0277.20 Attachment M

Kathryn E. Szmuszkovicz
Anthony L. Michaels
David A. Barker
1350 I Street NW Suite 700
Washington, DC 20005-3311
+1.202.789.6000
[email protected]
[email protected]
[email protected]

April 6, 2020
SUBMITTED THROUGH REGULATIONS.GOV
Alexandra Dunn
Assistant Administrator
Office of Chemical Safety and Pollution Prevention
OPP Docket
Environmental Protection Agency Docket Center (EPA/DC)
1200 Pennsylvania Ave, NW
Washington, DC 20460-0001
Re:

Proposed Renewal of EPA ICR No. 02277.20, OMB Control No. 2070-0060
“Application for New and Amended Pesticide Registration” –
Formulator’s Exemption Statement (EPA Form 8570-27)
Docket ID No. EPA-HQ-OPP-2019-0644

Dear Ms. Dunn:
Undersigned counsel, on behalf of pesticide research and development companies Bayer
CropScience LP, Corteva Agriscience, and Valent U.S.A. LLC (“the Companies”), submits the
following comments in response to the Agency’s proposed renewal of the Information Collection
Request entitled “Application for New and Amended Pesticide Registration” published on
February 6, 2020 (85 Fed. Reg. 6944). The Companies request that the Agency implement
certain changes to the Formulator’s Exemption Statement (EPA Form 8570-27) (Exhibit A) and
the Agency’s process for reviewing formulator’s exemption applications in response to the
practice of obtaining unlawful product registrations through false certifications of the purchase of
registered sources. The Companies also request that the Agency correct the regulatory citations
in the Formulator’s Exemption Statement to conform to the current regulations.
A.

Introduction and Requested Revisions

The formulator’s exemption functions as intended in most cases. However, a minority of
companies persist in the practice of obtaining unlawful registrations for end-use products by

Austin, TX
Baltimore, MD
Boston, MA
New York, NY
San Francisco, CA
Seattle, WA
Washington, DC

April 6, 2020
Page 2
falsely certifying that the applied-for product is formulated with a registered pesticide product
that “is purchased” to formulate the product when in reality they have no commercial access to
the registered product and no intention of ever purchasing it. In most instances, these companies
do not even contact the registrant to attempt to secure supply, and in other cases they certify the
use of the purchased product even after supply inquiries are flatly rejected. Instead, they plan to
amend the registration to reflect the actual intended source once it is subsequently registered by
EPA, or to abandon the registration altogether in favor of a subsequent, legitimately-registered
product (with a similar product name) in order to inappropriately begin marketing and offering
product for sale before it is legitimately registered by EPA.
These false registrations, sometimes called “paper registrations,” are unlawful and
inconsistent with sound public policy for many reasons:
•

They rely on and are obtained through the knowing submission of false certifications
in violation of 18 U.S.C. § 1001 and FIFRA § 12(a)(2)(M), 7 U.S.C. 136j(a)(2)(M).

•

They burden the agency with processing applications and approving registrations that
serve no lawful commercial purpose and with the subsequent amendments or
duplicative registrations required by the scheme.

•

They burden the agency with petitions to deny or cancel the illegitimate registrations,
filed by the original registrants seeking to protect their commercial and data rights.

•

They allow companies to obtain a registration without offering to pay data
compensation to the original registrant and without purchasing the product that is
claimed as the registered source of active ingredient, violating the letter and purpose
of the formulator’s exemption and the original registrant’s data compensation and
property rights.

•

They complicate policing of the import, sale, and advertising of unregistered
products, and can be used to disguise the unlawful import or manufacture of products
using unregistered sources of active ingredients.

•

They are used to list, offer, and advertise a product for sale before that product is
legitimately registered by EPA, circumventing the prohibition on offering a product
for sale before it is registered and creating an unfair advantage against competitors
who follow a lawful process.

•

They are used to apply for state registrations before a legitimate federal registration is
obtained, creating an unfair advantage against competitors who follow a lawful
process.

April 6, 2020
Page 3
•

They send misleading signals to the marketplace, suggesting that the company has a
business agreement with the original registrant or a viable independent registration,
when neither is the case.

•

Registrations based on false certifications that the product is formulated with a
registered technical product raise significant data integrity issues when the applicant
lacks access to the claimed technical and thus cannot produce a test substance that
matches the certified Confidential Statement of Formula to conduct required productspecific data.

•

Registrations based on false certifications that the product is a 100% repack of a
registered product may not comply with FIFRA absent agreement by the original
registrant, and would clearly violate general trademark and unfair competition laws.

EPA’s actions to date have failed to curb the practice of obtaining registrations based on
false claims of registered sources and have not resolved the significant legal, competitive,
fairness, and transparency problems the practice creates. For these reasons, the Companies
request that the Agency make the following changes to the Formulator’s Exemption Statement
form and the Agency’s internal checklist and process for reviewing formulator’s exemption
applications.
•

Add the following new paragraph (4) to the certifications required in the Formulator’s
Exemption Statement (Exhibit A) and renumber paragraph (4) as paragraph (5):
(4) A signed letter from the registrant of each product identified in paragraph (5)
stating that the registrant does not object to the applicant identifying the
registrant’s product(s) as the source of the active ingredient(s) in the product
for which the formulator’s exemption is claimed is attached to this statement.

•

Update the 21 Day Content Screen Review Worksheet internal checklist (Exhibit B)
to include an additional item under Item 4 “Formulator’s Exemption” as follows:
Letters of non-objection from registrant of each identified registered source
product are attached to Formulator’s Exemption Statement. – Yes/No/NA

•

Update and supersede the guidance provided in the 1997 Memorandum issued by Jim
Jones as Director of the Office of Pesticide Program’s Registration Division (Exhibit
C) to state that the practice of obtaining registrations under the formulator’s
exemption based on false certifications of the purchase of registered sources is
unlawful, and that going forward EPA will not accept or process applications under
the formulator’s exemption unless supported by a letter from the registrant of the
claimed registered source indicating that it does not object to the applicant identifying
the registrant’s product(s) as the source of the active ingredient(s) in the applied-for
product.

April 6, 2020
Page 4
The Formulator’s Exemption Statement form has not been updated since June 2004. The
formulator’s exemption regulations were consolidated under 40 C.F.R. § 152.85 as part of the
technical amendments to the pesticide data requirement regulations issued in 2007. Pesticide
Data Requirements; Technical Amendments, 72 Fed. Reg. 61025 (Oct. 26, 2007). Paragraph 2
should be amended to conform to the current regulations, correct a grammatical omission, and
accommodate the new paragraph (4):
(2) Of these, each active ingredient listed in paragraph (4)(5) is present solely as
the result of the use of that active ingredient in the manufacturing, formulation
or repackaging of another product which contains that active ingredient which
is registered under FIFRA Section 3, and is purchased by us from another
person as required by 40 CFR section 152.85(c)(1) and meets the
requirements of 40 CFR Section 158.50(e)152.85(c)(2) or (3).
B.

Support for the Requested Actions
1.

Requiring acknowledgment by the original registrant is consistent
with the history and purpose of the formulator’s exemption.

Courts have recognized that data submitters have property rights in the data they submit
to EPA, subject to the terms of FIFRA’s data citation and data compensation provisions. The
adoption of FIFRA Section § 3(c)(1) in 1972 and its further amendment in 1978 provided EPA
with the statutory authority to consider data in its files to support a new registration, but “only if
the applicant has made an offer to compensate the original data submitter.” Thomas v. Union
Carbide Agric. Prods., Co., 473 U.S. 568, 573 (1985). Thus, FIFRA “establishes a mandatory
licensing scheme” whereby an applicant may cite data originally submitted to EPA by another
person only “once [the] applicant has extended a proper offer to pay compensation . . . .” EPA,
Procedures to Ensure Protection of Data Submitters’ Rights, 49 Fed. Reg. 30884, 30889 (Aug. 1,
1984). Allowing companies to obtain registrations based on the original registrant’s data in a
manner not permitted under FIFRA would violate the original registrant’s property rights. See,
e.g., Ruckelshaus v. Monsanto Co., 467 U.S. 986, 1007 (1984) (FIFRA’s data reliance provisions
do not violate data submitters’ property rights to the extent the data are used by EPA in a manner
that is authorized under FIFRA).
The formulator’s exemption, FIFRA Section 3(c)(2)(D), was enacted in 1978. Pub. L.
95-396, 92 Stat. 819 (1978) (codified at 7 U.S.C. § 136a(c)(2)(D)). It creates a limited exception
to the core requirement that each application for registration of a pesticide product must be
supported by data that are either submitted or cited by the applicant. The implementing
regulations make clear that the exemption from data requirements is premised on the actual
purchase and use of the identified registered product. 40 C.F.R. § 152.85(a), (b)(1)&(2), (c)(1)
(establishing that the formulator’s exemption “excuses an applicant from the requirement to
submit or cite data pertaining to any pesticide contained in his product that is derived solely from
one or more EPA-registered products which the applicant purchases from another person” and
referring to “the purchased product,” “the purchase from another person of an identified

April 6, 2020
Page 5
registered product,” and “the use of the purchased product in formulating the product”) 40
C.F.R. § 152.85(a), (b)(1)&(2), (c)(1)-(3) (emphasis added).
The legislative history confirms that the formulator’s exemption serves two purposes.
First, it simplifies the application and review process for formulated products that incorporate
registered sources of active ingredient:
The Subcommittee agreed to the provision in S. 1678 authorizing the Administrator
to make one safety finding on a basic ingredient that would apply to all pesticides
using that ingredient.
It was noted that once the Administrator made a finding that there were no
unreasonable adverse effects to the environment caused by a basic ingredient, or
“generic” chemical, it would be a waste of resources to review that decision each time
an application was received for the registration of an end-use product containing the
generic chemical and supported by the data base used to establish the original
registration.
Under the provision adopted by the Subcommittee, the formulator of an end-use
product who uses a registered technical material would only furnish or cite data
pertinent to the end-use and not have to cite data supporting the technical registration.
S. Rep. No. 95-334, at 8-9 (1977).1
Second, the formulator’s exemption addresses the issue of compensation to the original
registrant for the cost of the data required to support the registration of the purchased product.
Under the exemption, formulators are “relieved of the need to offer to pay for the registration
data [that support the registration of the purchased product] except in the purchase price of the
basic pest control chemical.” H. Rep. No. 95-663, at 19 (1997). Focusing on this aspect of the
formulator’s exemption, EPA later stated that “[i]t seems clear that the purpose of the
formulator’s exemption was to eliminate duplicative payment of data development costs.” 49
Fed. Reg. at 30892. In other words, the formulator’s exemption envisions a commercial business
relationship between the formulator and the original registrant and understands that the original
registrant can receive some form of compensation from the formulator who has relied on the

1

See also id. at 19 (Section 3(c)(2)(D) creates a “simplified system”); H. Rep. No. 95-663, at 19
(1977)(explaining that “[f]ormulators who buy registered basic pest control chemicals from
another producer to formulate [the] purchased pesticide into an end-use product would not be
required to submit data requirements as to the basic best control chemical” and “[a]pplications
will be simplified”); 49 Fed. Reg. at 30892 (“the formulator’s exemption can result in a
substantial reduction in the number of data requirements that must be listed for a significant
number of applicants”).

April 6, 2020
Page 6
original registrant’s data that ultimately supports the formulator’s registration.2 The requirement
that the formulator actually “purchase” the identified product is a critical component of the
formulator’s exemption and a necessary justification for the exemption from the requirement to
submit or offer to pay for data that supports the purchased registered product.
The false registration scheme devised and employed by some companies circumvents this
requirement. These companies falsely certify that they will “purchase” the identified product for
formulation into the applied-for product, with no intent of ever actually doing so. This false
certification allows them to obtain a registration that they can exploit for their own purposes
without submitting their own data, offering to pay compensation to the original registrant, or ever
purchasing or paying for the product.3 This violates the letter and intent of the formulator’s
exemption and denies the original registrant’s right to data compensation under FIFRA.
2.

The use of false certifications to obtain registrations is a longstanding
and unresolved issue.

EPA has been aware of the use of false certifications of the purchase of registered
products to obtain registrations under the formulator’s exemption for many years. In the 1997
Memorandum, the Registration Division Director noted that EPA “has been receiving an
increasing number of letters or formal petitions to deny a registration from registrants with
technical or manufacturing use products . . . who claim a registrant has cited their product for a
formulator’s exemption” even though the basic manufacturer “do[es] not sell their product to the
registrant who is citing their product.” Exhibit C at 1. As discussed below, the guidance
contained in the 1997 Memorandum has not been effective at curtailing the practice or redressing
the harms it causes.
The scheme employed by some companies to obtain premature product registrations
through false certifications of source has remained relatively consistent over time, and if
anything appears to have increased in recent years. Such companies intend to enter the market
with a new product that relies on its own new source of active ingredient that is not yet
registered. While pursuing registration of the new technical source, they also apply for an enduse product under the formulator’s exemption, certifying that the technical material used to
formulate the product is purchased from an existing registered source (of which there is often
only one, belonging to the original registrant of the active ingredient). In fact, the company has
no access to the registered product, no ability to purchase it, and no intent to do so. In most
cases, the company makes no effort to obtain the claimed source product, does not approach the
2

This is consistent with how formulator’s exemption registrants are treated by arbitrators in data
compensation disputes. Formulator’s exemption registrants, like other customers that purchase
registered products, are not assigned an independent share of the data costs. Only companies
that obtain or switch to their own independent registrations, supported by data, are assigned a
share of the data costs in the form of data compensation.
3
These companies also avoid bearing any of the costs of stewardship of the registered product,
including any federal or state-imposed stewardship programs and requirements.

April 6, 2020
Page 7
original registrant to inquire about purchasing it, and does not even inform the registrant that it
has applied to register a product based on a certification that it “is purchasing” the registered
technical.
Companies may also obtain false registrations by claiming that their product qualifies for
registration under the formulator’s exemption because it is a 100% repack of an existing
registered end-use product, which (some companies have argued) could hypothetically be
purchased “off the shelf” without the original registrant’s consent. However, these companies
have no access to the product at volumes and prices that are commercially viable for repacking
and resale and no intent to ever actually do so. Indeed, it is not clear that repacking and reselling
the original registrant’s product without its consent is allowed under FIFRA, and relabeling and
selling a another company’s product as your own without their consent is unlawful under general
commercial law.
The overall purpose of the scheme is to obtain a false “paper” registration that the
applicant can exploit for its own purposes before the legitimate registration for the actually
intended product is granted. Once that registration is approved, the company either amends its
falsely-obtained registration to incorporate the newly registered technical source (as intended all
along), or simply abandons it.
Although it appears that this ploy is employed by a minority of companies the false
registration scheme remains persistent and widespread. The undersigned Companies are aware
of several companies that have obtained multiple registrations in recent years based on false
certifications of the purchase of a registered product. In recent years, at least five petitions to
deny, cancel, or revoke registrations have been filed by registrants due to false certifications of
the purchase of a registered product. To the Companies’ knowledge, EPA has not responded to
any of these petitions, some of which have been pending for years, yet registrants are forced to
continue to file them to protect their rights and to combat the injuries caused by false paper
registrations. Eliminating false certifications of source by requiring applicants to include
statements of non-objection from the registrants of claimed source products will eliminate the
practice of submitting false certifications to EPA, will protect the rights of original registrants
and data submitters, and will relieve the burdens on the Agency of processing applications,
amendments, and petitions regarding registrations that serve no lawful purpose. This remedy
would create little or no administrative burden for EPA or applicants, while saving substantial
EPA resources currently used to process duplicate applications and address petitions and
disputes.
3.

Submitting false statements in an application package undermines the
integrity of the registration process and violates FIFRA and other
federal law.

EPA requires all applicants to certify under penalty of law the truth, accuracy, and
completeness of the information provided in a pesticide product application. See Application for
Pesticide Registration (EPA Form 8570-1) (attached as Exhibit D). More specifically, the

April 6, 2020
Page 8
Formulator’s Exemption Statement requires applicants to submit signed certifications that the
product “contains” an active ingredient that “is present solely as the result of” the use of that
active ingredient in the manufacturing, formulation, or repackaging of another product that “is
registered under FIFRA Section 3,” “is purchased by us from another person,” and that “meets
the requirements of 40 CFR Section [152.85(c)(2) or (3)].” Formulator’s Exemption Statement,
Exhibit A (emphasis added). Applicants must also certify to the active ingredient, product name,
and registration number of each registered product they are using to formulate their product and
must provide EPA with a Confidential Statement of Formula that identifies the registered
products that are incorporated into the formulated product. Id.; Confidential Statement of
Formula (Form 8570-4) (Exhibit E). These certifications are not merely an academic exercise.
As described above, the formulator’s exemption and its implementing regulations require that the
applicant actually purchase the registered product in order to be exempt from the requirement to
submit or cite data in support of the registration.
EPA has long recognized that its obligation to determine that a pesticide will not
“generally cause unreasonable adverse effects on the environment” under FIFRA Section 3(c) is
dependent upon the accuracy of data and certified statements submitted by the registrant. See,
e.g., EPA, Termilind Ltd.; Notice and Order of Revocation of Registrations, 62 Fed. Reg. 61890,
61893 (Nov. 19, 1997). As the Agency has noted, its ability to make an accurate finding in its
registration determinations is “directly related to the reliability of the material submitted.” Id.
Accordingly, EPA has determined that a “fitness” or “reliability” criterion is applicable to the
registrant as an implied component of the “unreasonable adverse effects” standard and may
therefore serve as the basis for cancellation or revocation of a product registration. Id.
More directly, it is illegal to “knowingly falsify all or part of any application for
registration” submitted to EPA under FIFRA. FIFRA § 12(a)(2)(M). Likewise, it is a violation
of federal law subject to civil and criminal penalties to knowingly and willfully “falsif[y],
conceal[], or cover[] up by any trick, scheme, or device a material fact” or to “make[] any
materially false, fictitious, or fraudulent statement or representation” in any matter within the
jurisdiction of the federal government. 18 U.S.C. § 1001. Applicants that (i) certify on a
Formulator’s Exemption Statement that an active ingredient “is present” in the applied-for
product due to a registered product that “is purchased” by the applicant when they have no
access to the registered product and no intent to ever purchase it, and (ii) use such false
certifications as a pretext to obtain premature registration under the formulator’s exemption of a
product they actually intend to market using a different source of active ingredient have violated
FIFRA and other federal law by knowingly and willfully submitting false statements and
representations in their application for registration. These actions are unlawful in themselves,
regardless of whether the registrations so obtained are ever used to offer, advertise, import,
manufacture or sell any product or for any other purpose. This is reason enough for EPA to
adjust its practices and requirements to ensure that companies cannot continue to make such false
certifications for their own benefit with impunity.

April 6, 2020
Page 9
4.

False certifications regarding the purchase of registered technical
product create significant issues regarding data integrity.

Applicants that formulate their product using registered technical product are required to
submit certain product-specific data, including product chemistry data. See 40 C.F.R. § 152.85
(“In general, data for which the required test substance is the product proposed to be registered
are not eligible for the formulator’s exemption.”); 40 C.F.R. §§ 158.300-355 (Product Chemistry
data requirements). Among other things, applicants are required to submit a Confidential
Statement of Formula that identifies the specific registered source of active ingredient consistent
with the statements and certifications made in the Formulators’ Exemption Statement,4 and to
describe the starting materials and formulation process, discuss any impurities of concern, and
provide certified limits regarding the amount of active ingredient in the product. 40 C.F.R.
§§ 158.320-340.
Applicants are also required to analyze and report on the physical and chemical
properties of the actual formulated end-use product, including information on the formulated
product’s corrosion characteristics, stability, flashpoint, particle size distribution, and other
attributes. 40 C.F.R. § 158.310. These analyses are required to be conducted using the actual
formulated end-use product as the test substance. Id. This is impossible for applicants who do
not actually have access to the claimed source of technical material. Thus, there must be
discrepancies between what the applicant represents as the contents of the product in its
Confidential Statement of Formula, Formulators’ Exemption Statement and product identity and
composition study and the test substance actually used for the chemical and physical
characterization study and the product chemistry data submitted to EPA to support the
application. On information and belief, companies pursuing this false registration scheme have
submitted data to EPA that falsely identifies or misrepresents the test substance. Indeed, by
definition, companies pursuing the false registration scheme lack access to the formulation they
are purporting to test.
EPA must be able to rely on the accuracy of the certifications and data submitted by
applicants. EPA’s ability to properly regulate pesticides depends on its ability to know that the
product it reviews and approves for registration is the product actually offered for sale and use
under that registration. Allowing applicants to knowingly submit false or misleading test results
undermines the entire FIFRA regulatory process. Such actions are properly viewed by EPA as
serious transgressions that warrant vigorous enforcement. This provides another reason to end
the practice of obtaining registrations through false certifications of source.

The instructions for the Confidential Statement of Formula state that the complete chemical
composition of the pesticide “must be known so it can be evaluated for registration” and require
applicants to list the components of a formulation “as actually introduced into the formulation.”
Exhibit E at 2, items 10, 13a.
4

April 6, 2020
Page 10
5.

Companies cannot lawfully repack another company’s product and
offer it for sale under their own label without that company’s consent.

As described above, companies sometimes obtain registrations under the formulator’s
exemption by falsely claiming that the product is a 100% repack of a registered end-use product
purchased from another company. They sometimes seek to justify this approach by claiming that
they could hypothetically purchase the product “off the shelf” from a distributor or retailer,
repackage it under their own label in their own containers, and offer it for sale as their own
product, regardless of how commercially unreasonable it may be to do so. However, offering
this pretext to conceal their true intent – obtaining a premature “paper” registration for a product
they actually intend to sell using another source – is itself a false representation.
Furthermore, it is not clear that actually repacking and offering a product for sale in this
manner without the original registrant’s consent would comply with FIFRA. See e.g., FIFRA
§ 12(a)(1)(F)&(a)(2)(A) (making it a violation “to detach, alter, deface, or destroy . . . any
labeling required under this subchapter” or to sell or distribute “any pesticide which is . . .
misbranded”). Repackaging and offering another company’s product for sale as one’s own
product without that company’s consent would constitute unlawful “reverse passing off” in
violation of general trademark and unfair competition laws. See, e.g., Universal Furn. Intern.,
Inc. v. Collezione Europa USA, Inc., 618 F.3d 417 at 438-440 (4th Cir. 2010) (finding that a
company that offered a competitor’s furniture for sale under its own name as its own furniture
was guilty of was “‘reverse passing off,’ which occurs when a ‘producer misrepresents someone
else’s goods or services as his own,’” in violation of the Lanham Act, 15 U.S.C. § 1125(a)(1)(A)
and the state Uniform Deceptive Trade Practices Act) (citations omitted).5 In other words,
applicants claiming the formulator’s exemption based on claims that they could hypothetically
purchase the registered source product “off the shelf” without the original registrant’s permission
are not only making certifications based on false pretexts but also proposing a course of action
that would be unlawful if carried out.

5

See also Dastar Corp. v. Twentieth Century Fox Film Corp., 539 U.S. 23, 32 (2003) (“Section
43(a) of the Lanham Act prohibits actions like trademark infringement that deceive consumers
and impair a producer's goodwill. It forbids, for example, the Coca–Cola Company's passing off
its product as Pepsi–Cola or reverse passing off Pepsi–Cola as its product.”); CMSI, Inc. v. Pac.
Cycle, Inc., 2006 WL 2942794, at *2 (W.D. Wash. Sept. 15, 2006) (quoting Summit Mach. Tool
Mfg. Corp. v. Victor CNC Sys., Inc., 7 F.3d 1434, 1437 (9th Cir.1993) (“Although courts have
expressed the Lanham Act’s prohibition on reverse passing off in various ways, all agree that the
practice entails selling another’s goods as one’s own. In the prototypical case, a party ‘purchases
or otherwise obtains a second party’s goods, removes the second party’s name, and then markets
the product under its own name.’”).

April 6, 2020
Page 11
6.

Falsely obtained paper registrations are used for improper purposes.

Some companies have argued in response to petitions to cancel that registrations based on
false certifications of source are harmless “paper registrations” that do not implicate any legal
requirements and should not concern the Agency. That is incorrect. Companies obtain false
registrations to exploit them for their own commercial advantage, including circumventing
FIFRA requirements, misleading the market, gaining an unfair advantage, and concealing illegal
activity. Among other things:
•

Some companies have used falsely obtained registrations to conceal the illegal
import, manufacture, or sale of product made from an unregistered source.6

•

Except for certain exceptions not applicable here, FIFRA prohibits any person
from offering for sale (advertising) any pesticide product without a valid
registration for the product. See FIFRA §§ 2(gg), 3(a), & 12(a)(1)(A); 40 C.F.R.
168.22(b)(4). Registrants have used the cover of a falsely obtained “paper
registration” to advertise or offer a product for sale before an actually viable
registration is obtained.

•

Companies use falsely obtained registrations to compete unfairly against other
registrants. Falsely obtained end-use registrations mislead consumers by
suggesting that the company has access to a viable and legitimately registered
product. Customers may also wrongly assume the company is working in concert
with the original registrant where no other registered technical source is yet
available. Companies can use falsely obtained registrations to apply for state
pesticide registrations, beginning that process earlier than they would otherwise
be able to. This may, for example, allow them to obtain a state registration in
time to sell the product for a growing season when following the rules would
mean waiting until the following year. All these options give companies that
obtain premature registrations based on false certifications an unfair advantage
over competitors who follow a lawful process.

The Agency should adjust its formulator’s exemption process and requirements as
proposed to eliminate false certifications of registered source, protect the integrity of the FIFRA
registration process, and ensure unlawful activity is not rewarded by unfair competitive
advantages.

6

See, e.g., EPA, Termilind Ltd.; Notice and Order of Revocation of Registrations, 62 Fed. Reg.
61890 (Nov. 19, 1997).

April 6, 2020
Page 12
7.

The policy described in the 1997 Memorandum is inadequate to
curtail false registrations and to address the problems they create.

To our knowledge, EPA’s most recent guidance regarding false certifications of source
was issued more than twenty years ago. Exhibit C. That guidance has proved ineffective. The
1997 Memorandum continued EPA’s policy of presuming, absent objection by the basic
manufacturer, that the applicant has access to the registered source product on grounds that there
is “no way for [the Agency under existing processes] to know whether or not the registrant has
access to the material” cited in its application and the Formulators’ Exemption Statement “or just
wants a paper registration.” Id. However, nothing in the guidance authorizes the abuse of the
formulators’ exemption process to obtain “paper registrations” based on false certifications
regarding the purchase of registered source products. Instead, the guidance states that if the
Agency receives a letter or petition to deny from the original registrant before the registration is
granted, the Agency will impose conditions on the registration requiring the applicant to provide
‘[t]he name and address of the entity from which the manufacturing product was obtained” and
“[a] copy of the bill of sale,” which will be reviewed and referred to the Office of Enforcement
and Compliance Assurance as appropriate. Id. at 1-2. The guidance also indicates that
“[p]etitions to revoke a registration due to concerns with the formulator’s exemption will be
handled on a case-by-case basis.” Id. at 2. The policy does not permit companies to obtain a
registration based on false certifications without an actual commercial source consistent with
their certified representations to EPA.
The approach outlined in the 1997 guidance has proved inadequate for three reasons.
First, the original registrant generally has no way to determine that an applicant has falsely
claimed its registered product under the formulator’s exemption until the registration is granted.
Under existing EPA practices, the original registrant is not given notice of the identification of its
registered product in a formulator’s exemption application, EPA generally does not produce
application materials in response to requests under the Freedom of Information Act until after a
registration is granted, and information regarding the identity of product source materials,
including Confidential Statements of Formula and the registered product(s) identified on the
Formulator’s Exemption Statement, would generally be redacted as confidential business
information. Since false registrations are often sought in parallel with efforts to obtain
registrations based on a new independent source, original registrants typically cannot discern
based on public information provided in accordance with FIFRA (e.g. NPIRS) that a particular
end use product application is based on a false formulator’s exemption claim using their
registered product. No data submissions are required for 100% repack applications, so the
original registrant will typically have no indication that such a product was even applied for until
it is granted. Thus, original registrants are typically not able to submit a letter or petition to deny
a registration that relies on a false certification of source before it is granted.
Second, even if it could be invoked, the recourse provided under the 1997 Memorandum
is inadequate. Requiring the applicant to provide a bill of sale before selling the product does not
address the other ways in which companies exploit false registrations, including by prematurely
offering the product for sale, applying for state registrations, and misleading the market.

April 6, 2020
Page 13
Third, the policy’s assurance that petitions to revoke registrations that falsely invoke the
formulator’s exemption will be “handled on a case-by-case basis” has proved hollow. The
Agency has received numerous such petitions and has been unable or unwilling to issue a ruling
on them. This has left original registrants with no effective recourse against falsely obtained
registrations under current policies and processes.
The proposed remedy better addresses the concerns expressed in the 1997 Memorandum
and its recognition that original registrants have the right to object to applications based on false
certifications of the purchase of their products. The approach set out in the Memorandum does
not condone false “paper registrations,” but instead reflects the Agency’s perceived inability and
apparent reluctance to get involved in policing commercial transactions. The remedy proposed
by the Companies addresses EPA’s concerns more effectively and efficiently, does not require
EPA to become involved in commercial matters, and completely preserves an applicant’s ability
to pursue legitimate applications.
8.

Requiring formulator’s exemption applicants to furnish a letter from
the registrant of the claimed registered source product is an
appropriate and effective response that on balance will reduce the
administrative burdens on the regulated community and save EPA
resources.

Given the persistent practice by some companies of applying for registrations based on
false certifications of source, with no ability or intent to ever purchase and use the identified
product, it is no longer practical or prudent for EPA to continue to operate on the presumption
that certifications of source are genuine and that applicants have access to and actually intend to
purchase the registered products identified in the Formulator’s Exemption Statement. The
ongoing willingness of some companies to abuse the formulator’s exemption process and the
Agency’s trust requires a change in the process to prevent such false certifications.
As detailed above, this problem can be efficiently and effectively solved by simply (1)
adding a requirement to the Formulator’s Exemption Statement that the applicant provide a
signed letter from the registrant of each product identified on the form and (2) changing the front
end screening process for formulator’s exemption applications to require confirmation that such
letters have been provided before processing the application.
As discussed above, the formulator’s exemption excuses applicants from the obligation to
submit or cite data based on the purchase and use of the identified registered products in
formulating their products and the presumed business relationship between the applicant and the
original registrant. Requiring applicants to contact the original registrants and obtain, at a
minimum, a simple statement confirming that they are aware of and do not object to the
applicant’s identification of their products in support of their application is consistent with the
intent and requirements of the formulator’s exemption. Allowing formulator’s exemption
applicants to obtain registration without even notifying the registrants of the products they claim
to be purchasing is not. This approach also allows for commercial transactions to occur, or not,

April 6, 2020
Page 14
as determined by the companies’ ability to make a commercial agreement without holding up the
registration process and causing undue delay where there is genuine collaborative interest.
The new requirement will impose a negligible up-front burden on the applicant and the
original registrant. A legitimate applicant who intends to purchase the registered product as
claimed would already be in contact with the original registrant anyway (if not already working
under a supply agreement). A simple form letter suitable for the purpose can be developed and
used in each case. Companies have developed standard letters that authorize a regulatory agent
to act on their behalf for a specific application, and a similar approach would work for the
required non-objection letters.
The notice from the applicant to the original registrant that would be required to obtain a
non-objection letter does not implicate any legitimate confidentiality concerns. There is no
legitimate commercial reason to keep claims that the applicant “is purchasing” a registered
product confidential from the registrant of that product. Parties would not be required to disclose
any details of their business arrangement, or even whether a final agreement has been reached or
is likely to be reached. Information on the Confidential Statement of Formula and Formulator’s
Exemption Statement about the identity of the claimed registered source products can still be
kept confidential from other parties, as can the required letter of non-objection. Requiring only a
simple non-objection statement provides maximum flexibility to the original registrant and the
applicant to conduct and manage their business relationship on their own terms and schedule. It
does not require the parties to finalize an agreement or actually purchase the product in
commercial quantities before applying for the registration. Importantly, this remedy does not
involve EPA in any commercial matters whatsoever. EPA’s role would be limited to simply
confirming that the non-objection statement has been submitted as certified by the applicant, as
part of the front-end screen of the application package.
9.

The proposed remedy improves the efficiency and effectiveness of the
formulator’s exemption process and reduces burdens on EPA.

The proposed new requirement is consistent with the requirements and goals of the
Paperwork Reduction Act. Requiring formulator’s exemption applicants to submit letters of
non-objection from the registrants of identified registered source products is a necessary and
practical solution that serves to protect the integrity of the registration process against false
certifications, ensure companies do not obtain unfair commercial advantages through unlawful
practices, and protect the data and commercial rights of original registrants. 44 U.S.C. § 3508.
The proposed remedy will improve the efficiency and effectiveness of EPA’s review and
approval of formulator’s exemption applications while minimizing burdens on the Agency,
applicants, and the registrants whose products they cite. 44 U.S.C. §§ 3501(3)&(5); 3502(2),
3506(a)(1)&(b)(1).
Confirming receipt of the non-objection letters can be easily incorporated into the
existing 21 day screening process and requires minimal additional effort by the Agency, which
already reviews and confirms the consistency of the products identified in the Confidential

April 6, 2020
Page 15
Statement of Formula and the Formulator’s Exemption Statement. After confirming receipt of a
non-objection letter, the reviewer can proceed on the assumption that it is valid, just as it does for
letters authorizing a regulatory agent to act on a company’s behalf. The reviewer need not
undertake any further fact investigations, review business documents or bills of sale, or impose
or track any conditions of registration. The new requirement would screen out false
certifications at the outset, eliminating the need for EPA to review, approve and manage the
subsequent amendment or cancellation of duplicative false “paper registrations” that serve no
legitimate commercial purpose and are not intended to be used to ever sell actual product. It
would also eliminate the substantial burdens of processing and responding to petitions to deny or
revoke such registrations after they are granted.
C.

Conclusion

For the reasons stated above, the Companies respectfully request that EPA revise the
Formulator’s Exemption Statement and update its policies to require applicants that invoke the
formulator’s exemption to obtain and submit non-objection letters from the registrant of each
claimed registered source product.
Sincerely yours,

Kathryn E. Szmuszkovicz
Anthony L. Michaels
David A. Barker
Counsel for Bayer CropScience LP,
Corteva, Inc., and
Valent U.S.A. LLC

EXHIBIT LIST

Exhibit A.

Formulator’s Exemption Statement (EPA Form 8570-27)

Exhibit B.

21 Day Content Screen Review Worksheet

Exhibit C.

James Jones, Director Registration Division Memorandum re Formulator’s
Exemption and Letters or Petitions to Deny Registration (November 21,
1997)

Exhibit D.

Application for Pesticide Registration (EPA Form 8570-1)

Exhibit E.

Confidential Statement of Formula (EPA Form 8570-4)

EXHIBIT A

Form approved. OMB No. 2070-0060, 2070-0057, 2070-0107, 2070-0122, 2070-0164.

United States

Environmental Protection Agency
Washington, DC 20460

Formulator’s Exemption Statement
(40 CFR 152.85)

Applicant’s Name and Address

EPA File Symbol/Registration Number

Product Name

Date of Confidential Statement of Formula (EPA Form 8570-4)

As an authorized representative of the applicant for registration of the product identified above, I certify that:
(1) This product contains the following active ingredient(s):

(2) Of these, each active ingredient listed in paragraph (4) is present solely as the result of the use of that active ingredient in the manufacturing,
formulation or repackaging another product which contains that active ingredient which is registered under FIFRA Section 3, is purchased by
us from another person and meets the requirements of 40 CFR section 158.50(e)(2) or (3).
(3) Indicate by checking (A) or (B) below which paragraph applies:

 (A) An accurate Confidential Statement of Formula (EPA FORM 8570-4) for the above identified product is attached to this statement.
That formula statement indicates, by company name, registration number, and product name, the source of the active ingredient(s) listed in
paragraph (1).
OR



(B) The Confidential Statement of Formula (CSF)(EPA Form 8570-4) referenced above and on file with the EPA is complete, current, an
accurate and contains the information required on the current CSF.

(4) The following active ingredients in this product qualify for the formulator’s exemption.

Source
Active Ingredient

Signature

EPA Form 8570-27 (Rev. 06-2004)

Product Name

Name and Title

Registration Number

Date

Copy 1 – EPA
Copy 2 - Applicant copy

Paperwork Reduction Act Notice
The public reporting burden for this collection of information is estimated to average 1.5. hours per response,
including familiarization with the form, organizing the necessary information, and completing the form. Send
any comments regarding the burden estimate or any other aspect of this collection of information to: Director,
Collection Strategies Division (2822T), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue,
N.W., Washington, DC 20460. Do not send the completed form to this address.

EPA Form 8570-27 (Rev. 06-2004) Reverse Copy 1 - EPA Copy 2 - Applicant copy

EXHIBIT B

PRIA 3 – 21 Day Content Screen Review Worksheet
(EPA/OPP Use Only)
September 2017
21 Day Screen Start Date: ___________________________________
Experts In-Processing Signature: _____________________ Date______
Fee Paid: Yes __
Division management contacted on issues No_______Yes ________Date _______________
EPA Reg. Number:

EPA Receipt Date:
Items for Review

Yes

1

Application Form (EPA Form 8570-1) signed & complete including package
type

2

Confidential Statement of Formula all boxes completed, form signed, and
dated (EPA Form 8570-4)
yes
no
a) All inerts, including fragrances, approved for the proposed
uses (see Footnote A)

3

Certification with Respect to Citation of Data (EPA Form 8570-34)
completed and signed (N/A if 100% repack)
Certificate and data matrix consistent
If applicant is relying on data that are compensable, is the offer
to pay statement included. (see Footnote B)

yes

no

If applicable, is there a letter of Authorization for exclusive use only.
4

5

Formulator’s Exemption Statement (EPA Form 8570-27) completed and
signed (N/A if source is unregistered or applicant owns the technical)
Data Matrix (EPA Form 8570-35) both internal and external copies (PR 98-5)
completed and signed (N/A if 100% repack)
yes
no
a) Selective Method (Fee category experts use)
b) Cite-All (Fee category experts use)
c) Applicant owns all data (Fee category experts use)

6
7
8

5 Copies of Label (Electronic labels on CD are encouraged and guidance is
available)
Is the data package consistent with PR Notice 86-5
Notice of Filing included with petitions
1

No

N/A*

9

If applicable for conventional applications, reduced risk rationale

Required Data and/or data waivers. See Footnote C.
a) List study (or studies) not included with application

10

Comments:

2

* N/A – Not Applicable

Footnotes
A. During the 21 day initial content review, all CSFs will be reviewed to determine
whether all inerts listed, including fragrances, are approved for the proposed uses or have
an application pending with the Agency. If an unapproved inert with no application
pending with the Agency is identified, the applicant must either 1) resolve the inert issue
by, for example, removing the inert, substituting it with an approved inert, submitting
documentation that EPA approved the inert for the proposed pesticidal uses, correcting
mistakes on the CSF, etc. or 2) provide the data to support OPP approval of the inert or 3)
withdraw the application. Removing or substituting an inert ingredient will require a new
CSF and may require submission of data. All information, forms, data and
documentation resolving the inert issue must have been received by the Agency or the
application withdrawn within the 21 day period, otherwise, the Agency will reject the
application as described below.

To successfully complete this aspect of the 21 day initial content screen, applicants are
strongly encouraged to verify that all inert ingredients have been approved for the
application’s uses or have an application pending with the Agency even if a product is
currently registered by consulting the inert Web site and if the inert is not approved nor
has an application pending with the Agency, to obtain the necessary inert approval
prior to submitting an application to register a pesticide product containing that
inert ingredient. Some inert ingredients are no longer approved for food uses or certain
types of uses. The name and/or CAS number on a CSF must match the name and CAS
number on this web site. Simple typographical errors in the name or CAS number have
resulted in processing delays.
If an inert is not listed on the inert ingredient web site and the applicant believes that the
inert has been approved, the applicant should contact the Inert Ingredient Assessment
Branch (IIAB) at [email protected] and resolve the issue. Copies of the
correspondence with IIAB resolving the issue should accompany the application. All
new inerts except PIP inerts are reviewed by IIAB. The IIAB should also be contacted
for any questions on what supporting data needs to be submitted for and the Agency’s
inert review process. Questions on PIP inerts should be directed to the Chief of
Microbial Pesticides Branch.
When a brand, trade, or proprietary name of an inert ingredient is listed on a CSF,
additional information such as an alternate name of the inert, CAS number or other
information must also be included to enable the Agency to determine if it has been
approved. Each component of an inert mixture (including a fragrance) must be
identified. In some cases, the supplier of the mixture or fragrance may need to provide
this information to the Agency. Prior to the Agency’s receipt of an application,
applicants must arrange with a proprietary mixture or fragrance supplier to provide the
component information to the Agency or promptly upon EPA’s request. If the inert
ingredients in a proprietary blend (including fragrances) cannot or are not identified or
provided within the 21-day content review period, the Agency will reject the application.
3

During the 21 day content review, applicants should submit information to the individual
identified by the Agency when the applicant is informed of an unapproved inert.
Unapproved Inerts Identified on CSFs
All applications except conventional new products and PIPs
Once an unapproved inert is identified on a CSF, the Agency will contact the
applicant with the following options:
1. Correct the application by, for instance, correcting the inert’s identity or CAS
number, providing documentation that the inert has been approved, or
removing the unapproved inert from the CSF or replacing it with one that is
approved for the application’s uses; or
2. Provide the required information necessary to identify an inert approval
application that is pending with the Agency; or
3. Submit the information and data needed for the Agency to approve the
unapproved inert. If this option is selected and implemented, the Agency may
request an extension in the PRIA decision review timeframe to accommodate
the inert review/approval process;
4. Withdraw the application (the Agency retains 25% of the full fee for the fee
category estimated); or
If none of these options is selected and implemented by the applicant within the
21 day content review period, the Agency will reject the application and retain
25% of the full fee of the category identified.
Conventional New Product Applications
When the Registration Division identifies an unapproved inert on a CSF with an
application for a new product that the applicant has not identified as requiring an
inert approval (R300 or R301), it will contact the applicant with the following
options:
1. Correct the application by, for instance, correcting the inert’s identity or CAS
number, providing documentation that the inert has been approved, or
removing the unapproved inert from the CSF or replacing it with one that is
approved for the application’s uses; or
2. Submit the information and data needed for the Agency to approve the
unapproved inert, including any required petition to establish or amend a
tolerance or exemption from a tolerance. (This option may change the PRIA
category for the application, which could require a longer decision review
time and a larger fee. If additional fees are due, they must be received by the
Agency within the 21 day content review period.)
4

3. Withdraw the application (the Agency retains 25% of the full fee for the fee
category estimated); or

If none of the above options is selected and implemented during the 21-day
content-review period, the Agency will reject the application and retain 25% of
the appropriate fee for the new product-inert approval category.
PIP Applications
When the Biopesticide and Pollution Prevention Division identifies an
unapproved inert on a PIP CSF and a request to approve the inert does not
accompany the application, it will contact the applicant with the following
options:
1. Correct the application by, for instance, correcting the spelling or name of the
inert to that in 40 CFR 174, or providing documentation that the inert has been
approved; or
2. Submit the information and data needed for the Agency to approve the
unapproved inert. If an inert ingredient tolerance exemption petition is
required, the petition must be received by the Agency and the B903 fee paid
within the 21 day period. If this option is selected and implemented, the
Agency will discuss harmonizing the timeframe for both actions.
3. Withdraw the application (the Agency retains 25% of the full fee for the fee
category estimated); or
If none of the above options is selected and implemented during the 21 day
content review period, the Agency will reject the application and retain 25% of
the fee.

B. A policy on documentation of offers to pay is still being developed, however, for a
me-too or fast track (similar/identical) new product, R300 or A530, an application
without the necessary authorizations of offers to pay will be placed into either R301 or
A531. The Agency recommends that authorizations of offers to pay be submitted with
other PRIA applications to avoid delays in the Agency’s decision.
C. Biopesticide applicants are advised to contact the Agency and discuss study waivers
prior to submitting their application to the Agency. Documentation of such discussions
should be submitted with the study waiver.

5

EXHIBIT C

UNITED STATES ENVIRONMENTAL PROT&CnON AGENCY
WASHINGTON, D.C. 20460
OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

MEMORANDUM
TO: Registration Division Branch Chiefs
FROM: James Jones, Director Registration Division

Signed 11/21197

SUBJECT: Formulator's Exemption and Letters or Petitions to Deny Registration
The Registration Division has been receiving an increasing number af letters or
formal petitions to deny a registration from registrant& with technical or
manufacturing use products (hereafter basic manufacturer) who claim a
registrant has cited their product for a formulator's exemption. The basic
manufacturers are claiming that they do not sell their product to the registrant
who is citing their product and, therefore, the registration should be denied.

In the past the Registration OMsion has always registered products when they

take a formulator's exemption and have a complete application. There Is no way
for us to know whether or not the registrant has access to the material or just
wants a paper registration. In addition there generally Is no evidence that the
registrant wiU not be able to obtain the formulating product he has cited.
Unfortunately. we al$o do not know ff the registrant wiU use an unregistered
technical af known or unknown quality in the event he cannot get the cited
material. In a situation where the basic manufacturer has written us in adVance
of a registration to tell us he has no intention . of selling hiS product to the
registrant our confidence that the registrant will be using the cited material in his

registered product is weakened.
In general, the Registration Division will continue its policy of continuing to
register products based on the formulator's exemption with out accompanying
proof of purchase. However, if the Agency has received a letter or petition to
deny a registration which is relying on a formulator's exemption and it is
submitted by the basie manufacturer who owns the cited product prior to a

product branch taking action on the registration request. the product
conditionally registered. Conditions of registration will include:

wm

be

The registrant must provide the Agency the foUowing information prior to formulating
their product:
1. The registration number and establishment number of the manufacturing or
technical product from which their product is derived,

2. The name and address
was obtained. and.

at the entity

from which the manufacturing product

3. A oopy of the biD of sale.
The product branches should review this information and use their judgment in
determining whether to refer It to OECA for action as OECA deems appropriate.
Referrals should be sent to Phytrls Flaherty of the Agricultural Branch.
Agrioulturaf and Ecosystem OMsion (2225A).
Petitions to revoke a registration due to concerns with the formulator's
exemption will be handled on a case-by-case basis.
This paicy is effective as of the date of this memorandum.

EXHIBIT D

 

PAPERWORK REDUCTION ACT NOTICE and INSTRUCTIONS
PAPERWORK REDUCTION ACT NOTICE: Public reporting burden for this collection of information is estimated to average 0.85 hour per response, including time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send
comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to Director, Collection
Strategies Division (2822T) U.S.Environmental Protection Agency,1200 Pennsylvania Ave, NW,Washington, DC20460.

INSTRUCTIONS: This form is to be used all applications for new registration, amendment, resubmission, to applications for notifications, final printed labeling,
reregistration, etc. In order to process an application for a new registration submitted on this form, the following material must accompany the application:

1.

Certification with Respect to Citation of Data (EPA Form 8570-34). [If not exempted by 40 CFR 152.81(b)(4)].

2.

Confidential Statement of Formula (EPA Form 8570-4);

3.

Formulator's Exemption Statement (EPA Form 8570-27);

4.

Five copies of draft labeling;

5.

Three copies of any data submitted;

6.

Authorization letter where applicable;

7.

Data Matrix.

Submission of Labeling -Labeling should first be submitted in the form of draft labeling with all applications. Such draft labels may be in the form of typed label text on 8.5
x 11 inch paper for submission or a mockup of the proposed label. If prepared for mockup, it should be constructed in a way as to facilitate storage in an 8.5 x 11 inch file.
Mockup labels significantly smaller than 8.5 x 11 inches should be mounted on 8.5 x 11 inch paper for submission.
Submission of Data -Data submitted in support of this application must be submitted in accordance with PR Notice 86-5.

SPECIFIC INSTRUCTIONS: Please read the instructions listed below before completing this application. First determine the type of registration action, listed in Block A,
for which you are submitting this application. For applications submitted in connection with new registration actions, Sections I, III, and IV must be completed by the
applicant. For applications submitted in connection with amendments actions, resubmissions, notifications, reregistrations, etc., Sections I, II, and IV must be completed by the
applicant.
Block A - Check the appropriate action for which you are submitting this form.

Section I - The section must be completed, as applicable, for all registration actions.
1. Company /Product Number - Insert your company number, if one has been assigned by EPA. This number rnay have been assigned to you as a basic
registrant, a distributor, or as an establishment. If your product is registered, insert the Product Number.
2. EPA Product Manager -If known, fill in the name end PM number of the EPA Product Manager.
3. Proposed Classification -Specify the proposed classification of this product. For most products the classification would be “None”.
4. Product Name -Enter the complete product name of this pesticide as it will appear on the label. The name must be specific to this product only. Duplication of
names is not permitted among products of the same company. Do not include any brand name or company line designations.
5. Name and Address of Applicant -The name of the firm or parson and address shown in your application is the person or firm to whom the registration will be
issued. If you are acting on behalf of another party, you must submit authorization from that party to act for them in registration matters. An applicant not residing
in theUnited Statesmust have an authorized agent residing in theUnited Statesto act for them in all registration matters. The name rand complete mailing address of
such an agent must accompany this application.
6. Expedited Review -FlFRA section 3 (c) 3 (B) provides for expedited review of applications for registration, or amendments to existing registrations, that are similar
or identical to other pesticide products that are currently registered with the EPA. In order for your application to be eligible for expedited review, you must provide
us with the EPA Registration Number and product name of the product you believe is similar to or identical to your product. The product must be similar or
identical in both formulation and labeled uses.
SECTION II -This section must be completed for a11 applications submitted to amend the registration only of a currently registered product (Amendment), for a
resubmission in response to an Agency letter, for notifications to the Agency, for the submission of final printed labeling, for reregistration and for any other action
that pertains to a specific EPA registered product. The Explanation Section should be used for any additional information regarding Sections I and II.
1. Subject of submission -Check the applicable block and provide the Agency letter date if appropriate. Provide a brief explanation of the purpose(s) for he submission,
such as “the addition of a site, pest or crop (specify)”; “amend the Confidential Statement of Formula by…”; “reregistration submission”; “general label revision of
direction for use”, `notification for…”. Attach a separate page if additional space is needed.
SECTION III - This Section must be completed for all applications submitted in connection with new registration or applicable amendments.
1. Type of Packaging -Check the appropriate block if your product will be packaged in the indicated packaging types. Indicate the size of the
individual packets and number per retail container.
2. Type of Retail Container- Indicate type of container in which product will be marketed.
3. Location of Net Contents -Indicate the location of the net contents information for your product.
4. Size(s) of Retail Container -Specify the net contents of all retail containers for your product.
5. Location of Use Directions -Indicate the location of the use directions for your product.
6. Manner in which label is affixed to product -Indicated the method product label is attached to retail container.
SECTION IV (Contact Point) -This section must be completed for all applications for Registration actions, i.e., new products registration, resubmission, "metoo," reregistration, etc.
1-5.Self-explanatory
6. EPA Use Only

EXHIBIT E

 

Instructions and Paperwork Act Notice
Please Read Carefully Before Completing This Form
Paperwork Reduction Act Notice

4. Rcgistlation Number/Filc Symbol: Enter the EPA registration number
or file symbol, if known for this product

The public reporting burden for this collection of
information is estimated to average 1.0 hour per
response, including familiarization with the form,
organizing the necessary information, and
completing the form. Send any comments
regarding the burden estimate or any other aspect
of this collection of information, including
suggestions for reducing this burden to: Chief,
Information Policy Branch, 2136, U.S.
Environmental Protection Agency, 401 M Street,
S.W., Washington, D.C. 20460.

5. EPA Product Manager/Team Number: Enter the name and team
number of the EPA Product Manager assigned to this product, if known.
6. Country Where Formulated: Specify the country where this product is
formulated

Instructions
The complete chemical composition of each pesticide must be known so it can
he evaluated for registration under the Federal Insecticide, Fungicide, and
Rodenticide Act, as amended.
This form is designed for reporting the ingredients used in the formulation of
a pesticide product. It must be completed and submitted with each application
for new registration of a pesticide and application for amended registration if
the revision involves a formula change.

Block A: Check the appropriate action for which you are submitting the
form.
Block B: Number all pages consecutively. Enter on each page the total
number of pages submitted. If more than one page is required, number them
"1 of 2", "2 of2", "3 of 3", etc.
1. Name and Address of Applicant/Registrant: Enter the name and
address of your firm or authorized agent.
2. Name and Address of Producer: Specify the name of the producer and
the address of the site where this product will be produced.

7. Weight per Gallon/Bulk Density: For a liquid product specify pounds per
gallon of formulated product. For a powder or granular product, enter the
hulk density of formulated product (as used). Enter weight per unit if the
product is produced as a tablet, briquette, or other uniformly shaped product
8. pH: Enter the pH of aqueous formulations and products which are either
dispersible or soluble in water. If not applicable enter "N/A".

9. Flash Point/Flame Extension: Specify the flash point as determined by
the regulations for pressurized products and/or products known or suspected
to burn. State the results of the flame extension test for pressurized products
including positive flashbacks.
10. Components in Formulation: List as actually introduced into the
formulation. For each component in your formulation, provide the product
name, commonly accepted chemical, the trade name, and the Chemical
Abstract (CAS) number for each identifiable ingredient present in the product.
CAS numbers may be obtained from the Chemical Abstract Service of the
American Chemical Society, Columbus, OH. For each original and
alternate source of each active ingredient in the product, indicate the percent
purity of the manufacturing use product, technical product, or other source
of active ingredient. If one or more components will be obtained from more
than one source, enter all alternate sources and all alternate EPA Reg. Nos.
in blocks 10, 11, and 12 or on a separate attachment.
Attention: (       ) Any impurities
greater than or equal to 0.1% (or less than 0.1% if the impurity is
toxicologically significant) which are associated with the active ingredient(s)
of n technical grade (manufacturing or reformulating use) product or an end
use product produced by an integrated formulations system should also be
listed in column 10, and the corresponding amount, percent by weight, and
upper certified limits in columns I3 and 14.
11. Supplier Name and Address: Provide the name and address of the
supplier of each component in the formulation. If one or more components
will be obtained from more than one source, specify the names addresses
of the alternate sources also.

3. Product Name: Specify the complete name of this pesticide product as it
will appear on the label. This name must be the same as that which appears
on the application form.

EPA Form 8570-4 (Rev. 8-94) Reverse

*U.S. GOP: 2000-519-239/94558

12. EPA Reg. No.: Specify the EPA registration number, if any, for each
active ingredient in the formulation. If an unregistered active ingredient is
used, have the suppliers submit the chemical specifications, as well as any
data required under 40 CFR Part 158.
13. Each Component in Formulation a. Amount: Specify the quantity of
each component as actually introduced into the formulation. Units (e.g.,
pounds, grams, gallons, liters) should be expressed as used in the
formulation. If the quantity is a liquid measure, enter the volume and the
specific gravity or the pounds per gallon of the
component.
b. Percent by Weight: Specify the weight percentage of each component in
your formulation. Check Your Calculations. Note that the weight percentage
in many cases will not agree with that shown on the label ingredient statement
where the weight percentage of the per active ingredient(s) must he declared.
Attention: Producers of Microbial Products: Special Instructions for
Column 13b.) Please state the percent of active ingredient in British
International Units (BIUs). International Toxic Units (ITUs). Polyhedral
Inclusion Bodies (PIBs)(viruses), Colony Forming Units (CFUs)(Fungi), as
appropriate, and include an equivalent statement of active ingredient per
milligram, ounce, pound, etc. of product (e.g., a 50% active Bacillus
thuringiensis product may have an equivalency value of 1.59 million
Aedis aegypti ITU per pound of product.
14. Certified Limits: These limits are to be set based on representative
sampling and chemicnl analysis (i.e., quality control) of the product.
a. Upper Limit: Specify the maximum percentage of each active ingredient,
intentionally added inert ingredient, and any impurities greater than 0.1% to
he permitted in the product.
b. Lower Limit: Specify the minimum percentage of each active ingredient
and intentionally added inert ingredient to he permitted in the product.
15. Purpose In Formulation: Specify the purpose of each ingredient both
active and inert. (For example, disinfectant, herbicide, synergist surfactant,
defoamer, sequestrant, etc.) If space is insufficient, abbreviate.
16. Typed Name of Approving Offirial: Complete this item for
identification of individual to he contacted if necessary
17. Total Weight: Specify the total weight of the batch (column 13a.)
18-21: Complete these items for identification of individual to be contacted if
necessary.