E8-21737. Inert Ingredient: Exemption From the Requirement of a Tolerance for amylopectin, acid-hydrolyzed, 1-octenylbutanedioate and for amylopectin, hydrogen 1-octadecenylbutanedioate

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes exemptions from the requirement of a tolerance for residues of amylopectin, acid-hydrolyzed, 1-octenylbutanedioate (CAS Reg. No. 113894-85-2) and for amylopectin, hydrogen 1-octadecenylbutanedioate (CAS Reg. No. 125109-81-1) when used in antimicrobial formulations (food-contact surface sanitizing solutions) under 40 CFR 180.940(a), and when used in accordance with good agricultural or manufacturing practice under 40 CFR 180.950. The petitioner, Lewis & Harrison, LLC, on behalf of Alco Chemical, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of amylopectin, acid-hydrolyzed, 1-octenylbutanedioate and amylopectin, hydrogen 1-octadecenylbutanedioate.

DATES:

This regulation is effective September 17, 2008. Objections and requests for hearings must be received on or before November 17, 2008, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:

EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2006-0791. To access the electronic docket, go to http://www.regulations.gov, select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

Karen Samek, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

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

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

C. Can I File an Objection or Hearing Request?

Under section 408(g) of FFDCA, as amended by FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0791 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 November 17, 2008.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0791, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW. Washington, DC 20460-0001.
• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is [phone].

II. Background and Statutory Findings

In the Federal Register of December 20, 2006 (71 FR 76321) (FRL-8104-4), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 6E7083) by Lewis & Harrison, LLC, on behalf of Alco Chemical, 122 C St., NW., Suite 740, Washington, DC 20001. The petition requested that 40 CFR 180.940(a) and 40 CFR 180.950 be amended by establishing exemptions from the requirement of a tolerance for residues of amylopectin, acid-hydrolyzed, 1-octenylbutanedioate (CAS Reg. No. 113894-85-2) and amylopectin, hydrogen 1-octadecenylbutanedioate (CAS Reg. No. 125109-81-1) when used in antimicrobial formulations (food-contact surface sanitizing solutions) under 40 CFR 180.940(a) and when used in accordance with good agricultural or manufacturing practice under 40 CFR 180.950. That notice included a summary of the petition prepared by the petitioner. There were no comments received in response to the notice of filing. For ease of reading in this document amylopectin, acid-hydrolyzed, 1-octenylbutanedioate (CAS Reg. No. 113894-85-2) and amylopectin, hydrogen 1-octadecenylbutanedioate (CAS Reg. No. 125109-81-1) are referred to as starch octenylsuccinates.

Section 408(b)(2)(A)(i) of 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(b)(2)(A)(ii) of FFDCA 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. Section 408(b)(2)(C) of FFDCA 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 starch octenylsuccinates are discussed in this unit.

The following provides a brief summary of the risk assessment and conclusions for the Agency's review of starch octenylsuccinates. The Agency's full decision document for this action is available in EPA's Electronic Docket at http://www.regulations.gov, under docket number EPA-HQ-OPP-2006-0791.

The toxicity database is sufficient for starch octenylsuccinates. In terms of hazard, there are low concerns (practically non-toxic). In subchronic and chronic toxicity feeding studies in rats, the results show that the compound does not produce compound-related effects at dietary concentrations as high as 30% of the diet (equivalent to 15 gram/kilogram/day (g/kg/day)). While no neurotoxicity studies where submitted, neurotoxicity was not observed in the dietary studies at concentrations as high as 30% (15 g/day) of the test material. The compound does not suggest increased toxicity in young rats and all the mutagenicity testing results were negative. The metabolism data showed that with oral dosing in dogs,¹⁴ C-octenylsuccinate was absorbed and eliminated via the urine and feces. The major route of elimination was via urine (62-72% of the administered radioactivity). No developmental toxicity studies are available in the data base. However, in the dietary study conducted in rats fed octenylsuccinate modified starch during gestation through post-natal day 90 at doses up to 30% (15 g/day), there was no systemic toxicity in female rats and their offspring.

Furthermore, it should be noted that starch octenylsuccinate anhydride is currently permitted by the U.S. Food and Drug Administration (FDA) as a direct food additive under 21 CFR 172.892.

IV. Aggregate Exposures

In examining aggregate exposure, section 408 of FFDCA 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).

For dietary exposures, application of starch octenylsuccinates to food (including crops, meats, and fish) as inert ingredients in pesticide products is not expected to result in significant human exposure to starch octenylsuccinates residues considering their rapid biodegradation in soil and water and lack of persistence in the environment. For the same reason, significant drinking water exposures from the use of these chemicals as inert ingredients in pesticide formulations are not anticipated.

In evaluating the potential for exposure from the use of starch octenylsuccinates in residential pesticide products, inhalation exposures are not anticipated since the compounds are not likely to volatize and are not expected to be absorbed via inhalation due to their large particle size. It is expected that dermal exposure is the primary route of exposure; however, based on their molecular weight, these chemicals are not likely to be absorbed via the dermal route. Therefore, there is no concern for dermal exposure.

Starch octenylsuccinates are widely used in a variety of consumer products. An aggregate assessment for starch octenylsuccinates was not conducted because the exposures to the chemicals by non-pesticide consumer products are not likely to result in significant residues of concern. Furthermore, starch octenylsuccinates are used as food additives and are normal constituents of the human diet.

V. Cumulative Effects

Section 408(b)(2)(D)(v) of 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 starch octenylsuccinates and any other substances and, these materials do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that starch octenylsuccinates have 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/​.

VI. Safety Factor for Infants and Children

Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. The toxicity database is sufficient for starch octenylsuccinates and potential exposure is adequately characterized given the low toxicity of starch octenylsuccinates. In terms of hazard, there are low concerns (practically non-toxic) and no residual uncertainties regarding prenatal and/or postnatal toxicity. No developmental toxicity studies are available in the data base. However, in the dietary study conducted in rats fed octenylsuccinate modified starch during gestation through post-natal day 90 at doses up to 30% (15 g/day), there was no systemic toxicity in female rats and their offspring. Based on lack of any systemic toxicity at doses up to 15 g/day in rats, lack of any apparent developmental effects, and lack of any systemic toxicity in weanlings at doses up to 15 g/day, EPA concluded that there is no evidence of increased susceptibility to infants and children. Given the low toxicity of starch octenylsuccinates, a safety factor analysis has not been used to assess risk. For similar reasons, including the lack of any concern regarding increased sensitivity in the young, the additional 10X FQPA safety factor for protection of infants and children is not necessary.

VII. Determination of Safety

The toxicity database is sufficient for the risk assessment of starch octenylsuccinates as specified. In terms of hazard, there are low concerns (practically non-toxic). The toxicity database does not indicate susceptibility in fetuses, thus there is no concern at this time for increased sensitivity to infants and children to starch octenylsuccinates when used as ingredients in pesticide formulations.

Dietary (food and drinking water) exposures of concern are not anticipated from the use of starch octenylsuccinate as inert ingredients in pesticide and non-pesticide products, considering their rapid biodegradation in soil and water and lack of persistence in the environment. Inhalation and dermal exposures of concern from the use of these chemicals as inert ingredients in pesticide products in residential settings are not anticipated because these compounds are not likely to volatize and are not expected to be absorbed due to their large particle size.

Considering their low toxicity (practically non-toxic), ready biodegradation in soil and water, and lack of persistence in the environment, it is unlikely that dietary and residential exposures of concern would result from the use of starch octenylsuccinates as ingredients in pesticides. An aggregate assessment for starch octenylsuccinates was not conducted because the exposures to the chemicals by non-pesticide consumer products are not likely to result in significant residues of concern.

Based on this information, EPA concludes that starch octenylsuccinates do not pose a risk to the general population, or to infants and children, under reasonably foreseeable circumstances. Therefore, EPA finds that the exemptions from the requirement of a tolerance for amylopectin, acid-hydrolyzed, 1-octenylbutanedioate (CAS Reg. No. 113894-85-2) and for amylopectin, hydrogen 1-octadecenylbutanedioate (CAS Reg. No. 125109-81-1) when used in antimicrobial formulations (food-contact surface sanitizing solutions) under 40 CFR 180.940(a), and when used in accordance with good agricultural or manufacturing practice under 40 CFR 180.950 will be safe under section 408(c) of FFDCA and is granting the requested tolerance exemptions.

VIII. Other Considerations

A. 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.

B. International Tolerances

The Agency is not aware of any country requiring a tolerance for amylopectin, acid-hydrolyzed, 1-octenylbutanedioate (CAS Reg. No. 113894-85-2) and for amylopectin, hydrogen 1-octadecenylbutanedioate (CAS Reg. No. 125109-81-1) nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.

IX. Statutory and Executive Order Reviews

This final rule establishes a tolerance under section 408(d) of FFDCA 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 final rule has been exempted from review under Executive Order 12866, this final 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) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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., 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).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance 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.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not 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).

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).

X. 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 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: September 4, 2008.

Lois Rossi,

Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180—[AMENDED]

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

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

2. Section 180.940 is amended by alphabetically adding entries to the table in paragraph (a) to read as follows:

§ 180.940

Tolerance exemptions for active and inert ingredients for use in antimicrobial formulations (Food-contact surface sanitizing solutions).

(a) * * *

Pesticide Chemical	CAS Reg. No.	Limits
*      *   *      *   *    *   *
Amylopectin, acid-hydrolyzed, 1-oxtenylbutanedioate	113894-85-2	none
Amylopectin, hydrogen 1-octadecenylbutanedioate	125109-81-1	none
*      *   *      *   *   *   *

* * * * *

3. Section 180.950 is amended by alphabetically adding entries to the table in paragraph (e) to read as follows:

§ 180.950

Tolerance exemptions for minimal risk active and inert ingredients.

* * * * *

(e)  *  *  *

Chemical	CAS No.
*     *     *   *   *
Amylopectin, acid-hydrolyzed, 1-octenylbutanedioate	113894-85-2
Amylopectin, hydrogen 1-octadecenylbutanedioate	125109-81-1
*     *     *   *   *