[Federal Register Volume 60, Number 85 (Wednesday, May 3, 1995)]
[Proposed Rules]
[Pages 21965-21968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10876]



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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.

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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, [email protected] or 
[email protected].

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 [[Page 21966]] 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 [[Page 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 post-application 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.

    [[Page 21968]] 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 post-
application 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 
registrant-verified 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 stop-sale 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