[Federal Register Volume 69, Number 129 (Wednesday, July 7, 2004)]
[Rules and Regulations]
[Pages 40781-40787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15352]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0190; FRL-7364-4]


Sulfuric Acid; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of sulfuric acid (CAS Reg. No. 7664-93-9) 
when used as an inert ingredient. Magna Bon Corporation submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act, as 
amended by the Food Quality Protection Act of 1996, requesting an 
exemption from the requirement of a tolerance. This

[[Page 40782]]

regulation eliminates the need to establish a maximum permissible level 
for residues of sulfuric acid.

DATES: This regulation is effective July 7, 2004. Objections and 
requests for hearings must be received on or before September 7, 2004.

ADDRESSES:  To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
ID number OPP-2004-0190. All documents in the docket are listed in the 
EDOCKET index at http://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, 1921 Jefferson Davis 
Hwy., 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: Bipin Gandhi, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8380; e-mail address: [email protected].

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 manufacturing (NAICS 311)
     Pesticide manufacturing (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 (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of August 21, 2002 (67 FR 54203) (FRL-7194-
7), EPA issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food 
Quality Protection Act (FQPA) (Public Law 104-170), announcing the 
filing of a pesticide tolerance petition (PP 2E6476) by Magna Bon 
Corporation, 1531 NW 25th Drive, Okeechobee, FL 34972. This notice 
included a summary of the petition prepared by the petitioner Magna Bon 
Corporation.
    The petitioner requested to amend 40 CFR 180.1001(c) newly 
redesignated as 180.910 by amending an existing exemption from the 
requirement of a tolerance for sulfuric acid (see 40 CFR 180.910). As 
currently established, sulfuric acid as an inert ingredient in 
formulated pesticide products can be applied to crops pre-harvest and 
post-harvest with a limitation of 0.1% in the pesticide formulation 
when used as a pH control agent. The petitioner requested to increase 
the limitation to 10% and to include a new use as a chelating agent. 
The petitioner requested the establishment of an exemption from the 
requirement of a tolerance in plants and plants products, meat, milk, 
poultry, eggs, fish, shellfish, and irrigated crops when it results 
from the use of sulfuric acid as an inert ingredient in a pesticide 
product used in irrigation conveyance systems and lakes, ponds, 
reservoirs, or bodies of water in which fish or shellfish are 
cultivated. Two comments were received in response to the notice of 
filing. See Unit IX.
    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) defines ``safe'' to 
mean 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.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Pursuant to section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C), which requires EPA to give special consideration 
to exposure of infants and children to the pesticide chemical residue 
in establishing a tolerance and to ``ensure that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue. . . .''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. The nature of the toxic effects caused by 
sulfuric acid are discussed in this unit.
    In formulating a pesticide product, an acidic chemical such as 
sulfuric acid serves a specific purpose, that of a neutralizing agent 
or a pH adjuster. During the manufacture of a pesticide product (or, in 
fact, many industrial chemicals), it may be necessary to adjust the pH 
of the product. An acid functions as a neutralizing agent when the 
hydrogen ion (H+1) combines with the hydroxy 
(OH-) in a basic solution to form a molecule of water. Small 
amounts of the hydrogen ion would be added to the solution to lower the 
pH until a neutral pH is reached. After the pH adjustment is performed 
and the neutralization reaction occurs, sulfuric acid is no longer 
present. The reaction

[[Page 40783]]

products that are then present are the sulfate (II) negatively charged 
ion and water.
    Alternatively, it might be necessary to have a pesticide product 
maintain an acidic pH; thus, the sulfuric acid would be added during 
the manufacturing process to deliberately lower the pH, which would 
mean an excess of the hydrogen ion. Such products are not likely to be 
sold to the residential market.
    As a chemical class, acids are significantly different from many of 
the chemicals regulated as inert ingredients in pesticide products. 
First, acids are highly corrosive. Due to this property, toxicity 
testing can only be performed on very diluted solutions. Therefore, 
toxicity studies performed with undiluted (concentrated) sulfuric acid 
are not available. Second, acids are highly reactive, and therefore are 
not expected to be persistent in the food supply, the environment, or 
in water resources. Sulfuric acid would be expected to dissociate and 
immediately react with both plant and animal materials.
    Chemically, an acid, is a substance that when dissolved in water 
yields hydrogen (H+1) ion. The increase of the concentration 
of the H+1 ion reduces the pH. It is the hydrogen ion that 
is highly reactive, thus displaying the corrosive characteristic. The 
consequences of acute exposure to acids are well understood; they are 
corrosive to the eyes, the skin, and the respiratory tract. The hazard 
of any acidic chemical derives directly from and is due to these 
irritation and acidic effects.
    Sulfuric acid is a strong acid. It is also a commonly used 
chemical. It has been used for years, and therefore, there is a 
significant body of existing publicly-available information.
     Solutions of sulfuric acid greater than 10% are severely 
corrosive by all routes of exposure.
     Solutions of sulfuric acid of less than 10% are strong 
irritants.
     There is sufficient evidence that occupational exposure to 
strong-inorganic-acid mists containing sulfuric acid is carcinogenic 
(International Agency for Research on Cancer).
     There were no significant developmental or reproductive 
effects in mice or rabbits exposed to 20 mg/m3 sulfuric acid 
aerosols 7 hours per day on gestation days 6 to 15 (Agency for Toxic 
Substances and Disease (ATSDR)).
    Previously, the Agency reviewed several acute toxicity studies 
conducted with sulfuric acid. The following information on the acute 
toxicity of sulfuric acid was extracted from the 1993 Mineral Acid RED 
(Reregistration Eligibility Decision Document):
     The oral lethal dose (LD)50 is 350 mg/kg, 
Toxicity Category II.
     The dermal LD50 is > 2,000 mg/kg, Toxicity 
Category III.
     Sulfuric acid is Toxicity Category I for eye and dermal 
irritation.
    No other toxicological data were required based on the use patterns 
at the time of the issuance of the RED, and considering the 
corrosiveness shown in the acute studies for dermal and eye irritation. 
More recently, the Office of Pesticide Programs at the Environmental 
Protection Agency, as part of the tolerance reassessment process, 
completed its tolerance reassessment review of sulfuric acid with 
particular emphasis on the role of sulfuric acid in pesticide products.
    The National Institute of Occupational Safety and Health (NIOSH) 
Immediately Dangerous to Life or Health (IDLH) Documentation and the 
International Chemical Safety Card for sulfuric acid indicate that it 
is a colorless, oily, odorless liquid. The IDLH is 15 mg/m3. 
The Threshold Limit Value (TLV) is 1 mg/m3 (TWA). Sulfuric 
acid reacts violently with water. It is corrosive to the skin and the 
respiratory tract, and on ingestion.
    Sulfuric acid is considered to be a strong acid. The following 
acids have been approved by the Food and Drug Administration (FDA) for 
direct use in the food supply. In fact, FDA has determined that the 
following substances are Generally Recognized as Safe (GRAS) when used 
as direct food additives.

------------------------------------------------------------------------
            Chemical               FDA GRAS Citation   GRAS Use Pattern
------------------------------------------------------------------------
Sulfuric acid                     21 CFR 184.1095     pH control agent,
                                                       processing aid
------------------------------------------------------------------------
Hydrochloric acid                 21 CFR 182.1057     neutralizing agent
                                                       (no limitations
                                                       specified)
------------------------------------------------------------------------
Phosphoric acid                   21 CFR 182.1073     (no limitations
                                                       specified)
------------------------------------------------------------------------

    Sulfuric acid is also cleared under 21 CFR 178.1010 for use in 
food-contact surface sanitizing solutions.
    In 1975 FDA published an assessment entitled ``Evaluation of the 
Health Aspects of Sulfuric Acid and Sulfates as Food Ingredients.'' 
``Sulfates are natural constituents of foods and normal products of 
sulfur metabolism in animals. It is evident that the toxic 
manifestations following oral administration of the sulfates considered 
in this report appear only at levels that are many times greater than 
those to which man is exposed in his daily diet.'' It was concluded 
that: ``There is no evidence in the available information on sulfuric 
acid that demonstrates or suggests that reasonable grounds to suspect, 
a hazard to public when they are used at levels that are now current or 
that might reasonably be expected in future.''

IV. Conclusions of the Human Health Assessment

    Sulfuric acid in its concentrated form is highly corrosive. Due to 
this property, toxicity testing can only be performed on dilute 
concentrations or on neutralized forms of the acid such as a salt. The 
consequences of acute exposure to sulfuric acid are well-understood. 
According to NIOSH and ATSDR, ``Concentrated sulfuric acid has an 
extremely irritant, corrosive, and destructive action on all living 
matter including human tissues, not by virtue of its acidity (in 
concentrated form it is only slightly ionized) but because of its 
affinity for water. The affinity is so strong that it will remove the 
elements of water from even anhydrous organic matter such as 
carbohydrates, resulting in charring or carbonization with the 
liberation of heat. In sulfuric acid splashing accidents, the heat 
liberated by dilution of the concentrated acid with water used to flush 
the affected areas, can add thermal burn to chemical injury of the 
body.'' Thus sulfuric acid ``can burn and char the skin. It is even 
more rapidly injurious to the mucous membranes, and exceedingly 
dangerous to the eyes. Dilute sulfuric acid, while it does not possess 
this charring property, irritates the skin and mucous membranes by 
virtue of its acidity and can cause dermatitis.''
    Exposure to a mist of sulfuric acid can cause irritant effects on 
the mucous membranes and chemical corrosive effects upon the teeth. 
Strong inorganic acid mists containing sulfuric acid are listed as 
known human carcinogens.

[[Page 40784]]

    However, exposure to sulfuric acid in pesticide products as an 
inert ingredient would be in the role of a pH adjuster, that is, a 
liquid form, not a mist. As an inert ingredient small amounts of 
sulfuric acid are incorporated in a pesticide product to lower the pH. 
After the pH adjustment is performed, the sulfuric acid would be 
neutralized, and therefore no longer present. It is recognized that 
sulfuric acid must be used and applied according to good manufacturing 
or good agricultural practices.
    There are no available information on sulfuric acid indicative of a 
human health hazard from the ingestion of food directly treated with 
sulfuric acid. In fact, sulfuric acid would not be present in consumed 
foods. The small amounts of acids that might be added to a food during 
processing react rapidly with a food substance. Thus, the exposure is 
actually to sulfate residues.
    The sulfate residues (resulting from the use of sulfuric acid) are 
of minimal toxicity. In fact, calcium, sodium, magnesium, and potassium 
sulfates have been classified as List 4A, chemical substances of 
minimal risk. Various sulfate chemicals have uses as direct food 
additives. The human body metabolizes sulfate through well-understood 
pathways. It is a necessary human nutrient. There are no significant 
adverse effects, to the general public or any population subgroup from 
consumption of residues of sulfuric acid (actually the neutralized form 
which is the sulfate ion in solution) resulting from pesticide product 
uses.

V. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).

A. Dietary Exposure

    1. Food. During the manufacture of a pesticide product, it is very 
possible that sulfuric acid (when used as an inert ingredient) could be 
used to adjust the pH of the pesticide product. Sulfuric acid is highly 
reactive. Adjusting the pH creates a chemical reaction known as 
neutralization, in which the acidic characteristics of the sulfuric 
acid disappear. At this point the sulfate ion is in solution in the 
pesticide product. The amount of the sulfate ion in the solution from 
the neutralization reaction would be equivalent to the amount of 
sulfuric acid used.
    Sulfuric acid can also be used as an active ingredient when used as 
a herbicide in the production of garlic and onions and as a potato vine 
desiccant, prior to harvest, to make harvesting less difficult. There 
is no reasonable expectation that residues of sulfuric acid would be 
present in the harvested commodity.
    FDA has determined that sulfuric acid is generally recognized as 
safe as a direct food additive. Sulfuric acid can be used as a 
component of a food-contact surface sanitizing solution. Given the 
highly reactive nature of sulfuric acid, the actual exposure would be 
to sulfate residues. Thus, the public is not directly exposed to 
sulfuric acid in its food supply.
    2. Drinking water. Sulfuric acid is not expected to be persistent 
in the environment. Instead it is expected to dissociate, react with 
organic or inorganic materials, and complex with ionic substrates. 
Releasing low levels of sulfuric acid would not normally be expected to 
adversely affect water resources. Sulfates form the basis of many rocks 
and minerals which are naturally occurring materials.

B. Other Non-Occupational Exposure

    As a group mineral acids, including sulfuric acid constitute a 
group of chemicals with many industrial uses. However, considering the 
reactivity and corrosivity of these acids, there are few uses of even 
diluted solutions of strong acids in and around the home. As stated 
previously the actual exposure is to sulfate. Several sulfate chemicals 
(sodium, calcium, magnesium, and potassium) have been classified as 
List 4A chemicals, that is chemicals of minimal risk.

VI. Cumulative Effects

    Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' Unlike other pesticides for 
which EPA has followed a cumulative risk approach based on a common 
mechanism of toxicity, EPA has not made a common mechanism of toxicity 
finding as to sulfuric acid and any other substances, and sulfuric acid 
does not appear to produce toxic metabolites produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has not assumed that sulfuric acid has a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the policy 
statements released by EPA's Office of Pesticide Programs concerning 
common mechanism determinations and procedures for cumulating effects 
from substances found to have a common mechanism on EPA's website at 
http://www.epa.gov/pesticides/cumulative.

VII. Children's Safety Factor

    Due to its reactive nature, sulfuric acid used in pesticide 
products will not carryover to the food supply. Residues of sulfuric 
acid in the form of sulfate pose minimal risk and therefore a safety 
factor analysis has not been used to assess the risk. For the same 
reasons the additional tenfold safety factor is unnecessary.

VIII. Determination of Safety for U.S. Population, Infants and Children

    The toxicity of sulfuric acid derives from the irritation and 
caustic effects. However, the actual exposure in the food supply is to 
the sulfate ion. The human body metabolizes sulfate through well-
understood pathways. Based on the information in this preamble and 
considering the use patterns of pesticide products, EPA concludes that 
there is a reasonable certainty of no harm from aggregate exposure to 
residues of sulfuric acid. Accordingly, EPA finds that exempting non-
aerosol uses of sulfuric acid from the requirement of a tolerance with 
a limitation of not exceeding 10% of the formulated product will be 
safe.

IX. Other Considerations

A. Endocrine Disruptors

    There is no available evidence that sulfuric acid is an endocrine 
disrupter.

B. Analytical Method

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

C. Existing Tolerance Exemptions

    Sulfuric acid is exempt from the requirement of a tolerance under 
40 CFR 180.910 (formerly 40 CFR 180.1001(c)) when used as an inert 
ingredient as a pH adjuster in pesticide formulations applied to 
growing crops and to raw agricultural commodities after harvest at 
concentrations not to exceed 0.1%. This exemption is being amended in 
today's final rule.

[[Page 40785]]

    Sulfuric acid is also exempt from the requirement of a tolerance 
under 40 CFR 180.1019 as an active ingredient, a herbicide, in the 
production of garlic and onions and as a potato vine desiccant in the 
production of potatoes. This text is not being changed.

D. International Tolerances

    The Agency is not aware of any country requiring a tolerance 
exemption for sulfuric acid.

E. Public Comments

    Two comments were received in response to the Notice of Filing. A 
private citizen who works for the United States Geological Survey 
(USGS) contacted the Agency using his USGS e-mail address account. He 
stated that sulfuric acid can be harmful to teeth and gum at 0.3% 
concentration. The Merck Index from 1960 was quoted as the source of 
his information.
    The Agency is well-aware of the fact that sulfuric acid is a strong 
acid. The effects of sulfuric acid are well studied. Sulfuric acid has 
been assessed by other governmental agencies, including NIOSH and 
ATSDR.
    The Agency believes that the commenter misinterpreted the intent of 
the tolerance exemption proposed. The 10% limitation is for the 
pesticide products that would be marketed for application to crops. The 
Agency has never suggested that 10% of the food supply would be 
sulfuric acid. As is explained in Unit III., it is not possible for 
significant amounts of sulfuric acid to be present in the food supply.
    A comment was also received asking about the use of sulfuric acid 
as a chelating agent. The Agency contacted the petitioner to provide 
additional information regarding sulfuric acid's use as a chelating 
agent. The petitioner did not provide additional information but 
informed the Agency on November 6, 2002, that the petitioner wished to 
withdraw the request for the use of sulfuric acid as a chelating agent.

X. Conclusion

    Based on the information in this preamble, EPA concludes that there 
is a reasonable certainty of no harm to the general population 
including infants and children from aggregate exposure to residues of 
sulfuric acid (CAS Reg. No. 7664-93-9). EPA finds that exempting 
sulfuric acid from the requirements of a tolerance will be safe.
    Therefore, the exemption from the requirement of a tolerance for 
residues of sulfuric acid not to exceed 10% of the pesticide 
formulation (non-aerosol formulations only) is established.

XI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the 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. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2004-0190 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 September 
7, 2004.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VIII.A., 
you should also send a copy of your request to the PIRIB for its 
inclusion in the official record that is described in ADDRESSES. Mail 
your copies, identified by docket ID number OPP-2004-0190, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in  ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not

[[Page 40786]]

include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

XII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) in response to a petition 
submitted to the Agency. 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 final 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 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(d), such as the exemption in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601  et 
seq.) do not apply. 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 final 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 FFDCA section 408(n)(4). 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.

XIII. 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 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: June 21, 2004.
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.


0
2. In Sec.  180.910, in the table, the entry for sulfuric acid is 
revised to read as follows:


Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert Ingredient                Limits               Uses
------------------------------------------------------------------------
                                * * * * *
Sulfuric acid (CAS Reg. No. 7664- Not to exceed 10%   pH Control agent
 93-9).                            of the pesticide
                                   formulation; non-
                                   aerosol
                                   formulations only.
                                * * * * *
------------------------------------------------------------------------


[[Page 40787]]


0
3. Section 180.1019 is revised to read as follows.


Sec.  180.1019  Sulfuric acid; exemption from the requirement of a 
tolerance.

    (a) Residues of sulfuric acid are exempted from the requirement of 
a tolerance when used in accordance with good agricultural practice 
when used as a herbicide in the production of garlic and onions, and as 
a potato vine dessicant in the production of potatoes.
    (b) Residues of sulfuric acid are exempted from the requirement of 
a tolerance in meat, milk, poultry, eggs, fish, shellfish, and 
irrigated crops when it results from the use of sulfuric acid as an 
inert ingredient in a pesticide product used in irrigation conveyance 
systems and lakes, ponds, reservoirs, or bodies of water in which fish 
or shellfish are cultivated. The sulfuric acid is not to exceed 10% of 
the pesticide formulation (non-aerosol formulations only).

[FR Doc. 04-15352 Filed 7-6-04; 8:45 am]
BILLING CODE 6560-50-S