ASTM E2169-01(2007)
(Practice)Standard Practice for Selecting Antimicrobial Pesticides for Use in Water-Miscible Metalworking Fluids
Standard Practice for Selecting Antimicrobial Pesticides for Use in Water-Miscible Metalworking Fluids
SIGNIFICANCE AND USE
This practice summarizes the steps in the antimicrobial pesticide selection process, reviewing technical and regulatory considerations inherent in the process. It complements and amplifies information provided in Practice E 1497.
5.1.1 Steps in the antimicrobial selection process include: needs identification, use strategy selection, efficacy testing, chemical compatibility testing, regulatory consideration review, handling and disposal issue review.
This practice provides stakeholders in the microbicide selection process an overview of its complexities, including the process of obtaining pesticide registration from cognizant governing bodies.
Personnel responsible for antimicrobial pesticide selection will be able to use this practice as a roadmap through the process.
Personnel responsible for industrial hygiene, product or plant management will gain insight to the tradeoffs attendant with antimicrobial use and selection.
SCOPE
1.1 This practice provides recommendations for selecting antimicrobial pesticides (microbicides) for use in water-miscible metalworking fluids (MWF). It presents information regarding regulatory requirements, as well as technical factors including target microbes, efficacy and chemical compatibility.
1.2 This guide is not an encyclopedic compilation of all the concepts and terminology uses by chemists, microbiologists, toxicologists, formulators, plant engineers and regulatory affairs specialists involved in antimicrobial pesticide selection and application. Instead, it provides a general understanding of the selection process and its supporting considerations.
1.3 The values in SI units are to be regarded as the standard.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: E2169 − 01(Reapproved 2007) An American National Standard
Standard Practice for
Selecting Antimicrobial Pesticides for Use in Water-Miscible
Metalworking Fluids
This standard is issued under the fixed designation E2169; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope from Waters Analyzed by Plating Methods
E686 Method for Evaluation of Antimicrobial Agents in
1.1 This practice provides recommendations for selecting
Aqueous Metal Working Fluids (Withdrawn 2004)
antimicrobial pesticides (microbicides) for use in water-
E1302 Guide for Acute Animal Toxicity Testing of Water-
miscible metalworking fluids (MWF). It presents information
Miscible Metalworking Fluids
regarding regulatory requirements, as well as technical factors
E1326 Guide for Evaluating Nonconventional Microbiologi-
including target microbes, efficacy and chemical compatibility.
cal Tests Used for Enumerating Bacteria
1.2 This guide is not an encyclopedic compilation of all the
E1497 Practice for Selection and Safe Use of Water-
concepts and terminology uses by chemists, microbiologists,
Miscible and Straight Oil Metal Removal Fluids
toxicologists, formulators, plant engineers and regulatory af-
E2144 Practice for Personal Sampling and Analysis of En-
fairs specialists involved in antimicrobial pesticide selection
dotoxin in Metalworking Fluid Aerosols in Workplace
and application. Instead, it provides a general understanding of
Atmospheres
the selection process and its supporting considerations.
2.2 Government Standards:
1.3 The values in SI units are to be regarded as the standard.
29 CFR 1910 Occupational Safety and Health Standards
1.4 This standard does not purport to address all of the 40 CFR 152 Pesticide Registration and Classification Proce-
dures
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro- 40 CFR 158 Pesticide Programs Data Requirements for
Registration
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use. 49 CFR 100-180 Research and Special Programs
Administration, Department of Transportation
2. Referenced Documents
PR Notice 2000-1 Applicability of the Treated Articles
Exemption to Antimicrobial Pesticides
2.1 ASTM Standards:
Directive 98/8/EC of the European Parliament and of the
D1067 Test Methods for Acidity or Alkalinity of Water
Council of 16 February 1998 concerning the placing of
D1293 Test Methods for pH of Water
biocidal products on the market
D3519 Test Method for Foam in Aqueous Media (Blender
Test)
3. Terminology
D3946 Test Method for Evaluating the Bacteria Resistance
of Water-Dilutable Metalworking Fluids (Withdrawn 3.1 active ingredient (a.i.), n—the chemical component or
2004) components of an antimicrobial pesticide that provides its
D4478 Test Methods for Oxygen Uptake (Withdrawn 1994) microbicidal performance.
D5465 Practice for Determining Microbial Colony Counts
3.2 activity spectrum, n—variety or range of microbes
against which an antimicrobial pesticide is effective.
3.3 antimicrobial pesticide, n—chemical additive, regis-
This practice is under the jurisdiction of ASTM Committee E34 on Occupa-
teredunder40CFR152,forusetoinhibitgrowth,proliferation
tional Health and Safety and is the direct responsibility of Subcommittee E34.50 on
Health and Safety Standards for Metal Working Fluids.
or both of microorganisms.
Current edition approved April 1, 2007. Published June 2007. Originally
3.3.1 Discussion—Antimicrobial pesticides are registered
approved in 2001. Last previous edition approved in 2001 as E2169 - 01. DOI:
for one or more end-use applications, or sites, for use within an
10.1520/E2169-01R07.
approved dose range.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3 4
The last approved version of this historical standard is referenced on Code of Federal regulations available form United States Government Printing
www.astm.org. Office, Washington, DC.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E2169 − 01 (2007)
3.4 bactericide, n—antimicrobial pesticide specifically or 3.16 half-life (T ⁄2 ),n—time required for concentration of a
primarily effective against bacteria. microbicide to diminish to one-half its initial concentration.
3.17 microbicide, n—synonymous with antimicrobial pesti-
3.5 biocide, n—any chemical intended for use to kill or
inhibit organisms. cide.
3.5.1 Discussion—Biocide is a term commonly used syn-
3.18 minimum inhibitory concentration (MIC), n—lowest
onymously with the preferred antimicrobial pesticide or mi-
treatment-dose that will prevent test population from growing,
crobicide.
proliferating or otherwise contributing to biodeterioration.
3.6 bioburden, n—the level of microbial contamination
4. Summary of Practice
(biomass) in a system.
4.1 Microorganisms can grow in all water-miscible metal-
3.6.1 Discussion—Typically bioburden is defined in terms
working fluids including water-miscible metal removal fluids,
of either biomass or numbers of cells per unit volume or mass
a subset of the broader class of metalworking fluids. Conse-
or surface area material tested (g biomass/mL sample; g
quences of uncontrolled microbial contamination in metal-
biomass/g sample; cell/mL sample, colony forming units
working fluids may include biodeterioration, rancidity and
(CFU)/mL, and so forth).
aerosolization of potentially pathogenic microbes and toxic or
3.7 biodeterioration, n—the loss of commercial value, per-
allergenic microbial cell constituents. Consequently microbial
formance characteristics or both of a product (metalworking
contamination control is desirable from both operational and
fluid) or material (coolant system or finished parts) through
industrial hygiene perspectives.
biological processes.
4.2 Antimicrobial pesticides are used to prevent biodeterio-
3.8 biofilm, n—a film or layer composed of microorganisms,
ration and may also reduce the risk of disease associated with
biopolymers, water, and entrained organic and inorganic debris
the use of water-miscible metalworking fluids. They may be
that forms as a result of microbial growth, proliferation, and
used in-drum, on-site or both. Antimicrobial pesticides work
excretion of polymeric substances at phase interfaces (liquid-
either by killing microbes, inhibiting specific undesirable
liquid, liquid-solid, liquid-gas, and so forth). (synonym: skin-
microbial activities or both in the treated fluid. Antimicrobial
nogen layer).
pesticides used in metalworking fluids include representatives
3.9 bioresistant, adj—ability to withstand biological attack.
from a number of chemical groups. Consequently, antimicro-
3.9.1 Discussion—Bioresistant, or recalcitrant, chemicals
bial pesticides vary widely in their mode of action, compat-
are not readily metabolized by microorganisms.
ibility with other fluid components and other performance
properties.
3.10 biostatic, adj—able to prevent existing microbial con-
taminants from growing or proliferating, but unable to kill
4.3 The process of selecting an antimicrobial pesticide for
them.
use in metalworking fluids shall include, minimally, confirma-
3.10.1 Discussion—Biostatic additives may be registered
tion that the product is (1) approved for the intended applica-
antimicrobial pesticides or unregistered chemicals with other
tion; (2) compatible with other fluid and system constituents;
performance properties. The difference between biocidal and
and (3) effective. Other considerations including, but not
biostatic performance may be attributed to dose, chemistry or
limited to intended application, target microbes, desired speed
both.
of action, performance persistence, handling precautions, toxi-
cological properties, water and oil miscibility, and waste
3.11 contamination control, n—maintenanceofbioburdenat
treatability may affect microbicide selection.
an operationally defined level, at or below which the bioburden
does not affect the fluid or system adversely.
4.4 Microbicide selection begins with a fundamental under-
standing of the coolant formulation chemistry, biodeterioration
3.12 demand, n—the sum of all factors that contribute to
control strategy and specific customer needs. General back-
decreasing the effective concentration of antimicrobial pesti-
ground information regarding MWF system management is
cide.
available in Practice E1497 and elsewhere. Armed with this
3.12.1 Discussion—Processes contributing to demand
information, candidate microbicides can be selected for further
include, but are not limited to, reaction with microbes, reac-
evaluation. Products that meet all of the selection criteria are
tions with other chemicals in the fluid, adsorption onto
ultimately tested in field application. Since antimicrobial pes-
surfaces, absorption into materials and temperature.
ticide efficacy can diminish over time, the selection process
3.13 dose, n—concentration of antimicrobial pesticide
may be viewed as cyclic. Moreover, since microbicides can be
added to treated solution.
toxic,theyrequirerigorousandcompetentproductstewardship
3.13.1 Discussion—Dose is generally expressed as either
throughout their use-cycle.
ppm active ingredient (a.i.) or ppm as supplied (a.s.).
5. Significance and Use
3.14 fungicide, n—antimicrobial pesticide specifically or
primarily effective against fungi.
5.1 This practice summarizes the steps in the antimicrobial
pesticide selection process, reviewing technical and regulatory
3.15 lethal dose, n—concentration at which treatment kills
at least one of test subjects.
3.15.1 Discussion—The LD is the term used in toxicology
50 Organization Resources Counselors. Management of the Metal Removal Fluid
defining the dose that kills fifty-percent of the test population. Environment. Web site: http://www.aware-services.com/orc/.2000.
E2169 − 01 (2007)
considerations inherent in the process. It complements and putatively non-biocidal, performance additive shall be more
amplifies information provided in Practice E1497. benign than those of the microbicides they are replacing.
5.1.1 Steps in the antimicrobial selection process include: 6.2.4 What are the target microbes (see 7.3)?
needs identification, use strategy selection, efficacy testing, 6.2.5 Will the microbicide be added into the formulation,
chemical compatibility testing, regulatory consideration tankside or both (see 7.1)?
review, handling and disposal issue review. 6.2.6 Will the microbicide, either in-formulation or as
tankside additive be used at a single or multiple end-use sites?
5.2 This practice provides stakeholders in the microbicide
Approved chemical lists vary among companies conducting
selectionprocessanoverviewofitscomplexities,includingthe
metalworking operations. Antimicrobials to be considered for
process of obtaining pesticide registration from cognizant
use should be listed on prospective users’ approved chemicals
governing bodies.
lists.
5.3 Personnel responsible for antimicrobial pesticide selec-
6.2.7 Will the microbicide, either in-formulation or as
tion will be able to use this practice as a roadmap through the
tank-side additive be used domestically only, or will it be
process.
traded internationally? Industrial pesticide regulations differ
5.4 Personnel responsible for industrial hygiene, product or around the world. Not all products approved by the U.S. EPA
plant management will gain insight to the tradeoffs attendant are approved in Canada, Europe or other industrialized regions
with antimicrobial use and selection. or vice versa. Moreover, registration and reporting require-
ments vary amongst nations. Global acceptability may be an
important consideration (see Section 10).
6. Needs Information
6.1 The first step in the microbicide selection process is the 6.3 Completion of this needs analysis step will facilitate the
balance of the microbicide selection process.
recognitionofaneed.Recognitionmaycomeasaconsequence
of new metalworking fluid formulation development or evolv-
ing requirements in one or more fluid end-use applications. 7. Antimicrobial Pesticide Use Strategies
6.1.1 Antimicrobial pesticide needs typically fall into either,
7.1 Microbicides may be added either in-formulation, tank-
or both of the following categories:
sideorboth.Users,understandinghowthemetalworkingfluids
6.1.1.1 Biodeterioration Prevention—The various strategies
they use are formulated, should select an appropriate pesticide
used to enhance coolant life.
use-strategy for each end-use application.
6.1.1.2 Health and Safety—Reducing the risk of employee
7.1.1 In-formulation microbicide use means that antimicro-
exposure to potentially pathogenic microbes or allergenic
bial(s) are formulated into coolant concentrate.
microbial constituents such as endotoxins (E2144).
7.1.1.1 Microbicide addition at this stage may reduce or
6.2 Once the need has been recognized, the next step is to eliminate the requirement for subsequent tankside addition. It
define the need operationally. This is achieved by determining also protects high water-content formulations from spoilage
the answers to the needs analysis questions, for example: during storage and transport.
6.2.1 What type of metalworking fluid formulation requires 7.1.1.2 When formulated into coolant, microbicides are
microbicidal augmentation? Antimicrobials vary in their re- added at concentrations sufficient to provide adequate a.i. once
spective oil and water solubilities. Moreover, chemical incom- the formulation has been diluted to end-use strength. In-drum
patibilities exist between certain antimicrobials and other demand may reduce the residual microbicide concentration
metalworking fluid constituents. Microbicides that are deemed availablebythetimecoolantconcentrateisdilutedforend-use.
inappropriate based on their incompatibility with the other 7.1.1.3 With coolants intended for a variety of end-use
formulation components need not be considered further (see applications, each requiring different final coolant
9.1). concentrations, it may be difficult to blend a single microbicide
6.2.2 What are the desired performance-life and biodegrad- concentration in-drum. For example, assume that the target
ability criteria for the finished formu
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