Registration Requirements for Antimicrobial Pesticide Products and Other Pesticide Regulatory Changes
Federal RegisterSep 17, 1999
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SUMMARY: EPA is proposing to establish procedures for the registration
of antimicrobial products, as well as implement other provisions of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended
by the Food Quality Protection Act. This proposal is required by FIFRA.
In addition to registration procedures for antimicrobial products,
EPA also proposes to establish labeling standards for antimicrobial
public health products, which will ensure that these products are
appropriately labeled for the level of antimicrobial activity they
demonstrate; to modify its notification process for antimicrobial
products to conform to the statutorily prescribed process; and to
exempt certain antimicrobial products from FIFRA regulation.
EPA believes that the new procedures and provisions will streamline
and improve the registration process, increase consistency and
certainty for antimicrobial producers, reduce the timeframes for EPA
decisions on antimicrobial registrations, increase public health
protection by ensuring the continued efficacy of antimicrobial public
health pesticides, and promote international harmonization efforts.
EPA is also proposing to implement a number of general provisions
of FIFRA that are not specific to antimicrobial pesticides. EPA
proposes to interpret the applicability of the new FIFRA definition of
``pesticide'' that excludes liquid chemical sterilants from FIFRA
regulation and includes nitrogen stabilizers, and to describe
requirements pertaining to use dilution labeling. These proposals are
intended to implement new provisions of FIFRA, and to update current
regulations and procedures.
Finally, EPA is proposing technical, conforming and organizational
changes to portions of its regulations on pesticide registration and
labeling for clarity and understanding.
DATES: Comments, identified by the docket control number OPP-300890,
must be received on or before November 16, 1999.
ADDRESSES: Comments may be submitted by regular mail, electronically,
or in person. Please follow the detailed instructions for each method
as provided in Unit I of the SUPPLEMENTARY INFORMATION section of this
notice.
FOR FURTHER INFORMATION CONTACT: Jean M. Frane, Field and External
Affairs Division (7506C), Office of Pesticides Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone
number: 703-305-5944; e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Notice Apply to You?
You may be potentially affected by this notice if you are a
producer or registrant of antimicrobial or other pesticide products.
Regulated categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Category Examples NAICS Code
------------------------------------------------------------------------
Producers Pesticide products
32532
Antifoulant paints
32551
Antimicrobial
pesticides 32561
Nitrogen
stabilizer
products 32531
Wood preservatives
32519
------------------------------------------------------------------------
Wholesalers Pesticide products
42291
Antimicrobial
products 42269
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed in the ``FOR FURTHER INFORMATION
CONTACT'' section.
B. How Can I Get Additional Information or Copies of Support Documents?
1. Electronically. You may obtain electronic copies of this
document and various support documents from the EPA Home page at the
Federal Register Environmental Documents entry for this document under
``Laws and Regulations'' (http://www.epa.gov/fedrgstr/).
2. In person. The Agency has established an official record for
this action under docket control number OPP-300890. 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 Highway, 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 by mail, in person, or electronically. To
ensure proper receipt by EPA, it is imperative that you identify docket
control number OPP-300890 in the subject line on the first page of your
response.
1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460.
2. In person or by courier. Deliver comments to: Public Information
and Records Integrity Branch in Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. The Docket Control Office
telephone number is (703) 305-5805.
3. Electronically. You may submit your comments electronically by
e-mail to: ``[email protected] ,'' 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 5.1/6.1 or ASCII file format. All comments in electronic
form
[[Page 50673]]
must be identified by docket control number OPP-300890. Electronic
comments may also be filed online at many Federal Depository Libraries.
D. How Should I Handle Information That I Believe Is Confidential?
You may claim information that you submit in response to this
document as confidential 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. A copy of the
comment that does not contain CBI must be submitted for inclusion in
the public record. Information not marked confidential will be included
in the public docket by EPA without prior notice.
E. We Invite Your Comments
EPA invites you to provide your views on this proposal, approaches
we have not considered, the potential impacts of the various options
(including possible unintended consequences), and any data or
information that you would like the Agency to consider. 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 solid technical information and/or data to support your
views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate.
5. Indicate what you support, as well as what you disagree with.
6. Provide specific examples to illustrate your concerns.
7. Make sure to submit your comments by the deadline in this
proposed rule.
8. At the beginning of your comments (e.g., as part of the
``Subject'' heading), be sure to properly identify the document you are
commenting on. You can do this by providing the docket control number
assigned to the proposed rule, along with the name, date, and Federal
Register citation.
II. Organization of Preamble
This preamble is organized according to the outline in this unit.
I. General Information
II. Organization of Preamble
III. Authority
A. The Federal Insecticide, Fungicide, and Rodenticide Act
B. The Food Quality Protection Act
C. The Antimicrobial Regulation Technical Corrections Act
IV. Antimicrobial Provisions Addressed in this Proposal
A. Overview
B. Defining Classes of Antimicrobial Use Patterns
C. Defining Types of Application Reviews
D. Conforming Degree of Review to Risks and Benefits
E. Ensuring Efficacy
F. Implementing Deadlines for Process Management
G. Certification Process for Regulatory Actions
H. Certification of Laboratories
I. Notification Processes
J. Revised Procedures for Application Review
K. Allocation of Resources
L. Completeness of Applications
V. Other Statutory Provisions Addressed in this Proposal
A. Changes to the Definition of ``Pesticide''
B. Notification Procedures
C. Use Dilution Labeling
VI. What is an Antimicrobial Pesticide?
A. General Definition
B. Food Use Exclusion
C. Other Specific Exclusions
D. Products Included
VII. Current Registration Procedures for Pesticides
A. Overview of Procedures
B. Volume of Work
C. Review Times
D. Non-regulatory Guidance Documents
VIII. Proposed Antimicrobial Procedures
A. Organization of Proposed Subpart W and Relationship to
Current Regulations
B. Applicability of Subpart W
C. Definitions
D. Types of Applications
E. Consultations During the Application Process
F. Contents of Applications
G. EPA Action on Applications
H. Review Periods
IX. Duration of Registration for Products Bearing Public Health
Claims
A. Statutory Requirements
B. Alternatives Considered
C. Sunset Provision
X. General Conditions of Registration
XI. EPA/FDA Jurisdiction over Antimicrobial Products Used in or on
Food
A. Background
B. FDA Regains FFDCA Jurisdiction
C. EPA Retains FIFRA Jurisdiction
XII. Efficacy Performance and Labeling Standards for Antimicrobial
Products
A. Need for Rule
B. 1984 Proposal
C. Current Proposal
XIII. Other Labeling Revisions
A. Use Dilution Labeling
B. Reorganization of Labeling Regulations
C. Updated Toxicity Categories
XIV. Chemical Sterilants
A. Liquid Chemical Sterilants Excluded by Statute
B. Non-liquid Chemical Sterilants Exempted by Regulation
C. Antimicrobial Products Neither Excluded nor Exempted
D. Ethylene Oxide
XV. Nitrogen Stabilizers
A. Nitrogen Stabilizers are Regulated as Pesticides
B. What is a Nitrogen Stabilizer?
XVI. Notification of Registration Changes
A. FQPA Modifications
B. Comparison of Current and New Procedures for Antimicrobial
Products
XVII. Conforming and Organizational Changes
A. Changes in Definitions
B. Exclusions and Exemptions Under FIFRA
XVIII. Consultations During the Development of this Proposal
A. Stakeholder Meetings
B. Workshops
C. Food and Drug Administration
D. Canada
XIX. Table of Affected Sections
XX. Statutory Review Requirements
XXI. Regulatory Assessment Requirements
III. Authority
A. The Federal Insecticide, Fungicide, and Rodenticide Act
This proposal is issued under the authority of FIFRA sections 3 and
25, 7 U.S.C. 136a and 136w. Under FIFRA, a pesticide product may not be
distributed or sold in the United States unless it is registered with
the EPA. Registration is a licensing process in which EPA evaluates
each proposed product, its uses, and its labeling to determine whether
it meets the standard for registration in FIFRA section 3(c)(5). That
standard states that, for a registration to be approved, EPA must
determine that the pesticide product, when used in accordance with its
intended uses and with widespread and commonly recognized practice,
will not cause unreasonable adverse effects on the environment. The
registration standard is a risk/benefit standard, which must take into
account the economic, social and environmental costs and benefits of
use.
B. The Food Quality Protection Act
On August 3, 1996, Congress enacted the Food Quality Protection Act
(FQPA), modifying FIFRA and the Federal Food, Drug and Cosmetic Act
(FFDCA). Most of its provisions were effective immediately, although
some require implementing regulations. Units IV. and V. discuss the
statutory provisions of FIFRA as amended by FQPA that this proposal
would implement.
C. The Antimicrobial Regulation Technical Corrections Act
On October 30, 1998, Congress enacted the Antimicrobial Regulation
Technical Corrections Act (ARTCA), which modified the Federal Food,
Drug, and Cosmetic Act (FFDCA) to effectively transfer authority over a
number of pesticide residues to FDA. Regulatory authority over these
residues had originally been transferred to EPA by FQPA. Unit XI.
discusses the
[[Page 50674]]
consequences of this statute and how EPA and FDA jurisdiction over
antimicrobial pesticide residues in food has been allocated by ARTCA.
IV. Antimicrobial Provisions Addressed in this Proposal
A. Overview
The FQPA amendments to FIFRA focus attention on antimicrobial
pesticides specifically, and the procedural framework under which the
Agency reviews and approves applications for registration and amendment
of antimicrobial pesticides. This unit discusses the new statutory
provisions for antimicrobial products and how this proposal satisfies
each statutory requirement.
1. Under FIFRA section 3(h)(1), EPA must evaluate its registration
process to identify improvements and reforms that would reduce
historical review times for antimicrobial applications.
2. FIFRA section 3(h)(2) defines the goals for review that process
improvements should be designed to achieve, expressed as review period
reduction goals for various types of applications.
3. Under FIFRA section 3(h)(3)(A), EPA must propose regulations
that address a number of application process elements, with the goal of
implementing specified process management improvements and meeting
section 3(h)(2) goals. EPA is today proposing these regulations. Unit
VIII. discusses each of following statutorily mandated elements, and
briefly describes how today's proposal addresses those requirements:
a. Defining the classes of antimicrobial use patterns.
b. Defining types of application review.
c. Conforming reviews to risks and benefits.
d. Ensuring efficacy.
e. Meeting review time goals.
4. Under FIFRA section 3(h)(3)(B), EPA must in its final rule
consider specified types of application and process improvements that
would contribute to meeting the review time goals or otherwise simplify
the application process, including:
a. Certification mechanisms for applications.
b. Certification of laboratories.
c. Expanded use of notification and non-notification procedures.
d. Clarification of completeness criteria for applications.
e. Revised procedures for application review.
f. Allocation of resources.
In order to consider these topics for inclusion in the final rule,
EPA must offer proposals or options for notice and comment today that
could be incorporated into a final rule. EPA is today proposing
regulations addressing expanded use of notification procedures (see
Unit XVI.) and completeness criteria (See Unit VIII.F.). EPA has
considered certification mechanisms for applicants, and, as discussed
in Unit IV.G., may establish such a mechanism administratively. EPA has
also considered the possibility of laboratory certification programs,
but is not making a specific proposal at this time.
Under FIFRA section 3(h)(3)(B), a final regulation must be
promulgated no later than 240 days after the end of the comment period
for those portions of this proposal required by FIFRA section 3(h).
B. Defining Classes of Antimicrobial Use Patterns
FIFRA section 3(h)(3)(A)(ii)(I) requires that EPA ``define the
various classes of antimicrobial use patterns.'' EPA has developed a
comprehensive list of antimicrobial use patterns in conjunction with
its upcoming part 158 proposal on antimicrobial data requirements. That
proposal would establish a set of data requirements that apply solely
to antimicrobial pesticides. EPA has developed an appendix of all
current antimicrobial use patterns, divided into 12 use categories
having common exposures or other similarities. The proposal meshes with
the statutory mandate to identify classes of antimicrobial use patterns
by defining, for each use category, the data requirements that apply.
Unit VIII.D. includes a list of the use categories. A copy of the full
draft Use Appendix is in the docket for this proposal. EPA intends its
proposal of part 158 data requirements to satisfy the statutory
requirement to define classes of antimicrobial use patterns.
C. Defining Types of Application Reviews
FIFRA section 3(h)(3)(A)(ii)(II) requires that EPA ``differentiate
the types of review undertaken for antimicrobial pesticides.'' Since
the primary purpose of differentiating types of review is to ensure
that review time goals are met, EPA views the statutory requirement as
equivalent to defining the types of applications associated with the
review periods in section 3(h)(2). Proposed Sec. 152.445 addresses the
various application types, and describes the general criteria EPA uses
to characterize an application. EPA intends that this section will
satisfy the statutory requirement to differentiate types of reviews,
and also in part will satisfy the requirement for setting out differing
levels of data requirements for various classes of products under FIFRA
section 3(h)(3)(A)(ii)(I).
D. Conforming Degree of Review to Risks and Benefits
FIFRA section 3(h)(3)(A)(ii)(III) requires that EPA ``conform the
degree and type of review to the risks and benefits presented by
antimicrobial pesticides and the function of review under this Act,
considering the use patterns of the product, toxicity, expected
exposure and product type.''
The function of review under FIFRA for any pesticide product, not
just an antimicrobial pesticide, is grounded in the registration
standards of FIFRA section 3(c)(5). As such, EPA review must:
1. Assess the risks and benefits of the pesticide and its use,
relevant to the determination of unreasonable adverse effects. In the
case of a public health antimicrobial pesticide, a determination that
the product is efficacious when used as directed is central to a
benefits assessment.
2. Determine the adequacy of the pesticide labeling in directing
the pesticide user as to intended and safe use of the pesticide,
thereby minimizing potential adverse effects to the user and the
environment.
EPA believes that its proposed part 158 regulation defining use
categories and data requirements clearly acknowledges that different
use patterns have different exposure patterns and risks. The data
requirements for each use category are commensurate with the potential
exposures and risks associated with that use pattern, and in some cases
are tiered so that higher exposures or higher risks require a second
level of data. The amount and types of data required in and of
themselves dictate a review process that is more detailed, requiring a
more complex assessment for these potentially higher exposures or
higher toxicity. Therefore, in issuing part 158, EPA intends that the
mandate to conform the degree and type of review to risks and benefits
of use will be satisfied.
E. Ensuring Efficacy
FIFRA section 3(c)(5) has required since 1972 that the composition
of a pesticide be such as to warrant the claims made for it, i.e., that
a product work as claimed. Moreover, the registrant must ensure that
the pesticide product continues to meet that efficacy standard as long
as the product is registered. What has changed over time is the manner
in which EPA is assured of product efficacy. Until 1980, EPA
[[Page 50675]]
reviewed efficacy data for every pesticide product prior to
registration, and thus could assure that, at least at the time of
registration, each product would perform as intended. In 1980, EPA
determined that, for pesticides of economic or aesthetic significance,
the marketplace can be relied upon to weed out inefficacious products.
EPA reasoned that because users can determine for themselves whether a
product works, and are motivated by economic reasons to ensure that
they are using the most efficacious products, less efficacious products
would not survive in a highly competitive marketplace. Accordingly, EPA
no longer routinely reviews efficacy data prior to registration for
most insecticides, fungicides, herbicides, and non-public health
antimicrobial pesticides. Registrants must maintain data demonstrating
efficacy in their files, and submit it to the Agency upon request.
EPA recognized, however, that it could not reduce its efficacy
oversight of public health products and still be assured of product
efficacy. The failure of public health products to work as intended
could have consequences far beyond those of mere economic or aesthetic
significance. Consumers and public health officials must have assurance
that a product will work against pests that pose public health threats.
Many public health products are antimicrobial pesticides registered to
control bacteria, viruses, protozoa, and other microorganisms
pathogenic to man (others are insecticides and rodenticides controlling
pests that are vectors of disease in man). Unlike insects or weeds,
microbial pests cannot be seen, and users cannot determine by
observation whether the product actually performs as claimed.
Therefore, EPA cannot rely upon the users or marketplace forces to
ensure product efficacy. Accordingly, EPA has continued to review
efficacy data for public health products prior to registration.
Subdivision G of the Pesticide Assessment Guidelines describes the
efficacy tests required, and the Labeling Guidelines for Pesticide Use
Directions - Antimicrobial Products (Subdivision H) contain the
performance standards that EPA uses to ensure that antimicrobial
products achieve an acceptable level of efficacy for the claims made.
The Pesticide Assessment Guidelines are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA
22161.
FIFRA section 3(h)(3)(A)(ii)(IV) requires EPA to ``ensure that the
registration process is sufficient to maintain antimicrobial pesticide
efficacy and that antimicrobial pesticide products continue to meet
product performance standards and effectiveness levels for each type of
label claim made.'' At first glance, this language may appear merely to
reinforce the existing efficacy standard of FIFRA section 3(c)(5) that,
to be registered, a product must be efficacious. On closer reading,
however, it is clear that the language carries a broader mandate making
explicit the role of the registration process in ensuring continued
efficacy after registration.
EPA has relied on post-registration mechanisms, including
enforcement monitoring, good laboratory practice monitoring and data
audits, testing by EPA and States as co-regulators, registrant
reporting under FIFRA section 6(a)(2), and user complaints to target
inefficacious products in the marketplace. In recent years, enforcement
actions have found a number of incidents of product failure which have
called into question the ability or willingness of producers to ensure
and maintain the efficacy of their products after registration. As a
result, EPA has since 1990 undertaken a systematic testing program for
antimicrobial pesticides. In cooperation with FDA, EPA has tested
sterilant products and has brought a number of enforcement and
regulatory actions against products found to be inefficacious. EPA is
now testing tuberculocides and hospital disinfectants.
After a product has been identified as failing in efficacy, EPA may
use enforcement measures (such as Stop Sale, Use and Removal Orders) to
correct problems. EPA may also use remedies such as cancellation of
registration under FIFRA section 6 to remove inefficacious products
from the marketplace. EPA has found that post-registration reporting,
monitoring, testing and cancellation processes can be cumbersome and
time-consuming. In some cases, products that EPA has found to be
inefficacious have taken years for resolution through the hearing and
appeals processes available to registrants.
EPA agrees wholeheartedly that measures to strengthen the Agency's
oversight of antimicrobial efficacy as part of registration are
desirable. Today's proposal contains two specific provisions to improve
and strengthen EPA's regulatory oversight of the efficacy of public
health antimicrobial pesticides:
1. EPA proposes to incorporate into its regulations, as subpart W
of part 156, the efficacy performance standards for public health
products that are now contained only in its Labeling Guidelines. Unit
XII. further discusses efficacy performance standards for public health
antimicrobial pesticides.
2. EPA proposes to limit the duration of registrations bearing
public health claims to 5 years. In order to extend the registration
for an additional 5 years, each registrant would have to confirm by
analysis that the product composition was the same as that in Agency
files previously demonstrated to be efficacious, and that the product
continued to meet efficacy standards specified in subpart W for each
public health claim. Unit IX. discusses the 5-year duration provision
in greater detail.
EPA believes that these two regulatory provisions will fulfill the
statutory requirement that EPA ensure continued product efficacy
through the registration process.
F. Implementing Deadlines for Process Management
FIFRA section 3(h)(3)(A)(ii)(V) requires that EPA ``implement
effective and reliable deadlines for process management.'' EPA believes
that the ``deadlines'' referred to are those contained in FIFRA section
3(h)(1), which requires EPA to identify and evaluate reforms to the
antimicrobial registration process; FIFRA section 3(h)(2), which
establishes goals for reduction of review periods for antimicrobial
applications for registration; and FIFRA section 3(h)(3)(D), which
establishes default review periods that apply if EPA fails to issue its
final antimicrobial rule by the statutorily required deadline. As
discussed more fully in Unit VIII.H., EPA is today proposing in
Sec. 152.457 to adopt the ``goal'' review periods rather than the
``default'' review periods.
G. Certification Process for Regulatory Actions
FIFRA section 3(h)(3)(B)(iii)(I) requires that, in issuing final
regulations, EPA must ``consider the establishment of a certification
process for regulatory actions involving risks that can be responsibly
managed, consistent with the degree of risk, in the most cost-efficient
manner.''
Certification statements are currently permitted by
Sec. 152.44(b)(2) for various types of amendments to registration when
directed by EPA. Typically, EPA uses certification to accomplish
specific changes to registration (frequently labeling changes). EPA has
included in this proposal a broader provision that would allow the
Agency to implement self-certification programs as needed in
[[Page 50676]]
the future administratively. Unit VIII.A. discusses further this
provision.
With respect to data certification, EPA has considered two self-
certification programs in the recent past, and has implemented one of
these. PR Notice 98-1, Self-Certification of Product Chemistry Data,
was issued on January 12, 1998. In that notice, EPA describes the types
of product chemistry information (product characteristics) that can be
supplied to the Agency together with a self-certification that the data
were conducted according to EPA Guidelines. Under this program, EPA
would generally review only the summarized results of testing at the
time of application, but could review full study reports if EPA
determines that a complete evaluation of the study is warranted. Review
of the summary results of testing rather than of the complete study
report would decrease the time needed for all applications for
registration of new products and reregistration of existing products.
EPA also considered a similar self-certification procedure for
acute toxicity data, and intends in the future to implement such a
program for antimicrobial products only. EPA originally considered an
acute toxicity data self-certification program because a backlog of
applications requiring acute toxicity data review extended review
periods while applications waited in queue. The certification mechanism
considered would have been available only with respect to a study
indicating that the product should be assigned to Toxicity Category III
or IV. The certification procedure was viewed as a means of reducing
the resources needed for review, and thus making more decisions with
the same level of resources. At the same time, EPA recognized that the
certification procedure could also reduce to some extent the Agency's
confidence in hazard and precautionary statements on labeling. Since
EPA issued its notice for comment, however, the Agency has achieved a
significant reduction in the backlog and consequently in the review
times for applications in the queue. The Agency decided therefore not
to pursue a certification approach for acute toxicity studies at this
time.
Although EPA has decided not to adopt such an approach for
pesticides in general, the Agency has decided to consider a pilot
program that allows applicants for registration of antimicrobial
product to certify the results of an acute toxicity study when the test
data would indicate the product is in Toxicity Category I (the highest
toxicity category). Because such a product would be subject to the most
stringent labeling requiements, applicants would have no incentive to
certify that a product of lower toxicity was in Toxicity Category I.
Moreover, EPA's review of such data would add little value and would
use limited resources. EPA invites comment on this proposed approach to
certification of acute toxicity data, which would be implemented by a
notice to registrants if EPA decides to adopt it.
H. Certification of Laboratories
FIFRA section 3(h)(3)(B)(iii)(II) requires EPA to ``consider the
establishment of a certification process by approved laboratories as an
adjunct to the review process.'' EPA currently has underway a broad
program across the Agency evaluating the feasibility of laboratory
accreditation mechanisms for a variety of program and regulatory needs.
The Office of Pesticide Programs has also been actively working with
outside groups, such as the Chemical Specialties Manufacturers'
Association to further their efforts to develop laboratory
accreditation programs for antimicrobial products. EPA has considered
whether a program could be instituted at this time for antimicrobial
products, and believes that these efforts need further evaluation and
development before being integrated into the Agency's regulatory
programs. EPA intends to continue its cooperative work, and to fold its
efforts into the larger Agency process. Thus, EPA is not today
proposing a specific laboratory accreditation process as part of this
proposed rule.
I. Notification Processes
FIFRA section 3(h)(3)(B)(iii)(III)(aa) requires that, in issuing
final regulations, EPA must use ``expanded use of notification and non-
notification procedures.'' This requirement dovetails neatly with the
statutorily expanded scope of notifications under FIFRA section
3(c)(9). EPA is today proposing to include in new Sec. 152.446 the new
procedures to expand the use of notification as a mechanism for the
label modification as directed by section 3(c)(9).
J. Revised Procedures for Application Review
FIFRA section 3(h)(3)(B)(iii)(III)(bb) requires that, in issuing
final regulations, EPA must use ``revised procedures for application
review.'' As outlined in Unit VII, EPA's current regulations for
registration of pesticide products, including antimicrobial pesticides,
are generally limited to describing the applicant's and Agency's
responsibilities and interactions. The summary description given in
that unit is similar for all pesticides. EPA intends to issue or revise
its current non-regulatory guidance documents that address the
application process in greater detail. To the extent that EPA develops
different procedures for antimicrobial products than for other
products, EPA will make those procedures available via direct notice to
affected registrants, and will make them widely available by all
feasible means, including electronic accessibility.
The Agency has already implemented a number of administrative
reforms to improve the process, including revised procedures for
review. Since FQPA was enacted, the Agency has established a separate
Division solely responsible for antimicrobial products. The new
Antimicrobials Division is charged with all aspects of antimicrobial
regulation, and includes a full complement of scientific personnel in
biology, microbiology, chemistry, toxicology, and other scientific
disciplines, as well as an ombudsman to deal directly with registrant
issues and concerns.
The new Division has focussed initially on meeting the review
period goals established by the statute for all new applications. To
assist this effort, a dedicated Expedited Review Team has been formed
for the purpose of processing notifications and screening and
processing applications that are ``fast-track'' or with review periods
of 90 days or less. By identifying and handling the less complex
actions, this team allows the Division to channel its scientific and
management resources into review of applications that are of higher
priority or that require in-depth review. The Division has added more
Product Managers, so that each Product Manager has a smaller and more
focussed product universe.
The Division has also targeted increased outreach, communication
and information exchange as a high priority. Training materials,
information sheets, operating procedures and science reviews have been
developed or reevaluated for streamlining opportunities.
Additional administrative accomplishments and plans are detailed in
the Agency's first progress report to Congress, Streamlining
Registration of Antimicrobial Pesticides, July 1997. EPA will issue
this report annually as required by section 3(h)(4). Each report will
identify further progress in management and administrative reforms.
K. Allocation of Resources
FIFRA section 3(h)(3)(B)(iii)(III)(cc) requires that, in issuing
final
[[Page 50677]]
regulations, EPA must address ``allocation of appropriate resources to
ensure streamlined management of antimicrobial pesticide
registrations.'' The allocation of resources is not a reform that can
be accomplished by Agency regulations, and EPA is not proposing any
regulations for doing so. Budget and resource allocations are guided by
Executive branch and Congressional priorities and are determined year
by year based on overall needs of the Agency and the pesticide program.
L. Completeness of Applications
FIFRA section 3(h)(3)(B)(iii)(IV) requires that, in issuing final
regulations, EPA must ``clarify criteria for determination of the
completeness of an application.'' EPA is today proposing in Sec. 152.3
a definition of a ``complete application'' for all registration
applications. In addition, specific to antimicrobial products, and
directly responsive to the requirement of FIFRA section 3(h)(3)(B), EPA
is proposing in Sec. 152.450 to describe in detail the contents of an
application, and the criteria that will be used to judge the
completeness of the application as a whole, and of its individual
components. EPA's proposals are discussed further in Unit VIII.F.
V. Other Statutory Provisions Addressed in this Proposal
A. Changes to the Definition of ``Pesticide''
FQPA modified FIFRA section 2(u) to exclude certain liquid chemical
sterilant products from the definition of ``pesticide,'' and to include
certain nitrogen stabilizer products. This provision was effective on
August 3, 1996. In recognition of this provision, EPA is proposing to
add a new Sec. 152.6 entitled ``Substances excluded from regulation by
FIFRA.'' EPA has issued a notice to registrants, entitled ``Liquid
Chemical Sterilant Products'' (PR Notice 98-2; January 15, 1998),
explaining how it will treat liquid chemical sterilants affected by
section 2(u). Units XIV. and XV. discuss chemical sterilants and
nitrogen stabilizers.
B. Notification Procedures
FIFRA section 3(c)(9)(C) now authorizes registrants of
antimicrobial products to make certain defined labeling modifications
by notification to the Agency instead of amendment, and establishes a
procedure for notifications and Agency decisions. This provision was
effective on August 3, 1996, and the new procedures are exclusive to
antimicrobial products. Today's proposal codifies these new
notification procedures. The substance of the expanded notifications
permitted by FIFRA section 3(c)(9) is issued in notices to registrants
(PR Notices), and not in today's proposal. Unit XVI. discusses
antimicrobial notifications.
C. Use Dilution Labeling
FIFRA section 3(c)(9)(D) authorizes registrants to include on their
labeling precautionary statements about the product as diluted for use
(use dilution labeling). This provision was effective on August 3,
1996. EPA proposes to reformat its human hazard labeling requirements
in Sec. 156.10(h) and to incorporate use dilution requirements in
appropriate sections. Unit XIII.A. discusses use dilution labeling.
VI. What is an Antimicrobial Pesticide?
EPA proposes in Sec. 152.3 a definition and interpretation of
antimicrobial pesticide. The proposed definition is paraphrased from
that in section 2(mm) of FIFRA, and interprets the undefined elements.
Because FIFRA section 3(h) directs EPA to develop and implement special
procedures in its regulatory program for antimicrobial pesticides, it
is important that there be a well-defined and commonly understood
universe of products to which the statutory provisions apply. The
practical consequences of being included or excluded as an
``antimicrobial pesticide'' are significant for both pesticide
producers and the Agency. FIFRA section 2(mm) defines the term
``antimicrobial pesticide,'' carefully delineating its boundaries to
mesh with the practical implementation of section 3(h) requirements.
This unit discusses the definition in detail.
A. General Definition
Under FIFRA section 2(mm)(1)(A), an antimicrobial pesticide is
defined as
:(A) [A pesticide that] is intended to:
(i) disinfect, sanitize, reduce or mitigate growth or
development of microbiological organisms; or
(ii) protect inanimate objects, industrial processes or systems,
surfaces, water, or other chemical substances from contamination,
fouling or deterioration caused by bacteria, viruses, fungi,
protozoa, algae, or slime;
With respect to the scope of pests covered by the definition,
paragraph (i) focusses on the intended pesticidal function (disinfect,
sanitize, etc.) against non-specific ``microbiological organisms,''
while paragraph (ii) focusses on non-specific ``protection'' provided
by the pesticide against specified microorganisms (bacteria, viruses,
etc). As a practical matter, EPA believes that the term
``microbiological organisms'' in paragraph (i) should be considered to
include each of the specific types of microorganisms in paragraph
(ii)--bacteria, viruses, fungi, protozoa, and algae. Therefore, EPA
will consider any product intended for use against the microorganisms
specified in paragraph (ii) to be an antimicrobial pesticide (subject
to the exclusions discussed in Unit VI.B. and C.)
Having identified the universe of substances that, based upon the
intended pesticidal purpose, are antimicrobial pesticides, the
definition goes on in paragraphs (1)(B) and (2) to exclude certain
pesticides from the definition of antimicrobial pesticide. These
exclusions may be characterized as use-based, that is, a pesticide is
excluded because of how or where it is used, and not because of the
pests or purpose of use.
B. Food Use Exclusion
FIFRA section 2(mm)(1)(B) excludes from ``antimicrobial pesticide''
those pesticides whose intended antimicrobial use is such that residues
in food requiring regulation under section 408 or 409 of the FFDCA
might result.
(B) [A pesticide that] in the intended use is exempt from, or
otherwise not subject to, a tolerance under section 408 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a and 348) or a
food additive regulation under section 409 of such Act.
In creating this exclusion, Congress recognized that applications
for registration of food uses that require clearance under FFDCA
require extensive data and relatively complex risk assessments that
take longer to review. Moreover, obtaining an FFDCA clearance is a
formal regulatory procedure. As discussed in Unit VIII.H., FIFRA
section 3(h) establishes goals for completion of Agency review of an
application for registration. In EPA's view, Congress recognized the
difficulty of requiring the review timeframes for registration to
encompass the complexities of FFDCA clearance as well. Accordingly, EPA
believes that Congress intended the statutory definition to allow
exclusion of any antimicrobial pesticide that would require the
extensive clearance process of the FFDCA.
The statutory language uses the phrases ``exempt from'' and ``not
subject to'' a clearance under FFDCA. The phrase ``exempt from'' is
clear and has meaning under FFDCA: an exemption from the requirement of
a tolerance is a formal regulatory determination made by EPA.
Exemptions from the requirement of a tolerance are found in 40 CFR part
180.
[[Page 50678]]
The phrase ``not subject to'' is not a formal determination under
FFDCA. Any product that bears a food use is ``subject to'' a tolerance,
that is, a tolerance or other clearance is required, whether that
tolerance has been established or not. EPA believes the statutory
language may be unintentionally broad in not differentiating between
food uses subject to an ``existing'' tolerance and those subject to a
``new'' tolerance. Products and uses subject to an existing tolerance
do not require extensive review; only products subject to a new
tolerance require such review. As written, the definition excludes both
types of antimicrobial pesticides, although the apparent intent is to
exclude only those requiring the lengthy and complicated tolerance-
setting review associated with a new clearance.
In its discretion, EPA proposes to narrow the food use exclusion to
conform to what it believes is the probable intent of Congress. EPA
proposes to exclude from the definition of ``antimicrobial pesticide''
only products bearing one or more uses for which a new clearance is
needed, or an amendment of an existing clearance. EPA proposes to
include in the definition of ``antimicrobial pesticide'' (to exclude
from the exclusion) product/uses ``subject to'' an existing tolerance.
EPA believes that this narrower policy choice, while not required, more
closely reflects the intent to include in the definition of
``antimicrobial pesticide'' products requiring little or no review and
to exclude only products needing the extensive and time-consuming
evaluation associated with the establishment of a new or amended
clearance.
An antimicrobial pesticide, then, is a product bearing only non-
food uses, only food uses covered by an existing clearance under FFDCA,
or some combination of these two.
Given the food use exclusion, it is clear that the status of an
antimicrobial product as an ``antimicrobial pesticide'' within the
meaning of FIFRA section 3(h) is not necessarily a permanent
designation, but may shift according to its intended use. A product
could be included or excluded from the definition if the intended use
changes. The status of a pesticide as an ``antimicrobial pesticide''
becomes pertinent and can only be determined at the time of submission
of an application for Agency decision. At that time, EPA must determine
whether the pesticide application is for an antimicrobial pesticide
within the meaning of the statutory definition.
The prime example of this use-dependent phenomenon is an
application seeking the first food use of an antimicrobial pesticide. A
product that heretofore has been an ``antimicrobial pesticide'' because
it bears only non-food uses or tolerance-covered food uses is no longer
an ``antimicrobial pesticide'' for purposes of EPA review and decision
on that first food use action. Provisions of FIFRA applying only to
``antimicrobial pesticides,'' notably the review periods, would not be
triggered for that action. Once the food use issue is resolved or a
tolerance issued, such that the food use is covered by an existing
tolerance, the product may revert to ``antimicrobial pesticide'' status
for a subsequent action.
C. Other Specific Exclusions
FIFRA section 2(mm)(2) contains further specific exclusions to the
definition. These are intended to clarify that certain types of
products that might be considered ``antimicrobial pesticides'' because
they have a pesticidal effect on the defined types of microorganisms
are nonetheless not to be regulated as antimicrobial pesticides for
purposes of FIFRA section 3(h). It should be noted that certain types
of antimicrobial products are already excluded from regulation under
FIFRA, and therefore from any coverage under this proposed rule.
Products used against microorganisms in or on man or other living
animals are not pesticides because such microorganisms are not
``pests'' under FIFRA section 2(t). Products intended for use against
microorganisms in or on man and animals are regulated solely by FDA.
This is not a change from longstanding FIFRA provisions.
1. Certain wood preservatives and antifouling paints. Any product
that is a wood preservative or antifoulant paint, and that also bears
any claim for a pesticidal activity other than or in addition to those
specified in section 2(mm)(1) is not an antimicrobial pesticide. The
pesticidal activities that generally define an ``antimicrobial
pesticide'' include activity against any microbiological organisms, and
``protection'' against the destructive effects of bacteria, viruses,
fungi, protozoa, algae, and slime.
Both wood preservatives and antifoulant paints (which are used to
protect surfaces in contact with water such as boats) may function to
protect against bacteria, fungi, etc., and thus, without a specific
exclusion, would be deemed to be antimicrobial pesticides. However,
since most wood preservatives also protect against insect damage, and
most antifouling paints also protect against barnacles, the majority of
these products are not likely to be ``antimicrobial pesticides.'' As
discussed in Unit VIII.H., however, some wood preservative products may
be eligible for the review deadlines that apply to antimicrobial
pesticides.
2. Agricultural fungicides. The definition of antimicrobial
pesticide in FIFRA section 2(mm) excludes ``agricultural fungicides.''
Traditionally, the term ``fungus'' in an agricultural context has been
used to mean microorganisms that are pathogenic to plants. Fungi (and
other microorganisms) that are pathogenic to man and animals have
historically been treated separately because of their public health
implications. However, FIFRA section 2(k) defines ``fungus'' broadly to
include a variety of other microorganisms, including rust, smut,
mildew, mold, yeast, and bacteria, without specific reference to
whether the microorganisms are pathogenic to plants or to man and
animals.
EPA intends the term ``agricultural fungicide'' to apply to all
products applied in or on growing crops or to soil (i.e., pre-harvest
application), regardless of the type of pest fungus. Although this
would exclude as ``antimicrobial pesticides'' products applied pre-
harvest against microorganisms that might be pathogenic to man and
animals, EPA is not aware that any pesticides are currently registered
against human and animal pathogens on growing crops. EPA would regulate
such products if the need arose, but they would not be covered by
subpart W.
Under this interpretation, a product intended for post-harvest
application against fungi (including bacteria) would not be an
``agricultural fungicide.'' Significantly, however, such a product
would not necessarily be an ``antimicrobial pesticide'' either, since
the food use exclusion also comes into play. Post-harvest application
of fungicides or antimicrobial products to food or feed crops would run
afoul of the food use exclusion if a new or amended tolerance were
needed to cover pesticide residues. All post-harvest use antimicrobial
products would be subject to subpart W generally; however, not all
would be ``antimicrobial pesticides'' eligible for the review periods
in Sec. 152.457.
3. Aquatic herbicides. Further, the definition of antimicrobial
pesticide excludes aquatic herbicide products. EPA interprets the term
aquatic herbicide to mean pesticides used in or near environmental
bodies of water, such as lakes, streams, or ponds, for the control of
algae or weeds. In contrast, a
[[Page 50679]]
product intended for control of algae in industrial systems or
processes or swimming pools would be considered an antimicrobial
product.
D. Products Included
Finally, section 2(mm)(3) lists a number of products that are
deemed to be antimicrobial pesticides, to ensure that they are not
inadvertently excluded by application of the various exclusions
elsewhere. These include chemical sterilants other than those excluded
under FIFRA section 2(u), other disinfectant products, industrial
microbiocides, and preservatives other than wood preservatives.
VII. Current Registration Procedures for Pesticides
Under FIFRA prior to FQPA, antimicrobial pesticides were not
singled out as a class of pesticide products requiring special
procedural attention. Antimicrobial pesticides were registered using
the same procedures and policies as other pesticide products.
Antifoulants, wood preservatives, and traditional antimicrobial
pesticides were in separate organizational units within EPA.
A. Overview of Procedures
A brief discussion of the registration procedures which have
applied to all products follows. Even though products that are
``antimicrobial pesticides'' will now be subject to a more carefully
drawn and rigorously applied regulatory program, the basic procedures
for registration will continue to apply.
1. A person seeking to register any pesticide product must submit
an application for registration. That application contains information
on the pesticide, copies of the proposed labeling of the product, and
data of various types supporting the registration (such as chemistry,
toxicology, environmental fate, ecological effects). If a food use is
involved, data supporting a clearance for residues in food are also
required, and if the product is of public health significance, efficacy
data must be submitted. Current regulations governing submission of
applications are found in 40 CFR part 152. Data requirements are
described in 40 CFR part 158, and labeling requirements in 40 CFR part
156. The tolerance-setting process is contained in 40 CFR part 180.
2. At EPA, the application is processed in several stages, each of
which evaluates different elements of the application.
a. A ``front end'' process assigns administrative numbers, checks
that basic elements are contained in the application, does a data check
for formatting purposes, and packages the application for review.
b. The application package is directed to the appropriate review
Division and thence to a Product Management (PM) team. Until recently,
two Divisions, the Registration Division and the Biopesticides and
Pollution Prevention Division, were the regulatory Divisions which
reviewed all applications. Antimicrobial pesticide applications were
processed within one branch, and antifoulants and wood preservatives
were located in a different branch, both in the Registration Division.
EPA has established a separate Antimicrobials Division (AD) to help
focus its regulatory management of these products, and antifoulants and
most wood preservatives are also now assigned to this Division.
c. The PM team enters the application into a tracking system,
reviews product labeling and data compensation elements, and determines
whether a scientific review is needed. Every application for new
registration contains some data; the amount and type of data vary
depending on the type of product, its composition and uses. Even
applications without new data often require scientific consultation to
determine the relevance and adequacy of existing data to support the
application.
d. If a scientific review is needed, the PM team sends the
application and data to various scientific reviewers. These reviews are
generally conducted in parallel, although certain assessments must
await the results of other reviews (for example, ecological effects
risk assessment may depend upon the environmental fate profile of the
chemical).
3. Upon completion of all reviews, the PM team consolidates review
recommendations and decisions and determines whether the product can be
registered. If it can, EPA issues a registration, approves the labeling
(often with required modifications), and notifies the applicant. If the
application cannot be approved, the PM notifies the applicant of
deficiencies (data, labeling, administrative) that must be corrected
before proceeding.
Once issued, a registration may be amended by submission of an
application for amendment, which undergoes a similar review process as
outlined above. The significant difference is that many amendments are
administrative, or require no scientific review, and thus entail a less
intensive and time-consuming process. Often amendments can be handled
entirely within a PM team. Some minor modifications to registration can
be accomplished by notification; these are modifications EPA has
determined have no potential for adverse effects. Notifications require
the most minimal review, primarily to ensure compliance with pre-
existing Agency policies or guidance.
B. Volume of Work
Typically, applications for new registration comprise about one-
third of the applications processed by the Agency, but require more
time and resources per application because of the scientific review
involved. Applications for registration of new chemicals and major new
uses require the most resources, but are relatively few in number. For
sheer numbers, the bulk of registration actions are (and likely will
continue to be) amendments to existing registrations that require no
scientific review (so-called ``fast track'' amendments). In FY 1997,
ending September 1997, EPA received a total of 635 actions related to
new applications for registration of pesticides assigned to AD,
including 11 high-resource new chemicals. In addition, there were 1,189
actions related to amendments to existing registrations, including 61
high-resource new uses. The number of ``actions'' includes both the
initial submission of applications for new and amended registration and
resubmissions of information after EPA has notified the applicant that
the application is deficient.
Finally, there were 506 notifications for antimicrobial products,
which under FIFRA section 3(c)(9) must be reviewed and a decision
issued within 30 days of receipt. While these require minimal review,
the large volume coupled with the short review time requires dedicated
resources.
C. Review Times
As with any complex process, the speed at which an application can
be reviewed and a decision made depends upon many things, some within
the control of the Agency, others dependent upon the applicant. FIFRA
prescribes in section 3(c)(3) that an application decision be reached
``as expeditiously as possible.'' Until modified by FQPA, FIFRA
contained only a single statutory decision deadline of 90 days, for so-
called ``fast-track'' applications--those which require no review of
scientific data. This review time is predicated upon receipt of a
``complete'' application. EPA is not required to review and reach a
decision on a fast-track application until it is deemed to be complete
(however, EPA must determine whether such an application
[[Page 50680]]
is complete within 45 days after receipt).
``Fast-track'' deadlines continue to apply to all products,
including antimicrobial pesticides. For antimicrobial pesticides,
however, FIFRA as modified by FQPA imposes additional statutory review
periods.
D. Non-Regulatory Guidance Documents
EPA uses detailed guidance documents to amplify, clarify, and
interpret its regulations in areas such as data and labeling
development and review, process changes, and applicant
responsibilities. EPA has developed a number of documents, which are
available to applicants and registrants, to elaborate on the general
regulations. In particular:
1. A guidance document called simply the ``Blue Book'' provides
specific details about the application process.
2. The Labeling Manual contains guidance for developing labeling
which complies with FIFRA and EPA regulations.
3. The Pesticide Assessment Guidelines describe test methods,
standards, and data reporting requirements used to satisfy data
requirements.
4. Standard Evaluation Procedures describe how EPA will review and
evaluate each type of study submitted in support of registration.
5. EPA uses direct notice to registrants (PR Notices) to inform
them of procedural changes, to clarify and interpret its regulations in
specific circumstances, and for general information purposes.
All of these will continue to apply to antimicrobial pesticides.
Given the special attention FIFRA now focusses on antimicrobial
products, EPA may develop specific guidance documents for antimicrobial
pesticides that would augment or replace existing guidance.
VIII. Proposed Antimicrobial Procedures
This unit discusses in detail the proposed procedural regulations
applicable to antimicrobial products. Proposed changes that apply to
all pesticides are discussed in later units of this preamble.
A. Organization of Proposed Subpart W and Relationship to Current
Regulations
40 CFR part 152 currently contains regulations pertaining to the
registration of pesticide products, including antimicrobial pesticides.
Part 152 contains appropriate definitions and criteria for determining
whether a product is a pesticide that must be registered (subpart A);
exemptions from FIFRA requirements (subpart B); procedures for applying
for registration (subpart C); data compensation procedures (subpart E);
the Agency's review of an application (subpart F); fees for
applications (subpart U) (currently suspended), and criteria and
procedures for classifying a pesticide for restricted use (subpart I).
Most of these provisions are unaffected by changes in FIFRA that target
antimicrobial program reform measures, and will continue to apply to
antimicrobial products as well as other pesticides.
However, FIFRA section 3(h)(3)(A) requires that EPA propose
procedural regulations focussing on antimicrobial pesticides. Because
the statutory reform measures are designed to implement specific goals
directed at antimicrobial products only, EPA proposes to create an
entirely separate subpart devoted to antimicrobial registration
procedures. Proposed new subpart W, entitled ``Registration of
Antimicrobial Products,'' would be a freestanding subpart describing
the application and Agency review procedures mandated by FIFRA section
3(h).
1. Relationship of subpart W to other subparts in part 152. Subpart
W would supersede subpart C of current part 152 for antimicrobial
products only; subpart C would continue to apply to all other products.
In addition, subpart W--for antimicrobial products only--would
supersede certain individual sections of subpart F--Agency Review of
Applications; subpart F would continue to apply to all other products.
Specifically, the following sections would be superseded:
a. Sec. 152.104, Completeness of applications. Completeness of
applications covered by subpart W is contained in Sec. 152.450,
Contents of application.
b. Sec. 152.110, Time for Agency review. Review periods for
applications covered by subpart W are contained in Sec. 152.457, Review
period for applications.
c. Sec. 152.115, Conditions of registration. Conditions of
registration for products covered by subpart W are contained in
Sec. 152.459, Terms and conditions of registration.
d. Sec. 152.117, Notification to applicant. Notification of Agency
decision on an application is contained in Sec. 152.455, Action on
applications.
e. Sec. 152.118, Denial of application. Denial of an application
covered by subpart W is also included in Sec. 152.455, Action on
applications, although the procedures for denial in Sec. 152.118 are
cross-referenced in Sec. 152.455.
As described in Sec. 152.440, all other subparts of part 152 would
continue to apply to products covered by subpart W and other
pesticides. Some minor modifications are proposed to current Sec. 152.1
to properly refer to the antimicrobial subpart. If subpart W and
subpart F conflict for an antimicrobial product or application,
Sec. 152.440 states that subpart W would take precedence.
2. Requirements duplicated in subpart C and subpart W. To be
comprehensive, avoid confusion for users, and avoid cross-referencing
unnecessarily, EPA has repeated in subpart W certain elements of its
current registration regulations from subpart C. In so doing, EPA has
made minor editorial changes not requiring proposal for clarity and
organization. EPA has captured the content of the following sections in
subpart W, and is not requesting comment at this time:
a. Sec. 152.40, Who may apply, which also appears as new
Sec. 152.443.
b. Sec. 152.42, Application for new registration, which has been
incorporated into new Sec. 152.443.
c. Sec. 152.43, Alternate formulations, which also appears as
Sec. 152.444, unchanged.
d. Sec. 152.44, Application for amended registration, which is also
incorporated into new Sec. 152.443.
EPA has incorporated into proposed Sec. 152.443(e) a general
provision for certification programs at the Agency's discretion and
direction. Current regulations in Sec. 152.44(b)(2) allow a
certification submission, in the Agency's discretion, which EPA has
typically used only for Agency-directed actions. EPA has not to date
expanded the certification option to a class of actions submitted on
the applicant's initiative. EPA believes that it may implement
certification programs administratively without regulations.
Nonetheless, in light of the statutory provision requiring
consideration of a certification process, EPA proposes a broader, but
still discretionary, use of certification programs. Under today's
proposal, EPA could identify elements of an application that the Agency
believes are amenable to a certification mechanism. EPA would issue a
guidance document (typically a notice to registrants) that would detail
how a certification program would be used.
B. Applicability of Subpart W
The applicability of subpart W is governed by the statutory mandate
of FIFRA section 3(h) in the first instance. However, because of
differences in scope between the statutory mandate and the Agency's
administration of the antimicrobial program, EPA proposes a
[[Page 50681]]
broader applicability than is provided for by the statute. This unit
explains why certain products would be covered by subpart W and others
would not be.
1. Antimicrobial pesticides and food/feed use antimicrobial
products are covered by subpart W. Although this proposal reflects the
mandate of FIFRA to address ``antimicrobial pesticides,'' EPA has
chosen to cover a broader range of antimicrobial products than
mandated. It makes sense for these procedural regulations to mesh as
closely as possible with the Agency's organization and administration
of the antimicrobial program, so as not to cause confusion either
within the regulated community or within EPA itself. EPA has created an
Antimicrobial Division within the Office of Pesticide Programs, whose
responsibilities extend to all antimicrobial products, not just those
defined as ``antimicrobial pesticides.''
Accordingly, EPA proposes that subpart W would apply to both
``antimicrobial pesticides,'' as defined by FIFRA section 2(mm) and
antimicrobial products that are food/feed use pesticides, but are not
defined as ``antimicrobial pesticides'' by FIFRA section 2(mm).
Virtually all products in these two categories are processed within the
Antimicrobial Division. The procedures and requirements of subpart W
would be applied equally to these two categories of products (with the
exception of review periods).
2. Wood preservatives and antifouling products are not covered by
subpart W. This subpart would not apply to any product that is neither
an ``antimicrobial pesticide'' as defined by FIFRA nor a food/feed use
antimicrobial product. Inclusion in this subpart would complicate the
registration process for products not processed in the Antimicrobials
Division, which are subject to the registration procedures of subpart
C.
The status of wood preservatives and antifoulant paints is
complicated under FIFRA. FIFRA is very specific in defining certain
types of products as antimicrobial pesticides and excluding other,
similar products, depending upon the type of claims made for the
product. A wood preservative or antifoulant paint that makes only an
antimicrobial pesticidal claim is an ``antimicrobial pesticide'' and
would be covered by subpart W as an antimicrobial pesticide. By
contrast, any multi-claim wood preservative or antifoulant paint is not
an ``antimicrobial pesticide'' and would not be covered by subpart W.
As a practical matter, because most antifoulant paints assert non-
antimicrobial barnacle claims, they would not be covered by subpart W.
Likewise, many wood preservatives make insecticidal or fungicidal
claims and would not be covered by subpart W.
Under FIFRA section 3(h)(3)(E), certain wood preservative products
that would not be covered by subpart W may nonetheless be eligible for
the same review periods as antimicrobial pesticides that are covered by
subpart W (see Unit VIII.H. for a full discussion of this provision).
EPA's responsibility for wood preservative products that qualify under
section 3(h)(3)(E) is fulfilled by ensuring that the statutory review
period is met. EPA need not, and does not propose to, make subpart W
apply to these products merely to implement the statutory review
periods.
Because the status of wood preservatives and antifoulant paints is
complex, EPA is providing in Table 1 below a summary of the status of
these products. The table breaks down wood preservatives and
antifoulant paints by type of claim (or combination of claims). Column
1 of the table lists the claim or combination of claims possible;
Columns 2, 3, and 4 answer the questions posed at the top of each
column.
Table 1.--Status of Wood Preservatives and Antifoulant Paints
----------------------------------------------------------------------------------------------------------------
Is this product
Is this product an Will this product be eligible for
``antimicrobial subject to this statutorily-required
pesticide''? proposal? review periods?
----------------------------------------------------------------------------------------------------------------
Wood Preservatives
Insecticide claims only No No No
----------------------------------------------------------------------------------------------------------------
Fungicide claims only No No No
----------------------------------------------------------------------------------------------------------------
Antimicrobial claims only Yes Yes Yes
----------------------------------------------------------------------------------------------------------------
Fungicide and insecticide claims No No No
----------------------------------------------------------------------------------------------------------------
Antimicrobial and insecticide claims No No Yes
----------------------------------------------------------------------------------------------------------------
Antimicrobial and fungicide claims No No Yes
----------------------------------------------------------------------------------------------------------------
Antimicrobial, insecticide and No No Yes
fungicide claims
----------------------------------------------------------------------------------------------------------------
Antifoulant Paints
Insecticide claims (barnacles) only No No No
----------------------------------------------------------------------------------------------------------------
Antimicrobial claims only Yes Yes Yes
----------------------------------------------------------------------------------------------------------------
Antimicrobial and insecticide claims No No No
----------------------------------------------------------------------------------------------------------------
3. Applicability is not dependent on where a product application is
processed. EPA has chosen to extend the proposal to food/feed use
antimicrobials for practical organizational reasons. However, EPA
emphasizes that where a product application is reviewed does not in any
way determine whether subpart W applies. For example, the Antimicrobial
Division currently reviews most antifoulant products, that for the most
part are not covered by subpart W. The Antimicrobial Division also
reviews those wood preservatives that do not make insecticidal claims,
some of which are covered by subpart W. This allocation of products may
change based upon workload and resource needs.
EPA may, in its discretion and for its convenience, choose to treat
products that are not covered by subpart W as if
[[Page 50682]]
they were covered. For example, EPA currently reviews applications for
non-covered products within the review periods of Sec. 152.457, but,
except for the narrow class of wood preservatives discussed above, the
Agency is not required to do so, and would not be subject to any
consequences if it failed to meet a review period.
C. Definitions
Section 152.442 contains definitions that apply to subpart W.
Relatively few definitions are needed here, since most terms are
defined elsewhere, either in FIFRA itself or in part 152. Terms
pertaining to antimicrobial levels of activity (e.g., sterilant,
disinfectant) are defined in subpart W of part 156, because they are
used in conjunction with labeling and not with registration procedures.
Comments are solicited on any additional terms that should be defined
in subpart W to inform or clarify the subpart.
Proposed Sec. 152.442 defines the following terms:
1. The term ``clearance'' is proposed to refer to all types of
clearances required under a regulatory authority other than FIFRA
before a product may be marketed. The term encompasses food tolerances,
exemptions and food additive regulations under FFDCA section 408 and
409, and FDA clearances for medical devices under FFDCA section 510.
2. The term ``complete application'' is the general definition
describing an application that may be placed into formal review. A
complete application is one that contains all elements described by
Sec. 152.450, but not necessarily all information required for
approving a registration or amendment.
3. The terms ``major new use,'' ``substantive amendment,'' and
``minor amendment'' are proposed as concise terms for application types
defined in rather longer phrases in the statute.
D. Types of Applications
1. What the statute requires. FIFRA section 3(h)(2) establishes
review period goals for antimicrobial applications, shown in Table 2
below, and requires in section 3(h)(3) that EPA differentiate in its
regulations the types of review undertaken for antimicrobial
pesticides. As discussed in Unit IV.C., EPA intends that defining these
application types in this proposal, coupled with EPA's part 158
proposal, will serve to adequately differentiate the types of review
undertaken by the Agency. EPA proposes in Sec. 152.445 to define
application types that correspond to the statutory review period goals
prescribed in the statute. The categories EPA proposes are discussed in
this unit.
Table 2.--Statutory Application Categories and Review Periods
------------------------------------------------------------------------
Review period goal
Description of application type ---------------------------------------
Days Months
------------------------------------------------------------------------
Product containing a new active 540 18
ingredient
------------------------------------------------------------------------
Product that is identical or 90 3
substantially similar (to
another registered product)
------------------------------------------------------------------------
Other new product 120 4
------------------------------------------------------------------------
A new antimicrobial use of a 270 9
registered active ingredient
(either a new registration or
an amendment)
------------------------------------------------------------------------
Other amendment that does not 90 3
require scientific review of
data
------------------------------------------------------------------------
Other amendment that requires 90 - 180 3 - 6
scientific review of data
------------------------------------------------------------------------
2. Applications requiring FFDCA clearance. The review periods for
which application types must be described apply only to antimicrobial
pesticides as defined in FIFRA section 2(mm). That definition excludes
food/feed use products that require a clearance under FFDCA. Before
assigning an application to a category having a review period, EPA must
first exclude any application for a food/feed use that requires a new
or revised clearance under FFDCA.
All other antimicrobial pesticide applications fall into one of the
categories, described in proposed Sec. 152.445(b) for new registrations
and proposed 152.445(c) for amendments to existing products.
3. Current application categories. Currently, EPA does not define
types of applications for registration by regulation, but has a
detailed tracking system (the Pesticide Regulatory Action Tracking
System or PRATS) for actions of all types flowing through the pesticide
review process. The system works by assigning action codes to each type
of action for purposes of PRATS tracking, reporting and process
management; the action code definitions are detailed and do not
correlate exactly with the six described in the statute. The PRATS
system describes application types and assigns target review periods
based on features that are not addressed by the general descriptions in
the statute, including:
a. The applicant's method of support for the application
(eligibility for the formulator's exemption, for example).
b. The amounts and types of data that require scientific review
(product chemistry or confirmatory efficacy data, for example, require
minimal review, while toxicology studies require considerable review
time).
c. In the case of amendments, what aspect of the registration is
being amended (composition, labeling).
d. Whether the application is an initial submission or a
resubmission following a rejection of an initial application.
Moreover, combinations of registration actions (for example, a
change in composition and labeling simultaneously, each with supporting
data requirements) complicate EPA's task of describing a categorization
scheme in simple terms.
It would be costly and inefficient for EPA to develop and manage
separate tracking systems for antimicrobial decisions and other
registration decisions. Nor does it make sense to do so. If EPA is to
successfully manage the review process and track review periods for
antimicrobial applications, it must use its existing tracking system.
Accordingly, EPA's approach to defining types of antimicrobial
applications was to crosswalk the types of applications defined by the
statute with the descriptors used in PRATS.
[[Page 50683]]
EPA first sorted the categories of actions in PRATS and identified
those that should be included in one of the six statutory categories.
EPA then fleshed out the statutory descriptions using the greater
detail of PRATS action code descriptions for purposes of this proposal.
The results of this approach are presented in proposed Sec. 152.445.
4. Terms defined for this proposal. EPA proposes to define more
concise terms than the statutory ones for the purposes of this proposed
rule. EPA proposes the following terms: (1) The term ``major new use''
for the statutory term ``new antimicrobial use of a registered active
ingredient''; (2) the term ``substantive amendment'' for the statutory
term ``amendment to an antimicrobial registration that requires
sceintific review of data''; and (3) the term ``minor amendment'' for
the statutory term ``amendment to an antimicrobial product that does
not require scientific review of data.''
5. Single category. Because each antimicrobial pesticide
application type will have a prescribed review period under FIFRA, and
EPA's failure to issue a decision within that review period will be
judicially reviewable, each application must be assigned to a single
application category. Ideally, the applicant and EPA would have a
common understanding of the designation of an application to avoid
disputes over the review period. In all situations, the application
categories in proposed Sec. 152.445 are discrete, that is, there is
only one possible application type that logically should apply. An
application either is for a new registration or is an amendment to an
existing registration. Beyond that broad division, the categories may
be less well understood and subject to disagreement. Under proposed
Sec. 152.445(a), EPA would determine the appropriate category.
There is one situation in which the statutorily designated review
period cuts across the application types as defined in the proposal.
The Act sets a review period of 270 days for a ``new antimicrobial use
of a registered active ingredient'' or ``major new use.'' Proposed
Sec. 152.445 defines application types in the first instance according
to whether they are submitted to EPA as applications for new
registration or amended registration. In the construct of the proposal,
therefore, an application for a ``major new use'' may be either an
application for new registration that includes a major new use, or an
application for amended registration to add a major new use.
Accordingly, both Sec. 152.445(b) and (c) include a separate category
for ``major new use. In both cases, the review period would be 270
days.
6. Applications for new registration--a. A product containing a new
active ingredient. Products containing new active ingredients are a
well-understood category. An application that proposes the registration
of an active ingredient that has never before been registered falls
into this category. A product containing a new active ingredient
typically requires review of considerably more data than one containing
already registered active ingredients.
b. A product bearing a major new use. This category consists of an
application for new registration of a product bearing a major new use.
A major new use is any use that is not registered for one or more of
the active ingredients in a product. Typically a major new use would
involve a significantly different pattern of use that changes or
increases the exposures to the active ingredient, such that substantial
amounts of new data are required to evaluate the different or
incremental risks presented. This definition is comparable to that in
Sec. 152.3 for ``new use'' for non-antimicrobial products.
EPA intends in its part 158 proposal to categorize all
antimicrobial uses into one of the following 12 use categories. All
currently registered antimicrobial use patterns are included in one of
these larger use classifications for data requirement purposes, but EPA
has not to date classified the existing use patterns in this organized
fashion.
Agricultural premises and equipment.
Food handling/storage establishments premises and
equipment.
Commercial, institutional, and industrial premises and
equipment.
Residential and public access premises.
Medical premises and equipment.
Human drinking water systems.
Materials preservatives.
Industrial processes and water systems.
Antifouling coatings.
Wood preservatives.
Swimming pools.
Aquatic areas.
Some categories would be further divided into subcategories.
Subcategories would generally be defined on the basis of similar
exposures and data requirements. Examples of significant use/exposure
differentials among use categories and subcategories are food/non-food
use and indoor/outdoor use or exposure.
Using these categories and subcategories of antimicrobial use
patterns, EPA would regard as a major new use of an antimicrobial
active ingredient any use in a different use category or subcategory
from currently registered uses for that active ingredient. As an
example, an active ingredient is registered with uses in the category
of ``Materials Preservatives'' and subcategory ``Indoor non-food
uses.'' If a registrant proposed a new use either in that same category
for an ``Indoor food use'' (a different subcategory), or in the
different category of ``Residential and Public Access Premises,'' that
application would be a major new use of that active ingredient.
c. A product that is identical to an existing product. For clarity,
this proposal separates ``identical'' and ``substantially similar''
products into two categories, even though they have the same review
period. Applications for end use products of these types are generally
indistinguishable from the so-called ``fast-track'' applications of
FIFRA section 3(c)(3).
Identical products are those that have an identical composition to
another registered product and bear identical use patterns. Both active
and inert ingredients must be identical and in exactly the same
proportion as the existing product. In the universe of antimicrobial
products, ``identical'' products include products that are formulated
by one company and simply repackaged by another company. These so-
called ``repacks'' must be separately registered by the repackager.
Identical products also include those that are actually formulated by a
second producer based upon specifications provided by another
registrant. The significant difference between these two types of
identical products is that ``repacks'' require virtually no data for
registration, while those that are produced separately require certain
minimal ``bridging'' data to ensure that they are actually identical in
composition and efficacy.
Identical use patterns mean that the label does not deviate in
terms of organisms controlled, use sites, or directions for use. An
applicant's product may have fewer (but identical) claims than another
registered product and still be an ``identical'' product, but may not
have different or expanded claims.
d. A product that is substantially similar to an existing product.
Substantially similar products are those that are permitted to have
minor differences in three areas--composition, use pattern, or method
of data support--from another registered product. When evaluated
against another identified registered product, a ``substantially
[[Page 50684]]
similar'' product must have the same active ingredients as the claimed
similar product, in substantially the same proportion. The inert
ingredients must also be substantially similar in chemical composition
and functionality to the claimed similar product. For example,
emulsifiers, fillers, solvents, propellants, etc., in the applicant's
product must have similar counterparts in the cited registered product
so EPA can reasonably conclude that both formulated products will have
essentially the same chemical and physical characteristics and toxicity
profile. Because substantial similarity may depend on the
characteristics of the individual products or the active and inert
ingredients, decisions on similarity would be made on a case-by-case
basis.
Substantially similar use means that the product bears a use
pattern similar to the claimed product. Again, fewer use patterns do
not make the product dissimilar, but adding or changing use patterns
would exclude the applicant's product from treatment as a substantially
similar product. A use pattern is a claim for control of a specified
organism on a specified site under specified conditions of use. With
respect to public health products, for which efficacy considerations
are paramount, use sites must be carefully considered in relation to
the pest organism, and small formulation changes or variations in use
directions can mean the difference between an efficacious product and a
non-efficacious product. For this reason, ``substantially similar'' use
patterns for public health products would be limited to identical
organisms on both products. For non-public health products,
substantially similar use patterns could involve organisms that are
similar but not identical.
A similar method of data support means that the applicant is using
methods of data support that do not require EPA to evaluate data (other
than product chemistry data) to review the application. As a practical
matter, this means that the applicant is either citing all required
studies or requesting a waiver of required studies. Many antimicrobial
products must be supported by efficacy data of some sort. Such products
are not substantially similar even if they are similar in composition
and use pattern to another product, because the submitted efficacy data
must be reviewed by EPA. Such products would be considered ``other''
products.
e. ``Other'' products. All applications for new registration other
than new chemicals, identical or substantially similar products, or
those bearing a major new use, would be assigned to the ``other''
category. These are products which have significant differences in
composition, uses, method of data support or labeling. Proposed
Sec. 152.445(b)(5) provides examples of applications that would be
categorized as ``other'' new applications, but is not comprehensive or
explicit, since it is essentially a default category of application. If
a new application cannot readily be categorized either as a ``new
active ingredient'' or as an ``identical'' or ``substantially similar''
application, it would routinely be placed in this category.
7. Applications for amendment. Applications for amendment to an
existing registration are categorized in much the same fashion as new
applications, that is, by defining the ends of the review spectrum, and
placing all amendments not clearly delineated into a middle category.
EPA therefore defines in this proposal three categories of amendments.
a. Amendment to add a major new use. As noted earlier, a major new
use may be presented to EPA in the form of a new registration or an
amendment. This category is for amendments to add a major new use to an
existing registration (as opposed to a new registration that bears a
major new use). ``Major new use'' would be the same as described
earlier.
b. Minor amendment. At the other end of the amendment spectrum, EPA
proposes an application category termed ``minor amendment.'' This
category is intended to parallel the ``identical or substantially
similar'' category for new applications, and is also identical to the
statutorily-defined ``fast-track'' provision of FIFRA section 3(c)(3).
In no case would a minor amendment require the review of any data. The
examples in proposed Sec. 152.445(c)(3) list minor amendments not in
terms of the actual registration changes that might be proposed, but in
terms of the nature of the evaluation that EPA must do. EPA does not
believe that this proposal can, or needs to, describe all the possible
types of ``minor amendments.''
The following are some characteristics of a minor amendment:
The evaluation can be conducted entirely within a Product
Manager team, without any scientific consultation.
The decision relies only on non-technical, non-scientific
information readily at hand.
The decision requires only regulatory or administrative
judgments, not scientific ones.
The decision applies existing policy, evaluates adherence
to existing policy, or ensures consistency among decisions.
The evaluation consists of simple comparisons among products.
The evaluation requires no separate documentation (such as
a scientific review) beyond the decision itself.
c. Substantive amendment. EPA proposes a category termed
``substantive'' amendments. This type of application would parallel the
``other'' category of new registrations, and would encompass all
amendments that are neither ``major new uses'' nor ``minor''
amendments. This category consists of amendments that require the
review of any scientific data.
Most changes in label precautionary statements or use directions
are included in this category, as well as many changes in product
composition. Inclusion of such a wide variety of amendments in this
category simply reflects the fact that these changes require the review
of some data. The data may consist solely of bridging or confirmatory
chemistry, toxicity, or efficacy data to demonstrate that the product
and its uses, as modified, would not significantly increase risks, or
that the product as modified remains efficacious. Moreover, the review
may be a cursory evaluation of existing data to determine that the
amendment is adequately supported. Nonetheless, the defining
characteristic of a substantive amendment is the need to review some
data, either submitted by the applicant or cited from Agency files.
This category is the only one in the statute that carries a range
of review periods (90 to 180 days), a provision that recognizes the
variety of amendments that can conceivably be proposed to a
registration. Arguably, the inclusion of a range of review periods
suggests that there are gradations of application types within this
range--applications that are relatively less complex that could fall at
the short end of the review period (90 to 120 days) and others that
require the full 180 days. Under this interpretation, EPA could be
expected to establish by regulation subcategories of application to
which a specific review period within the 90- to 180-day range would
apply. Equally consistent with the statute would be an interpretation
holding that the range was included simply to allow EPA the flexibility
to deal on a case-by case basis with the wide variety of amendments
covered by this category, and that no further differentiation or other
regulatory treatment is required.
EPA adheres to the latter view. EPA does not believe that it is
statutorily obligated to establish subcategories of 90- to 180-day
substantive
[[Page 50685]]
amendments. EPA has not discerned any great benefit to the Agency in
doing so, especially by regulation, while noting a number of
disadvantages. A proliferation of categories in itself creates
administrative burdens for EPA in tracking applications. The more
categories that are created--each having its own description against
which applications must be judged and a distinct review period--the
more time it takes EPA generally to administer a tracking system and
ensure that review periods are met. Likewise, the more EPA is bound by
regulatory categories and review periods, the less flexibility the
Agency has to respond to changing review needs or critical priorities
without running afoul of its regulations. EPA is not precluded from
adopting administrative subcategories if it does not choose to adopt
regulatory ones. Moreover, it is not clear that there would be
significant benefits to applicants in gaining a decision 30 to 60 days
earlier that would justify the additional administrative burden for
EPA. Accordingly, EPA is not proposing any specific subcategories.
Under today's proposal, all substantive amendments would be afforded
the same review period, that is, a maximum of 180 days.
In its stakeholder meetings over the past year, however, industry
representatives requested that EPA solicit comment on whether
subcategories should be established. Suggestions from the Chemical
Specialties Manufacturers' Association (CSMA) included the following,
all of which would be classified as substantive amendments:
1. Amendment with data to add a ``me-too'' use that requires full
toxicology and efficacy review.
2. Amendment with data to change a formulation that requires full
toxicology and efficacy review.
3. Amendment with data to modify a label requiring a toxicology or
efficacy review.
4. Amendment without data to modify a label which requires a
toxicology or efficacy review.
EPA solicits comments on these and other sub-categorizations and
review periods. Commenters should consider the following factors
important to EPA's decision:
A suggested category must be capable of unambiguous
description. EPA would likely not consider a category of uncertain
description that could be subject to dispute between applicants and the
Agency.
A suggested category must be meaningful in terms of both
numbers of applications likely to fall in that category and in the
suggested shorter review period. A category that includes relatively
few amendments would be equally unsatisfactory as one that includes too
many amendments. A suggested review period with less than a 30-day
decrement (180 to 160 days for example) would likely not be considered
meaningful. Nor would EPA likely adopt a category with a suggested
review period of 90 days, since there would then be no distinction
between that subcategory of substantive amendment and a minor
amendment.
A suggested category must be comprised of amendments that
can be reviewed within a review period of less than 180 days without
jeopardizing EPA's ability to meet other review periods. EPA is
committed to making decisions on applications as rapidly as possible,
and currently is meeting the review period goal of 180 days
consistently for all substantive amendments, but without consideration
of subcategories.
If commenters persuade EPA that additional subcategories should be
established, and that the benefits of less than 180-day decisions
outweigh the added administrative burdens (bearing in mind that the
Agency has limited resources and that additional administrative burdens
mean fewer resources for reviewing applications), EPA may in the final
rule adopt one or more subcategories of substantive amendments that
would refine the review period within the 90- to 180-day range. EPA
will not consider subcategories of any types of applications other than
substantive amendments.
E. Consultations During the Application Process
Because EPA is required to process complete applications for
registration within judicially reviewable timeframes, it is critical
that applications and data be complete and conform to Agency
requirements, and, as much as possible, that applicants and the Agency
have a common understanding of requirements and expectations about the
process and its outcomes.
EPA recognizes that the registration process can be complicated for
persons who are unfamiliar with FIFRA and its requirements; even for
those who deal routinely with the Agency, keeping up with new policies
and procedures can be challenging.
In the past, deficiencies in applications or data have been
resolved during or after the review process, either informally, for
example with a telephone call for a minor problem, or formally, by
rejecting an application with significant deficiencies. The current
review process has tended to encourage consultation only after an
application has been rejected, when EPA can explain both the results of
its review and what an applicant needs to do to correct deficiencies.
Pre-submission consultation has not typically been the case with
antimicrobial products.
With the completeness of an application at stake for an applicant,
and strict review periods in place for EPA, it makes sense for both to
consult as much as is practicable and as early as possible.
Misunderstandings about requirements and expectations may lead to
needless determinations of incompleteness or denial for the applicant,
while impeding EPA's ability to reach decisions in a timely fashion as
required by the statute.
EPA encourages consultation with the Agency on any application
prior to a determination of completeness. However, the majority of
antimicrobial applications are for so-called ``me-too'' products and
uses, those which are identical or substantially similar to others
already registered. Such applications are relatively easy to submit
correctly, seldom raise new or controversial issues, and should not
routinely require specific consultation. Once an application has been
determined to be complete, and has been placed in review, the applicant
should not need or expect to consult the Agency until the end of the
appropriate review period (which for ``me-too'' products is only 90
days), or until EPA notifies the applicant of a deficiency.
However, EPA has identified two areas where it believes advance
consultation is essential to the submission of a complete application,
and proposes in Sec. 152.447 to require pre-submission consultation.
The first is applications for new chemicals and major new uses. These
consultations, which are common for agricultural chemicals but rare for
antimicrobial chemicals, help the applicant and the Agency agree upon
data requirements, data waivers, or issues that typically arise for new
chemicals and major new uses (such as food use status).
In addition, EPA proposes to require pre-submission consultation
whenever an efficacy test protocol or method must be approved by the
Agency either because there is no protocol or because the applicant
wishes to modify an exising protocol.
The regulation does not prescribe how consultation is to be
accomplished. There is no requirement that a required consultation
occur in a meeting; a conference call, letter, or other form of
[[Page 50686]]
communication may be sufficient, depending on the nature of the new
chemical, new use, or protocol approval needs. However, proposed
Sec. 152.447 emphasizes that any regulatory determinations must be in
writing. EPA expects the applicant to follow up any consultation with a
summary of any decisions so that EPA may confirm them in writing.
Proposed Sec. 152.450 would require written documentation of a
consultation describing the substance of the consultation to be
submitted with the application to verify that the consultation took
place as required.
In turn, EPA would commit to adhere to the decisions agreed upon in
a pre-submission consultation unless the circumstances of the
application change, its determinations were in error, or a question of
adverse effects arises.
F. Contents of Applications
1. What the statute requires. FIFRA section 3(h) requires formal
Agency review only upon submission of a ``complete'' application, and
requires that EPA clarify its criteria for completeness of an
application. Current regulations in 40 CFR 152.50 describe the contents
of an application for registration, including applications for
antimicrobial products. EPA proposes in subpart W an expanded and more
detailed description of the contents of a complete application,
including some new elements of an application not currently required.
2. Definition of complete application. First, EPA is proposing a
general definition of ``complete application'' in Sec. 152.3, a
definition that would apply to all applications for registration. Other
provisions of FIFRA also link Agency priority, review or action to
completeness of an application, for example, the fast-track and minor
use provisions of section 3(c)(3), and the expedited review provisions
of section 3(c)(10). The general definition is repeated in Sec. 152.442
to apply to antimicrobial applications.
The definition draws a distinction between the completeness of the
application itself (which allows EPA to commence formal Agency review),
and the completeness of the information needed for EPA to approve the
application. It is relatively easy to define a core set of items--
forms, labels, routine and uncomplicated data--which, if present in an
application, suffice to begin review. But completeness for Agency
decision purposes encompasses an element of ``adequacy'' that, for many
applications, can only be determined on a case-by-case basis, and only
during or after substantive review of the application. Accordingly, the
decision by EPA that an application is ``complete'' (and, for
``antimicrobial pesticides,'' that begins a review period), represents
only a preliminary or interim determination of overall completeness
intended to allow EPA to initiate formal review.
Completeness becomes a question of adequacy as the amount of
scientific data and the complexity of the risk assessment increase.
Typically, applications for new chemicals or new uses, and actions
involving food uses or increased non-dietary exposures require more
data. FQPA significantly expanded the scope of dietary risk assessment
under the FFDCA, particularly for infants and children.
Correspondingly, EPA will be enhancing its non-dietary assessment of
risks to infants and children, such as might occur with antimicrobial
pesticides. However, ``fast-track'' or ``me-too'' applications that
require little or no scientific review comprise the bulk of
antimicrobial applications submitted to EPA. These actions are
relatively straightforward as to application and approval criteria and
EPA expects that the completeness determinations for review purposes
and for approval of the application generally would be equivalent. For
these types of applications, EPA would be less likely to find during
its formal review that it requires data or information beyond that
provided at the time of application.
3. Contents of an antimicrobial application. FIFRA section 3(h)
requires that, in its final regulation, EPA clarify criteria for
determination of the completeness of an application for antimicrobial
pesticides. EPA is proposing in Sec. 152.450 detailed requirements for
applications, which, if satisfied, would allow a preliminary
determination of completeness.
Current requirements in Sec. 152.50 form the basis for the
requirements in proposed Sec. 152.450, but EPA proposes an expanded
level of detail. Table 3 below sets out each element of an
antimicrobial application as proposed today. Column 1 identifies the
application requirement. Column 2 gives the reference in proposed
Sec. 152.450 of the requirement. Column 3 gives the cross-reference to
Sec. 152.50, or indicates that the requirement is new. New elements are
discussed more fully afterwards. Column 4 provides explanatory notes,
indicating that a requirement is unchanged from current requirements,
or describing additions or changes for antimicrobial applications.
Table 3.--Contents of an Antimicrobial Application for Registration
----------------------------------------------------------------------------------------------------------------
Explanatory notes/
differences for
Requirement Sec. 152.450 reference Sec. 152.50 reference antimicrobial
applications
----------------------------------------------------------------------------------------------------------------
Application form (a) (a) Unchanged. Detail is
provided on the
elements and
completeness of the
form.
----------------------------------------------------------------------------------------------------------------
Authorization for agent (b) (b)(3) Unchanged.
----------------------------------------------------------------------------------------------------------------
Summary of application (c) (c) Unchanged. This summary
and that required for
results of studies may
be consolidated.
----------------------------------------------------------------------------------------------------------------
Statement of formula (d) (d), (f)(2) Unchanged. The Statement
of Formula includes
both product identity
and composition.
----------------------------------------------------------------------------------------------------------------
Draft labeling submission (e) (e) Unchanged. Detail is
provided on the
presentation and
completeness of the
labeling submission.
----------------------------------------------------------------------------------------------------------------
Method of support documentation (f) (f)(1) Unchanged. Consists of
forms and information
required to demonstrate
compliance with data
compensation
requirements of FIFRA.
Sec. 152.450
summarizes the existing
methods of data
support.
----------------------------------------------------------------------------------------------------------------
Data (g) (c), (f)(2) Unchanged.
----------------------------------------------------------------------------------------------------------------
[[Page 50687]]
Adverse effects information (h) (f)(3) Unchanged. The proposal
clarifies that such
information is not
required with an
application for
amendment.
----------------------------------------------------------------------------------------------------------------
Tolerances or other food clearances (i) (i) Unchanged.
----------------------------------------------------------------------------------------------------------------
Consultation documentation (j) New If a pre-submission
consultation occurred
under Sec. 152.447, or
decisions or agreements
were made at an
optional consultation,
the applicant would be
required to provide
documentation of that
consultation.
----------------------------------------------------------------------------------------------------------------
Data reviews conducted by other (k) New If reviews have been, or
regulatory authorities are being, conducted by
other regulatory
authorities, the
applicant would be
required to submit
those that are
available.
----------------------------------------------------------------------------------------------------------------
Other clearances (l) Not previously in Unchanged. Applicants
regulatory form are currently required
to provide evidence
that the applicant has
requested clearances
required by other
Agencies.
----------------------------------------------------------------------------------------------------------------
Packaging (m) (g) Unchanged. Clarifies
that packaging itself
is not to be submitted
with an application
unless specifically
requested by EPA.
----------------------------------------------------------------------------------------------------------------
Product samples (n) Not previously in Unchanged. Clarifies
regulatory form that product samples
are not to be submitted
with an application
unless requested by
EPA.
----------------------------------------------------------------------------------------------------------------
Self-addressed means of EPA (o) New Voluntary submission of
notification a postcard or other
means for EPA to notify
the applicant of a
preliminary
determination of
completeness.
----------------------------------------------------------------------------------------------------------------
Fees (p) Part 152, subpart U Unchanged. Application
fees are currently
suspended. Included
here only for
completeness.
----------------------------------------------------------------------------------------------------------------
Authorization to share data and data (q) New Optional. The applicant
reviews is requested to
authorize EPA to share
either data or EPA
reviews of data with
State, Federal,
national, or
international
regulatory authorities.
----------------------------------------------------------------------------------------------------------------
4. New required elements of applications. Only three required
elements of an application are entirely new in today's proposal.
Proposed Sec. 152.450(j) would require that applicants submit
documentation of the results of pre-submission conferences, either
those required by Sec. 152.447 or optional ones, at which regulatory-
related decisions were discussed or agreements reached. The
documentation could be minutes of the meeting that EPA has reviewed, or
could be a letter from EPA confirming the decisions reached or
approving a specific test regimen or protocol.
Proposed Sec. 152.450(k) would require the applicant to submit
available reviews of the application, or of individual studies, that
have been conducted by other regulatory agencies or organizations. If
an application has been submitted for regulatory review elsewhere, the
applicant would be required to inform EPA of that fact. Applications
may have been submitted concurrently to international regulatory
bodies, or to Federal Agencies or States. If EPA is able to use the
results of reviews conducted elsewhere, it will save time and resources
in reaching a decision on the application, which may allow earlier
entry into the marketplace. An applicant would not be required to
either await the results of ongoing reviews or to specifically obtain
copies of the reviews to submit with his/her application. However, if
reviews have been provided, the applicant would be required to submit
them to EPA with his/her application.
Proposed Sec. 152.450(l) would require that applicants provide EPA
with documentation that they have received (or have applied for) any
other clearances from Federal agencies that might be necessary to
market or use the product. EPA currently requires such documentation
before issuing a registration bearing the use in question. Submission
with the application of evidence that the clearance has been requested
or obtained would help assure EPA that the applicant is fully aware of
its obligations under other laws. Ensuring that all regulatory
clearances are underway concurrently also makes the review periods for
EPA meaningful. EPA approval of an application within a review period
would have little meaning if the applicant cannot market the product or
users cannot use it because additional clearances are needed.
5. Non-mandatory or clarified elements of applications. Four
further elements of the antimicrobial application are either clarified
by inclusion of explanatory language, or are voluntary information.
Proposed Sec. 152.450(m)(2) clarifies that product packaging is not
to be submitted unless requested. The submission of labeling is
accomplished using draft typescript copies or mock-ups that are
suitable for microfilming and filing.
Proposed Sec. 152.450(n) clarifies that applicants are not to
submit actual product samples with an application unless requested. EPA
typically requires samples of active ingredients or analytical
standards in conjunction with
[[Page 50688]]
setting tolerances. EPA may also request samples of antimicrobial
pesticides bearing public health claims for EPA evaluation of efficacy.
In each case, EPA will separately request such samples and instruct the
applicant how and where to provide them.
Proposed Sec. 152.450(o) provides that applicants who wish to be
notified whether an application is preliminarily complete (and
therefore has been placed into review with a review period) furnish EPA
with a means of notifying them. This could take the form of a postcard,
form letter, or other means of such notification. Without an easy means
of notification, EPA cannot commit to written notification. Nor will
EPA use notification methods such as telephone or e-mail that cannot
properly be documented by an authorized signature as EPA-originated,
although advances in technology may make this feasible in the future.
Finally, EPA would notify the applicant only at the time the
application is determined to be complete; at that time the formal
review period would have started, and EPA's next communication with the
applicant would normally be a decision on the application
(Sec. 152.455, Action on applications.) EPA would not accept multiple
postcards or requests simply to advise the applicant of the status of
the application review during the review period.
Proposed Sec. 152.450(q) requests, but does not require, that the
applicant provide authorization for EPA to share the data or EPA
reviews of data with other regulatory agencies. The ability to share
data and reviews among regulatory authorities will contribute to
streamlining EPA review processes for antimicrobial products, and is an
essential element in achieving harmonization of reviews.
An applicant who intends to market a product in the United States
may be required to register the product with individual States; an
applicant who intends to market the product abroad (such as in Canada)
must meet the regulatory requirements of other countries. While the
depth of regulatory scrutiny of a product varies among States and
countries, many require the submission of equivalent amounts of data as
the applicant has submitted to EPA. The ability to share data submitted
to one regulatory authority with others can reduce the paperwork and
review burden of all by reducing multiple identical submissions and
allowing the sharing of the review load. EPA already is engaging in
work-sharing efforts with the State of California and with Canada.
This effort can be complicated by confidentiality claims under
FIFRA section 10(b) or the disclosure restrictions of section 10(g).
Section 10(g) permits the Agency to disclose data in support of
registration only to those who affirm that they will not further
disclose the information to foreign or multinational pesticide
producers. Although a mere claim of confidentiality under FIFRA section
10(b) does not conclusively prevent disclosure of information, it does
require the Agency to follow certain procedures (which may include
obtaining a substantiation of the claim from the registrant) to
determine whether the information is entitled to confidential
treatment. These procedures can interfere with free and unimpeded
exchange of information and data among regulatory authorities.
On November 27, 1985, EPA issued Class Determination 3-85 (50 FR
48833). EPA declared as non-confidential (and not subject to the
disclosure restrictions of FIFRA section 10(g)) reviews of data that do
not contain information which would disclose: (1) Manufacturing or
quality control processes; (2) the details of any methods for testing,
detecting, or measuring the quantity of any deliberately added inert
ingredient of a pesticide product; (3) the identity or percentage
quantity of any deliberately added inert ingredient of a pesticide
product; (4) unpublished information concerning the production,
distribution, sale, or inventories of a pesticide (such information
might appear in reviews which discuss the amount of a pesticide sold or
used in a given time, and thus might concern the significance of data
from a test or experiment); (5) any complete unpublished report
submitted to EPA by a registrant or applicant; or (6) excerpts or
restatements of any such report which reveal the full methodology and
complete results of the study, test, or experiment, and all explanatory
information necessary to understand the methodology or interpret the
results.
Agency data reviews are normally drafted to avoid inclusion of
information that is within the six categories described in the
paragraph above, but EPA cannot guarantee that all reviews will meet
these criteria. Moreover, as discussed above, the Agency may have a
need to share raw data in addition to study reviews with States and
other countries.
EPA believes it is in the interest of both applicants and the
Agency to have free and unimpeded exchange of information and data
among regulatory authorities. To that end, this proposal requests that
applicants authorize such exchange at the time of application. Sharing
data and reviews with other regulatory authorities would not compromise
the protection against disclosure provided by section 10, because such
sharing would not constitute a public disclosure of the information.
To authorize data- or review-sharing, the applicant would submit a
statement authorizing EPA to share either any data submitted with the
application or EPA's reviews of such data with regulatory authorities
as needed. An appropriate permission statement would be similar to the
following:
This letter grants permission for EPA to share all data submitted
with this application, EPA reviews of data submitted with this
application, with State, other U.S. Federal, or other national
regulatory authorities. This authorization does not waive any
restrictions on public disclosure of the data reviews.
G. EPA Action on Applications
1. Completeness screens. EPA currently screens all applications for
completeness, not just antimicrobial applications. The Office of
Pesticide Programs Front End Processing Unit (FEPU) receives all
applications, processes them administratively, and conducts a simple
screen to ensure that required application items are present and
properly submitted. An application accompanied by data is subsequently
screened for submission and format requirements of the data itself.
Data submissions must include specific items prescribed by Agency
regulations in 40 CFR 158.32 and 158.33, as well as meet format and
presentation requirements detailed in PR Notice 86-5. Neither of these
screens evaluates the substance of the application or the data. In
either the FEPU or data screen, EPA may identify deficiencies that must
be corrected. Depending on the nature of the deficiency, the
application may be placed into review anyway, and deficiencies
corrected during the review process. This informal screening and
correction process has served the Agency and applicants well over the
years.
Nonetheless, because FIFRA directs EPA to develop completeness
criteria, and because antimicrobial pesticides are now subject to
review periods, which are computed only if an application is determined
to be complete, it is imperative that EPA not only establish more
formal criteria for completeness, but that EPA conduct a more rigorous
completeness screen before determining even preliminarily that an
application is complete. Section 152.455 of today's proposal describes
what actions EPA
[[Page 50689]]
may take on complete and incomplete applications.
2. Preliminary determination of completeness. In addition to the
FEPU administrative screen and the data review screen, the
Antimicrobial Division has instituted a more in-depth screening process
to ensure that only applications that meet the standards of proposed
Sec. 152.450 enter formal Agency review. The antimicrobial screening
process builds on the earlier screens in two ways: by evaluating the
adequacy of certain application items that are typically not evaluated
in a simple administrative screen (e.g., are clearly required studies
included?), and by evaluating application requirements peculiar to
antimicrobial pesticides (e.g., efficacy data requirements).
Based on this screen, EPA would make a preliminary determination
whether an application is complete (proposed Sec. 152.455(a) and (b)).
If the application is incomplete, EPA would notify the applicant,
describe the deficiencies and await resubmission by the applicant. If
complete, and a self-addressed notification has been provided in
accordance with proposed Sec. 152.450(o), EPA would notify the
applicant of the determination, compute the date under proposed
Sec. 152.457 when a decision may be expected (calculated from date of
receipt of the application), and place the application into formal
review. If no self-addressed notification is provided, EPA would place
the application into formal review, but would not notify the applicant.
Because some elements of completeness cannot be evaluated until the
application is reviewed in depth, a determination of completeness
sufficient to place the application into formal review must, of
necessity, be a preliminary one.
EPA is likely to apply its completeness criteria very strictly, for
several reasons. Strict application of completeness criteria appears to
be consistent with the statutory direction to base enforceable
deadlines on completeness determinations. Further, consistent treatment
of applications is more likely if EPA establishes and adheres to
relatively ``bright line'' criteria for completeness. Finally, the
sheer number of applications that EPA receives means that it must
allocate its review resources very carefully. EPA does not believe it
unreasonable to use completeness determinations as a management tool
for those resources. While refusing entry into review for a minor
deficiency may appear inflexible, it is important to recognize that
what is flexibility for one applicant may appear to be inconsistency or
inequity to another. EPA believes that lack of completeness criteria
and inconsistent application of such criteria have been a source of
applicant dissatisfaction.
3. Effect of incompleteness determination on review period.
Regardless of when a determination of incompleteness is made, the
consequence is the same: the review period would either not be computed
or would be halted and recomputed anew upon receipt of all items
completing the application. EPA would notify the applicant that the
application is incomplete, and specify how it can be made complete.
4. Applicant resubmission. Proposed Sec. 152.455(b) specifies that
EPA will deem the review period to have begun only upon receipt of the
last item that completes an application. Partial information clearly
does not satisfy the completeness criteria, or allow the application to
be placed into review. EPA discourages applicants from correcting
application deficiencies in a piecemeal fashion; nonetheless,
historically this has happened (and been tolerated by the Agency)
because some deficiencies are easy to correct (a form not signed, an
unreadable draft label), while others may take longer (a missing
required study).
An applicant may wish to resubmit rapidly what can be readily
corrected, and EPA may wish to accommodate the applicant's desire to
begin review of available information. As noted earlier, under the
current application review system, both of these can often be
accommodated. EPA frequently is requested and agrees to place an
application into review while waiting for some item that has not yet
been submitted, expecting that the missing item can ``catch up'' before
it is needed for review. Under the tight review periods provided for
antimicrobial application review, however, EPA cannot afford the time
and resources that may be lost if an applicant fails to provide the
needed information in a timely manner. Other applicants also suffer
because their applications are not reviewed as promptly as possible.
Accordingly, EPA would not place an application into review until all
deficiencies are corrected, and a preliminary determination of
completeness can be made.
5. Agency review. Once EPA has issued a preliminary determination
of completeness, EPA will place the application into substantive Agency
review. EPA conducts scientific reviews in parallel as much as
possible, although some reviews depend upon the results of others and
must be conducted sequentially. Proposed Sec. 152.455(d) specifies
that, once in review, EPA will complete all reviews for the application
before issuing a decision of any sort, even a determination that the
application remains incomplete. EPA intends, however, to continue, to
the extent practicable, its longstanding practice of communicating
informally with applicants about interim results of reviews as they are
completed. Informal communications are not Agency decisions on the
application itself, and are entirely at the Agency's discretion.
6. EPA decisions after review. Section 3(h)(3)(F)(i) provides that:
[T]he Administrator shall notify an applicant whether an
application has been granted or denied not later than the final day
of the appropriate review period under this paragraph, unless the
applicant and the Administrator agree to a later date.
This provision is probably the single most significant element of
the overall antimicrobial reform effort mandated by FIFRA. All process
improvements and efficiencies directed elsewhere in FIFRA section 3(h)
are for the purpose of shortening review periods to the goals specified
in FIFRA section 3(h)(2). This provision holds EPA to a decision within
the review periods that would be established under this proposal. EPA's
failure to meet those review periods is judicially reviewable.
EPA takes seriously its mandate for antimicrobial process reforms:
meeting its review period goals is the most visible and tangible
evidence of the success of its reforms. Hence, how EPA implements this
provision, both in making decisions and in managing the review period
process, is critical.
EPA review must culminate in one of two specified decisions--
approval or denial--by the end of the review period. The ``review
period'' can be either that established in proposed Sec. 152.457, or an
extended review period agreed to between an applicant and EPA. The
statute does not provide for negotiated shorter review periods; those
that would be established under this proposal are minimum review
periods that would apply unless extended by agreement.
The statute is silent on whether EPA may take other unspecified
actions prior to the expiration of the review period and what those
actions might be, but clearly no action other than approval or denial
is authorized at the end of the review period. EPA believes that it is
within its discretion to take interim actions prior to the expiration
of the review period, as long as the final decision on an application
is either approval or denial. Interim actions might include
communications with applicants on the application, preliminary
indications of
[[Page 50690]]
incompleteness or other deficiencies that might lead to denial, or
notice of the Agency's intent to approve the application.
Approval is of course the desired decision from the applicant's
point of view. If the application is complete and relatively
uncomplicated, reaching a decision within the review period is mostly a
function of efficient management of the review process. The bulk of the
antimicrobial applications that EPA receives are for so-called ``me-
too'' products and amendments (those with review periods in the range
of 90 days). These can be fairly characterized as uncomplicated, and
problems with completeness are more likely to be the reason for delays
in approval than the complexity of the review or decisionmaking
processes. Delays due to incompleteness are not included in EPA's
review period. A rigorous application of the completeness criteria of
proposed Sec. 152.450 to weed out incomplete applications should enable
EPA to reach a decision within the review period for applications that
are complete.
For applications of greater complexity--new chemicals, major new
uses and other products and uses that are not substantially similar--
the decision process is not a straightforward one-time review leading
to a single decision point of approval or denial. Rather it involves a
series of decisions, with stops and starts in the process as the
application progresses. Typically, such an application goes through
several cycles of review. Under current practice, EPA commences review
of an application and often determines that it is incomplete,
inadequate, or raises risk or efficacy concerns that must be addressed.
The Agency notifies the applicant and places the application into
pending status until the applicant responds. The ``down time'' awaiting
applicant response varies considerably based on the type of problem,
but if a new study is required, may be from 6 months to 2 years. For
the most complex applications, those for new chemicals and major new
uses, the cycle may be repeated several times. Thus, the total elapsed
time from beginning of review to an approval or denial decision may be
lengthy, but the length is generally not attributable solely to EPA
inaction or delay. The time may be marked by interruptions when the
application is awaiting applicant action and not EPA action.
In the current review process, an interim decision is not a denial,
which carries the right to administrative appeals. EPA refers to such a
decision as a ``rejection,'' a term used to reflect the interim
incomplete status of the application and of EPA's review.
The provision in FIFRA section 3(h) that EPA must reach a decision
within a specified review period is silent on whether or how the review
period should accommodate the cyclical nature of the review process, in
which EPA review time and applicant response time typically alternate.
A strict interpretation of the provision would be that the review
period includes applicant ``down time.''
Congress rightly anticipated that EPA might reasonably need a
longer review period in certain circumstances, and the statute
contemplates, but does not specify, a process for reaching agreement on
a longer period for the formal approval or denial decision. The
excepting clause, ``unless the applicant and the Administrator agree to
a later date,'' while not perfect in that it does not reflect the
reality of the review process, does allow EPA and the applicant, by
agreement, to extend the total review period. An agreement on extension
could be tailored to account appropriately for applicant ``down time,''
without penalizing EPA or subjecting the Agency to the threat of
judicial review. EPA believes that this clause provides much-needed
flexibility both in the types of actions that EPA may take and the
process by which an appropriate review period is to be agreed upon.
Regardless of the reasons for needing an extension, EPA cannot
afford to engage in case-by-case negotiation for every application that
might approach the end of its review period without a decision. To
reflect more closely the actual review process, EPA needs to be able to
take actions before the end of the review period that have the effect
of extending the overall review period by stopping it for some period
of time. Without such flexibility, EPA may be compelled to use its
denial authority more frequently to meet the statutory requirement to
issue a decision.
EPA does not intend to violate its regulations by failing to make
decisions in a timely manner. If EPA is unable for any reason to issue
a decision on an application within the review period, and cannot agree
with the applicant on an extension, EPA's failure permits the applicant
to seek judicial review. EPA views the judicial process as the least
desirable means of resolving disputes over the review period. Not only
is it time-consuming and costly for both parties, but a predictable
result of judicial review is that a court would order EPA to complete
review within some further period of time, an outcome which has the
same effect on the review schedule as if EPA and the applicant had
agreed to an extension.
EPA's alternative course of action, permitted by the statute, is
simply to deny the application. Denial would be governed by the
provisions of FIFRA section 3(c)(6), which permits an administrative
hearing process. While EPA may thereby satisfy the requirement to issue
a decision and avoid the threat of judicial review, the Agency believes
there is little value added by the administrative hearing process,
which can be as protracted, costly, and uncertain as judicial review.
Nor does EPA believe that applicants, many of whom are small companies
without substantial financial or technical resources, are well served
by either an administrative or judicial process in this particular
context. Their objective is presumably to obtain an EPA decision in the
most timely manner and without extraordinary effort or cost on their
part.
Given that individual negotiation is not feasible for any large
number of applications, that EPA and applicants may reasonably disagree
on the need for or length of extension, and that neither judicial
review nor denial of the application is an appealing means of resolving
such disputes, EPA believes it prudent to establish rules for
implementation of review periods that build in provisions for
extension. Today's proposal would do so, while not foreclosing the
opportunity for case-by-case extension agreements when warranted.
Accordingly, EPA proposes in Sec. 152.455 a series of possible
decisions arising from substantive Agency review, incorporating
proposals for dealing with extensions. These are: (1) The application
may be approved; (2) the application remains incomplete; (3) the
applicant has failed to furnish sufficient information to determine
whether the application may be approved (two circumstances with
different consequences for the review period); and (4) denial for
cause.
7. Approval. If EPA approves the application, it would follow its
customary procedures to notify the applicant by issuing a Notice of
Registration or letter of approval for an amendment and sending back a
stamped copy of the approved labeling if called for.
8. Opportunity for rebuttal. EPA frequently issues a registration
that is conditioned upon the applicant's making certain corrections or
modifications to the registration before sale or distribution. Such
terms and conditions generally only require changes which are minor in
nature and
[[Page 50691]]
most often consist of labeling changes to be consistent with similar
products, adhere to Agency policies, or clarify label statements. In
EPA's experience, virtually all new registrations require some
modification to the label; for this reason EPA requests and approves
draft labeling as part of the application, and requires that the
applicant submit final printed labeling prior to sale or distribution
of the product.
EPA's approval of the registration and permission to distribute or
sell the product is premised on the applicant's acceptance of EPA's
terms and conditions. Proposed Sec. 152.455(d)(1) would permit
applicants who disagree with the terms or conditions of EPA's approval
to submit an objection within 30 days of receipt of registration. In a
process analogous to the appeals process for notifications in FIFRA
section 3(c)(9), EPA would review the applicant's arguments and issue a
final decision. EPA would try to review the objection and render a
decision within 45 days of receipt by the Agency. It should be kept in
mind that EPA's limited resources must be devoted first and foremost to
its review period obligations for application decisions; EPA cannot
promise that objections to decisions already made will receive equal
attention.
9. Determination that the application remains incomplete. EPA may
decide that, notwithstanding its preliminary determination of
completeness, the application remains incomplete. One reason EPA might
determine incompleteness is if the deficiency is the result of the
applicant's failure to follow well-established and clearly stated
guidance, procedures, or policies. Such ``incompleteness'' could be
identified when studies are reviewed in depth and found not to have
been conducted in a manner that provides EPA with adequate information
on which to reach a decision on the application. This type of
incompleteness would normally be discovered only during substantive
review. EPA cannot however, preclude the possibility that some
deficiencies could be overlooked at the earlier preliminary
completeness screening.
EPA expects that it would choose to use the incompleteness
determination only rarely after an application is preliminarily
determined to be complete, electing instead to deny the application or
seek agreement with the applicant on an extension of the review period.
Applications having relatively short review periods (120
days) are generally straightforward enough that EPA believes it would
catch most incomplete applications at the earlier preliminary
completeness screening phase. EPA believes there should be few ``me-
too'' type applications that are determined to be incomplete after
entering formal review. EPA would rarely seek to extend the original
review period for these short-term applications since it is
considerably easier in Agency tracking systems to close out a review
period altogether than to track an extension. Tracking the review
period is a time-consuming operation. EPA does not believe it should
devote its scarce resources to tracking an original review period
through a series of short-term extensions. This is especially true
given the high volume of applications that fall into the
120-day review period.
With respect to longer review period applications (120
days), EPA might choose to determine that an application is incomplete
if a deficiency is discovered early in the review process (e.g., in the
first 90 days of a 270-day review period).
If, at later points in a lengthy review period (e.g., 200 days into
a 270-day review period), EPA judges an application to be deficient for
reasons attributable to incompleteness, the Agency would want to
examine why this is occurring. Why are incomplete applications being
submitted and not being identified earlier in the process? Over time,
as process improvements continue to be put in place and EPA and
applicants familiarize themselves with new procedures and requirements,
EPA expects that incompleteness determinations after beginning Agency
review would decrease. Nonetheless, EPA must reserve to itself the
right to determine after placing an application into formal review that
the application is actually incomplete.
EPA is not obligated to begin review of or compute a review period
for an application that is incomplete. If EPA determines after putting
the application into formal review and computing a review period that
the application is incomplete, EPA would normally stop the review,
notify the applicant of its incompleteness, and recompute a new review
period upon receipt of submission completing the application. Proposed
Sec. 152.455(d)(2)(ii) specifies this typical result.
10. Qualifying resubmission for incomplete applications. However,
in its discretion, EPA proposes in Sec. 152.455(d)(2)(i) to offer
applicants somewhat more flexibility in Agency review periods if the
incompleteness determination occurs after putting the application into
formal review and if completing the application can be accomplished on
an accelerated basis. For applications having short review periods
(120 days) and minor incompleteness deficiencies, EPA
believes that it need not necessarily take the full review period that
it would be entitled to when the complete application is resubmitted.
Generally, if a minor deficiency can be corrected within 30 days after
notice to the applicant, EPA proposes to term that resubmission a
``qualifying resubmission'' and to complete review within a shorter
review period than would otherwise be computed. In general,
Sec. 152.455(d)(2)(i) proposes a subsequent review period 30 days
shorter than the original base review period for that type of
application, i.e., 60 days instead of 90 days for an identical or
substantially similar application, and 90 instead of 120 days for an
``other new application.'' The choice to offer an abbreviated review
period is entirely within EPA's discretion; EPA could instead take its
entire review period.
EPA proposes to limit such ``qualifying resubmissions'' to
applications having a review period of 120 days or less. EPA believes
that the incompleteness deficiencies likely to arise in such
applications would generally not be multiple deficiencies and are less
likely to involve serious data deficiencies. By contrast, EPA review of
an application for a new active ingredient or major new use would in
all probability identify multiple deficiencies, including data
deficiencies, not amenable to correction within 30 days.
11. Determination that the applicant has not submitted all needed
information. If there are deficiencies other than incompleteness
deficiencies, the Agency may determine that the applicant has not
provided sufficient data or information to make a decision on the
application. EPA proposes two procedures (termed Cases 1 and 2); which
would apply to any particular application would depend upon the nature
of the deficiency. In each case, EPA would stop the review period as of
the date that it notifies the applicant of this decision. In neither
case would the review period resume until the applicant provided the
necessary information, and elapsed time with the applicant would not be
counted against EPA's original review period. The difference lies in
when EPA would restart the review period (the ``clock''). In Case 1,
EPA would restart the clock immediately upon receipt of a complete
resubmission correcting the deficiencies. In Case 2, EPA would restart
the clock only after an additional
[[Page 50692]]
period after receipt of a complete resubmission.
Case 1 - Immediate restarting of the review clock. If the
deficiency is one that can be rapidly corrected by the applicant and
upon resubmission rapidly reviewed by Agency reviewers without
significant Agency downtime to re-review, refamiliarize, or reconstruct
the decision logic, EPA would restart the clock as of the date that the
applicant resubmitted all information or data required. EPA emphasizes
that EPA would restart the clock only after all deficiencies have been
corrected. The resubmission must also be ``complete.'' The kinds of
deficiencies EPA envisions in this category are short-term studies,
upgrading an existing study, or providing an explanation of such
studies.
If EPA chose this response, the Agency would specify in its notice
to the applicant the deficiencies needing correction, and require that
they be corrected within a relatively short timeframe--based upon the
type of deficiency, probably less than 6 months. If the resubmission
time is too short, the applicant could suggest a longer time for
resubmission. If that resubmission time is considerably longer than EPA
anticipated, such that the Agency would need additional time upon
receipt to refresh its review, EPA would reserve the right to restart
the clock at some later time after resubmission (Case 2).
Case 2 - Delayed restarting of the review clock. For deficiencies
that take longer to correct (e.g., new studies must be generated) or
where interruption of EPA review means that EPA must essentially begin
some portion of its review again, EPA would restart the clock after
both a period for applicant resubmission and an additional time for the
Agency to bring the review and reviewer back up to date. The longer the
interruption of review, the more likely it is that EPA reviewers may
have changed, that policies may have changed or evolved, or that the
original reviewer must refresh his/her knowledge of the product, the
application or the data. In EPA's experience, a review that is
interrupted for longer than 6 months has become stale.
In this case, EPA would notify the applicant, specifying the
deficiencies and requiring correction by a certain date. EPA would also
estimate how long after resubmission the clock would start.
12. Negotiating extended review periods for deficient applications.
FIFRA section 3(h)(3)(F) allows the review period to be extended by
agreement between EPA and applicants. As noted earlier, EPA intends
that this proposal set boundary rules for extending review periods, so
that case-by-case negotiated extensions would be used only
infrequently. Deficient applications for which EPA would stop the clock
and restart it, but where EPA cannot define the specifics of the
resulting extended review period are an area where negotiations would
be appropriate. Individual negotiation might be appropriate, for
example, if the deficiency entailed development of new methodology or
data with which EPA had no prior experience to judge its review time.
Case 1 - Negotiating resubmission dates for simple deficiencies.
EPA anticipates it would provide only a limited opportunity for
negotiation over the appropriate resubmission time for Case 1
resubmissions. EPA's ability to restart the clock immediately upon
resubmission and thereafter to meet the review period deadline depends
on the fact that the deficiency can be corrected rapidly. Simply
restarting the clock is not feasible if protracted negotiations would
result in significant delay in resubmission. EPA's concern is not the
effect of the negotiation per se on the clock (since the clock will
have stopped upon notification of the deficiency), but the fact that
any appreciable delay in resubmission because of negotiation may mean
that the application review would become stale. EPA must strictly limit
the negotiating time for simple deficiencies, or such deficiencies
would, because of the passage of time, have to be treated as complex
deficiencies under Case 2. EPA does not intend in this proposed rule to
define specific types of simple deficiencies for which Case 1 could be
used. However, EPA solicits comment on how this procedure could be
implemented in a realistic manner, and what would be an appropriate
length of time to allow for negotiations to commence and conclude.
Case 2 - Negotiating resubmission dates for complex deficiencies.
Resubmission dates would be more flexible with Case 2 complex
deficiencies. Because the deficiencies are complex, the resubmission is
expected to be on a longer schedule. Since time after notification of a
deficiency until resubmission is on the applicant's clock and not
EPA's, EPA could be flexible both in negotiating and in the
resubmission dates established. Unless the deficiency raised serious
risk concerns for a product already on the market (in which case EPA
likely would consider denying the application), EPA believes it could
generally accommodate applicant needs for resubmission.
In addition to interruption of the review period while the
applicant corrects deficiencies and resubmits to the Agency, Case 2
negotiations would need to build in an additional period of time for
EPA to ``refresh'' the application review before the review period
clock would start. The appropriate length of this ``delay time'' is
less easily determined and more likely to be an issue that requires
negotiation between EPA and applicants. EPA is not proposing either
specific delay times or criteria for determining appropriate delay
times in this document, but is proposing to establish the ``delay
time'' as a regulatory decision.
The delay time could be based on several factors. First, the delay
time could be a function of the actual time needed for review of the
submitted material (which may be one or more new studies). EPA could
develop some general timeframes for review of particular types of
studies, for example, a standard review time for a chronic toxicology
study or an indoor exposure study. These would serve as a starting
point for determining the delay time. If EPA develops such standard
review times for studies, it would share these with registrants and
others before implementing them.
Second, the delay time could also include the time needed for EPA
to bring the review and reviewers back up to speed, to adjust for new
reviewers, and, once completed, to integrate the new material into the
application review and risk assessment. The longer the clock has been
stopped and the application put aside, the longer the time needed to
refresh it and the more likely that changes in personnel or policies
will have occurred. These times are more variable, but may depend in
part on the complexity of the application type. The definitions of
application types in proposed Sec. 152.445 roughly track the complexity
of an original application review and therefore how much re-review
might be needed to come up to speed later. EPA expects that the types
of deficiencies that would trigger a delay time typically would be
associated with new chemicals and major new uses.
Finally, the delay time must of necessity take into account
variable external factors such as competing priorities and workload and
resource balancing. As a practical matter, although EPA may be able to
roughly estimate the delay time when it notifies an applicant of a
deficiency, the actual delay time may be dictated not by circumstances
at the time of notification, but by circumstances at the
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time of resubmission. Depending on the nature of the deficiency, and
whether new studies must be generated, resubmission could be a year or
more away. In
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