Inert Ingredients; Revocation of Tolerance Exemptions with Insufficient Data for Reassessment, 45415-45424 [E6-12877]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 71, Number 153 (Wednesday, August 9, 2006)]
[Rules and Regulations]
[Pages 45415-45424]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12877]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0230; FRL-8084-1]


Inert Ingredients; Revocation of Tolerance Exemptions with 
Insufficient Data for Reassessment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This final rule revokes under section 408(e)(1) of the Federal 
Food, Drug, and Cosmetic Act (FFDCA) the existing exemptions from the 
requirement of a tolerance for residues of certain inert ingredients 
because there are insufficient data to make the determination of safety 
required by FFDCA section 408(b)(2), or because they are redundant and, 
therefore, are not necessary. In addition, EPA has identified 
substances within certain of these tolerance exemptions that meet the 
definition of low-risk polymers and is establishing new tolerance 
exemptions for them. The revocation actions in this document contribute 
towards the Agency's tolerance reassessment requirements under FFDCA 
section 408(q), as amended by the Food Quality Protection Act (FQPA) of 
1996. By law, EPA is required by August 2006 to reassess the tolerances 
that were in existence on August 2, 1996. The regulatory actions in 
this document pertain to the revocation of 130 tolerance exemptions 
which are counted as tolerance reassessment toward the August 2006 
review deadline.

DATES: This rule is effective August 9, 2008, except amendatory 
instructions dd for Sec.  180.910; jj and pp for Sec.  180.920; m, q, 
bb, and kk for Sec.  180.930; and Sec.  180.960 which are effective 
August 9, 2006. Objections and requests for hearings must be received 
on or before October 10, 2006, and must be filed in accordance with the 
instructions provided in 40 CFR part 178 (see also Unit I.C. of the 
SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0230. All documents in the 
docket are listed in the index for the docket. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at https://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Kerry Leifer, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8811; e-mail address: leifer.kerry@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in Unit II. If you have 
any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at https://www.epa.gov/ fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by FQPA, any person may 
file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178.

[[Page 45416]]

You must file your objection or request a hearing on this regulation in 
accordance with the instructions provided in 40 CFR part 178. To ensure 
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2006-0230 in the subject line on the first page of your submission. All 
requests must be in writing, and must be mailed or delivered to the 
Hearing Clerk on or before October 10, 2006.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0230, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

A. What Action is the Agency Taking?

    1. Revocation because of insufficient data. This final rule revokes 
the inert ingredient tolerance exemptions with insufficient data 
identified in two documents that published in the Federal Register on 
May 3, 2006 (71 FR 25993; EPA-HQ-OPP-2006-0230) (FRL-8060-9) and June 
7, 2006 (71 FR 32895; EPA-HQ-OPP-2006-0493) (FRL-8072-4). EPA is now in 
the process of reassessing all inert ingredient exemptions from the 
requirement of a tolerance (``tolerance exemptions'') established prior 
to August 3, 1996, as required by FFDCA section 408(q). Under FFDCA 
section 408(q), tolerance reassessment may lead to regulatory action 
under FFDCA section 408(e)(1). When taking action under FFDCA section 
408(e)(1), EPA may leave a tolerance exemption in effect only if the 
Agency determines that the tolerance exemption is safe. EPA is revoking 
130 inert ingredient tolerance exemptions because insufficient data are 
available to the Agency to make the safety determination required by 
FFDCA section 408(c)(2).
    In making the FFDCA reassessment safety determination, EPA 
considers the validity, completeness, and reliability of the data that 
are available to the Agency, FFDCA section 408(b)(2)(D), and the 
available information concerning the special susceptibility of infants 
and children (including developmental effects from in utero exposure), 
FFDCA section 408(b)(2)(C). Data gaps exist for these inert ingredients 
in areas critical to reassessment. Without these data, the assessment 
of possible effects to infants and children cannot be made. EPA has 
insufficient data to make the safety finding of FFDCA section 408(c)(2) 
and is revoking the inert ingredient tolerance exemptions identified in 
this final rule.
    The Agency is revoking two other inert ingredient tolerance 
exemptions with insufficient data under 40 CFR part 180 that were 
identified in the preamble of the proposed revocation document (71 FR 
25993; EPA-HQ-OPP-2006-0230). They were inadvertently removed from the 
CFR some time ago but are considered to be active tolerance exemptions 
subject to reassessment as required by FFDCA section 408(q). The 
tolerance exemptions being revoked are:
    i. Sec.  180.910: ``[alpha]-Alkyl(C12-C15)-
[omega]- hydroxypoly(oxyethylene) sulfate, ammonium, calcium, 
magnesium, potassium, sodium, and zinc salts; the poly(oxyethylene) 
content averages 3 moles.''
    ii.Sec.  180.930: ``[alpha]-Alkyl (C12-C15)-
[omega]-hydroxypoly(oxyethylene) sulfate and its ammonium, calcium, 
magnesium, potassium, sodium, and zinc salts; the poly(oxyethylene) 
content averages 3 moles.''
    EPA's response to the comments received on the proposed rule is 
provided in Unit II.B. In summary, the safety finding required by FFDCA 
section 408(b)(2) cannot be made for certain inert ingredient tolerance 
exemptions due to insufficient data. Therefore, EPA is revoking under 
FFDCA section 408(e)(1) the tolerance exemptions identified in this 
document under Sec. Sec.  180.910, 180.920, 180.930, and 180.940, with 
the revocations effective 2 years after the date of publication of this 
rule in the Federal Register.
    2. Five new tolerance exemptions for polymer chemicals. In this 
final rule, EPA is establishing five tolerance exemptions under 40 CFR 
180.960 for chemicals that meet the criteria for defining a low-risk 
polymer under 40 CFR 723.250. No comments were received on the proposal 
to establish these tolerance exemptions (71 FR 25993; EPA-HQ-OPP-2006-
0230). The establishment of these tolerance exemptions is effective on 
the date of publication of this rule in the Federal Register.
    3. Revocations for administrative reasons. The Agency is revoking 
seven redundant and incorrect tolerance exemptions under 40 CFR part 
180, as described in this unit. No comments were received on the 
proposal to revoke these tolerance exemptions (71 FR 25993; EPA-HQ-OPP-
2006-0230). These tolerance exemptions are revoked on the date of 
publication of this rule in the Federal Register.
    i. In Sec.  180.920, the tolerance exemption for: ``Sodium mono- 
and dimethyl naphthalenesulfonate; molecular weight (in amu) 245-260.''
    ii. In Sec.  180.930, the tolerance exemptions for: ``Ethyl vinyl 
acetate (CAS Reg. No. 24937-78-8)'' and ``[alpha]-(Methylene (4-
(1,1,3,3-tetramethylbutyl)-o-phenylene)bis-[omega]-
hydroxypoly(oxyethylene) having 6-7.5 moles of ethylene oxide per 
hydroxyl group.''
    iii. In Sec.  180.920 and 180.930, the tolerance exemptions for: 
``Sodium butyl naphthalenesulfonate.''
    iv. In Sec.  180.910 and 180.930, the tolerance exemptions for: 
``[alpha]-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-[omega]-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl) phenol with an average of 4-14 or 30-70 
moles of ethylene oxide; ...''.

B. EPA's Rsponses to Comments

    1. Identifying data gaps. Several commenters claim that EPA has not 
communicated specific data gaps for each tolerance exemption, and has 
been reticent in communicating whether testing must be conducted for 
each chemical or whether inert ingredients can be grouped and data 
submitted that supports all the inert ingredients within a group. EPA 
disagrees. The proposed rule identified the data gaps that resulted in 
the Agency being unable to make the safety finding of FFDCA section 
408(c)(2). In addition, EPA discussed these topics at some depth during 
both public meetings on the proposed revocation (See the Federal 
Register of May 3, 2006 (71 FR 26000) (FRL-8068-5).
    In the proposed rule, EPA clearly stated that tests agreed to under 
the Organization for Economic Cooperation and Development's (OECD) 
Screening

[[Page 45417]]

Information Data Set (SIDS) program would have permitted the Agency to 
evaluate the tolerance exemptions for reassessment. The proposed rule 
stated that there are data gaps critical to reassessment including 
acceptable repeat-dose, developmental, and reproductive toxicity 
studies. EPA stated that the preferred test for repeat-dose toxicity is 
the ``Combined Repeated Dose Toxicity Study with the Reproduction/
Developmental Toxicity Screening Test'' (OECD Test Guideline 422). The 
OECD SIDS is a well-known international program that also is used in 
EPA's High Production Volume (HPV) program.
    In the proposed rule, EPA stated that for some inert ingredients, 
the full SIDS may not be necessary because EPA has available a limited 
number of studies and information (e.g., acute toxicity studies). The 
Agency anticipates that most inert ingredients will only need the OECD 
422 screening level study, but it must be noted that the results of 
this study may indicate a need for further testing. EPA is reiterating 
here the recommendation stated in the proposed rule that all parties 
interested in supporting a chemical consult with EPA prior to embarking 
on a testing strategy in order to determine the data gap and what data 
the Agency already has available. In addition, the proposed rule lists 
numerous broad multi-chemical tolerance exemptions, each of which could 
encompass many chemicals. EPA continues to offer to work with industry 
to clarify whether testing certain chemicals within a multi-chemical 
tolerance exemption will suffice rather than testing each chemical in 
the group. This will help reduce the number of studies conducted. EPA 
is pleased to report that numerous companies have already consulted 
with the Agency, and more meetings have been scheduled for the near 
future.
    One commenter asserted that sufficient publicly available data 
exists for several of the inert ingredients proposed for revocation. 
The Agency disagrees. EPA searched Agency and publicly available data 
sources, including EPA's HPV program, and found inadequate and 
insufficient data for all of the inert ingredients being revoked in 
this final rule.
    2. Concern about whether 2 years is sufficient time. Most 
commenters expressed concern that the effective date of the revocation 
action for the tolerance exemptions with insufficient data, which is 2 
years from the publication of the final rule, is too short a timeframe 
to identify supporters of inert ingredients, generate the data, and 
complete Agency review. Some commenters asked for assurance that the 
Agency will grant revocation extensions if a good-faith effort is 
demonstrated by the supporter of an inert ingredient.
    The Agency determined that the safety finding of FFDCA section 
408(c)(2) could not be made for the inert ingredient tolerance 
exemptions with insufficient data being revoked in this final rule. 
While the Agency does not anticipate dietary risks of concern for the 
majority of these chemicals based on what is known of their physical-
chemical properties and the history of their use, the lack of data 
requires revocation.
    EPA selected the 2-year timeframe after considering what data would 
typically be needed to fill the data gaps for these inert ingredients. 
As discussed in this unit, the Agency anticipates that most inert 
ingredients will only need the OECD 422 screening level study to fill 
the data gap. The OECD 422 is an oral 28-day repeat-dose screening 
level study (with developmental and reproductive toxicity testing) that 
is known to have a relatively short development time--approximately 9 
months from test initiation to report completion. Two years provides 
sufficient time for the study development and submission process, and 
for Agency review and decisionmaking.
    The Agency is aware that unforeseen or other circumstances may make 
it challenging to complete data development work within the 2-year 
timeframe. The Agency envisions extending the expiration date of 
individual inert ingredient tolerance exemptions on a case-by-case 
basis when legitimate extenuating circumstances arise. EPA may be able 
to through rulemaking delay the effective date of the revocation to 
allow sufficient time for testing and data submission to be completed 
when, soon after the publication of this final rule, the submitter 
clearly communicates to EPA their commitment to support an inert 
ingredient, demonstrates a concerted effort to develop and submit the 
data within the 2-year timeframe, keeps the Agency informed of 
challenging circumstances as they arise, and, most importantly, 
provides the Agency with early indications of data that would support a 
safety finding.
    Most commenters asserted that 2 years is an inadequate amount of 
time if they need to reformulate their pesticide products with other 
inert ingredients. The Agency believes that the majority of inert 
ingredients affected by this final rule that are currently used in 
pesticide products will be successfully supported with adequate data. 
Developing the data, rather than costly reformulation, is the likely 
path forward considering the relatively low cost of conducting the 
screening level study (approximately $150,000). It should be noted that 
for some pesticide products, no action is needed because the 
registrants already have permission to use alternate inert ingredients 
with tolerance exemptions that have been reassessed. The Agency will 
work with registrants on a case-by-case basis if the tolerance 
exemption for an inert ingredient cannot be reinstated because study 
results are unacceptable.
    3. Low Risk Methodology and DCIs. Several commenters claim that EPA 
has not followed the guidance of the ``Low Risk Methodology'' and 
issued Data Call-In (DCI) notices requiring studies. The commenters are 
referring to EPA's ``Guidance Document on Methodology for Determining 
the Data Needed and the Types of Assessments Necessary to Make FFDCA 
Section 408 Safety Determinations for Lower Toxicity Pesticide 
Chemicals.'' Posted to EPA's website 4 years ago (June, 2002), this 
non-binding guidance document was developed in cooperation with a 
committee comprised of representatives of pesticide and industrial 
chemical manufacturers. It generally describes the reassessment and 
petition process for inert ingredients, sources of publicly available 
data and information, and the types of data and information that might 
be needed for risk characterization depending on various chemical-
related factors. The screening level assessments that EPA is using to 
reassess inert ingredients are generally described in the guidance 
document. Data are discussed in some detail in the guidance document, 
including the need for repeat-dose, developmental, and reproductive 
toxicity studies and the OECD 422 study. Therefore, the need for these 
studies for inert ingredient reassessment has been public knowledge for 
some time.
    The guidance document generally describes how DCIs are used by EPA, 
but never states that the Agency would definitely issue DCIs for inert 
ingredients. The mention of DCIs in the guidance document focuses on 
chemicals that have significant toxicity concerns and need a more 
robust (``Tier 3'') evaluation rather than a screening level 
assessment. The guidance document states, ``These chemicals may have 
already been classified as List 1 `inerts of toxicological concern' or 
List 2 `potentially toxic inerts/high priority for testing.' Usually, 
registrants whose products contain Tier 3 chemicals would be required 
to provide these data via a Federal Insecticide, Fungicide, and

[[Page 45418]]

Rodenticide Act (FIFRA) section 3(c)(2)(B) DCI notice.'' The guidance 
document wisely and purposefully built in flexibility to the general 
process and states ``The policies and process described herein are not 
binding on either EPA or pesticide registrants, and EPA may modify or 
disregard the process described herein where circumstances warrant and 
without prior notice.''
    Some commenters believe that EPA may not revoke a tolerance or 
exemption for lack of supporting data unless it has first solicited 
data through a DCI under FFDCA section 408(f)(1). Although FFDCA 
section 408(f)(1) may be used to solicit data required to support a 
tolerance or exemption, the statute provides direct authority for 
revocation in the absence of such data. Section 408(q)(1)(C) of FFDCA 
requires that ``100 percent of... tolerances and exemptions are 
reviewed within 10 years of August 3, 1996.'' When reviewing a 
tolerance exemption, FFDCA section 408(c)(2)(A)(i) provides the 
following: The Administrator may establish or leave in effect an 
exemption from the requirement for a tolerance for a pesticide chemical 
residue in or on food only if the Administrator determines that the 
exemption is safe. The Administrator shall modify or revoke an 
exemption if the Administrator determines it is not safe.
    Under FFDCA section 408(c)(2)(A)(i) safety must be shown, and not 
presumed: The term ``safe,'' with respect to an exemption for a 
pesticide chemical residue, means that the Administrator has determined 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the pesticide chemical residue, including all 
anticipated dietary exposures and all other exposures for which there 
is reliable information.
    Thus, EPA is required by August of 2006 to determine that all 
tolerance exemptions are safe. And if there are insufficient data to 
determine that an exemption is safe, the assessment mandated by FFDCA 
section 408(q)(1)(C) requires that the Agency revoke the exemption, 
regardless of whether a DCI has been issued.
    4. Request for guidance. Several commenters requested written 
guidance, including process steps and schedules, on how to support 
chemicals with insufficient data. EPA is now developing written 
guidance that will help those interested in developing data on the 
inert ingredients with insufficient data identified in this final rule. 
The helpful guidance will include a recommended process with interim 
steps toward the completion of the inert ingredient evaluation. For 
example, the guidance will (among other things) suggest ways to:
    i. Demonstrate an intention to support an inert ingredient (such as 
an official letter to the Agency).
    ii. Consult with the Agency on data gaps and chemicals to be 
tested.
    iii. Show commitment by contracting with a testing laboratory.
    iv. Submit the study to the Agency.
The guidance will be made public on EPA's website and widely 
distributed among industry and other interested stakeholders.
    5. Previously reassessed tolerance exemptions. Several commenters 
noted that five tolerance exemptions were listed in the revocation 
proposal by mistake because they had already been reassessed by the 
Agency. The five tolerance exemptions are as follows:
    i. In both Sec.  180.910 and 180.930: ``[alpha]-Lauryl-[omega]-
hydroxypoly(oxyethylene), average molecular weight (in amu) of 600.''
    ii. In both Sec.  180.910 and 180.930: ``Polyglyceryl phthalate 
ester of coconut oil fatty acids.''
    iii. In Sec. 180.920: ``Tall oil diesters with polypropylene glycol 
(CAS Reg. No. 68648-12-4).''
    Previous Agency reassessment determinations did include four of the 
above-listed tolerance exemptions, however, subsequent to those 
decisions, it was determined that the inert ingredients were 
erroneously included in those reassessment documents. In the case of 
polyglyceryl phthalate esters of coconut oil fatty acids, the two 
tolerance exemptions were initially considered to be reassessed based 
primarily upon an inaccurate assumption that the molecular weights for 
this inert ingredient are greater than 1,000 amu. The tolerance 
exemptions are no longer considered to be reassessed because there are 
no molecular weight limitation in the inert ingredient's tolerance 
exemption expressions. In the case of [alpha]-Lauryl-[omega]-
hydroxypoly(oxyethylene), the two tolerance exemptions were 
inappropriately included in a reassessment document as a member of a 
group of polyethylene glycol fatty acid ester-type substances. The 
tolerance exemptions are no longer considered to be reassessed because 
they are not a part of this group. The reassessment documents that 
initially erroneously included these four tolerance exemptions have 
been revised and these tolerance exemptions have been removed. The 
Agency then attempted to evaluate these inert ingredients but found 
that insufficient data exists to make the FQPA reasonable certainty of 
no harm safety finding. As a result, the Agency is revoking the four 
tolerance exemptions in this final rule.
    The tolerance exemption for ``Tall oil diesters with polypropylene 
glycol (CAS Reg. No. 68648-12-4)'' in Sec.  180.920 has not been 
reassessed and is not part of any reassessment document.
    6. Channels of trade. Commenters raised two issues regarding 
channels of trade. First, a number of commenters indicated that 
existing stocks of pesticides containing ingredients whose exemptions 
are to be revoked, or of chemical blends intended only for such 
pesticides, may not be used up by the time the exemption expires. As 
stated in this unit, the Agency envisions extending the expiration date 
of individual inert ingredient tolerance exemptions on a case-by-case 
basis when circumstances allow. Nevertheless, the Agency does not 
anticipate serious existing stocks problems as a result of this 
revocation action. The Agency believes that submission of acceptable 
new studies and acceptable existing studies that were previously 
unavailable to EPA will keep the need to reformulate pesticide products 
to a minimum. The Agency has already received several communications 
from pesticide registrants indicating their intention to submit 
unpublished data in their possession, and an industry association has 
stated that they are working to obtain unpublished data cited in 
various publications.
    Second, one commenter raised a question regarding FFDCA section 
408(l)(5), which provides that commodities containing pesticide 
residues whose tolerances or exemptions that have been revoked are not 
considered adulterated provided that it is shown to the satisfaction of 
the Food and Drug Administration (FDA) that:
    i The residue is present as the result of an application or use of 
a pesticide at a time and in a manner that was lawful under FIFRA.
    ii. The residue does not exceed a level that was authorized at the 
time of that application or use to be present on the food under a 
tolerance, exemption, or food additive regulation.
The commenter stated that it is highly doubtful that the agriculture 
industry would be able to provide FDA sufficient documentation to meet 
the standards in this provision. EPA has revoked a large number of 
tolerances since the enactment of FQPA, and is not aware of widespread 
difficulties in this area.
    7. Data compensation. A number of commenters have expressed concern 
regarding the ability to receive compensation under FFDCA section

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408(i) for data generated to demonstrate the safety of the ingredients 
subject to this revocation. EPA has made clear that it interprets FFDCA 
section 408(i) to provide exclusive use and data compensation rights in 
data submitted to EPA by pesticide registrants or inert ingredient 
manufacturers and sellers to support or maintain tolerances or 
tolerance exemptions for inert ingredients. See the Federal Register of 
April 17, 2003 (68 FR 18977) (FRL-7279-9). Accordingly, should EPA rely 
upon such data to reinstate any of the listed tolerance exemptions 
subject to this action, such data will be subject to the protections of 
FFDCA section 408(i). The obligation for others to provide compensation 
for such protected data would accrue from DCIs as well as registration 
and registration review actions under FIFRA with respect to products 
containing the ingredients subject to this revocation action.
    8. Cost of the rule, OMB review, and the Regulatory Flexibility 
Act. Several commenters expressed the opinion that the costs of the 
rule are significant, exceeding the $100 million threshold for OMB 
review under Executive Order 12866. Commenters also claimed EPA's 
analysis of the impact on small business did not comply with the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.). The costs 
asserted by the commenters include, among other things, testing of 
every ingredient subject to the tolerance exemptions to be revoked, 
lost sales due to cancellation of pesticides because of the 
revocations, lost value to farmers resulting from the unavailability of 
these pesticides, and the cost of reformulation to change inert 
ingredients. These costs have been estimated by some commenters to be 
in excess of 1 billion dollars.
    EPA disagrees with this analysis. Companies will choose the lowest 
cost alternative between testing, reformulation, and abandoning a 
product. In most cases, testing, which EPA expects to average around 
$150,000, will be by far the cheapest alternative, and EPA anticipates 
very few instances in which reformulation or pesticide product 
abandonment will be appropriate. EPA also anticipates that testing will 
not have to be performed for every chemical affected for several 
reasons. First, it is likely that some of these exemptions cover 
chemicals no longer used in pesticide products. Testing would not be 
conducted for such chemicals and there would be no costs for 
reformulation or due to pesticide product cancellation. Second, 
preliminary discussions with pesticide registrants and inert ingredient 
manufacturers that would be affected by this rule suggest that there 
are a significant number of unpublished studies already conducted that 
would meet the data needs identified here. Third, in many instances, 
similarities among these chemicals will allow EPA to rely on data 
produced on one chemical to support another chemical or a whole group 
of chemicals. Therefore, the overall cost of this rule will be far 
below the Executive Order 12866 threshold.
    Although several commenters claimed that EPA's RFA certification of 
no significant impact on a substantial number of small businesses was 
deficient, little or no explanation was provided for that claim other 
than to argue that EPA needed to perform a more comprehensive analysis. 
EPA has reexamined this question and again concluded that there will be 
no significant negative impact on a substantial number of small 
entities (here, small businesses). As explained in this unit, the costs 
associated with this action are most likely to be testing costs borne 
by pesticide registrants. EPA has identified 1,720 pesticide 
registrants and approximately 58% of this total meet the definition of 
a small business. Even assuming some of these small businesses have to 
conduct testing on their own, the cost of testing ($150,000) would only 
be a small fraction of average annual sales for these companies 
(0.60%). EPA believes, however, that it is unlikely that small 
pesticide registrants will bear solely the costs of testing for an 
exemption. First, for the reasons explained in this unit, EPA believes 
that the number of tests conducted will be far fewer than the number of 
inert ingredients covered by these revocations. Second, and more to the 
point, the statute has cost-sharing provisions to ensure that the costs 
are divided between all affected parties. Although EPA has not matched 
up exemptions with pesticide products for pesticide registrants, EPA 
expects impacts to be widely spread through the group of 1,720 
registrants because the same inert ingredients are frequently used in 
several pesticide products. Therefore, in all likelihood, the costs 
will be divided between many registrants. In fact, EPA has information 
indicating task forces are already being formed to share the cost of 
producing data. One commenter asserted that small registrants did not 
have the resources to participate in cost-sharing task forces. EPA's 
analysis, however, suggests that the shared costs of conducting these 
studies will be insignificant. Finally, with respect to RFA, EPA would 
note that tolerance revocations generally are under FFDCA, and these 
actions in particular, are based solely on safety grounds, and costs 
may not be considered. For example, it would not be relevant under 
FFDCA to contest these revocations on the ground that the tests needed 
to demonstrate safety are too costly. Thus, the testing costs 
associated with this rule are not actually costs that must be 
considered under the RFA in determining whether there is an impact on 
small entities.

C. What is the Agency's Authority for Taking this Action?

    A ``tolerance'' represents the maximum level for residues of 
pesticide chemicals legally allowed in or on raw agricultural 
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a, 
as amended by FQPA, Public Law 104-170, authorizes the establishment of 
tolerances, exemptions from tolerance requirements, modifications in 
tolerances, and revocation of tolerances for residues of pesticide 
chemicals in or on raw agricultural commodities and processed foods. 
Without a tolerance or exemption, food containing pesticide residues is 
considered to be unsafe and therefore ``adulterated'' under FFDCA 
section 402(a), 21 U.S.C. 342(a). Such food may not be distributed in 
interstate commerce (21 U.S.C. 331(a)). For a food-use pesticide to be 
sold and distributed, the pesticide must not only have appropriate 
tolerances under FFDCA, but also must be registered FIFRA (7 U.S.C. 136 
et seq.). Food-use pesticides not registered in the United States must 
have tolerances in order for commodities treated with those pesticides 
to be imported into the United States.

D. When do These Actions Become Effective?

    1. EPA is revoking the tolerance exemptions identified in this 
document that have insufficient data effective 2 years after the date 
of publication of this rule in the Federal Register. Any commodities 
listed in this rule treated with pesticide products containing the 
inert ingredients and in the channels of trade following the tolerance 
revocations, shall be subject to FFDCA section 408(1)(5), as 
established by FQPA. Under this section, any residues of these 
pesticide chemicals in or on such food shall not render the food 
adulterated so long as it is shown to the satisfaction of FDA that:
    i. The residue is present as the result of an application or use of 
the pesticide at a time and in a manner that was lawful under FIFRA.

[[Page 45420]]

    ii. The residue does not exceed the level that was authorized at 
the time of the application or use to be present on the food under a 
tolerance or exemption from tolerance. Evidence to show that food was 
lawfully treated may include records that verify the dates when the 
pesticide was applied to such food.
    2. EPA is establishing new tolerance exemptions under 40 CFR 
180.960 effective on the date of publication of this rule in the 
Federal Register.
    3. EPA is revoking for administrative reasons the redundant and 
incorrect tolerance exemptions identified in this document under 40 CFR 
180.910, 180.920, and 180.930 effective on the date of publication of 
this rule in the Federal Register.

E. What is the Contribution to Tolerance Reassessment?

    By law, EPA is required by August, 2006 to reassess the tolerances 
and exemptions from tolerances that were in existence on August 3, 
1996. This document revokes 130 inert ingredient tolerance exemptions, 
which count as a tolerance reassessment toward the August, 2006 review 
deadline under FFDCA section 408(q), as amended by FQPA in 1996.

III. Are the Actions Consistent with International Obligations?

    The tolerance revocation in this rule is not discriminatory and is 
designed to ensure that both domestically produced and imported foods 
meet the food safety standard established by FFDCA. The same food 
safety standards apply to domestically produced and imported foods.
    EPA is working to ensure that the U.S. tolerance reassessment 
program under FQPA does not disrupt international trade. EPA considers 
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in 
reassessing them. MRLs are established by the Codex Committee on 
Pesticide Residues, a committee within the Codex Alimentarius 
Commission, an international organization formed to promote the 
coordination of international food standards. It is EPA's policy to 
harmonize U.S. tolerances with Codex MRLs to the extent possible, 
provided that the MRLs achieve the level of protection required under 
FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the 
tolerance reassessment section of individual Reregistration Eligibility 
Decision (RED) documents. EPA has developed guidance concerning 
submissions for import tolerance support which was published in the 
Federal Register of June 1, 2000 (65 FR 35069) (FRL-6559-3). This 
guidance will be made available to interested persons. Electronic 
copies are available on the Internet at https://www.epa.gov. On the Home 
Page select ``Laws, Regulations, and Dockets,'' then select 
``Regulations and Proposed Rules'' and then look up the entry for this 
document under ``Federal Register--Environmental Documents.'' You can 
also go directly to the ``Federal Register'' listings at https://
www.epa.gov/fedrgstr.

IV. Statutory and Executive Order Reviews

    This rule establishes and revokes tolerance exemptions under 
section 408(d) of FFDCA. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq., or impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review 
or any Agency action under Executive Order 13045, entitled Protection 
of Children from Environmental Health Risks and Safety Risks (62 FR 
19885, April 23, 1997). This action does not involve any technical 
standards that would require Agency consideration of voluntary 
consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 
104-113, section 12(d) (15 U.S.C. 272 note).
    Pursuant to RFA (5 U.S.C. 601 et seq), the Agency hereby certifies 
that this action will not have a significant negative economic impact 
on a substantial number of small entities. The factual basis for this 
certification is included in Unit II.B.8.
    In addition, the Agency has determined that this action will not 
have a substantial direct effect on States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government, as 
specified in Executive Order 13132, entitled Federalism (64 FR 43255, 
August 10, 1999). Executive Order 13132 requires EPA to develop an 
accountable process to ensure ``meaningful and timely input by State 
and local officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This rule directly regulates growers, food processors, 
food handlers, and food retailers, not States. This action does not 
alter the relationships or distribution of power and responsibilities 
established by Congress in the preemption provisions of section 
408(n)(4) of FFDCA. For these same reasons, the Agency has determined 
that this rule does not have any ``tribal implications'' as described 
in Executive Order 13175, entitled Consultation and Coordination with 
Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive 
Order 13175 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by tribal officials in the development of 
regulatory policies that have tribal implications.'' ``Policies that 
have tribal implications'' is defined in the Executive order to include 
regulations that have ``substantial direct effects on one or more 
Indian tribes, on the relationship between the Federal Government and 
the Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes.'' This rule will not 
have substantial direct effects on tribal governments, on the 
relationship between the Federal Government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

V. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must

[[Page 45421]]

submit a rule report, which includes a copy of the rule, to each House 
of the Congress and to the Comptroller General of the United States. 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
this final rule in the Federal Register. This final rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: July 31, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


Sec.  180.910  [Amended]

0
2. In Sec.  180.910, the table is amended by removing the following 
entries:
    a. [alpha]-Alkyl (C9-C18-[omega]-
hydroxypoly(oxyethylene) with poly(oxyethylene) content of 2-30 moles.
    b. [alpha]-(p-Alkylphenyl)-[omega]-hydroxypoly(oxyethylene) 
produced by the condensation of 1 mole of alkylphenol (alkyl is a 
mixture of propylene tetramer and pentamer isomers and averages 
C13) with 6 moles of ethylene oxide.
    c. [alpha]-Alkyl (C6-C14)-[omega]-
hydroxypoly(oxypropylene) block copolymer with polyoxyethylene; 
polyoxypropylene content is 1-3 moles; polyoxyethylene content is 4-12 
moles; average molecular weight (in amu) is approximately 635.
    d. [alpha]-(p-tert-Butylphenyl)-[omega]-hydroxypoly (oxyethylene) 
mixture of dihydrogen phosphate and monohydrogen phosphate esters and 
the corresponding ammonium calcium, magnesium, monoethanolamine, 
potassium, sodium, and zinc salts of the phosphate esters; the 
poly(oxyethylene) content averages 4-12 moles.
    e. [alpha]-(o,p-Dinonylphenyl)-[omega]-hydroxypoly (oxyethylene) 
mixture of dihydrogen phosphate and monohydrogen phosphate esters and 
the corresponding ammonium, calcium, magnesium, monoethanolamine, 
potassium, sodium, and zinc salts of the phosphate esters; the nonyl 
group is a propylene trimer isomer and the poly(oxyethylene) content 
averages 4-14 moles.
    f. [alpha]-(o,p-Dinonylphenyl)-[omega]-hydroxypoly (oxyethylene) 
produced by condensation of 1 mole of dinonylphenol (nonyl group is a 
propylene trimer isomer) with an average of 4-14 or 140-160 moles of 
ethylene oxide.
    g. Dodecylbenzenesulfonic acid, amine salts.
    h. [alpha]-(p-Dodecylphenyl)-[omega]-hydroxypoly (oxyethylene) 
produced by the condensation of 1 mole of dodecylphenol (dodecyl group 
is a propylene tetramer isomer) with an average of 4-14 or 30-70 moles 
of ethylene oxide; if a blend of products is used, the average number 
of moles of ethylene oxide reacted to produce any product that is a 
component of the blend shall be in the range of 4-14 or 30-70.
    i. Ethylene oxide adducts of 2,4,7,9-tetramethyl-5-decynediol, the 
ethylene oxide content averages 3.5, 10, or 30 moles.
    j. [alpha]-Lauryl-[omega]-hydroxypoly(oxyethylene), average 
molecular weight (in amu) of 600.
    k. [alpha]-Lauryl-[omega]-hydroxypoly(oxyethylene) sulfate, sodium 
salt; the poly(oxyethylene) content is 3-4 moles.
    l. Manganous oxide.
    m. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene) mixture 
of dihydrogen phosphate and monohydrogen phosphate esters and the 
corresponding ammonium, calcium, magnesium, monoethanolamine, 
potassium, sodium, and zinc salts of the phosphate esters; the nonyl 
group is a propylene trimer isomer and the poly (oxyethylene) content 
averages 4-14 moles or 30 moles.
    n. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene) 
sulfate, ammonium, calcium, magnesium, potassium, sodium, and zinc 
salts; the nonyl group is a propylene trimer isomer and the 
poly(oxyethylene) content averages 4 moles.
    o. Polyglyceryl phthalate ester of coconut oil fatty acids.
    p. Poly(methylene-p-tert-butylphenoxy)- poly(oxyethylene) ethanol; 
the poly(oxyethylene) content averages 4-12 moles.
    q. Poly(methylene-p-nonylphenoxy)poly(oxyethylene) ethanol; the 
poly(oxyethylene) content averages 4-12 moles.
    r. Secondary alkyl (C11-C15) 
poly(oxyethylene) acetate, sodium salt; the ethylene oxide content 
averages 5 moles.
    s. Sodium diisobutylnaphthalenesulfonate.
    t. Sodium dodecylphenoxybenzenedisulfonate.
    u. Sodium isopropylisohexylnaphthalenesulfonate.
    v. Sodium lauryl glyceryl ether sulfonate.
    w. Sodium monoalkyl and dialkyl (C8-C16) 
phenoxybenzenedisulfonate mixtures containing not less than 70% of the 
monoalkylated product.
    x. Sodium mono- and dimethylnaphthalenesulfonates, molecular weight 
(in amu) 245-260.
    y. Sodium mono-, di-, and tributyl naphthalenesulfonates.
    z. Sodium mono-, di-, and triisopropyl naphthalenesulfonate.
    aa. Sodium N-oleoyl-N-methyltaurine.
    bb. Sodium sulfite.
    cc. [alpha]-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl)phenol with a range of 1-14 or 30-70 moles of 
ethylene oxide: if a blend of products is used, the average range 
number of moles of ethylene oxide reacted to produce any product that 
is a component of the blend shall be in the range of 1-14 or 30-70.
    dd. [alpha]-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-[omega]-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl) phenol with an average of 4-14 or 30-70 
moles of ethylene oxide; if a blend of products is used, the average 
number of moles of ethylene oxide reacted to produce any product that 
is a component of the blend shall be in the range of 4-14 or 30-70.
    ee. Tridecylpoly(oxyethylene) acetate, sodium salt; where the 
ethylene oxide content averages 6-7 moles.


Sec.  180.920  [Amended]

0
3. In Sec.  180.920, the table is amended by removing the following 
entries:
    a. [alpha]-Alkyl (C12-C18)-[omega]-
hydroxypoly(oxyethylene) copolymers with poly(oxypropylene); 
polyoxyethylene content averages 3-12 moles and polyoxypropylene 
content 2-9 moles.
    b. [alpha]-Alkyl (C10-C16)-[omega]-
hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and 
monohydrogen phosphate esters and the corresponding ammonium, calcium, 
magnesium, monoethanolamine, potassium, sodium, and zinc salts of the 
phosphate esters; the poly(oxyethylene) content averages 3-20 moles.
    c. [alpha]-Alkyl (C12-C15)-[omega]-
hydroxypoly(oxyethylene)

[[Page 45422]]

sulfosuccinate, isopropylamine and N-hydroxyethyl isopropylamine salts 
of; the poly(oxyethylene) content averages 3-12 moles.
    d. [alpha]-Alkyl(C10-12)-[omega]-
hydroxpoly(oxyethylene) poly(oxypropylene) copolymer; poly(oxyethylene) 
content is 11-15 moles; poly(oxyproplene) content is 1-3 moles.
    e. [alpha]-Alkyl(C12-C18)-[omega]-hydroxypoly 
(oxyethylene/oxypropylene) hetero polymer in which the oxyethylene 
content averages 13-17 moles and the oxypropylene content averages 2-6 
moles.
    f. [alpha]-Alkyl (C10-C16)-[omega]-
hydroxypoly(oxyethylene)poly(oxypropylene) mixture of di- and 
monohydrogen phosphate esters and the corresponding ammonium, calcium, 
magnesium, monoethanolamine, potassium, sodium, and zinc salts of the 
phosphate esters; the combined poly(oxyethylene) poly(oxypropylene) 
content averages 3-20 moles.
    g. [alpha]-Alkyl (C12-C18)-[omega]-
hydroxypoly(oxyethylene/oxypropylene) hetero polymer in which the 
oxyethylene content is 8-12 moles and the oxypropylene content is 3-7 
moles.
    h. [alpha]-Alkyl (C12-C15)-[omega]-
hydroxypoly(oxyethylene/oxypropylene) hetero polymer in which the 
oxyethylene content is 8-13 moles and the oxypropylene content is 7-30 
moles.
    i. [alpha]-Alkyl (C21-C71)-[omega]-
hydroxypoly (oxyethylene) in which the poly(oxyethylene) content is 2 
to 91 moles and molecular weight range from 390 to 5,000.
    j. n-Alkyl(C8-C18)amine acetate.
    k. Amine salts of alkyl (C8-C24) 
benzenesulfonic acid (butylamine, dimethylaminopropylamine, mono- and 
diisopropylamine, mono- , di- , and triethanolamine).
    l. N-(Aminoethyl) ethanolamine salt of dodecylbenzenesulfonic acid.
    m. N,N-Bis[[alpha]-ethyl-[omega]-hydroxypoly(oxyethylene) 
alkylamine; the poly(oxyethylene) content averages 3 moles; the alkyl 
groups (C14-C18) are derived from tallow, or from 
soybean or cottonseed oil acids.
    n. N,N-Bis(2-hydroxyethyl)alkylamine, where the alkyl groups 
(C8-C18) are derived from coconut, cottonseed, 
soya, or tallow acids.
    o. N,N-Bis 2-([omega]-hydroxypolyoxyethylene) ethyl) alkylamine; 
the reaction product of 1 mole N,N-bis(2-hydroxyethyl)alkylamine and 3-
60 moles of ethylene oxide, where the alkyl group (C8-
C18) is derived from coconut, cottonseed, soya, or tallow 
acids.
    p. N,N-Bis-2-([omega]-hydroxypolyoxyethylene/polyoxypropylene) 
ethyl alkylamine; the reaction product of 1 mole of N,N-bis(2-
hydroxyethyl alkylamine) and 3-60 moles of ethylene oxide and propylene 
oxide, where the alkyl group (C8-C18) is derived 
from coconut, cottonseed, soya, or tallow acids.
    q. Butoxytriethylene glycol phosphate.
    r. Cyclohexanol.
    s. [alpha]-(Di-sec-butyl)phenylpoly(oxypropylene) block polymer 
with poly(oxyethylene); the poly(oxypropylene) content averages 4 
moles, the poly(oxyethylene) content averages 5 to 12 moles, the 
molecular.
    t. Disodium 4-isodecyl sulfosuccinate.
    u. Dodecylphenol.
    v. [alpha]-Dodecylphenol-[omega]-hydroxypoly(oxyethylene/
oxypropylene) hetero polymer where ethylene oxide content is 11-13 
moles and oxypropylene content is 14-16 moles, molecular weight (in 
amu) averages 600 to 965.
    w. Isopropylbenzenesulfonic acid and its ammonium, calcium, 
magnesium, potassium, sodium, and zinc salts.
    x. (3-Lauramidopropyl) trimethylammonium methyl sulfate.
    y. Linoleic diethanolamide (CAS Reg. No. 56863-02-6).
    z. Methyl bis(2-hydroxyethyl)alkyl ammonium chloride, where the 
carbon chain (C8-C18) is derived from coconut, 
cottonseed, soya, or tallow acids.
    aa. [alpha],[alpha]'-[Methylenebis]-4-(1,1,3,3-tetramethylbutyl)-o-
phenylene bis[[omega]-hydroxypoly(oxyethylene)] having 6-7.5 moles of 
ethylene oxide per hydroxyl group.
    bb. Methylnaphthalenesulfonic acid--formaldehyde condensate, sodium 
salt.
    cc. Methyl poly(oxyethylene) alkyl ammonium chloride, where the 
poly(oxyethylene) content is 3-15 moles and the alkyl group 
(C8-C18) is derived from coconut, cottonseed, 
soya, or tallow acids.
    dd. Methyl violet 2B.
    ee. Morpholine salt of dodecylbenzenesulfonic acid.
    ff. Naphthalenesulfonic acid-formaldehyde condensate, ammonium and 
sodium salts.
    gg. Partial sodium salt of N-lauryl-[alpha]-iminodipropionic acid.
    hh. Poly(methylene-p-nonylphenoxy)poly(oxypropylene) propanol; the 
poly(oxy-propylene) content averages 4-12 moles.
    ii. Primary n-alkylamines, where the alkyl group (C8-
C18) is derived from coconut, cottonseed, soya, or tallow 
acids.
    jj. Sodium butyl naphthalenesulfonate.
    kk. Sodium 1,4-dicyclohexyl sulfosuccinate.
    ll. Sodium 1,4-dihexyl sulfosuccinate.
    mm. Sodium 1,4-diisobutyl sulfosuccinate.
    nn. Sodium 1,4-dipentyl sulfosuccinate.
    oo. Sodium 1,4-ditridecyl sulfosuccinate.
    pp. Sodium mono- and dimethyl naphthalenesulfonate; molecular 
weight (in amu) 245-260.
    qq. Sulfosuccinic acid ester with N-(2,-hydroxy-propyl) oleamide, 
ammonia and isopropylamine salts of.
    rr. Tall oil diesters with polypropylene glycol (CAS Reg. No. 
68648-12-4).
    ss. N,N,N',N''-Tetrakis-(2-hydroxypropyl) ethylenediamine.
    tt. [alpha]-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and 
monohydrogen phosphate esters and the corresponding sodium salts of the 
phosphate esters; the poly(oxyethylene) content averages 6 to 10 moles.


Sec.  180.930  [Amended]

0
4. In Sec.  180.930, the table is amended by removing the following 
entries:
    a. [alpha]-Alkyl (C9-C18)-[omega]-hydroxy 
poly(oxyethylene): the poly(oxyethylene) content averages 2-20 moles.
    b. [alpha]-Alkyl (C12-C15)-[omega]-
hydroxypoly(oxyethylene/oxypropylene) hetero polymer in which the 
oxyethylene content is 8-13 moles and the oxypropylene content is 7-30 
moles.
    c. [alpha]-Alkyl (C8-C10) 
hydroxypoly(oxypropylene) block polymer with polyoxyethylene; 
polyoxypropylene content averages 3 moles and polyoxyethylene content 
averages 5-12 moles.
    d. [alpha]-Alkyl (C6-C14)-[omega]-
hydroxypoly(oxypropylene) block copolymer with polyoxyethylene; 
polyoxypropylene content is 1-3 moles; polyoxyethylene content is 7-9 
moles; average molecular weight (in amu) approximately 635.
    e. [alpha]-(p-Alkylphenyl)-[omega]-hydroxypoly (oxyethylene) 
produced by the condensation of 1 mole of alkylphenol (alkyl is a 
mixture of propylene tetramer and pentamer isomers and averages 
C13) with 6 moles of ethylene oxide.
    f. Amine salts of alkyl (C8-C24) 
benzenesulfonic acid (butylamine; dimethylamino propylamine; mono- and 
diisopropyl- amine; and mono- , di-, and triethanolamine).
    g. [alpha]-(p-tert- Butylphenyl)-[omega]-hydroxypoly(oxyethylene) 
mixture of

[[Page 45423]]

dihydrogen phosphate and monohydrogen phosphate esters and the 
corresponding ammonium, calcium, magnesium, monoethanolamine, 
potassium, sodium, and zinc salts of the phosphate esters; the 
poly(oxyethylene) content averages 4-12 moles.
    h. [alpha]-(o,p-Dinonylphenyl)-[omega]-hydroxypoly (oxyethylene) 
mixture of dihydrogen phosphate and monohydrogen phosphate esters and 
the corresponding ammonium, calcium, magnesium, monoethanolamine, 
potassium, sodium, and zinc salts of the phosphate esters; the nonyl 
group is a propylene trimer isomer and the poly(oxyethylene) content 
averages 4-14 moles.
    i. [alpha]-(o,p-Dinonylphenyl)-[omega]-hydroxypoly (oxyethylene), 
produced by the condensation of 1 mole of dinonylphenol (nonyl group is 
a propylene trimer isomer) with an average of 4-14 moles of ethylene 
oxide.
    j. Dodecylbenzenesulfonic acid, amine salts.
    k. [alpha]-(p-Dodecylphenyl)-[omega]-hydroxypoly (oxyethylene) 
produced by the condensation of 1 mole of dodecylphenol (dodecyl group 
is a propylene tetramer isomer) with an average of 4-14 or 30-70 moles 
of ethylene oxide; if a blend of products is used, the average number 
of moles of ethylene oxide reacted to produce any product that is a 
component of the blend shall be in the range of 4-14 or 30-70 moles.
    l. Ethylene oxide adducts of 2,4,7,9-tetramethyl-5-decynediol, the 
ethylene oxide content averages 3.5, 10, or 30 moles.
    m. Ethyl vinyl acetate (CAS Reg. No. 24937-78-8).
    n. [alpha]-Lauryl-[omega]-hydroxypoly(oxyethylene), average 
molecular weight (in amu) of 600.
    o. [alpha]-Lauryl-[omega]-hydroxypoly(oxyethylene), sulfate, sodium 
salt; the poly(oxyethylene) content is 3-4 moles.
    p. Manganous oxide.
    q. [alpha]-(Methylene (4-(1,1,3,3-tetramethylbutyl)-o-phenylene) 
bis-[omega]-hydroxypoly(oxyethylene) having 6-7.5 moles of ethylene 
oxide per hydroxyl group.
    r. Mono-, di-, and trimethylnaphthalenesulfonic acids-formaldehyde 
condensates, sodium salts.
    s. Naphthalenesulfonic acid and its sodium salt.
    t. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene) mixture 
of dihydrogen phosphate and monohydrogen phosphate esters and the 
corresponding ammonium, calcium, magnesium, monoethanolamine, 
potassium, sodium, and zinc salts of the phosphate esters; the nonyl 
group is a propylene trimer isomer and the poly(oxyethylene) content 
averages 4-14 moles.
    u. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene) 
sulfate, and its ammonium, calcium, magnesium, potassium, sodium, and 
zinc salts; the nonyl group is a propylene trimer isomer and the 
poly(oxyethylene) content averages 4 moles.
    v. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene) 
sulfate, and its ammonium, calcium, magnesium, monoethanolamine, 
potassium, sodium, and zinc salts; the nonyl group is a propylene 
trimer isomer and the poly(oxyethylene) content averages 4-14 or 30-90 
moles of ethyiene oxide.
    w. Polyglyceryl phthalate esters of coconut oil fatty acids.
    x. Poly(methylene-p-tert-butylphenoxy)poly(oxyethylene) ethanol; 
the poly(oxyethylene) content averages 4-12 moles.
    y. Poly(methylene-p-nonylphenoxy)poly(oxyethylene) ethanol; the 
poly(oxyethylene) content averages 4-12 moles.
    z. Poly(methylene-p-nonylphenoxy)poly(oxypropylene) propanol; the 
poly(oxypropylene) content averages 4-12 moles.
    aa. Secondary alkyl (C11-C15) 
poly(oxyethylene) acetate, sodium salt; the ethylene oxide content 
averages 5 moles.
    bb. Sodium butylnaphthalenesulfonate.
    cc. Sodium diisobutylnaphthalenesulfonate.
    dd. Sodium isopropylisohexylnaphthalenesulfonate.
    ee. Sodium isopropylnaphthalenesulfonate.
    ff. Sodium monoalkyl and diakyl (C8-C13) 
phenoxybenzenedisulfonate mixtures containing not less than 70% of the 
monoalkylated product.
    gg. Sodium mono- and dimethylnaphthalenesulfonate, molecular weight 
(in amu) 245-260.
    hh. Sodium mono-, di-, and tributylnaphthalenesulfonates.
    ii. Sodium N-oleoyl-N-methyl taurine.
    jj. [alpha]-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p 
(1,1,3,3-tetramethylbutyl)phenol with a range of 1-14 or 30-70 moles of 
ethylene oxide: if a blend of products is used, the average range 
number of moles of ethylene oxide reacted to produce any product that 
is a component of the blend shall be in the range of 1-14 or 30-70.
    kk. [alpha]-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,-3,3-tetramethylbutyl) phenol with an average of 4-14 or 30-70 
moles of ethylene oxide; if a blend of products is used, the average 
number of moles of ethylene oxide reacted to produce any product that 
is a component of the blend shall be in the range of 4-14 or 30-70.
    ll. Tridecylpoly(oxyethylene) acetate sodiums salt; where the 
ethylene oxide content averages 6-7 moles.


Sec.  180.940  [Amended]

0
5. Section 180.940 is amended as follows:

0
a. The table in paragraph (a) is amended by removing the following 
entries:
    i. [alpha]-Alkyl(C10-C14)-[omega]- 
hydroxypoly (oxyethylene) poly(oxypropylene) average molecular weight 
(in amu), 768 to 837.
    ii. [alpha]-Alkyl(C12-C18)-[omega] 
hydroxypoly (oxyethylene) poly(oxypropylene) average molecular weight 
(in amu), 950 to 1120.

0
b. The table in paragraph (b) is amended by removing the following 
entries:
    i. [alpha]-Lauroyl-[omega]-hydroxypoly (oxyethylene) with an 
average of 8-9 moles ethylene oxide, average molecular weight (in amu), 
400.
    ii. Oxirane, methyl-, polymer with oxirane, ether with (1,2-
ethanediyldinitrilo)tetrakis [propanol] (4:1).

0
c. The table in paragraph (c) is amended by removing the following 
entries:
    i. [alpha]-Alkyl(C10-C14)-[omega]-hydroxypoly 
(oxyethylene) poly (oxypropylene) average molecular weight (in amu), 
768 to 837.
    ii. [alpha]-Alkyl(C11-C15)-[omega]-
hydroxypoly (oxyethylene) with ethylene oxide content 9 to 13 moles.
    iii. [alpha]-Alkyl(C12-C15)-[omega]-
hydroxypoly (oxyethylene) polyoxypropylene, average molecular weight 
(in amu), 965.
    iv. [alpha]-Alkyl(C12-C18)-[omega]-
hydroxypoly (oxyethylene) poly(oxypropylene) average molecular weight 
(in amu), 950 to 1120.
    v. [alpha]-Lauroyl-[omega]-hydroxypoly (oxyethylene) with an 
average of 8-9 moles ethylene oxide, average molecular weight (in amu), 
400.
    vi. Naphthalene sulfonic acid, sodium salt.
    vii. Naphthalene sulfonic acid sodium salt, and its methyl, 
dimethyl and trimethyl derivatives.
    viii. Naphthalene sulfonic acid sodium salt, and its methyl, 
dimethyl and trimethyl derivatives alkylated at 3% by weight with 
C6-C9 linear olefins.

[[Page 45424]]

    ix. Oxirane, methyl-, polymer with oxirane, ether with (1,2-
ethanediyldinitrilo)tetrakis [propanol] (4:1).


Sec.  180.960  [Amended]


6. In Sec.  180.960, the table is amended by alphabetically adding the 
following entries:


Sec.  180.960  Polymers; exemptions from the requirement of a 
tolerance.

* * * * *

------------------------------------------------------------------------
                  Polymer                              CAS No.
------------------------------------------------------------------------
                                * * * * *
[alpha]-(o,p-Dinonylphenyl)-[omega]-        9014-93-1
 hydroxypoly(oxyethylene) produced by
 condensation of 1 mole of dinonylphenol
 (nonyl group is a propylene trimer
 isomer) with an average of 140-160 moles
 of ethylene oxide
------------------------------------------------------------------------
                                * * * * *
[alpha]-(p-Dodecylphenyl)-[omega]-          9014-92-0
 hydroxypoly(oxyethylene)