance for a given commodity. Implicit in this assumption is that there would be similar rates of degradation (if any) between the active and inert ingredient and that the concentration of inert ingredient in the scenarios leading to these highest of tolerances would be no higher than the concentration of the active ingredient.
The Agency believes the assumptions used to estimate dietary exposures lead to an extremely conservative assessment of dietary risk due to a series of compounded conservatisms. First, assuming that the level of residue for an inert ingredient is equal to the level of residue for the active ingredient will overstate exposure. The concentration of active ingredients in agricultural products is generally at least 50 percent of the product and often can be much higher. Further, pesticide products rarely have a single inert ingredient; rather there is generally a combination of different inert ingredients used which additionally reduces the concentration of any single inert ingredient in the pesticide product in relation to that of the active ingredient.
Second, the conservatism of this methodology is compounded by EPA's decision to assume that, for each commodity, the active ingredient which will serve as a guide to the potential level of inert ingredient residues is the active ingredient with the highest tolerance level. This assumption overstates residue values because it would be highly unlikely, that a single inert ingredient or class of ingredients would be present at the level of the active ingredient in the highest tolerance for every commodity.
Finally, a third compounding conservatism is EPA's assumption that all foods contain the inert ingredient at the highest tolerance level. In other words, EPA assumed 100 percent of all foods are treated with the inert ingredient at the rate and manner necessary to produce the highest residue legally possible for an active ingredient.
In summary, EPA chose a very conservative method for estimating what level of inert residue could be on food, and then used this methodology to choose the highest possible residue that could be found on food and assumed that all food contained this residue. No consideration was given to potential degradation between harvest and consumption even though monitoring data shows that tolerance level residues are typically one to two orders of magnitude higher than actual residues in food when distributed in commerce.
Accordingly, although sufficient information to quantify actual residue levels in food is not available, the compounding of these conservative assumptions will lead to a significant exaggeration of actual exposures. EPA does not believe that this approach underestimates exposure in the absence of residue data.
2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for calcium formate, a conservative drinking water concentration value of 100 parts per billion (ppb) based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.
3. From non-dietary exposure. The term &#;residential exposure&#; is used in this document to refer to non-occupational, non-dietary exposure ( e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).
There are no known or anticipated residential uses for calcium formate and therefore, residential exposure is not expected.
4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider &#;available information&#; concerning the cumulative effects of a particular pesticide's residues and &#;other ( print page ) substances that have a common mechanism of toxicity.&#;
EPA has not found calcium formate to share a common mechanism of toxicity with any other substances, and calcium formate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that calcium formate does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/&#;pesticides/&#;cumulative.
Section 408(b)(2)(c) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for pre-natal and post-natal toxicity and the completeness of the database on toxicity and exposure unless EPA determines, based on reliable data, that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data is available to EPA to support the choice of a different factor.
EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:
1. Toxicological studies were identified for calcium formate in the publicly available databases. However, calcium formate breaks down into calcium and formate ions. Calcium ions are ubiquitous in the natural environment and can be considered as having little toxicity or hazard risk. The toxicological database for calcium formate is limited. There is available data on formic acid and related formate compounds (such as ammonium, sodium and methyl formate), which can serve as suitable surrogates for calcium formate. Studies conducted with methanol are also applicable to formate compounds, since methanol is metabolized into formic acid. Therefore, the database is considered adequate for FQPA assessment.
2. There is no evidence of increased susceptibility of infants and children in the available reproduction and developmental toxicity studies with calcium formate and/or sodium formate. No developmental or maternal systemic toxicity was observed in rats at doses up to 200 mg/kg/day when calcium format was administered via drinking water. No developmental or maternal toxicity was observed in mice at doses up to 750 mg/kg gavage dose of sodium formate on gestation day 8. No evidence of increased susceptibility was observed following pre- and post-natal exposure to calcium formate. In a multigeneration reproduction study (three to five generations), no parental, reproductive or offspring toxicity was observed at doses up to 200 mg/kg/day.
3. No neurotoxicity studies are available in the database. However, there is no evidence of clinical signs of neurotoxicity in the database, nor evidence of susceptibility in the young in the database. Therefore, EPA concluded that the developmental neurotoxicity study is not required. There is no evidence of immunotoxicity in the available database.
4. The dietary food exposure assessment utilizes highly conservative default assumptions that would not under estimate the dietary risk to all populations. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for ammonium formate, a value of 100 ppb for drinking water based on screening level modeling was used for the chronic dietary risk assessment. The value of 100 ppb is considered to be a high end, conservative assumption that is not likely to underestimate drinking water risks.
Taking into consideration the available information, EPA concludes the additional 10X FQPA safety factor can be reduced to 1X. These assessments will not underestimate the exposure and risks posed by calcium formate.
Taking into consideration all available information on calcium. EPA has determined that there is a reasonable certainty that no harm to any population subgroup will result from aggregate exposure to calcium formate under reasonable foreseeable circumstances. Therefore, the establishment of an exemption from tolerance under 40 CFR 180.920 for residues of calcium formate when used as an inert ingredient in pesticide formulations applied is safe under FFDCA section 408.
1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, calcium formate is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure analysis, EPA has concluded that risk estimates for chronic exposure to calcium formate from food and water are not of concern (<100% cPAD with a risk estimate at 31.2% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for calcuim formate.
3. Short-and intermediate term risk. Short- and intermediate-term toxicological endpoints were established; however, calcium formate is not registered for any use patterns that would result in short- or intermediate-term residential exposure. Short- and intermediate-term risk is assessed based on short- and intermediate-term residential exposure plus chronic dietary exposure. Because there is no short- or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short- or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for calcium formate.
4. Aggregate cancer risk U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, calcium formate is not expected to pose a cancer risk to humans.
5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to calcium formate residues.
An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.
Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.920 for calcium formate (CAS Reg. No. 544-17-2) when used as an inert ingredient (carrier) in pesticide formulations applied to growing crops only. ( print page )
This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order , entitled &#;Regulatory Planning and Review&#; (58 FR , October 4, ). Because this action has been exempted from review under Executive Order , this action is not subject to Executive Order , entitled &#;Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use&#; (66 FR , May 22, ) or Executive Order , entitled &#;Protection of Children from Environmental Health Risks and Safety Risks&#; (62 FR , April 23, ), or Executive Order , entitled &#;Reducing Regulations and Controlling Regulatory Costs&#; (82 FR , February 3, ). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. et seq.), nor does it require any special considerations under Executive Order , entitled &#;Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations&#; (59 FR , February 16, ).
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order , entitled &#;Federalism&#; (64 FR , August 10, ) and Executive Order , entitled &#;Consultation and Coordination with Indian Tribal Governments&#; (65 FR , November 9, ) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. et seq.).
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a &#;major rule&#; as defined by 5 U.S.C. 804(2).
Donna Davis,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
2. In §&#;180.920, add alphabetically the inert ingredient to the table to read as follows:
§&#;180.920Inert ingredients used pre-harvest; exemptions from the requirement of a tolerance.
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For more information, please visit Potassium Diformate Supplier.
Inert ingredients Limits Uses &#; *&#;&#;&#;&#;&#;&#;&#;&#;&#;*&#;&#;&#;&#;&#;&#;&#;&#;&#;*&#;&#;&#;&#;&#;&#;&#;&#;&#;*&#;&#;&#;&#;&#;&#;&#;&#;&#;*&#;&#;&#;&#;&#;&#;&#;&#;&#;*&#;&#;&#;&#;&#;&#;&#;&#;&#;* Calcium formate (CAS Reg. No. 544-17-2) Carrier &#; *&#;&#;&#;&#;&#;&#;&#;&#;&#;*&#;&#;&#;&#;&#;&#;&#;&#;&#;*&#;&#;&#;&#;&#;&#;&#;&#;&#;*&#;&#;&#;&#;&#;&#;&#;&#;&#;*&#;&#;&#;&#;&#;&#;&#;&#;&#;*&#;&#;&#;&#;&#;&#;&#;&#;&#;*Previous: Lithopone
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