EPA 730-N-O1-002
1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
" WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND
T, ~ ^ „ TOXIC SUBSTANCES
Fax On Demand
Item Number
January, 8 2001
PESTICIDE REGISTRATION (PR) NOTICE 2001-2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS, AND
REGISTRANTS OF PESTICIDE PRODUCTS
ATTENTION: Persons Responsible for the Registration and Reregistration of Pesticides
SUBJECT: Acute Toxicity Data Requirements For Granular Pesticide Products, Including
Those With Granular Fertilizers in the Product.
v
This PR Notice announces guidance intended to streamline the acute toxicity review and
classification process for certain granular pesticide products, including those products that
contain granular fertilizers. Based on OPP's extensive experience with granular pesticide
products, the Agency believes that an effective precautionary labeling policy can be
implemented without testing of each individual product. Please refer to Section IV on how
OPP will implement this guidance. This guidance is supported by a large toxicology data base
and involves the application of sound scientific principles. This guidance should achieve the
following objectives: (1) significantly reduce the number of animals subject to testing; (2)
reduce the use of Agency resources while maintaining protection of the public health and
environment; and (3) decrease the time required to register qualifying granular pesticide
products. This notice is effective immediately, but comments will be accepted for 30 days,
after which the Agency may revise the notice.
I. Background
FIFRA and Agency regulations require that each pesticide product bear on the label
danger, warning or caution statements. The signal word and precautionary statements are
based on the acute toxicity category of the pesticide, which is designed to protect the public
health. This labeling informs pesticide users/workers of the acute health hazards from
exposure to the pesticides and what precautions should be taken to mitigate adverse effects. To
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determine the appropriate human hazard signal word and label instructions the Agency
evaluates six acute toxicological studies: acute oral toxicity (870.1100), acute dermal toxicity
(870.1200), acute inhalation toxicity (870.1300), eye irritation (870.2400), dermal irritation
(870.2500) and dermal sensitization (870.2600). The Series 870 numbers are the new
guideline numbers which previously appeared in 40 CFR 158.340 as guidelines § 81-1 through
§ 81-6.
Pesticide products are generally composed of the active ingredient(s) and inert
ingredient(s). This notice refers to those granular pesticide products that are composed of a
registered source product at less than 10% active ingredient, one or more clearly recognized
innocuous (List 4) inert carrier(s) and/or a fertilizer component(s) at greater than 90% and a
sticker/binder (5% of the formulation). Innocuous inerts (List 4) are carriers that are
considered to be chemically inactive based on available information and experience. Inerts hi
this category include corncobs, clay, limestone, sand or food, etc.
This policy only applies to granular pesticide products and granular fertilizer pesticide
products. The Agency will not extrapolate for other products, because; 1) the LD50 is
imprecise (dilution does not always equal reduced toxicity); 2) a complete dose response curve,
required at a minimum, is rarely available; and 3) the Agency does not have a database that
indicates that dilution always means reduced toxicity.
H. Products Affected By the Guidance
A. Granular Pesticide Products
For purposes of this guidance, the Agency defines granular pesticide products to
include those products composed of less than 10% of a registered active ingredient(s), greater
than 90% of List 4 inert carriers) (corn cobs, clay, limestone, sand, food) and a minimal
amount of sticker/binder (5% or less of the formulation).
If the acute toxicity profile of the registered source product(s) is in Category III or IV
for all endpoints, then the proposed pesticide product may use the acute toxicity profile of the
registered source product.
In addition, for systemic toxicity (i.e. acute oral, dermal and inhalation) endpoints, it is
acceptable to extrapolate Category ffl data down to Category IV. This extrapolation for acute
systemic toxicity is based on dilution. The assumption is that the innocuous inert does not
contribute to the toxicity, and thus acts as a diluent. If an extrapolated dose is borderline
between two toxicity categories, the Agency will label with the more restrictive toxicity
category.
If the primary eye and dermal irritation effects are classified in Category III and/or IV,
the categories of the source registered product may be used for the proposed pesticide product
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and the toxicity profile will be complete.
EXAMPLE 1:
Source Product Study Toxicity Category Toxicity Category for Granular
Product
Acute oral LD50 III IV
Acute dermal LD50 HI IV
Acute inhalation LD50 III IV
Primary Eye Irritation III m
Primary Skin Irritation m III
Skin Sensitization Non-sensitizer Non-sensitizer
If the acute LD50, dermal LD50, Inhalation LD50, primary dermal and/or eye irritation
effects for the registered product(s) are classified in Category I and/or II, then the Agency will
not accept calculations that bridge down from these categories and additional data would be
required for the proposed pesticide product. Either these studies would need to be submitted,
or the registrant would need to cite data on a substantially similar product.
EXAMPLE 2:
Source Product Study Toxicity Category Toxicity Category for Granular
Product
Acute oral LD50 n n
Acute dermal LD50 II II
Acute inhalation LD50 I I
Primary Eye Irritation III HI
Primary Skin Irritation III HI
Skin Sensitization Non-sensitizer Non-sensitizer
For dermal Sensitization, if a granular product contains any ingredient which is a
known sensitizer, the formulated product would be labeled as a sensitizer. If the product is not
a dermal sensitizer, and there are no known dermal sensitizers in the product, a dermal
Sensitization study may be waived and the product will not require Sensitization labeling. If
dermal Sensitization data on a substantially similar product indicates no dermal Sensitization at
low concentrations, these data may be cited in support of the product. This determination will
be made with data on the active ingredient or information provided by the registrant on an inert
(e.g., Material Safety Data Sheet - MSDS). If the registrant knows there is a sensitizing
component and can justify the finding, the Agency will not require testing.
B. Granular Fertilizer Pesticide Products
For purposes of this guidance, EPA defines granular fertilizer pesticide products to
include those products composed of less than 10% of a registered active ingredient(s), greater
than 90% granular fertilizer components plus clearly recognized innocuous (List 4) inert
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carrier(s), and a minimal amount of sticker/binder (5% or less of the formulation). v
The fertilizer components of these products are considered analogous to the innocuous I
inert described above with the exception of eye irritation. In some cases, fertilizer products |
are more irritating to the eye than the comparable non-fertilizer granular products. Therefore,
the primary eye irritation results may not be bridged under this guidance. A separate eye
irritation study is expected to be performed with the pesticide/fertilizer formulation containing
the highest free level of nitrogen. If, at some point, the nitrogen content of the fertilizer
component is increased above the tested level, a new primary eye irritation study will be
required.
m. Exclusions To This PR
Rodenticide baits are not included in this policy. In the Agency's experience,
rodenticide baits are often more toxic than would be predicted using the bridging methods
outlined above. In general, the Agency will continue to allow similar baits to use one set of
data for purposes of precautionary labeling.
IV. What Registrants And Applicants Should Do
The registrant should submit the following information with the application: (1) request
in writing that the Agency apply this guidance to their product; (2) the acute toxicity profile
(with corresponding MRID Numbers) for the registered product(s); and (3) the current label
for the registered product(s). The Agency will use this information to determine an acute
toxicity profile for the product.
VI. Non-Binding Statement
This PR Notice provides guidance to EPA and to pesticide registrants. This notice is
not binding on either EPA or pesticide registrants, and EPA may depart from the guidance
provided in individual circumstances. Likewise, pesticide registrants may assert that the
guidance is not appropriate for a specific pesticide or situation.
VI. Additional Information
You may contact: John Redden
Registration Division (7505C), USEPA
401 M Street, SW
Washington, DC 20460
(703) 305-1969
redden.john@epa.gov
James J. Jones, Director
Registration Division
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FILENAME: pnshelLwpd (11/1/2000)
ENVIRONMENTAL PROTECTION AGENCY
[OPP-OOXXX; FRL-XXXX-X]
Acute Toxicity Data Requirements For Granular Pesticide Products, Including Those With
Granular Fertilizers in the Product; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
i
ACTION: Notice.
SUMMARY: EPA is announcing the availability of guidance which intends to streamline the
acute toxicity review and classification process for certain granular pesticide products,
including those products that contain granular fertilizers. The policies should achieve the
following objectives: (1) significantly reduce the number of animals subject to testing; (2)
reduce the use of Agency resources while maintaining protection of the public health and
environment; and (3) decrease the time required to register qualifying granular pesticide
products. Pesticide Registration (PR) Notice 2001-2 is effective now, but comments will be
accepted for 30 days, after which the Agency may revise the notice.
DATES: Pesticide Registration (PR) Notice 2001-2 is effective now, but comments will be
accepted for 30 days, after which the Agency may revise the notice. Comments, identified by
docket control number OPP-XXXXX, must be received on or before 30 days after date of
publication in the Federal Register].
ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow
the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket
control number OPP-XXXXX in the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: John Redden, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg.,
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-1969: fax-
number: (703) 308-9382; e-mail address: reddenjohn@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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2 V
A. Does this Action Apply to Me?
This action is directed to the public in general. This action may, however, be of interest
to those persons who are or may be required to conduct testing of chemical substances under
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since other entities may
also be interested, the Agency has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of this Document and Other Related
Documents?
1. Electronically. You may obtain electronic copies of this document, and certain other
related documents that might be available electronically, from the EPA Internet Home Page at
http://www.epa.gov/. To access this document, on the Home Page select "Laws and
Regulations," "Regulations and Proposed Rules," and then look up the entry for this document
under the "Federal Register—Environmental Documents." You can also go directly to the
Federal Register listings at http://www.epa.gov/fedrgstr/,
2. Fax on Demand. You may request a faxed copy of the PR Notice titled, "Acute
Toxicity Data Requirements For Granular Pesticide Products, Including Those With
Granular Fertilizers in the Product," by using afaxphone to call (202) XXX-XXXXand
selecting item XXXX. You may also follow the automated menu.
2. In person. The Agency has established an official record for this action under docket
control number OPP-XXXXX. The official record consists of the documents specifically
referenced in this action, any public comments received during an applicable comment period,
and other information related to this action, including any information claimed as Confidential
Business Information (CBI). This official record includes the documents that are physically
located in the docket, as well as the documents that are referenced in those documents. The
public version of the official record does not include any information claimed as CBI. The
public version of the official record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period, is available for inspection in the
Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2,1921
Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or electronically. To ensure
proper receipt by EPA, it is imperative that you identify docket control number OPP-XXXXX in
the subject line on the first page of your response.
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1. By mail. Submit your comments to: Public Information and Records Integrity Branch
(PIRIB), Information Resources and Services Division (7502C), .Office of Pesticide Programs
(OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC
20460.
2. In person or by courier. Deliver your comments to: Public Information and Records ,
Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of
Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
3. Electronically. You may submit your comments electronically by e-mail to:
opp-docket@epa.gov, or you can submit a computer disk as described above. Do not submit
any information electronically that you consider to be CBI. Avoid the use of special characters
and any form of encryption. Electronic submissions will be accepted in WordPerfect 6.1/8.0 or
ASCII file format. All comments in electronic form must be identified by docket control number
OPP-XXXXX. Electronic comments may also be filed online at many Federal Depository
Libraries.
D. How Should I Handle CBI that I Want to Submit to the Agency?
Do not submit any information electronically that you consider to be CBI. You may
claim information that you submit to EPA in response to this document as CBI by marking any
part or all of that information as CBI. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of
the comment that includes any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion in the public version of
the official record. Information not marked confidential will be included in the public version of
the official record without prior notice. If you have any questions about CBI or the procedures
for claiming CBI, please consult the person listed raider FOR FURTHER INFORMATION
CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA ?
You may find the following suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used that support your
views.
4. If you estimate potential burden or costs, explain how you arrived at the estimate that •
you provide.
5. Provide specific examples to illustrate your concerns.
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6. Offer alternative ways to improve the notice or collection activity.
7. Make sure to submit your comments by the deadline in this notice.
8. To ensure proper receipt by EPA, be sure to identity the docket control number
assigned to this action in the subject line on the first page of your response. You may also
provide the name, date, and Federal Register citation.
II. Background
A. What Guidance Does This PR Notice Provide?
This Pesticide Registration (PR) Notice provides a policy intended to streamline the
acute toxicity review and classification process for certain granular pesticide products,
including those products that contain granular fertilizers. The policies should achieve the
folio-wing objectives: (1) significantly reduce the number of animals subject to testing; (2)
reduce the use of Agency resources while maintaining protection of the public health and
environment; and (3) decrease the time required to register qualifying granular pesticide
products. This guidance is supported by a large toxicology data base and involves the
application of sound scientific principles. This notice is effective immediately, but comments
•will be accepted for 30 days, after which the Agency may revise the notice.
B. PR Notices are Guidance Documents
The PR Notice discussed in this notice provides guidance to EPA personnel and decision
makers and to pesticide registrants. This notice is not binding on either EPA or pesticide
registrants, and EPA may depart from the guidance where circumstances warrant and without
prior notice. Likewise, pesticide registrants may assert that the guidance is not appropriate
generally or not applicable to a specific pesticide or situation.
List of Subjects
Environmental protection, granular pesticide products, granular fertilizers,
Precautionary Labeling.
Dated:
James
__ /
J. Jones. Director
9 ^
Registration Division (7505C)
[FRDoc. 01-?????? Filed ??-??-01; 8:45 am]
BILLING CODE 6560-50-S
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