Type of Registration Action

Use Site Group: I W A L F I H W A L

# of actions 2000-2005: 2 3 1 7 12 11 13 2 1 38

# of sample actions 2000-2005: 2 1 1 7 8 8 11 1 1 30

Guideline Data Requirement Test Cost Indirect 

Food

Wood 

Pres

AntiFoulantLo 

Exp Food Indirect Food

Hi 

Exp

Wood 

Pres

AntiFoulantLo 

Exp

PRODUCT CHEMISTRY

Product Identity, Composition, and Analysis

830.1550 Product Identity and Composition $233 100% 0% 0% 71% 38% 38% 45% 0% 100% 47% 6.7

830.1600 Description of Materials Used to Produce the Product $334 100% 0% 0% 57% 38% 25% 55% 0% 100% 40% 6.1

830.1620 Description of Production Process $418 50% 0% 0% 71% 38% 38% 45% 0% 100% 33% 5.7

830.1650 Description of Formulation Process $418 100% 0% 0% 57% 13% 38% 55% 0% 100% 33% 5.4

830.1670 Description of Formation of Impurities $418 0% 0% 0% 71% 38% 38% 36% 0% 100% 33% 5.3

830.1700 Preliminary Analysis $29,465 100% 0% 0% 71% 38% 38% 45% 0% 100% 30% 5.7

830.1750 Certified Limits $248 100% 0% 0% 100% 38% 25% 45% 0% 100% 50% 7.0

830.1800 Enforcement Analytical Method $15,455 100% 0% 0% 14% 25% 13% 27% 0% 100% 37% 4.3

830.1900 Submittal of Samples $495 0% 0% 0% 0% 0% 0% 9% 0% 0% 7% 0.6

Physical and Chemical Properties

830.6302 Color $700 100% 100% 100% 86% 38% 38% 36% 0% 100% 37% 6.7

830.6303 Physical State $700 100% 100% 100% 86% 38% 38% 36% 0% 100% 47% 7.3

830.6304 Odor $700 100% 100% 100% 86% 38% 38% 36% 0% 100% 33% 6.5

830.7200 Melting Point/Melting Range $1,200 100% 100% 100% 14% 0% 25% 27% 0% 0% 20% 3.5

830.7220 Boiling Point/Boiling Range $1,500 50% 100% 0% 29% 0% 38% 18% 0% 0% 17% 3.1

830.7300 Density/Relative Density/Bulk Density $1,400 100% 100% 100% 86% 38% 38% 36% 0% 100% 47% 7.3

830.7840 

830.7860 Water Solubility $9,635 100% 100% 0% 43% 0% 38% 18% 0% 0% 17% 3.5

830.7950 Vapor Pressure $15,000 100% 100% 0% 43% 0% 38% 18% 0% 0% 17% 3.5

830.7370 Dissociation Constants in Water $4,845 50% 0% 0% 29% 0% 25% 18% 0% 0% 17% 2.4

830.7550

830.7560

830.7570

Partition Coefficient (n-octanol/water) $6,667 50% 0% 0% 0% 0% 13% 9% 0% 0% 13% 1.4

830.7000 pH $750 100% 100% 100% 71% 25% 13% 27% 0% 0% 37% 5.5

830.6313 Stability $8,250 100% 100% 100% 43% 0% 38% 27% 0% 0% 23% 4.3

830.6314 Oxidation/Reduction: Chemical Incompatibility $2,994 100% 0% 0% 57% 25% 0% 18% 0% 0% 20% 3.2

830.6315 Flammability $2,000 100% 100% 0% 57% 13% 25% 27% 0% 100% 23% 4.4

830.6316 Explodability $4,163 100% 0% 100% 29% 13% 25% 27% 0% 0% 23% 3.6

830.6317 Storage Stability $11,500 100% 0% 0% 57% 25% 13% 27% 0% 100% 23% 4.0

830.7100 Viscosity $1,400 100% 100% 0% 14% 13% 0% 27% 0% 100% 30% 3.9

830.6319 Miscibility $1,100 50% 0% 0% 0% 13% 0% 9% 0% 0% 17% 1.7

830.6320 Corrosion Characteristics $2,750 100% 0% 100% 43% 13% 0% 18% 0% 100% 40% 4.3

830.6321 Dielectric Breakdown Voltage $2,525 50% 0% 0% 0% 0% 0% 9% 0% 0% 7% 0.8

830.7050 UV/visible light absorption--new requirement $2,022 33% 33% 33% 14% 25% 25% 25% 25% 25% 7% 2.5

830.7520 Particle Size, Fiber Length, and Diameter Distribution $1,333 5% 5% 5% 5% 5% 5% 5% 5% 5% 5% 0.8

TOXICOLOGY

Acute Testing

870.1100 Acute oral toxicity - rat $3,474 100% 100% 0% 86% 38% 38% 36% 0% 100% 40% 6.8

870.1200 Acute dermal toxicity $5,437 50% 100% 0% 71% 50% 38% 27% 0% 100% 37% 6.3

870.1300 Acute inhalation toxicity - rat $26,275 50% 100% 0% 43% 13% 38% 27% 0% 100% 30% 4.8

870.2400 Primary eye irritation - rabbit $2,000 50% 100% 0% 57% 38% 38% 18% 0% 100% 37% 5.7

870.2500 Primary dermal irritation $2,000 100% 100% 0% 71% 38% 38% 27% 0% 100% 37% 6.2

870.2600 Dermal sensitization $7,589 100% 100% 0% 71% 25% 38% 27% 0% 100% 30% 5.5

870.6200 Acute neurotoxicity - rat $155,600 50% 33% 33% 14% 25% 25% 25% 25% 25% 10% 2.8

Subchronic Testing

870.3100 90-Day oral toxicity - rodent $138,106 100% 100% 0% 71% 0% 63% 27% 0% 0% 17% 4.5

870.3150 90-Day oral toxicity - nonrodent $221,047 50% 100% 0% 14% 0% 63% 9% 0% 0% 7% 2.6

870.3200 21/28-Day dermal toxicity $83,240 0% 50% 0% 0% 0% 0% 9% 0% 0% 10% 1.1

870.3250 90-Day dermal toxicity $132,130 50% 50% 0% 14% 0% 13% 0% 0% 0% 10% 1.4

870.3465 90-Day inhalation - toxicity - rat $489,879 0% 0% 0% 43% 0% 13% 9% 0% 0% 3% 1.1

870.6200 90-Day neurotoxicity - rat $184,039 50% 0% 0% 0% 0% 0% 0% 0% 0% 3% 0.4

Chronic Testing

870.4100 Chronic toxicity - rodent $757,910 50% 100% 0% 14% 0% 25% 0% 0% 0% 10% 1.9

870.4100 Chronic toxicity - non-rodent OUT 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0.0

870.4200 Carcinogenicity - rat preferred $1,508,341 50% 0% 0% 0% 0% 25% 9% 0% 0% 3% 1.0

870.4200 Carcinogenicty - mouse preferred $1,508,341 50% 0% 0% 0% 0% 0% 0% 0% 0% 3% 0.4

Developmental Toxicity and Reproduction

870.3700 Prenatal developmental toxicity - rat preferred $117,053 100% 100% 0% 86% 0% 50% 18% 0% 0% 23% 4.6

870.3700 Prenatal developmental toxicity - rabbit preferred $166,653 50% 100% 0% 14% 0% 13% 0% 0% 0% 7% 1.5

870.3800 Reproduction and fertility effects $393,307 50% 100% 0% 0% 0% 63% 9% 0% 0% 7% 2.4

870.6300 Developmental neurotoxicity $702,500 3% 3% 3% 3% 1% 1% 1% 1% 1% 1% 0.2

Subdivision F, Mutagenicity

870.5100 Reverse mutation assay $4,257 100% 100% 0% 86% 13% 38% 18% 0% 0% 7% 3.6

870.5300

870.5375 In vitro mammalian gene mutation $19,211 100% 100% 0% 57% 13% 63% 18% 0% 0% 20% 4.6

870.5385

870.5395 In vivo cytogenetics $30,004 100% 100% 0% 57% 0% 63% 27% 0% 0% 20% 4.5

Special Testing

870.7485 Metabolism and pharmacokinetics $182,729 50% 100% 0% 0% 13% 13% 0% 0% 0% 7% 1.6

870.7200 Companion animal safety $156,000 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0.0

870.7600 Dermal penetration $147,529 0% 0% 0% 0% 0% 0% 0% 0% 0% 3% 0.2

870.7800 Immunotoxicity $204,400 100% 100% 100% 100% 25% 25% 25% 25% 25% 25% 5.4

APPLICATOR

875.1100 Dermal outdoor exposure $450,000

875.1200 Dermal indoor exposure $450,000

875.1300 Inhalation outdoor exposure $450,000

875.1400 Inhalation indoor exposure $450,000

875.1600 Data reporting and calculations $7,500 16% 16% 16% 16% 16% 16% 16% 16% 16% 16% 2.4

875.1500 Biological monitoring $375,000 10% 10% 10% 10% 5% 5% 5% 5% 5% 5% 0.9

875.1700 Product use information $3,000 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 15.0

 Expected 

Number of 

Tests per 

Year for 

the 

Industry

Appendix B. Data Requirement Probabilities 

for Antimicrobial Pesticides

Percent of Registration Actions

 Test is Likely to be Required under the Final Rule

 New Active Ingredient Major New Use/Amendment 

16% 16% 16% 16% 16% 16% 16% 16% 2.4

16% 16% 16% 16% 16% 2.4

16%

16% 16% 16% 16% 16%

16%
Type of Registration Action

Use Site Group: I W A L F I H W A L

# of actions 2000-2005: 2 3 1 7 12 11 13 2 1 38

# of sample actions 2000-2005: 2 1 1 7 8 8 11 1 1 30

Guideline Data Requirement Test Cost Indirect 

Food

Wood 

Pres

AntiFoulantLo 

Exp Food Indirect Food

Hi 

Exp

Wood 

Pres

AntiFoulantLo 

Exp

 Expected 

Number of 

Tests per 

Year for 

the 

Industry

Appendix B. Data Requirement Probabilities 

for Antimicrobial Pesticides

Percent of Registration Actions

 Test is Likely to be Required under the Final Rule

 New Active Ingredient Major New Use/Amendment 

POST APPLICATION

875.2200 Soil residue dissipation $253,733 0% 100% 0% 0% 0% 0% 0% 100% 0% 0% 0.8

875.2300 Indoor surface residue dissipation $75,427 25% 25% 0% 0% 10% 10% 10% 10% 0% 0% 0.8

875.2400 Dermal exposure $450,000 10% 10% 10% 10% 5% 5% 5% 5% 5% 5% 0.9

875.2500 Inhalation exposure $450,000 10% 10% 10% 10% 5% 5% 5% 5% 5% 5% 0.9

875.2600 Biological monitoring $375,000 10% 10% 0% 0% 5% 5% 5% 5% 0% 0% 0.4

875.2700 Product use information $3,000 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 15.0

875.2800 Description of human activity $3,000 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 15.0

875.2900 Data reporting and calculations $3,000 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 15.0

875.3000 Non-dietary ingestion exposure OUT 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0.0

NONTARGET ORGANISM

Tier One Testing

850.2100 Avian acute oral toxicity $10,100 100% 100% 100% 100% 25% 38% 25% 25% 25% 25% 5.6

850.1010 Acute freshwater invertebrates toxicity $17,000 100% 100% 100% 100% 25% 38% 25% 25% 25% 25% 5.6

850.1075 Acute freshwater fish toxicity $11,957 100% 100% 100% 100% 25% 38% 25% 25% 25% 25% 5.6

Higher Tier Testing

Avian Testing

850.2200 Avian dietary toxicity $6,480 100% 100% 5% 29% 13% 13% 9% 1% 1% 13% 2.7

850.2300 Avian reproduction $168,250 1% 5% 5% 1% 1% 1% 1% 1% 1% 1% 0.2

Aquatic Organisms Testing

850.1010 Acute freshwater invertebrates toxicity $17,000 The % of actions this test is required is accounted for under Tier 1 

850.1075 Acute freshwater fish toxicity $11,957 The % of actions this test is required is accounted for under Tier 1 

850.1025 

850.1035 

850.1045 

850.1055 

850.1075

Acute estuarine and marine organisms toxicity $20,138 150% 300% 100% 14% 1% 13% 25% 10% 25% 10% 3.8

850.1400 Fish early-life stage $37,279 50% 100% 100% 5% 1% 13% 25% 50% 25% 10% 2.5

850.1300 

850.1350 Aqatic invertebrate life cycle $36,334 100% 100% 100% 5% 1% 1% 25% 50% 100% 1% 2.0

850.1500 Fish life cycle $512,500 50% 10% 25% 1% 1% 13% 10% 5% 100% 3% 1.1

850.1710 

850.1730

850.1850

Aquatic organism bioavailability, 

biomagnification, toxicity tests $325,000 50% 100% 25% 5% 1% 1% 10% 5% 10% 7% 1.5

850.1950 Simulated or actual field testing for aquatic organisms $600,000 1% 5% 10% 1% 1% 1% 5% 1% 1% 1% 0.3

see Notes Acute pore water invertebrates OUT OUT 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0.0

Sediment Testing

850.1735 Whole sediment; acute freshwater invertebrates $21,903 100% 100% 100% 5% 1% 1% 25% 10% 100% 3% 2.0

850.1740 Whole sediment; acute marine invertebrates $37,500 5% 100% 100% 5% 1% 1% 25% 10% 100% 3% 1.7

None Whole sediment; chronic invertibrates freshwater and 

marine $64,757 5% 25% 50% 5% 1% 1% 10% 5% 10% 1% 0.6

Insect Pollinator Testing

850.3020 Honey bee acute contact $3,175 50% 100% 0% 0% 0% 0% 0% 100% 0% 3% 1.2

850.3030 Toxicity of residues to honeybees $13,368 50% 100% 0% 0% 0% 0% 0% 100% 0% 3% 1.2

NONTARGET PLANT PROTECTION

850.4225 Seedling emergence, Tier II - dose response $20,375 50% 50% 50% 5% 1% 1% 25% 25% 25% 3% 1.5

850.4250 Vegetative vigor, Tier II - dose response $36,963 50% 50% 50% 5% 1% 1% 25% 25% 25% 3% 1.5

850.4400 Aquatic plant growth (aquatic vascular plant) Tier II - 

dose response $35,155 100% 100% 100% 5% 1% 1% 25% 25% 100% 7% 2.3

850.5400 Aquatic plant growth (algal) Tier II - dose response $14,426 100% 100% 100% 100% 25% 25% 25% 25% 25% 25% 5.4

850.4300 Terrestrial field $44,000 0% 1% 0% 0% 0% 0% 0% 1% 0% 0% 0.008

850.4450 Aquatic field $28,500 0% 0% 1% 0% 0% 0% 0% 0% 1% 0% 0.003

ENVIRONMENTAL FATE

Degradation Studies -- Laboratory

835.2120 Hydrolysis $41,938 100% 100% 100% 100% 25% 25% 25% 25% 25% 25% 5.4

835.2240 Photodegradation in water $47,875 50% 100% 25% 5% 0% 13% 25% 10% 10% 7% 2.0

835.2410 Photodegradation in soil $73,979 0% 100% 0% 0% 0% 0% 0% 100% 0% 0% 0.8

Toxicity and Fate in Wastewaster Systems

850.6800

OECD 209 Activated Sludge, Respiration Inhibition Test $4,292 100% 100% 100% 100% 75% 75% 75% 75% 75% 75% 11.8

835.1110 Activated Sludge Sorption Isotherm $19,733 50% 50% 50% 50% 50% 50% 50% 50% 50% 50% 7.5

835.3110 Ready Biodegradability $8,667 50% 50% 50% 50% 50% 50% 50% 50% 50% 50% 7.5

835.3220 

or

835.3280 

or

835.3240

Porous Pot Test or

Simulation Tests to Assess the Biodegradability of 

Chemicals Discharged in Wastewater or

Simulation Test – Aerobic Sewage Treatment: Activated 

Sludge Units

$33,000 50% 50% 50% 50% 50% 50% 50% 50% 50% 50% 7.5

Mobility Studies

835.1230 Adsorption/desorption $42,741 50% 100% 100% 5% 1% 13% 25% 25% 100% 10% 2.6

835.1240 Soil column leaching $46,780 50% 100% 100% 5% 1% 13% 25% 25% 100% 7% 2.4

Metabolism Studies -- Laboratory

835.4100 Aerobic soil metabolism $94,375 50% 100% 25% 5% 1% 1% 25% 40% 100% 7% 2.1

835.4200 Anaerobic soil metabolism $150,167 50% 100% 25% 5% 1% 1% 25% 40% 10% 3% 1.7

835.4300 Aerobic aquatic metabolism $102,200 100% 100% 100% 5% 1% 1% 25% 25% 25% 7% 2.2

835.4400 Anaerobic aquatic metabolism $107,224 100% 100% 100% 5% 1% 1% 25% 25% 25% 10% 2.4

Dissipation Studies

835.6200 Aquatic (sediment) $267,250 1% 10% 100% 1% 1% 1% 5% 5% 100% 1% 0.6

Ground and Surface Water Monitoring

None Monitoring of representative U.S. waters $215,833 0% 0% 1% 0% 0% 0% 0% 0% 1% 0% 0.003

Special Studies

None Special leaching $43,000 50% 100% 100% 0% 13% 1% 0% 25% 100% 1% 1.4
Type of Registration Action

Use Site Group: I W A L F I H W A L

# of actions 2000-2005: 2 3 1 7 12 11 13 2 1 38

# of sample actions 2000-2005: 2 1 1 7 8 8 11 1 1 30

Guideline Data Requirement Test Cost Indirect 

Food

Wood 

Pres

AntiFoulantLo 

Exp Food Indirect Food

Hi 

Exp

Wood 

Pres

AntiFoulantLo 

Exp

 Expected 

Number of 

Tests per 

Year for 

the 

Industry

Appendix B. Data Requirement Probabilities 

for Antimicrobial Pesticides

Percent of Registration Actions

 Test is Likely to be Required under the Final Rule

 New Active Ingredient Major New Use/Amendment 

RESIDUE CHEMISTRY

Supporting Information

860.1100 Chemical Identity $1,250 100% 1% 1% 0% 25% 25% 25% 0% 0% 0% 1.8

860.1200 Directions for Use $4,000 100% 1% 1% 0% 25% 25% 25% 0% 0% 0% 1.8

860.1550 Proposed Tolerance/Tolerance Exemption $5,362 100% 1% 1% 0% 25% 25% 25% 0% 0% 0% 1.8

860.1560 Reasonable Grounds In Support of Petition $10,000 100% 1% 1% 0% 25% 25% 25% 0% 0% 0% 1.8

860.1650 Submittal of Analytical Reference Standards $334 50% 1% 1% 0% 10% 10% 25% 0% 0% 0% 1.1

Food-contact surfaces or impregnated materials

860.1460 Food Handling $205,000 50% 0% 0% 0% 25% 25% 0% 0% 0% 0% 1.1

none Nature of residue on surfaces $95,000 25% 0% 0% 0% 10% 10% 0% 0% 0% 0% 0.5

none Migration Studies $105,000 15% 0% 0% 0% 10% 10% 0% 0% 0% 0% 0.4

860.1340 Residue Analytical Method for data collection $65,500 60% 0% 0% 0% 40% 40% 0% 0% 0% 0% 1.7

860.1380 Storage Stability $18,500 60% 0% 0% 0% 40% 40% 0% 0% 0% 0% 1.7

Higher Tiered

860.1300 Nature of the Residue in Plants $100,000 0% 0% 0% 0% 0.5% 0% 0% 0% 0% 0% 0.01

860.1300 Nature of the Residue in Livestock $105,833 0% 0% 0% 0% 0.5% 0% 0% 0% 0% 0% 0.01

860.1340 Residue Analytical Method for tolerance/tolerance 

exemption enforcement $65,000 1% 0% 0% 0% 1% 1% 0% 0% 0% 0% 0.04

860.1360 Multiresidue Method Testing $24,000 1% 0% 0% 0% 1% 1% 0% 0% 0% 0% 0.04

860.1400 Potable Water $53,750 1% 0% 0% 0% 1% 1% 0% 0% 0% 0% 0.04

860.1400 Fish $104,000 1% 0% 0% 0% 1% 1% 0% 0% 0% 0% 0.04

860.1400 Irrigated Crops $87,500 1% 0% 0% 0% 1% 1% 0% 0% 0% 0% 0.04

860.1480 Meat/Milk/Poultry/Eggs $149,000 1% 0% 0% 0% 1% 1% 0% 0% 0% 0% 0.04

860.1500 Crop Field Trials $83,650 0% 0% 0% 0% 0.5% 0% 0% 0% 0% 0% 0.01

860.1520 Processed Food or Feed $89,925 0% 0% 0% 0% 0.5% 0% 0% 0% 0% 0% 0.01

None Anticipated Residues $15,000 0% 0% 0% 0% 0.5% 0% 0% 0% 0% 0% 0.01

PRODUCT PERFORMANCE*

Products for hard surfaces $6,261 0% 0% 0% 0% 13% 0% 64% 0% 0% 10% 2.3

Products requiring confirmatory data $6,261 0% 0% 0% 0% 13% 0% 64% 0% 0% 10% 2.3

Products for use on fabrics and textiles $3,250 0% 0% 0% 0% 0% 0% 0% 0% 0% 3% 0.2

Air sanitizers $5,500 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0.0

Products for control of microbial pests associated with 

human and animal waste $5,720 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0.0

Products for treating water systems $7,500 0% 0% 0% 0% 0% 0% 9% 0% 0% 0% 0.2

Total All Tests $16,094 Total All Tests 409.4

 Bold indicates changes from propesed rule.

* The product performance guidelines have been reorganised; however, the probabilities are based on current practice (2000-2005) under the old test guidelines. 

 Since the new organization does not impose new tests, there are no incremental costs for product performance.

 new active ingredient major new use/amendment 

Data Discipline All Tests

Indirect 

Food

Wood 

Pres

AntiFoulant Lo Exp Food Indirect 

Food

Hi 

Exp

Wood 

Pres

AntiFoulant Lo Exp

Product Chemistry $131 $119 $44 $21 $57 $23 $34 $36 $1 $69 $32 131.1

Toxicology $7,349 $3,169 $2,462 $277 $897 $134 $1,364 $426 $97 $144 $439 80.9

Applicator Exposure $2,186 $187 $187 $187 $187 $169 $169 $169 $169 $169 $169 23.1

Post Application Exposure $1,613 $155 $409 $99 $99 $80 $80 $80 $334 $54 $54 48.8

Ecological Effects $1,915 $592 $686 $503 $83 $29 $99 $171 $124 $679 $66 37.8

Plant Protection $179 $78 $79 $79 $19 $5 $5 $27 $27 $53 $8 10.6

Environmental Fate $1,299 $501 $812 $761 $109 $58 $69 $206 $320 $613 $87 57.8

Residue Chemistry $1,388 $218 $0 $0 $0 $117 $115 $5 $0 $0 $0 14.3

Product Performance $34 $0 $0 $0 $0 $2 $0 $9 $0 $0 $1 4.9

Total $16,094 $5,021 $4,679 $1,927 $1,451 $615 $1,934 $1,128 $1,071 $1,780 $856 409.4

Baseline $4,415 $4,379 $21 $759 $66 $1,437 $386 $0 $1,174 $432

Incremental $606 $301 $1,907 $692 $549 $497 $742 $1,071 $606 $424

Total

Average # of actions per year 0.33 0.50 0.17 1.17 2.00 1.83 2.17 0.33 0.17 6.33 15.0

Incremental Cost per Year $202 $150 $318 $808 $1,098 $911 $1,607 $357 $101 $2,685 $8,237

Column Headings

Guideline. Guideline number for the data requirement.

Data Requirement. Data requirement name.

Test Cost. The average cost for conducting the tests according to the guideline protocol. Labs were surveyed (mostly 2005-2010) to estimate this cost.

Percent of Registration Actions Test is Likely to be Required Under the Final Rule. Indicates the probability that the test will be required by:

Type of Registration Action

New Active Ingredient Registration

Major New Use Registration or Amendment

Use Site Group. See Table 5-3 for descriptions.

Expected Number of Tests per Year for the Industry. The total number of tests that is likely to be required per year for the antimicrobial industry under the final rule.

 Expected 

# of tests 

per year
Guideline Data Requirement Test Cost FR CP BL FR-BL FR-CP Final Rule 

= FR

Current Practice

= CP

Baseline

= BL

Incremental

= FR - BL

New Costs

= FR - CP

PRODUCT CHEMISTRY

Product Identity, Composition, and Analysis

830.1550 Product Identity and Composition $233 6.7 6.7 6.7 0.0 0.0 $1,564 $1,564 $1,564 $0 $0

830.1600 Description of Materials Used to Produce the Product $334 6.1 6.1 6.1 0.0 0.0 $2,034 $2,034 $2,034 $0 $0

830.1620 Description of Production Process $418 5.7 5.7 5.7 0.0 0.0 $2,380 $2,380 $2,380 $0 $0

830.1650 Description of Formulation Process $418 5.4 5.4 5.4 0.0 0.0 $2,253 $2,253 $2,253 $0 $0

830.1670 Description of Formation of Impurities $418 5.3 5.3 5.3 0.0 0.0 $2,228 $2,228 $2,228 $0 $0

830.1700 Preliminary Analysis $29,465 5.7 5.7 5.7 0.0 0.0 $166,645 $166,645 $166,645 $0 $0

830.1750 Certified Limits $248 7.0 7.0 7.0 0.0 0.0 $1,743 $1,743 $1,743 $0 $0

830.1800 Enforcement Analytical Method $15,455 4.3 4.3 4.3 0.0 0.0 $66,593 $66,593 $66,593 $0 $0

830.1900 Submittal of Samples $495 0.6 0.6 0.6 0.0 0.0 $307 $307 $307 $0 $0

Physical and Chemical Properties

830.6302 Color $700 6.7 6.7 6.7 0.0 0.0 $4,700 $4,700 $4,700 $0 $0

830.6303 Physical State $700 7.3 7.3 7.3 0.0 0.0 $5,143 $5,143 $5,143 $0 $0

830.6304 Odor $700 6.5 6.5 6.5 0.0 0.0 $4,552 $4,552 $4,552 $0 $0

830.7200 Melting Point/Melting Range $1,200 3.5 3.5 3.5 0.0 0.0 $4,179 $4,179 $4,179 $0 $0

830.7220 Boiling Point/Boiling Range $1,500 3.1 3.1 3.1 0.0 0.0 $4,705 $4,705 $4,705 $0 $0

830.7300 Density/Relative Density/Bulk Density $1,400 7.3 7.3 7.3 0.0 0.0 $10,287 $10,287 $10,287 $0 $0

830.7840 

830.7860 Water Solubility $9,635 3.5 3.5 3.5 0.0 0.0 $33,435 $33,435 $33,435 $0 $0

830.7950 Vapor Pressure $15,000 3.5 3.5 3.5 0.0 0.0 $52,055 $52,055 $52,055 $0 $0

830.7370 Dissociation Constants in Water $4,845 2.4 2.4 2.4 0.0 0.0 $11,666 $11,666 $11,666 $0 $0

830.7550

830.7560

830.7570

Partition Coefficient (n-octanol/water) $6,667 1.4 1.4 1.4 0.0 0.0 $9,582 $9,582 $9,582 $0 $0

830.7000 pH $750 5.5 5.5 5.5 0.0 0.0 $4,107 $4,107 $4,107 $0 $0

830.6313 Stability $8,250 4.3 4.3 4.3 0.0 0.0 $35,114 $35,114 $35,114 $0 $0

830.6314 Oxidation/Reduction: Chemical Incompatibility $2,994 3.2 3.2 3.2 0.0 0.0 $9,463 $9,463 $9,463 $0 $0

830.6315 Flammability $2,000 4.4 4.4 4.4 0.0 0.0 $8,887 $8,887 $8,887 $0 $0

830.6316 Explodability $4,163 3.6 3.6 3.6 0.0 0.0 $15,030 $15,030 $15,030 $0 $0

830.6317 Storage Stability $11,500 4.0 4.0 4.0 0.0 0.0 $45,592 $45,592 $45,592 $0 $0

830.7100 Viscosity $1,400 3.9 3.9 3.9 0.0 0.0 $5,471 $5,471 $5,471 $0 $0

830.6319 Miscibility $1,100 1.7 1.7 1.7 0.0 0.0 $1,836 $1,836 $1,836 $0 $0

830.6320 Corrosion Characteristics $2,750 4.3 4.3 4.3 0.0 0.0 $11,946 $11,946 $11,946 $0 $0

830.6321 Dielectric Breakdown Voltage $2,525 0.8 0.8 0.8 0.0 0.0 $1,984 $1,984 $1,984 $0 $0

830.7050 UV/visible light absorption--new requirement $2,022 2.5 0.8 0.0 2.5 1.8 $5,150 $1,589 $0 $5,150 $3,561

830.7520 Particle Size, Fiber Length, and Diameter Distribution $1,333 0.8 0.6 0.0 0.8 0.1 $1,000 $825 $0 $1,000 $174

TOXICOLOGY

Acute Testing

870.1100 Acute oral toxicity - rat $3,474 6.8 6.8 6.8 0.0 0.0 $23,476 $23,476 $23,476 $0

870.1200 Acute dermal toxicity $5,437 6.3 6.3 6.3 0.0 0.0 $34,075 $34,075 $34,075 $0 $0

870.1300 Acute inhalation toxicity - rat $26,275 4.8 4.8 4.8 0.0 0.0 $125,115 $125,115 $125,115 $0 $0

870.2400 Primary eye irritation - rabbit $2,000 5.7 5.7 5.7 0.0 0.0 $11,307 $11,307 $11,307 $0 $0

870.2500 Primary dermal irritation $2,000 6.2 6.2 6.2 0.0 0.0 $12,368 $12,368 $12,368 $0 $0

870.2600 Dermal sensitization $7,589 5.5 5.5 5.5 0.0 0.0 $41,829 $41,829 $41,829 $0 $0

870.6200 Acute neurotoxicity - rat $155,600 2.8 0.8 0.8 2.0 2.0 $437,495 $124,480 $124,480 $313,015 $313,015

Subchronic Testing

870.3100 90-Day oral toxicity - rodent $138,106 4.5 4.5 4.5 0.0 0.0 $615,810 $615,810 $615,810 $0 $0

870.3150 90-Day oral toxicity - nonrodent $221,047 2.6 2.6 2.6 0.0 0.0 $574,359 $574,359 $574,359 $0 $0

870.3200 21/28-Day dermal toxicity $83,240 1.1 1.3 0.7 0.4 -0.3 $89,924 $110,734 $58,016 $31,909 -$20,810

870.3250 90-Day dermal toxicity $132,130 1.4 1.1 1.1 0.4 0.4 $191,038 $140,388 $140,388 $50,650 $50,650

870.3465 90-Day inhalation - toxicity - rat $489,879 1.1 1.1 1.1 0.0 0.0 $557,114 $557,114 $557,114 $0 $0

870.6200 90-Day neurotoxicity - rat $184,039 0.4 0.4 0.4 0.0 0.0 $69,526 $69,526 $69,526 $0 $0

Chronic Testing

870.4100 Chronic toxicity - rodent $757,910 1.9 1.9 1.9 0.0 0.0 $1,458,977 $1,458,977 $1,458,977 $0 $0

870.4100 Chronic toxicity - non-rodent OUT 0.0 0.7 0.7 -0.7 -0.7 $505,273 $505,273 -$505,273 -$505,273

870.4200 Carcinogenicity - rat preferred $1,508,341 1.0 1.0 1.0 0.0 0.0 $1,558,238 $1,558,238 $1,558,238 $0 $0

870.4200 Carcinogenicty - mouse preferred $1,508,341 0.4 0.4 0.4 0.0 0.0 $569,818 $569,818 $569,818 $0 $0

Developmental Toxicity and Reproduction

870.3700 Prenatal developmental toxicity - rat preferred $117,053 4.6 4.6 4.6 0.0 0.0 $540,987 $540,987 $540,987 $0 $0

870.3700 Prenatal developmental toxicity - rabbit preferred $166,653 1.5 1.5 1.5 0.0 0.0 $247,433 $247,433 $247,433 $0 $0

870.3800 Reproduction and fertility effects $393,307 2.4 2.4 2.4 0.0 0.0 $956,401 $956,401 $956,401 $0 $0

870.6300 Developmental neurotoxicity $702,500 0.2 0.0 0.0 0.2 0.2 $135,817 $0 $0 $135,817 $135,817

Subdivision F Mutagenicity

870.5100 Reverse mutation assay $4,257 3.6 3.6 3.6 0.0 0.0 $15,270 $15,270 $15,270 $0 $0

870.5300

870.5375 In vitro mammalian gene mutation $19,211 4.6 4.6 4.6 0.0 0.0 $87,534 $87,534 $87,534 $0 $0

870.5385

870.5395 In vivo cytogenetics $30,004 4.5 4.5 4.5 0.0 0.0 $135,120 $135,120 $135,120 $0 $0

Special Testing

870.7485 Metabolism and pharmacokinetics $182,729 1.6 1.6 1.6 0.0 0.0 $286,529 $286,529 $286,529 $0 $0

870.7200 Companion animal safety $156,000 0.0 0.0 0.0 0.0 0.0 $0 $0 $0 $0 $0

870.7600 Dermal penetration $147,529 0.2 0.2 0.2 0.0 0.0 $31,145 $31,145 $31,145 $0 $0

870.7800 Immunotoxicity $204,400 5.4 0.0 0.0 5.4 5.4 $1,098,650 $0 $0 $1,098,650 $1,098,650

APPLICATOR

875.1100 Dermal outdoor exposure $450,000 $1,092,746 $183,636 $0

875.1200 Dermal indoor exposure $450,000 $0 $0 $0

875.1300 Inhalation outdoor exposure $450,000 $1,092,746 $258,636 $0

875.1400 Inhalation indoor exposure $450,000 $0 $0 $0

875.1600 Data reporting and calculations $7,500 2.4 0.0 0.0 2.4 2.4 $18,212 $0 $0 $18,212 $18,212

875.1500 Biological monitoring $375,000 0.9 0.0 0.0 0.9 0.9 $321,875 $0 $0 $321,875 $321,875

875.1700 Product use information $3,000 15.0 0.2 0.0 15.0 14.8 $45,000 $591 $0 $45,000 $44,409

POST APPLICATION

875.2200 Soil residue dissipation $253,733 0.8 0.0 0.0 0.8 0.8 $211,444 $0 $0 $211,444 $211,444

875.2300 Indoor surface residue dissipation $75,427 0.8 0.0 0.0 0.8 0.8 $63,484 $0 $0 $63,484 $63,484

875.2400 Dermal exposure $450,000 0.9 0.0 0.0 0.9 0.9 $386,250 $0 $0 $386,250 $386,250

875.2500 Inhalation exposure $450,000 0.9 0.0 0.0 0.9 0.9 $386,250 $0 $0 $386,250 $386,250

875.2600 Biological monitoring $375,000 0.4 0.0 0.0 0.4 0.4 $150,000 $0 $0 $150,000 $150,000

875.2700 Product use information $3,000 15.0 0.0 0.0 15.0 15.0 $45,000 $0 $0 $45,000 $45,000

875.2800 Description of human activity $3,000 15.0 0.0 0.0 15.0 15.0 $45,000 $0 $0 $45,000 $45,000

875.2900 Data reporting and calculations $3,000 15.0 0.0 0.0 15.0 15.0 $45,000 $0 $0 $45,000 $45,000

875.3000 Non-dietary ingestion exposure OUT 0.0 0.0 0.0 0.0 0.0 $0 $0

Expected Industry Cost per Year of Data Requirement

 = Test cost × Expected # of tests required per year 

$909,110

0.6 0.0

2.4 0.4 0.0 2.4 2.0 $1,092,746

Expected Number of Tests per Year for 

the Industry

Appendix C. Data Requirement Costs for Antimicrobial 

Pesticides

2.4 2.4 1.9 $1,092,746 $834,110
Guideline Data Requirement Test Cost FR CP BL FR-BL FR-CP Final Rule 

= FR

Current Practice

= CP

Baseline

= BL

Incremental

= FR - BL

New Costs

= FR - CP

Expected Industry Cost per Year of Data Requirement

 = Test cost × Expected # of tests required per year 

Expected Number of Tests per Year for 

the Industry

Appendix C. Data Requirement Costs for Antimicrobial 

Pesticides

NONTARGET ORGANISM

Tier One Testing

850.2100 Avian acute oral toxicity $10,100 5.6 3.6 3.6 2.1 2.1 $56,602 $35,892 $35,892 $20,710 $20,710

850.1010 Acute freshwater invertebrates toxicity $17,000 5.6 3.3 3.3 2.3 2.3 $95,271 $56,823 $56,823 $38,447 $38,447

850.1075 Acute freshwater fish toxicity $11,957 5.6 4.7 4.1 1.6 0.9 $67,009 $56,441 $48,470 $18,539 $10,568

Higher Tier Testing

Avian Testing

850.2200 Avian dietary toxicity $6,480 2.7 3.2 2.7 0.0 -0.5 $17,500 $20,653 $17,413 $86 -$3,154

850.2300 Avian reproduction $168,250 0.2 0.0 0.0 0.2 0.2 $29,724 $0 $0 $29,724 $29,724

Aquatic Organisms Testing

850.1010 Acute freshwater invertebrates toxicity $17,000

850.1075 Acute freshwater fish toxicity $11,957

850.1025 

850.1035 

850.1045 

850.1055 

850.1075

Acute estuarine and marine organisms toxicity $20,138 3.8 3.0 1.9 2.0 0.8 $77,177 $61,000 $37,506 $39,671 $16,177

850.1400 Fish early-life stage $37,279 2.5 1.5 0.9 1.6 1.0 $94,098 $57,006 $33,396 $60,703 $37,093

850.1300 

850.1350 Aqatic invertebrate life cycle $36,334 2.0 1.0 1.0 1.0 1.0 $73,939 $36,334 $36,334 $37,605 $37,605

850.1500 Fish life cycle $512,500 1.1 0.8 0.6 0.6 0.4 $579,267 $396,476 $288,281 $290,986 $182,792

850.1710 

850.1730

850.1850

Aquatic organism bioavailability, 

biomagnification, toxicity tests $325,000 1.5 1.1 1.1 0.4 0.4 $480,097 $353,889 $353,889 $126,208 $126,208

850.1950 Simulated or actual field testing for aquatic organisms $600,000 0.3 0.0 0.0 0.3 0.3 $163,000 $0 $0 $163,000 $163,000

see Notes Acute pore water invertebrates OUT OUT 0.0 0.2 0.2 -0.2 -0.2 $6,250 $6,250 -$6,250 -$6,250

Sediment Testing

850.1735 Whole sediment; acute freshwater invertebrates $21,903 2.0 1.2 1.0 1.0 0.8 $44,889 $26,527 $21,903 $22,986 $18,362

850.1740 Whole sediment; acute marine invertebrates $37,500 1.7 0.9 0.7 1.1 0.9 $64,979 $32,917 $25,000 $39,979 $32,063

None Whole sediment; chronic invertibrates freshwater and 

marine $64,757 0.6 0.0 0.0 0.6 0.6 $41,121 $0 $0 $41,121 $41,121

Insect Pollinator Testing

850.3020 Honey bee acute contact $3,175 1.2 0.0 0.0 1.2 1.2 $3,778 $0 $0 $3,778 $3,778

850.3030 Toxicity of residues to honeybees $13,368 1.2 0.9 0.9 0.3 0.3 $16,190 $11,734 $11,734 $4,456 $4,456

NONTARGET PLANT PROTECTION

850.4225 Seedling emergence, Tier II - dose response $20,375 1.5 1.0 0.7 0.8 0.4 $30,042 $21,281 $13,583 $16,458 $8,761

850.4250 Vegetative vigor, Tier II - dose response $36,963 1.5 1.0 0.7 0.8 0.4 $54,499 $38,605 $24,642 $29,857 $15,894

850.4400 Aquatic plant growth (aquatic vascular plant) Tier II - dose 

response

$35,155 2.3 1.4 0.0 2.3 0.9 $81,228 $49,998 $0 $81,228 $31,229

850.5400 Aquatic plant growth (algal) Tier II - dose response $14,426 5.4 1.3 0.9 4.5 4.1 $77,540 $18,550 $12,459 $65,081 $58,990

850.4300 Terrestrial field $44,000 0.008 0.0 0.0 0.01 0.01 $367 $0 $0 $367 $367

850.4450 Aquatic field $28,500 0.003 0.0 0.0 0.00 0.00 $95 $0 $0 $95 $95

ENVIRONMENTAL FATE

Degradation Studies -- Laboratory

835.2120 Hydrolysis $41,938 5.4 2.8 2.8 2.6 2.6 $225,415 $117,065 $117,065 $108,350 $108,350

835.2240 Photodegradation in water $47,875 2.0 1.3 1.3 0.7 0.7 $96,215 $63,102 $63,102 $33,114 $33,114

835.2410 Photodegradation in soil $73,979 0.8 0.0 0.0 0.8 0.8 $61,649 $0 $0 $61,649 $61,649

Toxicity and Fate in Wastewaster Systems

850.6800

OECD 209 Activated Sludge, Respiration Inhibition Test $4,292 11.8 0.0 0.0 11.8 11.8 $50,613 $0 $0 $50,613 $50,613

835.1110 Activated Sludge Sorption Isotherm $19,733 7.5 0.0 0.0 7.5 7.5 $147,994 $0 $0 $147,994 $147,994

835.3110 Ready Biodegradability $8,667 7.5 0.0 0.0 7.5 7.5 $65,006 $0 $0 $65,006 $65,006

835.3220 

or

835.3280 

or

835.3240

Porous Pot Test or

Simulation Tests to Assess the Biodegradability of 

Chemicals Discharged in Wastewater or

Simulation Test – Aerobic Sewage Treatment: Activated 

Sludge Units

$33,000 7.5 0.0 0.0 7.5 7.5 $247,500 $0 $0 $247,500 $247,500

Mobility Studies

835.1230 Adsorption/desorption $42,741 2.6 1.7 1.1 1.5 0.9 $109,665 $72,481 $45,412 $64,253 $37,184

835.1240 Soil column leaching $46,780 2.4 1.5 1.1 1.3 0.9 $110,154 $69,455 $49,704 $60,450 $40,699

Metabolism Studies -- Laboratory

835.4100 Aerobic soil metabolism $94,375 2.1 1.5 1.1 1.0 0.6 $195,251 $140,121 $100,273 $94,978 $55,131

835.4200 Anaerobic soil metabolism $150,167 1.7 0.9 0.7 1.0 0.8 $256,451 $131,813 $100,111 $156,340 $124,638

835.4300 Aerobic aquatic metabolism $102,200 2.2 1.3 0.8 1.4 0.9 $223,364 $128,318 $85,167 $138,197 $95,046

835.4400 Anaerobic aquatic metabolism $107,224 2.4 1.5 0.8 1.6 0.9 $256,981 $157,262 $89,354 $167,627 $99,719

Dissipation Studies

835.6200 Aquatic (sediment) $267,250 0.6 0.2 0.2 0.5 0.5 $167,031 $44,542 $44,542 $122,490 $122,490

Ground and Surface Water Monitoring

None Monitoring of representative U.S. waters $215,833 0.003 0.0 0.0 0.00 0.003 $719 $0 $0 $719 $719

Special Studies

None Special leaching $43,000 1.4 1.1 0.7 0.7 0.3 $60,845 $46,583 $28,667 $32,178 $14,262

RESIDUE CHEMISTRY

Supporting Information

860.1100 Chemical Identity $1,250 1.8 0.2 0.2 1.6 1.6 $2,300 $286 $286 $2,014 $2,014

860.1200 Directions for Use $4,000 1.8 0.2 0.2 1.6 1.6 $7,360 $917 $917 $6,443 $6,443

860.1550 Proposed Tolerance/Tolerance Exemption $5,362 1.8 0.0 0.0 1.8 1.8 $9,866 $0 $0 $9,866 $9,866

860.1560 Reasonable Grounds In Support of Petition $10,000 1.8 0.0 0.0 1.8 1.8 $18,400 $0 $0 $18,400 $18,400

860.1650 Submittal of Analytical Reference Standards $334 1.1 0.0 0.0 1.1 1.1 $367 $0 $0 $367 $367

Food-contact surfaces or impregnated materials

860.1460 Food Handling $205,000 1.1 0.0 0.0 1.1 1.1 $230,625 $0 $0 $230,625 $230,625

none Nature of residue on surfaces $95,000 0.5 0.0 0.0 0.5 0.5 $44,333 $0 $0 $44,333 $44,333

none Migration Studies $105,000 0.4 0.0 0.0 0.4 0.4 $45,500 $0 $0 $45,500 $45,500

860.1340 Residue Analytical Method for data collection $65,500 1.7 0.0 0.0 1.7 1.7 $113,533 $0 $0 $113,533 $113,533

860.1380 Storage Stability $18,500 1.7 0.0 0.0 1.7 1.7 $32,067 $0 $0 $32,067 $32,067

Higher Tiered

860.1300 Nature of the Residue in Plants $100,000 0.01 0.0 0.0 0.0 0.0 $1,000 $0 $0 $1,000 $1,000

860.1300 Nature of the Residue in Livestock $105,833 0.01 0.0 0.0 0.0 0.0 $1,058 $0 $0 $1,058 $1,058

860.1340 Residue Analytical Method for tolerance/tolerance 

exemption enforcement $65,000 0.04 0.0 0.0 0.0 0.0 $2,708 $0 $0 $2,708 $2,708

860.1360 Multiresidue Method Testing $24,000 0.04 0.0 0.0 0.0 0.0 $1,000 $0 $0 $1,000 $1,000

860.1400 Potable Water $53,750 0.04 0.0 0.0 0.0 0.0 $2,240 $0 $0 $2,240 $2,240

860.1400 Fish $104,000 0.04 0.0 0.0 0.0 0.0 $4,333 $0 $0 $4,333 $4,333

860.1400 Irrigated Crops $87,500 0.04 0.0 0.0 0.0 0.0 $3,646 $0 $0 $3,646 $3,646

860.1480 Meat/Milk/Poultry/Eggs $149,000 0.04 0.0 0.0 0.0 0.0 $6,208 $0 $0 $6,208 $6,208

860.1500 Crop Field Trials $83,650 0.01 0.0 0.0 0.0 0.0 $837 $0 $0 $837 $837

860.1520 Processed Food or Feed $89,925 0.01 0.0 0.0 0.0 0.0 $899 $0 $0 $899 $899

None Anticipated Residues $15,000 0.01 0.0 0.0 0.0 0.0 $150 $0 $0 $150 $150
Guideline Data Requirement Test Cost FR CP BL FR-BL FR-CP Final Rule 

= FR

Current Practice

= CP

Baseline

= BL

Incremental

= FR - BL

New Costs

= FR - CP

Expected Industry Cost per Year of Data Requirement

 = Test cost × Expected # of tests required per year 

Expected Number of Tests per Year for 

the Industry

Appendix C. Data Requirement Costs for Antimicrobial 

Pesticides

PRODUCT PERFORMANCE*

PRODUCT PERFORMANCE $6,261 2.3 2.3 2.3 0.0 0.0 $14,163 $14,163 $14,163 $0 $0

Products requiring confirmatory data $6,261 2.3 2.3 2.3 0.0 0.0 $14,163 $14,163 $14,163 $0 $0

Products for use on fabrics and textiles $3,250 0.2 0.2 0.2 0.0 0.0 $686 $686 $686 $0 $0

Air sanitizers $5,500 0.0 0.0 0.0 0.0 0.0 $0 $0 $0 $0 $0

Products for control of microbial pests associated with 

human and animal waste $5,720 0.0 0.0 0.0 0.0 0.0 $0 $0 $0 $0 $0

Products for treating water systems $7,500 0.2 0.2 0.2 0.0 0.0 $1,477 $1,477 $1,477 $0 $0

Total All Tests $16,094 409.4 253.4 240.8 168.5 156.0 $19,322,179 $12,086,874 $11,084,730 $8,237,449 $7,235,306

Data Discipline All Tests

Product Chemistry $131 131.1 129 128 3.3 1.9 $531,630 $527,894 $525,479 $6,150 $3,736

Toxicology $7,349 80.9 73.9 73.2 7.7 7.0 $9,905,355 $8,833,306 $8,780,587 $1,124,767 $1,072,049

Applicator Exposure $2,186 23.1 1.2 0.0 23.1 22.0 $2,570,580 $442,864 $0 $2,570,580 $2,127,717

Post Application Exposure $1,613 48.8 0.0 0.0 48.8 48.8 $1,332,429 $0 $0 $1,332,429 $1,332,429

Ecological Effects $1,915 37.8 25.4 21.8 16.0 12.4 $1,904,641 $1,151,941 $972,891 $931,751 $752,700

Plant Protection $179 10.6 4.8 2.2 8.4 5.8 $243,770 $128,434 $50,684 $193,086 $115,336

Environmental Fate $1,299 57.8 13.6 10.5 47.4 44.2 $2,274,854 $970,742 $723,396 $1,551,458 $1,304,112

Residue Chemistry $1,388 14.3 0.5 0.5 13.8 13.8 $528,431 $1,203 $1,203 $527,228 $527,228

Product Performance $34 4.9 4.9 4.9 0.0 0.0 $30,490 $30,490 $30,490 $0 $0

Total $16,094 409.4 253.4 240.8 168.5 156.0 $19,322,179 $12,086,874 $11,084,730 $8,237,449 $7,235,306

* The product performance guidelines have been reorganised; however, the probabilities are based on current practice (2000-2005) under the old test guidelines. 

 Since the new organization does not impose new tests, there are no incremental costs for product performance.

Column Headings

Guideline. Guideline number for the data requirement.

Data Requirement. Data requirement name. 

Test Cost. The average cost for conducting the tests according to the guideline protocol. Labs were surveyed (mostly 2005-2010) to estimate this cost.

Expected Number of Tests per Year for the Industry. The total number of tests that is likely to be required per year for the antimicrobial industry under the final rule.

FR = The number of tests that are expected to be required of the industry per year under the final rule.

Expected Industry Cost per Year of Data Requirement = test cost multiplied by the expected number of tests required per year for the industry.

Current Practice = CP = The cost to the industry based on test probabilities estimated from available registration data (2000-2005).

Incremental = FR − BL = The increase in cost of data requirements as a result of the final rule compared to the baseline.

New Costs = FR − CP = The increase in cost of data requirements as a result of the final rule compared to current practice.

Final Rule = FR = Cost to the industry under the final rule. The test probabilities used to estimate these costs are based on both available registration data (2000-2005) and the 

experience of EPA scientists.

BL = The number of tests required of the industry per year that were identified by reviewing various Agency decision documents completed during 2000-2005 for existing data 

requirements codified in part 161 only.

Baseline = BL = The cost to the industry based on test probabilities estimated from available registration data (2000-2005) for existing data requirements codified in part 161 

only.

CP = The number of tests required of the industry per year that were identified by reviewing various Agency decision documents completed during 2000-2005, which includes 

existing data requirements codified in part 161 and uncodified data requirements that are routinely considered to register an antimicrobial product. 
Guideline Data Requirement Test Cost Test 

Status

Final Rule = 

FR

Current Practice 

= CR Existing Uncodified

PRODUCT CHEMISTRY

Product Identity, Composition, and Analysis

830.1550 Product Identity and Composition $233 E $1,564 $1,564 $0

830.1600 Description of Materials Used to Produce the Product $334 E $2,034 $2,034 $0

830.1620 Description of Production Process $418 E $2,380 $2,380 $0

830.1650 Description of Formulation Process $418 E $2,253 $2,253 $0

830.1670 Description of Formation of Impurities $418 E $2,228 $2,228 $0

830.1700 Preliminary Analysis $29,465 E $166,645 $166,645 $0

830.1750 Certified Limits $248 E $1,743 $1,743 $0

830.1800 Enforcement Analytical Method $15,455 E $66,593 $66,593 $0

830.1900 Submittal of Samples $495 E $307 $307 $0

Physical and Chemical Properties

830.6302 Color $700 E $4,700 $4,700 $0

830.6303 Physical State $700 E $5,143 $5,143 $0

830.6304 Odor $700 E $4,552 $4,552 $0

830.7200 Melting Point/Melting Range $1,200 E $4,179 $4,179 $0

830.7220 Boiling Point/Boiling Range $1,500 E $4,705 $4,705 $0

830.7300 Density/Relative Density/Bulk Density $1,400 E $10,287 $10,287 $0

830.7840 

830.7860 Water Solubility $9,635 E $33,435 $33,435 $0

830.7950 Vapor Pressure $15,000 E $52,055 $52,055 $0

830.7370 Dissociation Constants in Water $4,845 E $11,666 $11,666 $0

830.7550

830.7560

830.7570

Partition Coefficient (n-octanol/water) $6,667 E $9,582 $9,582 $0

830.7000 pH $750 E $4,107 $4,107 $0

830.6313 Stability $8,250 E $35,114 $35,114 $0

830.6314 Oxidation/Reduction: Chemical Incompatibility $2,994 E $9,463 $9,463 $0

830.6315 Flammability $2,000 E $8,887 $8,887 $0

830.6316 Explodability $4,163 E $15,030 $15,030 $0

830.6317 Storage Stability $11,500 E $45,592 $45,592 $0

830.7100 Viscosity $1,400 E $5,471 $5,471 $0

830.6319 Miscibility $1,100 E $1,836 $1,836 $0

830.6320 Corrosion Characteristics $2,750 E $11,946 $11,946 $0

830.6321 Dielectric Breakdown Voltage $2,525 E $1,984 $1,984 $0

830.7050 UV/visible light absorption--new requirement $2,022 C $5,150 $1,589 $3,561

830.7520 Particle Size, Fiber Length, and Diameter Distribution $1,333 C $1,000 $825 $174

TOXICOLOGY

Acute Testing

870.1100 Acute oral toxicity - rat $3,474 E $23,476 $23,476 $0

870.1200 Acute dermal toxicity $5,437 E $34,075 $34,075 $0

870.1300 Acute inhalation toxicity - rat $26,275 E $125,115 $125,115 $0

870.2400 Primary eye irritation - rabbit $2,000 E $11,307 $11,307 $0

870.2500 Primary dermal irritation $2,000 E $12,368 $12,368 $0

870.2600 Dermal sensitization $7,589 E $41,829 $41,829 $0

870.6200 Acute neurotoxicity - rat $155,600 E $437,495 $124,480 $313,015

Subchronic Testing

870.3100 90-Day oral toxicity - rodent $138,106 E $615,810 $615,810 $0

870.3150 90-Day oral toxicity - nonrodent $221,047 E $574,359 $574,359 $0

870.3200 21/28-Day dermal toxicity $83,240 E $89,924 $110,734 -$20,810

870.3250 90-Day dermal toxicity $132,130 E $191,038 $140,388 $50,650

870.3465 90-Day inhalation - toxicity - rat $489,879 C $557,114 $557,114 $0

870.6200 90-Day neurotoxicity - rat $184,039 C $69,526 $69,526 $0

Chronic Testing

870.4100 Chronic toxicity - rodent $757,910 E $1,458,977 $1,458,977 $0

870.4100 Chronic toxicity - non-rodent OUT E $505,273 -$505,273

870.4200 Carcinogenicity - rat preferred $1,508,341 E $1,558,238 $1,558,238 $0

870.4200 Carcinogenicty - mouse preferred $1,508,341 E $569,818 $569,818 $0

Developmental Toxicity and Reproduction

870.3700 Prenatal developmental toxicity - rat preferred $117,053 E $540,987 $540,987 $0

870.3700 Prenatal developmental toxicity - rabbit preferred $166,653 E $247,433 $247,433 $0

870.3800 Reproduction and fertility effects $393,307 E $956,401 $956,401 $0

870.6300 Developmental neurotoxicity $702,500 N $135,817 $0 $135,817

Subdivision F, A Mutagenicity

870.5100 Reverse mutation assay $4,257 E $15,270 $15,270 $0

870.5300

870.5375 In vitro mammalian gene mutation $19,211 E $87,534 $87,534 $0

870.5385

870.5395 In vivo cytogenetics $30,004 E $135,120 $135,120 $0

Special Testing

870.7485 Metabolism and pharmacokinetics $182,729 E $286,529 $286,529 $0

870.7200 Companion animal safety $156,000 E $0 $0 $0

870.7600 Dermal penetration $147,529 E $31,145 $31,145 $0

870.7800 Immunotoxicity $204,400 N $1,098,650 $0 $1,098,650

New Costs = FR − CP

New 

Tests

 Appendix D New Costs Expected Cost to Industry 

per Year According to
Guideline Data Requirement Test Cost Test 

Status

Final Rule = 

FR

Current Practice 

= CR Existing Uncodified

New Costs = FR − CP

New 

Tests

 Appendix D New Costs Expected Cost to Industry 

per Year According to

APPLICATOR

875.1100 Dermal outdoor exposure $450,000 C

875.1200 Dermal indoor exposure $450,000 C

875.1300 Inhalation outdoor exposure $450,000 C

875.1400 Inhalation indoor exposure $450,000 C

875.1600 Data reporting and calculations $7,500 C $18,212 $0 $18,212

875.1500 Biological monitoring $375,000 C $321,875 $0 $321,875

875.1700 Product use information $3,000 C $45,000 $591 $44,409

POST APPLICATION

875.2200 Soil residue dissipation $253,733 N $211,444 $0 $211,444

875.2300 Indoor surface residue dissipation $75,427 C $63,484 $0 $63,484

875.2400 Dermal exposure $450,000 E $386,250 $0 $386,250

875.2500 Inhalation exposure $450,000 E $386,250 $0 $386,250

875.2600 Biological monitoring $375,000 C $150,000 $0 $150,000

875.2700 Product use information $3,000 C $45,000 $0 $45,000

875.2800 Description of human activity $3,000 C $45,000 $0 $45,000

875.2900 Data reporting and calculations $3,000 C $45,000 $0 $45,000

875.3000 Non-dietary ingestion exposure OUT N $0

NONTARGET ORGANISM

Tier One Testing

850.2100 Avian acute oral toxicity $10,100 C $56,602 $35,892 $20,710

850.1010 Acute freshwater invertebrates toxicity $17,000 C $95,271 $56,823 $38,447

850.1075 Acute freshwater fish toxicity $11,957 E $67,009 $56,441 $10,568

Higher Tier Testing

Avian Testing

850.2200 Avian dietary toxicity $6,480 E $17,500 $20,653 -$3,154

850.2300 Avian reproduction $168,250 E $29,724 $0 $29,724

Aquatic Organisms Testing

850.1010 Acute freshwater invertebrates toxicity $17,000 E $0

850.1075 Acute freshwater fish toxicity $11,957 E $0

850.1025 

850.1035 

850.1045 

850.1055 

850.1075

Acute estuarine and marine organisms toxicity $20,138 C $77,177 $61,000 $16,177

850.1400 Fish early-life stage $37,279 C $94,098 $57,006 $37,093

850.1300 

850.1350 Aqatic invertebrate life cycle $36,334 C $73,939 $36,334 $37,605

850.1500 Fish life cycle $512,500 C $579,267 $396,476 $182,792

850.1710 

850.1730

850.1850

Aquatic organism bioavailability, 

biomagnification, toxicity tests $325,000 E $480,097 $353,889 $126,208

850.1950 Simulated or actual field testing for aquatic organisms $600,000 E $163,000 $0 $163,000

see Notes Acute pore water invertebrates OUT OUT E $6,250 -$6,250

Sediment Testing

850.1735 Whole sediment; acute freshwater invertebrates $21,903 E $44,889 $26,527 $18,362

850.1740 Whole sediment; acute marine invertebrates $37,500 E $64,979 $32,917 $32,063

None Whole sediment; chronic invertibrates freshwater and 

marine $64,757 E $41,121 $0 $41,121

Insect Pollinator Testing

850.3020 Honey bee acute contact $3,175 C $3,778 $0 $3,778

850.3030 Toxicity of residues to honeybees $13,368 C $16,190 $11,734 $4,456

NONTARGET PLANT PROTECTION

850.4225 Seedling emergence, Tier II - dose response $20,375 E $30,042 $21,281 $8,761

850.4250 Vegetative vigor, Tier II - dose response $36,963 E $54,499 $38,605 $15,894

850.4400 Aquatic plant growth (aquatic vascular plant) Tier II - 

dose response $35,155 E $81,228 $49,998 $31,229

850.5400 Aquatic plant growth (algal) Tier II - dose response $14,426 E $77,540 $18,550 $58,990

850.4300 Terrestrial field $44,000 E $367 $0 $367

850.4450 Aquatic field $28,500 E $95 $0 $95

$1,092,746 $183,636 $909,110

$1,092,746 $258,636 $834,110
Guideline Data Requirement Test Cost Test 

Status

Final Rule = 

FR

Current Practice 

= CR Existing Uncodified

New Costs = FR − CP

New 

Tests

 Appendix D New Costs Expected Cost to Industry 

per Year According to

ENVIRONMENTAL FATE

Degradation Studies -- Laboratory

835.2120 Hydrolysis $41,938 E $225,415 $117,065 $108,350

835.2240 Photodegradation in water $47,875 E $96,215 $63,102 $33,114

835.2410 Photodegradation in soil $73,979 N $61,649 $0 $61,649

Toxicity and Fate in Wastewaster Systems

850.6800

OECD 209 Activated Sludge, Respiration Inhibition Test $4,292 N $50,613 $0 $50,613

835.1110 Activated Sludge Sorption Isotherm $19,733 N $147,994 $0 $147,994

835.3110 Ready Biodegradability $8,667 N $65,006 $0 $65,006

835.3220 

or

835.3280 

or

835.3240

Porous Pot Test or

Simulation Tests to Assess the Biodegradability of 

Chemicals Discharged in Wastewater or

Simulation Test – Aerobic Sewage Treatment: Activated 

Sludge Units

$33,000 N $247,500 $0 $247,500

Mobility Studies

835.1230 Adsorption/desorption $42,741 E $109,665 $72,481 $37,184

835.1240 Soil column leaching $46,780 E $110,154 $69,455 $40,699

Metabolism Studies -- Laboratory

835.4100 Aerobic soil metabolism $94,375 E $195,251 $140,121 $55,131

835.4200 Anaerobic soil metabolism $150,167 E $256,451 $131,813 $124,638

835.4300 Aerobic aquatic metabolism $102,200 E $223,364 $128,318 $95,046

835.4400 Anaerobic aquatic metabolism $107,224 E $256,981 $157,262 $99,719

Dissipation Studies

835.6200 Aquatic (sediment) $267,250 E $167,031 $44,542 $122,490

Ground and Surface Water Monitoring

None Monitoring of representative U.S. waters $215,833 C $719 $0 $719

Special Studies

None Special leaching $43,000 C $60,845 $46,583 $14,262

RESIDUE CHEMISTRY

Supporting Information

860.1100 Chemical Identity $1,250 E $2,300 $286 $2,014

860.1200 Directions for Use $4,000 E $7,360 $917 $6,443

860.1550 Proposed Tolerance/Tolerance Exemption $5,362 E $9,866 $0 $9,866

860.1560 Reasonable Grounds In Support of Petition $10,000 E $18,400 $0 $18,400

860.1650 Submittal of Analytical Reference Standards $334 E $367 $0 $367

Food-contact surfaces or impregnated materials

860.1460 Food Handling $205,000 E $230,625 $0 $230,625

none Nature of residue on surfaces $95,000 N $44,333 $0 $44,333

none Migration Studies $105,000 C $45,500 $0 $45,500

860.1340 Residue Analytical Method for data collection $65,500 E $113,533 $0 $113,533

860.1380 Storage Stability $18,500 E $32,067 $0 $32,067

Higher Tiered

860.1300 Nature of the Residue in Plants $100,000 E $1,000 $0 $1,000

860.1300 Nature of the Residue in Livestock $105,833 E $1,058 $0 $1,058

860.1340 Residue Analytical Method for tolerance/tolerance 

exemption enforcement $65,000 E $2,708 $0 $2,708

860.1360 Multiresidue Method Testing $24,000 E $1,000 $0 $1,000

860.1400 Potable Water $53,750 E $2,240 $0 $2,240

860.1400 Fish $104,000 E $4,333 $0 $4,333

860.1400 Irrigated Crops $87,500 E $3,646 $0 $3,646

860.1480 Meat/Milk/Poultry/Eggs $149,000 E $6,208 $0 $6,208

860.1500 Crop Field Trials $83,650 E $837 $0 $837

860.1520 Processed Food or Feed $89,925 E $899 $0 $899

None Anticipated Residues $15,000 E $150 $0 $150
Guideline Data Requirement Test Cost Test 

Status

Final Rule = 

FR

Current Practice 

= CR Existing Uncodified

New Costs = FR − CP

New 

Tests

 Appendix D New Costs Expected Cost to Industry 

per Year According to

PRODUCT PERFORMANCE

Products for hard surfaces $6,261 E $14,163 $14,163 $0

Products requiring confirmatory data $6,261 E $14,163 $14,163 $0

Products for use on fabrics and textiles $3,250 E $686 $686 $0

Air sanitizers $5,500 E $0 $0 $0

Products for control of microbial pests associated with 

human and animal waste $5,720 E $0 $0 $0

Products for treating water systems $7,500 E $1,477 $1,477 $0

Total All Tests $16,094 $19,322,179 $12,086,874 $2,290,824 $2,881,476 $2,063,006

Data Discipline All Tests

Product Chemistry $131 $531,630 $527,894 $0 $3,736 $0

Toxicology $7,349 $9,905,355 $8,833,306 -$162,418 $0 $1,234,467

Applicator Exposure $2,186 $2,570,580 $442,864 $0 $2,127,717 $0

Post Application Exposure $1,613 $1,332,429 $0 $772,500 $348,484 $211,444

Ecological Effects $1,915 $1,904,641 $1,151,941 $411,642 $341,058 $0

Plant Protection $179 $243,770 $128,434 $115,336 $0 $0

Environmental Fate $1,299 $2,274,854 $970,742 $716,369 $14,981 $572,761

Residue Chemistry $1,388 $528,431 $1,203 $437,394 $45,500 $44,333

Product Performance $34 $30,490 $30,490 $0 $0 $0

Total $16,094 $19,322,179 $12,086,874 $2,290,824 $2,881,476 $2,063,006

Total New Costs = $7,235,306

Column Headings

Guideline. Guideline number for the data requirement.

Test Status indicates if a data requirement in the final rule is:

E = Existing - a test that is codified in the current 40 CFR part 161.

C = Current Practice - A test that is routinely considered in current practice, but is uncodified in the current 40 CFR part 161.

Expected Industry Cost per Year of Data Requirement = test costs multiplied by the expected number of tests required per year for the industry.

Existing = Changes (usually increases) in the cost of existing tests (defined E above) currently codified in 40 CFR part 161.

Uncodified = Changes (most often increases) in the cost of uncodified tests (defined C above).

New Tests = Costs of new tests to the industry (defined N above).

Current Practice = CP = The cost to the industry based on test probabilties estimated from available registration data 

(2000-2005). 

New Costs are the differences between the expected costs to the industry per year according to the final rule and current practice and are broken out by 

category as follows:

Data Requirement. Data requirement name.

Test Cost. The average cost for conducting the tests according to the guideline protocol. 

Final Rule = FR = Cost to the industry under the final rule. The test probabilities used to estimate these costs are based on both available 

registration data (2000-2005) and the experience of EPA scientists.

N = New - a test that is required by the final rule that has never been required or has rarely been required on a case-by-case basis, and has 

not been routinely considered during the Agency’s evaluation of the data needed for the purpose of risk assessment.