Updating Generic Pesticide Chemical Tolerance Regulations, 33354-33363 [05-11384]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 109 (Wednesday, June 8, 2005)]
[Rules and Regulations]
[Pages 33354-33363]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11384]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9, 23, 163, 177, 178, 179, and 180

[OPP-2003-0176; FRL-7706-9]


Updating Generic Pesticide Chemical Tolerance Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY:  EPA is updating generic provisions of its procedural 
regulations pertaining to pesticide chemical tolerances and exemptions 
from the requirement of a tolerance under section 408 of the Federal 
Food, Drug, and Cosmetic Act. This update is necessary due to various 
changes made in the underlying statute by the Food Quality Protection 
Act of 1996. The amendments are primarily administrative in nature. EPA 
believes that these revisions will clarify the regulations and reduce 
confusion for users.

DATES: This final rule is effective August 8, 2005.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number OPP-2003-0176. All documents in the docket 
are listed in the EDOCKET index at https://www.epa.gov/edocket/. 
Although listed in the index, some information is not publicly 
available, i.e., 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 either electronically in EDOCKET or in hard copy at the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket telephone number is (703) 305-
5805.

FOR FURTHER INFORMATION CONTACT: Jonathan Fleuchaus, Office of General 
Counsel, Mail code 2333A, Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (202) 564-5628; fax number: (202) 564-5644; e-mail 
address: fleuchaus.jonathan@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 111)
     Animal production (NAICS 112)
     Food manufacturer (NAICS 311)
     Pesticide manufacturer (NAICS 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. 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 and Other 
Related Information?

    In addition to using EDOCKET (https://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR is 
available at E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.

II. Background

    In the Federal Register of October 8, 2004 (69 FR 60320) (FRL-7308-
2), EPA proposed to amend various sections of 40 CFR parts 9, 23, 163, 
and 177-180 pertaining to pesticide chemical tolerances to make them 
consistent with the changes to section 408 of the Federal Food, Drug, 
and Cosmetic Act (FFDCA), 21 U.S.C. 346a, contained in the Food Quality 
Protection Act of 1996 (FQPA). These proposed changes were primarily 
procedural in nature.
    Two substantive comments were received on the proposal. EPA's 
response to these two comments is contained in Unit IV. In brief, 
neither of these comments objected to the changes proposed by EPA; 
rather, the commenters argued that EPA should have made further changes 
to the tolerance regulations. As explained in Unit IV., EPA believes 
that certain additional changes in this regulation are merited based on 
the comments.
    Further, as explained in Unit III., EPA has identified several 
additional minor changes to the tolerance regulations that help to 
conform the existing tolerance regulations to the changes made by the 
FQPA.
    Accordingly, other than the modifications identified in Units III. 
and IV., EPA is adopting in the final rule its revisions to the FFDCA 
tolerance regulations as proposed.

III. Additional Changes To Tolerance Regulations Identified by EPA

    EPA proposed to amend 40 CFR 178.37(c) by removing language that 
specified that the effective date for an order responding to objections 
``must not be earlier than the 90th day after it is published unless 
the order contains findings as to the existence of emergency conditions 
that necessitate an earlier effective date.'' See 40 CFR 178.37(c). The 
90-day limitation on effectiveness was drawn directly from FFDCA 
section 408 prior to its amendment by the FQPA. Specifically, prior 
section 408(d)(5) stated that ``[n]o order [following a hearing on a 
tolerance regulation] shall take effect prior to the ninetieth day 
after its publication, unless the Administrator finds that emergency 
conditions exist necessitating an earlier effective date, in which 
event the Administrator shall specify in the order of his findings as 
to such conditions.'' 21 U.S.C. 346a(d)(5) (1994). That language, 
however, was dropped from section 408 upon its amendment by the FQPA. 
See 21 U.S.C. 346a(g)(2)(C). Similar language requiring a 90-day delay 
in effectiveness also appears in 40 CFR 179.105(b)(ii). EPA 
inadvertently missed this obsolete requirement in 40 CFR part 179 in 
issuing its proposal. Because removal of this language is consistent 
with the revised statute and the proposal, EPA is deleting the 90-day 
limitation on effectiveness from 40 CFR 179.105(b)(ii) as well as from 
40 CFR 178.37(c).

[[Page 33355]]

    The second change identified by EPA is to amend the authority 
citation for parts 9, 23, 178, and 179 to delete the reference to FFDCA 
section 409. Following the FQPA's consolidation of the authority over 
pesticide chemicals in section 408, these parts no longer rely on, or 
pertain to, FFDCA section 409.
    The third change identified by EPA is to amend 40 CFR 180.7(h) to 
include among the options that the Administrator has in ruling on a 
petition to establish, modify, or revoke a tolerance the option of 
denying the petition. This option was explicitly added by the FQPA in 
section 408(d)(4)(A)(iii).
    Finally, EPA has added a definition for the abbreviation ``FFDCA'' 
in part 180, and revised the definitions for ``pesticide chemical'' and 
``pesticide chemical residue'' to adopt the modifications to these 
definitions enacted by the Antimicrobial Regulation Technical 
Correction Act of 1998, Public Law 105-324, 112 Stat. 3035, and to 
cross-reference the existing regulatory exceptions to these definitions 
in 40 CFR 180.4.

IV. Response to Comments

A. Comment Concerning Filing Time for Judicial Review

    Edward C. Gray questioned whether the proposed amendments to 40 CFR 
23.10 would clarify when a party needs to file a judicial challenge to 
a final order on a tolerance regulation or petition denial so that 
party would come within the 10-day window prescribed in 28 U.S.C. 2112 
to address the ``races to the courthouse'' problem. Pertinent 
background information helps to explain Mr. Gray's concern.
    Section 2112 of Title 28 of the United States Code addresses 
various procedural requirements pertaining to judicial review of agency 
orders including what United States Circuit Court of Appeals will hear 
a case when a challenge to an agency order or rule is filed in multiple 
circuit courts. Prior to the 1988 amendments to 28 U.S.C. 2112, section 
2112 specified that if review of an agency order or rule was sought in 
more than one circuit, the circuit where a petition for review was 
first filed would hear the challenge. To avoid the ``races to the 
courthouse'' that were produced under this procedure, section 2112 was 
amended in 1988 to establish a random selection scheme to deal with 
filings in multiple circuits. S.Rep. No. 100-263, pp. 2-4, 1987 
U.S.C.C.A.N. 3198, 3198-3201 (1987). Under amended section 2112, if an 
agency receives two or more petitions for review involving at least two 
circuits within 10 days of ``issuance of an order,'' the agency is 
required to notify the judicial panel on multi-district litigation of 
the fact that there have been multiple filings and provide the panel 
with the petitions. 28 U.S.C 2112(a)(3). The judicial panel is then 
required to select by ``random'' one of the circuits in which a 
petition was filed to hear all of the petitions.
    Prior to the 1988 amendment to 28 U.S.C. 2112, various agencies, 
including EPA, promulgated rules in an attempt to mitigate ``races to 
the courthouse'' to challenge agency orders and rules. In 40 CFR part 
23, EPA generally specified that the time and date of the entry or 
promulgation of an order or rule for the purpose of judicial review is 
1 p.m. eastern time on the date that is 2 weeks after the date on which 
the order or rule is published in the Federal Register. Although these 
regulations did not eliminate races to the courthouse, they at least 
provided all parties with fair notice of when the starting gun would be 
fired. A specific provision in 40 CFR part 23 addressed orders issued 
under the FFDCA. See 40 CFR 23.10.
    Upon amendment of section 2112 in 1988, EPA promulgated a new 
section to 40 CFR part 23 specifying the manner in which service of 
petitions should be filed with the Agency so that the EPA could comply 
with section 2112's new requirement that an agency, whose order or rule 
is challenged in more than one circuit court, file the multiple 
petitions for review with the judicial panel on multi-district 
litigation. In promulgating this new section of 40 CFR part 23, EPA 
made clear that, out of consideration of fairness to all parties, it 
intended to leave in place the existing sections of 40 CFR part 23 
establishing a 2-week delay between publication of an order or 
regulation and the time when the order or regulation could be 
challenged. As EPA explained: ``In other words, agency actions covered 
under these sections will continue to be deemed `final' for purposes of 
judicial review (and the ten-day period for petitions for review to 
enter the random selection process will begin) at 1:00 p.m. fourteen 
days after the date of publication or date of signature.'' (53 FR 
29320) (August 3, 1988).
    40 CFR 23.10 currently specifies that ``the time and date of the 
entry of an order'' issued under the FFDCA is 2 weeks after 
publication. EPA's proposed amendment to 40 CFR 23.10 principally 
involved conforming the statutory references in 40 CFR 23.10 to the 
FQPA's structural change of moving the judicial review provision in 
FFDCA section 408 from subsection (i) to subsection (h). EPA did not 
propose to change the ``time and date of the entry of an order'' 
language.
    Mr. Gray contends that, because EPA's regulations speak in terms of 
``entry'' of an order and the United States Code uses the word 
``issuance,'' there could be confusion about when a petition for review 
must be filed to come within the 10-day window provided by 28 U.S.C. 
2112. Mr. Gray suggests deleting 40 CFR 23.10 and amending the relevant 
portions of 40 CFR parts 178, 179, and 180 to make clear that an order 
or regulation is consider ``issued'' at the time of publication. As Mr. 
Gray explains, a court may determine that ``issuance'' occurs prior to 
``entry,'' thus penalizing those filers who delay action based on 40 
CFR 23.10. Alternatively, a party who files within 10 days of 
publication may have the filing ruled to be premature, and thus not 
within 28 U.S.C. 2112's 10-day window, if a court treats ``issuance'' 
and ``entry'' as equivalent under 40 CFR 23.10.
    In light of Mr. Gray's comments, EPA has reviewed again the 
statutory provisions in section 408 pertaining to the timing of 
judicial review; the requirements in 28 U.S.C. 2112; EPA's existing 
regulations on judicial review of FFDCA actions in 40 CFR parts 178, 
179, and 180, and on ``races to the courthouse'' in part 23; and EPA's 
proposals with regard to these regulations.
    This review has revealed an oversight in EPA's proposal with regard 
to the timing of the filing for petitions for judicial review. Prior to 
the passage of the FQPA, section 408 specified that petitions for 
judicial review must be filed ``within sixty days after entry of [an 
appropriate] order.'' 21 U.S.C. 346a(i) (1994) (emphasis added). FQPA 
amended this language to specify in section 408(h) that a petition must 
be filed ``within 60 days after publication of [an appropriate] order 
or regulation.'' 21 U.S.C. 346a(h)(1) (emphasis added). EPA's existing 
regulations in parts 23, 178, and 179 pertaining to judicial review for 
section 408 orders reflect the focus on ``entry,'' as opposed to 
``publication,'' in the pre-FQPA statute. See 40 CFR 178.65 and 
179.125. In proposing to amend its FFDCA regulations, EPA overlooked 
this change. Correcting 40 CFR parts 178 and 179 to reflect the change 
to ``publication'' as the starting point for the running of the 60-day 
clock is easy enough. EPA proposed that these provisions retain 
existing language stating that various EPA orders shall be final and 
reviewable ``as of the date of entry of the order, which shall be

[[Page 33356]]

determined in accordance with Sec. Sec.  23.10 and 23.11 of this 
chapter,'' and that petitions for judicial review must be filed within 
60 days of the ``entry of the order.'' In the final rule, EPA is 
amending 40 CFR 178.65 and 179.125 to state that the specified orders 
and regulations are final and reviewable ``upon publication'' and that 
petitions for review must be filed within 60 days from ``publication.'' 
The reference to 40 CFR part 23 is dropped because the statute now 
establishes publication as the date from which the 60-day clock for 
filing petitions for judicial review begins to run.
    As to 40 CFR 23.10, the matter is only slightly more complicated. 
EPA believes two changes are appropriate here. First, to bring 40 CFR 
23.10 into step with 28 U.S.C. 2112, the reference in 40 CFR 23.10 to 
``entry'' of an order is being changed to ``issuance'' of an order. 
Second, 40 CFR 23.10 is amended to make clear that it is not defining 
the date of issuance of an order for the purposes of determining the 
time for filing a judicial review petition under FFDCA section 408(h) 
but rather for the purposes of determining the date upon which the 10-
day clock established in 28 U.S.C. 2112 begins to run. Although there 
is some merit to Mr. Gray's suggestion to simply delete 40 CFR 23.10, 
EPA believes that it is clearer to retain 40 CFR 23.10 with the 
substitution of the term ``issuance'' for ``entry.'' Additionally, EPA 
is reluctant to reverse, in the context of action pertaining to a 
single statute, the prior Agency-wide decision to retain the additional 
2-week period prior to the beginning of the 28 U.S.C. 2112 10-day 
clock. The revised 40 CFR 23.10 is amended to read:
    Unless the Administrator otherwise explicitly provides in a 
particular order, the time and date of the issuance of a regulation 
under section 21 U.S.C. 346a(e)(1)(C), or any order under 21 U.S.C. 
346a(f)(1)(C) or 21 U.S.C. 346a(g)(2)(C), or any regulation that is 
the subject of such an order, shall, for purposes of 28 U.S.C. 2112, 
be at 1 p.m. eastern time (standard or daylight, as appropriate) on 
the date that is for a Federal Register document, 2 weeks after the 
date when the document is published in the Federal Register, or for 
any other document, 2 weeks after it is signed.

EPA believes that, under this language it will be clear, that the 10-
day window created by 28 U.S.C. 2112 will not begin to run until 2 
weeks after publication of the FFDCA rule or order in the Federal 
Register. At the same time, EPA regulations in 40 CFR parts 178 and 179 
make clear that the 60-day period for seeking judicial review of an 
order or regulations under section 408(h)(1) begins upon publication of 
the order or regulation. No change is required in 40 CFR part 180 
because the provision addressing judicial review in that part does not 
address the timing for the filing of a petition.
    On a related matter, EPA would note that its interpretation of 
section 408(h)(5) as mandating the exclusivity of the judicial review 
provision in section 408(h) as to tolerance-related issues was 
confirmed by a federal district court in New York v. EPA, No. 03 Civ. 
7155 (GEL) (S.D.N.Y. July 29, 2004). In that case, the court held that 
parties wishing to challenge tolerances or tolerance reassessment 
decisions finding a tolerance to be safe must first exhaust the 
petition procedures in section 408(d), and the objection procedures in 
subsection 408(g), before seeking judicial review.

B. Comment on Pesticide Residues in Processed Foods

    The Pesticide Policy Coalition, representing various food, 
agriculture, and pesticide manufacturer organizations, filed a detailed 
comment regarding pesticide residues in processed food. The PPC raised 
two issues with regard to EPA's tolerance regulations. First, the PPC 
is concerned that EPA's traditional practice of evaluating the need for 
and establishing tolerances for only a select group of dried 
commodities means that many dried commodities may have violative 
pesticide residues. Second, the PPC is concerned that EPA's proposal 
did not respond to the FQPA's removal of the ``ready to eat'' 
requirement from a provision addressing the legality of pesticide 
residues in processed foods. The PPC suggests that EPA's lack of action 
will result in dehydrated or concentrated products, such as juice 
concentrates, being found to be adulterated even though when re-
hydrated they would be fully in compliance with the applicable 
regulations.
    1. Background. Traditionally, pesticide chemical tolerances on 
foods have been set primarily on raw agricultural commodities rather 
than processed foods. In the 1954 law establishing the modern system of 
pesticide tolerances, such tolerances were only authorized as to raw 
agricultural commodities. See 21 U.S.C. 346a(b) (1994). Although later 
amendments to the FFDCA pertaining to food additives did establish a 
similar system that included authority for tolerances for pesticide 
residues in processed food, these amendments were crafted in such a 
manner that tolerances for pesticides in processed foods were rarely 
necessary in comparison to the need for raw food tolerances. See 21 
U.S.C. 321(s) and 348 (1994). Specifically, in seeking to coordinate 
action under the pesticides provision (section 408) and the food 
additives provision (section 409), Congress provided in section 402 
that:
    . . . where a pesticide chemical has been used in or on a raw 
agricultural commodity in conformity with an exemption granted or a 
tolerance prescribed under section 408 and such raw agricultural 
commodity has been subjected to processing such as canning, cooking, 
freezing, dehydrating, or milling, the food shall, notwithstanding 
the provisions of section 406 and 409, not be deemed unsafe if such 
residue in or on the raw agricultural commodity has been removed to 
the extent possible in good manufacturing practice and the 
concentration of such residue in the processed food when ready to 
eat is not greater than the tolerance prescribed for the raw 
agricultural commodity . . . .

21 U.S.C. 342(a)(2)(C) (1994). In sum, this provision applied the 
tolerance level for a pesticide residue in raw food to processed food 
derived from that raw food. The provision became known as the ``flow-
through'' provision because it permitted, in most cases, legal residues 
in a raw food to flow-through to the processed commodity without 
adulterating that latter commodity. A similar version of the ``flow-
through'' provision was contained in the FQPA.
    Given the ``flow-through'' provision, the only processed foods that 
need tolerances are those processed foods in which pesticide residues 
concentrate during processing to levels higher than the tolerance in 
the raw food. An increase in the concentration of residues can occur 
during processing in a number of processing operations including 
dehydration or drying of a raw food and separation of a raw food into 
its component parts. These processing operations may lead to all or 
most of the pesticide residues in the overall raw food being primarily 
allocated to a single component of the food, as processed, with the 
effect that the concentration of residues in that component (on a 
weight to weight basis) exceeds the concentration in the original raw 
food. For example, when apples are processed into juice, two 
commodities are created: Apple juice and apple pomace, an animal feed. 
The concentration of pesticide residues in the juice or pomace may be 
higher on a weight to weight basis than in the whole apple if the 
pesticide residue is either highly soluble in water or the reverse 
because in those circumstances the residue tends to partition unequally 
between the juice and the pomace rather than being equally distributed 
between them.

[[Page 33357]]

    EPA determines the need for processed food tolerances by requiring 
the submission of food processing studies in the registering of 
pesticides under the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA), 7 U.S.C. 136 et seq., and when establishing corresponding 
section 408 tolerances under the FFDCA. See 40 CFR 158.340. Food 
processing studies for a pesticide document the residue level of the 
pesticide in a treated raw commodity and the residue level in various 
processed commodities that can be derived from the raw commodity. In 
the Office of Prevention, Pesticides and Toxic Substances (OPPTS) Test 
Guidelines, EPA has provided guidance on which processed commodities, 
if any, food processing data should be submitted so that EPA can 
determine whether a processed food tolerance is needed. EPA, OPPTS 
Harmonized Test Guidelines, Series 860, Residue Chemistry, OPPTS 
Harmonized Guideline 860.1000 Table 1 (August 1996) (listing raw 
commodities and processed foods for which processing data is 
recommended). The criteria EPA has used for designating processed food 
on which processing data should be submitted relate both to the 
likelihood of an increase in concentration during processing and the 
significance of the processed commodity in the American diet. OPPTS 
Harmonized Guideline 860.1000(m).
    When in 1996 Congress amended the FFDCA to, among other things, 
consolidate pesticide tolerance authority in section 408, it moved the 
flow-through provision to section 408 with minor changes. One of these 
minor changes was the dropping of the requirement in the flow-through 
provision that specified that residues in processed foods be judged 
against the raw food tolerance only when the processed food is at the 
``ready to eat'' stage.
    Although the legislative history regarding this change is sparse, 
EPA believes the reason the change was made was due to concerns with 
the phrase raised by EPA following the difficulties it had in applying 
the ready-to-eat requirement in the context of several legal and 
administrative challenges to various processed food tolerances or to 
uses which allegedly needed such tolerances. One of the issues that 
arose in this dispute was EPA's interpretation of the ``ready to eat'' 
requirement in the flow-through provision. When EPA looked into the 
questions surrounding its implementation of the ready-to-eat 
requirement, it discovered that, due to the wide variety in consumers' 
diets, it was difficult to define what foods are ready to eat, and for 
foods that are not ready to eat, the stage when they become ready to 
eat. See 60 FR 31300, 31306 (June 14, 1995) (``EPA envisions that this 
definition [of ready-to-eat food] may be difficult to apply in many 
instances.''). Given the problems with the ready-to-eat concept it is 
not surprising that EPA sought and Congress agreed to dropping the 
phrase from the statute.
    2. Dried foods. The PPC expressed concern that EPA only considers 
whether processed food tolerances are necessary in a few dried 
commodities (e.g., raisins) and does not examine whether pesticide 
residues may concentrate in other dried commodities. According to the 
PPC, ``[t]oday there are many more forms of dried or otherwise 
processed foods in commerce than was the case forty or fifty years ago 
when the tolerance establishment process was developed (e.g., banana 
chips, sun-dried tomatoes, freeze-dried berries).'' EPA has 
traditionally only focused its tolerance-setting resources on those 
processed foods that are consumed at a significant enough level that 
they could meaningfully affect a risk assessment. The PPC, however, 
notes that EPA's approach may leave food processors with a ``regulatory 
problem'' as to certain minor foods in that routine drying of those 
foods may result in a processed commodity that bears illegal residues 
even though the raw food prior to drying was well within the applicable 
pesticide tolerance. The PPC argues that ``[a]s a general matter, the 
drying or other routine processing of a compliant [raw agricultural 
commodity] should not be regarded as the adulteration of that [raw 
agricultural commodity] to yield unlawful processed food.''
    The PPC proposed that EPA issue a tolerance regulation applying to 
all processed foods that directs the tolerance for any processed food 
not having a specific tolerance shall be the tolerance level of the 
applicable raw food tolerance adjusted to ``take account of the 
concentration of the product caused by the drying or other processing 
of the [raw agricultural commodity].'' The PPC argues that such a 
tolerance regulation is ``risk-neutral'' because the amount of 
pesticide consumed as a total amount would be the same whether a food 
is consumed in its raw or dried form. Additionally, the PPC notes that 
this approach has been adopted by the European Union.
    Although EPA understands that the PPC is concerned about pesticide 
residues in processed foods, the dried food issue in the PPC's comments 
goes beyond the scope of the proposed rule. The proposed rule focused 
entirely on changes to EPA's regulations in response to the passage of 
the FQPA or other routine changes (e.g., updating addresses). It does 
amend the EPA regulation addressing the flow-through provision but only 
with regard to the changes that were accomplished by the FQPA. 
Similarly, EPA discussed how it is handling the interpretation of a few 
tolerance regulations that got caught between a change in EPA policy on 
``ready-to-eat'' foods and the dropping of that requirement by the 
FQPA. The question of whether EPA has adequate tolerance regulations in 
place to deal with dried foods, however, is a question that exists 
independent of any changes in the law effectuated by the FQPA. Put 
another way, the potential regulatory problem identified by the PPC as 
to dried foods would be present even if the FQPA had never been passed. 
Accordingly, EPA will not be adopting the PPC's proposed regulation in 
this final rule. If the PPC continues to be concerned about the need 
for additional processed food tolerances for dried commodities, EPA is 
committed to working with them to explore options for resolution of 
their concerns.
    EPA would note, however, that in response to the PPC's concern 
about how the deletion of the ``ready to eat'' language from the 
statute affects dried foods, EPA is making a change in the rule to 
address that issue, as discussed in the following section.
    3. Juice concentrates and similar products. The PPC also is 
concerned that EPA has not addressed the legality of juice concentrates 
and similar products in light of the removal from the flow-through 
provision of the ``ready to eat'' requirement. The PPC argues that the 
removal of the ``ready to eat'' requirement may render these 
commodities adulterated even if they are produced from below-tolerance 
raw foods and will have below-tolerance residues when reconstituted and 
consumed.
    As explained above, EPA believes that the ``ready to eat'' 
requirement was removed based on EPA's concerns that this vague 
language complicated both the tolerance establishment program and the 
enforcement of tolerances in the field. There is no indication that 
Congress removed the requirement because it thought it was important 
that concentrated juices be analyzed ``as is'' to determine whether or 
not they comply with tolerances applying to raw fruit and fruit juice 
in the form they are consumed. Obviously, examining whether 
concentrated apple juice meets a tolerance applicable to apple juice as 
consumed makes little sense from a risk

[[Page 33358]]

perspective. From an administrative standpoint, requiring tolerances 
for concentrated juices or other similar foods makes equally little 
sense because separate tolerances might need to be set on a food 
processor by food processor basis taking into account the degree of 
concentration used by individual processors in preparing their food 
products.
    Traditionally, FDA has followed the commonsense approach of 
sampling concentrated apple juice for pesticide residues by either 
diluting the juice to its normal moisture content or compensating for 
the lack of normal moisture content in calculating the pesticide 
concentration in the juice. FDA's approach to sampling concentrated 
apple juice is spelled out in the section of the Pesticide Analytical 
Manual, Volume I, addressing the preparation of test samples of food 
for laboratory analysis of pesticide residues. See FDA, Pesticide 
Analytical Manual, Volume I, Table 102-b. The Pesticide Analytical 
Manual builds upon EPA regulations that provide general guidance on how 
some foods are to be sampled. See 40 CFR 180.1(j). Both EPA's 
regulations and the FDA guidance are directed at designing food 
sampling procedures to give a realistic measure of residues to which 
people are likely to be exposed (e.g., removing shells from nuts and 
stems from melons and re-hydrating juice concentrates before analyzing) 
and make sampling practicable for FDA personnel (e.g., analyzing not-
ready-to-eat processed food used as an ingredient in other foods on an 
``as is'' basis).
    Accordingly, in response to the PPC's comment, EPA is adding an 
additional provision to its regulations in 40 CFR 180.1(j) regarding 
food sample preparation that tracks FDA's approach to concentrated 
products as set forth in the Pesticide Analytical Manual.

III. Regulatory Assessment Requirements

    This rule makes several changes in the EPA regulations governing 
pesticide tolerances and exemptions from tolerance. The amendments are 
procedural in nature and, for the most part, correct the CFR so that it 
is consistent with FFDCA section 408, as amended by the FQPA, and EPA's 
ongoing implementation of FFDCA. Other than making EPA regulations more 
accurate, these amendments are not expected to have any impact on 
regulated parties or the public. Accordingly, these amendments are not 
subject to review under Executive Order 12866, entitled Regulatory 
Planning and Review (58 FR 51735, October 4, 1993), as a significant 
regulatory action.
    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).
    Since, as detailed above, these amendments will have no detrimental 
impact on regulated parties or the public, EPA certifies under the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) that the 
amendments will not have a significant impact on a substantial number 
of small entities.
    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 is directed at pesticide manufacturers and 
others who seek to establish, modify, or revoke pesticide tolerances 
and exemptions, 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 the 
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.

IV. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and 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 the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Parts 9, 23, 163, 177, 178, 179, 180

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


[[Page 33359]]


    Dated: May 24, 2005.
Suzan B. Hazen,
Acting Assistant Administrator, Office of Prevention, Pesticides and 
Toxic Substances.
    Therefore, 40 CFR chapter I is amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 is revised to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 31 U.S.C. 9701; 33 
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 
9601-9657, 11023, 11048.

Sec.  9.1  [Amended]

0
2. Section 9.1 is amended by removing the entries and center headings 
for parts 163 and 177 in the table.

PART 23--[AMENDED]

0
3. The authority citation for part 23 is amended to read as follows:

    Authority: Clean Water Act, 33 U.S.C. 1361(a), 1369(b); Clean 
Air Act, 42 U.S.C. 7601(a)(1), 7607(b); Resource, Conservation and 
Recovery Act, 42 U.S.C. 6912(a), 6976; Toxic Substances Control Act, 
15 U.S.C. 2618; Federal Insecticide, Fungicide, and Rodenticide Act, 
7 U.S.C. 136n(b), 136w(a); Safe Drinking Water Act, 42 U.S.C. 300j-
7(a)(2), 300j-9(a); Atomic Energy Act, 42 U.S.C. 2201, 2239; Federal 
Food, Drug, and Cosmetic Act, 21 U.S.C. 371(a), 346a, 28 U.S.C. 
2112(a), 2343, 2344.
0
4. Section 23.10 is revised to read as follows:


Sec.  23.10  Timing of Administrator's action under the Federal Food, 
Drug, and Cosmetic Act.

    Unless the Administrator otherwise explicitly provides in a 
particular order, the time and date of the issuance of a regulation 
under section 21 U.S.C. 346a(e)(1)(C), or any order under 21 U.S.C. 
346a(f)(1)(C) or 21 U.S.C. 346a(g)(2)(C), or any regulation that is the 
subject of such an order, shall, for purposes of 28 U.S.C. 2112, be at 
1 p.m. eastern time (standard or daylight, as appropriate) on the date 
that is for a Federal Register document, 2 weeks after the date when 
the document is published in the Federal Register, or for any other 
document, 2 weeks after it is signed.

PART 163--[REMOVED]

0
5. Part 163 is removed.

PART 177--[REMOVED]

0
6. Part 177 is removed.

PART 178--[AMENDED]

0
7. The authority citation for part 178 is revised to read as follows:

    Authority: 21 U.S.C. 346a, 371(a); Reorg. Plan No. 3 of 1970.

0
8. Section 178.20 is amended by revising paragraph (a) to read as 
follows:


Sec.  178.20   Right to submit objections and requests for a hearing.

    (a) On or before the 60th day after the date of publication in the 
Federal Register of an order under part 180 of this chapter 
establishing, modifying, or revoking a regulation, or denying all or 
any portion of a petition, a person adversely affected by such order or 
petition denial may submit, in accordance with Sec.  178.25, one or 
more written objections to the order (or to the action that is the 
subject of the order).
* * * * *
0
9. Section 178.25 is amended by revising paragraphs (a)(7) and (b)(2) 
to read as follows:


Sec.  178.25  Form and manner of submission of objections.

    (a) * * *
    (7) Be received by the Hearing Clerk not later than the close of 
business of the 60th day following the date of the publication in the 
Federal Register of the order to which the objection is taken (or, if 
such 60th day is a Saturday, Sunday, or Federal holiday, not later than 
the close of business of the next government business day after such 
60th day).
* * * * *
    (b) * * *
    (2) For personal delivery, the Office of the Hearing Clerk is 
located at: Room 104, Crystal Mall 2, 1801 S. Bell St., 
Arlington, VA.
0
10. Section 178.35 is amended as follows:
    a. By revising the section heading.
    b. By revising paragraph (a).
    c. By revising ``rule'' to read ``order'' in paragraph (b).


Sec.  178.35   Modification or revocation of regulation or prior order.

    (a) If the Administrator determines upon review of an objection or 
request for hearing that the regulation or prior order in question 
should be modified or revoked, the Administrator will publish an order 
setting forth any revision to the regulation or prior order that the 
Administrator has found to be warranted.
* * * * *
0
11. Section 178.37 is amended by revising the introductory text of 
paragraph (a) and paragraph (c) to read as follows:


Sec.  178.37   Order responding to objections on which a hearing was 
not requested or was denied.

    (a) The Administrator will publish in the Federal Register an order 
under FFDCA section 408(g)(2)(B) or section 408(g)(2)(C) setting forth 
the Administrator's determination on each denial of a request for a 
hearing, and on each objection submitted under Sec.  178.20 on which:
* * * * *
    (c) Each order published under paragraph (a) of this section must 
state its effective date.
0
12. Section 178.65 is revised to read as follows:


Sec.  178.65  Judicial review.

    An order issued under Sec.  178.37 is final agency action 
reviewable in the courts as provided by FFDCA section 408(h), as of the 
date of publication of the order in the Federal Register. The failure 
to file a petition for judicial review within the period ending on the 
60th day after the date of the publication of the order constitutes a 
waiver under FFDCA section 408(h) of the right to judicial review of 
the order and of any regulation promulgated by the order.


Sec.  178.70  [Amended]

0
13. Section 178.70 is amended by removing paragraphs (a)(2) and (a)(3) 
and redesignating existing paragraphs (a)(4) through (a)(8) as 
paragraphs (a)(2) through (a)(6), respectively.

PART 179--[AMENDED]

0
14. The authority citation for part 179 is revised to read as follows:

    Authority: 21 U.S.C. 346a, 371(a); Reorg. Plan No. 3 of 1970.

Sec.  179.20  [Amended]

0
15. Section 179.20(a)(3) is amended by removing the phrase ``Sec.  
177.81 or ''.


Sec.  179.24  [Amended]

0
16. Section 179.24 is amended by removing ``177,'' and removing the 
comma after ``178'' in paragraph (a).


Sec.  179.83  [Amended]

0
17. Section 179.83 is amended by revising ``parts 177, or 180'' to read 
``part 180'' in paragraph (a)(1).
0
18. Section 179.91 is amended by revising paragraph (b) to read as 
follows:

[[Page 33360]]

Sec.  179.91  Burden of going forward; burden of persuasion.

* * * * *
    (b) The party or parties who contend that a regulation satisfies 
the criteria of section 408 of the FFDCA has the burden of persuasion 
in the hearing on that issue, whether the proceeding concerns the 
establishment, modification, or revocation of a tolerance or exemption 
from the requirement for a tolerance.
0
19. Section 179.105 is amended by revising paragraph (b)(1)(ii) to read 
as follows:


Sec.  179.105  Initial decision.

* * * * *
    (b) * * *
    (i) * * *
    (ii) A conclusion that changes in the order or regulation are 
warranted, the language of the order or regulation as changed, and an 
effective date for the order or regulation as changed.
* * * * *
0
20. Section 179.125 is amended by revising paragraph (a) to read as 
follows:


Sec.  179.125  Judicial review.

    (a) The Administrator's final decision is final agency action 
reviewable in the courts as provided by FFDCA section 408(h), as of the 
date of publication of the order in the Federal Register. The failure 
of a person to file a petition for judicial review within the period 
ending on the 60th day after the date of the publication of the order 
constitutes a waiver under FFDCA section 408(h) of the right to 
judicial review of the order and of any regulation promulgated by the 
order.
* * * * *


Sec.  179.130  [Amended]

0
21. Section 179.130 is amended by removing paragraphs (a)(2) and (a)(3) 
and redesignating existing paragraphs (a)(4) through (a)(12) as 
paragraphs (a)(2) through (a)(10), respectively.

PART 180--[AMENDED]

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

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

0
23. Section 180.1 is amended as follows:
0
a. By adding text to reserved paragraph (c).
0
b. By removing paragraph (d).
0
c. By redesignating existing paragraphs (e) through (p) as paragraphs 
(d) through (o), respectively.
0
d. By revising newly designated paragraphs (e), (j), and (n).
0
e. By revising the introductory text and adding a new paragraph (10) to 
newly designated paragraph (i).


Sec.  180.1  Definitions and interpretations.

* * * * *
    (c) FFDCA means the Federal Food, Drug, and Cosmetic Act, as 
amended, 21 U.S.C. 301-392.
* * * * *
    (e) Where a raw agricultural commodity bearing a pesticide chemical 
residue that has been exempted from the requirement of a tolerance, or 
which is within a tolerance permitted under FFDCA section 408, is used 
in preparing a processed food, the processed food will not be 
considered unsafe within the meaning of FFDCA sections 402 and 408(a), 
despite the lack of a tolerance or exemption for the pesticide chemical 
residue in the processed food, if:
    (1) The pesticide chemical has been used in or on the raw 
agricultural commodity in conformity with a tolerance under this 
section;
    (2) The pesticide chemical residue has been removed to the extent 
possible in good manufacturing practice; and
    (3) The concentration of the pesticide chemical residue in the 
processed food is not greater than the tolerance prescribed for the 
pesticide chemical residue on the raw agricultural commodity.
* * * * *
    (i) Unless otherwise specified in this paragraph or in tolerance 
regulations prescribed in this part for specific pesticide chemicals, 
the raw agricultural commodity or processed food to be examined for 
pesticide residues, shall consist of the whole raw agricultural 
commodity or processed food.
* * * * *
    (10) For processed foods consisting primarily of one ingredient and 
sold in a form requiring further preparation prior to consumption 
(e.g., fruit juice concentrates, dehydrated vegetables, and powdered 
potatoes), the processed food to be examined for residues shall be the 
whole processed commodity after compensating for or reconstituting to 
the commodity's normal moisture content, unless a tolerance for the 
concentrated or dehydrated food form is included in this part. If there 
exists a tolerance for a specific pesticide on the processed food in 
its concentrated or dehydrated food form, for the purpose of 
determining whether the food is in compliance with that tolerance, the 
processed food to be examined for residues shall be the whole processed 
commodity on an ``as is'' basis.
* * * * *
    (j) The term pesticide chemical shall have the meaning specified in 
FFDCA section 201(q)(1), as amended, except as provided in Sec.  180.4.
* * * * *
    (n) The term pesticide chemical residue shall have the meaning 
specified in FFDCA section 201(q)(2), as amended, except as provided in 
Sec.  180.4.
* * * * *


Sec.  180.2  [Removed]

0
24. Section 180.2 is removed.
0
25. The undesignated center heading that precedes Sec.  180.7 and Sec.  
180.7 are revised to read as follows:

Procedure for Filing Petitions Seeking the Establishment, 
Modification, or Revocation of Tolerances or Exemptions


Sec.  180.7  Petitions proposing tolerances or exemptions for pesticide 
residues in or on raw agricultural commodities or processed foods.

    (a) Petitions to be filed with the Agency under the provisions of 
FFDCA section 408(d) shall be submitted in duplicate. If any part of 
the material submitted is in a foreign language, it shall be 
accompanied by an accurate and complete English translation. The 
petition shall be accompanied by an advance deposit for fees described 
in Sec.  180.33. The petition shall state the petitioner's mail address 
to which notice of objection under FFDCA section 408(g)(2) may be sent. 
The petition must be signed by the petitioner or by his attorney or 
agent, or (if a corporation) by an authorized official.
    (b) Petitions shall include the following information:
    (1) An informative summary of the petition and of the data, 
information, and arguments submitted or cited in support of the 
petition. Both a paper and electronic copy of the summary should be 
submitted. The electronic copy should be formatted according to the 
Office of Pesticide Programs' current standard for electronic data 
submission as specified at https://www.epa.gov/oppfead1/eds/
edsgoals.htm.
    (2) A statement that the petitioner agrees that such summary or any 
information it contains may be published as a part of the notice of 
filing of the petition to be published under FFDCA section 408(d)(3) 
and as a part of a proposed or final regulation issued under FFDCA 
section 408.
    (3) The name, chemical identity, and composition of the pesticide 
chemical residue and of the pesticide chemical that produces the 
residue.

[[Page 33361]]

    (4) Data showing the recommended amount, frequency, method, and 
time of application of the pesticide chemical.
    (5) Full reports of tests and investigations made with respect to 
the safety of the pesticide chemical, including full information as to 
the methods and controls used in conducting those tests and 
investigations.
    (6) Full reports of tests and investigations made with respect to 
the nature and amount of the pesticide chemical residue that is likely 
to remain in or on the food, including a description of the analytical 
methods used. (See Sec.  180.34 for further information about residue 
tests.)
    (7) Proposed tolerances for the pesticide chemical residue if 
tolerances are proposed.
    (8) Practicable methods for removing any amount of the residue that 
would exceed any proposed tolerance.
    (9) A practical method for detecting and measuring the levels of 
the pesticide chemical residue in or on the food, or for exemptions, a 
statement why such a method is not needed.
    (10) If the petition relates to a tolerance for a processed food, 
reports of investigations conducted using the processing method(s) used 
to produce that food.
    (11) Such information as the Administrator may require to make the 
determination under FFDCA section 408(b)(2)(C).
    (12) Such information as the Administrator may require on whether 
the pesticide chemical may have an effect in humans that is similar to 
an effect produced by a naturally occurring estrogen or other endocrine 
effects.
    (13) Information regarding exposure to the pesticide chemical 
residue due to any tolerance or exemption already granted for such 
residue.
    (14) Information concerning any maximum residue level established 
by the Codex Alimentarius Commission for the pesticide chemical residue 
addressed in the petition. If a Codex maximum residue level has been 
established for the pesticide chemical residue and the petitioner does 
not propose that this level be adopted, a statement explaining the 
reasons for this departure from the Codex level.
    (15) Such other data and information as the Administrator requires 
by regulation to support the petition.
    (16) Reasonable grounds in support of the petition.
    (c) The data specified under paragraphs (b)(1) through (b)(16) of 
this section should be on separate sheets or sets of sheets, suitably 
identified. If such data have already been submitted with an earlier 
application, the present petition may incorporate it by reference to 
the earlier one.
    (d) Except as noted in paragraph (e) of this section, a petition 
shall not be accepted for filing if any of the data prescribed by FFDCA 
section 408(d) are lacking or are not set forth so as to be readily 
understood. The availability to the public of information provided to, 
or otherwise obtained by, the Agency under this part shall be governed 
by part 2 of this chapter. The Administrator shall make the full text 
of the summary referenced in paragraph (b)(1) of this section available 
to the public in the Environmental Protection Agency Electronic Docket 
at https://www.epa.gov/edocket no later than publication in the Federal 
Register of the notice of the petition filing.
    (e) The Administrator shall notify the petitioner within 15 days 
after its receipt of acceptance or nonacceptance of a petition, and if 
not accepted the reasons therefor. If petitioner desires, the 
petitioner may supplement a deficient petition after notification as to 
deficiencies. If the petitioner does not wish to supplement or explain 
the petition and requests in writing that it be filed as submitted, the 
petition shall be filed and the petitioner so notified.
    (f) A notice of the filing of a petition for a pesticide chemical 
residue tolerance that the Administrator determines has met the 
requirements of paragraph (b) of this section shall be published in the 
Federal Register by the Administrator within 30 days after such 
determination. The notice shall state the name of the pesticide 
chemical residue and the commodities for which a tolerance is sought 
and announce the availability of a description of the analytical 
methods available to the Administrator for the detection and 
measurement of the pesticide chemical residue with respect to which the 
petition is filed or shall set forth the petitioner's statement of why 
such a method is not needed. The notice shall explicitly reference the 
specific address in the Agency's Electronic Docket (https://www.epa.gov/
edocket) where the full text of the summary required in paragraph (b) 
of this section and refer interested parties to this document for 
further information on the petition. The full text of the summary may 
be omitted from the notice.
    (g) The Administrator may request a sample of the pesticide 
chemical at any time while a petition is under consideration. The 
Administrator shall specify in its request for a sample of the 
pesticide chemical, a quantity which it deems adequate to permit tests 
of analytical methods used to determine residues of the pesticide 
chemical and of methods proposed by the petitioner for removing any 
residues of the chemical that exceed the tolerance proposed.
    (h) The Administrator shall determine, in accordance with the Act, 
whether to issue an order that establishes, modifies, or revokes a 
tolerance regulation (whether or not in accord with the action proposed 
by the petitioner), whether to publish a proposed tolerance regulation 
and request public comment thereon under Sec.  180.29, or whether to 
deny the petition. The Administrator shall publish in the Federal 
Register such order or proposed regulation. After receiving comments on 
any proposed regulation, the Administrator may issue an order that 
establishes, modifies, or revokes a tolerance regulation. An order 
published under this section shall describe briefly how to submit 
objections and requests for a hearing under part 178 of this chapter. A 
regulation issued under this section shall be effective on the date of 
publication in the Federal Register unless otherwise provided in the 
regulation.
0
26. Section 180.8 is revised to read as follows:


Sec.  180.8   Withdrawal of petitions without prejudice.

    In some cases the Administrator will notify the petitioner that the 
petition, while technically complete, is inadequate to justify the 
establishment of a tolerance or the tolerance requested by petitioner. 
This may be due to the fact that the data are not sufficiently clear or 
complete. In such cases, the petitioner may withdraw the petition 
pending its clarification or the obtaining of additional data. This 
withdrawal may be without prejudice to a future filing. A deposit for 
fees as specified in Sec.  180.33 shall accompany the resubmission of 
the petition.
0
27. Section 180.9 is revised to read as follows:


Sec.  180.9  Substantive amendments to petitions.

    After a petition has been filed, the petitioner may submit 
additional information or data in support thereof, but in such cases 
the petition will be given a new filing date.


Sec. Sec.  180.10, 180.11 and 180.12  [Removed]

0
28. Sections 180.10, 180.11 and 180.12 are removed.
0
29. The undesignated center heading that precedes Sec.  180.29, and 
Sec.  180.29 are revised to read as follows:

[[Page 33362]]

Establishment, Modification, and Revocation of Tolerance on 
Initiative of Administrator; Judicial Review; Temporary Tolerances; 
Modification and Revocation of Tolerances; Fees


Sec.  180.29   Establishment, modification, and revocation of tolerance 
on initiative of Administrator.

    (a) Upon the Administrator's own initiative, the Administrator may 
propose, under FFDCA section 408(e), the issuance of a regulation 
establishing a tolerance for a pesticide chemical or exempting it from 
the necessity of a tolerance, or a regulation modifying or revoking an 
existing tolerance or exemption.
    (b) The Administrator shall provide a period of not less than 60 
days for persons to comment on the proposed regulation, except that a 
shorter period for comment may be provided if the Administrator for 
good cause finds that it would be in the public interest to do so and 
states the reasons for the finding in the notice of proposed 
rulemaking.
    (c) After reviewing any timely comments received, the Administrator 
may by order establish, modify, or revoke a tolerance regulation, which 
order and regulation shall be published in the Federal Register. An 
order published under this section shall state that persons may submit 
objections and requests for a hearing in the manner described in part 
178 of this chapter.
    (d) Any final regulation issued under this section shall be 
effective on the date of publication in the Federal Register unless 
otherwise provided in the regulation.
0
30. Section 180.30 is revised to read as follows:


Sec.  180.30   Judicial review.

    (a) Under FFDCA section 408(h), judicial review is available in the 
United States Courts of Appeal as to the following actions:
    (1) Regulations establishing general procedures and requirements 
under FFDCA section 408(e)(1)(C).
    (2) Orders issued under FFDCA section 408(f)(1)(C) requiring the 
submission of data.
    (3) Orders issued under FFDCA section 408(g)(2)(C) ruling on 
objections to establishment, modification, or revocation of a tolerance 
or exemption under FFDCA section 408(d)(4), or any regulation that is 
the subject of such an order. The underlying action here is Agency 
disposition of a petition seeking the establishment, modification, or 
revocation of a tolerance or exemption.
    (4) Orders issued under FFDCA section 408(g)(2)(C) ruling on 
objections to the denial of a petition under FFDCA section 408(d)(4).
    (5) Orders issued under FFDCA section 408(g)(2)(C) ruling on 
objections to the establishment, modification, suspension, or 
revocation of a tolerance or exemption under FFDCA section 408(e)(1)(A) 
or (e)(1)(B). The underlying action here is the establishment, 
modification, suspension, or revocation of a tolerance or exemption 
upon the initiative of EPA including EPA actions pursuant to FFDCA 
sections 408(b)(2)(B)(v), 408(b)(2)(E)(ii), 408(d)(4)(C)(ii), 
408(l)(4), and 408(q)(1).
    (6) Orders issued under FFDCA section 408(g)(2)(C) ruling on 
objections to the revocation or modification of a tolerance or 
exemption under FFDCA section 408(f)(2) for noncompliance with 
requirements for the submission of data.
    (7) Orders issued under FFDCA section 408(g)(2)(C) ruling on 
objections to rules issued under FFDCA sections 408(n)(3) and 408(d) or 
(e) regarding determinations pertaining to State authority to establish 
regulatory limits on pesticide chemical residues.
    (8) Orders issued under FFDCA section 408(g)(2)(C) ruling on 
objections to orders issued under FFDCA section 408(n)(5)(C) 
authorizing States to establish regulatory limits not identical to 
certain tolerances or exemptions.
    (b) Any issue as to which review is or was obtainable under 
paragraph (a) of this section shall not be the subject of judicial 
review under any other provision of law. In part, this means that, for 
the Agency actions subject to the objection procedure in FFDCA section 
408(g)(2), judicial review is not available unless an adversely 
affected party exhausts these objection procedures, and any petition 
procedures preliminary thereto.
0
31. Section 180.31 is revised to read as follows:


Sec.  180.31  Temporary tolerances.

    (a) A temporary tolerance (or exemption from a tolerance) 
established under the authority of FFDCA section 408(r) shall be deemed 
to be a tolerance (or exemption from the requirement of a tolerance) 
for the purposes of FFDCA section 408(a)(1) or (a)(2) and for the 
purposes of Sec.  180.30.
    (b) A request for a temporary tolerance or a temporary exemption 
from a tolerance by a person who has obtained or is seeking an 
experimental permit for a pesticide chemical under the Federal 
Insecticide, Fungicide, and Rodenticide Act shall be accompanied by 
such data as are available on subjects outlined in Sec.  180.7(b) and 
an advance deposit to cover fees as provided in Sec.  180.33.
    (c) To obtain a temporary tolerance, a requestor must comply with 
the petition procedures specified in FFDCA section 408(d) and Sec.  
180.7 except as provided in this section.
    (d) A temporary tolerance or exemption from a tolerance may be 
issued for a period designed to allow the orderly marketing of the raw 
agricultural commodities produced while testing a pesticide chemical 
under an experimental permit issued under authority of the Federal 
Insecticide, Fungicide, and Rodenticide Act if the Administrator 
concludes that the safety standard in FFDCA section 408(b)(2) or (c), 
as applicable, is met. Subject to the requirements of FFDCA section 
408(e), a temporary tolerance or exemption from a tolerance may be 
revoked if the experimental permit is revoked, or may be revoked at any 
time if it develops that the application for a temporary tolerance 
contains a misstatement of a material fact or that new scientific data 
or experience with the pesticide chemical indicates that it does not 
meet the safety standard in FFDCA section 408(b)(2) or (c), as 
applicable.
    (e) Conditions under which a temporary tolerance is established 
shall include:
    (1) A limitation on the amount of the chemical to be used on the 
designated crops permitted under the experimental permit.
    (2) A limitation for the use of the chemical on the designated 
crops to bona fide experimental use by qualified persons as indicated 
in the experimental permit.
    (3) A requirement that the person or firm which obtains the 
experimental permit for which the temporary tolerance is established 
will immediately inform the Environmental Protection Agency of any 
reports on findings from the experimental use that have a bearing on 
safety.
    (4) A requirement that the person or firm which obtained the 
experimental permit for which the temporary tolerance is established 
will keep records of production, distribution, and performance for a 
period of 2 years and, on request, at any reasonable time, make these 
records available to any authorized officer or employee of the 
Environmental Protection Agency.
0
32. Section 180.32 is revised to read as follows:


Sec.  180.32  Procedure for modifying and revoking tolerances or 
exemptions from tolerances.

    (a) The Administrator on his/her own initiative may propose