[Federal Register Volume 61, Number 158 (Wednesday, August 14, 1996)]
[Notices]
[Pages 42244-42249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20458]


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ENVIRONMENTAL PROTECTION AGENCY
[OPP-30000/18F; FRL-5386-5]


Ethylene Bisdithiocarbamates (EBDCs); Announcement of 
Modifications to Existing EBDC Cancellation Orders and Issuance of New 
Cancellation Orders for Four Crops

AGENCY: Environmental Protection Agency (EPA).

ACTION: Announcement of Two Modifications to EBDC Cancellation Orders 
and Issuance of New Cancellation Orders.

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SUMMARY: The EBDC Notice of Intent to Cancel (NOIC) (PD 4) was 
published in the Federal Register of March 2, 1992 (57 FR 7484) and 
announced the Agency's intent to cancel certain EBDC product 
registrations. This document announces three actions which have 
occurred since the publication of the NOIC. The three actions are: (1) 
May 28, 1992 modification of the pre-harvest interval on potatoes, (2) 
August 3, 1994 modification allowing the use of more than one EBDC per 
crop per season, and (3) February 1, 1996 issuance of the Cancellation 
Order for four leafy green crops - collards, mustard greens, turnips, 
and spinach -except for limited use in Georgia and Tennessee.
FOR FURTHER INFORMATION CONTACT: Amy Porter, Special Review and 
Reregistration Division (7508W), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460. 
Telephone: (703) 308-8054, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: This document announces two previous 
modifications to the EBDC Cancellation Order and the issuance of an 
additional Cancellation Order cited in the summary above. This document 
is organized into four units. Unit I is the Regulatory Background. Unit 
II is the announcement of a previous modification to the Cancellation 
Order related to the use of EBDCs on Potatoes. Unit III is the 
announcement of a previous modification to the Cancellation Order 
related to the use of more than one EBDC on one crop during one season. 
Unit IV announces the issuance of a Cancellation Order for Collards, 
Mustard Greens, Turnips, and Spinach.

I. Regulatory Background

    The EBDCs are a group of pesticides consisting of four registered 
active ingredients: mancozeb, maneb, metiram, and nabam. They are used 
primarily as protectants against fungal pathogens on apples, cucurbits 
(i.e., cucumbers,

[[Page 42245]]

melons, pumpkins and squash), lettuce, onions, potatoes, small grains, 
sweet corn, and fungal and bacterial pathogens on tomatoes. Nabam is 
currently registered as an industrial biocide; all registrations of 
nabam for agricultural uses have been voluntarily canceled (54 FR 
50020) and currently there are no established tolerances.
    The regulatory history of the EBDCs is described in detail in the 
March 2, 1992 Notice of Intent to Cancel and Conclusion of Special 
Review (57 FR 7484), the PD 4. In brief, EPA has twice initiated a 
Special Review of the EBDCs. In 1977, EPA initiated a Rebuttable 
Presumption Against Registration, or RPAR, (later referred to as a 
Special Review) based on the presumption that the EBDCs and ETU, a 
common contaminant, metabolite, and degradation product of EBDCs, posed 
the following potential risks to humans and/or the environment: 
carcinogenicity, developmental toxicity, and acute toxicity to aquatic 
organisms. In 1982, EPA concluded this RPAR by issuing a PD 4, which 
announced measures designed to preclude unreasonable adverse effects 
pending development of additional data needed to arrive at a more 
realistic assessment of the risks. At that time, EPA deferred a 
decision on carcinogenic effects because of the lack of sufficient 
information to estimate risk.
    On July 17, 1987, EPA initiated a second Special Review by issuing 
a Notice of Initiation of Special Review of the EBDC pesticides because 
of carcinogenic, developmental, and thyroid effects caused by ETU (52 
FR 21772).
    On September 6, 1989, the four technical registrants of mancozeb, 
maneb, and metiram (Elf Atochem, BASF, DuPont, and Rohm and Haas) 
requested that EPA amend their registrations to delete 42 of the 55 
registered food uses and to restrict formulation of their technical 
products only into products labeled for the 13 retained uses. These 
amendments were accepted on December 4, 1989 (54 FR 50020) and made 
effective December 14, 1989. The thirteen remaining uses on affected 
EBDC labels were: almonds, asparagus, bananas, caprifigs, cranberries, 
grapes, onions, peanuts, potatoes, sugar beets, sweet corn, tomatoes, 
and wheat.
    EPA issued a Notice of Preliminary Determination (also known as a 
PD 2/3) on December 20, 1989 (54 FR 52158) announcing its proposed 
decision to cancel all but 10 uses on the basis of unreasonable risk 
and a lack of support by the registrants. Forty-two of these were 
deleted by the registrants and three additional uses were proposed for 
cancellation by the Agency.
    On May 16, 1990 (55 FR 20416) EPA issued a proposal to revoke and 
reduce tolerances for the 42 deleted uses plus the three additional 
uses proposed for cancellation.
    On March 2, 1992 (57 FR 7484) EPA published in the Federal Register 
a Notice of Intent to Cancel and Conclusion of Special Review (PD 4). 
Based on information and comments received in response to the PD 2/3 
and data submitted by registrants in response to a March 10, 1989 Data 
Call-In, EPA revised its risk and benefits assessments. EPA determined 
that 45 of the 56 uses posed acceptable risks and 11 of the 56 crops 
posed unreasonable risks. (The 56 uses referred to in the PD 4 were 
inadvertently referred to as 55 in the PD 2/3.) All maneb, mancozeb, 
and metiram registrations for products with these 11 uses would be 
canceled unless these uses were deleted from all EBDC labels. The 11 
food uses were: apricots, carrots, celery, nectarines, peaches, 
rhubarb, succulent beans, collards, mustard greens, spinach, and 
turnips. Since publication of the NOIC, all product registrations with 
one or more of the following eight food uses have been canceled or 
amended to delete the affected uses: apricots, carrots, celery, 
nectarines, peaches, rhubarb, succulent beans, and spinach. (Collards, 
mustard greens, and turnips were not canceled, but use has been 
modified as per a settlement agreement. See Unit IV of this notice for 
discussion.)
    Further, EPA determined that the remaining 45 food uses did not 
pose an unreasonable risk provided certain use restrictions specified 
in the PD 4 were incorporated into all EBDC product registrations and 
labeling. The 45 uses subject to the specified modifications to terms 
and conditions of registrations were: almonds, apples, asparagus, 
bananas, barley, broccoli, Brussels sprouts, cabbage, cauliflower, corn 
(field, sweet and pop), cotton, cranberries, crabapples/quince, 
cucumbers, dry beans, eggplant, endive, fennel, grapes, kadota figs, 
kale, kohlrabi, lettuce (head and leaf), melons: cantaloupe, casaba, 
crenshaw, honeydew, watermelon, oats, onions (dry bulb and green), 
papayas, peanuts, pears, pecans, peppers, potatoes, pumpkins, rye, 
squash, sugar beets, tomatoes, and wheat.

II. Modified Cancellation Order Regarding the Use of EBDCs on 
Potatoes

A. Background

    The 1992 NOIC included certain requirements which product 
registrations for potato use had to satisfy to avoid cancellation. For 
a product to remain registered for potato use, the registrations had to 
be amended to include directions for use including maximum application 
rates, maximum number of applications per season, application interval, 
and pre-harvest interval (PHI). The Agency allowed a minimum 3-day PHI 
in Connecticut, Florida, Maine, Massachusetts, New Hampshire, New York, 
Pennsylvania, Vermont, and Wisconsin due to disease pressures caused by 
late blight. A 14-day PHI was required in all other states.
    At the time the NOIC was issued, the Agency had no information 
suggesting that Delaware, Michigan and Ohio had a late blight problem 
and included those states among the states subject to a minimum 14-day 
PHI. Subsequent to the NOIC being issued, a group of registrants and 
growers submitted to the Agency information on late blight supporting a 
minimum 3-day PHI for Delaware, Michigan and Ohio. This group 
(petitioners) requested a hearing to add these three states to the list 
of states for which a 3-day PHI was permitted.
    Additionally, at the time the Agency issued the NOIC, it understood 
that the ``New England'' states as well as some other states had a late 
blight problem and allowed a minimum three day PHI for those states. 
Rhode Island was erroneously omitted from the list of states.

B. Potato--Pre-harvest Interval

    1. Risks. Based on data received after the publication of the PD 4 
and the PD 4 risk estimates, the Agency determined that the changes 
proposed would not result in any significant changes in risk caused by 
EBDC/ETU.
    2. Benefits. The Agency understood that quality and yield impacts 
were likely to occur in potato growing states where late blight was 
present. Prior to the publication of the PD 4, the Agency was not aware 
of the existence of late blight on potatoes in Delaware, Michigan, or 
Ohio. When the Agency became aware of the late blight problems in these 
states, the Agency determined that quality and yield impacts would 
likely occur.
    3. Risk/benefit conclusion. The Agency determined that in the 
states with substantial late blight occurrence, the benefits outweigh 
the risk associated with a 3-day PHI.
    4. Provisions of use. On May 28, 1992, a settlement agreement was 
reached allowing a 3-day PHI in Delaware, Michigan and Ohio on the 
basis of late blight problems in those states. The Agreement also 
included the addition of

[[Page 42246]]

Rhode Island to the list of other New England states for which a 3-day 
PHI was allowed. (Ref. 1)

III. Modified Cancellation Order Regarding the Use of More Than One 
EBDC on One Crop During One Season

A. Background

    The March 2, 1992 NOIC contained a requirement that, to avoid 
cancellation, all EBDC labels and product registrations bearing 
agricultural uses must be amended to include the following label 
statement: ``If this product is used on a crop, no other product 
containing a different EBDC active ingredient may be used on the same 
crop during the same growing season.'' This requirement prohibited the 
use of more than one EBDC active ingredient per crop per season. 
Although the reason for this requirement was not stated in the NOIC, 
the Agency's decision to limit EBDC application as such was to avoid 
the potential overuse of EBDC's through active ingredient switching. 
The decision was not based on specific risk concerns or on the risk 
calculations underlying the Agency's EBDC regulatory decision.
    Subsequent to the NOIC becoming an effective order of cancellation, 
the Agency received a request for a hearing from Elf Atochem and 
Griffin Corporations (petitioners) with supporting letters from the 
Florida Fruit and Vegetable Association and the National Potato Council 
to replace the label requirement which allowed the use of only one EBDC 
per crop per season and prohibited certain seed treatment applications.
    A hearing was granted under subpart D of 40 CFR part 164, 40 CFR 
164.130 - 164.133. 40 CFR part 164, subpart D allows the Administrator 
to consider modifying a prior cancellation decision if the petitioner 
presents substantial new evidence which may materially affect the prior 
cancellation order and which was not available to the Administrator at 
the time the final cancellation determination was made, and this 
evidence could not, even with due diligence, have been discovered by 
the petitioner prior to the issuance of the final order.
    The petitioner's hearing request was found to meet these criteria 
and a hearing was held on June 20, 1994. At this hearing, the 
petitioners successfully demonstrated that since the issuance of the 
NOIC, there had been considerable confusion in the marketplace and an 
unexpected impact on the benefits of use. (See detailed discussion of 
benefits below.) In light of the petitioners' evidence and reasoning, 
the Administrator modified the Cancellation Order on July 8, 1994 to 
reflect the proposed language. (Refs. 2 and 3)
    Estimated risks/label change. The petitioners did not submit any 
new information which would affect the validity of the Agency's 
analysis of the toxicity of EBDCs or the methodology used to estimate 
exposure to EBDCs. The petitioners asserted that the proposed language 
did not increase the individual or seasonal application limits and 
provided equivalent protection in terms of limiting exposure while 
addressing the Agency's concerns about multiple EBDC use as well as 
having the added advantage of being more easily understood. The 
petitioners further asserted that the decision to restrict EBDC use as 
per the restrictive language of the NOIC was not based on specific risk 
concerns but on concerns of exceeding maximum amount of product allowed 
per crop per season. The Agency agreed with the petitioner's 
assertions, and agreed that there are other disincentives to growers 
that should dissuade them from engaging in that type of practice, such 
as the risk of having crops with over-tolerance residues. The Agency 
concluded that the proposed label change would not result in a change 
in EBDC risk.
    Estimated benefits/label restriction. The petitioner's submission 
included information and evidence on the benefits of using more than 
one EBDC active ingredient per crop per season which was not available 
to or considered by the Agency prior to the final Cancellation Order. 
The petitioners asserted that the current label restriction had a 
substantial impact on the industry, including negative effects on 
competition, industry-wide confusion, and hardship for suppliers and 
growers alike. The Agency agreed with the points included in the 
submission which are summarized below:
    The post PD 4 label specification precluded growers from switching 
among EBDCs for any reason, even if a particular product was high 
priced due to limited availability or if a particular product was 
unavailable.
    Many potato growers were required by contract with food processors 
or packers to make pre-storage applications of Ridomil 
(metalaxyl) which contains mancozeb, because consultants and 
researchers have strongly recommended this as a way to prevent root rot 
or late blight. This, coupled with the post PD 4 prohibition on 
switching among EBDC active ingredients, precluded any potato grower 
under such a contract from using any EBDC but mancozeb on that crop for 
the remainder of the season--even though it may not have been the most 
effective treatment for the pest. The Agency agreed with petitioners 
that there is increased risk of resistance when the range of active 
ingredients is limited.
    Fungal problems associated with potatoes include root rot or late 
blight which is commonly treated with a metalaxyl product that is 
considered most effective when it is used in a metalaxyl/EBDC mix. 
Product mixes (as opposed to tank mixes) are preferred because of their 
convenience, ease in handling, reduced potential exposure, and reduced 
costs. Post PD 4 labeling precluded growers from using metalaxyl/EBDC 
mixes such as Ridomil Mz (metalaxyl and mancozeb) if they had 
used maneb earlier in the season. This limited growers to using 
metalaxyl without an EBDC which may be a less effective treatment and 
may have limited the potatoes' marketability.
    Reliability of supply was of concern for growers. All EBDC active 
ingredients are manufactured abroad and domestic suppliers have little 
control over ensuring their steady supply. The failure of a foreign 
supplier or manufacturer to deliver the active ingredients as scheduled 
can result in the shortage of a particular formulation. This was 
creating problems for growers who were bound by post PD 4 label 
specifications to use a specific active ingredient.
    The submission provided evidence of the registrant/marketplace/
grower confusion that resulted from the post PD 4 language that was not 
available at the time of the NOIC. The submission provided examples in 
which misinterpretations of the language were printed in a grower group 
newsletter and a journal.
    The misinterpretations of the language differed substantially from 
the EPA's post-cancellation order interpretation which was explained in 
a 5/26/92 letter from Jack Housenger/EPA to Janet Ollinger (Ref. 4) 
which clearly limited only switching among active ingredients and did 
not restrict switching among different brands of the same EBDC active 
ingredient. Petitioners asserted that this confusion was likely to 
influence purchasing decisions and create unfair advantages for certain 
products while undermining integrated pest control practices.
    Risk/benefit conclusion. The Agency had attempted to clarify this 
issue, but even with clarification, unintended impacts continued. The 
Agency recognized that the label language required by the NOIC created 
confusion and therefore there were

[[Page 42247]]

implementation problems in the marketplace and at the grower level. It 
is obvious from the information provided at the hearing that the 
confusion continued even after the Agency attempted to clarify the 
requirement and its intent. The Agency agreed that the previous label 
restriction was inconsistent with the nature of Integrated Pest 
Management (IPM) programs which are based on selective use of different 
classes of pesticides, and recognized letters of support from the 
Florida Fruit and Vegetable Association and the National Potato Council 
for changing the EBDC label language. The Agency agreed that the 
revised language adequately addressed the objective of the original 
language, did not increase risk from EBDCs, and reduced impacts to 
growers.
    Provisions of use/label change. The language proposed by the 
petitioners allowed the use of more than one EBDC active ingredient per 
crop per season, specified formulas to follow for maximum poundage 
allowed when different EBDCs are used, and allowed for a single seed 
treatment per crop per season in addition to the foliar applications 
where the crop has a registered seed treatment use. The language 
approved by the Agency to replace the previous statement, if requested, 
is as follows:
      Foliar Applications:
      Where EBDC Products Used Allow the Same Maximum Poundage of 
Active Ingredient Per Acre Per Season:
        If more than one product containing an EBDC active 
ingredient (maneb, mancozeb, or metiram) is used on a crop during 
the same growing season and the EBDC products used allow the same 
maximum poundage of active ingredient per acre per season, then the 
total poundage of all such EBDC products used must not exceed any 
one of the specified individual EBDC product maximum seasonal 
poundage of active ingredient allowed per acre.
      Where EBDC Products Used Allow Different Maximum Poundage of 
Active Ingredient Per Acre Per Season:
        If more than one product containing an EBDC active 
ingredient is used on a crop during the same growing season and the 
EBDC products used allow different maximum poundage of active 
ingredient per acre per season, then the total poundage of all such 
EBDC products used must not exceed the lowest specified individual 
EBDC product maximum seasonal poundage of active ingredient allowed 
per acre.
      Seed Treatment:
        In addition to the maximum number of foliar applications 
permitted by the formula stated above, a single application for seed 
treatment may be made on crops which have registered seed treatment 
uses.


IV. Cancellation Order for Collards, Mustard Greens, Turnips, and 
Spinach

    Background. As discussed above, the NOIC of March 2, 1992 announced 
the Agency's decision to cancel 11 uses including collards, mustard 
greens, turnips (includes tops), and spinach. The NOIC stated that 
under FIFRA section 6(b), persons adversely affected by the Notice 
could request a hearing within 30 days of receipt of the Notice or 30 
days from the date of publication. A hearing request was submitted by 
the American Food Security Coalition (AFSC), a group of Georgia leafy 
greens growers, and United Foods, Inc. (the petitioners) regarding 
cancellation of the use of EBDCs on collards, mustard greens, turnips, 
and spinach. (Ref. 5)
    On June 25, 1993, the Court granted a motion which stated that the 
Agency and the petitioners had initiated settlement discussions and 
that the petitioners had developed new scientific data that the Agency 
would review. The parties were required to file monthly status reports 
while reviews and negotiations were conducted.
    The petitioners conducted field trial residue studies for maneb on 
collards, mustard greens and turnips at use rates lower than those 
previously allowed. These reports were submitted to the Agency in 
December of 1993. Reviews of these studies and negotiations continued 
through February 1, 1996 when the proceedings were concluded with the 
Settlement Agreement between the petitioners and the Agency. (Refs. 5 
and 6) This agreement canceled all EBDC uses on collards, mustard 
greens, turnips, and spinach - except limited use on collards, mustard 
greens, and turnips in Georgia and Tennessee, and announced the 
petitioners' withdrawal of their hearing request.
    Treated greens-risks. The Agency determined in the PD 4/NOIC that 
the dietary risk of continued use of EBDCs on collards, mustard greens, 
and turnips exceeded the benefits based on the evidence available at 
the time. The PD 4 risk assessment for these crops was based on pre-PD 
4 labels which allowed an unlimited number of applications with no 
application intervals, required a 10-day pre-harvest interval, limited 
the maximum rate per application to 2.4 lbs a.i., and permitted 
nationwide use.
    The petitioners claimed that the dietary exposure estimates used 
for the leafy greens in the PD 4 (field trial data) were based on 
residue estimates significantly higher than the estimates that would be 
expected from market basket data, with adjustments for washing and 
processing. The petitioners submitted residue data from new maneb field 
trials conducted on collards, mustard greens, and turnips in Georgia 
and Tennessee. These data reflect use rates lower than those previously 
allowed.
    Post PD 4 risk assessment. The field trial data were reviewed on 
January 25, 1994. (Ref. 7) Using the cancer potency factor (Q1*) 
of 0.11 (mg/kg/day)-1 as had been used for the PD 4, and assuming 
100% crop treated, risk was estimated for a variety of registration 
scenarios and population groups (Refs. 8, 9, 10, and 11). The risk from 
treated greens to the general population was estimated to be 1.0  x  
10-6 and risk to non-Hispanic blacks (the most sensitive sub-
population) was estimated to be 5.8  x  10-6. (A cancer risk of 
5.8  x  10-6 indicates that the individual has an estimated 5.8 
out of 1 million chance of developing cancer over a lifetime due to 
exposure to the chemical.) The risk to Non-Hispanic Blacks is higher 
than the general population because of higher reported consumption. The 
Agency considered the risk to non-Hispanic blacks to be unacceptable.
    The Agency met with the petitioners in September 1994 to convey the 
determination that risk continued to outweigh benefits.
    Revised Post PD 4 risk assessment. Subsequent to the September 1994 
meeting with the petitioners, two significant factors led the Agency to 
reassess the risk of these uses -- a revised interspecies scaling 
factor was adopted by the Agency, and additional information was 
submitted regarding percent crop treated.
    In late 1994, the Agency adopted the Unified Interspecies Scaling 
Factor for translation of animal bio-assays to humans. Because this 
factor is used in calculating the Q1*, the Agency adjusted the 
Q1* from 0.11 to 0.06. The revised Q1* resulted in a revised 
risk estimate for the 45 retained uses, which decreased from 1.6  x  
10-6 to 0.9  x  10-6 for the general population. Risk 
estimates for greens for the general population decreased from 1.0  x  
10-6 to 4.6  x  10-7 and for non-Hispanic blacks decreased 
from 5.8  x  10-6 to 2.6  x  10-6. (Ref. 12)
    Percent crop treated is the number of acres of treated crop divided 
by the total number of acres of a crop grown in the United States if a 
crop is only treated in certain areas of the United States, then the 
Agency would normally assume that the percent crop treated was the same 
as the percent of nationwide acreage grown in a particular area. 
Originally, EPA used the conservative assumption that in certain areas 
all of the leafy greens being marketed would have been treated with 
maneb (100% crop treated). This

[[Page 42248]]

was based on EPA's belief at the time that leafy greens markets were 
relatively static and that certain supermarket chains or regions would 
tend to sell, over long periods of time, leafy greens grown in the same 
area.
    In May, 1995, however, the petitioners argued that a better way to 
estimate the percent crop treated with maneb would be to take into 
account the relative percentage of the leafy green crops grown in 
Georgia and Tennessee. Turnips, collards, and mustard greens grown in 
these states represents 22%, 31%, and 36% of national production, 
respectively. In support of this request, petitioners provided market 
distribution data for Georgia and Tennessee grown greens. The 
information submitted demonstrated that Georgia and Tennessee greens 
are distributed nationally, as are greens from other states, and that 
in any given region the source of greens varies with the season and 
with changes in marketing contracts. This information convinced the 
Agency that there was no need to assume that individuals would be 
exposed to 100% maneb-treated leafy greens over their lifetime. 
Instead, the Agency assumed that 100% of these leafy greens grown in 
Georgia and Tennessee (and 0% elsewhere) would be treated, resulting in 
a nationwide percent of crop treated of 22% for turnips, 31% of 
collards, and 36% of mustard greens.
    The Agency's final risk assessment based on the 1993 leafy greens 
data is presented in detail in the Health Effects Division's 2/21/95 
Review of Potential Section 18 use, and the corresponding DRES Analysis 
dated 3/23/95. (Refs. 12 and 13) The final risk estimate for maneb on 
greens only with the revised Q1* and the 22/31/36 Georgia and 
Tennessee percent crop treated assumption, is 1.3  x  10-7 for the 
general population and 7.1  x  10-7 for non-Hispanic blacks.
    Treated greens--benefits. At the time of the PD 4, the Agency 
anticipated significant impacts from the loss of use of EBDC on the 
three greens. The estimated impacts were $13 - $31 million, and this 
was confirmed by yield loss information reported after the PD 4. The 
current estimates are consistent with those from the PD 4.
    Treated greens--risk/benefit conclusion. In the PD 4, the Agency 
used cost-effectiveness to compare risks and benefits among uses. Cost-
effectiveness is a tool used to compare the impact to society 
associated with the loss of use (cost) on a particular site to the 
estimated reduction in risk of that site (effectiveness). For the 
EBDCs, the cost-effectiveness refers to the societal cost per cancer 
case avoided for a specific use. Although the cost estimates for the 
greens have not changed since the PD 4, the risk estimates have 
decreased significantly, bringing the cost-effectiveness ratios to an 
acceptable range. The current cost-effectiveness estimates for 
collards, mustard greens, and turnips are consistent with the PD 4 
estimates for the other retained uses.
    The revised risk from all EBDC treated crops combined, including 
the addition of Georgia and Tennessee treated greens, is estimated to 
be 1.6  x  10-6 for non-Hispanic blacks -- the level determined to 
be acceptable at the PD 4, with comparable cost-effectiveness ratios. 
The revised risk to the general population is 1.0  x  10-6 which 
is lower than risk estimated at the PD 4. Based on current estimates, 
EPA concludes that risk does not outweigh benefits, provided that the 
use is limited to the use of maneb on leafy greens in Georgia and 
Tennessee only at the use rates specified below.
    Treated greens--provisions of use. As finalized by the February 1, 
1996 Settlement Agreement, all EBDC/maneb uses on collards, mustard 
greens, turnips, and spinach other than the uses in the following Table 
1 for Maneb 75DF or Maneb 80WP in Georgia and Tennessee only, are now 
canceled:

                            Table 1.--Application Rates for Maneb 75DF and Maneb 80WP                           
                                          (Georgia and Tennessee only)                                          
----------------------------------------------------------------------------------------------------------------
                                                                   Turnips (Varieties                           
                 Crop                          Collards          grown for greens only)       MustardGreens     
----------------------------------------------------------------------------------------------------------------
Number of Applications Per Cutting...  3                        1                        2                      
Interval between Applications........  14 days                  N/A                      14 days                
Pre-Harvest Interval.................  14 days                  14 days                  14 days                
Rate Per Application.................  1.2 lb active            1.2 lb active            1.2 lb active          
                                        ingredient per acre      ingredient per acre      ingredient per acre   
Rate Per Cutting.....................  3.6 lb active            1.2 lb active            2.4 lb active          
                                        ingredient per acre      ingredient per acre      ingredient per acre   
----------------------------------------------------------------------------------------------------------------

References

     The following sources are referenced in this document.
    1. IN RE: American Food Security Coalition (AFSC), et al. Joint 
Motion for Accelerated Decision and Settlement Agreement. May 28, 
1992. FIFRA Hearing Docket 646.
    2. IN RE: Elf Atochem of North America, Inc. and Griffin 
Corporation. Initial Decision, Recommended Order. July 8, 1994. 
FIFRA Hearing Docket 657.
    3. IN RE: Elf Atochem of North America, Inc. and Griffin 
Corporation. Order Declining Review. August 3, 1994. FIFRA Hearing 
Docket 657.
    4. Housenger, Jack. Response to April 14, 1992 letter regarding 
the ``Restriction Statement Required in the PD 4.'' May 26, 1992.
    5. IN RE: American Food Security Coalition (AFSC), et al. Joint 
Motion for an Accelerated Decision and Order and Settlement 
Agreement. January 31, 1996. FIFRA Hearing Docket 646.
    6. IN RE: American Food Security Coalition (AFSC), et al. 
Accelerated Decision and Order. February 1, 1996. FIFRA Hearing 
Docket 646.
    7. Hummel, Susan V. Maneb on Collards/Field Trials, Residue 
Decline Studies, Reduction of Residue Study, Final Reports. January 
25, 1994.
    8. Griffin, Richard. EBDC/ETU Special Review. DRES Dietary 
Exposure and Risk Estimates for Use of Maneb on Collards, Mustard 
Greens, and Turnip Tops. Estimates Based on New Residue Studies. 
February 3, 1994.
    9. Griffin, Richard. EBDC/ETU Special Review. DRES Dietary 
Exposure and Risk Estimates for Use of Maneb on Collards, Mustard 
Greens, and Turnip Tops. March 11, 1994.
    10. Griffin, Richard. EBDC/ETU Special Review. DRES Dietary 
Exposure and Risk Estimates for Use of Maneb on Collards, Mustard 
Greens, and Turnip Tops. March 18, 1994.
    11. Griffin, Richard. Special Review for Maneb (EBDC) Use on 
Turnips, Collards, and Mustard Greens. DRES Dietary Exposure and 
Risk Estimates. June 3, 1994.
    12. Griffin, Richard. Special Review. DRES Dietary Exposure and 
Risk Estimates for Proposed Section 18 Use of Formulations

[[Page 42249]]

Containing Metalaxyl, Maneb, Mancozeb, and Chlorothalonil. March 23, 
1995.
    13. Hummel, Susan V. Potential Section 18 use on Turnip, 
Mustard, and Collards. February 21, 1995.

List of subjects

    Environmental protection, Administrative practice and procedure, 
Pesticides and pest, Reporting and recording requirements.

    Dated: July 31, 1996.

Daniel M. Barolo,
Director, Office of Pesticide Programs.

[FR Doc. 96-20458 Filed 8-13-96; 8:45 am]
BILLING CODE 6560-50-F