[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, 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 [[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
