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Reporting Requirements For Risk/Benefit Information; Amendment
and Correction
Related Material
[Federal Register: June 19, 1998 (Volume 63, Number 118)]
[Rules and Regulations]
[Page 33580-33583]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19jn98-26]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 159
[OPP-60010J; FRL-5792-2]
RIN 2070-AB50
Reporting Requirements For Risk/Benefit Information; Amendment
and Correction
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This is a two-fold action to make minor adjustments to the
reporting requirements for risk/benefit information regulation. EPA is
amending and correcting the final regulation published in the Federal
Register on September 19, 1997 (62 FR 49370). The regulation codified
EPA's interpretation and enforcement policy regarding the requirement
of pesticide registrants to report to the Agency information concerning
unreasonable adverse effects of their products as mandated in section
6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). In the first part of this action, EPA is issuing a final rule
to change the definition of a registrant to provide consistency with
that which is in the statute. The amendment to the regulation will also
serve to clarify the scope of the registrant's responsibilities and
liabilities. In the second part of this action, the Agency is making
technical corrections to the regulations for clarification purposes.
These corrections include omitted, yet implied, reporting time frames
and required information, missing conjunctions, and minor editorial
changes.
DATES: These actions will become effective June 19, 1998.
FOR FURTHER INFORMATION CONTACT: By mail: Kathryn Bouve, Office of
Pesticide Programs (7502C), U.S. Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. Office location, telephone number, and
e-mail address: Crystal Mall #2, Room 224, 1921 Jefferson Davis
Highway, Arlington, VA 22202; (703) 305-5032;
bouve.kate@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
I. Affected Parties
Entities potentially affected by this rule are persons who hold or
ever held a pesticide registration under FIFRA section 3 or 24(c). This
rule may also affect any officer, employee, agent, or any other person
acting on behalf of a registrant. This listing is not intended to be
exhaustive, but rather to provide examples of those entities that are
likely to be affected by this action. To determine whether you or your
business is affected, refer to the regulatory text contained in
Sec. 159.153 (definition of registrant), and Sec. 159.155(d). Any
questions regarding applicability should be directed to the Agency
Contact Person listed above.
II. Background
In the Federal Register of September 19, 1997 (62 FR 49370) (FRL-
5739-1), EPA issued a final rule to codify its interpretation and
enforcement policy under section 6(a)(2) of FIFRA. This section of the
law requires pesticide registrants to report information concerning
unreasonable adverse effects of their products to EPA. The rule
clarifies what information must be submitted, how and when to submit
it, as well as what failures to report information, or delays in
reporting, will be regarded by EPA as violations of FIFRA section
6(a)(2), and actionable under FIFRA sections 12(a)(2)(B)(ii) and 12
(a)(2)(N). The rule is to become effective on June 16, 1998. As
published, the final regulation contains several errors which may prove
to be misleading and are in need of clarification. This notice makes
the needed corrections to the regulation.
EPA is issuing the first part of this action as a final rule
without prior proposal because it believes public comment on this part
of the rule would be unnecessary, impracticable, and contrary to the
public interest, and therefore is not required pursuant to the ``good
cause' exemption under section 553(b)(B) of the Administrative
Procedure Act. The Agency believes it is important to make this change
as expeditiously as possible, so that the change can be incorporated
into the new part 159 before publication of the next volume of the Code
of Federal Regulations, and so that the change can be effective before
the new part 159 becomes effective on June 16, 1998. A provision for
public comments is not warranted because the rule only implements a
technical correction and does not impose any new requirements. As
explained below, the change is being made to assure that the definition
of registrant in the rule is consistent with that which is in the
underlying statute authorizing the rule.
III. Agency Decision
Section 6(a)(2) of FIFRA imposes an obligation on pesticide
registrants to report to the Agency additional factual information
regarding unreasonable adverse effects on the environment related to
their pesticide products. By its terms, this requirement is placed only
on a ``registrant,'' a term defined in section 2(y) of FIFRA as ``a
person who has registered any pesticide pursuant to [FIFRA].''
The Agency changed the definition of ``registrant'' in the final
rule issued on September 19, 1997 from that in the proposal to include
agents and other persons acting on behalf of a registrant. As explained
in the preamble to the final rule, the purpose of the change was to
clarify that ``registrants [are] responsible for the actions of their
agents'' and that ``registrants will be held liable for the actions of
their agents.'' The intent in drafting the rule was to make absolutely
clear that a registrant is deemed to possess information when certain
people
[[Page 33581]]
working for the benefit of the registrant possess the information.
The effect of including language on agents in the definition of
registrant in Sec. 159.153, however, was to make agents potentially
liable themselves for failing to report information to the Agency
pursuant to section 6(a)(2). A number of persons have complained to the
Agency that this broadens the reach of section 6(a)(2), because the
statutory requirement is imposed only upon registrants, and because
agents who have never registered a pesticide product can not be
considered a registrant under FIFRA. This was never the Agency's
intent, and the Agency agrees that the definition in the final rule
published in September 1997 could be interpreted to exceed, as written,
the statutory reach of section 6(a)(2).
The Agency is therefore issuing this final rule to correct the
definition of registrant in Sec. 159.153, so that it only will include
``any person who holds, or ever held, a registration for a pesticide
product issued under FIFRA section 3 or 24(c).'' The rest of the
definition in the final rule published in September 1997 referring to
employees and agents has been moved to Sec. 159.155(b) (redesignated as
Sec. 159.155(d) in this document). The effect of this change is that
registrants are still responsible under section 6(a)(2) for information
possessed by their employees and agents, but the employees and agents
themselves, who are not registrants under FIFRA, are not themselves
responsible for reporting adverse effects information to the Agency.
IV. Technical Corrections
The corrections listed in this notice address errors in the
regulation published on September 19, 1997. The technical corrections
consist of three types: reporting time frames, required information,
and editorial.
The majority of the corrections ensure that the time frames for
submitting all types of adverse effects information are clearly
established. In the proposed rule, the time frame for reporting all
section 6(a)(2) information was 30 days. In response to the public
comments it received, the Agency decided to allow for different
reporting schedules for different types of information. The final rule,
however, listed only those categories where the time frames had been
changed and erroneously failed to establish time frames for all other
types of submissions.
Information concerning pesticides in food or feed above the
tolerance level or if no tolerance has been established; metabolites,
degradates, contaminants, and impurities; efficacy failure studies for
public health products; substantiated incidents of pest resistance; and
other information described in Sec. 159.195 must be received by EPA no
later than the 30th calendar day after the registrant first possesses
or knows of the information. Incidents of efficacy failure of public
health products and pesticide detections in water above the maximum
contaminant level (MCL) or health advisory level (HAL) may be
accumulated for 1 month and submitted by the end of the month following
the accumulation period.
A correction will be made to the regulation to specify that
detections of pesticides in water below the MCL or HAL but otherwise
reportable (Sec. 159.178(b)) may be accumulated for 3 months and
submitted by the end of the second month following the accumulation
period. The preamble to the final rule stated that this type of
information must be aggregated into quarterly statistical summaries as
described in Sec. 159.184(d)(3) and (e).
Other technical corrections ensure that useful information is
submitted to the Agency. Although these informational items are
implied, the specifics relating to the information required was
inadvertently omitted. First, for detections of pesticides in or on
food or feed (Sec. 159.178), and in surface water and ground water
(Sec. 159.184(c)(4)(iv) and (v)) will be changed to specify that the
amount of pesticide detected is reportable. Second, the technical
corrections will create a cross reference between the requirement to
report detections of pesticides in or on food or feed, or water found
in Sec. 159.178 with the appropriate specified reportable data elements
listed in Sec. 159.184(c).
The last group of corrections to the regulation include missing
conjunctions, typographical errors, and minor cross referencing errors.
V. Statutory Review Requirements
A draft of this rule was provided to the Secretary of Agriculture
(USDA), the Committee on Agriculture, Nutrition, and Forestry of the
United States Senate, and to the Committee on Agriculture of the House
of Representatives. The FIFRA Scientific Advisory Panel has waived its
review of this rule.
VI. Regulatory Assessment Requirements
This final rule does not impose any new requirements. It only
implements a technical correction to a previously issued Federal
Register notice and the Code of Federal Regulations (CFR). Any
assessments necessary for the original final rule being corrected
through this action are discussed in that final rule and are not
affected by today's action. In fact, this action does not require
review by the Office of Management and Budget (OMB) under Executive
Order 12866, entitled Regulatory Planning and Review (58 FR 51735,
October 4, 1993), the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). For the same reason, it does not require any action under Title
II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4),
Executive Order 12875, entitled Enhancing the Intergovernmental
Partnership (58 FR 58093, October 28, 1993), or Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
In addition, since this type of action does not require any proposal,
no action is needed under the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.).
VII. Submission to Congress and the General Accounting Office
Pursuant to the Congressional Review Act (5 U.S.C. 801(a)(1)(A)),
the Agency will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
this rule in today's Federal Register. This is a technical correction
to the CFR and is not a major rule as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 159
Environmental protection, Pesticides and pests, Policy statements,
Reporting and recordkeeping requirements.
Dated: June 5, 1998.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Amendment to 40 CFR Part 159
Therefore, 40 CFR part 159 is amended as follows:
PART 159--[AMENDED]
1. The authority citation for part 159 continues to read as
follows:
Authority: 7 U.S.C. 136-136y.
2. In Sec. 159.153 the definition of ``Registrant'' is revised to
read as follows:
Sec. 159.153 Definitions.
* * * * *
[[Page 33582]]
Registrant includes any person who holds, or ever held, a
registration for a pesticide product issued under FIFRA section 3 or
24(c).
* * * * *
Correction to Rule Published in the Federal Register
Accordingly, the publication on September 19, 1997 of the final
regulations which were the subject of FR Doc. 97-24937 and published on
page 49370 is corrected as follows:
1. On page 49388, in the table of contents for part 159, the title
of Sec. 159.160 is corrected to read ``Obligations of former
registrants.''
2. On page 49388, Sec. 159.155 is corrected to read as follows:
Sec. 159.155 When information must be submitted.
(a) The following reportable information must be received by EPA
not later than the 30th calendar day after the registrant first
possesses or knows of the information:
(1) Scientific studies described in Sec. 159.165.
(2) Information about discontinued studies described in
Sec. 159.167.
(3) Human epidemiological and exposure studies described in
Sec. 159.170.
(4) Detection of a pesticide in or on food or feed described in
Sec. 159.178(a).
(5) Detection of metabolites, degradates, contaminants, impurities
described in Sec. 159.179.
(6) Failure of performance studies described in Sec. 159.188(a)(2),
(b)(2), and (c).
(7) Other information described in Sec. 159.195.
(b) Reportable information concerning detections of pesticides in
water described in Sec. 159.178(b), adverse effects incidents described
in Sec. 159.184(a), and efficacy failure incidents described in
Sec. 159.188(a)(1) and (b)(1) must be reported according to the time
frames set forth in Sec. 159.184(d).
(c) EPA may, in its discretion, notify a registrant in writing of a
different reporting period that will apply to specific types of
reportable information or eliminate reporting requirements entirely.
Such notification supersedes otherwise applicable reporting
requirements set forth in this part.
(d) For purposes of this part, a registrant possesses or knows of
information at the time any officer, employee, agent, or other person
acting for the registrant first comes into possession of, or knows of,
such information; provided that, such person performs any activities
for the registrant related to the development, testing, sale or
registration of a pesticide or the person could be reasonably expected
to come into possession of information otherwise reportable under this
part. In the case of information known to or possessed by an agent or
other person acting for the registrant, a registrant is responsible for
such information only if the agent or other person acquired such
information while acting for the registrant.
Sec. 159.158 [Corrected]
3. On page 49389, Sec. 159.158 is corrected as follows:
i. In paragraph (a) the introductory text, the second sentence is
corrected to read:
(a) * * * Information relevant to the assessment of the risks or
benefits also includes conclusion(s) or opinion(s) rendered by a person
who meets any of the following:
* * * * *
ii. In paragraph (b)(1), after the heading, the introductory text
is corrected to read:
(b) * * *
(1) * * * Information need not be submitted if before that date
on which the registrant must submit such information if all of the
following conditions are met:
* * * * *
iii. In paragraph (b)(3) introductory text, the phrase ``either of
the categories described in paragraphs (b)(3)(i) or (b)(3)(ii) of this
section.'' is corrected to read ``either of the following
categories:''.
iv. On page 49390, paragraph (b)(4) introductory text, the phrase
``reportable under this part, if:'' is corrected to read ``reportable
under this part, if both of the following conditions are met:''.
Sec. 159.159 [Corrected]
4. On page 49390, in Sec. 159.159 is corrected as follows:
i. Paragraph (a)(1) introductory text is corrected to read:
(a) * * *
(1) Information is otherwise reportable under Sec. 159.184, and
pertains to an incident that is alleged to have occurred on or after
January 1, 1994, and to have involved any of the following:
* * * * *
ii. In paragraph (a)(2), the reference to ``Sec. 159.195(b),'' is
corrected to read ``Sec. 159.195(c).''
Sec. 159.160 [Corrected]
5. On page 49390, in Sec. 159.160, in paragraphs (b)(1), (3), and
(4), the phrase ``formerly-registered'' is corrected to ``formerly
registered.''
Sec. 159.165 [Corrected]
6. On page 49390 Sec. 159.165 is corrected as follows:
i. In paragraph (b)(4), the introductory text is corrected to read:
* * * * *
(b) * * *
(4) For plants when tested at the maximum label application rate or
less, if either of the following conditions is met:
* * * * *
ii. On page 49391, paragraphs (d)(1) and (d)(2), the introductory
text in both paragraphs is corrected to read:
(d) * * *
(1)* * * A study using a test regimen lasting 90 calendar days or
less, and all of the following conditions are met:
* * * * *
(2)* * * A study using a test regimen lasting 90 calendar days or
less, and all of the following conditions are met:
* * * * *
Sec. 159.178 [Corrected]
7. On page 49391, Sec. 159.178 is corrected as follows:
i. In paragraph (a), the phrase ``the pesticide is present on food
or feed'' is corrected to read ``the pesticide is present in or on food
or feed.''
ii. In paragraph (a) by adding a new sentence to the end thereof
reading as follows:
(a) * * * The information to be submitted is the same as that
required in Sec. 159.184(c)(1), (2), (3), and (4)(iv)(E), (F), (G), and
(H).
* * * * *
iii. In paragraph (b)(1), in the introductory text, the phrase
``the water reference level in:'' is corrected to read ``the water
reference level in any of the following instances:''.
iv. By adding paragraph (b)(5) to read as follows:
* * * * *
(b) * * *
(5) Information to be submitted is the same as that required in
Sec. 159.184(c)(1), (2), (3), (4)(iv) and (v), and (5)(vi).
Sec. 159.179 [Corrected]
8. On page 49391 Sec. 159.179 is corrected as follows:
i. In paragraph (a), in the introductory text, the phrase ``must be
submitted if:'' is corrected to read ``must be submitted if either of
the following conditions is met:''.
ii. In paragraph (a)(2), in the introductory text, the phrase ``and
one of the conditions in paragraph (a)(3)(i)
[[Page 33583]]
or (ii) of this section is met:'' is corrected to read ``and either of
the following conditions is met:''.
Sec. 159.184 [Corrected]
9. On page 49392, Sec. 159.184 is corrected as follows:
i. In paragraph (c)(2), in the introductory text, the phrase
``reports must be submitted if the registrant'' is corrected to read
``reports must be submitted for each pesticide that may have
contributed to the incident, if the registrant''.
ii. Paragraph (c)(2)(vi) is removed.
iii. On page 49393, paragraph (c)(4)(iv)(G), is corrected to read:
* * * * *
(c) * * *
(4) * * *
(iv) * * *
(G) Pesticides and degradates analyzed for, the detection limits,
and the amount detected.
* * * * *
iv. In paragraph (c)(4)(v)(A) is corrected to read:
* * * * *
(c) * * *
(4) * * *
(v) * * *
(A) Pesticides and degradates analyzed for, the analytical method
used, the detection limits, and the amount detected.
* * * * *
v. On page 49393 in paragraph (c)(5)(iii), in the introductory
text, the phrase ``if any of the criteria listed in paragraphs
(c)(5)(iii)(A) through (c)(5)(iii)(G) of the section are met, or'' is
corrected to read ``if any of the following criteria are met, or''.
vi. On page 49393, in paragraph (c)(5)(iii)(D), the word
``relativelycommon'' is corrected to read ``relatively common.''
vii. On page 49394, in paragraph (c)(5)(iii)(G), the word
``orthreatened'' is corrected to read ``or threatened.''
viii. On page 49394, paragraph (c)(5)(iv), in the introductory
text, the phrase ``if the single criterion listed in paragraph
(c)(5)(iv)(A) of this section is met, or'' is corrected to read ``if
the following criterion is met, or''.
ix. On page 49394, paragraphs (d)(2) and (d)(3) are corrected to
read as follows:
* * * * *
(d) * * *
(2) Information concerning incidents which meet the criteria for
the following exposure and severity category labels described in
paragraph (c)(5) of this section, reports of detections of pesticides
in water, and efficacy failure incidents described in
Sec. 159.188(a)(1) and (b)(1), may be accumulated for a 30-day period,
and submitted to the Agency within 30 days after the end of each 30-day
accumulation period for: Humans, H-B, and H-C; Wildlife, W-A; Plants,
P-A; Water, G-A; Property Damage, PD-A.
(3) Incidents or reports of detections of pesticides in water
meeting all other exposure and severity label categories, information
may be accumulated by registrants for 90 days and submitted within 60
days after the end of each 90-day accumulation period.
* * * * *
Sec. 159.195 [Corrected]
10. On page 49395, in Sec. 159.195, paragraph (b), the word
``sectioin'' is corrected to read ``section,'' and the phrase
``otherwise-reportable'' is corrected to read ``otherwise reportable.''
[FR Doc. 98-16410 Filed 6-18-98; 8:45 am]
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