美国豁免聚酰胺酯聚合物残留限量要求( Polyamide Ester Polymers; Tolerance Exemption)

Final Rule.

SUMMARY

This regulation establishes an exemption from the requirement of a tolerance for residues of several polyamide ester polymers as listed in this final rule. Spring Trading Co. on behalf of Croda, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of the listed chemicals on food or feed commodities.

TABLE OF CONTENTS

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DATES:

ADDRESSES:

FOR FURTHER INFORMATION CONTACT:

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

B. How can I get electro nic access to other related information?

C. Can I file an objection or hearing request?

II. Background and Statutory Findings

III. Risk Assessment and Statutory Findings

IV. Aggregate Exposures

V. Cumulative Effects From Substances With a Common Mechanism of Toxicity

VI. Additio nal Safety Factor for the Protection of Infants and Children

VII. Determination of Safety

VIII. Other Considerations

A. Existing Exemptions From a Tolerance

B. Analytical Enforcement Methodology

C. Internatio nal Residue Limits

IX. Conclusion

X. Statutory and Executive Order Reviews

XI. Co ngressional Review Act

List of Subjects in 40 CFR Part 180

PART 180—[AMENDED]

TABLES

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DATES:

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This regulation is effective December 14, 2015. Objections and requests for hearings must be received on or before February 12, 2016, 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:

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The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0451, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Enviro nmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Co nstitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Mo nday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additio nal information a bout the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

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Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Enviro nmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

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I. General Information

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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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this docu ment applies to them. Potentially affected entities may include:

Crop production (NAICS code 111).

Animal production (NAICS code 112).

Food manufacturing (NAICS code 311).

Pesticide manufacturing (NAICS code 32532).

B. How can I get electro nic access to other related information?

You may access a frequently updat ed electro nic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. Can I file an objection or hearing request?

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. 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-2015-0451 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before February 12, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

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 (excluding any Co nfidential Business Information (CBI)) for inclusion in the public docket. Information not marked co nfidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0451, by one of the following methods.

Federal eRulemaking Portal: http://www.regulations.gov. Follow the o nline instructions for submitting comments. Do not submit electro nically any information you co nsider to be CBI or other information whose disclosure is restricted by statute.

Mail: OPP Docket, Enviro nmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

Additio nal instructions on commenting or visiting the docket, along with more information a bout dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

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In the Federal Register of Wednesday, August 26, 2015 (80 FR 51763) (FRL-9931-74), EPA issued a docu ment pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-10834) filed by Spring Trading Co., 203 Dogwood Trl., Magnolia, TX 77354 (on behalf of Croda, Inc., 315 Cherry Ln., New Castle, DE 19720). The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of the following polyamide ester polymers: Fatty acids, C 18-unsatd., dimers, polymers with ethylenediamine and stearyl alcohol (CAS Reg. No. 363162-42-9); fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with ethylenediamine, neopentyl glycol and stearyl alcohol (CAS Reg. No. 678991-29-2); fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with ethylenediamine and stearyl alcohol (CAS Reg. No. 951153-32-5); Fatty acids, C 18-unsatd., dimers, polymers with 1-docosanol and ethylenediamine (CAS Reg. No. 1699751-19-3); Fatty acids, C 18-unsatd., dimers, polymers with cetyl alcohol., neopentyl glycol and trimethylenediamine (CAS Reg. No. 1699751-23-9); fatty acids, C 18-unsatd., dimers, polymers with hexamethylenediamine and stearyl alcohol (CAS Reg. No. 1699751-24-0); fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with cetyl alcohol and ethylenediamine (CAS Reg. No. 1699751-25-1); fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with neopentyl glycol, stearyl alcohol and trimethylenediamine (CAS Reg. No. 1699751-28-4); fatty acids, C 18-unsatd., dimers, polymers with 1-docosanol and trimethylenediamine (CAS Reg. No. 1699751-29-5); fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with 1-docosanol, hexamethylenediamine and neopentyl glycol (CAS Reg. No. 1699751-31-9) and fatty acids, C 18-unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and sorbitol (CAS Reg. No. 1685271-04-8).

That docu ment included a summary of the petition prepared by the petitio ner and solicited comments on the petitioner's request. No comments were received by the Agency in respo nse to the notice of filing.

Section 408(c)(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) o nly if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reaso nable 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 use in residential settings, but does not include occupatio nal exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special co nsideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to “ensure that there is a reaso nable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . .” and specifies factors EPA is to co nsider in establishing an exemption.

III. Risk Assessment and Statutory Findings

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EPA establishes exemptions from the requirement of a tolerance o nly in those cases wher e it can be shown that the risks from aggregate exposure to pesticide chemical residues under reaso nably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency co nsiders the toxicity of the inert in co njunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reaso nable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Co nsistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and co nsidered its validity, completeness and reliability and the relatio nship of this information to human risk. EPA has also co nsidered available information co ncerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d).

The polyamide ester polymers listed in this final rule co nform to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.

1. The polymer is not a catio nic polymer nor is it reaso nably anticipated to become a catio nic polymer in a natural aquatic environment.

2. The polymer does co ntain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen.

3. The polymer does not co ntain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).

4. The polymer is neither designed nor can it be reaso nably anticipated to substantially degrade, decompose, or depolymerize.

5. The polymer is manufactured or im ported from mo nomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.

7. The polymer does not co ntain certain perfluoroalkyl moieties co nsisting of a CF3- or lo nger chain length as specified in 40 CFR 723.250(d)(6).

Thus, polyamide ester polymers listed in this final rule (i.e., fatty acids, C 18-unsatd., dimers, polymers with ethylenediamine and stearyl alcohol; fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with ethylenediamine, neopentyl glycol and stearyl alcohol; fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with ethylenediamine and stearyl alcohol; fatty acids, C 18-unsatd., dimers, polymers with 1-docosanol and ethylenediamine; fatty acids, C 18-unsatd., dimers, polymers with cetyl alcohol., neopentyl glycol and trimethylenediamine; fatty acids, C 18-unsatd., dimers, polymers with hexamethylenediamine and stearyl alcohol; fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with cetyl alcohol and ethylenediamine; fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with neopentyl glycol, stearyl alcohol and trimethylenediamine; fatty acids, C 18-unsatd., dimers, polymers with 1-docosanol and trimethylenediamine; fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with 1-docosanol, hexamethylenediamine and neopentyl glycol; and fatty acids, C 18-unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and sorbitol) meet the criteria for a polymer to be co nsidered low risk under 40 CFR 723.250. ba sed on their co nformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation or dermal exposure to these polymers.

IV. Aggregate Exposures

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For the purposes of assessing potential exposure under this exemption, EPA co nsidered that these polymers could be present in all raw and processed agricultural commodities and drinking water, and that non-occupatio nal non-dietary exposure was possible. The minimum number average MW (in amu) of each of these polymers is 1,400 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since these polymers co nform to the criteria that identify a low-risk polymer, there are no co ncerns for risks associated with any potential exposure scenarios that are reaso nably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

V. Cumulative Effects From Substances With a Common Mechanism of Toxicity

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Section 408(b)(2)(D)(v) of FFDCA requires that, when co nsidering whether to establish, modify, or revoke a tolerance, the Agency co nsider “available information” co ncerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found these polymers to share a common mechanism of toxicity with any other substances, and these polymers does not appear to produce a toxic me tabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that these polymers does not 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 e valuate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

VI. Additio nal Safety Factor for the Protection of Infants and Children

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Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additio nal 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 data ba se unless EPA co ncludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of these polymers, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additio nal tenfold safety factor is unnecessary.

VII. Determination of Safety

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ba sed on the co nformance to the criteria used to identify a low-risk polymer, EPA co ncludes that there is a reaso nable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of fatty acids, C 18-unsatd., dimers, polymers with ethylenediamine and stearyl alcohol; fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with ethylenediamine, neopentyl glycol and stearyl alcohol; fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with ethylenediamine and stearyl alcohol; fatty acids, C 18-unsatd., dimers, polymers with 1-docosanol and ethylenediamine; fatty acids, C 18-unsatd., dimers, polymers with cetyl alcohol, neopentyl glycol and trimethylenediamine; fatty acids, C 18-unsatd., dimers, polymers with hexamethylenediamine and stearyl alcohol; fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with cetyl alcohol and ethylenediamine; fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with neopentyl glycol, stearyl alcohol and trimethylenediamine; fatty acids, C 18-unsatd., dimers, polymers with 1-docosanol and trimethylenediamine; fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with 1-docosanol, hexamethylenediamine and neopentyl glycol; and fatty acids, C 18-unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and sorbitol.

VIII. Other Considerations

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A. Existing Exemptions From a Tolerance

Not applicable.

B. Analytical Enforcement Methodology

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. Internatio nal Residue Limits

In making its tolerance decisions, EPA seeks to harmo nize U.S. tolerances with internatio nal standards whenever possible, co nsistent with U.S. food safety standards and agricultural practices. EPA co nsiders the internatio nal maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an internatio nal food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for fatty acids, C 18-unsatd., dimers, polymers with ethylenediamine and stearyl alcohol; fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with ethylenediamine, neopentyl glycol and stearyl alcohol; fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with ethylenediamine and stearyl alcohol; fatty acids, C 18-unsatd., dimers, polymers with 1-docosanol and ethylenediamine; fatty acids, C 18-unsatd., dimers, polymers with cetyl alcohol, neopentyl glycol and trimethylenediamine; fatty acids, C 18-unsatd., dimers, polymers with hexamethylenediamine and stearyl alcohol; fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with cetyl alcohol and ethylenediamine; fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with neopentyl glycol, stearyl alcohol and trimethylenediamine; fatty acids, C 18-unsatd., dimers, polymers with 1-docosanol and trimethylenediamine; fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with 1-docosanol, hexamethylenediamine and neopentyl glycol; or fatty acids, C 18-unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and sorbitol.

IX. Conclusion

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Accordingly, EPA finds that exempting residues of fatty acids, C 18-unsatd., dimers, polymers with ethylenediamine and stearyl alcohol; fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with ethylenediamine, neopentyl glycol and stearyl alcohol; fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with ethylenediamine and stearyl alcohol; fatty acids, C 18-unsatd., dimers, polymers with 1-docosanol and ethylenediamine; fatty acids, C 18-unsatd., dimers, polymers with cetyl alcohol, neopentyl glycol and trimethylenediamine; fatty acids, C 18-unsatd., dimers, polymers with hexamethylenediamine and stearyl alcohol; fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with cetyl alcohol and ethylenediamine; fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with neopentyl glycol, stearyl alcohol and trimethylenediamine; fatty acids, C 18-unsatd., dimers, polymers with 1-docosanol and trimethylenediamine; fatty acids, C 18-unsatd., dimers, hydrogenated, polymers with 1-docosanol, hexamethylenediamine and neopentyl glycol; and fatty acids, C 18-unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and sorbitol from the requirement of a tolerance will be safe.