Federal Register / Vol. 60, No. 85 / Wednesday, May 3, 1995 / Proposed Rules 21965

private sector. In fact, this action

actually involves a reduction in burden

and overall cost.

In addition to the consultations prior

to proposal, EPA has had several

informal consultations regarding the

proposed rule with some States through

the EPA regional offices and at regularly

scheduled State meetings. No significant

issues or information were identified as

a result of EPA’s discussion with the

States.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Labeling, Occupational safety and

health, Pesticides and pest.

Dated: April 24, 1995.

Lynn R. Goldman,

Assistant Administrator for Prevention,

Pesticides and Toxic Substances.

[FR Doc. 95–10873 Filed 5–2–95; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 156

[OPP–00399A; FRL–4950–8]

Worker Protection Standard; Reduced

Restricted Entry Intervals for Certain

Pesticides

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Policy Statement.

SUMMARY: EPA is issuing a final policy

statement on ‘‘Reduced Restricted Entry

Intervals for Certain Pesticides.’’ EPA

will allow registrants to reduce the

interim Worker Protection Standard

(WPS) restricted entry intervals (REIs)

from 12 to 4 hours for certain low risk

pesticides. EPA developed a two Tiered

screening process to determine the

eligibility of all Toxicity Category III

and IV pesticides. The first Tier

screened all Toxicity III and IV active

ingredients against the low toxicity

criteria. This policy statement contains

a candidate list of those active

ingredients that meet the low toxicity

criteria, and may be eligible for reduced

REIs. End use products containing

active ingredients that appear on the list

are to be evaluated by the criteria set in

the second Tier of the screening process,

described in this policy, to determine if

the current REI may be reduced to 4

hours.

EFFECTIVE DATE: This policy will become

effective May 3, 1995.

FOR FURTHER INFORMATION CONTACT: Judy

Smith or Ameesha Mehta, Office of

Pesticide Programs (7506C),

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location, telephone number, and

e-mail address: 1921 Jefferson Davis

Highway, Crystal Mall #2, Rm. 1121,

Arlington, VA, (703) 305–7371,

smith.judy@epamail.epa.gov or

mehta.ameesha@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: The

Agency is issuing a final policy

statement that allows registrants to

reduce the current interim Worker

Protection Standard (WPS) restricted

entry intervals (REIs) from 12 to 4 hours

for certain low risk pesticides. This

policy is one of a series of Agency

actions since the publication of the final

WPS in August 1992. In addition, EPA

is also publishing final actions

regarding: (1) Worker training

requirements; (2) allowing early entry

for irrigation activities; (3) allowing

provisions for limited contact activities;

and, (4) reduced requirements for crop

advisors. Final determinations on the

other four actions mentioned above are

being published elsewhere in this issue

of the Federal Register.

I. Summary of the Policy

EPA will permit registrants to reduce

the current interim WPS REIs from 12

to 4 hours for pesticides which contain

specific active ingredients and which

meet certain additional criteria. Using

the criteria described in Unit III of this

policy statement, the Agency screened a

total of 495 active ingredients and

determined that over 100 active

ingredients met the low toxicity criteria.

As a result, end use products containing

these active ingredients may be eligible

for a reduced REI. Unit IV of this policy

statement lists the candidate active

ingredients that the Agency has

determined meet the low toxicity

criteria.

Registrants of end use products which

are subject to WPS, and which contain

only these active ingredients may apply

the criteria in Unit VI of this policy

statement to determine whether their

end use product qualifies for the

reduced REI. To revise labeling to reflect

the reduced REI, the Agency will allow

registrants to use a streamlined

notification process process which is

described in this policy statement until

December 31, 1995. After that date,

registrants must use the existing

registration label amendment process to

submit an application for a reduced REI.

Such applications would be evaluated

and approved on the basis of the criteria

provided in this policy statement.

If the Agency becomes aware of

information and determines at any time

that the reduced REI is not appropriate,

EPA will inform and, after opportunity

for discussion, may direct the registrant

to revise the REI on the label.

If any person believes that an active

ingredient, not listed as a candidate for

reduced REI in Unit IV of this policy

statement, meets the low toxicity

criteria of this policy statement, and that

the end use products containing that

active ingredient should be eligible for

a reduced REI, the registrant should

contact EPA at the address provided in

the FOR FURTHER INFORMATION

CONTACT unit.

II. Background

The 1992 WPS established an interim

minimum REI of 12 hours for all end

use pesticide products for agricultural

uses. Longer interim REIs were

established for more toxic products.

Many commenters, during the

promulgation of the rule, stated that it

was difficult to determine when the

sprays have dried or dusts have settled;

thus, judgment was required to assess

when such REI had expired. Other

commenters requested the Agency

establish minimum REIs to protect

workers against possible unknown

chronic or delayed health effects as a

product-specific health effect evaluation

would take the Agency a long time to

conduct. Therefore, the 12-hour

minimum REI was established for two

reasons: (1) To replace previous REI

which was the statement ‘‘when sprays

have dried and dusts have settled’’; and

(2) to incorporate a margin of safety for

unknown chronic or delayed health

effects.

Since 1992, numerous registrants and

pesticide users have asked EPA to

consider reducing the minimum 12–

hour REI for lower toxicity products that

they believe do not need a 12–hour REI

to protect workers. In response to these

concerns, on January 11, 1995, the

Agency published a proposal (60 FR

2848) for public comment. The January

proposal contained 75 candidate active

ingredients that were eligible for 4–hour

REIs. Many comments stated that all

Toxicity Category III’s and IV’s should

be included on the list. EPA screened a

total of 495 WPS in-scope active

ingredients, and has added 39 more

active ingredients to the candidate list.

III. Policy and Rationale for Low

Toxicity Criteria

The 1992 WPS revised a 1974

regulation that expressed REIs in terms

of the statement ‘‘when sprays have

dried and dusts have settled.’’ This

phrasing was sufficiently vague to cause

both enforcement problems and

concerns about necessary margins of

safety for chronic or delayed health
21966 Federal Register / Vol. 60, No. 85 / Wednesday, May 3, 1995 / Proposed Rules

effects. The 1992 revision addresses

these problems and concerns by

establishing an interim minimum REI of

12 hours for all end use pesticide

products for agricultural uses. The 12–

hour figure was applied because data

indicated that many of the residue

concerns were not present after 12

hours.

The 12–hour default covers a very

large number of active ingredients, with

only active ingredients in Toxicity

Categories I and II (more toxic) having

longer REIs under the WPS. Some of the

active ingredients subject to the 12–hour

REI, however, have such low levels of

toxicity as to pose minimal risk to

workers, even if a fair degree of

exposure occurred. These active

ingredients are classified as: microbial

pesticides (living organisms, including

protozoa, fungi, bacteria, and viruses);

biochemical pesticides (materials that

occur in nature and possess a non-toxic

mode of action to the target pest(s); and

certain conventional agricultural

chemicals.

Therefore, EPA developed screening

criteria to identify those active

ingredients with low toxicities from the

universe of all Toxicity Categories III

and IV active ingredients covered by the

WPS. The Agency was concerned that

the active ingredient should not be

acutely toxic and have no other

associated developmental, reproductive,

neurotoxic, or carcinogenic effects.

Additionally, the active ingredient

should not be a cholinesterase inhibitor

(N-methyl carbamate and

organophosphate) since those chemicals

are known to cause a large number of

pesticide poisonings and have the

potential for serious neurological

effects. Finally, no adverse incident data

must be present for those active

ingredients.

For the few active ingredients where

limited data were available, EPA

evaluated data on chemically similar

active ingredients (analogs which EPA

believes are predictive of the toxicity of

those active ingredients) and used that

data as a surrogate. Examples of such

active ingredients are , 2,4-D Isopropyl,

and 2,4-D, Isooctyl(2-octyl).

The Agency believes that reducing the

REIs for pesticides which meet the

criteria below would still provide

adequate protection to workers.

Moreover, reducing the REI would

provide agricultural producers with

greater flexibility and may promote the

use of these inherently less toxic

products over those with greater risks

and longer REIs. The Agency concludes

that the modification of the REIs will

not result in unreasonable risk to

workers.

Accordingly, the Agency established

the following criteria to select the active

ingredients with low toxicity, which

would be eligible for shorter REIs.

1. The active ingredient is in Toxicity

Category III or IV based upon data for

acute dermal toxicity, acute inhalation

toxicity, primary skin irritation, and

primary eye irritation. Acute oral

toxicity data were used if no acute

dermal data were available. If EPA

lacked data on primary skin irritation,

acute inhalation, or primary eye

irritation of the active ingredient, in

question the Agency reviewed data on

that end-point for similar active

ingredients (analogs). If the analog was

in Toxicity Category I or II, EPA

excluded such active ingredients from

consideration for the reduced REI.

2. The active ingredient is not a

dermal sensitizer (or in the case of

biochemical and microbial active

ingredients, no known reports of

hypersensitivity exist).

3. The active ingredient is not a

cholinesterase inhibitor (N-methyl

carbamate or organophosphate) as these

chemicals are known to cause large

numbers of pesticide poisonings and

have the potential for serious

neurological effects.

4. No known reproductive,

developmental, carcinogenic, or

neurotoxic effects have been associated

with the active ingredient. If active

ingredients did not have data available

for these chronic health effects, EPA

considered data on appropriate

chemical and biological analogs. Active

ingredients that have been classified as

carcinogenic in Category B (probable

human carcinogen) or Category CQ*

(possible human carcinogen, for which

quantification of potential risk is

considered appropriate), or are

scheduled for EPA’s Health Effects

Division Cancer Peer Review process,

were omitted from consideration.

5. EPA does not possess incident

information (illness or injury reports)

that are ‘‘definitely’’ or ‘‘probably’’

related to post-application exposures to

the active ingredient.

6. Some active ingredients are not

included in Unit IV of this policy

statement because they have been the

subject of a reregistration eligibility

decision document (RED) which

concluded that a 12–hour or longer REI

was necessary to protect workers. Active

ingredients with REIs established during

the recent reregistration activities are

not eligible for reduced REIs through the

notification process. Although a RED

has been completed on Glyphosate, the

REI for Glyphosate was set utilizing end

use product data, and hence, the Agency

will add it to the candidate active

ingredient list. However, the registrant

for those end use products must meet

criteria listed in Unit VI of this policy

statement to be eligible for a 4–hour REI

reduction.

It should also be noted that WPS does

not apply to pheromones used in insect

traps.

IV. Candidate Active Ingredients

Meeting Low Toxicity Criteria

The following is a list of 114 active

ingredients currently subject to the WPS

requirements that meet the lower

toxicity criteria.

Acetylchitin

Agrobacterium radiobacter

Ampelomyces quisqualis isolate M-10

Azadirachtin (neem extract)

B.t. subsp. aizawai

B.t. subsp. aizawai strain GC-91

B.t. subsp. israelensis

B.t. subsp. kurstaki

B.t. subsp. kurstaki HD-263

B.t. subsp. kurstaki strain EG2348

B.t. subsp. kurstaki strain EG2371

B.t. subsp. kurstaki strain EG2424

B.t. subsp. san diego

B.t. subsp. tenebrionis

Bacillus popilliae and B. lentimorbus

Bacillus sphaericus

Bacillus subtilis GB03

Bacillus subtilis MBI 600

BNOA (b-naphythoxy acetic acid)

Borax

Calcium hypochlorite

Calcium oxytetracycline

Calcium thiosulfate

Candida oleophila

Capsicum oleoresin

Checkmate peach twig borer pheromone

Chitosan

Chlorsulfuron

Colletotricum gleosporoides

Copper as ammonia complex

Copper salts of fatty acids

Cytokinin

2,4-DB, isooctyl

Diatomaceous earth

Disodium octaborate tetrahydrate

Disparlure

Ethylene

Ethoxyquin

Farnesol

Fatty acids, C8-12, Methyl esters

Fenridazone-potassium

Fluazifop-butyl

Fluazifop-r-butyl

Gibberellic acid

Gibberellins A4 and A7

Gliocladium virens G-21

Glyphosate, ammonium

Glyphosate, isopropylamine

Glyphosate, sodium

Gossyplure: hexadecadien-1-ol acetate

Gypsy moth npv

Heavy aromatic naphtha

Imazethapyr

Imazethapyr, ammonium salt

Indole-3-butyric acid

Lagendidium giganteum, mycelium

Mefluidide, diethanolamine

Mefluidide, potassium salt

Methyl nonyl ketone
Federal Register / Vol. 60, No. 85 / Wednesday, May 3, 1995 / Proposed Rules 21967

Metsulfuron-methyl

Milky spore

Mineral oil

Muscalure, component of (e)-9-tricosene

Muscalure, component of (z)-9-tricosene

N-6-Benzyladenine

NAA, Ethyl ester

Nerolidol

Nicosulfuron

Nosema locustae

Octyl bicycloheptenedicarboxamide

Oxytetracycline hydrochloride

Paradichlorobenzene

Paraffin oils

Periplanone B

Polyhedral inclusion bodies of Autographa

californica

Polyhedral inclusion bodies of Heliothis

zea NPV or Helicoverpa zea NPV

Polyhedral inclusion bodies of beet

armyworm npv

Polyhedral inclusion bodies, Neodiprion

sertifer NVP

Potassium gibberellate

Promalin

Pseudomonas cepacia type wiscons.

Pseudomonas fluorescens

Pseudomonas fluorescens A506

Pseudomonas fluorescens EG–1053

Pseudomonas fluorescens strain NCIB

12089

Pseudomonas syringae

Puccinia canaliculata (Schweinitz)

Rimsulfuron DPX–E9636

Ryania speciosa

Ryanodine

s-Kinoprene

s-Methoprene

Sesame plant, ground

Siduron

Silica gel

Silicon dioxide

Sodium carboxymethylcellulose

Sodium metaborate

Soybean oil

Streptomyces griseoviridis

Streptomycin

Streptomycin sesquisulfate

Sulfometuron-methyl

Thifensulfuron-methyl

Thiobencarb

Tomato pinworm (e)-4-tridecen-1-yl acetate

Tomato pinworm (e)-11-tetradecenyl

acetate

Triasulfuron

1-Triacontanol

Trichoderma harzianum var. rifai (KRL–

AG2)

Trichoderma harzianum (ATCC 20476)

Trichoderma polysporum (ATCC 20475)

Tussock moth npv

V. Procedure for Adding Active

Ingredients To List

If a registrant believes an active

ingredient not on the candidate list

meets the criteria set forth in Unit III of

this policy statement, and that end use

products containing that active

ingredient should be eligible for a

reduced REI, the registrant should

contact EPA at the address given in the

FOR FURTHER INFORMATION

CONTACT unit, before December 31,

1995. To be considered for a reduced

REI, the active ingredient must meet the

criteria outlined in this policy, based

upon studies determined by the Agency

to be acceptable. To use the streamlined

notification process, the registrant is

required to submit the studies or cite

their MRID numbers and provide copies

of Agency reviews that confirm that the

criteria are met.

If a registrant believes a new active

ingredient may meet the criteria set

forth in Unit III of this policy statement,

the registrant should request that EPA

apply the screening criteria for the

reduced REI and reference this policy in

the application for registration.

Registrants having pending applications

may also request the reduced 4–hour

REI by amending their application for

registration. The registrant must also

cite this policy and indicate that a

reduced REI of 4 hours is being sought.

Such pending applications will be

considered against the criteria of this

policy statement, and, if acceptable, will

be permitted the reduced REI. The

screening criterion for incident data

would not apply to new active

ingredients.

If a registrant wishes to add a new

WPS use to an existing WPS product,

and the active ingredient and product

would qualify for a 4–hour REI, the

registrant must use the standard label

amendment process.

After December 31, 1995, registrants

must use the existing label amendment

process to request a reduction in a REI.

In the future, the Agency will continue

to apply the lower toxicity criteria to

identify active ingredients which may

be eligible for the 4–hour REI during

both registration and reregistration

process. The Agency will update the list

of the candidate active ingredients

periodically.

VI. Procedures for Determining

Eligibility of End-Use Products

If the registrant wishes to qualify for

REI reduction of an end use product(s)

that contains any active ingredient(s)

included on the candidate list in Unit IV

of this policy statement or any

subsequent update, the registrant is

responsible for determining if that end

use product(s) qualifies. To qualify, the

following criteria must be met:

1. The end-use product is in Toxicity

Category III or IV for all of the following

acute toxicity studies: acute dermal

toxicity, acute inhalation toxicity,

primary skin irritation, and primary eye

irritation.

2. Based on the required sensitization

or hypersensitivity studies, the end use

product is not a sensitizer and there

have been no reports of

hypersensitivity.

3. The registrant has no data

indicating, and is not aware of, adverse

health effects associated with the end

use product, e.g., carcinogenicity,

neurotoxicity, developmental effects, or

reproductive effects.

4. The registrant is not aware and has

not been informed of incident

information (illness or injury reports)

that are ‘‘definitely’’ or ‘‘probably’’ (as

defined by the California Incident

Reporting System) related to postapplication exposures to the product.

VII. Procedure for Notification/

Certification

A. Notification Statement

If a registrant determines that an end

use product qualifies for a reduced REI,

the registrant may notify EPA using the

following streamlined notification

procedure. The registrant would submit,

for each product, to the Agency, Office

of Pesticide Programs, Registration

Division:

1. An Application for Registration

(EPA Form 8570–1), identified as a

notification under this policy.

2. One copy of the current product

label, clearly marked to highlight the

interim WPS REI.

3. Two copies of a revised label,

clearly marked to highlight the revised

REI.

4. In order to certify to the Agency

that the end use product meets all of the

criteria outlined above, the registrant

must submit the following proof

required to demonstrate that the product

is eligible for the reduced REI:

i. The registrant must submit the

required studies, and cite the MRID

numbers for all studies submitted. EPA

need not have completed reviews of

these studies.

ii. If EPA has permitted the use of

studies performed on a substantially

similar end use product (analog) to

fulfill the acute toxicity data

requirements, then the registrant must

submit proof that EPA has accepted

such data to satisfy end use product

data requirements.

iii. If EPA has waived a data

requirement for one or more of the

required studies, the registrant must

submit proof that the requirement for

data was waived.

Note: All studies required for evaluating

the acute dermal, acute inhalation, eye

irritation, skin irritation or skin sensitization/

hypersensitization on the end use product

must have been submitted, cited, or waived

by EPA; only then, can the REI be reduced

for the end use product under this

notification procedure.
21968 Federal Register / Vol. 60, No. 85 / Wednesday, May 3, 1995 / Proposed Rules

5. The following certification

statement:

I certify that this notification is complete

in accordance with the provisions of EPA’s

reduced REI policy and that no other changes

have been made to the labeling or the

confidential statement of formula of this

product. I further understand that if this

notification does not comply with the terms

of EPA’s reduced REI policy, this product

may be in violation of the Federal

Insecticide, Fungicide and Rodenticide Act

(FIFRA) and I may be subject to enforcement

action and penalties under sections 12 and

14 of FIFRA. I understand that the Agency

may direct a change in the REI of a product

subject to this notice if the Agency

determines that a change is appropriate, and

that products may be subject to regulatory

and enforcement action if the appropriate

changes are not made.

Notifications should be sent to:

U.S. Postal Service Deliveries,

Document Processing Desk (WPS:95–

1), Office of Pesticide Programs

(7504C), Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460–0001.

Personal/Courier Service Deliveries

(Monday thru Friday, 8 a.m. to 4:30

p.m. except Federal holidays),

Document Processing Desk (WPS:95–

1), Office of Pesticide Programs

(7504C), Environmental Protection

Agency, Rm. 266A, Crystal Mall 2,

1921 Jefferson Davis Highway,

Arlington, VA 22202.

B. Final Printed Labeling

For each product, final printed

labeling must be submitted either as

part of the notification or separately in

accordance with PR Notice 82–2, before

the product may be distributed or sold.

VIII. Sale and Distribution of Pesticide

Products Qualifying for a Reduced REI

After the registrant has submitted the

information and certification specified

in Unit VII of this document, the

registrant may sell or distribute

products bearing the registrant-certified

revised labeling that was submitted to

the Agency.

Such registrants may revise labeling

of products already in channels of trade

through stickering or full relabeling.

Stickering, or full relabeling, may occur

at sites where product is not under

direct registrant control (such as

distribution or retail sites) by any

person the registrant designates and

without registration of the site as a

pesticide producing establishment.

However, the registrant retains full

responsibility for ensuring that such

labeling modifications are carried out

correctly.

IX. Agency Determination to Revise the

REI

FIFRA section 6(a)(2) requires that

registrants submit to the Agency

‘‘additional factual information

regarding unreasonable adverse effects

on the environment of the pesticide.’’

Registrants may become aware of

information or data concerning adverse

effects, illnesses or injury associated

with exposure of an agricultural worker

to a pesticide product or its use,

including those resulting from postapplication exposures. The Agency

generally regards this information as

relevant to the Agency’s on-going

assessment of the risks associated with

pesticide products.

If, on the basis of information

received from a registrant or other

sources, the Agency determines that the

REI should be increased, the Agency

will inform the registrant of that

determination and of the new REI to

replace the existing REI. The Agency

will also inform the registrant at that

time of actions, if any, that must be

taken with respect to existing stocks of

product labeled with a 4–hour REI.

Reregistration decisions or decisions

resulting from other Agency review

processes may supersede this policy

statement. Please note that REIs

established through the streamlined

notification procedure in this policy are

considered to be interim REIs. Once an

active ingredient has gone through the

reregistration process, it may result in

an active ingredient either being

removed or added to the candidate list,

and a subsequent change in the length

of the REI.

X. Compliance

Registrants are responsible for the

content and accuracy of labeling and for

compliance with labeling requirements.

The Agency will monitor selected

submissions to verify compliance with

the required criteria in this policy

statement. Registrants that submit

notifications which do not comply with

this policy or EPA’s requirements may

be subject to enforcement action under

FIFRA sections 12 and 14.

Registrants electing to sell or

distribute products bearing registrantverified revised labeling are responsible

for correcting any errors on the

proposed label. In most cases,

incorrectly reducing the REI from 12

hours to 4 hours would be considered

a serious error possibly requiring stopsale orders, recalls, or civil penalties. A

serious error is one which may create a

potential for harm to workers, handlers,

or other persons, or the environment, or

when the errors prevent achievement of

the basic goals of the WPS or FIFRA.

XI. Public Docket

A record has been established for this

policy statement under docket number

‘‘OPP–00399’’ A public version of this

record, which does not include any

information claimed as confidential

business information, is available for

inspection from 8 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

Rm. 1132, Office of Pesticide Programs

(7506C), Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Highway, Arlington, VA.

XII. Consultations

A. Executive Order 12866

This action was submitted to the

Office of Management and Budget

(OMB) for review under Executive

Order 12866 (58 FR 51735, October 4,

1993). Any comments or changes made

during OMB’s review have been

documented in the public record.

B. Unfunded Mandates Reform Act

Pursuant to Title II of the Unfunded

Mandates Reform Act of 1995, which

the President signed into law on March

22, 1995, EPA has assessed the effects

of this administrative decision on State,

local, and tribal governments, and the

private sector. This action does not

result in the expenditure of $100

million or more by any State, local or

tribal governments, or by anyone in the

private sector. In fact, this action

actually involves a reduction in burden

and overall cost.

In addition to the consultations prior

to proposal, EPA has had several

informal consultations regarding the

proposed rule with some States through

the EPA regional offices and at regularly

scheduled State meetings. No significant

issues or information were identified as

a result of EPA’s discussion with the

States.

List of Subjects in 40 CFR Part 156

Environmental protection, Labeling,

Occupational safety and health,

Pesticides and pest, Reporting and

recordkeeping requirement.

Dated: April 26, 1995.

Daniel M. Barolo,

Director, Office of Pesticide Programs.

[FR Doc. 95–10876 Filed 5–3–95; 8:45 am]

BILLING CODE 6560–50–F