Pronamide Position Document 4
£fi/o/sP*l> - so/ty
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50275-101
E^piiP^T DOCUMENTATION ! »• no.
. PAGE " : FPA/SPRD-80/fiQ
2.
3. RocJolftilt'ft Accenicri No.
WW ill 2?. x 6
4. Title and Subtitle
Promatr.ide: Position Document 4
5. Report Oate
10/25/79
£.
7. AuU crlv)
C. Performing Organization Rep!. Mr>
9. Performing Organization Name and Address
Special Pesticide Review Division
Environmental Protection Agency
Crystal Mall 42
Arlington, VA 22202
10. P.'oject/Tosk/Worx 'Jnit N?.
11. Contract(C) Of GranUG) No
(C)
(G)
1?. Sfjcn'.ormg Organization Name and Address
Environmental Protection AGency
401 M ST..S.M.
WAshington, D.C. 20460
13. Typa of Report fl. Period Covered
14.
IS. Supplementary Na'.ci
16. Abstrec'. (Limit: 200 word:)
Agency Regulatory Decision on Registration of Pesticide: Also contains
comments from USDA and Scientific Advisory Panel and EPA's response_to
these concerns on economic, agricultural, environmental and health impact
of the regulatory decision.
17. Onc-.imrnf An,vy«;is n Descriptors
0504,0606,0703
b Itlcfst fioci/Open-£n<5«d Terms
c COS ATI Fieid/G'oup
IB. Av*ilabi»'ty Stetemeo*.
Unlimited
i9. Seejrlty Claes (This Roport)
Unclassified
20- Security Clft&o (This Pago)
Unclassified
22. No, cf Pjgcs
37
22. Price
(Sec ANSI-A39 ia:
See /n«fructjOns en Rfvefs«
OPTIONAL FORM 272 £4-7?)
(Formerly NT|S—35)
Department of Commerce
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Table of Contents
Page
I». Introduction- . 1
II. Analysis of Comments 4
A. Comments Relating to Risk 5
1. Background 5
2. Extrapolating Risk to Human Populations 6
3. Calculating Dietary Exposure 6
4. Estimating Applicator Exposure 8
5. Risks of Alternate Pesticides 10
B. Comments Relating to Benefits 11
1. Background 11
2. Incomplete Assessment of Benefits 12
3. Benefits of Alternate Pesticides 13
C. Ccmaent3 Relating to Regulatory Options 14
1. Classification of Restricted Use and Requirement for
Certified Applicators 14
2. Required Use of Protective Clothing During the Mixing
and Application of Pronamide Wettable Powder 16
3. Required Formulation of Pronamide (Wettable Powder)
in Water-Soluble Bags 18
4. Cancellation of Hand-Spraying Uses 20
5. Revision of the Tolerance on Lettuce to 1 ppm,
Extension of the Time-to-Harvest (THI) to 60 Days,
and Limitation of Applications to ?re-emergent Use 20
6. Required 5-Year Monitoring of Pronamide in Cow's Milk 22
III. Conclusions 23
Bibliography 28
Appendices
Appendix A: FIFRA SAP, "Review of Notice of Determination
Concluding the Rebuttable Presumption Against Registration
. (RPAH) of Pesticide Products Containing Pronamide" A-l
Appendix B: Letter from Bob Bergland, Secretary of Agriculture,
to Douglas Costle, Administrator, U.S. Environmental Protection
Agency B-l
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Pronamide Project Support Team
R. Colelli, Attorney, OPP
3. Day, chemist, HED, OFP
R. (iardner, Tox.1coJ.og2.st, HED, off'
D. Johnson, Chemist, HED, OPP
K. Keaney, Regulatory Analyst, SPRD, OPP
G. Kaitt, Plant Physiologist, BFSD, OPP
J. Leitzke, Biologist, HED, OPP
L. Zygadlo, Economist, BFSD, OPP
R. Troast, Project Manager, SPRD, OPP
Pesticide Chemical Review Committee (JCSC)
S. Anderson, CAG
R. 2111, OTS
A. Jennings, OPM
0. Xuroda, ORO
J. Heylan, PTSED
M. Winer, OGC
M. Williams, Chairman, SPRD, OPP
Writing StafS
K. Flagstad
£. Johnson
R. Troast
l£
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I. Introduction
Under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) , as amended (7 tl.S.C. 136 et seq.) , the Environ-
jnentaI_Er.Q.te£tJ._o.p.Agency (EPA or "the Agency") regulates all
pesticide products. FIFRA, Section 6(b), authorizes the
Administrator of EPA to issue a notice of intent (1) to
cancel the registration or (2) to change the classification
of a pesticide product if in his judgement either the
pesticide or its labeling "does not comply with the provi-
sions of [FIFRA] or, when used in accordance with widespread
and" commonly recognized practice, generally causes unreasonable
adverse effects on the environment...." FIFRA, Section
3(c)(6), authorizes the Administrator to deny any application
for pesticide registration which does not meet the statutory
. standards f.or registration.
To implement it3 authorized functions, the Agency has
designed the Rebuttable Presumption Against Registration
(BPAR) process (described in 40 CF1 162.11), which involves
gathering data on the risks and benefits associated with the
use of suspect pesticides. By allowing all interested
parties to participate by submitting information, the
process enables EFA to make balanced decisions concerning
problem pesticides.
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On May 20, 1977, the Agency issued an RPAR Notice (42 FR
25906) for all pesticide products containing pronamide on
the basis that pronamide had been shown to be oncogenic in
male mice. A detailed Position Document 1 accompanied this
notice.
On January 15, 1979. the Agency issued Position Document
2/3 for pronamide and published a Notice of Determination
-ami announced the availability of the Position Document iti
the Federal Register (43 FR 3083). In Position Document
2/3, the Agency analyzed the rebuttals it received in
response to the original RPAR notice, presented its analysis
of both risks and benefits associated with the uses of
pronamide, and proposed a decision to conclude the RPAR
process.
In Position Document 2/3, the Agency recommended Option
4 and concluded that the benefits of pronamiders use outweighed
the risks if the following modifications to the terms and
conditions of registration were adopted:
1. Pronamide would be classified as a restricted use
pesticide, and applicator certification would be
required.
2. The use of protective clothing during the mixing and
the application of pronamide would be required.
3. Pronamide (wettable powder) must be formulated in
water-soluble bags.
U. Hand spray use would be cancelled.
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5. The tolerance on lettuce must be revised from 2 ppm
to 1 ppm to lower the dietary exposure, with label
restrictions limiting the use to pre-emergent use
only with a 60-day time-to-harvest interval (THI).
'(r. A monitoring report on residues in milk from pronamide
use on alfalfa would be required at 5-year intervals
coincident with rereeistration.
40 CFR 162.11 requires that the Agency submit notices
Issued pursuant to FIFRA, Section 6, to the Secretary of the
U.S. Department of Agriculture (USDA) for comment on the
impact of the proposed action on the agricultural economy
[Section 6(b)] and to the FIFRA Scientific Advisory Panel
(SAP) for comment on the impact of the proposed action on
health and the environment [Section 25(d)]. The Agency is
required to submit these documents to the Agriculture
Secretary and the SAP at least 60 days before sending them
to registrants or making them public. The Secretary
and the SAP are invited to comment in writing within 30 days
of receiving the notice. The Agency is required to publish
their written comments if submitted within 30 days of the
receipt of the Notice and the EPA Administrator1s response
to these comments.
Although not required to do so under the statute, the
Agency has decided that it is consistent with the purposes
of the RPAR process and the Agency's overall policy of open
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decision-making to also afford registrants and other inte-
rested persons an opportunity to comment on the bases for
the proposed action while it is under review by the Secretary
of Agriculture and the SAP. The Position Document was
therefore made available to all interested parties for
comment.
.1 Ag e ncy_re_c_eived comments from_six parties in.re_s2.ons_e__
to the notice of January 15, 1979. Their comments are
addressed and analyzed in Section II of this document.
Section III summarizes the Agency's decision concerning
pesticide products containing pronamide. SAP's response is
reproduced in its entirety as Appendix A of this Position
Document. USDA's response is reproduced in it3 entirety
as Appendix B. All comments are available for review in the
public file.
II• Analysis of Comments
In response to the publication of the Notice of Deter-
mination and Position Document 2/3, EPA received comments
from six parties: pesticide manufacturers Rohm and Haas Co.
(2[300Q0/14BJ) and PPG Industries (5C30000/14B]); an individual
who signed her letter "Karen" (1C30000/14B]); Gordon Harvey,
University of Wisconsin (3C30000/14B]); the Secretary
of Agriculture (5C30000/143]); and the SAP, which reviewed
the entire decision.
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A. Comments Relating to Risk
1. Background
The Agency conducts a qualitative and a quanti-
tative risk assessment based on its evaluation of the hazard
of the pesticide in conjunction with a best estimate of
the potential for human and environmental exposure to the
chemical. The magnitude of the carcinogenic hazard of any
pesticide (i.e., the number and types of tumors it-oa-u&e-s-
is determined from chronic feeding studies. The most
sensitive valid feeding study available serves as the basis
for estimating the degree of hazard. For pronamide, an
10-month mouse oncogenicity study which demonstrated a
positive response in male mice, was used as the basis for
risk extrapolation. This study provided the only evidence
that pronamide is likely to be a human carcinogen.
The potential for human and environmental
exposure to pronamide was derived from available data- and-
assumptions about work place practices, current agricultural
practices, dietary habits, and body weight. The exposure
figures obtained represented the Agency's best estimate of
the exposure potential of pronamide. Although there
are uncertainties in these estimates, this approach allows a
measurement of risk to the population at large and subgroups
with specific exposure potentials, as well as a measurement
of risk comparative to that posed by other carcinogens.
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2. Extrapolating Risk to Human Populations
Rohm and Haas Co. (2C30000/1MB]) claimed that
EPA'3 assessment of risk is unfairly based on a progression
of wor3t-case and most conservative assumptions. The Agency
rejects this contention. In its Interim Procedures and
Guidelines for Health Risk and Economic Impact Assessments
o-f--Suspected. Carcinogens-[Ca_n.cer_ Guidelines,] _C^1_ F_R 214Q2,.
et seq., May 25, 1976), the Agency adopted a framework for
decision-making which is fundamentally conservative in
approach due to the irreversibility of the effect and which
demands that caution be exercised wherever risk to public
health is concerned.
3- Calculating Dietary Exposure
Rohm and Haas objected to the Agency's use of
--the tolerance levels (i.e., maximum permissible residues) in
calculating dietary exposure, instead of the amounts of
actual residues measured in controlled experiments or
monitoring studies.
EPA finds the Rohm and Haas' objection unmeri-
torious. In estimating ri3k from dietary exposure, the Agency
must use the best available measurements or estimates of
exposure. Wherever valid and sufficient residue data are
available they of course represent the best index of exposure.
In the absence of such residue data, however, the tolerances
established for various foodstuffs represent the best and
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most conservative estimates of the levels of pesticide
residues to which the populace may be exposed. Likewise,
use of the limit of analytical sensitivity (detection
limits) represents a conservative and reasonable approach to
. dietary., residue estimates, where the available data indicate,
no likelihood that actual residues exceed the detection
level. The Agency has followed the approach of using the
best available measurements to determine dietary exposure
levels and has used tolerance levels oniy when data were not
available to allow a determination of actual residues.
In determining exposure to pronamide from
dietary sources, the Agency reviewed residue data for
established tolerances on lettuce, on meat, milk, and eggs,
and on berries. In the case of lettuce, available data on
residues from field monitoring studies (0.1 ppm) and from a
study of radioactively labeled pronamide (0.8 ppm) demon-
strated that actual residues were likely to be below the
tolerance level (2.0 ppm). The Agency believes that the
value of 0.8 ppm obtained in the study of radioactively
labeled pronamide best represents a conservative estimate of
dietary exposure from lettuce. In the case of meat, milk,
and eggs, the Agency used the limit of analytical sensitivity
(0.01 ppm) as a measure of exposure because the data indicate
little likelihood that residues will exceed the value. In
the case of berries, the Agency used the tolerance level
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(0.05 ppm) for exposure estimates because there were insuf-
ficient data on which to predict a level of residues below
the tolerance level, and available data indicated that
residues may exceed the limit of analytical sensitivity.
Rohm~and iiaas. .also^otgected..5.0. EPA'.s use of the
residue value of 0.8 ppm obtained from controlled field
studies in calculating the dietary risk from lettuce. The
registrant claimed that only part of this residue was the
parent compound (pronamide) because degradation and meta-
bolism had reduced the actual amount of parent compound. The
Agency rejects this argument and holds that the calculation
based on the value of 0.8 ppm does indicate a reasonable
upper bound of expected residues. Rohm and Haas was probably
correct in claiming that not all of the 0.8 ppm is parent
compound. However, the company did not report, ncr is the
Ag-ency aware of, data that demonstrate that pronamide is the
only oncogenic agent among its degradation products and
metabolites. Therefore, using the total residue value 0.8
ppm represents a conservative but reasonable approach to
calculating oncogenic risk.
M. Estimating Applicator Exposure
Rohm and Haas objected to the Agency's use of
extrapolated data, rather than data from actual measurements,
to estimate the risk to applicators.
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EPA rejects Rohm and Haas' argument because the
extrapolated data represent the most reliable data available
to the Agency. In developing its exposure assessment,
.til.e. Agency__analy£ecL_three sets--of—data -to-determine- the—
quantity of pronamide dust and spray to which applicators
may be exposed. Two of these analyses relied on extrapola-
tions of the data presented in studies which used other
pesticides with formulations similar to that of pronamide
(Jegier, 1964; and Wolfe, 1971*). The third analysis used
data from a pronamide study. The results of all three
analyses were included in PD 2/3. However, limitations
in the study performed with pronamide^ precluded the use
of data from this study as a reliable estimate of exposure,
and the Agency was therefore forced to rely on extrapolated
daJiaL.-. The middle-range of exposure values extrapolated from
Jegier*s data was used rather than the extremely conservative
values obtained from extrapolation of Wolfe's data.
To again attempt to show that the Agency
overstated applicator exposure, Rohm and Haas submitted, on
April 2Uf 1979 (Krzeminski, 1979), an additional study
designed to determine the exposure of applicators with and
without protective clothing. The study consisted of two
tests in which applicators wore protective clothing of the
type specified in PD 2/3 and two tests in which applicators
wore no protective clothing. (The same two applicators were
1/ This study was performed with only one applicator and
was not replicated.
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involved in each test.) The Agency can not accept this
study since it had a very limited data base (Day, 1979).
The study also demonstrated a high degree of variability
which further lessens its reliability for determining an
average exposure to pronamide. Therefore, EPA again rejects
Rohm and Haas' contention that the Agency has overstated
applicator exposure."
Rohm and Haas also objected to the Agency's
assumption that two people are involved in mixing and
applying pronamide on alfalfa farms. The Agency rejects
this contention. The assumption is based upon published data
indicating that in fact there are, on an average, two
workers on alfalfa farms. In keeping with the other conser-
vative assumptions, it is reasonable to assume that both
workers would be involved in the mixing and spraying of
pronamide. Moreover, Rohm and Haas did not offer any data
to support their contention that only one worker is used in
mixing and spraying.
5. Risks of Alternate Pesticides
PPG Industries claimed that propham is not
teratogenic, as reported in PD 2/3. EPA has again reviewed
the data on which the original conclusion concerning tera-
togenicity in PD 2/3 was based, including an EPA study
conducted by Dr. K. Diane Courtney at the Health Effects
Research Laboratory, Research Triangle Park, North Carolina.
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On the basis of this review, the Agency agrees that at this
time, data on which to judge the teratogenicity of propham
are insufficient.
PPG Industries also claimed that chioropropham
is not as strongly oncogenic as indicated in PD 2/3. The
Agency rejects this argument. As stated in the Cancer
-Guidelines a positive .initiation-promotion skin _test
constitutes evidence of oncogenicity—unless a valid animal
feeding bioassay is submitted which is negative. The
only available study on chioropropham is an initiation-
promotion skin test performed on mice, the results of which
are positive. EPA is unaware of any animal feeding bioassays
for chioropropham. Moreover, in PD 2/3 the Agency merely
reported the positive result of the available initiation-
promotion skin test. Ho judgment was made concerning the
potency of the potential oncogenicity of chioropropham.
B. Comments Relating to Benefits
1. Background
In assessing the benefits of the continued
use of pronamide, the Agency evaluated the economic, social,
and environmental effects which would result should any or
all uses of the pesticide be cancelled. The benefits of
continued use were weighed against the attendant risks.
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The benefits analysis included a quantitative assessment of
the impact of all possible EPA regulatory actions on crop
production, prices of agricultural commodities, retail food
prices - and the a-gricultural economy in general. The data
which provided the basis for the benefits analysis were
derived from information supplied by Rohm and Haas, the
U'.S. "Department" of "Agriculture, and~other interested parties.-
2. Incomplete Assessment of Benefits
Rohm and Haas submitted in rebuttal to PD 1 a
set of economic values which differed from those the Agency
ultimately used for pronamide in PD 2/3- The most noticeable
difference between the two assessments was in the area of
minor uses (e.g., nursery stock and Christmas tree plantings),
and the commenter's main concern was that EPA failed
to_ad_dress adequately these minor uses.
The economic analysis presented in PD 2/3 was
based in part on data supplied by the USDA under a joint
program to permit active USDA participation in benefits
analyses. The analysis of minor use benefits was, however,
qualitative rather than quantitative, simply because
quantitative data were insufficient. Rohm and Haas did
submit some quantitative data; however, because EPA in its
analysis was unable to substantiate the data, the
Agency chose to address the minor uses qualitatively.
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Aside from the problem of substantiation, moreover, the
quantitative data supplied would in all likelihood not have
changed the regulatory decision.
3. Benefits of Alternative Pesticides
.PPG Industries objected to the Agency's "intima-
tions that detract from the usefulness of [the] alternatives"
rt p
propham (IPC ) and chloropropham (Chloro IPC ).
PPG contended (1) that application methods
for pronamide are not unique, since wet weather affects the
use of all pesticides; (2) that mechanical and hand cultiva-
tions in lettuce are required when pronamide is used; (3)
that pronamide, like propham, must be activated by water;
and (4) that the list of alternate pesticides used in clover
was incomplete.
The Agency rejects PPG's arguments (1) through
(3) above for the following reasons. It is true that very
wet fields cannot be worked, regardless of the pesticide
used; however, pronamide does offer an advantage in that it
can be sprayed onto the wet soil sooner than its alternates.
Propham and chloropropham require cultivation into the soil,
a practice which cannot be carried out on wet soils.
It was not the intent of the Agency to indicate
that mechanical or hand cultivations will be eliminated by
the use of pronamide. However, the Agency does believes that
fewer mechanical and hand cultivations are required with use
of pronamide and that this reduction in mechanical and hand
cultivations increases the benefits to the growers.
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It is true that water is necessary to activate
both pronamide and propham. However, propham is volatile
and can lose effectiveness through volatilization unless it
is incorporated or watered-in; pronamide can remain in dry
soil without loss of effectiveness. This property of
pronamide is critically important in alfalfa fields in the
Northwest, .which.are dependent .entirely.upon rainfall.
The Agency accepts PPG's argument (4) above and
grants that the availability of chloropropham for weed
control in all clovers was overlooked in PD 2/3. However,
this does not alter any of the Agency's conclusions concerning
comparative benefits since chloropropham has drawbacks
similar to propham.
C. Comments Relating to Regulatory Options
1. Classification for Restricted Use and Requirement
for Certified Applicators
Rohm and Haas argued that since the Agency's
primary objective was to keep pronamide out of the hands of
unskilled homeowners, other measures short of classification
for restricted use can be used to achieve that goal.
Specifically, Rohm and Haas proposed label directions such
as "Not for Home Use" or "For Commercial Crop Production
Only" and contended that these directions would successfully
keep the product from getting into the hands of the unskilled
and untrained. EPA rejects this argument on the grounds
that relabeling is insufficient insurance against mishandling
of pronamide by lay users.
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Rohm and Haas, Secretary of Agriculture Bergland,
and Dr. Gordon Harvey commented that overuse of the restricted
use classification would reduce its significance.
The -Agency rejects this comment and holds that
th-e -po-tentiaJ_ _impa'ct_of a pesticide, not the number of
times any particular regulatory classification has been
used, must determine regulatory decisions. The primary
reason for assigning a restricted use classification to
pronamide is the oncogenic hazard posed to applicators due
to the dustiness of the wettable powder formulation.
Dr. Harvey also argued that pronamide did not
meet the criteria for restricted use, claiming pronamide
presents a low hazard to wildlife and has a low potential
for bioaccumulation.
The Agency rejects this argument. Whether or
claim is cornsc.t, hazard to wildlife and
potential for bioaccumulation are only two criteria for
restricting the use of a pesticide. FIFRA, Section 3(d)(l)(c;,
also lists applicator hazard as a criterion for restricted
use, and it is on the basis of applicator hazard that the
Agency has proposed to restrict the use of pronamide.
Rohm and Haas has argued that granular formula-
tions should be exempt from restricted use classification
because these formulations do not pose the same dermal and
inhalation hazard as wettable powders.
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After reviewing the available data on particle
size in the granular formulation, the Agency agrees that
granular products in fact do not represent as great a hazard
to the applicator as wettable powders. Accordingly,
granular formulations of 1? or less are excluded from a
restricted use classification at this time. However,
to-minimize-exposure-, th.e_direc.tions_.fcir use of Rranular
formulations on turf will be modified to indicate that the
pronamide should be watered-in within 24 hours after applica-
tion.
2. Required Use of Protective Clothing During the
Mixing and Application of Pronamide Wettable
Powder
Generally, all comments received on the Agency's
requirement regarding use of protective clothing were
favorable. However, the following comments were made regarding
specific aspects of the requirement.
Rohm and Haas argued that only mixers and
hand-spray applicators should be required to wear protective
clothing since professional applicators routinely wear the
protective clothing specified in PD 2/3-
The Agency rejects the argument on the grounds
that exposure will not be reduced by limiting the requirement
for protective clothing to professional applicators.
The Agency agrees that professional applicators are more
likely to wear at least some protective clothing than are
nonprofessional custom applicators who are involved
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in hand spraying; nonetheless, a uniform requirement for
protective clothing will insure protection for all applica-
tors, professional and nonprofessional alike.
Secretary of Agriculture Bergland suggested
modifying-the-req-uirement for- fabric-.glav.es to includ.e..
neoprene gloves. The Agency will accept this modification
since neoprene will provide as effective a barrier to dermal
exposure as would cloth.
Secretary of Agriculture Bergland and Dr.
Gordon Harvey suggested that the requirement for "one-piece
protective clothing" be modified to include protective
clothing such as coveralls and overalls with long-sleeved
shirts because one-piece clothing is not available in all
areas of the country.
The Agency has reviewed available information
and has concluded that clothing other than one-piece clothing
can offer adequate protection to the applicator. The Agency
also realizes that, in the absence of one-piece clothing,
individuals will wear available work clothes. Consequently,
by broadening the definition to include coveralls and
overalls with long-sleeved shirts, the Agency is providing
additional impetus to the applicator to protect himself.
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3. Required Formulation of Pronaaide (Wettable
Powder) in Water-Soluble Bags'
Rohm and Haas, Secretary of Agriculture Bergland,
the Scientific-Advisory Panel, and Dr. Gordon Harvey objected
"tTT'the "Agency"'s~~requirement that -wcttable'-powder f-ormula-fc-i-ons
must be packaged in water-soluble bags, on the basis that
(1) the Agency's estimates of applicator exposure are
unrealistically high, and (2) exposure data are too incom-
plete to demonstrate any significant risk.
The first argument has been addressed in
Section II above. The Agency has concluded that the new data
submitted by Rohm and Haas are fragmentary and inconclusive,
and that such data fail to justify any downward adjustment
of exposure projections. The second argument, that available
exposure data are incomplete, is factually correct. The
"Agency points out, however, that the affirmative burden of
proof lies with the registrant, not with EPA. Because
the exact amount of exposure involved is uncertain, the
Agency based its regulatory decision concerning water-
soluble packaging upon reasonably conservative exposure
estimates.
In Position Document 2/3, the Agency's reasons
for requiring water-soluble bags for wettable powder
formulations are set forth in detail . In summary, this new
packaging technology is highly effective in that it virtually
eliminates applicator contact with wettable powder formula-
tions during mixing operations, thereby eliminating the
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2/
primary source of applicator exposure^- . The costs of
water-soluble packaging are small, approximately 50 cents
per acre and application costs as stated in PD 2/3 are
approximately $70 acre, which the Agency estimates will
.result.. ln_ leas., thin_a l$_.increase in application costs. In
addition, since the publication of Position Document 2/3t
Rohm and Haas has in fact applied for conditional registra-
tion of a wettable powder pronamide product which will be
packaged in water-soluble packaging.
For these reasons, the Agency has decided to
retain the requirement for water-soluble packaging for
wettable powder formulations and hereby specifies a two-year
implementation period. In the Agency's judgement, two years
should be a more than adequate amount of time for an orderly
and efficient transition. If however, during th(e implementa-
- txon—period £or__water-soluble .packaging, Rohm and Haas
develops another technology which will essentially eliminate
applicator exposure at comparable costs, it should be
brought to the Agency's attention. The Agency would then
consider modifying or eliminating the requirement for
water-soluble packaging—''.
2/ The projected application exposure without water-soluble pack-
aging would result in an increased lifetime risk of cancer in the
range of 10 for applicators wearing protective clothing.
3/ Rohm and Haas objected to the requirement that it
implement an exposure reduction approach selected by the
Agency, and argued that the registrant should be permitted
to determine the mechanism for exposure reduction. This
objection overlooks the fact that the Agency cannot impose
exposure reduction requirements in a vacuum. Under the
statute, the Agency is required to assess the risk and
benefit consequences of specific options, and select an
option which achieves a balance between risks and benefits.
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4. Cancellation of Hand-Spraying Uses
Secretary of Agriculture Bergland, Rohm and
Haas, and the SAP objected to the cancellation of all
hand-spray uses as proposed in PD 2/3. The grounds for
objection were (1) that hand-spray application is important
in the minor uses such as uses on ornamentals and nursery
stock an_d_(_2)___that _protective clothing can be employed to
reduce exposure to acceptable levels.
The Agency acknowledges that hand-spray uses
of pronamide may be crucial for ornamental and nursery stock
uses and that protective clothing can provide hand-spray
users some protection from exposure to pronamide. However,
the remaining hand-spray uses present a different setting of
higher risks with no offsetting benefits. The data indicate
that for these uses mechanical application methods are
predominant. In view of the above, the Agency will rescind
its decision to cancel hand-spray uses for ornamentals and
nursery stock.
5. Revision of Tolerance on Lettuce to 1 ppm.
Extension of the Time-to-Barvest (TKI) to 60
Days, and Limitation of Applications to Pre-
emergent Use
All commenters agreed with the provision to
reduce the tolerance on lettuce to 1 ppm.
However, Rohm and Haas and Secretary of Agricui
ture Bergland objected to the label restrictions designed to
insure that the 1 ppm tolerance would not be exceeded. Rohm
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and Haas contends that label restrictions are unnecessary and
that their company's evaluation of the data indicates
that current label directions are sufficient to insure the
-proposed tolerance of 1 ppm is not exceeded. The Secretary
of Agriculture agreed with Rohm and Haas.
EPA disagrees with the Rohm and Haas' opinion
that the current label directions, which require "a" "3 5-Hay
time-to-harvest interval, are sufficient to insure that a
tolerance of 1 ppm will not be exceeded. Before proposing
the label restrictions described in PD 2/3, EPA reviewed
Rohm and Haas' data and concluded that the data presently
available do not support a 1 ppm tolerance on lettuce
without a 60-day time-to-harvest interval and a limitation
to pre-emergent use.
The Agency acknowledges there are indications
in the original data base that a 1 ppm tolerance might be
supported by a label less restrictive than that proposed in
PD 2/3. While some of the residues reported exceeded the
proposed 1 ppm tolerance, virtually none of these were
significantly higher.
The Agency will require the registrant to
provide residue data on "head" and "leaf" lettuce, following
both pre-emergent and post-emergent applications of pronamide,
and residue data on "transplant" lettuce following post-emergent
-------
treatment. All studies must use a minimum THI of 35 days.
The studies must be conducted on samples of lettuce grown
during the spring/summer in California and New Jersey and
during fall/winter in California. The Agency will require
J.ata_to. be _submitted no later than SeptemberJL, 1980
The Agency has decided not to require modifica-
tion of the THI and not to limit applications to pre-emergent
use until these data have been submitted to the Agency. The
Agency will use these data to set a 1 ppm tolerance with the
least restrictive measures which will still protect the
public health . In order to facilitate an expeditious
regulatory response once the data are submitted, the Agency
will immediately start the tolerance revision process.
However, no tolerance revision will be finalized until the
residue data have been submitted and evaluated.
6. Required 5-Year Monitoring of Fronamide Residues
in Cow's Milk
Rohm and Haas and the SAP note that present
data support the 0.02 ppm tolerance for milk. Rohm and Haas
has also stated that they would carry out additional studies
to broaden the data base, if needed.
In PD 2/3 the Agency reviewed the current
potential for residues in milk and the risks posed from
those residues. On the basis of the SAP comments that these
-22-
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studies were unnecessary, the Agency has re-analyzed the
data on an absolute worst-case basis. Using a percentage of
crop treatment of 10$, the lifetime risk of developing a
tumor- -from-pronamide- residues -ia-nUJ.k-is-.9-Z0~x_LQ~_.
(Rossi, 1979). The current lifetime risk at 0.5% of crop
treatment is 8.90 x 10~^. Given this low level of hazard,
even if pronamide's use on alfalfa were to increase 20
times, risk would remain negligible. The risk remains
negligible even when the remainder of the lifetime dietary
risk is factored into the lifetime dietary risk from milk.
The Agency therefore rescinds the requirement for monitoring.
III. Conclusions
After reviewing comments from the Secretary of Agricul-
ture, the Scientific Advisory Panel, and others who commented
--¦on-'E-PA's findings-and recommenda-tions concerning pronamide
as set forth in PD 2/3, the Agency has decided to implement
Option ^ as put forward in PD 2/3 and restated in Section
1 of this document with the following modifications:
1. Pronamide as a 1% granular formulation with
fertilizer will not be classified for restricted
use, but labeling for these products must stipulate
that watering-in within 2M hours will be required
for uses on turf.
-23-
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Protective clothing will still be required during
the mixing and application of pronamide as a
wettable powder. Use of rubber or fabric gloves
will be required. Boots will be required for
hand-spray applicators of pronamide.
The manufacturer will.be allowed two._years to_
implement water-soluble packaging for wettable
powder formulations. Specific labeling modifica-
tions must be adopted.
The cancellation of hand spraying in all uses will
be modified to allow hand-spray applications of
pronamide only on ornamentals and nursery stock.
The Agency will start the tolerance revision
process to lower the toelrance from 2 ppm to 1
ppm. Residue studies will be required to provide
data to establish the least restrictive labeling
modifications to insure that all pronamide residues
on lettuce will fall within the 1 ppm tolerance.
The tolerance revision will not be finalized until
the new residue data is received and evaluated by
the Agency.
The requirement for monitoring of milk at 5-year
intervals will be rescinded.
-2H-
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With the above modifications, Option ^ of PD 2/3
is amended as follows:
1. Cancellation and denial of registrations of
hand-spray application of pronamide for all uses
except ornamentals and nursery stock.
2. Cancellation and denial of registrations of all
pronamide products regist~ered"for use-on lettuce,
alfalfa, and forage legume and other uses unless
the registrant or applicant for registration
agrees to modify the terms and conditions of
registration as follows:
A. Classification of pronamide wettable powder
for Restricted Use Only, for use only by or
under the direct supervision of Certified
Applicators and only for those uses covered by
the Certified Applicators certification.
B. Modification on the labeling of pronamide
wettable power products to include the
following:
(1) Restricted Dse Pesticide
For retail sale to and use only by certified
applicators or persons under their direct
supervision and only for those uses covered
by the Certified Applicators certification.
(2) General Precautions
a. Take special care to avoid contact with eyes,
skin, or clothing.
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b. Wash clothing and gloves after use.
(3) Protective Clothing
The following items of clothing are required
-when mixing -or applying pronamide:
a. Long-sleeved shirts and long pants, preferably
one piece (overalls).
b. Hat with brim.
c. Heavy-duty fabric or rubber work gloves.
d. Hand-spray applications of pronamide will
require the use of heavy-duty leather or
rubber boots.
(4) Water-Soluble Packaging
For all wettable-powder products introduced
in commerce after A'ow 2U /Pit? ,
the statement:
"Dilution Instructions"
The enclosed pouches of this product are
water soluble. Do not allow pouches to
become wet prior to adding to the spray
tank. Do not handle the pouches with wet
hands or gloves. Always reseal overwrap bag
to protect remaining unused pouches. Do not
remove water soluble pouches from overwrap
except to add directly to the spray tank.
-26-
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Add the required number of unopened pouches
as determined by the dosage recommendations
into the spray tank with agitation. Depending
on the water temperature and the degree of
¦agiirati-on , - th-e pouches-should- dissolve-
completely within approximately five minutes
from the time they are added to the water.
C. Modification of the granular formulation pronamide
labels to include the following for turf use.
"This product should be watered in within 24
hours."
In addition to these provisions, the Agency
will start the tolerance revision process to amend the
lettuce tolerance from 2 ppm to 1 ppm and will require
4/
residue data— to determine if the 1 ppm tolerance can be
supported with less restrictive measures than a THI of 60
days and a limitation to pre-emergent use. This data will
include residue studies on "head" and "leaf" lettuce after
both pre-emergent and post-emergent treatments and on
"transplant" lettuce after post-emergent treatment with a
time-to-harvest interval of at least 35 days for all the
studies. These samples must be from lettuce grown during
the spring/summer in California and New Jersey and during
the fall/winter in California.
4/ The Agency's requirement for additional studies under
Section 3(c)(2)(b) is not challengeable in any Hearing held
concerning the cancellation of pronamide registrations
or denial of pronamide applications for registration.
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BIBLIOGRAPHY
Courtney, Diane K. 1978. Memo to Nancy Beach. Bionetics
Study of IPC. February 9, 1978.
Day, Harry R. 1979- Memo to Richard Troast. Rohm and Haas.
"Additional:-Pronami-xie-Exposure Da-ta-.-- June -1-, 1979-
Fowler, H. W. 1979. Scientific Advisory Panel Review of
Pronamide. February 25, 1979.
-Gardener, R-. 1978.-Memo to Richard Iroast. Additional
Toxicological Profile for Propham. October 26, 1978.
Gardener, R. 1979« Memo to Richard Troast. Comments on
Pronamide Position Document 2/3. April 2, 1979-
Jegier, Z. 1964. Exposure to Guthion During Spraying.
Archives of Environmental Health, V8. April 11, 1964.
Keitt, G. 1979. Memo to Richard Troast. Pronamide - Response
to Position Document 2/3. April 16, 1979.
Krzeminski, S. 1978. Letter to Richard Troast. Applicator
Exosure Study with Pronamide. November 15, 1978.
Krzeminski, S. 1979. Letter to Richard Troast. Additional
Applicator Exposure Study with Pronamide. April 24, 1979.
Rossi, Lois. 1979. Memo to Richard Troast. Pronamide
Risk Calculations. July 23, 1979.
Wolfe, H. K. 1967. Exposure of Workers to Pesticides.
Archives of Environmental Health, V14. April 1967.
OPP 1 [30,000/lUB]. "Karen" Undated.
OPP 2 [30,000/14B]. Krzeminski, S. F. Rohm and Haas Co.
February 6, 1979.
OPP 3 [30,000/14B]. Harvey, G. University of Wisconsin.
February 2, 1979.
OPP 4 [30,000/14B]. Bergland, Robert. Secretary of Agriculture.
February 14, 1979.
OPP 5 [30,000/14B]. Flanagan, John F. PPG Industries.
March 12, 1979-
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Appendix A
FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT (FIFRA)
SCIENTIFIC ADVISORY PANEL
Review of Notice of Determination Concluding
the Rebuttable Presumption Against Registration (RPAR)
of Pesticide Products Containing Pronamide
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
Scientific Advisory Panel has completed review of plans by the
Environmental Protection Agency (EPA) for initiation of regulatory action
on pronamide pesticide products under the provisions of Section 6(b) of
FIFRA as amended. The review was completed after open meetings were held
¦in Arlington, Virginia, during the periods January 25-26, 1979, and
February 14, 1979.
Maximum public participation was encouraged during formal review of
the RPAR on pronamide by the Scientific Advisory Panel. Federal Register
notices announcing Panel meetings for review of pronamide were published on
October 30, 1978; January 5, 1979; January 18, 1979; and February 7, 1979.
A-1
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The meeting announced in the Federal Register notice dated October 30,
1978, for November 15 and 16, 1978, was cancelled and rescheduled for
January• The Panel was unable to complete review of the regulatory package
on pronauu.de during the meeting held on January 25-26, 1979. Consequently,
final action on pronamide was deferred until February 14, 1979. In
addition, telephone calls and special mailings were sent to the general
public who had previously expressed an interest in activities of the Panel.
Written statements relative to regulatory action on pronamide were received
over a period of several weeks from the Rohm and Haas Company; the
Carcinogen Assessment Group of EPA; and EPA technical staff. In addition,
oral comments were received from Rohm and Haas technical staff; EPA
technical staff; representatives of the University of California Extension
Service? and USDA staff.
In consideration of all matters brought out during Panel meetings,
matters detailed in written and oral statements, and careful study of all
documents submitted by the Agency, the Panel submits the following report
on pronamide:
The fact that pronamide is oncogenic only in the liver of male mice
suggests pronamide is at best a weak carcinogen in man.
1. However, because of the potential oncogenicity of pronamide in
man, the Panel concurs with the EPA position that pronamide should
be classified as a restricted use pesticide.
2« The Panel believes that the hand spray use of pronamide for
nursery and ornamental purposes is an important "minor use" and
should be allowed to continue with the specification that protec-
tive clothing be used by hand spray operators.
A-2
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3. The Scientific Advisory Panel endorses the statement proposed by
EPA to be placed on the labels of pronamide wettable powders, with
special emphasis on the use of protective clothing as outlined in
the regulatory decision:
a. Take st»ecial care to avoid oetting pronamide in eves, on skin,
or on clothing.
b. The following items of clothing to be required when applying
pronamide.
(1) Long'sleeved, one-piece protective outergaraent•
(2) Hat with brim.
(3) Heavy-duty fabric workgloves.
(4) Replace any contaminated clothing.
c. This product is in a water-soluble bag.
Do not break open bag prior to use.
Do not use in quantities smaller than one full bag.
If bag is leaking, use extreme care in handling.
Do not get in eyes, on skin, or on clothing.
However, the Scientific Advisory Panel believes that the
requirement for formulation of pronamide in water-soluble bags is
unnecessarily restrictive. In our opinion, water-soluble bags or
other changes in formulation should be required only if, as
determined in field trials, the exposure of applicators to
pronamide when wearing proposed protective clothing exceeds that
considered by EPA to be acceptable»
A-3
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4. The Scientific Advisory Panel agrees that the pronamide tolerance
on lettuce should be reduced to 1 ppm.
-Sri- Concerning- the -time-to-harvest-interval xthi~3 r the~ Panel"is "of" the "
opinion that the subject of the THZ should be reexamined by EPA
in consultation with the manufacturer. As a result of these con-
sultations, the requirement for the 60-day THZ should be
reassessed. If the data ensures that pronamide levels will not
exceed the tolerance, a shorter THI is encouraged. This will
allow more flexibility to growers in the use of this product.
6. The Panel advises that EPA, in consultation with the manufacturer,
reexamine the proposed requirement for market basket surveys of
pronamide levels in milk at five-year intervals. Experiments
performed in cattle by the manufacturer in using alfalfa
contaminated with pronamide- at the current tolerance level suggests
the proposed monitoring need not be done.
7, The Panel believes that postemergence use of pronamide on trans-
plant lettuce should be allowed if the residues at harvest do not
exceed the 1 ppm tolerance.
A—4
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FOR THE CHAIRMAN;
Certified as an accurate report of ..findings
I. Hade Fowler, Jr., Ph.D.
Executive Secretary
FXFSA Scientific Advisory Panel
Date.»
February. 14,. 15?t_
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Appendix B
Honorable Douglas M. Costle
Administrator, U.S. Environmental
Protection Agency
Washington, D.C. 20460
Dear Mr. Costle:
This is the United States Department of Agriculture's response to the
D.S. Environmental Protection Agency's (EPA) Notice of Determination
pursuant to 40 CFR 162.11(a)(5), concluding the Rebuttable Presumption
Against Registration (SPAR) of Pesticide Products Containing Pronamide,
and EPA's proposed intent to cancel and/or modify the terms and
conditions of registration, pursuant to Section 6(b)(1) of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA).
The Department of Agriculture and State Cooperators, under the
National Agricultural Pesticide Impact Assessment Program (NAPLAP),
recognize the need to interact with EPA in developing biological, economic,
and exposure information according to the current Memorandum of
Understanding between the Department and the Agency. We are also pleased
to have the opportunity to review and comment on the Notice of
B-1
-------
Determination and the accompanying position document* We are dedicated to
the mutual resolution of issues including health risks to applicators, farm
workers, and consumers as well as possible adverse impacts on wildlife, non-
target organisms, and/or the environment.
_We_^»ncur_.with ,E?Ais selection of regulatory options that are _
consistent with the biological and economic assessments. We, therefore,
commend the decision that the registered uses of pronamide are important
and meet the requirements for continued registration. The Department
agrees that the reduction in the lettuce tolerance from 2 ppm to 1 ppm will
continue to provide effective consumer protection.
The issues of concern to the Department and cooperating States and our
recommendations relative to the regulatory actions proposed in the Notice
of Determination are as follows:
1. "Restricted Use" Classification: The Department does not
concur with the proposal to classify pronamide as a "Restricted
Use" pesticide. The information presented to users from the
certification program for general and restricted use is that
classification for "Restricted Use" implies jk definite concern
over and above the normal precautions exercised in the handling,
mixing, and application of pesticides. These precautions have
been emphasized by registrants in labeling and in the educational
programs of Cooperative Extension for many years. As far as is
known, there is no appreciable hazard from the registered uses
of pronamide to wildlife or the environment. Zt has low acute
oral toxicity, is not water soluble, has relatively short soil
B-2
-------
residual activity and other hazards are relatively low.
"Restricted Use" classification would not reduce the rate of
treatment, the amount of residue in "the crop or the exposure to
workers. The lowest effective rate is already being used and
therefore residues in the crop would not be affected.
We support the concept of "Restricted Use" and have devoted
considerable time and funding to the development of State programs
for certification. However, we believe that this classification
should be limited to those pesticides that, when used as directed,
pose a substantial risk to the user and/or the environment.
We do not believe that pronamide falls into this category and feel
3trongly that a classification of "Restricted Use" may further
dilute the sense of caution that should accompany "Restricted Use"
pesticides.
Further the Department disagrees with classifying pronamide
as a "Restricted Use" pesticide because it will unnecessarily
hamper the development of a herbicide that is still expanding in
potential. This classification will discourage many current and
potential users, particularly small farmers, from using or
adopting a practice that could be of great benefit.
Prohibiting Hand Spraying: The Department does not concur
with the proposed label statement prohibiting hand spraying.
Prohibiting this application method reduces the flexibility of
pronamide use and eliminates its potential benefits in "minor use"
areas of nursery and ornamental weed control. Hand spraying
B-3
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involves only a Small volume of spray material. It is used
infrequently and on Limited acreages. In our judgment, the use
of normal protective clothing during mixing/loading and
application will afford an acceptable level of exposure
.protection to the applicator.an acceptable..level .of .exposure
protection to the applicator.
Protective Clothing: Me do not concur with some of the
"protective clothing" statements under the General Precautions
section. For example, fabric work gloves may absorb some pronamide
and would require frequent washing or replacement. We believe the
following precautional statements would provide more adequate
protection.
A. Take special care to avoid getting Pronamide in eyes, on skin,
or on clothing.
B. In case of contact with skin, wash as soon as possible -with
soap and plenty of water. If clothing is contaminated, remove
clothing and wash affected parts of the body with soap and
water.
C. Wear clean clothes each day and launder separately before
reusing. At the end of the day, bathe entire body with soap
and water•
D. Required protective clothing for mixing/loading, or mixing/
loading and application with hand sprayers:
1. Long sleeved shirts and long pants, preferably
one piece (coveralls).
2. Rubber (or neoprene) gloves.
B-4
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3. Boots - for hand applicators.
4. Closely woven hat with brim.
4~. " Wetrarble Powder Formulation tn~WaTer~ SoluftTe~ 8a
-------
preharvest interval is unduly restrictive. Such a regulatory
action will deprive many lettuce producers of utilizing an
effective- -management -tool- in—theix production programs - and will
significantly increase costs of production because of increased
hand-labor requirements. It will also severely impact the growers
of early varieties and those who have switched to transplant
programs because of the availability of pronamide for effective
weed control. We believe that pre- and post-emergence treatments
are necessary for effective utilization of pronamide by lettuce
producers and should be continued with the reduced tolerance level
applying to all situations.
We are oonfident EPA will give favorable consideration to these
suggestions and recommendations in developing the final pronamide
regulatory decisions." The opportunity to have cooperated on this important
agricultural matter is very much appreciated by us as well as the whole
agricultural community. Please let us know if additional information would
be helpful. ~
Sincerely,
Bob Bergland
Secretary
B-6
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ENVIRONMENTAL PROTEC1ION AGENCY
(GPF - 30000/14C)
NOTICE OF INTENT TO CANCEL REGISTRATIONS AND
DENY APPLICATIONS FOR REGISTRATION OF PESTICIDE
PRODUCT'S CONTAINING PRONAhlDE PURSUANT 10
THE FEDERAL INSECTICIDE, FUNGICIDE,
AND RODENTICIDE ACT
AGENCY: Office of Pesticide Programs, Environmental
Protection Agency (EPA).
ACTION: Notice of Intent to Cancel Registrations
and Deny Applications for Registration of Pesticide
Products Containing Pronamide; Analysis of Comments
(Position Document 4) Concerning Pronamide.
SlihKARY: On hay 20, 1977, the Environmental
Protection Agency published in the FEDERAL REGISTER
(42 FR 25506) a notice of rebuttable presumption against
registration and continued registration {RPAR) of
pesticide products containing pronamide. Registrants
and other interested persons were provided the opportunity
to submit data and information to rebut the presumption.
After reviewing all available information, the EPA
determined that the cancer risk presumption announced
in the pronamide RPAR had not been rebutted, and that
the uses of pronamide posed risks of cancer to certain
exposed groups. The Agency also reviewed information
relating tc oenefits of these uses ana, after considering
risks in relation to benefits, determined that these risks
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may be reduced by modifying the terms and conditions of
registration for some uses. These preliminary decisions
were announced in the Notice of Determination anc Avail-
ability of Position Document on Pronamide published on
January 15, 1979 [44 FR 3083](The "Preliminary Notice").
Thereafter, a comment period was provided.
This Notice initiates actions to cancel the pronamide
registrations or deny applications unless the terms and
conditions of registration are modified as follows:
(1) the cancellation and denial of registrations of hand
spray application of pronamide for all uses except ornament-
als and nursery stock; (2} the classification of pronamide
wettable powoers for restricted use and the requirement
for applicator certification; (3) the amendment of the
labeling for pronamide (wettable powder) to require the
use of protective clothing during the mixing and appli-
cation of pronamide; (4) the requirement for the packag-
ing of pronamide wettable powder in water soluble bags;
(5) precautionary labeling on pronamide wettable powder
formulations; and (6) amendment of the granular formulat-
ion labels for turf use.
In addition to these modifications in the terms and
conditions of registration, the Agency will start the
tolerance revision process to amend the lettuce tolerance
-------
from 2 ppm to 1 ppm and will require the submission of
residue data to determine if the 1 ppm tolerance can be
supported with less restrictive measures than a THI of 60
days and a limitation to pre-emergent use.
FOR FURTHER INFORMATION CONTACT: Richard Troast,
Project Manager, Special Pesticide Review Division,
Office of Festicide Programs (TS-791), Room 711E,
Crystal Mall #2, EPA (703-557-7420).
SUPPLEMENTARY INFORMATION: Position Document 4
{PD 4), which accompanies this Notice, discusses in
detail the comments which were received concerning
Position Document 2/3 (PD2/3) and the Preliminary
Notice which accompanied PD 2/3. The comments of the
FIFRA Scientific Advisory Panel and the Secretary of
Agriculture are included in their entirety as
Appendices to PC 4.
I. INTRODUCTION
On January 6, 1979 (43 FR 3083, January 15, 1979}
the Environmental Protection Agency issued a Notice of
Determination (the "Preliminary Notice") pursuant to
40 CFR 162.11(a)(5), terminating the pronamide RPAR.
The Preliminary Notice was accompanied by a Position
Document (PD) 2/3 which set forth in detail the,Agency's
-3-
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analysis of rebuttal comments to the RPAR. In this FD 2/3
the Agency determined that the risks of using pronamice
are greater than the social, economic, and environmental
benefits of these uses, unless risk reductions are
accomplished oy modifications in the terms or conditions
of registration. The Agency further determined that
these modifications in the terms and conditions of
registration accomplish significant risk reductions,
and that these can be achieved without significant
impacts on the benefits of the uses. The Agency also
recommended that certain studies be performed.
This Notice and accompanying PD 4 set forth in de-
tail the Agency's analysis of the comments submitted by
the Secretary of Agriculture, the FIFRA Scientific Ad-
visory Panel (SAF), and other interested parties regard-
ing the reasons and factual bases for the regulatory
actions announced in the Preliminary Notice of Deter-
mination. The regulatory actions announced in this
Notice have been modified, as appropriate, in light of
the comments and other information received on FD 2/3
ana the preliminary Notice from all sources.
This notice is organized into four Sections. This
introduction is Section I. Section II, titled "Legal
-------
Background," is a general discussion of the regulatory
framework within which these actions are taken. Section
III sets forth the regulatory actions the Agency is
implementing concerning pronamide; Section III and the
Position Document set forth the bases for the actions.
Secrion IV, titled "Procedural Matters," provides a brief
discussion of the procedures which will be followed in
implementing the regulatory actions which the Agency is
announcing in this notice.
II. LEGAL BACKGROUND
In order to obtain a registration for a pesticide
under the Federal Insecticide, Fungicide, and Rodenticide
Act, as amended (FIFRA), a manufacturer must demonstrate
that the pesticide satisfies the statutory standard for
registration. That standard requires (among other things)
that the pesticide perform its intended function without
causing "unreasonable adverse effects" on the environment
[Section 3(c)(5)]. "Unreasonable adverse effects on the
environment" is defined as "any unreasonable risk to man
or the environment, taking into account the economic,
social and environmental costs and benefits of the use
of any pesticide" [Section 2(bb)]. In effect, the
registration standard requires a finding that the
benefits from each use of the pesticide exceed the risks
from that use, when the pesticide is used in accordance
-------
with commonly recognized practice. Tne burden of proving
that a pesticide satisfies the registration standard
is on the proponents of registration (e.g., registrants
or users) aria continues as long as the registration
remains in effect. Under Section 6 of FIFRA, the
Administrator is required to cancel the registration of a
pesticide or modify the terms and conditions of regis-
tration whenever he determines that the pesticide no
1/
longer satisfies the statutory standard for registration.
The Agency created the RPAR process to facilitate
the identification of pesticide uses which may not satisfy
the statutory standard tor registration and to provide
a public, informal procedure for the gathering and
evaluation of information about the risks and benefits
of these uses.
17 The statutory standard for registration also requires
that the pesticide satisfy the labeling requirements of
FIFRA. These requirements are set out in the statutory
definition of "misbrandea" [FIFRA Secton 2(c)]. Among
other things, this section provides that a pesticide is
misbranaed if the "labeling ... does not contain
directions for use which are necessary for effecting the
purpose for which the product is intended and if
complied with, together with any ... [restrictions]
imposed under Section 3(d) ... are adequate to protect
health ana the environment."
The Agency can require changes in the directions for
use of a pesticide in most circumstances either by
finding that the pesticide is misbrandea if the labeling
is not changed, or by finding that the pesticide would
cause unreasonable adverse effects on the environment
unless labeling changes are made which accomplish risk
reductions.
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The RPAk process is set forth at 40 CFR 162.11.
This section provides that a rebuttable presumption shall
arise if a pesticide meets or exceeds any of the risk
criteria set out in the regulations. After an RPAK is
issued, registrants and other interested persons are
invited to review the data upon which the presumption is
based and to submit data and information tc rebut the
presumption. Respondents may rebut the presumption of
risk by showing that the Agency's initial determination
of risk was in error, or by showing that use of the
pesticide is not likely to result in any significant
exposure to man or the animal or plant of concern with
2/
regard to the adverse effect in question. Further, in
addition to submitting evidence to rebut the risk
presumption, the respondents may submit evidence as to
T? 40 CFR 162.11(a)(4) provides that registrants and
applicants may rebut a presumption against registration
by sustaining the burden of proving: "(i) In the case
of a pesticide which meets or exceeds the criteria for
risk set forth in paragraphs (a)(3)(i) or (iii) that
when considered with the formulation, packaging, method
of use, and proposed restrictions and directions for use
and widespread and commonly recognized practices of use,
the anticipated exposure to an applicator or user and to
local, regional or national populations of nontarget
organisms is not likely to result in any significant
acute adverse effects; "or (ii) In the case of a
pesticide which meets or exceeds the criteria for risk
set forth in paragraph (a)(3)(ii) that when considered
with proposed restrictions on use and widespread and
commonly recognized practices of use, the pesticide
will not concentrate, persist, or accrue to levels in
man or the environment likely to result in any
significant chronic adverse effects or (iii) that
the determination by the Agency that the pesticide
meets or exceeds any of the criteria for risk was in
error."
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whether the economic, social and environmental benefits
of the use of the pesticide subject to the presumption
outweigh the risk of use.
The regulations require the Agency to conclude an
RPAR by issuing a notice of determination. In that
notice, the Agency states and explains its position on
the question of whether the risk presumption has been
rebutted. If the Agency determines that the presumption
is not rebutted, it then considers information relating to
the social, economic, ana environmental costs and benefits
which registrants ana other interested persons submitted
to the Agency, ana any other benefits information known
to the Agency. If the Agency determines that the risks
of a pesticide use appear to outweigh its benefits, the
RPAR process finally concludes with a Notice of Intent
to Cancel or Deny Registration, pursuant to FIFRA Sectior
6(b)(1) or Section 3(c)(6).
Khen the uses of a pesticide appear to pose risks
which are greater than benefits, the Agency considers
modifications to the terms and conditions of registration
which can reduce risks, and the impacts of such modifi-
cations on the benefits of the use. The risk reduction
measures, short of cancellation, which are available to
the Agency, include requiring changes in the directions
for use on the pesticide's labeling, and classifying the
pesticide for "restricted use," pursuant to FIFRA,
Section 3(d).
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The statute requires the Agency to submit notices ¦
issued pursuant to Section 6 to the Secretary of
Agriculture tor comment and to provide the Secretary of
Agriculture with an analysis of the impact of the
proposed action on the agricultural economy [Section
6(b)]. The Agency is required to submit these documents
to the Secretary at least 60 days before making the
notice effective by sending it to registrants or making
it public. If the Secretary of Agriculture comments in
writing within 30 days of receiving the notice, the
Agency is required to publish the Secretary's comments
and the Administrator's response together with the
Notice. The statute also requires the Administrator to
submit Section 6 notices to a Scientific Advisory Panel
(SAP) for comment on the impact of the proposed action
on health and the environment, at the same time and under
the same procedures as those described for review by the
Secretary of Agriculture [FIFRA Section 25(d)].
Although not required to do so under the statute,
the Agency decided that it is consistent with the general
theme of the RPAR process and the Agency's overall policy
of open decisionmaking to afford an opportunity to
registrants and other interested persons to comment on
the bases for the proposed action during the time that
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the proposed action is under review by the Secretary of
Agriculture and the Scientific Advisory Panel (SAP).
Accordingly, the Preliminary notice and PD 2/3 were
published in the Federal Register ana made available
to registrants and other interested persons at the time
the decision documents were transmitted for formal
external review. Registrants and other interested
persons were allowed the same period of time to comment,
30 days, that the statute provides for receipt of
comments from the Secretary of Agriculture and the SAP.
III. DETERMINATIONS AND ANNOUNCEMENT OF
REGULATORY ACTIONS
As detailed in the Preliminary Notice and PD 2/3,
the Agency considered information on the risks associated
with the use of pronamiae, including information submitted
by registrants and other interested persons in rebuttal
to the pronamiae RPAR. The Agency also considered
information on social, economic and environmental benefits
of the uses of pronamide subject to the RPAR, including
benefits information submitted by registrants and other
interested persons in conjunction with their rebuttal
submissions and information submitted by the United States
Department of Agriculture. The Agency's assessment of
the risks and benefits of the uses of pronamide subject
to this RPAR, its conclusions and determinations on
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whether any uses of pronamiae pose unreasonable adverse
effects on the environment, and its determinations on
whether modifications in terms or conditions of regis-
tration reduce risks sufficiently to eliminate any
unreasonable adverse effects, were set forth in detail
in PD 2/3. The PD 2/3 was adopted by the Agency as its
statement of reasons for the determinations and actions
previously announced in the Notice of Determination and
as its analysis of the impacts of the proposed regulatory
actions on the agricultural economy.
This Notice constitutes the Agency's Final Notice of
Determination Concluding the Fronamide REAR. It reflects
any modifications in the Agency's initial determinations
on the risks and benefits of pronamiae pesticide uses
which the Agency has concluded are appropriate, after
review of the comments and information received concerning
PL 3 and the Preliminary Notice from the Secretary of
Agriculture, the SAP, and other sources. This Notice also
reflects the modifications in the regulatory actions
announced in the Preliminary Notice which the Agency has
concluded are appropriate, ir. light of the comments ana
other information received on PD 3 and the Preliminary
Notice from all sources. PD 4, which accompanies this
Notice, discusses in detail the information that was
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3/
received, ana the Agency's reasons for changing or not
changing its initial determinations and the regulatory
actions announced in the Preliminary Notice. Finally,
this Notice announces the regulatory actions which the
Agency is implementing concerning pronamide. The Agency
hereby incorporates PD 3 and PD 4 as its statement of
reasons for these actions.
A. Determinations on Risks
The pronamide RFAR was based on laboratory
studies showing that pronamide induced oncogenic effects
in experimental mammalian species. The Agency has
determined that the presumption that pronamide poses an
oncogenic risk was not rebutted. The Agency has further
determined that human exposure may result from the uses
of pronamide, ana that pronamide use therefore poses a
cancer risk to man of sufficient magnitude to require
the Agency to determine whether the uses of pronamide
offer offsetting social, economic, or environmental
benefits. The Agency identified the key populations at
risk with respect to pronamide use: the U.S. population
at large, ana pesticide applicators.
37 The comments from the SAP and the Secretary of
Agriculture are attached as appendices to PD 4. All
other comments are available in the pronamide public
file for inspection and review.
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E. Determinations on Eenefits
The uses of pronamide which are subject to
this notice are grouped into three categories: lettuce
1/
use, alfalfa use, and other uses.
1. Lettuce Use
Pronaraioe is used on lettuce to control a variety
of weeds and grasses. Most of the pronamide used for
lettuce (70%) is used in Arizona and California.
Significant adverse economic impacts would result if
pronamide were unavailable for this use and alternate
methods of weed control were employed. Pronamide offers
a wider spectrum of activity than its alternates; thus,
if pronamide were unavailable, more pesticides would be
applied to control weeds. Pronamide also offers a wider
versatility of application methodology than the
alternatives, and timing is not as critical to assure
maximum effectiveness. Finally, pronamide is more
biologically active than the alternatives and thus the
use of this pesticide reduces the frequency of field
reentry to mechanically control weeds which develop
after herbicide application.
4/ The category of "other uses" consists of these
agricultural crops: blueberries, boysenberries, rasp-
berries and other cane fruit, sugar beet grown for seed,
ornamental nursery stock, Christmas tree plantings ana
ornamental turf.
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2. Alfalfa and Cther Forage Legumes
In alfalfa, pronamide offers growers control of
one noxious weed, quackgrass, for which there are no
alternatives presently registered. Non-chemical control
methods are also generally ineffective, as well as
costly to the grower.
Pronamide also offers some increase in utility
over alternatives to alfalfa growers similar to that
achieved in lettuce use, since its use does not require
critical timing to insure maximum effectiveness for
control of weeds.
3. Other Uses
The ability and utility of pronamide to control
weeds (berries, ornamental turf, and nursery stock) for
these "other uses" is similar to that of lettuce and
alfalfa. There are few, if any, alternatives which can
be used to adequately control weeds more efficiently and
economically than pronamide.
C. Determinations on Unreasonable Adverse Effects
For the reasons set forth in detail in the
PC 2/3, as discussed and modified in PC 4, the Agency
has made the following unreasonaole adverse effect
determinations with respect to the uses of pronamide
subject to this RPAR:
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1. Determinations on All Wettable Power
Formulations
The Agency has determined that the risks resulting
from the use of the wettable powder formulations are
greater than the social, economic, and environmental
benefits of these uses, unless risk reductions are
accomplished by modifications in the terms or conditions
of registration, as described below. The Agency has
further determined that these modifications in the terms
and conditions of registration accomplish significant
risk reductions, and that these risk reductions can be
achieved without significant impact on the benefits of
the uses. Accordingly, the Agency has determined that
unless changes are made in terms and conditions of
registration, the uses of pronamide as a wettable powder
will generally cause unreasonable adverse effects on the
environment when used in accordance with widespread and
commonly recognized practice, and that the labeling of
pronamide pesticide products will not comply with the
provisions of FIFRA.
2. Determinations on Granular Formulations
for lurf weed ControX "~
The Agency has determined that the use of pronamide
as a granular product poses risks which are greater than
the social, economic and environmental benefits of these
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uses unless risk reductions are accomplished by modifi-
cations in tne terras and conditions of registration, as
describee below. The Agency has further determined that
these modifications in the terms and conditions of
registration accomplish significant risk reductions, ana
that these risk reductions can be achieved without
significant impact on the benefits of these uses.
Accordingly, the Agency has determined that unless
these changes in the terms and conditions of registration
are accomplished, the uses of pronamiae as a granular formu-
lation will generally cause unreasonable adverse effects
on the environment when used in accordance with widespread
and commonly recognized practice, and that the labeling
of pronamiae pesticide products will not comply with
the provisions of fIFRA.
D. Other Determinations
Under Section 3(c)(2)(E) of FIFRA the Agency
has authority to determine that registrants must conduct
certain additional studies as a condition of continued
registrations. In the event a registrant fails to
take appropriate steps to secure the data required
by the Agency, the Administrator may take appropriate
action to suspend the registrant's registrations for
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which additional data is required. Since require-
ments that registrants conduct certain studies are imposed
pursuant to Section 3(c)(2)(B) and not as terms or
conditions of registration pursuant to Section 6(b),
the Agency's requirement of certain tests is not
challengeable in a Section 6(b) hearing. The Agency has
determined that pronamide registrants holding lettuce
use registrations must submit the results of the lettuce
residue studies detailed in Section III, E. of this
Notice to the Agency by September 1, 1980.
E. Announcement of Regulatory Actions
Eased upon the determinations summarized above
and developed in detail in the PD 2/3 as modified by PL 4,
the Agency is initiating the following regulatory actions,
and this document shall constitute its notice of intent
regarding these actions.
1. Cancellation and denial of registrations of
hand spray application of pronamide for all
uses except ornamentals and nursery stock.
2. Cancellation and denial of registrations
of all pronamide products registered for
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use on lettuce, alfalfa and forage legumes
and other uses unless the registrants
or applicants for registration modify
the terras and conditions of registration
6/
as follows:
A. Classification of pronamide wettable
powder products for Restricted Use Only,
For use only by or under the direct
supervision of Certified Applicators
and only for those uses covered by
the Certified Applicators certification.
B. Modification of the labeling of
pronamide wettable power products to
include the following:
(1) RESTRICTED-USE PESTICIDE
For retail sale to ana use only by
67 FIFRA Section 6(b)(1) provides that the Adminis-
trator may initiate proceedings to cancel a registration
or change its use classification, where the Adminis-
trator finds that the pesticide does not satisfy the
statutory standard for registration. However, the
registered pronamide products subject to this action
have not yet been initially classified. Accordingly,
any classification action with respect to these
products is an initial classification and not a change
in classification. Initial classification generally does
not give rise to a right to review the classification
decision in an adjudicatory hearing. [See Preamble to
Optional Procedures for Classification of Pesticide Uses
by Regulation, 43 FR 5762, 5734 (Feb. 9, 1978)]. However,
Tn view of the fact that the Agency is proposing other
changes to the terras or conditions of the registration
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certified applicators or persons
under their direct supervision and
only for those uses covered by the
certified applicator's certification.
(2) General Precautions
(a) Take special care to avoid
contact with eyes, skin or
clothing.
(b) Wash clothing and gloves
after use.
(3) Protective Clothing
The following items of clothing
are required when mixing or applying
pronamide:
(a) Long-sleeved shirts and long
pants, preferably one piece
(overalls}.
(b) Hat with brim.
(c) Heavy-duty fabric or rubber
work gloves.
T/ (Footnote continued from previous page)
(e.g. labeling changes 5 for registered pronamide products,
which are reviewable in adjudicatory hearings, the
Agency has determined that it is appropriate to exercise
its discretion to fashion procedures in excess of minimum
statutory requirements, and to permit the question of
whether pronamide uses should be initially classified
for restricted use and its use limited to certified
applicators to be reviewed in any such adjudicatory
hearing as well.
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(d) Hand-spray applications of
pronamide will require the
use of heavy-duty leather or
rubber boots.
(4) Kater~Soluble Packaging
For all wettable-powder products
introduced in commerce after
, the statement:
"Dilution Instructions"
The enclosed pouches of this product
are water soluble. Dc not ailow
pouches to become wet prior to adding
to the spray tank. Do not handle the
pouches with wet hands or gloves.
Always reseal overwrap bag to protect
remaining unused pouches. Do not
remove water soluble pouches from
overwrap except to add directly to the
spray tank.
Add the required number of unopened
pouches as determined by the dosage
recommendations into the spray tank
with agitation. Depending on the
water temperature ana the degree of
agitation, the pouches should dissolve
completely within approximately five
minutes from the time they are added
to the water.
Modification of the granular
formulation pronamide labels to
include the following for turf use.
"This product should be watered in
within 24 hours."
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In addition to these actions, the Agency will
start the tolerance revision process to amend the
lettuce tolerance from 2 ppra to 1 ppm and pursuant to
Section 3(c)(2)(B) will require residue data to determine
if the 1 ppra tolerance can be supported with less
restrictive measures than a THI of 6C days and a
limitation to pre-emergent use. This data will include
residue studies on "head" and "leaf" lettuce after
both pre-emergent ana post-emergent treatments and
on "transplant" lettuce after post-emergent treatment
with a time-to-harvest interval of at least 35 days
tor all the studies. These samples must be from lettuce
grown during the spring/summer in California ana New-
Jersey ana during the fall/winter in California. The
Agency is requiring the submission of the studies
by September 1, 1980.
IV. PROCEDURAL NATTERS
This notice initiates actions to cancel the
registration of pronamiae unless registrants modify the
terras ana conditions of registration as required by this
notice. This notice also notifies applicants for new
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registrations that unless the applicant complies with
the conditions required by this notice and notifies the
Agency of such action within 30 cays from receipt by the
registrant or publication, the Agency will refuse to
approve the application.
Under Sections 6(b) and 3(a) of FIFRA, applicants,
registrants, and other interested or affected persons
may request a hearing on the cancellation and denial
actions that this notice initiates. This section of the
Notice explains how affected persons may request a
hearing, and the consequences of requesting or failing
to request a hearing in accordance with the procedures
specified in this notice.
A. Procedure for Requesting a Hearing
1. When a Hearing Must Ee Requested for
Cancellation Actions
Registrants affected by the actions
initiating conditional cancellation of the registered
uses of pronaraide may request a hearing on specific
registered uses within 30 days of receipt of this notice,
or on or before , whichever occurs
later. Any person adversely affected by the cancellation
actions initiated by this notice may request a hearing on
specific registered uses affected by this notice on or
before .
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2. When a Hearing Must Be Requested for
Actions to Deny Applications
Applicants for new registration of the
uses affected by this notice may request a hearing on
specific uses within 30 days of receipt of this notice,
or on or before , whichever occurs
later. Other interested persons may request a hearing
with the concurrence of the applicant during the time
period available to the applicant.
3. How to Request a Hearing
All hearing requests must be filed in
accordance with the Agency's Rules of Practice Governing
Hearings (40 CFR Fart 164). Ajnong other things, these
procedures require all hearing requests to be accompanied
by objections that are specific for each use for which
oT"hearing is requested and to describe the specific
product(s) to which the hearing request refers. All
requests must be received by the Hearing Clerk
within the applicable 30 day time period [40 CFR
164.5(a)]. Failure to comply with these procedures
will automatically result in denial of the request for
a hearing.
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Request for hearings must be submitted to:
Hearing Clerk (A-110)
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, C.C. 20460
B. Consequences of Filing or Failing to File a
Hearing Request
1. Consequences of Filing a Timely and
Effective Hearing Request
If a hearing is requested in a timely and effective
manner before the end of the 30-day notice periods, the
hearing will oe governed by the Agency's Rules of
Practice for hearings under FIFRA section 6 (40 CFR Part
164). In the event of a hearing, the conditional cancel-
lation and denial actions will not become effective with
respect to pesticide products and uses subject to the
hearing, except pursuant to orders of the Administrator
at the conclusion of the hearing.
2. Consequences of Failure to File in a
Timely and Effective Manner
A registrant or applicant for registration who does not
file a timely and effective hearing request shall be deemed to
have acquiesced in the changes to the terms or conditions
of registration required by this Notice. Such registrants
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ana applicants for registration will receive detailed
instructions from the Agency at a later date about how to
Dring their registrations into compliance with this Notice.
Date: .. • .1- ¦
Steven D. Jellinek
Assistant Administrator
for Toxic Substances
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