Label Review Manual 

Chapter 7: Precautionary Statements

USDA NRCS, Jeff Kramer
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Chapter 7: Precautionary Statements 7-1

I. Introduction

The precautionary statements are designed to provide the pesticide user with information 

regarding the toxicity, irritation and sensitization hazards associated with the use of a pesticide, 

as well as treatment instructions and information to reduce exposure potential. While the 

Precautionary Statements include Personal Protective Equipment (for uses that trigger worker 

protection standards), User Safety Requirements, Engineering Controls, User Safety 

Recommendations, Environmental Hazards, and Physical or Chemical Hazards, for the purposes 

of this manual, those topics are addressed in other chapters. The remaining sections (Signal 

Word, Child Hazard Warning, Hazards to Humans and Domestic Animals, First Aid and

Personal Protective Equipment (Non-Worker Protection Standard (WPS)) are fully addressed in 

this chapter. Label reviewers should consult the mandatory/advisory PR Notice 2000-5 for 

guidance in recommended language for precautionary statements.

II. Background information

A. Documents Used to Determine Precautionary Statements on Labels

The Code of Federal Regulations specifies both the acute toxicity category endpoints 

(40 CFR 156.62) and the Hazards to Humans and Domestic Animals statements associated 

with each toxicity category (40 CFR 156.70). These toxicity categories and labeling 

statements however are not currently being used by the Agency, because they are less 

detailed and provide less protection for pesticide users than other guidance. The 

40 CFR 156.70(c) states that specific statements pertaining to the hazards of the product and 

its uses must be approved by the Agency. The labeling statements provided in the Federal 

Register Notice issued on 9/26/84, entitled Proposed Rule on Labeling Requirements 

(Volume 49, Number 188) have been used by the Agency for the past twenty years. The 

acute toxicity categories listed in the Proposed Rule are also being used with one exception.

The acute inhalation toxicity category endpoints currently used are from a 2/1/94 Health 

Effects Division paper entitled “Interim Policy for Particle Size and Limit Concentration 

Issues in Inhalation Toxicity Studies”.

B. Acute Toxicity Data

The Signal Word, Hazards to Humans and Domestic Animals, Personal Protective 

Equipment (non-WPS) and First Aid statements are typically determined by the results of 

the six acute toxicity studies performed with the product formulation. The acute oral, acute 

dermal and acute inhalation studies evaluate systemic toxicity via the designated routes of 

exposure. The primary eye irritation and primary skin irritation studies measure irritation or 

corrosion, while the dermal sensitization study evaluates the potential for allergic contact 

dermatitis. With the exception of dermal sensitization, each acute study is assigned to a 
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Chapter 7: Precautionary Statements 7-2

toxicity category based on the study results (See Table 1 below). The results of these six 

acute toxicity studies must be known in order for the appropriate labeling language to be 

determined.

Table 1. Toxicity Categories

Study Category I Category II Category III Category IV

Acute Oral Up to and including 

50 mg/kg

> 50 thru 

500 mg/kg

> 500 thru 

5000 mg/kg

> 5000 mg/kg

Acute Dermal Up to and including 

200 mg/kg

> 200 thru 

2000 mg/kg

> 2000 thru 

5000 mg/kg

> 5000 mg/kg

Acute 

Inhalation1

Up to and including 

0.05 mg/liter

> 0.05 thru 

0.5 mg/liter

> 0.5 thru 

2 mg/liter

> 2 mg/liter

Primary

Eye Irritation

Corrosive (irreversible 

destruction of ocular 

tissue) or corneal 

involvement or 

irritation persisting for 

more than 21 days

Corneal 

involvement or 

other eye irritation 

clearing in 8-21 

days

Corneal 

involvement or 

other eye 

irritation clearing 

in 7 days or less

Minimal effects 

clearing in less 

than 24 hours

Primary

Skin 

Irritation

Corrosive (tissue 

destruction into the 

dermis and/or 

scarring)

Severe irritation at 

72 hours (severe 

erythema or 

edema)

Moderate 

irritation at 72 

hours (moderate 

erythema)

Mild or slight 

irritation at 72 

hours (no 

irritation or 

slight 

erythema)

1 4 hr exposure

C. Use of Reregistration Eligibility Decision (RED) Documents

During Reregistration, the RED document may also specify personal protective equipment, 

engineering controls and user safety recommendations. In cases where RED specifications 

differ from those determined by the acute toxicity categories, the most protective statements 

must be employed. The regulations allow use of a higher signal word for human hazard 

when necessary to prevent unreasonable adverse effects on man and the environment. 

(40 CFR 156.64(b)(1))

III. Determining the precautionary labeling

A. The Signal Word

1. When Required. A Signal Word is required for all registered pesticide products unless 

the pesticide product meets the criteria of Toxicity Category IV by all routes of 

exposure. If a signal word is used in this case, it must be “Caution”.

2. Determining the Signal Word. The Signal Word is determined by the most severe 

toxicity category assigned to the five acute toxicity studies (see table 1) or by the 
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presence of methanol in concentrations of 4% or more. The Signal Words and 

associated toxicity categories are as follows:

Toxicity Category I DANGER

Toxicity Category II WARNING

Toxicity Category III CAUTION

Toxicity Category IV None Required

Refer to the acute toxicity data review to determine the most severe toxicity category.

Also check the Confidential Statement of Formula to determine if methanol is present in 

concentrations of 4% or more. If so, the Signal Word, regardless of the toxicity 

categories noted in the acute toxicity review, is DANGER.

3. Location and Prominence. The Signal Word is required to appear on the front panel of 

the label, and the Agency requests that it appear on a separate line from the required 

Child Hazard Warning statement, Keep Out of Reach of Children (KOROC). It is 

preferred that it appear below the KOROC statement. The Signal Word is also required 

on any supplemental labeling intended to accompany the product in distribution or sale.

The Agency also requests that it appear in the Precautionary Statements section 

immediately below the subheading “Hazards to Humans and Domestic Animals”. In 

cases where the “First Aid” and “Hazards to Humans and Domestic Animals” statement 

appear on the front panel, the Agency requests that the Signal Word be placed directly 

below the Child Hazard Warning statement, but it does not have to be repeated after the 

“Hazards to Humans and Domestic Animals” statement. All required front panel 

warning statements shall be grouped together on the label, and shall appear with 

sufficient prominence relative to other front panel text and graphic material to assure 

that they will not be overlooked under customary conditions of purchase and use 

(40 CFR 156.60(b)). See Chapter 3 for the Minimum Type Size requirements for the 

Signal Word, Child Hazard Warning statement and the sample label format. The 

Agency prefers that the Signal Word appear in all capital letters and be oriented in the 

same direction as other label text.

4. Related Information. Because of the potential for confusion, the Agency historically 

has not approved labels containing the terms “caution”, “warning”, or “danger”, except 

as the Signal Word for that label (e.g., “CAUTION: Wash hands before eating, or 

smoking” on a label with the signal of “Caution”). California’s Proposition 65 may 

require the term “warning” be used on a label. However, registrants should use the term 

“notice” or “attention” instead, so that it does not conflict with the EPA required Signal 

Word.
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B. Poison – Skull and Crossbones Symbol

1. When Required. The word “POISON” and the skull and crossbones symbol are 

required for products classified as toxicity category I for acute oral, acute dermal, or 

acute inhalation toxicity studies (40 CFR 156.64(a)(1)). It is also required if the inert, 

methanol, is present at 4% or more in the subject product.

Table 2. Examples of Signal Word Determination

Type of 

Study

Product A Product B Product C* Product D Product E*

Acute Oral III IV I III III

Acute Dermal IV III III IV III

Acute 

Inhalation

III IV III III III

Primary Eye III II I I III

Primary Skin IV IV II IV III

Special Inert, 

e.g., methanol

No No No No Yes*

CORRECT 

SIGNAL 

WORD

CAUTION WARNING DANGER

(Poison with 

Skull & 

Crossbones)

DANGER DANGER

(Poison with 

Skull & 

Crossbones)

*Product C and Product E must also bear additional labeling (Skull & Crossbones symbol in close proximity 

to the word “POISON” which must appear in red on a contrasting background). Product C must bear the 

additional labeling as a result of the toxicity category I classification for the acute oral toxicity study.

Product E must bear the additional labeling because it contains a special inert (methanol) at greater than 

4%, as described in paragraph B.1. above.

2. Location and Prominence. If required, the word “POISON” and the skull and 

crossbones symbol must appear in immediate proximity to each other. The word 

“POISON” must appear in red on a background of a distinctly contrasting color. If the 

proposed label does not indicate these display requirements, include this requirement in 

your response to the registrant. In addition, the Agency requests that the “Poison” and 

the skull and crossbones symbol appear near the Tox.1 signal word “Danger”.

C. Child Hazard Warning Statement

1. When Required. The Child Hazard Warning statement, “Keep Out of Reach of 

Children” (KOROC) is required on all product labels, unless the requirement is waived.

The warning statement requirement may be waived when the registrant adequately 

demonstrates that the likelihood of contact with children during distribution, storage or 

use (e.g., an MUP in some situations) is extremely remote or if the pesticide is approved 

for use on infants or small children.
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Chapter 7: Precautionary Statements 7-5

2. Location and Prominence. The Child Hazard Warning statement must appear on the 

front panel (40 CFR 156.66). It is preferred that the Child Hazard Warning appear on a 

separate line above the Signal Word. If the Signal Word and Child Hazard Warning 

were to appear on the same line, a pesticide user could incorrectly assume that the 

Signal Word is intended primarily for children rather than as a general precaution for all 

persons. If the label under review has the signal word and Child Hazard Warning on the 

same line, request that the registrant revise the label. Also make sure that the Child 

Hazard Warning statement is oriented in the same direction as other label text.

3. Additional Information. Based on the FIFRA unreasonable adverse effects standard, 

the Agency has not allowed the Precautionary Statements or the Directions for Use to 

contain any statement which implies that the product may be used by children. For 

example, draft labels of products intended to repel insects should not contain 

instructions such as “Do not allow use by small children without close adult 

supervision”. Such labeling creates unacceptable risk issues, as it implies that a child 

can apply the product as long as an adult watches.

A modified Child Hazard Warning statement may be used for products where child 

contact is expected during normal use. For products requiring a modified statement, 

make sure that the statement is appropriate for the use pattern. Examples of appropriate 

statements are as follows:

“Do not allow children to apply product” or “Do not allow children to play 

with pet collar”.

D. Hazards to Humans and Domestic Animals Statements

1. When Required. Hazards to Humans and Domestic Animals statements are required 

when any acute toxicity study results in a product classification of toxicity category I, II, 

or III and/or when the dermal sensitization study result is positive. Hazards to Humans 

and Domestic Animals statements may specify both mandatory actions and advisory 

information.

2. Required Header. The Hazards to Humans and Domestic Animals statements must 

appear under the section heading “Precautionary Statements” and below the subheading 

“Hazard to Humans and Domestic Animals”. The Signal Word must appear before the 

precautionary paragraph. (40 CFR 156.70)

3. Location and Prominence. The Hazards to Humans and Domestic Animals section 

may appear on any panel. Please note, however, that these statements should not be 

included within the Directions For Use section. These statements should be organized so 

that the routes of exposure of most concern (severe routes of exposure) as supported by 

the toxicity category classification are listed first.
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4. Determining the Hazards to Humans and Domestic Animals Statements for 

Fumigant Products. Refer to PR Notice 84-5, Registration Standards or Reregistration 

Eligibility Decision Documents (REDs) suggested Hazards to Humans and Domestic 

Animals statements.

5. Determining the Hazards to Humans and Domestic Animals Statements for NonFumigant Products. Statements from the tables 3-8 can be selected based on the 

toxicity category assigned to each study. Statements from these tables should be 

combined to form a concise paragraph. Repetitious sentences should be omitted. In 

cases where the toxicity categories are not known, the precautionary labeling must be 

consistent with the signal word.

6. Related Information. Hazards to Humans and Domestic Animals statements must be 

appropriate for all uses on the label. These statements must be consistent with each use 

pattern listed on the label. No statement should be used that is reasonably beyond the 

control of the typical applicator. Hazards to Humans and Domestic Animals statements 

must not require use of specialized equipment which would not be readily available to 

the typical user of the product.

7. Products that contain greater than 4% Methanol. If the product contains 4% or more 

of methanol, the Agency believes that in order to mitigate potential risk the following 

statement should be added to the label:

“Methanol may cause blindness”.

Table 3. Typical Statements for Acute Oral Toxicity

Toxicity 

Category

Signal Word Statements

I DANGER-POISON

Skull & 

Crossbones 

required

Fatal if swallowed. Wash thoroughly with soap and water after 

handling and before eating, drinking, chewing gum, using 

tobacco or using the toilet.

II WARNING May be fatal if swallowed. Wash thoroughly with soap and water 

after handling and before eating, drinking, chewing gum, using 

tobacco or using the toilet.

III CAUTION Harmful if swallowed. Wash thoroughly with soap and water after 

handling and before eating, drinking, chewing gum, using 

tobacco or using the toilet.

IV CAUTION 

(optional)

No statements are required. However, the registrant may choose 

to use category III labeling.
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Table 4. Typical Statements for Acute Dermal Toxicity

Toxicity 

Category

Signal Word Statements

I DANGER-POISON

Skull & 

Crossbones 

required

Fatal if absorbed through skin. Do not get in eyes, on skin, or on 

clothing. Wash thoroughly with soap and water after handling and 

before eating, drinking, chewing gum, using tobacco or using the 

toilet. Wear (specify appropriate protective clothing). Remove and 

wash contaminated clothing before reuse.

II WARNING May be fatal if absorbed through skin. Do not get in eyes, on skin, 

or on clothing. Wash thoroughly with soap and water after 

handling and before eating, drinking, chewing gum, using tobacco 

or using the toilet. Wear (specify appropriate protective clothing). 

Remove and wash contaminated clothing before reuse.

III CAUTION Harmful if absorbed through skin. Avoid contact with skin, eyes or 

clothing. Wash thoroughly with soap and water after handling and 

before eating, drinking, chewing gum, using tobacco or using the 

toilet. Remove and wash contaminated clothing before reuse.

Wear (specify any appropriate protective clothing, if appropriate).

IV CAUTION 

(optional)

No statements are required. However, the registrant may choose 

to use category III labeling.

Table 5. Typical Statements for Acute Inhalation Toxicity

Toxicity 

Category

Signal Word Statements

I DANGER-POISON

Skull & 

Crossbones

required

Fatal if inhaled. Do not breathe (dust, vapor, or spray mist).* 

Wear (specify appropriate respiratory protection from Table 4, 

Chapter 10). Remove and wash contaminated clothing before 

reuse.

II WARNING May be fatal if inhaled. Do not breathe (dust, vapor or spray 

mist).* Wear (specify appropriate respiratory protection from 

Table 4, Chapter 10). Remove and wash contaminated clothing 

before reuse.

III CAUTION Harmful if inhaled. Avoid breathing (dust, vapor or spray mist).*

Remove and wash contaminated clothing before reuse.

IV CAUTION 

(optional)

No statements are required. However, the registrant may choose 

to use category III labeling.

* Choose the word which appropriately describes the product during use.
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Table 6. Typical Statements for Primary Eye Irritation

Toxicity 

Category

Signal Word Statements

I DANGER Corrosive.* Causes irreversible eye damage. Do not get in eyes or 

on clothing. Wear (specify appropriate protective eyewear such as 

goggles, face shield, or safety glasses). Wash thoroughly with soap 

and water after handling and before eating, drinking, chewing gum, 

using tobacco or using the toilet. Remove and wash contaminated 

clothing before reuse.

II WARNING Causes substantial but temporary eye injury. Do not get in eyes or 

on clothing. Wear (specify appropriate protective eyewear such as 

goggles, face shield, or safety glasses). Wash thoroughly with soap 

and water after handling and before eating, drinking, chewing gum, 

using tobacco or using the toilet. Remove and wash contaminated 

clothing before reuse.

III CAUTION Causes moderate eye irritation. Avoid contact with eyes or clothing.

Wear (specify protective eyewear, if appropriate). Wash thoroughly 

with soap and water after handling and before eating, drinking, 

chewing gum, using tobacco or using the toilet.

IV CAUTION 

(optional)

No statements are required. However, the registrant may choose to 

use category III labeling.

*The term “corrosive” is not required if corrosive effects were not observed during the study.

Table 7. Typical Statements for Primary Skin Irritation

Toxicity 

Category

Signal Word Statements

I DANGER Corrosive. Causes skin burns. Do not get in eyes, on skin, or on 

clothing. Wear (specify appropriate protective clothing and gloves).

Wash thoroughly with soap and water after handling and before 

eating, drinking, chewing gum, using tobacco or using the toilet.

Remove and wash contaminated clothing before reuse.

II WARNING Causes skin irritation. Do not get on skin or on clothing. Wear 

(specify appropriate protective clothing and gloves). Wash 

thoroughly with soap and water after handling and before eating, 

drinking, chewing gum, using tobacco or using the toilet. Remove 

and wash contaminated clothing before reuse.

III CAUTION Avoid contact with skin or clothing. Wash thoroughly with soap and 

water after handling and before eating, drinking, chewing gum, 

using tobacco or using the toilet. Wear (specify protective clothing 

and gloves, if appropriate).

IV CAUTION 

(optional)

No statements are required. However, the registrant may choose to 

use category III labeling.
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Table 8. Typical Statements for Dermal Sensitization

Study Results Statement

Product is a sensitizer or is positive for 

sensitization

Prolonged or frequently repeated skin contact may 

cause allergic reactions in some individuals.

Product is not a sensitizer or is negative 

for sensitization

No labeling is required for this result.

E. Personal Protective Equipment (PPE)

PPE requirements are specified for uses covered under the Worker Protection Standard 

(WPS), but there are no regulatory requirements for non-WPS products, products used by 

residents, or products intended only for manufacturing use. However, to protect human 

health, the following guidance is offered.

1. For Non-WPS (Industrial/Commercial) Uses. While there are no regulatory 

requirements that demand PPE for non-WPS products, applicators are tested on their 

comprehension regarding what types of PPE are used and how to use them correctly.

This testing implies that PPE is expected to be worn by commercial applicators. In order 

to protect human health, label reviewers are encouraged to review the toxicity data and 

the potential exposures from the product’s uses to determine whether PPE would be

necessary to meet the standards for registration. In cases where the reviewers determine 

PPE would be necessary, the various PPE tables in Chapter 10 provide information 

about which PPE is protective in specific circumstances. If there is an applicable 

regulatory document which specifies PPE requirements based on concerns specific to 

the active ingredient then those PPE requirements must be placed on the label.

2. For Products used by Residents/Consumers. In order to protect human health, label 

reviewers are encouraged to review the toxicity data and the product’s uses to determine 

whether PPE would be necessary to meet the standards for registration. In cases where 

the reviewers determine PPE would be necessary, the PPE tables in Chapter 10 provide 

information about which PPE is protective in specific circumstances. In some cases, the 

PPE indicated in these tables may need to be modified; for example, to fit the 

consumer’s ability to acquire it. For example, “shoes” may need to be substituted for 

“chemical resistant footwear” or “safety glasses” may need to be substituted for 

“protective eyewear”. If there is an applicable regulatory document which specifies PPE 

requirements based on concerns specific to the active ingredient then those PPE 

requirements must be placed on the label.
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Chapter 7: Precautionary Statements 7-10

F. First Aid Statements

1. When Required. A First Aid statement is required when any acute toxicity study result 

is classified as category I, II, or III. It is acceptable for the registrant to include First Aid 

statements for study results that are classified as category IV.

2. Appropriate Headers. The first aid statements appear under either of the following 

headings: “First Aid” or “Statements of Practical Treatment”. (PR Notice 2001-1). The

heading “First Aid” is preferred by the Agency. In addition, EPA historically has not 

allowed the heading “Antidote” in conjunction with the first aid statements unless a 

specific antidote is necessary.

3. Location and Prominence. First Aid statements shall appear on the front panel of the 

label for all products classified as toxicity category I (40 CFR 156.68). The Agency 

may, however, permit reasonable variations in the placement of the First Aid statement 

as long as the reference statement, “See First Aid (or Statement of Practical Treatment) 

on (identify appropriate panel)” appears on the front panel, preferably near “Poison” and 

the skull and crossbones. First Aid statements for toxicity categories II and III 

classification may appear on any panel of the label. However, any time First Aid 

statements appear other than on the front panel, a referral statement such as, “See 

side/back panel for First Aid” should appear on the front panel in close proximity to the 

Signal Word. Furthermore, First Aid statements on the side or back panel should be 

grouped near the other precautionary labeling text, yet set apart or distinguishable from 

the other label text. First Aid statements should be organized so that the most severe 

routes of exposure, as demonstrated by the toxicity classification, are listed first.

4. Determining the First Aid Statements for Fumigant Products. Refer to 

PR Notice 84-5 and Registration Standards/REDs.

5. Determining the First Aid Statements for Non-Fumigant Products. Review Table 9 

to determine the preferred First Aid statements for each route of exposure. Registrants 

should support alternative First Aid statements with medical evaluations of the product.

Approval of alternative First Aid statements is guided by considerations such as those 

set out in the “Content and Clarity” section below. The Agency has not approved the use 

of salt water for emesis as a first aid technique. (PR Notice 80-2).

(a) Content and Clarity. First Aid statements should be brief, clear, simple and in 

straightforward language so that the average person in an emergency can easily and 

quickly understand the instructions. First Aid statements should apply to all ages or 

when necessary, should include distinctions between the treatments for different 

ages (e.g., children vs. adults). Any reasonably competent individual should be able 

to perform the First Aid statements. These statements should not include procedures 

which must be performed by medical personnel or require specialized equipment.

Such procedures belong under the Note to Physician heading (see section G below).
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(b) Acute Dermal and Primary Skin Irritation. Because both of these studies focus 

on the dermal route of exposure, any first aid statements required by the results of 

these two studies can be combined. Use the first aid statement required for the acute 

dermal toxicity study if the results of both studies place the product in the same 

acute toxicity category. Use the statements for the more severe acute toxicity 

category if the results of the studies would place the product in different acute 

toxicity categories.

(c) Eye and Skin Irritation. If the product is corrosive and is in toxicity category I or 

II for eye or dermal irritation, then a first aid statement for ingestion may also be 

included.

6. Products that contain an organophosphate (i.e., an organophosphorus ester that 

inhibits cholinesterase) or an N-methyl carbamate (i.e., an N-methyl carbamic acid 

ester that inhibits cholinesterase). If the product contains either chemical, the following 

phrase should be included in the First Aid statement (PRN 2001-1):

“CONTAINS AN _________ (either organophosphate or N-methyl 

carbamate) THAT INHIBITS CHOLINESTERASE”.

7. Products that contain zinc phosphide. If the product contains zinc phosphide, the 

following First Aid statement is recommended (PRN 2001-1):

“If swallowed: Immediately call a Poison Control Center or doctor or 

transport the person to the nearest hospital. DO NOT DRINK WATER. Do 

not administer anything by mouth or make the person vomit unless advised to 

do so by a doctor”.

8. Products that contain petroleum distillates. If the product contains ≥10% petroleum 

distillates, the following First Aid statement should be used (PRN 2001-1):

“If swallowed: Immediately call a poison control center or doctor. Do not 

induce vomiting unless told to do so by a poison control center or doctor. Do 

not give any liquid to the person. Do not give anything by mouth to an 

unconscious person”.

However, if registrants have data to show there is benefit in drinking water or milk after

ingesting their product(s), they may submit alternate wording via amendment.

9. Telephone numbers. EPA encourages registrants to include a company telephone 

number or toll-free hotline number for emergency information in the first aid section. If 

a number is included, confusion can be avoided by placing emergency numbers with the 

“First Aid” or “Hot Line Number” text. If a number is included, it should include a 
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Chapter 7: Precautionary Statements 7-12

phrase or statement indicating the kinds of information the number should be used for

and it may include hours of service. For example:

“Have the product container or label with you when calling a poison control 

center or doctor, or going for treatment. For emergency information on 

(product, usage, etc.), call (1-XXX-XXX-XXXX), Monday through Friday, 9 a.m. 

to 5 p.m. After 5 p.m. call your poison control center at 1-800-222-1222”.

If a registrant does not have its own number, the registrant may use the National 

Pesticides Information Center (NPIC) 800 number (see below).

Table 9. First Aid Statements

Route of Exposure 

and Toxicity Category

First Aid Statement

Ingestion treatment for 

acute oral toxicity 

categories 1, 2, and 3

If swallowed:

– Call a poison control center or doctor immediately for treatment 

advice.

– Have person sip a glass of water if able to swallow.

– Do not induce vomiting unless told to by a poison control center or 

doctor.

– Do not give anything to an unconscious person.

Acute oral toxicity 

category 4

Statement is not required. Registrants may use toxicity category 1-3 

statements if they choose.

Skin exposure treatment 

for acute dermal 

toxicity, and irritation 

categories 1, 2, and 3

If on skin:

– Take off contaminated clothing.

– Rinse skin immediately with plenty of water for 15-20 minutes.

– Call a poison control center or doctor for treatment advice.

Dermal and skin 

irritation toxicity 

category 4

Statement is not required. Registrants may use toxicity category 1-3 

statements if they choose.

Inhalation treatment for 

acute toxicity categories 

1, 2, and 3

If inhaled:

– Move person to fresh air.

– If person is not breathing, call 911 or an ambulance, then give artificial 

respiration, preferably mouth-to-mouth if possible.

– Call a poison control center or doctor for further treatment advice.

Inhalation toxicity 

category 4

Statement is not required. Registrants may use toxicity category 1-3 

statements if they choose.

Eye exposure treatment 

for eye irritation 

categories 1, 2, and 3

If in eyes:

– Hold eye open and rinse slowly and gently with water for 15-20 

minutes. Remove contact lenses, if present, after the first 5 minutes, 

then continue rinsing.

– Call a poison control center or doctor for treatment advice.

Eye irritation toxicity 

category 4

Statement is not required. Registrants may use toxicity category 1-3 

statements if they choose.
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Route of Exposure 

and Toxicity Category

First Aid Statement

General information to 

include either near the 

first aid statement or 

emergency phone 

number

– Have the product container or label with you when calling a poison 

control center or doctor or going for treatment.

– For emergency information on (product, use, etc.), call the National 

Pesticides Information Center at 1-800-858-7378, 6:30 AM to 4:30 PM 

Pacific time (PT), seven days a week. During other times, call the 

poison control center 1-800-222-1222.

10. National Pesticides Information Center. Regarding the General Information provided 

under the First Aid statements section (Table 9), the emergency phone number could be 

the National Pesticides Information Center’s 800 number. The section could read:

“Have the product container or label with you when calling a poison control 

center, doctor, or going for treatment. For emergency information concerning 

this product, call the National Pesticides Information Center (NPIC) at 

1-800-858-7378 seven days a week, 6:30 am to 4:30 pm Pacific Time (NPIC 

Web site: www.npic.orst.edu)”.

G. Note to Physicians

1. When Used. The Note to Physician is not required nor mentioned in the 40 CFR. If the 

label under review is for a product which is a fumigant, refer to PR Notice 84-5 or

relevant Registration Standards or REDS for the appropriate Note to Physician. For all 

other products, EPA currently uses a Note to Physician as specified in the 1984 

proposed rule for the following types of products:

(a) All products that are classified as toxicity category I.

(b) Products which are corrosive or classified as toxicity category I for eye or skin.

These products must include the following Note to Physician: “Probable mucosal 

damage may contraindicate the use of gastric lavage”.

(c) Products which contain ≥ 10% petroleum distillate should include the following 

Note to Physician: “Contains petroleum distillate. Vomiting may cause aspiration 

pneumonia”.

(d) Products which produce physiological effects requiring specific antidotal or medical 

treatment such as: Cholinesterase Inhibitors (e.g., carbamates and phosphorothioates, 

and organophosphates); Metabolic Stimulants (e.g., dichlorphenols); Anticoagulants 

(e.g., warfarin).
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2. Location and Prominence. The Note to Physician should be located in close proximity 

to the First Aid statement, but should be clearly distinguished from it. In other words, it 

should not be placed within the First Aid statement, but should appear below the last 

First Aid statement.

3. Contents of Note. The Agency does not provide specific Notes to Physicians except for 

toxicity category I eye and skin irritants. However, the Agency does provide the 

following guidance concerning the content of Notes to Physicians. Check the label 

under review to make certain that it addresses the following information:

► technical information on symptomatology;

► use of supportive treatments to maintain life functions;

► medicine that will counteract the specific physiological effects of the pesticide;

► company telephone number to specific medical personnel who can provide 

specialized medical advice.

IV. Labeling options

A. Use Dilutions (Aqueous Solutions only)

1. When Used. Additional Hazards to Humans and Domestic Animals and First Aid 

statements which correspond with the toxicity categories associated with a product’s use 

dilution may be allowed on product labels provided the conditions below are 

satisfactorily addressed. Following is guidance for the submission and review of such 

data and for the content and placement of associated labeling.

2. Data Requirements. All data and draft labeling for use dilution Hazards to Humans and 

Domestic Animals statements should be sent to the appropriate Product Manager with a 

request for pesticide amendment. In some cases, use dilution labeling statements 

triggered by systemic toxicity (acute oral, dermal or inhalation toxicity) may be 

supported by extrapolation from the LD50/LC50 for the concentrate. At a minimum the 

following is required to even consider extrapolating toxicity categories. This 

information must be submitted by the Registrant with the extrapolation request.

(a) A slope calculated from at least three, and preferably more, dose levels having 

partial responses (i.e., a well characterized dose-response);

(b) Dose groups sufficiently large (>5 per group) to allow for the calculation of 

confidence limits that fall within the defined Toxicity Category boundaries;

(c) Extrapolation to higher toxicity categories will only be applied to water dilutions. It 

should also be determined that there are no other factors affecting the toxicity of the 
Label Review Manual

Chapter 7: Precautionary Statements 7-15

EP (e.g., inerts that enhance the absorption of the active ingredient, promote the 

active ingredient’s toxicity, etc.). Other types of extrapolations will be done on a 

case by case basis.

(d) Use dilution Hazards to Humans and Domestic Animals statements triggered by 

skin or eye irritation must be supported by new or cited studies. If another 

registered diluted product (such as a ready-to-use formulation) has acceptable data 

and is found similar to the concentrated product after it has been diluted, those data 

may also be used to support revised labeling.

3. Labeling Requirements. It is not EPA’s intent to allow dual sets of Hazards to Humans 

and Domestic Animals statements and/or First Aid statements on the label. Rather, EPA 

will allow certain modified statements to be added that are applicable to the most 

concentrated use dilution only. (40 CFR 156.68(b)) These additional statements 

(triggered by the toxicity category of the most concentrated use dilution) must be placed 

directly after the required statements for the concentrate. The following are some 

examples (in italics) of how use dilution labeling could appear on product labeling:

Hazards to Humans and Domestic Animals:

“Causes substantial but temporary eye injury. Do not get in eyes or on clothing.

Wear goggles or face shield. After product is diluted in accordance with the 

directions for use, goggles or face shield are not required”.

First Aid:

“If on skin: Wash with plenty of soap and water. Get medical attention. If product, 

diluted in accordance with the directions for use, gets on skin, medical attention is 

not required”.

B. Optional Labeling/Deviations

1. Optional Hazards to Humans and Domestic Animals Statements. Registrants may 

submit Hazards to Humans and Domestic Animals statements which reflect specific 

hazards. (40 CFR 156.70(c)) Such requests must be supported by data (or substantive 

justification), and should be routed to label reviewers or the Chemistry and Exposure 

Branch (for PPE). For example, the statements “Do not remove contact lenses, if worn.

Get immediate medical attention”. would not be approved by the Agency without 

supporting data or rationale.

2. Toxicity Category IV Precautionary Labeling. If the product is all toxicity 

category IV (non-sensitizer), precautionary labeling statements are normally not 

required. However, if registrants desire to place precautionary labeling on such a 

product they may do so. To promote labeling consistency it is recommended that the 

registrant use precautionary statements triggered by toxicity category III. Registrants 
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Chapter 7: Precautionary Statements 7-16

may propose alternate labeling which should be reviewed by precautionary labeling 

reviewers.

3. Me-Too Deviations. If a me-too product is citing a product that has optional use 

dilution hazard statements on the label, those statements are not required on the me-too 

if the acute toxicity data results are available. Questions about the availability of the 

acute studies should be referred to the precautionary labeling reviewers.
Additional photo credits 

▲USDA ARS,

Bruce Fritz

▲National Garden 

Bureau

▲Public domain ▲USDA NRCS,

Lynn Betts

▼USDA ARS

▼istock.com, 

rights reserved ▼USDA NRCS

▼istock.com, 

rights reserved